The prominent medical journal PLOSOne elevated interest in testosterone treatment products and their cardiac side effects in a way that no study had done before. And one of its editors believes the reason why is simple: access to the study is free and open to the public.
Reaction to PLOSOne’s study was immediate. The U.S. Food and Drug Administration launched an investigation.
In a recent blog post, Michelle Dohm, associate editor of PLOSOne, noted the publicity the study received has caused the public to have a heightened awareness of testosterone product side effects, as well as other possible side effects of other medications. The study was published in January.
The research indicated that men are twice as likely to have a heart attack on testosterone products if they are under the age of 65 if they have pre-existing heart disease, but are susceptible regardless if they are 65 or over. Researchers analyzed data from more than 55,000 men who received low testosterone treatment prescriptions, and compared them to men who received a prescription for an erectile dysfunction drug. Researchers concluded that taking testosterone therapy products may increase the overall risk of heart attack by 36 percent, but the risk was substantially higher among men over the age of 65 and those with a history of heart disease.
Overview of Testosterone Treatment Complications
The testosterone risk study was available for free and for anybody to read online, resulting in an “atypical trajectory post-publication.” Days after the study was released, the FDA announced it would be investigating the safety of testosterone therapy drugs and evaluating whether additional warnings are needed.
“Rather than gaining traction first in the media, riding a flurry of social media activity, and then eventually attracting the attention of health regulators, immediate action was taken by the FDA within days of publication. Concurrently, the article received an explosion of media coverage within a week post-publication in the New York Times: Well Blog, NPR-Health News, and The Wall Street Journal MarketWatch, among others, and was continuing to receive coverage in the BBC News and NPR as late as April 2014,” Dohm notes in the post.
Dohm started investigating why the article had so much impact, particularly considering that the study had been a continuation of an earlier study published in JAMA, and that numerous other studies had been published about the same issue. After analyzing the reaction to these other studies, Dohm theorized that the reaction to PLOSOne’s version was based on concern about low testosterone among men and because the article was free to access while most research papers are not.
“[T]he value of this article may not be strictly in its views, shares, citations, or even saves, or any combination or calculation thereof, but instead in its open access visibility to the public, healthcare providers, federal agencies, and media outlets,” Dohm wrote. “Anyone, anywhere in the world with Internet access can read this article and its surrounding discussion and then decided for themselves how to respond and react. and that alone is worth more than any level of metrics combined.”
In general, testosterone product lawsuits are filed individually by each plaintiff and are not class actions.
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