Post by Admin on Jan 24, 2021 14:30:38 GMT
Medicine Is Made for Men
Alexandra D. Lahav
In medical research, drug regulation, and product design, the male body is too often considered as the default — which can have dangerous, even fatal, consequences for women.
February 11, 2021 issue
www.nybooks.com/articles/2021/02/11/medicine-is-made-for-men/
On September 24, 2010, Michelle Pfleger, a champion equestrian, former varsity cheerleader, and freshman at Elon University in North Carolina collapsed on her way to class, then died. She was eighteen years old. The autopsy listed the cause of death as pulmonary thromboemboli—a blocked blood vessel in the lung—and stated that she had died of natural causes. Why would a young person in excellent health suddenly die of a blood clot? Pfleger had no risk factors other than the birth control she was on: a pill called Yaz, made by the pharmaceutical manufacturer Bayer.
Yaz was approved by the Food and Drug Administration in 2006. In the FDA’s initial report, released that year, regulators expressed some concern that the drug’s principal ingredient, drospirenone, caused an increased incidence of blood clots. The agency mandated that the company conduct post-market studies, but these were not begun until 2009. Meanwhile, Yaz quickly became one of Bayer’s top sellers, aided by an aggressive advertising campaign, including one commercial that showed balloons marked “irritability,” “headaches,” “bloating,” “fatigue,” and “acne” floating off into the sky and disappearing, as though Yaz could improve moods and cure ailments. In October 2008 the FDA deemed this ad misleading and deceptive and forced Bayer not only to pull it but to run corrective advertising—a rare step. The following year, Pfleger, then a high school senior, was prescribed the drug.
All birth control pills currently on the market carry a small risk of blood clots, but independent observational studies published in The BMJ (formerly the British Medical Journal) in 2009 and 2011 indicated that, as compared with other birth control pills, Yaz more than doubled the chances of a blood clot. By 2011 tens of millions of women were taking Yaz. The following year the FDA required Bayer to include a warning on its label stating that drospirenone increased the risk of blood clots relative to birth control pills with the hormone levonorgestrel or some other progestins.
The possibility that Pfleger might have lived if she had been prescribed a different birth control pill haunted her mother, who sued Bayer in 2011. That lawsuit was one of over 11,000 filed over Yaz in state and federal courts. In 2016 Bayer announced that it would pay $2.04 billion to resolve 10,300 pending claims by women who had taken the contraceptive. Such a settlement may seem enormous, but it is not especially large in relation to product sales—in 2012 alone Bayer sold more than $1.3 billion worth of Yaz. By 2015 this figure had dropped to about $918 million.
Alexandra D. Lahav
In medical research, drug regulation, and product design, the male body is too often considered as the default — which can have dangerous, even fatal, consequences for women.
February 11, 2021 issue
www.nybooks.com/articles/2021/02/11/medicine-is-made-for-men/
On September 24, 2010, Michelle Pfleger, a champion equestrian, former varsity cheerleader, and freshman at Elon University in North Carolina collapsed on her way to class, then died. She was eighteen years old. The autopsy listed the cause of death as pulmonary thromboemboli—a blocked blood vessel in the lung—and stated that she had died of natural causes. Why would a young person in excellent health suddenly die of a blood clot? Pfleger had no risk factors other than the birth control she was on: a pill called Yaz, made by the pharmaceutical manufacturer Bayer.
Yaz was approved by the Food and Drug Administration in 2006. In the FDA’s initial report, released that year, regulators expressed some concern that the drug’s principal ingredient, drospirenone, caused an increased incidence of blood clots. The agency mandated that the company conduct post-market studies, but these were not begun until 2009. Meanwhile, Yaz quickly became one of Bayer’s top sellers, aided by an aggressive advertising campaign, including one commercial that showed balloons marked “irritability,” “headaches,” “bloating,” “fatigue,” and “acne” floating off into the sky and disappearing, as though Yaz could improve moods and cure ailments. In October 2008 the FDA deemed this ad misleading and deceptive and forced Bayer not only to pull it but to run corrective advertising—a rare step. The following year, Pfleger, then a high school senior, was prescribed the drug.
All birth control pills currently on the market carry a small risk of blood clots, but independent observational studies published in The BMJ (formerly the British Medical Journal) in 2009 and 2011 indicated that, as compared with other birth control pills, Yaz more than doubled the chances of a blood clot. By 2011 tens of millions of women were taking Yaz. The following year the FDA required Bayer to include a warning on its label stating that drospirenone increased the risk of blood clots relative to birth control pills with the hormone levonorgestrel or some other progestins.
The possibility that Pfleger might have lived if she had been prescribed a different birth control pill haunted her mother, who sued Bayer in 2011. That lawsuit was one of over 11,000 filed over Yaz in state and federal courts. In 2016 Bayer announced that it would pay $2.04 billion to resolve 10,300 pending claims by women who had taken the contraceptive. Such a settlement may seem enormous, but it is not especially large in relation to product sales—in 2012 alone Bayer sold more than $1.3 billion worth of Yaz. By 2015 this figure had dropped to about $918 million.