Two decades on, consumers are still largely unaware of the persistent harm caused by Finasteride in clinical trials

New YouTube video breaks down the explosive findings from 2019 Reuters investigation.

For over two decades, consumers, clinicians and the general public have been misled about the safety of Finasteride, and its potential to cause persistent adverse effects in a subset of men.

That’s the focus of our latest YouTube video, part of an ongoing awareness campaign launched earlier this month. Headlined by our new podcast series, this campaign aims to bring the issue of Post-Finasteride Syndrome out of the shadows and firmly into the spotlight.

Persistent adverse effects reported by 7 subjects

The most significant finding from Reuters 2019 investigation was that at least one man, and potentially as many as seven, reported sexual dysfunction that persisted even after stopping Finasteride during Merck’s five-year clinical trials in the 1990’s.

Reuters’ investigation found that results from the study, which documented the experiences of 323 men over a five year period, had not been reported accurately or fairly to regulators. Rather than reporting the experiences of these men plainly and transparently, the drug manufacturer made a small but significant change to the warning label in 2002.

It changed the advice on side effects from “resolution of side effects occurred in all men following discontinuation of Propecia” to “resolution occurred in men following discontinuation of Propecia”.

With such deceitful and ambiguous phrasing, consumers cannot possibly decipher that resolution of side effects did not occur in every patient after stopping the drug during Merck’s five-year clinical trials.

Warning label “totally misleading” after “weeding out the dropouts”

While Merck’s 2002 change to the warning label was the most egregious transgression Reuters discovered, it also discovered major problems with how the drug manufacturer reported its adverse event data overall.

When the warning label was updated, it stated that among the 323 men who took the drug for five years, “the incidence of each type [of sexual side effect] decreased to no more than 0.3% by the fifth year of treatment.”

However, in internal company documents uncovered by Reuters, the clinical head of Propecia Dr Keith Kaufman told colleagues the 0.3% figure was “totally misleading” because, by the fifth year, “you have weeded out the dropouts with the sexual [adverse experiences]”.

The warning label remains the same today, even after Reuters’ investigation.

Reuters discovered that only the experiences of men who took the drug in the first and fifth year of the study were included on the drug’s warning label. It omitted data about men who dropped out of the study due to sexual side effects, or those who completed the study before the five year period. It is unknown what happened to those subjects.

According to Dr Jerry Avorn, a Harvard pharmacoepidemiologist, it is not “fair or standard practice” to selectively report results from a multi-year study because it “systematically underestimates the risk of any side effect”.

Put simply, it is impossible to tell what percentage of men actually experienced on-drug or persistent adverse effects during clinical trials.

Profits over patient safety

A deposition from Paul Howes, former VP of Marketing at Merck, showed that Merck knew sales from its new blockbuster drug would suffer drastically if consumers were aware it caused side effects which persisted even after discontinuation.

During his deposition, Howes confirmed at the time surveys found that 20% of men who knew about Propecia would never take the drug because they were concerned about on-drug side effects. There was no public knowledge the drug could cause side effects which persisted after discontinuation. He said that if the potential for persistent sexual dysfunction was known, sales would certainly take a hit.

He also confirmed at the time Merck had several key patents expiring on other drugs, and that Propecia would plug a significant revenue gap for its North American business.

This deposition is extremely important, as those who challenge the existence of Post-Finasteride Syndrome often claim it is a delusional disorder caused by stimulated reporting.

However, the experiences of the men reporting persistent dysfunction after discontinuation of Finasteride during clinical trials cannot be dismissed as psychosomatic, as there was no public knowledge or reporting of persistent side effects at the time.

Perpetuated for two decades

Almost 20 years on from the 2002 warning label change, practically nothing of significance has changed.

Alarmingly, consumers considering the drug, and clinicians prescribing it to their patients, are still dangerously unaware of significant harm caused by Finasteride in clinical trials over two decades ago. And despite significant adverse event reporting since, regulators have been dangerously absent in updating the drug’s safety advice. The same clinical trials data is still present on the label today.

An unfortunate consequence of this regulatory inaction is that those who challenge the existence of Post-Finasteride Syndrome often cite the drug’s clinical trials and warning label as proof there is no evidence of persistent side effects.

In fact, clinical trials demonstrated exactly the opposite.

This misleading data has now been perpetuated by hair loss doctors, companies and influencers for two decades, leaving potential consumers completely unaware they are playing a dangerous game of Russian Roulette with their health.

It is urgent that regulators begin taking adverse event reporting seriously, particularly as Finasteride’s popularity rapidly increases.

Upcoming research

In case you missed it, PFS Network recently announced a new research project slated to begin in early 2022 pending successful fundraising. The study, titled “Elucidating epigenetic mechanisms as a cause of Post-Finasteride Syndrome” will take place at The Institute for Human Genetics at the University Medical Center Schleswig-Holstein and will build upon the important results from Baylor College of Medicine.

We have already raised €35,000 of our €80,000 target, and we urgently encourage all patients and their families to contribute what they are able.

Thank you for your continued bravery,

PFS Network team