According to a study in the Journal of the American Medical Association (JAMA), of the 222 drugs that were approved by the Food and Drug Administration (FDA) from 2000 to 2010, 71 later merited additional warnings. These notifications included 61 “black box warnings”, a label on the package indicating the drug in question had potentially dangerous side effects. The black box warning is the strongest warning the FDA can assign a drug.
One of the study’s authors, Dr. Joseph Ross, a Yale School of Medicine Associate Professor, stressed that in recent years, there has been pressure for the FDA to approve drugs more quickly. In contrast, the governmental approval process for such drugs in Europe is much slower.
Dr. Ross notes, “While the administration pushes for less regulation and faster approvals, those decisions have consequences.” He further warns, “It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up.”
Two Out of Three Ain’t Bad?
The path from initial research and development to a pharmacy shelf isn’t short for most prescription drugs — it can take 12 years on average. In addition, of 5,000 drugs initially developed by drug companies, only five will be allowed to be tested on human subjects, and only one will be approved by the FDA.
Drug companies conduct in-house studies, then send those results to the FDA with an application for review. Following that approval, the company can start trials to determine the drug’s efficacy and possible side effects on human patients. A majority of these studies are extremely limited in scope. They do not collect data from patients for more than six months, and tend to involve less than 1,000 individuals.
Over the past three decades, the FDA has been vetting drugs for the market more rapidly than in previous years. This “fast track” approval process started in 1988, and four years later an “accelerated approval” status was created for drugs that were meant to treat serious or terminal illnesses. Notably, some of the drugs that were revealed to have additional safety risks were ones that had been fast-tracked.
Meanwhile, President Trump has promised to make that process even quicker for pharmaceutical companies. The question we must ask is this: How does this rush to the marketplace compromise our safety as consumers, and just how many risks we are willing to (literally) swallow?
Wait Six Months and Call Me in the Morning…
Importantly, this study brings to light that many long-term effects of a drug may not be known when it starts to be prescribed. Dr. Nicholas Downing, an author of the study who works at Brigham and Women’s Hospital in the Department of Medicine, explains the limitations of the approval process:
“At a certain point, the FDA has to draw a line and say enough is known about the safety of a new drug to put it on the market. But that doesn’t mean we know everything about a new drug.”
This uncertainty shifts the burden onto doctors and patients deciding whether to prescribe or take a new drug, since they are essentially part of a continuing “study.”
Dr. Downing emphasizes that physicians have a responsibility to explain that while trying newly available drugs may have benefits, there can be hidden risks. He notes, “Everybody involved in drug development needs to commit to learning about them throughout the life cycle of the drug. Research doesn’t end at the point of FDA approval.”
Commenting on the results of this study and the FDA review process, an agency spokesperson said:
“FDA performs post-market monitoring to identify new safety information that may impact product labeling. In general, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”
Life-Savers vs. Lab Specimens
After the expensive research and development process, it is obvious that drug companies want new medications to be put on the market quickly, before all the dangers may be known. The biggest question is: How much risk do consumers want to assume when they take a new drug? Further, how much can any patient or doctor know about the extent of the risk? The answer after a six-month trial study: not much.
It is up to consumers to be as educated and proactive as possible regarding the medications they choose to take, and to realize there are flaws in the approval process. This may mean forgoing newer medications for more time-tested options, if the potential for harmful side effects seems too great.
In the end, our lessons as consumers are these:
- Big Pharma does not have your back. They’re more interested in your wallet.
- “Approved” is not synonymous with “entirely safe and effective.”
Perhaps we should consider a longer rather than a shorter drug approval process. Just a thought.