Earlier this year, the death of a participant in a French drug trial made headlines worldwide. There was public outcry across Europe and even in the U.S. The world called for more stringent rules and more oversight. The trial was halted. And it stayed halted.
What didn’t make worldwide headlines — what actually barely made a blip on the radar outside of pharma-stock articles — was the U.S. drug trial that had killed someone a couple of months previously. This trial was “partially” halted. The FDA didn’t feel that one death was enough of a reason to really stop testing, however, and it took a second death and a slew of “adverse events” for them to stop the trial completely.
Now the drug manufacturer, Zafgen, is waving data showing the drug’s effectiveness — in spite of the fact that it kills people — under the FDA’s nose and pressuring them to allow the trial to resume.
And the FDA is probably going to cave in.
I have to ask: Where is the outrage over this? Where are the scathing news headlines? Where is the call for more safety testing, more oversight, more protection for the end consumer? What on earth are we doing here? If there was ever any question that Big Pharma has no concern whatever for patients, or that the FDA is anything more than the lapdog of Big Pharma, this story answers it nicely. When Pharma says, “Jump!” the FDA asks, “How high?” and that’s all there is to it.
Dying to lose weight
The drug in question is called Beloranib. It’s intended to treat Prader-Willi syndrome, a form of obesity caused by a defective gene. Once it was approved for that, the manufacturer intended to get it approved to treat regular garden-variety obesity too — which is where the money is. The drug was in Stage III trials when the deaths occurred.
Now, this is a completely different story than the French one that caused so much gnashing of teeth and wringing of hands. The French trial was only a Phase I trial. Its entire goal was to determine whether or not the drug in question was safe. Obviously, it wasn’t.
The Zafgen trial, however, was a Stage III trial. At this point, a drug is supposed to already have been shown to be safe. The stage III trial is intended to address what dosage is most effective and similar issues. But somehow, someone missed the fact that this drug causes blood clots in the lungs. Or at least they hid the information. Zafgen is currently embroiled in several class action lawsuits that claim they withheld data linking beloranib to blood clots.
In October, the first person died. Several others also had “adverse events” involving blood clots.
The FDA “partially halted” the trial at this point but allowed testing to continue with more stringent screening and safety guidelines. Then in December another person died of a blood clot in the lungs, and more had “adverse events.” Altogether, out of 400 people taking the drug, two died and X had “serious adverse events” involving blood clots. And at the rate of one person every other month, who knows how high the likelihood of death would have grown if the trial had continued? A 1 in 400 chance of dying, and a X in 400 likelihood of developing a serious blood clot doesn’t sound very reassuring.
To put it in perspective, you’re more likely to die from taking this drug than you are to die in a car crash if you’re a passenger and not the driver. I don’t know about you, but considering Big Pharma’s track record, that sounds like the next blockbuster drug to me.
Unbelievable: the news sites are only talking about how effective this drug is
The FDA finally shut the trial down completely in December, after the second person died. Since then, Zafgen has been busily analyzing the data and writing up papers. Are they talking about the people who died? Of course not.
According to Zafgen, the trial was successful and the drug is effective. They claim that it met its goal, which was to reduce weight in people with Prader-Willi syndrome. How much weight was lost, however, seems to depend on what news outlet they’re talking to. According to Fierce Biotech, they say patients lost 5.3% of their body weight at a high dose and 4.05% at a low dose. But if that doesn’t sound like a big enough reduction to risk your life for, that’s ok.
They told BioPharma DIVE that the numbers were 9.45% and 8.2%. The number changed again when CNBC — coincidentally, the news outlet with the biggest readership — reported the story. According to CNBC, high-dose patients lost an amazing 13.5% of their weight while low-dose users lost 12.7%. Unbelievably, most news outlets are focusing on these magic numbers and not on the fact that people died or had serious blood clots.
Keep in mind that the French trial, which was specifically intended to test safety, is still in the news, and not in a good way. Zafgen’s deaths, however, which occurred in the U.S. at the hands of a U.S. drug maker, are simply being glossed over.
Using the weight-loss data, Zafgen is petitioning the FDA to let them continue testing this killer drug. They claim they’ll take more safety precautions. They say that people with Prader-Willi may just be more prone to blood clots. They’re saying anything they must in order to get this drug approved. According to one company spokesman:
“This is by no means an unusual situation, nor is it one that would keep us from having a commercially viable product. It’s just something that requires some discussion.”
And there you have it. Straight from the horse’s mouth. Just because a few people died is no reason to keep it off the market, according to Big Pharma.
Zafgen is currently negotiating with the FDA using its ever-changing weight-loss figures as ammunition, and the drug will undoubtedly end up approved with a “black box” warning that it can cause blood clots in the lungs.
The takeaway? Don’t believe for a moment that any drug you’re offered is safe. And don’t just ask your doctor about it. Insist on reading the safety data yourself — there are a multitude of websites that publish the package insert information from drugs. If you read anything that makes you uncomfortable, do ask your doctor about it…and make sure you get real answers.