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web page Medical Papers by Ghostwriters Pushed Therapy
Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.
The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.
But the seeming consensus fell apart in 2002 when a huge federal study on hormone therapy was stopped after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke. A later study found that hormones increased the risk of dementia in older patients.
The ghostwritten papers were typically review articles, in which an author weighs a large body of medical research and offers a bottom-line judgment about how to treat a particular ailment. The articles appeared in 18 medical journals, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology.
The articles did not disclose Wyeth's role in initiating and paying for the work. Elsevier, the publisher of some of the journals, said it was disturbed by the allegations of ghostwriting and would investigate.
The documents on ghostwriting were uncovered by lawyers suing Wyeth and were made public after a request in court from PLoS Medicine, a medical journal from the Public Library of Science, and The New York Times.
A spokesman for Wyeth said that the articles were scientifically accurate and that pharmaceutical companies routinely hired medical writing companies to assist authors in drafting manuscripts.
The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.
"It's almost like steroids and baseball," said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. "You don't know who was using and who wasn't; you don't know which articles are tainted and which aren't."
Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their prescribing habits after reading certain articles, unaware they were commissioned by a drug company.
"The filter is missing when the reader does not know that the germ of an article came from the manufacturer," said James Szaller, a lawyer in Cleveland who has spent four years going through the ghostwriting documents on behalf of hormone therapy plaintiffs.
Wyeth faces about 8,400 lawsuits from women who claim that the company's hormone drugs caused them to develop illnesses. Twenty-three of the 31 cases that had been set for trial were resolved in Wyeth's favor; the company has also settled with five plaintiffs. Others cases are on appeal.
Doug Petkus, a spokesman for Wyeth, said the articles on hormone therapy were scientifically sound and subjected to rigorous review by outside experts on behalf of the medical journals that published them.
Although Wyeth continues to work with medical writing firms, the company adopted a policy in 2006 mandating that authors become involved early in the publication process and that any financial assistance by Wyeth or contributions by medical writers be acknowledged in the published text, said Stephen Urbanczyk, a lawyer representing Wyeth.
Doctors have long debated the merits and risks of hormone therapy to treat the symptoms of menopause. Although studies have shown that hormones have benefits like reducing the incidence of hip fractures, they have also shown that the drugs can increase the risk of various cancers.
At one time, the Premarin family of drugs, which dominated the market for hormone therapy, was among Wyeth's best-selling brands. And the company worked with several ghostwriting companies to maintain that dominance.
In 1997, for example, DesignWrite, a medical communications company in Princeton, N.J., proposed to Wyeth a two-year plan that would include the preparation of about 30 articles for publication in medical journals.
The development of an article on the treatment of menopausal hot flashes and night sweats illustrates DesignWrite's methodology.
Sometime in 2003, a DesignWrite employee wrote a 14-page outline of the article; the author was listed as "TBD" - to be decided. In July 2003, DesignWrite sent the outline to Dr. Gloria Bachmann, a professor of obstetrics and gynecology at the Robert Wood Johnson Medical School in New Brunswick, N.J.
Dr. Bachmann responded in an e-mail message to DesignWrite: "Outline is excellent as written." In September 2003, DesignWrite e-mailed Dr. Bachmann the first draft of the article. She also pronounced that "excellent" and added, "I only had one correction which I highlighted in red."
The article, a nearly verbatim copy of the DesignWrite draft, appeared in 2005 in The Journal of Reproductive Medicine, with Dr. Bachmann listed as the primary author. It described hormone drugs as the "gold standard" for treating hot flashes and was less enthusiastic about other therapies.
The acknowledgments thanked several medical writers for their "editorial assistance," not disclosing that those writers worked for DesignWrite, which charged Wyeth $25,000 to generate the article.
Dr. Bachmann, who has 30 years of research and clinical experience in menopause, said she played a major role in the publication by lending her expertise. Her e-mail messages do not reflect contributions she may have made during phone calls and in-person meetings, she said.
"There was a need for a review article and I said 'Yes, I will review the draft and make sure it is accurate,' " Dr. Bachmann said in an interview Tuesday. "This is my work, this is what I believe, this is reflective of my view."
In response to a query from a reporter, Michael Platt, the president of DesignWrite, wrote 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."
As medical journals learn more about ghostwriting through documents released in lawsuits and in Congress, some editors have started asking authors harder questions. A few leading journals, like The Journal of the American Medical Association, have instituted authorship forms that require contributors to detail their role in an article and to disclose conflicts of interest.
But many journals have yet to take such steps.
Browns is the Browns
... there goes Joe Thomas, the best there ever was in this game.
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Quote:
Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.
You have to wonder how prevalent that is in any and all aspects of media ... the global warming "debate" comes to mind.
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There is no more Winter in Cleveland ! 
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Precisely.
You can bet that it is rampant in pretty much any arena that involves public opinion.
This is just another bit of emphasis for me that the Gov't chasing the insurance industry is a load of crap.
They should instead be focusing on HEAVY Tort Reform and also on stomping the Pharmaceuticals "questionable" practices.
The Gov't should only be involved in regulating an industry.. it should never be participating in one.
Browns is the Browns
... there goes Joe Thomas, the best there ever was in this game.
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Legend
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Quote:
Precisely.
You can bet that it is rampant in pretty much any arena that involves public opinion.
This is just another bit of emphasis for me that the Gov't chasing the insurance industry is a load of crap.
They should instead be focusing on HEAVY Tort Reform and also on stomping the Pharmaceuticals "questionable" practices.
The Gov't should only be involved in regulating an industry.. it should never be participating in one.
You get "The Big Bad Dog Bone of The Week." 
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There is no more Winter in Cleveland !
Yeah, there ain't no summer, either 
Browns is the Browns
... there goes Joe Thomas, the best there ever was in this game.
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And no baseball,.... 
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Wow...this is clearly a major problem, and there needs to be a full investigation into criminal/ethical wrongdoing (since doctors have a strict doctrine for ethical standards). It sounds like a whole lotta heads should roll over this.
It seems that the major problem is the intentional failure to acknowledge that the drug company is behind the research and publication. It's expected that a drug company would do research in order to determine the efficacy of their treatments, and, if the research showed good results, would likely try to publish it. There's nothing wrong with that, because in order to design good drugs you have to do "in house" analysis.
But, you can't lie and say it was an independent report, that's highly misleading and does a disservice to other academics trying to replicate your work, as well as a disservice to doctors who are using the articles in order to prescribe treatments.
~Lyuokdea
"When a foreigner resides among you in your land, do not mistreat them. The foreigner residing among you must be treated as your native-born. Love them as yourself, for you were foreigners in Egypt. I am the LORD your God." Leviticus 19:33-34
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I feel like we've discussed this before, but IMO the three biggest problems are, in order --
1) insurance companies
2) pharm companies
3) lawyers
None of those three entities appear remotely interested in contributing adequate health care system.
And as for the issue at hand...I can't say this news shocks me in the least.
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I would rearrange that order and put insurance companies at the bottom.
1) lawyers
2) pharm companies
3) insurance companies
If the lawsuits weren't so prevalent and ridiculously expensive - and the costs being charged by the pharms wasn't so ridiculous - then the insurance companies would actually be tolerable.
Browns is the Browns
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Quote:
If the lawsuits weren't so prevalent and ridiculously expensive - and the costs being charged by the pharms wasn't so ridiculous - then the insurance companies would actually be tolerable.
How so?
The biggest problem with the health insurance industry is that they don't do what they're supposed to. The basic premise behind the whole operation is that you pay them a monthly premium, and in exchange for that, you are covered for the bulk of your medical expenses.
However...they work very hard to deny claims in any way that they can...not false claims, mind you -- any claims. If they can deny a legitimate claim, they will. And they get better at it by the day.
And *that* is the biggest problem with them...I don't see the pharm companies and the lawyers having much to do with that in a basic sense. Involved? Sure...but I don't see it as you describe.
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This will go on regardless of whos running it...no perfect system exists...
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This is very interesting and something I wasn't aware of. My initial concern, knowing the institution involved, is did Dr. Gloria Bachmann receive compensation? That is almost a moot point, publishing alone is a reward. Publishing without doing any work is a total benefit.
My second, and more critical concern, is how these articals make it into the publications. RWJ hospital is the clinical arm of University of Medicine and Dentistry of New Jersey. I cut my teeth at RWJ (and met my wife there). They are a highly academic and well respected entity in the medical arena. Medical academics are judged partially on how much they publish. Having an article in JAMA is pretty prestigious, I'm not familiar with the publication mentioned here, but publishing is publishing.
As far as I'm concerned, the only similarities to this and steroids, is that both these physicians taking credit for ghost written artical and player juicing are cheaters. These publications are supposed to have a board of physicians who evaluate the merit of submissions. Seeing biased information get through like this is disturbing.
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Quote:
How so?
The biggest problem with the health insurance industry is that they don't do what they're supposed to. The basic premise behind the whole operation is that you pay them a monthly premium, and in exchange for that, you are covered for the bulk of your medical expenses.
However...they work very hard to deny claims in any way that they can...not false claims, mind you -- any claims. If they can deny a legitimate claim, they will. And they get better at it by the day.
Phil, if you think that's the biggest problem, you'll have a wonderful time if O's health care gets passed. You think private companies are bad? Just wait till the gov't. takes control of it.
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You think private companies are bad? Just wait till the gov't. takes control of it.
Everything I've read on the health care plan indicates that the private sector will still be in the driver's seat.
Obama's plan does little aside from shifting around the flow of the money. It addresses none of the major problems with the system...except to magnify many of them.
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The article's abstract can be found here. It's a review of previous research, so no actual experimentation was involved on her part. However, I don't think i need to tell anyone that this is completely wrong on many different levels. And as some have hinted already, it's not just hormone replacement treatments that this practice of reviewing select papers and putting a bias on the outcome is probably taking place in. This is a good example of one of the reasons why primary research papers are more important than reviews to any topic.
There are no sacred cows.
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This is a good example of one of the reasons why primary research papers are more important than reviews to any topic.
Yes and no.... primary papers are great because they're cutting edge and can go into great detail on a subject.
On the other hand, primary papers are often wrong, or deal inside a framework so small (or based on a very specific set of assumptions) that they may not be greatly applicable to the whole field.
For work in your own sub-field, you absolutely work with the primary papers, because you're working on the edge, and are able to competently evaluate the various claims of different papers in their entirety.
For fields that are outside your own, I'd rely much more often on review articles from known experts in the field. These should (if well written), provide an overall view on where a specific field has been going over the last 5-10 years....and should clarify the similarities and differences between the different ideas out there.
But, then again, things are a little different in astrophysics...the field moves slower (though it doesn't always seem that way), and there really isn't a lot of money at stake, so it's unlikely that there are major conflicts of interests such as this.
~Lyuokdea
"When a foreigner resides among you in your land, do not mistreat them. The foreigner residing among you must be treated as your native-born. Love them as yourself, for you were foreigners in Egypt. I am the LORD your God." Leviticus 19:33-34
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I doubt there would be ghost writers pushing information through for astrophysicists, but you point out a great difference in the two. Maybe an industrial entity would want to push through a technology they would profit from. But what would the scientist gain? Being highly published is a big asset in all intellectual endeavors, but how does that affect your science as opposed to mine? That is a really great question. I think the medical sciences have become a little more profit driven and less result driven than astrophysics.
When you think back to Lister and Pasteur, their science imposed a net loss in profit to the profession at the time. They did their research on pure scientific terms, results, not gains. It was pure science back then, unfortunately, I was never really exposed to that type of research. There has always been a profit concern since I have been part of the industry.
That doesn't mean there isn't good research being done. I have been part of some very good projects and studies. It's just all tempered by outcomes now.
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