Has the U.S. Food and Drug Administration (FDA) become too lax in its approval of new drugs? Is it, as many critics now claim, allowing drugs on the market too easily, and, as a result, undermining its ability to protect the public’s health?
This is a important — and timely — issue. Last July, the U.S. House of Representatives passed the 21st Century Cures Act, which, among other things, would allow drug companies to use evidence other than clinical trials — including case histories (the experience of individuals) — to support their claims of their drugs’ efficacy and safety. The legislation will be voted on by the Senate this fall. It is expected to pass.
When change was needed
As Belluz explains, “the FDA now oversees one of the speediest drug-approval processes in the world.” New drugs today are approved within six to 10 months, on average. That compared with about three years in 1975.
The process began to pick up pace in the 1980s, when AIDS activists pushed FDA officials to get then-experimental drugs to patients who were dying.
That lobbying saved many lives. “An HIV diagnosis is no longer a death sentence today, in part because those activists pushed the regulator to be less hidebound,” Belluz writes.
“But fast-forward 30 years, and many observers think the pendulum has swung too far in the opposite direction,” she says. “Instead of being too conservative, critics nowadays worry the FDA has become too lax. So far in 2015, the agency has approved a stunning 96 percent of drug applications considered. The big concern is that the FDA is waving through ineffective and potentially harmful drugs too quickly.”
One of those drugs, she notes, is the insomnia medication Belsomra. As Consumer Reports pointed out last summer, Belsomra is only marginally effective at best. Yet it has a very serious side effects: an increased risk of remaining extremely drowsy the next day and experiencing sleep paralysis or hallucinations, including while driving.
A ‘hijacked’ process
Belluz describes how the drug industry — with the aid of patient advocacy groups, which today are often funded by the drug industry — sometimes “hijacks” the drug-approval process. A well-publicized case in point: the FDA’s recent approval of flibanserin (“pink Vigara”), a drug purported to treat women’s sexual dysfunction.
A public meeting convened by the FDA last June sometimes “seemed more like a football match” than a sober examination of the scientific evidence regarding the drug’s effectiveness and potential side effects, says Belluz. There was “clapping, booing, and high-fiving” after the “tear-filled testimonials” of women and doctors who rose to speak in favor of the drug, she adds.
As one FDA official explained to Belluz, the FDA committee members “were really over-barreled.” They voted to approve the drug, even though 1) they had twice previously voted against approval (stating that the benefits of the drug did not outweigh its harms), and 2) no new evidence in favor of the drug had been presented.
The testimonials at the public hearing gave a very unbalanced view of the drug. Writes Belluz:
There were 38 members of the public who got up to speak. At least six were paid by Sprout [the company that developed flibanserin] to be there, according to the company. Still other attendees had either participated in the flibanserin clinical trials or worked with Sprout in other capacities. Some of the consumer groups that spoke, such as the National Consumers League, receive funding from the drug industry.
[These] potential conflicts of interests weren’t obvious from the meeting itself. Seventeen of those who didn’t disclose travel payments made statements like, “I have no financial stake in the outcome of this meeting.” But, oddly, that included at least two Sprout consultants and a Sprout advisory board member.
Gaming the system
“The pink Viagra case shows how sober scientific decisions about new medicines can now be gamed by savvy advocates, turned into emotive spectacles,” says Belluz.
And the problem does not just occur at public advisory meetings. “Experts think drug companies exert influence in all sorts of subtle ways — often in favor of lower standards and faster approvals,” she writes.
As a result, she adds, drugs with “marginal benefits and potentially dangerous side effects have recently made it through the FDA,” including Belsomra and the weight-loss drug Contrave.
Furthermore, most of the new drugs receiving approval aren’t really needed. As Belluz points out, research has shown that 85 to 90 percent of new drugs approved since the mid-1990s do not offer any clinical advantages for patients over existing drugs.
Pushing the pendulum back
The FDA needs to be efficient in its drug-approval process. No one wants to return to the days when it took three years to get a life-saving drug to people who need it. And — as the AIDS experience made only too clear — the public should have a say in that approval process.
But recent changes in the approval process “aren’t necessarily a win for patients,” writes Belluz.
“We’ve tipped the balance far away from rigor now, and patients will pay the price, because they will now become more and more unsure of what the drugs they put in their bodies are actually doing in the most essential sense,” explained Gregg Gonsalves, an AIDS activist and advocate and co-director of Yale University’s Global Health Justice Partnership, in an interview with Belluz.
Do the drugs we are being given “extend health and life?” That’s the question, said Gonsalves, that all of us must now ask.
You can read Belluz’s article on the Vox.com website.