TGN 1412 notes


I’ve been getting lots of hits over the TGN 1412 issue. I normally get around 20-25 visits a day, and in the last 5 days I’ve gotten nearly 400. If this humble blog is any indication, people are starting to ask questions about ethics in clinical trials, as well they should. It also looks like “lawyers are asking as well”:http://www.rinf.com/columnists/news/german-prosecutors-consider-probe-of-tegenero.

The fact of the matter is, going from animals to humans in drug testing requires a lot of faith. We conduct a lot of _in vitro_ and animal studies and have a lot of discussions with regulators before putting new compounds into humans. Coming off serious medical ethical tragedies such as the Nazi medical experiments, the “Tuskegee syphilis study”:http://en.wikipedia.org/wiki/Tuskegee_Syphilis_Study, studies in prison populations, we’ve instituted some very high standards of informed consent to conduct these clinical trials. And, given that taking a new experimental compound is very risky, most drug companies will pay well for healthy volunteers in early clinical development. Of course, as the risk goes down in later trials, the compensation goes down. (And as the number of patients goes up so that we collect enough data to prove safety and efficacy.) In the US, the normal informed consent rules are supplemented by HIPAA(Health Insurance Portability and Accountability Act), which governs how identifying information is used. Study protocols have to be approved not only by regulatory agencies such as the FDA but also by ethics boards at each of the sitesMore accurately, there are some ethics boards, or Institutional Review Boards, that cover several sites.. It’s possible for the FDA to approve a protocol and an ethics board for a particular study site to reject it or ask for a lot of information. A lot of eyes look at exactly how the study is going to be conducted, what data is collected when, how the drug is stored, administered, and unused portions recollected and disposed, and just about every other detail of the study. Rationales have to be given for dosing, especially early in clinical testing.

Clinical studies will get scrutinized again. As long as the scrutiny is fruitful and genuinely protects human life while protecting our ability to advance our understanding about ourselves, our bodies, and how to maintain and restore health, this can only help.

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