The GenoMed Approach, Clinical Trials

COMMENT:
Thank You for all the research and wonderfull work that You’re doing! I think I’ve read all of your publications and interviews, and I know that You’re a very frank person. I would like to invest some money for future benefits, and I find Your approach extremely unique. People with illnesses usually go first with FDA approved medicine, if that doesn’t help they start seeking alternatives. I know that You can prevent those terrible deseases, but can You cure them? What’s the outcome of the trials that You initiate? If You can cure those illnesses, is that gonna be legal in the US without FDA approval? I beleive that the end of the pill is about 10 years away. Stemcell companies are giving some very promising results, and some of them are undergoing Phase l/ll clinical trials as we speak. If those trials prove successful, pretty much all you have to do in the future is having regular stemcells shots, or they’ll have organs grown for you. Could You please describe how Your approach is better, or equal.

Thank You very much For Your Time.

RESPONSE:
Thanks for your great question about stem cells.

Clinically, I trust small molecular weight drugs more than anything else–more than monoclonal antibodies (humanized or not), and certainly more than stem cells.

Here’s why.

As one of my residents once told me when I was an intern, each patient you treat is a brand new experiment. No matter how much has been published about a treatment before, when you give it to your patient, anything could happen. Some new allergic reaction, some new toxicity could develop that was never described in the literature before. (We were always looking for such reactions so we could write a case report to the New England Journal of Medicine).

By definition, these would be rare reactions, the kind that happen in only 1 in 10,000 patients. Since drugs get approved after about 3,000 patient-years’ experience (3000 patients treated for 1 year = 3,000 patient-years), a 1 in 10,000 adverse event only gets picked up after the drug has been approved and is being used on entire patient populations.

Small drugs don’t stay long in the body. Their half-life is usually no more than 24 hours. So no matter what happens, if you just wait 3 days (3 half-lives), the drug will be gone.

Not so with antibodies, which are very large, and which aren’t cleared for a month. Recently a normal, control person died when he received an immunosuppressant antibody in a Phase I trial. Controls aren’t supposed to die!

Stem cells are never cleared. So if anything goes wrong, there’s no way to get rid of the stem cells.

The truth is, we don’t know how to control cells. The fear I’ve always had with stem cells is that they could cause cancer. Sure enough, a boy treated for a neurodegenerative disorder in Britain recently developed a medulloblastoma (brain tumor).

So my take on stem cells is that they’re still way too dangerous to use from the clinical point of view. Rather than replace worn-out organs, I’d like to keep them from wearing out in the first place. That’s becoming increasingly possible, certainly for kidneys, as we published in 2002.

Thanks again for your question.

Best regards,

Dave Moskowitz MD FACP
CEO & Chief Medical Officer
GenoMed, Inc.