From the CEO’s Desk: What Can We Learn?

Each morning I receive an e-mail from MedPage Today, updating me with the latest medical and research news from a variety of sources. Last week, the second item in the lengthy message was a survey: “Should FDA listen to patients?” The tagline under the question identified the topic as being prompted by the recent heated debate at an FDA meeting about Avastin and its indication for breast cancer. For a moment, though, I anticipated a link to CFS. A week earlier, the British Medical Journal published four articles describing the “stalemate” between CFS patients and researchers over the PACE study and XMRV, including one written by Nigel Hawkes under the title, “Dangers of research into CFS/ME.” Amy Dockser-Marcus’ article put this issue on the front page of the Wall Street Journal back in March (“Amid war on mystery disease, patients clash with scientists”), and every day it’s on display in CFS-related online discussion forums, Facebook pages and comments posted to news articles and blogs.

The Avastin issue provides an opportunity to look at the often contentious boundaries between researchers, physicians, regulatory agencies and patient communities. An opinion piece in the Los Angeles Times about it follows under the headline, “Avastin debate, science vs. emotion.”

“The debate over whether federal regulators should allow Avastin to be marketed as a breast cancer treatment has been characterized as a battle between science and emotion. On one side stands a Food and Drug Administration appeals panel that urged the agency last week to rescind its approval of the drug’s use against advanced breast cancer, citing clinical studies that showed no improvement in a patient’s chances of survival or quality of life. On the other is a group of women who told the panel at a hearing that they’d be dead if not for Avastin.”

There were hundreds of media reports about the outcome, a unanimous recommendation by the advisory panel to withdraw the breast cancer indication from Avastin’s label. The process leading up to the meeting and the drama that unfolded over its two days also got a lot of attention from industry and cancer advocacy bloggers. In this interview (“Avastin and FDA were both on trial”) on the blog Pharmalot, Harvard professor Daniel Carpenter describes the setting:

“There were several distinctive features to this meeting. First, it comes at an incredibly polarized time in our national politics, where every conceivable issue is getting mapped onto the left-right battles in Washington. With the debate over health care reform, the scientific debate over Avastin has been imbued with the ideological overtones of a debate over rationing and the role of regulation in American society.”

And it could be that the MedPage Today polling question was prompted by this MedPage Today reporter’s post after the meeting, “Avastin hearing provokes some cruel words”:

“The stories were gripping, inspirational, and at many points, observers in the room were fighting back tears. For these women, Avastin appeared to offer what other cancer treatment had not: Time of being free from illness to enjoy life.

But many of the patient speakers and patient advocates were extremely hostile toward the FDA, in particular Richard Padzur, MD, director of the FDA’s Office of Oncology Drug Products. He was called lots of names during the two-day meeting and accused of stacking the panel with people who had a vendetta to see Avastin no longer used for breast cancer. Padzur sat facing forward, away from the public speakers, for most of the two-day hearing as insults were hurled at the back of his head.”

On June 16, 2011, the organization FasterCures released a report, “Back to Basics: HIV/AIDS Advocacy as Model for Catalyzing Change.” It’s an important chronicle of history and a rich resource for anyone interested in getting stronger traction from government agencies and the pharmaceutical industry. Breast cancer organizations and CFS advocates regularly refer to the diverse and often confrontational tactics employed by early HIV/AIDS activists who succeeded in reshaping the clinical trials that have transformed HIV infection from a deadly diagnosis to one that is manageable with access to care and disciplined compliance with treatment regimens. The report certainly recognizes the value that groups like ACT UP provided in mobilizing people and anger to engage public health officials and lawmakers. FasterCures executive director Margaret Anderson summarized one of the main findings of the report this way in her blog, “What have we learned from HIV/AIDS activism? The basics made all the difference”:

“HIV/AIDS activists were successful in turning a cause into a movement because they were organized and knowledgeable about the issues, not just loud. It started with fear and anger, which led to theater, which led to getting smart on the science – and it was that combination of factors that was absolutely key.”

As the CFIDS Association narrows its focus to build a critical mass of rigorous research that validates the biological basis for CFS and leads to improved methods for diagnosis and treatment, the lessons learned by those on the front lines of the breast cancer, HIV/AIDS and autism movements are instructive. The Avastin debate pitted some breast cancer organizations against one another and against patients who had benefitted from that treatment. In the world of autism research, there remains a very active and vocal segment of the community firmly committed to exposing vaccines as a primary cause of autism, while another segment has shifted its focus to other environmental and genetic possibilities. There are plenty of divisive topics in the CFS community, from case definition, to XMRV, to the name itself. Researchers and patients alike feel the heat and for some, it deters them from engagement. The divisions manifest when trying to recruit new investigators to the field or building a coalition for action — a problem made greater for conditions that don’t yet have the kind of broad public support that breast cancer has built and the funding and commercial opportunities it presents.  

When I checked the MedPage Today poll responses this morning, there were nearly 1,000 responses to this longer question: “How seriously should the FDA consider patient views that conflict with clinical trial results?” In spite of coverage that highlighted the polarized environment, the responses were pretty evenly split between “Very Seriously,” “Somewhat Seriously” and “Not Seriously At All.” This is at least one sign that in spite of the divisions that exist, there is belief in the advantages of keeping all the stakeholders at the table, talking and trying to find ways to alleviate suffering.

From the CEO’s Desk is a monthly feature of the Association’s free e-newsletter, CFIDSLink. The July issue can be viewed at http://www.cfids.org/archives/cfidslink/july-2011.asp. Subscribe here: http://www.cfids.org/development/checkemail.aspx.

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