with Paulina Firozi
“People who are terminally ill should not have to go from country to country to seek a cure — I want to give them a chance right here at home,” the president said Tuesday night. “It is time for the Congress to give these wonderful Americans the right to try.”
If Right to Try doesn’t make it through Congress, it won’t be for a lack of champions. It’s a pet issue for Vice President Pence, who as Indiana governor signed a state Right to Try law and has been advocating for federal legislation with key lawmakers in recent weeks according to aides and activists.
Yesterday, Pence's staff (Pence was in West Virginia speaking at the GOP retreat) hosted at the White House an Indianapolis family the vice president befriended several years ago as they advocated for the Indiana state law. Eight-year-old Jordan McLinn is battling Duchenne muscular dystrophy, a muscular weakening disorder where patients are often using a wheelchair by age 12 and have a life expectancy of age 25. His mom, Laura, told me she and Jordan attended a weekly Bible study held in Pence's office.
"The vice president genuinely loves Jordan and the relationship they have is very special," Laura said. "Pence made us a promise back in Indiana when we got the Right to Try law passed there...that he would do anything he could to help Jordan and our family."
A photo of the two last year:
Laura said on Tuesday that she and Jordan met with Indiana's two senators -- Joe Donnelly and Todd Young -- who have also been supportive of Right to Try, before watching Trump give his address later that evening.
"I was watching the State of the Union address with Jordan in my pajamas," Laura told me. "When the president mentioned it, I just held him tight to me and sobbed."
Right to Try laws — first championed by the libertarian Goldwater Institute but which the Koch-backed Americans for Prosperity and other right-leaning groups recently adopted as a top priority — have gained huge momentum at the state level in recent years. Advocates argue that adopting such laws are a way to get potentially lifesaving treatments into the hands of desperately ill patients with no routes left.
Indiana is one of 38 states to have enacted such laws, which allow patients to take experimental medications outside of clinical trials as long as the therapies have undergone preliminary safety testing. Similar bills have been proposed in all the remaining states, according to Goldwater senior policy adviser Starlee Coleman.
Federal legislation, which would prevent the government from interfering with state Right to Try laws, is picking up speed on Capitol Hill. The Senate passed Sen. Ron Johnson’s (R-Wis.) Right to Try bill in August by unanimous consent, and Rep. Andy Biggs (R-Ariz.) is an enthusiastic sponsor on the House side.
Yet there appear to be some hiccups in the lower chamber. Although the House Energy and Commerce Committee held a hearing on Right to Try last fall, hauling in FDA Commissioner Scott Gottlieb to give his take, Chairman Greg Walden (R-Ore.) hasn’t scheduled a vote, and there’s talk of staff making changes to the version passed by the Senate.
“While we don’t have a scheduling announcement at this time, Chairman Walden looks forward to continuing to work with the administration to get these reforms over the finish line for patients,” a committee spokeswoman told The Health 202 yesterday.
But advocates are pressing for the House to pass the Senate version, which had been revised to respond to concerns expressed by the drug industry. Unlike initial versions, the final measure allows the FDA to consider information on safety problems as part of its approval process for a drug used under Right to Try. The Pharmaceutical Research and Manufacturers of America still takes a neutral position on Right to Try, but concedes the changes improved the underlying bill.
Critics have questioned the effectiveness of passing Right to Try measures in the states, since they don’t require but only allow pharmaceutical companies to give patients access to experimental treatments. Gottlieb has been somewhat cool toward the legislation, telling lawmakers the FDA authorizes 99 percent of all requests for access to experimental therapies.
“FDA is proud of its efforts to serve patients through its expanded access program who are unable to participate in trials and are in the difficult, heart-wrenching position of having no other therapeutic options,” Gottlieb told the Energy and Commerce panel.
Yet there has been little real pushback from the industry or advocacy community on the Right to Try push. Merck is the only major drugmaker to formally oppose the federal proposal (and that was before the final revisions).
Indeed, the measure has picked up a remarkable amount of steam this year, even as Congress lagged on major health-care priorities such as long-term funding for the Children’s Health Insurance Program (finally approved in last week’s spending bill) and community health centers.
Last month in a tweet, Pence urged Congress to move forward on Right to Try:
Yesterday I met with @SGottliebFDA on the importance of passing a Right to Try law. It's about restoring hope and giving patients with life threatening diseases a fighting chance. Let's get this DONE.— Vice President Mike Pence (@VP) January 18, 2018
Americans for Prosperity and Freedom Partners, two groups funded by the conservative Koch brothers, launched digital ads in early January:
Coleman credited the success of Right to Try to Goldwater's incremental, state-by-state approach — and the practical implications for families watching their loved ones grapple with terminal diagnoses.
“We have been introduced and met families in basically all 50 states who would be impacted by this legislation,” Coleman told me. “They’re real people — they’re Democrats, they’re Republicans, they’re independents, they are apolitical, they’re hyperpolitical — but they are amazing at reaching out to their members and telling their stories.”
Sen. Johnson and others who were pleased Trump included the efforts in SOTU:
Sen. Dean Heller (R-Nev.):
From the Republican Main Street Partnership:
And some critics. David Gorski, a surgical oncologist and editor of the blog Science-Based Medicine:
National grass-roots organization Breast Cancer Action:
Too many #women still die of #breastcancer every yr & there’s far too little progress to show for all the money spent on #pinkribbon products. We desperately need more effective, less toxic treatments. But #RightToTry doesn't bring promises of a cure, just more false hope. #STOU— Breast Cancer Action (@BCAction) January 31, 2018
Former biotech executive and author Michael Becker:
Correction: An original version stated the American Cancer Society Cancer Action Network supports the Right to Try legislation. ACS-CAN opposes the legislation.
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— One person was killed yesterday and six people were injured when an Amtrak train carrying House and Senate Republicans to an annual retreat at the historic Greenbrier Resort in West Virginia collided with a truck.
None of the dozens of lawmakers, their family members or aides were among the injured, our colleagues Martine Powers, Faiz Siddiqui, Ed O'Keefe and Hawes Spencer report, but Rep. Jason Lewis (R-Minn.) was taken to the hospital. A spokesman for Lewis said he suffered a concussion, was treated and then released.
The man who died was identified as 28-year-old Christopher Foley, by Albemarle County Police who said he was a truck passenger, per our colleagues. The two others on the truck, which belonged to garbage collection service Time Disposal, were taken to the hospital, per the New York Times.
Republican members of the House and Senate, as well as some of their spouses, children and aides were on board the 10-car Amtrak train. Members who are also medical professionals rushed to help. “Shortly after impact, the doctors among the Republican rank and file ignored security officials’ warning not to leave the train and rushed to help,” Ed, Mike DeBonis and Paul Kane write. “Sen. Bill Cassidy (La.), a physician, along with Sen. Jeff Flake (Ariz.) and Rep. Brad Wenstrup (Ohio) helped carry one truck passenger several hundred yards to an ambulance."
Rep. Barry Loudermilk (Ga.) said they “literally pried open the doors and jumped off the train to assist those injured.” “They were very insistent,” Rep. Tom Cole said. “Anybody who had any [medical] training was moving quickly.”
President Trump, who is scheduled to address the group of Republicans today, was "fully briefed on the situation in Virginia and is receiving regular updates,” White House press secretary Sarah Huckabee Sanders said Wednsday.
AHH: San Francisco will immediately dismiss all marijuana misdemeanor convictions dating to 1975 and will wipe arrest records clean for anyone who faced such charges, the city's District Attorney George Gascón said yesterday. The city also plans to review all marijuana felonies recorded during the same time period and, in appropriate cases, dial them down to misdemeanor offenses, The Post's Katie Zezima reports.
“We want to address the wrongs that were caused by the failures of the war on drugs for many years in this country and begin to fix some of the harm that was done not only to the entire nation but specifically to communities of color,” Gascón said at a news conference Wednesday.
"The decision stems from a lesser-known provision in California law that legalized recreational marijuana, language that offers a second chance to people convicted of marijuana crimes in the state," Katie writes. "The new law allows people with misdemeanor marijuana records to have them expunged and those with felony convictions the opportunity to have them reduced."
OOF: Another top HHS official bites the dust. CDC Director Brenda Fitzgerald resigned yesterday because of "complex financial interests" that repeatedly forced her to recuse herself from the agency's activities and kept her from testifying before lawmakers on public-health issues.
HHS Secretary Alex Azar accepted Brenda Fitzgerald's resignation because she could not divest from those interests “in a definitive time period," according to a statement from the agency. Her exit comes on the heels of a Politico report yesterday that Fitzgerald had purchased shares in a tobacco company shortly after becoming CDC director.
"Fitzgerald, 71, a physician who served as the Georgia public health commissioner until her appointment to the CDC post in July, said in an interview late last year that she already had divested from many stock holdings," The Post's Lena H. Sun reports. "But she and her husband were legally obligated to maintain other investments in cancer detection and health information technology, according to her ethics agreement, requiring Fitzgerald to pledge to avoid government business that might affect those interests.
"The ethics issues were part of a broader set of questions about Fitzgerald's general leadership at the agency, which Trump has targeted for deep budget cuts," Lena writes. "Since her appointment, she had made few public statements. She waited 133 days before holding her first agencywide staff meeting, on Nov. 17. And she was scheduled several times to testify before Congress — on opioids and other issues — but had to cancel each appearance. Deputies were sent instead."
OUCH: Some are expressing concerns about data privacy following the major announcement from Amazon, Berkshire Hathaway and JP Morgan Chase that they’re partnering to tackle health-care costs. Our colleague Abha Bhattarai reports privacy experts are sounding the alarm about how Amazon’s increasingly dominant role in people’s lives could affect such a venture. “What happens...when a company that has access to our weekly shopping lists, eating habits and in-home Alexa-based assistants also becomes involved in our medical care?,” Abha asks.
She notes the Health Insurance Portability and Accountability Act of 1996, or HIPAA, prevents health insurances companies or other groups from sharing identifiable medical information. But even if the new partnership is subject to HIPAA, the law doesn’t cover everything. Even if a company doesn’t collect or share medical records, there are other ways a person’s habits and actions can be used to gather information about their health.
“You could say, ‘This patient uses our system to book doctors’ appointments six times a year,’ and compare that with that person’s purchase history to make certain connections,” Glenn Cohen, a Harvard Law School professor who specializes in health law policy told The Post. “Non-healthcare data can often be a rich source of information.”
Here’s one positive sign: Abha writes there's a possibility Amazon is already considering these implications. The company posted a job opening for a HIPAA expert who can “own and operate the security and compliance elements of a new initiative.”
-- Leaders of the House Energy and Commerce Committee have written to two regional drug distributors in Williamson, West Virginia, asking why the companies oversupplied this town with painkillers. In its investigation on the opioid crisis, the committee discovered that over the past decade, 20.8 million prescription painkillers were shipped to Williamson, a town with a community college, a rail yard — and fewer than 3,200 residents. That's more than 6,500 pills per person — though not all of the painkillers stayed in Williamson, The Post's Lindsey Bever reports.
“These numbers are outrageous, and we will get to the bottom of how this destruction was able to be unleashed across West Virginia,” Chairman Greg Walden (R-Ore.) and ranking member Frank Pallone Jr. (D-N.J.) said in a statement.
--A few more good reads from The Post and beyond:
- Health Affairs holds an event on health spending.
- The Senate Health, Education, Labor and Pensions committee holds a hearing on the opioid crisis on Feb. 8.
President Trump weighed in on Wednesday's deadly train collision:
Fact-checking the Democratic responses to Trump's State of the Union Address:
Watch former first lady Michelle Obama talk about the gift exchange with the Trump family on Inauguration Day:
Here's how lawmakers responded to the Daily Caller's Benny Johnson about what they wore to the State of the Union:
At the #SOTU Red Carpet, I asked politicians "Who Are You Wearing?"— Benny (@bennyjohnson) January 31, 2018
Ted Cruz: "I don't know"
Cory Gardner: "JoS. A. Bank"
Cory Booker: *Laughs*
Elizabeth Warren: "Blue"
Sherrod Brown: "Suit, Union made, ten miles from my house"
Sheldon Whitehouse: "Men's Wearhouse"
Gorsuch: "?" pic.twitter.com/VLSQGGwwK8