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Thread: Stop acceptance of the FDA power

  1. #11
    Quote Originally Posted by Eileen View Post
    Paolo, I agree with you entirely, and if some brave citizens wanted to volunteer for trials I think they should be allowed to, although I can see where ultimately it could end up costing taxpayers money if their health failed or if there were complications. I agree with you that this complex society probably won't let even those willing to take the risk do so, but it would hasten results if they did.
    I would have to agree with Eileen on this one. This post sums it up. Throw in our sue-happy entitled culture and it shouldn't be surprising as to why it takes so long to move the envelope forward.
    No one ever became unsuccessful by helping others out

  2. #12
    Senior Member 0xSquidy's Avatar
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    Quote Originally Posted by Eileen
    Paolo, I agree with you entirely, and if some brave citizens wanted to volunteer for trials I think they should be allowed to, although I can see where ultimately it could end up costing taxpayers money if their health failed or if there were complications. I agree with you that this complex society probably won't let even those willing to take the risk do so, but it would hasten results if they did.
    Quote Originally Posted by Tufelhunden View Post
    I would have to agree with Eileen on this one. This post sums it up. Throw in our sue-happy entitled culture and it shouldn't be surprising as to why it takes so long to move the envelope forward.
    The argument of risky trials costing money to taxpayers is fallacious for several reasons. One of the reasons is the way clinical trials are escalated. First 20 patients, then several hundreds in the final stage... not the other way around.

    Another reason why that argument is flawed is that the people "carelessly" applying for that trial is already costing money to taxpayers. A lot of money.

    So you have a million people injured costing taxpayers a ridiculous amount of money. You only try a ""dangerous"" (we know it woulnd't be that dangerous, that's why preclinical safety data is for) trial in 20 of them at a time. If it goes really bad and i mean completely messed up, then you'll have to pay their healthcare...but wait you were already paying that, and probably a similar amount. No lawsuits whatsoever as there was informed consent.
    If it goes good, you save yourself the healthcare of that million...not to mention fucking curing SCI.

    There are more reasons but seriously (and i don't know if i explained myself very well, been sick these days), just think about the argument and you'll find out it's completely stupid, no offense.
    Don't ask what clinical trials can do for you, ask what you can do for clinical trials.

    Fenexy: Proyecto Volver a Caminar

    http://www.fenexy.org (soon in english too)

  3. #13
    Senior Member lynnifer's Avatar
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    Quote Originally Posted by paolocipolla View Post
    If I had a biotech I would look for a place to run clinical trials with a rasonable regulotory agency and at reasonable cost.
    Then just when I know a therapy works I would do trial in the US.

    In the case of chronic SCI I think this approach is very practical as we can fly wherever the clinical trial center is.

    Paolo
    Whatever happened with MacDonald and the primates in South America? Or was that just a rumor? Or an idea that never met fruition because it was there and then fell off the radar. This would have been before most of you were in your chairs - does anyone know?
    Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

    T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

  4. #14
    Quote Originally Posted by 0xSquidy View Post
    No lawsuits whatsoever as there was informed consent.
    This is what you would hope happens, but unfortunately that is not reality.
    No one ever became unsuccessful by helping others out

  5. #15
    I am going to play a bit of "devil's advocate" here. The FDA is everybody's favorite punching bag but I don't think that they are the problem. The problem is the risk-averse behavior of therapeutic companies and their unwillingness to invest in clinical trials on treatments for "orphan diseases". The FDA was charged with ensuring the safety of drugs, devices, and food, as well as truth in labelling of products. In order to get approval to market products for certain indications, companies have to carry out clinical trials. Unfortunately, the cost of clinical trials have gone up probably 100x in the past two years.

    Companies complain that it now costs them over $2 billion to move a therapy from discovery to market. In reality, it costs less than a billion for a successful therapy but they are counting the cost of failures. Nevertheless, even a billion is a lot of money and most companies are reluctant to invest in therapies that have are unlikely to generate billions of dollars of profits. The recent abandonment of GRPC1, the embryonic stem cell product by Geron, is a good example. The company had invested over $40 million into preclinical studies and was about to invest $20 million in phase 1 trial. Their board was looking at the future profit potential, their inability to find partners, and the likely future cost. They got cold feet and bailed.

    One fo the reasons for the high costs of clinical trials for companies is because many of them don't know what they are doing and they are paying full cost for everything. Often, it is the first time that they are doing a trial for that particular condition. They spend a lot of time and money recruiting the centers, training them, and organizing them to do the trials. They proceed slowly and cautiously because they have little experience. They pay full hospital costs and have many consultants. They may encounter delays in recruiting patients. There may be glitches in delivery of product, quality control, and followup on the patients.

    In contrast, a clinical trial network will already have solved many of the problems of training the doctors, recruiting the patients, doing the surgery, and collecting followup data. They will have figured out the best and most efficient ways of doing the work. They have experienced trial coordinators and efficient database management systems. NIH recognized this many years ago when they funded so-called National Cancer "Centers of Excellence" around the United States to assess chemotherapies and other therapies. By paying each center a relatively small grant of several hundred thousands dollars per year, they are maintaining a network of centers that have proven clinical trial experience, patient populations, doctors, and data collections systems. When a company has a chemotherapy they want to test, all they have to do is go to the network and offer them the data and treatment to test. If it looks good, the network can test the therapy in a year for substantially less cost that it would take for the company to set up a network, train everybody, work out all the glitches, and do the trials.

    From 1985-1991, we did the first placebo-controlled double-blind randomized multicenter clinical trial of any therapy for spinal cord injury. NIH funded the study for about $6 million. Fourteen of the leading spinal cord injury centers participated and demonstrated the first therapy for human spinal cord injury. Today, this same trial would like cost $600 million. Most of it is due to the high costs of medical care, which then reflects in the high cost of clinical trials. I believe that it is possible to do clinical trials much more efficiently and for substantially less money if we use clinical trial networks to do so.

    We must lower the cost of clinical trials for chronic spinal cord injury. First, it is important to understand that clinical trials can be done relatively inexpensively, if you know what you are doing and you set up clinical trial networks, which are the cheapest ways of testing therapies. Second, we have to convince companies and grant-funding agencies that it can be done for much less, so that they will start investing. We are in fact doing this in ChinaSCINet, using mostly volunteer doctors, donated therapies, and subsidized hospital care, to show that we can get a cell transplant (umbilical cord blood) and drug (lithium) combination through phase 1, 2, and 3 trials and regulatory approval for less that US$6 million. Third, we have to get the community to start investing in clinical trials, rather than waiting for some sugar daddy to come along. Bill Gates may one day fund spinal cord injury research but we should not be waiting until this happens.

    The FDA and IRB (institutional review boards) will generally approve all sorts of clinical trials, even risky ones, if the right arguments and the trials are reasonably safe. FDA approval is seldom the barrier to clinical trials. Funding is usually the barrier. It is much harder to convince a company to spend hundreds of millions of dollars on a trial than to convince the FDA to approve a trial. 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.

  6. #16
    I Agree Wise. Without the FDA and Attorneys the pharmaceutical companies would use people like lab rats without remorse to get a drug into market. Lie to you, kill you and develop drugs haphazardly to make money........Money drives research not altruism............

  7. #17
    Medical research is very complex in the U.S. I have been involved at several levels for more than 40 years. The FDA is in a “damned if you do, damned if you don’t” situation. When long-term experience reveals unexpected harmful side effects they get blamed for approving them too quickly, and if some potential beneficiaries are negatively affected because of the time consumed by acceptable testing they are blamed.. Their job is a balancing act that operates within a politically sensitive organization.

    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.

    During World War II the Nazis conducted quick, uncontrolled research on human subjects. No one would want that. However, even following that atrocity, research abuse was widespread, even in this country. I know because as an undergraduate research assistant in the 1960s, I participated in some, not fully understanding what I was doing or the ramifications. It is from those past, often horrific, abuses that the current control system has evolved.

    As Wise said there is room for improved efficiency. But the system should not be condemned. Anything having to do with health care is expensive in this country because of the state of our system.
    You will find a guide to preserving shoulder function @
    http://www.rstce.pitt.edu/RSTCE_Reso...imb_Injury.pdf

    See my personal webpage @
    http://cccforum55.freehostia.com/

  8. #18
    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.

  9. #19
    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.
    You will find a guide to preserving shoulder function @
    http://www.rstce.pitt.edu/RSTCE_Reso...imb_Injury.pdf

    See my personal webpage @
    http://cccforum55.freehostia.com/

  10. #20
    SCIfor55yrs.
    You turned it upside down: it’s the majority that took over my life. It keeps me safe but paralyzed. I don’t play with anyone’s life, I don’t force anyone to do anything, all I want is to take the responsibility for my own.

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