‘Right to try’ advocacy from Pence and an Indianapolis second-grader gets surprising pushback

Jordan McLinn, 7, of Indianapolis shares a high-five with Vice President Mike Pence at his ceremonial office in the Eisenhower Executive Office Building on Feb. 7, 2017. McLinn has muscular dystrophy and he and others with serious diseases are lobbying the federal government to allow them to use experimental drugs.

WASHINGTON — Indianapolis second-grader Jordan McLinn has been the adorable face of a national push to give seriously ill patients increased access to investigational drugs.

He’s had private meetings with Vice President Pence — a champion of the “Right to Try” legislation that bears Jordan’s name. He sat with lawmakers on the House floor last week when the bill came up for consideration — and suffered a surprising defeat. And House Republicans sent around a photo of a grinning Jordan talking to Pence when announcing Monday the legislation will be reconsidered this week.

“They aren’t giving up hope, and we won’t give up on them either,” House Majority Leader Kevin McCarthy’s office said of patients like Jordan in announcing the bill’s return.

All this attention is for legislation that would offer no immediate benefit to Jordan, who is in a clinical trial for a drug to treat his form of muscular dystrophy. That said, it could be a lifeline in the future.

Critics of the bill argue it offers little but false hope to others. They say it’s nothing more than the “right to ask” a drugmaker for access to a drug that’s in early testing stages – and the valid reasons the drugmakers may have for not providing the drug wouldn’t be changed by the bill.

Robert Truog, head of the Harvard Center for Bioethics, has called “right to try” laws “political candy” — “sweet for lawmakers’ constituents but offering little substance.”.

Like the state versions of the legislation approved in Indiana and 37 other states, the federal version is based on the false premise that the Food and Drug Administration is blocking access to drugs they haven’t approved, said Rep. Frank Pallone, D-N.J.

“This is simply not the case,” he said.

Four former FDA commissioners and more than 75 patient groups have come out against the federal legislation after it unanimously passed the Senate last year. Indiana Sen. Joe Donnelly was one of the lead sponsors of the bill because of Jordan.

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Jordan’s mother, Laura McLinn, said the legislation is needed because while it won’t help masses of people, it will help some.

“In my heart, I don’t believe that millions (of people) are necessarily going to be saved,” she said. “But I do believe that a few are, and those few are very important.”.

The compassionate case for the legislation helped speed versions through state legislatures, as did the Goldwater Institute, a conservative think tank based in Phoenix that took up the cause. The institute wrote model legislation for states to protect “the fundamental right of people to try to save their own lives.”.

Jordan was at Pence’s side when, as Indiana’s governor, Pence signed Indiana’s version into law in 2015.

“`If there’s anything I can ever do to help you, let me know,'” Laura McLinn remembers Pence telling her family.

No one suspected Pence would be in a powerful position to do that in a few years.

In addition to keeping up with the McLinns, who had joined the push for federal legislation, Pence encountered on the 2016 vice presidential campaign trail a boy whose father is dying from Lou Gehrig’s disease. Pence promised Zack Mongeillo a Trump administration would “open the doors to treatment.”.

The FDA contends, however, that they’re already doing that.

Of the nearly 5,800 requests the FDA received from 2012 through 2015 for its expanded drug access program, the agency approved 99 percent of them, according to the Government Accountability Office. The most common reasons requests were denied included incomplete applications, safety concerns, the availability of adequate alternative therapies and evidence that the drug was ineffective for the intended use, according to the GAO.

“The bottom line is, in the vast majority of cases, we do approve it,” FDA Commissioner Scott Gottlieb told lawmakers in October. The biggest obstacle, he said, is drug availability.

Drugmakers may have only a limited quantity of the drug, may not have enough resources to administer expanded access requests, or may worry that offering the drug would make it harder to recruit participants for the clinical trials necessary to get FDA approval of the product.

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“I think there’s a perception that this legislation will create more pressure on companies to offer the drug,” Gottlieb testified. “That’s an open question.”.

Jordan encountered the lack of drug availability after Indiana passed its “right to try” legislation.

“Even though Jordan legally has the `Right to Try’ now, the drug company has to be willing to give or sell him the drug,” Laura McLinn testified at a Senate hearing in 2016. “At this point, they are not open to do that…For reasons that are understandable but not really OK for us at the same time.”.

While Jordan has since qualified for a clinical trial for a drug that could slow the progression of his disease, Laura said drugs to cure his disease could be available in the future.

McLinn said drugmakers might be afraid of getting “sideways” with the FDA, which is why federal legislation approving the process is needed.

Matt Bellina — one of the other patients the bill is named for — said two drug companies have indicated that they would try to treat him if the legislation becomes law, according to a statement he released through the Goldwater Institute.

The federal protection is needed to assure drugmakers that providing a drug that’s only been tested preliminarily won’t jeopardize the drug’s chances of continuing through the FDA’s drug approval process, said Starlee Coleman, Goldwater Institute senior policy adviser.

Coleman also discounts the GAO’s statistic that the FDA already approves nearly all requests for access to experimental treatments through its expanded drug access program. Doctors only apply to the program if they’ve gotten an informal indication from the FDA that their patient would qualify, she said.

But patient advocacy groups, including the American Cancer Society Action Network and the American Lung Association, worry that allowing patients to bypass the FDA’s expanded access program is too risky.

“The FDA would not have the opportunity, as they currently do, to provide consultation on dosing, route of administration, dosing schedule and other important safety measures which they are uniquely positioned to understand,” the groups wrote in a letter to congressional leaders.

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McLinn, who said those groups don’t speak for all of their patients, was watching from the balcony last week when the House first debated the bill.

Expected to easily pass, the bill had been brought up under an expedited procedure that required approval from two-thirds of those voting.

When that failed 259 to 140, backers said they would consider the bill under regular rules. While it could pass as early as today, the opposition the bill has generated since the Senate approved its version last year will make it more difficult for lawmakers to agree on a final version. Advocates had hoped the House would take up the Senate’s bill, instead of more narrowly limiting what patients can go outside the FDA’s existing program, so the bill could’ve been sent to the president’s desk.

“We do not see a path for a separate House bill to make it back to the Senate,” Coleman said. “They feel like they’ve done their work.”.

McLinn and her son were watching on television President Trump’s State of the Union address this year when the president called on Congress to pass the legislation, the only specific bill Trump plugged in the speech.

Pence met privately with the McLinns before last week’s vote and helped arrange for Jordan, now 8, to be on the House floor with the bill’s sponsors during the debate. (In previous trips to Washington, Jordan has tested out jokes on the vice president, attended a Bible study held in Pence’s office and watched as Pence swore in Education Secretary Betsy DeVos in the vice president’s ceremonial office.).

“He loves every part of being in Washington,” Laura McLinn said. “He used to want to be a fireman and now he wants to be president.”.

McLinn said she’s proud that her son is the national face of the “right to try” movement, particularly because the family could’ve stayed focused on Jordan’s treatment once he got into a clinical trial.

“The reason we have remained on this journey and fighting so hard for it is not necessarily for Jordan immediately,” McLinn said, “It’s for all the patients that we’ve met along the way.”.

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