Study: Women Exposed to More Dangerous Drugs and Devices Than Men

Women are more exposed to dangerous drugs and medical devices than men, according to a new report by the American Association for Justice (AAJ).

The nonprofit advocacy group for trial lawyers took a look at back some of the dangerous and defective drugs and devices given to women throughout history, from women being treated for hysteria with morphine in the 1800s to birth control patches still on the market today that carry significantly increased risks of blood clots.

In the 44-page report titled “From Accutane to Zonite: A History of Dangerous Drugs & Devices Marketed to Women,” the authors explore why and how women are often exposed to underdeveloped and unsafe medications.

“In many ways, women are fundamentally more at risk from the potential dangers posed by drugs and medical devices, but not because of such archaic beliefs about their inferiority,” according to the report. “Women take more medications than men, respond differently to them, and are more likely to suffer adverse drug events.”

Women’s Mental Health Targets For Medicine as Early as the 1800s

The earliest example in modern history the AAJ gives deals with drugs targeting the mental health of women. In the late 1800s, people were sometimes diagnosed with hysteria or neurasthenia, which were attributed to the stresses brought upon by urbanization.

Women were significantly more likely to be diagnosed with the symptoms.

“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.”

Opium, cocaine, and morphine were often prescribed for treatment at the time. By the early 1900s, the vast majority of people who suffered from opium abuse disorders were women.

The AAJ followed the through-line to the present day where more than a quarter of American women are still being prescribed at least one mental health medication, two times as many as men. Some of the companies, including the makers of the antidepressant Paxil, have been sued over claims that the drugs are sometimes promoted for unapproved uses.

AAJ Blames Issues on FDA and Underrepresentation

In the report, the AAJ explores why women are often exposed more to dangerous drugs and devices than men.

One of the issues the organization points to is underrepresentation. Despite legislation enacted in 1993 that requires women to be added in human subject research, women remain underrepresented in studies.

According to a 2015 report published in BMC Womens Health, progress has been “painfully slow.”

“For example, women remain underrepresented in clinical trials in cardiovascular disease, the primary killer of both women and men in the United States, and cancer, the nation’s second leading cause of death for both women and men,” the report said. “Even when women have been included as subjects in clinical research, the influence of sex or gender is not widely analyzed and reported for various health outcomes.”

The AAJ also points to the lack of stringent requirements by the U.S. Food and Drug Administration (FDA) in approving some devices. Certain devices are allowed to be approved without the need for clinical trials under the agency’s 510(k) approval process as long as it is “substantially equivalent” to a device that’s already on the market.

For example, power morcellators used in gynecological surgeries like minimally-invasive hysterectomies and removing uterine fibroids are now thought to spread aggressive forms of cancer in some women. The devices were originally approved from an existing product but were untested in gynecological surgeries. Some morcellators are still being approved, despite the FDA warning against their use.

AAJ Criticizes Currently Pending ‘Protecting Access to Care Act’

The lobbying group released the report to highlight some of the ways women have been mistreated and marginalized by the health community, according to a statement.

“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. “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 AAJ is targeting legislation currently pending in the U.S. House of Representatives called the “Protecting Access to Care Act” as another example of how women are still unfairly targeted.

According to the organization, the bill would deny patients who are injured or killed from dangerous drugs prescribed by health care providers from pursuing justice in the courts.

“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.”