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Re: Lawsuit
Sep 28, 2003

This is in regard to Mr./Mrs. (AZT) Lawsuit.

If 95 of all the people who died in car accidents in the last year ate carrots in the week before they died should their loved ones bring suit against carrot growers, distributors and retailers?

I've taken Retrovir/zidovudine/AZT for most of the last 17 years. I'd love to stop taking it because of the nasty side effects. But, I want to stay away from the drugs with less efficacy and/or more side-effects. I have to strike a balance. But the point that hasn't been made with respect to this "AZT=Death" non-sense is that the balance that MUST be struck is saving the adaptive immune system verses problems with the treatment.

The adaptive immune system has been "clocked" suppressing 6log (base 10) to 7log (base 10) of HIV (or 99.9999 to 99.99999).

Suppressing 90 of someone's HIV equals 1log (base 10) of suppression. Suppressing 99 of HIV equals 2logs of suppression. Suppressing 99.9 of HIV equals 3logs of suppression.

If I have 14,000 copies of HIV in my blood and take a drug that lowers the amount to (say) 140 copies, that equates to 2logs (base 10) of viral suppression (of HIV).

The HIV virus hyper-mutates, i.e., it is extremely adaptive. No anti-HIV drugs or HIV vaccines are adaptive. Only the ADAPTIVE IMMUNE SYSTEM is adaptive.

I recommend that Mr./Mrs. Lawsuit focus on the failure to save the very thing that can chase after HIV as it mutates - the adaptive immune system. The barriers to preserving the adaptive immune system are: 1) a lack of HIV awareness, 2) a lack of early testing, 3) high costs of anti-HIV drugs and 4) high toxicity of the anti-HIV drugs.

A major barrier to finding less costly and toxic anti-HIV treatment regimens is the lack of focus on "healthy" HIV+ patients in clinical trials.

Almost two years after Viread/tenofovir was FDA approved, hundreds of HIV+ paying customers are finding that the drug doesn't work well with Ziagen/abacavir. HIV+ patients have wasted millions of dollars on drug combinations and blood tests because of the irresponsible way that the FDA handles HIV drug approvals. Multiple small cohorts of HIV+ patients can and must be added to new phase-III (non-salvage) drug trials to find out whether a new anti-HIV candidate drug works well with other suitable and commonly prescribed anti-HIV drugs.

Cipla (India) makes many anti-HIV drugs for pennies/day.

The issue of whether to fully test new drugs is not a cost issue; it is a lack of concern and lack of cooperation on the part of the pharmaceutical industry issue. This is where we must focus our lawyers.

There is no excuse for the FDA's poor performance with respect to the Viread/Ziagen debacle. The FDA is not performing its job. HIV+ patients need to know BEFORE they purchase multiple anti-HIV drugs whether they are compatible with each other.

Comments? Questions?

Tom

Response from Dr. Young

not much to add; and not wanting to fuel this fire any more than we have already-- BY



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