Personal Injury Law

Lawsuit Documents Reveal Ghostwriters Penned Accolades For Wyeth

By Jane Akre

Writing For Dollars

At least 26 scientific papers touting hormone therapy for menopausal women, were secretly produced with the help of ghostwriters and for-hire communications companies, documents unsealed as part of a lawsuit over hormone replacement therapy reveal.

The judge in Arkansas presiding over 10,000 lawsuits filed by women who claim their breast cancer was caused by hormone replacement therapy (HRT), ordered the documents unsealed at the request of the New York Times, a medical journal from the Public Library of Science, PLoS Medicine, and lawyers for former Prempro users.

Little Rock attorney Gerry Schulze, who represented the Times stated: "These documents will educate the public and allow them to better understand materials they use every day in making their often life-depending health care decisions."

Plaintiffs have filed against Wyeth and Pfizer's Pharmacia & Upjohn over HRT drugs.

The articles were published in 18 medical journals including the American Journal of Obstetrics and Gynecology and the International Journal of Cardiology.

Wyeth did not disclose the role of ghostwriters and instead hired physicians to lend their name to the final document, whether they had any editorial input or not.

The unsealed court documents reveal the influence of the pharmaceutical industry and questions the professional credibility and oversight of medical publications, which doctors and the public rely on to form medical opinion.

What The Documents Reveal

Wyeth Pharmaceuticals hired the writers between the years of 1998 and 2005 to promote the use of HRT to treat everything from hot flashes to dementia and Parkinson's disease.

The documents reveal how it worked.

Wyeth hired a public relations firm, DesignWrite, in Princeton, New Jersey, among others. A freelance writer would draft the outline and first draft, and then a medical-communications firm would review the article.

For some articles, the author was listed at 'TBD' – to be decided. For this service, DesignWrite charged Wyeth $25,000.

The drug giant then hired doctors to be listed as the author of the professional journal article. The point of contention is just how much input physicians had during the editorial process.

In one instance in 2003, a doctor had some editorial oversight. Dr. Gloria Bachmann, a professor of obstetrics and gynecology at the Robert Wood Johnson Medical School in New Brunswick, N.J., was sent a draft article, reports the NYT. She wrote back that the outline was 'excellent'. Her name then appeared at the author.

Speaking to Bloomberg, company spokesman Doug Petkus said the articles were 'scientifically accurate' and never 'misrepresented the science'.

Wyeth says it adopted a new policy in 2006 requiring doctor-authors to have some involvement with the publication process.

What's The Harm?

Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine, tells the New York Times this is like the steroid controversy and baseball.

'You don't know who was using and who wasn't; you don't know which articles are tainted and which aren't.'

Many doctors obtain their professional opinions from professional journals then share that information with their patients.

For Wyeth the payoff was great.

Sales of its hormone drugs, Premarin and Prempro soared to nearly $2 billion in 2001 alone, reports the New York Times.

It all fell apart in 2002 when a huge federal study on HRT revealed that menopausal women who took certain hormones had an increased risk of breast cancer, heart disease and stroke. By that time more than six million women had taken HRT.

Among the 8,400 lawsuits pending, 23 cases were resolved in Wyeth's favor and the company has reportedly settled with five plaintiffs.

Many medical journals now require the participants to disclose their financial relationship with the pharmaceutical industry which is published alongside their article.

Last year, Sen. Charles Grassley began investigating the influence Wyeth had over professional publications touting its drugs. Some articles were published even after the disclosure of the link between HRT and breast cancer. #

Full post as published by InjuryBoard on August 06, 2009 (boomark / email).