The following is a guest post by Dr. Richard Hoffman, a long-time story reviewer who’s been helping us knock down inflated claims from drug and device companies for years. This time, he’s raising questions about the harms attributed to a drug and whether the messages about those harms are evidence-based. There are many forces that seek to shape and sometimes distort the media discussion about health; all of them are fair game for our blog and systematic reviews.
Many years ago I participated, for the first and only time, as a site investigator for a pharmaceutical study. The study was designed to evaluate the efficacy and tolerability of finasteride, marketed as Proscar, for treating men with symptomatic benign prostatic hyperplasia (BPH) in primary care settings (original studies showing clinical benefit were conducted in urology practices and enrolled only men with markedly enlarged prostate glands). Merck wanted to show that finasteride could be added to the “therapeutic armamentarium” of primary care physicians, thus expanding the use of their drug. Finasteride did reduce urinary symptom scores compared to placebo, though the statistically significant findings were of limited clinical importance. The discrepancy with the urology studies was likely because the primary care study enrolled men with relatively smaller prostate glands. Strikingly, drug use was associated with a 14% risk of sexual side effects, including erectile dysfunction, decreased libido, and ejaculation disorders. These findings are not surprising given that finasteride acts to reduce prostate size by blocking testosterone (which is why, marketed as Propecia, it is also used to treat male-pattern baldness). I’ve prescribed finasteride for many years to treat lower urinary tract symptoms in men with an enlarged prostate and routinely inform patients about the potential side effects.
Until recently, however, I had never heard of the “Post-Finasteride Syndrome” (PFS). I received an e-mailed advisory — essentially a news release — from Dr. John Santmann, described as an emergency medicine-trained physician and health informaticist, who is the CEO of the Post-Finasteride Syndrome Foundation. (The document emailed to me was nearly identical to this “Global Public Health Advisory” on the PFS Foundation website.) Santmann alerted me that PFS is a condition that “often has a life-altering impact on victims and their families, such as job loss and the breakup of marriages and romantic relationships, while also being linked to suicides.” The advisory was timed to coincide with the apparent addition of PFS to the NIH’s Genetics and Rare Diseases Information Center (GARD) and because a meta-analysis just published in JAMA Dermatology (not the more prestigious JAMA, as erroneously reported by the advisory) noted the seemingly biased and poor quality of reporting on the sexual adverse harms of low-dose finasteride for androgenic alopecia (male-pattern baldness).
This alert raises some interesting issues. The sexual adverse harms of finasteride for BPH are well documented; I was not aware of any long-term harms following discontinuation of the drug. The average age of men in the BPH treatment trials was about 65, so aging is also contributing to declining sexual function—thus confounding efforts to attribute harms to the medication. However, many of the men enrolled in the hair-loss trials were in their 20s or 30s. Hair loss is not exactly a life-threatening condition, and sexual dysfunction certainly adversely affects quality of life. Expecting more rigorous efforts to determine the incidence and severity of important side effects of pharmacotherapy is reasonable—a point raised by an editorialist of the meta-analysis.
Nonetheless, the advisory seems rather hyperbolic in admonishing physicians to be vigilantly looking out for “symptoms in adverse drug reaction reports, suicide post-mortems, suicide-prevention services, and other patient records” and to alert the general population of this newly recognized condition. These appeals strike me as uncomfortably reminiscent of late-night TV and billboard pitches for malpractice attorneys.
In highlighting the growing concerns about this condition, the Foundation cites ongoing studies at prominent institutions–implying that this has become a priority research issue. However, these studies were actually funded by the Foundation, in part to “help establish PFS as a bona fide condition.” An announcement describing one of these studies and providing patient recruitment details refers to those suffering from finasteride-related side effects as “victims.”
The NIH has also expressed concerned about the quality of media communications on this topic. The PFS Foundation advisory referenced above was headlined, “U.S. National Institutes of Health Recognizes Post-Finasteride Syndrome” — suggesting that the NIH had given its imprimatur to classify PFS as a rare disease. However, inquiries from HealthNewsReview.org suggest that the agency interprets things differently. Bobbi Gardner, a public affairs specialist at NIH, wrote that the purpose of the NIH Genetics and Rare Diseases Information Center is to distribute information about conditions or syndromes, “not to determine or proclaim something a rare disease.” She emphasized that the page has a primary name “Adverse events of 5-alpha-reductase inhibitors” and was added in response to an outside inquiry. “The statement by the Post Finasteride Foundation you referenced therefore is not accurate and was not determined by us,” she said.
Why is this important? While I applaud efforts to obtain better evidence about the possible side effects of finasteride and communicate that information to patients, the public discussion about this issue seems to be troublingly skewed toward worst-case scenarios and personal stories highlighting speculative harms of the drug. The JAMA Dermatology meta-analysis did not find any evidence for a life-altering impact of finasteride, just that studies consistently failed to provide sufficient data to adequately characterize the potential harms of the drug. And yet the media coverage of the topic, based on these individual stories, presents an extremely dire portrait.
Just as narratives driven by personal stories can lead to an exaggerated sense of the benefits of drugs and treatments — as we often point out in our story reviews — personal narratives about harm have the potential to distort the public discussion that we are consistently hoping to elevate. More accurate, evidence-based news releases can lead to more balanced and informative coverage of these types of issues.
Additional reporting for this post was contributed by Kevin Lomangino.