Brainstorm Health: Supplements Crackdown, Praluent Price Slash, Ebola Outbreak
Happy Monday, readers. I hope you enjoyed your weekend.
The Food and Drug Administration (FDA) is preparing to battle what has, for decades, been one of the less-regulated mass consumer industries in America: Dietary supplements.
FDA Commissioner Scott Gottlieb issued a pair of press releases on Monday that suggest an upcoming overhaul of the supplements industry, which has often gotten away with some dubious claims about what their products can and cannot do.
Case in point: Regulators sent a dozen warning letters today to companies suggesting that their dietary supplement products can help treat Alzheimer’s (these sorts of claims are also regularly made about cancers and other serious medical conditions).
“Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago,” wrote Gottlieb.
The agency also provided some broader context of the unchecked growth of supplements since the initial passage of the DSHEA nearly three decades ago, noting that, “what was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000—and possibly as many as 80,000 or even more—different products available to consumers.”
So how does the FDA plan to rein in the sector? For one, through aggressive communication with the public about dietary supplements that could potentially pose a threat (such as those tainted with actual prescription drugs), as well as the creation of a modernized regulatory framework (though we have yet to see what such a framework would look like).
Read on for the day’s news.
Immunotherapy shows (early) promise in brain cancer. Brain cancer is one of the deadliest forms of the disease there is. Chances of survival following diagnosis are precipitously low, and new treatments have been hard to come by for a host of reasons (including the difficulty of getting medication to the afflicted, highly sensitive area). But a new study of immunotherapy to treat glioblastoma (the form of brain cancer that killed former Sen. John McCain) has, for the first time, shown some initial promise, according to a new study in the journal Nature. (Nature)
A case study in slashing drug list prices. Sanofi and partner Regeneron are about to slash the list price of an expensive cholesterol treatment called Praluent by 60%—a move that mirrors that of competitor Amgen, which has a rival therapy called Repatha. These drugs originally came with a list price of about $14,000 but have now been slashed to about $6,000, speaking to the slow uptake of the medications that have been shown to reduce “bad” cholesterol levels by 60% or more. But an important question will be just how much of those savings are ultimately passed on to consumers (and whether the price was the only reason for these products’ slow uptake). (Reuters)
THE BIG PICTURE
The Ebola outbreak has killed nearly 100 children. The latest Ebola outbreak in the Democratic Republic of Congo has now claimed the lives of at least 97 children, according to a health charity fighting the pandemic, in what is now the second deadliest outbreak of the virus in history. While health authorities on the ground have been mounting an aggressive vaccination campaign, instability in the region has made matters particularly difficult. (ABC News)
Global suicide rate plunges since 1990. Suicide rates across the world declines by more than 33% between 1990 and 2016, according to a new study published in BMJ. The researchers cite improved access to health care, improving socioeconomic conditions in poor nations, and other related factors as the likely reasons for the drop. But it should be noted that in certain regions (including the U.S.), some communities have actually experienced an uptick in suicide, including among youth. (Fortune)
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|Produced by Sy Mukherjee|
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