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talk turkey with me once again
Feb 9, 2003

ok give it to me straight - how much money would it cost to do proper research on an herb - say ginseng for example - that would prove its efficacy, or lack there of, as a monotherapy or in conjunction with antiretrovirals against hiv infection? are we talking 7 figures? 8 figures? 10 figures? what did say these new fusion inhibitors cost to get the research and study needed to get them fda approved, etc?

Response from Dr. Wohl

Development of new therapies can cost a bundle. A drug like T-20 required many steps including but not at all limited to someone to invent the compund, the testing to see if there was any evidence it could impact the virus lifecycle, safety testing in animals then people and then a series of clinical trials. This translates into millions of dollars.

Now an herbal medication may not need to go through the same procedure. If the compund is known to be safe it may be able to skip some steps. A study in which ginseng, for example, plus HIV therapies versus HIV therapies alone can be done and seems ethical on the face of it.

The key cost factors are, what is your outcome that you wish to measure? Is it viral load? Quality of life? What you choose will affect how many people you would need to enroll, what tests to perform etc. How long would you study people? Who would be paid to see them for evaluations? At one clinic or across the country? You would want to be sure everyone got the same formulation of the agent under study. As you can imagine, the variables add up as can the costs.

To provide an example of doing it on a shoestring, I am doing a study of fish oil for HIV therapy associated hypertriglyceridemia. We will enroll 70 subjects. Total cost will be around $30,000 plus the donation of some expensive lab tests from our university and a commercial lab, as well as the fish oil itself. DW

Where do you see it
P24 testing and window question

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