Brainstorm Health: Gottlieb on Price Gouging, Opioid Prescriptions, AliveCor’s Bloodless Blood Test
Hello, readers—This is Sy.
Here’s something you don’t see every day: The Commissioner of the Food and Drug Administration (FDA) took a very public (and harsh) stance on drug price gouging in response to a story published by the Financial Times‘ David Crow.
The background: Nostrum Laboratories CEO Nirmal Mulye attempted to use a Martin Shkreli-style excuse (Mulye literally defended the infamous drug-price-hiker-turned-convicted-felon) in a gambit to justify sharply raising an antibiotic mixture’s price as a matter of defending shareholder value. “I think it is a moral requirement to make money when you can . . . to sell the product for the highest price,” Mulye told FT, adding that he believes the FDA is “incompetent and corrupt” for levying certain fees on drug makers.
1/2 Regarding @FT story today @bydavidcrow; there’s no moral imperative to price gouge and take advantage of patients. FDA will continue to promote competition so speculators and those with no regard to public health consequences can’t take advantage of patients who need medicine
2/2 There are other suppliers of this product and, by its own admission in @FT, the company in question isn’t actively marketing their formulation. Their excessive price, detached from market principles, exists only on a list and should remain there in a competitive marketplace
Gottlieb, who has moved (at times controversially) to ease the drug approval process, particularly for generics, in a bid to lower pharmaceutical list prices, went on to promise further action on the matter as a direct consequence of the FT story. “We’ll release more data soon but this is a competitive drug category, it’s not on our shortage list, and the brand product at issue isn’t even marketed. It’s a list price that exists only on a list. As for the CEO, those who market medical products should show regard for patients,” he said in another tweet.
As for whether or not drug companies at large are actually committed to holding down prices? That’s a more complicated story. Several major biopharmaceutical companies have pledged to, at least temporarily, hold off on drug price increases in the wake of criticism from President Donald Trump’s administration. But the net effect for consumers, given all the various middlemen and general opacity in the drug supply chain, is a lot more difficult to assess.
Read on for the day’s news.
AliveCor’s bloodless blood test gets an FDA green light. The FDA has given AliveCor’s test for the deadly blood disorder hyperkalemia a “breakthrough device” designation, likely foretelling the product’s ultimate approval. What’s unique about AliveCor’s device is that it’s able to suss out elevated potassium levels in the blood through remote electrocardiogram technology that harnesses neural networks and artificial intelligence—essentially allowing patients to detect that something might be wrong before consulting a doctor for follow-up. (TechCrunch)
Few explanations for opioid prescriptions. A sobering new study from the RAND Corporation finds that nearly 30% of opioid painkiller prescriptions in the U.S. lacked an actual, documented reason over a ten-year period. Of the 809 million scripts written for opioids over the study timeframe, about 5% were prescribed for cancer-related pain while more than 66% were prescribed for other kinds of pain, such as back injuries. The rest? A mystery. “If a doctor does not document a medical reason for prescribing an opioid, it could mean that the prescription is not clinically appropriate,” lead study author Dr. Tisamarie Sherry told CNN. “But it could also mean that the doctor simply missed recording the medical justification for an opioid, perhaps due to time constraints, clinic workflows or complicated documentation systems.” (CNN)
THE BIG PICTURE
Why do kids puke so much? NPR is out with a fascinating exploration of one of parenting’s eternal questions: Why do kids vomit all the time? Interestingly, vomiting may actually be akin to a hair-trigger response in children to a number of different stimuli—including stress and other related factors. That’s one of the reasons that kids seem to succumb to the upchuck much more than their parents, even though it’s a perfectly natural response in people of all ages. (NPR)
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