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Defining Research

By Sara Calabro

On Thursday, the FDA recommended to reverse the approval of Avastin for breast cancer, a decision that The Washington Post says, “intensifies a politically charged debate over costly cancer drugs that appear to produce modest benefits—if any.” It also raises questions about the research processes by which therapies, including acupuncture, are deemed effective.

In a case of crystal-ball reporting, The New Yorker, three days before the Avastin news broke, covered the “decline effect” in research. This refers to the increasingly common phenomenon of follow-up studies failing to confirm original research findings. Avastin gained approval for breast cancer in 2008, based on one study that showed it slowed the growth of breast tumors. The FDA signed off with the understanding that the drug’s maker would conduct follow-up studies to confirm the results. Those studies proved unimpressive.

Debating the efficacy (or cost) of Avastin is beyond the scope of this post. However, the struggle to explain evolving, multifaceted clinical realities through defined research protocols relates strongly to acupuncture’s plight in the research world.

A common criticism of acupuncture is that it does not consistently demonstrate therapeutic benefit in clinical trials. There are numerous examples to the contrary, but compared with the overwhelmingly positive anecdotal feedback on acupuncture, its on-paper report card is weak. There are several reasons for this—lack of funding, cultural bias, poorly defined placebos, among many others. But perhaps most problematic is the rigidity with which research is conducted and interpreted.

Our tendency—as Westerners, and particularly in science and medicine—to want to put things in boxes, to understand and control them, causes us to negate that which cannot be clearly defined according to expected outcomes. An acupuncture study that does not improve pain scores by a certain percentage gets tossed in the acupuncture-doesn’t-work category. Yet in real life, acupuncture often improves conditions other than just the one that brought a patient in the door. Those changes can be what ultimately lead to improvement in the primary complaint.

A patient, for example, who comes in complaining of back pain may also be depressed and have a sedentary lifestyle. As acupuncture improves the depression, the patient becomes more motivated to exercise, which eventually alleviates the stiffness and pain in his back. “Does acupuncture work for back pain?” is not as easily answerable as sensationalized headlines encourage us to believe.

The conclusion of the New Yorker article on decline effect sums this up nicely: “The decline effect is troubling because it reminds us how difficult it is to prove anything. We like to pretend that our experiments define the truth for us. But that’s often not the case. Just because an idea is true doesn’t mean it can be proved. And just because an idea can be proved doesn’t mean it’s true. When the experiments are done, we still have to choose what to believe.”

Health is a personal state of being. Achieving it is about deciding what works for us. All the research in the world will not convince Pat Howard, interviewed by the Post about Avastin, that the drug does not work for breast cancer. “This is horrific,” she says of the reversed approval. “Without Avastin, I’m going to die.”

Acupuncture doesn’t fix everyone’s back pain. (Neither do cortisone shots.) But if it fixes yours—or your patient’s, or your husband’s—who cares what the data says?

This isn’t to suggest that scientific research is worthless, nor is it to say that there aren’t well-designed studies demonstrating acupuncture’s efficacy. But when it comes to making decisions about our health, it’s worth thinking about what factors may have influenced research findings and questioning whether those results should trump real-life experience.

By opening ourselves to the idea that medical research is neither foolproof nor always relevant, we’ll facilitate a dialogue about potential improvements.

“I’m convinced that we can use the tools of science to figure this out,” says a scientist featured in the New Yorker article. “First, though, we have to admit that we’ve got a problem.”

Photo by Sara Calabro

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Comments

Mary
Reply

Thanks for bringing this debate to the surface. There is always so much to say regarding the link between research and practice. Ideally, each would inform the other creating an optimum treatment environment for the patient. When this works, such as with cures to diseases and effective interventions for mental health, we can improve people’s lives. When research and practice don’t easily fit together, we’re quick to chose one or the other and quickly form opinions about the opposite side. In regards to acupuncture, it seems to me the common goal should be improving patients lives and working together to bridge this gap rather than dismissing it because it highlights the vulnerabilities of western research methods. Regardless, we as patients are ultimately the experts of our situation. The more informed we are about good research practices as well as treatment options the more able we are to live healthy lives.

Editor
Reply

Thanks for the thoughtful feedback, Mary.

I really like what you said about being the experts of our own situations. When patients feel empowered to embrace that idea, and practitioners are willing to accept it and think of healing as a process that they help to facilitate rather than dictate, improvements come easier — and last longer.

Thanks for reading, and happy holidays!

Eric Grey
Reply

This topic is, as you know, one of my great passions. My thoughts on this matter are ultimately too complicated (and unfinished) for a blog comment, but I want to commend you for bringing them forward. I think, ultimately, the problem lies in the research community’s uncritical acceptance of what constitutes “evidence” and lack of disciplined investigation into these important issues. Looking forward to hearing more about this from you…

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