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Concerns re: Incomplete "Competing Interests" Disclosure

Posted by hhubbard on 27 Sep 2010 at 17:22 GMT

Wyeth has expressed concern to PLoS Medicine regarding the incomplete “competing interests” disclosure in this article, and also has highlighted some important omissions in the article itself. Please see our letter to PLoS Medicine below.


September 23, 2010

Virginia Barbour
Editor, PLoS Medicine
Public Library of Science
1160 Battery Street
Koshland Building East, Suite 100
San Francisco, CA 94111

Dear Dr. Barbour:

On behalf of Wyeth, I am writing to raise concerns about Dr. Adriane Fugh-Berman’s September 7, 2010, article for PLoS Medicine. While the article is critical of Wyeth’s past disclosure policies, it fails to disclose the extent of her – and the journal’s own – “competing interests.” We believe PLoS Medicine owes its readers a clarification that fully discloses the nature of the journal’s and Dr. Fugh-Berman’s ties to plaintiffs’ lawyers.

According to the article’s “competing interests” disclosure, “Dr. Fugh-Berman was a paid expert witness on behalf of plaintiffs in the litigation referred to in this paper” (emphasis added). In fact, the author still is an expert witness for lawyers representing plaintiffs both in the cases referred to in her article and in at least six active cases. In addition, the company referred to in her article, Wyeth, is a defendant in all of these cases. The omission of these material facts renders the disclosure incomplete and misleading.

Furthermore, PLoS Medicine fails to make any disclosure of its own relationship to plaintiffs’ lawyers. Consider: PLoS Medicine itself has sued Wyeth for access to the documents cited in Dr. Fugh-Berman’s article. Its legal counsel in those matters, Public Justice P.C., is led by many of the same plaintiffs’ lawyers suing Wyeth. These lawyers include Public Justice Secretary Esther Berezofsky and board members Kenneth Suggs, Roberta Ashkin and James Szaller, from whom Dr. Fugh-Berman took “all documentation of ghostwriting” in her paper and whose research served as “an invaluable resource in preparing this paper.”

The bottom line is that Dr. Fugh-Berman, her article, and PLoS Medicine serve the current and future interests of plaintiffs’ lawyers suing Wyeth. Indeed, the law firm of Public Justice Director Kenneth Suggs wasted no time in filing Dr. Fugh-Berman’s article as evidence in one of its HT cases on September 8 – just one scant day after it was published.

As to the integrity of the medical articles Dr. Fugh-Berman cites, she could not establish that they contained any inaccuracies or that their authors relinquished control over them. She ignores the fact that the published manuscripts were subject to rigorous peer-review by outside experts on behalf of the medical journals that published them, and that their integrity and scientific rigor have been recognized by multiple courts. For example, in Bailey v. Wyeth, New Jersey Superior Court Judge Jamie Happas wrote on July 11, 2008: “There is no dispute that the articles were subject to a rigorous peer review process and were factually and medically sound.”

We take the issue of transparency in medical writing very seriously, but plaintiffs’ lawyers are using it in the courtroom to distract jurors from the fundamental facts that (1) our HT products are not responsible for their clients’ breast cancer and (2) science cannot determine what caused or contributed to any individual woman’s breast cancer. Even the National Cancer Institute says on its website, “no one knows the exact causes of breast cancer. Doctors seldom know why one woman develops breast cancer and another doesn't.” Thus, for example, the last jury to reach a verdict in HT litigation – a case involving two plaintiffs in Philadelphia – looked exclusively at the science and found that Wyeth’s hormone medications did not cause the plaintiffs’ breast cancer. This was the second such jury verdict in a row.

To summarize: The lawyers that represent plaintiffs in HT litigation also direct the law firm that represents PLoS Medicine. These same lawyers continue to name Dr. Fugh-Berman as one of their litigation experts, and they are already using her September 7 article in legal proceedings. Plaintiffs’ lawyers appear to be using PLoS Medicine as an ostensibly independent third party to attack Wyeth as part of their legal strategy. And while criticizing Wyeth for its past disclosure policies, PLoS Medicine and Dr. Fugh-Berman fail to disclose fully the legal and financial relationships they enjoy with these lawyers today.

We encourage PLoS Medicine and Dr. Fugh-Berman to be more forthcoming about their relationships to plaintiffs’ lawyers involved in HT litigation. More immediately, we believe PLoS Medicine’s disclosures regarding Dr. Fugh-Berman’s “competing interests” with respect to her September 7 article were incomplete and warrant a correction.


Heidi K. Hubbard
Williams & Connolly, LLP

Competing interests declared: I am posting this comment on Wyeth's behalf.

RE: Concerns re: Incomplete "Competing Interests" Disclosure

plosmedicine replied to hhubbard on 27 Sep 2010 at 21:48 GMT

PLoS Medicine has a long-standing interest in the practice of ghostwriting, which predates the journal's intervention in the release of documents from the Wyeth Prempro litigation. Our interest is noted in the material relating to the intervention that we posted on our public website (http://www.plosmedicine.o...), and articles we have published previously on ghostwriting . As we noted in the "Declaration in Support of PLoS Medicine's Motion to Intervene" (http://www.plosmedicine.o...)": "PLoS Medicine has an interest in documenting ghostwriting and its negative effects. We believe that the scientific integrity of any medical journal article depends not just on the quality of the science being reported, but on the honesty and transparency of the authorship." And as we concluded: "PLos Medicine believes that there is now a very strong public health case to be made for unsealing the sealed documents--we have a rare opportunity to make public a documented example of a coordinated ghostwriting campaign."

We intervened in the Prempro case solely because of our interest in unmasking this practice. We have no professional, financial, legal or other relationship with the plaintiffs or their lawyers in any of the cases that Wyeth is defending, or in any other past or ongoing legal case. Specifically, we have received no payment from the plaintiffs or their lawyers. And, none of the lawyers who represented PLoS Medicine in its Motion to Intervene to obtain the documents represent any of the plaintiffs suing Wyeth.

We have forwarded Wyeth's letter to Dr Fugh Berman for her review and response. Even if she is still an expert witness that would not have affected our decision to publish this article, which not only involved an important topic but also was subjected to rigorous external peer-review. However, in compliance with our strict competing interests disclosure policies, it would have altered the declaration made on the article. We will be happy to augment the declaration if needed in regard to this.

Dr Virginia Barbour
Chief Editor, PLoS Medicine
Public Library of Science

Competing interests declared: I am the Chief Editor of PLoS Medicine

RE: RE: Concerns re: Incomplete "Competing Interests" Disclosure

Fugh-Berman replied to plosmedicine on 29 Sep 2010 at 01:18 GMT

Unrecognized commercial influence on publications in the medical and scientific literature distorts medical discourse to the detriment of public health. By acting as intervenors in the litigation that brought these fascinating documents to light, PLoS Medicine and The New York Times (notably unmentioned in Wyeth's letter) assisted in bringing to light facts that support the interests of scientific integrity, rational medicine and public health. The disclosure in my article used an incorrect verb tense in reference to my service as a paid expert witness on behalf of the women involved in lawsuits against Wyeth. I have been and currently am an expert witness. However, I received no payment for any part of researching or writing this article.
Adriane Fugh-Berman MD
Associate Professor, Dept. of Physiology
Georgetown University Medical Center

Competing interests declared: I am a paid expert witness on behalf of plaintiffs who have brought claims related to the development of breast cancer while taking the menopausal hormone therapy Prempro (conjugated equine estrogens and medroxyprogesterone acetate). I direct 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.

RE: Concerns re: Incomplete "Competing Interests" Disclosure

BCElliott replied to hhubbard on 28 Sep 2010 at 13:26 GMT

Let me make sure I have this right. Wyeth, the company responsible for the Fen-Phen disaster (valvular heart disease, pulmonary hyptertension, $13 billion in legal damages so far) and which has recently been acquired by Pfizer, a three-time felon for illegal marketing and fraud, is in legal trouble yet again for manipulating the medical literature on hormone replacement therapy -- and it is complaining that its critics have undisclosed conflicts of interest? Give me a break. In the long history of corporate PR and damage control, this complaint has to be one of the most ill-conceived efforts on record. If there is any justice in the world, this letter will generate the kind of public backlash against Wyeth that the company so richly deserves.

No competing interests declared.