Harp has repeatedly credited a “Right to Try” law, pushed by the president and signed into law in May 2018 for saving her life. But the treatment she said she has received — “an FDA-approved immunotherapy drug for an unapproved use” in her own words — would not have been covered under Right to Try because the drug had already been approved.
In online accounts and interviews, Harp said that when she was diagnosed with Stage 2 bone cancer she “failed the two available chemotherapies for my rare disease and was denied from clinical trials.” In the end, she “found another oncologist who was willing to try a different approach — an FDA-approved immunotherapy drug for an unapproved use.”
Medical experts say such applications — called “off-label use” — are common in cancer treatment and long predated the law. Right To Try, on the other hand, was supposed to help patients gain access to drugs that have not been “approved or licensed by the FDA for any use.” Indeed, the justification the law’s backers gave was to allow desperately ill patients to bypass the government to get experimental medicines if they were willing to take the risk.
It is also striking that two months before Trump even signed the law, Harp had already spoken online about receiving her new treatment.
She tweeted on March 27, 2018: “Just so you know, President Trump is setting records in speeding up the drug approval process. The chemo I’m on now wasn’t approved 5 years ago.”
At some point before 2017, the business-degree graduate of Liberty University also wrote a 29-page report that blamed Democrats for her health problems with chronic pain and suffering after a medical error during which a nurse put sterile water instead of saline into her IV.
Harp — a member of the president’s campaign advisory board described on her LinkedIn page as a self-employed entrepreneur — did not respond to calls and emails requesting comment. Officials at the White House and Trump campaign declined to answer questions about the account she gave during the GOP convention.
For the past two years, Trump has claimed passage of the Right-to-Try law as a hallmark accomplishment and a centerpiece in his campaign. He has bragged that it will save “thousands and thousands, hundreds of thousands” and last year called it “a miracle — so many people have been saved.”
But Alison Bateman-House, a medical ethicist at the New York University School of Medicine, has tracked the law’s application and estimates that fewer than 10 people have used it to get treatments since it was passed.
“The problem is it’s a classic case of Trump demagoguery. It sounds good — cutting red tape and saving lives — but at the root of it there’s nothing there,” said Peter Lurie, former top official of the Food and Drug Administration, now president of the Center for Science in the Public Interest. “The FDA already had a process that approved more than 90 percent of people who wanted access to these drugs and treatments.”
The measure was originally pitched by a Phoenix-based libertarian think tank called the Goldwater Institute as a way to give terminally ill patients access to unapproved medications from pharmaceutical companies without being bogged down by FDA regulations. But since at least the 1970s, there had already been a way for patients to get access to such drugs That pathway — called expanded use or compassionate use — is used by hundreds of people a year, and more than 90 percent of such requests are granted by the FDA, experts say.
When seriously ill patients struggle to access unapproved drugs outside clinical trials, drug companies, not the FDA, are most often the main obstacle. But the law did not address that.
“They tackled an issue that was not a problem, and did not tackle the issues that were a problem,” Bateman-House said.
After Harp began making claims on behalf of the Trump campaign about how Right to Try had saved her life, Jeremy Snyder, a public health ethics professor at Simon Fraser University in British Columbia, examined accounts she gave of her medical struggles on LinkedIn, Twitter in interviews with conservative outlets such as Fox News. Snyder compiled the discrepancies he found in a detailed essay last year for The Washington Post
Superficially, he said, Right to Try is good fodder for a political campaign because it fits the libertarian and conservative impulses of cutting government restrictions.
“But it falls apart if you dig even a little bit into it,” he said. “If this woman who didn’t even use the Right to Try law is the best example they can come up with, it just shows the emptiness of the achievements they are trying to claim. They are telling dying people that they have given them some new access to medicine. when that’s not true.”
Julie Tate contributed to this story.