What Drug Companies Don't Tell You

The F.D.A.'s recent approval of a new drug, named Corlanor and developed by the drug and biotech company Agmen, may keep millions of Americans suffering from heart disease out of the hospital/

Whereas many "new" drugs released are basically the same as older medications, Corlanor actually does promise to have a different effect on its patients, those suffering from chronic heart failure. According to the New York Times, "the drug works by inhibiting what is known as the 'funny current' in the heart's natural pacemaker". Based on the study that won the drug the F.D.A.'s approval, the drug promises a reduction in risk [of hospitalization for heart failure] of 26 percent".

This sounds like fairly good news, but the problems lay in the way the study was conducted. First of all, it says in the New York Times article itself that the study was payed for by Servier, a french pharmaceutical company. Although Servier and Agmen may be different companies, this is still a tremendous conflict of interests because the companies have collaborated together in the past. Even if that wasn't the case, the study would still be inherently bias because, as I have learned from my Junior theme book, Our Daily Meds by Melody Petersen, drug companies that pay for studies tend to disproportionately favor the interest of the company. According to the book, one way that drug companies can make this happen is by requiring those who conduct the studies to test the drug against a placebo instead of against a competing drug or an older drug.

Interestingly enough, that is exactly what is done in the study that was cited in the New York Times. The article says that "[patients] were randomly assigned to take either the ivabradine [Corlanor] or a placebo. The obvious problem with this is that Corlanor is really being compared with nothing. Therefore, the "promising" results really only mean that taking this $4500 a year drug is better than nothing.

Corlanor has also shown signs of being unsafe in trials. The article states that cardiologists are "lukewarm" about the drug's approval in part because the it has been shown to drop heart rates "dangerously low" in some patients.

Based on the flawed studies and with its potential risks, should Corlanor have even been approved?Should the FDA hold companies like Agmen to higher standards?