Ineffective Drugs Being Approved By the FDA

​​​A new study published in JAMA Internal Medicine found that over the past five years, approximately two-thirds of cancer drugs considered by the United States Food and Drug Administration (FDA) were approved without proof they improved health outcomes or extended the length of patients’ lives. Subsequent studies have shown that 86% of the drugs approved with “surrogate endpoints” (or measures) and approximately 57% of the cancer drugs approved by the FDA “have known effects on overall survival or fail to show gains in survival.”

Afinitor has been approved by the FDA five times in the past six years and has won approval for a new use each time. The drug is used to treat “breast and kidney cancer, a rare type of pancreatic tumor and two types of nonmalignant tumors.” Since Afinitor was first approved in 2009, and its subsequent expansion into the pool of potential users, there have been almost 9,000 reports of serious adverse reactions, including over 2,700 deaths and more than 3,100 hospitalizations. In the United States, the sales rose drastically from $110 million in 2007 to $803 million in 2014. Afinitor, like other cancer drugs on the market, was approved for its ability to slow the growth of tumors, which is considered a surrogate measure of its effectiveness, rather than its ability to improve survival rates.

Using surrogate endpoints is the key issue in the approval process. Pharmaceutical companies believe the alternative measures “permit smaller, cheaper and faster clinical trials, allowing desperately needed drugs to get to market faster.” Politicians, pharmaceutical companies, and advocacy groups pressured the FDA to allow shortcuts to make an easier and quicker pathway for drugs to be released onto the market. Allowing these shortcuts undermines the FDA’s responsibility to approve drugs that will treat people’s ailments and extend their lives. There is no physical proof that these lower standards actually extend someone’s life expectancy. The FDA has conducted studies that show a positive outcome on a surrogate measure may have no relation to the drug’s actual effectiveness. An FDA representative stated in an email, “[w]hile it is acknowledged that shrinking a tumor or preventing it from progressing may not be a direct measure of improvement in survival, symptoms or function, as the magnitude of that shrinkage or delay in growth increases, our confidence that the result is likely to predict clinical benefit increases.

Surrogate measures also do not result in lower drug prices once they are approved by the FDA. Rather, the drugs approved by the FDA averaged around $10,000 per month. Four of these drugs cost $20,000 per month and one even costs $40,000 per month. It seems counterproductive to charge these exorbitant prices for drugs that have little to no impact on the patient’s outcome. As a result of these studies, there are questions as to whether the FDA is deeply entrenched in the influence of pharmaceutical companies. As a correlation, the physicians unbiased prescribing of the ineffective medication to their patients is called into question of whether the pharmaceutical companies are placing undue influence on the physicians through their pharmaceutical representatives.

Kate Reynolds is currently a 2L at DePaul University College of Law. Ms. Reynolds completed her undergraduate degree at the University of Illinois Springfield. Ms. Reynolds wishes to pursue a career in Health Law after graduating in May of 2017.​​​