Posted by Rick on April 25, 2004, at 14:54:58
That's the title of this interesting article. Of course, to the extent it's true, it can affect what our pdocs will (and won't) prescribe. It's not mentioned here, but I believe Pfizer has been accused of doing this a lot. They are the world's biggest drug company and make blockbusters like Zoloft, Lipitor and Neurontin. I do know they are in trouble with the FDA for touting Neurontin for unapproved uses, and I believe ghostwriting was somehow involved in the accusations.
Rick
http://www.straightgoods.ca/ViewFeature3.cfm?REF=576
DRUG MAKERS DECEIVE DOCTORS
Pay "authors" of major studies for use of their name, credibility; ask minimal participation in research or writing.
Dateline: Friday, April 16, 2004
By Gordon Guyatt
Peter (not his real name) is a physician-scientist who, a couple of years ago, was finishing his research training in Canada. Shortly before returning to his native Australia, Peter received an interesting offer.
A pharmaceutical company was ready to pay Peter several thousand dollars to write an opinion piece for a prominent medical journal. Peter is smart, and a good writer. Producing the article would be a cinch. Attractive proposition, no?
Well, a couple of catches. First, Peter would have to follow the company's direction about what to say. Second, when the article was published, Peter's name would not appear.
Rather, a respected senior researcher who has conducted many studies funded by the pharmaceutical industry would get the credit.
Peter refused the offer. The company probably succeeded in finding a different, willing ghost-writer.
Like all unethical practices, it is difficult to establish the size of the medical ghost-writing problem. Senior authors will never threaten their prestige by admitting someone else wrote their article. Professional ghostwriters won't embarrass their clients. People like Peter won't embarrass their colleagues.
Ghost writing is a big enough business, though, to sustain companies focused on medical writing. Medical editors recognize ghostwriting as a widespread practice and have tried to tighten up their rules. Still, there is no protection against misleading or dishonest representations, and authorities suggest that up to 50% of articles reporting results of pharmaceutical trials are ghostwritten.
Lead authors of major drug studies may not only have done little of the writing, but their participation in the research itself may have been minimal. Company personnel may have developed the research plan, supervised the collection of the data, conducted the analyses, and written the first draft of the article.
The companies then go to prominent researchers, and ask: "Would you like to be an author, or even the leading author, on the article?"
The higher the profile of the author, the better for the company. The author's prestige helps to establish the credibility of the study, and contributes to the attention that the article receives.
While these extreme situations are not the most common way drug studies are reported, they merge into a grey area that is very common. Academic researchers may participate in planning the study and carrying it out, but they may never see the actual data. The company conducts the analysis, and presents the academic authors with tables that summarize the results.
A McMaster University researcher, P.J. Devereaux, has just completed a study comparing how medical scientists report their research, and what actually happens in their studies.
To carry out his research, Devereaux interviewed authors over the phone, asking them detailed questions about the conduct of their studies.
One lead author of a study published in a top journal had little idea what happened. He informed Devereaux that the company had completed the study, analyzed the data and wrote the first draft of the article. He advised Devereaux to contact the company for further information about the trial.
On other occasions, Devereaux found that authors' knowledge was sketchy because their role in the planning, conduct and particularly the analysis of their studies was limited.
Such situations mean that academic authors may never see important information, or that the company may present results in a misleading way.
That helps to explain the findings of a recent study showing that the odds of industry-funded trials enthusiastically recommending treatment are more than five times as great as non-industry funded studies.
Biased presentations affect not only how individual doctors understand research results, but how experts who create guidelines understand the results. Worse yet, the industry exerts direct influence on those experts.
Investigators at the University of Toronto conducted a survey that included 44 guidelines designed to help doctors make decisions about diagnosis and treatment for their patients.
The Toronto researchers found that 58% of guideline developers had received research funding from the industry, and 38% had served as employees or consultants. Fifty-nine per cent had relationships with companies whose drugs were considered in the guideline they authored.
Whether they are recruiting ghostwriters, giving credit to academic authors while controlling the conduct and analysis of research studies, or providing generous funding to researchers, the industry's goal is the same. Having researchers and experts carry their sales pitch to the practising doctor enhances the credibility of the company's message.
The result is often poorer and less efficient patient care. Industry bias leads to overuse of medication, and particularly overuse of new drugs.
Drugs that are recently developed and released are far more expensive. About 25% of the time, these new drugs turn out to have serious side effects that are not suspected at the time they were released. On occasion, these side effects are fatal.
Doctors expect objectivity in the research reports and expert recommendations that guide their practice. Too often, the drug industry ensures that bias, rather than objectivity, is what doctors receive.
Gordon Guyatt MD, FRCPC, lives in Dundas, Ontario. He is an academic physician at McMaster University's Department of Clinical Epidemiology and Biostatistics and Department of Medicine.
poster:Rick
thread:339877
URL: http://www.dr-bob.org/babble/20040423/msgs/339877.html