Court let Merck hide secrets about baldness drug’s risks
DANGEROUS CONVENIENCE
Court secrecy has become pervasive even though, as a matter of law, court records are presumed to be public. Though exceptions can be made when national security, individual privacy or company trade secrets are at stake, the principle of open justice is rooted in American law. In most U.S. jurisdictions, judges are supposed to weigh a litigant’s request for secrecy against the broader public interest in being able to see the evidence, and they must explain on record any decision in favor of secrecy.
They rarely do. Secrecy is convenient — for judges concerned about efficiency, for corporate lawyers concerned about protecting their clients’ reputations, and for plaintiffs’ lawyers seeking speedy resolution for their clients.
The Propecia case in federal court in Brooklyn has followed this familiar pattern. Judge Cogan has, without explanation, allowed Merck and plaintiffs’ lawyers to keep information submitted in court confidential.
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. The contents of both are reported here for the first time, more than two years after the first was filed in Cogan’s court.
Had he known the additional information about Merck’s clinical trials, Nelson Novick, a dermatology professor at Mount Sinai School of Medicine in New York, said he would have been more cautious when prescribing the drug for young men. “I would have appreciated being apprised of this information earlier,” Novick said.
Novick said any medical information about Propecia still being kept secret in court should be unsealed. “It goes without saying that the more information a physician has, the more he can share with the patient and the more informed the decision-making process becomes,” Novick said.
Use of the drug remains widespread. It is now sold as Propecia and, since 2013, in generic versions under the chemical name finasteride. Last year alone, finasteride was prescribed for hair loss more than 1.6 million times in the United States, according to healthcare data company IQVIA. U.S. President Donald Trump has taken it, according to summaries of his past two annual physical exams.
From 2009 to 2018, the FDA received about 5,000 reports of sexual side effects or mental health side effects – and in many cases, both – occurring in men who took Propecia. Of those, about 350 reported suicidal thoughts, and about 50 said a patient committed suicide. The data do not show whether the symptoms resolved after stopping the drug.
Pfaff is among a small group of plaintiffs who haven’t accepted settlement offers from Merck. She said she is pursuing her lawsuit not just for monetary damages, but also to bring to the public’s attention anything Merck knows about mental health problems, particularly suicidal thoughts, that may be associated with Propecia. “If I can save a family from losing their husband, if I could just save one, that would mean the world to me,” she said.
Judge Cogan did not respond to questions about why he has allowed the court filings to remain secret.
RESOLVED IN ‘ALL MEN’
Merck developed finasteride in the 1980s. The drug reduces a testosteronerelated hormone in certain tissues, including skin and the prostate gland. Merck initially obtained FDA approval in 1992 to market finasteride in a five-milligram pill called Proscar to treat enlarged prostate. Five years later, the FDA approved a onemilligram version, which Merck named Propecia, to treat male pattern baldness.
From the beginning, Merck knew that Propecia could cause sexual dysfunction. In three clinical trials Merck conducted prior to receiving FDA approval of Propecia, 3.8% of the hundreds of men who took the drug experienced sexual side effects, including erectile dysfunction or decreased libido.
That result has appeared on Propecia’s label since the drug hit the market in 1997. The original label, based on a year of clinical trial results, also said the symptoms resolved in “all men” once they stopped taking the drug.
That’s a crucial point for doctors and patients when considering a drug for treating a cosmetic problem. Even a slight risk of sexual dysfunction could give some doctors pause, but they would be reassured if a patient could reverse the problem by no longer taking the pills, said Dr Jerry Avorn, a professor at Harvard Medical School.
The distinction was also important to Merck, according to a sealed document Reuters was able to review because it was filed publicly elsewhere. A 1999 internal marketing study cited in the document found that 40% of men who had heard of Propecia were aware of potential sexual side effects, and that such knowledge would prevent half of those men from taking it. The court document does not say how many men were surveyed.
The sealed document also cites a 2016 sworn deposition in which a plaintiffs’ lawyer asked former Merck marketing vice president Paul Howes: “So you knew internally that if these sexual adverse events were prolonged or lengthened or never went away, that that would be something that would impact sales in a negative way. Right?”
“Yes,” Howes said.
Howes, who held that marketing job from 1998 until 2001, declined to comment for this article.
RESEARCH SUBJECTS DROPPED
In 2002, more than four years after Propecia hit the market, Merck revised the drug’s label to reflect the results of a study that expanded upon two of the drug’s three original clinical trials. The original trials were one-year studies; the extended trials covered four additional years. All were conducted by Merck in the mid- to late 1990s.
The revised label retained the original label’s statement that 3.8% of the 945 men taking Propecia in the first year of research experienced sexual side effects. But the company added that, among the 323 men who took the drug for all five years of the extended study, “the incidence of each type [of sexual side effect] decreased to no more than 0.3% by the fifth year of treatment.”
A 60-page motion plaintiffs’ lawyers filed in Cogan’s court alleges that Merck’s 0.3% figure on the revised label underreports the number of men who experienced sexual side effects during the extended study. The passages of the motion pertaining to the study were redacted. However, Reuters was able to view the blacked-out material after copying it from a digital version of the motion and pasting it into a document in a different format.
The motion cites an email in which a Merck analyst tells executives that 23 men taking Propecia experienced sexual side effects during the final three years of the expanded study. That phase comprised 922 men who took the drug for varying lengths of time, according to a 2002 article Merck published in the European Journal of Dermatology.
The label, as revised in 2002, omits the experiences of nearly all of those men, reporting only on sexual dysfunction in men who took Propecia in the first year of research and in those who took it continuously for all five years. Merck didn’t include the experiences of men who finished the study before the fifth year or who were given placebo doses earlier in the study. The revised label also omitted information about six men who dropped out of the study during the final three years due to sexual side effects.
It is impossible from the numbers Merck has published to tell what percentage of men experienced sexual dysfunction over the full five years.
It is “not fair or standard practice” to report results from only a portion of a multi-year study because it systematically underestimates the risk of any side effect, said Avorn, the Harvard pharmacoepidemiologist who reviewed the court filing and Merck’s statements at Reuters’ request.
Before the 2002 label change, Dr Keith Kaufman, clinical head of Propecia, discussed different ways of interpreting clinical trial data, the plaintiffs’ court filing says. The 0.3% figure is “totally misleading” because, by the fifth year, “you have weeded out the dropouts with the sexual [adverse experiences],” the motion quotes him as saying. The legal filing does not specify who received Kaufman’s correspondence.
Kaufman referred Reuters’ questions to Merck, which said his remarks were unrelated to the language on the label. Merck said that he was referring to a flawed report submitted by an outside expert and that the company settled the litigation before it could provide proper context for Kaufman’s comments.
Plaintiffs’ lawyers filed Kaufman’s original correspondence in court under seal, and it thus cannot be viewed. Merck declined to waive its claims of confidentiality to share that filing and the Merck analyst’s memo with Reuters.
The redacted motion argues that Merck not only underreported the number of men who experienced sexual dysfunction while taking Propecia, but also concealed the duration of those problems. Citing the Merck analyst’s memo, the motion says that of the 23 study subjects who experienced sexual side effects during the last three years of the study, seven continued to experience symptoms when they completed it. The symptoms of nine others resolved after they stopped taking the drug, but the time it took was unknown, the motion says. And of the six men who dropped out of the study, it says, one still had symptoms at least 66 days after stopping treatment.