According to a story from PBS, the FDA has been approving new treatments at a noticeably faster rate than it has in the past. As a result, it appears that the agency is beginning to not fulfill its duty to determine whether experimental treatments are effective and safe for public use. A flurry of new reports suggest that some of the drugs gaining approval either provide minimal benefit or have pronounced side effects that are putting patient’s lives in danger.
Dangerous Drugs?
Some examples include the treatment Nuplazid, designed to control hallucinations and delusions that can occur with Parkinson’s disease. The drug failed two clinical trials, but after changing the endpoints of the trial design, it passed the third one. The drug displayed minimal benefit and the drug increased mortality and side effects compared to those that had not taken the drug. Folotyn, designed to treat rare blood cancer, got accelerated approval from the FDA but was entirely rejected in Europe. While the drug could shrink some tumors, it failed to actually demonstrate real benefits for survival.
The Industry’s Best Friend
Indeed, the situation at the FDA over the past few decades has grown consistently more precarious. To many outside observers, the agency has become too closely intertwined with the pharmaceutical industry, such as in 1992, when companies and patient groups began to directly contribute to the salaries of drug reviewers. The conflict of interest is shamelessly blatant. No one in the agency gets promoted unless they have ties with the industry; in fact, holding a job there at all is out of the question without being pro-industry.
Rare Disease Drug Incentives Are a Double-Edged Sword
Facing strong pressure both from industry and patient groups, the agency has steadily introduced new mechanisms for faster drug approvals. Designations such as Orphan Drug, Fast Track, and Breakthrough Therapy all make it easier for pharma companies to skip regulatory hurdles, even while these designations also provide important incentives to encourage the development of drugs for rare diseases. In the field of rare diseases, where treatments are few and far between, many patient groups are willing to accept more uncertainty. Expedited reviews mean fewer trials in order to demonstrate safety and effectiveness.
No Fear of Rejection
Less than 20 percent of applications were given outright rejection from the FDA in 2017. Researchers have also long debated the need for changes to the design of clinical trials, but sometimes these changes can be manipulated to make a drug seem more useful than it actually is in reality.
While the FDA will never be perfect, there is a clear need for more balance to be struck. Long review times in the past, which sometimes took several years, has led to a barrage of criticism that encouraged the agency to move more quickly, but now the momentum seems to have swung too far the other way. The agency must rid itself of industry influence so that drugs that get approved are safe and make a significant difference.
