President Donald Trump pledged his support for the Right to Try Act during his State of the Union address last week. However, the bill, which would sidestep FDA regulations to give terminally ill patients access to experimental drugs, has seen much pushback from health experts and physicians.
Michael Becker, a former biotech CEO and terminal cancer patient, shared three reasons he opposes the bill during an interview with NPR.
1. Patients can already access experimental drugs through the FDA's Compassionate Use program. "Compassionate Use process is extremely easy," Mr. Becker told NPR. "Basically, go to your doctor. Find one who will agree to administer the therapy. Contact the drug company. See if they're also willing to agree. Fill out the paperwork. And then if the FDA doesn't object, the patient can get the treatment. And the only difference with the new legislation is that last part. The FDA is taken out of the equation."
2. Most of the time, experimental drugs are not effective. About 5 percent of all experimental drugs earn FDA approval, according to Mr. Becker. "So you're talking about giving people medications that, in historical context, have only had a 5 percent chance of actually working at the end of the day," he said. "And then you're exposing these patients to, potentially, additional toxicities that could accelerate their death or cause additional problems for them."
3. Patients may be blind to an experimental drug's adverse effects. Mr. Becker said terminal cancer patients often have a lot of false hope about experimental drugs. "You want to cling to anything that's going to sound like it's an opportunity to live longer or have a better quality of life. And that hope can sometimes cover up the realities of some of the more sinister aspects of getting a drug," he said.