Dirty Medicine and the Pharmaceutical Companies

A very enlightening article, confirming our suspicions…  As I have to depend on medications these days, I have become even more aware of what is really going on. I can only hope we stop it soon!

Dirty medicine

October 15th, 2010 by admin · 41 Comments

After 21 years of reporting on the excesses and dangers of modern medicine for my newsletter What Doctors Don’t Tell You, I have become a bit ho-hum when confronted by yet another new revelation about the practices of drug companies.

But I have to tell you that I have been shaken to the core by new evidence that a good percentage of the medical research published in the world’s top medical literature is ghostwritten.

In the pharmaceutical world, ‘ghostwriting’ has a particular meaning.  A drugs company will hire a PR firm — known in pharma-speak as a ‘medical education and communication company  (MECC)’ –  to prepare clinical trials, engage a ghost to write an article with a positive spin on the results, and then enlist a prominent academic to put his name to a paper he’s had nothing to do with in order to give it a patina of respectability.

This ‘study’ will then be submitted (and usually published) in a respectable medical journal.

Class action
This practice only came to light several months ago during the discovery process in a class action of a lawsuit against drugs manufacturer Wyeth by 14,000 women who developed breast cancer after taking Premarin, its bestselling hormone replacement therapy drug.

It was only with the efforts of PLoS Medicine, the Public Library of Science’s peer–reviewed open access journal, and the New York Times that Wyeth’s sealed documents about the marketing of Premarin were made available to the public.

The 1500 documents afford an unprecedented glimpse into the underworld that is pharmaceutical marketing. The paper trail shows clearly how an MECC called DesignWrite hired by Wyeth launched a major damage-limitation exercise after the first clear study emerged demonstrating a link between HRT and life-threatening illness.

Wyeth’s HRT products had reached annual revenues of $2bn but that all changed in 2002, when the US National Institutes of Health-sponsored Women’s Health Initiative (WHI) study discovered that HRT increases the risk of breast cancer, ovarian cancer, stroke and heart disease. The risk was so unequivocal that the researchers running the study called a halt to HRT use in their patient population.

Wyeth’s sales abruptly nosedived by some 65 per cent after the first WHI reports, when doctors were understandably loath to prescribe the drugs to their patients.

Marketing plan
DesignWrite produced an ambitious marketing plan to flood the professional press with positive stories about Premarin.  This  “comprehensive publication program”, it claimed, would include “peer-reviewed journal articles, editorials, letters to the editor, sales training backgrounders, and critiques of the current literature, all designed to support the marketing efforts by Wyeth-Ayerst for the Premarin Family of Products.”

The disclosure papers show that the articles appeared in 18 prestigious medical journals, including the American Journal of Obstetrics and Gynecology and The International Journal of Cardiology.

The true purpose of all this was a massive effort to influence the prescribing habits of doctors; as DesignWrite noted in correspondence with Wyeth, ‘Research shows high clinician reliance on journal articles of credible product information.”

Downplayed risk
Virtually all the studies were ‘meta-analyses’ — a review pooling all previous trials on a drug or procedure. A meta-analysis is the gold standard in medicine for reviewing the safety and effectiveness of a drug.

According to Adrian Fugh-Berman, of the Georgetown University Medical Center in Washington, D. C., who has carried out a complete analysis of the Wyeth disclosure documents, the ghostwritten articles downplayed the carcinogenic potential of HRT, claimed that HRT had cardiovascular benefits, and promoted off-label and unproven uses of HRT, such as for prevention of dementia, even though off-label prescribing is illegal.

DesignWrite was paid $25,000 apiece to write four clinical trials on low-dose Prempro, another of Wyeth’s HRT products.  Many of DesignWrite’s articles disputed the WHI’s conclusions, or implied that breast cancers caused by HRT are less aggressive and easily treatable.

Aside from its ghostwriting campaign, several months after the WHI results, the Council on Hormone Education, working with University of Wisconsin-Madison’s School of Medicine and Public Health, launched a medical education program for doctors to promote hormone therapy and downplay the risks.

To date, thousands of doctors around the US have taken this online course, entirely funded by a $12 million grant by Wyeth. The University of Wisconsin received $1.5 million of the money and university faculty were also individually paid.

The course material was largely developed by — you guessed it — DesignWrite. The Council on Hormone Education was formed by DesignWrite, Wyeth and the University of Wisconsin.  Of the 40 member physicians on the council, 34 —including the course chairman, a UW doctor and professor of medicine — have financial ties to Wyeth.

File-drawer research
Just a few months after the Wyeth revelations, new evidence emerged this week showing that another major drug company had concealed virtually all research with results unfavorable to their products.

In mid-October, the British Medical Journal reported that the German Institute for Quality and Efficiency in Health Care, which produces evidence-based consumer health information, encountered ‘serious obstacles’ when attempting to wrest from Pfizer all sponsored published and unpublished studies about its antidepressant, reboxetine.

Although Pfizer had produced data on some patient trials, eventually it emerged that the drug company had withheld 74 per cent of patient data from the unpublished trials on the drug.

After Pfizer finally handed over its remaining data and the Institute was able to carry out a full assessment of all available data, it concluded that the drug was ‘overall an ineffective and potentially harmful antidepressant.’

As the full scale of Wyeth’s deception is laid bare, there is evidence that their practices are simply standard operating procedure.

In a review carried out between 1994-5, the Scientific-Ethical Committees for Copenhagen and Frederiksburg concluded that as much as three-quarters of every medical journal could be ‘ghosted’ – either the paper was prepared or promoted by an MECC or the author didn’t write it.

Medical researchers and university professors are encouraged to lend their names to studies because of the ‘publish or perish’ practices in most academic institutions.

The problem is, there is no way of smoking out research that is either ghostwritten or the result of biased reporting.  As Dr. Joseph S. Ross, professor of geriatrics at Mount Sinai School of Medicine in New York, put it:  “It’s almost like steroids and baseball.  You don’t know who was using and who wasn’t; you don’t know which articles are tainted and which aren’t.”

Crumbling edifice
These disclosures do nothing less than to undermine the entire edifice of modern medicine.  As the ordinarily sanguine British Medical Journal noted, it is likely that the medicine’s “current evidence base. . . contains incomplete and questionable evidence”.

Although new Food and Drug Administration regulations will make these practices more difficult, what is to be done about the mountain of published material on which doctors, patients and policy makers have relied for many years to make clinical decisions?

The BMJ plans to launch a major effort next year to ‘re-evaluate the integrity of the existing base of research evidence’.  By this the editors are actually suggesting, in decidedly cautious language, that we need to do virtually all of existing medical research over again.

To me, this is evidence of the same problem that gripped the finance world.  We have come to the very end of ‘naked tooth and claw’ commercial enterprise, the mindset that must make a bigger and better a profit every year, at any cost.

It is clear to me that for modern medicine to survive, pharmaceutical companies must be state-owned and have no shareholders. Anything less than that is nothing but dirty medicine.

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About martisima

After over 50 years of teaching literature to undergraduate and graduate students, I feel I have earned my retirement (it happened when I was 72, five years ago). I do miss the classroom, however, but not the meetings and all other requirements of the profession. I love teaching, and wish I could still do it. But now I read for pleasure, and watch films, and listen to all kinds of music (no TV, though). I love to travel, and hope I can resume doing it soon. I need to get over my health issues caused by thyroid surgery three years ago!
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3 Responses to Dirty Medicine and the Pharmaceutical Companies

  1. martisima says:

    P.S. With the drug industry’s annual global sales now approaching 1 trillion dollars, there can be no doubt that the whole of humanity is being held to ransom. It is worth remembering this the next time someone asks you to donate money to a charity for research into new drug treatments for cancer and other chronic diseases. After all, with astronomical sales figures like these, the pharmaceutical industry is clearly not short of funds for research. To learn the facts about the drug industry – and understand why it constitutes the largest fraud in the history of mankind — click here: http://www.pharma-fact.org/main.html

  2. Rafael says:

    Sobering indeed. But, Martha, this is no more so than what robber barons in any capitalist age have done. That is the great price of capitalism: some novel value is created–in this case specialized chemicals–that is sold, often without constraint or oversight, for exorbitant profit.
    Other socio-political systems often lack the ability to innovate as rapidly as capital-driven systems. So you won’t find large-scale novel value creation under socialism, much less communism. You will find it in capitalist superstructures. But it often comes with a terrible price: greed without constraint, social disparity without fairness, and misleading or even outright false claims, as your article points to.
    All that is ultimately a result of our basic biological construction; the result of evolution selecting for cunning, intelligence, and aggressiveness. And there’s no way around that except through cultural superstructures. And we haven’t figured out how to build truly large scale cultures that permit the best of individual initiative while preventing the abuses of individual initiative. We may never figure that out. But you can keep trying!

  3. martisima says:

    Indeed, I can and will keep trying, dear Rafael, but it is obvious that success cannot be accomplished in my lifetime… You make excellent points!

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