Could Donald Trump Be Good For Chronic Fatigue Syndrome and Fibromyalgia?

Discussion in 'General Discussion' started by Cort, Mar 1, 2017.


Donald Trumps Plans to Deregulate the FDA would be ? for ME/CFS and/or FM

  1. Very good

    16 vote(s)
  2. Somewhat good

    5 vote(s)
  3. Neutral or don't know

    5 vote(s)
  4. Somewhat bad

    0 vote(s)
  5. Very bad

    8 vote(s)
  1. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    One could hardly imagine the bombastic Donald Trump - the man who called veterans with PTSD "weak", who said the National Football League was "soft", who derided Hillary Clinton's and Jeb Bush's lack of energy - thinking anything good about a disease called "chronic fatigue syndrome".

    Besides the tough guy persona that Trump loves to project, however, there is the man who wants to take an axe to any and all regulations that impede business, including pharmaceutical companies.

    Trump hasn't appointed a new FDA chief but the first name leaked by his team was a doozie. Jim O'Neil, the managing director of Peter Thiel’s Mithril Capital supports a dramatic change in how the FDA approves drugs. O'Neil supports something called "progressive approval" of drugs championed by a former FDA chief Andrew Von Eschenbach.

    Citing stats indicating that it takes about 12 years and $1.2 billion to bring a new drug to market in the U.S. Eschenbach asserts that the drug and device approval system employed by the FDA is broken.

    Under Eschenbach's system all a company would have to do to get an initial FDA approval would be to do a Phase I trial that proves the drug is safe. If it is, then the drug's effectiveness would be monitored. If it works, insurance companies would pay for it; if it doesn’t they wouldn't. Eschenbach believes that the informational technologies available today make it easy to monitor drug effectiveness in patients.

    The main problem, Eschenbach believes, are the large and costly Phase III trials required to prove efficacy. These trials are so costly - they take up about 25% of the cost to bring a drug to market and generally take several years to complete - that they have a name. They’re called the "valley of death" for the many drugs whose progress gets stymied by them.

    Pain researcher Linda Watkins blames the "valley of death", for instance, for the overemphasis doctors have on using opioids for pain reduction. Citing dozens of potential pain-killing drugs that got stalled in the “valley of death” she suggested that it was the current drug business model – not the science – that has let consumers down.

    “A lot of really innovative stuff reaches ‘Death Valley’—it’s a good idea, it has good rodent data, and it’s on the edge of a clinical trial, but it needs millions of dollars in funding, It’s very difficult to get a pharmaceutical company or venture capitalist firm to invest without data showing that the treatment works in humans, she says. From a business perspective, opioids are a much safer bet."

    Eschenbach argues that in the past these trials often worked, but with the precision medicine revolution producing drugs that are increasingly being aimed at smaller and smaller subsets of patients, these large and expensive trials don't make sense. That argument could be made larger if disease groups such as chronic fatigue syndrome which drug manufacturers have been eluctant to fund drug trials for get behind it .

    Eschenbach's system sounds something like ME/CFS advocates have proposed for Ampligen for years: get the safety data, then target patients and do post-marketing studies. If the drug fails then pull it - or as Eschenbach proposes - allow insurers to not pay for the drug if it does not succeed.

    Under our proposed system, the drug could have come to market after promising early-stage research in targeted patients, with appropriate post-marketing studies required. Payers and patients would be the ultimate judge about the quality of the product, and companies could learn from the experience to develop superior products if needed.

    Companies would still be liable for unforeseen side effects, but patients and doctors would be warned -- through the drug’s labeling -- that the product had been approved based on promising but provisional research.

    Eschenbach asserts that simply doing away with the Phase III trials would free up drug makers to introduce at least twice as many drugs as they are now. Safety concerns would be largely alleviated by Phase I safety trials. Japan is now using a similar system.

    Big pharma, interestingly, is not a fan. With their deep pockets they’re in the position to pick and choose products developed by smaller pharmaceutical companies that lack the cash to go to large phase III trials.

    Patients would undoubtedly have to assume more risk under this new system but they would also have access to more drugs. One article cited Dr. Michael West's spinal cord stem cell therapy that was recently approved -20 years after it was invented – to help quadriplegics.

    At a meeting with industry execs Trump, as he so often does, said he could have it both ways:

    “When you have a drug, you can actually get it approved if it works, instead of waiting for many, many years. We’re going to be cutting regulations at a level that nobody’s ever seen before, and we’re going to have tremendous protection for the people.” He estimated that a jaw-dropping 75% to 80% of regulations are unnecessary.

    Dr. Carome of the consumer watchdog group Public Citizen called that idea horrifying.

    "Trump's horrifying proposal reflects utter ignorance about the FDA's essential role in protecting public health and once again demonstrates his commitment to placing corporate profits above protecting the safety of the American people,"

    Pushing back, the FDA published a report of 22 drugs that did well in smaller trials only to fail in larger ones. FDA proponents reported that the FDA now approves drugs more quickly than Europe does (but that for now 1000 staff appointments are going unfilled because of Trump’s hiring freeze.)

    Plus naysayers cite a chaotic future where drug companies pour out legions of drugs most of which end up having little efficacy. Since Medicare and Medicaid are required to pay for FDA approved drugs, the costs of those programs would skyrocket.

    Others believe putting companies in charge of assessing drug efficacy after approval would be foolhardy given the dollars involved.

    But then there's Ampligen with it’s established safety record but no money for a big phase III trial for decades. Rituximab is working for at least some patients in Norway but there is no push for a Rituximab trial in the U.S. (Dr. Koroshetz made it clear that it would be years before the NIH could even begin thinking about funding ME/CFS treatment trials.)

    Dr. Peterson reported that 17 cytokine blocking drugs that might work for some people with ME/CFS are on the market -none of which are available for ME/CFS. Many drugs will never receive Phase III testing for ME/CFS or FM because the numbers don't pan out for drug companies under the current drug testing regime.

    Whatever happens with the FDA, Trump hardly looks like his term will be an unalloyed benefit for ME/CFS or FM patients. His plans to increase military spending, repeal and replace the Affordable Care Act, and cut taxes for the wealthy and corporations could impact ME/CFS?FM patients in other ways. NIH spending could be cut and some could lose their heath insurance and/or other benefits. A ballooning deficit under Trump could put pressure on medical funding for years to come.

    But his ideas for the FDA? Those could be something. What do you think?
    Last edited: Mar 1, 2017
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  2. serotone9

    serotone9 Member

    Like or dislike Trump, the FDA policy he promotes can only be good for ME/CFS. We take so many drugs off-label anyway, what difference does FDA approval (usually meaningless with regard to safety, and highly political) really matter? Access to more possible treatments can only be better, imho, including the first one to come to mind, namely Ampligen.
    Sly Dover likes this.
  3. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    I tend to think they could be good for diseases like ME/CFS and FM which don't get much recognition. I'm not sure about other diseases though or the medical field in general.
  4. JennyJenny

    JennyJenny Well-Known Member

    I think it is good. I mean, could it get any slower or worse concerning Ampligen? I don't think so.
    Sly Dover likes this.
  5. Thank you for at least being open to the possibility that President Trump may do some good things for us and the country. Maybe the cost of drugs will come down, also.
    Sly Dover, Tina and Hello! like this.
  6. Remy

    Remy Administrator

    The cost of drugs won't come down and you will still be required to pay. Trump does not give two teeny tiny rat shits about the state of our health. He cares about increasing profits for businesses, in this case the drug makers. Big Pharma may not be on board right now because the current gravy train is sweet, but they will get in line and figure out a new way to take their cut, rest assured.

    What good does it do for something like Ampligen to be FDA approved if insurance companies don't have to pay unless efficacy is somehow proven? Ditto for the cytokine blockers? How does that process work any differently than a Phase III trial, really?

    Maybe people on Medicare and Medicaid will be able to have access...but most people with ME/CFS are not on Medicare or Medicaid.

    I'm all for reforms to the FDA, namely, the drug companies shouldn't be funding their budgets. But Trump is as clueless here as everywhere else unfortunately.
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  7. Laura Olinger

    Laura Olinger New Member

    I am usually a very positive person, but maybe working as a pharmacist has made me view this issue in a different or more complicated way. I can see the pitfalls on both sides of this issue.

    While their may be places to safely roll back the regulations of the FDA, they are there for patient safety. It is the most in need among us - the elderly, the chronically ill, those needing novel new medications (for pain, for cancer, for orphan diseases), children and women - who will bear the brunt of testing these medications in the real world.

    As far as cost saving is concerned, in the long run perhaps, there might be some. Initially, I don't see it because it will be Medicare, Medicaid, and insurance being asked to pay for medications that are not known to work. Already such insurance programs are reluctant to pay for all medications, let alone unproven medications.

    Yes, the drug approval process has long needed an overhaul. I believe that medications researchers and physicians have found to be helpful for patients not included in the initial trials, should be allowed a different path to approval - a more accelerated path. A path more along the lines of an abbreviated new drug application like generic medications go through because after all, the medication has already been fully tested. Perhaps there should be a category opened just for novel medication testing also, involving disease volunteers instead of only healthy male volunteers. The medication insert would then need to reflect this information.

    I have also long thought that the FDA has too much on its plate - along with drug safety and all of the aspects of that, the FDA also takes care of food safety in the US. Another extremely large and complicated job. The FDA has been asked to do these 2 tasks for the majority of its existence woefully understaffed and underfunded.
  8. SuziRider

    SuziRider Member

    The doctors choosing these new or off-label drugs for their patients are usually specialists familiar with the drug's development, the patient's medical history, AND the disease they are treating. They are a better judge of what might work or have adverse side effects than just what worked for 60% (or whatever) of the random test subjects.
    A lot of drugs and devices have made it through the billion dollar approval process, then ended up total disasters.

    Maybe by getting rid of Phase III trials and limiting certain drugs only to Specialists (vs GPs), they could do a better job ensuring effectiveness and safety.
    Sly Dover likes this.
  9. SuziRider

    SuziRider Member

    The Phase III Testing should be comparing the new drug against it's top 3 competitors. It must show equal or better efficacy, even if it is for a special subset of patients. THAT is the information the doctors need.
    No competition, since there previously was no approved treatment? Then it gets provisionally approved for a few years, until more feedback comes in from long term use and unbiased reporting.
  10. Strike me lucky

    Strike me lucky Well-Known Member

    Wasnt there video footage of obama talking to a cfser at a conference a few yrs back and was going to have his people look into it?? Still waiting.

    If people dont just look at cnn for news, trump was mentioning quicker drug approvals and also increase market competition so people could get cheaper medication overseas covered by insurance. Wants more opportunities to shop around for better prices instead of limiting peoples choices.
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  11. fdotx

    fdotx Well-Known Member

    I heard Trump, when his campaign just started, say he thought it was terrible that sick folk have to wait so long for drugs that could help them and he wanted to speed up that process. We shall see....
    Sly Dover and GG like this.
  12. joanne roberts

    joanne roberts New Member

    That depends if you believe in the silver bullet miracle of the modern drug..or if it is deregulated so much that people suffer from side effects of a new miracle drug, which is why we have these checks and balances in the first place. I personally feel that we are not powerless and dependent upon a drug company to save us. Just read Bruce Lipton's "The Power of Belief". We have more potential to heal ourselves than we have been led to believe.
  13. Kathy Bungard

    Kathy Bungard Member

    Since some are giving their opinions on Trump in general, I guess my right to free speech applies as well :) Just watch, he is going to be one of the best Presidents this nation has ever seen.

    You certainly can't say he 'owes' big pharma anything, or anyone else for that matter and for those who think he doesn't care about people, well you might think again, because he got elected by people who recognized someone who cares and cares a lot about the citizens of this country. In contrast to someone who thinks that those who don't support them are 'deplorable'.

    In answer to the question posed in this thread, I'd ask just what did the past eight years do for ME/CFS, research, cost of insurance, or drugs? Looking at the new secretary of HHS, Dr. Price, and what he's always said about the state of health care and his suggestions to improve the system, I'm very optimistic that indeed this administration will be better for ME/CFS patients.
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  14. diane

    diane Member

    Even the approved drugs have their dangers! Last May I had a chest infection, misdiagnosed as asthma (as 4 doctors could not hear any rales in my lungs). With the asthma drugs and then the antibiotics I ended up being on 3 drugs that carried warnings of potentially causing me to have suicidal thoughts. (No reaction, luckily.) The prednisolone left me absolutely exhausted. The new nasal spray wrecked my sense of taste. Then the new asthma inhaler caused me to have atrial fibrillation, which then meant ECGs and an echocardiogram.

    I am not sure if I am saying that we need to beware and test carefully, or if I think that testing does not seem to matter as I react to supposedly safe drugs anyway.
  15. Thank you , Kathy, for your well thought out response.
  16. And I agree.i just wish some would give him at least a chance. Obama was never called hateful things. President Trump has only been in office a little more than a month. Good grief!
  17. Remy

    Remy Administrator

    Trump lies like he breathes. He can't stop and people eat it up with a spoon. It's mind boggling. He is a master manipulator, for sure.

    There is such a thing as a verifiable fact. Sometimes your opinions just make you wrong. Which is fine, to each their own, until those opinions cause the suffering of others.

    People are already coming out saying that they didn't really believe Trump would dismantle the ACA...and voted against their own interests. I feel really bad for people that fell for his lies because they are the ones that will suffer in the end.

    I was not a HC supporter but there is no question that her position on issues that matter to the disabled and elderly would have been far more beneficial.
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  18. Roseann

    Roseann New Member

    I think it is great that Trump is looking into a better way for finding ways for medicine to be approved faster. I don't believe he is looking into getting "richer" and cutting Tax money to give to the rich. Why would he be looking into the pharmacy companies and how they are processing new medicines? I think he has all the money he needs and has realized it is time to help others. I also think he believes that the Federal Goverment has too many unnecessary regulations. None of the past presidents have put this as their priority especially to those who need medicine so desperately. This has been long overdue and about time a President follows his convictions.
    Tina likes this.
  19. Paw

    Paw Well-Known Member

    That's pretty funny. We could start with the President himself who led the nasty, racist birther conspiracy movement, then move on down the list of his cronies at Breitbart and InfoWars who trashed Obama with nonstop lies. And then there's the entire GOP who decided to obstruct everything he tried to do whether they supported it or not...

    Anyway, I don't trust someone with regulations who declares, randomly, that for every new regulation two have to be repealed. There's no evidence he cares about sick people -- or, for that matter, anyone but himself. Such a nightmare.
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  20. ankaa

    ankaa Well-Known Member

    1. what the whole de-regulation of FDA argument doesn't take into account is insurance companies.... If there's no FDA vetting process, do you really think insurance companies are just going to cover every new drug that suddenly becomes available?? Drugs that hurt ppl are bad business for the insurance cos. b/c they keep ppl sick, or make them even sicker... sick ppl = bad customers for insurance biz.. Insurance companies want healthy ppl paying premiums; that is the constant. Premiums will go up, and the ACA, or it's follower, will get even more expensive for the government and they will cut the program altogether... God forbid we should go to a single payer systems and cut out insurance companies!

    2. Also, drugs will still be expensive... GOP will argue now that we don't have the lobbyist briberies and expensive clinical trials to get approval, drugs costs will come down.... I'm old enough to know that the GOP "trickle-down" argument is b.s. ... The ppl at the top will just keep more money...

    3. The demand for affordable, quality healthcare - independent of office jobs - is only going to escalate dramatically... One third of US workers are independent (consultants, contractors, etc.). That will rise to 50% independent workers in the next 5 years..

    4. Will the worsening environment caused by the abolition of the EPA outweigh any benefits we gain from abolition of the FDA? ie, will more ppl get immune illnesses the more our environment goes downhill? I believe so....There are studies that connect particulate matter & pollution to diabetes and alzheimer's.

    the lack of wholistic thinking of the GOP drives me crazy... and I don't even mean that in a political way b/c I hate politics! I do think they're much worse than the alternative, though.
    Last edited: Mar 1, 2017
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