Right Wing Paradise-- A World With No Regulations... Take Yaz And Bayer

Would Bayer put your life at risk? Well... that depends on how much profit they could make. The company was founded in Germany in 1863 and later became a key component of IG Farben, the biggest of the Nazi conglomerates that bankrolled Hitler, made mega profits off slave labor in concentration camps and manufactured all the chemicals needed to exterminate the Jews and anyone else the Nazis decided were untermeschen. Bayer also invented heroin. Bayer, like all the big pharmaceutical companies calculates the value of new drugs by including the inevitable wrongful death suits and fines, fines that more often than not result in their having hidden evidence from the FDA in the process of getting approval.

Bayer spends immense amounts of money on legalistic bribes-- overwhelmingly to Republicans (80%) and some conservative Democrats willing to vote against consumer interests with the Republicans. In he 2010 cycle Bayer spent $334,018 to help the Republicans take control of Congress, understanding full well the GOP attitude towards regulations that protect the public from predatory drug companies like itself.

Big Pharma has spent $121,637,009 on direct "contributions" to federal candidates, again, most of it to Republicans and most of the rest to corrupt conservative Democrats. Big Pharma's biggest friend in the House are all well-known for protecting drug manufacturers interests over the interests of the public, particularly 5 of Congress' sleaziest and most corrupt Members:

Joe Barton (R-TX)- $849,738
Fred Upton (R-MI)- $631,241
Dave Camp (R-MI)- $586,897
John Boehner (R-OH)- $582,280
Charlie Rangel (D-NY)- $570,402

I heard Mike Papantonio discussing the Yaz case with Sam Seder on the radio this evening. That's how I came to find the video above.

Lawsuits have been filed against Bayer HealthCare Pharmaceutical for the birth control drug Yaz, Yasmin and Ocella. Yaz, Yasmin and Ocella birth control pills all contain drospirenone, a synthetic form of progestin which works in combination with ethinyl estradiol (estrogen) to prevent pregnancy. Drospirenone is not contained in other forms of birth control and is believed to be the major cause of side effects from Ocella, Yasmin and Yaz. Two recent case-control studies published in the British Medical Journal show that patients on the birth control pills containing drospirenone have a 200% higher risk of serious injury than those patients using first or second generation oral contraception. The New York Times recently published a major news story on the growing safety concerns with Yaz. Bayer manufactures and markets Yaz and Yasmin. Ocella, meanwhile, is a generic form of Yasmin. Bayer manufactures Ocella which is then packaged and sold by Barr Laboratories, which has recently been acquired by Teva Pharmaceuticals.

Side effects of Yaz, Yasmin and Ocella may include:

• heart attacks
• strokes
• deep vein thrombosis
• pulmonary embolism
• blood clots in the legs and lungs
• cardiac arrhythmia
• gallbladder disease
• kidney failure
• sudden death

From the 2009 NY Times story by Natasha Singer:

The oral contraceptives Yaz and Yasmin are the top-selling pharmaceutical line for Bayer HealthCare, largely as a result of marketing that presents them as much more than mere pregnancy prevention.

Yaz, in particular, the top-selling birth control pill in the United States, owes much of its popularity to multimillion-dollar ad campaigns that have promoted the drug as a quality-of-life treatment to combat acne and severe premenstrual depression.

Yaz, a newer sister drug to Yasmin, contains less estrogen. The franchise had worldwide sales of about $1.8 billion last year, based on Bayer’s successful positioning of Yasmin and Yaz as the go-to drug brands for women under 35.

But recently, the Yaz line’s image has been clouded by concerns from some researchers, health advocates and plaintiffs’ lawyers. They say that the drugs put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do.

Those critics, though, are up against a large European health study, sponsored by Bayer, the German pharmaceutical giant, that reported the opposite conclusion. The Bayer-financed study said that cardiovascular risks in women taking Bayer products were comparable to those taking an older formula of birth control pills.

But regulators are finding other faults with the Yaz franchise. The Food and Drug Administration early this year asked Bayer to correct misleading television commercials. Last month, the agency cited the company for not following proper quality control procedures at a plant that makes hormone ingredients.

In e-mail responses to a reporter’s queries, the American unit of the company said that its birth-control drugs had been and continued to be extensively studied and that the company stood behind their safety. The company also said it had responded to the F.D.A.’s questions about manufacturing practices, which it said it took very seriously.

But even if Bayer can adequately respond to the safety and other concerns, some industry analysts say that the avalanche of criticism could tarnish the Yaz line’s image. Other products by Bayer, like the erectile dysfunction drug Levitra and the intrauterine birth-control system Mirena, generate far less income than the Yaz product family.

“For Bayer, it is by far the highest margin and the fastest-growing brand,” Martin Brunninger, an analyst with the European investment bank Bryan, Garnier & Company, said in a phone interview from London on Wednesday. “Whether this turns out to be a serious issue or not, when a drug is stigmatized in public, people just withdraw from taking it.”

Bayer said that the company had been served with 74 lawsuits brought by women who charge that they developed health problems after taking Yaz or Yasmin. The company says it intends to defend itself vigorously against the suits.

...Lawyers suing Bayer on behalf of plaintiffs who claim that they developed blood clots, heart attacks and other health problems because they took the drugs said they intended to argue that the company knew or should have known that the pills entailed a higher risk.

One such plaintiff is Anne Marie Eakins, a history teacher in Grafton, Ohio, who developed blood clots in both lungs in 2007 and, as a result, she said, lost partial use of her right lung. She had used a variety of different birth control pills over more than a decade before starting Yaz in 2007, she said.
“To be perfectly honest, I asked my doctor about Yaz because I had seen the commercial and it mentioned helping control your period symptoms and acne, which was very attractive to me,” said Ms. Eakins, 34. “I didn’t think it was going to be worse than any other pill.”

Because drug labels for Yasmin and Yaz contain warnings about the risk of side effects like blood clots and strokes, plaintiffs may have a difficult time winning cases with the argument that the company should have issued stronger alerts. But, armed with F.D.A. warning letters to Bayer, lawyers may find more success with the argument that misleading Yaz commercials enticed women to take the drug, thereby exposing them to health risks they might not otherwise have incurred.

Last October, the agency sent Bayer a warning letter, citing the company for running two false and misleading television ads about Yaz. According to the letter, the ads overstated the drug’s efficacy, promoted it for conditions like premenstrual syndrome for which the drug is not approved, and minimized serious risks associated with the drug. In February, Bayer agreed to spend $20 million on a corrective advertising campaign to counteract misimpressions created by the original television spots.

Last month, the agency sent Bayer a warning letter about another problem-- deviations from quality control standards at a manufacturing plant in Germany that makes drospirenone and other hormone ingredients used in Bayer’s birth control pills sold in the United States. The letter said that the way in which the facility calculated variability in ingredients did not meet American standards.

Bayer said it was taking the matter seriously. Maintaining good manufacturing practices and patient safety continue to be top priorities at Bayer, the company said in a statement.

But Mr. Santoro of the Rutgers Business School said that drug companies should set higher standards for themselves than those set by the F.D.A.

“It tells me,” Mr. Santoro said of Bayer, “that it is not understanding the business that it is in, that it is not understanding the health risks that it is posing to the public or the financial risk that it is creating for its shareholders.”