Takeda Ignored Bladder Cancer Warning Signs

More than 10 years ago during animal trials of the diabetes drug Actos, its manufacturer (Takeda International) learned that rats exposed to Actos developed more bladder tumors than rats exposed to a placebo. Takeda did not research the cause of increased rate of tumor formation, nor did it conduct further studies with human volunteers. Instead, Takeda minimized the risks, pushed through production and sought FDA approval. Takeda claimed “the evidence did not point to a risk in humans.”

Despite the results of the rat study and though Takeda never tested on human volunteers, the FDA approved Actos for sale in the U.S.

As a condition of its approval, the FDA required Takeda to conduct a 10-year observational safety study. In effect, the FDA gave its endorsement to use the entire global population of Actos users as “human lab rats”. When interim data was available in 2010 , it revealed that patients taking Actos for the longest period had an increased risk of developing bladder cancer -- a result consistent with the rat study.

Again, Takeda decided not to warn users. But this time, the FDA disagreed and advised the public that taking Actos for more than a year may indeed carry an increased risk of bladder cancer. The European regulators went even further, banning Actos altogether from the European market.

Takeda’s failure to properly investigate Actos' side effects and the FDA’s lackadaisical approach raises questions: What purpose do investigative studies serve? Why conduct animal studies if the correlation to humans is ultimately ignored? Can a drug manufacture use patients as “lab rats” and get away with it? If Actos had been properly tested before it hit the global market, how many victims might have been spared bladder cancer?

Actos victims are hopeful that their attorneys will find answers through the newly created multi-district litigation, In Re: Actos (Pioglitazone) Products Liability Litigation.

 

Drug Companies' Ads for Doctors are not FDA Compliant

Four out of five ads in medical journals targeting doctors fail to follow FDA guidelines.  Over half fail to quantify the risks. Dr. Deborah Korenstein, lead author of  a recent study and Associate Professor of Medicine at Mount Sinai School of Medicine states:

Marketing research has consistently shown that journal advertising is the most profitable form of drug marketing, with an estimated return on investment of five dollars for every dollar spent. . . the current system is not in the best interest of the health of the public.

Drug companies know that the FDA does not have the resources to enforce its advertising "guidelines." In fact, the FDA has asked doctors for help, launching a "Bad Ads" campaign that urges doctors to take it upon themselves to report the drug companies' bad ads to the FDA.  As if, doctors have more time and resources than the FDA? And absent independent research, how will the doctors know the ad is bad?  

Without enforcement, the drug companies will continue to violate the rules; doctors will not have the relevant information needed for safe prescribing practices and the public will be suffer avoidable harms. Doctors, as well as the public, need to be reminded not to be swayed by flashy ads and to conduct independent investigation about a drugs safety and efficacy. 

FDA Taking Another Look at Dangers of Yaz and Yasmin

The Food and Drug Administration approved Yaz and Yasmin based on research that Bayer provided saying that the drugs were safe. We've been saying all along that the research was suspect and that, in fact, the drug is more risky than other birth control pills with no added benefits. The danger, we said, was the drugs' unique ingredient, drospirenone.

In April, two independent studies were published concluding that Yaz and Yasmin are, in fact, two to three times more likely to cause potentially lethal blood clots than competing birth control pills. The studies can be found here and here.

Now the FDA has taken notice. Yesterday, it released a "safety announcement" concerning the drugs. As part of it's "ongoing safety review of birth control pills that contain drospirenone" (Yaz and Yasmin were the first and hold the largest market share), the FDA says it will take another look at the risks the drugs carry. It will look most closely at the risk of death resulting from blood clots:

A blood clot that forms in a deep vein in the body is called a deep vein thrombosis (DVT). A DVT is a rare side effect of taking birth control pills. A blood clot can break loose from the vein, move through the body to the lung, and cause a serious problem in the lung, called a pulmonary embolism (PE). This can lead to death.

The FDA says that it will do two things to see whether Yaz and Yasmin do, in fact, have a higher risk of blood clots and death. First, it will be looking closely at the new studies. Second, it has commissioned its own "large study exploring the association of blood clots with hormonal contraception." It says that the results of that study are "currently being finalized and reviewed."

Depending on what it determines, the FDA could (1) do nothing, (2) work to take the drugs off the market, or (3) order a stronger warning so that women who use the drugs know the risks.

Meanwhile, the 6000 lawsuits brought by women injured after using the drugs march toward trial. The first cases will be tried next year.
 

FDA's Role In Approving Yaz and Yasmin Examined

The legal talk show Lawyer2Lawyer invited Mike Danko and an FDA expLawyer2Lawyer Podcastsert, Professor James T. O'Reilly from the University of Cincinnati College of Law, to discuss Yaz and the Yaz lawsuits.  Mike talked about the lawsuits while Professor O'Reilly provided his insights on what the FDA does and, more importantly, does not do when approving a drug for the market.

Bayer was invited to come on the show but didn't accept.

It is an interesting discussion that can be heard on line.

Yaz and Yasmin: Drug Company Places Profits over Safety

The trendy Yaz and Yasmin birth control pills are unlike any others because they contain a new synthetic hormone, drospirenone. Bayer has aggressively marketed the drugs, especially to young Yazwomen, as a cure for everything from acne to pre-menstrual syndrome. Unfortunately, Bayer did not adequately test the drug before bringing it to market, and it now ignores two studies on Dutch and Danish women suggesting that the drugs are more dangerous than other birth control pills that don't contain the synthetic hormone. 

Women who take Yaz or Yasmin have suffered a list of harmful side effects. One of the most common is blood clots. Blood clots may lead to debilitating strokes, pulmonary emboli and heart attacks. Women on Yaz or Yasmin have also been stricken by disease and damage to the gallbladder, liver, and pancreas, among other conditions.

The Food and Drug Administration has now decided that Bayer's television commercials were misleading, because they undersold the risks of the drug while at the same time overstating its benefits. In addition, the consumer protection group Public Citizen warns all women against using either Yaz or Yasmin, and instead suggests sticking to a pill that does not contain drospirenone.

Yaz and Yasmin are no more effective than traditional birth control drugs, but they appear to be more dangerous. Nonetheless, because of Bayer's aggressive and misleading advertising, they are now Bayer's most popular drugs. In fact, the drugs are the most popular birth control pills in the world. Last year alone, Bayer sold $1.8 billion worth of Yaz and Yasmin .

Not surprisingly, with that type of money on the line, Bayer continues to promote the drugs, regardless of their risks.

FDA Determines Yasmin/Yaz Commercials Misleading

Beginning in July 2003, the Food and Drug Adminstration warned Bayer (or more accurately, Bayer's predecessor, Berlex Laboratories ) that its television commercials for Yasmin were misleading and should be corrected.  The FDA warned Bayer again in 2008, and again in 2009.  Among Bayer's more serious violations, accorYaz Commercial Screen Shotding to the FDA, was that the commercials minimized the risks associated with Yaz while at the same time overstating its benefits -- especially for conditions such as premenstrual syndrome for which the drug was never approved.  According to the FDA:

These violations are concerning from a public health perspective because they encourage use of YAZ in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with YAZ.

 

FDA Warning Re Yaz