Air Date: Mar 25, 2003 Reporter: Erica Johnson Producer: Michael Gruzuk Researcher: Colman Jones
http://www.cbc.ca/consumers/market/files/health/ghostwriting/ Medical ghostwriting. You may not have heard of it, but you'll probably want to know about it. It's a world that could make your doctor prescribe the wrong drug. For trusted guidance - articles rigorously reviewed in medical journals - are the gold standard when it comes to scrutinized, scientific reports. They're what our doctors rely on to make decisions affecting our health. But more and more - we can't be sure who's serving up that medical advice. JOIN THE DISCUSSION: Share your thoughts on this story Medical ghostwriting can be as scary as it is spooky. People with scientific backgrounds - often, with PhDs - are paid to stay in the shadows and crank out favourable reports for drug companies. Then, drug companies get doctors to put their names on the studies - for money, prestige, or perks. Marketplace tracked down ghostwriters in Vancouver, Montreal and Ottawa - one agreed to talk with us, but only if we protected their identity. Their job could vanish if their identity is revealed. We'll call our busy ghostwriter, Blair Snitch. Blair Snitch: I'm given an outline about what to talk about, what studies to site. They want us to be talking about the stuff that makes the drug look good. Erica Johnson : They don't give you the negative studies? Blair Snitch: There's no discussion of certain adverse events. That's just not brought up. Blair Snitch is paid to write up positive reports. So bad side effects that could affect patient safety, are sometimes completely ignored. Snitch makes over $100,000 a year as a medical ghostwriter. An article that makes its way into a prestigious medical journal - like the Lancet, British Medical Journal, New England Journal of Medicine - will earn up to $20,000. Snitch's work is brisk and busy, but not problem free. Erica Johnson: How much pressure is there from the drug company to write something favourable? Blair Snitch: You're being told what to do. And if you don't do it, you've lost the job. 'A matter of efficiency' Snitch works for what's called a "medical writing" company. There's a whole industry churning out drug company bumph. It's partly a matter of efficiency, says Snitch. "Doctors don't have time to write those articles. The people who have their names on those articles are very busy professionals." Busy - and usually high-profile. The higher the profile, the greater the credibility for the article. "What appear to be scientific articles are really infomercials of some sort," says Dr. David Healy of the University of Wales. Healy's no stranger to controversy: his job at the University of Toronto was suspended after he criticized the pharmaceutical industry. But he still gets invited to lecture and remembers one in particular. "I said 'yes' to the meeting. To my big surprise I had an e-mail shortly afterwards. 'In order to reduce your workload, we have had our ghostwriters produce a first draft based on your published work. I attach it here.'" Healy wasn't comfortable with the glowing review of the drug, so he crafted his own article. The drug company wrote back and said he'd missed something key. In the end, the drug company put someone else's name on the article. Healy is spooked by the deception. He says it goes beyond being misleading - it can be dangerous. He's seen a lot of articles on drugs - like anti-depressants - that don't mention serious problems. "People and children, for instance, that have been put on these drugs, actually committing suicide. Or becoming suicidal. But the finished articles actually don't reflect this at all. Reason for concern Blair Snitch says the public should be concerned. "Are they being prescribed a drug because it's the best drug or because it's the drug most favourably positioned?" JOIN THE DISCUSSION: Share your thoughts on this story Erica Johnson: Do you have any concerns about what you're doing? Blair Snitch: I don't feel ownership of the product. Erica Johnson: But you are taking the research and delivering to the drug company something that's favourable. Blair Snitch: I expect that all the drug companies are doing it with all the drugs. So I figure in the end, it'll be balancing itself out. Healy's not so sure. He's seen internal drug company documents. They had lists of scientific papers written up, ready to go. All that was missing, was the name of a high profile doctor to be listed as author. Healy estimates as much as 50 per cent of the literature on drugs is ghostwritten. Ghostwriters we talked to said they do a good job of taking complicated science and turning it into something understandable. We wanted to ask a doctor why they'd agree to sticking their name on a paper. But it's tricky getting people to fess up. Some doctors didn't call back. One we reached said he "couldn't remember who wrote the paper" his name was on. Then said the drug company "might have" written the first draft. But by the end of our conversation, he'd remembered - he'd written every word. The world's leading medical journals - say they're trying to ferret out who lurks behind the pen. When a study is submitted to top journals like the Canadian Medical Association Journal, The Lancet, New England Journal of Medicine, everyone whose had anything to do with the article is listed - like a film credit. John Hoey, the editor of the CMAJ, admits it's a tough rule to enforce. "We have no way of checking. We barely have the resources to do what we're doing, let alone whether so-and-so is telling us honestly what they did." Hoey says drug companies don't just want positive articles, but positive research results. But some critics say all this industry influence is a problem because ghostwriters rely on research material that's given to them by drug companies - so it may be biased to begin with. That means even ghostwriters might not know about negative side effects and safety problems. 'Clearly unethical' "I think it is clearly unethical," said Dr. Mohit Bhindari, an orthopaedic surgeon at McMaster University. He's just penned a report on drug company studies - one that he wrote himself. "If you have funding from an industry sponsor, you are four times more likely to include a positive, pro-industry result which favours that particular industry's product." Bhindari says researchers have told him there's pressure to come up with "good results." Dr. David Healy says that's dangerous and has to change. "The only way to know whether the articles really are honest is for people, if need be, to be able to get access to the raw data." Blair Snitch is in a rush to go. There's another big drug company contract to work on, with no regrets. Blair Snitch: As long as I do my job well, it's not up to me to decide how the drug is positioned. I'm just following the information I'm being given. Erica Johnson: Even though you know that information is often biased? Blair Snitch: The way I look at it, if doctors that have their name on it, that's their responsibility, not mine. So for now, keep in mind that medical information you read may be other-worldly. Since people paid big bucks to spin research show no sign of giving up the ghost. GHOSTWRITING: THE BASICS What is medical ghostwriting? The practice of drug companies drafting review articles endorsing new medicines and presenting them to prominent doctors and scientists to put their names to, in exchange for financial (or other) compensation. How widespread is the practice? Ghostwriting has reportedly become widespread in various areas of medicine, including cardiology and psychiatry, where pharmaceutical drugs play a significant role in treatment. Overworked doctors have become willing to serve as "authors" for papers written for them by ghostwriters paid by drug companies. Why has ghostwriting become more prevalent? In the last decade, pharmaceutical companies have become the prime source of funding for medical research, particularly of large multi-center drug trials published in respected, peer-reviewed journals. Those who are listed as chief authors in these drug studies are usually medical school professors who are seen as experts in their fields, but much of the research is paid for, and largely carried out by, companies with a large commercial stake in the outcome. Pharmaceutical company employees usually collect and analyze the data, and often decide how it should be presented and write the reports. Where are ghostwritten articles found? Ghostwriting, once limited to journal supplements sponsored by drug companies, can now be found in all the major medical journals. In some cases, it is claimed, the doctors listed as authors will not have reviewed the raw data they are writing about - just tables compiled by company employees. Are there specific examples of articles subsequently discovered to be ghost-written? In the 1990s, Wyeth-Ayerst Laboratories commissioned ghostwriters at Excerpta Medica, Inc. to write ten articles promoting the diet-drug combo fen-phen (a combination of fenfluramine, dexfenfluramine, and phentermine) as a treatment for obesity, receiving $20,000 for each article. Two of the ten articles were published in peer-reviewed medical journals before other studies linked fen-phen to heart valve damage and an often-fatal lung disease, forcing the company to pull the drugs from the market in September 1997. In lawsuits filed by injured fen-phen users, internal company documents were subpoenaed showing that Wyeth-Ayerst had also edited the draft articles to play down and occasionally delete descriptions of side effects associated with the drugs. The final articles were published under the names of prominent researchers, one of whom claimed later that he had no idea that Wyeth had commissioned the article on which his name appeared. In February 2003, the New England Journal of Medicine announced that it was retracting an article it published last year because several listed authors said they had little or nothing to do with the research, conducted at the National Heart Institute and the Imperial College of Science, Technology and Medicine in London, England. The NEJM said that documents backing up the research contained "false signatures" from doctors who insisted they hadn't signed any such papers. Although no one could fault the science behind the study, the journal's editors said they felt compelled to retract the article anyway because falsifying signatures is a "serious infraction." How much money can doctors make by affixing their name to articles they have not written? According to a survey conducted by Fuller Torrey, executive director of the Stanley Foundation Research Programmes in Bethesda, Maryland, found that British psychiatrists were being paid around $2,000 a time for symposium talks, plus airfares and hotel accommodation, while Americans got about $3,000. Some payments ran as high as $5,000 or $10,000. How have medical journals responded to this phenomenon? In September 2001, 12 medical journals, including the Canadian Medical Association Journal, criticized the pharmaceutical industry for imposing restrictions on the raw data to which scientists are given access in the clinical trials funded by industry. A joint editorial published by the journals warned they will reject any scientific studies that are not coupled with an assurance that the sponsor - whether a drug company or other entity - offers researchers complete access to the data and freedom to report the findings. Some of the journals have proposed to demand a signed declaration that the papers scientists submit are their own. According to the editorial, company sponsors of studies should only be able to review a draft article for a limited time -- 30 to 60 days -- before allowing it to be published and should not be able to suppress aspects of a study that are detrimental to their products. This is because, in the past companies have blocked publication of unfavorable findings or delayed it for years. [Sources: The Guardian, Washington Post, HealthScout News] -- The Silver List is a moderated forum for discussing Colloidal Silver. 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