On September 17, an advisory panel for the FDA concluded that many of the inundating efforts to promote “low testosterone” treatment therapies by major pharmaceutical companies need to be reigned in. The advisory panel also concluded that additional warnings and studies need to be developed in order to evaluate and warn of the risk of heart attack and other cardiovascular injuries related to the use of testosterone therapies.
“The findings of the advisory panel further support what has been a concern for some time,” commented Christopher Paulos, an attorney with the Levin, Papantonio law firm who practices in the areas of mass torts and defective drug litigation. “So called ‘low-t’ drugs are being over-promoted and then over-prescribed for treating illness that they are not intended for, or even effective at treating and this conduct places patients at too great a risk for injury, especially when compared with the actual benefits of thee drugs.”
Unfortunately, the panel’s finding does not force a change on current prescription practices and has no legal mandate until the FDA chooses to adopt the recommendations of the panel. While the FDA often does follow the advisement of the panel, it is under no requirement to do so. Nevertheless, the overwhelming results of the panel’s voting statistics are hard for physicians and pharmaceutical companies, who’ve made billions from selling these drugs, to ignore.
Testosterone therapies have experienced a drastic increase in the number of prescriptions issued in the past several years. Often, these therapies are marketed as magical elixirs of youth that can restore the vitality of an aging man. “Low-T”, the moniker given to the supposed disease that many of these prescriptions are made to treat, has symptoms of decreased libido, fatigue, depression and decreased muscle mass – many of the common effects of aging.
Some companies are resistant to the idea of a link between the risk of cardiovascular problems with Low-T therapies. Pharmaceutical company AbbVie claimed that there was “no evidence of a causal relationship between testosterone replacement therapies and cardiovascular problems,” according to Reuters. Additional study, however, as the FDA panel advises, was not resisted by the company.
“Without knowing, for certain, the exact degree of risk associated with these therapies, drug companies are encouraging doctors and patients to make decisions without knowing all the facts,” Mr. Paulos added. “The world will be watching closely to see how future studies are designed so the companies who have an enormous financial interest in these efforts don’t stack the deck when it comes to the true safety of their products.”
