Healthy Discussion

2009 October 30
by Jason Yeh

Over at Experimental Drug Therapies Blog there was some great discussion around the Abigail Alliance’s mission. When we caught wind of it, Frank stopped by and added his own thoughts. Click here to to read it all. Below are Frank’s comments:

This is great that there is such an excellent discussion going here on this blog. Let me add and clarify a few things from the extensive comments.

As regards safety, what the Abigail Alliance and the bill in Congress, Access, Compassion, Care, and Ethics for Seriously Ill Patients Act (ACCESS Act S.3046 H.R.6270), are talking about are drugs and vaccines for cancer and other serious life-threatening illnesses that are showing significant efficacy in clinical trials. Also it is important to keep in mind that drugs and vaccines in clinical trials are very closely monitored for safety. Another important point is that the decision to take an investigational drug by a person who has run out of FDA approved options and cannot get into a clinical trial, should be the patient’s in consultation with their doctor.

Here is what is profound (from
“Every drug for cancer and other serious life-threatening illnesses that the Abigail Alliance has pushed for earlier access to in our eight-year history is now approved by the FDA! There is not one drug that we pushed for earlier access to that did not make it through the clinical trial process. Many lives could have been saved or extended, if there had been earlier access to these drugs!”

As of early 2009 the count is 16 drugs! EVEN the FDA’s own Science and Technology Board in their late 2007 report recommended there be a provisional approval mechanism for promising developmental drugs.

Speaking of the FDA Science and Technology Board, they and for a long time the Critical Path Initiative ( have been pushing the FDA to use more modern scientific and statistical tools in clinical trial design, drug data, drug review, and approval. The ACCESS Act covers many early access issues, including jump starting the FDA using more modern tools.

By the FDA using more modern scientific and statistical tools, the use of placeboes would be greatly reduced. There are a significant number of patients who opt not to enroll in clinical trials, because they don’t want to take the risk of getting a placebo. Therefore the ACCESS Act would actually help speed up clinical trial enrollment.

One last note for now is that data outside a clinical trial can add to the knowledge about a new therapy.

Thank you all for your input.

Frank Burroughs, Abigail Alliance

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