In yet another stunning show of disregard for patient safety, the FDA just approved a drug that’s been shown to make people commit suicide in clinical trials.
That’s right. Suicide.
Oh—and it might also make you have a fatal heart attack, stroke, or other “cardiovascular event.”
These concerns were recently brought up before an FDA panel, which then decided that “the benefits of this drug outweigh the risks” and approved it anyway.
What? The benefits outweigh the risk of death by your own hand? It must be a true miracle drug.
So is this a new cancer treatment? An Alzheimer’s drug that actually works? A cure for diabetes? Or maybe it treats something life-threatening for which there’s no current treatment at all? Surely the benefits must be earth-shaking if they outweigh the risk of SUICIDE or death from a heart attack, right?
This drug doesn’t treat any life-threatening condition. And there are plenty of treatments already on the market that don’t make you want to kill yourself. The drug is brodalumab, and it’s intended to treat not some killer disease but…psoriasis.
Dying for clearer skin?
If you don’t know what psoriasis is, it’s an autoimmune disorder that affects your skin. And like other autoimmune diseases such as rheumatoid arthritis or lupus, we’re still not sure what causes it even after decades of research. But unlike some of the other autoimmune diseases, psoriasis isn’t life-threatening or crippling. It is, however, unsightly. So unsightly, in fact, that they can have a devastating effect on your life.
Psoriasis causes the normal life cycle of skin cells to go haywire. The cells, instead of dying slowly and sloughing off, build up in thick scaly patches. The most common type of psoriasis looks like thick, flaky, silvery or yellowish dandruff on red, inflamed skin and it can affect any part of the body. Patches of psoriasis can also be any size, from tiny areas the size of a dime to huge swathes of your body. The skin beneath and around these patches is usually dry, red, and itchy. It’s uncomfortable and, quite frankly, ugly. It can have a crippling effect not on your body, but on your self-image.
Now don’t get me wrong. I’m not suggesting that psoriasis is no big deal. Sure, it’s not life-threatening, but it can seriously affect your quality of life. If you have psoriasis or you know someone who does, you’ll know that just the strain on your self-esteem might make even a risky treatment attractive as long as it actually worked. But to risk suicide? For a treatment that not only doesn’t cure the problem but is only marginally better than what’s already on the market? I don’t think most psoriasis sufferers would consider that a fair trade.
The FDA, however, disagrees. The question is, once this dangerous drug hits the market, will they let patients decide for themselves? Or will the risk be glossed over?
My bet is on a whitewash.
The spin doctors are already at work
The signs of this are already clear. There were concerns about this drug over a year ago, and the drug manufacturer briefly considered stopping clinical trials. But of course money always trumps people’s lives in the world of Big Pharma. Instead of stopping the trials, the spin machine kicked into gear.
Here’s what happened: in the course of three Phase 3 clinical trials, there were 4 suicides. The trials compared the drug to another psoriasis treatment already on the market and to a placebo. There was one suicide in the control drug group and none in the placebo group.
There were also 18 attempted suicides in the active drug group, and 24 instances of “suicidal ideation” (or thoughts about suicide even if it wasn’t attempted). In the other groups? None. And none of these people—suicides, attempted suicides, or those with suicidal ideation—had any prior history of suicidal behavior.
There were also 16 heart attacks, 5 strokes, and one “fatal cardiovascular event” in the brodalumab group. That’s a total of 22 “cardiovascular events” of varying severity. The other groups? None.
And finally, there were two suicides in two other trials of the drug for other autoimmune diseases.
This is not a good track record.
However, mouthpieces for the pharmaceutical industry tried to downplay these frightening numbers by stigmatizing psoriasis patients more than they already are. In one instance, they implied that psoriasis sufferers are more likely than the general population to be suicidal anyway. In another, a spokesperson said that the “rate of suicidal behaviors [was] no higher than in the general population.” But if this were true, how do they explain the fact that there were no instances of suicide or suicidal behavior in the placebo group, and only one in the control drug group?
I smell a rat.
The FDA says suicide is acceptable
The FDA didn’t buy this spin either. The panel recommended—surprise!—a warning on the package insert (which no one but your doctor ever reads). Some members thought a database of users should be created to “collect patient data and assess suicide risk.” I’m sure that will be very helpful in the moments before someone pulls the trigger or tightens the rope.
There was argument over whether this registry should be voluntary or mandatory. Those in favor of mandatory were shouted down—the others claimed that making it mandatory would “create unnecessary barriers to accessing the drug.” In other words, Big Pharma would lose money. And in spite of all this, the panel voted eighteen to zero to approve this insanely dangerous drug.
Remember this word: brodalumab.
It doesn’t have a brand name yet. And it will be approved for other treatments soon—probably beginning with arthritis. So if you have psoriasis, rheumatoid arthritis, or psoriatic arthritis, be wary of any new drug your doctor prescribes. Ask him for the real name of the drug, not just the brand name.
And if it’s “brodalumab,” run like hell. Your life may depend on it.
In the meantime, there are steps you can take to decrease the severity of your psoriasis symptoms. Take fish oil supplements and eat a diet high in omega-3 fatty acids. (Chia seeds are an excellent source, and chia pudding is very tasty.)
Get some sun exposure—sunlight in moderation works miracles for some people.
Moisturize your skin after bathing and several times throughout the day. I recommend an oil-based cream containing plant oil such as grapeseed oil rather than lotion. You can even use straight olive oil, which has healing properties of its own.
And decrease your stress. All autoimmune disorders are intensified by stress, including psoriasis.