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Re: Re: Spring Break Study

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PozBod wrote:

>,

>If Merck called it's integrase inhibitor, " Spring Break, " and advertised it

under that name, showing scenes of active twenty somethings at the beach, would

you think that was ethical marketing?

I understand your concern with the name, however, the announcement did not

inclue any such scenes. So that is unfair--and I think that pharmaceutical

company advertising should be sent back to the dustbin of history. It has

terrible consequences that have much more to do with profit than health. So we

agree there.

As to the name, that's the informal name that one of the investigators came up

with--there is another one, TLZ-8. I'm on the road right now and actually don't

remember it! (TLZ-6??)

It was a bit of a tongue-in-cheek name and the investigator who came up with it

has been on and off ARV for many years. Indinavir actually probably saved his

life back around 94 or 95.

In our case, we hope the announcement will help people understand that, if they

either haven't started or have decided to take a break from ARV, there is an

option besides just tracking the downward slope of the CD4 count and viral load!

Does it work? We don't know. A few people trying it seem to be getting some

benefit but it is way too early to say. How else do we find out?

Of course, people must be working with their physician's awareness and

involvement. And by no means is this meant to replace ARV or discourage people

from using their medications. And close monitoring is extremely important.

One of the people trying it simply isn't interested in meds OR getting bloodwork

done. So he's trying it and they're evaluating him clinically. And encouraging

him gently to consider getting bloodwork.

Another has never used ARV so far and has seen some viral load drop and increase

in CD4 count. Other clinical symptoms have improved. He has some loose stools,

though.

Are the improvements a result of the herbs? Are the loose stools? Are there

other problems? We don't yet know. But we're trying to address this process with

care and meticulous data development.

And as a capacity grant, we hope this serves as a model for developing other

clinical trials of CAM approaches. Part of the effort will be developing the

extensive and labor intensive Investigational New Drug application which in the

context of Chinese herbs is a bit over-the-top.

So there is lots of work for us to do--and at the end of the day, the only thing

that matters is if it works or not. And if it does, with what benefits and

limitations.

M.

M.

Director, FIAR

http://www.fiar.us

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