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Thread: Get behind DA like me

  1. #21
    Quote Originally Posted by Eric.S View Post
    Trying to factor out risk only slows progress and science in general. And in the end what happens, you still get risk as even you have addmitted with the recalls in drugs. if the process is so safe why do we see recalls at all, and on top of that the recall of drugs that aren't even all that neccessary.

    I'm not saying just throw out therapies willynilly. what i'm saying is take the risks, dont try to factor them out because you wont you will just hinder progress. by slowing progress your hurting more people than your helping. just like freedom progress costs, sometimes people get hurt. its worth it for progress. but lets behonest here the real issue is careers as opposed progress or safety.

    its the lack of progress that puts snake oil on the market. Do you know Dr. Young personally or something? you sound like him..
    Eric,

    The above is one of the more cogent statements that I have seen you make on CareCure. Bravo. It is true that fear of risk does slow clinical trials. That fear is why it is taking so long for Geron to get approval from the FDA for the first trial of embryonic stem cell therapy of spinal cord injury. But, as you yourself have acknowledged, a single death in the Geron trial will probably kill the therapy or at least delay it for a long time.

    The fear is not theoretical. When Jesse Gelsinger died in a trial involving a adenovirus mediated gene therapy, in part because his father pushed him into the trial and the investigators were lax in not rejecting him from the trial, this led to a furor over gene therapies that virtually stopped all adenovirus mediated gene therapy trials for over a decade.

    The balance of risk and benefit in clinical trial decisions is a daily struggle for me for moral reasons and not because of risk to my career, as you rather insultingly suggest. If I truly wanted to avoid risk, I would not be organizing clinical trials at all. Almost all scientist who involve themselves in clinical trials are taking enormous risks with their careers.

    The risk is not just the demise of a therapy. If a decision that I made killed somebody, I can assure you that it will affect me very deeply and not because it harms my career. I have had patients die and I can assure you that the soul-searching that follows is not pleasant. In fact, it can be painful enough to derail one's own motivation to go on with clinical trials.

    But, aside from personal pain, there are compelling reasons to go about the testing of therapies systematically for risk and benefit. The purpose of clinical trials is to establish risk and benefit. It is important to minimize risk and maximize benefit. The trial must be properly designed and executed. In my opinion the greatest risk comes from improper design and execution of clinical trials. Let me talk about that more.

    We are doing a clinical trial involving surgical exposure and injection of cells into the spinal cord. The surgeon often has never done that surgery before. The cells have never been transplanted before. I can assure you that lives of people are at stake when it is not done right, i.e. if the cells were contaminated, the surgery was not done right, the patient was not screened for risky medical problems...

    There are so many reasons that things may go wrong, particularly things that have nothing to do with the therapy. I view a clinical trial in the same way that a NASA administrator views sending an astronaut into space. The astronaut (the subject) is my responsibility. I take that responsibility very seriously and will not cut corners.

    Wise.

  2. #22
    Quote Originally Posted by Eric.S View Post
    Trying to factor out risk only slows progress and science in general. And in the end what happens, you still get risk as even you have addmitted with the recalls in drugs. if the process is so safe why do we see recalls at all, and on top of that the recall of drugs that aren't even all that neccessary.

    I'm not saying just throw out therapies willynilly. what i'm saying is take the risks, dont try to factor them out because you wont you will just hinder progress. by slowing progress your hurting more people than your helping. just like freedom progress costs, sometimes people get hurt. its worth it for progress. but lets behonest here the real issue is careers as opposed progress or safety.

    its the lack of progress that puts snake oil on the market. Do you know Dr. Young personally or something? you sound like him..
    The current controls were put into place because of the research atrocities committed into the 1960 when there were minimal guidelines and controls. Study the Nazi research programs and you will realize how bad things can get. The system put into place is one developed to reflect the ethics and morals of this country.

    It seems you have a problem with the way our democracy functions, and neither Wise nor me are going to change that. We only have one vote each, and we cast it as best we can like any good citizen.

    I do not know Wise, but I am a scientist and I understand what he is saying. From you remarks, you seem not interested in, nor capable of understanding. You can continue to stay wrapped up in your fantasy world, or you can spend some time learning about what you are trying to talk about. The choice is yours.
    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/

  3. #23
    Quote Originally Posted by SCIfor55yrs. View Post
    The current controls were put into place because of the research atrocities committed into the 1960 when there were minimal guidelines and controls. Study the Nazi research programs and you will realize how bad things can get. The system put into place is one developed to reflect the ethics and morals of this country.

    It seems you have a problem with the way our democracy functions, and neither Wise nor me are going to change that. We only have one vote each, and we cast it as best we can like any good citizen.

    I do not know Wise, but I am a scientist and I understand what he is saying. From you remarks, you seem not interested in, nor capable of understanding. You can continue to stay wrapped up in your fantasy world, or you can spend some time learning about what you are trying to talk about. The choice is yours.
    so We're trying to avoid Nazi style research programs? Do you believe thats even a remote chance of us doing things like that? This isnt a black or whie issue. you can have regulation which doesn't completely hault progress.

    Really it doesn't even need to changed in this country. You could drag this country into scientific progress (which will proabably happen anyway) by taking the research and application eles where... We have all the research money, and facilities but none of the will to take advantage of it. take that knowledge to a place were it can be applied cheaper and more efficiently they are bound to be the originators of true progress. but it would be so "unethical" I'm sure the scientific community would be in complete uproar, but what if it works, and helps people? what if it doesn't? what would be lost? less (monetary, time) risk more reward.

    Oh i'm trying to learn but I'm looking to learn not from those that are apart of where we are now. I refuse to accept things the way they are just because guys like you and Dr. Young say so. But like i said I'll accept the roll of the idiot with a fantasy. I bet theres been many historic figures that started out as idiots with a fantasy.

    “science changes one funeral at a time.” -Max Planck Nobel Laureate

  4. #24
    Our democracy has determined that human research should be done this way. Neither Wise nor I wrote the rules; as law-biding citizens, we work within the laws of the land. If you want to change the system, you have the wrong target.
    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/

  5. #25
    Quote Originally Posted by Wise Young View Post
    Eric,

    The above is one of the more cogent statements that I have seen you make on CareCure. Bravo. It is true that fear of risk does slow clinical trials. That fear is why it is taking so long for Geron to get approval from the FDA for the first trial of embryonic stem cell therapy of spinal cord injury. But, as you yourself have acknowledged, a single death in the Geron trial will probably kill the therapy or at least delay it for a long time.

    The fear is not theoretical. When Jesse Gelsinger died in a trial involving a adenovirus mediated gene therapy, in part because his father pushed him into the trial and the investigators were lax in not rejecting him from the trial, this led to a furor over gene therapies that virtually stopped all adenovirus mediated gene therapy trials for over a decade.

    The balance of risk and benefit in clinical trial decisions is a daily struggle for me for moral reasons and not because of risk to my career, as you rather insultingly suggest. If I truly wanted to avoid risk, I would not be organizing clinical trials at all. Almost all scientist who involve themselves in clinical trials are taking enormous risks with their careers.

    The risk is not just the demise of a therapy. If a decision that I made killed somebody, I can assure you that it will affect me very deeply and not because it harms my career. I have had patients die and I can assure you that the soul-searching that follows is not pleasant. In fact, it can be painful enough to derail one's own motivation to go on with clinical trials.

    But, aside from personal pain, there are compelling reasons to go about the testing of therapies systematically for risk and benefit. The purpose of clinical trials is to establish risk and benefit. It is important to minimize risk and maximize benefit. The trial must be properly designed and executed. In my opinion the greatest risk comes from improper design and execution of clinical trials. Let me talk about that more.

    We are doing a clinical trial involving surgical exposure and injection of cells into the spinal cord. The surgeon often has never done that surgery before. The cells have never been transplanted before. I can assure you that lives of people are at stake when it is not done right, i.e. if the cells were contaminated, the surgery was not done right, the patient was not screened for risky medical problems...

    There are so many reasons that things may go wrong, particularly things that have nothing to do with the therapy. I view a clinical trial in the same way that a NASA administrator views sending an astronaut into space. The astronaut (the subject) is my responsibility. I take that responsibility very seriously and will not cut corners.

    Wise.
    i dont doubt you are affected by losing people. we all should be, but thats the price of progress. it would be nice if we cure everything with no one getting hurt, but the fact is people are already getting hurt and dying. i would never expect a researcher to do more than make a procedure as safe as he possibly can. but this idea of factoring out completely any risk is as harmful to the masses as it is helpful to the individual.

    you think of it as insulting but we all know the fall out of someone getting hurt in this country by a procedure. and its not just emotional, its legal and career costing fallout. it shouldnt be that way but as sci 55 reminds us we only have 1 vote so it is how it is. thats why risks must be taken by all, not only the patient but the doctors also if we are to have progress.

    with the amount of knowledge and capability we have scientifically you would think atleast short term safety would have a high probability from the out set. I mean if there was anything that showed a possible negative outcome would you not work on it more to attempt to address the possible negetive outcome atleast until it becomes remote. I mean if safety is seen as anywhere near 50-50 ofcourse you don't go ahead. even 30% would be high.

  6. #26
    Senior Member DA's Avatar
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    Quote Originally Posted by SCIfor55yrs. View Post
    I can tell you this, if you start injecting people with an inadequately tested vaccine and they all start dying because of it, that is not ethical. I will also go sofar as to tell you this: I have served on human subjects review committees and I have cast my vote to stop or delay clinical trials because there were developmental or other deficiencies in the study that posed too great a risk to subjects if implemented. Even with the current checks and balances, some harmful things get through. You must be aware of the drugs, etc. that are being recalled because of long term effects that were not detected in the trials.

    You cannot appreciate the difficulty in making decisions that put people's life at risk. I know first hand. I have also served on grant review committees, and funding decisions are not easier.

    I am one of the people who have been involved medical research, and from your standpoint, I am part of the problem as you see it.

    Finally, you should realize that it is a disregard for legitimate, ethically conducted science that puts "snake oils" in the marketplace fast.
    i wonder how many cures you stopped.

  7. #27
    Senior Member DA's Avatar
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    Quote Originally Posted by SCIfor55yrs. View Post
    Development of a cervical cancer vaccine was started in the mid 1980s and approved by the FDA in 2006.
    apple and oranges. without a vaccine today polio would have a shit load of companys selling medical supplies at outrageous prices to the pollio community.and you can bet those companys would fight against a vaccine.

    research how fast viagra was approved. i bet congress didnt forget to fund viagra.

  8. #28
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    Quote Originally Posted by Jim View Post
    He sounds like Wise because with age and experience comes wisdom. You ought to try and learn from their experience rather than disagree with everything they say. They have the wisdom to know which path to travel, you and DA will get lost in the desert and die of thirst.
    well let see. 1945 to 2010...65 years. no functional improvement for chronic sci in 65 years... and i should be impressed.

  9. #29
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    Quote Originally Posted by DA View Post
    apple and oranges. without a vaccine today polio would have a shit load of companys selling medical supplies at outrageous prices to the pollio community.and you can bet those companys would fight against a vaccine.

    research how fast viagra was approved. i bet congress didnt forget to fund viagra.
    So how much money did the US Government fund for Viagra?

  10. #30
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    Quote Originally Posted by Eric.S View Post
    so We're trying to avoid Nazi style research programs? Do you believe thats even a remote chance of us doing things like that? This isnt a black or whie issue. you can have regulation which doesn't completely hault progress.

    Really it doesn't even need to changed in this country. You could drag this country into scientific progress (which will proabably happen anyway) by taking the research and application eles where... We have all the research money, and facilities but none of the will to take advantage of it. take that knowledge to a place were it can be applied cheaper and more efficiently they are bound to be the originators of true progress. but it would be so "unethical" I'm sure the scientific community would be in complete uproar, but what if it works, and helps people? what if it doesn't? what would be lost? less (monetary, time) risk more reward.

    Oh i'm trying to learn but I'm looking to learn not from those that are apart of where we are now. I refuse to accept things the way they are just because guys like you and Dr. Young say so. But like i said I'll accept the roll of the idiot with a fantasy. I bet theres been many historic figures that started out as idiots with a fantasy.

    “science changes one funeral at a time.” -Max Planck Nobel Laureate
    Are you suggesting that research done without the proper trials to assure efficacy and safety be done in a third world nation? That would be completely unethical, and I assure you that your life is in no way more valuable than the life of a third world person you wish to experiment on. When one is discussing the replication of cells you have to be very certain that they replicate in a safe and controlled way, since the opposite is called cancer. The reason science functions as it does is to protect individuals from mistreatment, abuse, and the horrors that could come about if someone decided to act without proper guidelines.

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