The Origin of AIDS: Bio-warfare – is AIDS part of it?

The Origin of AIDS: Bio-warfare – is AIDS part of it?

by Martha Magenta and Wilfrid Hartnagel, exlusive for infoholix.net

Today, the firstday of December 2006, the AIDS epidemic is officially 25 years old. AIDS haskilled 20 million people worldwide. 40 million more are currently infected withthe human immunodeficiency virus (HIV) – one million of these are Americans andalmost half of the new cases are African-American.[i] 95% of infected people live indeveloping countries; South Africa has the highest rates of infection, Indiathe second highest, and the Caribbean the third highest rates of HIV.[ii] Thisarticle pursues the question: Is AIDS a man made virus?

When you repeatlike a parrot what everybody else says, then you are considered to be anexpert. I am not an expert, so I won’t tell you that a green monkey in Africalured some gay men into the jungle and made a virus jump species – and all thisyears after AIDS had already broken out in New York and San Francisco. I willtell the truth, the cold, investigated truth.

Let me present mywitnesses to make the case:

WitnessA:

WilliamCampbell Douglass, M.D.

Profile:

Education: BS,University of Rochester, New York; MD, University of Miami School of Medicine;Graduate, U.S. Navy School of Aviation and Space Medicine

Career: U.S.Navy, 7 years — Flight Surgeon. In practice for over 25 years. Former statepresident, Florida, American College of Emergency Physicians. On Board ofGovernors of the National Health Federation. Doctor of the Year: NationalHealth Federation, 1985.

Dr. Douglass hasstudied in England with Dr. Katharina Dalton, discoverer of the premenstrualsyndrome. He was one of the first doctors in the United States to diagnose andtreat PMS. He opened his PMS Clinic in 1981.

Dr Douglasspresents his data:

“A shortvirology lesson will help you understand that AIDS is indeed an animal virusand that it was laboratory-made as a weapon of biological warfare against thefree world.

A basic rule ofvirology is that if two viruses have the same shape, design and size, then theyare almost certainly the same virus (a very simple and easy to understandrule).

For example, thisvirus:

< InsertDouglass’ diagram section>

For example, this virus:

… a virus of bacteria (bugs have diseases, too),doesn’t look anything like this virus:

… a virus of ticks that’s transmitted to pigs,or this virus:

… which is found in horses. The AIDS virus,which “couldn’t have come from animal viruses” is almost certainly a recombinantvirus from fusing a cattle virus, bovine leukemia virus:

…with sheep visna virus:

You combine the two in human tissue culture cellsand you get bovinevisna virus:

… A VIRUS THAT HERETOFORE DID NOT EXIST — aproduct of man, engineered in a laboratory. Now, if you isolate the AIDS virusfrom an infected human, it looks like this:

It doesn’t look like this (the tickvirus):

… or this (the cattle virus):

It looks like THIS:

… therecombinant virus from cattle and sheep AND ITS CALLED AIDS. You don’t have tobe a genius to understand this. Any properly instructed 10-year-old canunderstand it ….” [iii]

WitnessB:

AlanCantwell, J.R., M.D.

Profile:

Dr Alan Cantwellis a dermatologist and scientific researcher in the field of cancer and AIDSmicrobiology. He is a graduate of New York Medical College, and studieddermatology at the Long Beach Veteran’s Administration Hospital in Long Beach,California. He was a member of the Dermatology Department at the SouthernCalifornia Permanente Medical Group in Hollywood from 1965 until his retirementin 1994.

In 1994 his book QUEER BLOOD won the Benjamin Franklin Book Award for literaryexcellence.

For more than 40 years Dr. Cantwell has been a cancer researcher who believesthat cancer is caused by bacteria (not viruses). For the past two decades hisresearch also points to AIDS as a man-made disease. There is probably no otherphysician on the planet whose cancer and AIDS publications are ascontroversial.

In 1984 (the yearHIV was identified) his best-selling book AIDS: THE MYSTERY AND THE SOLUTIONwas published, showing the presence of cancer-associated bacteria in thisdisease. And in 1990, THE CANCER MICROBE: The Hidden Killer in Cancer, AIDS,and Other Immune Diseases, was published documenting a century of vitallyimportant and suppressed research into the bacterial cause of cancer. His othertwo books, exclusively on the subject of man-made AIDS, are AIDS AND THEDOCTORS OF DEATH: An Inquiry Into the Origin of the AIDS Epidemic; and QUEERBLOOD: The Secret AIDS Genocide Plot. All these titles are published by AriesRising Press, Los Angeles. [iv]

Dr Cantwell hasgiven kind permission to re-publish the following article:

AIDS: A Doctor’s Note on theMan-Made Theory

By Alan Cantwell, J.R.,M.D.

When AIDSofficially began in 1981 the public was told that anal sex, drugs, andhomosexuality were at the root of the new “gay plague.” The firstcases were all young, predominantly white, and previously healthyhomosexual men from Manhattan who were dying mysteriously from “gaypneumonia” and “gay cancer” in the form of Kaposi’s sarcoma. Theassociation with homosexuality was so remarkable that the disease was initiallytermed GRID (“gay-related immune deficiency”). To this day, gays arestill blamed for the spread of AIDS into the U.S. population.

When the diseasefirst broke out, a new virus was suspected, but officials reassured “thegeneral public” there was nothing to worry about. Of course, the healthexperts were wrong. Now most of the world’s AIDS cases are heterosexuals. TheAIDS virus (HIV) can also be transmitted vaginally; and one does not need to bea drug abuser, a promiscuous person or a homosexual to contract AIDS.

The Green Monkey Theory

Where did HIVoriginate? Prominent cancer virologists and government epidemiologists havetheorised that HIV originated in African green monkeys. Purportedly the monkeyvirus “jumped species” and entered the black population. From thereit migrated to Haiti and Manhattan. After the virus entered the blackheterosexual population in the late 1970s, it rapidly spread to millions ofblacks because of transfusions with HIV-infected blood, dirty needles,promiscuity and genital ulcers — or so the experts said.

Not allscientists believe the official monkey story, although it is rare to findpeople who express this view publicly. One persistent underground rumor is thatAIDS is biological warfare. Proponents of the AIDS conspiracy theory believethat AIDS has nothing to do with green monkeys, homosexuality, drug addiction,genital ulcerations, anal sex or promiscuity, but that it has to do withscientists experimenting on blacks and gays: in short, AIDS is genocide. MostAfrican-Americans have heard the story that HIV is a manufactured virusgenetically-engineered to kill off the black race. Thirty percent of New YorkCity blacks polled by The New York Times (October 29, 1990) actuallybelieve AIDS is an ethno-specific bioweapon designed in a laboratory to infectblack people.

Despite thegeneral acceptance that HIV came from monkeys and the rain forest, there is noscientific evidence to prove that HIV and AIDS originated in Africa. What istrue is that the first AIDS cases were uncovered in the U.S. in 1979, aroundthe same time that AIDS cases were discovered in Africa. In addition, no storedAfrican tissue from the 1970s tests positive for HIV. And scientists have ahard time explaining how a black heterosexual epidemic centered in Africa couldhave quickly transformed itself into a white homosexual epidemic in Manhattan.

The Gay Hepatitis-B VaccineExperiment

Conveniently lostin the history of AIDS is the gay Hepatitis-B vaccine experiment thatimmediately preceded the decimation of gay Americans. A “cohort” ofover a thousand young gays was injected with the vaccine at the New York BloodCenter in Manhattan during the period November 1978 to October 1979.1 Similar gay experiments were conducted in San Francisco, Los Angeles, Denver,St. Louis, and Chicago, beginning in 1980.2 The AIDS epidemicbroke out shortly thereafter.

The experimentwas run by Wolf Szmuness, a Polish Jew born in 1919. He was a young medicalstudent in eastern Poland when the Nazis invaded the country in 1939. Hisentire family perished in the Holocaust. When Poland was partitioned, Szmunesswas taken prisoner and sent to Siberia.

After the war, hewas allowed to finish medical school in Tomsk in central Russia. He married aRussian woman, had a daughter, and in 1959 was allowed to return to Polandwhere he became an expert in hepatitis.

According to JuneGoodfield’s account of his life in Quest for the Killers, Szmunessdefected from Poland with his family in 1969, arriving penniless in New Yorkwith $15 in his pocket.3 Through scientific connections he foundwork as a laboratory technician at the New York Blood Center. Within a fewyears he was given his own lab at the center and was also appointed Professorof Public Health at Columbia University. By the mid-1970s, Szmuness was a worldauthority on hepatitis, and was invited back to Moscow in 1975 to give ascientific presentation. As a defector he was terrified to set foot back in theSoviet Union, but his colleagues assured him he would have the full protectionof the U.S. State Department. His return to Russia was a scientific triumph.

In the late1970s, Wolf Szmuness was awarded millions of dollars to undertake the mostimportant mission of his life: the Hepatitis-B vaccine experiment. Szmunessspecifically wanted to use gay men to avoid “serious legal and logisticalproblems.”4 For his study he did not want monogamous men,nor men with lovers. He chose only healthy, young, responsible, intelligent,and primarily white homosexuals. The experiment was costly and he didn’twant any uncooperative or hard-to-find gays messing up his experiment. Involvedin the experiment were the Centers for Disease Control, the National Institutesof Health, the National Institute of Allergy and Infectious Diseases, AbbottLaboratories, and Merck, Sharp & Dohme. Szmuness’ experiment was hugelysuccessful, and his vaccine was hailed as having tremendous globalimplications.

The Gay Plague

The links of thegay experiment to the outbreak of AIDS are obvious to anyone who wants to seethe connection. Three months after the experiment began, the first cases ofAIDS reported to the CDC appeared in young gay men in Manhattan in 1979. Thefirst San Francisco AIDS case appeared in that city in September 1980, sixmonths after the Hepatitis-B experiment started there.5 In June1981 the AIDS epidemic became “official.”

Were gay mengiven experimental vaccines contaminated with the AIDS virus? The governmentsays no, but government agencies have a long history of covert and unethicalmedical experimentation, particularly with minorities. Was it simply a quirk ofnature that a virus “out of Africa” would suddenly decimate the mosthated minority in America?

Why did the U.S.government choose Wolf Szmuness, a Soviet-trained doctor and a recent Americanimmigrant to head this dangerous experiment? Goodfield, who has written thedefinitive account of the Hepatitis-B experiment, claims Szmuness has a painfullife. Confined as a political prisoner in Siberia during World War II, he wasrepeatedly interrogated and beaten by the Russian KGB for refusing to cooperatein spy activities. When he could not be broken, they warned him: “Saynothing of this to anyone, but remember. We will reach you anywhere in the world.No matter where you go, no matter where you try to hide, you will never be outof our grasp.”6

The experimentalHepatitis-B vaccine was primarily manufactured by Merck. However, during theexperiment Szmuness was concerned about possible vaccine contamination.Goodfield writes, “This was no theoretical fear, contamination having beensuspected in one vaccine batch made by the National Institutes of Health,though never in Merck’s.”7

After theHepatitis-B experiment ended, Szmuness insisted that all thirteen thousandblood specimens donated by gay men be retained at the Blood Center for futureuse. Due to space requirements, it is highly unusual for any laboratory toretain so many old blood specimens. However, several years later when thisblood was retested for the presence of HIV antibodies, governmentepidemiologists were able to detect the “introduction” and the spreadof HIV into the gay community.

When asked why hewas keeping so many vials of blood, Szmuness replied, “Because one dayanother disease may erupt and we’ll need this material.”8 Afew months after the Hepatitis-B experiment began at the Center, the first AIDScases began to appear in gay men living in Manhattan. And the retesting of gayblood at the Blood Center proved that HIV was first introduced into the gaypopulation of New York City sometime around 1978-1979, the same year Szmuness’gay Hepatitis-B experiment began.9

Was Szmunesspsychic in his prediction that a new disease would appear in the gay community?Or did he actually know or suspect that a new, deadly virus was beingintroduced into the gay volunteers? Unfortunately, the answers to thesequestions can only be surmised. In June 1982 Szmuness died of lung cancer. Inhis eulogy, Aaron Kellner of the Blood Center wrote: “It is the rarephysician who, like Wolf Szmuness, is given the grace to touch the lives ofbillions of people; those living on this planet and generations yetunborn.”10

The African Origin of AIDS

Was HIVintroduced into millions of Africans in the late 1970s during the smallpoxvaccine eradication programs sponsored by the World Health Organisation? It isknown that animal and human cells harbor all sorts of viruses, includingviruses not yet discovered, and animal tissue cell cultures are often used inthe manufacture of viral vaccines. Therefore, the possibility of vaccinecontamination with an animal virus is a constant danger in the manufacture ofvaccines.

Despite the mostmeticulous precautions in production, contaminating animal viruses are known tosurvive the vaccine process. For example, during the 1950s, millions of peoplewere injected with polio vaccines contaminated with “SV-40”, acancer-causing green monkey virus. Such vaccine contamination problems arelargely kept hidden from the public. Yet in spite of the known danger, drugcompanies and physicians always pooh-pooh any suggestion that AIDS could havearisen from animal virus-contaminated vaccines. Animal cancer viruses are alsocontained in fetal calf serum, a serum commonly used as a laboratory nutrientto feed animal and human tissue cell cultures. Viruses in calf serum can becarried over as contaminants into the final vaccine product.

The problem ofvaccine contamination by fetal calf serum and its relationship to AIDS is thesubject of a letter by J. Grote (“Bovine visna virus and the origin of theAIDS epidemic”) published in the Journal of the Royal (London) Societyof Medicine in October 1988. Grote discounts the green monkey theory andquestions whether bovine visna contamination of laboratory-used fetal bovineserum could cause AIDS. Bovine visna virus is similar in appearance to HIV.Grote, a London-based AIDS researcher, writes:

The seriousness of this becomes apparent when weconsider the manufacture of vaccines requires the growth of virus in cellcultures using fetal calf serum in the growth medium. The contamination ofvaccines with adventitious viruses has been of concern for many years and thepresence of virus-like structures in ‘virus-screened’ bovine serum has been reported.It seems absolutely vital that all vaccines are screened for HIV prior to useand that bovine visna virus is further investigated as to its relationship toHIV and its possible causal role in progression towards AIDS.

Millions ofAfrican blacks are reportedly infected with HIV. This large number could neverhave been infected by the simple act of a monkey virus “jumping” overto infect one African in the late 1970s. If that were the case, why don’t wenow have millions of AIDS cases in the U.S.? One logical explanation for themillions of Africans infected is that the vaccines used in the World HealthOrganisation’s mass inoculation programs were contaminated. Was thecontamination accidental or deliberate? It is well-known in vaccine circlesthat the vaccinia (cowpox) virus used in the manufacture of the smallpoxvaccine works well in genetic engineering. Charles Pillar and Keith Yamamoto,authors of Gene Wars: Military Control Over the New Genetic Technology,state: “Researchers have been able to splice genes coding for the surfacecoats of other viruses, such as influenza, hepatitis, and rabies into vacciniavirus DNA. The result: a ‘broad spectrum’ vaccine with a coat of manycolors.”11

In 1985, theRussians caused an international furore by claiming that AIDS was caused byexperiments carried out in the USA as part of the development of new biologicalweapons. Responding to this Soviet accusation, Pillar and Yamamoto admit that”although no evidence has been presented to support this claim, manipulatinggenes to defeat the body’s immune system is quite feasible.”12

In Magic Shots,Allan Chase claims that during the years 1966-1977, the WHO utilised”200,000 people in forty countries — most of them nondoctors trained byseven hundred doctors and health professionals from over seventy participatingcountries — spent $300 million, and used forty million bifurcated vaccinatingneedles to administer 24,000 million (2.4 billion) doses of smallpoxvaccine.”13

On May 11, 1987, TheLondon Times, one of the world’s most respected newspapers, published afront-page story entitled “Smallpox vaccine triggered AIDS virus.”The story suggests that African AIDS is a direct outgrowth of the WHO smallpoxeradication program. The smallpox vaccine allegedly awakened a”dormant” AIDS virus infection in the black population. Robert Gallo,the co-discoverer of HIV, was quoted as saying, “The link between the WHOprogram and the epidemic is an interesting and important hypothesis. I cannotsay that it actually happened, but I have been saying for some years that theuse of live vaccines such as that used for smallpox can activate a dormantinfection such as HIV (the AIDS virus).” The Times story is one ofthe most important stories ever printed on the AIDS epidemic; yet the story waskilled and never appeared in any major U.S. newspaper or magazine.

Despite coverthuman experimentation, vaccine contamination problems, and the geneticengineering of new and highly dangerous viruses, the medical establishment ignoresthe AIDS bio-warfare issue. For example, in the prestigious British MedicalJournal (May 13, 1989), Myra McClure and Thomas Schultz wrote a paper onthe “Origin of HIV” and quickly disposed of the idea that AIDS isconnected to germ warfare. They simply state: “Lack of supporting evidenceprecludes serious discussion of such a bizarre hypothesis. This review dealswith the theories on the origin of HIV that are scientifically plausible.”

Thus, medicalscience ignores evidence suggesting AIDS originated as a secret experiment.Most physicians and microbiologists steadfastly hold on to the illogical andimprobable green monkey theory of AIDS. And the major media remain silent,often dismissing the bio-warfare theory as communist propaganda of the most malicioussort. Forgotten is the connection between the National Academy of Sciences andthe military bio-warfare establishment in the development of biological weaponsfor mass killings.

Creation of a Super Germ

A decade beforethe first cases of AIDS, Dr. Donald M. MacArthur, a spokesman for the U.S.Department of Defense, told a Congressional Hearing that a “supergerm” could be developed as part of our experimental bio-warfare program.This genetically engineered germ would be very different from any previousmicrobe known to mankind. The agent would be a highly effective killing agentbecause the immune system would be powerless against this super-microbe(Testimony before a Subcommittee of the Committee on Appropriations, House ofRepresentatives, Department of Defense Appropriations for 1970, dated July 1,1969). A transcript of this meeting on “Synthetic Biological Agents”records the following comments of Dr. MacArthur:

1. All biological agents up to the present time arerepresentatives of naturally occurring disease, and thus are known byscientists throughout the world. They are easily available to qualifiedscientists for research, either for offensive or defensive purposes.

2. Within the next 5 to 10 years, it would probablybe possible to make a new infective microorganism which could differ in certainimportant aspects from any known disease-causing organisms. Most important ofthese is that it might be refractory to the immunological and therapeuticprocesses upon which we depend to maintain our relative freedom from infectiousdisease.

3. A research program to explore the feasibility ofthis could be completed in approximately 5 years at a total cost of $10million.

4. It would be very difficult to establish such aprogram. Molecular biology is a relatively new science. There are not manycompetent scientists in the field, almost all are in university laboratories,and they are generally adequately supported from sources other than theDepartment of Defense. However, it was considered possible to initiate anadequate program through the National Academy of Sciences — National ResearchCouncil (NAS-NRC). The matter was discussed with the NAS-NRC, and tentativeplans were made to initiate the program. However, decreasing funds in CB(chemical/biological) research, growing criticism of the CB program, and ourreluctance to involve the NAS-NRC in such a controversial endeavor have led usto postpone it for the past two years. It is a highly controversial issue andthere are many who believe such research should not be undertaken lest it leadto yet another method of massive killing of large populations… Should anenemy develop it, there is little doubt that it is an important area ofpotential military technological inferiority in which there is no adequateresearch program.

Was the AIDSvirus, or other so-called “emerging viruses” such as Ebola andMarburg viruses, created in bio-warfare laboratories during the 1970s? Duringthe 1970s, the U.S. Army’s bio-warfare program intensified, particularly in thearea of DNA and gene splicing research. Renouncing germ warfare except for”medical defensive research,” President Richard Nixon in 1971 orderedthat a major part of the Army’s bio-warfare research be transferred over to theNational Cancer Institute (where HIV would be discovered a decade later byGallo). That same year, Nixon also initiated his famous War on Cancer, andoffensive bio-warfare research (particularly genetic engineering of viruses)continued under the umbrella of orthodox cancer research. Cancer virologistslearned “to jump” animal cancer viruses from one species of animal toanother. Chicken viruses were put into lamb kidney cells; baboon viruses werespliced into human cancer cells; the combinations were endless. In due process,deadly man-made viruses were developed, and new forms of cancer,immunodeficiency, and opportunistic infections were produced when these viruseswere forced or adapted into laboratory animals and into human tissue cellcultures.14

As predicted bythe bio-warfare experts, new cancer-causing monster viruses were created thathad a deadly effect on the immune system. In one government-sponsoredexperiment reported in 1974, newborn chimpanzees were taken away from theirmothers at birth and weaned on milk obtained from virus-infected cows. Some ofthe chimps sickened and died with two new diseases that had never been observedin chimps. The first was a parasitic pneumonia known as Pneumocystis Cariniipneumonia (later known as AIDS); the second was leukemia.15

Monkey Business

Almost twodecades after the first U.S. AIDS cases were diagnosed, most people stillbelieve the government’s green monkey story; and AIDS educators teach that HIVoriginated in Africa. However, a few cracks in the monkey theory have appearedin print.

A story entitled”Research refutes idea that human AIDS virus originated in monkey,”appeared in the Los Angeles Times (June 2, 1988). In the process ofdecoding the genetic structure of the monkey virus and the human AIDS virus,Japanese molecular biologists discovered that the gene sequences of the twoviruses differed by more than 50% — indicating absolutely no geneticrelationship between the green monkey virus and HIV. The Japanese investigatorsspecifically criticised Myron Essex and Phyllis Kanki of Harvard MedicalSchool, who “discovered” a second AIDS virus in African green monkeysthat was widely heralded in the media. Essex and Kanki’s “second”AIDS virus was later proven to be a contaminant monkey virus traced back to theHarvard researchers own laboratory.

More than adecade earlier, in 1975, Gallo reported the “discovery” of a”new” and “human” HL-23 virus he cultured from humanleukemia cells. Eventually the virus was proven to be three contaminating apeviruses (gibbon-ape virus, simian sarcoma virus, and baboon endogenous virus).Gallo claims he has no idea how these animal viruses contaminated his research.16

If HIV is notrelated to a green monkey virus, what is its origin? On November 13, 1988, TheOrange County Register devoted an entire section of the newspaper to AIDSin Africa. Several African officials were interviewed; all were adamant thatAIDS did not originate in Africa. The theory “is false and has never beenscientifically proved, so why should Africa be the scapegoat?” declaredDr. Didace Nzaramba, director of the AIDS prevention program in Rwanda. The Register commented:

From early on, scientists have speculated that thedisease might have begun in Africa. Researchers in Africa tested old bloodsamples and said they found HIV-infected serum that went back years. In 1985,Harvard researchers, Phyllis Kanki and Myron Essex, announced the discovery ofa new virus isolated in green monkeys that seemed similar to HIV. Eventually,researchers concluded that early blood tests used in Africa were not reliable,and Kanki and Essex said their blood tests probably had been contaminated andthat their results were invalid. But the perception of an African link wasestablished.

Media Disinformation

With thepublication of And The Band Played On in 1987, the media became obsessedwith author Randy Shilts’ “Patient Zero” story. In the popular,award-winning book, a young Canadian airline steward named Gaeton Dugas isportrayed as the promiscuous gay man “who brought the AIDS virus fromParis and ignited the epidemic in North America.” Shilts, who later diedof AIDS, never explained where or how Dugas got his infection.

After a year ofswollen lymph nodes and a rash, Dugas was finally diagnosed withAIDS-associated “gay cancer” in June 1980 in New York City. WhatShilts probably did not know is that when Dugas was diagnosed in 1980, overtwenty percent of the Manhattan gays in the Hepatitis-B experiment wereHIV-positive. This 20% infection rate was discovered after the HIV blood testbecame available in 1985, and after the stored blood at the New York BloodCenter was retested for HIV antibodies (JAMA, Vol. 255, pp. 2167-2172,1986). Remarkably, these gay men had the highest recorded incidence of HIVanywhere in the world for that time! Even in African populations, where AIDShas been theorised to exist for decades, or even millennia, there were neverreports of such a high incidence of HIV in 1980.

Shilts’sensational Patient Zero story quickly became “fact.” Even theAMA-sponsored American Medical News (October 23, 1987) fell for theludicrous story, claiming that Dugas “may have brought AIDS to the UnitedStates.” The media continue to promote unlikely stories about the originof AIDS, always avoiding discussion of the idea that HIV came out of alaboratory, and always pointing the finger to black Africa.

In late 1987, themedia widely reported an “old AIDS case” dating back to 1968. DNAtesting of the blood and tissue was reported as HIV-positive.17 For the last year of his life, “Robert”, a 15-year-old black boy fromSt. Louis, wasted away with a bizarre disease that severely bloated his legsand genitalia. His sexual preference was unknown, but his doctors tried hard toinsinuate the dying boy was gay. At autopsy, internal Kaposi’s sarcoma of therectum was discovered, along with anal warts and lacerations. And afterfingering the dead boy’s rectum, the pathologist noted “a lax analsphincter.” When newer viral identification techniques were reapplied toRobert’s blood in 1990, his blood retested HIV-negative, proving that Robertnever had AIDS.18

In 1990 the mediasensationalised another “old AIDS case,” this time an unmarriedEnglish sailor who died in Manchester in 1959. When his stored tissue remainstested positive for HIV, major newspapers throughout the world used this caseto again discredit the persistent rumor that AIDS was a man-made disease. TheNew York Times (July 24) declared:

The case also refutes the widely publicised chargesmade by Soviet officials several years ago that AIDS arose from a virus thathad escaped from a laboratory experiment that went awry or was a biologicalwarfare agent. The human retrovirus group to which the AIDS virus belongs wasunknown at the time. Nor did scientists then have the genetic engineeringtechniques needed to create a new virus.

In a letter tothe medical journal Lancet in January 1996, this 1959 case was ruled notto be AIDS because the DNA tests were found to be contaminated due to alaboratory error.

Despite thedenial of the Times regarding the laboratory creation of new AIDS-likeviruses, it was common practice during the early 1970s for virologists to alteranimal viruses by inserting them into other animal species and into humantissue cells in culture. Experiments performed at Harvard in the mid-1970s byMax Essex and Donald Francis (two of the best-known AIDS experts) produced AIDSin cats with the feline leukemia retrovirus. In addition, a decade before theoutbreak of AIDS in the U.S., Robert Gallo was engineering cancer-causingretroviruses and studying the effects of viral mutants and their ability tosuppress the immune system. A full description of Gallo’s animal retrovirusresearch activities dating back to 1967 is chronicled in Emerging Viruses,AIDS and Ebola: Nature, Accident or Genocide? by Dr. Leonard Horowitz.19

Secret and Covert
Biological Warfare Research

It is difficult,if not impossible, to determine the truth about global biological warfarecapabilities and their possible effects on world health. The American taxpayeris kept ignorant about U.S. chemical and bio-warfare programs. Scientistsinvolved in bio-warfare research are sworn to secrecy and silence. Thus, “classified”and “top secret” medical experimentation continues to be promoted bypowerful government agencies, such as the CIA, the CDC, the Department ofDefense, the military, and other institutions.

Recentrevelations of horrific radiation experiments conducted on unsuspecting U.S.citizens during the Cold War years up until the 1980s have shocked the nation.Some of this research was conducted at the most prestigious medicalinstitutions in our country. None of the perpetrators have been brought to trial.In light of these revelations, it is inconceivable to think that leading AIDSscientists would be unaware of the connections between their institutionalresearch and the bio-warfare establishment.

Currently,strange and unprecedented diseases are mysteriously appearing in various partsof the world. The peculiar Persian Gulf War Syndrome has sickened over50,000 of our vets who served in Desert Shield/Storm. Their illnesses have beenlargely dismissed by health experts as due to “psychological stress,”even though there is evidence that this new disease is contagious andsexually-transmitted. Nevertheless, government health officials remain silenton these issues.

A few scientistsinsist that some cases of Gulf War Syndrome are related to biological warfareagents. Dr. Garth Nicholson and his wife Nancy, formerly scientists at the M.D.Anderson Cancer Center in Houston, have discovered in the blood of some sickreservists a new infectious microbe (a mycoplasma) that has part of the AIDSvirus spliced into its genetic material! The Nicholsons say: “The type ofmycoplasma we identified was highly unusual and it almost certainly didn’toccur naturally. It has one gene from the HIV-1 virus — but only one gene. Thismeant it was almost certainly an artificially modified microbe — alteredpurposefully by scientists.” (National Enquirer, April 2, 1996).

By censoringcertain aspects of AIDS history, particularly the origin of HIV, we allowdangerous medical experimentation to continue. The New York Blood Center is nowtesting a new vaccine made from a “harmless” canary-pox virus thathas been genetically engineered to carry parts of HIV, the AIDS virus. TheCenter is recruiting HIV-negative gay men by funding Project Achieve, anorganisation designed to test and sign-up young men for the new vaccineexperiment. Homosexual men are lured into the program by posters that featurecute, multi-ethnic gay boys. According to Timothy Murphy of HX magazine,there is a waiting list for the Center’s vaccine experiment. Gay men are urgedto sign-up with Project Achieve at (212) 388-0008.

The enigmatic Dr.Szmuness has been erased from AIDS chronicles. His name does not appear inShilts’ Band, nor in Mirko Grmek’s History of AIDS (1990), or inLaurie Garret’s massive tome on emerging viruses, The Coming Plague (1994).Although his untimely death went largely unnoticed in medical journals, he wasremembered and honored on May 11, 1984, by a small coterie of medical powerbrokers and distinguished scientists who convened at a landmark symposium inthe U.S. capitol. The meeting entitled “Infection, Immunity, and BloodTransfusion” was sponsored by the American Red Cross.20

Paying tribute toSzmuness were top government scientists in AIDS and cancer research, the mostwell-known researchers in animal experimentation, the heads of the mostprestigious biomedical establishments in the country, and the chief executivesof drug companies tied to genetic engineering, vaccine production, andbiological warfare research. Dr. Robert Gallo, who had announced the discoveryof the AIDS virus to the American public three weeks earlier, was one of themost distinguished attendees.

There is anominous link between cancer and AIDS, between animal experimentation and thegenetic engineering of viruses, between biological warfare technology and drugcompanies, between gay experiments and AIDS, between vaccine programs and thecontamination of the nation’s blood supply. Why else would all these peoplefrom diverse areas of science be attending this high level governmentconference?

There is also aconnection between Szmuness’ gay experiment and the outbreak of AIDS thatcannot be denied. This connection is not coincidental or a paranoid fantasy. Itis time for a serious study of the link between covert biological warfareresearch and the initial outbreak of the “gay AIDS plague.” Ignoringevidence pointing to AIDS as a man-made disease makes a sham out of AIDSeducation.

References

1. Szmuness W,Stevens C, Harley E, et al: Hepatitis-B vaccine; Demonstration of efficacy in acontrolled clinical trial in a high-risk population in the United States. NewEngland J Med 303: 833-841, 1980.

2. Francis D,Hadler S, Thompson S, The prevention of Hepatitis-B with vaccine. Report of theCenters for Disease Control multi-center efficacy trial among homosexual men. AnnalsInt Med 97: 362-366, 1982.

3. Goodfield J:Vaccine on trial. Goodfield J. Quest for the Killers. Birkhauser,Boston, 1985, p. 51-97.

4. Szmuness W:Large scale efficacy trials of Hepatitis-B vaccines in the USA; Baseline dataand protocols. J Med Virology 4: 327-340, 1979.

5. Cantwell, A:The Hepatitis-B vaccine trials (1978-1981). In AIDS & The Doctors ofDeath. Aries Rising Press, Los Angeles, CA, 1988, pp. 65-80.

6. Goodfield, Questfor the Killers, p. 57

7. Ibid, p. 86

8. Ibid, p. 92

9. Stevens CE,Taylor PE, Zang EA, et al: Human T-cell lymphotropic virus type III infectionin a cohort of homosexual men in New York City. JAMA 255: 2167-2172,1986.

10. Kellner A:Reflections of Wolf Szmuness in, Progress in Clinical and BiologicalResearch 182: 3-10, 1985.

11. Piller C andYamamoto K: Gene Wars: Military Control over the New Genetic Technologies.Beech Tree Books/William Morrow, New York, 1988, p. 103

12. Ibid, p. 97

13. Chase A: MagicShots. William Morrow and Company, New York, 1982, pp. 81-82.

14. Cantwell:Biowarfare. In Queer Blood. Aries Rising Press, Los Angeles, 1993, pp.31-40.

15. McClure HM,Keeling ME, Custer RP, et al: Erythroleukemia in two infant chimpanzees fedmilk from cows naturally infected with the bovine C-type virus. CancerResearch 34: 2745-2757, 1974.

16. Connor S:AIDS science stands on trial. New Scientist, February 12, 1987, pp.49-58.

17. Garry RF,Witte MH, Gottleib AA, et al: Documentation of an AIDS virus infection in theUnited States in 1968. JAMA 260: 2085-2087, 1988.

18. Cantwell:AIDS: New or old? In Queer Blood. Aries Rising Press, Los Angeles, 1993,pp. 61-69.

19. Horowitz LG.: Emerging Viruses, AIDS & Ebola: Nature, Accident or Genocide? Tetrahedron,Inc, Rockport, MA, 1996.

20. Dodd RY,Barker LF (Eds): Infection, Immunity and Blood Transfusion. Prcdngs ofthe XVIth Annual Scientific Symposium of the American Red Cross, Wa. DC. Alan RLiss, Inc, NY 1985, pp. xiii-xv.[v]

I will producefurther witnesses, so look out for my updates …

© By MarthaMagenta and Wilfrid Hartnagel 2006.


[i] ‘Is AIDS a manmade virus? Special Report’ Alan Cantwell, J.R., M.D., 2006, Political Gateway, online:http://www.politicalgateway.com/news/read.html?id=5420

[ii] AIDS, You Think, online:http://youthink.worldbank.org/issues/aids/

[iii] ‘Aids as aWeapon of War’ Dr.W. Douglas,Introduction & Comments by Jim Shults, online:http://www.biblebelievers.org.au/aidsplot.htm

[iv] Aries Rising Press, online:http://ariesrisingpress.com/about/

[v] ‘AIDS: A Doctor’s Note on theMan-Made Theory’ AlanCantwell, J.R., M.D., 1998, online:

http://www.biblebelievers.org.au/46a.htm#AIDS:%20A%20Doctor’s%20Note%20on%20the%20Man-Made%20Theory

Reprint of web pages are only allowed with explicit permission. Please request our permission by emailing us with a complete description of the intended use.

Posted in iHN Archive, Medical Tsunami N°4 | Comments Off on The Origin of AIDS: Bio-warfare – is AIDS part of it?

Asthma is curable – why are people dying?

Asthma is curable – why are people dying?

by Martha Magenta exclusive for infoholix.net

What they don’t want you to know about Buteyko

“Western doctors have now either stopped looking for the sources of asthma, angina and high blood pressure or have faulty ideas of them. That is why these illnesses are still incurable.” K. P. Buteyko[i]

The Buteyko breathing therapy (BBT) is a treatment that can cure asthma and many related disorders, save many lives, and make medications unnecessary.[ii] It was invented by Dr K. P. Buteyko, a Russian scientist of Ukrainian origin whose early research was held back due to lack of funds,[iii] and repression by the medical establishment.[iv] [v] In 1985 BBT was officially recognised by the Russian Government.[vi]

In Western countries the proven success of BBT appears to pose a threat to the consumer oriented medical system and there is evidence that it is suppressed by pharmaceutical companies and their beneficiaries.[vii] As long as we have a health system that puts its own welfare over the needs of the people it is meant to serve, people will continue to die unnecessarily from asthma. This article looks at the reasons why BBT has yet to be integrated into medical practice in the West.

What is asthma?

Asthma is a serious, chronic and potentially life threatening condition.[viii] The term “asthma” comes from a Greek word a?ζειν (aazein), which means “to breath with open mouth or to pant”.[ix] Asthma accounts for one in 250 deaths worldwide.[x]

Western medicine has no clear definition of asthma, nor has it identified the cause or found a cure.[xi] [xii] Dr K P Buteyko claimed that bronchial asthma and other conditions such as high blood pressure and angina are symptoms of an underlying disorder caused by over breathing.[xiii] [xiv] Further research into environmental factors will not find the cause or cure of asthma.[xv]

Why is Buteyko Breathing Therapy important?

The prevalence of asthma has increased by 50% since the 1980s.[xvi] The World Health Organization reported in 2000 that 150 million people suffer from asthma worldwide, and 180,000 die of asthma each year.[xvii] A Global Initiative for Asthma (GINA) report in 2004 claimed the number of asthma sufferers worldwide stood at 300 million.[xviii] [xix] This figure is predicted to rise to 400 million by 2025.[xx]

The GINA report 2004 claims the United Kingdom has the highest percentage of people with asthma in the world: over 18% of the population of Scotland has asthma, Wales 17% and England 15.3%, a total of 10 million people.[xxi] [xxii] [xxiii]

A European Commission survey estimates that the number of people with asthma in the UK is almost double the EU average, with 1,500 deaths from asthma each year.[xxiv] [xxv]

Treatment of asthma costs the National Health Service (NHS) ?900 million per year.[xxvi] The total annual costs of asthma in the UK including NHS costs, social security payments and lost productivity have risen to ?2.3 billion.[xxvii] The NHS could save a fortune if people with asthma used BBT, and most asthma deaths could be prevented.[xxviii] [xxix]

Medical statistics for the developed countries in 1999 reveal that there has been an epidemic increase in bronchial asthma in proportion to the increase in intensity of drug therapy.[xxx] The high death rate and the development of allergies indicate that drugs are not effective in controlling asthma. Studies show that drug treatments relieve asthma symptoms in the short term but do not cure the condition; as dependency on medication increases over time, the symptoms, and side-effects of medication, worsen in the long term.[xxxi] [xxxii]

Due to concerns about side effects, long-term dependence and escalation of medication with little improvement of symptoms, asthma patients are increasingly choosing BBT, which is “…most notably reported to enhance symptom control and enable reduction in medication.” [xxxiii]

The problems with current asthma treatment

A public health information service provided by AstraZeneca claims that: “There is no cure for asthma, but there are different types of medicines that will help to keep it under control and relieve symptoms.”[xxxiv] The UK Department of Health claims it has achieved a reduction in the incidence of asthma and that current drug treatments are effective.[xxxv] However, there is much evidence that these claims are not true.[xxxvi]

The results of a clinical study published in the Lancet in 1990[xxxvii] highlighted the dangers of asthma reliever inhalers: “…regular inhalation of a beta-sympathomimetic agent was associated with deterioration of asthma control in the majority of subjects. The trends to use of regular, higher doses or longer-acting inhaled beta-sympathomimetic treatment may be an important causal factor in the worldwide increase in morbidity from asthma.”

A clinical trial shows that the risk for asthma attacks increases when patients develop a tolerance for beta-agonist reliever drugs; a second study shows that beta-agonist use increases the risk of heart attack.[xxxviii] Pharmacists claim that the asthma reliever drug albuterol (Ventolin) can cause headaches,[xxxix] palpitations, fast heart rate, high blood pressure, tremor, nausea, nervousness, dizziness, heart burn, throat irritation, nose bleeds,[xl] urticaria, angioedema, bronchospasm, hoarseness, oropharyngeal oedema, and arrhythmias.[xli]

Many asthmatics are prescribed higher steroid doses to get worsening symptoms back under control, but research shows that increased doses of steroids have no effect on asthma.[xlii] Many studies show that corticosteroid drugs can have serious side effects.[xliii] Corticosteroids reduce airway inflammation by preventing the immune system from overreacting to allergens, but they suppress natural immunity and promote systemic bacterial infection and fungal growth.[xliv] Other side effects include: sore throat, oral thrush, hoarseness, dysphonia, easy bruising, dermal thinning, cataract formation, osteoporosis, glaucoma, adrenal failure, bone fractures,[xlv] [xlvi] allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); numbness, tingling, open sores, and worsening respiratory symptoms.[xlvii] Steroids also cause psychiatric side effects such as depression, mood swings, aggression, irritability, insomnia and occasionally “steroid psychosis”.[xlviii] [xlix] [l] [li] [lii]

Clinical trials have shown that drugs containing salmeterol, long-acting beta-2-agonist bronchodilators, such as Advair, Serevent and Foradil, improve symptoms but make the underlying problem worse.[liii] There is evidence that long acting beta-agonists increase the risk of severe, potentially life-threatening asthma attacks in some people. A British study shows that the risk of dying as a result of asthma is three times higher in asthmatics using long-acting Serevent than short-acting Ventolin, yet long-acting beta-2 agonist bronchodilators continue to be the most widely prescribed asthma medications, with both the public and primary care doctors unaware of the dangers.[liv] [lv]

Salmeterol is now aggressively marketed as part of a combination asthma drug with inhaled steroids.[lvi] A large population study showed that combined salmeterol and inhaled corticosteroid was associated with an increased risk of asthma-related death.[lvii]

Buteyko Breathing Therapy

BBT is a highly effective, safe asthma management therapy that is totally free from side effects.[lviii] The inventor of BBT, Dr. K. P. Buteyko, found that asthma and many other chronic conditions such as allergy, rhinitis, high blood pressure and angina were protective mechanisms caused by habitual over breathing. The technique he developed stops attacks of asthma and brings about recovery in at least 90% of patients within a few days of training. In addition, drug use is markedly reduced and eventually patients no longer need them.[lix] The therapy is easy to learn and can be taught to children from three years of age. It can be used with very ill patients and is most effective in acute bronchial asthma.[lx] If BBT were taught to all schoolchildren the incidence of asthma would decline within five years.[lxi]

Buteyko found that conditions such as asthma, angina, and high blood pressure are not illnesses, as diagnosed by Western doctors, but symptoms that result from the disease of deep breathing; also that there is a direct correlation between the depth of breathing and the degree of symptoms – the deeper the breath, the worse the symptoms become. Conversely, the shallower the breath, the healthier and stronger the organism becomes. Buteyko found there were no adverse effects from correcting over breathing.[lxii] However, recovery from a chronic hyperventilation involves overcoming at least one period of worsening of symptoms as the mechanisms of regulation and restoration are reset to accept a higher carbon dioxide (CO2) level as the norm.[lxiii] Bronchodilators have the reverse effect, opening up the airways to allow more oxygen in and expelling CO2.[lxiv]

In “The First Hand Buteyko Method” M. Buteyko and V. Buteyko describe how the extent of incorrect breathing is identified by means of the dual measurement of the control pause and pulse.[lxv] They explain that BBT reduces breathing primarily by means of breathing through the nose, relaxation, reduction of breathing until “slight air hunger” is felt, and avoidance of breath-increasing factors: drugs, chemicals, synthetic fumes, overeating, lack of exercise, emotional excess and overindulgence.

There are less than 300 people teaching versions of BBT in the western world, fewer than 20 full-time Buteyko practitioners in any Western country.[lxvi] They work independently, competing against each other for clients, and have not contributed to a central research fund. Buteyko classes are available only in a few countries: Russia, Australia, New Zealand, Israel, USA, Canada, Germany, Holland and the United Kingdom. Millions of asthmatics worldwide do not have access to Buteyko therapists.[lxvii]

It is important to note that BBT was never meant to be a complementary or alternative therapy; rather, it was intended to constitute a revision of medical diagnosis and treatment of disease. Dr Vladimir Buteyko and Dr Marina Buteyko explain this in ?The Buteyko theory about a key role of breathing for human health?[lxviii]

Dr M. Buteyko and Dr V. Buteyko write that many opportunistic “pseudo-Buteyko” practitioners with no medical knowledge teach a distorted version of BBT.[lxix] They state that: “The rules discovered by K.P. Buteyko prove that direct control of respiratory movements (inhale/exhale/pause amplitude and/or duration) is extremely dangerous. This means that almost all known methods of ‘respiratory gymnastics’ have nothing to do with BBT and may turn to be quite hazardous.”[lxx] They also point out that it is incorrect to refer to BBT as ?the breath-holding technique? as breath holding is used only for special purposes.

BBT and other chronic conditions

BBT has been shown to be effective in curing or at least improving many other chronic conditions such as allergy, rhinitis, high blood pressure, angina,[lxxi] obstructive sleep apnoea,[lxxii] arthritis, weak immunity,[lxxiii] bronchitis, emphysema, chronic obstructive pulmonary disorder, sinusitis, anxiety, migraine,[lxxiv] and panic attacks.[lxxv]

A BBC Inside Out programme [lxxvi] featured a woman with severe chronic obstructive pulmonary disease (C.O.P.D.) who had a poor quality of life, severe mobility problems due to breathlessness and relied on many medications, including a nebulizer, reliever and preventer. Since the Buteyko training her quality of life has improved substantially; she no longer needs to use her nebulizer or the reliever, and is able to walk up hills without stopping for breath.

Clinical trials prove the efficacy of BBT

Clinical trials have all demonstrated that most people who complete the Buteyko course no longer need their reliever medication and eventually give up preventive steroids as well. K. P. Buteyko conducted a six-year trial of 100,000 patients with asthma who were being treated with drugs. Approximately 92,000 of the subjects do not take drugs today.[lxxvii]

Buteyko tested his theory on very ill children with asthma and other chronic disorders. Most had allergic reactions to drugs that had little effect on their symptoms. The children learned BBT quickly, and after 1-5 days asthma and related symptoms disappeared. 73% of patients stopped their medication at the start of the trial, and most of the remaining subjects reduced drug use after 4 days. All patients showed improvement in asthma control: 83% showed considerable improvement and 17% showed some improvement.[lxxviii]

Subsequent trials have confirmed Buteyko’s results. In 1995 a four month trial in Brisbane, Australia, showed an average reduction in reliever medication of 90% in the Buteyko group, and after three months, a reduction of 49% in steroid preventive drugs, as compared to no significant changes in the control group.[lxxix]

A six month trial in New Zealand in 2000 showed similar results to the Brisbane trial, with a reduction of reliever drugs of 85% and steroids by 50%.[lxxx] An Australian trial of BBT taught by video showed a 60% reduction of reliever drugs and a major improvement in quality of life in the Buteyko group.[lxxxi]

A major two-year trial in Glasgow, Scotland, UK showed similar results to the Brisbane study. In the BBT group asthma symptoms decreased by 98%, and remained the same after six and twelve months. Use of reliever medication decreased by 98%, preventive medication decreased by 92%, reliever oral medication decreased by 100%, preventive oral medication decreased by 96%, and incidence of cold or viral infection decreased by 20%. The quality of life increased by 100%. There was no significant change on any of these outcome measures in the placebo and control groups.[lxxxii]

In addition, there have been two trials comparing BBT with other breathing techniques. A six-month trial in Nottingham compared the effects of BBT with pranayama yogic breathing.[lxxxiii] The BBT group decreased use of reliever medication by 100%. After six months 40% of remaining participants reduced steroid use by 75-100% and 15% of subjects reduced steroid use by 25-50% – significantly more than reductions in the pranayamic or control groups.[lxxxiv]?

More recently a study in Calgary, Canada, compared results of BBT with breathing techniques used by physical therapists for asthma.[lxxxv] The findings show that at six months, while both the BBT and control groups substantially improved in terms of asthma control and quality of life, the BBT group showed significantly reduced symptoms and decreased use of steroid drugs. 29% of the remaining BBT subjects stopped using steroid drugs, compared with just over 6% of the control group.

A recent three-month study of children at Gisborne Hospital, New Zealand showed results similar to studies of adult asthmatics: There was a 66% reduction in bronchodilator medications and a 50% reduction in steroid use.[lxxxvi]

Without doubt, BBT “…has been scientifically proven to be a safe, highly effective and complementary technique for treating asthma.”[lxxxvii] Moreover, it has saved many thousands of lives, and if it were introduced to mainstream medical practice in the West, it could save many more lives.[lxxxviii] It has also proven to be highly cost effective since it requires a course of just five 90 minute sessions at a cost of around ?300,[lxxxix] [xc] which is very little compared to the huge potential savings in terms of lives and medication costs.

BBT is highly cost effective

A report by the research company Dr Foster Intelligence shows that ?64 million a year is spent on emergency asthma admissions to hospital in the UK.[xci] A report commissioned by Asthma UK argues that given that asthma costs the UK more than ?2.3 billion a year in NHS services and drugs, benefits and lost productivity, it would make more financial sense to invest in primary care programmes to help people with asthma control their symptoms.[xcii] Besides saving lives and keeping asthma patients out of hospital,[xciii] BBT is inexpensive and can save health services a lot of money.

A QED Science programme told how Dr Spence, a Glasgow GP, taught BBT after the expensive drug treatments currently on the market failed to improve his patients’ asthma. Dr Spence said: “The simple fact is that 34 patients, prior to BBT, were costing ?15,000 for their asthma medication. After BBT, they were costing ?5,000. That’s a reduction of two-thirds in their drugs bill. If this was extended to the rest of the country, very significant savings could be made.”[xciv]

A Cornish GP, Dr Rupert Manley, carried out a pilot study of BBT and found that most of his patients used fewer drugs as a result of the breathing training. He claims BBT could save the NHS ?270m – more than half of what it spends nationally on asthma drugs.[xcv]

Asthma is curable – so why are people dying?

Evidence has shown that asthma is curable, yet the official line is that there is no known cure for asthma.[xcvi] [xcvii] The Department of Health claims it has achieved a reduction in the incidence of asthma, and that current drug treatments are effective, despite evidence to the contrary.[xcviii]

Evidence also demonstrates that BBT is highly cost effective, that it could reduce the burden on the NHS, improve the health of people with asthma and other chronic conditions without drugs, and save many lives. Yet respiratory specialists still do not prescribe it; it is still not available on the NHS. BBT is portrayed as a complementary therapy with no proven scientific basis, and this view is difficult to change due to the lack of willingness on the part of funding bodies to support further research.[xcix] Despite repeated parliamentary debates the Department of Health remains dismissive of BBT.[c] [ci] [cii] [ciii] [civ]

The House of Commons debates

Despite the official Government stance, and the reluctance of the medical profession to take the Buteyko theory seriously,[cv] Ministers of Parliament, including Anne Campbell[cvi] and Jonathan Aitken, have been among the first British asthma patients to benefit from BBT.[cvii]

In November 1998 Mr Letwin MP asked the Health Secretary to assess the advantages of using BBT in the NHS for the treatment of asthma. Mr Hutton replied that there were no plans to carry out a trial of BBT and the Medical Research Council was not currently funding research into BBT.[cviii]

The positive results of the Glasgow trials of BBT, pioneered by Jill McGowan, seemed to herald a new era of hope for asthma sufferers.[cix] The success of the trials led to a new Parliamentary debate. On 10th June 2002 Anne Campbell MP asked the Health Secretary what assessment had been made of the effectiveness of BBT in asthma treatment, but there was little change in the response. Ms Blears answered that the Department of Health had not commissioned an evaluation of BBT, and the Medical Research Council was not currently funding research into BBT.[cx]

John McDonnell then asked what the cost would be of providing free medication to all asthmatics. Ms Blears replied “We estimate that the loss of prescription charge income in England would be over ?50 million a year…”[cxi]

On the 25th June 2002, Anne Campbell brought BBT to the House of Commons again.[cxii] She described the increase in asthma cases, the rising death rate, the financial costs, and the theory and practice of Dr Buteyko. She said: “It is time we admitted that the current treatments appear to be making us worse, not better…” She described how, as asthma sufferer, after learning BBT her symptoms were significantly reduced, and her use of reliever medication dropped from four or five doses a day to occasional use.

Mrs Campbell referred to evidence provided by the New Zealand and Brisbane trials and a UK pilot study that showed a 90% reduction of reliever drugs within a few weeks. She explained that the success of these trials had led to a two-year clinical study in Glasgow, and asked that the chief medical officer examine the evidence and support further trials to prove the efficacy of BBT.[cxiii]

The Under-Secretary of State for Health, David Lammy, replied to Mrs Campbell that he wanted to see ?robust scientific evidence? that BBT is effective in the treatment of asthma, and that it would be as effective as existing drug therapies.[cxiv]

On the 3rd December 2002, Anne Campbell once again asked the Health Secretary what assessment had been made of BBT of asthma management. Ms Jacqui Smith replied that the chief medical officer found that more research was needed into BBT, “…to show that this method would be as clinically effective as the drug treatments that are proving effective at the moment.” When Mrs Campbell pointed out that the Glasgow trial had achieved a 98% reduction in reliever medication and a 92% reduction in preventive medication, indicating a great saving for the NHS, Ms Smith dismissed the evidence saying that the trial would not be finished until April 2003.[cxv]

David Tredinnick argued that sufficient evidence had already been provided by the Brisbane trial results, to which Ms Smith gave the stock response: “… there is no robust scientific evidence that any complementary therapy on its own can provide a lasting cure for asthma.” She repeated that the chief medical officer and the Medical Research Council agreed that more research was needed.[cxvi]

Why isn’t more research undertaken to prove the efficacy of BBT?

K. P. Buteyko demonstrated a success rate of 96% in curing high blood pressure and angina, and 98% recovery rate for asthma, bronchitis, allergy and rhinitis.

The recovery rate of conventional medicine at that time for all of these conditions was nil. On the basis of this proven success, BBT was granted a patent in 1985, number N 1067640, and USSR Minister of Health initiated the use of BBT in general medicine.[cxvii]

In the UK, the public organisations that claim to be dedicated to helping asthmatics, such as the Government Department of Health and the Medical Research Council, say that more research is needed before BBT can be prescribed by the NHS, but they are not willing to support further research.[cxviii] [cxix] [cxx] In 1996 the Health Secretary Stephen Dorrell announced a five-year ?5 million research programme to find the cause of asthma. None of this money went towards research of BBT.

The government spends a mere ?3 million a year on asthma research – the amount spent by the charity Asthma UK.[cxxi] Compare this with ?900 million per year that is spend on hospital admissions and medications for asthma.[cxxii] All the clinical trials of BBT in the West have been funded by private donations or by charities.[cxxiii] When researcher Jill McGowan was denied funding for a pilot study she sold her house to fund it herself, and donated three quarters of her salary to fund the two-year clinical trial in Glasgow.[cxxiv]

In April 2004 Mr Watson asked the Health Secretary what research the Department of Health had conducted into reasons for increases in asthma rates in the previous twenty-five years. Mr Ladyman replied that King’s College, London led a ?2.1 million European Commission funded study of allergy and low lung function of adults in Europe, and the National Asthma Campaign (now Asthma UK) produced a consultation document that listed seven key areas of asthma research including airway remodelling.[cxxv]

Asthma UK and the Medical Research Council

Asthma UK is the only charity that claims to be “…dedicated to improving the health and well-being of people with asthma.”[cxxvi] Funded by private and corporate donors, it spends ?3 million per year on asthma research. It has spent a total of ?30 million on research aimed at finding the cause of asthma and identifying new treatments to control and prevent asthma.[cxxvii]

The Medical Research Council (MRC) is funded by the Government Department of Trade and Industry. Its main objectives are “…to promote the balanced development of medical and related biological research, with the aim of maintaining and improving human health.”[cxxviii] Its accounts for the year 2005-2006 show that its parliamentary grant-in aid totalled ?459.5 million.[cxxix] Since 1998 it has generated an income of more than ?200 million from its involvement in antibody technology and the formation of biotechnology companies. The MRC spends more than ?500 million a year on its 40 Institutes, Units and Centres, grants and training awards to individuals and teams in universities and medical schools. King’s College is in the top group of UK universities for research income with grants and contracts of ?100 million.[cxxx]

In September 2005, Asthma UK and the MRC launched a new, jointly funded research centre: The MRC-Asthma UK Centre in Allergic Mechanisms of Asthma, based at King’s College, London and Imperial College, London. The research at King’s College is studying the effects of vitamins and steroids on asthma.[cxxxi] Research at Imperial College London involves protein production, molecular structural studies, cellular work on allergy and asthma, animal airway function, and animal testing of potential new drugs. Guys Hospital and other hospital based research institutions are researching “airway re-modelling” i.e. how genetics, environment and drugs alter the structure of the airway wall in asthma.[cxxxii] [cxxxiii] [cxxxiv]

The MRC and Asthma UK are also spending their combined research budget on inhalers that deliver anti-viral proteins to the lungs to prevent severe asthma attacks during viral infections.[cxxxv] Asthma UK provides ?2 million every five years to research geared towards the development of “targeted treatments”[cxxxvi] Studies include the causes and triggers of asthma in childhood, such as family history, home environment and physical activity.[cxxxvii] [cxxxviii] Asthma UK also supports Professor Anne Tattersfield’s research into how drugs work in asthma, with the aim of ensuring the optimum use of drugs.[cxxxix]

Asthma UK claims it is committed to supporting research into non-drug approaches to control asthma, yet the Asthma UK Fact File is dismissive of BBT. It makes the false claim that studies showed that the Pranayama breathing technique was more successful in reducing asthma symptoms than BBT.[cxl] This statement is based on Anne Tattersfield’s report of the Nottingham trial, which she claims found that BBT reduced asthma symptoms and the need for reliever drugs but had no effect on the underlying condition or the need for preventer medicine.[cxli] This is a misrepresentation of the results of the trial. In fact, the results showed a 100% reduction in bronchodilators, and after six months 40% of participants reduced steroid use by 75-100% and 15% reduced steroid use by 25-50%. There was no reduction in bronchodilators in the pranayamic or placebo groups. Tattersfield describes this result as ?non-significant.? [cxlii] [cxliii] Could this researcher’s integrity have been compromised?

The Asthma UK Fact File also claims that: “Very little research has been published in medical journals about BBT.”[cxliv] This is untrue. Numerous studies have been published in medical journals worldwide that prove the efficacy and safety of BBT.[cxlv] [cxlvi] [cxlvii] [cxlviii] [cxlix] [cl] [cli] [clii] [cliii] [cliv] [clv] There is no evidence that BBT is not safe and effective. However, abundant evidence has been published in worldwide medical journals that asthma medications are unsafe and ineffective.[clvi] [clvii] [clviii] [clix] [clx] [clxi] [clxii] [clxiii] [clxiv] [clxv] [clxvi]

The honesty and integrity of Asthma UK is further called into doubt by the lack of veracity in the figures it quotes as to the number of people in the United Kingdom with asthma. A report commissioned by Asthma UK in 2004 claimed the number of people diagnosed with asthma in the UK was 5,200,000.[clxvii] [clxviii] [clxix] In an Audit in 2001 the charity claimed that 8 million people in the UK were diagnosed with asthma.[clxx] Given the evidence that asthma is increasing and not decreasing,[clxxi] [clxxii] these figures are impossible. Since the population of the UK in 2004 was about 60 million,[clxxiii] [clxxiv] an average of the percentages quoted by the GINA report indicates that the figure given by Asthma UK is about half of the real number of people in the UK with asthma.

The direction that Asthma UK has taken in the research it selects to support, together with its dismissive stance towards BBT, suggests that there are greater benefits to be gained from supporting drug companies rather than research that would ascertain the cause and cure of asthma. The charity’s Accounts for 2005/2006 lists many pharmaceutical companies among its corporate donors: GlaxoSmithKline, Altana Pharma Ltd, Lloydspharmacy, Novartis Pharma UK Ltd, Superdrug Stores plc, AstraZeneca UK Ltd, Boots The Chemist, IVAX Pharmaceuticals UK, Schering-Plough Ltd, and Ranbaxy UK Ltd.[clxxv]

The pharmaceutical companies

Most clinical trials are funded by drug companies for the purpose of proving that their products are safe and effective. They have no incentive to invest in research that will find a drug-free cure for asthma.[clxxvi] The total sales for asthma drug treatments worldwide in 2005 was more than $35 billion.[clxxvii] The leading asthma drug companies are GlaxoSmithKline and AstraZeneca. The shareholders of these companies are likely to resist anything that threatens profits.[clxxviii]

The pharmaceutical companies are spending their research money on developing new combinations of existing drugs, such as a combined broncholidator/steroid inhaler,[clxxix] that have been proven unsafe.[clxxx] GlaxoSmithKline has developed a range of asthma products, most of which contain long-acting beta-2 agonists.[clxxxi] Novartis and Schering-Plough are developing a once-daily combination drug for asthma and COPD.[clxxxii]

Due to reports of adverse reactions of salmeterol,[clxxxiii] [clxxxiv] GlaxoSmithKline began a clinical trial of the drug (SMART) in 1996, but abandoned it in 2003 after analysis showed four times as many respiratory related deaths among those on salmeterol than those on existing asthma medication.[clxxxv] A report by the United States Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee in 2005 shows how GlaxoSmithKline failed to publish the results and manipulated the data it submitted to the FDA in order to diminish the apparent risks of the drug.[clxxxvi] In 2003 it was reported that salmeterol was subject to a government investigation in the UK.[clxxxvii] Doctors have called on the European Medicines Agency to review the use of long acting beta-agonist drugs, including salmeterol and formoterol.[clxxxviii] [clxxxix]

Following the Serevent news, Merck also stopped trials of their asthma drug due to safety concerns. This was followed by news of a link of Novartis’ asthma drug Xolair to cancer. Other asthma drugs, Acculate and Flovent were found to cause fatal illnesses, and Isoprenaline caused the deaths of over 3,500 children and young adults in the UK.[cxc]

It is interesting to note that Dr Seif Shaheen’s research at Kings’ College found that countries with the highest rates of asthma also have the highest levels of paracetamol sales. The prevalence of wheeze in adolescents increased by half a percent for each gram increase in paracetamol sales per head of population.[cxci]

The Medical Profession

Buteyko’s deep breathing disease theory is a fundamental challenge to orthodox medicine.[cxcii] The medical profession is reluctant to examine the theory seriously. Peter Kolb suggests that the reasons for this include: fear of loss of credibility and respect, and fear of loss of an important area of the health care industry, but the most sinister reason is the influence of the pharmaceutical industry’s dependence on asthma remaining incurable.[cxciii]

Medical resistance would seem to be influenced by the relegation of BBT to the ‘alternative and complimentary therapies’ category, combined with a denial of the mounting evidence that disproves the efficacy of current drug treatments for asthma. Credibility of BBT is further undermined by opportunistic ?pseudo-Buteyko? practitioners.[cxciv]

Some doctors express concern about asthmatics stopping their medication.[cxcv] However, BBT does not involve stopping medication before there is a cessation of symptoms. Wendy Haddock, a physiotherapist who teaches a version of BBT, has found that doctors are happy to reduce drugs that can have side effects in the long term, providing their patient?s condition is improving.[cxcvi]

Jennifer Stark claims one area of scientific contention is the lack of improved lung function results in trials, but BBT researchers claim that lung function tests have been shown to cause airway narrowing and asthma symptoms, which casts doubt on their accuracy.[cxcvii] [cxcviii] Jill McGowan claims the Australian study measured responses too soon. In her Strathclyde study, lung function and CO2 levels measured normal after 24 months, but because only a random group was measured the results were viewed as inconclusive.[cxcix]

The Times published a letter addressed to the chief executives of all 476 acute and primary care trusts in the UK, from Professor M. Baum who objects to non-drug therapies and claims to be “concerned about ways in which unproven or disproved treatments are being encouraged for general use in the NHS.”[cc] Baum states: “…we want patients to benefit from the best treatments available,” but he would put an end to the benefits that people derive from non-mainstream treatments. Sixteen British Professors signed the letter. Further research may reveal that pharmaceutical companies fund their work and research.

The letter coincided with Prince Charles’ speech in which he expressed his support for Complimentary and Alternative Medicine (CAM). A spokesman for the prince?s Foundation for Integrated Health accused Baum and the other signatories of being ?clinical barons? and much of the media also attacked them.[cci]

The scientific and physiological basis of Buteyko?s theory

Dr Mike Thomas, a consultant in Aberdeen, claims that BBT has no physiological or scientific basis.[ccii] All the evidence indicates this is untrue.

Dr Buteyko was an outstanding scientist and doctor. He held a scientific degree of the Candidate of Medical Sciences and published more than 40 scientific publications. He was head of the laboratory of functional diagnostics at the Institute of Cardiology of the Siberian Branch of the Academy of Sciences, USSR.[cciii] The scientific basis of his work in the laboratory and hospital trials has been well documented.[cciv] [ccv] [ccvi] [ccvii] [ccviii] [ccix] [ccx] [ccxi] [ccxii] [ccxiii]

BBT is based on Buteyko’s well substantiated, scientifically proven, theory of disease: disease is a disorder of the mechanisms of regulation and restoration of an organism’s function. Since breathing is the highest in the hierarchy of functions, hyperventilation, with the consequent depletion of CO2 leads to disease that manifests in a variety of forms, including asthma, high blood pressure and heart disease. If breathing is corrected, it leads to correction of the other functions, and restores the patient to good health.[ccxiv]

K. P Buteyko claimed that CO2 is the staple for all living matter on the Earth, and the principal regulator of all functions in the organism.[ccxv] The depletion of CO2 from the atmosphere, pollution, drugs, and bad breathing habits, combine to reduce the level of CO2 in our lungs to a dangerously low level. This prevents normal metabolism, and gives rise to protective mechanisms such as bronchospasm, vasospasm, high cholesterol, and unstable blood pressure as the body tries to stabilise the CO2 level. The consequences are respiratory, metabolic, cardiovascular, nervous and immune system disorders, allergies and cancer.

The underlying basis for Buteyko?s theory was developed in the nineteenth century by C. Bohr in his theory of the role of CO2 in the body.[ccxvi] CO2 is not merely a waste gas as it is taught in the West, but plays a substantial role in body functions. [ccxvii] [ccxviii] [ccxix] [ccxx] [ccxxi] [ccxxii] [ccxxiii] Shortage of CO2 in the blood and cells causes physiological and biochemical imbalances, which lead to many chronic conditions. As the blood circulates through the alveoli in the lungs, molecules of oxygen bind to haemoglobin and are carried to the internal organs. Bohr found that CO2 is necessary for oxygen to bind to haemoglobin, and a 6.5% CO2 level in the blood is required for oxygen to be released from haemoglobin to the tissue cells. If the CO2 level in the blood is too low, this leads to a decreased oxygen supply to the body cells and organs including the brain, heart and kidneys.[ccxxiv]

BBT is based on the elimination of excessive ventilation of the lungs, which causes depletion of CO2. Bronchial asthma may be a protective reflex to resist loss of CO2 through hyperventilation.[ccxxv] Buteyko found that oxygen does not improve severe asthma and can result in death. The more severe the bronchial asthma, the more hyperventilation decreases CO2 and increases oxygen. As the CO2 in the lungs decreases, oxygen increases; at the same time CO2 in the blood increases and oxygen decreases; as a result the blood supply to the tissues worsens and cells suffer from hypoxia – a loss of oxygen to the brain – in which case the patient will die even though the lungs are full of oxygen.[ccxxvi]

It is interesting to note that Dr Mike Thomas “…is now investigating a breathing retraining programme using respiratory physiotherapists to see if it improves people’s breathing.”[ccxxvii] The scientific and physiological basis of his research is unclear.

Conclusion

Asthma costs the UK ?2.3 billion in terms of drugs, hospitalisation, social security payments and lost productivity.[ccxxviii] It would make more financial sense to invest in BBT at primary care level; this would save lives as well as money.[ccxxix] But the Department of Health, the Medical Research Council, and Asthma UK say that more research is needed before BBT can be prescribed on the NHS, but they are not willing to support further research.[ccxxx] [ccxxxi] [ccxxxii] All of these institutions appear to have been compromised directly or indirectly by income from pharmaceutical companies.[ccxxxiii] [ccxxxiv] [ccxxxv] [ccxxxvi] [ccxxxvii]

The medical profession is also influenced by drug companies that invest in hospital based research and pay the salaries of research scientists and professors.[ccxxxviii] [ccxxxix] [ccxl] [ccxli] The relegation of BBT to the status of a complementary therapy with no proven scientific basis is convenient for a medical system that denies the evidence that disproves the efficacy and safety of current drug treatments for asthma.[ccxlii] [ccxliii]

Those elected to represent our interests lie to us and claim that there has been a reduction of asthma cases, and that current drug treatments are effective.[ccxliv] [ccxlv]

They also mislead us about the number of people diagnosed with asthma.[ccxlvi] [ccxlvii] [ccxlviii] [ccxlix] [ccl] [ccli] There is mounting evidence that asthma medications are unsafe and ineffective and this has been published in many worldwide medical journals.[cclii] [ccliii] [ccliv] [cclv] [cclvi] [cclvii] [cclviii] [cclix] [cclx] [cclxi] [cclxii]? On the other hand, many studies published in medical journals conclusively prove the efficacy and safety of BBT.[cclxiii] [cclxiv] [cclxv] [cclxvi] [cclxvii] [cclxviii] [cclxix] [cclxx] [cclxxi] [cclxxii] [cclxxiii]??

A cure that requires no drugs is seen as a threat to the drug industry and the system that depends on its revenues.[cclxxiv] With a global asthma drug industry of more than $35 billion, the drug companies have no incentive to invest in research that will find a drug-free cure for asthma.[cclxxv] [cclxxvi] The future profits of drug companies depend on a rapidly growing incurable market of asthma sufferers that is predicted to rise to 400 million by 2025.[cclxxvii]

BBT constitutes a challenge to current theories of medical diagnosis and treatment of disease.[cclxxviii] [cclxxix] It threatens to destroy the doctrines of western medicine that operate in a system in which disease has become a consumer industry. Capitalism is thriving on our illness and has no interest in promoting our well being.

The Health Secretary said in her summary to Mrs Campbell: “Complementary medicine treatments may be provided on the national health service if those responsible for commissioning health services on behalf of patients locally (primary care trusts) consider that they are a clinically and cost effective means of meeting an identified health need.? [cclxxx] General practitioners Dr Spence and Dr Manley[cclxxxi] [cclxxxii] found that BBT fulfils these criteria. Therefore it would seem that the future of BBT lies with people with asthma who want a better quality of life and doctors who genuinely want to help their patients.[cclxxxiii]

BBT has proven to be a cost effective, efficacious and safe treatment for asthma, but it is perceived by the health system as potentially destructive. This is because the health system is dominated by a belief that the only effective way to treat disease is by means of drugs. The integration of BBT into medical practice in the West needs a health system that is genuinely concerned about the health of the people, investment in unbiased research that has no conflict of interests, and a change in the way we think about medicine.

? By Martha Magenta 2006.

6501 words


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[ccxliii]? House of Commons Hansard Debates, 25 June 2002, Column 855-858, online: http://www.publications.parliament.uk/pa/cm200102/cmhansrd/vo020625/debtext/20625-34.htm

[ccxliv] House of Commons Hansard Debates, 3 December, 2002, Column 745, online: http://www.publications.parliament.uk/pa/cm200203/cmhansrd/vo021203/debtext/21203-03.htm

[ccxlv] Stark J, “Asthma- Ignorance or Design?” 2005, from Nexus Magazine, Vol. 13, No.1, Dec 2005-Jan 2006, online: http://www.whale.to/a/stark.html

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[cclii] Sears MR, Taylor DR, Print CG, Lake DC, Li QQ, Flannery EM, Yates DM, Lucas MK, Herbison GP, “Regular inhaled beta-agonist treatment in bronchial asthma” Lancet, 1990 Dec 8; 336(8728): 1391-6

[ccliii] Tattersfield A E, Harrison T W, Hubbard R B, Mortimer K, “Safety of Inhaled Corticosteroids” The Proceedings of the American Thoracic Society 1:171-175 2004, online: http://pats.atsjournals.org/cgi/content/abstract/1/3/171

[ccliv] “New safety warning for salmeterol in US” The Pharmaceutical Journal, Vol. 271, 23 August, 2003, pdf:? http://www.pjonline.com/pdf/_donotindex/pj_20030823_news5.pdf

[cclv] Taylor R, “Adverse Respiratory Reactions to Long-acting Beta-agonists” Information for Health Professionals, May 1999, online: http://www.medsafe.govt.nz/Profs/PUarticles/laba.htm

[cclvi] “Misleading data analyses in salmeterol (SMART) study (HRG Publication #1752)” S. Wolfe, P. Lurie, The Lancet, Vol. 366, 1261-1262, No. 9493, 8 October, 2005, online: http://www.thelancet.com/journals/lancet/article/PIIS0140673605675186/fulltext

[cclvii] Vassiliou V, Zipitis C, “Long-acting bronchodilators; time for a re-think” Journal of the Royal Society of Medicine, Vol. 99, August 2006, pdf, online: http://www.rsm.ac.uk/media/downloads/j06-08bronch.pdf

[cclviii] Segelken R, “Regular use of asthma drugs poses respiratory, cardiac dangers, Cornell, Stanford researchers find in study critical of drug industry” Cornell News, June 17, 2004, online: http://www.news.cornell.edu/releases/June04/beta_agonist.hrs.html

[cclix] “Inhaled Corticosteroids” Therapeutics in Respiratory Medicine, Journals: ? Priory Lodge Education Limited, 1996-1999, online: http://www.priory.com/cmol/steroids.htm

[cclx] “Doctors Warning on Asthma Drugs” The Royal Society of Medicine, Media Release, online: http://www.rsm.ac.uk/media/pr207.htm

[cclxi] Hope J, “Asthma drugs ‘that are putting lives at risk” Daily Mail, 27 July, 2006, online: http://www.dailymail.co.uk/pages/live/articles/health/healthmain.html?in_article

[cclxii] Weinberger M, Abu-Hasan M, “Life-threatening asthma during treatment with salmeterol” The New England Journal of Medicine, Aug. 24, 2006; Vol. 355: pp. 852-853, online: http://content.nejm.org/cgi/content/extract/355/8/852

[cclxiii] Official site about the Buteyko Method, References, Journals, online: http://www.buteyko.ru/eng/bibliogr.shtml

[cclxiv] Buteyko K P, Genina V A, “The results of the Approbation of the ‘BBL’ Method in the Department of Children’s Diseases in the First Moscow Medical Institute of E. M. Sechenov”, 1981. Online: http://www.buteyko.co.uk/buteyko-results.htm

[cclxv] McHugh P, Duncan B, Houghton F, “Buteyko breathing technique and asthma in children: a case series” The New Zealand Medical Journal, 19 May, 2006, No. 1234, online: http://www.nzma.org.nz/journal/119-1234/

[cclxvi] Bowler S D, Green A, Mitchell C A, “Buteyko breathing techniques in asthma: a blinded randomised controlled trial” MJA 1998; 169: 575-578, online: http://www.mja.com.au/public/issues/xmas98/bowler/bowler.html

[cclxvii] McGowan J, “Health Education in Asthma Management – Does the Buteyko Institute Method Make a Difference?” Clinical Trials Report, Education and Training Consultant, Acorn Nursing Agency, Glasgow, Thorax Vol. 58, suppl III, page 28, December 2003, online: http://www.buteyko.info/sr-ct-thorax.html

[cclxviii] Cooper S, Oborne J, Newton S, Harrison V, Thompson Coon J, Lewis S, Tattersfield A., “Effect of two breathing exercises (Buteyko and pranayama) in asthma: a randomised controlled trial.” Division of Respiratory Medicine, City Hospital, Nottingham, Thorax, August 2003; 58:674-679, online: http://thorax.bmjjournals.com/cgi/content/full/58/8/674

[cclxix] Opat AJ, Cohen MM, Bailey MJ, Abramson MJ, “A clinical trial of the Buteyko Breathing Technique in asthma as taught by a video” Journal of Asthma, 2000; 37(7): 557-64

[cclxx] Davies S J C, Jackson P R, Ramsay L E, Kuiper D, Thomas M, “Dysfunctional breathing and asthma” British Medical Journal, 2001, 323; 631, online: http://bmj.bmjjournals.com/cgi/content/full/323/7313/631

[cclxxi] McHugh P, Aitcheson F, Duncan B, Houghton F, “Buteyko Breathing Technique for asthma: an effective intervention” Journal of the New Zealand Medical Association, 12 Dec 2003, Vol. 116 No. 1187, online: http://www.nzma.org.nz/journal/116-1187/710/

http://www.buteyko.info/clinical_research_buteyko.asp?crid=4

[cclxxii] Cowie R L, Conley D P, Underwood M F, Reader P.G, “A Randomized Controlled Trial of the Buteyko Technique for Asthma Management” Calgary, AB, Canada, Proceedings of the American Thoracic Society, 2006; 3: A530, online: http://www.abstracts2view.com/ats06/view.php?nu=ATS06L_1512

[cclxxiii] Birch M, “Obstructive sleep apnoea and breathing retraining” ANJ Clinical Update, 74, August 2004, online: http://www.buteyko.info/latest_buteyko_news.asp?newsid=19

http://www.anf.org.au/04_anf_anj_publications/anj_2004/0408_clin_update.pdf

[cclxxiv] Stark J, “Asthma- Ignorance or Design?” 2005, from Nexus Magazine, Vol. 13, No.1, Dec 2005-Jan 2006, online: http://www.whale.to/a/stark.html

http://www.nexusmagazine.com/articles/Buteyko%20&%20Asthma.html

[cclxxv] Hughes-Onslow J, “Stop This Asthma Disgrace”, The Daily Express, 6th August 1996, online: http://members.westnet.com.au/pkolb/express2.htm

[cclxxvi] W. Stow, “Attacking asthma”, Adis International, 2006, online: http://www.pmlive.com/ddd.cfm?showArticle=1&ArticleID=4665

[cclxxvii] “The Unmet Needs of Asthma” World Asthma Day – Tuesday 2nd May 2006, Asthma Foundation, New South Wales, online: http://www.asthmansw.org.au/content.cfm?id=495&menulink=221&subid=31&x=1&menuid=221

[cclxxviii] “Interview with K.P. Buteyko” in “The Buteyko Method. An Experience of Use in Medicine” 1990, Moscow, Patriot Publishers, online:

http://www.buteyko.ru/eng/interw.shtml

[cclxxix] Buteyko V.K., Buteyko M. M., “The Buteyko theory about a key role of breathing for human health. Scientific introduction to the Buteyko therapy for experts” Buteyko Co Ltd, Voronezh, 2005, ISBN 5-88563-072-0, online pdf: http://www.buteyko.ru/eng/index.shtml

[cclxxx] House of Commons Hansard Written Answers, 10 June 2002, Column 1074W, online:
http://www.publications.parliament.uk/pa/cm200102/cmhansrd/vo020610/text/20610w84.htm

[cclxxxi] “The breathless way to ‘cure’ asthma” BBC News, Health, Tuesday, August 18, 1998, online:? http://news.bbc.co.uk/1/hi/health/153320.stm

[cclxxxii] “Treatment could save asthma cash” BBC News, Monday, 19 June 2006, online: http://news.bbc.co.uk/1/hi/england/cornwall/5096844.stm

[cclxxxiii] Stark J, “Asthma- Ignorance or Design?” 2005, from Nexus Magazine, Vol. 13, No.1, Dec 2005-Jan 2006, online: http://www.whale.to/a/stark.html

http://www.nexusmagazine.com/articles/Buteyko%20&%20Asthma.html

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Antibiotics – adverse reactions cause 100k+ death

Antibiotics – adverse reactions cause 100k+ death

by Dr. Piyali Mukherjee exclusive for infoholix.net

Lets flashback 2.5 billion years, the precambrinic period of earth, land masses are shifting, the atmosphere is at the formation stage with only traces of oxygen. It is in this era that life first appeared on earth. Tiny creatures consisting of DNA strands enmeshed in a bit of chemical soup, sheathed by a membrane. These tiny creatures were the fore runners of the present day bacteria. In time these microbes differentiated to different forms. The basic rules of ‘survival of the fittest’ applied to these simple life forms. To ensure survival of its kind some of these microorganisms started secreting chemicals to kill other organisms in its immediate vicinity.

Indeed, by the time humans came on earth, bacteria had carved out its own niche, and inhabited almost every corner of the earth. Our early animal ancestors were host to them and even today each of us have billions of commensal bacteria living within us. These commensal bacteria have marked us out as there own territory and help to ensure that their territory; that is our bodies are not invaded by pathogenic bacteria. They form a vital part of our inherit resistance to diseases.

During the early years of civilization the bacteria reigned supreme, a small infected cut or fever could shift our finely tuned immune balance and prove fatal. In the beginning of the last century tuberculosis, pneumonias, meningitis, typhoid, whooping cough were all untreatable fatal diseases. Bacterial diseases like tuberculosis, meningitis, gastroenteritis and diphtheria were amongst the top ten leading causes of death in the United States.

For centuries people have been using natural substances from the living world to combat infection, the early Chinese, Indians and Egyptians all used various natural remedies to treat wounds, but the exact component that brought about the cure was not known. In the latter half of the 19th century scientists stumbled upon those very chemicals that micro- organisms use to combat other organisms in their vicinity.  In 1860’s Louis Pasteur showed that we may be able to fight germs with other microbes. Rudolf Emmerich and Oscar Low conducted their experiments in the 1890’s. They proved that the germs that would cause one disease may be the cure for another. In 1928 Alexandra Flemming isolated penicillin, a chemical secreted from common mold, which lyses and destroys bacteria. The “magic bullet” had been discovered. It lived up to its name ‘Anti – biotic’ (against life). The death knell for the bacteria had been sounded.

By the 1940’s and 1950’s  commercial viable options for large scale manufacturing of penicillin were in place, It coincided with the second world war, thousands of injured soldiers from the battle field fueled the demand for more and better antibiotics. Money and time were pumped into research and soon a crop of new and more potent antibiotics flooded the market. Streptomycin, terramycin, tetracycline, chloramphenicol, aminoglycosides, cephalosporins, erythromycins and many more. Originally an antibiotic was a substance derived from one living organism which inhibited the growth of another living organism.  However soon semi-synthetic derivatives of natural antibiotics and even totally synthetically derived antibiotics came into the market; often they proved to be more powerful than the original natural molecule. Today some 150 different varieties of antibiotics are available.

Since then people both doctors and patients alike have come to regard antibiotics as a cure all for every thing from a bout of sniffles to more serious ailments like tuberculosis and meningitis. Data shows that 235 million doses of antibiotics were consumed in the year 2000.   Humans were not the only ones to benefit from the antibiotic magic. Antibiotics are routinely mixed in the feed of healthy farm animals to ensure that they grow faster and remain disease free. A survey conducted in 1996 showed that in that year alone 37,058 kilograms of streptomycin were used for animals compared to 5,409 kilos by humans. These figures clearly demonstrate the rampant   usage of antibiotics in animal husbandry. Even in agriculture antibiotics are regularly used to prevent bacterial plant infection.

Antibiotics act in different ways; some of them break up the cell wall leading to cell lysis. Some antibiotics interfere with the synthesis of protein in the bacteria and still others damage the bacterial DNA. However, bacteria are one of the most versatile creatures alive; they soon devised ways to overcome the antibiotic assault. In 1943 just four years after the onset of mass production of antibiotics, bacteria resistant to antibiotics made an appearance. The first bacteria to demonstrate this property was Staphylococcus aureus resistant to penicillin.  In a bid to overcome resistant bacteria, newer antibiotics were used. As soon as resistant strains developed a new molecule would be discovered to tame them.

How do resistant bacteria develop? When an antibiotics is used on bacteria almost all of them succumb to the antibiotic assault. Only a few bacteria resistant to that antibiotic survive. These resistant bacteria then proliferate rapidly passing on their resistant genes to a whole new genre of bacteria. In takes only about twenty short minutes for a bacterium to reproduce. So in no time, new colonies of bacteria are formed, all of who are resistant to the antibiotic.  A person infected with this new strain of bacteria will no longer respond to that antibiotic therapy. A different antibiotic is then used to control the infection. The same process can reoccur with this new antibiotic to give rise to multi drug resistant bacteria (MDR Bacteria).

MDR bacteria are especially found in hospitals and nursing homes. These places are inhabited by sick and old people, with low resistance who have already been treated with multiple antibiotics and are particularly vulnerable. These germs are apparently innocuous in healthy humans, who are the carriers, but once transmitted to a patient with a low immunity it results in flagrant infection which can not be controlled by most antibiotics. Vancomycin was one of the few effective antimicrobial drugs available but in recent years a spate of Vancomycin resistant infection has swept across hospitals around the world making it the second leading cause of nosocomial infections.

The list of dangerously virulent drug-resistant microbes is growing all the time. There has been a resurgence of disease like tuberculosis, pneumonia, and meningitis. Bacteria which once had been successfully vanquished from the developed world were back. This time around the micro-organisms are smarter and can resistant the antibiotic cocktails used to suppress them earlier.

The indiscriminate use of antibiotics accelerates the process of bacterial resistance. It is very common for a patient to visit a doctor and insist on an antibiotic prescription for minor ailments of unknown etiology. Many a doctor gives in to the pressure and prescribes. In the United States alone each year more than 160 million prescriptions are written for antibiotics, of which an estimated 20% -50% of that use is unnecessary.

The antibiotics once ingested by humans or animals are only partially digested and absorbed. A good portion of the antibiotics are passed out unchanged into the sanitary system, where it pollutes the soil and water. Antibiotics, amongst other drugs have been measured in surface water, ground water and drinking water. Because of the drug residues that contaminate our food and water supply, most of us ingest trace amounts of antibiotics and other prescription drugs on a daily basis. These quantities are small, but this constant exposure is responsible for the increasing menace of drug resistance.

Antibiotic usage is associated with the risk of side effects, ranging from the minor to serious life threatening ones. The most common side-effect of antibiotic use is diarrhea. When an antibiotic is taken for a bacterial infection not only does it kill the disease causing bacteria but even the friendly bacteria present in the body are killed. This disturbance in the intestinal flora is the cause of antibiotic induced diarrhea. Once the friendly bacteria are removed from the intestine it becomes susceptible to an attack from Claustridium difficile, a pathogenic bacterium. The toxins produced by this bacterium results in diarrhea and colitis.

Besides diarrhea, use of some antibiotics like Chloramphenicol, can lead to severe blood diseases, use of streptomycin can cause ear and kidney damage, azithromycin use can induce acute interstitial nephritis. Although most cases of antibiotic induced acute interstitial nephritis are benign and self-limited, some patients may be at risk for permanent renal injury. Occasionally some people may be allergic to certain antibiotics, this is specially seen with the penicillin group of antibiotics, it can lead to symptoms like shortness of breath, hives, itching. A full fledged allergic reaction can prove to be fatal.

Antibiotics can also react with other drugs. For example erythromycin is known to cause some abnormalities in cardiac rhythm. However when concurrently prescribed with certain other drugs it can result in ‘Torsades de Pointes’, a potentially life-threatening arrhythmia. Erythromycin is usually metabolized by an enzyme Cytochrome P-450 3A (CYP3A). A recent study of medical records revealed that combining erythromycin with strong inhibitors of the liver enzyme CYP3A increased the risk of sudden death from cardiac causes probably by abnormally raising the blood levels of erythromycin.

Retrospective data show that an alarming increase in the incidence of autism has occurred since the late 1980’s this coincides with the introduction of clavulanate/amoxicillin a commonly used broad spectrum antibiotic, used for respiratory tract infection.

Each year in the United States, more than 160 million prescriptions are written for antibiotics and in much of the world, in the third world countries where pharmaceutical markets are not so well regulated, an antibiotic can be bought over the counter by people in a bid to self medicate, people unarmed with the knowledge of the dangers they are exposing them self to. The most common form of antibiotic misuse is when an antibiotic is taken to treat viral infections like fever and cold.  Another common practice is to take an antibiotic for a few days and discontinuing treatment once symptoms are controlled and the patient feels better. Incomplete antibiotic therapy abets antibiotic resistance.

At times taking an antibiotic can be a life saving proposition. However with the risks involved does every minor attack of fever warrant a course of antibiotic? One accepted medical theory is the “hygiene hypothesis”, which states early childhood exposure to infection helps in building the muscles of the immune system; such children are less prone to allergies and asthma in later life. In spite of the all the evidence and known risks involved blatant antibiotic misuse for minor illness continues. Recent data indicates that 75% of all outpatient prescription for antimicrobial medication has been used for five ailments namely: otitis media, sinusitis, bronchitis, pharyngitis or nonspecific upper respiratory tract infection.

Just as micro-organisms secrete chemical substances to protect themselves human too are equipped with a complex immune system.

A healthy immune system keeps infection at bay. Every time an antibiotic is used it further suppresses the immune system by killing the friendly bacteria in our body that boost our immunity. Using probiotics is one way of combating this effect. Probiotics contain live culture of bacteria that are normally present in our intestine. They help in digestion, produce vitamin K and make our bowel ecology inhospitable to pathogenic micro-organisms. This is a perfect example of harmonious symbiosis.

Breast milk has high immunoglobin content. Studies show that babies who are nursed suffer from fewer infections. Besides this there are several herbs and essential oils that posses immunomodulatory properties and can kill bacteria as well as viruses, to enlist a few

  1. Grapefruit seed extract has demonstrated antimicrobial activities
  2. Green tea has been used for centuries and to increase resistance
  3. Noni also called Indian mulberry is effective against bacterial and viral infections.
  4. The essential oils derived from the Australian Tea Tree extract have clearly demonstrated its antibacterial efficacy. In a clinical trial a topical application of it proved to be as powerful as benzoylperoxide in reducing acne, with fewer reported side effects.
  5. Neem is one of the most powerful blood-purifiers and detoxifiers in Ayurveda.
  6. Garlic, its immune enhancing properties has been documented by research.
  7. Turmeric is a powerful antiseptic used for wound healing.
  8. In recent times Ginseng has gained a reputation of being a stimulant, however in the Far East it has always been used to increase overall immunity.

The history of antibiotics is just half a century old, compared to the billions of years bacteria have survived on earth, overcoming many a challenge. In the early days of antibiotics total annihilation of bacteria seemed feasible, but in recent times the microbes are successfully fighting back. Modern medicine has placed a vital tool in our hands, antibiotics have saved many a life, indeed it has altered our whole our lifestyle. If we are not careful then all too soon we will find ourselves catapulted into the dark ages of the pre-antibiotic era, where uncertainty prevailed. A time when a simple wounds could turn nasty, minor surgical procedures carried the same casualty rates as complicated surgeries of today, a time when mothers had several children to ensure at that at least a few of their offspring survived the obstacle course of life.

The optimal way to equip ourselves against the threat of bacteria is to boost our natural immunity. It is here that alternative therapy offers a treasure trove of time tested natural resources that can enhance your immunity and restore you to health without the added baggage of risks involved.

? By Dr. Piyali Mukherjee 2006.

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US Senate Committee Report January 2010

US Senate Committee Report January 2010

COMMITTEE
ON FINANCE
MAX
BAUCUS, Montana, Chairman
 
JOHN
D. ROCKEFELLER IV, West
Virginia
    CHUCK
GRASSLEY, Iowa
KENT
CONRAD, North Dakota
ORRIN
G. HATCH, Utah
JEFF
BINGAMAN, New Mexico
OLYMPIA
J. SNOWE, Maine
JOHN
F. KERRY, Massachusetts
JON
KYL, Arizona
BLANCHE
L. LINCOLN, Arkansas
JIM
BUNNING, Kentucky
RON
WYDEN, Oregon
IKE
CRAPO, Idaho
CHARLES
E. SCHUMER, New York
PAT
ROBERTS, Kansas
DEBBIE
STABENOW, Michigan
JOHN
ENSIGN, Nevada
MARIA
CANTWELL, Washington
MICHAEL
B. ENZI, Wyoming
BILL
NELSON, Florida
JOHN
CORNYN, Texas
ROBERT
MENENDEZ, New Jersey
THOMAS
R. CARPER, Delaware
RUSSELL SULLIVAN, Staff
Director
KOLAN
DAVIS, Republican Staff Director and Chief Counsel

(II)

CONTENTS

Page

Executive
Summary
…………………………………………………………………………………….
1
Introduction
………………………………………………………………………………………………..
1
Response to the Nissen Study
……………………………………………………………………..
4
Leaked Manuscript and a Scrambled Defense
……………………………………………… 5
The RECORD Trial as a Marketing Tool for Competition
…………………………….. 11
Concerns About Avandia Raised Prior to 2007
…………………………………………….. 13
Conclusion
………………………………………………………………………………………………….
14
Appendix I: Visual Timeline of Public and Internal Information
…………………… 17
Appendix II: Timeline
………………………………………………………………………………….
19
Appendix III: Relevant Definitions
………………………………………………………………
21
Appendix IV: Documents Not Publicly Available
………………………………………….. 25


(III)

EXECUTIVE
SUMMARY

This
staff report
was developed over the last 2 years by U.S. Senate
Committee on Finance investigators who reviewed over 250,000
pages
of documents provided by GlaxoSmithKline (GSK/the Company), the
Food and Drug Administration (FDA), the University of
North
Carolina, and others. Committee investigators also conducted
numerous interviews and phone calls with GSK, the FDA,
and
anonymous whistleblowers.

Committee
staff began this investigation in May 2007 after a study was
published in the

New England Journal of Medicine,
showing
a link between the diabetes drug Avandia (rosiglitazone)
and
heart attacks. However, the reviewed evidence suggests that
GSK
knew for several years prior to this study that there were possible
cardiac risks associated with Avandia. As a result, it can be
argued
that GSK had a duty to warn patients and the FDA of the
Company’s
concerns. Instead, GSK executives attempted to intimidate
independent physicians, focused on strategies to minimize or
misrepresent
findings that Avandia may increase cardiovascular
risk,
and sought ways to downplay findings that a competing drug
might
reduce cardiovascular risk.

When
an independent scientist sought to publish a study in 2007
pointing
out the cardiovascular risk of Avandia, GSK acquired a leaked copy of
that study from one of its consultants prior to the
study
being published. The company’s own experts analyzed the
study,
found it to be statistically reliable, and then attacked the
soundness of that study in press releases and public comments.
GSK
also sought to counter the study’s findings by quickly releasing
preliminary results from its own study on Avandia, even
though
the company’s internal communications established that its
study
was not primarily designed to answer questions about cardiovascular
risk.

INTRODUCTION

For
the past 4
years, the staff of the Senate Committee on Finance
(Committee) has been examining allegations that pharmaceutical
companies attempt to manipulate science to improve the
marketability
of drugs, potentially at the expense of public safety.
These
allegations include intimidating scientists, ghostwriting studies for
academic researchers, suppressing studies that may
show
that a drug could be dangerous, and selecting data to publish results
that favor one product over another.

In
November 2007, the Committee reported on the intimidation
of
Dr. John Buse, a professor of medicine at the University of

(1)

2

North
Carolina (UNC) who specializes in diabetes.
1
Based partly on internal documents from GSK, the Committee reported
on what
appeared
to be an orchestrated plan by GSK to stifle the opinion
of
Dr. Buse in 1999. At that time, Dr. Buse argued at several medical
conferences and in letters to the FDA that GSK’s diabetes drug

Avandia
may cause cardiovascular problems.
2

According
to GSK emails made available to the Committee, GSK
executives
labeled Dr. Buse a ”renegade” and silenced his concerns
about
Avandia by complaining to his superiors at UNC and threatening a
lawsuit. The call to Dr. Buse’s superiors was made by Dr. Tachi
Yamada, then GSK’s head of research. In discussions with
Committee
investigators, Dr. Yamada denied that his call was
meant
to intimidate Dr. Buse. Instead, Dr. Yamada argued that he had made
the call to determine if Dr. Buse was making legitimate
statements
or if he was possibly on the payroll of a GSK rival.

Dr.
Yamada also made a call to the University of Pennsylvania (Penn)
regarding two physicians who were about to publish a case study that
Avandia may have caused liver problems in one of their patients.
3
Committee investigators contacted the two Penn physicians. Both
physicians chose to remain anonymous because of concerns
about possible retaliation by pharmaceutical companies.
4

In
hindsight, both physicians agree that Avandia probably does
not
cause liver problems. However, in 1999 Avandia was a new drug and the
two physicians wanted to publish a report on their patient who had
liver failure while on Avandia. Both physicians also said that the
calls placed by GSK officials, including Dr. Yamada, were highly
unprofessional and had a chilling effect on their
professional activity.
5

Commenting
on the calls by GSK, one of the two physicians told
Committee
investigators, ”It was really ridiculous. It was a case report
and I had no intention of bringing down GSK. I just wanted
people
to know.” The physician added, ”It left a really bad taste in
my
mouth. After that happened, I said that I would never work for

a
drug company.”

6

Also
commenting on the calls from GSK, the other physician told
Committee
investigators, ”I have never encountered anything like
this
in my career. I don’t even know how [GSK] knew that we were
publishing. It’s the kind of thing you imagine happening on TV.”

7

1
Committee Staff Report to the Chairman and Ranking Member, Committee
on Finance,
United
States Senate, November 2007, ”The Intimidation of Dr. John Buse and
the Diabetes

Drug
Avandia.”

2
Id.

3
According to GSK internal emails, Dr. Yamada placed a call to senior
officials at the University
of Pennsylvania
Medical School after receiving the following email on August 4, 1999,
from

a
GSK executive:

Tachi,
I need you to
place another call to your contacts at U Penn. The situation is that

Dr.
NAME REDACTED is apparently on the Takeda speaker’s circuit. He is
reported to be speaking about the case and implicating Avandia.
Obviously, this is not in anyone’s best
interest.

The
following day,
Dr. Yamada responded:

What
exactly do you
want me [sic] ask for? Obviously, we are not going to be able to pre-

vent
Dr. NAME REDACTED from speaking on behalf of Takeda. I would be happy
to speak
with
either NAME REDACTED (Dept. Chair) or NAME REDACTED (Hepatology
Chief) but
we
need to be clear on the message we want to send.

4
Staff interviews, December 2007.
5
Id.
6
Id.
7
Id.

3

In
an interview with
Committee investigators, Dr. Yamada stated
that he had no intention of intimidating the two physicians at
Penn,
and that he had merely placed the call because he was concerned
that Avandia may cause liver problems.

In
a December 2007 floor speech, Senator Grassley revealed that
Dr.
Steve Haffner, a professor of medicine at the University of Texas
Health Sciences Center, San Antonio, and a consultant for GSK, leaked
to GSK the draft of a study critical of Avandia that was to appear in
the

New England Journal of Medicine (NEJM).
8
Dr.
Haffner was entrusted with a confidential copy of the manu
script
draft because he was peer-reviewing the study for the
NEJM.
The study’s lead author, Dr. Steven Nissen, professor of
cardiology
at the Cleveland Clinic, found that Avandia was associ
ated
with a 43-percent increased risk of heart attacks, one of the main
health outcomes physicians hoped to avoid by treating diabetic
patients with medication.
9

According
to documents produced by GSK, the leaked manuscript
was
widely disseminated within the Company, and allowed GSK to
launch
a public relations plan to protect Avandia, a multi-billion
dollar
product.
10
The Committee staff reviewed documents showing
that
over 40 executives at GSK received and/or learned of the results
in the leaked study, including then CEO Dr. Jean-Pierre
Garnier;
head of research, Dr. Moncef Slaoui; Vice President of
Corporate
Media Relations, Nancy Pekarek; and GSK Senior Advisor,
Sir Colin Dollery.
11

Before
Dr. Nissen’s study on Avandia was published, GSK’s statistical
experts were examining the study for potential flaws. In addition,
GSK officials were drafting ”key messages” to undermine
the
main conclusion of the Nissen study. GSK had already published
several large trials on Avandia (rosiglitazone) including
studies
named ADOPT and DREAM. After Nissen’s study was published,
GSK began publicly referencing those trials, as well as another
trial called RECORD, in what appeared to be an effort to further
repudiate any link between Avandia and heart attacks.
RECORD
is a study GSK had been conducting for several years. GSK later
published the interim results of the RECORD trial in
what
appeared to be an attempt to cast doubt on Nissen’s results.

However,
internal GSK emails indicate that GSK executives, not the study’s
independent steering committee, made the final decision to publish
the RECORD trial results. Further, based on a review of emails, it
can be argued that the authors of the RECORD
trial
appeared more concerned about countering claims that
Avandia
may be associated with heart attacks, than in trying to understand
the underlying science. While circulating a draft of a
manuscript
on the RECORD trial, one of the authors wrote to his

8
Stephanie Saul, ”Doctor accused of leak to drug maker,”

The New York Times,

January 30,
2008.

9
Steven E. Nissen et. al. ”Effect of Rosiglitazone on the Risk of
Myocardial Infarction and
Death
from Cardiovascular Causes” the

New England Journal of Medicine,

May 21, 2007.

10In
2006, global sales of Avandia reached nearly $3.4 billion. Citation:
Gardiner Harris, ”Report
Backs Up Warnings About Drug Avandia,”

The New York Times,

July 27, 2007.

11
Letter from Daniel F. Donovan III, counsel to GSK, to Senator
Grassley, dated May 23,
2008.

4

colleagues,
”[W]hat’s to stop [Nissen] adding the events from

RECORD
to his meta-analysis and re-enforcing his view?”

12

Further,
after the authors of the RECORD study submitted their
paper
to the

NEJM,

one of the peer reviewers and several of the
NEJM
editors replied, ”an explanation for the continued use of

[Avandia]
is needed in this manuscript.”

13

Committee
investigators also learned that GSK was aware since at least 2004
that the RECORD trial was statistically inadequate,
or
”underpowered”

14

to answer questions regarding cardiovascular safety. Such
”inconclusive” results could be favorable to GSK and
the
marketing strategy for Avandia. Further, experts were advising GSK
since 2004 about the possible biological mechanisms related
to
why Avandia may cause an increased risk for heart attacks.
However,
GSK appeared eager to design studies to prove that
Avandia
was safer than its competitor ACTOS (pioglitazone), which is
manufactured by Takeda.

At
a July 30, 2007, safety panel on Avandia, Food and Drug Ad-
ministration (FDA) scientists presented an analysis estimating that
Avandia
use was associated with approximately 83,000 excess
heart
attacks since the drug came on the market.
15
Had GSK considered
Avandia’s potential increased cardiovascular risk more seriously
when the issue was first raised in 1999 by Dr. Buse, as well
as
by some of their own consultants in later years, some of these
heart
attacks may have been avoided.

RESPONSE
TO THE
NISSEN STUDY

In
March 2007, GSK
held a meeting with company officials and

academic
advisors to discuss several studies on Avandia and its
cardiac
risks and benefits.
16
Several presentations were made
about
studies on Avandia’s possible cardiac risk. During the discussion
of a GSK meta-analysis (integrated study) and a study GSK
commissioned
by Ingenix, GSK noted that the academic advisors

stated
the
following:

Dr.
NAME REDACTED
commented that the [cardiovascular]
effect seen in the Integrated Clinical Trials Analyses
with rosiglitazone was small but real, and that it is
counter
to the proposed [cardiovascular] benefits associated with Avandia.
Dr. NAME REDACTED agreed, noted
that
all data point to rosiglitazone having a hazard ratio greater than
unity. . . . Dr. NAME REDACTED summarized
the discussion on the Integrated Clinical Trials data
by
stating that rosiglitazone causes weight gain and

edema,
leading to a greater number of events.
17

12
Email
13
Letter

1,
2007.

from
John McMurray
to Nigel Jones et al., dated May 29, 2007.

from
the

New England Journal of Medicine

to Philip H. Home, M.D., dated June

14
A study is underpowered if it does not meet the statistical
requirements to adequately
measure
a medical outcome or study endpoint.

15
FDA, ”Assessment of the cardiovascular risks and health benefits of
rosiglitazone,” presented
July 30, 2007. Estimate presented publicly at FDA advisory committee
meeting.

16
Internal GSK report, ”GSK Diabetes Franchise Cardiology Advisory
Board,” meeting held March 1-2, 2007, report dated March 16, 2007.

17
Id.

5

Moreover,
during the discussion of the DREAM

18

trial, a cardiologist
from Stanford
stated:

[T]he
diabetes
prevention afforded by rosiglitazone was

very
impressive, but there was no cardioprotective benefit.
He
then asked what the point of diabetes prevention
is
if there is no cardiovascular benefit.
19
[Emphasis

added]

When
discussing ADOPT,
20
the academic advisors concluded

that,
”The data in ADOPT and DREAM as well as in the CV Clinical Trials
are consistent in indicating a signal for heart failure and
ischemic
events.” According to GSK interal documents, GSK’s experts
were discussing problems with DREAM as early as 2006.
21

Around
this same time, Dr. Steven Nissen began studying the
potential
cardiac risks of Avandia, by reviewing data found in previously
published studies. He placed several requests to GSK asking
for patient level data on several studies published about
Avandia.
However, GSK would provide the requested data only if Dr. Nissen
agreed to use a GSK statistician for the analysis.
22
Dr. Nissen refused to use the Company’s statistician, citing a need
to

maintain
independence.
23

On
May 2, 2007, Dr. Nissen submitted an analysis of 42 published
and unpublished clinical trials on Avandia to the

NEJM

for peer review and publication.

NEJM

then sent confidential copies of the study to several independent
experts, including Dr. Steve Haffner, to peer review the Nissen
study. According to

NEJM
,
peer reviewers must acknowledge in writing that the material they
are reviewing is confidential, not to be shared with others, and is
to be destroyed or returned to the medical journal after a review is
com-

pleted.24

However,
the very next day, May 3, 2007, Dr. Haffner faxed Dr.
Nissen’s
unpublished study to a GSK executive. Dr. Haffner wrote
”confidential”
on the fax cover sheet and checked a box marked ”urgent.”

25

LEAKED
MANUSCRIPT
AND A SCRAMBLED DEFENSE

One
day after
receiving the unpublished study from Dr. Haffner,

GSK
produced a
detailed, 8-page analysis of Dr. Nissen’s paper,

18
DREAM is an acronym for ”The Diabetes Reduction Assessment with
Ramipril and Rosiglitazone
Medication.” DREAM is an international, multi-center, randomized,
double-blind diabetes
trial involving 5,269 patients from 21 countries. The DREAM study was
conducted by the Population Health Research Institute and published
in the middle of 2006.

19
Internal GSK report, ”GSK Diabetes Franchise Cardiology Advisory
Board,” meeting held March 1-2, 2007, report dated March 16, 2007.

20
ADOPT is an acronym for ”A Diabetes Outcome Progression Trial.”
ADOPT is a randomized,
double-blind, parallel-group study conducted on

3,600
drug-naive patients designed to

measure
the efficacy
of rosiglitazone in controlling the glycemic levels of Type 2
diabetes patients.

21
Internal GSK slide show, ”DREAM: Results of the Rampiril Arm,”
undated but several
slides
state ”updated Sept 6/06.” One particular slide titled, ”DREAM vs.
Previous Trials,” notes
that
DREAM ”was low power to detect differences in CVD events (short
duration, low risk participants).” The summary and conclusions
slide on DREAM finds that the study had ”too few

events
to draw any
conclusion re the effect on other CV events or death.”

22
Internal GSK emails, dated May 3, 2007. ”I have made oit [sic] clear
in my letter of Feb 26 [to Dr. Nissen] that analyses should be
conducted by GSK personnel pursuant to prospectively
agreed
analyses plan.”

23
Multiple staff discussions with Dr. Steven Nissen, from June 2007 to
the present.
24
Email from

NEJM

editor to Committee staff, dated December 18, 2007.
25
Steven Haffner, fax to Alex Cobitz, dated May 3, 2007.

6

weeks
before the paper’s public release.
26
The GSK statistician attempted
to find deficiencies in Nissen’s meta-analysis but noted, ”The
selection of trials therefore appears to be thorough, though others
more familiar with the trials can comment more knowledgeably.”

27

The
GSK statistician also performed a regression analysis

28

on
each
study that Dr. Nissen used in his meta-analysis to see if the
effects
of myocardial infarction and/or cardiovascular death would
still
appear. The statistician stated, ”These results are very similar
to
the conclusion from the [Nissen] paper using the Peto method.
29
As
such there is no statistical reason for disregarding the findings

as
presented.”

30

The
GSK statistical analysis was circulated to senior executives within
GSK. These executives then discussed several large trials,
such
as RECORD, DREAM and ADOPT that GSK could use to
combat
Dr. Nissen’s analysis. RECORD was an ongoing trial that
had
not been published. On the other hand, DREAM and ADOPT
were
published and were included in Dr. Nissen’s analysis. GSK, as well as
the FDA, had also performed their own meta-analyses.

Both
meta-analyses were consistent with Dr. Nissen’s results.
31

On
May 8, 2007, Dr. Moncef Slaoui, head of research at GSK, wrote an
email to several company executives.
32
Commenting on
the
meta-analyses,
he wrote:

FDA,
Nissen and GSK all come to comparable conclusions
regarding
increased risk for ischemic events, ranging

from
30 percent to
43 percent!

FDA
and Nissen (but no final data from GSK [to] date)

reach
the conclusion
of an [hazard ratio] for death (CHF

+
IHD) of 1.72 or 1.75!

33

Dr.
Slaoui also
noted in this email that a GSK commissioned

study
by Ingenix did not find any significant problems with
rosiglitazone.
Ingenix had performed an epidemiological study of
Avandia.
While medical experts place greater importance on a clinical
trial over an epidemiological study, Dr. Slaoui sought to highlight
the Ingenix results. He also expressed concern that a beneficial
effect was observed (6 to 16 percent) in the PROactive

34

study
of ACTOS in high-risk cardiovascular disease patients.
35

26
Internal GSK document, ”Report on the article by SE Nissen & K
Wolski ‘Effect of rosiglitazone on the risk of myocardial
infarction and cardiovascular death.’ ” Research Statistic
Unit,
GSK, DRAFT May 4, 2007.

27
Id.

28
A statistical method that allows data to be simultaneously adjusted
for differences in the

distribution
of a wide variety of measured risk factors that may exist between
patients in a
study
treated with one therapy compared to those treated with another or
with placebo.

29
Peto Method is a widely used way of combining odds ratios in
meta-analysis.

30
Internal GSK document, ”Report on the article by SE Nissen & K
Wolski ‘Effect of rosiglitazone
on the risk of myocardial infarction and cardiovascular death.’ ”
Research Statistic
Unit,
GSK, DRAFT May 4, 2007.

31
Internal GSK email from Moncef Slaoui to multiple GSK executives,
dated May 8, 2007.
32
Id.
33
Id.

34
PROactive
”PROspective
PioglitAzone Clinical Trial In MacroVascular Events Study.” The

PROactive
Study was initiated as a randomized, double-blind, placebo-controlled
cardiovascular outcome study to determine the effects of pioglitazone
on reducing the risk of a wide variety of cardiovascular events as
well as to determine its ability to control blood glucose levels of
patients with Type 2 Diabetes. The study was commissioned by Takeda
pharmaceuticals, a company
that competes directly with GSK and produces a similar diabetes
medication called
ACTOS.

35
Internal GSK email from Moncef Slaoui to multiple GSK executives,
dated May 8, 2007.

7

Dr.
Slaoui asked,
”How can we reinforce the value of the

[Ingenix]
study? The FDA criticizes the fact that we excluded cases
of
sudden cardiac death.”

36

He then asked his team to strategize

further
on the
issue:

[W]hat
studies could
we offer the FDA to further assess

the
contradictory data between the integrated study and
the
two others? can we expand Record? Propose something
else
(very high risk patients? ok? ethical?), compare to

Actos
for superiority on some end points?

37

By
May 9, 2007, GSK
began drafting ”key messages” to counteract
the findings of the Nissen study.
38
In an email, GSK’s Vice
President
for Corporate Media Relations noted, ”The Nissen
analysis
is one way of looking at the data, but it doesn’t reflect all we know
about the safety of this medicine. . . . [W]e are not seeing
a
proven link between Avandia and increased cardiovascular

deaths.
. . .”

39

On
May 9, 2007, Sir Colin Dollery, a senior consultant to GSK,
laid
out many of the problems with Avandia in an email to Dr.

Slaoui
and others.
He wrote:

To
a great extent,
the numbers are the numbers, the [Nissen]
analysis is very similar to our own. . . . We cannot undermine
the numbers but I think they can be explained so

we
must concentrate on effective risk management.
40

Later
in the email,
Sir Dollery noted that the PROactive study

on
ACTOS
(pioglitazone) is undermining Avandia (rosiglitazone).

He
wrote:

The
main argument
here lies in that pioglitazone [ACTOS]

causes
a small reduction of LDL [Low-Density Lipoprotein] and rosiglitazone
causes a small elevation. . . . [W]e should
search
for evidence that the use of statins in diabetics generally and
with rosiglitazone in particular has risen steeply
over the time the thiazolidenediones have been on the market. We can
then argue that any problem that existed
with
LDL is now controlled or controllable. It would also
be
worth obtaining the evidence that the use of antihypertensives
in diabetics has also been increasing rap-

idly.41

On
fluid retention
and links with cardiovascular disease, Sir

Dollery
mentioned a
possible mechanism to explain how Avandia

may
cause heart
attacks. He wrote:

If
[fluid retention
is] substantial in patients with an impaired
myocardium it can lead to [cardiac heart failure] and to cardiac
ischemia by decreasing myocardial efficiency
in the face of existing coronary disease. . . . If there
is
criticism of GSK it might be that we were a bit slow off

36
Id.
37
Id.

38
Internal GSK email from VP Corporate Media Relations, US
GlaxoSmithKline, dated May

9,
2007.

39
Id.

40
Internal GSK email from Colin Dollery to Moncef Slaoui and other GSK
officials, dated May

9,
2007.

41
Id.

8

the
[mark] in making
firm recommendations about the use

of
diurectics . . .
42
and recognizing that the sodium retention
is mediated via distal renal tubular ENaC.
43

On
May 21, 2007,

NEJM

published online Dr. Nissen’s metaanalysis
that found a link between Avandia and heart attacks.
That
same day, GSK responded, ”GSK strongly disagrees with the
conclusions
reached in the

NEJM

article, which are based on incomplete evidence and a methodology
that the author admits has
significant
limitations.”

44

Instead, GSK highlighted the results of company sponsored trials like
RECORD as ”the most scientifically rigorous way to examine the
safety and benefits of a medicine.”

45

In
a subsequent letter to

The Lancet,

GSK maintained that the
RECORD
trial is ”compelling evidence” for the safety of Avandia.
46

On
May 23, 2007, a GSK official emailed members of the
RECORD
steering committee, the group of independent academics overseeing the
study, to alert them of a teleconference to be held
the
following day.
47
GSK officials also emailed internal talking
points
to help guide their discussion with the steering committee. However,
it appears that prior to receiving input from the steering committee,
GSK had already decided to publish the RECORD results.
Later that same day, a GSK official wrote, ”. . . we’ve decided

to
disclose the results. . . .”

48

The
following day, GSK officials discussed potential problems if the
academics on the RECORD steering committee raised concerns about
publishing the interim results of the RECORD trial.
49
In an

email,
one GSK
official wrote:

[I]f
the Steering Committee [SC] are reluctant to publish

Frank
and I will argue the case that there is a balance to be drawn between
very negative press coverage and specific
reassurance for the patients in the study. However if
the
SC believe that publishing interim data will fatally damage their
ability to bring the study to a completion

Frank and I will bring that opinion with reasons back to GSK, before
pursuing the line
that
a decision has been

madelive
with it.
50

42
Diuretics are blood pressure medications that cause the body to
excrete water and sodium
(salt).

43
Internal GSK email from Colin Dollery to Moncef Slaoui and other GSK
officials, dated May
9,
2007.

44
GlaxoSmithKline press release, ”GlaxoSmithKline responds to NEJM
article on Avandia,” published online May 21, 2007.

45
Id.

46
Ronald Krall M.D., Chief Medical Officer, GlaxoSmithKline,
”Cardiovascular Safety of

Rosiglitazone,”
The Lancet,

letter published online May 30, 2007. ”The most compelling evidence
comes
from RECORD (Rosiglitazone Evaluated for Cardiac Outcomes and
Regulation of glycaemia in Diabetes), an open-label, 6-year,
cardiovascular outcomes trial (with prospectively defined
cardiovascular
endpoints) in 4458 patients that started in 2000.”

47
Email to GSK officials and RECORD steering committee, dated May 23,
2007.
48
Internal GSK email, dated May 23, 2007.
49
Internal GSK email, dated May 24, 2007.
50
Id.

9

A
few hours after
this email, the acting chair of the RECORD

steering
committee, contacted the

NEJM

to inquire about publishing the interim results.
51
The editor of the

NEJM

responded

that
the journal would be interested in publishing the study.
52

By
May 29, 2007, several authors of the RECORD study began passing
around a manuscript, discussing the results, and offering
suggestions
for improvement. The third author on the RECORD study wrote, ”We do
not find more myocardial infarctions with rosiglitazone treatment,
but again there is a tendency supporting the Nissen argument. It is
important to stress that it does not affect
cardiovascular death.”

53

That
same day, a
senior author of the RECORD study, wrote:

There
are several
striking issues:

(1)
The HR ratio
(and 95 percent CI) for MI in RECORD

is
not inconsistent with Nissen’s
and
he had more events; what’s to stop him adding the events from RECORD
to his meta-analysis and re-enforcing his view? . . .

(2)
Same is for CV
death, although the number of events

in
RECORD and in the
meta-analysis are similar and at

least
in RECORD the
HR is in the other direction!

(3)
Manuscript looks
to downplay the 239 percent INCREASE
in HF. I have
taken the liberty of doing some rewording.
54

Once
a study is
submitted to a journal, the journal editors then

send
the article to several experts for peer-review. After the review,
the
editors send the peer-review comments back to the author. On
June
1, 2007, the RECORD authors received a reply from

NEJM
regarding
their earlier submitted manuscript. The

NEJM

editors
summarized
the issues presented by all 8 peer reviewers, many of

whom
were highly critical of the study in their reply.
55

Reviewer
A, along with other reviewers, asked that the authors ”modify the
language in multiple locations in the manuscript to
tone
down your conclusions.”

56

The editor also noted, ”[I]n the
opinion
of all the readers, the data that you present are completely
compatible with the results of the meta-analysis by Nissen and the
meta-analysis for myocardial ischemic events posted on the GSK

Web
site.”

57

Regarding
the comments of Reviewer B, the editors wrote that
for
myocardial infarction the ”estimates in the RECORD trial and
the
Nissen meta-analysis” overlap in their confidence intervals,
meaning
that they found a similar trend for heart attacks.
58
They
continued,
”The editors feel strongly that your data do not support

51
Email from Acting Chair of the RECORD trial to Editor at

NEJM,

dated May 24, 2007.
The
Acting Chair wrote, ”We the Steering Committee of the RECORD Study
would like to submit a brief report of the current interim findings
of this ongoing trial concerning the key cardiovascular
outcomes.”

52
Email from Editor at

NEJM

to the acting chair of RECORD trial, dated May 24, 2007.
53
Email between members of the RECORD trial, dated May 29, 2007.
54
Email between members of the RECORD trial, dated May 29, 2007.

55
Letter from the

New England Journal of Medicine

to Philip H. Home, M.D. dated June 1,

2007.

56
Id.
57
Id.
58
Id.

10

the
statement that
the RECORD results for MI contradict the Nissen
meta-analysis; this statement must be removed or modified.”
59

Reviewer
C noted that the RECORD trial is not blinded,
60
and
pointed
out ”the serious problem of the low event rate, especially
for
MI events, in this study.”

61

He continued to ask, ”Do you have
an
explanation for the very low event rate?” This reviewer also
noted
the ”need to greatly tone down your language to reflect the

substantial
level of uncertainty in the data.”

62

Reviewer
D
questioned the need for keeping rosiglitazone on the market. ”The
editors also agree that an explanation for the continued
use of rosiglitazone is needed in this manuscript.”

63

The
NEJM

published the interim analysis of the RECORD study
on
July 5, 2007. The GSK study authors concluded that the data
was
”insufficient” to find a link between Avandia and heart attacks.
64

However,
an editorial by the

NEJM

questioned the RECORD study, as well as several of GSK’s studies of
Avandia such as DREAM and ADOPT. The authors of the editorial wrote,
”The
DREAM
trial and ADOPT focused largely on marketing questions
and
failed to address questions of myocardial infarction-related risk
or
benefit directly.” In addition, the editorial noted that the
RECORD
trial had ”several weaknesses in design and conduct” including
a lack of blinding when treatment was assigned. The authors
also pointed out that events of myocardial infarction would have been
a preferred clinical endpoint for the study. Studies are normally
designed to evaluate certain clinical endpoints or disease symptoms
such as heart attack, tumor size, or depression. The authors also
added that the RECORD study was not powered (or designed)
to detect a myocardial infarction as an endpoint.
65

On
June 6, 2007, the House of Representatives Committee on
Oversight
and Government Reform held a hearing on Avandia. Despite
mounting criticism of the RECORD trial, Dr. Slaoui again highlighted
the study in his sworn testimony. ”I will say that we
found
the RECORD data which we published yesterday in the

New England Journal of Medicine

very reassuring, recognizing that it

is
interim and therefore not fully conclusive.”

66

That
same day, GSK dismissed the idea that Dr. Nissen’s study
spurred
the publication of the RECORD interim results. Instead,
the
Company placed blame on the media. In talking points created
for
its sales force, GSK stated, ”Because of the widespread media

59
Id.

60
A blinded study is a study done in such a way that the patients or
subjects do not know

what
treatment they are receiving to ensure that the results are not
affected by a bias on the
part
of patients, doctors, or the sponsors who are paying for the study.

61
Letter from the

New England Journal of Medicine

to Philip H. Home, M.D. dated June 1,
2007.

62
Id.
63
Id.

64
Philip D. Home et al., ”Rosiglitazone Evaluated for Cardivascular
Outcomes
An
Interim

Analysis,”
the

New England Journal of Medicine,

July 5, 2007. The study authors concluded,
”Rosiglitazone
was associated with an increased risk of heart failure. The data were
insufficient
to
determine whether the drug was associated with an increase in the
risk of myocardial infarction.”

65Bruce
M Psaty, et al. ”The Record on Rosiglitazone and the Risk of
Myocardial Infarction,”
the
New England Journal of Medicine,

July 5, 2007.

66
House of Representatives, Committee on Oversight and Government
Reform, ”Hearing on
FDA’s
Role on the Evaluation of Avandia’s Safety,” June 6, 2007,
preliminary transcript, page 168 (
see
also http://oversight.house.gov/documents/20071114160344.pdf

).

11

coverage
of the

NEJM

[Nissen] meta-analysis and the confusion it

has
created, the RECORD Steering Committee decided it was important
to publish the interim analysis in the interests of patient

safety.”
67

Regarding
its
competitor Takeda, which sells ACTOS, GSK advised its sales force
if asked questions about the PROactive study:

Please
do not
discuss Actos or the Proactive study with

your
physicians. For questions regarding Actos or the Proactive study,
healthcare providers should contact
Takeda.
GSK’s focus is on Avandia. Communicate the key
points
from the interim analysis of RECORD to your physicians.
68

THE
RECORD TRIAL
AS A MARKETING

TOOL
FOR
COMPETITION

Despite
attempts to
highlight the RECORD study, it appears

that
GSK knew for years that the study was ”underpowered,” i.e.,
the
study did not provide sufficient data to test for cardiovascular
safety. And executives appeared more concerned about designing a
study
to limit competition from ACTOS. Such evidence can be found in a GSK
slide presentation, emails, and other documents
created
in 2004 to 2006.

For
instance, in an undated slide show, apparently created in
2004,
GSK noted that RECORD does not have sufficient ”power.”

69
The
slide presentation also noted that GSK was trying to create studies
to counter the PROactive study on ACTOS that Takeda

planned
to release.
70

Slide
number 6 titled, ”PROactive: Potential Impact,” noted that
GSK’s
challenge was to ”maintain share in growing market over

next
2-3 years.”

71

Slide
number 8
reads:

Situation
Summary:

We
have a gap

In
2005 Actos will have some [cardiovascular] outcome data

To
keep our share of the growing class

Additive
benefit to RECORD of non-inferiority result

However
this gap may be permanent

RECORD
has a lower event rate than expected

PROPOSAL

Fill
this gap with
an outcome study reporting in 2007

Slide
number 10
compared the potential impact of a new GSK

study
to counter the marketing danger of PROactive and the potential
impact on sales in UK pounds in 2010. The slide reads: ”Timely
CV
Outcomes data would more than fill the RECORD ‘potential
gap’
and would have twice the impact on our sales than PRO-

67
GSK’s
RECORD
Study Questions, dated June 6, 2007, for GSK Internal Use Only.
68
Id.

69
GSK
Internal
Slide Show, ”European Commercial Need for a Post-ACS Study
Proposal,” undated.

70
Id.
71
Id.

12

active.”
72

The final slide pointed out that GSK should do a ”kick
off
study only after review of results from Proactive in Sept 2005

and
assessing benefits/risks.”

73

A
second instance is found in a June 2005 email where GSK executives
discussed the need for a study to counter PROactive. In
the
email, a GSK official wrote, ”Clearly no patients will be re-
cruited until [we] have made a decision based on the go-no go cri-
teria
from the PROactive data. However, there is a great deal of

EU
commercial push to initiate this study in 2005.”

74

A
third case is found in an internal GSK document outlining an
upcoming
meeting for December 2004. Several points were discussed about
RECORD and PROactive. Regarding RECORD, the
document
noted that RECORD has ”low events rates.” This means that the study
did not have the statistical ”power” to give sufficient
cardiovascular event data. The document also stated, ”PROactive
results
to be coming soon
need
to be able to respond to a variety
of
different outcomes. Communications plan in place for various

possible
outcomes of PROactive.”

75

A
fourth instance is
found in a briefing document for a June 2005 meeting on Avandia’s
cardiovascular plan. The document

notes
several ”important limitations of RECORD.”

76

the
study will not be available until 2009

the
current observed rate for the primary endpoint is very

much
lower (approximately 3.5 percent per annum) than that
anticipated
in the original protocol (11 percent per annum).
77

A
fifth case is
found in another GSK email. On July 26, 2005,

GSK
officials began
emailing each other about potential problems with RECORD and how the
PROactive study by Takeda on ACTOS

will
create problems
for Avandia. One official wrote:

Ron
Krall [then GSK
Chief Medical Officer] has asked

Lawson
[unknown GSK executive] to provide an urgent
update
to David Stout [then GSK President of Global
Pharmaceutical
Operations] regarding RECORD. In particular
he has asked for our ”intent to manage information
flow
in Europe to manage the competitive situation.”
Clearly
we can provide a summary of the communications
around
PROactive but I wonder if you could put a few sentences
together regarding the communications piece

around
RECORD.
78

A
sixth incident is
documented in July 2005, when GSK officials

continued
expressing concerns about cardiovascular problems with Avandia and
potential problems arising from the PROactive study
which
focused on positive findings with ACTOS. GSK held a meeting
on July 18, 2005 to discuss the need for a study to compete

72
Id.
73
Id.

74
Internal
75
Internal
76
Internal

GSK
email, dated
June 16, 2005.

GSK
document,
untitled, unknown date.

GSK
document,
”Briefing Document for 27 June 2005 PMB Avandia Cardiovascular
Modeling
Plan.”

77
Id.

78
Internal GSK email, dated July 26, 2005.

13

with
PROactive.
79
The briefing document from this meeting discussed
the
”European Commercial Need” for a study:

A
recently completed
evidence gap analysis completed by

the
Metabolic Centre of Excellence has identified the need
for
the rapid generation of clinical endpoint data to support
the superiority of rosiglitazone [Avandia] for the prevention of
future cardiovascular clinical events in patients
with
[type 2 diabetes mellitus]. Publication of the PROactive
data may result in important commercial disadvantage in Europe. We
therefore have the opportunity to start
a
CV outcomes study with the aim of getting superiority

data
in 2007.
80

The
document also
noted that GSK’s studies provided insufficient

data
on
cardiovascular outcomes:

The
primary endpoint
in RECORD is powered for noninferiority
and taking into account the low observed event rate, it is unlikely
that this study will demonstrate any potential for [Avandia]
combination to be superior in terms
of
the primary endpoint compared to SU+MET combination
therapy. DREAM and ADOPT are collecting CV safety
data,
but these are low risk populations and it is unlikely that [Avandia]
will be superior to controls for the prevention
of CV events.
81

CONCERNS
ABOUT
AVANDIA RAISED PRIOR TO 2007

In
June 2004, GSK’s
leader for a cardiac safety study called the

”Avandia
211 Cardiac Heart Failure Study”

82

reported on a meeting
with a consulting academic. The academic was the chairman of the
independent clinical endpoint committee for the Avandia 211
study.83
The study leader’s report of the academic consultant’s

feedback
on Avandia
211 follows:

With
regard to CV
mortality and morbidity data, [the academic
consultant] said that the results were ‘almost identical’ to the
results he had seen from a previous glitazone
study
as a member of the DSMB with increased CV
events,
hospitalizations, and ischaemic events. [The academic consultant]
said that he felt this was a class effect as a result of reduced
oxygen carrying capacity as a result

of
haemodilution to fluid-retention.
84

The
report of the
Avandia 211 meeting noted that the academic

consultant
said he would not stop prescribing Avandia, as the
study
was too small, and that he ”would continue to use [Avandia]

79
Internal GSK document, ”MDC Briefing Document: Ad-hoc meeting 18th
July 2005.

AVD104821:
rosiglitazone in post-acs patients.”

80
Id.
81
Id.

82
Internal GSK slide show titled ”Avandia 211 CHF study: Senior Review
of Additional Analysis,”
undated.

83
Internal GSK report, ”Avandia 211 CHF study
Review
of Study Results, Feedback from
Professor
NAME REDACTED,” dated June 3, 2004.

84
Id.

14

as
a second or third
line therapy whilst taking appropriate precautions.”

85

Later
that month,
several GSK representatives met with the advisory
board for study protocol 211.
86
The meeting notes state:

There
was
disappointment verbalized about the morbidity

and
mortality table that showed that there were ten ischemia-related
adverse events in the rosiglitazone group
versus
five events in the placebo group. . . . Dr. NAME REDACTED
found [it] unusual that there was an increase in
edema
and cardiac events despite the fact that there was significant
improvement in glycemic control in the rosiglitazone
arm of the trial. He thought the glycemic control
and
pleitrophic [sic] effects of rosiglitazone would have predicted
a different outcome than what was observed.
87

In
late 2005, GSK
published a draft retrospective analysis of cardiovascular
events in Avandia clinical trials discussing the underlying cause
for the increase in ischemia.
88
In a section of the analysis
that examined myocardial ischemia, the authors mention a
”hypothesis
that small degrees of fluid retention may be an important
contributor to the development of worsening myocardial ischemia
in high risk patients.”

89

After
GSK reviewed the evidence found in this analysis, it appears
that the Company was aware of the potential cardiovascular risks
associated with Avandia in late 2004 or early 2005. In 2005,
GSK
commissioned an ”observational” trial study that was conducted
in two parts: the first part in 2005 and the second in 2006. The
results of these studies support the further investigation of the
cardiovascular
risks associated with Avandia.

The
first study included 11,586 subjects randomly placed in clinical
trials before September 20, 2004. The analysis of the trials was
completed during the fall of 2005, giving a hazard ratio for myocar-
dial
ischemia of 1.29, meaning that rosiglitazone increased the risk
of
heart-related ischemia by 29 percent. This number was statistically
significant.

GSK’s
second observational study involved analyzing 14,237 patients
by the summer of 2006. The results found a hazard ratio of 1.31,
meaning that Avandia increased the risk of myocardial ischemia
by 31 percent.
90

CONCLUSION

In
preparing this
report, Committee investigators reviewed over

250,000
pages of
documents provided by GSK, the FDA, the University of North
Carolina, and others. Anonymous whistleblowers who contacted Senator
Grassley’s investigators provided hundreds of other pages. For well
over a year, Committee investigators also

85
Id.

86
GSK Internal Meeting Minutes, ”Summary of the feedback from the
Advisory Board Meeting
held on June
23rd, 2004, the Philadelphia Airport Marriot to discuss Study
Protocol 211.”

87
Id.

88
Internal GSK document titled, ”Rosiglitazone: Further Interim
Results from Retrospective

Analysis
of
Cardiovascular Events in Clinical Trials DRAFT,” undated.

89
Id.

90
GlaxoSmithKline, Studies ZM2005/00181/01 and
HM2006/00497/00/WEUSRTP866;

http://

ctr.gsk.co.uk/Summary/rosiglitazone/studylist.asp.

15

conducted
numerous
interviews and phone calls with GSK, the

FDA
and anonymous
whistleblowers.

The
totality of evidence suggests that GSK was aware of the possible
cardiac risks associated with Avandia years before such evidence
became public. Several years prior to Nissen’s study, it can
be
argued that GSK was on notice that Avandia may have problems. Based
on this knowledge, GSK had a duty to sufficiently
warn
patients and the FDA of its concerns in a timely manner. Instead,
GSK executives intimidated independent physicians, focused on
strategies to minimize findings that Avandia may increase cardiovascular
risk, and sought ways to downplay findings that the
rival
drug ACTOS (pioglitazone) might reduce cardiovascular risk.

In
recent years, pharmaceutical companies have committed acts that
forced them to pay the largest criminal fines in American history.
91
In cases involving Pfizer, Eli Lilly, Bristol Myers Squibb
and
four other drug companies, these fines and penalties have totaled
over $7 billion since May 2004.
92
In particular, Pfizer has been fined multiple times in the past 6
years for illegal off-label
promotion
of their drugs. In its latest plea agreement, which took place last
September, Pfizer paid $2.3 billion in fines and penalties for
off-label promotion of Bextra. This settlement was the largest
criminal fine in U.S. history.
93
Such an environment requires diligent
oversight by the FDA to protect the citizens of this country
and
to ensure the safety of American medicine.

91
David Evans, ”Pfizer Broke the Law by Promoting Drugs for Unapproved
Uses,”

Bloomberg,
November
9, 2009.

92
Id.
93
Id.

The full 342 pages can be read via this link: http://finance.senate.gov/press/Gpress/2010/prg022010a.pdf.

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Posted in iHN Archive, Medical Tsunami N°1 | Comments Off on US Senate Committee Report January 2010

U.S. Senate Committee exposes Big Pharma medical fraud

The U.S. Senate Committee on Finance investigated the diabetes drug Avandia and its manufacturer GlaxoSmithKline. A report was published in January 2010. It comprises of 342 pages, hence it took me some time to study it all.

The report can be purchased from the Superintendent of Documents, U.S. Government Printing Office (full details via link?below).

The findings of this report, based on a most thorough investigation spanning two years,?are important for public health?to say the least. I therefore take the liberty to post the 18 most significant pages here: US Senate Committee Report January 2010.

What we can learn from this report:

1. “Scientific research results” are NOT “Scientific research results”. The script is written by Big Pharma and scientists serve as willing tools to produce the desired result.

2. The investigated diabetes drug Avandia may be the worst of the lot, but all cause heart attacks instead of preventing them as the public is made to believe. Avandia increases death from heart attacks by 43%. This means that 43 out of 143 diabetes patients that?die from heart attack do so because they are on Avandia. Relate this figure to the millions who take Avandia and you get a graveyard of a respectable size.

3. Behaviour and actions of GlaxoSmithKline, their executives and scientists to be exact, are the norm in Big Pharma and constitute an Industry Standard. This includes?but is not limited to intimidation of unwilling scientists, deception of regulating bodies, falsification and supression of evidence. Getting caught is a calculated risk. This is reflected in the fact that?”The Industry” paid fines and penalties of some $7billion since 2004 in the U.S. alone.

The report reads like a James Bond 007 script, enjoy reading. http://infoholix.net/article_US-Senate-Committee-report-January2010.php

24.02.2010

Cheers,
Wilfrid

Wilfrid Hartnagel
ceo, infoholix.net
www.infoholix.net

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MRI-industry hits back

Update to “MRI is safe, – the contrast agent only kills.

09.03.2010

MRI-industry hits back

The MRI-industry is busy whitewashing their gadolinium based contrast agents.

This is done via “scientific clinical studies”.

The principle findings of these is based on the switch from one brand to another.

One clinic switches from contrast agent “A” to “B+C”, another switches from “B+C” to “A”. Both conclude that their procedure is now safe.

At least some have the decency to mention limitations of their study as in the case of researchers at Emory University Hospital in Atlanta and the University of North Carolina (UNC) at Chapel Hill. This study was published online in Radiology on October 7, 2009 with Dr. Ersan Altun as lead author (1)

The use of a relatively short follow-up period was cited as a possible limitation. Because NSF generally develops in two to three months following gadolinium exposure in the majority of patients.

Naturally data was collected from patients in the care of the above two clinics and did not include patients who went there for an MRI only to return to their physician who may not associate symptoms with NSF that occur two or three months later, or even several months later. Not all affected patients develop fully blown NSF, some have a selection of NSF symptoms only.

Noteworthy is an Italian study that finds that half a dose of gadolinium works as well as a full dose:

“Until now, there has been no consensus on the ideal dose of contrast medium and the exact time of data acquisition,” said lead author Dr. Iacopo Carbone from the University of Rome “La Sapienza.” “We should take into account, especially in patients with acute myocardial infarct who already underwent administration of iodinated contrast media for primary angioplasty, that it is common sense to use as little as possible a dose of gadolinium to avoid the complication of NSF.”

Dr Iacopo Carbone’s clinical trial was conducted on 15 patients only. It had no commercial sponsor and hence fails to recommend a particular brand.

“Based on our results, we can conclude that a half dose of gadolinium-BOPTA gets comparable results to a full dose, with shorter acquisition times for the depiction of delayed enhancement in patients with acute myocardial infarction,” Dr Iacopo Carbone said. “The use of gadolinium-BOPTA at the half dose can help reduce examination times, reduce costs, and especially could be very useful in patients at high risk for NSF.”

The European Congress of Radiology (ECR) was held on Sunday, 7th March 2010, in Vienna.

Dr. Olivier Clement, Ph.D., from European Hospital Georges Pompidou in Paris presented results from the CIRTACI study, a multicenter, prospective investigation in France examining contrast agent reactions over four and half years, concluding in March 2009. The study involved 31 centers at university hospitals in France.

The study focuses on reactions of both gadolinium-based MRI contrast agents and iodinated contrast agents. Five gadolinium agents were included in the trial, and ten iodinated products were included.

I shall report on this once it has been officially published and I’ve studied it in detail.

Gadolinium is here to stay, there are no indications that it will be withdrawn.

People are unaware, or nobody would dare to subject him/herself to such a procedure.

There are also no indications that allopathy is searching for a cure of NSF.

Such a cure would be counter-productive, it would tell the public that there is a problem.

It would hardly enhance the image of allopathy to say:

“MRI is safe, – we can cure the damage it causes”

Cheers,
Wilfrid

Wilfrid Hartnagel
ceo, infoholix.net
www.infoholix.net

References:

(1) radiology.rsna.org

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Update 04.02.2010 + 17.02.2010: MRI is safe, the contrast agent only kills

Update 17.02.2010 MRI is safe, the contrast agent only kills.

What can you do when you have had an MRI and you experience symptoms?

These symptoms may appear days or weeks after the MRI. The treating physician may not associate these with MRI and may not even know that you have had one.

I’ve been contacted by therapists who use bio-feedback systems, they
suggest it may be possible to detect a change in “Aura”, “Human Energy Field”, or whatever terminology the manufacturer of the system uses. Bio-feedback systems are widely used in Central Europe and to a much lesser extend in the English speaking hemisphere. They originate in Russia and Germany where even big manufacturers of medical equipment are getting into this market.

Gadolinium will have caused the damage while it was present in your body, resulting in a change of your aura or energy field. This change will persists after gadolinium is flushed out of your body. Bio-feedback may also detect gadolinium residues that have not been flushed out.

Do you have a bio-feedback system of any make? Please get in touch with me.

Cheers,
Wilfrid

Wilfrid Hartnagel
ceo, infoholix.net
www.infoholix.net

Update 04.02.2010

When Toyota has a problem with a gas pedal the mass media gets excited and the whole world discusses possible implications. Shares fall, politicians add their two cents and the survival of the human species is in danger.

Arguably this generates advertising revenue from competitors.

When gadodiamide based contrast agents get injected into millions of people the mass media does not get excited and chooses to ignore the issue.

Arguably exposing this threat would not generate advertising revenue as there are no competitors. Gadodiamides are produced throughout Big Pharma. Bayer produces the market leader Magnevist, Omniscan by GE Healthcare, Optimark by the Covidien unit Mallinkrodt, MultiHance and ProHance by Bracco Diagnostics, to name but a few.

Neither physicians who provide MRI nor the public is informed about how much gadolinium is released by which contrast agent and under what circumstances. The information about damage done is elusive in most cases. The reporting chain seems not to be working.

When a patient develops symptoms days or weeks after an MRI he/she is in the care of the regular physician who knows little about NSF and does not associate symptoms with MRI. The MRI provider never learns about these cases.

MRI providers experience instant adverse reactions, and these are plentiful. Reports about these are pouring in, thank you, keep sending them. I quote from one of these reports:

“I was sent for an MRI on June 16 to determine the size of the cancer in my left breast. I did not know that the procedure included I.V. injection of gadolinium contrasting agent into my veins. I had no time to research or understand what the substance was.

I had to sign a release about the gadolinium in order to have the MRI. The MRI technician told me that gadolinium was a problem only for people with kidney disease.”

The patient in question did not have any kidney disease before the MRI. The patient developed severe, debilitating symptoms thereafter that persist until today.

Why should you have to “sign a release” if you have no kidney disease? This indicates that problems are known that go beyond the stage of “kidney disease”.

Let’s get to the bottom of this – and find a cure.
Please take part in this project and register under
http://infoholix.net/category.php?mId=118

For your convenience please find last weeks newsletter below.

04.02.2010

Cheers,
Wilfrid

Wilfrid Hartnagel
ceo, infoholix.net
www.infoholix.net

Posted in iHN Archive, Medical Tsunami N°1 | Comments Off on Update 04.02.2010 + 17.02.2010: MRI is safe, the contrast agent only kills

MRI is safe, the contrast agent only kills

MRI is safe, the contrast agent only kills

Gadodiamide based contrast agents used in MRI have been found to release the highly toxic metal Gadolinium and cause a new disease termed Nephrogenic Systemic Fibrosis, NSF.

Please read about the symptoms of this man-made disease and the devastating consequences for NSF patients http://infoholix.net/category.php?mId=118. You’ll also learn who discovered NSF and when and the response of regulating bodies to this discovery.

The bottom line:

Since at least 1993 millions, possibly hundreds of millions, have been affected. It seems to be health-politically incorrect to disseminate information about NSF to health professionals and patients alike. MRI is the “(w)holy cow” of allopathy, “you shall not taint its image”.

Physicians are not aware of NSF and hence fail to diagnose. Symptoms of early stage or less severe stage can easily be mis-diagnosed.

There is no cure and nobody in allopathy seems to be interested in finding one as it would require to expose that the contrast agent in MRI is the cause. This has political and legal consequences as well, a situation to be avoided at all costs, so it seems.

When a physician states “it is unethical and risky to use this contrast agent” and consequently refuses to use it he will face a libel case. This sends a clear message to all physicians: “do not stop using our contrast agent and do not make negative statements or we will sue you”.

As evidence for this remark I refer to “GE Healthcare vs Henrik Thomsen”,

The High Court of Justice

Queen’s Bench Division

Claim No. HO 08X01610

This is an ongoing case and I’ll be glad to send you court documents as attachments.

My primary concern are the NSF patients, those who have been diagnosed with NSF which are a few hundreds only, and those who suffer from it and have no idea that they have NSF and why they have it which may be millions.

You, the therapist, are in a position to identify these NSF patients in your area. You can ask the patient with appropriate symptoms if he/she has had an MRI, then investigate to find out what contrast agent was used. This is a worldwide issue and I am asking all of you for your support.

You can list on infoholix.net under “Nephrogenic Systemic Fibrosis – cure needed!”. Start your listing with the area you cover – ……..

…then we need to find a cure, I trust you are as interested in this as I am.

I am available to discuss this matter on yahoo IM: infoholixdotnet@yahoo.com, or send an email to the same.

27.01.2010

Cheers,
Wilfrid

Wilfrid Hartnagel
ceo, infoholix.net
www.infoholix.net

Reprint of web pages are only allowed with explicit permission. Please request our permission by emailing us with a complete description of the intended use.

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Prescription drugs that cause Diabetes

Prescription drugs that cause Diabetes
by Mark Sircus Ac., OMD Director International Medical Veritas Association

extract from his forthcoming book New Paradigms in Diabetic Care
exclusively for infoholix.net

If there is any justice in the world history will remember Ely Lilly as the company that killed babies. These were words I wrote three years ago but now they are dated for Zyprexa related adult deaths are being fed into a lethal equation that should end up with someone behind bars. Referencing the killing of babies had to do with deaths centered on the injection of thimerosal, a mercury based preservative used in vaccines.[1] This is still going on, it?s not a thing of the past except in intelligent humane societies that know enough not to poison their infants with mercury based preservatives. America is not one of them and Brazil is perhaps the worst because against all measures of sanity they double the amount of mercury in the vaccines they give to infants.

Thimerosal is one of the most toxic compounds I know of,
I can’t think of anything that I know of is more lethal.

Dr. Boyd Haley
Chairman of the Chemistry Department Kentucky U.

For more than sixty years the medical community simply trusted the Eli Lilly Company’s assertion that thimerosal/merthiol ate (fifty percent mercury by weight) had a low potential toxicity if injected into humans. Several generations of public health care officials, doctors and medical educators were duped into injecting the most toxic and lethal chemical known to man into infants. Interesting to note though that the FDA itself in 1982 specifically found that thimerosal was significantly more toxic for living tissue than it was for the bacteria it was supposed to kill. Documents from the archives of Eli Lilly & Company clearly demonstrate that it was known as early as April 1930 that the thimerosal was dangerous yet we still have people swearing to its safety.

The Bush administration has tried to protect
Lilly from liability for harm done with its drugs.[2]
The big question is why would a president of the US do that?[3]

But today the uproar is not about the babies it?s about adults who have died from Lilly?s blockbuster drug Zyprexa[4], which is used in the treatment of schizophrenia and in the short-term treatment of manic episodes associated with bipolar disorder. Many thousands of people have taken this drug and have developed diabetes, pancreatitis (inflammation of pancreas), ketoacidosis, hyperglycemia, seizures, diabetic coma, stroke, heart attack, amputation of a limb (due to diabetes), severe weight gain, and other medical conditions. If they took Zyprexa* on or before March 2004 they are entitled to compensation because of appropriate warnings of the drugs (no longer hidden) dangers were not given.

There were 20 deaths, including 12 suicides, in the Zyprexa
group. Shockingly, these deaths went unreported in the
scientific literature. The death cover-ups also took place in
reporting trial results of several other atypical anti-psychotics.

Dr Stefan Kruszewski, a Harvard trained, certified psychiatrist in adult, adolescent, and geriatric psychiatry finds Lilly’s conduct appalling. Zyprexa causes both a severe metabolic syndrome consisting of obesity, diabetes and cardiovascular problems.” Medical science has discovered how sensitive the insulin receptor sites are to chemical poisoning. Metals such as cadmium, mercury, arsenic, lead, fluoride[ii] and possibly aluminum may play a role in the actual destruction of beta cells through stimulating an auto-immune reaction to them after they have bonded to these cells in the pancreas.

Today, a month’s supply of Zyprexa costs about $380, 10-30 times
more expensive than a month’s supply of a conventional anti-psychotic.

Many drugs have toxic effects that can participate in destroying insulin creation and cell receptivity to it. In her 1994 book, Poisonous Prescriptions, Landymore-Lim’ s says that diabetes may in fact be a major side effect of pharmaceutical drugs. The book provides evidence from studies and hospital records. Diabetes, usually thought to be largely a genetic disorder, may actually have increased so much in the last 50 years due in large part to the proliferation in the use, and over-use, of medicines.
The American Diabetes Association found in 2004 that Zyprexa
was more likely to cause diabetes than other, similar drugs.[5]
The American Diabetes Association, American Psychiatric Association, American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity issued a consensus statement asking doctors to carefully screen and monitor patients on these medications for signs of rapid weight gain or other problems that could lead to diabetes, obesity and heart disease and refer them to specialists if necessary.[6] Some reports claim a tenfold increase in the risk of metabolic disorders and diabetes with the use of Zyprexa as opposed to other drugs in this same class.

Documents reveal the illegal marketing schemes
used by Lilly to make Zyprexa its best-seller.

The New York Times reported in the first week of January of 2007 that Eli Lilly agreed today to pay up to $500 million to settle 18,000 lawsuits from people who claimed they developed diabetes or other diseases after taking Zyprexa, Lilly’s drug for schizophrenia and bipolar disorder. Including earlier settlements over Zyprexa, Lilly has now agreed to pay at least $1.2 billion to 28,500 people who claim they were injured by the drug. At least 1,200 suits are still pending, the company said. About 20 million people worldwide have taken Zyprexa since its introduction in 1996.

The internal documents show that in Lilly?s clinical trials, 16 percent
of people taking Zyprexa gained more than 66 pounds after a year
on the drug, a far higher figure than the company disclosed to doctors.

New York Times[7]

Eli Lilly paid nearly 700 million dollars in a first settlement to settle existing suits from people who have been harmed after using Zyprexa. This settlement was based on allegations that the Zyprexa label in use before March 2004 did not contain adequate warnings regarding serious potential side effects. In addition, published reports indicate that as far back to the 1950?s, studies tied the use of Zyprexa and similar drugs to increased risk of diabetes, pancreatitis, hyperglycemia and other serious conditions. However, it is alleged that Eli Lilly continued to market Zyprexa without adequate warnings, even in light of this information.

Eli Lilly had been the number one player in the US diabetes market
since the 1920’s. Of all companies they should have been highly
sensitive about producing and marketing a drug that causes diabetes
.

Ted Chabasinski, a human rights activist on the MindFreedom board, commented that, “I’m an attorney, and I think the reason Lilly is panicking is that these documents literally show a conspiracy to commit murder. People talk about how these documents show that Lilly committed fraud. They do. But more importantly, if someone deliberately does something that they know will cause the death of another person, they have committed a homicide — murder. Lying about the effects of Zyprexa has led to the deaths of many people. “Since Lilly does business in almost all states, and since people died as a result of Lilly’s behavior as evidenced by these documents, if there were a courageous prosecutor somewhere who saw these documents, conceivably Lilly’s executives could go to jail.” Speaking to the judge in hearings to grant an injunction against distribution of these documents Mr. Chabasinski stated: ?The documents are evidence of Lilly?s criminal behavior and willingness to kill people for profit.?

The Lilly documents prove that the company knew that
Zyprexa was causing diabetes, and kept pushing the drug anyways

Evelyn Pringle

?Lilly entered into an out-of-court settlement in June 2005, and agreed to pay $690 million to cover claims by about 8000 Zyprexa victims. But in order to get paid, the plaintiffs were required to sign a confidentiality clause and basically keep their mouths shut about Zyprexa from then on,? writes Pringle. But the secret has gotten out and the files were posted up on many sites on the internet. Read Evelyn Pringles most recent article which will update you to the most recent legal struggles with Lilly.[8]

Ellen Liversridge wants a criminal investigation of Lilly. She lost her 30-year-old son, Rob, to the adverse effects of the drug. “He gained almost 100 pounds while taking Zyprexa,” Ellen says. “Rob lapsed into a coma,” she recalls, “and died of profound hyperglycemia four days later on October 5, 2002.” “I believe that the people who did this should have a criminal trial,” Ellen says. “Enron executives went to prison for wiping out people’s life savings,” she points out. “Lilly executives should go to prison,” she says, “for knowingly being responsible for people’s deaths, shattered families; ruined and grieving families.”

Can there ever be justice for a crime as heinous as this?

Ellen Liversridge

?The most important story about Eli Lilly is that Lilly?s two current blockbuster psychiatric drugs?Zyprexa and Prozac?are, in scientific terms, of little value. It is also about how Lilly and the rest of Big Pharma have corrupted psychiatry, resulting in the increasing medicalization of unhappiness. This diseasing of our malaise has diverted us from examining the social sources for our unhappiness?and implementing societal solutions,? writes Bruce E. Levine, PhD, a psychologist and author of Commonsense Rebellion: Taking Back Your Life from Drugs, Shrinks, Corporations and a World Gone Crazy. One review of 52 studies involving 12,649 patients concluded, “There is no clear evidence that the atypical anti-psychotics are more effective or better tolerated than conventional anti-psychotics. “[9]

What Eli Lilly had to do was cover up that risk of mania
and psychosis, cover up that some people were
becoming suicidal because they were getting this nervous
agitation from Prozac. That’s the only way it got approved.

Eli Lilly is still paying their hard-hitting attorneys to try to frighten citizens into silence,” said David Oaks, director of MindFreedom International. “This is reminiscent of the way the Nixon administration tried to keep the Pentagon Papers secret even after the materials were in the hands of the NY Times.” So intense is the heat coming from Lilly?s lawyers that writers like Evelyn Pringle attached the following to the end of her essay. ?To avoid having my name added to the dastardly list above and the risk of being subjected to the harassment tactics of Lilly attorneys; I hereby declare for the record, that I did not receive copies of the Lilly documents from Mr. Gottstein.?

It is criminal behavior on a huge scale that is being virtually
totally ignored by the authorities responsible for the public safety.
Larry Bone

For more than 10 years, the drug companies have consistently downplayed some of the serious risks associated with taking atypical anti-psychotic drugs. Psychiatrist E. Fuller Torrey, a leading proponent of drug therapy for schizophrenics, has written about one of the techniques used to mislead physicians and the public: “Psychiatrists trying to evaluate schizophrenia drugs are not told that the expert who minimizes the side effects of Zyprexa receives a $10,000 retainer from Eli Lilly and also owns substantial company stock.” [American Prospect, July 15, 2002]

Though the government is in bed with Lilly the company is facing Medicaid fraud charges in lawsuits all over the county. Because Zyprexa causes diabetes public health programs have been left to pick up the tab for the medial expenses. States are going after Lilly for fraud and restitution related to the promotion of Zyprexa for off-label use and the concealment of its risks.

In 2002, British and Japanese regulatory agencies warned
that Zyprexa may be linked to diabetes, but even after the
FDA issued a similar warning in 2003, Lilly?s Zyprexa train
was not derailed, as Zyprexa posted a 16 percent gain over 2002.

Despite all these facts, the media has paid scant attention to the fact that Lilly has had to pay out now more than a billion dollars to victims of its drug Zyprexa. And despite these facts, there hasn’t been a single voice of outrage or protest heard in the halls of Congress or on the evening news. The fact that Eli Lilly has made no special effort to warn the public of the potentially disastrous consequences of taking Zyprexa, as it continues to rake in profits from the sale of this drug, tells us all we need to know about the heart of this company.

Worldwide in 2003, Zyprexa grossed $4.28 billion, accounting for
slightly more than one-third of Lilly?s total sales. In the United
States in 2003, Zyprexa grossed $2.63 billion, 70 percent of
that attributable to government agencies, mostly Medicaid.

?The drug is of paramount importance to Eli Lilly’s bottom line. The company seems to have developed a Zyprexa addiction, from which withdrawal will be difficult. Eli Lilly has also realized indirect profits from Zyprexa sales. It’s a cruel irony that while the company is filling its coffers by selling a drug that can cause diabetes, four of its top-selling drugs are treatments for diabetes, with Humulin and Humalog each expected to top $1 billion in annual revenues. Eli Lilly gets the customer coming and going,? writes Leonard Roy Frank.

The review of Medicaid records, reported in the
April 2006, Oregon Health News, found that 41% of
the preschoolers were prescribed psychiatric drugs for ADD.[10]

The rate of children treated with atypicals “is growing dramatically faster than the rate for adults,” said Dr. Robert Epstein, chief medical officer for Medco. “Doctors need to be judicious when prescribing antipsychotic drugs to children,” Epstein warned. “There is evidence that the risk of diabetes and metabolic disorders from using atypical anti-psychotics could be much more severe for pediatric patients than adults,” he said. The use of these drugs,” Dr Epstein warned, “can have the pediatric patient trading a behavioral condition for a lifelong metabolic condition that can lead to significant health complications.”

The studies in adults with Zyprexa that Lilly submitted to the
FDA demonstrate, as far as I can establish, a higher death rate
on Zyprexa than on any other anti-psychotic ever recorded.

David Healy M.D.[11]

Where is all this damaging information leading and particularly concerning the children exposed to this drug, often for inappropriate uses? The huge issue that no one seems to want to pay much attention to is the fact that the inappropriate uses of Zyprexa are skyrocketing in children. The reason all this hidden information has come to light is because they found out Lilly was promoting for use in elderly with dementia, a use of the drug that is most inappropriate. Very little though is brought up anywhere about its use in children. The drug is being used in children who do not have schizophrenia or bipolar disorder; in children with depression, anxiety, behavior disorders, school problems, Attention Deficit Disorder, and even eating disorders.

“The young tend to run into problems quickly,” said Henk-Jan Aanstoot, a pediatric diabetes specialist from Rotterdam who is helping to coordinate the International Diabetes Foundation?s childhood diabetes campaign. “Diabetes has become a chronic and common disease among children and often these children die,” Francine Kaufman, a professor of pediatrics at the University of Southern California medical school, told a news conference at the World Diabetes Congress in Cape Town . “The childhood obesity epidemic is really driving diabetes in children,”

No story about Eli Lilly can be complete without including the fact that they, for business reasons alone, have removed efficacious insulins from the market, used for years by diabetics to maintain good control, and with fewer adverse incidents than the newer and faster insulins. In 2005 they removed all natural insulins from the market, leaving thousands of type one diabetics stranded without their lifelines, forced to switch to rDNA insulins or import at tremendous cost and burden to their wellbeing. [12], [13] ,[14]

It is clear that Eli Lilly executives have taken no responsibility for the harm they’ve caused. They’ve made no apology. There’s been no contrition. There’s only been denial. Eli Lilly CEO Sidney Taurel has said of the first legal settlement: “While we believe the claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their doctors. We wanted to reduce significant uncertainties involved in litigating such complex cases.”

Frank concludes his essay on Lilly with these words. ?Because of Enron’s fraudulent accounting practices, many people lost their savings. Because of fraudulent drug-information from Eli Lilly, many more people lost their health or their lives. But unlike the Enron scandal, none of the responsible parties at Eli Lilly has been sent to prison or even been charged with a crime. Bringing Eli Lilly executives to justice is not likely to happen anytime soon. Meanwhile, what is to be done? Call it a crime; call it a tragedy; it’s surely a public-safety problem of vast proportions, one demanding government intervention. Warning people who take or might take Zyprexa about its grave risks is not a sufficient safeguard. When, in the early 1960s, the drug thalidomide was shown to cause horrible deformities in the newborns of thousands of women, the FDA banned it. Is death a less disastrous drug effect than deformity? How many more people will have to die before the government steps in to protect citizens by prohibiting the sale of Zyprexa??[15]
.

So is Eli Lilly continuing to get away with murder? Or is it perfectly fine to have people die as a consequence of corporate activity and profit? When it comes to Lilly there is no end to the horror and terror. Dr. Bruce Levine writes that ?Perhaps the most cinematic of all Lillygates culminated in 1997. The story began in 1989 when Joseph Wesbecker?one month after he began taking Prozac?opened fire with his AK-47 at his former place of employment, killing 8 and wounding 12 before taking his own life. British journalist John Cornwell covered the Louisville , Kentucky trial for the London Sunday Times Magazine, ultimately writing a book about it. Cornwell?s The Power to Harm (1996) is not only about a disgruntled employee becoming violent after taking Prozac, but is also about Eli Lilly?s power to corrupt the judicial system.?

?Victims of Joseph Wesbecker sued Eli Lilly, claiming that Prozac had pushed Wesbecker over the edge. The trial took place in 1994, but received scant attention as the public was transfixed by the O.J. Simpson spectacle. While Eli Lilly had been settling many Prozac violence cases behind closed doors (more than 150 Prozac lawsuits had been filed by the end of 1994), it was looking for a showcase trial that it could win. Although a 1991 FDA ?blue ribbon panel? investigating the association between Prozac and violence had voted not to require Prozac to have a violence warning label, by 1994 word was getting around that five of the nine FDA panel doctors had ties to Big Pharma?two of them serving as lead investigators for Lilly-funded Prozac studies. Thus, with the FDA panel now known to be tainted, Lilly believed that Wesbecker?s history was such that Prozac would not be seen as the cause of his mayhem.?
Yet millions of diabetics and the general population at large are supposed to continue to trust the Eli Lilly Company with their lives. The wonderful government of the United States thinks so and continues to condone the poisoning of its citizens with drugs made by corporations even if they have been proven to cause harm. The general population acts like a child who is being abused by its parents. They continue to love and trust even if that abuse becomes outright sexual abuse and rape. There are deep psychological fault lines that run through us that leave us vulnerable to vultures who suck up our trust for their own profit.
As long as we allow such companies to exist society is filling up its foundation with blood. We can begin to have hope in the future when we see the doors to companies like Lilly closed for good. But many will fill their brains with rationalizations for why we should continue to allow chemical rapists to continue to operate. A chemical rapist company is one who knows their product will kill and do immeasurable harm and continues to do so for great gain. In reality we are talking about something simple, its murder for profit!

People should question strongly the doctors who are prescribing Zyprexa for any reason. For bipolar disorder, they are not prescribing Zyprexa for short term management of mania. It is prescribed for long term use, and is now even used in combination with antidepressants. So out of touch with reality are Lilly executives that believe it or not they are now conducting clinical trials for using Zyprexa for the prevention of migraine.[16] It is more than stupid to substitute an extremely dangerous drug like Zyprexa for a natural substance like magnesium chloride, which would be extremely effective in both the avoidance of and treatment of migraines. If Lilly believes that medical poisons are the royal road to disease prevention we should not miss them and certainly not trust them for anything other than continuing to act from a criminal inhumane paradigm that kills babies and people.

If everything said above is not enough to bury Lilly executives and their shareholders let it be known that this company is now also conducting clinical trials using Zyprexa on autistic children.[17] Imagine the company that has killed babies and in all likelihood provoked a great part of the autism epidemic by injecting mercury into them but now poisons the kids again with another toxic drug that puts them at risk for diabetes. This is corporate America at its worst. It is also government at its worst because of the close ties between ruling families like the Bush family.
All of the above reveals an incredible lack of integrity among health officials, medical organizations, the medical media and doctors themselves. We keep hearing that there is no cure for diabetes and no exactly known cause. But this is a lie and a bold one at that. Zyprexa causes diabetes! This needs to be repeated many times. Zyprexa causes diabetes! Many cases of diabetes can be avoided simply by taking this drug off the market. Unfortunately many drugs and chemicals used in foods also cause diabetes but no one wants to talk about that. But this book will and in the end we will see that diabetes is caused in large part by the medical industrial complex and thus is an iatrogenic disease. The FDA though bears the greatest responsibility in the end for not only are drugs a primary cause but many of the chemicals routinely put in foods are also causing this disaster.

? By Mark Sircus Ac., OMD
Director International Medical Veritas Association
http://www.imva.info
.

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Notes

[1] In 1972, Lilly received an article that confirmed that its product, used as a preservative in vaccines, caused 6 deaths from mercury poisoning. In Exhibit ELI-392K of Waters & Kraus, LLP Plaintiffs’ response to Eli Lilly it is stated, “The symptoms and clinical course of the 6 patients suggests sub acute mercury poisoning.” Eli Lilly and Co., the Indianapolis drug-maker faces at least 45 lawsuits over its role in developing and selling for more than 40 years a mercury-based preservative used in childhood vaccines and now suspected of causing autism. Autism affects 500,000 to 1.5 million Americans and has grown at an annual rate of 10 percent to 17 percent since the late 1980s.

[2] The Homeland Security Bill was signed into law by President George W. Bush. It was a bill that removed pharmaceutical industry liability for mercury induced vaccine injuries and deaths caused by thimerosal (ethyl-mercury) . It was a prevision that was inserted at the 11th hour and for a while no one would come forward to take credit for the dirty deed. It was later repealed and the source of the special clauses was traced back to White House insistence. The Bush family and the administration have too many ties to Eli Lilly. There’s President Bush’s father, who after stepping aside as Director of Central Intelligence in 1977, was made director of the Eli Lilly Pharmaceutical Company by the family of Dan Quayle, who owned the controlling interest in the company. There was White House budget director Mitch Daniels, once an Eli Lilly executive; and Eli Lilly CEO Sidney Taurel, who serves on the president’s homeland security advisory council.

[3] In 2002, Eli Lilly flexed its muscles at the highest level of the U.S. government in an audacious Lillygate. The event was the signing of the Homeland Security Act, praised by President George W. Bush as a ?heroic action? that demonstrated ?the resolve of this great nation to defend our freedom, our security and our way of life.? Soon after the Act was signed, New York Times columnist Bob Herbert discovered what had been slipped into the Act at the last minute and on November 25, 2002, he wrote, ?Buried in this massive bill, snuck into it in the dark of night by persons unknown?was a provision that?incredibly? will protect Eli Lilly and a few other big pharmaceutical outfits from lawsuits by parents who believe their children were harmed by thimerosal.?

[4] Zyprexa, whose generic name is olanzapine, belongs to a class of psychiatric drugs known as atypical antipsychotics. Others in this class are Novartis’ Clozaril (clozapine), Janssen’s Risperdal (risperidone) , AstraZeneca’ s Seroquel (quetiapine) , Bristol-Myers Squibb’s Abilify (aripiprazole) , and Pfizer’s Geodon (ziprasidone) .

[5] http://www.diabetes.org/for-media/2004-press-releases/jan-27-04.jsp

[6] The consensus statement, published in the February issue of Diabetes Care, outlines guidelines for doctors treating people with a class of drugs known as second-generation antipsychotics (SGAs).The panel also concluded that the SGAs differ in their risk profiles and that some SGAs, such as clozapine and olanzapine (Zyprexa), while effective treatment options, raise a greater risk of weight gain, diabetes and lipid disorders than others. The panel recommended frequent follow-up monitoring of any patient receiving SGA therapy, and concluded that people at greatest risk for these complications should be prescribed SGAs least likely to cause them.

[7]http://www.nytimes.com/2007/01/05/business/05drug.html? ex=1325653200&en=aa5ab55b87eedc83&ei=5088&partner=rssnyt&emc=rss

[8] http://www.counterpunch.org/pringle01042007.html

[9] John Geddes et al., British Journal of Psychiatry, December, 2000

[10] Experts say the prospect of children under 5, receiving psychiatric drugs intended for adults is alarming. Also alarming was the finding that about 50% the prescriptions were written by primary care providers and not psychiatrists. An equally disturbing report was published in the April 25, 2005, Columbus Dispatch on an investigation of state Medicaid records that found 18 babies ranging from newborn to 3 years-old in Ohio had been prescribed antipsychotic drugs in July 2004.

[11] David Healy, MD University of Wales College of Medicine April 30th 2002.
http://www.ahrp. org/children/ healy0402. php The background against which this paper is prepared is that in 1997 I organized, chaired and wrote up the recommendations from an International Roundtable Meeting for the British Association for Psychopharmacology on the use of psychotropic drugs in children. This meeting involving senior regulators from the United States and Europe as well as professors of child psychiatry from a number of European countries, North America and the UK. In addition to this Lilly have suppressed data on suicidal acts on Zyprexa from these trials. The data are not available in the scientific literature, nor from FOI requests to the FDA, nor from enquiries to the company.Despite this Lilly are engaged in trials with this agent in children. These trials will underpin vigorous company promotion for this drug in a wide swathe of children with hyperactivity, neurosis, bipolar and psychotic disorders – they won’t enable clinicians to use the drug if needed

[12] http://www.organicconsumers.org/patent/geinsulinbad.cfm

[13] Genocide is alive and well, and being practiced right here in the good ol’ USA . Diabetics (certainly not the ONLY target) have had necessary drugs removed from the marketplace. Numbers of diabetics cannot use the genetically engineered products that are ALL that remain on the American market. Even a Lilly executive in public forum admits that “not all diabetics can be switched from animal insulins.” However, he does NOT address HOW these unfortunate individuals are to survive without needed medications. Lilly’s decision to remove animal-based insulins was merely “a business decision” supported by a marketplace that they have severely manipulated for more than a decade. Allowing patients to die because producing their needed medication no longer fits their “business model” should be criminal. Understandably, not all diseases have viable treatment modalities; but in the case of diabetes, a safe, proven medicine has been WITHDRAWN from the marketplace, replaced by high-profit, less efficacious, DANGEROUS “substitutes” that are hyped as “advances in diabetes treatment.” The real advances exist only on the profit side of Lilly’s business ledger. Comment in Huffington Post: Dr. Peter Rost: The White House, The Drug Industry, Genocide; October 2006; http://www.huffingt onpost.com/ dr-peter- rost/the- white-house- the-drug_ b_19678.html

[14] Parting Causes Such Sorrow; Robin Harris; Diabetes Interview, 1998 http://members.tripod.com/diabetics_world/Diabetes_Interview_Beef_Need.htm

[15] http://whale.to/a/zyprexa1.html

[16] A Research Study Examining the Use of Olanzapine for the Prevention of Migraine http://www.clinicaltrials.gov/ct/gui/show/NCT00203307

[17] http://www.clinicaltrials.gov/ct/show/NCT00183404

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Prescription Drugs: Are They Killing Your Kidneys?

Prescription Drugs: Are They Killing Your Kidneys?

by Jodie Gilmore exclusive for infoholix.net

If gasoline companies marketed fuel that was highly likely to damage your car’s fuel filter, there’d be a huge public outcry. And yet, the pharmaceutical companies market many drugs that are known to pose a serious threat to patients’ kidneys – the body’s filtration system – and it seems anyone barely notices, much less cares.

Not only that, but use of prescription drugs, including those damaging to kidneys, is on the upswing. The following data comes from a report published by the Centers for Disease Control (CDC).[1] While it is based on U.S. data, countries such as the U.K., and Canada are undoubtedly following the same path.

The percentage of the U.S. population that reported taking at least one prescription drug in the previous month rose sharply between 1994 and 2000, from 39.1% to 44.3%. The number of people taking three or more prescription drugs rose from 11.8% to 16.5% (approximately one out of every six individuals). The number of children less than 18 years old taking three or more prescription drugs increased by more than 50% between 1994 and 2000. As of 2000, almost 4% of children were taking three or more prescription drugs.

Those 65 years and older were the greatest users of prescription drugs. As of 2000, 83.9% of seniors took one or more prescription drugs, up more than 10 percent from the 1994 figure of 73.6%. The percentage of seniors taking three or more drugs increased by more than one-third to 47.6%.

This article attempts to paint a picture of the severity of the prescription-drug-induced kidney disease problem across the world, by illustrating why kidneys are important, what common drugs damage kidneys, and how prescription drug use is escalating.

What’s the big deal about kidneys?

First, let’s do a brief review of what kidneys do and why they’re important.

Your body produces, and is exposed to, many toxins every day. If left in the blood, these toxins would kill you quickly. Luckily, your body is equipped with a very efficient filtering system. Every day, every ounce of your blood (between five and six quarts) is filtered many times – the kidneys can process up to 200 quarts of blood a day – filtering out some two quarts of waste products and excess water. This waste is eventually excreted in the urine.

If your kidneys are damaged, they cannot efficiently filter the toxins, which begin to accumulate in your body tissues, and can make you sick, and even lead to death.

Although medical jargon scares most people, it is important to learn some terminology that can help you understand how prescription drugs can harm your kidneys. First of all, “kidney failure” is the layman’s term. You might also run across references to “renal failure,” “renal dysfunction,” “end-stage renal disease” (ESRD) and “nephropathy.”

If you looked inside a kidney using a microscope, you would see clusters of looping blood vessels, called glomeruli. Attached to each glomerulus is a tiny tube (tubule) that collects the waste that has been filtered out. The filtering unit (glomerulus and tubule) is called a nephron.

These terms also show up in references to kidney damage, such as glomerulonephritis (also known as Bright’s disease) and interstitial nephritis (which are just fancy words for inflammation of portions of the kidney – they are not diseases, per se). A drug that can damage kidneys is referred to a “nephrotoxic.”

What types of drugs can harm kidneys?

Several classes of drugs are known to potentially cause kidney damage, including non-steroidal anti-inflammatory drugs (NSAIDs), statins, some drugs used with heart conditions, and bowel-cleansers.

NSAIDs: If their knee aches, or they have a headache, many people turn to NSAIDs, such as acetaminophen (Tylenol®), ibuprofen (includes Advil® and Motrin®), and COX-2 inhibitors. The COX-2 inhibitors class includes rofecoxib (Vioxx®), naproxen (Aleve®, Naprosyn®, Anaprox®, Naprelan®), and celecoxib (Celebrex®). While occasional use of these drugs does not pose much risk to the average patient, long-term use is associated with kidney damage. In a study of Quebec (Canada) health databases, published in the American Journal of Epidemiology, Dr. James Brophy states that “There was a significant association for both selective and nonselective NSAIDs with acute renal failure, but confirmatory studies are required.”[2] In an interview with Reuters Health, Dr. Brophy stated “NSAIDs are associated not uncommonly with renal failure…I think physicians should use the lowest possible dose of all NSAIDs for the shortest possible period of time.”[3]

This is hardly news. In 1994, the New England Journal of Medicine published an article that stated “Heavier acetaminophen use was associated with an increased risk of ESRD in a dose-dependent fashion.”[4] And in 2003, Clinical Nephrology published a study that stated “Both membranous glomerulopathy and acute interstitial nephritis have been reported to occur following treatment with non-steroidal anti-inflammatory drugs. We report the first cases of membranous glomerulopathy and acute interstitial nephritis following treatment with celecoxib (Celebrex).”[5]

Statins: Statins are another class of drugs that can cause serious kidney damage. Currently, there are six statin drugs on the market: atorvastatin (Lipitor®), fluvastatin (Lescol®), lovastatin (Mevacor® and Altocor®), pravastatin (Pravachol®), simvastatin (Zocor®), and rosuvastatin (Crestor®). It is this last statin that has been recently in the news. The consumer group, Public Citizen, stated in a 2005 letter to the FDA “We found that the rate of reports of rhabdomyolysis sent to the FDA per million prescriptions filled for Crestor (13.1 reports per million prescriptions) is 6.2 times higher than the rate for all of the other statins combined (2.1 reports per million prescriptions filled).”[6] According to Public Citizen data, 5.2 million Crestor prescriptions were filled from Oct. 2003 through Sept. 2004. Crestor is approved in at least 64 countries worldwide. Much of the kidney damage controversy surrounding statins centers on a serious side effect known as rhabdomyolysis (a muscle disorder), which in turn causes serious and often fatal kidney damage. For example, in 2001, cerivastatin (Baycol®) was banned by the FDA, due to its tendency to cause a fatal form of rhabdomyolysis. However, Public Citizen stated that “The rate of reports of kidney failure or damage among patients taking the cholesterol drug Crestor is 75 times higher than in all patients taking all other statins.”[7] In fact, Public Citizen claims that Crestor’s rate of rhabdomyolysis approaches “that of Baycol.” Others are also concerned about Crestor’s safety. In an article published in Circulation, a journal published by the American Heart Association, authors stated that “rosuvastatin was significantly more likely to be associated with the composite end point of rhabdomyolysis, proteinuria, nephropathy, or renal failure [adverse event reports]. Reported cases of rhabdomyolysis, proteinuria, or renal failure tended to occur early after the initiation of therapy and at relatively modest doses of rosuvastatin…The present analysis supports concerns about the relative safety of rosuvastatin at the range of doses used in common clinical practice in the general population.”[8] (emphasis added) Not surprisingly, Crestor’s manufacturer, AstraZeneca, denies Crestor is dangerous – or at least, no more dangerous than any other statin. As of December 2006, the AstraZeneca web site stated “The post-marketing safety profile of rosuvastatin is consistent with that seen in the clinical trial programme and comparable to that of other currently marketed statins.” Well – that’s comforting, isn’t it!!?? And the FDA estimates that 21 million MORE people ought to be taking statins that aren’t yet – how many more instances of kidney disease would that be?!

Heart Drugs: We’ve all heard the cliché, “the cure is worse than the disease.” In the case of heart patients, this saying seems to be true. For example, nesiritide (marketed under the name Natrecor® and approved by the FDA in 2001 to treat hospitalized congestive heart-failure patients) is the “recombinant form of human B-type (brain) natriuretic peptide (BNP).”[9] A 2006 Pharmacotherapy article stated that two meta-analyses raised the question of safety with nesiritide therapy, specifically an “increased risk of renal dysfunction and mortality.” The author of one of these meta-analyses, which looked at the results of two previous studies, Dr. Jonathan Sackner-Bernstein, has stated that “There appears to be a very strong association between the use of nesiritide and the risk of death within 30 days.” In fact, of the 400 patients included in the meta-analysis, 7.8 percent of the patients taking Natrecor died within 30 days – nearly twice the death rate of patients taking another heart drug.[10] Of course, Natrecor’s manufacturer, Scios, a subsidiary of Johnson and Johnson, denies the conclusions of these studies. And there is some evidence that a portion of the increased death rate may be due to off-label prescriptions of the drug, which was never approved for outpatient use on a continuing basis but is nevertheless prescribed for such use by doctors.[11] But you have to wonder – if the drug is so safe, why has Scios authorized a huge safety study (to begin in 2007), to include 7,000 Natrecor patients, half of which will be from North America and the balance from other areas of the world? Another heart-related drug, Trasylol (aprotinin) is dangerous to kidneys. This drug is used to control bleeding during heart surgery. Granted, no one wants to bleed to death during surgery. But research has shown that Trasylol doubles the risk of kidney failure, and has other side effects to boot – patients taking Trasylol have a 48 percent higher risk of a heart attack, 109 percent higher risk of heart failure, and 181 percent higher risk of stroke![12] The study included patients from North America, Europe, Columbia, Israel, and Thailand.

Aprotinin has been on the market since 1993, and the author of the study cited above estimates that as many as 10,000 patients may now be on dialysis due to their being given Trasylol. What’s worse, he also says that there are two other anti-bleeding drugs available that do not have the horrific side effects of Trasylol (aminocaproic acid and tranexamic acid) – but these drugs are “underused.”

Bowel Cleansers: You don’t have to have a serious heart condition or dangerously high levels of cholesterol before you have to worry about drug-induced kidney damage. A simple procedure such as a colonoscopy can raise your risk. According to a 2005 study published in the Journal of the American Society of Nephrology, bowel-cleansing products, including oral sodium phosphate solution (OSPS), Visicol®, Fleet Phospho-soda®, and Fleet Accu-Prep®, can cause a type of kidney damage termed acute phosphate nephropathy (APN).[13] In the study, the researchers looked at 7,349 renal biopsies. They found that of the 31 biopsies that APN, 21 had a history of taking an OSPS. In May 2006, the FDA published a warning to doctors and patients, stating that they had documented 22 cases of OSPSs causing acute phosphate nephropathy. Patients with hypertension or who use ACE-inhibitor or ARB drugs to manage hypertension, who are dehydrated, or who are over 65 have the most risk of OSPS-induced kidney damage.

Unfortunately, the above study did not report how many of 7,349 patients had a colonoscopy, so it is unclear what percentage of OSPS users incur kidney damage. But it is certain that a large number of people could be at risk: OSPSs are commonly used prior to colonoscopies. The average gastroenterologist performs a mean of approximately 21 colonoscopies per month; according to the American Board of Internal Medicine, there are 11,044 board-certified gastroenterologists in the U.S. Annual demand for colonoscopy ranges from 2.21 to 7.96 million.[14] The U.S. Preventive Services Task Force recommends people over 50 have a colonoscopy every 10 years[15], and there are more than 38,738,059 people over 50 just in the United States.[16] I wonder how many patients are warned about the risks before they slug down their tasty OSPS?

And More…: The above list is not exhaustive. There are plenty of other drugs that pose risks to your kidneys. Here is a brief list:

  • Angiotensin-converting enzyme inhibitors (ACE inhibitors, such as Enalapril® and Captropril®), which are used to treat hypertension and sometimes diabetic and nondiabetic nephropathies, can cause acute renal failure in some patients.[17]
  • Allopurinol (Zyloprim®), which is used to treat severe gout, and furosemide (Lasix®), a commonly-prescribed diuretic, have also been linked with kidney damage.[18]
  • Ciprofloxacin (Cipro®, Cipro XR®), a powerful antibiotic, has also been associated with granulomatous interstitial nephritis.[19]
  • Isotretinoin (Accutane or Roaccutane), used to treat severe acne, is also known to cause glomerulonephritis.
  • Perhaps most ironic of all, immunosuppressants given to kidney transplant patients, can over time, cause kidney damage!

In fact, there are so many prescription drugs that can cause kidney damage, medical students around the world learn a mnemonic to help them remember them: SMART CAN. Each letter in this mnemonic stands for a class of drugs that can cause acute interstitial nephritis:

Sulfonamides, Methicillin, Ampicillin, Rifampicin, Thiazides, Cimetidine, Allopurinol, NSAIDs.[20]

Note: the above list and discussion is not exhaustive; plenty of other drugs may cause kidney damage. Always ask your doctor before starting any medication!

How many people are affected?

Kidney disease is no small concern, as shown by the following U.S. statistics:

  • The National Center for Health Statistics ranks kidney disease as the 9th leading cause of death in the U.S. in 2004.[21]
  • The National Kidney Foundation’s web site states that “20 million Americans – 1 in 9 US adults – have chronic kidney disease, and another 20 million more are at increased risk.”[22]
  • The National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC) claims “4.5 percent of adults 20 years of age and older have physiological evidence of chronic kidney disease.”[23]
  • The NKUDIC also states that about 18% of ESRD patients died in 2003.
  • The CDC states that the prevalence of chronic kidney failure in the U.S. increased 104 percent during 1990-2001.[24]
  • According to Dr. Julian Whitaker, “the prevalence of kidney failure has doubled in the past decade.”[25]

The U.S. Renal Data System (USRDS) presents the following data in its 2006 report.[26] As you can see incidence of ESRD has climbed steadily since 1980. [*]


Although, the overall incidence rate of ESRD appears to have leveled off in the last few years, in another part of the same USRDS report, the authors state, “Among older patients, rates have increased 24 percent for those age 65–74, and 67 percent for those age 75 and above.”

Kidney disease is on the rise not just in the U.S., but in all parts of the world, as shown by the following statistics:

  • The New Zealand Kidney Foundation estimates that there are more than 268,000 adults with significant renal impairment in New Zealand.[27] This represents about 6.7% of the NZ population.[28]
  • Australian researchers state that “Rates of treated end-stage renal disease have risen relentlessly throughout the Western world over the past 30 years.”[29]
  • Another researcher presents data that indicates from 1996 to 2000, the annual intake of new ESRD patients (per million population) increased by 15.4 percent in Australia and by 37.2 percent in New Zealand.[30]
  • A 2004 study indicated that at least a third of Spain’s population suffers from Stage 2 chronic kidney disease (CKD), and between 3.5 and 8.5 percent suffers from Stage 3 CKD.[31]
  • In 2005, researchers determined that in Paraguay, the incidence of kidney disease is rising, and 75 percent of ESRD cases are of “unknown etiology.”[32]
  • A resident physician in India attributes the “attention being paid globally to CKD” to five factors, the first of which is its “rapid increase in prevalence.”[33]

The USRDS also presents data about the international kidney disease scene:[34]

The difficulty with all these numbers is that rarely is drug-induced kidney disease singled out, and numbers for ESRD paint only part of the picture (leaving out less severe kidney damage). Many researchers claim that a majority of the increase in kidney disease worldwide results from an increase in Type 2 diabetes, obesity, and hypertension. While in some countries, almost half of ESRD patients are also diagnosed as diabetic (e.g., Mexico), in other countries, only about 16–17 percent of ESRD patients are diagnosed as diabetic (e.g., Scotland, Italy, the Netherlands, and Norway).[35]

Although diabetes is indubitably on the rise (possibly due to poor diet and exercise habits), concentration on it may mask an equal concern about what effect the increasing use of prescription drugs is having on people’s kidneys. Says one researcher, “The list of drugs implicated in causing AIN continues to expand. Drugs are more frequently recognized as etiologic factors in AIN because of the increased frequency with which drugs are used…”[36] The Merck Online Medical Library concurs, stating “The most common cause of acute tubulointerstitial nephritis is an allergic reaction to a drug.”[37] The Chairman of Nephrology at Cairo University, Egypt, stated in 2000 that while increasing awareness of kidney disease could give a false impression of an actual increase in incidence, “there is good reason for a true expansion of the pool of renal failure patients as …chemically induced interstitial nephritis” has “significantly increased.”[38] (emphasis added)

To illustrate how difficult it is to single out drug-induced kidney damage, consider the 2003 data from the NKUDIC. They state that of the 452,957 U.S. residents under treatment for ESRD during 2003, 74,444 of them were due to “glomerulonephritis” and 83,349 were due to “all other” causes (besides diabetes, hypertension and cystic kidney). But how many of these (35 percent of the total) were caused by prescription drugs? Nobody knows. Or at least, nobody is telling. By the same token, 26 percent of the new (as opposed to ongoing) ESRD patients in 2003 were classified as “glomerulonephritis” and “all other” – again, drug-induced kidney disease wasn’t listed.

One way, however, to correlate the effect of drugs on kidney disease incidence is to compare the rate of increased drug usage versus the rate of increased kidney disease.

Upping the Uptake

For several classes of drugs, at least – namely statins and NSAIDs, there is a quantity of data describing their increased usage.

Speaking of statin sales in the U.S., David Noonan, Newsweek Senior Editor, stated that “Statin sales have already jumped a whopping 32.5 percent in the two years ending March 2003.”[39] More recent data shows that statin use in the U.S. continues to climb. Consumer Reports’ “Best Buy Drugs,” published in January 2006, states that “Monthly prescription for statins rose 2.6%” between the six-month period 11/2004 to 4/2005 and the six-month period 5/2005 to10/2005.[40]

The report also acknowledges statins may not be all that safe, stating that growth in statin use seems to have stalled somewhat, possibly due to “more caution by doctors in prescribing the drugs, under pressure from insurers or in the wake of safety concerns raised about Crestor in late 2004 and early 2005.”

According to the CDC, only 11.8% of visits by older adults resulted in prescriptions for cholesterol-lowering drugs in 1996. By 2002, this percentage had climbed to 39.8%.[41]

Statin use has also exploded across Europe. The following figure appears in the report, “”.[42] As you can see, use of statins has climbed significantly between 1989 and 1999.

Worldwide growth in statin use continues apace, according to a study published in the British Medical Journal. Below is an excerpt of the data presented in that study:[43]

Country Average annual increase in statin use 1997-2002
Austria 37%
Denmark 38%
Finland 37%
Germany 26%
Italy 52%
Spain 31%
Sweden 34%
U.K. 48%

The researchers say that the average increase in statin use during this period in Europe was 31 percent. The same researchers, in a different paper, state clearly that “the use of statins across Europe has increased hugely over the study period” (1997-2003).[44] They also stated that “Worldwide, the statins had the largest value of sales of any drug class in 2003 amounting to $22.7 billion with a growth of 14% over the previous 12 months.”[45]

Statins aren’t the only kidney-unfriendly class of drug on the upswing. The same is true for NSAIDs. Dr. Soren Johnsen called NSAIDs “the most commonly used drugs worldwide, and even a small increase in risk could have grave implications for millions.”[46] According to MedicineWorld.org, an “estimated 50 billion aspirin tablets are consumed worldwide and approximately 60 million prescriptions are written for NSAIDs each year in the U.S., predominantly for older patients.”[47] The CDC claims that the use of COX-2 inhibitors increased by over 64 percent between 1999 and 2002, from 27.1% to 44.6%. When you look at just seniors, more than two-thirds of those over 65 are taking a COX-2 drug![48]

In Ontario, Canada in 1998, approximately 15 percent of individuals aged 65 years and over received prescriptions for conventional NSAIDs. By 2000, that percentage had dropped to about 10 percent – BUT, another approximately 11 percent received a prescription for COX-2 inhibitors.[49] That’s a total of 22 percent – a significant increase in NSAID prescriptions in just two years.

Who’s Taking What?

Another possible way to gauge the effect of prescription drug use on kidney disease incidence is to look at who is using the drugs known to pose a threat to kidney function. For example, in England, a study revealed that “of 12,493 patients aged 60+, currently on regular treatment for osteoarthritis (OA)… 73% were found to have been prescribed an NSAID on three or more occasions in the preceding 3 months.”[50] Seniors are at higher risk for kidney damage, since renal function diminishes with age.

As another example, consider the following table, taken from a study published in the Annals of the Rheumatic Diseases. The data shows that a significant number of people taking NSAIDs already have “established risk factors”:[51]

Patients with established risk factor (%)


Patients with GI sensitivity (%)


Country Age 65+ Past ulcer Angina Past MI/CVA Hyper-tension Diabetes Liver disease Kidney disease Co-med aspirin Co-med steroids Dyspepsia/reflux

UK 34 6 13 7 33 6 3 6 22 4 16
France 25 5 1 1 33 5 8 8 23 6 14
Germany 35 17 8 5 41 10 9 10 17 8 22
Spain 42 10 2 4 28 8 1 18 19 3 11
Ireland 43 12 7 4 38 6 1 9 15 6 16
Sweden 35 5 4 7 21 7 7 4 14 2 16
Italy 43 4 4 5 39 9 5 9 21 11 8
Switzerland 35 7 3 3 33 5 5 10 12 7 21

In particular, note that except in Sweden, nearly 10 percent of the patients taking NSAIDs already have kidney disease! Also, between 20 to 40 percent have hypertension, which is known to itself lead to kidney disease – so taking NSAIDs on top of the hypertension will only increase the risk. Also note that between 25 and 43 percent of patients taking NSAIDs are over 65! Talk about setting the stage for kidney damage…

Conclusion

It is an irrefutable fact that many prescription drugs pose a serious threat to patients’ kidneys. It is also an irrefutable fact that kidney disease is on the rise throughout the civilized world. Are all new cases of kidney disease due to prescription drugs? Obviously not. But with escalating use worldwide of the two classes of drugs that are best-known for causing kidney damage – statins and NSAIDs – it only makes sense to assume that some, and possibly a significant percentage of the increase in kidney disease is due to an increase in kidney-damaging prescription drugs. It naturally follows that, since kidney disease is on the rise, there is a concomitant increase in dialysis and transplants. In the next installment, I will explore this situation further, drawing some interesting conclusions.

Note: None of the information in this article is intended to be or should be construed as medical advice.

[*] The data reported here have been supplied by the United States Renal Data System (USRDS). The interpretation and reporting of these data are the responsibility of the author(s) and in no way should be seen as an official policy or interpretation of the U.S. government.


[1] “Health, United States, 2004.” (Centers for Disease Control and Prevention, 2005).

[2] Schneider, Verena; Lévesque, Linda; Zhang, Bin; et al. “Association of Selective and Conventional Nonsteroidal Antiinflammatory Drugs with Acute Renal Failure: A Population-based, Nested Case-Control Analysis.” American Journal of Epidemiology 164 (Sept. 2006): 881-89.

[3] Online: http://www.doctorbob.com/06_11_8news13.html

[4] Perneger, Thomas; Whelton, Paul; and Klag, Michael. “Risk of Kidney Failure Associated with the Use of Acetaminophen, Aspirin, and Nonsteroidal Antiinflammatory Drugs.” The New England Journal of Medicine 331 (Dec. 22, 1994): 1675-79.

[5] Markowitz, G. S.; Falkowitz, D. C.; Isom, R.; et al. “Membranous glomerulopathy and acute interstitial nephritis following treatment with celecoxib.” Clinical Nephrology 59 (Feb. 2003): 137-42.

[6] Online: http://www.citizen.org/publications/release.cfm?ID=7370 (March 10, 2005).

[7] Online: http://www.citizen.org/pressroom/release.cfm?ID=1819 (Oct. 29, 2004).

[8] Alsheikh-Ali, Alawi; Ambrose, Marietta; et al. “The Safety of Rosuvastatin as Used in Common Clinical Practice.” Circulation.111 (May 2005): 3051-57.

[9] Dorsch, M.P. and Rodgers, J.E. “Nesiritide: Harmful or Harmless?” Pharmacotherapy 26 (October 2006): 1465-78.

[10] Johnson, Steve. “Scios drug linked to death risk.” ContraCosta Times online, Sept. 29, 2006.

[11] Johnson, Steve. “Off-label drug marketing: Missing the mark.” Mercury News online, Oct. 22, 2006.

[12] Mangano, Dennis; Tudor, Iulia C.; and Dietzel, Cynthia. “The Risk Associated with Aprotinin in Cardiac Surgery.” The New England Journal of Medicine 354 (January 2006): 353-65.

[13] Markowitz, Glen S.; Stokes, M. Barry; Radhakrishnan, Jai; and D’Agati, Vivette D. “Acute Phosphate Nephropathy following Oral Sodium Phosphate Bowel Purgative: An Underrecognized Cause of Chronic Renal Failure.” Journal of the American Society of Nephrology 16 (Sept. 2005): 3389-96.

[14] Vijan, S.; Inadomi, J.; Hayward, R. A.; et al. “Colonoscopy Related Demand & Capacity – Colon Cancer Screenings.” Alimentary Pharmacology & Therapeutics 20(May 2004): 507-515.

[15] Online: http://www.ahrq.gov/clinic/3rduspstf/colorectal/colorr.htm

[16] Online: World Fact Book. https://cia.gov/cia//publications/factbook/geos/us.html

[17] Schoolwerth, Anton; Sica, Domenic; Ballermann, Barbara; et al. “Renal Considerations in Angiotensin Converting Enzyme Inhibitor Therapy.” Circulation 104 (2001): 1985.

[18] Mouson, C.; Justrabo, E.; Tanter, Y.; et al. “Acute granulomatous interstitial nephritis and hepatitis caused by drugs. Possible role of an allopurinol-furosemide combination.” Nephrologie 7 (March 1986): 199-203.

[19] Lim, S. and Alam, M.G. “Ciprofloxacin-induced acute interstitial nephritis and autoimmune hemolytic anemia.” Renal Failure 25 (July 2003): 647-51.

[20] Online: http://www.rxpgonline.com/medicalmnemonic91762.html

[21] National Vital Statistics Reports, Volume 54, No. 19 (June 28, 2006). Published by the Centers for Disease Control and Prevention. [22] Online: http://www.kidney.org/kidneyDisease/

[23] Online: National Kidney and Urologic Diseases Information Clearinghouse, a service of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Health. http://kidney.niddk.nih.gov/kudiseases/pubs/kustats/index.htm

[24] Centers for Disease Control and Prevention. MMWR Morbidity Mortality Weekly Report 53 (Oct. 8, 2004): 918-20.

[25] Dr. Julian Whitaker. Health and Healing, September 2005: p. 6.

[26] U.S. Renal Data System, USRDS 2006 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2006. “Incidence and Prevalence” chapter.

[27] April 2006, New Zealand Kidney Foundation, Submission to Health Select Committee inquiry into Obesity and Type 2 Diabetes.

[28] U.S. Census Bureau, International Database, 2004.

[29] McDonald, S.; McCredie, M.; Williams, S.; and Stewart, J. “Factors influencing reported rates of treated end-stage renal disease.” Advanced Chronic Kidney Disease 12 (Jan. 2005): 32-8.

[30] Russ, Dr Graeme. “ANZDATA Registry Overview.” Darwin (September 2001): Slides 4 and 5

[31] Simal, F.; Martin, Escudero; Bellido, J; et al. “Prevalence of mild to moderate chronic kidney disease in the general population of Spain” Nefrologia 24 (April 2004): 329-32, 334, 336-7.

[32] Santa Cruz, F.; Cabrera, W.; Barreto, S.; et al. “Kidney disease in Paraguay.” Kidney International Supplement, 2005: 120-5.

[33] Udayakumar, N. “Chronic kidney disease in India: from a resident physician’s perspective.” Postgraduate Medical Journal 82 (2006): 697-698.

[34] U.S. Renal Data System, USRDS 2006 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2006. “International” chapter.

[35] Ibid.

[36] Kodner, Charles and Kudrimoti, Archana. “Diagnosis and Management of Acute Interstitial Nephritis.” American Family Physician, June 15, 2003.

[37] Online: Merck Online Medical Library, 2nd Home Edition. http://www.merck.com/mmhe/print/sec11/ch144/ch144e.html

[38] Online: Baroum, Rashad. “A forecast of the New Century.” Egyptian Society of Nephrology, 2000.

[39] Online: MSNBC. http://www.msnbc.com/m/nw/talk/archive.asp?lt=070903_noonan

[40] Consumers Union. “Consumer Reports: Best Buy Drugs – The Statin Drugs: Prescription and Price Trends November 2004 to October 2005.” January 2006. www.CRBestBuyDrugs.org

[41] “Health, United States, 2004.” (Centers for Disease Control and Prevention, 2005).

[42] Dickson, Michael and Jacobzone, Stéphane. “Pharmaceutical Use and Expenditure for Cardiovascular Disease and Stroke: A Study of 12 OECD Countries.” (Organisation for Economic Co-operation and Development, Feb. 2003): p. 64.

[43] Walley, Tom; Folino-Gallo, Pietro; Schwabe, Ulrich; and Van Ganse, Eric. “Variations and increase in use of statins across Europe: data from administrative databases.” British Medical Journal 238 (Feb. 14, 2004): 385-6.

[44] Walley, Tom; Folino-Gallo, Stephens, P.; and Van Ganse, Eric. “Trends in prescribing and utilization of statins and other lipid lowering drugs across Europe 1997-2003.” British Journal of Clinical Pharmacology 60 (May 2005): 543-551.

[45] Ibid, p. 547.

[46] Johnsen, S.P.; Larsson, H.; Tarone, R.E., et al. “Risk of hospitalization for myocardial infarction among users of rofecoxib, celecoxib, and other NSAIDs a population-based case-control study.” Archives of Internal Medicine 165 (May 9, 2005): 978-984.

[47] Online: http://medicineworld.org/cancer/lead/9-2006/nsaids-and-gi-complications.html

[48] “Health, United States, 2004.” (Centers for Disease Control and Prevention, 2005).

[49] Kasman, Naomi and Badley, Elizabeth. “Arthritis in Canada – An Ongoing Challenge.” (Public Health Agency of Canada: 2003). Chapter 5, “Arthritis-Related Prescription Medications.”

[50] Belsey, JD. “An Epidemiologically-Based Burden of Disease Model.” Current Medical Research Opinion 19 (April, 2003): 306-312.

[51] Woolf, A. D.; Zeidler, H.; Haglund, U.; et al. “Musculoskelatal pain in Europe: its impact and a comparison of population and medical perceptions of treatment in eight European countries.” Annals of the Rheumatic Diseases 63 (April, 2004): 342-347.

? By Jodie Gilmore 2006.

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