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The findings of a new review suggest that the clinical trials used to obtain approval for the male pattern baldness drug Propecia appear to have been “systematically biased,” failing to adequately report instances of sexual complications on Propecia.
Researchers from Chicago’s Northwestern University Feinberg School of Medicine raise questions about the validity of the Propecia clinical trials after conducting their own analysis of the reporting of safety and adverse events.
According to a report published by the medical journal JAMA Dermatology on April 1, the majority of the trials appear to be of poor quality and were heavily influenced by the manufacturer of Propecia
The study looked at 34 clinical trials and two meta-analyses, and found a disturbing trend in underreporting of potential Propecia side effects and poor safety reporting procedures.
“Of 34 studies, none met the criteria…for adequate safety reporting,” the researchers noted. “Most provided no description of the duration or severity of signs or symptoms of sexual dysfunction and failed to distinguish between mild, reversible sexual dysfunction and severe, permanent sexual dysfunction.”
Propecia (finasteride) is a prescription medication marketed by Merck to help men restore natural hair loss that occurs with male pattern baldness.
While men generally take the medication to help improve their appearance and overall quality of life, the drug maker now faces a number of Propecia lawsuits have been filed by men who allege that they have been left with permanent sexual complications, such as erectile dysfunction, decreased libido, genital shrinkage and problems with cognition.
Propecia was originally developed by Merck as an enlarged prostate treatment and marketed as Proscar in 1992. It was later approved to treat male pattern baldness, when it was given the name Propecia.
This latest study raises questions about the quality of the clinical trials that were given to the FDA as the basis for using the drug to treat adrogenic alopecia (AGA), also known as male pattern baldness. The researchers found that none of the 34 clinical trials reviewed had adequate safety reporting.
Only 19 had partially adequate safety reporting, while 12 had inadequate safety reporting and three claimed that there were no adverse events during the clinical trials. More than 53% of the articles had authors with a conflict of interest, and 56% were funded by the manufacturer. However, 12 articles, or 35% never disclosed who actually funded their study.
The study also found that 26 of the 34 studies only evaluated the effects of the drug for a year or less, and that only 31% of the men involved in the clinical trials actually met the inclusion critera for the trials the manufacturer used for the drug’s approval.
“Available toxicity information from clinical trials of finasteride in men with AGA is very limited, is of poor quality, and seems to be systematically biased,” the researchers determined. “Published reports of clinical trials provide insufficient information to establish the safety profile for finasteride in the treatment of AGA.”
There are currently more than 1,100 product liability lawsuits pending against Merck in state and federal courts nationwide, which all allege that men suffered severe and often permanent sexual problems after using Propecia.
Since April 2012, the federal Propecia cases have been centralized before U.S. District Judge John Gleeson in the Eastern District of New York, as part of a multidistrict litigation (MDL).
According to allegations raised in the complaints, Merck has failed to adequately warn consumers or the medical community about the link between Propecia and sexual dysfunction, which may continue long after the medication is no longer used.
Prior warning information provided by the drug maker suggested that sexual dysfunction associated with the medication was rare, and that the problems resolve after use of the medication is discontinued.
Even after many men reported experiencing permanent sexual issues after Propecia use, Merck continued to provide information suggesting that the problems were temporary until the Propecia warning label was updated in April 2012.