Tuesday, April 21, 2015
Should FDA make experimental drugs available for terminal patients? - posted for Awad
Should FDA make experimental drugs available for terminal patients?
A growing number of states are proposing laws to allow terminal ill patients to have access to experiential drugs prior to FDA approval and it’s called the "Right-to-try" law. Five states have already "Right-to-try"— Arizona, Colorado, Louisiana, Michigan and Missouri, according to the National Conference of State Legislatures.Twenty-five more have proposed similar legislation.
Also, the FDA proposed a change in their policy to allow terminal patient to have access to experimental drugs if their physician fills a form that requires 45 minutes to complete rather than the current process that takes a 100 hours approximately 3-4 months to finish. Many doctor such as Doctor Gorski, expresses his concern due to drugs merely having passed phase I trials is not enough to determine whether a drug is safe, since these trials are based on small sample sizes, often of less than 30 patients, and are only meant to determine the maximum tolerated dosage of the drug, as well as any obvious side effects. Moreover, he adds, "Most drugs that pass phase I never make it to market, and it's not at all infrequent for serious toxicities and side effects to be identified in phase II and III trials." In addition, Dr. Arthur Caplan, says that, “"Experimental drugs can make you die quicker or you can die much more miserably and much more quickly if the drug is bad." My report is about the positive and negative outcomes from making an experimental drugs available to terminal patients.
(posted for Awad)