In “MOM WARNS BIRTH CONTROL KILLED HER DAUGHTER”, ABC 7 WXYZ.COM, DETROIT, MI, reports on the recent funeral of S. Burns. The 25 year old died and was buried on Mother’s Day 2012, following an aneurysm. In the heart breaking video above, her surviving Mother, Natalie Rogers, explains that YAZ “was the only medication she was on” and that she believed she died from taking the #DROSPIRENONE (#DRSP) containing contraceptive.

(Source: yazrecall.com)

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/

February 28, 2012
”Women Warned Over Popular Birth Control Medication” by Sandra Chapman, of Indianapolis, 13, WTHR.COM, explores the history of DRSP (DROSPIRENONE) containing birth control pills and the claim of one woman who suffered a DVT (Deep Vein Thrombosis).  As previously reported on this blog, DRSP LAWSUITS, or DROSPIRENONE LAWSUITS continue to exceed 11,000 as of February 2012. The story does not address the December 8, 2011 Advisory Committee vote that found the warnings were inadequate and do not (even as of this writing) communicate the elevated risks of blood clots associated with #DRSP #DROSPIRENONE containing birth control pills. Additional information on that subject is available at DRSPRecall.

INDIANAPOLIS -

It was one the best selling birth control pills on the market. But now, a warning for women.

Fifty patients have reportedly died from taking the contraceptive and thousands of others say it causes potentially life-threatening side effects, prompting a trusted drug maker to spend millions to highlight the risks.

Linda Rosenberg was the picture of a healthy baby. She recalls growing up on Bayer Baby Aspirin and planned to care for her own baby in the same way, someday.

In 2007, motherhood was still in the future when her doctor told her about Yaz, a new oral contraceptive manufactured by Bayer. It was sweeping the country with a flashy ad campaign.

“There was no reason to believe the product was, you know, that there was any danger in taking it,” explained Rosenberg.

But two years after taking daily doses of Yaz, Linda began experiencing unexplainable swelling. At her doctor’s urging, she got an ultrasound. It probably saved her life. A blood clot was discovered in her ankle.

“Yes and right behind my knee, which was causing the swelling in the ankle,” she told 13 Investigates.

Linda went through 18 months of treatment. But along the way, she lost more than she could have imagined.

“Now, I can’t have children,” she revealed.

The treatment for the blood clot left her unable to conceive children and her trust in a childhood name was gone. Rosenberg is now among hundreds of women nationwide blaming Bayer’s Yaz birth control for devastating health effects.

“I’d like to see it off the shelves, if it’s not safe,” Linda insists.

“It doesn’t happen just with Yaz,” according Dr. Sara Sayger.

Sayger has prescribed Yaz as the medical director at the Purdue Health Center and Women’s Clinic in West Lafayette. In fact, Sayger concludes all oral contraceptives come with some risk.

“Blood clotting is an uncommon side effect. A real danger, but an uncommon side effect,” she said.

But according to lawsuits nationwide, Yaz is being blamed for the deaths of at least 50 women, including young college students.

Dr. Sayger confirms the new ingredient.

“We’ve seen a couple of new synthetic progesterones that have come onto the market. Yaz is one of those new synthetic progesterones,” she said.

Sayger describes Yaz as a “niche” contraceptive and evaluates closely whether it’s a good fit for each patient.

“It’s a pill that’s been very positively received by women who have been on other products and still had very extreme emotional, premenstrual mood swings. Yaz seemed to be a good answer for those people” she found in her practice.

But Sayger agrees it’s not for everyone.

In 2008, the FDA sent Bayer a warning letter regarding its advertising for Yaz. The FDA took issue with claims by Yaz to treat PMS and acne of all severities, even though Yaz had not been evaluated to do such.

The FDA also said “Yaz has additional risks because it contains the progestin, Drospirenone…which may result in potentially serious heart and health problems” in high risk patients.

The FDA said Bayer knew about the risks, the information came from the company’s own studies. Yet it’s warning labels failed to adequately disclose the potential danger.

Bayer declined an on-camera interview with 13 Investigates about Yaz, but in a released statement said “..the benefits…outweigh the potential risks” and that “labels…do not adequately reflect the risk…and should be revised to include additional information from available studies.”

Bayer is now airing corrective ads.

Sayger points out that the FDA shares responsibility to ensure products for women are safe and wants to see more studies.

“Birth control pills have been on the market for 50-plus years. We now have three or four generations of pill users, so we have lots of experience with birth control pills,” Sayger said.

But it’s too late for Linda Rosenberg.

“Had I known that it could have been an issue, or a problem, I certainly would have not chosen to go that route,” she said, hoping to warn other women.

The FDA did not take Yaz off the market.

Sayger says fewer college students are using that contraceptive, but for other reasons. She says Yaz costs around $70 a month, compared to other brands that range from $9 to $20.

Bayer is facing 10,000 lawsuits surrounding its Yaz and Yasmin birth control.

Read the FDA warning letter about Yaz

(Source: Women Warned Over DRSP DROSPIRENONE Birth Control)

Obama birth control compromise distracts from issue of whether the pill is safe, activists say

By Elizabeth Flock  |  04:33 PM ET, 02/10/2012 

Tags:  National, Obama, birth control, the pill

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.