September 8th, 2010
04:10 PM ET

Ghostwriting misled thousands about HRT, analysis says

Pharmaceutical giant Wyeth paid hundreds of thousands of dollars to ghostwriters to write misleading information about hormone therapy, promoted benefits and downplayed the negative effects of hormones, according to an analysis published in PLoS Medicine.

The analysis by Dr. Adriane J. Fugh-Berman of Georgetown University Medical Center says that Wyeth, now part of Pfizer, manipulated media messages when it used ghostwriters to insert desired messages into articles published in medical journals.

The documents became public when PLoS Medicine and the New York Times argued that ghostwriting undermines public health and that documents backing this practice should be unsealed. A federal judge agreed. The documents are part of litigation by 14,000 women who claim their use of the hormones led to their development of breast cancer.

Wyeth is accused of paying a company - DesignWrite - hundreds of thousands of dollars to produce multiple articles about the benefits of Prempro, a brand of hormone therapy that became the first FDA approved treatment for hot flashes in 1942.

The analysis of those articles found that they “implied that estrogen could preserve youth and health." Further, the study says, physicians were prescribing estrogen to millions of women who had no symptoms.

"In 1975, an eight-fold increase in endometrial cancer was linked to estrogen use and estrogen sales decreased," Fugh-Berman wrote. "Today, despite definitive scientific data to the contrary, many gynecologists still believe that the benefits of HT outweigh the risks in asymptomatic women. This non-evidence based perception may be the result of decades of carefully orchestrated corporate influence on medical literature.”

The articles were crafted to downplay the perceived risks of hormone therapy and to promote unproved uses for hormone therapy, such as preventing dementia, Parkinson’s disease, vision problems and wrinkles, according to Fugh-Berman’s analysis.

Use of HRT fell in 2002 after the Women's Health Initiative study linked the use of hormones to increased risk for breast cancer, ovarian cancer, strokes and other problems.

Fugh-Berman was a paid expert witness on behalf of plaintiffs referred to in the paper. PLoS Medicine says the doctor was not paid for any part of writing or researching the paper.

In a written statement, Pfizer said, “The author of this article, Dr. Adriane Fugh-Berman, is a paid expert witness for plaintiffs in hormone therapy litigation, and even with her critical perspective, she could not establish that there were inaccuracies in any of the peer reviewed articles, or that their authors relinquished control over their work. The PLoS article breaks no new ground and fails to acknowledge the significant changes in policy undertaken by Pfizer and other companies to help strengthen disclosure in connection with medical literature. Most importantly, this article completely – and conveniently – ignores the fact that the published manuscripts were subjected to rigorous peer-review by outside experts on behalf of the medical journals that published them, and that their integrity and scientific rigor has even been recognized by multiple courts.”

soundoff (12 Responses)
  1. Christine

    "Ghostwriters" are THE easy target for blame when widely-held, but erroneous, beliefs about what treatments and which medications are best for certain medical problems, mostly cancer.

    If doctors blame "ghostwriters" spreading inaccurate informatiom that they follow, in "good faith," then what does that say about the capabilities of those doctors?

    "Ghostwriters" who work in the medical/healthcare field are PROFESSIONAL medical writers. Our professional organization, the American Medical Writers Association, dates from the 1930s. There are 5 "professional skill areas" that all members are required to complete and they earn professional certification through written tests and producing work that is peer-reviewed.

    I have strong ethics as a professional medical writer, which include pointing out errors or unclear information in the documents I'm working from in order to complete my assignment. Speaking of source materials, exactly what was provided to those writers as source materials? Certainly those materials would include medical textbooks and medical peer-reviewed journals, which are written by our all-knowing medical leaders!

    As a personal example, I was working on a freelance assignment on a report for a clinical study in which the patients received the test medication or a placebo. The medical director (I mean, doctor) insisted that I add this statement to the report's conclusion:

    "In our clinical opinion, these data [from the study] demonstrate that [our drug] shows significantly better activity than other products currently on the market."

    I asked the doctor if he really wanted to say that in this report, which was just about this one study (which was placebo-controlled, not compared to another medication), but he repeated somewhat more loudly,"In my clinical opinion, [our drug] is significantly more effective than other drugs available on the market.

    So I did as I was told and added that erroneous statement to the report. An hour later, he walked right to my desk, red-faced and furious. Of course the other medical professionals in their big meeting ripped him from side to side because when a study compares an investigational drug to a placebo, or even one marketed drug, the study will NEVER provide evidence that the new product is the best!

    He was so upset that he couldn't speak for a few minutes, then tried to tell me how it was MY fault that he had crashed and burned in the worst way possible, because I "didn't make sure that all of the facts were straight before the meeting." I replied that when my MD colleagues throw their MD in my face, I do exactly as I'm told. I reminded him that I had questioned whether that sweeping comment about the new drug's effectiveness was appropriate because in that study, it was compared only to a placebo.

    I am a professional medical writer, with all professional certifications, over 20 years of experience, and I ran a freelance business for 5 years that was profitable every single year. I am not a doctor, nor a biostatistician, but neither am I a "ghostwriter."

    It is my job to write accurate and complete reports, but legally and ultimately, it's "the boss" who is paid the big bucks to know enough about those clinical studies before he or she signs off on them!

    There seems to be a common attitude among Americans, well-educated or not, that "writing" is easy because after all, everyone learned how to do it in the 3rd grade, right? This really bothers me. There are so many ways to make a living as a professional writer: screenplays, textbooks, novels, and for me, regulatory papers that play a part in research protocols, drug approvals from the FDA, information printed in the Physicians Desk Reference, patient education materials ... and so on. Just as I would be a lousy screenplay writer, so a person with general writing skills (BA in English or Journalism) cannot jump in and write a satisfactory Investigator's Brochure.

    The professional expertise of all writers deserves respect. It's unfair to expect quality medical writing from what sounds like a group of people who were eager to do their best but who didn't have the training nor skills to produce quality work.

    And don't call me a "ghostwriter."

    September 9, 2010 at 16:39 | Report abuse | Reply
    • PubProcess

      Excellent points, Christine. Dr. Lanier's (editor of the Mayo Clinic Proceedings) keynote at the upcoming AMWA annual meeting should be of great interest for you – and everyone else at AMWA

      September 13, 2010 at 00:36 | Report abuse |
  2. Corporate Fraud

    Exxon Mobil has been caught doing the same thing regarding global warming–very successfully too. Just like the old tobacco companies.

    September 9, 2010 at 23:02 | Report abuse | Reply
  3. Lisa

    They would tell you the sky is green if it meant money in their pockets. The pharmaceutical companies have done this for decades, playing up the positives and covering up/downplaying the negatives in order for the masses to buy their products. Only when a noticeable amount of people have serious side effects, or die, will they admit to "there may be problems". As a whole, we're over-medicated, and think the answer to every perceived ailment/defect is to pop a pill.

    September 9, 2010 at 23:24 | Report abuse | Reply
  4. Chi-town Chick in Houston

    I made the decision to go on HRT for severe hotflashes. I started having side effects within two weeks. We tried adjusting the dosage, the method of delivery and the type of hormone all to no avail. Against my doctor's advice I completely stopped the HRT and opted for lifestyle changes. I still have hotflashes but I feel better about how I am treating my body.

    September 15, 2010 at 08:00 | Report abuse | Reply
  5. Pink Skies

    What we have in this country right now is the perfect storm in regards to health care, or the more appropriate title "sick care." The triad is Television, Processed Foods and Pharmaceuticals. Children are exposed to over 12,000 snack food commercials a year on television. Even if parents fed them great food and ate with them 365 days a year – their message gets across 1095 times. They can't compete. And then there are the drug ads, alternating with the snack foods. "We have a pill for whatever ails you." Yes they mention all the side affects, many of which are horrific – but people are getting numb to them. The processed food companies, health insurance companies and pharmaceutical companies are raking in a fortune making people sick! No wonder the pharmaceutical and health products industry spend more lobbying dollars in Washington every year than any other group – 266.8 million dollars in 2009. This triad is killing people, even people that should know better. Its mass inculcation. It works. That's why they hire the ghostwriters, ad companies and make commercials. Its time to play a different game. This one will be the demise of this country.

    September 18, 2010 at 01:32 | Report abuse | Reply
  6. Johnny

    Can't too many growth hormones in the body cause a disease called acromegaly, which causes the internal organs and bones to grow too large for normalcy? This is actually a killer disease, how can a doctor promote a hormone which could cause total organ failure, plus cause severe pain because of excessive adult bone growth, and then kill you?? How do these doctors and pharma companies live with themselves? Death isn't funny, and neither is pain.

    October 22, 2010 at 04:09 | Report abuse | Reply
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    April 29, 2011 at 10:14 | Report abuse | Reply
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