“Merck understated the number of men who experienced sexual symptoms in clinical trials, and how long those symptoms lasted.”

“Merck understated the number of men who experienced sexual symptoms in clinical trials, and how long those symptoms lasted.”

Papers filed by US legal teams allege that Merck understated Propecia side effects during key clinical trials. Specifically, the number of patients who developed sexual symptoms whilst on Propecia – and how long those symptoms lasted after treatment. Other documents show that Merck knew two decades ago that Propecia sales would be hit if consumers learned of its potential impact on their health.

Reuters highlight the plight of Kelly Pfaff whose husband, John, tragically took his own life after developing severe side effects from Propecia. As part of her legal action, Kelly has refused to settle with Merck, instead seeking to get the rest of the currently-secret documents out into the open. “If I can save a family from losing their husband, if I could just save one, that would mean the world to me,” she told Reuters.

The papers accessed by Reuters were originally made available to plaintiff’s legal teams as part of a mass product liability trial ongoing in the US. The principles of American law, however, mean that such documents ought to be made public – in the interests of consumer safety. They are often kept secret in what Reuters describes as a practice of convenience between the courts and the parties’ lawyers. Reuters were only able to access certain papers due to mistakes in how they were administered. The rest of the information remains under seal – and hidden from public scrutiny.

The revelations have raised questions from the medical profession. Doctor Nelson Novick, a dermatology practitioner and professor at Mount Sinai School of Medicine, told Reuters that if he had known the additional information about the clinical trials, he would have been more cautious in prescribing it to patients. Novick went on to call for the courts to release the rest of the documents to the public.

Other medical professionals have voiced their concerns. Dr Michael Irwig, an endocrinology professor at George Washington University, has conducted detailed research on Propecia’s side effects. After reviewing the documents provided by Reuters, he noted that Merck’s statistics were made to “look much better” because men who dropped out of clinical trials were eliminated from their data. This reflects an overall lack of transparency regarding subjects who experienced sexual side effects, he explained.

A Harvard Medical School professor, Dr Jerry Avorn, also provided his thoughts to Reuters, after they asked him to review the documents. Like Irwig, Avorn also honed in on the data – stating that “it’s not fair or standard practice” to report results from only part of a multi-year study – because it systematically downplays the risk of any side effect.

Reuters are now seeking to uncover the rest of the documents filed during the product liability case. Judge Brian Cogan, presiding over the trial, was asked by Reuters why he chose to keep the court filings secret. In most US jurisdictions, judges are required to weigh up whether to permit confidentiality – and then to record the reasons behind their decision. Judge Cogan has issued no such explanation and has declined to give comment to Reuters.

The team at Propeciahelp.com is profoundly grateful to Kelly Pfaff.  For her relentless pursuit of open justice, for her determination to honour her late husband, and for the inspiration she has given to patients worldwide affected by Post-Finasteride Syndrome.  Propeciahelp.com have a lasting tribute to the life of John Pfaff on our In Memoriam page, and for others brought to our attention by families and the media.