Avastin Spring helps spur a resistance against bureacracy
By Dr. ROBERT GOLDBERG
Times Guest Columnist
Sometimes, profound change happens so swiftly it’s 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 Europe’s equivalent of the FDA, the European Medicines Agency (EMA). Indeed, the EMA 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 health 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 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 Avastin rendition, is being ignored in practice.
The uprising against the Avastin decision could signal a clear shift in power from the Beltway groups that claim to be patient or consumer “advocacy” groups - but are beholden to a particular party or just staying in favor with the powers that be — to individuals organizing on their own and in their own best interest.
More to the point, such movements are well informed and shaped by what the science says. They are often funding research to accelerate better treatment and detection of illnesses. The attempt to demean or diminish such movements as the expression of anecdotal experience and emotions 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 a contempt for any use of social media that does not seek to spread fear or skepticism of innovation.
Most immediately, the Avastin Spring has undermined the legitimacy of the effort to use comparative effectiveness research to delay access or payment for new technologies. 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. Consumers will be skeptical of one-size fits all judgments made by so-called “experts.”
Similarly, companies who develop new products will have to contend with consumers demanding credible and substantive clinical information.
The Avastin Spring suggests that resistance against bureaucrats telling the rest of us what treatments we can and cannot use will only grow. This is not an anti-science enterprise. Rather, these are movements that regard individual choice as an imperative as the science of personalized medicine advances. It means less authority for those claiming only they have science on their side en route to restricting access to innovations. Both changes bode well for our well being.
Dr. Robert Goldberg is co-founder and vice president of the Center for Medicine in the Public Interest. He is also author of the book, “Tabloid Medicine: How the Internet is Being Used To Hijack Medical Science For Fear and Profit.”
