“Jimmy Clark figures he has only so much time left, maybe five years in a best-case scenario, less than two if things go south quick. He’s trying to stay positive, knocking things off his bucket list, but he knows the deterioration that comes with ALS portends a gradual loss of the ability to speak, move, eat, and breathe. Clark, a 59-year-old Texarkana retailer, wants to take an experimental drug its manufacturer touts produced ‘dramatic’ results in a recent trial.” However, “because federal regulators require larger-scale clinical trials before deeming new drugs safe and effective, it’s likely to be years before the potential lifeline is available, if ever.”
The Texas Legislature will soon take their final vote on the “right to try” bill. This bill will grant patients with terminal illnesses more access to experimental drugs. Currently, a drug must go through the full FDA approval process, including large-scale clinical trials, before being released as a new, safe, and effective drug. Unfortunately, this process can often take years. With this bill in place, terminal patients will be able to obtain a drug, which has passed at least the 1st of 3 FDA-required investigatory trials and the patient’s doctor believes could prove to be beneficial for the patient, from the direct drug manufacturer.
So, there are many benefits to allowing access for patients who have no other alternatives:
- Grants access to potentially life-saving treatments
- Allows the doctors and patients the ability to take quick actions
- Allows terminally ill patients the ability to make the decision to try an experimental drug containing some promise for improving or extending life
- Allows for the utilization of the time and money that goes into drug development and medical innovations by deserving patients
- Under the Senate version of the bill, the drug companies donate their medications
BUT, it also carries risks and dangers that maybe patients should not take and create false hope:
- Attempt to remove/bypass the FDA and clinical trial process
- Undermines the federal process for ensuring patients are protected from receiving harmful or ineffective treatments
- Drug companies have little motivation to grant “right-to-try” drug requests, since they do not want to supply unapproved medication outside the supervision of the FDA
- Patients worry the “right-to-try” law will not be different than the FDA’s inefficient program for fast-tracking promising new drugs
- Under the House version of the bill, the patients must pay for the experimental drugs
What do you think? Should patients be able to make the decision to try experimental drugs? Should the “right-to-try” bill be passed by Texas Legislature?
Source: Ackerman, Todd. “Terminal Patients Soon May Have Options.” Houston Chronicle 10 May 2015, Vol. 114, No. 209: A1/A13. Print.