Why “right-to-try” is doomed to fail

Everyone’s talking about the new “right-to-try” law. And seeing as how it’s caught the attention of so many of my own cancer patients, I’m willing to bet that you know at least one person who thinks it’s the answer to their prayers.

And it’s no wonder. Anything that offers a shred of hope to patients living with an otherwise hopeless diagnosis is bound to get some attention.

Plenty of people believe that there are promising drugs out there that could help if they only had access to them. And that, somehow, this law is going to make new and more effective options available to them virtually overnight.

But unfortunately, none of this is true. And given the law’s misleading name, I really can’t fault anyone for falling for it. I do, however, consider it my duty to share the facts with everyone I know.

Fixing a problem that never existed

If the “right-to-try” laws are unfamiliar to you, let me fill you in. This legislation gives terminally ill patients — like those fighting aggressive forms of cancer — the right to use experimental medications that have not yet been approved by the Food and Drug Administration (FDA). It was passed and signed into law at the end of May.

But like most “new” legislation spit out by the current administration, what we’re talking about is really just an exaggerated repackaging of existing laws.

Neither doctors nor drug-makers will be forced to give experimental medicines to anyone who comes knocking. Though it may help patients get their hands on these drugs without having to enroll in a clinical trial.

But here’s the thing: Your doctor can already provide you with experimental drugs outside of clinical trials. They just have to go through the FDA’s proper “compassionate use” channels.

So in essence, this law is designed to fix a problem we didn’t really have in the first place.

What does it do? Well, it directs drug makers to provide a yearly summary — detailing the number of doses they’ve supplied, the number of patients treated, the intended uses of the drug, and any known serious side effects — to the Department of Health and Human Services. And of course, it better limits their liability, should something go wrong.

Which is why you should view the bill with a more cynical eye. Because with this kind of cold, hard look, its true intentions really couldn’t be more obvious.

One person might see legislation that makes it easier for patients to access untested drugs. But I see legislation that exempts drug companies from any responsibility should those same patients be harmed by their drugs.

And let’s face it. Big Pharma doesn’t exactly have a clean track record in this department. So here we have yet another law designed to protect Big Pharma. Yet it’s couched in the promise that it’s going to make your life better.

Guess again…

The odds of success are lower than ever

It’s important to understand that your odds of finding success with any of these drugs, even with the passage of right-to-try, aren’t good. Ultimately, the treatments have only made it through the initial hurdle of phase one trials. And the only thing that means is that they’re safe enough for further testing.

Once a drug makes it to phase two, the investigation turns to efficacy. But only a third of experimental drugs make it past this phase. And only a quarter of those succeed under further study.

Maybe all of this sounds unnecessary. That’s certainly the impression “right-to-try” advocates want to give. And although I have no love lost on the FDA, the fact is, the agency’s oversight does offer patient protection in this case. (Though if you ask me, not as much as it should.)

But at the very least, these steps ensure that patients know what they’re getting into when they sign on to take these treatments. And they also ensure that physicians know how to use the treatments properly.

Take the FDA out of the picture, like “right-to-try” does, and you’re basically looking at an experimental drug free-for-all. One where patients are left to weigh (and potentially suffer) the consequences on their own. And more to the point, one where doctors will lean on Big Pharma for any guidance. That’s a scary thought…

So if you were wondering why this administration felt the need to push “right-to-try” through? Well, I suspect your answer’s right there.

Source:

medscape.com/viewarticle/898030