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Speed and ease with which new drugs receive FDA approval have many experts concerned

REUTERS/Jason Reed
Health reporter Julia Belluz reports drugs with “marginal benefits and potentially dangerous side effects have recently made it through the FDA.”

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? 

Health reporter Julia Belluz explores those questions in a measured and comprehensive article published last Friday on Vox.com.

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.

Comments (5)

  1. Submitted by Ray Schoch on 09/21/2015 - 11:17 am.

    Sadly, it’s no surprise

    …that the pendulum has likely swung back too far. Pharmaceutical companies don’t exist to make us healthier. They exist to make money, whether the products they produce have any real efficacy or not, and money spent on lobbying and faux “citizen” representatives at Congressional hearings is apparently money well-spent in the relatively long run. Years from now, if drug ‘x’ is finally ruled to be of no real medicinal value, the company that makes it, after vociferous protests, will quietly pocket the profits from producing it and go on to some other product. It’s just one of several facets of our health/medical industry that leaves much to be desired from both the ethical and the health care standpoint.

  2. Submitted by Bill Gleason on 09/21/2015 - 11:23 am.

    Doesn’t anyone remember

    thalidomide?

  3. Submitted by Dimitri Drekonja on 09/21/2015 - 01:05 pm.

    It’s appalling that people could speak in favor of a drug and deny relationships to the company; it seems like a 30-second fix would be to give people a form to fill out and sign that stated:
    -Whether they were a company employee or contractor
    -Who paid for their travel and meals to attend the meeting
    -Whether they had been asked by anyone to speak
    -Whether anyone “ghostwrote” their remarks

    Awful.

  4. Submitted by N Foust on 09/21/2015 - 01:42 pm.

    Invokana is a good example of this

    There were a large number of involved experts telling the FDA to not approve this class of drugs, that it was too risky. That was flatly ignored. Now the FDA is releasing repeated label warnings for these drugs.

    My husband was given Invokana and ended up so ill he could barely walk across the room. His doctor missed that this was a drug reaction for almost a month. Meanwhile they ran him through a ton of diagnostic tests including 3 different medical radiation exposures. They left him thinking for two weeks that he was having some sort of horrible cardiac issue. This ran up a huge medical bill.

    I finally convinced him to stop taking this stupid medication. He felt normal again after two days without it, problem solved. The FDA issued label warnings for exactly what happened to him just recently. They are releasing these drugs to the market and letting patients be their lab rats for adverse effects.

  5. Submitted by Rachel Kahler on 09/22/2015 - 09:04 am.

    Reasons

    At least some of the reasons for slowing down drug approval provided in this article aren’t terribly relevant. Whether a drug provides no new benefit over existing drug should have no weight on whether it is approved. As long as the drug is efficacious for its intended use and isn’t unnecessarily harmful, it should be approved. Just as bad, the system reduces access to relatively safe drugs through a tight grip on the approval and need for prescription.

    The author (and many others) also forgets that current rules place the burden of proving safety and efficacy in the hands of the drug company, not some independent (or government) testing company. It’s no wonder that the results are fudged sometimes–it’s amazing that they’re not completely fudged all the time! The approval process is not quick, despite the tone of the article, and includes lots of time and money before even reaching human testing at any level. All of this time and money comes out of the pocket of the drug company, whose overarching goal is to make money. It is in the company’s best interest to produce relatively safe drugs, but not necessarily absolutely safe drugs, even if it was possible.

    In addition, no drug is without risks–to claim that they should be is ridiculous. Even aspirin has side effects, including death in some people. The question is whether the side effects outweigh the benefits. As we get more understanding about how an individual’s genome might affect how they respond to medications, hopefully we’ll also be able to only prescribe the safest, most efficacious medication for each individual.

    Also, remember the “no benefit” thing over existing drugs? One of the reasons some drugs appear efficacious and safe during trials and then are shown to have an unanticipated negative side effect or reduced efficacy during regular use is because of the luck of the draw on the testing group vs. the general population. We are finding that there are old drugs that ARE efficacious and safe in the right people, maybe even most people, while another group reacts differently. In the meanwhile, because the approval process is mainly in the hands of the drug companies, who in the end want to sell as much of the drug as possible to more than recoup their costs, there is no incentive to identify which populations react in which way. Of course, it may be statistically impossible to do so in the test groups even if such incentive was there.

    As for thalidomide, there was little excuse for prescribing it to pregnant mothers. It should be noted that its use as a treatment for morning sickness was an off-label use, not one that was approved (Drs are allowed to do that to this day). Still, the company that made the drug advertised it as safe for pregnant mothers, probably without testing in pregnant subjects (the teratogenic effects of thalidomide are common to standard test species, including mice and rats). However, the tragedy of thalidomide is one of being the right drug for the wrong diagnosis. It turns out it has benefits after all as a treatment for cancer (multiple myeloma) and inflammation in tuberculosis patients.

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