Monday, May 18, 2009

Ampligen Update

The latest deadline for an FDA decision on Ampligen is scheduled for one week from today, May 25th. To say that no one knows what the FDA will do is to say that the sky is blue. The FDA is notoriously closed mouthed.

Just thought I would pass on to the support group that we are nearing an interesting date. The FDA was supposed to give a decision about 3 months ago and they extended the deadline until May. I believe they wanted some more information from the company that makes the drug.

I'll keep you posted.
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As long ago as when "Osler's Web" was written, one of the CFS experts pointed out that FDA could not approve Ampligen (an anti-viral) so long as CDC/NIH insisted that the disease it's intended to treat is IAIYH (it's all in your head).
For 18+ years, I've been hearing that "Ampligen is 18 months from approval" and muttering "at least they're consistent".  And for 18+ years I've been hearing the same excuse "need more information from the company" for why it wasn't approved at the end of that 18 months.  They cannot approve the drug for political reasons, but have not been able to find scientific reasons to turn it down, so they've been delaying for two decades.
It's been approved in other countries, including Belgium and Canada, so there's plenty of information out there.  Like any drug (even aspirin!), there will be people who have a bad reaction or an allergy, but those few people who did should not prevent everyone else from having access.  I'm highly allergic to soy, but I'm not lobbying the health food industry to stop selling tofu or soy burgers ... I just don't buy them myself.  And the same should be true for Ampligen -- if you have a bad reaction, stop taking it, but don't keep it away from everyone because a few people couldn't tolerate it.
What I would really like to see happen is for the government to offer each CFS patient a one-year free trial on Ampligen.  Many of us were professionals -- if we go back to work, we can afford to pay for our own Ampligen the rest of our lives, if the government is willing to help us pull ourselves up by our bootstraps.  But after decades on the pittance you get for Disability benefits (if you're lucky enough to get them, which many patients are not), there will be a lot of patients who could be helped by Ampligen who won't even get the chance to try it because they can't afford it, and our government is penny wise and pound foolish -- would rather not pay for the Ampligen to get you off Disability, even though the net savings over a lifetime would more than pay for that one-year trial. 
I've never tried Ampligen, I don't know if I can take it or not; I have bad reactions to a lot of drugs, so I may not be able to take it.  But if there's something that works, I want to have the opportunity to try it and get back to work, rather than having doctors and judges and everyone else put the blame on me for not returning to work when the blame really needs to be placed on the unavailability of successful treatments for my condition.
Instead of blaming the patients, blame the government, who have been hearing for decades from patients in the clinical trial that Ampligen is a miracle drug, yet the government has repeatedly refused to approve it, making it impossible for patients to get well enough to work because we're not being treated for the root of the problem.  Anti-depressants (which almost every CFS patient has been given at some point) are not going to beat a virus into submission.

Dr. Montoya at Stanford has had success in treating CFS patients with an anti-viral which is already FDA-approved for another virus, and a member of my online support group, who didn't have the $1100 a month for that one, improved somewhat on a related anti-viral that's only $200/month.  So, there are ways to get around the FDA's refusal to approve Ampligen, but only if you have a doctor willing to prescribe Montoya's drug off-label, and only if you have one of the viruses it works on (which not all CFS patients test positive for).

Fingers crossed that this time, there's enough evidence that CFS is a viral illness and not purely psychological, that the FDA will approve Ampligen on this go-round.  But I'm not holding my breath.

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