PFS Foundation Files Supplements to FDA Citizen Petition Seeking Finasteride’s Removal from the Market

Petition Supplement 2 refers exclusively to a Reuters report headlined Court let Merck hide secrets about a popular drug’s risks.

Published Sept. 11, 2019 after a yearlong investigation, the story by Dan Levine uncovered testimony by former Merck executives in the US Propecia litigation suggesting that the pharmaceutical giant downplayed the drug’s side effects during clinical trials. Specifically, Merck found evidence of persistent side effects in their original clinical trials for finasteride but failed to disclose such in their warning label.

Compounding this lack of transparency, the judge in the litigation, Brian Cogan, inexplicably allowed Merck and plaintiffs’ lawyers to keep information submitted in court confidential. As Levine, whose report also broke the news of our Citizen Petition, explained:

Some of these documents slipped through cracks in the wall of secrecy. One was inadvertently entered into the public record, staying in the open for a year before being sealed, but in the meantime, it made its way into an obscure public filing, where Reuters found it. The other was faultily redacted, making it possible for this reporter to read it.

Among those documents were depositions of Charlotte Merritt, who oversaw regulatory activity for Propecia, and Paul Howes, who headed up marketing for the prescription medication.

Merritt admitted that, in 2002, four years after Propecia came to market, Merck altered the drug’s label for sexual adverse events, from “resolution occurred in all men who discontinued therapy with Propecia” to “resolution occurred in men who discontinued therapy with Propecia.” Then she testified that Merck deleted the word “all” because of evidence from the clinical trials that adverse events did not clear up after patients quit the drug.

Howes admitted that Merck knew that warnings of sexual side effects, especially persistent to permanent side effects, would have negatively impacted Propecia sales.

A day after Levine’s story broke, Reuters filed a motion in US Federal Court to unseal all documents filed in the Propecia litigation. The largest news agency in the Western world argued that “This is a case of tremendous importance that has been sealed without on-the-record findings explaining that sealing. The First Amendment precludes such an outcome.”

Sixteen months later, on January 25, US Magistrate Judge Peggy Kuo approved Reuters’ motion, clearing the way to make public all the Merck documents in Propecia-related litigation.

In her decision, Kuo noted that Merck’s arguments for keeping the lid on those documents “are so weak that they would not overcome even a low presumption of access under the common law.”