FDA Pick Shows Promise
Donald Trump promised to shake things up in Washington and he has. President Trump is arousing some strong emotions but it’s important to try to look at his policies objectively. An earlier Health Rising blog suggested that Trump’s emphasis on deregulation at the FDA could have positive effects for chronic fatigue and fibromyalgia.
Trump’s FDA pick could make it easier to produce drugs for ME/CFS and FM
Trump’s first apparent choice to head the FDA was an outsider who believed that the expensive phase III clinical trial phase – termed the “valley of death” – should be done away with. Instead, he believed that the FDA should focus on proving safety and let the market decide which drugs were effective. He was backed by a former FDA chief but the major pharmaceutical companies were not on board.
In the end Trump settled on Scott Gottlieb, a drug company insider who believes that an overemphasis on safety at the FDA has deprived consumers of much needed drugs (and drug companies of revenues). Gottlieb is a more middle of the road pick who may end up instituting changes that end up being helpful to people with chronic fatigue syndrome (ME/CFS) and fibromyalgia (FM).
Trump Proposes Almost 20% Cut In NIH Spending
The effects of Trump’s first budget proposal are more clear cut for chronic fatigue syndrome and fibromyalgia. At first glance the budget looks like a deficit reduction budget but it’s not. Instead it’s trading off major increases Trump believes are needed to improve national security for significant budget decreases just about everywhere else. Trump’s emphasis (some might say obsession) with national security and his commitment not to touch entitlements has left him little choice but to whack away at spending for much of the rest of the government.
That’s because the Defense department’s budget – at about 600 billion dollars a year – chews up such an enormous amount of discretionary spending (about 53%). Add in Homeland Security and Veteran Affairs, the two other departments getting significant funding increases in Trump’s 2017 budget proposal, and we’re looking at almost 700 billion dollars a year. Adding just 5-10% to those departments budgets requires slashing other smaller department budgets dramatically, and that’s exactly what Trump proposes to do.
The Department of Health and Human Services, which the NIH falls under, is cut by 16% but the NIH itself is given an 18% cut. That’s a staggering drop for an agency which was already getting 20% fewer dollars in real money compared to 2003. From 2003 to 2014 sequestration, flat budgets and increasing research costs left deep the NIH in the red. Among other things that’s has played out in lower and lower grant application success rates (10-15%) – not a good thing for two research communities which aren’t exactly flooding the NIH with applications.
Trump’s budget cuts imperil the progress ME/CFS has made at the NIH
In 2016 President Obama reversed the trend with a $2 billion increase last year but Trumps budget proposal would cut almost $6 billion from the NIH – leaving world’s biggest medical research effort spending about what it was 17 years ago.
Researchers aghast at the proposed cuts are, of course, beginning to speak out.
Reducing NIH’s funding by nearly 20% will devastate our nation’s already fragile federal research infrastructure and undercut a longstanding commitment to biomedical science that has fueled advances in cancer prevention, diagnosis and treatment,” Daniel Hayes, MD, president of the American Society of Clinical Society
.Speaking about the rising problem of heart disease, American Heart Association President Steven Houser said “”I thought we were, all of us, interested in improving the health of all Americans. We need to give more, not less…You can save $6 billion today and spend $1 trillion down the road.”
“Congress must reject this budget and start anew with a balanced approach that protects vital health programs in HHS and at EPA (the Environmental Protection Agency),” Lung Association CEO Harold Wimmer.
Trump’s move to shift the AHRQ – the quality control valve for the NIH – will effectively kill it experts say.
Congress will, of course, holds the purse strings. The only good news for ME/CFS and FM patients hoping for more much needed funding is that Trump’s budget appears to have landed on Capitol Hill desks with something of a leaden thunk. It’s been described as dead on arrival – which doesn’t mean it won’t have an impact. Trump’s popularity among his base is high and his budget proposals will have an effect. The question is how much.
When Trump picked on the National Institutes of Health he picked on one of the few agencies that gets bipartisan support.
Just two years ago Republicans lead the charge to boost the NIH’s budget by $2 billion – it’s biggest increase in more than a decade. Just last year Republicans and Democrats worked to pass the Faster Cures legislation which boosted the agencies bottom line once more. Recently Republican Senator Roy Blunt called for increases, not decreases in the NIH budget.
“The fiscal year 2016 funding increase cannot and should not be a one hit wonder. We should not point to that and believe we have accomplished our goal. … We do not know the scientific advances that will be made in the next 10 years, but we do know that if we keep investing in NIH, they will keep making life-saving breakthroughs.”
Another Republican Rep Yoder of Kansas suggested that the administration was bucking the trend in slashing the budget of an agency his own party had recently worked to boost.
“More than 300 members voted to boost medical research by billions in November. We cannot turn around a few short months later and slash its budget.”
Trump also has a plan to reorganize the NIH but Trump seems inclined to reduce spending on innovative projects in all branches of science. The budget of the Advanced Research Projects Agency-Energy (ARPA-E) which has funded high-risk, high-reward projects in renewable energy and efficiency, for instance, is proposed to be cut entirely. (That will cede that huge field to the Chinese and other governments which have made, among other things developing the next breakthrough in battery technology a top priority.) Earth and oceanic science is out, space exploration is in. Climate science, Gold Star programs and energy efficiency standards, loan programs for clean energy projects and fuel-efficient cars are all history. Think more coal and oil – less solar and wind power and less government investment in breakthrough research in general.
Trump’s approach overall seems antithetical to that of Francis Collins who has been effective at delivering high risk/high gain initiatives which will require breakthroughs in technology to succeed. For the moment Collins – an important asset for ME/CFS – is still leading the NIH.
A Clear and Present Danger to the Progress Made for Chronic Fatigue Syndrome
It’s hard to imagine two diseases already struggling for funding faring well under Trump’s cuts and easy to imagine them faring worse than other diseases. It took over a year to convince 15 or so Institutes to band together to increase ME/CFS’s budget by a mere $6 million/year. As for fibromyalgia, it’s funding has decreased thirty percent over the past few years. It’s clearly very, very low on the NIH’s totem pole.
In her superb blog “The Cut” Jennie Spotila noted that the ME/CFS research center RFA’s explicitly states, “Future year amounts will depend on annual appropriations.” So it is possible that future years of funding could be cut or eliminated.
The increased funding the NIH has enjoyed recently has directly benefitted us. Francis Collins said he was depending on increased NIH funding to pay for a boost in ME/CFS research. He got the funding and we got the boost. Yes, the NIH got a ton of money and we didn’t get that much but that increased funding will pay for three research centers we didn’t have before and double our funding.
Tell your congressmen and women not to cut NIH funding
After 20 years of declining funding we got a one year reprieve. It’s ironic, tragic, unbelievable – pick the term you want – that the NIH budget is potentially getting whacked just as ME/CFS was finally getting off the ground. I, for one, don’t want to live through another multi-year drought in ME/CFS funding. I want to build our funding not watch it decrease.
We have to face the fact that we probably have a long term problem, that President Trump is probably going to hammer at the NIH’s budget for the next four years. The way to blunt that is to put aside party affiliations and push back against President Trump’s proposed cuts so strongly that he gives up trying to cut the NIH budget. This is not a partisan issue; it’s an ME/CFS and FM issue.
Because the Democrats will be utterly opposed to the budget (and won’t have a say in it anyway) saving the NIH will fall on the shoulders of the Republicans. Contacting Republican congressmen or women will make the most difference.
“The only hope for the NIH and medical researchers across the country is if for Republicans like Blunt to oppose Trump and put country above ideology. I hope that these guys have enough gumption to stand up and say no” John DiPersio
Trump’s budget was a first draft. The time to go to work is now – before the full budget is delivered in May. If you’re concerned about the future of FM and ME/CFS research and particularly if you have a Republican for a congressperson please ask them to support more money for the NIH not less.
I am writing something like this:
Dear Congressperson
I am writing to express my alarm over the massive reduction in funding provided to the NIH under President Trump’s budget. As someone with a long term illness which has few treatment options I want to insure you that NIH funding is a core issue for me.
After years of neglecting the NIH, Congress acted in a bipartisan manner when it increased the NIH budget by $2 billion and then when it passed the Faster Cures legislation last year. Much more is needed, however, for the NIH to continue to produce the breakthroughs needed to help me and the millions of other Americans battling chronic illnesses.
President Trump’s budget is terribly short-sighted in its attempt to reduce NIH funding to levels not seen for almost 20 years. I request that you work hard to ensure that funding for the NIH is not just kept at its current levels but that it significantly increases over time. Thanks for your time.
Yours truly
Find out to contact your elected officials here.
Is it possible to convince Trump that ME/CFS is spread by illegal aliens or Islamic terrorists, and that it should be funded via the DOD?
I think we’re talking small change here, by the way, in a multi-trillion dollar budget.
Very small change relatively speaking. Compare the $6 billion Trump wants to cut from the NIH to the $600 billion defense budget. There must be a way to have good defense and good medical research spending.
When the Founders, half of them slaveholders, set up the Constitution, it wasn’t possible for one man, the President, to destroy the country and maybe the world. All post WW2 presidents have wielded that power and destruction of our medical research groups is just one more depressing example.
Thank you, Cort, for another great, if depressing, article. I’ve been very worried that the NIH website is shut down to the public as far as I can tell. Cannot even imagine that would have ever happened.
It must be nice to live in a fantasy world where only the young get decent insurance & NHI doesn’t do anything important enough to warrant a increase in budget, so slashing it doesn’t matter to anyone.
The future of our healthcare is heading for a nightmare. The long awaited research into CFS/ME is likely to suffer, with the only bright spot being personal funding.
What example have we set for future generations? That older people should fend for themselves. That investing in research of CFS/ME is not worthy of our time or money.
To have such a unrealistic view as the President is shameful. As a leader, Trump should be doing what is best for the People not the Corporations. Where is the compassion? Where is the leadership we have come to expect from our President?
First off the Allopahtic community research will go on indefinitely because there is so much money to be made on pharmaceuticals. As we know Allopathic Doctors don’t look for the root cause and there are many. They just write prescriptions after 5 minutes of seeing you.
Doctors in the Alternative Field of Medicine is the hope and success for CFS and Fibromyalgia. You just have to find a good one who understands the issues which can be many.
Don’t be fooled into thinking that what Trump proposes is going to affect you. Just write to him as ask him to include Alternative Medicine in the new health car plans. Just go to Twitter donald Trump @ real Donald Trump. I do frequently and express my ideas.
If all of us just did this it would carry a lot of weight. Trump is not opposed to natural medicine.
Alternative health doctors often charge a fortune for ineffective drugs and treatment .
Another reason we need more research and less guessing…Those treatments do help some but they’re guessing right now – and that guessing is costing a lot of people a lot of money…
Can you give us a sample letter to write to our congressman regarding the funding of the NIH that has some punch to it and gets the point across. I am not great at writing these types of letters so would welcome any suggestions or samples so I can start the process. It sounds like this needs to happen fast. Thanks
We do need this type of form letter asap with space for our personal comments added in; those who are good at this, please assist. Thanks.
Here’s something I did:
ear Congressperson
I am writing to express my alarm over the massive reduction in funding provided to the NIH under President Trump’s budget. As someone with a long term illness which has few treatment options I want to insure you that NIH funding is a core issue for me.
After years of neglecting the NIH, Congress acted in a bipartisan manner when it increased the NIH budget by $2 billion and then when it passed the Faster Cures legislation last year. Much more is needed, however, for the NIH to continue to produce the breakthroughs needed to help me and the millions of other Americans battling chronic illnesses.
President Trump’s budget is terribly short-sighted in its attempt to reduce NIH funding to levels not seen for almost 20 years. I request that you work hard to ensure that funding for the NIH is not just kept at its current levels but that it significantly increases over time. Thanks for your time.
Yours truly
Here’s something:
ear Congressperson
I am writing to express my alarm over the massive reduction in funding provided to the NIH under President Trump’s budget. As someone with a long term illness which has few treatment options I want to insure you that NIH funding is a core issue for me.
After years of neglecting the NIH, Congress acted in a bipartisan manner when it increased the NIH budget by $2 billion and then when it passed the Faster Cures legislation last year. Much more is needed, however, for the NIH to continue to produce the breakthroughs needed to help me and the millions of other Americans battling chronic illnesses.
President Trump’s budget is terribly short-sighted in its attempt to reduce NIH funding to levels not seen for almost 20 years. I request that you work hard to ensure that funding for the NIH is not just kept at its current levels but that it significantly increases over time. Thanks for your time.
Yours truly
Dear Cort,
Couldn’t we make a major common petition. Like AVAAZ, who successfully influences the world.
With kind regards
I’m not so sure this really matters. Judging by the glacial speed at which government research into ME/CFS has always moved, it does not seem to me like Uncle Sam has ever really had much interest in solving this thing.
If someone in this country (and not Norway or Australia) ends up cracking the code, it will be someone privately funded, like Ron Davis. The thing we need to do is to make sure that he and people like him get the funding they need from private sources. That is our best hope.
Yes it has moved with glacial speed but please bear in mind that however slow the feds move they are still easily the biggest single funder of ME/CFS research believe it or not. We need both the private funding of innovative people like Ron Davis and public funding as well. (Davis is applying for a research center grant).
Plus if we ever REALLY make it at the NIH that means many tens of millions of dollars of funding a year… Nobody else can duplicate that. So I encourage looking at what is possible from the NIH; i.e. really a lot of money – and speaking to that.
Good point! Thanks Cort.
Once Ron Davis’ research is further along, he will probably get his NIH funding, that is if there is still money to hand out. The NIH is the biggest funder of medical research in the world. Davis has done well with private funds, but there is nothing like an NIH grant.
Dr. Ron Davis said that he need $5 million per year guaranteed for several years in a row if he isnto attract any experts. There is no way private donations can come even close to that.
I agree! I believe that the NIH like so many other big businesses waste more of their assets with over payment for the administration than they need to. Investing in private research seems to be more beneficial than big businesses. JUST SAYING!
Its not about total amount..Obama increased budget and fibro got less funding..cfs slightly more but really hardly anything.
Focus should be on what diseases and conditions get studied…Not overall budget because there is a ton of wasteful spending.
So letters should be written to specifically say increase budget for cfs not the budget as a whole.
Doesn’t this budget have to go through an approval process before it’s set in stone? Is there a congressman that Canadians can write to? Maybe one close to our border.
This budget from the president is just the start of the process and it’s really Congress that crafts the budget. However, it sets the tone for sure. As to writing to Congress, the many organizations working to resist Trump emphasize that members of Congress only pay attention to their own constituents. They usually don’t respond to Americans who aren’t their constituents, much less Canadians.
Trump will need all the money for a upcomming war against North Korea.
Appropriations are, by the Constitution, originated in the House of Representatives. Trump’s budget is a wish list and a starting point for negotiations. However, I have to ask, What has the NIH really done for us? Not a lot, really.
Then there is this: “Reducing NIH’s funding by nearly 20% will devastate our nation’s already fragile federal research infrastructure…” So what he’s saying is that the previous administration left us with an “already fragile” research infrastructure? That’s not much credit to the previous administration, is it?
I guess my expectations are so low, having watched the federal research establishment plod and bumble along for 30 years now, I can hardly be sad about the NIH’s ox being gored. I’m convinced there is tremendous waste in all areas of government.
We’re entering a difficult period. I’m not expecting help from government, given their record of failure. We can advocate for more CFS research, and certainly we get an unfairly small proportion of funds. I hope that changes. I suppose I can write my Congressman.
It is not the job of the government to fund any of this stuff. It needs to come from private investors and get the government out of it. We’ve all become so programmed to assume that the Fed will provide. Send it back to the states like it says in the Constitution!
??? Why would private investors have any interest at all in investing in understanding ME/CFS or other diseases? For one thing it can take decades of research to uncover the foundation for a new treatment. No investors are going to put money into a project like that.
I don’t know what state you live in but the state I live in certainly doesn’t have hundreds of millions of dollars to invest in medical research…it has trouble enough keeping the schools in good shape.
The federal government is the only entity that can take on tasks like understanding diseases which don’t have immediate payoffs.
I take it you don’t have CFS. Or, if you do, you let your replace common sense with your political ideology. Most states do not have the funding for medical research, let alone for Chronic Fatigue Syndrome.
I take it you don’t believe in taxes either. That’s where states get most of their funding. And it’s not enough to help fund vitally needed research for Cancer, Alzheimer’s, Diabetes, ALS, infectious diseases, ad nauseam.
You think the states will solve everything. That’s utter nonsense.
http://www.nbcnews.com/health/health-news/trump-budget-cuts-scientific-medical-research-will-have-devastating-effect-n734401
I have to say that one thing that was in this article that I could draw that was positive to me is that “Scott Gottlieb, a drug company insider who believes that an overemphasis on safety at the FDA has deprived consumers of much needed drugs (and drug companies of revenues”. I believe that Xyrem is to CFS what LDN has been for pain for fibromyalgia. Many people haven’t got a chance to try it to see if it helps CFS. The insurance companies that do cover it with patients who have CFS won’t at over $10000 a month that it costs and Jazz has already taken the one that was supposed to be a generic to court. And I’ve never heard anything I like from Trump….