It was mere hours after Rebecca Bapp called her parents to say that she wasn’t feeling well that the 21-year-old was dead. Mysteriously, her health declined so rapidly even doctors were baffled by what was making her so ill. Not long after her parents rushed her to the hospital, she was placed on a breathing machine and sedated. She coded three times before she gave up her fight for life.
Bayer didn’t want anyone to find out its top-selling birth control pill Yasmin could be more dangerous than older oral contraceptives, and even went so far as to promote the pill for uses for which it had not been approved, according to a Food and Drug Administration (FDA) report unsealed in federal court last week.
The birth control pill for women has been around for more than 50 years, and during that time, no one has tackled a similar contraceptive for men, until now. Researchers have developed a contraceptive for men that can be taken orally, injected or applied topically. The medication releases small amounts of testosterone into the bloodstream to stop the production of sperm. Men will still be able to ejaculate but their ability to impregnate a woman would be compromised as long as they are on the medication.
Europe’s biggest drug company, Bayer AG, has won a lawsuit in the United Kingdom, protecting the patent on its birth control pill Yasmin against a challenge by Hungary’s Gedeon Richter Nyrt. Justice Christopher Floyd ruled in the High Court of London that the inventions the patents covered for Yasmin would not have been “obvious” to experts in the industry. The ruling is in contrast to a case in the United States in 2008, in which the Yasmin patent was found to be invalid because it was “obvious” to other experts in the field. That ruling opened the door for Israel’s massive generic drug manufacturer, Teva Pharmaceuticals Industries Ltd., to sell a version of Yasmin, known as Ocella, in the United States.
Bayer AG has its eyes set on the Latin American country Brazil to win back profits lost from lawsuits and bad press surrounding its blockbuster birth control pill Yaz. The German pharmaceutical company announced this week that it expects to post double-digit annual growth in Brazil through the next four years, from 15 billion in 2008 to a whopping $27 billion by 2015.
Six months ago, Lucy* was released from the hospital. Just months after starting Yaz birth control pills, the young woman was diagnosed with a pulmonary embolism (PE), gallstones, and an unknown growth on her adrenal gland. “The doctors told me Yaz was the reason for the PE and that I was very lucky,” she wrote to a community board on Yaz on Medications.com. “I work in a hospital and had no knowledge of these problems until I entered the ER by ambulance on Saturday.”
Bayer HealthCare has launched another birth control pill packed with the hormone ethinyl estradiol, the diuretic drospirenone, and the B vitamin folic acid. The new oral contraceptive, called SAFYRAL, follows by three months the introduction of Beyaz, a near-identical pill packed with the same active ingredients. Folic acid has been shown to protect unborn babies against neural tube defects if the vitamin is taken regularly by women before and during the first three months of pregnancy.
When Katie Ketner was 15, she met with a gynecologist about birth control. The doctor told Katie that Yaz “helped people regulate their menstruation, helped people control their acne, and things like that,” Katie remembers. The ads for Yaz were everywhere then, colorful commercials with smiling women praising the pill that not only prevented pregnancy, but also squashed irritability and moodiness associated with premenstrual syndrome as well as cleared up bothersome acne. It was an easy sale for Katie.
The number of lawsuits against Bayer for its top-selling birth control pill, Yaz, has climbed to more than 4,200. The lawsuits allege that Bayer knew its pills put women at risk for blood clots, strokes, and heart attacks, a common side effect with any oral contraceptive. However, nearly half of the lawsuits against Bayer allege that the pills caused damage to the gallbladder and in many instances resulted in gallbladder removal. Bayer dismisses the notion that its pills can cause gallbladder problems and maintains its pills are no more dangerous than other oral contraceptives.
Watson Pharmaceuticals has received approval from the Food and Drug Administration (FDA) under the Abbreviated New Drug Application for Zarah, its new oral contraceptive pill that serves as a generic version of Bayer’s best-selling birth control pill Yasmin. Yasmin and its generic equivalents sold approximately $97 million in the U.S. for the twelve months ending June 30, 2010.
