Thursday, April 08, 2010

Comparative Effectiveness Research and Alternative Medicine: Bring it On

The debate over a federal comparative effectiveness research institute in the US was one of the big issues for biopharma companies early in the health care reform debate, and one of the first flash points for hyperbolic, partisan disagreement over the direction of reform. (Before the “death panels,” there was the “rationing” debate.)

Like so much in the final health care reform law, the outcome of CER was pretty much as good as industry could hope: a federal institute relying on a public/private partnership model rather than a federal agency akin to the UK National Institute for Health and Clinical Excellence. (You can read much more on the background of this debate here.)

Still, it is fair to say that the potential impact of CER on biopharma companies makes plenty of people in industry nervous. It is all-too-easy for a pharmaceutical sponsor to imagine a federal study pitting its biggest product against something else head-to-head in a setting where the sponsor has no input or control—and maybe the deck is stacked against the drug to start with.

But is that really how it is going to work out?

After all, love ‘em or hate ‘em, pharmaceuticals at least have mountains of evidence to work with. There is plenty of room to argue about whether a given drug works better than something else, but at least—thanks to those pesky regulators at FDA—you can basically be sure that the drug works for something.

Isn’t it at least possible that CER will focus on determining whether other commonly used therapies meet even that baseline standard?

So rather than thinking of CER as a threat to big pharmaceutical brands, maybe there is an alternative vision for how it might work. Literally: as a tool to test the value of so-called “alternative” medicine.

We were struck by how HHS Secretary Kathleen Sebelius responded to a question during her appearance at the National Press Club April 6. Sebelius was asked about the role of alternative medicine in health care reform—whether things like acupuncture or homeopathic remedies will or should be covered.
Sebelius diplomatically avoided taking a stand on the value of alternative medicine, and stressed that private plans—not the feds—will decide what to cover.

“I anticipate there will be plans offered in the new exchanges, which will give patients a wide variety of choices,” she said. “While there's likely to be a definition of what is a preventive care plan, insurers are likely to compete based on having a more wide range of choices for consumers.”

Fair enough. But then she continued by noting the role for “our comparative effectiveness research.”

“I think our comparative effectiveness research will continue to look at variety of alternatives for expensive care, whether or not earlier interventions, or more homeopathic therapies, or a variety of choices, are ones that really do lead to better health outcomes at a lower cost. And I think those are often consumer choices, and also wise healthcare choices.”

Now, that may sound pretty ominous. There is no doubt that plenty of alternative medicines are “less expensive” than, say, Avastin. And it is certainly possible that a federal center could conclude that acupuncture is in fact more effective than opioids for some forms of chronic back pain, or something like that.

But don’t let Sebelius’ astute political sensibility cloud the issue too much: politicians have learned that you don’t get very far by questioning the value of alternative medicine as a whole.

Government scientists are less reticent when you get specific. Here is what HHS has to say about alternative therapies when it comes to the H1N1 flu pandemic.

"The first and most important step to prevent the flu is to get vaccinated. Vaccination stimulates an immune response using a killed or weakened virus that uses the body’s own defense mechanisms to prevent infection. CDC's current
recommendations to protect against 2009 H1N1 virus do not include natural
remedies as a sole prevention method. If you want to use a natural remedy to
reduce symptoms, CDC recommends that you talk to your healthcare provider about options.

“Alternative medicine should not be used as a replacement for proven conventional care, or to postpone seeing a doctor about a medical problem. The National Institutes of Health (NIH) provides information…on specific alternative options, including scientific information, potential side effects, and cautions for each.

“The Federal Trade Commission (FTC) warns consumers to be cautious about products that claim to prevent, treat, or cure 2009 H1N1 influenza, specifically products like pills, air filtration devices, and cleaning agents can kill or eliminate the virus.

“The U.S. Food and Drug Administration warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus.”

Those are the types of views likely to emerge in the context of CER run through the new federal center.

The day after Sebelius spoke, a somewhat less politic politician—former Vermont Governor Howard Dean—made similar points during a panel discussion at the DTC Perspectives national conference in Washington. (We'll have more on Dean's presentation in an upcoming post).

Dean, a critic of pharmaceutical DTC, was asked whether he thinks other forms of medical communication should be restricted. Rather than talk about pharmaceutical marketing practices, he talked about alternative medicine, noting his views as a physician and as a governor.

“Medical doctors and chiropractors fight a lot, and as Governor I had to come to terms with that because there are a lot of people who like chiropractors and think that they should be covered,” Dean began. But “there were two chiropractors who were promoting the idea that children shouldn’t be vaccinated. I just went through the roof.”

“I do think that what is good for the goose is good for the gander,” Dean said. He praised the approach taken by Senate Health Committee Chairman Tom Harkin (D-Iowa), who is an advocate for alternative medicine but who sponsored legislation mandating “a fundamental study of alternative medicines with the view that they wanted to cover alternative medicines if they worked, but if they didn’t then they shouldn’t have to cover them.”

“We need to hold alternative health care to the same standards that we hold ‘regular’ medicine or whatever you call us,” Dean said.

Alternative therapies shouldn’t be dismissed just because “we don’t know why they work. We have to be more open minded. Just because we don’t know why something works, doesn’t mean we shouldn’t let people use it.”

“But I don’t think you ought to be able to advertise stuff that is hocus pocus. Whether it is the medical stuff that is hocus pocus or the alternative stuff that is hocus pocus. There ought to be some standard that applies to everybody.”

That is a vision of CER that biopharma companies can get behind.
image by flickr user KayVee.INC used under a creative commons license

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