The Bitter Pill

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Behind the Scenes Snake Oil Salesmen

Evelyn Pringle March 7, 2007

While the pharmaceutical industry’s corrupt practice of peddling ineffective drugs and concealing dangerous side effects has come under scrutiny in recent years, critics say the contributions of the research scientists, academics, medical journals, and the FDA deserve far more credit for their part in the industry’s overall marketing schemes.

Drug companies now control clinical trial design, the criteria for patient selection, the analysis of the research, as well as the results that are reported and the side effects that are not. “In short, in controlling what gets published in journals, the industry controls what gets passed off as medical evidence to influence physician prescribing practices,” according to, “Research and Clinical Practice Guidelines: Can We Trust the Evidence in Evidence-Based Medicine?”, by Dr John Abramson, of Harvard, and Dr Barbara Starfeld, a professor at Johns Hopkins, in the Journal of the American Board of Family Practice.

A report by the UK Parliament in 2005, found that 75% of clinical trials published in the major medical journals, including the New England Journal of Medicine, The Lancet, and the Journal of the American Medical Association, were funded by the industry.

“The sources of knowledge that doctors have been trained to trust have been taken over by the medical marketing community,” says Dr Abramson, author of Overdose America. “We can never trust what we’re reading.”

Adding to the problem, when a trumped up study is published, Dr Timothy Scott, author of, “America Fooled,” says few doctors in private practice have a research design background that would enable them to recognize a fraudulent study.

“The blame lies,” he explains, “not so much with individual physicians as with the drug approval system and the drug companies which today are very knowledgeable about how to design a study that is fraudulent yet capable of getting their drug approved and still be used in marketing and advertising.”

“Most academic physicians,” Dr Scott states, “could look at many of the studies used to promote drugs and know very quickly they are worthless, but this is not a skill that many private practice physicians have.”

“Journals have devolved into information laundering operations for the pharmaceutical industry,” says Richard Horton, editor of the Lancet, in the May 17, 2005 PLos Medical Journal.

Doctors may not be as uninfluenced by the drug ads as they would like to believe, he says, but the bigger problem lies with the original studies, particularly the clinical trials, published by journals. Mr Smith notes that doctors consider randomized controlled trials as one of the highest forms of evidence and states:

A large trial published in a major journal has the journal’s stamp of approval (unlike the advertising), will be distributed around the world, and may well receive global media coverage, particularly if promoted simultaneously by press releases from both the journal and the expensive public-relations firm hired by the pharmaceutical company that sponsored the trial.

For a drug company, a favourable trial is worth thousands of pages of advertising, which is why a company will sometimes spend upwards of a million dollars on reprints of the trial for worldwide distribution.

“The doctors receiving the reprints may not read them,” Mr Smith says, “but they will be impressed by the name of the journal from which they come.”

He contends that the quality of the journal “will bless the quality of the drug.”

On December 13, 2005, the Wall Street Journal reported on a 1999 document that surfaced in litigation that described Pfizer’s strategy for publishing articles in medical journals to market the antidepressant, Zoloft.

The document, prepared by a unit of advertising agency WPP Group, included 81 different proposed articles for journals to “promote the drug’s use in conditions from panic disorder to pedophilia,” the WSJ states.

For some, the name of the author was listed as “TBD,” short for “to be determined,” even though the article or a draft was listed as completed. And several of the articles did appear in publications such as the Journal of the American Medical Association, without disclosing the outside writers, the WSJ said.

In 2004 New York State Attorney General, Eliot Spitzer, sued GlaxoSmithKline charging that the company had engaged in “repeated and persistent fraud” in concealing the negative results from a number of studies that showed Paxil increased the risk of suicidality and was ineffective when prescribed to children.

Critics say that even when positive results of studies are reported, the methodology used often leads to questionable results because the research is carried out in a way that ensures that a drug will be found effective, according to Joseph Wyatt and Donna Midkiff of Marshall University, in Biological Psychiatry: A Practice in Search of Science (2006).

Prior to the start of a study, they explain, researchers attempt to remove all subjects who might respond favorably to a placebo before dividing the patients into the drug and the placebo groups for the actual study.

To that end, for up to 3 weeks, all trial subjects are given a placebo and observed in what is referred to as the placebo “run-in” or “wash-out” period and those subjects who improve on a placebo are removed and have no further participation in the study.

The study is then conducted with the remaining subjects divided into the drug and placebo groups and the predictable outcome is that the drug is more effective than placebo. However, according to Biological Psychiatry, even when playing with a stacked deck, the results of studies are frequently negative or only marginally positive.

For example, a review of 38 studies on SSRI antidepressants such as Prozac, Zoloft, Paxil, Serzone, Celexa and Effexor, conducted during 1987-1999, showed an average 10-point improvement in mood for patients who took the drugs, and an 8-point improvement for those who took a placebo (Kirsch, Moore, Scoboria & Nicholls, 2002).

“It is doubtful,” Joseph Wyatt and Donna Midkiff say, “that the two-point average advantage for the drugs is meaningful in the real world in which patients function every day, or that the drugs would have had even that slight advantage over placebo had it not been for the wash-out methodology.”

Psychiatrist, Dr Grace Jackson, author of, “Rethinking Psychiatric Drugs,” and one of the leading US authorities on psychiatric drugs, explains why the study designs used to gain FDA approval for atypicals antipsychotics, like Zyprexa, were seriously flawed.

In typical drug trials, she notes, study participants are required to go off all medications for 2 weeks and at the end of the two weeks, half of the patients are given the new drug and half are given a sugar pill. Then, at the end of 4 weeks, the researchers assess which patients seem to be doing better.

“The problem with these studies is the first two weeks,” Dr Jackson says, “because those patients who had previously received medications may have gone into abrupt withdrawal.”

These studies make a new drug look good, she explains, only because no one is paying attention to the fact that patients in the placebo group may be going through withdrawal.

As an example, Dr Jackson points to a study that compared Haldol and Zyprexa in which researchers took patients off Haldol, and gave some patients Zyprexa and the others a placebo. Naturally, she notes, those on Zyprexa did better than the patients taking a sugar pill and going through withdrawal.

According to Dr Jackson, all the published studies are on Haldol and Zyprexa or Zyprexa and placebo, and in every one of them, “the researchers have ignored the effects of withdrawal symptoms due to the placebo washout period.”

“This is a trick,” she states, “that drug companies used for every single psychiatric drug.”

According to the January 15, 2006, LA Times when it comes to the role of medical journals having a positive impact on the marketing of a drug, “There is no better cautionary tale than the unwarranted success of Vioxx.”

The only reason doctors prescribed Vioxx was because it was heavily promoted as being safer than other anti-inflammatory drugs when in fact Merck’s own study showed that Vioxx caused more heart attacks, blood clots and strokes, even in patients with no prior history of cardiovascular disease, and was no better at pain relief than the drugs already on the market.

The Times pointed out that the FDA and Merck knew all this and said American doctors prescribed $7 billion worth of Vioxx, “Because the New England Journal article that ostensibly reported the results of Merck’s study didn’t even mention either the cardiovascular or the overall dangers of Vioxx.”

“Instead,” the Times said, “it reported only selective data on heart attacks and strokes allowing Merck to claim that Vioxx wasn’t a risk to people without a history of these problems.”

In the not too distant past, the majority of research funding came from the Federal government, through the National Institutes of Health. However, major research institutions, like Harvard Medical School for instance, now receives nearly 25% of its research funding from nonfederal sources, including nearly $3.5 million from Aventis Pharmaceuticals, $2.5 million from Bristol-Myers Squibb, and $2.1 million from Merck.

In addition, on April 12, 2006, The Phoenix, reported that SEC filings show Harvard stock holdings of $16 million worth of Merck, $8 million of Bristol Myers Squibb, $34 million of Johnson & Johnson, and $33 million of Pfizer.

The investments made through research funding pay big dividends. For example, Merck, controlled every aspect of a 2002 study reported in the Annals of Internal Medicine, praising the use of Fosamax for osteoporosis. The paper’s lead author, Susan Greenspan, was a Harvard professor, and the director of the Beth Israel Deaconess Osteoporosis Prevention and Treatment Center.

As it turns out, Merck paid for the recruitment and participation of 327 patients; collected the data from 25 separate facilities, and Merck employees were involved in, “coordinating the early phases of the study,” which translates into controlling the design and execution of the trial, and in “providing expertise in study conduct.”

Most of these details were revealed in the paper’s disclosures but such acknowledgements seldom appear in the media or on internet Web sites where most people learn about studies. Merck also retained full control and ownership of the research itself.

In 2001, the year before Dr Greenspan’s article appeared, Fosamax had a little over $1 billion in sales; in 2003 sales were at $2.7 billion.

Fosamax was promoted extensively and successfully for use by young women on the premise that taking the drug daily early in life would prevent osteoporosis. However, Fosamax has now been linked to jaw bone death, a condition that involves severe pain, infection, loose teeth, exposed bone, loss of function and disfigurement, according to the American Association of Oral and Maxillofacial Surgeons.

Back on July 24, 2006, the Goldsboro News-Argus reported that more than 3,000 published cases of ONJ had been reported since 2003.

On July 11, 2006, the LA Times stated: “As Merck & Co. defends itself against a deluge of litigation involving its pain reliever Vioxx, the pharmaceutical giant also is fielding the first of what could be another wave of lawsuits involving Fosamax, its second-biggest seller.”

In one of the more recent research fiascos, on February 8, 2006, the FDA issued a Public Health Advisory and recommended that doctors limit the use of Trasylol (aprotinin), a drug used to control bleeding in open heart surgery, marketed by Bayer Pharmaceuticals, to patients where the benefit of reduced blood loss outweighed the risks.

The Advisory was based on studies that found Trasylol to be associated with a 48% increase in myocardial infarction, a 109% increase in heart failure, and a 181% increase in strokes, when compared to other drugs, and that patients treated with Trasylol had a risk of kidney failure 259% greater than patients who received no drugs.

On September 21, 2006, an FDA Advisory Committee met to review the findings and when it came time for Bayer’s presentation, Mike Rozycki, Director of US Regulatory Affairs, told the panel that when the company learned of the studies, “We immediately began a comprehensive review of all the data that we had.”

“This was conducted in very close association and under the guidance of the FDA,” he stated. “All that information has been submitted and is under review by the FDA.”

Mr Rozycki specifically said, “Dr. Pamela Cyrus, of Bayer’s U.S. Medical Affairs organization will review the clinical data that Bayer has and that is in the literature for aprotinin.”

At the end of the hearing, the panel decided that there was no need for an additional warning on Trasylol, and Bayer immediately issued a press release stating, “the committee overwhelmingly affirmed (18 yes votes and one abstention) that the totality of clinical data presented in today’s meeting supports acceptable safety and efficacy for Trasylol among coronary artery bypass graft (CABG) surgery patients.”

However, while testifying, Bayer “forgot” to mention the negative results of a study of 67,000 patients commissioned by Bayer in June 2006, from a private research firm that confirmed the risks associated with Trasylol discussed at the hearing, that Bayer had received on September 14, 2006. When the study was not mentioned at the hearing, one of the researchers who worked on it informed the FDA of its existence.

After reviewing the research, the FDA issued a new advisory saying the results of the study demonstrate “that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes.”

One of the latest cases of a drug company concealing a drug’s dangerous adverse events and lack of efficacy, involves the antibiotic, Ketek, made by Sanofi-Aventis.

During the approval process for the drug, FDA reviewers learned that evidence of liver damage was found early in the company’s own clinical trials but it was suppressed. In addition to liver problems, Ketek has been found to cause blurred vision and loss of consciousness.

To support approval, Aventis also submitted fraudulent studies to the FDA with the conduct in one study so extensive that the doctor involved, Anne Kirkland-Campbell, was sentenced to nearly 5 years in prison.

At a Congressional hearing on September 13, 2007, Dr David Ross, the primary reviewer and safety team leader during the Ketek approval process, told the Committee that top FDA officials approved Ketek despite knowing that it could kill people and that tens of millions of people would be exposed to it. Because Ketek was approved, Dr Ross said, “dozens of people have died or suffered needlessly.”

Internal FDA emails that surfaced during Congressional investigations show that at least 3 other safety officials, Dr Charles Cooper, Dr David Graham, and Dr Rosemary Johann-Liang, had also expressed serious concerns about Ketek.

“I tried to argue that given Aventis’s track record in which they have proven themselves to be nontrustworthy that we have to consider the possibility that they are intentionally doing a poor job of collecting the postmarketing data to protect their drug sales,” Dr Cooper said in an email.

A former employee of Pharmaceutical Product Development (PPD), the contract research organization hired by the Aventis for the Ketek studies, also testified at the hearing and said both Aventis and the PPD were aware of fraudulent data in the clinical trials.

Ann Marie Cisneros was a clinical research associate for PPD who monitored Dr Kirkman-Campbell’s site and said, “Dr Kirkman-Campbell indeed had engaged in fraud.”

“But what the court that sentenced her did not know,” she said, “is that Aventis was not a victim of this fraud.”

“On the contrary,” she testified, “I knew it, PPD knew it, and Aventis knew it.”

Mr Cisneros told the panel that a number of “red flags” at the trial site were apparent. For example, she said, over 400 patients were enrolled at $400 per patient for Ms Kirkman, and by comparison, another site in Gadsden had enrolled just 12 patients.

In addition, she noted, no patients had withdrawn from the study and none were lost to follow up, “an unusual occurrence given the number of subjects,” she said.

Sanofi-Aventis, for its part, submitted a typical fraudulent statement for the hearing saying in part: “It was only after FDA criminal investigators conducted an evaluation having tools at their disposal that may not be available to study sponsors, that the fraud was discovered.”

Senator, Chuck Grassley (R-Iowa), also gave a statement and described the on-going attempts to frustrate his investigation into why FDA officials approved Ketek and said:

The FDA and the Department of Health and Human Services have put up so much resistance to my efforts to find out what happened inside the FDA with a relatively new antibiotic called Ketek that I can only wonder what there is to cover up.

Every excuse under the sun has been used to create roadblocks, he said, even in the face of Congressional subpoenas requesting information and access to FDA employees.

Immediately before the hearing, the FDA announced the removal of approval for 2 of the three uses for Ketek. The drug is now approved only to treat mild to moderate severity of community acquired pneumonia, acquired outside of hospitals or long-term care facilities.

Filed under: 2007, antipsychotics, Fosamax, Ketek, SSRIs, studies, Trasylol, Vioxx

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