Blog of the Society for Menstrual Cycle Research

Pfizer to pay $72 Million in Philadelphia PremPro Case

December 9th, 2011 by Chris Hitchcock

Three women who developed breast cancer after their use of combination hormone therapy have been initially awarded $72 million by a jury in Philadelphia, with further judgement about punitive damages still to come. The case concerns the use of PremPro, a combination of conjugated equine estrogen and medroxyprogesterone made by Wyeth. Wyeth has since been purchased by Pfizer. Women’s Health Initiative trial results released in 2002 found an increased risk of breast cancer in those randomized to estrogen + progestin compared with placebo. Earlier this year, Pfizer announced that it has set aside $772 million in its budget for settling PremPro lawsuits.

Prior to 2002, hormone replacement therapy was often recommended to otherwise healthy women as a health-enhancing preventative therapy. SMCR has long held that menopause is a natural stage in women’s lives, rather than a condition to be treated. Hormone therapy is no longer recommended for the prevention of disease in healthy women.

 

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Ghostwritten articles funded by Wyeth overstated benefits and downplayed harms

September 8th, 2010 by Chris Hitchcock

An open-access article published in PLOS Medicine yesterday, Dr. Adriane Fugh-Berman, associate professor in the Department of Physiology at Georgetown University Medical Center in Washington DC, presents an article describing the ways in which the pharmaceutical industry used a medical education & communication company to produce ghostwritten articles that inserted marketing messages into articles published in medical journals.

This article is the first academic analysis of the 1500 documents unsealed in recent litigation against the pharmaceutical giant Wyeth (now part of Pfizer). It reveals the ways in which pharmaceutical companies use ghostwriters to insert marketing messages into articles published in medical journals. Dr. Adriane Fugh-Berman, associate professor in the Department of Physiology at Georgetown University Medical Center in Washington DC, analyzed dozens of ghostwritten reviews and commentaries published in medical journals and journal supplements that were used to promote unproven benefits and downplay harms of Prempro—a brand of menopausal hormone therapy (HT)—and to cast competing therapies in a negative light. These articles were widely circulated to drug reps and doctors to disseminate the company’s marketing messages. The analysis appears in this week’s PLoS Medicine.

Wyeth used a medical education & communication company, DesignWrite, to produce ghostwritten articles in order 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, writes Fugh-Berman.

The analysis revealed that DesignWrite was paid US$25,000 to ghostwrite articles reporting clinical trials, including four manuscripts on the HOPE trials of low-dose Prempro. DesignWrite was also assigned to write 20 review articles about the drug, for which they were paid US$20,000 each.

The analysis concludes that “Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted.”

In July 2009, PLoS Medicine, represented by the public interest law firm Public Justice, and The New York Times acted as intervenors in litigation against menopausal hormone manufacturers by 14,000 plaintiffs whose claims related to the development of breast cancer while taking the hormone therapy Prempro (conjugated equine estrogens). This resulted in a US federal court decision to release approximately 1500 documents to the public. The Wyeth Ghostwriting Archive is available at http://www.plosmedicine.org/static/ghostwriting.action or through the UCSF Drug Information Document Archive at http://dida.library.ucsf.edu/documents.jsp

Funding: The author received no specific funding for this article.

Competing Interests: Dr. Fugh-Berman was a paid expert witness on behalf of plaintiffs in the litigation referred to in this paper. She was not paid for any part of researching or writing this paper. Dr. Fugh-Berman directs PharmedOut, a Georgetown University-based project founded with public money from the Attorney General Consumer and Prescriber Grant program and currently supported by individual donations.

Citation: Fugh-Berman AJ (2010) The Haunting of Medical Journals: How Ghostwriting Sold ‘‘HRT’’. PLoS Med 7(9): e1000335. doi:10.1371/journal.pmed.1000335

(This blog largely lifted from the article press-release).

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“You can’t bias a jury with the truth”

December 16th, 2009 by Elizabeth Kissling

That was Zoe Littlepage’s response to Pfizer’s request to a judge that her law firm remove this video press release about Pfizer’s malfeasance regarding cancer risk of Prempro, their menopause hormone therapy drug. The motion reads, in part, “Plaintiff’s counsel should be compelled to remove this video from the Internet and refrain from making any further inflammatory and prejudicial public statements.”

No word on when the court will make its decision, but Oscar Chase, a professor of legal ethics at New York University School of Law, said a lawyer’s use of YouTube videos to promote his or her case isn’t all that different from a press release.

“We might say it is typical lawyer grandstanding,” Chase said in an interview. “The danger of jury tainting is outweighed by the public’s right to know.”

(Alert readers may recall seeing this video at re:Cycling last month.)

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PremPro’s Losing Streak Continues

November 23rd, 2009 by Elizabeth Kissling

There are more than 10,000 lawsuits against Wyeth/Pfizer regarding the link between PremPro and breast cancer. There have been 12 verdicts so far, and juries have awarded money to the plaintiffs in ten of those cases. The latest was announced today, in Donna Kendall v. Wyeth (Phila. CCP, June Term, 2004, No. 0965). The jury awarded Ms. Kendall $6.3 million in compensatory damages, and $28 million in punitive damages.

So far, thirteen women have settled their claims with Wyeth/Pfizer, but if awards like these continue, can we expect Pfizer soon to be offering to settle the rest?

The film clip at left is a video press release prepared by Littlepage Booth, the Houston law firm that represented both Connie Barton and Donna Kendall in their claims against Wyeth/Pfizer.

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Update in Prempro Case

November 4th, 2009 by Elizabeth Kissling
Image from Online Journal

Image from Online Journal

Even though the verdict regarding punitive damages awarded to Connie Barton in her suit against Prempro was sealed (as we wrote last week), the figure has leaked out. A Philadelphia jury awarded her $75 million in punitive damages, in addition to $3.7 million in compensation for her trouble.  Although Pfizer/Wyeth will surely appeal, it’s a substantial victory to see punitive damages in an amount that is more than 20 times the compensatory damages. The jury found Wyeth’s conduct in marketing and selling the drug was “willful and wanton,” and put their money where their mouth is.

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Pyrrhic Victory for Prempro Users

October 27th, 2009 by Elizabeth Kissling

Connie Barton, an Illinois woman who developed breast cancer after taking Prempro for menopausal symptoms, was awarded punitive damages by a jury in Philadelphia yesterday. The jury has already awarded her $3.7 million in compensatory damages, back in September, but we will not learn the amount of punitive damages until another Philadelphia jury reaches their verdict in similar case against the Pfizer, the drug’s manufacturer. (Technically, the case was filed against Wyeth, but the two companies just completed a merger deal last week, and Wyeth is now a subsidiary of Pfizer.)

Wyeth’s attorneys successfully argued that public revelation of the amount of damages might influence the jurors in Kendall v. Wyeth. However, the jury’s finding that Wyeth ignored evidence that the drug could cause cancer is now public information. Would I sound bitter if I said I hope that news influences potential jurors?

According to the news story about Barton’s case at philly.com, Pfizer has now lost five of eight trials over its hormone-replacement drugs since cases began reaching juries in 2006. 1500 more trials against Wyeth are pending at the Philadelphia Court of Common Pleas. But a longer story in Philadelphia Magazine reports 23 out of 31 cases set for trial have been resolved favorably for Wyeth; the company has settled five, and several are on appeal.

Christine Speer also writes,

The future of Prempro . . . seems pretty stable, no matter what the juries decide. Doctors in some 85 countries continue to prescribe it for hot flashes.

[. . . .]

The Philadelphia judge who basically invented mass tort pharmaceutical litigation — Sandra Mazer Moss — has made it her court’s mission to get through this docket and hear all 1,500 Philly-based trials. There might even be cases tried in groups. “The plaintiffs are due their day in court,” Moss says. “And so are the defendants. That is justice. Even one-tenth of a courtroom in your lifetime is better than nothing because you’re dead.”

If you were on the jury, you’d likely hear that Moss — who came to this court’s bench in January — arrived too late for the 205 women who died still waiting for their cases to come to trial. If you were on the jury, you’d hear that WHI’s lead researcher thinks 200,000 women who got breast cancer in the past decade have long-term hormone therapy to thank for it. If you were on the jury, you’d hear that Wyeth did everything a responsible drug company can possibly do in getting out a drug whose benefits still outweigh its risks.

Of course, if you’re not on the jury, you might never hear any of that. You might just be a patient.

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Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.