what’s wrong with right to try laws

Giving terminally ill patients a chance to try experimental drugs also means protecting them from scammers.

spoonful of drugs

On the surface, laws allowing terminally ill patients to try a new treatment that hasn’t been approved by the FDA seems almost common sense. What if this is the long awaited cure for their condition? Denying them just one last shot at even another few months of life certainly seems cruel. If a potential side effect that will aggravate their illness or lack of efficacy is a concern, it shouldn’t be. After all, the patient is basically doomed so what’s the worst that could happen? Exactly what the doctors said? When you have nothing left to lose isn’t a shot at just a little more life worth the risk? What kind of cold, evil, heartless monster could object to a right to try a dying patient’s last shot at survival? Well, unfortunately, when it comes to giving people a brand new experimental drug that is yet to be tested for safety, what seems like bureaucratic cruelty from the outside is actually driven by concern and reluctance of doctors who take the “do no harm” oath seriously.

Here’s the problem. When dealing with a patient for whom medicine can’t really do much, the quality of their remaining life matters. You don’t want them to spend the rest of their days in pain, or dealing with irritating and limiting side-effects. You want them to be able to have enough strength to cross some things off their bucket list, get their affairs in order, spend the time they have left with family and friends, say their goodbyes, and when their time is up, let them die with dignity. Pumping patients full of barely tested, unknown drugs means you’re playing with fire. Advocates of those right to try laws focus on the off chance that patients may find a cure or a life-extending treatment at best, or contribute to science to help others at worst. But they skip over or downplay the very real risk that some of those experimental drugs could be toxic in the quantities they’re administered, and could actually shorten the patient’s life or ruin whatever quality their palliative care was trying to give them.

There’s also a very significant risk that quacks and cranks could abuse the law to make money off desperate and dying patients, giving them nothing more than false hope and placebos at best, or poisoning them with a toxic, pseudoscientific concoction. These people already have a thriving industry selling snake oil to cancer patients under DHSEA, the law giving cranks a license to sell anything they want until they’re sued enough times, just as long as they use a very specific clause in their sales pitches known around the skeptical internet as The Quack Miranda. I find it very doubtful that a passionate right to try advocate hoping to give the terminally ill one more shot at survival would be fine with quacks defrauding patients whose last shot is being wasted on their cargo cult medicine. Wouldn’t they want the rules involved in approving viable medications of last resort to make sure patients will be given something safe and with a real shot at working?

But if that’s the goal, the FDA already gives expedited approval to any last resort drug that seems to have a shot at helping patients, and it approved virtually all the treatments provided by pharmaceutical companies able to demonstrate a few promising trials. So in a conventional, responsible sense, right to try already exists and approves more than 96% of requests that it receives under what’s called a compassionate use program. This means the renewed push some states are seeing now is either motivated by a serious lack of knowledge about FDA’s rules regarding experimental treatment for terminally ill patients, or by a desire to weaken the FDA so more drugs can hit the market with less scrutiny and with a boost to profit margins. And as numerous lawsuits over the last few decades demonstrate, when you rush drugs and devices to market, people will get hurt. For those at the end of their lives, that would be a cruel, painful insult to injury…

# science // health / healthcare / medicine / pharma

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