February 8, 2012 - Sixty (60) Days After FDA Advisory Committee Vote on DRSP (DROSPIRENONE) Containing Birth Control Pills.
Prior to #FDA Advisory Committee hearings, held on 12/8/11, regarding #DRSP (#DROSPIRENONE) containing birth control pills, the manufacturer released a newsletter confirming that it had been ‘served’ with 10,400 lawsuits alleging personal injuries or death. This figure was an estimate as of 10/8/11, two months before the FDA Advisory Committee hearings would consider the latest FDA funded study confirming the pills present a significantly higher risk to users of blood clots that is estimated at 75%-77% higher in comparison to other pills. This finding was released by FDA in late October 2011.
The FDA Advisory Committee voted 15-11 that the pills effectiveness in prevention of pregnancy outweighed their safety risks. This narrow vote of confidence meant the pills barely survived a recommendation that they be the subject of a ‘recall’ or ‘market withdrawal’. Recently released transcripts of the FDA Advisory Committee vote arguably reveal confusion on the vote and a missed opportunity to intervene on behalf of a Generation of #DRSP (#DROSPIRENONE) Vicitms, or YAZ VICTIMS. The FDA Advisory Committee also voted, and recommended, an updated warning label to reflect new and emerging scientific evidence that the pills in fact present higher risks of blood clots to users of all ages. Official FDA action the Advisory Committee recommendations remain pending today - February 8, 2012 - 60 (sixty) days after the Advisory Meeting met and held public hearings.
Gabriel F. Zambrano, P.A., is the author of this commentary. Gabriel F. Zambrano, P.A. is actively investigating cases of blood clots- for YAZ VICTIMS - from the use of #DRSP (#DROSPIRENONE) containing birth control pills: #YASMIN, #YAZ, #BEYAZ, #SAFYRAL, #OCELLA and #GIANVI, as well as related generic equivalents. Additional information is available from Gabriel F. Zambrano, P.A., or by contacting this office directly.
Did FDA Panelist with Ties to BAYER prevent a YAZ RECALL?
THE YAZ MEN: MEMBERS OF FDA PANEL REVIEWING THE RISKS OF POPULAR BAYER CONTRACEPTIVE HAD INDUSTRY TIES.
January 09, 2012 9:24 AM
Last month, the U.S. Food and Drug Administration convened a committee of medical experts to weigh new evidence concerning the potential dangers of drospirenone, a synthetic hormone contained in popular birth control pills including Bayer AG’s Yaz and Yasmin. In a decision that helped ensure the continued presence of these drugs on American pharmacy shelves, the committee concluded by a four-vote margin that the benefits of drugs with drospirenone outweigh the risks. However, an investigation by the Washington Monthly and the British medical journal BMJ has found that at least four members of the committee have either done work for the drugs’ manufacturers or licensees or received research funding from them. The FDA made none of those financial ties public.
Yaz and Yasmin are among Bayer’s top selling pharmaceutical products. According to the German drug manufacturer, over 4 million women worldwide use Yasmin alone. But the drug has also sparked growing controversy in recent months. A series of studies published in BMJ have shown that users of pills containing drospirenone have an increased risk of blood clots, which can cause deep vein thrombosis, pulmonary embolism, stroke, heart attack and death. And thousands of women have filed a lawsuit against Bayer, saying they were injured by Yaz or Yasmin.
Other Bayer products containing the hormone drospirenone are Beyaz and Safyral. In addition, four companies—Bayer, Teva, Watson and Sandoz—sell five generic versions of the drugs evaluated by the committee last month.
The FDA’s decision not to reveal its advisors’ relationships with the drugs’ manufacturers and Bayer raises serious questions about the agency’s treatment of potential conflicts of interest, a historically problematic area for the department. In 2004, controversy erupted over another FDA advisory hearing—involving the painkiller Vioxx—when it became clear that advisors with financial conflicts of interest were more likely than those without conflicts to vote that Vioxx was safe and should be allowed to stay on the market. The drug was ultimately withdrawn after a study showed it was associated with approximately 60,000 deaths. In 2008, partly in response to this uproar, the agency issued a new guidance on how to handle conflicts of interest among its advisors, stating that it wanted to reduce “bias” and to be more “transparent.”
The agency’s handling of the drospirenone hearings casts major doubt on how far it has gone to attain those goals.
What’s more, interviews and records also show that the drospirenone advisory committee, when it voted last month, lacked significant information about increased risks to the health of women using contraceptives containing drospirenone.
The FDA ordered the safety review of drugs containing the hormone after three articles published in the BMJ found an increased incidence of blood clots among users of the pills. The advisors were given these studies prior to the December 8 meeting. However, the panel was not shown documents from a report by David Kessler, a former FDA commissioner and an expert witness in the lawsuit filed against Bayer on behalf the women who say they were injured by Yaz and Yasmin. Kessler’s report cites internal Bayer corporate documents that suggest the company had withheld safety data from the FDA.
The documents show that in 2004, Bayer scientists reported in a draft analysis that Yasmin incurs a “several-fold increase” in reporting rates for blood clots compared to three other oral contraceptives, and that Yasmin’s rate of all serious adverse events was “10 fold higher” than that of other products.
In his report, Kessler writes that Bayer failed to report safety data to the FDA, engaged in off-label promotion of the pills, and paid $450,000 to a high profile gynecologist to sponsor her book tour in which she promoted such off-label uses.
Kessler’s report, originally under seal, was not released until December 6, two days prior to the advisory meeting. The FDA said it could not give the advisors the information because the date to submit documents had passed.
The FDA relies on some 50 advisory committees to obtain “independent” expert advice and “maintain the public trust.” Recommendations on evidence for safety and efficacy can lead to drug approvals and withdrawals; while nonbinding, recommendations by such committees can move stock prices and are generally regarded as indicators of official FDA action.
Under FDA guidelines, when advisory committee members have a financial relationship with a drug company whose product is under review, the agency can issue waivers that acknowledge the advisors’ links to industry but allow them to vote if their expertise is needed and no other specialists are available. Such waivers often serve as the only public signal that advisors have financial conflicts of interest. In the hearings on drospirenone, the FDA issued none.
And yet, according to public records, recently unsealed court documents, and interviews with some of the FDA advisors, at least four of the advisory committee members in this case have served as paid researchers, consultants, “key opinion leaders,” or speakers for Bayer or other manufacturers or licensees of drospirenone. A fifth advisor agreed to serve as a consultant but never executed the agreement. A sixth received consulting fees from a law firm representing Bayer.
In a 15-to-11 vote, the committee decided that the benefits of drospirenone outweighed its risks.Had those members with undisclosed conflicts of interest voted the other way, the committee would have come to the opposite conclusion. The committee also voted 21 to 5 to change the drug labels to warn that the hormone can cause blood clots. But the panel stopped short of recommending that the labels should warn that they are more likely than other contraceptive pills to cause blood clots. Instead the experts suggested that the labels say that the evidence about blood clots is “conflicting.”
Ironically, while the FDA allowed voting by advisors with business connections to drospirenone, the agency did bar another advisor—Sidney M. Wolfe, the panel’s lone consumer advocate—on the grounds that he has an “intellectual conflict of interest.” Wolfe, a former researcher, is a frequent critic of FDA practices on behalf of the advocacy group Public Citizen. Wolfe, the author of the consumer guide Good Pills, Bad Pills, had marked Yaz with a “do not take” advisory to readers. Jerome Hoffman, professor emeritus of medicine at UCLA, questioned Wolfe’s exclusion from the panel: “The idea that because he has an opinion on data that already exist he should be prevented from voting is nutty.”
Each of the advisors with ties to manufacturers told the Washington Monthly andBMJ that they fully disclosed their ties to the FDA, and there are no indications that the advisors failed to make required disclosures to the agency. The FDA, however, has declined to make public advisors’ financial conflict of interest forms, explaining that the forms are “confidential” and no information from them can be shared under a section of the Ethics in Government Act.
When asked whether the agency was aware of any financial ties between its advisors and manufacturers or distributors of drospirenone, FDA spokeswoman Morgan Liscinsky said, “No waivers were issued.”
But the committee’s financial ties to Bayer begin with no less than its 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 or its subsidiary Berlex, a manufacturer of drospirenone. She said in an e-mail, “The FDA is very vigilant on examining potential conflicts of interest and was aware of all my research.” When asked for an interview, she said, “The U.S. FDA states that I cannot speak about the meeting.”
Another advisor with ties to industry is Paula Hillard, a professor of obstetrics and gynecology at Stanford School of Medicine who has served as a paid consultant to Bayer Schering. Dr Hillard said she had fully complied with all FDA disclosures and referred the Washington Monthly and BMJ to the FDA for further questions. The FDA declined to respond to any questions, again citing the confidentiality clause of the Ethics in Government Act.
Elizabeth Raymond, a senior medical associate at Gynuity Health Projects in New York and another member of the committee, conducted studies funded by Barr, which has a licensing agreement with Bayer for generic versions of Yaz. Dr Raymond said that the FDA was “fully aware of all of my relevant current and past activities.”
Anne E. 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. Dr Burke said that she fully disclosed this to the agency.
According to Dr Kessler’s report, an internal Bayer document indicated that a fifth advisor received payment from Bayer, but that advisor told the Washington Monthlyand BMJ that although she initially agreed to serve as a consultant for Bayer, the company never pursued the agreement. She said FDA records indicated that she had ties to Bayer due to her disclosure about her agreement, but after she was nominated to be on the drospirenone advisory committee, she corrected the error.
A sixth advisor, meanwhile, confirmed that he received consulting fees from a law firm representing Bayer in 2006. He told BMJ and the Washington Monthly that he 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.”
Bayer spokesperson, Rosemarie Yancosek, said in an e-mailed statement: “Bayer had no input on who serves on the U.S. FDA Advisory Committee panel as the FDA has its own process for selecting panel members. Furthermore, it is Bayer’s understanding that the FDA has a procedure for determining conflicts of interest for potential panel members.”
The FDA does indeed have such a procedure, but critics argue that its guidelines define conflicts of interest too narrowly and provide too much flexibility in how they are applied. The guidelines are technically “suggested or recommended, but not required” provisions (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf). Whether an advisor can participate depends on “whether the discussion at the meeting or outcomes of the meeting will have a direct and predictable effect on the individual’s interest.” For instance, someone who was previously involved in another role for a manufacturer, or whose university received money from a manufacturer, may be allowed to participate. Even having a contract for $100,000 over a five-year period would not necessarily exclude an advisor, according to the guidelines.
Despite the FDA’s frequent claims that there aren’t enough experts independent of industry, a list of over 100 industry-independent experts has been presented to the agency - yet none of those experts has been tapped as an advisor.
The Project on Government Oversight, a Washington-based nonpartisan watchdog group, plans to raise concerns about the FDA’s conflict of interest policies in a letter to the agency’s top official, Margaret Hamburg.
“It shouldn’t require a lawsuit and investigative journalism to learn about these kinds of conflicts,” said the group’s executive director, Danielle Brian. “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.”
The organization intends to urge the FDA to routinely disclose industry ties and more aggressively determine whether an advisor has a conflict. “Right now,” said Brian, “the bar for considering whether an advisor has a conflict is too high.”
MARKETPLACE, CANADA’S CONSUMER WATCHDOG, investigates #YASMIN, #YAZ birth control pills that contain #DRSP #DROSPIRENONE. HEALTH CANADA announced this week that it had concluded a ‘safety review’ of the pills and found they presented a 1.5x to 3.0x higher risk of blood clots than other pills. This story was aired prior to this announcement in early 2011. FDA is holding hearings 12.8.11-12.9.11 to consider blood clot risks of these pills and other contraceptives. In May 2011, the EMA (European Medicines Agency) announced the pills presented a 1.5x to 3.0x higher risk of blood clots. FDA funded studies concluded the pills were 74%, or 1.74x. higher risk in comparison to other hormonal contraceptives it considered.
Birth Control YAZ Dangerous? asks ABC WORLD NEWS with Diane Sawyer.
U.S. favors more risk info on #DRSP #DROSPIRENONE birth control pills #YAZ #YASMIN #BEYAZ #SAFYRAL and generics http://usat.ly/vM8Btn
”BAYER WITHELD YASMIN DATA FROM U.S., FORMER FDA HEAD SAYS”
Bloomberg is reporting that Former FDA Commissioner, David Kessler, has stated that the manufacturer of popular #DRSP (#DROSPIRENONE) containing birth control pills, BAYER, failed to include early disclosures of data that indicated the pills were associated with higher blood clot risks. Higher blood clots, or ‘venous thromboembolism’ (VTE), include deep vein thrombosis (DVT) and pulmonary emboli (PE) and can be fatal if undetected or untreated.
Bloomberg quotes the Former FDA Commissioner as stating that “BAYER presented a selective view of the data, and that presentation obscured the potential risks associated with YASMIN”.
Kessler has been hired as an expert in cases brought against BAYER for failure to warn of risks from the popular line of birth control pills. There are over 10,500 lawsuits pending with civil jury trials scheduled to commence in January 2012.
FDA is scheduled to hold hearings on the risk presented by #DRSP (#DROSPIRENONE) birth control pills on 12.8.11.
Only hours before the BLOOMBERG story was published, HEALTH CANADA
(See related post http://www.gfzambrano.tumblr.com/archive)
announced that it had completed a ‘safety review’ of data on the pills and determined they presented a 1.5x-3.0x higher risk of blood clots.
While all birth control pills carry some risk of blood clots, or other side effects, the lawsuits that arose prior to April 2010 all involve women that did not have the benefit of an warning of increased risk. The manufacturers warnings have ‘evolved’ to include, but also question, studies that the manufacturer claims show risk similar to other forms of hormonal birth control. Today’s announcement by HEALTH CANADA appears to call the manufacturers claims into question.
What the FDA will do next is hold open hearings. Thereafter, they will consider the recommendation of expert panels and comments on the data they are considering. However, one has to wonder openly what added benefit birth control pills with any added risk and no proven superiority to other products offer future Generations of Girls & Women. A Generation of Girls & Women have already been exposed to added risk, arguably unnecessarily, and challenged as they come forward to present their claim with prior studies that Former FDA Commissioner Kessler’s testimony calls into question. A #YAZ recall, or #DRSP recall, may be a consideration, however that will do little to compensate girls and women that have already suffered, while the pills prospered as a brand and reached Blockbuster status. Any additional updates on a recall will be posted at YAZRecall.com
Gabriel F. Zambrano, P.A., is the author/sponsor of this blog and commentary.
Gabriel F. Zambrano, P.A., is actively investigating cases of serious personal injuries arising out of the use or #DRSP #DROSPIRENONE containing birth control pills. As YAZ LAWYER @YAZATTORNEY he has been providing free updates and information on the risks and dangers of #DRSP #DROSPIRENONE birth control pills for over 2 (two) years. Gabriel F. Zambrano is a Member of the YAZ MDL 2100 Discovery Committee, Lead Counsel and/or Co-Counsel of several women among 1st 100 YAZ Lawsuits filed in YAZ MDL and State Mass Tort Proceedings, has been selected to conduct depositions(s) of BAYER Corporate Representatives by State Liaison Counsel on behalf of coordinated Mass Tort Proceedings in YAZ MDL 2100, and Admitted Pro Hace Vice in PA YAZ Mass Tort Proceedings as Legal Representative of one of 1st 100 DRSP Lawsuits filed in PA Mass Tort Proceedings. Please contact the author with any requests for additional information or a FREE CASE EVALUATION. Additional information is available at YAZRecall.com
With FDA hearings looming in the US, on 12.8.11, HEALTH CANADA has completed a “safety review” of available science and data related to #DRP (#DROSPIRENONE) birth control pills and announced that the “overall, the body of current evidence suggest that the risk of blood clots is 1.5 to 3 times higher with oral contraceptives that contain #drospirenone relative to those that contain levonorgestrel, a different hormone”. In “YASMIN BIRTH CONTROL CLOT RISKS UPDATED”, CBCNews, reports on HEALTH CANADA’s findings and completed ‘safety review’ of the popular #YASMIN & #YAZ family of birth control pills.
This announcement is consistent with prior determinations in other studies published in the British Medical Journal (BMJ) beginning in 2009. The manufacturer in the US, BAYER HEALTHCARE PHARMACEUTICALS, has repeatedly denied that their product is higher risk and actually printed a label during April 2010 that claimed studies presenting findings of higher risk contained errors or were statistically unreliable. This finding by HEALTH CANADA, as well as subsequent findings appear to clearly call these claims into question. In October, FDA released findings from their own study that came to similar conclusions and found 74% higher risk, or 1.74x, in comparison to other birth control pills it considered. Prior to the release of this data, FDA announced that it had schedule hearings between two panels to consider conflicting evidence, emerging science and to help in the evaluation of the blood clot risks presented by DRSP (DROSPIRENONE).
Sadly, there are women that did not have the benefit of the ‘evolving warnings’ that only came into being after mass tort lawsuits were filed in the United States. There are 10,500 lawsuits claiming personal injuries in the US for women that allege they suffered blood clots, deep vein thrombosis, pulmonary emboli, strokes, cardiac events and in some cases death. Based upon the continually ‘evolving warnings’ it cannot be said these women were warned of known risks by the manufacturer, and other reports today call into question what was known, when it was known and if in fact it was disclosed to the FDA for consideration.
Updates regarding this subject, FDA hearings and news reports will be provided as they become available. Additional information is also available at YAZRecall.com
Gabriel F. Zambrano, P.A., is the sponsor of this blog, author of this commentary and actively involved in representing survivors of #DRSP (#DROSPIRENONE) containing birth control. Gabriel F. Zambrano, is a Member of the YAZ MDL (Federal Multi District) Discovery Committee, Representative Counsel and/or Lead Counsel to Women injured by DRSP (DROSPIRENONE) birth control, including several of the YAZ 1st 100 Discovery Bellwether Cases.
Units of Bayer AG (BAYN), Germany’s largest drugmaker, may have sought to market the Yasmin family of birth- control pills for unapproved uses and misled women about the health risks the drug posed, according to company e-mails.
Bayer unit officials discussed promoting the contraceptive known as Yaz, a spinoff of Yasmin, for treatment of all types of premenstrual syndrome, according to company files provided to lawyers for women suing Bayer. U.S. regulators approved Yaz only for the most severe form of PMS. Salespeople for Bayer unit Berlex Laboratories Inc., acquired in the 2006 purchase of Schering AG, received an e-mail that year from a company official citing a Woman’s Day magazine article about Yaz.
“This article is a nice way of using YAZ for PMS treatment instead of just focusing on the specific” class of women battling premenstrual dysphoric disorder, the most severe form of PMS, wrote Matt Sample, a Berlex sales consultant, according to a copy of the e-mail produced as evidence.
The message and other internal company files were disclosed as part of litigation claiming the drug caused blood clots, heart attacks and strokes. Bayer faces more than 10,000 lawsuits over injuries allegedly caused by the contraceptives. Lawyers suing the drugmaker cited Food and Drug Administration reports of at least 50 deaths tied to the pills from 2004 to 2008.
‘Safe and Effective’
“Bayer’s oral contraceptives have been and continue to be extensively studied worldwide and are safe and effective when used as directed and according to product labeling,” said Rose Talarico, a U.S.-based spokeswoman for the company, in an e- mail. She declined to comment further on the litigation.
Bayer’s contraceptives generated $1.58 billion (1.17 billion euros) in sales last year, making them the company’s biggest-selling drugs after Betaseron, a multiple sclerosis medication. The contraceptives, which contain the hormone drospirenone, have been the focus of regulators who question their safety.
Last month, the FDA warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives. The FDA examined data on 835,826 women who took pills containing the hormone, including Bayer’s Yasmin line of birth-control pills, according to the FDA report. The agency has set a Dec. 8 hearing to discuss the findings.
Besides the off-label marketing allegations, attorneys for women suing Bayer alleged internal company files show Berlex and Schering officials withheld some information from patients, doctors and regulators about the drug’s risk for blood-clots. The lawyers also claim in court filings that company officials wrongfully touted Yasmin and Yaz to be just as safe as rival birth-control pills.
The drugmaker and its units “sacrificed women’s health in its rush for profit and they continue to do so every day,” said Paul Pennock, a New York-based lawyer representing women suing over the contraceptives.
In January, Bayer is scheduled to face the first trials of lawsuits in which Yaz and Yasmin are alleged to have caused blood clots, which can lead to heart attacks and strokes. The trials are to take place in Illinois and Pennsylvania.
Bayer fell 1.01 euros, or 2.2 percent, to 45.25 euros at 2:03 p.m. in Frankfurt trading.
Bayer turned over Sample’s e-mail and other documents obtained by Bloomberg News to the plaintiffs’ lawyers as part of discovery, or the pre-trial exchange of evidence and information, in the consolidated Yaz cases.
The lawyers contend Sample’s e-mail about the Woman’s Day article amounts to an effort to have Yaz promoted for a use not approved by the FDA. Under U.S. law, a doctor can prescribe a medicine for any condition, as long as it’s licensed by the FDA and proven safe and effective.
Drug companies, however, aren’t allowed to promote a drug for uses other than those approved by the regulator.
In the e-mail, Sample encourages Berlex’s sales representatives to use the article to ask doctors “what percentage of your patient population suffers from” symptoms common to PMS, versus the more severe form of the disorder, and to seek information on “what they think the impact of Yaz will be.”
The women’s lawyers also rely on a May 2002 e-mail from Kimberly Schillace, then a Berlex executive, about a contract with Dr. Judith Reichman, a Los Angeles-based gynecologist who writes a blog about women’s health issues. A copy of the e-mail was included in the litigation discovery files.
The attorneys contend the e-mail supports their arguments that the drugmaker sought to market the Yasmin line of contraceptives for unapproved uses.
In the e-mail, Schillace noted that she spoke with Reichman, who appeared regularly on NBC’s “Today” show as a contributor on women’s health.
“She definitely will mention the off-label benefits of our products,” Schillace said, according to the copy of the e-mail.
“Attached please find the contract,” the e-mail states. The message doesn’t contain details of the agreement.
Sample couldn’t be immediately reached for comment. It is unclear whether he is employed by Bayer, which didn’t respond to requests for comment on his status. Schillace, referred to in a 2006 Schering press release as Kimberly Schillace Wix, declined to comment, saying only she is no longer with Bayer.
‘May Be Helpful’
Reichman noted in a November 2003 MSNBC.com article that some studies showed Berlex’s Yasmin “may be helpful in diminishing PMS-like symptoms.” In her 2005 book, “Slow Your Clock Down,” Reichman wrote that Yasmin may help women with PMS-related symptoms such as “fluid accumulation and bloat,” or with depression.
The FDA approved Yasmin only as a contraceptive. The regulator hasn’t cleared it as a treatment for any form of PMS or other ailments, according to the agency’s website. Reichman didn’t return calls seeking comment on the e-mail.
The FDA said Bayer made misleading claims about Yaz in television advertising, which prompted the drugmaker to spend $20 million on corrective spots. U.S. regulators said in 2008 that Bayer overstated the pill’s effectiveness and minimized “serious risks associated” with it in two 60-second television ads. The regulator said the spots misled viewers about approved uses for the drug.
FDA officials ordered the company to pull the ads. The following year, Bayer agreed to run new ads stating Yaz hadn’t been approved as a treatment for all forms of PMS or acne as part of a settlement of a claims brought by 27 U.S. state attorneys general.
Nearly 12 million women in the U.S. and more than 100 million women worldwide use oral contraceptives, Scott Monroe, an FDA official, said last year.
Bayer bought Schering, then a rival German drugmaker, and its New Jersey-based Berlex unit for $21.8 billion to acquire the Yasmin line of contraceptives and Bataseron. North American revenue from the birth-control pills has fallen as the pharmaceutical company, based in Leverkusen, faces competition from generics made by Teva Pharmaceutical Industries Ltd. (TEVA)
The first trial over the pills is to start Jan. 9 in federal court in East St. Louis, Illinois. The plaintiff, Kerry Sims of Belleview, Illinois, contends she developed a blood clot and a lung disorder after taking Bayer’s medicine in July 2008.
Bayer “denies that any of the plaintiff’s alleged injuries were caused by Yas and/or Yasmin,” the company said in a Nov. 16 filing in the suit. “The labeling for Yaz and Yasmin provides appropriate warnings regarding the risks.”
“All birth control pills approved for use in the U.S. are associated with reports of adverse events, including death,” lawyers for the company said.
About 10,400 suits have been filed over injuries allegedly caused by the contraceptives, Bayer officials said last month in a filing with the U.S. Securities and Exchange Commission. Some of the cases have been consolidated before U.S. District Judge David Herndon in East St. Louis.
The FDA scheduled its December hearing on drospirenone- laden contraceptives, such as the Yasmin line, because of “the conflicting nature of the findings from six published studies evaluating this risk,” the agency said in September.
‘Benefits and Risks’
The FDA advisory committee will discuss “the benefits and risks” of contraceptives such as Yasmin and Yaz “in light of the emerging safety concern that the risk of venous thromboembolism (blood clots that can break loose and move within the circulatory system) associated with use of these products may be higher compared to oral contraceptives that contain the progestin, levonorgestrel,” Morgan Liscinsky, an FDA spokeswoman, said in a Nov. 18 e-mailed statement.
Plaintiffs’ lawyers said company-sponsored studies downplayed potential side effects. A Schering-sponsored study of 58,684 women using contraceptives such as the Yasmin line found no increased risk of clots.
The lead author of the European Active Surveillance Study was Juergen Dinger, then director of the Center for Epidemiology and Health Research in Berlin. Dinger previously was a Schering vice president overseeing drugs used in gynecology and played a role in the development of the Yasmin contraceptives, according to the documents provided by plaintiffs’ lawyers.
Dinger’s tenure at Schering and his involvement with the Yasmin birth-control pills weren’t disclosed in the study when the final results were published in the medical journal Contraception in 2007.
Plaintiffs’ lawyers alleged that the EURAS study was structured to minimize the number of clots linked to the contraceptives. The study results helped support sales of Yasmin and Yaz, the women’s attorneys claimed.
Maureen Cronin, a Schering executive, said in a 2005 e-mail that she met with Dinger and “reached agreement on the future reporting on EURAS” study results. The e-mail was included as an exhibit in an Oct. 27 request that the court unseal additional documents.
“One major reason for providing only tables and a synopsis is that we do not want to imply that we have a VTE problem but emphasize the fact that the study results indicate that Yasmin’s VTE/ATE is comparable to other” contraceptives, Cronin wrote, according to a copy of the e-mail. VTE refers to venous thomboembolisms, while ATE refers to clots in patient arteries.
‘Out of Context’
“The document has been taken out of context,” Dinger said Nov. 18 in an e-mail. Other e-mails to which he doesn’t have access would support him, he said.
Cronin didn’t respond to a call or e-mail seeking comment about her work on the Yasmin line. She left Bayer in 2010 to become the global head of medical affairs for Vifor Pharma, a Swiss drugmaker, according to a copy of her resume posted on the Internet. A call to her there wasn’t returned.
“Bayer has sponsored several independently-conducted, large-scale, prospective, observational safety studies on the use of combined oral contraceptives,” Talarico, the U.S. spokeswoman for the drugmaker, said in her statement. “The EURAS study was designed with input and approval from the European regulatory authorities.”
“Bayer affirms that the benefit-risk profile of its oral contraceptives, based on an established body of well-grounded data, shows the risk of venous thromboembolism (VTE) is comparable to the other combined oral contraceptives studied,” she said.
The company’s assessment “is supported by consistent clinical findings over a 15-year period and up to 10 years of post-marketing study results,” Talarico said.
Pennock, the plaintiffs’ lawyer, claimed Dinger’s involvement casts doubt on the legitimacy of the science Bayer relies on to show its birth-control pills are safe.
“Schering bought and paid for allegedly independent, favorable science that was neither independent nor correct,” Pennock said in an interview. “Bayer continues to foist the myth that these drugs are not more dangerous upon millions of unsuspecting patients and doctors.”
Pennock and other plaintiffs’ attorneys asked Judge Herndon to unseal Bayer’s files about the design and handling of the EURAS study. The lawyers said they wanted to present the materials to the FDA panel reviewing Yaz next month.
Herndon rejected that request Nov. 10, finding Bayer had a right to keep the materials related to the EURAS study confidential.
The case is In Re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court for the Southern District of Illinois (East St. Louis).
To contact the editor responsible for this story: Michael Hytha at firstname.lastname@example.org
Additional background information on the status of FDA investigation of the blood clot risk of YAZ BIRTH CONTROL and YAZ SIDE EFFECTS is available from the sponsor of this blog and post at YAZRecall.com The sponsor of this post and blog is Gabriel F. Zambrano, P.A.