- advertisement -

Updates to my "Status of Research to Cure Type-1 Diabetes" Web Page‏

Discussion in 'Research' started by joshualevy, Jan 21, 2009.

  1. joshualevy

    joshualevy Approved members

    Joined:
    Dec 30, 2008
    Messages:
    663
    I have recently finished a complete update to my web page which contains status of research aimed at "curing" type 1 diabetes. You can see it here:
    http://joshualevy.pbwiki.com/DiabetesCureReadyForHumanTrials
    I've updated many of the entries, and also added new sections on "studies you can participate in" and generally improved the organization.

    The summary is simple: there are 3 options currently in phase-III human trials, 7 in phase-II trials, and 9 in phase-I trials. That is good news!

    Joshua Levy
     
    Last edited by a moderator: Jan 23, 2009
  2. My_Dana

    My_Dana Approved members

    Joined:
    Apr 25, 2006
    Messages:
    596
    Very nice work..keep it up!
     
  3. Ellen

    Ellen Senior Member

    Joined:
    Oct 22, 2005
    Messages:
    8,240
    Do you view rituximab as a reasonable treatment? Have you seen the potential side effects and the new black box warning for that drug? http://www.formularyproductions.com/master/showpage.php?dir=blackbox&whichpage=147

    My personal feeling is it's abhorrent to run trials of this drug in children newly diagnosed with type 1 diabetes who are unable to make informed consent decisions for themselves. Parents are sometimes so desperate at dx to try anything to "potentially" arrest progression of diabetes. No one knows the long term effects of putting this in the body of an otherwise healthy child.
     
    Last edited: Jan 22, 2009
  4. TheFormerLantusFiend

    TheFormerLantusFiend Approved members

    Joined:
    Sep 10, 2006
    Messages:
    4,925
    A bunch of your links need fixing, particularly ones to the trials that are recruiting.
    Yours is an interesting site. Keep up the good work.:)
     
  5. joshualevy

    joshualevy Approved members

    Joined:
    Dec 30, 2008
    Messages:
    663
    Absolutely! Rituximab is already approved for general use for rheumatoid arthritis and certain cancers. So it has already passed more safety tests than many other drugs undergoing clinical trials now. Yes it has a major (black box) warning. Some drugs do. That doesn't preclude it from use: it does mean that doctors and patients need to think about it use. That's the whole idea behind prescription medicines. They need to be used with care and knowledge: they often have side-effects and limitations on their use.

    I think Rituximab is a perfect example of personal choice in treatment. One family can look at that black box warning and choose to use it, another family can look at that black box warning and choose not to use it. As it should be.

    I disagree. If we are going to cure diseases of children, we are going to need to test new treatments in children. This is especially true of childhood cancers, childhood diabetes, etc. Parents make medical decisions for their kids all the time. I don't see the decision to enroll in a clinical trial to be any different than the decision about what treatment option to use (which parents are expected to make).

    Yes the initial diagnosis of type-1 diabetes is a very stressful time. The onset of any major health problem is very stressful. People still need to make medical decisions at that time.

    I don't agree with you that a child with type-1 diabetes is "otherwise healthy". That child has a life expectancy years shorter than other kids. That child will die without constant BG control and external insulin. That child is not "otherwise healthy".

    Also, the bit about "no one knows the long term effects" is true for every experimental drug. If we stopped all experiments on drugs where the long term effects were not known, we would never do research and never learn the long term effects of any new drug.

    Joshua Levy
     
  6. joshualevy

    joshualevy Approved members

    Joined:
    Dec 30, 2008
    Messages:
    663
    I've fixed the bad links in the recruiting section and the "header" material in general. There are still bad links in the rest, which I'll fix over the next few days. Thanks for pointing this out.

    Joshua
     
  7. Ellen

    Ellen Senior Member

    Joined:
    Oct 22, 2005
    Messages:
    8,240
    I would never consent to put this drug in my child as an experiment to delay or prevent diabetes. Do you have any children?
     
  8. joshualevy

    joshualevy Approved members

    Joined:
    Dec 30, 2008
    Messages:
    663
    I do have a child.

    One great thing about America is the freedom to do what you want. You can decide that your child should not participate in a research study; some other parent can decide to participate. You seem to mix up "Ellen thinks this is dangerous" with "Everyone should think this is dangerous". The two are different.

    I would never second guess your decision not to participate in this research, but I think it is equally wrong for you to second guess the decisions of the 100s of parents who decided to participate.

    Joshua
     
  9. buggle

    buggle Approved members

    Joined:
    Mar 24, 2008
    Messages:
    4,267
    When my son was first diagnosed and we parents were attending our classes to learn how to keep our kids alive and we were all sitting there in shock... after a CDE finished up, the research team came in with consent forms. They gave us a talk about all the wonderful opportunities to keep our kids in a longer honeymoon. Not one word about risks during the pitch. If you don't have experience with T1, you have a steep learning curve to understand the disease. Even people with scientific backgrounds need time to absorb and learn about how the disease works and what the different treatments actually entail, including risks and possible benefits. People with no scientific or medical background have an even bigger mountain of info to learn.

    Under those circumstances, some people would never dream that a famous research center like Joslin or Barbara Davis would offer a treatment for their kids that could have dangerous consequences with unknown odds of any lasting effect. I really felt that we parents were a captive audience. I later emailed the study coordinator and asked for all the technical documentation they would send me and when I read the study protocol, I completely agree with Ellen. These treatments are incredibly risky. Obviously, parents can decide what they want and I'd completely understand why parents would enroll their kids in these studies for a chance to extend the honeymoon. But these are not cures, they're only available for new onset cases and they carry major risks.
     
  10. cwdAdmin

    cwdAdmin Administrator Staff Member

    Joined:
    Oct 4, 2005
    Messages:
    22
    Children's Clinical Trials Resource

    As an add-on to this conversation, the US Food & Drug Administration (FDA) offers information on their Web site that may be useful in exploring this topic and making a decision for yourself and/or child/family:
    Should Your Child Be in a Clinical Trial?
    Up until the last decade, children were rarely included in studies of medical treatments. As a result, much is still unknown about how children respond to drugs, some biologics (such as gene therapy), and medical devices.

    "We had the peculiar situation of demanding a very high level of proof before a product was marketed for adults, but then having it used 'off-label' in children," says Dianne Murphy, M.D., Director of the Office of Pediatric Therapeutics at the Food and Drug Administration. This means that FDA did not have studies on how the product did or did not work in children, what different kinds of reactions children might have, or what the proper dose would be over the wide range of children's ages, weights, and developmental stages, Murphy says.

    But FDA's pediatric program, backed by federal laws, has helped propel more clinical trials to be conducted in children. And more parents may be considering whether to enroll a child in a clinical trial.

     
    Last edited: Jan 30, 2009
  11. Ellen

    Ellen Senior Member

    Joined:
    Oct 22, 2005
    Messages:
    8,240
    We can respectfully disagree as to ethics of recruiting children to clinical trials for prevention using potentially lethal/toxic immunosuppression. Every parent should evaluate the potential risks (and the fact that many are not known) when offering their child for the good of research which may or may not prove safe and/or effective. For the record I did not "second guess" or express judgment of the parents who choose to participate, I questioned the ethics of the researchers who create these trials with potentially toxic drugs....even the drugs that are used to suppress the immune system in recipients of islet cells, are known to be potentially diabetogenic and nephrotoxic.

    My opinion comes from an experienced position where there was an absolute dearth of information presented with respect to subjecting a sibling to a trial - and that includes the emotional component. Additionally, one friend comes to mind whose child was in a trial and even after that child fully presented with t1d, the researchers continued to hound her relentlessly to bring her child back for more mixed meal blood tests for the sake of data - ignoring the needs of the child at that point. It wasn't until that child's pediatric endocrinologist intervened, that the researchers stopped pressing the parent to continue in the study. What's been your personal experience? and what has been your experience of friends who have put children in these trials?

    I fully respect your consolidation of what's taking place with clinical trials. I think a balanced view of the potential negative aspects of trial participation is also important.
     
    Last edited: Jan 31, 2009

Share This Page

- advertisement -

  1. This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
    By continuing to use this site, you are consenting to our use of cookies.
    Dismiss Notice