Yaz - Yasmin - Side Effects Lawsuit News

A Conflicted FDA Panel, Bayer & Birth Control Pills

- Pharmalot

01/11/2012 - Last month, an FDA advisory committee voted 15-to-11 that the benefits of the Yaz and Yasmin birth control pills outweigh the risks, and so the drugs should remain on the market, albeit with added information about the risk of blood clots. The decision followed a long-running controversy - studies by Bayer, which sells the pills, found there is no risk, while other studies say the risk is evident.

However, four of the panel members held ties to Bayer - either as paid consultants or in the form of research funding - but the FDA did not disclose those conflicts. Attorneys for women who are suing Bayer had attempted to publicize the connections last fall, but were prevented from doing so because the information was contained in documents that were deemed to be confidential .

The episode underscores ongoing concern over agency handling of advisory panels and conflicted members. As noted in The Washington Monthly, which writes about the Yaz and Yasmin panel conflicts in great detail, a similar controversy occurred in 2004 when conflicted FDA panel members were more likely than those without conflicts to vote that the Vioxx painkiller was safe and should remain on the market.

In recent months, agency officials - including FDA commish Margaret Hamburg - have complained about a paucity of qualified experts to serve on panels who do not hold some type of conflict in a bid to loosen regulations. Meanwhile, though, panel vacancy rates have remained low and conflict of interest waivers granted have remained below target, suggesting the agency has not having as much difficulty finding qualified experts as officials maintain.

Ironically, the FDA did yank Sid Wolfe of Public Citizen Health Research Group from its Risk Management Advisory Committee - one of two advisory panels that were convened last month to review the Bayer pills - over an alleged ‘intellectual conflict of interest.’ Specifically, the agency cited a newsletter called ‘Worst Pills, Best Pills News’ and the WorstPills web site, in which the group has labeled both pills as ‘do not use’.

At the same time, the FDA did not provide the panel with a report by former FDA commish David Kessler - and who now serves as an expert witness for plaintiffs in the sprawling Yaz and Yasmin litigation - in which he offered a scathing expert opinion that the drugmaker wrongfully withheld safety information from the FDA after reviewing internal Bayer documents (you can read his report here). The report was unsealed prior to the advisory committee meeting last month, but became available after the deadline for submitting documents to the agency for use at the meeting, according to the FDA.

The lawsuits allege that Yaz and Yasmin have risks beyond those of traditional birth control pills and Bayer too aggressively promoted the pills without disclosing those higher risks. Earlier this year, a pair of studies found that women taking birth control pills containing drospirenone are more likely to develop blood clots than those who take an older oral contraceptive .

The FDA panel last month voted 21-to-5 to change the labeling on the pills to warn that drospirenone can cause blood clots. But as The Washington Monthly notes, “the panel stopped short of recommending that the labels should warn the pills are more likely than other contraceptive pills to cause blood clots. Instead, the panel suggested the labels say the evidence about blood clots is conflicting.”

So who were the conflicted panelists? Here is what the magazine writes: The acting chair, Julia Johnson, a professor of obstetrics and gynecology at the University of Massachusetts Medical School, conducted four clinical trials - including one of drospirenone as hormone replacement - for Bayer (look here). In an e-mail to the magazine, she wrote “the FDA is very vigilant on examining potential conflicts of interest and was aware of all my research,” but would not say anything else. “The US FDA states that I cannot speak about the meeting.”

Then there was Paula Hillard, a professor of obstetrics and gynecology at Stanford School of Medicine who has served as a paid consultant to Bayer Schering (see this). She tells the magazine she complied with all FDA disclosures, but referred questions to the FDA, which declined to respond by citing the confidentiality clause of the Ethics in Government Act.

There was also Elizabeth Raymond, a senior medical associate at Gynuity Health Projects in New York, who conducted studies funded by Barr, which has a licensing agreement with Bayer for generic versions of Yaz (look here). She tells the mag the the FDA was “fully aware of all of my relevant current and past activities.”

And Anne Burke, an assistant professor of gynecology and obstetrics at Johns Hopkins University in Baltimore, has received research funding from Bayer-Berlex and Duramed, which has a licensing agreement with Bayer for generic Yaz and Yasmin (take a peek). She also maintained that she fully disclosed this to the agency. However, when asked if the FDA was aware of the conflicts, an agency spokeswoman would only tell the magazine that no waivers were issued.

Another panel member confirmed to the magazine that he received consulting fees from a law firm representing Bayer in 2006, but did not disclose the information to the FDA because the FDA “did not require information for that time frame for consulting unrelated to the meeting topic,” the magazine writes.

“The Yaz case puts FDA’s feckless ethics policy into stark relief. It also reveals the human impact of conflicts of interest and why we need an FDA that shuns even the appearance of such conflicts,” Danielle Brian, executive director of the Project On Government Oversight, tells the mag. “Right now, the bar for considering whether an advisor has a conflict is too high.”

The litigation, which was to have begun this month, was postponed by a federal judge in favor of mediation

Yaz / Yasmin / Ocella Lawsuit News Archive::

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