En route to its conclusion that have suffered more than men from dangerous drugs and medical devices, the group explores some of the potential causes of the discrepancy, including the rollback of legislation requiring clinical trials and under representation.
“From snake oil ‘hormone treatments’ to deadly contraceptive devices, the last 150 years have been littered with dangerous drugs and devices that disproportionately target women,” the report argues.
Hysteria, the Dalkon Shield and More Point to Women as Targets
Modern American women have been targeted as early as the 1800s by those who thought women suffered from hysteria and a condition called neurasthenia attributed to the hustle and bustle of modern life.
“Women were particularly vulnerable because they were thought to be constitutionally weaker than men, and burdened by their reproductive systems,” the report says. “Conditions that would today be recognized as fibromyalgia and postpartum depression were considered indications of nerve disorders.”
Women at the time were treated with morphine, cocaine and even heroin. This led to women accounting for as much as 75 percent of those suffering from opium use disorders in the early 20th century. Today, twice as many women as men are prescribed at least one medication for mental health issues.
Birth control devices like the Yaz pill and Mirena IUD have targeted and harmed women over the years. But one of the biggest disasters surrounded the Dalkon Shield.
The intrauterine device was introduced in the early 1970s and marketed as a safer alternative to birth control pills. Before going to market, a manager at the pharmaceutical marketing firm A.H. Robins warned executives of the dangerous design, saying “the string or ‘tail’ situation needs a careful review since the present ‘tail’ is reported to have a wicking tendency.”
Within a few years, the CDC conducted a survey of physicians and found thousands of women had been hospitalized, including five reports of fatalities. Despite internal questions of safety, A.H. Robins continued to market the device.
More than a decade and hundreds of thousands of lawsuits from women alleging injuries later, the device was finally removed from the market. Billions of dollars were paid out in settlements to women who were left injured or infertile.
Women Underrepresented in Clinical Studies, AAJ Report Says
The AAJ points to a number of reasons why women are often exposed to greater dangers from medicines and devices than men, including limited use of women in clinical studies.
“Women take more medications than men, respond differently to them, and are more likely to suffer adverse drug effects,” the report says. “Yet it was not until 1993 that legislation was enacted requiring women to be included in human subject research. Even today, women are consistently underrepresented in studies, or outright excluded. Nor does the FDA require trials In 1980, a drug called Parlodel was introduced by Sandoz Pharmaceuticals to treat cocaine withdrawal, Parkinson’s disease and to suppress lactation in women who did not, or could not, breastfeed their babies.
But by 1989, the U.S. Food and Drug Administration (FDA) said lactation suppressants were dangerous, as dozens of women suffered strokes and seizures as a result of the drugs. Despite repeated requests from the FDA to stop selling Parlodel, Sandoz Pharmaceuticals continued sell the drug to hundreds of thousands of women a year.
It wasn’t until consumer rights advocacy group Public Citizen sued the FDA to get the product removed did Sandoz Pharmaceuticals finally stop selling the drug amid nearly a decade of reports of adverse effect.
That’s just one of the many stories recounted in a new report from the American Association for Justice (AAJ), which claims that women are disproportionately exposed to dangerous and defective drugs and medical devices. The AAJ is a nonprofit advocacy and lobbying organization for trial lawyers.
“This timely report sheds light on the disturbing ways women have been preyed upon by corporations in the name of profit,” said Julie Braman Kane, President of AAJ, in a statement. “More than a century of gender inequality in research and unhindered corporate greed continue to put women at risk of exposure to dangerous drugs and medical devices. We must protect women’s access to justice to ensure they can end their silent suffering and hold corporations accountable when corporations refuse to put Americans’ safety first.”
The 44-page report entitled “From Accutane to Zonite: A History of Dangerous Drugs & Devices Marketed to Women” documents just some of the many examples of women being marginalized by the health care community and exposed to dangers by pharmaceutical companies in modern history.
to compare dose e cacy between men and women, though women metabolize drugs differently. “
In one 2015 report published in BMC Womens Health, researchers say that despite the legislation, women remain underrepresented in clinical trials in cardiovascular disease and cancer. Gender is also not typically analyzed for different health outcomes when women are included.
AAJ Advocates Against Pending ‘Protecting Access to Care Act’
The organization is using this report as an example of why patients, particularly women, need more protections. A bill called “Protecting Access to Care Act” currently pending in the U.S. House of Representatives would do the opposite, AAJ says.
According to the organization, the bill would remove protections for patients and give more protection to health care providers who prescribe drugs to patients, even if it was found to be dangerous.
“Congress should be ashamed of masquerading corporate handouts as patient protections,” Kane said. “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.”
AAJ argues that the continued rollback of regulations by the FDA and the removal of patient safety in acts like the 21st Century Cures Act will continue to put both men and women at risk.