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  1. #1
    eye of the storm magpie's Avatar
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    Default When Evidence Says No, But Doctors Say Yes

    When Evidence Says No, But Doctors Say Yes - ProPublica

    What the patients in both stories had in common was that neither needed a stent. By dint of an inquiring mind and a smartphone, one escaped with his life intact. The greater concern is: How can a procedure so contraindicated by research be so common?

    When you visit a doctor, you probably assume the treatment you receive is backed by evidence from medical research. Surely, the drug you’re prescribed or the surgery you’ll undergo wouldn’t be so common if it didn’t work, right?

    For all the truly wondrous developments of modern medicine — imaging technologies that enable precision surgery, routine organ transplants, care that transforms premature infants into perfectly healthy kids, and remarkable chemotherapy treatments, to name a few — it is distressingly ordinary for patients to get treatments that research has shown are ineffective or even dangerous. Sometimes doctors simply haven’t kept up with the science. Other times doctors know the state of play perfectly well but continue to deliver these treatments because it’s profitable — or even because they’re popular and patients demand them. Some procedures are implemented based on studies that did not prove whether they really worked in the first place. Others were initially supported by evidence but then were contradicted by better evidence, and yet these procedures have remained the standards of care for years, or decades.

    Even if a drug you take was studied in thousands of people and shown truly to save lives, chances are it won’t do that for you. The good news is, it probably won’t harm you, either. Some of the most widely prescribed medications do little of anything meaningful, good or bad, for most people who take them.

    In a 2013 study, a dozen doctors from around the country examined all 363 articles published in The New England Journal of Medicine over a decade — 2001 through 2010 — that tested a current clinical practice, from the use of antibiotics to treat people with persistent Lyme disease symptoms (didn’t help) to the use of specialized sponges for preventing infections in patients having colorectal surgery (caused more infections). Their results, published in the Mayo Clinic Proceedings, found 146 studies that proved or strongly suggested that a current standard practice either had no benefit at all or was inferior to the practice it replaced; 138 articles supported the efficacy of an existing practice, and the remaining 79 were deemed inconclusive. (There was, naturally, plenty of disagreement with the authors’ conclusions.) Some of the contradicted practices possibly affect millions of people daily: Intensive medication to keep blood pressure very low in diabetic patients caused more side effects and was no better at preventing heart attacks or death than more mild treatments that allowed for a somewhat higher blood pressure. Other practices challenged by the study are less common — like the use of a genetic test to determine if a popular blood thinner is right for a particular patient — but gaining in popularity despite mounting contrary evidence. Some examples defy intuition: CPR is no more effective with rescue breathing than if chest compressions are used alone; and breast-cancer survivors who are told not to lift weights with swollen limbs actually should lift weights, because it improves their symptoms.

    A separate but similarly themed study in 2012 funded by the Australian Department of Health and Ageing, which sought to reduce spending on needless procedures, looked across the same decade and identified 156 active medical practices that are probably unsafe or ineffective. The list goes on: A brand new review of 48 separate studies — comprising more than 13,000 clinicians — looked at how doctors perceive disease-screening tests and found that they tend to underestimate the potential harms of screening and overestimate the potential benefits; an editorial in American Family Physician, co-written by one of the journal’s editors, noted that a “striking feature” of recent research is how much of it contradicts traditional medical opinion.

    That isn’t likely to change any time soon. The 21st Century Cures Act — a rare bipartisan bill, pushed by more than 1,400 lobbyists and signed into law in December — lowers evidentiary standards for new uses of drugs and for marketing and approval of some medical devices. Furthermore, last month President Donald Trump scolded the FDA for what he characterized as withholding drugs from dying patients. He promised to slash regulations “big league. … It could even be up to 80 percent” of current FDA regulations, he said. To that end, one of the president’s top candidates to head the FDA, tech investor Jim O’Neill, has openly advocated for drugs to be approved before they’re shown to work. “Let people start using them at their own risk,” O’Neill has argued.

  2. #2
    deplorable basketcase Tellenbach's Avatar
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    The answer is 17 years, what is the question: understanding time lags in translational research

    It is frequently stated that it takes an average of 17 years for research evidence to reach clinical practice.1,3,15 Balas and Bohen,16 Grant17 and Wratschko18 all estimated a time lag of 17 years measuring different points of the process. Such convergence around an ‘average’ time lag of 17 years hides complexities that are relevant to policy and practice which would benefit from greater understanding.
    It's actually worse than 17 years. The 17 year figure is only for 50% adoption by practicing physicians; some doctors never learn about new advances or treatments.

    I hope we see some real reform of the FDA under Trump. It's stupid and immoral to deny dying cancer patients a drug because the drug hasn't been approved. I would start by banning all funding of the FDA by the pharmaceutical corps. Currently, the FDA charges the drug companies to review clinical trials of various drugs; how can the FDA be impartial if they're being paid by the drug companies?

    I'd go further and put all cancer/MS drugs under the purview of the NIH instead. Let the FDA only regulate drugs that treat chronic conditions.
    Senator Rand Paul is alive because of modern medicine and because his attacker punches like a girl.
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  3. #3
    Senior Member Smilephantomhive's Avatar
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    Quote Originally Posted by Tellenbach View Post
    The answer is 17 years, what is the question: understanding time lags in translational research



    It's actually worse than 17 years. The 17 year figure is only for 50% adoption by practicing physicians; some doctors never learn about new advances or treatments.

    I hope we see some real reform of the FDA under Trump. It's stupid and immoral to deny dying cancer patients a drug because the drug hasn't been approved. I would start by banning all funding of the FDA by the pharmaceutical corps. Currently, the FDA charges the drug companies to review clinical trials of various drugs; how can the FDA be impartial if they're being paid by the drug companies?

    I'd go further and put all cancer/MS drugs under the purview of the NIH instead. Let the FDA only regulate drugs that treat chronic conditions.
    Yeah, I mean if other drugs that are approved don't work, then who cares if the other drugs are perfect. They are going to die anyway.
    "Avoid getting too preoccupied thinking about what you’re going to do, to actually do it."
    — Rachel Wolchin

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  4. #4
    deplorable basketcase Tellenbach's Avatar
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    Quote Originally Posted by Smilephantomhive
    Yeah, I mean if other drugs that are approved don't work, then who cares if the other drugs are perfect.
    There's a great book called "The Death of Cancer" by a former director of the National Cancer Institute. The author describes several very promising drugs that are being held up by the FDA for years, even though the doctors know that the new drug is better than anything they currently have.

    Also, every antidepressant currently on the market works only as good as an active placebo and both the FDA and the drug companies know this.
    Senator Rand Paul is alive because of modern medicine and because his attacker punches like a girl.
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  5. #5
    eye of the storm magpie's Avatar
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    Quote Originally Posted by Tellenbach View Post
    Also, every antidepressant currently on the market works only as good as an active placebo and both the FDA and the drug companies know this.
    I am extremely interested in this specific topic and have read as many articles as I can find on it. You seem like you'd be good at finding resources or already have a lot compiled. Are there any articles or books you'd recommend about this?

    I think viewing antidepressants as working as well as a placebo is actually a bit optimistic, given that antidepressants have horrific and sometimes permanent side effects that include suicidal ideation, homicidal ideation, and severe cognitive decline, among others.
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  6. #6
    Senior Member Yuu's Avatar
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    Quote Originally Posted by Smilephantomhive View Post
    Yeah, I mean if other drugs that are approved don't work, then who cares if the other drugs are perfect. They are going to die anyway.
    Huh, that's so odd to hear from the inside. Probably sounds incredibly foreign to those on the outside. Reminds me-if only for a second- that yes, my world may be slightly different than most.
    ( I mean that purely as an observation. Not some angsty nonsense.)

    It should be up to the patient.

    When I was born the only drugs known to treat my very rare and at the time terminal disease had been under research for twenty years.
    They had been proven to work long before but came with nasty side effects that the FDA-who were not personally having to make the choice-decided were worse than death. So they were not approved.
    So we had to not only take the drugs along with side effects but to get them we had to travel across the country and take part in research ( like lab rats) the entire time.
    All the while being told by the Drs that we could not have them otherwise because someone else decided we were better off dead. The research was only allowed to be continued via constant research grants and that is why the medication costs $180k a year ( down from $250 ).
    This the reason many drugs are overpriced. The drugs themselves are dirt cheap to manufacture but the fed gov needs to recoup their losses on the decades of unnecessary research.

    The eye drops however ( the very same medication just in a saline solution) is STILL being tested. To get them I need to go to DC out of pocket ( the plane tickets, the hotel, food, everything) since I am no longer a child because fuck me for making the choice to keep living. After all, they told me so.
    Like the other medication they are also the only thing known to work but come with side effects. I really don't care because I either take them or I deal with the constant searing pain of a hot poker in my cornea until I eventually go blind-which will not stop the pain. Oh, and after that they are still $6k a mo.

    Okay, TBH I have not had to do that for the past few years. My best friend is a saint who makes them for me because well they cost pennies and are just that easy to make.

    The system is a huge mess but we cannot blame the government for the ridiculous regulations. We have only ourselves to blame. Well, not myself. ( not those of us who are not going to complain because to hell with the side effects we just like being alive) but the entitled who think that everything needs to easy and painless solution, who don't understand that sometimes you need to make a choice and sometimes even sacrifices. I'm talking about those who are very litigious, who claim to be desperate to fix something that can be easily lived with and then sue -when something they've agreed to- does not go smoothly.

    That is why my friend will only make eye drops for myself. I feel awful, everyone with Cystanosis should be able to get these eye-drop easily but people have proven themselves untrustworthy. Say they leave them refrigerated, maybe even with the cap off, maybe they had something on their eye and they get an infection. Maybe their stupid kids drinks them and get's sick. I don't trust they will not sue. Then no one gets anything my friends is homeless or worse in jail because he tried to help someone. That is the underlying issue behind all of this.
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  7. #7
    deplorable basketcase Tellenbach's Avatar
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    Quote Originally Posted by magpie
    Are there any articles or books you'd recommend about this?
    There's an excellent book titled "The Emperor's New Drugs: Exploding the Antidepressant Myth" by Irving Kirsch. Lots of nice charts comparing antidepressants to placebos. You'll learn that the entire premise behind the SSRI class of drugs, the chemical imbalance theory, has been debunked decades ago but the drug companies are still putting out SSRIs.

    While you're waiting for the book, you may want to read this article:

    Antidepressants and the Chemical Imbalance Theory of Depression: A Reflection and Update on the Discourse

    So Carlat is aware of the clinical trials, which essentially refute the serotonin theory, yet still tells patients that they have a serotonin imbalance.
    They didn’t know that the chemical imbalance metaphor was used in an attempt to reduce stigma, or stress hormones, rather than
    being accurate information presented by their trusted health-care provider. Since chemical imbalance is often presented as a rationale for taking SSRIs, some such patients now understandably feel lied to by their clinicians.
    In truth, the “chemical imbalance” notion was always a kind of urban legend—never a theory seriously propounded by well informed psychiatrists.
    “In the 1990s…No one knew if SSRIs raised or lowered serotonin levels; they still don’t know…There
    was no evidence that treatment corrected anything.”
    “Although it is often stated with great confidence that depressed people have a serotonin or norepinephrine
    deficiency, the evidence actually contradicts these claims”
    This would be a huge scandal if the national media ever covered it. The FDA has allowed these drug companies to sell placebos (with very dangerous side effects) to treat a condition that the psychiatrists don't even understand.
    Senator Rand Paul is alive because of modern medicine and because his attacker punches like a girl.
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    deplorable basketcase Tellenbach's Avatar
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    Quote Originally Posted by magpie
    I think viewing antidepressants as working as well as a placebo is actually a bit optimistic, given that antidepressants have horrific and sometimes permanent side effects that include suicidal ideation, homicidal ideation, and severe cognitive decline, among others.
    In clinical trials, there's a phenomenon known as "breaking blind" that occurs when patients know (when they're not supposed to know) if they are in the control group or the placebo group because of the side effects. In the US, researchers are legally obligated to let patients know the side effects of the drugs in a clinical trial. If the side effect is nausea and dry mouth and the patient has these symptoms, it's a very big clue that they're taking the real medicine. The "breaking blind" effect can be as high as 80%, meaning that 80% of the participants in the study correctly guess that they're taking the real stuff.

    This is why antidepressants work; they have side effects-- very noticeable side effects -- and it's the side effects which convince the patients that the medicine they're taking is powerful. This is why antidepressants outperform inert placebos (sugar pills that have no side effects) but do not outperform active placebos (placebos that have similar side effects to the real medication).
    Senator Rand Paul is alive because of modern medicine and because his attacker punches like a girl.
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