Obama birth control compromise distracts from issue of whether the pill is safe, activists say
From THE WASHINGTON POST - NATIONAL - blog POST
After weeks of uproar over a new requirement that religious employers provide free birth control, President Obama said Friday he had found a compromise.
Norgestrel and Ethinyl Estradiol birth control tablets. (Reuters)
Workers at religious institutions, he said, will get free contraceptiondirectly from health insurance companies instead of their employer. Both sides of the debate welcomed the announcement.
So everybody wins, right?
Everybody except the women taking the pill, some activists say. During the past year, they say, there have been a number of troubling developments concerning birth control, and yet the national discussion remains focused on who is doling it out.
Last month, Pfizer recalled one million packets of birth control pills due to pregnancy concerns, because of a manufacturing mix-up. Several weeks before that, an advisory committee to the FDA said labels on the popular Yaz and Yasmin pills didn’t contain the information they should about possibly causing blood clots. Two different studies found those pills put women at a higher risk of blood clots.
Women began self-reporting health problems like blood clots, too, often on “survivor boards” As of last month, approximately 10,000 lawsuits piled up against Bayer by women who have suffered blood clots or by the families of women who have died while taking Yaz or Yasmin.
And yet the pill continues to see an almost universally positive representation in the media, writes Holly Grigg-Spall in Ms. Magazine, as “a quality of life treatment,” and curer of acne, bloating and anxiety.
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, wrote recently:
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.
Grigg-Spall thinks there is a lack of education because it helps sustain the profits pharmaceuticals companies.
“In this current climate… it is very difficult for women to have an intelligent, critical discussion about their birth control choices and particularly about the relative dominance of hormonal contraceptives,” she wrote in an email to The Post.
Grigg-Spall started a blog called “Sweetening the Pill,” about the dangers of birth control, because she started feeling depressed after switching to a new brand of pill. But these days, she is outraged about all the women she says she has encountered who have faced even worse side effects.
Friday, Obama sought to soothe a different outrage over birth control. “This is not only unacceptable, it is un-American,” Sen. Joe Manchin (D-W.Va.), a Catholic, had said of the requirement that religious employers provide free birth control. “Correct this decision which will erode the conscience rights,” another Catholic senator, Bob Casey of Pennsylvania, had said.
In Friday’s press conference, Obama corrected that decision. It did not escape activists’ notice, however, that he made no mention of the birth control pill’s possible risks.
By | 04:33 PM ET, 02/10/2012
Tags: National, Obama, birth control, the pill
This video from YouTube is available via this link. The video is a ‘corrective ad’ that #BAYER was required to run in conjunction with paying $27 Million Dollars to the Attorneys General of several states for violating a settlement agreement, as well as an FDA Warning Letter regarding prior promotion of their #DRSP #drospirenone birth control pill #YAZ. Essentially, these ads were mandated because while promoting the #DRSP #drospirenone pills, BAYER, did not sufficiently underscore serious risks associated with these hormonal contraceptive pills and their ‘new’, or novel, #progestin - #DRSP #drospirenone.
The #DRSP #drospirenone family of contraceptive pills are now the subject of nearly 10,000 DRSPLawsuits for personal injuries arising of out of their use. DRSP lawsuits involve claims alleging death, strokes, deep vein thrombosis (#DVT), blood clots, pulmonary emboli (#PE), cardiac events, pancreatitis and gallbladdery dysfunction, as well as complications from these injuries.
As of July 2011, there were over 9,500+ #DRSP Lawsuits over claimed injuries from #drospirenone. These cases are pending in a Federal Court Multi District Litigation (MDL) and coordinated #mass #tort proceedings in PA, CA & NJ. On September 26, 2011, the Food & Drug Administration (FDA) publicly announced that despite efforts to review emerging scientific data and literature, they were convening an Advisory Panel to hold public hearings over the blood clot risk the #DRSP #drospirenone family of pills present to the public. These hearings are scheduled for December 8, 2011. Essentially, the increased risk of a blood clot, from a #DRSP #drospirenone birth control pill, has been alleged to 1.5x to 3.0x more likely than other hormonal contraceptives. This risk was not articulated or disclosed to litigants in this fashion on until April 2011. As such, at the heart of DRSP Lawsuits is the issue of what the manufacturer knew, when it knew and why it was not disclosed or communicated earlier to both the FDA and injured consumers. Civil Jury Trials are scheduled for January 2012 and throughout 2012 to give both the litigants and Defendants their respective days in court.
Gabriel F. Zambrano, P.A., is the author and sponsor of this blog and commentary. He has been among the original thought leaders, or key opinion leaders, in this litigation for a number of years dating back to his first client. Gabriel F. Zambrano, P.A., is a member of the MDL Discovery Committee, and serves as Representative Legal Counsel to several of the 1st 100 YAZ Lawsuits, or DRSP Lawsuits, filed in the United States. As part of a continued effort to promote public awareness about these pills, the risk they pose, as well as these lawsuits, Gabriel F. Zambrano, P.A., is offering a FREE YAZ LAWSUIT CONSULTATION. Additional information regarding this litigation and information available to the public appears through his Twitter feed at the following: #YAZ Lawyers @yazattorney and GabrielFZambrano @gfzambrano.
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#Drospirenone lawsuits, #DRSP lawsuits, or #YAZ Lawsuits, involve the popular family of birth control pills, manufactured by #BAYER, and trademarked as #Yasmin #YAZ #BEYAZ or #SAFYRAL. While #BEYAZ & #SAFYRAL were only introduced last year, they also contain the controversial progestin - #DRSP #drospirenone. The FDA is holding a public advisory meeting in December 2011 to discuss the blood clot risks, and their continued ‘concern’ over, risks posed by this progestin.
The images above come from BAYER’s June 2011 Stockholder Newsletter and disclose over 9,300+ served #DRSP #lawsuits or #YAZ Lawsuits or Claims as of July 2011.
Additional information, as well as a link to a FREE #YAZ #LAWSUIT CASE EVALUATION, or #DRSP LAWSUIT CONSULTATION, is available through DRSP Lawsuits and this link.
Gabriel F. Zambrano, P.A., is the author of this blog and commentary, as well as DRSP Lawsuits. Gabriel F. Zambrano is actively representing and screening cases for DRSP survivors and a member of the MDL Discovery Committee; Representative Counsel or Lead Counsel for several of the 1st 100 YAZ Claims filed in the MDL and State Court proceedings, as well as a recognized thought leader in advocating against #DRSP #drospirenone pills.
Fear in Colorado town at heart of #Listeria outbreak and #Recalls http://usat.ly/ni89Ak
Tumblr is my Ferrari! http://www.twitter.com/gfzambrano
The above was posted two (2) years, on September 29, 2009, ago on Facebook - Yasmin & YAZ Claims/Lawsuits as awareness was growing on the risks associated with the #DRSP #drospirenone family of birth control pills. In August 2009, a BMJ study challenged the safety profile of these pills which only included YAZ, Yasmin & Ocella (generic). Today, there are a number of variations of these pills and this week the FDA noted a continued ‘concern’ over their safety and potential for a blood clot risk. Advisory panel meetings are scheduled for December 2011 to discuss conflicts in scientific evidence and interpretations of this risk.
The Wall Street Journal article below explains the FDA’s announcement and scheduled hearings. However, belated efforts by the manufacturer to ‘clear up’ their promotional campaign and risk profile of their pill offers little consolation to nearly 10,000 litigants claiming injuries from the #DRSP #drospirenone family of pills. #DRSP Lawsuits continue to be filed over injuries claimed from the use of drospirenone and are often referred to as DRSP Lawsuits or YAZ Lawsuits.
Gabriel F. Zambrano, P.A., is the sponsor of this blog and commentary. The Facebook Page - Yasmin & YAZ Claims/Lawsuits, as well as @yazattorney on Twitter are also maintained and updated, in a continued effort to raise awareness and the dangers of #DRSP. FREE CASE EVALUATIONS are also offered with regard to potential injuries from these ‘bitter pills’.
From The Wall Street Journal - Jennifer Corbett Dooreen
The U.S. Food and Drug Administration said Monday it “remains concerned” a certain type of birth-control pill that contains drospirenone could raise the risk of blood clots beyond that of other pills.
In a drug safety communication posted on the agency’s website Monday, the FDA said preliminary results of an agency-funded study involving 800,000 women suggest about a 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth-control pills, compared to users of other hormonal contraceptives.
Drospirenone is used in pills including Yaz and Yasmin, which are marketed by Bayer AG. Drospirenone is a type of female sex hormone called a progestin. Some drospirenone pills are also available in generic versions.
But the FDA said it hasn’t reached a final conclusion that the products raise the risk of blood clots beyond that of other pills, and the agency will convene an outside panel of medical experts on Dec. 8 to discuss the matter.
Most birth-control pills contain two types of hormones, estrogen and progestin. All types of pills increase the risk of blood clots, and product labels warn of such risk.
The FDA said there is conflicting information about the blood-clot risk possibly associated with drospirenone from six other published studies. Some of the studies have reported that the risk of blood clots for women who use birth-control pills containing drospirenone is higher than that for women who use birth-control pills containing levonorgestrel, while other studies haven’t found such a risk. While the risk of blood clots is low among women who take birth-control pills, the FDA said it is higher than the risk among women who aren’t taking the pills.
Blood clots form inside a vein and are known as deep vein thrombosis, or DVT. The clots usually form in the lower leg or thigh, but can break loose and travel to other areas of the body such as the lungs, where they are called a pulmonary embolism, or PE. The FDA said the symptoms of a DVT include the new onset of persistent leg pain, while those of a PE include severe chest pain and sudden shortness of breath.
Bayer has said its analysis of the available scientific evidence shows that the risk of developing a blood clot associated with taking pills containing drospirenone “is comparable” to that of other birth-control pills studied, but it is working with the FDA on the matter. Sales of Bayer’s Yaz product family have been declining, which the company blames on generic competition in the U.S.
In May, the European Medicines Agency said the risk of developing blood clots for oral contraceptives containing drospirenone was higher than that of pills containing levonorgestrel but said the risk for any type of birth-control pill was small. EMA said the product labels of birth-control pills containing drospirenone will be updated.
This KTLA story by Victoria Recano from November 2009 highlights the dangers of #DRSP #drospirenone birth control pills and the story of two survivors. At the time, the Federal Court MDL, (Multi District Litigation) was commencing, as were coordinated State mass tort proceedings in PA, CA & NJ. As of June 2011, 9,300+ lawsuits were pending by survivors of BAYER’s novel progestin - #DRSP #drospirenone - alleging injuries that include death, cardiac events, strokes, deep vein thrombosis (#DVT), pulmonary emboli (#PE), gallbladder removal, or complications from the above, as well as pancreatitis.
I was featured in this story and continue to provide representation and FREE CASE EVALUATIONS to survivors of the #DRSP family of pills.
Gabriel F. Zambrano, P.A., is the sponsor of this blog and commentary.
