The Avastin Spring

Sometimes profound change happens so swiftly that is unrecognized and unappreciated. Such is the case with the response to the Food and Drug Administration advisory committee’s decision to withdraw the agency’s approval for using Avastin to treat metastatic breast cancer. After the FDA Oncological Drug Advisory Committee declared Avastin to be unsafe and ineffective for women suffering from that incurable form of the disease the headlines and pundits spun the decision – and the discussion – as one where science triumphed over emotional and desperate women. Gary Schwitzer, a self-styled expert on objective medical reporting quoted the representative from the National Breast Cancer Coalition who at the ODAC hearing: "This decision can't be driven by anecdotes. It must be driven by science."

This is an unfair and lazy characterization of the debate over Avastin. The ODAC panel was stacked with members who already voted against Avastin’s use in MBC. The conflict was over the interpretation of clinical information and whether the FDA can pull an approval because, as it said in December of last year, Avastin doesn’t provide “a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.” But several other groups that looked at the same evidence came to a different conclusion including The National Comprehensive Cancer Network and the European Medicines Agency (Europe’s FDA) that expanded approval Avastin based on the same “science” ODAC used in rescinding the drug’s FDA endorsement.

In any event, the speed with which both the Obama administration and private health plans announced they would still cover the cost of Avastin for the use the FDA rejected was stunning. When the FDA decided to yank Avastin’s approval in December 2010, several healths plans and regional Medicare reimbursement contractors told women that Avastin would no longer be covered. (Such decisions were reversed only after the FDA said it would review its revocation.)

Last week the same organizations – along with the Obama administration – rushed to distance itself from the FDA and assure women it would cover the drug.

The difference in response is a result of the rapid organization of patients through social media. While it culminated in the presence of hundreds of women at the ODAC hearing, that participation was only a part of an extensive, sustained and scientifically informed movement.

The FDA officials and the interest groups urging Avastin’s revocation were outgunned by individual patients who joined together much as HIV patients did in the 1990s and MS patients did in pushing for the return of Tysabri to the market a few years ago. This time however, the use of social media to share clinical information, organize support and express opinions was rapid, sustained and, above all surprising. The cancer advocacy ‘establishment’ was outgunned and reduced to irrelevancy. This also happened after the Obama administration’s recommended not to cover mammograms for women under 50. The National Breast Cancer Coalition sided with the administration and cancer patients, oncologists and radiologists everywhere told them go stick it. That decision, like the FDA’s rendition of Avastin, is being ignored in practice.

We see in this recent uprising against the Avastin decision a clear shift in power from the Beltway groups that claim to represent patients to individuals organizing on their own and in their own best interest. More to the point, this movement is well informed and shaped by what the science says. The attempt to demean or diminish it as purely anecdotal and emotional reflects the arrogance of bloggers and pundits who have but a thimble full of the clinical understanding of the movement’s participants. And it suggests contempt for any use of social media that does not seek to spread fear or skepticism of innovation.

Companies who develop new products will have to contend with consumers that demand credible and substantive clinical information. Health plans and the government will have to expect ongoing challenges to their ‘expertise’ and claims that it is using the best evidence in determining what to cover. In particular the apparatus and funding supporting comparative effectiveness research will find that consumers will be skeptical of one-size fits all judgments made by so-called ‘experts.’

The Avastin Spring suggests that resistance against the use administrative means to tell the rest of us what treatments we can and cannot use will only grow. We don’t know how it will all play out. But we do know that it will lead to more individual choice and less authority for self-styled advocacy groups, government and corporate entities who claim that only they have science on their side en route to restricting access to innovations.