Bipartisan legislation recognizing terminally ill patients’ right to try experimental drugs could pass the Wisconsin State Legislature in 2017, after a national right-to-try (RTT) bill sponsored by Sen. Ron Johnson (R-WI) was blocked in the U.S. Senate.
State Rep. Joel Kleefisch (R-Oconomowoc) “is planning on reintroducing his right-to-try bill this upcoming session,” aide Katie Scott told Health Care News.
Senate Bill 125 and Assembly Bill 179, sponsored by 18 Democrats and 12 Republicans, besides Kleefisch, were introduced in April 2015 and failed to pass in April 2016, the last month of Wisconsin’s biennium session. The legislation would have granted terminally ill patients the state’s permission to try treatments not fully approved by the U.S. Food and Drug Administration (FDA) and limited the liability of developers and doctors who provide treatments under the law.
In September, U.S. Senate Minority Leader Harry Reid (R-NV) blocked a bill introduced by Johnson that would have given state RTT laws precedence over federal regulations.
Out of Options
Kleefisch says RTT legislation would permit patients to try experimental drugs only as a last resort.
“The bottom line is that right to try allows terminally ill patients who have considered all other treatment options and who have their doctor’s consent to use an investigative drug,” Kleefisch said.
Restricting a patient’s attempt to survive illness is beyond government’s proper scope, Kleefisch says.
“If somebody is dying, the government should not in any way stand in the way of letting that person try whatever they want, to survive,” Kleefisch said. “I would like to see somebody try to make a reasonable case for why somebody who is dying shouldn’t try to save their own life.”
Johnson expressed support for state RTT laws and his proposed U.S. Senate bill to reinforce them, the Trickett Wendler Right to Try Act of 2016, in a September 28, 2016, letter to Wisconsin Gov. Scott Walker (R).
Satya Thallam, chief economist of the U.S. Senate Committee on Homeland Security and Governmental Affairs, says the national legislation would enable states’ RTT laws to take effect legally.
“We believe this legislation is necessary because of federal preemption in the area of regulation of drugs and medical therapies,” Thallam said. “That is, without a federal law providing clarity and protection to the state laws, doctors and companies will be hesitant to administer RTT therapies. But it would only apply to those states that have adopted a RTT law. It would not be a mandate on those that have not.”
Thallam also says Johnson’s national legislation relies on FDA approval and applies only to patients who have no alternative medical options to combat a life-threatening illness.
“Ultimately, this legislation is not an anti-FDA legislation, as it relies on the FDA approval pathway as a mechanism to weed out ‘snake oil,'” Thallam said. “Medicines must have passed Phase I trials and be continuing on in the testing phase. It also limits applicability to patients who have no alternative, so it is not a bypass to participation in clinical trials.”
At least one doctor is taking his chances treating patients under state law, Thallam says.
“Despite the lack of legal certainty at the federal level, the committee was proud to highlight an example of a doctor successfully treating patients under his state’s RTT law despite the significant legal and professional risk he faces,” Thallam said. “We believe there are others like him treating patients but who are concerned to come forward, and many more will likely be able to treat patients after a federal law is successfully implemented.”
Under Texas’ RTT law, Dr. Ebrahim Delpassand has treated 78 cancer patients, many of whom have lived more than a year beyond doctors’ projections after receiving investigational treatment, Delpassand states in a video uploaded to YouTube on September 22.
Jordan Finney ([email protected]) writes from Boise, Idaho.
Matthew Glans, “Wisconsin Deserves ‘Right to Try,'” Research & Commentary, The Heartland Institute, October 7, 2016: https://heartland.org/publications-resources/publications/research–commentary-wisconsin-deserves-right-to-try
Michael Hamilton, “Unalienable ‘Right to Try’ Deserves Protection by Feds and All 50 States,” Consumer Power Report, The Heartland Institute, June 30, 2016.
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