[ad_1]
Controversial premature birth drug reignites debate among physicians over whether keeping fast-track drugs on the market without clear clinical benefits exacerbates racial health disparities I am letting
The Food and Drug Administration will decide in the next few months whether to withdraw Covis Pharma’s Makena, which the FDA granted accelerated approval in 2011. Over 10 years.
Makena is designed to reduce the risk of premature birth in women who have had an unexplained birth before 37 weeks of gestation.
Removing the drug from the market would be particularly harmful to black patients, who have a disproportionately high preterm birth rate, drug companies and patient advocacy groups say. Some groups were funded by former manufacturers Covis and Makena.
But prescribing treatments with little evidence of effectiveness could impose financial costs and exacerbate health risks for minority groups, say doctors and bioethicists. .
“Patients don’t just need approved products; they need products that actually have clinical benefit,” said Holly Fernandez Lynch, assistant professor of bioethics and law at the University of Pennsylvania. .
“I don’t want to allow a product to be marketed in the hope that it will work because it’s not really what patients need,” she added.
The pending Makena decisions are designed to speed up access to medicines by relying on surrogate endpoints, such as biomarkers or laboratory measurements, to predict the clinical benefit of medicines. It comes amid widespread pressure for a change to the FDA’s accelerated approval pathway.
Legislators aim to add to year-end government spending package regulations that would give the FDA more tools to withdraw expedited follow-up drugs that lack clinical benefit for approval.
Cobis defense
The FDA’s Center for Drug Evaluation and Research first proposed in October 2020 to remove Makena from the market because the required post-marketing studies failed to validate clinical benefit.
The FDA’s panel of independent advisors voted overwhelmingly on October 19 to recommend discontinuing the drug.
Covis acknowledged that its confirmatory trials did not show clear clinical benefit. However, the drug should be allowed to remain on the market to allow follow-up studies among groups at high risk of premature birth, including black women, Covis said.
A small clinical trial funded by the US National Institute of Child Health and Human Development in 2003 showed that 17 alpha-hydroxyprogesterone caproate (later approved as Makena) reduced the risk of premature birth in women who had previously had an unplanned birth. has been shown to be useful in reducing The study, popularly known as the Meis trial, was conducted in the United States with about 60 percent of black participants, and was criticized by Makena supporters for the drug’s potential benefit to high-risk groups. It is quoted as showing
Yolanda Lawson, associate physician at Baylor University Medical Center and president-elect of the American Medical Association, spoke at an advisory board hearing in October in support of keeping Makena on the market. said in an interview that the findings of the Meis trial showed “proven benefits” for the high-risk group.
“When I actually go about it, off the top of my head I can think of at least three patients who have lost babies, but who didn’t even give birth to live children, but who used drugs or other means to get them to lose their babies. They were able to have full-term healthy babies,” Lawson said.
Covis said at the hearing that removing Makena from the market would add to the uncertainty of the drug’s safety and lead to a historic distrust of trial participants, especially medical research due to decades of past abuse. He argued that it would make it difficult to recruit sensitive minority groups.
Lawson said it “could definitely cause suspicion and suspicion” among patients about whether the drug was safe.
“Spin Campaign”
Physicians and bioethicists who support removing Makena from the market disagree with Mr. Covis’ argument, saying that allowing physicians to continue to prescribe the drug could put patients at risk. , argues that there is little profit potential.
Adriane Fugh-Berman, a professor of pharmacology and physiology at Georgetown University, said using health equity as an argument for keeping drugs on the market “is an unethical use of the term.” rice field.
“Low risk doesn’t mean risk free,” added Fugh-Berman, director of Georgetown’s PharmedOut project, which aims to promote education about evidence-based prescribing and medical product marketing practices. I was.
“Any level of risk is only worth it if the drug actually has a benefit, and there is no benefit to this,” she said. And so on.
Adam C. Urato, a Massachusetts-based maternal-fetal medicine physician, was one of the people behind the 2019 citizen petition to withdraw Makena from the FDA. He said in an interview that health care providers, like himself, “do not give drugs to pregnant women or do anything that has not been proven to have safe, effective, clinical health benefits.” I don’t want to,’ he said.
“Health equity is a laudable goal and we wish everyone well,” Urato said. But health equity “can also be used, basically, to increase sales and profits, or as a spin campaign to keep drugs on the market.
Covis Pharma did not respond to multiple requests for comment.
path change
Both the FDA and lawmakers have called for legislative changes to minimize the time between a drug entering the market and studies demonstrating clinical benefit being completed.
Fernandez Lynch told Makena, “It took us two years from the time the FDA first recommended a withdrawal to get to this stage.” Is required.”
Part of facilitating the success of accelerated pathways is also ensuring that confirmatory study populations are representative of the composition of the disease population, says Fernandez Lynch.
Fugh-Berman was included in the House-passed user fee package (HR 7667), but removed from the final wording. Congress’ recent efforts to revamp accelerated approval “will not be enough.” She pointed to a series of additional recommendations contained in a September white paper from PharmedOut. For example, making randomized controlled trials the default within accelerated approval programs, allowing approval to be automatically withdrawn if post-market requirements do not meet certain requirements. date.
“The entire expedited approval process needs to be revamped to protect patients,” she said.
[ad_2]
Source link
