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QUALITY: The True Meaning of a Ghostwriter -- Is it All in the Game?

August 5, 2009 - 2:16pm

On the streets of Brooklyn in the mid-90s, Ghostwriter was a friendly spirit who taught a group of racially diverse friends the value of reading while helping them solve mysteries like: "Who pulled the fire alarm?" and "What's up with Alex?

Alas, in the pages of medical journals today, a ghostwriter has a more negative and controversial meaning.

The front-page of today's New York Times has an in-depth report detailing the questionable practice of medical companies hiring writers to ghostwrite articles which tout the benefits of their products while downplaying risks and potential alternatives. It's one more reason to have unbiased government-funded comparative effectiveness research to help us figure out the best ways to treat patients.

The Times piece in particular  focuses on the drug company Wyeth, which hired a medical communications firm, Design Write, to help produce 26 scientific papers published in 18 academic medical journals from 1998 to 2005 touting the benefits of hormone replacement therapy for women. The treatments were recommended for everything from menopause to heart attacks. The medical consensus that developed benefited Wyeth, which took in nearly $2 billion in 2001 from its hormone drugs, Premarin and Prempro.

That consensus evaporated, however, in 2002, when a large multi-center study from the Women's Health Initiative at the NIH found that such hormone therapy actually raised the risk of heart attacks and breast cancer in women. Use of hormone replacement therapy dropped precipitously following the report. Meanwhile rates for breast cancer declined by a staggering 15 percent in 2003 -- a correlation not unnoticed by researchers.

Using court documents obtained from suits against Wyeth, the Times article detailed how the company  worked with Design Write to develop treatment messages to be placed in medical journals. Design Write would produce a draft of an article whose objectives the Times reported may include:

  • Highlighting benefits of Wyeth drugs
  • Playing down their potential risks
  • Promoting new uses
  • Derogating a competitor's product

The outline would then be shopped to an expert who be asked to lend his name and credibility to the piece as its primary author. Design Writer would write the article, revise it with input from Wyeth and the author and then submit it for publication. The publishing journal was unaware of how the article was written and no disclosure was made of Wyeth's role in funding it.

The story (and others like it) has caused an outrage in the medical community. One doctor, interviewed by the Times likened it to steroids in baseball: "You don't know  who was using and who wasn't; you don't know which articles are tainted and which aren't."

The worry is that doctors will read an article, change their prescription habits or practice patterns not knowing that the study they are reading was funded by a drug company.

Wyeth claims all of the articles were subject to outside review before their publication. Michael Platt, the president of Design Write, wrote to the Times that the company "has not, and will not, participate in the publication of any material in which it does not have complete confidence in the scientific validity of the content, based upon the best available data."

But a review of extant literature is a different thing than analyzing the results from a Phase-III randomized, double blinded, placebo-controlled clinical trial. What you choose to emphasize, what's left out, what's given short shrift, matters. A doctor trying to keep up with the latest medical information assumes the author of a review with experience in the field has wisely made those decisions. Yet, in the case of the Design Write studies, it appears the ostensible primary authors had very little written input. Signing off on an article is not the same as writing it yourself. When such trusts are violated the progress of science can be bent for the purpose of profit. It may not be untrue, but it is almost certainly not unbiased. As the case of hormone replacement therapy illustrates, the results can be damaging, even deadly.

Part of the solution is to require greater transparency in the publishing process of sources and funding and potential conflicts of interest for authors and their contributors. This is already underway at periodicals like the Journal of the American Medical Association. At others it is not.

More importantly, we need system that places a premium on having the best possible information available. Where studies are done not because a company has a new drug it wants to market, but because that drug can be shown to do what it's supposed to do more safely and more effectively than what's currently available. This requires commitment and change from all partners -- industry, researchers, regulators and doctors. Funding for comparative effectiveness research will help but only if it is in a system where incentives are no longer just for more -- more drugs, more treatments, more money -- but for better -- better quality, better value, better outcomes.