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Too often, ‘ghosts’ are to blame for hiding scary news about hormone therapy and other drugs

I’m always stunned when women tell me that their gynecologists continue to tout the benefits of menopausal hormone therapy (HT).

I thought the 2002 results from the Women’s Health Initiative (WHI) — a large randomized controlled clinical trial — would be enough to persuade even the most recalcitrant physician. That study found that not only did HT not prevent heart disease (as was roundly believed at the time), but it also increased the risk for breast cancer and stroke. (The study was even halted early because of these increased risks.) Later analyses of the data revealed that HT also raised the risk for dementia and incontinence.

Sales of HT have plummeted from their pre-WHI highs, but some women continue to take it, believing, like their doctors (or, perhaps, because of their doctors), that the drug’s benefits (relieving hot flashes and reducing bone fractures) outweigh its risks.

So why in the face of scientific evidence does HT continue to be prescribed to women for whom it’s not medically indicated? An article in the current issue of the open-access journal PLoS Medicine describes a key — and disturbing — reason: “decades of carefully orchestrated corporate influence on medical literature.”

Some doctors, it seems, continue to believe the drug-industry’s marketing hype about HT. But, then, maybe — and I’m being generous here — they’re not aware that it is hype.

In the PLoS Medicine article, Dr. Adriane Fugh-Berman, a longtime women’s health activist and director of the Georgetown University-based project PharmedOut, details what she found after analyzing 1,500 documents uncovered during a recent lawsuit against the drug giant Wyeth (now part of Pfizer). The lawsuit was filed on behalf of 14,000 women who claim that Wyeth failed to adequately warn them about the breast cancer risk of its best-selling HT drug, Prempro. Lawyers for PLoS Medicine and the New York Times successfully persuaded the court to release the documents to the public. The New York Times published its analysis of the documents earlier. This is Fugh-Berman’s academic take on them. (Fugh-Berman served as a paid expert witness for the plaintiffs in the lawsuit but says she received no payment from anyone for writing the PLoS Medicine article.)

The Wyeth documents provide, Fugh-Berman says, “unprecedented insights into how pharmaceutical companies promote drugs, including the use of vendors to produce ghostwritten manuscripts and place them in medical journals.”

It’s a sorry tale, and involves many (too many) doctors and journals. Here are a couple of the summary points of Fugh-Berman’s analysis, as provided by the editors of PLoS Medicine:

  • “Dozens of ghostwritten reviews and commentaries published in medical journals and supplements were used to promote unproven benefits and downplay harms of menopausal [HT], and to cast raloxifene [a drug used to prevent bone fractures] and other competing therapies in a negative light.”
  • “Specifically, the pharmaceutical company Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular “benefits” of HT, and to promote off-label unproven uses of HT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles.”

The physicians who gave their names to these articles ghostwritten by a communications company working for Wyeth would often not make any changes to the manuscript sent to them. When a physician did suggest changes, Wyeth made sure none of them shed a negative light on its product. Many of these ghostwritten articles were published in medical journals after the WHI clinical trial was halted and sales of HT were in free fall. Wyeth was urgently trying to find ways to cast doubt on the WHI’s devastating findings.

Of course, this story isn’t just about Prempro. As Fugh-Berman points out, the industry-funded ghostwriting of medical journal articles has been used to promote other drugs. Writes Fugh-Berman:

Industry-funded marketing messages may infest articles in every medical journal. … Acceptance of ghostwriting, euphemistically termed “editorial assistance,” may be so widespread that it is considered normal. This could explain why several authors of ghostwritten article have defended their involvement.

Medicine, as a profession, must take responsibility for this situation. Naivete is no longer an excuse. Perhaps physician-investigators should create and uphold a standard where relationships with industry are regarded as unsavory rather than sought after. Academic institutions and medical journals should take a hard line on ghostwriting. Patient care will benefit if physicians draw together as a profession to denormalize relationships with industry and avoid the role of corporate pawns in the future.

Any woman taking HT — or thinking about taking it — should read the article, which is available free in its entirety online.

You can also browse through the documents yourself at the Wyeth Ghostwriting Archive or at the University of California, San Francisco Drug Information Document Archive.

Comments (1)

  1. Submitted by Bernice Vetsch on 09/09/2010 - 03:38 pm.

    Is there some reason the pharmaceutical companies are not prosecuted for what would seem to be purposeful endangerment of those using their products?

    (Another drawback not often mentioned when HR was widely used was that the hot flashes it eliminates return when the patient stops using it. The discomforts of menopause are not removed, but only delayed.)

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