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Genentech company has decided not to release the drug thrombopoietin

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  • Genentech company has decided not to release the drug thrombopoietin

    Today, I spoke with a member who is also on the Board of Directors of the Christopher Reeve Paralysis Foundation and he suggested that I post this on the Cure Forum.

    PN

    Thrombopoietin Clinical Update


    Research to Be Presented Suggesting Reversal of Lou Gehrig's Disease May Now Be Possible
    Annual Meeting: American Spinal Injury Association,
    April 2-6, 2003 - Hotel Inter-Continental Miami, Florida

    MIAMI, April 2 /PRNewswire/ -- Reversal of Lou Gehrig's disease may now be possible using thrombopoietin and thyroid hormone to cause regeneration of endogenous stem cells of the central nervous system. Evidence suggests spinal cord injury can be reversed through regeneration by stem cells. This research will be presented by George R. Schwartz, M.D., a senior researcher at Neuroregeneron Co., this week at the annual meeting of the American Spinal Injury Association held in Miami, Florida.

    The Food and Drug Administration (FDA) biologics division approved a unique clinical trial in May 2002, authorizing the use of thrombopoietin for Lou Gehrig's disease (amyotrophic lateral sclerosis) in a 40-year-old mother of three small children whose clinical condition was deteriorating rapidly. She was more than 90% paralyzed, with minimal speech capability, tremendous difficulty swallowing, and rapidly failing respiratory function.

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    The new treatment was approved for a clinical trial after it was demonstrated that platelet growth factors could be tremendously increased through use of thrombopoietin. Platelet growth factors act as stimulants for the growth and development of glial cells which act as repair cells for dying nerve cells. In addition, platelet growth factors can stimulate immature cells to differentiate into cells which act as neurons. Thyroid hormone was added to the trial after experimental evidence demonstrated that thyroid hormone acted as a signaling substance helpful for repair cells to function. Platelets were raised in cycles to more than 10 times the normal level resulting is blood serum rich in platelet growth factors. At day 42 of this clinical trial, this patient showed remarkably improved head and neck control and strength. At day 45, she exhibited improvement in tongue strength and motion with improved swallowing functions. As a result, a feeding tube was not necessary.

    At day 60, increased leg muscle strength was clearly evident. Along with this motion, the patient was able to turn her arms and hands which had been paralyzed for more than a year. At day 110, she began to move her hands. Muscle strength throughout her body increased and her pelvic muscles could support more weight.

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    The patient showed clear reversal of a previously deteriorating condition, and return of functions. Her downhill course stopped. The nerve cell regeneration and reversal of paralysis in this patient with Lou Gehrig's disease suggests that spinal cord injury and paralysis can also be treated with re-growth of the nerve cells of the spinal cord. Further trials are urgently needed since the average length of life in ALS patients is 3-5 years after diagnosis. There is also some indication that regeneration in cases of spinal cord injury would be more effective soon after the injury.

    The FDA has been extremely supportive of this clinical trial and has urged that other trials be conducted as soon as possible. "If this proves out, it is a very exciting result indicating a new treatment and approach to Lou Gehrig's disease and spinal cord injury," said a senior neurologist with the FDA in Rockville, Maryland.

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    However, despite the encouraging results and excitement generated by this clinical trial, the Genentech company has decided not to release the drug thrombopoietin for any further trials in neurologic disease or injury. "We will not proceed with any further trials at this time," said Mary Stutts, director of corporate relations at Genentech. The medication was manufactured in substantial quantity in the late 1990s and the current stock of clinical grade thrombopoietin will expire in the year 2003. "Remanufacture is not planned at this time," confirmed Heather Mccauley, spokeswoman at Genentech. She offered no other explanation for the decision not to conduct any further clinical testing.

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    A director of the Lou Gehrig's clinic at the Massachusetts General Hospital and a professor at the Harvard Medical School, has prepared a trial for ten people with this disease. "I am totally puzzled," commented the doctor, who was rebuffed when he approached Genentech with his proposal. "This defies all common sense and scientific responsibility. We have no other treatments for these conditions," he explained.

    Dr. Schwartz, who has been following his patient closely with the FDA approved trial, is also puzzled. "Are they blind to the implications of this drug for use in neurologic diseases or injury?" he remarked. Monica Collier, one of the researchers who has been following this patient's ground-breaking clinical course, expressed amazement at the lack of compassion shown by the spokespeople at Genentech. "I cannot understand their approach," she said. "It would seem to be in their interest to try to develop this medication, and the patients just cannot wait."

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    Dr. Schwartz added, "I know the people at Genentech would be happier if there was a large amount of animal experimentation before the clinical trial. However, the reality is that animal models are not suitable to test for regeneration of nervous system cells at this time. We have a treatment which is ground-breaking and which is working in our patient. Let us go forward with further testing. Re-manufacture will take years. Meanwhile all the medication for clinical testing is literally going to waste. Patients are suffering and family and spouses are watching tragic deterioration in their loved ones."

    Contact: George R. Schwartz, M.D. Senior Researcher, Neuroregeneron Company (a Division of Schwartz Pharma LLC) Tel: 505-610-8243 http://www.healingresearch.org.

    This release was issued through eReleases(TM). For more information, visit http://www.ereleases.com.

    Focus On ALS

    http://www.focusonals.com/thrombopoietin.htm

    [This message was edited by PN on 07-18-03 at 02:51 PM.]
    The test of success is not what you do when you are on top. Success is how high you bounce when you hit the bottom
    --General George Patton

    Complex problems need to be solved collectively.
    ––Paul Nussbaum
    usc87.blogspot.com

  • #2
    However, despite the encouraging results and excitement generated by this clinical trial, the Genentech company has decided not to release the drug thrombopoietin for any further trials in neurologic disease or injury. "We will not proceed with any further trials at this time," said Mary Stutts, director of corporate relations at Genentech.


    they must have gotten a contract to build wheelchairs and coffins.

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    • #3
      There should be a justification for there decision and not just oh well we decided not to manufacture anymore. They should be forced to answer and proove adequately why?, or be forced to release the formula in the interest of humanity and progress. (that's my two cents worth)

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      • #4
        Paul, let me put some thought and research into this. It is very puzzling to me that Genetech is doing this. Wise.

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        • #5
          deja vu. regeneron did the same thing back in the 90's. but ofcourse we should keep quiet.

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          • #6
            This is so unbelievable. Is it a liability
            issue? Not enough ALS sufferers to be profitable? This is terrible. How can it happen? How can we help to stop it?
            Life isn't about getting thru the storm but learning to dance in the rain.

            Comment


            • #7
              Originally posted by Lindox:

              This is so unbelievable. Is it a liability
              issue? Not enough ALS sufferers to be profitable? This is terrible. How can it happen? How can we help to stop it?
              Interesting legal questions. Can one force a company to manufacture a drug based upon public interest? That would be tough. Perhaps the better angle might be for one to argue that in refusing to manufacture the drug the pharmeceutical company has effectively abandoned its patent rights by violating the public interest and the patents to the drug are now part of the public domain free to be manufactured by other parties.

              Regardless, something wreaks hereand needs to be investigated.
              What we do in life echoes in eternity. Maximus - Gladiator

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              • #8
                PN, thanks for posting this.

                The biological response to this drug sounds amazing. Since the current stock is due to expire this year, it seems that some other pharmaceutical or biotech company could manufacture it or at least buy or acquire the rights to the patent if there is one. Kind of makes DA's theory about a conspiracy to keep us disabled sound credible. Is this drug related to Epoetin by the way?

                [This message was edited by seneca on 07-18-03 at 07:41 PM.]

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                • #9
                  Genetech has recently been a stock market darling. Over $2billion in current assets, lots of cash, quite profitable... there is no excuse for bailing out on a drug like this.
                  Attached Files
                  "Oh yeah life goes on
                  Long after the thrill of livin is gone"

                  John Cougar Mellencamp

                  Comment


                  • #10
                    Too much risk and liability? Too many side effects?

                    There's information here that's not being divulged.


                    Seneca, get a hold of yourself lol. Endorsing conspiracy theories??? You've been in the sun too long lol. [img]/forum/images/smilies/rolleyes.gif[/img]

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                    • #11
                      [QUOTE]Originally posted by ChrisD:

                      Too much risk and liability? Too many side effects?

                      ChrisD,
                      Could either of these so called reasons be
                      valid in relationship to ALS?

                      Really when your life expectancy is 3-5 years
                      is there any humane reasoning behind this action?

                      I doubt if ALS victims would consider risk
                      and sign any document put before them. And side effects...well none could be worse in this case then the ravages of this life-sucking disease IMO.
                      Life isn't about getting thru the storm but learning to dance in the rain.

                      Comment


                      • #12
                        Maybe this is just a knee-jerk reaction, but I feel a nicely organized media campaign would work well for getting this drug into development by somebody.

                        -Steven
                        ...it's worse than we thought. it turns out the people at the white house are not secret muslims, they're nerds.

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                        • #13
                          wcrabtex i already told you why. this is nothing new. this happened before with in-1. regeneron bought the rights to in-1, then announced no plans to develope in-1. so why buy the rights? well regeneron went into business selling medical supplies.


                          DEJAVU.

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                          • #14
                            Agreed Lindox.

                            However, business is capitalistic by nature not altruistic. Humanity doesn't often play a part - unfortunately.

                            Additionally, our U.S. medical system, by design would not allow an ALS sufferer the ability to "sign off" on their life. It protects, right or wrong, us from ourselves. We can't in essence pull our own trigger.

                            This debate can rage forever. My point is that the process, regardless of medical malady, is what it is. To change the rules the system and the processes (checks and balances) have to be altered, tweaked, bent, changed. This is not likely to happen - ever. Therefore we must work within the framework and lobby the areas most influential and beneficial to us.

                            Money talks...liability walks.

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                            • #15
                              Dr. Young,

                              I know you're busy but can you please find out the facts on this report. If this woman was given the drug a year into the progression of the disease sounds like this drug might also help chronics. I also have a very dear friend whose father is dying from ALS. Is there anything we can do?

                              Deb
                              "Save the last dance for me!"

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