Trelegy combines 3 medicines in 1 inhaler and boasts of its prowess as a treatment for COPD - chronic obstructive pulmonary disease. A company sponsored study superficially appears to lend support to this conclusion. Unfortunately looking beneath the headline suggests major questions exist about this horribly expensive product.
GSK sponsored, funded, designed and supported the study. Further potentially compromising the integrity of the investigation most of the authors received financial support from the company, and the lead author was an employee of the drug manufacturer. The study involved about 1200 locations in more than 35 countries ranging from Mexico to Russia, Ukraine, Colombia, Philippines and Peru in addition to several western nations. This widespread distribution of participants calls into question standardization and oversight.
Actually the study cast significant doubt its findings. While the study was designed to evaluate patients with COPD, it also appears to have included asthmatics. A large pool of patients recruited into the study were using inhaled steroids. For many the drug was abruptly discontinued which would be expected to precipitate flares in patients with asthma. According to an accompanying editorial in the New England Journal of Medicine, the study was designed to boost the likelihood of a favorable outcome for Trelegy.
Advertised as a treatment for anyone with COPD now also referred to as COLD - chronic obstructive lung disease - its use should be restricted to only those with the most recalcitrant disease. An international consortium combining talent from the World Health Organization and the National Institute of Health clearly sets the standard for treating COPD. They suggest triple therapy be limited to very advanced cases. Pneumonia is a relatively frequent complication of the inhaled steroid in Trelegy.
Further testifying to a lack of scruples at the company, they have resumed paying doctors to promote their medicines and attend meetings to speak as advocates for the company’s products. This reverses a policy to discontinue these dubious efforts announced in 2012 and supposedly fully implemented in 2016. Making matters more dicey, the company paid a $3,000,000,000.00 settlement to the United States government for failure to report safety issues and improperly promoting its drugs.
Does Trelegy provide sufficient advantages to warrant the cash price at a pharmacy of $627-$708 for a single inhaler? Sounds like the company may be up to its old tricks again.