Patients, consumers, and physicians comment on Avastin and FDA decision to rescind approval

As patients, consumers and physicians react to the FDA panel decision yesterday on Avastin, several themes are emerging.

Many are wondering what happens now to the 17,500 patients currently on Avastin. Others wonder why these women respond well, what is different about them and why no one knows how to define them as a subpopulation to target Avastin to the "right" patients. Some feel that since the disease is cancer and not "growing new eye lashes" that if Avastin works for some part of the population, it should be approved simply because it is cancer. Some feel that the idea that Avastin is too risky is a bit absurb given that Stage IV breast cancer patients would be more likely to die of cancer than drug side effects.

Some physicians are adamant that they do not use Avastin if it doesn't work, so cost shouldn't be an issue and the drug should be approved so that physicians and patients can work out whether Avastin is the right option. Now cost, is not supposed to be part of this equation, but it is hard to imagine it not occuring to anyone as Avastin is one of the most expensive drugs ever.

The FDA's decision is not without support. Some feel that a drug that consistently shows negative data should not be approved. Others feel that patients' stories are anectodal and should not sway the FDA's decision.

While it is rare for the FDA to even consider an appeal, I am not sure that these hearings where helpful to anyone. No one's opinion has changed. No one learned anything new. Patients were allowed to plead but Genentech did not support them with any new clinical data. Genentech also did not use the 7 months between December and now to have a hypothesis on why these women are able to benefit to give the FDA a reason to allow them to test that hypothesis and keep Avastin available.

The FDA is supposed to evaluate Avastin based on science. And many people feel that emotional appeals have no place in science.

But patient experiences are data points and are science. Patient experiences are what clinical trials are evaluated on and how drugs get approved. The FDA relies on patient experiences to review adverse events. Post-marketing studies are done to gather patient experiences.

The delivery of patient data over the last two days was heart-breaking and unnecessary because I think all anyone will remember is the emotional horror that patients and caregivers put themselves through and will miss the "data" part of the equation.

There are 17,500 data points that represent the basis for the science that needs to occur if we are going to understand Avastin. If someone was able to present the science of those 17,500 patients without any emotional pleas from the audience, perhaps that would have been a more productive and insightful hearing.