Bill Would Ease Access to Experimental Treatments for Terminally Ill

Andrew Kitchenman | August 14, 2014 | Health Care
But some cite concerns about legal jurisdictions in opposing ‘Right to Try Act’

Sen. Diane B. Allen (R-Burlington), sponsor of the "Right to Try Act."
Concerns over the difficulty that terminally ill patients can face in receiving experimental medications and other treatments have prompted state legislators to introduce a bill aiming to give these patients a right to these treatments.

But the Right to Try Act, S-2186/A-3474, is opposed by some medical regulators, who have expressed concern that it contradicts federal legislation and would conflict with the authority of hospital review boards.

Bill sponsor Sen. Diane B. Allen (R-Burlington) said her own experience with a treatment that hadn’t completed the FDA approval process led her to propose the measure.

“It was used because it was a life-saving technique and so far it’s been successful,” Allen said. “I had a very tough cancer about five years ago and things were a little bleak for a while. I was fortunate to get into a clinical trial and that clinical trial made a very big difference for me.”

While the federal Food and Drug Administration has a procedure to allow emergency uses of experimental or investigational treatments, advocates for similar bills enacted in Colorado, Missouri and Louisiana have argued that the application process is an obstacle for terminally ill patients.

Members of the State Board of Medical Examiners, which oversees licenses to practice medicine, are concerned about the bill. They said that the state shouldn’t attempt to approve treatments that are barred by federal law.

The board’s executive committee members also expressed concern that the measure could put patients at risk by bypassing hospital’s institutional review boards. In addition, committee members questioned whether patients’ consent was sufficient to provide the treatments; whether manufacturers would make investigational drugs available; and whether the drugs would be cost-prohibitive to patients.

“I don’t think anyone here is opposed to making drugs available to the terminally ill,” member Dr. Scott E. Metzger said at a board meeting yesterday, while adding that he was concerned with the way the bill was worded.

However, two board members — Dr. Chetan S. Shah and Dr. Sudhir Parikh — expressed support for the bill at the meeting. They effectively blocked the board from taking a position opposed to the measure, since a majority of the 18-member board is needed to take a position on legislation, and only nine members expressed opposition.

“For somebody who is terminally ill, I feel that for us to say, ‘No, you can’t try something, just because we don’t have enough data, we’d rather see you die than try something,’ just doesn’t seem right,” Shah said.

Other board members responded that federal safeguards are in place to ensure that patients are safe.

“We’re not saying, ‘Let people die,’ ” board member Dr. George Scott said.

Board official Dr. Sindy Paul noted that New Jersey already has regulations governing “new and novel” uses of medications to aid patients.

Instead of opposing the measure outright, the board instead adopted a position in support of the concept behind the bill – of providing terminally ill patients receiving drugs that could benefit them – but noted the board’s split opinion on the potential legal effects of the bill.

Deputy Attorney General Steven Flanzman, who advises the board, said the bill’s language “in many ways is attempting to pit New Jersey against the federal government.”

Assemblywoman Pamela R. Lampitt (D-Burlington and Camden), a sponsor of the bill, said that she was not swayed by the argument that the bill would put the state in conflict with federal law. In fact, she said having multiple states adopt similar measures would apply pressure on federal policymakers.

“We need you to be the one to enact something like this,” thereby sending a wake-up call to the federal government, Lampitt said. “Once the states take some action, the federal government takes some notice.”

Lampitt said a close friend of her mother has benefited from an experimental treatment for cancer, which inspired her to support the bill.

“This is about research,” said Lampitt, adding that the providing investigational treatments to terminally ill patients will provide data for researchers. She said that the bill could help extend the development of stalled treatments that are considered cost-prohibitive to produce.

“If we could get them off the ground, they could potentially save lives,” Lampitt said.

Allen said she’s interested in meeting with different groups — including members of the State Board of Medical Examiners — to incorporate their thoughts into the bill. She noted that the similar bills enacted in other states drew broad bipartisan support.

Allen said the experimental ZMapp medication, which was used on an experimental basis to help two Americans who contracted the Ebola virus in West Africa, shows the urgency of making experimental uses easier.

Allen noted that the bill requires that medications have successfully undergone one round of clinical trials before patients could get access to them.

“I think everybody should have the opportunity in a terminal situation to reach out and try something that very well might save their lives,” Allen said.

“The question isn’t really whether this is against federal law, the question is whether we’re looking to have a doctor be the person who says you are cleared to try drug X,” said Allen, noting that patients would still be dependent on a doctor prescribing the treatment.