FDA Approves Drug that Kills 5 Times More than Placebo

Bedaquiline kills more than 5 times as many subjects as the placebo does, so what did the FDA do? If you think they’d ban it, you’ll be mistaken. They have approved it.

by Heidi Stevenson

Update: The FDA didn’t just grant Sirturo (bedaquiline) fast track status. It’s worse than that. They have skipped fast tracking and went straight to approval! Sure, they say it’s only for patients for whom there are no other treatments—but they conveniently skip the fact that the drug outright kills 5 times as many people as placebo.

Read Gaia Health’s prescient story about it:

Would you take a drug that trials have shown kills 5 times as many patients as a placebo simply because there are no other drugs to treat your condition? No? Apparently, the FDA thinks you have the wrong attitude, because they’re on the verge of fast-tracking a deadly tuberculosis drug with precisely that same danger.

In its favor, there is no other drug for multi-drug resistant tuberculosis. Does that convince you to take it?

Also in its favor, the drug meets the endpoint defined by the studies. Now are you convinced to give it a try?

Those are the reasons cited by the FDA’s advisory committee for placing bedaquiline on fast track approval. Seriously!

FDA Advisory Group Meeting

On 28 November 2012, and FDA Anti-Infective Drugs Advisory Committee met to discuss whether to recommend fast track approval for Janssen Therapeutics’ drug bedaquiline, which they plan to sell as Sirturo. They discussed two phase 2 trials. The goal of the trials was to demonstrate that a particular endpoint could be met.

The endpoint in question was inhibition of adenosine triphosphate (ATP) synthase, a necessary substance in cellular energy production, though their goal was ATP synthase in Multiple Drug Resistant (MDR) tuberculosis. Just how they proposed it would affect only the tuberculosis bacteria, and not energy production in human cells, was left unsaid.

As it turns out, the studies demonstrated that the desired endpoint of ATP synthase suppression was met. However, it was at the expense of the patients. Out of 79 subjects who took bedaquiline, 10 died. Of the 81 who took placebo, 2 died.

A full five times as many who took Janssen’s drug died. The obvious conclusion of the advisory committee was, of course to strongly advice an immediate ban of the drug … ummm, recommend giving bedaquiline fast track approval.

Endpoint Insanity

Statistics can be tricky, but when it comes to selecting an endpoint that, by definition, means there will be serious damage, then no trials should be allowed for it. In the case of bedaquiline, the endpoint of ATP synthase suppression is obviously insane. ATP is necessary to life. It’s the energy our cells produce to allow us to live. Anything that could interfere with the process is clearly harmful.

Therefore, it shouldn’t be a surprise that bedaquiline is a killer. But, the FDA’s advisory committee focused solely on the drug meeting this idiotic endpoint to decide that fast track approval should be granted. That such an endpoint is, on its face, absurd, was ignored. So, I suppose it should come as no surprise that the fact that Janssen’s tuberculosis drug kills five times as many people as a placebo was completely ignored, too.

According to Pharmalot, one of the reviewers did note that the death was “concerning”. However, even that reviewer voted to recommend fast-tracking bedaquiline. We know that because the 18 members of the Anti-Infective Drugs Advisory Committee voted unanimously to recommend fast-tracking!

Apparently, their excuse is that they couldn’t figure out the specific mechanism of death. Therefore, those people who died can simply be ignored.

The Next Step

The FDA tends to overrule its committees only when they choose a conservative route. If they suggest that something not be approved, there’s a good chance that the FDA will ignore them. But when an advisory committee recommends moving full steam ahead … well, that’s like eliminating the brakes from the FDA train as it heads down a mile-long downward slope.

The fact that even a single person at the FDA can simply ignore a death rate 5 times greater than placebo is jaw-droppingly stunning. One would have expected such a person to be fired and marched off the agency’s site. Instead, though, such people are who the FDA wants on staff.

So the next step will most likely be the FDA’s formal approval to place bedaquiline on the fast track. Then, they’ll do yet another even bigger study placing ever more people at risk of death from their poison.

Is there a chance that the FDA will stop this insanity? I suppose so—about as much chance as a snowball has in hell.

Sources:

• Anti-Infective Drugs Advisory Committee Meeting November 28, 2012
• Will FDA Grant Accelerated Approval To J&J TB Drug?
• FDA Advisory Committee recommends accelerated approval of bedaquiline for drug-resistant TB
• FDA Panel Endorses Novel Tuberculosis Drug
• Anti-Infective Drugs Advisory Committee Meeting Briefing Document TMC207 (bedaquiline) Treatment of Patients with MDR-TB
• Bedaquiline: Drug-Resistant Tuberculosis Drug Backed By FDA Panel

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