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Morning Briefing

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Friday, May 31 2019

Full Issue

Those Drugs That Patients Are Shelling Out Thousands Of Dollars To Take May Not Even Be Doing Anything

Researchers recently looked at the efficacy of FDA-approved drugs and found that many of the pricey medications may be doing absolutely nothing for patients. In other pharmaceutical news: gender inequality in drug and medical trials, an experimental treatment never before tried in humans, and a look at upcoming cancer therapies.

It鈥檚 possible that the medicine you鈥檙e taking isn鈥檛 helping鈥攅ven if it鈥檚 been approved by the Food and Drug Administration. That鈥檚 the upshot of a pair of studies in the latest issue of JAMA Internal Medicine. Not good. As an invited commentary in the same issue says, 鈥淐harging vulnerable patients for drugs without evidence that they actually improve patients鈥 survival and quality of life is unconscionable.鈥 One study examines 93 cancer drug uses that were granted accelerated approval by the FDA between 1992 and 2017. Of those, only 19 showed improvement in overall survival. Another 39 showed improvement by a surrogate measure, such as tumor shrinkage. (Coy, 5/30)

Say you are prescribed medication for depression, anxiety or even just to sleep. Would you want to take it if you knew that the drug had only been tested on men and male animals? Rebecca Shansky, a neuroscientist at Northeastern University in Boston, thinks you might not. When she tells nonscientific audiences that researchers 鈥渇or the most part don鈥檛 study female animals, people are blown away,鈥 she said. She added: 鈥淚t seems like such an obvious thing to a normal person. But when you come up in the academic and science world, it鈥檚 like, 鈥極h no, females are so complicated, so we just don鈥檛 study them.鈥欌 (Klein, 5/30)

A family in Iowa believes the Food and Drug Administration will decide whether their only surviving daughter lives or dies, and they鈥檝e been on a monthslong crusade to break through its bureaucracy. And they鈥檙e succeeding. Just last week, the FDA gave Jaci Hermstad, a 25-year old Iowan who is dying from a rare form of ALS, an early sign that she will receive the first dose of an experimental drug never before tested in humans. The FDA鈥檚 move, which was confirmed to STAT by Jaci鈥檚 family and doctor, is a breakthrough for the Hermstads. (Florko, 5/31)

As a closely watched meeting of cancer researchers gets under way in Chicago on Friday 鈥 call it Woodstock for oncologists 鈥 a new analysis finds that more cancer therapies have been launched recently than ever before, an unprecedented amount of clinical development is underway, and the spending is rising at double-digit rates. Specifically, last year saw a record 15 new oncology treatments launched for 17 tumor types, the pipeline of drugs in late-stage development expanded by 19% in 2018 alone and 63% since 2013, and the mean cost for the new medications last year exceeded $175,500. This was less than $209,400 in 2017, but above the nearly $143,600 mean from 2012 to 2018. (Silverman, 5/30)

This is part of the Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.
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