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Thread: Where Are the Cures?

  1. #21
    Quote Originally Posted by Buck_Nastier View Post
    WOW! It's too bad they aren't as strict with things like food or
    pollution.

    I'm surprised to hear that though, with so many people going to Huang
    for stem cell treatments.
    Buck,

    The contaminated milk issue forced a lot of regulations in China. By the way, there are many rules but the government has trouble enforcing all of them, China is a monstrously huge country. Part of the problem is that things are unpredictable and it takes a long time to get anything new going. In fact, I am thinking of doing some of our ChinaSCINet trials first in the U.S. even though it is more expensive.

    Let me give an example. It would be very difficult, for example, to test embryonic stem cells in China. First, the rules say that no overseas product can be tested in China unless it has already gone through phase 1 testing. In other words, they don't want Chinese people to be used as guinea pigs to test drugs or treatments that are considered too dangerous or unethical to be tested on Americans. Second, in China, they don't have to respond to your application to test a new drug or cell transplant in clinical trial. In the U.S., when you apply to the FDA, they must respond in 90 days by law. Third, if the product is made in China, you have to inspect and make sure that things are done properly and everything is properly documented.

    Wise.

  2. #22
    Quote Originally Posted by Wise Young View Post
    Buck,

    The contaminated milk issue forced a lot of regulations in China. By the way, there are many rules but the government has trouble enforcing all of them, China is a monstrously huge country. Part of the problem is that things are unpredictable and it takes a long time to get anything new going. In fact, I am thinking of doing some of our ChinaSCINet trials first in the U.S. even though it is more expensive.

    Let me give an example. It would be very difficult, for example, to test embryonic stem cells in China. First, the rules say that no overseas product can be tested in China unless it has already gone through phase 1 testing. In other words, they don't want Chinese people to be used as guinea pigs to test drugs or treatments that are considered too dangerous or unethical to be tested on Americans. Second, in China, they don't have to respond to your application to test a new drug or cell transplant in clinical trial. In the U.S., when you apply to the FDA, they must respond in 90 days by law. Third, if the product is made in China, you have to inspect and make sure that things are done properly and everything is properly documented.

    Wise.
    You've explained much of that in the past. It certainly sounds
    complicated.

    Third, if the product is made in China, you have to inspect and make sure that things are done properly and everything is properly documented.
    Yeah, scan those cells for traces of lead. LAWL!

  3. #23
    Quote Originally Posted by Wise Young View Post
    Eric,

    I want to dispel the notion that it is easy to move U.S. therapies offshore and apply them to people. I have been running clinical trials in China for several years now and things are neither easier nor faster here. In fact, there are a lot more Chinese regulations restricting U.S. drugs and products here in China than one has to deal with in the United States. It is easier to do clinical trials on U.S. products in the U.S. than it is to do the trials in China. For example, China does not allow phase 1 trials of any new drug or cells from the U.S. in China.

    Wise.
    then why use china. why not some where with less restrictions. why keep banging your head against a wall of regulations and costly redundant restrictions. thats always been my arguement. why not just help people in the most direct cheapest way possible.

  4. #24
    Quote Originally Posted by Eric.S View Post
    then why use china. why not some where with less restrictions. why keep banging your head against a wall of regulations and costly redundant restrictions. thats always been my arguement. why not just help people in the most direct cheapest way possible.
    Eric, because I want to help the people of China. Wise.

  5. #25
    wise makes a point. why due premature tests in some third world country on the poor and leave them possibly worse off. then leave them with no followup care. i am desperate but still can't live with that.
    PS my family is Chinese and they donate yo charities in China.
    Han: "We are all ready to win, just as we are born knowing only life. It is defeat that you must learn to prepare for"

  6. #26
    Quote Originally Posted by jhope View Post
    wise makes a point. why due premature tests in some third world country on the poor and leave them possibly worse off. then leave them with no followup care. i am desperate but still can't live with that.
    PS my family is Chinese and they donate yo charities in China.
    then don't operate on the poor, operate on willing participants who fully understand the consiquences. theres plenty willing gueina pigs just no willing researchers. I'm open to the idea if I truly believe a therapy will work or atleast is relatively safe.

  7. #27
    Posted long article on this subject at
    http://sci.rutgers.edu/forum/showthread.php?t=111745

  8. #28
    I agree, just because you do the trials somewhere else does not necessarily mean your operating on the poor, or a certain race of people. Just because you want to help Chinese people doesn't mean you have to do it there. I think the point was, if its not able to get approved here, then go somewhere that will approve trials. For instance, if Dr. Davies stuff is proven to work without a doubt, but for some ridiculous reason the U.S didn't want to approve it, and lets say the U.N. says hey we can make money off of it so come here, why not do it there? It wouldn't make sense to say no, I'm not going to do it there because I want to help Americans! That's kind of messed up. If your a scientist supposedly wanting to help folks and you can, who cares where you do it. You act as if people won't travel for treatment. How many people travel out of they're own country just for these fake ole stem cell treatments. Now imagine if there's something real to go get done, people will go, no matter where it is. I don't mean to sound rude because that's not what I'm aiming for. It's just an opinion.

  9. #29
    Quote Originally Posted by Han Solo View Post
    I agree, just because you do the trials somewhere else does not necessarily mean your operating on the poor, or a certain race of people. Just because you want to help Chinese people doesn't mean you have to do it there. I think the point was, if its not able to get approved here, then go somewhere that will approve trials. For instance, if Dr. Davies stuff is proven to work without a doubt, but for some ridiculous reason the U.S didn't want to approve it, and lets say the U.N. says hey we can make money off of it so come here, why not do it there? It wouldn't make sense to say no, I'm not going to do it there because I want to help Americans! That's kind of messed up. If your a scientist supposedly wanting to help folks and you can, who cares where you do it. You act as if people won't travel for treatment. How many people travel out of they're own country just for these fake ole stem cell treatments. Now imagine if there's something real to go get done, people will go, no matter where it is. I don't mean to sound rude because that's not what I'm aiming for. It's just an opinion.
    I am with you why don't the Doctor's come out and tell us all exactly what thay have got For must time's thay talk in riddle's etc etc

  10. #30
    Quote Originally Posted by Wise Young View Post
    Eric, because I want to help the people of China. Wise.
    "Our goal is to move promising therapies, including those based on stem cells, from the laboratory into clinical trial as quickly as possible," Young [once] said.

    I must admit, I thought the prime reason you were futzing around in China was because it was the gateway to getting "laboratory into clinical trial as quickly as possible." I agree with the sentiment expressed: why on earth would doing research anywhere exclude people from anywhere else if viable therapies were developed? What are we missing?

    f
    ight

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