The AAJ report “From Accutane to Zonite: A History of Dangerous Drugs & Devices Marketed to Women” highlights some of the most egregious medical products marketed to women and underscores the role the American justice system has played in fighting back when women are harmed.
“More than a century of gender inequality in research and unhindered corporate greed continues to put women at risk of exposure to dangerous drugs and medical devices,” says AAJ President, Julie Braman Kane.
From the Lysol douche once sold to women as a “feminine hygiene” product (yes-really!) to Paxil and its potential to cause heart-breaking birth defects, and more recently the Power Morcellator’s role in metastasizing uterine cancers, the AAJ’s 58-page research paper is a powerful indictment of pharmaceutical industry’s record on safety and the many products produced with a greater emphasis on profit than proper testing.
According to research quoted in the study, women take more medications than men, respond differently to them, and are more likely to suffer adverse events.
However, the potentially different effects a drug may have on women versus men still does not need to be accounted for in human drug studies. Prior 1993 researchers did not need to include women in scientific studies at all.
Medical devices, which include many birth control devices that come to market, are “cleared on the manufacturer’s own assertion that the device is similar to ones already on the market”.
“I think what struck me most is really how little has actually changed in terms of the way manufacturers target women,” says Mary Graffam, the Director of Research at the AAJ. “We still often don’t know how these drugs and devices will affect women but they are still being marketed and sold to women.
In fact, Graffram added, “There are more devices and more drugs out there than ever causing problems.”
The report tags more current drugs and products issues of concerns for women including problems with the Essure contraceptive device, Talc and its alleged relationship to ovarian cancer, and alleged issues with the contraceptive Yazmin or Yaz – all of which are currently the subject of litigation.
The AAJ has become increasingly concerned with legislation it believes will encroach upon women’s rights to seek redress in the courts.
In particular, the AAJ is concerned about the pending “Protecting Access to Care Act” (H.R 1215) which it says “denies patients who are injured or killed by even the intentional acts of a health care provider access to justice and the courts”. The bill would go further and “grant blanket immunity to health care providers who prescribe a drug or device that was approved by the FDA.”
“Congress should be ashamed of masquerading corporate handouts as patient protections. This vengeful legislation severs Americans’ access to the courts, impedes state laws, and protects only those drug and device manufacturers and health care providers that cause our loved ones harm,” says Braman Kane.
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Many of the drugs and medical devices included in the report went through the American regulatory process and were sold around the world even though manufacturers were aware, or soon became aware, of serious risks associated with the drug or device.
The report digs into the international Thalidomide crisis of 1960s that lead to some 20,000 babies being born with missing or truncated limbs.
The drug, also known as Distaval, was offered to women to prevent morning sickness during pregnancy.
As Graffam says the pharmaceutical industry “makes just being a woman a disease in itself” in need of some kind of pill or device to make it all go away.