1. Why wasted time, money and energy on ANIMAL
studies; they don't seem to have any relevancy
to today's studies on human health. NIH please
review your past empirical data and move on.

Posted at 12:21PM on Aug 1st 2006 by Peter O'Donovan

2. Here are a couple of important things I've learned that pertain to Peter O'Donovan's comment that NIH should spend more on human studies and less on animal studies. I've learned these things mainly from participating as a survivor member of the Scientist-Survivor Program sponsored by the American Association for Cancer Research for the past two years. That hardly makes me infallible, but it does give me a different perspective on cancer research than the one I had before participating. Our main activity is attending the AACR's annual conference, then writing about it to our own survivor community.

Now back to those points about the roles of animal and human studies. First, the NIH shares Mr. O'Donovan's concern and is also eager to speed worthy drug candidates toward the marketplace, provided that can be done safely. The FDA is also on board. Dr. Anna Barker, Deputy Director of the NCI for Advanced Technologies and Strategic Partnerships, and others worked hard to put in place a program called "Exploratory IND", the IND standing for Investigational New Drug. The idea is to use low doses for short times in human patients, dispensing with animals, and using Good Laboratory Production (GLP) to make the drugs rather than a formal production line. The safety issue is much less of a problem because of the low doses and short exposures. Also, other advances in medicine such as sophisticated imaging techniques enable researchers to get more knowledge from each person serving as a research subject. Cost and delay are minimized by the GLP approach. The idea is to learn a lot safely in a short time to speed the way into Phase 1 trials. We were told about this by Dr. Gregory Curt, MD, who was with the NCI for most of his career but is now with Astra Zeneca Oncology. He talked about "Current Challenges in Cancer Drug Development." I believe some recorded talks about drug development from the national conference in April are available free at the AACR site, www.aacr.org, under the virtual conference button. You will also get hits if you search at the NIH site (www.nih.gov) for "Exploratory IND". It will be interesting to see how this new approach is used in the coming year.

Second, not enough of us are volunteering to serve in human research studies. That is a major obstacle for many initiatives and pushes researchers toward animal studies even in instances where human studies would be appropriate.

Third, not only the effectiveness but also the safety of many potential new drugs is unknown. Animal studies are used to learn about these issues before human Phase 1 trials are opened. Often the biology involved is so complex that there may be completely unforeseen drug interactions and other biological interactions even if the expected impact is clear cut. While it's a big leap from animal studies to approved drugs that work in humans, we can learn a lot from animal studies.

Jim (web site: http://www.mycancerplace.com/profile.php?id=147 )

Posted at 3:46PM on Aug 9th 2006 by Jim