New legislation may expand medical choices for terminally ill patients in Connecticut.
The Public Health Committee of the Connecticut General Assembly is currently considering a bill that would allow terminally ill patients to take experimental drugs if they have exhausted all other medical options. This type of law, known more generally as a “Right to Try” law, has gained momentum nationally and has been passed in five other states — Colorado, Michigan, Missouri, Louisiana and Arizona. The Public Health Committee held a public hearing last Monday to hear testimony on the bill.
“When there’s a possibility that somebody who’s been diagnosed with a terminal illness could extend their life or cure themselves, why should the government get in the way?” said state Sen. Kevin Witkos, one of the bill’s co-sponsors.
The bill would serve patients whose terminal illnesses have not responded to other treatments. Patients who have explored all other options would be permitted to use drugs that are currently undergoing clinical trials. The drugs must have already passed Phase I trials, which determine safety and side effects, and the patients must be fully educated on possible outcomes of treatment.
Patients who choose to try experimental drugs will be responsible for the medications’ costs, which insurers will not be required to cover. The drugs may only be dispensed to those patients upon recommendation from a doctor, but if a patient dies as a result, the doctor will not be held accountable, and the patient’s family will not be responsible for any remaining drug expenses.
State Rep. Matt Ritter, chair of the Public Health Committee, said that, to his knowledge, this is the first time a law like this has been proposed in Connecticut. If the bill is voted out of committee, it may have to enter other relevant committees such as General Law or Judiciary before being scheduled for a vote, Witkos said.
Debra Gove of Durham, Conn. testified at the public hearing in support of the bill, drawing from her recent experiences with Amyotrophic Lateral Sclerosis, more commonly known as ALS. Gove, who is currently participating in a clinical trial, emphasized in her testimony the importance of exploring new treatments that may have a chance, however small, of succeeding. She noted her recurring worry that she may have received a placebo and not the drug being tested.
Those who testified primarily included friends and family of patients with terminal illnesses, as well as legislators. Sandi Isner, who suffers from emphysema — a condition characterized by decreasing lung capacity — was one of those patients who testified at the hearing. She worries that her lungs are continuing to deteriorate.
A clinical trial at Yale-New Haven Hospital caught Isner’s eye. The trial tests the use of lung coils to treat emphysema, and although she is not yet a candidate, she said she knows the trial could benefit her in the future, and believes that patients should be able to choose to use such treatments.
“If you’re of sound mind and the drug is for your specific illness, I really think you should be able to help yourself,” Isner said.
Opposition to the bill has centered on both ethical issues and questions about who has the jurisdiction over the issue — the state or the Food and Drug Administration. Some people are concerned that experimental drugs favor high-income patients who can afford out-of-pocket costs, Ritter said. Additionally, the drugs may exacerbate families’ stress by providing “false hope” for recovery, said attorney Jann Bellamy, who is also a contributor to the blog Science-Based Medicine.
Right to Try laws may give states unconstitutional authority over drug regulation, Bellamy added. Ritter noted that the FDA has not stepped in to block other states from implementing their versions of the law, but agreed that the bill potentially creates issues for pharmaceutical companies distributing drugs without FDA approval. Since the drug companies are given a choice about whether to offer experimental drugs, some might simply be unwilling to offer them, Ritter said.
Current FDA regulation requires that a drug pass three phases of clinical trials before being made available to the public. But that means it can take almost a decade for a promising drug to reach the market, said Stephen Mendelsohn, a member of Second Thoughts Connecticut — an advocacy group that opposes assisted suicide — who provided written testimony for the public hearing.
“This is very limiting for people with life-limiting illnesses,” Mendelsohn said. “The risk-to-reward ratio is very different [for those with terminal illnesses].”
The FDA currently has an expanded access, or “compassionate use,” program for patients to use unapproved drugs, which was used on a large scale during the Ebola outbreak to treat cases with experimental drugs.
But even that process is often hindered by bureaucracy, and completing the paperwork can take about 100 hours, said Public Policy Assistant at the Family Institute of Connecticut Nicole Stacy in her written testimony to the committee. The FDA has announced that it will work to simplify the expanded access system.
The bill has bipartisan support, with both Republican and Democrat sponsors. According to Mendelsohn, similar bills have had bipartisan support in other states as well, and have faced very little opposition.
In May 2014, Colorado became the first state to pass a Right to Try law.