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.
Bloomberg:
Too Many Medicines Simply Don’t Work
It’s possible that the medicine you’re taking isn’t helping—even if it’s been approved by the Food and Drug Administration. That’s 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, “Charging vulnerable patients for drugs without evidence that they actually improve patients’ survival and quality of life is unconscionable.” 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)
The New York Times:
Fighting The Gender Stereotypes That Warp Biomedical Research
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 “for the most part don’t study female animals, people are blown away,” she said. She added: “It seems like such an obvious thing to a normal person. But when you come up in the academic and science world, it’s like, ‘Oh no, females are so complicated, so we just don’t study them.’” (Klein, 5/30)
Stat:
Congress Wants A Single ALS Patient To Get A Therapy Never Tested In Humans
A family in Iowa believes the Food and Drug Administration will decide whether their only surviving daughter lives or dies, and they’ve been on a monthslong crusade to break through its bureaucracy. And they’re 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’s move, which was confirmed to STAT by Jaci’s family and doctor, is a breakthrough for the Hermstads. (Florko, 5/31)
Stat:
More New Cancer Therapies Are Being Launched, But Spending Soars
As a closely watched meeting of cancer researchers gets under way in Chicago on Friday — call it Woodstock for oncologists — 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)