LIFE MATTERS MEDIA STAFF
A controversial new Nebraska law will allow terminally ill patients to experiment with drugs not approved by the Food and Drug Administration.
The so-called “Right to Try” bill, sponsored by conservative state Sen. Robert Hilkemann, will go into effect this summer, making Nebraska the 40th state in the nation with such legislation. Republican Gov. Pete Ricketts signed the bill into law this spring.
Supporters maintain the measure makes it far easier for seriously and terminally ill patients to access experimental treatments by bypassing regulators. These vulnerable patients are often unable to participate in clinical trials and have little chance of being cured.
Drug companies already allow some patients access to new drugs outside of clinical trials under a program known as “compassionate use” – as long as the FDA approves such requests. Such treatments must pass the first phase of safety testing.
Although the FDA approves the vast majority of compassionate use requests, sometimes companies refuse out of fear that negative results could be used against them by the government or patients injured by their products. Nebraska’s bill shields doctors and drug companies from some legal risk.
Strongly opposed by medical groups and some bioethicists, opponents are concerned “Right to Try” will cause dying patients unnecessary suffering and promote false hope.
Republican state Sen. John Kuehn opposed the bill because he fears it will harm the state’s most vulnerable.
Kuehn told the Lincoln Jounrnal-Star that roughly three-fourths of drugs that pass Phase 1 of the FDA approval process will ultimately fail to be approved because of safety concerns or lack of positive results.
In just four years, “Right to Try” legislation, backed by the libertarian Goldwater Institute, has spread across the nation. In 2014, Colorado became the first state to pass such legislation.
“This is another great win for patients’ rights,” said Victor Riches, the president and CEO of the Goldwater Institute, in a media release. “The question now is how many states have to pass this law before Congress does its part? Forty states—enough to amend the Constitution—have made it clear that this issue is critical for American patients. It’s time for the U.S. House and Senate to come together at the federal level so that the millions of Americans facing terminal diagnoses have access to new treatments.”
Congress is considering a “Right to Try” bill at the federal level. President Donald Trump, who highlighted the effort in his State of the Union speech, has said he plans to sign legislation into law if it reaches his desk.
Last month, Wisconsin’s Republican Gov. Scott Walker signed a similar bill into law with little fanfare.
R. Alta Charo, the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin at Madison, called the movement a “fraud.”
“The proponents have managed to make the public think it’s a personal, autonomy and civil right issue, and it’s not,” said Charo, an elected fellow of the National Academy of Medicine. “This is about ethical and responsible regulation of business.”