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Posts Tagged ‘yaz attorney’

Teen Blood clots From yaz are Destroying Lives, Parents are Out raged, yaz lawyers Filing lawsuits

Written by lisaspitzer on . Posted in Yaz Helpline News

Teen says blood clot after taking Yaz destroyed her life

 

 

Courtesy of Lynsey Lee

Lynsey Lee, 19, was diagnosed two years ago with a blood clot in her left lung, months after she began taking the birth control pill Yaz.

 

 

Lynsey Lee hoped Yaz would relieve her severe menstrual cramping and pelvic pain, so she began taking the birth control pills when she was only 16. But, instead of getting better, she started experiencing extreme mood swings, nausea and even more pain.

“I got really, really sick,” says Lee, now 19, of White Bluff, Tenn. “I was just constantly throwing up, and it was getting hard to breathe sometimes.”

Then, she started having unbearable chest pains that sent her to the hospital what seemed like every few days. Doctors initially couldn’t figure out what was wrong. “They kept telling me that it was just my body getting used to the medicine,” she says. “Finally, [when I was 17] I just stopped taking it.”

Later that year, after numerous medical exams, doctors diagnosed a blood clot lodged in her left lung. During one emergency room visit, doctors asked Lee what would become a life-changing question for thousands of young women like her: “Have you ever taken Yaz?”

Now, she is among the more than 10,000 American women who have filed class action lawsuits or claims against the German pharmaceutical giant Bayer, which makes Yaz, a popular birth control pill. Thousands more claims are expected. In documents released Tuesday, the Food and Drug Administration raised questions and other similar pills, including life-threatening blood clots, and said warning information should appear on labels for doctors and patients.

Thursday, the FDA's panel of experts agree  that current labeling on the medications isn't enough and should be updated with more information on the risks. But that news comes too late for Lee.

Central Florida yaz lawyers filing For Women with Yaz Injury

Written by lisaspitzer on . Posted in Florida Yaz Lawyers, Yaz States News

Yaz Birth control Pills Helpline and Yaz lawyers Helping women woth yaz related Injury in: Melbourne, Daytona, Deland,Orlando, Leesburg, Kissimmee, Ocala, Winter park,Altamonte Springs, Winterhaven and all of central Florida. Yaz can cause serer injury and death due to Blood Clots. yaz realted injury includes: stroke, heart attacks, Pulmonary embolism, Deep vein thrombosis and death,

If you are on Yaz and are having side effects you must seek emergency medical attention immediately.

Central Florida Hosptals include:

1.  Florida Hospital:  Located in Orlando, FL with 1,080 acute care beds and 46,876 acute care admissions.  Services offered:  Cardiology, neuroscience, transplants, cancer, pediatrics, orthopedics, digestive health, diabetes, women and obstetrics.

2.  Orlando Regional Medical Center:  Located in Orlando, FL with 808 acute care beds and 35,524 acute care admissions.  Services offered:  Level 1 trauma center, teaching hospital, burn center, heart and vascular, cancer, orthopedics, neurosciences, robotic surgery.

3.  Florida Hospital Altamonte:  Located in Altamonte Springs, with 341 acute care beds and 19,511 acute care admissions.  Services offered:  Orthopedics, bariatrics, general surgery, obstetrics, cancer, cardiac, radiology/imaging, emergency department, digestive.

4.  Leesburg Regional Medical Center:  Located in Leesburg, FL with 309 acute care beds, 18,472 acute care admissions.  Services offered: Cardiovascular, neurosurgery, general surgery, orthopedics, oncology, gastroenterology, vascular, pulmonary, obstetrics, pediatrics.

5.  WInter Park Memorial Memorial Hospital:  Located in Winter Park, FL with 297 acute care beds and  15,889 acute care admissions.  Services offered:  Obstetrics, women's health, orthopedics, ear, nose and throat, oncology,  minimally invasive surgery, emergency room services.

Yaz related lawsuits are underway and Bayer has begun settlements. Contact the Yaz Helpline for a yaz lawyer today.

Washington Yaz Birth Control Pills Helpline, Yaz Lawyers filing lawsuits

Written by lisaspitzer on . Posted in Washington Yaz Lawyers, Yaz States News

Yaz Birth Control Pills helpline Washington and Yaz lawyers are filing lawsuits against bayer for yaz injuries that include: Stroke, Heart Attack, Pumonary embolism, Deep vein thrombosis, Blood clots and deaths. Blood clots can dislodge and move effecting the brain, heart and lungs. This can be fatal.

The Washington Times reported that thousands of women are suing Bayer because of serious side effects from its popular contraceptives (birth control pills) Yaz and Yasmin. Yaz lawyers Helping Women with Yaz related injury  in: Bellingham, Moses Lake, Olympia, Pullman,Tacoma, Wanatchee , Seattle, Spokane, Tacoma, Vancouver, Bellevue, Everett, Kent, Yakima, Renton, Federal Way and all over Washington.

Washington Yaz News

WASHINGTON — Several members of the FDA advisory committee that endorsed drospirenone-containing birth control pills had ties to Bayer, the company that makes the two most popular drospirenone-containing drugs, Yaz and Yasmin, according to a media report.

The panelists all participated in a Dec. 8 joint meeting of the which voted 15-11 that the benefits of drospirenone-containing birth control pills outweigh the risk of venous thromboembolism.

All members reported their industry ties to the FDA, which determined the conflicts didn't preclude the members from participating in the meeting. The agency didn't issue waivers for those members that would allow them to participate despite known biases, or make the disclosures public in any way, an investigation by BMJ and the washington Monthly  revealed.

FDA and Yaz, Yaz lawyers Filing lawsuits

Written by lisaspitzer on . Posted in Yaz Helpline News

The Yaz Birth Control Pill helpline is here for women with Yaz related injury and Mothers who have lost a daughter due to a yaz related blood clot, stroke, pulmonary embolism or heart attack. Yaz lawyers are filing yaz lawsuits.

(NaturalNews) An investigation by the Washington Monthly and the British Medical Journal has found that at least four members of an advisory board which voted to approve a drug used in birth control pills had either done work for the drugs’ manufacturer or received research funds from the manufacturer. Though the four committee members disclosed their ties to the FDA, the FDA decided that the ties did not matter and did not make the disclosures public. Tragically, the drugs the committee endorsed have been killing the women who take them.

The birth control pills Yaz and Yasmin contain a drug called drospirenone, which the FDA advisory committee endorsed last December. According to the Alliance for National Health (ANH), women who take drospirenone are nearly seven times more likely to develop thromboembolism (obstruction of a blood vessel by a blood clot, which can cause deep vein thrombosis, pulmonary embolism, stroke, heart attack, and death) than women who do not take any contraceptive pill. Women who take drospirenone have twice the risk of developing thromboembolism than women who take widely prescribed contraceptive pills containing levonorgestrel.

FDA OK’s votes by members with financial ties to drug makers but not members who oppose dangerous drugs

Each of the four advisory board members with ties to the pills manufacturer voted in favor of the pills. The committee’s decision that the drug’s benefits outweighed the risks was decided by a four-vote margin. Interestingly, while the FDA allowed the four members with financial ties to vote on the drug, it barred another member and former researcher, Sidney M. Wolfe, from voting on the grounds that he had “an intellectual conflict of interest”. Based on several years of data, Wolfe had advised his readers six years earlier not to take Yaz. Because of this “conflict”, he was barred from voting.

In other words, the FDA apparently believes that there is no conflict when someone gets paid by a drug manufacturer but there is a conflict when someone has researched a drug and found it to be dangerous.

The FDA also failed to provide the panel with recently unsealed court documents which revealed that former FDA commissioner David Kessler had accused Bayer of hiding data on blood clot risks associated with the birth control pills. The court documents also revealed that Kessler reported that Bayer paid $450,000 to a high profile gynecologist to sponsor the pill, including off-label use of the drug, during her book tour.

It is far from the first time that the FDA has approved a dangerous drug or overlooked conflicts of interest. It is also far from the first time that drug companies have hid evidence of harm. Think of Vioxx, Fosamaxx, Avandia, and Gardasil to name just a few examples.

It is a common practice for drug companies to pay doctors and scientists to endorse their drugs, the same as it is common for drug companies to offer kickbacks and rewards to doctors who prescribe their drugs. Drug companies also pay doctors, researchers, and other medical experts for “consulting jobs” and speaking engagements to the tune of several hundreds of millions of dollars – which is considered legal despite the obvious blatant conflict of interest.

With Yaz being the top-selling birth control pill in the US, Bayer has quite the strong vested interest in getting endorsements for Yaz and Yasmin. Though thousands of women have filed lawsuits against Bayer, saying they were injured by Yaz or Yasmin, as we have seen with other highly profitable dangerous drugs, drug makers typically consider such lawsuits merely part of the price of doing business.

Female College students Injured by Yaz, Yaz Lawyers Filing Wrongful death lawsuits

Written by lisaspitzer on . Posted in Yaz Helpline News

Many young college girls were and still are taking Yaz to give them the freedom of a College lifestyle. But, a stroke or heart attack or embolism is a heavy price to pay for sexual freedom. Mothers are losing daughters to yaz birth control Pills like the story that follows. Yaz lawyers are filing lawsuits and the female social worker at the yaz Birth control Pills Helpline speaks to mothers and daughters on a daily basis with loss and serious complications from yaz. Yaz can cause blood clots that can be fatal. Blood clots from Yaz can cause, strokes, pulmonary embolism, deep vein thrombosis, and death.

Family Claims Birth Control Pill Killed College Student
Posted: Feb 10, 2010 1:32 PM EST

By Ben Hall

NASHVILLE, Tenn. – There are a growing number of lawsuits across the country from women claiming to have been harmed by the birth control drug, Yaz.

The latest involves the death of a local college student who had been taking YAZ for six months.

"She was all about laughing and having fun," said Traci Mayfield of her 20-old-daugher Leah. "We were more than mother/daughter, we were best friends."

Leah and her mom spoke every day even though Leah was hours away attending college at Tennessee Tech in Cookeville.

"She blossomed into a beautiful young lady up there. You can just see the transformation in pictures," said Mayfield.

By Leah's junior year she was a leader in her sorority, on the Dean's list and on her way to becoming a nurse.

"They would call her mama Leah, just as a joke. If anybody was sick, if anybody wasn't feeling good – they would call Leah," said Mayfield.

Suddenly last January, it was Leah who needed help. Her roommate called 911 for an ambulance after Leah passed out in the shower.

"Is she awake now?" asked the 911 operator.

"She's awake now. She's breathing really hard and very very pale, like very pale," said Leah's roommate.

The roommate then called Leah's mom and put Leah on the phone. 

"Leah told me that she was scared, and that she was tingling all over. I told her it was going to be okay, that me and daddy was coming," said Mayfield.

Leah's mom and dad did not make it in time. Leah died less than an hour later after the call.

"You go in the room and there's your child, your baby girl lying on the stretcher," said Mayfield as she wiped away tears.

Doctors said Leah died because of a blood clot in her lung. The official cause of death was a pulmonary embolism. 

"How does this happen to a healthy 20 year old young lady?" asked Leah's mom.

The Mayfields never expected the answer they received. An emergency room doctor said the birth control pill Leah started taking six months before, called YAZ, could have caused the blood clot. 

Flashy ads helped make YAZ the most popular birth control pill in the U.S.

The ads claimed YAZ helped cure acne and PMS. In 2008, the Federal Food and Drug Administration said Bayer Pharmaceuticals overstated the drugs effectiveness and required the company to run corrective ads.

"You may have seen some YAZ commercials that were not clear. The FDA wants us to correct a few points in those ads," said a spokeswoman in a YAZ commercial.

The FDA also found Bayer understated the risks associated with the new drug, risks that because of a unique progestin include blood clots and heart failure.

An attorney is suing Bayer on behalf of Leah's parents. The lawsuit claims "hundreds of young women have suffered serious or fatal injuries as a result of taking this widely prescribed medication."

"I think that they were trying to promote the drug as being better than other birth control pills when it in fact is more dangerous than other birth control pills," said Alexander.

The lawsuit claims "the FDA received reports of more than 50 deaths" where those who died were users of YAZ. It said Bayer "ignored the increased risks of the drug."

Bayer said it cannot comment on the lawsuit, but insists its "oral contraceptives have been and continue to be studied worldwide and are safe if used properly."

"I'm not surprised at all this drug is still on the market," said Alexander. "It's a very lucrative drug for Bayer." 

She said it made $600 million the year Leah died.

"She didn't have to die. She didn't have to die because of a pill," said Mayfield.

Mayfield does not want her daughter to have died in vain. She's warning others about the drug.

If you have been injured by Yaz stand up and get justice. Call the Yaz Birth control pill Helpline for a Yaz lawyer today.

Bayer Announces Yaz Settlement, Yaz Birth Control Pills Helpline Launched

Written by lisaspitzer on . Posted in Yaz Helpline News

Bayer Announces yaz Settlement, Yaz Birth Control Pills Helpline Launched

Yaz Helpline announces Bayer Has settled on 500 Yaz lawsuits and the FDA has added additional label warnings for yaz blood clots, stroke and Pulminary embolism. Yaz lawyers are accepting cases for review for yaz.

FOR IMMEDIATE RELEASE

PRLog (Press Release) – Apr 21, 2012 – Vaginal mesh helpline, Yaz helpline for Women informs that Bayer Pharmaceuticals has annonced a settlement for blood clots form yaz victims. The first round is settling for over $200,000 per claimant. This is good news for all litigations of dangerous drugs and medical devices harming women. Vaginal Mesh helpline has expanded resources to help women injured by other Drugs and Medical devices. With so many drugs and medical devices harming women we see a need for additional helplines. Th Fda Has issued increased warnings on labeling for yaz for strokes, blood clots and pulminary embolism.

The Yaz Helpline sponsored by Vaginal Mesh Helpline and Yaz Lawyers are pleased to announce Bayer, has agreed to pay out at least $110 million to settle 500 lawsuits involving Yaz blood clots. News of the settlements comes at a time when the Yaz lawsuit total exceeds 11,000, with plaintiffs claiming the birth control pill resulted in dangerous Yaz blood clots. The FDA has increased the details of warnings on Yaz labeling to include increased risk of strokes. We can expect justice. Victims of Yaz, It is not too late for you. If you have not filed a claim contact us immediately. yaz can cause wrongful death

Call our new Yaz Birth Control Pills Helpline and  Speak to a female Social Worker and be connected to an experienced Yaz lawyer

The Federal/State Yaz, Yasmin, Ocella Birth Control Lawsuits are being filed by Yaz Lawyers. The Yaz, Yasmine,Ocella Helpline is here to answer your questions and connect you with a YAZ, Yasmin or Ocella lawyer.Referencing the New York Times," Yaz has been one of the top-selling birth control pills in the U.S and Canada., with nearly 20 percent of the market. In 2008, more than $600 million dollars' worth of Yaz was sold in the U.S. However, the television commercials advertising Yaz were of concern to the FDA and the Attorney General because they implied that Yaz could be used to treat or cure symptoms for which it was not FDA-approved, such as:

  • Keeping a woman's mild acne at bay
  • Relieving symptoms of PMS (premenstrual syndrome):
  • irritability
  • increased appetite
  • moodiness
  • fatigue
  • headaches
  • bloating
  • muscle aches

Many Studies show Yaz linked to Blood Clots

two new studies recently published in the British Medical Journal, which concluded that women ages 15-44 taking birth control pills containing the synthetic progestin, drospirenone, are more likely to develop blood clots deep in the veins of the leg (venous thromboembolism), than women using birth control pills containing the common progestin levonorgestrel. The studies reported that the risk of developing blood clots for women taking the drospirenone-containing pills may be two to three times greater than those who take other pills. Yaz is one of these drugs.

Yaz New Warnings April 2012

In an announcement released April 10, 2012, the FDA stated that new warnings about the risk of blood clots will now be required on the labels of birth control pills that contain the progestin “drospirenone.” Yaz, Yasmin, Beyaz, and Safyral will now carry warnings detailing recent studies that suggest these pills may carry a slightly higher risk of Yaz blood clots

Yaz side effects include:

  • Deep vein thrombosis (DVT)
  • Pulmonary embolism (PE)
  • Blood clots
  • Stroke
  • Heart attack
  • Gallbladder problems
  • Pancreatitis

List of Drugs

Approved Oral Contraceptives containing Drospirenone

Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Ocella Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Safyral Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate calcium 0.451 mg

Syeda Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Yasmin Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Zarah Drospirenone 3 mg and ethinyl estradiol 0.03 mg

Beyaz Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate calcium 0.451 mg

Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Gianvi Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Loryna Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Yaz Drospirenone 3 mg and ethinyl estradiol 0.02 mg

Recent warnings have linked various birth control drugs and devices to serious injuries and even death:

  • Yasmin®
  • Yaz®
  • Ocella®

Injuries reported:

  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Stroke
  • Heart Attack
  • Wrongful Death
  • Blood Clot Related Injuries
  • Kidney Failure
  • Gallbladder Injury/Removal

If you or a loved one has suffered from any of the harmful side effects of Yaz,Yasmin or Ocella such as blood clots, stroke or heart attack you may be entitled to file a Yaz,Yasmin,Ocella lawsuit against the manufacturer. Call us for a yaz lawyer with experience in birth control drug lawsuits toevaluate your claim. Many women around the United States have suffered from life-threatening Yaz,Ocella and Yasmin birth control side effects. The manufacturer can be held liable.

The Woman's Yaz Birth Control Pills Helpline is here for women suffering from Yaz and Drospirenone side effects

Yaz Birth Control Pill helpline Announces Bayer Said to pay $110 Million, Yaz lawyers Ready

Written by lisaspitzer on . Posted in Yaz Helpline News

Yaz birth control pills have harmed many women by causing blood clots, Pulmonary Embolism, Stroke and heart Attacks. Yaz Birth Control pill helpline is happy to announce that Bayer Said to Pay $110 Million in Yaz Birth-Control Cases

By Jef Feeley and Margaret Cronin Fisk – Apr 13, 2012 5:48 PM ET

Bayer Germany’s largest drugmaker, will pay at least $110 million to settle about 500 lawsuits over claims that its Yasmin line of birth-control pills caused blood clots, in the first resolution of cases over the product, people familiar with the agreements said.

Officials of Bayer, based in Leverkusen, Germany, agreed to pay an average of about $220,000 a case to resolve the claims that its Yasmin and Yaz contraceptives caused sometimes fatal clots that can lead to heart attacks and strokes, two people familiar with the settlement said. The people sought anonymity because the accords haven’t been made public.

Bayer fell 2.5 percent in German trading today, and its American depositary receipts dropped 3.8 percent. The settlements came after a federal judge in Illinois postponed a Jan. 9 trial of a suit accusing Bayer and some of its units of misleading women about the health risks of its birth-control pills so a mediator could try to negotiate a settlement.

The case was the first set for trial of more than 11,000 lawsuits over injuries allegedly caused by the drugs.

“Sounds to me like mediation is paying off,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in a phone interview. “As a German company, Bayer probably would like to avoid the risks and costs of litigation in U.S. courts. Mediation tends to be a less- expensive way to deal with these kinds of cases.”

Stronger Warnings

The settlements come as the U.S. Food and Drug Administration April 10 ordered Bayer and other contraceptive makers to strengthen the blood-clot warnings on their products.

Pills like Bayer’s Yasmin, which contain a synthetic hormone called drospirenone, will have warning labels saying researchers have found they may triple the risk for clots.

Bayer’s contraceptives generated $1.58 billion in sales in 2010, making them the drugmaker’s biggest-selling drugs after Betaseron, a multiple sclerosis medication. The Yasmin drugs have been the focus of regulators who question their safety.

“Bayer HealthCare confirms that some cases pending in the current YAZ/Yasmin litigation in the U.S. are being settled,” Rosemarie Yancosek, a U.S. spokeswoman for the drugmaker, said in an e-mailed statement. She declined to comment on the number of cases settled or the amount of the accords.

Bayer’s American depository receipts, each worth one ordinary share, fell $2.60, or 3.8 percent, to $65.83 in over- the counter trading today. Shares in Germany dropped 1.28 euros, or 2.5 percent, to 50.56 euros.

Prior Settlements

Bayer officials said in a Feb. 28 U.S. Securities and Exchange Commission filing that the drugmaker has settled 70 cases over the Yasmin line of contraceptives.

Those settlements included “terms and conditions which Bayer views to be reasonable,” officials said in the filing. “Bayer will continue to consider the option of settling individual lawsuits in the U.S. on a case-by-case basis.”

The company is expecting additional suits, officials said in the SEC filing. Last year, the U.S. Food and Drug Administration warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives.

The FDA examined data on more than 835,000 women who took pills containing drospirenone, including Bayer’s Yasmin line of birth-control pills, according to the FDA report.

Bayer’s Yasmin was the No. 4 oral contraceptive in the U.S. in 2011, with 4.6 percent of the market as of September, according to data from IMS Health.

Wave of Litigation

Since 2009, the German drugmaker has faced a wave of lawsuits in courts across the U.S. alleging the birth-control pills caused sometimes fatal blood clots. Lawyers suing the drugmaker cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008.

Lawyers for former Yaz users contend in court filings that Bayer officials sought to market the contraceptive fgor unapproved uses and misled women about the drug’s health risks

The cases filed in federal courts were consolidated before U.S. District Judge David Herndon in East St. Louis, Illinois, for pretrial proceedings.

Scheduled Trials

Herndon scheduled a series of trials for early this year so juries could begin weighing claims that Bayer and its units marketed Yaz and other contraceptives as safer than rivals’ products while knowing they posed a higher clot risk.

At Bayer’s suggestion, Herndon called in Stephen Saltzburg, a George Washington University law professor, to serve as a mediator. Saltzburg’s job was to explore the possibility of “settlements in this litigation,” Herndon said in a December 2011 order. The judge put the trial schedule on hold while Saltzburg met with lawyers for the drugmakers and former Yaz users.

Among the lawyers settling Yaz cases as a result of Saltzburg’s efforts are mark Robinson, Chris Seeger and Michael Berg the people familiar with the accords said.

Those three lawyers are serving on the so-called plaintiffs steering committee in the cases before Herndon, according to court filings That group helps decide how the consolidated cases should progress through the litigation process.

Burg, a Denver-based plaintiffs’ lawyer who handles product-liability cases, also is listed in court filings as co- lead plaintiffs’ counsel in the Yaz cases. He declined to comment on the settlements in a interview today.

Seeger, based in New York, and Robinson, a Los Angeles- based attorney, didn’t immediately return calls seeking comment on the settlement.

The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, Southern District of Illinois (East St. Louis).

Margaret Cronin Fisk

editor responsible for this story: Michael Hytha

If you have been severly injured by Yaz or Yasmin or a loved one died contact us immediately to see if you are eligible to be a part of this lawsuit .

FDA Reviewed Risks Of yaz, Yaz Birth control Pills Helpline

Written by lisaspitzer on . Posted in Yaz Helpline News

Yaz lawsuits mounting up. Bayer began settlements for Yaz. Contact a yaz Blood Clot lawyer today. File your Yaz lawsuit.                                               The Yaz Men: Members of FDA panel reviewing the risks of popular Bayer contraceptive had industry ties

By Jeanne Lenzer and Keith Epstein

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Last month, the U.S. Food and Drug Administration convened a committee of medical experts to weigh new evidence concerning the potential dangers of drospirenone, a synthetic hormone contained in popular birth control pills including Bayer AG’s Yaz and Yasmin. In a decision that helped ensure the continued presence of these drugs on American pharmacy shelves, the committee concluded by a four-vote margin that the benefits of drugs with drospirenone outweigh the risks. However, an investigation by the Washington Monthly and the British medical journal BMJ has found that at least four members of the committee have either done work for the drugs’ manufacturers or licensees or received research funding from them. The FDA made none of those financial ties public.

Yaz and Yasmin are among Bayer’s top selling pharmaceutical products. According to the German drug manufacturer, over 4 million women worldwide use Yasmin alone. But the drug has also sparked growing controversy in recent months. A series of studies published in BMJ have shown that users of pills containing drospirenone have an increased risk of blood clots, which can cause deep vein thrombosis, pulmonary embolism, stroke, heart attack and death. And thousands of women have filed a lawsuit against Bayer, saying they were injured by Yaz or Yasmin.

Other Bayer products containing the hormone drospirenone are Beyaz and Safyral. In addition, four companies—Bayer, Teva, Watson and Sandoz—sell five generic versions of the drugs evaluated by the committee last month.

The FDA’s decision not to reveal its advisors’ relationships with the drugs’ manufacturers and Bayer raises serious questions about the agency’s treatment of potential conflicts of interest, a historically problematic area for the department. In 2004, controversy erupted over another FDA advisory hearing—involving the painkiller Vioxx—when it became clear that advisors with financial conflicts of interest were more likely than those without conflicts to vote that Vioxx was safe and should be allowed to stay on the market. The drug was ultimately withdrawn after a study showed it was associated with approximately 60,000 deaths. In 2008, partly in response to this uproar, the agency issued a new guidance on how to handle conflicts of interest among its advisors, stating that it wanted to reduce “bias” and to be more “transparent.”

The agency’s handling of the drospirenone hearings casts major doubt on how far it has gone to attain those goals.

What’s more, interviews and records also show that the drospirenone advisory committee, when it voted last month, lacked significant information about increased risks to the health of women using contraceptives containing drospirenone.

The FDA ordered the safety review of drugs containing the hormone after three articles published in the BMJ found an increased incidence of blood clots among users of the pills. The advisors were given these studies prior to the December 8 meeting. However, the panel was not shown documents from a report by David Kessler, a former FDA commissioner and an expert witness in the lawsuit filed against Bayer on behalf the women who say they were injured by Yaz and Yasmin. Kessler’s report cites internal Bayer corporate documents that suggest the company had withheld safety data from the FDA.

The documents show that in 2004, Bayer scientists reported in a draft analysis that Yasmin incurs a “several-fold increase” in reporting rates for blood clots compared to three other oral contraceptives, and that Yasmin’s rate of all serious adverse events was “10 fold higher” than that of other products.

In his report, Kessler writes that Bayer failed to report safety data to the FDA, engaged in off-label promotion of the pills, and paid $450,000 to a high profile gynecologist to sponsor her book tour in which she promoted such off-label uses.

Kessler’s report, originally under seal, was not released until December 6, two days prior to the advisory meeting. The FDA said it could not give the advisors the information because the date to submit documents had passed.

***

The FDA relies on some 50 advisory committees to obtain “independent” expert advice and “maintain the public trust.” Recommendations on evidence for safety and efficacy can lead to drug approvals and withdrawals; while nonbinding, recommendations by such committees can move stock prices and are generally regarded as indicators of official FDA action.

Under FDA guidelines, when advisory committee members have a financial relationship with a drug company whose product is under review, the agency can issue waivers that acknowledge the advisors’ links to industry but allow them to vote if their expertise is needed and no other specialists are available. Such waivers often serve as the only public signal that advisors have financial conflicts of interest. In the hearings on drospirenone, the FDA issued none.

And yet, according to public records, recently unsealed court documents, and interviews with some of the FDA advisors, at least four of the advisory committee members in this case have served as paid researchers, consultants, “key opinion leaders,” or speakers for Bayer or other manufacturers or licensees of drospirenone. A fifth advisor agreed to serve as a consultant but never executed the agreement. A sixth received consulting fees from a law firm representing Bayer.

In a 15-to-11 vote, the committee decided that the benefits of drospirenone outweighed its risks.Had those members with undisclosed conflicts of interest voted the other way, the committee would have come to the opposite conclusion. The committee also voted 21 to 5 to change the drug labels to warn that the hormone can cause blood clots. But the panel stopped short of recommending that the labels should warn that they are more likely than other contraceptive pills to cause blood clots. Instead the experts suggested that the labels say that the evidence about blood clots is “conflicting.”

Ironically, while the FDA allowed voting by advisors with business connections to drospirenone, the agency did bar another advisor—Sidney M. Wolfe, the panel’s lone consumer advocate—on the grounds that he has an “intellectual conflict of interest.” Wolfe, a former researcher, is a frequent critic of FDA practices on behalf of the advocacy group Public Citizen. Wolfe, the author of the consumer guide Good Pills, Bad Pills, had marked Yaz with a “do not take” advisory to readers. Jerome Hoffman, professor emeritus of medicine at UCLA, questioned Wolfe’s exclusion from the panel: “The idea that because he has an opinion on data that already exist he should be prevented from voting is nutty.”

Each of the advisors with ties to manufacturers told the Washington Monthly and BMJ that they fully disclosed their ties to the FDA, and there are no indications that the advisors failed to make required disclosures to the agency. The FDA, however, has declined to make public advisors’ financial conflict of interest forms, explaining that the forms are “confidential” and no information from them can be shared under a section of the Ethics in Government Act.

When asked whether the agency was aware of any financial ties between its advisors and manufacturers or distributors of drospirenone, FDA spokeswoman Morgan Liscinsky said, “No waivers were issued.”

But the committee’s financial ties to Bayer begin with no less than its acting chair. Julia Johnson, a professor of obstetrics and gynecology at the University of Massachusetts Medical School, conducted four clinical trials—including one of drospirenone as hormone replacement—for Bayer or its subsidiary Berlex, a manufacturer of drospirenone. She said in an e-mail, “The FDA is very vigilant on examining potential conflicts of interest and was aware of all my research.” When asked for an interview, she said, “The U.S. FDA states that I cannot speak about the meeting.”

Another advisor with ties to industry is Paula Hillard, a professor of obstetrics and gynecology at Stanford School of Medicine who has served as a paid consultant to Bayer Schering. Dr Hillard said she had fully complied with all FDA disclosures and referred the Washington Monthly and BMJ to the FDA for further questions. The FDA declined to respond to any questions, again citing the confidentiality clause of the Ethics in Government Act.

Elizabeth Raymond, a senior medical associate at Gynuity Health Projects in New York and another member of the committee, conducted studies funded by Barr, which has a licensing agreement with Bayer for generic versions of Yaz. Dr Raymond said that the FDA was “fully aware of all of my relevant current and past activities.”

Anne E. Burke, an assistant professor of gynecology and obstetrics at Johns Hopkins University in Baltimore, has received research funding from Bayer-Berlex and Duramed, which has a licensing agreement with Bayer for generic Yaz and Yasmin. Dr Burke said that she fully disclosed this to the agency.

According to Dr Kessler’s report, an internal Bayer document indicated that a fifth advisor received payment from Bayer, but that advisor told the Washington Monthly and BMJ that although she initially agreed to serve as a consultant for Bayer, the company never pursued the agreement. She said FDA records indicated that she had ties to Bayer due to her disclosure about her agreement, but after she was nominated to be on the drospirenone advisory committee, she corrected the error.

A sixth advisor, meanwhile, confirmed that he received consulting fees from a law firm representing Bayer in 2006. He told BMJ and the Washington Monthly that he did not disclose the information to the FDA because the FDA “did not require information for that time frame for consulting unrelated to the meeting topic.”

Bayer spokesperson, Rosemarie Yancosek, said in an e-mailed statement: “Bayer had no input on who serves on the U.S. FDA Advisory Committee panel as the FDA has its own process for selecting panel members. Furthermore, it is Bayer’s understanding that the FDA has a procedure for determining conflicts of interest for potential panel members.”

The FDA does indeed have such a procedure, but critics argue that its guidelines define conflicts of interest too narrowly and provide too much flexibility in how they are applied. The guidelines are technically “suggested or recommended, but not required” provisions (http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM125646.pdf). Whether an advisor can participate depends on “whether the discussion at the meeting or outcomes of the meeting will have a direct and predictable effect on the individual’s interest.” For instance, someone who was previously involved in another role for a manufacturer, or whose university received money from a manufacturer, may be allowed to participate. Even having a contract for $100,000 over a five-year period would not necessarily exclude an advisor, according to the guidelines.

Despite the FDA’s frequent claims that there aren’t enough experts independent of industry, a list of over 100 industry-independent experts has been presented to the agency – yet none of those experts has been tapped as an advisor.

The Project on Government Oversight, a Washington-based nonpartisan watchdog group, plans to raise concerns about the FDA’s conflict of interest policies in a letter to the agency’s top official, Margaret Hamburg.

“It shouldn’t require a lawsuit and investigative journalism to learn about these kinds of conflicts,” said the group’s executive director, Danielle Brian. “The Yaz case puts FDA’s feckless ethics policy into stark relief. It also reveals the human impact of conflicts of interest and why we need an FDA that shuns even the appearance of such conflicts.”

The organization intends to urge the FDA to routinely disclose industry ties and more aggressively determine whether an advisor has a conflict. “Right now,” said Brian, “the bar for considering whether an advisor has a conflict is too high.”

Jeanne Lenzer and Keith Epstein collaborated on this article. Lenzer is a medical investigative journalist based in New York. Epstein is a Washington-based investigative editor and writer.