The 21st Century Cures Act, a bill to provide billions of dollars of funding to the US National Institutes of Health (NIH), the Federal agency responsible for biomedical research, sailed through the US House of Representatives last week with a rare showing of strong bipartisan support. It is expected to pass the US Senate and to be signed by President Obama, a strong backer, later this month.
The $4.8 billion in funding for NIH is targeted at three areas: cancer research (as in Joe Biden's "cancer moonshot"), brain research (including Alzheimer's, Parkinson's and PTSD) and precision medicine (treatment informed by patient genomes).
However, $3.5 billion in funding of the bill will be redirected from Obamacare's Prevention and Public Health Fund, which is chartered to research Alzheimer's and other infectious diseases, so it could be argued that the bill reduces the Federal government's commitment to Alzheimer's research.
While the NIH employs thousands of researchers, most of the new funds are expected to be distributed to researchers at universities, hospitals, and other external labs.
The bill also authorizes $1 billion to fight the nation's opioid crisis, and $500 million in additional funding for the Federal Drug Administration (FDA).
As part of the compromise needed to attract Republican support, the bill loosens the guidelines on the FDA needed to approve a new drug or medical device; the industry and some patient advocates have complained about red tape in getting new drugs approved. However, the new approach has troubled some doctors who have followed the legislation.
Senators Elizabeth Warren (D-MA) and Bernie Sanders (I-VT) have attacked the bill as a giveaway to the pharmaceutical and medical device industries, at the expense of the health of consumers and patients. Some conservative groups also oppose the bill as a waste of public funds.
Legislation text; political analysis from StatNews.
Related Stories
U.S. Vice President Joe Biden has released another cancer progress report/wish list:
Vice President Joe Biden today released his vision for doubling progress against cancer over 5 years. It includes numerous policy recommendations and a laundry list of projects by the National Cancer Institute (NCI) and other federal agencies that would require additional funding. Biden and his wife, Jill, have met with thousands of experts and patient advocates, they explain in a 17-page strategic plan submitted to President Barack Obama, who asked Biden in January to lead the effort. "We sought to better understand and break down the silos and stovepipes that prevent sharing of information and impede advances in cancer research and treatment, while building a focused and coordinated effort at home and abroad," they explain.
The Bidens' wish list ranges from giving patients more control over their medical data to launching "a national conversation" about cancer drug pricing. They also want to see more high-risk research funding at NCI and changes to the institute's intramural research program to focus more on emerging science and major public health challenges.
An accompanying 29-page report from Biden's federal moonshot task force lists what agencies have done so far and their plans to address five strategic goals. The first goal, "catalyze new scientific breakthroughs," contains several items that "align with" the 10 research areas recommended last month by an NCI blue ribbon panel, the report says. For example, it describes Department of Defense (DOD) efforts to develop new imaging technologies for detecting early molecular changes in cells that may lead to cancer.
The Cancer Moonshot is part of the War on Cancer:
The mission of this Cancer Moonshot is not to start another war on cancer, but to win the one President Nixon declared in 1971. At that time, we didn't have the army organized, didn't have the military intelligence to know the enemy well, and therefore didn't have the comprehensive strategy needed to launch a successful attack—now we do. Because of the progress over the last 45 years we have an army of researchers and oncologists, the powerful technologies and weapons, and immense public support and commitment to action.
Related:
Biomedicine Facing a Worse Replication Crisis Than the One Plaguing Psychology
The White House Announces $121 Million Microbiome Initiative
"Cancer Moonshot" Releases Blue Ribbon Panel Report
Microsoft to "Solve the Problem of Cancer" Within Ten Years - Scientists are Skeptical
Francis Collins will remain the director of the National Institutes of Health, for now:
Ending weeks of speculation, President-elect Donald Trump has asked National Institutes of Health (NIH) Director Francis Collins to remain in his position. It is not clear for how long. "We just learned that Dr. Collins has been held over by the Trump administration," an NIH spokesperson said in a statement. "We have no additional details at this time."
Collins, a geneticist who has headed the $32 billion NIH for the past 8 years, has been campaigning to keep his job and met with Trump last week. On Wednesday, he told a reporter at the World Economic Forum in Davos, Switzerland, that he still didn't know what his fate would be. But although Collins had the support of key Republicans in Congress, he has been one of several candidates for the NIH post, including Representative Andy Harris (R–MD).
Related: NIH Won't Fund Human Germline Modification
Group of Scientists and Bioethicists Back Genetic Modification of Human Embryos
Human-Animal Chimeras are Gestating on U.S. Research Farms
NIH Plans To Lift Ban On Research Funds For Human-Animal Chimera Embryos
Neuroscientists Stand Up for Basic Cell Biology Research
Major Biomedical Research Funding Bill Sails Through US House
(Score: 2) by ikanreed on Tuesday December 06 2016, @05:14PM
$1 Billion to "fight" the opioid epidemic could be money into a memory hole, or worse: counterproductive and make things worse, depending on exactly what it's going towards.
More law enforcement would just make things worse. A billion towards researching it might actually be excessive. A billion towards non-punishment treatment and rehabilitation would do a lot of good.
I know I'm being a bit lazy, but a text search for "Heroin", "Opi*", and "Pain killers" yielded no results, so I couldn't easily find what their plan was.
(Score: 2) by takyon on Tuesday December 06 2016, @05:26PM
I'm not sure what NIH plans to do about it, but you can find some of our past coverage here:
https://www.google.com/?gws_rd=ssl#q=site:soylentnews.org+opioid [google.com]
I also read recently about some non-addictive opioid. It's not related to suboxone/buprenorphine, but a safer painkiller. I'll look for it later.
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 3, Interesting) by MichaelDavidCrawford on Tuesday December 06 2016, @05:33PM
states that have legalized marijuana have seen a dramatic decrease in opioid deaths.
Yes I Have No Bananas. [gofundme.com]
(Score: 2) by ikanreed on Tuesday December 06 2016, @05:46PM
This would not surprise me to learn, but I'd also be wary of deriving strong conclusions from it because, in general, marijuana has been legalized in more liberal places with better GDP per capita, and the opioid epidemic has hit hardest in places with lower average incomes, worse medical care, and less diversity.
(Score: 3, Informative) by dlb on Tuesday December 06 2016, @06:02PM
There was a significant increase in the rate of past-year heroin use in the United States between 2002–2004 and 2011–2013. Rates remained highest among males, persons aged 18–25 years, persons with annual household incomes [less than] $20,000, persons living in urban areas, and persons with no health insurance or with Medicaid.
(Score: 2) by tathra on Tuesday December 06 2016, @06:08PM
so what you're saying is that the opioid epidemic is a symptom of bigger problems. but nobody wants to address those, because then we'd have to admit that our society is broken. the opioids themselves are a problem too, but things like increasing access to naloxone [huffingtonpost.com], putting a focus on education and harm reduction efforts, including needle exchanges, and ending prohibition are whats necessary to fight it.
(Score: 2) by ikanreed on Tuesday December 06 2016, @06:15PM
That's certainly a big part of what I'm trying to say, yes. In general, I'd like to see evidence-based approaches, rather than moralizing approaches to drug problems.
(Score: 3, Informative) by dlb on Tuesday December 06 2016, @05:54PM
In states where it is legal to use medical marijuana to manage chronic pain and other conditions, the annual number of deaths from prescription drug overdose is 25 percent lower than in states where medical marijuana remains illegal, new research suggests.
(Score: 0) by Anonymous Coward on Tuesday December 06 2016, @06:46PM
Except opiods cause chronic pain. It may be that MJ is a good drug to ween off the dependence, which stops the pain in the long run. I hate medical-marijuana crusaders and their foot-in-the-door nonsense a lot, but this could be useful.
(Score: 0) by Anonymous Coward on Tuesday December 06 2016, @05:18PM
http://heritageaction.com/key-votes/no-revised-21st-century-cures-act-h-r-34/ [heritageaction.com]
No, this is not the source of the waste at all. The source of the waste is researchers publishing unreproducible papers with poorly described methods, usually p-hacked, testing a pointless null hypothesis of "no difference". This research exists just because they need to give the impression of "discovering something new" for their careers.
(Score: 0) by Anonymous Coward on Tuesday December 06 2016, @05:35PM
Reproducibility is a problem and it would be great if there was funding for such studies, but people want their money going towards researching cures and they are too short-sighted to value reproducibility.
(Score: 0, Insightful) by Anonymous Coward on Tuesday December 06 2016, @06:07PM
True, when it comes to medical research there sadly is not much interest in doing a good job these days.
(Score: 0, Troll) by khallow on Tuesday December 06 2016, @06:09PM
but people want their money going towards researching cures and they are too short-sighted to value reproducibility.
"People" don't decide to throw money at irreproducible research. Unaccountable bureaucrats in control of the purse strings do that.
(Score: 0) by Anonymous Coward on Tuesday December 06 2016, @07:42PM
If the voting public do not hold their elected officials accountable, then that is not a failing of the NIH.
(Score: 1) by khallow on Tuesday December 06 2016, @07:46PM
If the voting public do not hold their elected officials accountable, then that is not a failing of the NIH.
NIH is not an elected official.
(Score: 0) by Anonymous Coward on Tuesday December 06 2016, @08:47PM
The NIH didn't vote on how much money they get for their budget or pass bills such as the "21st Century Cures Act".
(Score: 1) by khallow on Wednesday December 07 2016, @07:18AM
(Score: 0) by Anonymous Coward on Wednesday December 07 2016, @03:18PM
That's a fair point.
Congress, as a whole, is largely incapable of holding any federal agency accountable unless it is related to a political controversy that they could get publicity for.
(Score: 1, Informative) by Anonymous Coward on Tuesday December 06 2016, @08:22PM
"People" don't decide to throw money at irreproducible research. Unaccountable bureaucrats in control of the purse strings do that.
Most of NIH's money is spent on extramural grants. Those grants are ranked by other scientists, not by NIH staff or bureaucrats. One imagines that active researchers in the relevant discipline are best able to evaluate the quality of the proposal and the scientists making the proposal. One imagines that those researchers are sensitive to the ideas of reproducibility, p-hacking, and generally credible science.
(Score: 1) by khallow on Wednesday December 07 2016, @07:23AM
Those grants are ranked by other scientists, not by NIH staff or bureaucrats.
Scientists are just more bureaucrats. There's nothing magical about them or their motivations. And what accountability is there to the ranking process?
(Score: 2, Informative) by Anonymous Coward on Tuesday December 06 2016, @05:23PM
Blog post from Dr. Lowe on the topic:
http://blogs.sciencemag.org/pipeline/archives/2016/12/05/the-21st-century-cures-act-a-giant-pinata [sciencemag.org]
(Score: 0) by Anonymous Coward on Tuesday December 06 2016, @10:15PM
i thought republicans were for smaller government? BS, they just have different lobbies to cater to.
(Score: 4, Informative) by Anne Nonymous on Tuesday December 06 2016, @10:20PM
2015 R&D Budgets:
Amgen $4.1 bln
Pfizer $7.7 bln
Merck $6.5 bln
Biogen $2.0 bln
Celgene $3.7 bln
Lilly $4.8 bln