[Infowarrior] - Medical Papers by Ghostwriters Pushed Therapy

[Richard Forno]

August 5, 2009
Medical Papers by Ghostwriters Pushed Therapy
By NATASHA SINGER
http://www.nytimes.com/2009/08/05/health/research/05ghost.html?_r=1&hp=&pagewanted=print

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.