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An amazing series of documents were unsealed by a court in a dangerous drug injury case involving Prempro, a hormone drug. Injured plaintiffs argue that the drug causes breast cancer and other medical problems, but the bomb drop is not the allegations, but what drug giant Wyeth did to "help" create medical journal articles about the safety of its drug.

But the court documents reveal scandalous email and correspondence which purportedly shows that Wyeth "fraudulently and intentionally polluted the scientific literature related to hormone therapy in general and their hormone drugs in particular" in that Wyeth hired ghostwriter physicians or scientists to “author” biased scientific and medical journal articles-but the articles were largely written before the “author” was on board.

A medical journal PLoS Medicine posted about 1,500 of the documents on a website ( ). It was through the action of the medical journal and the New York Times that the court decided to unseal a massive number of documents which reveal exactly how the ghostwriting was done for the drug manufacturer-reaching the suggested conclusions well before a “reputable” doctor was ever part of the “study” findings as the study’s author.

As further related in an article in Trial Magazine, American Association for Justice, October 2009, PLoS Medicine editors wrote an editorial that stated

"the story told in these documents amounts to one of the most compelling expositions ever seen of the systematic manipulation and abuse of scholarly publishing by the pharmaceutical industry and its commercial partners in their attempt to influence the healthcare decisions of physicians and the general public."

Here is how the ghostwriting generally occurs:

1. A drug manufacturer hires a professional medical writing or communications company which prepares a preferred title, outline and a possible draft of an article;

2. The drug company or its ghostwriters later find the names of proposed medical or scientific authors for the pre-determined article including its slant or bias;

3. The outline or draft is sent to the selected author for approval.

Can we imagine the day that newspaper advertisers write the headlines for newspaper’s and direct the content of the news stories? Or, if Newsweek magazine allowed the advertisers to dictate the topic of stories in exchange for ads in the magazine? But, the Medical journal ghost-writing issue is really more dangerous—as physicians are regularly prescribing medications based on the questionable results of ghost-written articles. It is fairly sickening.

In the Prempro litigation, Wyeth claims that the author, even if pre-selected, substantially controlled the editorial review of the originally ghostwritten articles and that there was no inaccurate science. The attorneys for the victims argue that the drug company exercised clear control over the message of the articles and that ghostwritten articles either downplay, dismiss or minimize a particular drug’s adverse health effects. But, according to one physician, Adriane Fugh-Berman M.D, quoted in a Science Daily article, she was approached to be an “author” and the ghost writers often use an “intermediary” medical education company and the true party behind the article is fuzzy or obscured. Fugh-Berman believes that the current voluntary standards for declaring conflicts of interest to readers of medical journals and audiences at medical conferences are inadequate, and that a public database detailing physicians’ and researchers’ conflicts of interest is needed.

The most distressing part of the Prempro ghostwriting scandal is that physicians around the country must do research on the safety and on the health effects of prescription and over-the-counter drugs and look to journal articles as a respected source of information. If peer reviewed medical articles that downplay safety or health concerns seem legitimate, how is a family doctor or internist to know the difference in an unbiased, valid medical journal article or one that is simply ghostwritten on behalf of a drug manufacturer? The answer is there is no easy way to make this determination from reading a journal article that appears in any respected magazine or publication.

One of the ghosting company’s indicates it attempts to "develop a consensus statement from [an expert] forum that would be endorsed by a national organization such as the American Heart Association."

A brochure released as part of litigation over health effects of Paxil, an antidepressant drug, also described a program that helped sales representatives facilitate having articles ghostwritten. The brochure said that publishing such articles "will benefit the sales force by expanding the database of published data to support Paxil."

PLoS Medicine in the above-referenced editorial has attacked the process of ghostwriting and called on medical journal editors to "decide whether they want to roll over and just join the marketing departments of pharmaceutical companies" or police the entire process in a more transparent way. Universities and medical journals have policies on ghostwriting but the policing of the process is far from reaching a level of transparency so that consumers as well as physicians can rely upon findings in a medical journal article.

This may require congressional action, because "self-policing" has a snowballs chance of gaining traction. U.S. Senator Charles Grassley has written a letter in August 2009 to the National Institute of Health asking for an investigation of this particular problem and specifically he noted that one or more ghostwriters were actually researchers who had obtained federal funds under NIH grants.

My Take: This is a troubling and growing problem that requires further investigation in order to keep the public safe from dangerous drugs. It has been only recently that the drug companies were forced to stop providing gifts and meals to doctors to foster prescriptions and the systematic "infection" of planted journal articles may be the next area requiring reforms.

About the Editors: Shapiro, Cooper Lewis & Appleton is a law firm which focuses on injury and accident law and we have experience handling dangerous drugs and prescription drug errors. Check out our case results to see for yourself. Our primary office in based in Virginia Beach, Virginia (VA) and we have another office in Elizabeth City, North Carolina (NC). Our injury attorneys also host an extensive injury law video library on Youtube. Furthermore, our lawyers proudly edit the Virginia Beach Injuryboard and Norfolk Injuryboard as a pro bono public information service.

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