Jun
3
The Right to Try
“Right to try. That’s such a great name. Some bills, they don’t have a good name. Really. But this is such a great name, from the first day I heard it. Right to try. And a lot of the trying is going to be successful. I really believe that. I really believe it.” — President Trump
A few years ago, Darcy Olsen — then President of the Goldwater Institute, a libertarian think tank — wrote a book on a subject she is passionate about, titled The Right to Try: How the Federal Government Prevents Americans from Getting the Lifesaving Treatments They Need (2015). From the Amazon description:
“Should you need the government’s permission to try to save your own life? Today, the FDA regulates medications available to Americans. But it takes an average of ten years to bring a new drug to market. Every day thousands of Americans die unnecessarily from fatal diseases for which lifesaving treatments that now exist or are being developed are ruled too “dangerous” for commercial distribution. But how does that FDA standard apply to someone in the terminal stages of cancer or ALS?
Right to Try is filled with stories of heroism and heartbreak — of courageous Americans who beat illnesses no one thought could be defeated; parents who won the fight to get their children access to cutting-edge cures; patients who were denied life-saving treatments by the government ostensibly for their own protection; and incredible doctors and researchers pioneering revolutionary cures. Drawing on her experience fighting for patients, Darcy Olsen goes inside the federal bureaucracy that is stopping millions from accessing these lifesaving treatments, lays out the case for expanding access to experimental medicines, and describes the ongoing national campaign to change these laws state-by-state.”
Olsen’s book and the “Right to Try” movement that has sprung up in recent years were the inspirations for the legislation that President Trump signed into law just a few days ago.
“[The Right to Try Act of 2017 (S.204)] authorizes certain patients to seek access to certain unapproved investigational drugs directly from a drug sponsor or manufacturer; limits the use of clinical outcomes and liability arising from the provision of such drugs; and provides reporting requirements for the use and outcomes of the new authority.” (from the official White House statement)
Roughly 40 states have already implemented right-to-try laws, beginning with Colorado in May 2014. This is great but, obviously, not enough and of limited effect. (Also, apparently some states’ right-to-try laws put patients at risk of losing hospice or home health care.) The FDA already grants around 1200 “compassionate use exceptions”, but “[m]any patients run out of time before they can qualify for the exemption or complete the process. Right To Try laws help patients get immediate access to the medical treatments they need before it’s too late.”
It should also be pointed out that “[t]he only treatments available under Right To Try laws are those that have already passed the FDA’s basic safety testing and remain within the FDA’s approval process. These are no different than the treatments currently available to the 3% of patients who are lucky enough to be accepted into clinical trials.”
President Trump signs Right to Try Act
As CNBC’s Angelica LaVito summarizes:
“It allows certain patients to ask drugmakers for medicines that have passed Phase 1 of the FDA approval process but haven’t been approved yet and are still undergoing testing. Patients must have exhausted other options and be unable to participate in a clinical trial. Drugmakers aren’t obligated to give patients the requested experimental medicines.
Critics say the legislation undermines the FDA’s authority to regulate drugs and could leave patients vulnerable to medicines that might not work or may even be harmful.”
Regarding that last point, terminally ill patients, particularly when they are already in a lot of pain, have very little to lose. They’re going to die anyway, so they are often willing to take those risks. As long as they are informed and have realistic expectations, they should have that option, and right-to-try laws give more people that option.
There are other issues, as well, which have kept it just controversial enough to delay passing of a federal right-to-try law before this, despite bipartisan support. (You can read about them here.) Writing for Eagle Rising, Onan Coca had this to say:
“The “Right to Try” Act had been supported by thousands of legislators on the right and the left, across the country, but when it came to a vote in Congress the GOP was forced to pass the law without help from the Democrat Party! The Act was also opposed by “Big Pharma,” which should make the Democrats’ stand against the law even more egregious to their anti-corporation voters. There really is no reason for the Democrats to have opposed the Act, other than the fact that it was being wholeheartedly supported by President Trump.”
While I admit that my knowledge of the controversy is somewhat limited, I tend to think the positives outweigh the negative concerns, and I heartily approve the passage of this legislation. Chalk up a win for Congress and the Trump administration and, more importantly, cheer for the new opportunities — and the hope that accompanies them — that so many more patients with life-threatening conditions will now have for improved treatments and possible cures.
