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Ineffective Generic AZT (w/correction)
May 16, 2010

Whose job is it to ensure that generics are effective?

I recently switched from brand-name AZT to generic AZT in a regimen that worked for me for about a decade (AZT+ABC). When viral load reached 1,500 and a genotype assay showed lots of TAMs for nearly every NRTI I had tried in the past, but not 3TC (which I took for about 1.5 years, 15 years earlier), I asked for prescription for brand name AZT and brand name 3TC.

One month later, viral load is <1/3 of what it was (1,500), and all the side effects that were barely detectable on generic AZT are now much more pronounced (muscle twitching, muscle pain, etc).

The generic AZT had a much lighter side-effect profile. It didn't even taste the same as the brand-name drug.

The generic AZT was about $100. Brand-name AZT costs about $489.00.

Big-pharma fights (tooth & nail) any attempt to purchase their drugs from Canada because (we are told) the drugs might not be effective.

Well, now that AZT is off-patent, and generic AZT can be sold in America, I find that it has poor efficacy. Whose to blame? Where are the head-to-head clinical trials of ANY generic AZT with brand-name AZT, in a least toxic, least expensive (dual-NRTI) regimen?

Laurie Barclay, MD's March 23, 2010 Medscape article titled 'Early Termination of Clinical Trials May Overestimate Treatment Effects contrasts with the first study of AZT in patients with >500 CD4+ T cells, which opened about 22 years ago in the AIDS Clinical Trials Group (ACTG019). That clinical trial (ACTG019) ran for six years! So, what I'm really asking is where are the long-term studies of brand-name AZT with generic AZT?

With the recent announcement that San Francisco will recommend immediate treatment for all, and the need to find least toxic and least expensive regimens for people with immune systems strong enough to keep their HIV from mutating around a dual-NRTI regimen for decades (like my immune system - which was preserved with early treatment), what options do the "new kids on the block" have for guaranteeing that their generic medicines are effective?

With jobs leaving this country by the multi-millions each year, and with human resource departments tracking-down people with high health care cost to push them out the door, generic drugs are a necessity in HIV disease. We must demand that those that are on sale in America are AT LEAST as effective as their brand name counter-parts.

There needs to be a new focus in clinical trials that focus on people with strong HIV-specific immunity. Because testing a generic drug in a regimen with three or four other drugs would likely NOT show a lack of efficacy in a short (1-year-long) study. We need more trials like ACTG019, from 1988, that test much more useful drug regimens, but not the $30K/year 5-drug regimens that Big Pharma would like to see everyone take.

We need to preserve the immune systems with the least toxic treatments until a known cure (GcMAF) can be brought forward. GOOGLE "GcMAF +Yamamoto +HIV" 39 patients have been cured, in two separate studies. All were cured in less than 18 weeks. Some were cured in 8 weeks.

Thank you!

Response from Dr. Holodniy

Lots of issues and questions to tackle, but the answers are not readily apparent.



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