Cancer will always be stupid.

Today's New York Times has an interesting article about Dr. Richard Pazdur, the FDA's cancer guy. If you get a chance to check it out. It brings up a few interesting issues that drug companies, advocates, regulators and patients face when dealing with drug development for serious illnesses.

What struck me most from this story is how good we have it in HIV. Through many types of dogged activism, we ended up with a system where, for the most part, the right drugs get approved in a timely fashion. We have validated surrogate markers, bright and dedicated community activists and a track record of success.

How different it could have been. What would the world be like had the FDA remained unmoved, unchanged by the early AIDS activists? Without parallel track, expanded access, accelerated approval, CABs- where would we be.

The business of drug approval is fraught with competing interests. Drug companies want their drug approved. Patients and advocates struggle with the desire for new drugs against the realities of toxicities and side effects. Regulators have to shepherd the process, balancing the desire for new treatments against the many vagaries of biomedical research.

AZT was approved based on its ability to extend lives by a matter of weeks. The first combination therapies- dual nucleosides (d4T plus 3TC for example), were used because the could be shown to slow the rate of immune decline. Three drug therapy- or HAART as it has become known- showed the potential to reverse HIV disease progression.

In the early days, it was a given that the drugs would make you sick. The main question was would they give you more life. Now, it is pretty much a given that new HIV drugs will 'work'- they will reduce HIV levels, improve or stabilize CD4 counts- and mostly we argue over tolerability and durability.

I am not familiar enough with the state of cancer research to have opinions on their drug development process. This article makes it clear there is still a lack of agreement on how these drugs should be studied and evaluated.

Cancer is the second leading killer in the US- behind only heart disease. Most research shows that people with HIV are at a higher risk of cancer overall, in addition to being at specific risk for HIV associated cancers like KS, and lymphomas. In short we have a dog in this fight.

Speaking of dogs and cancer- it is the 40^th anniversary of the declaration of the war on cancer, and the 40^th anniversary of Scooby Doo. How little both have changed over this time.