Worrisome ‘right to try’ legislation may soon become law. Here’s the story that some news outlets missed

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The following post is written by veteran health care journalist and regular HealthNewsReview.org contributor Trudy Lieberman. She tweets as @Trudy_Lieberman.

Right before Congress adjourned for the August recess, the Senate rushed through “right to try” legislation that its sponsor Sen. Ron Johnson of Wisconsin argued gives terminally ill patients the “right to access treatments that have demonstrated a level of safety and could potentially save their lives.” Johnson was selling hope, a commodity never in short supply in America’s bag of marketing tricks. He also was selling something else–a way to circumvent the FDA’s role in a process that has been in place for several decades that lets very sick people try experimental approaches not yet on the market.

right to try legislation

A still taken from a video clip from the office of Sen. Ron Johnson, R-WI.

Under what’s called the FDA’s compassionate use program, patients must first find a doctor who will agree to try the experimental approach and contact the drug company for permission to use it. After the doctor and patient get a drug maker’s sign-off, they must fill out paperwork and send it to the FDA. If the FDA says yes, the patient can try the drug. There’s still another step – approval by the Institutional Review Board (IRB) at the hospital or institution where the experimental approach will be delivered. And, of course, a patient must have money to pay for it.

House could vote on it soon

But the legislation, on its way to possibly an early vote in the House of Representatives in the next few weeks, eliminates the FDA in the process and with it any protections patients might have. For example, the FDA may know about other drugs in the same class as the experimental approach and can warn of problems that have arisen with those drugs. It also can ask for safety adjustments in administering the experimental drug. For example, should the dosage be changed, or is a heart monitor needed?

The FDA approves about 99 percent of the drugs that terminally ill people ask for, and the process moves quickly. The agency turns around emergency requests within 24 hours and, in non-emergency situations, within three to four days.

The FDA isn’t the gatekeeper here, says Alison Bateman-House, a medical ethicist at New York University’s Langone Medical Center in New York City. “The idea the FDA is the stumbling block is completely wrong.” It’s the drug companies that decide if someone can try one of their drugs that is still in development and not for sale to the public. 

“We don’t know how many times requests to the drug companies are approved or denied,” Bateman-House said. “But if the drug company says ‘no,’ that’s the end of it.”

Even drug companies are non-committal about the legislation

Why eliminate the FDA’s role in this? Even the drug industry has been non-committal about the legislation. The main force behind the legislation and also behind similar laws passed in 37 states is the Goldwater Institute, a libertarian think tank based in Phoenix, that has been on a crusade to pass right-to-try laws with the FDA its apparent target. The group calls itself “a national leader for constitutionally limited government” and believes these laws are the “ultimate in patient empowerment.” Institute executive vice president Christina Sandefur told The Washington Post that “patients ought to be able to make these life or death decisions to save their own lives.”

Who might benefit then, if not the drug companies? The organization Who.What.Why. reported that new drug startups might be interested in creating buzz for their products and finding a new revenue source–wealthy patients who can pay for their super-expensive experimental medicines. Dishonest doctors might be interested, too, in the fees they could collect for monitoring patients who use these drugs.

Most of these particulars about the FDA’s process and about harmful provisions in many of the state laws weren’t discussed in the limited sample of stories that we saw on this issue.

Right-to-try often comes with serious drawbacks

“The public has no idea this is not a good thing,” says Bateman-House. “They know nothing about the bill except that the right-to-try sounds like a good thing.” For example, few patients in the 37 states that have adopted such laws are likely to know they may lose hospice coverage or they may be denied coverage for home health care if they are using an experimental drug. In Colorado, Connecticut, Oklahoma, and West Virginia, patients may lose their health insurance. Their coverage may be denied for six months after the experimental approach ends.

And when those significant drawbacks were mentioned in the stories we saw, they were sometimes laced in along with glowing, positive comments from supporters like this one woman who told the Capitol Gazette, which serves Annapolis and Anne Arundel County MD, “It’s very exciting…This will allow us to have access to those treatments.” The Gazette’s story did note patients would have to sign a waiver acknowledging they may no longer be eligible for hospice care and that their insurance carrier would not have to pay for care needed because of the experimental treatment. But those caveats and the FDA’s position coming toward the end of the story were probably lost on many readers.

Local news coverage provides little help

News coverage of the legislation, especially by small local news outlets, reminds me of the paucity of coverage of the 21st Century Cures Act, which passed Congress last December after a two-year crusade by the House Energy and Commerce Committee, which, as HealthNewsReview.org reported many times, was largely ignored by the news media.

This time around, as Johnson’s bill gained traction in the Senate this summer, several national outlets, including Vox, MedPage Today, Roll Call and The Washington Post offered good assessments of the legislation and why it may not be necessary.

But, based on our limited sampling of news coverage,  people outside the Beltway who don’t read those publications mostly got short takes describing their state legislation or Johnson’s bill. In Johnson’s home state, Wisconsin, the Door County Pulse ran a one-paragraph item noting their senator “is one step closer to giving terminally ill patients the ability to try experimental treatments with Food and Drug Administration approval.” There was no mention of the fact that they can already do that.

The Milwaukee Journal Sentinel offered more–ten short graphs with one calling Senate passage “a key milestone in a push to allow terminally ill patients to receive experimental drugs not approved by the U.S. Food and Drug Administration.” The story was upbeat and reported that Johnson’s bill “would prohibit the federal government from taking action to prevent patient access to experimental medications when several conditions are met.” It didn’t say what they were. The paper offered two sentences at the end allowing critics of Johnson’s bill to have their say. It’s hard to see that readers in Wisconsin would know much of anything about this bill or that terminally ill patients already have a way to get experimental treatments or how that’s done.

Op-eds, meanwhile, espouse bill’s benefit

Around the country we found op-eds here and there advocating for Johnson’s bill. Rep. Morgan Griffith, R-Va., who has sponsored his version of Johnson’s bill in the House, penned one for the Martinsville Bulletin. Ted Abram, a board member of FreedomWorks, a conservative, libertarian advocacy group, wrote one in the East Oregonian, telling the story of young Diego Morris, a cancer patient, who couldn’t get a life-saving drug available in other countries. His family traveled to London to get it. The story didn’t discuss whether his family tried to get it through the FDA’s compassionate use program, or whether the drug company turned them down.   

When hope sells, bad journalism becomes acceptable. Stories about right-to-try legislation unfortunately are similar to what coverage there was about the 21st Century Cures. In the run-up to passage, the chief proponent, the House Energy & Commerce Committee, trotted out sick kids to bolster their case for loosening device regulations. The same is happening with right-to-try. Diego Morris became the honorary chair of the Goldwater Institute’s right to try campaign. An article that ran in the The Washington Post in March started and ended with the story of seven-year-old Jordan McLinn, who has Duchenne muscular dystrophy, a disease often cited by supporters of the Cures Act as a reason for its passage.

While there’s nothing wrong with a good tale, it’s the part between the beginning and the end that needs loads of improvement.        

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