Isoprinosine - why not FDA approved

[Guest guest]

HMK asked " why does one have to go out of country etc. to get a drug?

[isoprinosine] Are they not available in major cities and covered by insurance

palns ? Forgive me if this has already beeen covered. "

Here's what Cheney said about the fact that Isoprinosine is not approved by the

FDA. (And why we therefore have to order it from Ireland, Mexico, or Hong Kong

and pay for it ourselves.) " It's been approved in Canada for 18 years. The

company sought approval in the US in the late 80's. They ran into a problem when

they asked for approval based on the idea that it's an immune modulator

effective against all viruses, which they had proven in Europe. The FDA said 'We

can't give approval for every virus there is. We don't approve things like that.

You'd have people taking it for all kinds of viruses.' The company said that was

the whole idea. The FDA said 'One drug, one disease. That's our line.' The FDA

has a bias against what are called biological response modifiers, which really

have broader potential usages, because they undermine their one drug one disease

mentality. The company refused. (To narrow their application to one virus in

order to get approval). They stood on their principle that biological response

modifiers are different, and they ought to have the right to claim here what

they were able to claim about the drug in other countries. "

" It is not a safety issue. Ampligen and Alpha Interferon have or had the same

problem. But I think it's changing at the FDA. If they tried now, it might be

different. "

Take care. Carol