The U.S. House of Representatives recently passed legislation that could give terminally ill patients the “right to try” experimental treatments — so what’s the controversy? Catch up on the topic and share your thoughts below.
“Right-to-try,” in a nutshell
The “right-to-try” bill aims to give terminally ill patients who’ve exhausted all other treatment options quicker and easier access to an “experimental treatment” (this is a medication or treatment product that has passed “phase one” of the clinical trial process but has not yet received full Food and Drug Administration [FDA] approval). See this PatientsLikeMe guide to clinical trials to learn more about trial phases and the FDA drug approval process.
All in favor…
Backers of the bill have cited these “pros” in their reasoning:
- 38 states have already passed their own versions of “right-to-try” legislation, so a federal version of the law would grant access to experimental treatments nationwide.
- Although the FDA has existing “expanded access” (or “compassionate use”) policies that allow the use of investigational treatments in the most dire cases, patients must apply to the FDA for permission to receive the treatment — so “right-to-try” would eliminate the step of needing to apply.
- Most terminally ill patients don’t qualify to participate in clinical trials, so “right-to-try” could give them quick access to treatments that are still in the middle of years-long trials.
People who are against the bill have some arguments of their own:
- Four former FDA commissioners issued a joint statement opposing the federal “right-to-try” legislation, saying it would “create a dangerous precedent that would erode protections for vulnerable patients.” (When the FDA is involved in “expanded care” cases, it tries to provide any additional information on dosages, side effects and safety considerations — so removing the FDA from the process may eliminate expert guidance and safeguards.)
- Many drugs that make it through phase I of clinical trials (smaller initial studies to test for safety) fail to survive phase II of trials because they’re not proven to be effective — so “right-to-try” may open the door to developers peddling “snake oil” or hyped-up/unproven treatments to the most desperate patients.
- “Right-to-try” may not significantly expand access to treatments — the FDA says it grants approval in 99 percent of requests through the “expanded access” policies and often authorizes emergency requests immediately over the phone. And few pharmaceutical companies offer access to experimental treatments without FDA approval because of ethical and legal concerns.
“No ethical company that I know of would make their experimental medicine available outside of the FDA’s regulatory oversight process,” Kenneth Moch, CEO of drug developer Cognition Therapeutics, tells the Associated Press. “The FDA are not the bad guys here. You may not like their processes but they are involved here for a variety of reasons.”
Modern Healthcare points out that using an experimental treatment can derail a patient’s health insurance coverage for additional medical treatment or hospice care thereafter.
“If the bill is passed and signed, the campaign that made it law may not stop there,” Modern Healthcare also reports. “Some believe there is a chance the program’s scope could be expanded beyond terminally-ill patients to one day include those with severe chronic conditions.”
Next up, the “right-to-try” bill heads to the Senate. If they pass it, the president (who has expressed support) is expected to sign it into law.
What are your thoughts on the “right-to-try” bill? Join PatientsLikeMe to talk about this topic with a community of other real-world patients.
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