Legal Framework for Human Clinical Trials in Israel

Stem cell; cell based hair therapy
1

Apparently Israel is a big venue for human clinical trials for drugs, medical devices, etc., and there is a sophisticated legal framework for such trials there.

http://www.bio-itworld.com/BioIT_Article.aspx?id=106812

I know nothing about how human clinical trials are registered or overseen in Israel, but apparently it’s done under the auspices of the Ministry of Health.

If we could find out the exact agency or office within the Israeli MOH, then maybe we could track down a record of the Pilogics/Pilox trials, and more details.

I would assume that if Israel regulates human clinical trials so carefully, then the Pilogics trials would be registered and “official”, and some official public version of their description would be available through the regulating agency.

Furthermore if this device is actually being clinically tested, there has to be at least one licensed Israeli physician (MD) involved. Like, for instance when Intercytex was doing clinical trials in Manchester, England, Dr. Bessam Farjo was the medical doctor actually administering the procedure to the trials patients.

Who is/are the Israeli medical doctor(s) administering the testing to the Pilox trials patients?

2

earth to roger

earth to roger

we’re losing you roger

3

I think Roger-that has a great idea here. It’s a lot better than getting pieces of info from other posters. If we get in touch with the proper authorities in Israel we might be able to find some hard facts about pillox, which is a lot better than your delusional false hope beliefs.

4

roger-that, your approach is the best idea I’ve seen so far. Since brunobald is only getting sporadic incomplete and small amounts of info we need to get some facts some other way, and your idea is smart because it will tell us a lot and it will be factual.

If we can get the info you’re talking about we might learn if there really are studies or not, what phase study the treatment is in, when that study started, when the study will end, and the size and scope of the study. Learning these things could fill in some of the blanks and then we won’t have to rely on posters who are unable to secure adequate information.

[quote][postedby]Originally Posted by roger_that[/postedby]
Apparently Israel is a big venue for human clinical trials for drugs, medical devices, etc., and there is a sophisticated legal framework for such trials there.

http://www.bio-itworld.com/BioIT_Article.aspx?id=106812

I know nothing about how human clinical trials are registered or overseen in Israel, but apparently it’s done under the auspices of the Ministry of Health.

If we could find out the exact agency or office within the Israeli MOH, then maybe we could track down a record of the Pilogics/Pilox trials, and more details.

I would assume that if Israel regulates human clinical trials so carefully, then the Pilogics trials would be registered and “official”, and some official public version of their description would be available through the regulating agency.

Furthermore if this device is actually being clinically tested, there has to be at least one licensed Israeli physician (MD) involved. Like, for instance when Intercytex was doing clinical trials in Manchester, England, Dr. Bessam Farjo was the medical doctor actually administering the procedure to the trials patients.

Who is/are the Israeli medical doctor(s) administering the testing to the Pilox trials patients?[/quote]

5

This sounds like a job for Aka1 (or anybody else who speaks Hebrew).

6

Licht, I believe this is the department in the Health Ministry we have to inquire with…

http://www.health.gov.il/English/MinistryUnits/HealthDivision/MedicalTechnologies/Drugs/ClinicalPharm/Pages/default.aspx

There is also a separate unit for the licensing of medical devices, but I believe that refers to licensing for specific devices, like, if you wanted to license an MRI machine.

I believe the unit I linked above, which is concerned with Medical Technologies, is the one.

Also, note that the MOH has a Freedom of Information unit.

7

It’s worth looking into. I hope that Aka1 or other Israeli posters are still around.

I’m not sure what level of transparency Israeli trials run at. For example, as far as I know, trials run through the FDA, at least in the United States, are listed publicly, and if a drug or device is approved, significant data about that drug must be made available through Freedom of Information. Drugs not approved do not.

I couldn’t get a clear answer from their English literature.

8

True. Then there’s also the matter of transparency and accountability for prospective clinical trials patients. For instance, if some doctor or clinic suggests I become a subject in their clinical trials, I want to have a place where I can go to independently get more information. Are they reputable researchers? What are the risks? In Western countries, there is always a government agency that registers clinical trials and monitors these things.

In countries like India, China and Russia, things are a bit different. They may have such agencies on paper, but in practice, experimental medicine is a relatively unregulated environment and prospective clinical trials patients sometimes take big risks. (Note that I am not including Dr. Nigam in the category of “big risks”, because all you’re risking is your money and maybe some donor hairs, not your life or your health.)

I would imagine Israel is somewhere between the Western model and the more unregulated model, but possibly much closer to the Western model.

So one would expect a company that’s making needling holes in the skin of patients and putting copper ion solutions and electrical currents into the skin on a regular basis, and has already gone through 4 or 5 iterations of different versions of such a treatment, with photos to prove it, definitely would have registered its clinical trials with the authorities and have all the required permissions and documentation.

Right?

9

Israel does many clinical trials but not precisely to improve health.

10

Can we have this post (I mean the reply by “bugler” ) either erased or moved to off-topic?

It’s irrelevant, political, unsubstantiated, etc…

11

If you email Hairsite I’m sure they’ll delete it…

12

Might do. I’m surprised there’s no flag for posts like this. I guess every forum has its random conspiracy theorists and anti-semites (including, strangely, hair loss forums…)

13

Welcome to the Monkey House!!

14

I’m still here…
according to the ministry of health’s website, the clinical trials being conducted in Israel are listed in the American clinicaltrials.gov database, which does not contain any info about pilox.
frankly, I don’t think this is the right way to attack the issue, as the experiment sounds like Yoram’s private initiative and it probably isn’t regulated by the authorities.
all we need is for someone to get in touch with Yoram or one of the ppl participating in the trials - they should have all the answer we want.

15

[quote][postedby]Originally Posted by aka1[/postedby]
I’m still here…
according to the ministry of health’s website, the clinical trials being conducted in Israel are listed in the American clinicaltrials.gov database, which does not contain any info about pilox.
frankly, I don’t think this is the right way to attack the issue, as the experiment sounds like Yoram’s private initiative and it probably isn’t regulated by the authorities.
all we need is for someone to get in touch with Yoram or one of the ppl participating in the trials - they should have all the answer we want.[/quote]

The concern is, if Yoram doesn’t register these clinical trials with the Israeli government, how will he eventually be able to get legal approval to market his device and treatment?

I am sure this needs government approval. It can’t simply be done informally.

Is this at least being done under the supervision of licensed physicians?

16

[quote][postedby]Originally Posted by roger_that[/postedby]
Welcome to the Monkey House!![/quote]

This post made me laugh! It really can be a Monkey House at times.