Congress Is About To Pass A Bill That Shows D.C. At Its Worst — It May Also Fix The Opioid Crisis And Cure Cancer – Huffington Post

 In Health
WASHINGTON ― In 1996, Purdue Pharma introduced a new painkiller it said carried a low risk of abuse or addiction. It called the drug “OxyContin.”

In reality, of course, OxyContin was extremely addictive — and Purdue knew it. A decade later, three Purdue executives, and the company itself, pleaded guilty to criminal charges tied to OxyContin’s marketing and agreed to pay more than $600 million in fines.

But the executives dodged prison time, and the prosecution did little to slow the rise of opioid use. The pharmaceutical industry had spent the past 10 years and billions of dollars pushing the medical community to ramp up the use of OxyContin and other opioids. By 2013, the number of annual opioid prescriptions, including short term and multiple, had nearly tripled, topping 200 million — in a country of just over 300 million people.

Use of OxyContin and other opioids grew to crisis levels. As federal and state governments cracked down on doctors who dispensed pills and prescriptions indiscriminately, users turned to heroin instead: Four out of five new heroin users started out by abusing prescription painkillers. The results have devastated and overwhelmed first responders and an ill-equipped and ideologically hidebound treatment system. From 2010 to 2012, heroin overdose rates doubled in 28 states, according to a 2014 Centers for Disease Control and Prevention report. In 2014, more than 28,000 Americans died of opioid overdoses, an all-time high, according to the agency. There’s no reason to think the death rate has slowed since then.

Congress is ready to act. On Wednesday, the House will consider the 21st Century Cures Act, a bill that would commit billions of dollars to medical research while sending $1 billion to states to help combat heroin and painkiller addiction and recovery.

But there’s a complication: Instead of cracking down on the pharmaceutical companies that fueled the boom in opioid abuse, lawmakers are rewarding the industry. No health care-related bill of this size could move through Congress without the support of Big Pharma. The authors of the 21st Century Cures Act earned the industry’s support by including regulatory rollbacks that drugmakers have long sought and creating cheaper and quicker paths for drug approval by reducing safeguards. It’s as if the fire department had to pay off the arsonist to get permission to put out a fire.

Lawmakers have been left with a Hobson’s choice: The bill would make billions of dollars available for medical research. It would fund lofty goals, such as precision medicine, a White House initiative to map the human brain and Vice President Joe Biden’s “Cancer Moonshot.” It would save lives. But it would also undermine regulations that patient advocacy groups say are essential for making sure medical and drug research is conducted ethically and safely — meaning it could cost lives, too.

Some politicians think the choice is clear. On Monday evening, Sen. Elizabeth Warren (D-Mass.) denounced the measure in aggressive terms, calling it the result of “corruption” fighting words on the Senate floor and singling out Republican Majority Leader Mitch McConnell of Kentucky for taking millions from a donor with an interest in the bill’s passage. Warren was hoping to make a battle around the Cures Act the moment that Democrats announced, in the wake of Donald Trump’s election, that they were standing up and fighting against a broken and corrupt system.

The American people didn’t give Democrats majority support so we could come back to Washington and play dead,” she said on the floor. “They didn’t send us here to whimper, whine, or grovel. Now they are watching, waiting and hoping ― hoping we show some spine and start fighting back when Congress completely ignores the message of the American people and returns to all its same old ways.”

But others have read the politics around the bill differently. Sen. Johnny Isakson (R-Ga.), one of the bill’s supporters, called Warren’s floor speech “the most irresponsible statement anybody can possibly make,” adding: “She pontificates as if she knows everything, when in fact she knows nothing.”

Isakson and his allies will probably win. The bill heads for a fast-track vote in the House on Wednesday and will be taken up by the Senate next week, where it has significant bipartisan support, unless Warren and her progressive allies make inroads. The Obama administration formally announced its strong support on Tuesday evening. It’s extremely likely to become law.

The debate surrounding the 21st Century Cures Act has come to embody a larger dispute about how government can and should operate. Some 1,455 lobbyists acting on behalf of more than 400 companies and other organizations have lobbied on the legislation, according to the Center for Responsive Politics. Over the past year and a half, companies who disclosed they lobbied on the Cures Act spent half a billion dollars to influence Congress. The resulting bill is packed with politicians’ pet projects and sops to industry.

The 2016 election, like every one prior, was run on a promise to change this sort of legislating ― to drain the swamp. But those pledges, like ones before, will come in conflict with how Washington actually works: by blending good motives, bad compromises and giveaways to interest groups ― and holding your nose as you vote on the result. 


Congressman Fred Upton (R-Mich.) is the force behind the 21st Century Cures Act.
Rep. Fred Upton, the Michigan Republican who chairs the House Energy and Commerce Committee, became convinced of the need for a Cures-type bill in 2011, after he met Brooke and Brielle Kennedy, two sisters (ages 8 and 9, respectively) with spinal muscular atrophy, a rare disease that destroys the nerves that control voluntary muscle movement.

“I remember when they first came to my office in Kalamazoo,” Upton told The Huffington Post on Tuesday night. “I said, ‘What’s your name?’”

One of the girls answered that she was Cinderella and told Upton that her sister was Sleeping Beauty.

“So that’s who they’ve always been, those two,” Upton said. “But whether it’s that, whether it’s Duchenne, whether it’s Alzheimer’s, diabetes, lupus, cancer. I mean, we’re all impacted by these things.”

Gabe Griffin, an 11-year-old with Duchenne muscular dystrophy, became another inspiration for the bill. As did Upton’s family members. His wife has lupus, an autoimmune disease, his mother is a cancer survivor, and his father has diabetes. “I’m no different than anybody else,” Upton said. “We all have those stories.”

When Upton set out to craft the bill to help people like Griffin and the Kennedy sisters in December 2013, he knew he had to balance certain interests. Lots of politicians were pushing for more government funding for biomedical research. But Republicans didn’t want to raise taxes to pay for it — and argued the same result could be achieved by cutting regulatory red tape. The congressman saw an opportunity for a bargain in which both sides could get what they wanted.

In December 2013, he partnered with Democrat Diana DeGette of Colorado to begin painstakingly assembling draft legislation. They, in turn, worked with the chairman and ranking Democrat on the Senate Health Committee, Sens. Lamar Alexander (R-Tenn.) and Patty Murray (D-Wash.).

Upton and DeGette pulled together language from proposals intended to bring to market much-needed medical therapies that weren’t economically viable and from bills to stimulate investment in new infectious disease remedies. They added measures tinkering with the Food and Drug Administration’s approval processes and streamlining clinical trials. They proposed the creation of an administrative working group to address the hurdles scientists face when applying for federal research grants.

Most important, at a time when Congress was pinching every penny, the bill found revenue sources to fund more research. Upton and DeGette’s draft legislation devoted $8.75 billion to the National Institutes of Health and $550 million to the FDA over a five-year period — offset by selling oil from the Strategic Petroleum Reserve and cuts to the payments Medicare and Medicaid make to states, insurance companies and providers.

In April 2015, after eight hearings, 24 roundtable discussions and several white papers, the bipartisan pair released a discussion draft. The formal bill passed through committee by a 51-0 vote in May. In July of that year, the full House approved the bill by a vote of 344 to 77. PhRMA, United for Medical Research, Newt Gingrich and Katie Couric all applauded its passage.

House and Senate supporters of the legislation were working out the differences between their bills well before the Senate actually passed its own version. But the Senate was the Senate: slow to act. By the time that chamber took up the bill at the beginning of 2016, Congress had already used a chunk of Upton and DeGette’s funding sources on other things, forcing lawmakers to find new ways to pay for the bill or decrease its cost. They decreased its cost: bringing funding for the NIH from $8.75 billion over five years down to $4.8 billion over 10 years.

At the urging of Rep. Paul Ryan (R-Wis.), who became House speaker after the bill passed that chamber, they also changed the funding from mandatory spending, which is paid out automatically unless Congress votes to change it, to discretionary spending, which lawmakers have to vote to spend each year.

For biomedical research advocates, this shift complicated the part of the legislation that they actually loved. The NIH’s budget has grown slightly since taking a major hit in 2013: from $30.07 billion in fiscal year 2014 to $31.3 billion in FY 2016. But funding isn’t keeping up with inflation, and other countries are increasing the amount they spend on medical research at a much higher rate.

An infusion of $4.8 billion “isn’t anything to take lightly,” said one senior official for a biomedical research advocacy group. But by making the funding discretionary, the lawmakers also endangered it. Congress, for example, could decide to fund NIH at a lower level in 2017 by arguing that the funding made available from the 21st Century Cures Act justifies the cut. Congress could also choose to raid the $4.8 billion in NIH funding for unrelated purposes — fighting the next infectious disease outbreak, for example.

And then there is the matter of the incoming president, Donald J. Trump, who has promised to take advantage of low interest rates and borrow to invest in research and infrastructure, but whose commitment to science is not exactly sterling. Two Democratic senators said they spoke to Michael Botticelli, director of the Office of National Drug Control Policy, about concerns that Trump might not spend the opioid-related money for its stated purpose. Botticelli assured them that he could get the money out the door and to the states before Trump takes office on Jan. 20. It would be a bureaucratic feat, but “if anybody can do it, he can do it,” said Sen. Jeanne Shaheen (D-N.H.).

Still, believing that lawmakers and bureaucrats will keep their promises requires “an awful lot of putting faith in the process,” a second medical research advocate told HuffPost. And “faith” is not a sound foundation for science. Biomedical research relies, instead, on stability. Grants are awarded over several years and if a grant-awarding agency is worried that its funding pool might shift or dry up, the type of research it funds will be shorter-term investments.

“I am concerned that we’re talking about $6 billion of offsets, and of cuts, for only one year of guaranteed funding,” Sen. Bob Menendez (D-N.J.) told The Huffington Post. “I don’t know that I want to give the Republican majority 6 billion in cuts when I only have one year of funding.”

Republicans on Capitol Hill say they understand and recognize the worry about discretionary spending for the bill’s initiatives. But they argued it is overblown. As the congressional GOP aide noted, even mandatory funding isn’t guaranteed because no Congress can bind a future Congress. Far more important, he added, was that the research priorities funded by the 21st Century Cures Act enjoyed seemingly unshakeable bipartisan support.

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