Merck Knew About Suicides Linked To Propecia But Didn’t Update Label, Unsealed Documents Show
Internal records were made public in late January after a 2019 Reuters motion to unseal 11 documents. A 2011 update of the popular anti-baldness treatment's label didn't include a warning about suicidal behavior even though the FDA had by then received reports of 10 suicides. Since 2011, the FDA has received reports of another 100 deaths linked to the drug.
Reuters:
Exclusive: Merck Anti-Baldness Drug Propecia Has Long Trail Of Suicide Reports, Records Show
Newly unsealed court documents and other records show that Merck & Co and U.S. regulators knew about reports of suicidal behavior in men taking the company’s anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label. Internal records from Merck were made public in late January, when a federal magistrate in Brooklyn, New York, granted a 2019 Reuters motion to unseal 11 documents filed in years of litigation alleging Propecia caused persistent sexual dysfunction and other harmful side effects. (Levine and Terhune, 2/3)
AP:
Merck Loses $2.1B In Q4; Longtime CEO Frazier To Retire
Merck posted a big fourth-quarter loss due to a hefty charge and much higher spending on research, production and overhead. The company also announced Ken Frazier, its longtime chief executive, will retire on July 1. Frazier, Merck’s CEO for the past decade, will be replaced by Rob Davis, the chief financial officer, the company said Thursday. Frazier will become executive chairman of the board during a transition period. (2/4)
And McKinsey has agreed to a settlement related to its role in the opioid crisis —
The New York Times:
McKinsey Settles For $573 Million Over Role In Opioid Crisis
McKinsey’s extensive work with Purdue included advising it to focus on selling lucrative high-dose pills, the documents show, even after the drugmaker pleaded guilty in 2007 to federal criminal charges that it had misled doctors and regulators about OxyContin’s risks. The firm also told Purdue that it could “band together” with other opioid makers to head off “strict treatment” by the Food and Drug Administration. The consulting firm will not admit wrongdoing in the settlement, to be filed in state courts on Thursday, but it will agree to court-ordered restrictions on its work with some types of addictive narcotics, according to those familiar with the arrangement. McKinsey will also retain emails for five years and disclose potential conflicts of interest when bidding for state contracts. And in a move similar to the tobacco industry settlements decades ago, it will put tens of thousands of pages of documents related to its opioid work onto a publicly available database. (Forsythe and Bogdanich, 2/3)
In other pharmaceutical industry news —
Stat:
Jazz Pharma To Acquire GW Pharma, Maker Of CBD-Based Treatment
Jazz Pharmaceuticals said Wednesday that it is acquiring GW Pharma, adding an approved childhood epilepsy medicine derived from marijuana to its stable of neuroscience products. (Feuerstein, 2/3)
