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Thread: Stop acceptance of the FDA power

  1. #21
    Quote Originally Posted by Wise Young View Post

    Funding is the obstacle, not the FDA. If it only costs $6 million instead of $600 million to do clinical trials for spinal cord injury, a lot more companies will invest in trials, regardless of the FDA.

    Wise.
    Wise, isn't there a realtion between cost and FDA requirements?

    In any case, since there are less expensive places to do trials ( still with scientific rigour) let's move there or SCI will never become curable, I think.

    Last thing,

    I think that comparing clinical trials for acute SCI with trials fror chronic SCI is cofusing considering costs and structure needed.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  2. #22
    Quote Originally Posted by SCIfor55yrs. View Post

    Having served on IRBs, it is at times a gut wrenching task to weigh the wellbeing of subjects against the “possible” benefit of the outcome. Real lives are at stake. Even the issues of what constitutes “informed consent” can be contentious. For example, is someone who is under the duress of a new spinal cord injury in a mental state to evaluate the pros and cons of a stem cell implantation that must be done within a few hours post injury? These are not easy decisions when operating under prevailing ethical standards. It gets even more difficult when you have repeatedly coped with violations of research protocols by incompetent or profit pressured researchers.
    I suspect you don't realize we are all people with chronic SCI here

    Hope you don't serve in IRB anymore.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  3. #23
    Quote Originally Posted by Dmitriy View Post
    Dr. Young:
    I somewhat disagree – I think regulations are behind the majority of the cost of getting a new therapy to trials. That’s why injured dogs get better treatment than humans. You say it costs $2 billion. I say, it would cost me at most a few thousand to have a doctor give me polyethylene glycol (PEG) instead of the methylprednisolone which gave me nothing except maybe osteoporosis. Regrettably, I cannot do that because somehow the regulators have a claim to my body.

    Maybe initially “safety and truth in labeling” was the goal of FDA; right now the goal seems to be to grow larger get more power and control (they now want to monitor toys too), and they also interested in bribes from larger companies to prevent smaller ones from entering the market. They somehow allow cigarettes, but ban e-cigs which are safer, and that’s ridiculous.

    FDA creates numerous barriers for even entering the market, destroying the competition.

    But just imagine that there are many private rating agencies. That research businesses could pay them fees for approval. The agencies would compete by offering quickest most efficient approval; they would also compete for their reputation for safety.
    A business could go with company A, or B, or if they like with FDA. Or if they are so sure of their treatment they could put a label “not approved”, and people could choose.

    SCIfor55yrs.
    Comparing Nazis with researchers is insane: their subjects did not give their consent. I am talking about free markets: manslaughter and fraud laws are still in place.

    Assuming the FDA makes you safe by slowing the approval process is erroneous. You are not counting the people who die or suffer without the needed treatment. In reality, no one is safe and never will be. There are situations in which it is logical to take risks. You know that it is safer to drive at 20mph, yet you sometimes go at 60mph.

    Free markets will make finding out which product is safe and effective much faster. The flow of information today is very fast. And the funding will be more available. Just think how much more likely you would be willing to donate if truly promising trials could happen tomorrow; investors would be all over it.

    Until that happens, it would be very difficult to push the trials, networks or not. It should be our goal to create that environment.
    I somewhat agree

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  4. #24
    Quote Originally Posted by SCIfor55yrs. View Post
    Dmitriy, you and I live in different worlds. I have had experience in a medical research climate with little oversight and regulation. Moreover, I see the effectiveness of competition and laissez faire capitalism in the potions that supposedly cure the common cold and the proliferation of miracle weight loss drugs. They are taking in their share of dollars, not providing promised results, and not going away.

    In sum, you seem to play free and loose with human lives. Fortunately the conscience of the majority of people does not endorse your views.

    I don't think you have read Dmitry's post with appropriate attention.

    Paolo
    In God we trust; all others bring data. - Edwards Deming

  5. #25
    Quote Originally Posted by Dmitriy View Post
    Dr. Young:
    I somewhat disagree – I think regulations are behind the majority of the cost of getting a new therapy to trials. That’s why injured dogs get better treatment than humans. You say it costs $2 billion. I say, it would cost me at most a few thousand to have a doctor give me polyethylene glycol (PEG) instead of the methylprednisolone which gave me nothing except maybe osteoporosis. Regrettably, I cannot do that because somehow the regulators have a claim to my body.

    Maybe initially “safety and truth in labeling” was the goal of FDA; right now the goal seems to be to grow larger get more power and control (they now want to monitor toys too), and they also interested in bribes from larger companies to prevent smaller ones from entering the market. They somehow allow cigarettes, but ban e-cigs which are safer, and that’s ridiculous.

    FDA creates numerous barriers for even entering the market, destroying the competition.

    But just imagine that there are many private rating agencies. That research businesses could pay them fees for approval. The agencies would compete by offering quickest most efficient approval; they would also compete for their reputation for safety.
    A business could go with company A, or B, or if they like with FDA. Or if they are so sure of their treatment they could put a label “not approved”, and people could choose.

    SCIfor55yrs.
    Comparing Nazis with researchers is insane: their subjects did not give their consent. I am talking about free markets: manslaughter and fraud laws are still in place.

    Assuming the FDA makes you safe by slowing the approval process is erroneous. You are not counting the people who die or suffer without the needed treatment. In reality, no one is safe and never will be. There are situations in which it is logical to take risks. You know that it is safer to drive at 20mph, yet you sometimes go at 60mph.

    Free markets will make finding out which product is safe and effective much faster. The flow of information today is very fast. And the funding will be more available. Just think how much more likely you would be willing to donate if truly promising trials could happen tomorrow; investors would be all over it.

    Until that happens, it would be very difficult to push the trials, networks or not. It should be our goal to create that environment.
    Dimitriy,

    Thank you for your cogent comments. I don't have as much faith in free markets as you seem to. The FDA does not regulate most of medical care... Their mandate is to approve what manufacturers can say about their products, not to regulate medical care. Let me give three examples of areas that the FDA did not and still largely do not control.

    • Compounding pharmacies. These pharmacies are allowed to "compound" over 400 drugs. Amongst these drugs are 4-aminopyridine (4-AP), which doctors could write a prescription for and these pharmacies can send to you. For nearly 20 years, people paid for and took this drug for spinal cord injury, until Acorda Therapeutics spent over $100 million testing 4-AP in four clinical trials. The trials did not provide convincing data that 4-AP is effective for spinal cord injury although it did show that the drug is effective for multiple sclerosis (MS). The FDA approved Ampyra for MS. If the FDA had not been there are required the clinical trials to be done, do you think that any company would have spent the money to do the trial? People with spinal cord injury would still be taking compounded drug today with no more information concerning its safety and efficacy for spinal cord injury or MS.

    • Blood. The FDA generally avoids regulating the practice of medicine and particularly surgery unless some problems arise and regulations become necessary. For example, the FDA initially did not regulate blood transfusions until it became clear that people can contract AIDS or hepatitis from blood. So, now, blood banks must do mandatory testing. Umbilical cord blood fell under mantle of blood transfusions and therefore there was and are almost no regulations applied to all the companies that are collecting cord blood for private banking. As a result, we don't know whether millions of cord blood units that have been banked is any good. The FDA is belatedly trying to regulate publicly banked cord blood and they are applying the concept that a cord blood unit is a "product" that is being sold by a cord blood bank.

    • Transplants. Until recently, the FDA did not regulate transplantation of organs and tissues, particularly autologous (self) tissues. Even now, the FDA does not regulate skin grafts from one part of the body to another, or fat cells from the abdomen to the breast, etc. Most organ transplants are outside of the regulatory purview of the FDA. The FDA recently passed regulations requiring companies that sold genetically manipulated or expanded cells to show the safety and efficacy of the cells before they can make claims about the cells.

    You suggest that FDA regulations are behind most of the cost. I disagree. Trials are very costly in the United States because medical care is very expensive. For example, we are planning a clinical trial involving transplanting umbilical cord blood cells into the spinal cord. This requires detailed testing of the patient with MRI and neurological examinations, preoperative blood tests, and admission to a hospital. Just three days in a hospital and surgery can easily cost up to $100,000. If we include 3 months of rehabilitation, we are talking about $200,000. A trial of 100 patients at $300,000 each will cost $30 million.

    We can do clinical trials cheaper in China because medical care costs are lower. In some countries, medical care is paid for by the government and clinical trials are part of the medical care. In my opinion, that is the way it should be done. We are starting a trial in Norway, for example, and the cost of that trial is likely to be substantially lower than in the United States because everybody in Norway is entitled to cradle-to-grave medical care. Universal health care, for example, can help cover some costs of clinical trials. However, sadly, we don't have such coverage in the United States and trial sponsors must pay.

    Wise.

  6. #26
    Dr. Young:

    You say you don’t have faith in free markets, yet you move the clinical trials to China because it’s cheaper – that’s the working of the free market right there!

    Why we have high cost of medical care here is a whole other story. I grew up in Russia where care was free for all: while the quality was “so-so”, the access to it was not, you had to wait hours if not days to get your care because of long lines. They have that problem in other countries with universal medical care (like Canada).

    So while free care for all seems like a good idea in the short run, in the long run they are unsustainable. Same with our system of insurance: when the third party pays, one has no motivation to seek a cheaper price and providers don’t compete on price. Just think if there was insurance that paid for groceries and you could take as much as you want, how much would they cost (a lot I guess)?

    I once went to Europe to a private clinic for a spinal surgery; I could easily cover the costs out of pocket, doing the same in the US would be unrealistic. In a perfect world one would buy only illness and accident insurance (for devastating and unlikely occurrences) and pay out of pocket for everything else, that way our care would get cheaper and better like cell phones.

    When you go to Norway you just pass your costs to their government – illegal immigrants who get benefits in the U.S., they think we have a great system too.

    Regarding to FDA, you assume that they are the reason why dangers of a therapy are discovered. They are discovered after someone gets hurt, regardless of FDA. Also, assuming that without regulation companies would be pushing dangerous ineffective therapies is mistaken. In the free markets they would strive to provide cheapest most effective option. I bet that not many patients would choose unchecked blood over checked, so unchecked would go away by itself.

    Regarding the costs: Here is a video that better explains the issue (begin watching at 3 minutes in): http://www.youtube.com/watch?v=hqxfH...eature=related

    Because of the regulations, many SCI patients were “forced” to try not approved therapies overseas that were not their first choice, that’s all. Risks are taken regardless of regulations.

    It takes 10 years from discovery to marketing of a treatment, and somehow we are conditioned to accept it. Lowering the development cost of a therapy will make many therapies available for SCI. Cutting on regulations can achieve that. We – SCI injured who want the cure and willing to take risks – should make some sort of arrangement with regulators, and collect the data as we go.

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