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All FDA Committee Members Should Get to Speak Out Regarding Yaz
In a previous blog post, we shared a news story regarding the FDA and the recent Yaz, Yasmin vote that has come under scrutiny. Is the FDA in bed with big pharmaceutical companies? Why doesn’t it seem like all FDA committee members get to express their opinions? Does the FDA even care about public safety? Read more and make your own opinion.
Recently, an online news source, a December 20, 2011 article by Martha Rosenberg, printed in Dissident Voice* revealed that the Yaz, Yasmin committee meeting vote was not the first time the FDA has kept Dr. Sidney Wolfe from speaking out against a drug manufacturer.
Rosenberg’s article states that in 2010, at hearings for a different manufacturer’s drug “Wolfe’s microphone was turned off when he asked why the manufacturer’s guilty plea and $20 million penalty for illegal marketing a different drug was never brought up at the hearings.”
Why was his microphone turned off? His question wasn’t relevant to the issue at hand, according to Bob Rappaport, MD, director of the FDA Division of Anesthesia & Analgesia Products.
Interestingly enough, though, published reports said the FDA didn’t know about the legal issue before Wolfe’s disclosure, according to Rosenberg’s article.
The article goes on to point out other failings by the FDA to communicate effectively internally as well as other “conflicts of interest,” like the Psychopharmacologic Drugs Advisory Committee being chaired by a drug company speaker even while they reviewed that very manufacturer’s drugs.
Now THAT is a conflict of interest, and public safety continues to be in jeopardy until the FDA does their job to explore the good as well as the bad instead of just silencing the naysayers and allowing drugs to be pushed to market.
Get more information about Yaz lawsuits nationwide.
Comments (0)FDA’s Recent Yaz, Yasmin Vote Under Scrutiny
A recent MedPage Today article printed in EveryDay Health* reports that four FDA medical advisors voting on the risks versus benefits of birth control medications, like Yaz and Yasmin, had ties to Bayer.
These FDA medical advisors had performed research studies, clinical trials, and/or consulting services either for Bayer, its sister company (Bayer-Berlex) or one of this partnering companies (Barr/Duramed). On top of that, they received either payment or funding in exchange for their work.
All of the panelists then voted in favor of oral contraceptive containing drospirenone, leaving the final outcome of the vote to be 15-11 that the benefits of popular Bayer AG birth-control pills outweigh the blood-clot risk.
While the panelists did disclose their affiliation with Bayer to the FDA and the FDA subsequently determined they did not have conflicts of interest, the disclosures were made in confidential rather than public documents.
Meanwhile, another panelist, Sidney Wolfe, MD, director of health research at the consumer advocacy group Public Citizen, was banned from voting because of his conflict of interest.
Dr. Wolfe is an author of the consumer guide "Worst Pills, Best Pills." This guide warns its readers to avoid drospirenone-containing products because the ingredient increases the risk of blood clots. According to an FDA spokesperson Karen Riley, Dr. Wolf did not disclose this “intellectual conflict of interest” to the FDA, states news sources.
How is it that the panelists’ obvious financial gains were deemed not a conflict of interest? Well, the FDA has an answer: Financial conflicts of interest cannot disqualify unless they are ongoing or have occurred within the past 12 months.
But, like the article points out, the same goes for appearance conflicts, but the Riley explains this away by saying they didn’t identify the panelists as having an appearance conflict.
As if the conflicts of interest dispute isn’t enough, there is even more controversy. The article reports that court documents were unsealed days before the meeting. In these documents, former FDA commissioner David Kessler, MD, accused Bayer of: (1) not disclosing all the data on the blood clot risks associated with Yaz and Yasmin and (2) doing extensive off-label promotions to increase sales.
Yet, this information was not given to the FDA committee. Why? The FDA said it was because the date to submit such documents for review had passed.
Contact the Simmons Law Firm for more Yaz lawsuit information today.
* http://www.everydayhealth.com/sexual-health/0113/fda-yaz-panel-had-ties-to-industry.aspx
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FDA Requires Manufacturers to Study Surgical Mesh Risks
The Food & Drug Administration has required the makers of transvaginal surgical mesh, used to treat complications of pelvic organ prolapse, to study the risks associated with the medical device, according to the New York Times.
The move comes after the FDA earlier reported the number of adverse events associated with surgical mesh devices has increased fivefold from 2008 to 2010.
Transvaginal surgical mesh, like DePuy ASR and Pinnacle hip replacements, is an implantable medical device. There is no law requiring that these kinds of medical devices be studied and tested before being marketed to physicians and their patients. Instead, the FDA issues an order for manufacturers to study the devices after consumers experience serious complications.
This means that a number of women who underwent transvaginal POP repair with surgical mesh were unaware of the seriousness of the complications of the procedure.
Complications associated with transvaginal mesh include infection, painful sexual intercourse, urinary problems, and overall discomfort and bleeding, all caused by the mesh eroding through tissue or the skim contracting too tightly around the device.
The FDA estimates that about 100,000 women a year with pelvic organ prolapsed are treated with the plastic mesh. The irony is that the medical condition can most often be treated without mesh and thereby avoiding the increased risked associated with the medical device.
“There are clear risks associated with the transvaginal placement of mesh to treat POP,” said Dr. William Maisel, chief scientist of the FDA division that oversees medical devices, in a TVM press release. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications.”
The top producers of vaginal mesh, which will be responsible for studying the risks associated with these medical devices, include Boston Scientific, C.R. Bard, Ethicon and W.L. Gore & Associates.
Learn more about transvaginal surgical mesh.
Vioxx Settlement in Ohio
A November 23, 2011, Cleveland.com article reports that the state of Ohio will receive a $22.8 million settlement from the Merck, the manufacturer of the recalled drug Vioxx. This is according to an announcement made on November 22 by the U.S. Justice Department.
The article also reports that Ohio’s Attorney General Mike DeWine made a statement regarding the resolution saying that this settlement should serve as a reminder to drug manufacturers that they should represent their products truthfully.
The allegations made against Merck claimed that the manufacturer made false statements about the safety of Vioxx and also marketed the drug as a treatment for rheumatoid arthritis before getting regulatory approvals.
To resolve these allegations, Merck made an agreement with the federal government to pay a total of $950 million to 43 states and the District of Columbia but says the settlement does not constitute an admission of liability or wrongdoing.
The article can be read in full detail at http://www.cleveland.com/healthfit/index.ssf/2011/11/ohio_to_get_228m_from_vioxx_se.html.
About Vioxx
Vioxx is a nonsteroidal anti-inflammatory drug (NSAID) that works to reduce inflammation, pain and fever in the body. Many defective drug lawsuits were filed over Vioxx’s link to heart attack and stroke. Finally, the drug was recalled in September 2004.
While the 2004 recall and recent settlement does serve as a victory in the war against pharmaceutical negligence and greed, it does not compare to the human lives lost.
Yaz Causes More Harm Than Good
The FDA recently released the results of their long-expected study on contraceptives containing drospirenone. It confirmed that women who take contraceptives such as Yaz are 75 percent more likely to suffer serious side effects from blood clots compared to older birth controls which contain less estrogen. It’s the 10th study investigating the dangerous side effects of this drug.
How many studies will Bayer need before it will admit thatYaz causes more harm than good? It has been four years since they first ran an ad claiming sensational benefits if women just switched from their old pill to Yaz.
ABC News recently obtained troubling internal documents showing company executives’ reactions to the exaggerated claims of Yaz as a miracle drug.
“This is outstanding!!! Can we get good morning america to do the same segment!!!???!! (tee hee),” one wrote. (typos included)
According to the new FDA study, drospirenone-containing pills and similar birth controls have been linked to 267 deaths. On Dec. 8, the FDA will convene a scientific panel to review this research and nine other similar studies.
As a member of the Yaz Multidistrict Litigation Steering Committee and an attorney representing hundreds who were injured due to Yaz and Yasmin, I have seen what this drug has done to thousands of women first-hand.
It’s my hope that, on behalf of the thousands of women who have taken or are still taking Yaz, they will make the right decision and pull this dangerous drug from the shelves.
Avandia Revised Warning Not Adequate, Court Rules
A federal court has agreed with plaintiff’s counsel in a recent ruling that warnings about the dangers of Avandia, a drug used to help manage Type II Diabetes, may have been inadequate, according to an article published in Lawyers USA.
After years of knowing the dangers, the FDA decided last May to pull Avandia from pharmaceutical shelves beginning in November. Research links Avandia to serious side effects such as pulmonary edema, heart attack and heart failure.
Drug manufacturer GlaxoSmithKline tried to dismiss several of the cases where the plaintiff took Avandia after its product labels were updated with revised warnings in both 2001 and 2001.
However, the court ruled that it was not a matter of law that the revised warnings adequately warned users of the drug’s risks, according to the article.
“In short, a reasonable jury could conclude that although the 2001 and 2007 labels warned about [congestive heart failure] risks, they did not do so specifically enough or directly enough,” the court said.
Read the full article here (subscription required).Report Calls for Overhaul of Outdated FDA 510(k) Approval Process
Many defective medical devices, dangerous drugs approved by outdated 510(k) process
A FDA approval process called 510(k) meant to help expedite new drugs and medical devices to market may instead cause patients more harm because it fails to ensure products are safe for consumer use, according to a study by the Institute of Medicine.
FDA officials requested the Institute of Medicine, an independent organization, review the process in response to widespread recalls of medical devices including 90,000 DePuy ASR Hip Implants last summer.
The 501(K) clearance process allows a drug or a medical device to be cleared for consumer distribution provided it’s considered a “moderate-risk device” that is similar to any previously cleared 510(k) product or a product that was grandfathered in under the Medical Device Amendments of 1976, 1990, and 1997.
The committee has recommended that the process is flawed and be completely overhauled.
“The committee finds that the current 510(k) process is flawed based on its legislative foundation,” said the IOM report. “Rather than continuing to modify the 35-year-old process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and post market regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”
Decades of legislative fine-tuning has turned the 501(k) process into a loop hole. Products are being marketed as safe for consumer use when they’re not.
The problem comes from the fact that some of the “predicate” products were on the market before the Medical Device Amendments of 1976, 1990 and 1997 were passed, meaning that they were never systematically assessed for safety and effectiveness themselves, according to the study.
For example, in 2005 DePuy Hip Implants received FDA approval through the 501(k) process, even though the new implant used metal-on-metal components recycled from a different kind of hip device. After hundreds of thousands of items had been sold, it was discovered that the metal-on-metal components caused serious side effects that caused a higher than expected revision rate.
Another defective product that was reviewed under the 510(k) process is transvaginal surgical mesh, used to treat pelvic organ prolapse and stress urinary incontinence. The FDA has received thousands of reports of serious side effects which have become the subject of possible lawsuits.
If you have had a DePuy ASR Hip Implant or undergone POP surgery using transvaginal surgical mesh and would like additional information about the safety concerns regarding these defective medical devices, contact our experienced pharmaceutical attorneys today for additional information by calling 877-318-0580 toll free or filling out our online contact form.
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