Comments on: OSR to be pulled from the market?

By: Sullivan

Sullivan — Thu, 05 Aug 2010 18:32:03 +0000

Aaron Payne,

would you be so good as to explain how you justify continuing to sell a product that the FDA requested be pulled from the market?

Kathleen Seidel noted in a comment above:

“Under the circumstances, I’ll be interested to see how (or whether) Haley responds to this part of the warning: “Furthermore, please advise this office what actions you will take to address product that you have already distributed.””

By: Aaron Payne

Aaron Payne — Thu, 05 Aug 2010 18:13:21 +0000

Living Well International in Richmond,VA USA. Still has some OSR for sale if people are looking to buy some. Call and talk to Aaron.

By: daedalus2u

daedalus2u — Mon, 26 Jul 2010 16:59:28 +0000

Does anyone think that OSR-1 will still be available after July 29, 2010?

I mean, if people send in money will they just send the money back?

By: ANB

ANB — Sun, 25 Jul 2010 14:31:09 +0000

No kidding. Nothing moves product like impending scarcity. I wonder why Haley didn’t promise to stop selling OSR in mid August, or by 2001? Maybe be knew he could get away with seven days, but no more.

By: FreeSpeaker

FreeSpeaker — Sun, 25 Jul 2010 03:58:14 +0000

Haley’s delay in pulling the product off the shelf is an invitation to a “fire sale” at full price.

By: Sullivan

Sullivan — Fri, 23 Jul 2010 17:21:31 +0000

Joseph,

I would suggest that is not the longest limb you have ever crawled out upon.

By: brian

brian — Fri, 23 Jul 2010 15:29:58 +0000

Sullivan, I think Haley’s only option would indeed be to test OSR#1 as a chelating agent, although there are a variety of potential targets and applications—none of which have any apparent connection to ASD.

By: Kathleen Seidel

Kathleen Seidel — Fri, 23 Jul 2010 02:45:20 +0000

“The FDA is not going to be interested in data on faux mercury poisoning…”

I wonder whether FDA may be wary of the reliability of data originating from any investigator who has been involved in this initial attempt to make an end run around the regulations for IND’s. I also wonder whether anyone who’s already tried OSR would now be disqualified from enrolling in a properly run clinical trial, since they’re not drug-naive anymore and have already formulated opinions about the drug that would contribute to reporting bias.

By: Joseph

Joseph — Fri, 23 Jul 2010 01:19:21 +0000

Although we believe the product meets the legal definition of a “dietary supplement,” we have decided not to contest this point but to work with the agency.

I’m going to go out on a limb here and suggest that Haley was completely and utterly unable to contest this point, so he had no choice but to give up. Profit loss is no doubt significant.

By: Sullivan

Sullivan — Fri, 23 Jul 2010 00:50:25 +0000

brian,

I would be interested in what, exactly, he would do clinical trials on? As in, what is OSR supposed to treat?

The FDA is not going to be interested in data on faux mercury poisoning. Challenge chelation tests and porphyrin profiles are not going to make a clinical trial. It isn’t an autism treatment. What efficacy is Mr. Haley going to show? He has spent the past few years avoiding calling it a chelator. Will he do a 180 now and test it for its function? If so, is there really enough demand for a new chelator?