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Beware the ghost(writer)s of medical research

admin — Fri, 17 Jun 2011 18:37:17 +0000

The One Click Group – June 16, 2011

By Dr. Marc-André Gagnon
and Dr. Sergio Sismondo
Expert Advisors – EvidenceNetwork.ca

The medical research world has been concerned about the problem of ghostwriting for more than a decade.

The issue has been repeatedly raised in the mainstream media over the past few years, with most of the commentary focused on the ethics of academics serving as authors on papers they did not write and on some of the most egregious actions by pharmaceutical companies.

But these efforts miss the ways in which Big Pharma has developed new forms of medical research to serve its own interests.

How ghostwriting feeds Big Pharma profits

Big Pharma firms spend twice as much on promotion as on research and development (R&D). But it is worse than that: more and more medical R&D is organized as promotional campaigns to make physicians aware of products. The bulk of the industry’s external funding for research now goes to contract research organizations to produce studies that feed into large numbers of articles submitted to medical journals.

Internal documents from Pfizer, made public in litigation, showed that 85 scientific articles on its antidepressant Zoloft were produced and coordinated by a public relations company. Pfizer itself thus produced a critical mass of the favourable articles placed among the 211 scientific papers on Zoloft in the same period. Internal documents tell similar stories for Merck’s Vioxx, GlaxoSmithKline’s Paxil, Astra-Zeneca’s Seroquel, and Wyeth’s hormone-replacement drugs.

To promote the now-notorious Vioxx, Merck organized a ghostwriting campaign that involved some 96 scientific articles. Key ones did not mention the death of some patients during clinical trials. Through a class action lawsuit against Vioxx in Australia, it was discovered that Elsevier had created a fake medical journal for Merck – the AustralasSian Journal of Joint and Bone Medicine – and perhaps 10 other fake journals for Merck and other Big Pharma companies.

In another example, GlaxoSmithKline organized a ghostwriting program to promote its antidepressant Paxil. According to internal documents made public in 2009, the program was called “Case Study Publication for Peer-Review”, or CASPPER, a playful reference to the “friendly ghost”. Such strategies are not exceptions; they are now the norm in the industry. Most new drugs with blockbuster potential are introduced accompanied by 50, 60, or even 100 medical journal articles. Any firm that refused to play this game in the name of ethics would likely lose market share. Profits in the pharmaceutical industry depend on companies’ capacity to influence medical knowledge and create market share and market niches for their products.

A call for Evidence-Based medicine

In 2008, research showed that pharmaceutical companies systematically failed to publish negative studies on their SSRIs, the Prozac generation of antidepressants. Of 74 clinical trials, 38 produced positive results and 36 did not: 94 per cent of the positive studies were published, but only 23 per cent of the negative ones were, and two-thirds of those were spun to make them look more positive.

Physicians reading the scientific literature got a biased view of the benefits of SSRIs. This helps to explain the huge number of antidepressant prescriptions, in spite of the fact that, according to a meta-analysis in JAMA in January 2010, for 70 per cent of people taking SSRIs, the drug did not bring more benefits than a placebo. Compared to placebo, however, SSRI antidepressants can result in serious adverse drug reactions.

There we see one of the problems with the ghost management of medical research and publication. Pharmaceutical companies want upbeat reports on their drugs. They design, write, and publish studies that are likely to show their drugs in positive lights – and there are myriad ways to do so. Ghosts sometimes bend the truth, and sometimes even commit fraud, with grave results.

Why do academics serve as authors on scientific articles they did not write, using research they did not perform? Because they are rewarded, both by their universities and by their colleagues for how much they publish and for its prominence. Pharmaceutical companies and their agents are very good at placing articles in prestigious journals, and then make them even more prominent by having their armies of sales reps circulate them and talk them up.

Researchers who serve as authors on studies and analyses (perhaps scientifically correct) that are favourable to the industry can expect to see these articles increase their prestige and influence, and possibly even funding.

What happens, however, when a researcher produces studies and analyses (also scientifically correct) showing that some products are dangerous or inefficient, as some did about Vioxx before the scandal broke? Reading Merck’s internal e-mails, revealed during the class lawsuit, it was exposed that the company drew up a hit list of “rogue” researchers who needed to be “discredited” or “neutralized” – “seek them out and destroy them where they live,” reads one e-mail. Eight Stanford researchers say they received threats from Merck after publishing unfavourable results.

Corporate science

In the ghost management of research and publication by drug companies we have a new model of science. This is corporate science, done by many unseen workers, performed for marketing purposes, and drawing its authority from traditional academic science. The high commercial stakes mean that all of the parties connected with this new corporate science can find reasons or be induced to participate, support, and steadily normalize it. It also biases the available science by pushing favourable results and downplaying negative ones – and sometimes through outright fraud.

As long as pharmaceutical companies hold the purse strings of medical research, medical knowledge will serve to market drugs, not to promote health. And as long as universities grovel for more partnerships with these companies, the door will remain wide open to proceed with the corruption of scientific research.

http://www.theoneclickgroup.co.uk/news.php?id=6349#newspost

Dr. Marc-André Gagnon is assistant professor with the School of Public Policy and Administration at Carleton University. He is also an expert advisor with EvidenceNetwork.ca, a comprehensive and non-partisan online resource designed to help journalists covering health policy issues in Canada. Dr. Sergio Sismondo is professor of Philosophy and Sociology at Queen’s University. His current research is on the pharmaceutical industry’s relationships with academic medicine and practicing physicians.

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Profiting from mental ill-health

cchrint — Wed, 16 Mar 2011 03:38:06 +0000

There’s a reason psychiatrists prescribe drugs rather than talking therapy: the latter makes no money for pharmaceutical firms

The Guardian
By Harriet Fraad
March 15, 2011

More than one in ten Americans takes Prozac; the US comprises 5% of the world's population, yet consumes two thirds of psychological medications. Photograph: Stone/Jonathan Nourok/Getty

The New York Times recently led with a front-page splash about psychiatry’s propensity to prescribe pills, “Talk Doesn’t Pay, So Psychiatry Turns Instead to Drug Therapy”. That news is already widely known in the mental health field, but it has vast ramifications for Americans trying to maintain their sanity in our market-driven and medical system for delivering mental healthcare.

What does the turn to drug therapy mean for the mass of Americans?

Mental illness has not decreased with the change from talk therapy to drugs. In fact, as Robert Whitaker’s book diagnoses, mental illness in America has become an established epidemic. So-called miracle drugs like Prozac are taken by 11% of the population – and Prozac is only one of the 30 available antidepressants on the market. Antidepressants are accompanied by anti-anxiety and anti-psychotic drugs. Xanax, America’s leading anti-anxiety medication, is so ubiquitous that Xanax generates more revenue than Tide detergent, reports Charles Barber in his Comfortably Numb.

Anti-psychotics drugs alone net the pharmaceutical industry at least $14.6bn dollars a year. Psycho-pharmaceuticals are the most profitable sector of the industry, which makes it one of the most profitable business sectors in the world. Americans are less than 5% of the world’s population, yet they consume 66% of the world’s psychological medications.

Do these psycho pharmaceuticals work to restore mental health? Actually, the evidence is overwhelming that they fail. Antidepressants, the most popular psycho-pharmaceuticals, work no better than placebos. They work 25% of the time and stop working when the user stops taking them. In addition, they may actually harm patients in the long run. They disrupt brain neurotransmitters and may usurp the brain’s organic soothing functions.

Psycho-pharmaceuticals are less effective in the long run than talk therapy. Talk therapy, like drugs, does change brain and body chemistry; unlike drugs, though, talk therapy has no side-effects. Instead, talk therapy gives a patient tools that usually help to solve future problems. The latest research is most clearly expressed in both Irving Kirsch’s Antidepressants: The Emperors New Drugs and Gary Greenberg’s, Manufacturing Depression, both published last year. Kirsch is one of the world’s leading psychiatrists; Greenberg is one of the world’s most prestigious psychologists. Their views are echoed by many voices in the field of mental health. Why is prestigious and extensive research so widely ignored by doctors and patients alike? Our market-driven healthcare system gives us clues.

All 30 of the available antidepressants have suffered lawsuits within five years of their appearance on the market. These suits are often settled with large payments and gag clauses. The new generation of anti-psychotics are the latest case in point. Anti-psychotics were the single biggest targets of the False Claims Act. Every major company selling anti-psychotics – Bristol Meyers Squibb, Eli Lilly, Pfizer, Johnson and Johnson and AstraZeneca – has either settled investigations for healthcare fraud or is currently being investigated for it. Two recent settlements involving charges of illegal marketing set records for the largest criminal fines ever imposed on corporations. Their corporate logic is expressed in the words of Dr Jerome Avorn, a medical professor and researcher at Harvard: “When you are selling a billion a year or more of a drug, it’s very tempting for a company to just ignore the traffic ticket and keep speeding.”

There is also the widespread practice of paying physicians and psychiatrists heavy subsidies to recommend psycho-pharmaceuticals to their colleagues in small meetings at which a drug company representative is present. If doubt or criticism of the discussed drug is expressed, the doctor’s stipend stops. Another legally acceptable tool is to publish praise of a company’s drug in a scholarly article, which is often written by drug company personnel and simply tweaked by the physician whose name appears on the article. The physician is paid handsomely for such a service.

Under the pressure of legal settlements and embarrassing disclosures, eight pharmaceutical companies began posting doctors’ names and compensation on the web. ProPublica compiled these disclosures, totaling $320m, into a single database that allows patients to search for their doctor. Receiving payments for publishing articles written by drug companies is not illegal.

Two doctors, Dr Joseph Biederman and Dr Timothy Wilens of Harvard University Medical School, illustrate the close and cozy relationship between medical “scholarship” and drug companies. Drs Biederman and Wilens netted $1.6m each from drug companies for their work in recommending powerful anti-psychotic drugs for children. Biederman, Wilens and other extremely well-rewarded child psychiatrists are in part responsible for giving children the diagnosis of paediatric bipolar disorder for which anti-psychotic drugs like Risperidal and Zyprexa are used.

Experts agree that there is no long-term improvement in children’s lives from taking anti-psychotic drugs. In fact, these drugs have a substantiated pattern of metabolic problems and rapid weight gain that often leads to diabetes. The use of bipolar diagnoses and bipolar medications is one small example of how market-driven mental healthcare works in the United States. It illustrates the transformation of US healthcare into a system dominated by some of the richest corporations in the world.

Caring about profit is first, and that is why psychiatry has turned to drug therapy.

Read article here: http://www.guardian.co.uk/commentisfree/cifamerica/2011/mar/15/psychology-healthcare

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U.S. Sen Grassley-Demanding transparency for Pharma funds paid to doctors, researchers, patient ‘advocacy’ groups

cchrint — Thu, 19 Nov 2009 18:57:31 +0000

IowaPolitics.com
November 19, 2009

WASHINGTON — Senator Chuck Grassley has asked leading medical schools to describe their policies on ghostwriting as part of his continuing effort to shed light on financial ties between the pharmaceutical industry and medical professionals.

“I’m interested in transparency, and academic institutions play an important role in establishing adequate and meaningful disclosure. Letting the sun shine in and making information public is basic to building people’s confidence in medical research and the practice of medicine,” Grassley said.

Last July, Grassley wrote to eight leading medical journals to ask the same kinds of questions he’s presented to the medical schools. Prior to that, he asked two major drug companies about allegations that they hired ghostwriters to draft articles promoting company products and seek academics to sign on as primary authors.

Grassley also has conducted oversight and sought disclosure with physicians, continuing medical education and the patient advocacy community. He has worked to expose cases where there was vast disparity between drug-company payments received and reported by leading medical researchers. The National Institutes of Health is working on new disclosure guidelines for federal grant recipients in response to Grassley’s work.

In January, Grassley and Senator Herb Kohl introduced, for the second time, the Physician Payments Sunshine Act. The legislation would require annual public reporting by drug, device and biologic manufacturers of payments made to physicians nationwide. It was included in the health care reform bill passed in October by the Senate Committee on Finance.

Read entire article: http://www.iowapolitics.com/index.iml?Article=177376

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In the wake of U.S. Senator Charles Grassley investigations, Medical Editors Push for Ghostwriting Crackdown

cchrint — Fri, 18 Sep 2009 20:16:24 +0000

Natasha Singer and Duff Wilson
The New York Times
September 17, 2009

The scientific integrity of medical research has been clouded in recent years by articles that were drafted by drug company-sponsored ghostwriters and then passed off as the work of independent academic authors.

Yet the leading medical journals have continued to rely largely on an honor system of disclosure to detect such potential bias, asking authors to voluntarily report any industry ties or contributors to their manuscripts.

But now, in light of recently released evidence that some drug makers have gone to great lengths to turn scientific articles into marketing vehicles for their products, some influential medical editors are cracking down on industry-financed ghostwriting. And they are getting help from some members of Congress.

Read entire article: http://www.nytimes.com/2009/09/18/business/18ghost.html?_r=1&hp

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U.S. Senator charges “scientific” support of drugs often written by Pharma ghost writers

cchrint — Wed, 19 Aug 2009 19:04:10 +0000

Natasha Singer
The New York Times
August 18, 2009

A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products.

Experts in medical ethics condemn this practice as a breach of the public trust. Yet many universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account.

Those universities may not have much longer to get their houses in order before they find themselves in trouble with Washington.

With a letter last week, a senator who helps oversee public funding for medical research signaled that he was running out of patience with the practice of ghostwriting. Senator Charles E. Grassley, an Iowa Republican who has led a long-running investigation of conflicts of interest in medicine, is starting to put pressure on the National Institutes of Health to crack down on the practice.

Read entire article: http://www.nytimes.com/2009/08/19/health/research/19ethics.html?_r=2&ref=health

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CCHR International » ghost writing

Beware the ghost(writer)s of medical research

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