Individuals dying of cancer or other diseases should be able to try unproven new treatments that might save their lives without interference from the Food and Drug Administration. That’s the gist of state “right-to-try” laws that may soon get federal support. While these laws tap into human compassion, they actually undermine patient protection and the ability to determine how well these treatments work.
The right-to-try message has met with some success, owing in part to the work of the Goldwater Institute, a libertarian think tank that has developed model legislation and lobbied successfully for passage in more than 30 states — including Indiana, where Vice President Pence signed a right-to-try law in 2015 when he was governor of the state.
Pence met last month with a group of patients and advocates to signal his support for federal right-to-try legislation. The focus of a years-long advocacy campaign, this proposed law, now being considered by both the House and Senate, would prevent the federal government from blocking state-level right-to-try laws, which allow terminally ill patients to bypass the FDA’s existing pathways for accessing experimental therapies.
Burzynski, thalidomide, laetrile – all scare tactics . A sign of how weak the counter – argument to RTT is . RTT has already sped up FDA delay . A simple notification of compassion granted is all the FDA needs . if it comes from an entity they question – like Burzynski – the FDA can follow up . Do not let this weak argument take away from the many drugs scientifically tested for safety , and showing great efficacy , that are not available to dying pt.’s .
Great commentary! I note that STAT previously reported that the Burzynski clinic was using Texas state right to try laws to offer treatment while still awaiting an FDA decision (the 5-year-old patient in that case died after being treated) https://www.statnews.com/2016/08/29/stanislaw-burzynski-cancer-treatment-congress/?s_campaign=trendmd
Another in- accurate , ” scare tactic ” type article. 9500 compassionate use requests in 9 yrs is pathetic. For all terminal diseases in a country of 314 Million people . Part of that low number is a Slow FDA approval system , more focused on flexing it’s regulatory muscle with pharma than saving pt. lives . Including my wife’s life saving drug, delayed by the FDA for 3 long years – with a 30 % cure rate for a type of breast cancer that kills 15,000 Americans every one of those yrs. Yes – 7500 potential cures – lost . Here is her testimony in 2014 for RTT : http://youtu.be/AkQOLGpXf98 and she is very much alive, cancer – free 3 yrs later . Her drug is not the only cure actually banned by the FDA for a time . Iclusig is another . In a 20th Century Slow approval system that takes 7- 10 years to approve drugs . No wonder we fight for a Chance at Life. The author doesn’t report that the FDA has never used any data from compassionate use requests – so how would that have any effect on the approval process ? RTT applies to drugs that have passed Phase I safety testing , so stop with the scare tactics. These are 21st century drugs , often derivatives of already established science . Stop fighting RTT – not one day should be delayed by un – necessary FDA paperwork . Join us in reforming the slow approval system – bringing more compassion to it.