30 November 2011
Yaz: Food and Drug Administration to Discuss Dangerous Contraceptive Pills
Ban demanded / New surveys find increased thrombosis risks / 10,400 lawsuits against BAYER / More than 200 deaths
The Food and Drug Administration (FDA) of the United States has scheduled an experts' meeting for December 8th. This panel will discuss the future of contraceptive pills containing the active ingredient drospirenone. Recent FDA surveys show that drugs containing drospirenone, such as Yasmin and Yaz, carry a significantly higher risk of causing blood clots than other oral contraceptives. The Coalition Against BAYER Dangers, an international network based in Germany, therefore demands a ban on the sale of those drugs.
Over the past 10 years, the FDA has registered approximately 10,000 individual reports about contraceptive pills. According to these reports, 190 women have died after taking Yaz in the United States alone. A survey the FDA released in late October shows that the thrombosis risk of Yaz users is 75% higher than that of women who use older drugs; the records of more than 800,000 American patients were evaluated for this survey on behalf of the FDA. Two surveys recently published in the British Medical Journal even came to the conclusion that the thrombosis risk caused by drospirenone was 2.3 or 3.3 times higher than the risk caused by drugs containing the hormone Levenorgestrel.
In 2010 BAYER reached a turnover of 1.1 billion (US$ 1.47 billion) from the sale of this group of products, thus making Yaz/Yasmin the best-selling contraceptive pill in the world. Yaz is heavily advertised, especially towards girls and young women, by promising weight reduction and acne relief. However, BAYER does not draw any attention to the more pronounced risk profile associated with products containing the hormone drospirenone. This leads to accidents and fatalities that could have been avoided. In the United States BAYER has already had to pay fines of $20 million for making false claims in advertisements for Yaz. About 10,400 lawsuits are currently pending against BAYER in the US.
The Coalition Against BAYER Dangers, which has been pointing out the dangers of Yaz for years, demands a ban on all contraceptive pills with a profile of increased side effects. 'The purpose of contraceptives is to prevent pregnancy and older drugs do that just as reliably as new ones. Most of the injuries caused by Yasmin and Yaz could be avoided. A change on the leaflet is not sufficient anymore,' says Philipp Mimkes, board member of the Coalition.
There have been at least 12 deaths in connection with the drugs in question in Germany. Women who have suffered from these drugs founded the Self-Help Group of Drospirenone Victims (Selbsthilfegruppe Drospirenon Geschädigter) this spring. Kathrin Weigele, co-founder of the group, says: 'We demand honest information about the risks in pills containing drospirenone and the disclosure of all known side effects. We expect BAYER to finally have a critical look at the numerous surveys from independent scientists that point to a higher danger of thrombosis. This could prevent stories like mine happening again.' Kathrin Weigele suffered a severe lung embolism after taking the pill Yasmin.
Yaz, Yasmin FDA Advisors Had Cozy Relationships with Bayer
Shezad Malik MD JD, Attorney, January 11, 2012
Talk about the fox guarding the chicken house! In December, an advisory panel for the U.S. Food & Drug Administration (FDA) voted to recommend by 15-11 margin that the benefits of Yaz, Yasmin and similar pills made with the synthetic progestin, drospirenone, outweighed their risk of dangerous blood clots.Now it has come to light that three of the FDA advisors who voted with the majority had ties to Bayer AG, the maker of the drugs, that were not disclosed by the agency.
According to a report from The Wall Street Journal, (WSJ) those advisors were:
The panel's chair, obstetrics professor Julia V. Johnson of the University of Massachusetts Medical School, told the WSJ in an email that she has been an "investigator in four research studies from Bayer or Berlex a Bayer unit," including one that involved the use of a drospirenone product in post-menopausal women. In her email, Dr. Johnson said she has "received no funding or grants" for her work.
Paula Hillard, an obstetrics professor at Stanford University School of Medicine, who Bayer documents said ""enables us to now have another huge ... Yasmin advocate here in Nor Calshe will be well utilized!" Another Bayer "tactical brief" from 2010 describes a video clip the company planned at the time with Dr. Hillard to deal with the blood clots and other safety issues. She told the WSJ she received $10,000 for her work.
Anne E. Burke, professor of gynecology and obstetrics at Johns Hopkins Bayview in Baltimore, who declared in published articles that she received research funding from Bayer.
Their ties to Bayer were not revealed by the. According to the WSJ, the panelists' Bayer ties were first disclosed in a joint article by the British medical journal BMJ and Washington Monthly. Details of their work with Bayer also were revealed in documents in the ongoing Yaz and Yasmin litigation in federal court in Illinois.
The fact that the three were allowed to vote at all, however, does raise some ethical questions. Experts acknowledge that significant ties between committee members and drug makers could result in biased recommendations
As mentioned by an expert polled for his opinions on the matter by the WSJ, "Lack of disclosure undermines the credibility of the advisory committee process and undermines public trust in the fairness of the regulatory process."
Interestingly it should be noted that one panelist, Dr. Sidney Wolfe of the consumer group Public Citizen, was stripped of his voting rights by the FDA because he had publicly criticized the drugs' safety in newsletters published by the group.
Is it any wonder that the general public has lost faith in its government, particularly when it comes to the governmental watch dog, the FDA? The FDA instead of being the wonder dog, is essentially has become a toothless canine alongside all the other toothless and powerless federal agencies.
Look at the examples of Medtronic Infuse bone graft injuries, the defective DePuy ASR and Pinnacle metal on metal hips, defective Cardiac Pacemaker leads, Transvaginal mesh, the dangerous drugs including Accutane, Fosamax, Plavix, Tylenol, Actos, Nuvaring, SSRI left on the market with inadequate warnings.
Big Pharma putting profits before people.