Slashdot Mirror
U.S. Passes 'Right to Try' Law Allowing Experimental Medical Treatments (chicagotribune.com)
schwit1 shared this article from the Washington Post:
The House on Tuesday passed "right to try" legislation that would allow people with life-threatening illnesses to bypass the Food and Drug Administration to obtain experimental medications, ending a drawn-out battle over access to unapproved therapies. President Trump is expected to quickly sign the measure, which was praised by supporters as a lifeline for desperate patients but denounced by scores of medical and consumer groups as unnecessary and dangerous...
The FDA would be largely left out of the equation under the new legislation and would not oversee the right-to-try process. Drug manufacturers would have to report "adverse events" -- safety problems, including premature deaths -- only once a year. The agency also would be restricted in how it used such information when considering the experimental treatments for approval. Patients would be eligible for right-to-try if they had a "life-threatening illness" and had exhausted all available treatment options. The medication itself must have completed early-stage safety testing, called Phase 1 trials, and be in active development with the goal of FDA approval.
One Congressman opposing the bill argued that eliminating FDA oversight would "provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients," noting that the bill is opposed by over 100 patient advocacy and consumer groups.
The FDA would be largely left out of the equation under the new legislation and would not oversee the right-to-try process. Drug manufacturers would have to report "adverse events" -- safety problems, including premature deaths -- only once a year. The agency also would be restricted in how it used such information when considering the experimental treatments for approval. Patients would be eligible for right-to-try if they had a "life-threatening illness" and had exhausted all available treatment options. The medication itself must have completed early-stage safety testing, called Phase 1 trials, and be in active development with the goal of FDA approval.
One Congressman opposing the bill argued that eliminating FDA oversight would "provide fly-by-night physicians and clinics the opportunity to peddle false hope and ineffective drugs to desperate patients," noting that the bill is opposed by over 100 patient advocacy and consumer groups.
It doesn't sound like anyone is denied effective treatment in the current system (unless they end up control in a clinical trial) so I'm not sure what the new bill is going to do other than potentially open the doors to snake oil sellers.
The bill protects doctors and pharmaceutical companies from liability for giving experimental treatments to terminally ill patients, which is one of the reasons drug companies don't want to give these out. Drug company liability has gone bonkers in the last few years - people are suing because chemotherapy drugs are causing their hair to fall out, and blood thinners are causing them to bleed more easily. It's insane.
As long as the doctors and patients are fully informed that the drug is experimental I don't see a problem with this.
My Other Computer Is A Data General Nova III.
It doesn't sound like anyone is denied effective treatment in the current system (unless they end up control in a clinical trial) so I'm not sure what the new bill is going to do other than potentially open the doors to snake oil sellers.
The bill protects doctors and pharmaceutical companies from liability for giving experimental treatments to terminally ill patients, which is one of the reasons drug companies don't want to give these out. Drug company liability has gone bonkers in the last few years - people are suing because chemotherapy drugs are causing their hair to fall out, and blood thinners are causing them to bleed more easily. It's insane.
As long as the doctors and patients are fully informed that the drug is experimental I don't see a problem with this.
Doesn't sound like that's a problem:
Finally, expanded-access programs could bring liability exposure. Litigation in this arena, however, has been limited to obtaining access rather than seeking redress of treatment-related harm. The lack of adverse-event lawsuits may reflect the willingness of such patients to assume risks as well as the adequacy of existing regulatory and manufacturer safeguards.
I stole this Sig
The governement was already not forbidding you. They were forcing your doctor to consult with the scientists running studies to make sure you were getting the best dose. Oh, and 0.1% of the time they said "those studies are going really bad, it's not an option.
And yes, I want the government from forbidding me from getting desperate and having snake oil salesman make a bunch of pitches that won't work and I don't understand. (Again, 99.9% of the time they let the experimental treatment happen, withing 24 hours if you say its time critical.) I'm not educated enough about medicine, nor will I be thinking clearly enough.
Your ad here. Ask me how!