Companies Keep Deadly Information Sealed.
The courts help them do it.
The international news company, Reuters, has just found court documents that were accidentally revealed without full redactions. They show how court-sanctioned secrecy has become the lethal normal in product-liability litigation in the United States. Judges in large product-liability cases routinely seal evidence relevant to public health and safety. As a result, hundreds of thousands of Americans have been killed or seriously injured by allegedly defective products — cars, drugs, guns, medical devices — while evidence that could have alerted consumers and regulators to potential danger remained under seal.
The principle of open courts where the public is entitled to know what someone is accused of and entitled to know if they are found innocent is the bedrock of our system. Any American “knows” that our trials are open, and we instinctively know that this makes a difference between our government of the people and others where secret trials and secret evidence vanish people and facts. Of course, there are exceptions for national security and for a company’s trade secrets, but to invoke those exceptions, the courts are supposed to weigh the request for secrecy against the public’s interest in the facts to be hidden. That is not the way it works in practice involving big business.
The case that Reuters has unveiled involves what appears to be a serious side effects of Propecia, one of the largest drug company’s best selling drugs. Propecia treats male hair loss. Merck, with the cooperation of the lawyers in the case, kept drug testing information under seal. That testing and case reports appear to indicate that Propecia has a much greater effect on destroying male sexual function – that is, causing erectile dysfunction – and the effect lasts much longer after stopping the drug, than the public has been told. The story of the case begins when an otherwise healthy, successful, family man walked onto the railroad tracks into the path of a train, committing suicide. His widow watched him spiral into depression due to the effects of this medication. The story continues with a quote from a physician- a dermatology professor at Mount Sinai School of Medicine in New York, saying he would have been more cautious when prescribing the drug for young men: “I would have appreciated being apprised on this information earlier,” he said upon learning these facts from the Reuters investigator.
Now Propecia and its generic, finasteride, are still widely used. The generic was prescribed more than 1.6 million times in the US. Apparently, even Donald Trump has taken it. And the company notes that sexual dysfunction is listed on the insert as a possible side effect. But just from the FDA alone, there were about 5000 reports of sexual dysfunction or mental health problems with Propecia from 2009 to 2018, with hundreds of reports of suicidal thoughts, and about 50 reports of actual patient suicide. Merck has known from the beginning of these problems because just under 4% of hundreds of men in the original clinical trials experienced problems like erectile dysfunction or decreased sex drive. However, while the label has always warned of this, it also says the symptoms resolve in “all men” once they stop taking the drug. But Merck later revised its label to note that long term use did not result in the reversal of all symptoms in all men. In fact, the sealed documents appear to indicate that Merck simply did not report that 23 of men in the study group continued adverse symptoms in years up to the 5-year mark and omitted the information that 6 men dropped out because of the sexual side effects.
You may note that an investigation by regulators in Sweden reported that sexual dysfunction continued in men after they stopped taking the drug, and there, in Sweden, Merck changed Propecia’s label to warn of persistent erectile dysfunction. Not here. Reports of depression caused by the drug were added to the label in 2010, but not in a prominent location. You may also note that Merck argues that young men with premature hair loss already have low self-esteem and are just blaming the drug for suicidal thoughts they would have had anyhow. That we find to be insulting.
This note is not a comment on whether Propecia is good or bad. It is to emphasize how the courts have allowed information that can destroy the health and life of real people under seal. Sometimes, as here, it is only an accidental leak in the secrecy that lets us know anything.
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