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Regulatory Affairs News and topics related to marketing laws, regulations and guidelines. Includes news feeds from FDA, including press releases, advisory committee meeting announcements, and drug safety notices.

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Old 11th January 2012, 06:11 AM
Pharma Newshound Pharma Newshound is offline
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Default FDA Advisory Committee Members Had Ties to Bayer

Source: WSJ

FDA Panelists Had Ties to Bayer

By THOMAS M. BURTON

Food and Drug Administration advisers, in a recent vote, said the benefits of four popular Bayer AG birth-control pills outweigh the blood-clot risk. What the FDA didn't disclose is that three of the advisers have had ties to Bayer, serving as consultants, speakers or researchers.

The three doctors were members of a special safety committee convened last month to assess the safety of the products, called Yaz, Yasmin, Beyaz and Safyral. Bayer's own studies show no excess danger, but other research including an FDA-commissioned study suggests there is one.

The committee voted 15-11 that the benefits of the pills outweighed the risks. All three of the doctors voted with the majority, though two of them later voted to encourage stronger labeling.

FDA advisory committees are designed to give the agency independent judgments on medical issues. The FDA says members of the public speaking before advisory committees must declare any financial relationships to the relevant drug maker, to "ensure ... transparency." However, committee members must disclose potential conflicts only to the FDA, which doesn't generally make the information public.

Jill Hartzler Warner, an FDA official who oversees advisory committees, said the agency is "prohibited from giving the public any information contained in a financial disclosure" from committee members. When picking committees, the FDA weighs "whether a meeting would affect the financial interest" of a panelist. The agency also does "look at whether past relationships would give the appearance of being a conflict," she said.

Steven Nissen, a frequent FDA panel member and prominent Cleveland Clinic cardiologist, said that, in general, if panelists have significant financial ties to a drug maker whose product is under review, it can "bias the proceedings." He added, "Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process."

Bayer said it had no role in selecting the committee, and defended the safety of its products, all four of which contain the active ingredient drospirenone. The potential conflicts of the three panel members were earlier reported in a joint article by the British medical journal BMJ and Washington Monthly.

The December hearing was filled with emotional testimony from patients and family members. Joan Cummins of Hackettstown, N.J., told of the death of her 18-year-old daughter, Michelle Pfleger, in 2010. Ms. Pfleger, a freshman at Elon University in North Carolina, was taking Yaz. She collapsed and died of cardiac arrest from a blood clot in her lung, her mother testified. Ms. Pfleger's family's lawsuit against Bayer, in which the company denies liability, hasn't been decided.

Documents unsealed recently in federal litigation in Illinois disclosed the details of the panelists' ties to Bayer. Thousands of plaintiffs have filed lawsuits, now consolidated in federal district court in East St. Louis, Ill., alleging that injuries or deaths from deep vein thrombosis and lung clots stemmed from use of the products.

Bayer documents in the litigation discuss the company's dealings with Paula Hillard, an obstetrics professor at Stanford University School of Medicine and one of the 15 who voted in favor of the products. One company document, whose date is redacted, said Dr. Hillard's presence at Stanford "enables us to now have another huge ... Yasmin advocate here in Nor Cal—she will be well utilized!"

Another Bayer "tactical brief" from 2010 describes a video clip the company planned at the time with Dr. Hillard to deal with the blood clots and other safety issues. "The video will be recorded at a studio in San Francisco and ...will show Dr. Hillard speaking on the phone with a patient who is currently on Yaz and has safety concerns that she would like to better understand," it said. The document doesn't specify whether Dr. Hillard agreed to do a video.

In an email to The Wall Street Journal, Dr. Hillard said she notified the FDA she attended two Bayer meetings in 2010, and said she received less than $10,000 for her 2010 work. She declined to answer other questions.

Another committee member, Anne E. Burke, professor of gynecology and obstetrics at Johns Hopkins Bayview in Baltimore, which is part of the Johns Hopkins Health System, has declared in published articles that she received research funding from Bayer, according to documents in the Illinois litigation.

One Bayer document in the cases describes her as a "Bayer contraception expert," according to a filing in the litigation. That filing was a report by plaintiffs' expert David A. Kessler, a former FDA commissioner, who wrote, "It is my opinion that certain members of the advisory committee did have conflicts of interest such that a reasonable person with knowledge of the relevant facts could question the member's impartiality." Dr. Burke didn't respond to requests for comment.

Dr. Kessler's report contends that all three members' relationships are evidence that "the FDA advisory committee was not independent of Bayer and its recommendations and votes need to be viewed as such."

The chairman of the committee, obstetrics professor Julia V. Johnson of the University of Massachusetts Medical School, said in an email to The Wall Street Journal that she has been an "investigator in four research studies from Bayer or Berlex [a Bayer unit]." According to biographical information on the University of Massachusetts website, one study involved a drospirenone-containing product in postmenopausal women.

In the email, Dr. Johnson said the most recent study was in 2008 and that she has "received no funding or grants" for her work. "Research alone, without funding or grants, is not considered a conflict," she said. Bayer didn't respond to requests for more information.

While the FDA allowed the three to vote, the agency removed the voting rights of another panel member, public-interest doctor Sidney M. Wolfe, because he had publicly criticized the drugs' safety in newsletters published by his Public Citizen Health Research Group.

Write to Thomas M. Burton at tom.burton@wsj.com
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