InfoMail for April 17, 2002

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News Stories on Human ResearchProtection and
Commentary by Vera Hassner Sharav

April 17, 2002

Scandal: Scientists Take Cash forGhostwritten Papers

FYI

The pharmaceutical industry has gained unprecedentedcontrol over research data. The published papers ended up being written byghostwriters–company employees or commercial agencies. One psychiatristacknowledges: "Some of us believe that the present system is approaching ahigh-class form of professional prostitution."

Jonathan Quick, director of essential drugs and medicinespolicy of the World Health Organization, wrote in the latest WHO Bulletin:"If clinical trials become a commercial venture in which self-interestoverrules public interest and desire overrules science, then the social contractwhich allows research on human subjects in return for medical advances isbroken."

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http://www.guardian.co.uk/Archive/Article/0,4273,4351264,00.html
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Scandal of Scientists Who Take Money for PapersGhostwritten by Drug Companies
Doctors named as authors may not haveseen raw data

Sarah Boseley, health editor
Guardian, Thursday February 7, 2002

Scientists are accepting large sums of money from drugcompanies to put their names to articles endorsing new medicines that they havenot written – a growing practice that some fear is putting scientific integrityin jeopardy.

Ghostwriting has become widespread in such areas ofmedicine as cardiology and psychiatry, where drugs play a major role intreatment. Senior doctors, inevitably very busy, have become willing to"author" papers written for them by ghostwriters paid by drugcompanies.

Originally, ghostwriting was confined to medical journalsupplements sponsored by the industry, but it can now be found in all the majorjournals in relevant fields. In some cases, it is alleged, the scientists namedas authors will not have seen the raw data they are writing about – just tablescompiled by company employees.

The doctors, who may also give a talk based on the paperto an audience of other doctors at a drug company-sponsored symposium, receivesubstantial sums of money. Fuller Torrey, executive director of the StanleyFoundation Research Programmes in Bethesda, Maryland, found in a survey thatBritish psychiatrists were being paid around $2,000 (£1,400) a time forsymposium talks, plus airfares and hotel accommodation, while Americans gotabout $3,000. Some payments ran as high as $5,000 or $10,000. "Some of usbelieve that the present system is approaching a high-class form of professionalprostitution," he said.

Robin Murray, head of the division of psychologicalmedicine at the Institute of Psychiatry in London, is one of those who hasbecome increasingly concerned. "It is clear that we have a situation where,when an audience is listening to a well-known British psychiatrist, yourecognise the stage where the audience is uncertain as to whether thepsychiatrist really believes this or is saying it because they themselves ortheir department is getting some financial reward," he said. "I canthink of a well-known British psychiatrist I met and I said, ‘How are you?’ Hesaid, ‘What day is it? I’m just working out what drug I’m supportingtoday.’"

Marcia Angell, former editor of the New England Journal ofMedicine, wrote a year ago that when she ran a paper on antidepressant drugtreatment, the authors’ financial ties to the manufacturers – which the journalrequires all contributors to declare – were so extensive that she had to runthem on the website. She decided to commission an editorial about it and spoketo research psychiatrists, but "we found very few who did not havefinancial ties to drug companies that make antidepressants."

She wrote: "Researchers serve as consultants tocompanies whose products they are studying, join advisory boards and speakers’bureaus, enter into patent and royalty arrangements, agree to be the listedauthors of articles ghostwritten by interested companies, promote drugs anddevices at company-sponsored symposiums, and allow themselves to be plied withexpensive gifts and trips to luxurious settings. Many also have equity interestin the companies."

In September her journal joined the Lancet and 11 othersin denouncing the drug companies for imposing restrictions on the data to whichscientists are given access in the clinical trials they fund. Some of thejournals propose to demand a signed declaration that the papers scientistssubmit are their own.

The success of Prozac, the antidepressant which became acult "happy" drug in the 1990s, substantially raised the stakes inpsychiatry. Its promotion coincided with the decline of state funding forresearch, leaving scientists in all areas of medicine dependent onpharmaceutical companies to fund or commission their work. That in turn gave theindustry unprecedented control over data and ended with research papersincreasingly being drafted by company employees or commercial agencies.

The responsibility of scientists for the content of theirpapers takes on serious significance in the context of court cases in the US,where relatives of people who killed themselves and murdered others while onSSRIs (selective serotonin reuptake inhibitors) – the class of drug to whichProzac belongs – claimed the drugs were responsible.

According to David Healy, a north Wales-based psycho-pharmacologist who has given evidence for the families, the companies haverelied on articles apparently authored by scientists who may in fact have notseen the raw data.

Dr Healy, who had unprecedented access to the data thatthe companies keep in their archives, said: "It may well be that 50% of thearticles on drugs in the major journals across all areas of medicine are notwritten in a way that the average person in the street expects them to beauthored." He cites the case brought last year against the formerSmithKline Beecham (now GlaxoSmithKline) by relatives of Donald Schell. Thecourt found that the company’s best-selling antidepressant, an SSRI calledSeroxat, had caused Schell to murder his wife, daughter and granddaughter andcommit suicide.

The company’s defence was based on scientific papers whichanalysed the results of trials comparing Seroxat with a placebo and found therewas no increased risk of suicide for depressed people on Seroxat. But the rawdata probably does not support that, argues Dr Healy. Some of the placebosuicides took place while patients were withdrawing from an older drug. When thefigures are readjusted without these, he says, they show there is substantiallyincreased risk of suicide on Seroxat.

This raises the question of whether the eminent scientistswhose names were on the papers ever saw the raw data from the trials – or sawonly tables compiled by company employees, he says.

David Dunner, a professor at the University of Washington,who co-authored one of the papers in 1995, admits he did not see the raw data."I don’t know who saw it. I did not," he said. "My role in thepaper was that the data were presented to us and we analysed it and wrote it upand wrote references." His co-author Stuart Montgomery, then of St Mary’shospital medical school in London, declined to answer calls and emails from theGuardian. The third name on the paper is that of Geoff Dunbar, a companyemployee.

The World Health Organisation has expressed concern aboutthe ties between industry and researchers. Jonathan Quick, director of essentialdrugs and medicines policy, wrote in the latest WHO Bulletin: "If clinicaltrials become a commercial venture in which self-interest overrules publicinterest and desire overrules science, then the social contract which allowsresearch on human subjects in return for medical advances is broken."

Guardian Unlimited © Guardian Newspapers Limited 2002

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