Could you be taking a risky drug that was approved too soon?
On paper, it certainly sounds reasonable: The FDA should be allowed to “fast-track” drugs that fill an “unmet medical need,” especially ones for life-threatening illnesses.
In real life, however, this “accelerated approval” process has turned into one of the best money-making schemes around for Big Pharma.
It allows drugmakers to submit applications based on flimsy evidence, get super-speedy approvals, and have more time to sell these drugs exclusively, so they can make as much money as possible off of them.
But these fast-tracked drugs can put patients at an even bigger risk of suffering potentially deadly consequences from meds that are approved without much more than a wink and a nod to go on.
Too fast for comfort
The fast-tracked drug Northera — prescribed to patients who have blood pressure that drops too low after standing up, making them lightheaded or dizzy — got out of the FDA’s well-oiled door a mere six months after its maker submitted the application for it.
But surprise! After only two years on the market, it landed on the FDA’s list of meds that have “Potential Signals of Serious Risks.”
In this case, Northera does its job in raising blood pressure so well that the FDA is now warning it can cause you to have a stroke. And the agency found out that little tidbit not from studies done by the drugmaker, but from adverse events submitted to the FDA from patients and doctors!
Unfortunately, “too many doctors just ‘go with the flow’ rather than demanding high-quality evidence about what they’re prescribing.”
That would be a strong statement from any drug expert. But considering it comes straight from professor of medicine and former FDA Commissioner Dr. Robert Califf, it’s even more meaningful.
After all, who knows more about drug approvals at the FDA than a guy who once was in charge?
Dr. Califf made that comment in response to a frightening new study from doctors out of Harvard Medical School that just appeared in JAMA. The researchers followed 22 drugs that got accelerated approvals from the FDA between 2009 and 2013, 19 of which are to treat cancer.
That process allows drugmakers to submit “weaker-than-usual” evidence about the benefits of a med and promises them a fast-track approval, so they zoom out of the FDA and into your doctor’s office at the speed of light.
So what do drugmakers have to do in exchange for all those perks? As senior author of this study, Dr. Aaron Kesselheim called it, “there’s sort of a bargain at work.”
It’s a bargain, however, that Big Pharma has no apparent interest in keeping.
The FDA “requires” follow-up studies about the risks and benefits of these meds three years after they’ve been in use, but Dr. Kesselheim and his team at Harvard discovered that only half of those post-marketing studies had been submitted for the drugs they examined. On top of that, over 40 percent of the studies that actually did get done and sent to the FDA consisted of the same weak evidence that was submitted the first time around.
As one expert at Yale commented, that leaves both doctors and patients with no reliable research available to “figure out just how safe and effective” these drugs are.
Obviously, there’s a big problem here.
Fast-tracked meds are hitting the market all the time. In fact, the FDA has to update its list of accelerated drug approvals twice a year! So… how do you know if you’re being prescribed one?
You won’t find that information on a pill bottle or even that book-length label.
Perhaps the best advice is from Dr. Califf. He said that patients should ask their doctors when getting an Rx about what the “evidence” is showing that drug actually works and is safe.
And if your doctor is clueless, maybe it’s time to find one who reads up on meds before prescribing them, instead of just jumping on the bandwagon with the latest drug on the market.
“Flimsy evidence behind many FDA approvals” Reuters, August 15, 2017, reuters.com
