A reckoning for FDA fast drug approvals and moms’ mistreatment

makenadrug-300x67Federal regulators have hit a highly public reckoning for their policies to provide speedy approvals for prescription drugs, benefiting Big Pharma’s profits but not necessarily patients — notably women in serious need of help with a shame of the U.S. health care system: the nation’s dismal state with injuries and deaths to expectant moms and infants.

The federal Food and Drug Administration 11 years ago gave Covis Pharma an expedited review and approval to market its prescription drug Makena, which the maker promoted as a rare medication to prevent preterm births.

In exchange, the company was supposed to conduct broader, rigorous, and more detailed studies to prove definitively that Makena prevents moms from delivering before 37 weeks, which is a serious problem that affected 1 in 10 births in 2020 alone, the New York Times reported. The newspaper also noted that preterm births are a greater problem for black women:

 “That same year, the rate of preterm birth among African American women (14.4%) was about 50% higher than the rate of preterm birth among white or Hispanic women (9.1% and 9.8%, respectively).”

But for Covis, the big buildup that Makena would help reduce infant death and disability and boost mothers’ health never was fulfilled, the newspaper and other media reported:

“The company said 350,000 U.S. women have taken it in the past decade. After years of follow-up study, the drug failed to benefit newborns more than a placebo.”

Covis, now owned by the private equity firm Apollo Global Management, has battled the FDA over the follow-up studies it was required to conduct after receiving accelerated approval for Makena and what the research exactly showed. The company wants the drug to stay on the market, albeit for more narrowly focused use. But the FDA convened a group of its elite, independent advisors to consider what Dr. Robert Califf, the agency’s chief, should do about Makena. Here is what the experts said after three days of emotional sessions, according to the New York Times:

“The advisory committee weighed in on three separate votes [on Oct. 19]. All 15 of the voting panel members agreed that the lengthy post-market trial of the drug did not show a benefit to babies. Thirteen also agreed that the drug was not proven to be effective in reducing risk for preterm birth in women who already had one preterm birth. Fourteen agreed that the drug should be withdrawn from the market.”

The FDA advisors voted after hearing from the drug maker, health groups, and experts from the agency’s Obstetrics, Reproductive, and Urologic Drugs Advisory Committee, the Washington Post reported.

Glaring problems with regulation, mistreatment

That newspaper and others said the years long mess with Makena emphasized two glaring problems — the nation’s maternal and infant morbidity and mortality crisis and huge flaws in the FDA’s accelerated approval program for prescription drugs.

In brief, for expectant moms and infants, as Stat, a science and medical news site, explained recently:

“The U.S. is in a maternal care crisis, with the highest maternal mortality rate among comparable wealthy countries — one that continues to increase year over year. Black women, in particular, are three times more likely to die as a result of pregnancy than white women. In light of other stressors on the health care system including the pandemic, staff shortages, and increased abortion restrictions across the country, experts worry that access to comprehensive reproductive care will continue to decrease, putting pregnant people and their babies even more at risk.”

As for the FDA’s expedited approvals, a recent NPR headline summarizes the issue tersely:  “Drugmakers are slow to prove medicines that got a fast track to market really work…”

In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be inflicted on them by dangerous and bankrupting drugs.

Taxpayers spend a bundle of money on the FDA to safeguard themselves against risky, costly, and unhelpful prescription medications. Regular folks and doctors, too, lack the time, expertise, and experience to pore over the best available, rigorous clinical trials and other evidence to determine which drugs are safe, efficient, and excellent. The agency is supposed to work on behalf of the American people, not Big Pharma.

But advocates for innovative therapies have argued, with some good reason, that ponderous bureaucracies should not keep life changing and lifesaving meds away from the desperate. Business-minded politicians and lawmakers also have fiddled with agency finances, making the FDA increasingly budget reliant on fees paid by the very enterprises it regulates — drug and medical device makers. These and other steps are eroding public confidence that the FDA really is a public watchdog and not a lap puppy for industry.

It is, frankly, difficult to fathom how, if experts knew more and more that Makena was ineffective, why regulators allowed its maker to buck rake off the drug, about which the New York Times reported this of the med and others fast-tracked by the FDA:

“A recent government watchdog report estimated that Medicaid, which covers the cost of about 40% of births in the United States, paid nearly $700 million for courses of Makena since the study to gauge its benefits was due in 2018. The report, by the inspector general for the Department of Health and Human Services, found that government payers spent $18 billion in total on drugs that were approved based on promising findings — but stayed on the market after the date they were supposed to prove a benefit.”

Better maternal care isn’t just about pills

At the same time, as some advocates noted in the Makena hearing, not all medical challenges can be best responded to with pharmaceuticals. Instead, the U.S. health system and all in it must reckon in long overdue fashion with racist attitudes and practices that inflict unacceptable harms on communities of color, and especially black women.

Experts, for example, have drilled into data on the patients who are affluent, educated, and in good health enough to seek help from fertility medicine experts. More study is needed. But one disturbing data point that has emerged is that black women in this highly optimal group of patients still suffer disproportionate morbidity and infant harms and deaths when compared to their peers. The researchers say their information points to major changes in doctors failing to listen to and provide the best care to black patients.

Two prominent medical journals — the New England Journal of Medicine and BMJ, a publication of the British Medical Association — also both have reported on and editorialized about another grim issue with maternal morbidity. They note that recent research shows that a significant driver of this menace to expectant moms comes from interpersonal, gun violence inflicted against women. As a study by researchers at Harvard’s T.H. Chan School of Public Health found:

Women in the U.S. who are pregnant or who have recently given birth are more likely to be murdered than to die from obstetric causes—and these homicides are linked to a deadly mix of intimate partner violence and firearms, according to researchers from Harvard T.H. Chan School of Public Health. Homicide deaths among pregnant women are more prevalent than deaths from hypertensive disorders, hemorrhage, or sepsis, wrote Rebecca Lawn, postdoctoral research fellow, and Karestan Koenen, professor of psychiatric epidemiology, in an Oct. 19 editorial in the journal BMJ. The U.S. has a higher prevalence of intimate partner violence than comparable countries, such violence is often fatal, and it frequently involves guns, Lawn and Koenen noted. They cited one study that found that, from 2009–2019, 68% of pregnancy-related homicides involved firearms. That study also found that black women face substantially higher risk of being killed than white or Hispanic women.”

As an opinion article in NEJM also noted of the U.S. Supreme Court’s intrusion into women’s reproductive health in the Dobbs decision overturning 50 years of precedents on abortion:

“A critical but often overlooked consequence of state abortion restrictions is the profound effect they can have on people experiencing intimate-partner violence (IPV). IPV encompasses physical and sexual violence and intimidation, as well as psychological abuse. Overall, one in three women in the United States experiences contact sexual violence, physical violence, or stalking by an intimate partner (or a combination of these) at some point, with higher rates among women in historically marginalized racial or ethnic groups. At the same time, the Court’s decision in New York State Rifle & Pistol Association v. Bruen to strike down state limits on who may carry a firearm in public could also have important repercussions for people in abusive relationships. Most vulnerable in this new legal landscape will be people who have limited access to resources and services and inadequate protection against violence, especially those living in overburdened communities — primarily young, low-income women from historically marginalized racial or ethnic groups.”

Abortion is a complex issue, fraught with religious and other major concerns. But hardline politicians’ extreme approaches to it and other aspects of women’s health are too often unhelpful and unacceptable. We have much work to do to ensure that the oversight of prescription drugs and medical devices by the FDA is outstanding and serving regular folks — not special interests. We especially have much work to do to improve the wrongs in the nation’s maternal and infant care efforts, which current cost hundreds of women their lives needlessly and injure tens of thousands.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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