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Beyond Birth Control

Did Bayer Put Profits Before Patients?
By Rick Outzen

Pediatric nurse Carissa Ubersox, 24, was working her dream job at a Madison, Wis. Hospital. The recent college graduate was engaged to be married and switched in late 2007 to the popular Yaz birth control pill, believing the drug would help with acne and premenstrual bloating.

After three months, Carissa’s legs started to ache, which she first attributed to being on her feet for her 12-hour shift. By the next night, the young nurse was fighting to breathe. Blood clots had traveled from her legs to her lungs, causing a massive double pulmonary embolism.

Her heart stopped in the ambulance, but doctors revived her. However she went into a coma that lasted for almost two weeks. When she awoke, Carissa was blind.

It’s incidents such as Carissa’s that have placed the former wonder birth control drug under increased scrutiny for increased blood clots and other complications and has brought on thousands of lawsuits against Bayer HealthCare Pharmaceuticals, the drug’s manufacturer, for personal injury, negligence and for misleading users.

The U.S. Food and Drug Administration, which had originally approved Yaz in 2006, issued at the end of September its third warning letter regarding the oral contraceptive and has scheduled a joint meeting of the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on Dec. 8, to discuss the risks and benefits and, specifically, the risk of blood clots of Yaz and other drospirenone-containing birth control pills.

“Preliminary results of the FDA-funded study suggest an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives,” said Jennifer Shepherd, a pharmacist in the Division of Drug Information, in the FDA Drug Safety podcast for healthcare professionals on the latest warning.

On Oct. 14, ABC’s Nightline broadcasted the story of Carissa Ubersox, who is suing Bayer. Her lawsuit comes after the drug company admitted that its claims were exaggerated and independent studies have warned about an increased risk of blood clots while taking it.

Typically, two to four women per 10,000 on birth control pills will suffer blood clots, but independent studies have found that the risk is two to three times higher with Yaz, reported ABC News.

Yaz was originally marketed by Bayer to help cure acne and premenstrual syndrome while downplaying the health risks. Using the slogan “Beyond Birth Control,” the target market was women in their 20s, like Carissa. The German pharmaceutical giant promoted Yaz not only for pregnancy prevention but also as a lifestyle drug.

The ads were so effective that sales of the drug jumped from $262 million in 2007 to $616 million in 2008. Yaz became the best-selling oral contraception pill in the United States, with about 18 percent market share.

Then health complications began to show up. Yaz contains drospirenone, which can cause excess potassium production in some patients. Its side effects include an increased risk of blood clots, serious heart and other health problems, including hyperkalemia, liver or kidney damage, gallbladder problems, strokes and even death.

Independent studies found the drug wasn’t really that effective in treating acne or PMS. Attorney generals from 27 states challenged Bayer about its aggressive advertising campaign for the birth-control pill, charging the ads were deceptive. In 2008, the FDA agreed and said in a warning letter that Yaz had not been shown to be effective for common PMS, just a rare and serious form of menstrual symptoms, and that Yaz’s success with acne was “misleadingly overstate(d).”

Bayer reached a settlement with the FDA that allowed the drug manufacturer to keep Yaz on the market if it spent at least $20 million on a campaign to “correct” previous ads.

For many, the “corrective” ads were too little, too late. Sales of Yaz contraceptives dropped 15 percent in the first half of 2010, but that decline was due more to a rival marketing a generic copy than the new ads. Lawsuits were filed in the U.S. and Canada claiming Bayer ignored the health risks of the contraceptive.

As of Feb. 1, there were about 6,850 lawsuits pending in the United States, served upon Bayer on behalf of persons alleged to have suffered personal injuries, some of them fatal, from the use of Bayer’s oral contraceptive products, according to the company’s 2010 consolidated financial statements. In addition, 13 Canadian class actions have been served upon Bayer.

Pensacola attorney Mike Papantonio has a trial scheduled in St. Louis against Bayer. On his nationally syndicated Ring of Fire radio program, he pulled no punches on the drug manufacturer.

“This was a completely unnecessary drug,” said Papantonio. “Bayer knew there was a lot of competition in the market for contraceptives so they decided not to just sell Yaz as a contraceptive, but also as an acne and PMS drug.”

He believes Bayer produced the drug to capitalize on a young, impressionable consumer, knowing the drug was dangerous and couldn’t fulfill its exaggerated claims.

“In other words, hell with the fact the Mydol has been out there forever and hasn’t killed anybody. The hell with the fact that there are applications for acne that haven’t killed anybody.”

Bayer refused to go on air during the Nightline segment. In its consolidated financial statements, the company wrote, “Bayer believes that it has meritorious defenses and intends to defend itself vigorously.”