If you haven’t read about it yet, “immunotherapy” is one of the hottest new medical treatments in development. It’s being hailed as a possible solution for everything from cancer to multiple sclerosis, and clinical trials are underway all over the country. It’s had some truly spectacular results in a few trials, putting cancer into remission at an unprecedented rate. There’s only one problem: It’s also killing people.

Patients rarely die during clinical trials, and when they do it’s usually headline news—think of the world-wide shock and outrage when a patient died in a French drug trial last year. The entire western world was calling for answers. It dominated news headlines for weeks and still pops up now and again. Meanwhile, we practically have an epidemic of drug trial deaths going on in the United States, and the deaths all have two things in common: they’re connected to immunotherapy drug trials, and nobody is talking about them. Instead, they’re talking about…how wonderful immunotherapy is.  

 

This past summer, during the trial of an experimental brain cancer drug by Ziopharm Oncology Inc., a patient developed a brain hemorrhage and died two weeks after having the drug injected directly into his tumor. The company, of course, denied that his death was treatment-related. They also denied that two other deaths in the same trial earlier in the year were treatment-related. Since there’s no information on how they died readily available—even to the FDA—we just have to take their word for it.

 

However, since the trial only intended to enroll some 48 people in total (according to clinicaltrials.gov), three deaths seems incredibly suspicious. Consider: three people out of 48 is a shocking six percent death rate. The FDA, however, seems unconcerned, in spite of the fact that the company delayed telling it about the death until some time had passed. FDA didn’t put the trial on hold and showed no inclination to do so—in spite of this obscene death rate. The administration didn’t even ask for further information.

 

This seems to be par for the course. It begs the question: how many people must die before the FDA takes steps to protect those still alive? More than 6%, it seems.

The Ziopharm death was actually the second immunotherapy-related death in one month. The first was during a leukemia immunotherapy trial by Juno Therapeutics. It too was the third such death during the trial, with the first two occurring the previous January. That was around the same time as the widely-publicized French drug trial death, but got little mention in the U.S. press. As with the Ziopharm case, the company claimed that the first two deaths had nothing to do with the treatment being tested. But when the third person died, they admitted there could be a problem.

 

In all three cases, the study participants died of cerebral edema, or swelling of the brain.

 

The FDA had declined to put the study on hold after the first two deaths, taking the drug manufacturer at their word that the deaths weren’t treatment-related. After the third death, however, they did put the study on hold…for less than a week. Then it was allowed to continue, with a change in the chemotherapy drug used to “precondition” the patient before the main treatment. Nevermind the fact that—with only about 20 people enrolled in the trial at the time—the death rate had thus far been an astounding thirty percent in the treatment group. Would we allow any other trial to go forward with these kind of numbers? 

 

Not likely. 

 

However, that’s exactly what happened. The FDA allowed Juno to restart the trial after a very short hold. And—you guessed it—even more people died. Two more, to be exact. That’s a grand total of five deaths, all treatment related, in one small clinical trial.

 

Incredibly, the FDA still didn’t halt the trial. In the end, Juno itself voluntarily put the trial on hold. And now, after four months of deliberation, the company has decided to shut the trial down of its own accord.

 

The FDA, on the other hand, did absolutely nothing. It still claims that “fatal adverse events” are extremely rare. And immunotherapy is still being hailed as “the new frontier in the war on cancer” in spite of the insanely high death toll.

 

Why?

 

There are billions of dollars riding on immunotherapy drugs currently in development, and several are slated to be approved as early as this year. This makes it very tempting for both drug manufacturers and the FDA to sweep any “serious adverse reactions”—up to and including death—under the rug. And so far that’s what appears to be happening. While the world protested at the top of its lungs over the death of one Frenchman back in 2016, there has been little media mention of our own spate of drug deaths outside of the financial pages.

 

It also makes for a very frightening picture if any of these drugs do get approved in the next couple years. What kind of death rate is acceptable? Six percent? Thirty? Fifty? If you’ve been given a terminal diagnosis, playing that kind of Russian roulette with your health might be acceptable. But how likely is it that these therapies, however dangerous they may be, will be offered only to terminal patients?

 

Here’s my take on the topic: until we figure out why people on immunotherapy are dropping like flies, take any claims made with a whole pound of salt. There have been stunning successes. We’ve seen people go from terminal to cancer-free in short order. But we’ve also seen far too many who should have lived die needlessly. For now, unless you have a terminal diagnosis the benefit just doesn’t outweigh the risk.