Nearly a decade ago when I was living in the Bay area and receiving my medical care at Stanford Health, my urologist pulled a bait-and-switch on me. The urologist was monitoring me for complications relating to an enlarged prostate and was scheduled to see me after a pelvic scan and other tests. I was understandably taken aback when a physician assistant entered the exam room to discuss my results.
Virtually every male over 50 has an enlarged prostate, but mine was interfering with my urinary function, meaning I couldn’t properly void. The physician assistant advised that unless my prostate could be reduced in size, I would need surgery. She prescribed a drug called Finasteride.
I asked the PA about Finasteride’s risks and side effects, and she assured me there were none. I didn’t like the PA’s disregard for my concerns, so I researched them and quickly learned there were indeed some risks, including a so-called black box warning that Finasteride could possibly trigger a high-grade prostate cancer. At the time, I had a world-class primary care doctor who patiently walked me through the drug’s risks.
Although the statistical risk was small, studies had shown that Finasteride could potentially trigger a virulent prostate cancer that I likely wouldn’t survive if I was diagnosed with it. There were other possible side effects, including erectile dysfunction and loss of libido. I’ve long been wary of drugs and drug companies, and Finasteride’s risks in my mind outweighed the potential rewards. An enlarged prostate isn’t linked to cancer and there was no guarantee the drug would shrink mine regardless.
I opted not to take the drug. I’m counting my blessings that I didn’t.
Finasteride in a lower dose formulation is commonly known as Propecia, which the FDA approved in 1997 for the treatment of male-pattern hair loss. Turns out, the Propecia’s risks and side-effects are for more extensive and damaging than is commonly known – and the FDA for years turned a blind eye to those risks.
The Israeli publication Haaretz in September published an alarming story about Israeli men who have suffered severe side effects from taking Propecia, including chronic fatigue, erectile dysfunction, and depression resulting in suicidal ideation. Ronny Linder, the story’s author, did a remarkable job finding men willing to speak on the record about the suffering they claim to have endured after taking Finasteride. Linder’s expose was an impressive piece of investigative journalism, even more so when viewed in a broader context.
Linder’s colleague, columnist Yossi Melman, would be wise to read Linder’s feature, and brush up on how and why the FDA and the U.S. media ignored or downplayed safety warnings about Finasteride for years. Melman this week published a hatchet job on Professor Shmuel Shapira, the former head of the prestigious Institute for Biological Research, an arm of the Israeli military. Shapira, who is triple Covid vaccinated, has called on Israel to halt its vaccination program, warning that there is mounting evidence that Covid vaccine side effects are more serious and pervasive than have been publicly acknowledged.
Melman dismissed Shapira as a “delusional,” nut job who’s bitter because a Covid vaccine whose development Shapira was overseeing was terminated by the Netanyahu government. Melman claims his project showed great promise but was terminated because of “bureaucratic reasons.” An Israeli broadcast network interviewed Shapira, a video of which is embedded in this article. Shapira doesn’t strike me as a nut job, but to the credit of Israeli TV viewers are given an opportunity to make their own judgments.
Haaretz is a far-left publication, and Melman’s smear job on Shapira reminded me of some of the previous takedowns the far-left Atlantic published on U.S. critics warning about the safety and effectiveness of Pfizer’s and Moderna’s vaccines. The Atlantic figures into the Propecia story and serves as a cautionary tale about trusting the assessments of journalists working at publications with political agendas.
In 2012, Atlantic published this story ridiculing concerns about Propecia causing erectile dysfunction. Writer Lindsay Abrams blamed “anti-finasteride fanatics” for exaggerating the drug’s risks, arguing the sample size of cited research was too small to be relevant.
Among those taking issue with the Atlantic’s denigration of Finasteride critics was Ingerman & Horwitz, a Maryland-based personal injury law firm. In its rebuttal to Abrams’ article posted on the firm’s website, I&H noted that AdverseEvents, which it characterized as the leading resource for information on drug side effects, released a report earlier in 2012 identifying FDA approved medications that were most associated with causing brain-related side effects. By a wide margin, the top drug linked to side effects involving loss of libido was Propecia.
I&H quoted Professor P. Murali Doraiswamy, who the firm identified as Duke’s leading neuropsychiatric drug safety researcher, as saying this about the AdverseEvents report: “While the warning signals in this report don’t necessarily prove a causal relationship, they are often the first sign of such a link.”
As well, Doraiswamy warned, “It is critical for consumers and prescribers to be aware of such potentially adverse effects. Some of these side effects, such as loss of libido or amnesia, can have a devastating impact on a person’s quality of life.”
FDA decisions have a major impact on other country’s regulators, but that hasn’t been the case with Propecia.
According to I&H, the Swedish Medical Products Agency in 2009 concluded that Propecia could lead to permanent erectile dysfunction. Merck then changed the product label in other European countries to include a warning of permanent erectile dysfunction as an adverse reaction.
In the UK, Merck added this warning: “In addition, the following have been reported in post-marketing use; persistence of erectile dysfunction after discontinuation of treatment with Propecia; male breast cancer.”
In 2017, Bruce Horovitz of the respected and independent Kaiser Health News, published this column explaining why he wouldn’t take Propecia, even if he was compensated. Horovitz outlined the drug’s risks.
In February 2021, Reuters obtained court documents that revealed Merck, the company that developed Finasteride, and the FDA were aware of reports of men taking Propecia becoming suicidal but opted not to warn consumers of the risk in an update to the popular drug’s label. Reuters said the FDA had received more than 700 reports of suicide and suicidal thoughts among people taking Propecia or generic versions of the drug. Those included at least 100 deaths.
In the initial 14 years the drug was on the market, Reuters said the FDA received 34 such reports, including 10 deaths.
According to Public Citizen, European Medicines Agency required the addition of a warning about the risk of suicidal thoughts to the product labeling for the low-dose form of Finasteride in 2017. Health Canada took similar action in 2019.
“The FDA’s years long failure to mandate that Merck include such warnings in the drug’s U.S. product labeling is unconscionable and represents a dereliction of its duty to protect public health,” Public Citizen wrote in a March 2021 report.
Public Citizen, which publishes a newsletter called Worst Pills, Best Pills that I subscribe to and urge you to support, has long been critical of the FDA because the watchdog group claims the agency is too cozy with Big Pharma. Public Citizen was instrumental in getting the Inspector General for the U.S. Department of Health and Human Services to launch an investigation into the FDA’s controversial approval of the Biogen drug Aduhelm to treat Alzheimer’s.
Public Citizen alleged the FDA maintained an “inappropriate close collaboration with Biogen before and after the pharmaceutical company’s submission” of its Aduhelm drug application.
The Inspector General investigation hasn’t been completed, but a Congressional report into the FDA’s handling of the Biogen application released today concluded the FDA didn’t adhere to its own guidance and internal practices during the approval process for Aduhelm.
The Congressional report said the approval process was “rife with irregularities.”
The Wall Street Journal reported last week that multiple studies have conclusively proven that most widely used decongestants don’t work and credible doctors and researchers have called on the FDA to prohibit sales of the OTC drugs. The FDA told the researchers that it was reviewing the request but was unable to reach a decision because their petition “raises complex issues requiring extensive review and analysis.”
That was in 2016, and still no decision.
What troubles me most about the FDA were the resignations of Marion Gruber and Phil Krause, who trade publications said are among the world’s most respected experts on vaccines. Media reports said Gruber and Krause resigned because of undo political interference from the Biden Administration but there were no follow up stories. My previous commentary on the resignations of Gruber and Krause can be found here.
Vaccine experts quitting their FDA jobs in the midst of a pandemic is akin to Olympic athletes quitting in the midst of an Olympiad competition. The public should know the reasons Gruber and Krause resigned, and the politicos responsible should be held accountable.
Suffice to say, given the FDA’s poor record on drug safety, little wonder why the agency is no longer trusted by those in the know.