Following the convening of a joint panel of experts on 12.8.11 to discuss multiple independent studies related to the DRSP (DROSPIRENONE) family of contraceptives, on 4.10.12 the U.S. Food & Drug Administration issued the “FDA DRUG SAFETY COMMUNICATION” below. This communication has been reported in related news stories and “PR” from the manufacturer, BAYER HEALTHCARE PHARMACEUTICALS in a fashion that downplays the serious risk that this family of contraceptives, and their generic equivalents present to users. Moreover, the history of these pills, FDA sanctions against the manufacturer, over 11,000 pending civil lawsuits, allegations of “conflicts of interest” in the 12.8.11 Ad Comm Meeting, as well as testimony from Former FDA Commissioner D. Kessler regarding missing or hidden data is being complete ignored in recent reports. More information on the above and YAZ CLAIMS is available here YAZ RECALL.

FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone

This update is in follow-up to the FDA Drug Safety Communication posted on 9/26/11:  Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone.

Safety Announcement

[4-10-2012] The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin.  Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills.  See Table 1 for a list of drospirenone-containing products.

Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.

Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.

The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not.  The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots.  For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills. 

The revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products.  The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.

To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period. 

These studieswere discussed at the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. FDA’s briefing document for this meeting is found here.

Previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone were posted on May 31, 2011, September 26, 2011, and October 27, 2011.  The DSC posted in May 2011 updated the public about FDA’s ongoing safety review of two new studies that reported a greater risk of blood clots for women taking drospirenone-containing products as compared to the risk in women taking products containing other progestins.  Previously published studies had reported conflicting findings.  The DSC posted in September 2011 discussed preliminary results from a FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives.  The DSC posted in October 2011 released the final study report and appendices from the FDA-funded study in advance of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.

Today’s communication is in keeping with FDA’s commitment to inform the public about the Agency’s ongoing safety review of drugs.  FDA will communicate any new information on drospirenone-containing birth control pills and the risk of blood clots when it becomes available.

For more information: http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm

http://stoptheclot.org/News/article279.htm

Yaz Panel Was Filled With ‘Irregularities’: Advocates

PHARMALOT’S, Ed Silverman, from the Publishers of PharmaLive.com, examines the state of DRSP (DROSPIRENONE) birth control and the FDA Advisory Committee hearings of 12.8.11.
“Three months ago, an FDA advisory panel voted 15-to-11 that the benefits of the Yaz and Yasmin birth control pills outweigh the risks, and the drugs should remain on the market, albeit with added information about a 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 said risk is evident (see this).

But controversy also surrounded the meeting. Beforehand, the FDA yanked Sid Wolfe of the Public Citizen Health Research group from the panel due to an intellectual conflict of interest (read here). Afterwards, concerns were raised because four panel members held ties to Bayer, either as paid consultants or in the form of research funding, but the FDA did not disclose the conflicts, prompting the Project on Government Oversight, a watchdog group, to ask the FDA to convene an entirely new meeting (read this and this).

Now, a coalition of women’s health groups charges there were several irregularities that may well have altered the outcome. In a letter to FDA commish Margaret Hamburg, the coalition complains, in particular, that the key question panelists had to answer, which determined the outcome of the voting, was vague and confusing. And they maintain that several panelists who are practicing obstetricians and gynecologists may also have held intellectual conflicts that swayed their votes.

“Obviously, we can’t predict how people would have voted with different wording…,” the coalition wrote. “However, the vaguely (and, we believe, inappropriately) worded question and the difference in how conflicts of interest were handled raises very serious questions of bias.” The groups that signed the March 9 letter include the Jacobs Institute of Women’s Health, the National Research Center for Women & Families, the National Women’s Health Network and Our Bodies Ourselves.

The panelists were asked to vote on whether “the benefits of the DRSP-containing oral contraceptives for prevention of pregnancy outweigh their risks.” DRSP is drospirenone, which is a hormone contained in the Yaz and Yasmin pills. After voting, each panelist was asked to explain their vote, and the coalition noted that those who voted “no” explained that safer oral contraceptives were available.

However, the letter also notes that almost all of the 15 who voted “yes” indicated they voted on a comparison of risks and benefits compared to pregnancy, rather than on whether the risks and benefits of oral contraceptives containing DRSP outweigh risks and benefits compared to other oral contraceptives. These are two different issues, the coalition writes, the befuddled some panelists.

The coalition pointed to panelist Elaine Morrato, who voted “yes,” but said: “However, if the standard is to make a comparative, which… I just compared it in the absolute sense. I would agree that I didn’t see any benefit of the product that’s well demonstrated for Yasmin, perhaps for Yaz. And so if the regulatory standard would be that you’d have to demonstrate a comparative benefit, then I would vote no.” This would have changed the vote to 14-to-12.

Another panelist, Anne Burke, voted “yes,” and according to the letter, said: “I don’t think I was expecting it to be more effective than other pills on the market, and while I acknowledge that there does seem to be a moderate increased risk, it’s still lower than the risks of pregnancy. And like some other folks who have spoken, a no vote sounded like it would be - to take the product off the market. I’m not quite sure that’s necessary at this point.”

And panelist Julia Johnson voted “yes” and said: “I am significantly concerned regarding the most recent FDA study…I would like to see comparison with another U.S. study. I think that’s absolutely critical. I do not think there is one advantage for this pill over any other for use for women. If indeed there is truly an increased risk, then I would vote differently,” according to the letter. Both Johnson and Burke had ties to Bayer.

Meanwhile, seven other panelist are practicing OB/GYNs. “Given that practicing OB/GYNs routinely prescribe oral contraceptives, and that these physicians have likely made a decision to either prescribe or not prescribe/stop prescribing DRSP-containing OCs prior to the meeting, this certainly raises an intellectual conflict of interest as great as that attributed to Dr. Wolfe. Had they been ask to participate in the panel but not vote, as Dr. Wolfe was, this clearly would have resulted in a majority vote that the benefits do not outweigh the risks,” the coalition writes to Hamburg.

How so? Here is the math: If Wolfe voted no and at least one of the three panelist who expressed strong concerns voted “no” on the more specific question of whether the benefits outweigh the risks compared to other pills, the vote would have been 14 “no” and 13 “yes.” But if Wolfe and those with a financial conflict had not been allowed to vote, the final vote would have been 11-to-11. And if Morrato had been counted as a “no,” given her confusion, then the vote would have 12-to-10 against allowing the Bayer drugs to remain on the market, the coalition writes (here is the letter).

The coalition, however, stopped short of asking the FDA to hold a new meeting and, instead, wants Hamburg to review its policies “that resulted in biases” so a repeat does not occur. We asked the FDA, which previously indicated the POGO request for a new meeting would be reviewed, for a reply and will update you accordingly. [UPDATE: An FDA spokeswoman writes us to say the agency will respond directly to the coalition.]”

http://www.pharmalot.com/2012/03/yaz-panel-was-filled-with-irregularities-advocates/

Ms. MAGAZINE BLOG:

Just How Safe is Yaz? Women Need to Know!

The oral contraceptive Yasmin was released in 2001 by the pharmaceutical company Bayer, followed by Yaz in 2006. They differ from other birth control pills in the synthetic progesterone they utilize, drospirenone, which is marketed as less likely to cause weight gain and bloating than other birth control pills. Yaz soon became the most popular birth control pill in the U.S., due in part to a widespread advertising campaign promoting the drug as what theNew York Times dubbed “a quality of life treatment,” claiming it could also clear up acne, prevent bloating and ease the depression and anxiety associated with both PMS and the controversial condition ofPMDD. It prevents pregnancy at the same rate of effectiveness as all other oral contraceptives.

In 2009, the FDA requested that Bayer distribute a corrective advertisement to counter its aggressively screened commercials that were said to be making misleading assertions about the capabilities of the drug, promoting it for unapproved uses and making light of the more serious health risks (such as blood clots). However, in 2010 the drug remained the second-best-selling Bayer product, bringing in$1.5 billion in sales.

As of January 2012, there are approximately 10,000 lawsuits against Bayer by women who have suffered blood clots and by the families of those women who have died whilst taking Yaz or Yasmin. It is considered the most complained-about drug on the Internet, with thousands of women voicing concerns in online forums and support groups over health issues both physical and emotional. Jane Bennett and Alexandra Pope, authors of The Pill: Are You Sure It’s for You?, characterize many of these problems as “quality-of-life-threatening.” I have written extensively on my own experience with Yasmin in my blog, Sweetening the Pill, and for the UK Independent and have been quoted in Fabulous magazine the Washington Post.  

Two studies conducted with funding from Bayer revealed that Yaz and Yasmin held no higher risk of blood clots than other birth control pills. However, last month it was revealed that five other studies undertaken independent of Bayer suggested a 50-to-75 percent increased risk of clots for those taking these birth control pills in comparison to others. A former FDA commissioner, David Kessler, charged that Bayer deliberately withheld data about this early on in order to push through the drugs’ approvals. In response, the FDA called an advisory committee to evaluate the safety of birth control pills containing drospirenone. The decision had the potential to cause the drugs to be pulled off the market, but the panel voted by a four-person margin that the drugs’ benefit outweighed the risks.

Yet a government watchdog group, the Project on Government Oversight (POGO), conducted an independent investigation that revealed three of the advisors on the FDA panel had research or other financial ties to Bayer. A fourth advisor was connected to manufacturing the generic version of these pills. All four voted for Yaz and Yasmin to continue to be prescribed by doctors. POGO asked the FDA that a new advisory committee be brought together to make another assessment.

Should these developments impact women’s perspective on the birth control pill? Should we consider that use of the Pill for pregnancy prevention, let alone acne or PMS, is still today, as women’s health activist Barbara Seaman wrote in her 1969 book The Doctors’ Case Against the Pill, “like tinkering with nuclear bombs to fight off the common cold”?

Says Ms. blogger Elizabeth Kissling, professor of communication and women’s and gender studies at Eastern Washington University and past president of the Society for Menstrual Cycle Research:

I’m surprised there has not been a broader call for more research, or wider public discussions of the risks of this pill. When a drug company is withholding data and 10,000 lawsuits are pending, more than research is needed. I can’t help but wonder why we’re not seeing Congressional hearings–akin to the 1970 Nelson Pill Hearings–again, and more of an outcry from both physicians and patients.

Much of the media coverage of these recent developments and research was quick to assert the unimportance of women’s concerns. It was repeatedly reported that, when compared to the risk of blood clot development associated with pregnancy, the risk produced by taking any oral contraceptive–including Yasmin or Yaz–is of little concern. This is misleading in that it suggests there are only two states in which young women can choose to live: on birth control pills or pregnant. The fear has been voiced that any discussion of the negative impact of the Pill will prompt women to come off of it and fall unintentionally pregnant. No coverage that this writer has read discussed a comparison with non-hormonal contraceptive alternatives–which, of course, hold no increased risk of blood clots. Some of these alternatives are just as effective in preventing pregnancy as oral contraceptives, and others are more so.

According to Laura Wershler, veteran pro-choice sexual and reproductive health advocate and board director of theCanadian Federation for Sexual Health,

We need to reframe the idea that hormonal birth control is the gold standard of contraception. If women are quitting the Pill, and they have every right to do so, and they are not using alternative methods of birth control effectively, that’s proof positive that what we are teaching about contraception is incomplete and ineffective. If we make the Pill the ‘right’ choice, then why should we be upset when women stop taking it and get pregnant?

It is often claimed within news stories that the Pill “regulates” a woman’s menstrual cycle, when it, in fact, stops and replaces the cycle. All of this propaganda for the Pill is extremely misleading, and it further breeds a lack of confidence to know that Bayer paid women’s magazines to advocate for Yaz. Such actions blind women to their choices and to understanding how their bodies work. There is much research that supports the health benefits of consistent (typically monthly) ovulation, which can be found through the Centre for Menstrual Cycle and Ovulation Research.

The absence of education in body literacy is a major factor in unwanted pregnancies. However, this lack of education is beneficial to some: It helps sustain the billion-dollar profits of pharmaceutical companies.

Photo is the cover of The Pill: Are You Sure It’s for You?

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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.

(Source: yazrecall.com)

Temps Presents an investigative report from the award winning Swiss investigative news program on #DRSP (#DROSPIRENONE) containing birth control pills. The documentary profiles the aftermath of events for several YAZ VICTIMS and their stories of survival.

CNN previously explored events leading up to the FDA’s 12.8.11 Advisory Committee and public hearings on the potential health risk posed by #DRSP (#DROSPIRENONE) containing birth control pills: #YASMIN, #YAZ, #BEYAZ, #OCELLA, #GIANVI and other generics.

In a narrow 15-11 vote the experts on the Advisory Committee decided that the pills were sufficiently effective in the prevention of pregnancy to outweigh the confirmed risk of blood clots they presented to users of all ages. Notably, a growing body of scientific evidence has repeatedly found the pills present a higher risk of blood clots. Estimates vary on the significantly higher risk they pose. However, a FDA funded study found that they are 75%-77% higher risk in comparison to other available birth control pills.  The same experts voted that this risk was not adequately presented in current warnings associated with the product. This is significant because the warning labels and inserts had already been revised twice in less than a twenty-four (24) month period. As a result, it is anticipated that the confusing and arguably misleading labels will be revised yet again in coming months.

Sadly, #DRSP (#DROSPIRENONE) containing birth control pills have been available for over a decade in the United States. Recent science confirms that added risk were not communicated, and that scientific research is catching up with the #DRSP (#DROSPIRENONE) family of pills that delivered more risk than was communicated.

Gabriel F. Zambrano, P.A., is the author and sponsor of this post. Gabriel F. Zambrano, P.A., is actively representing girls and women that have suffered catastrophic injuries from blood clots associated with the DRSP (DROSPIRENONE) family of contraceptives. Additional information is available at DRSPRecall

Have These Symptoms? Buy This Drug by Pauline W. Chen, M.D.

It began suddenly a little over 10 years ago. With impressive fluency, friends, family members and patients started asking me about random medications, the odd syncopations of those invented, polysyllabic pharmaceutical brand names – Viagra, Lipitor — rolling perfectly off their tongues.

The questions they asked about those drugs did not reflect breaking news or the results of scientific studies. Rather, they were a reflection of sound bites, advertisements and the draw of celebrities who endorsed them, all part of carefully conceived marketing schemes.

There’s no question that Americans like their prescription medications. We spend nearly twice as much per person on pharmaceuticals as patients in other developed countries do, and we account for nearly half of all sales worldwide. But in 1997, when the Food and Drug Administration loosened its regulations and the United States became one of only four countries to allow direct-to-consumer advertising (the others are New Zealand, Bangladesh and South Korea), we entered a new era in pharmaceutical consumerism.

Players in the drug industry began aiming their advertisements at patients, and their goal was to define in the minds of patients not only the beneficial effects of the drugs but also the diseases they were designed to treat.

As Vince Parry, a well-known marketing expert, counseled his colleagues, “If you can define a particular condition and its associated symptoms in the minds of physicians and patients, you can also predicate the best treatment for that condition.”

The phenomenon is sometimes referred to as “disease mongering,” redefining what is normal and abnormal in a way that widens potential markets for those who sell treatments. And, as detailed in a recent study in the journal Social Science & Medicine, one marketing strategy has accomplished more in this regard than any other by using what has come to be the very symbol of quality and reliability for doctors and patients everywhere: the checklist. 

Placed on Web sites, on downloadable apps and in pamphlets in doctors’ offices, these checklists of symptoms have become a critical part of every major pharmaceutical marketing campaign. What makes them so attractive is that they make it easy for patients to diagnose their own ailments, to take some control over their own health.

What makes the checklists so powerful is their ability to influence patient preferences.

The makers of Yaz, a birth control pill, for example, used a checklist to help promote the use of their drug as a treatment for premenstrual dysphoric disorder, a controversial diagnosis said to affect up to 10 percent of women. Alongside links to articles on fashion, makeup, hair and celebrity news, Yaz’s Web site offered a “Body Diary” checklist to help patients determine whether they suffer from the disorder.

Taking its cues from the Diagnostic and Statistical Manual of Mental Disorders, or D.S.M., which mental health professionals use to diagnose disease, the checklist offered watered-down and potentially more inclusive descriptions. A symptom described in the D.S.M. as “persistent and marked anger or irritability or increased interpersonal conflicts” appeared in the Yaz questionnaire as “Felt angry, or irritable.” “Marked change in appetite, overeating, or specific food cravings” became “Had increased appetite or overate; or had cravings for specific foods.” The printable results that patients could then take to their doctors (the site has since been taken down) were on a form emblazoned with the birth control brand.

“The whole point of tools like this one is to confine people’s experiences into these categories in order to make a diagnosis in line with the branded drug,” said the author of the study, Mary Ebeling, an assistant professor of sociology at Drexel University in Philadelphia who got interested in the use of checklists while doing research at a marketing firm. “I became really intrigued when I saw a group of marketers sitting around a table in Midtown Manhattan and coming up with symptoms.”

Some symptom checklists are clearly branded, so patients and clinicians can easily discern the pharmaceutical interests involved. But many are less obvious or are used as part of advocacy groups’ materials or awareness events. For example, National Depression Screening Day, held annually at college campuses, military sites and community centers across the country, uses a symptom checklist called the Patient Health Questionnaire, or PHQ-9. The nine questions are based on a well-known anxiety screening tool, but its copyright is held by Pfizer, maker of the antidepressant Zoloft.

It’s difficult to ascertain whether efforts aimed directly at consumers ultimately translate into real sales. A recent marketing study found that fewer than 3 percent of patients mentioned a marketed drug by name and less than 1 percent asked for a prescription. However, a separate study comparing patients in Canada, where direct-to-consumer marketing is illegal, with those in the United States found that American patients were more than twice as likely to request advertised medications.

But sales may not be the only measure of success for these campaigns. “The whole point of this marketing and branding is that the name ends up in the minds of the consumers,” Dr. Ebeling said.

While the Obama administration is looking to force pharmaceutical companies to disclose any payments to doctors that might influence their treatment decision, marketing efforts directed at patients are likely to continue to grow. And with those efforts comes a widening, not shrinking, circle of interests that can influence their care.

“There are pharmaceutical marketers, medical device makers, health insurers and whoever is involved in the health industry sitting in the exam room, not just the doctor and patient,” Dr. Ebeling said.

She added, “I find that disturbing, because it’s our health and the quality of our lives that are at stake.”

Have These Symptoms? Buy This Drug by Pauline W. Chen, M.D.

Correction: An earlier version of this article incorrectly listed Pakistan as one of four countries that allow direct-to-consumer advertising of pharmaceuticals. The four countries are the United States, New Zealand, South Korea and Bangladesh, not Pakistan.

CBSNews explores YAZ Birth Control Link to Blood Clots and notes risk of blood clots from DRSP (DROSPIRENONE) containing pills is higher. 

(Source: yazrecall.com)

FDA required corrective ads, or ‘clear up’, following FDA WARNING LETTERS involving DRSP (DROSPIRENONE) pills and their direct to consumer promotion.

(Source: youtu.be)