Thursday, April 10, 2008

Personalized Medicine: Kennedy Weighs In

So now, even Ted Kennedy is talking about personalized medicine.

The Dean of the Senate stopped by a policy breakfast put together by The Hill newspaper and sponsored by AstraZeneca at Johnny’s Half Shell near Capitol Hill on April 8. He had some encouraging words for the personalized medicine enthusiasts out there.

“A new era of personalized medicine” is coming, Kennedy said at the breakfast. “And those are words we’re going to hear a great deal more about.”

He added: “The opportunity is unlimited.” AZ CEO David Brennan later echoed Kennedy, “the point Senator Kennedy made about personalized medicine is an important one.”

If the senior Senator from Massachusetts is aligned with the pharmaceutical industry on the future of medicine, ladies and gentlemen, break out your checkbooks, call your broker and start buying up biopharma concerns.

Kennedy’s comments were brief, so I don’t want to give the impression that his talk was a treatise on customized medicine. However, he made it a point to highlight the approach, along with prevention and disease management, as one road that should be well-traveled as the nation seeks solutions to the “health care crisis.”

Brennan related a story of meeting with the health minister of a foreign country and the minister said to him, “what we really need are the big breakthroughs.” Brennan shot back, “so do we.”

The AZ CEO continued: “Our experience with innovation is it’s incremental. We didn’t go from the Model T to the Mercedes 500 class in one step.... The bar for scientific innovation has been raised significantly.”

Personalized medicine—the right therapy for the right patient—is quickly emerging as one answer to various health challenges, including the innovation conundrum (incidentally, Brennan pointed to better science allowing companies to “kill products earlier” in the development cycle as a major reason for the low number of new molecular entity approvals over the last several years. Do with that what you want).

While there is still a lot of skeptical noise about turning a buzz word into real commercial success, it’s undeniable that the idea of customizeable therapy is gaining steam. HHS Secretary Michael Leavitt has made personalized medicine an agenda priority. Here is what he said during the Personalized Medicine Coalition’s annual meeting last March:

“It’s clear to me, and to many others in government and throughout the health care enterprise, that we’re on the threshold of a new era made possible by phenomenal leaps forward in two areas: first, new discoveries in bioscience, especially human genomics; and second, new tools in the computer age – meaning health information technology. These great leaps will enable us to give better care to all patients – by targeting the unique biology of every patient.”

HHS also issued a comprehensive report on the opportunities of personalized medicine last year to kick start the initiative. To read the full report, click here.

One thing I’ve found interesting is that a number of personalized medicine proponents are also comparative effectiveness proponents. Kind of odd since the two ideas are diametrically opposite each other. One looks at having the right medicine for the right patient while the other looks at comparing one therapy to another as they relate to a broad population and typically assigning a value to that comparison. Right? If you can better explain the relationship, click here to email me and I’ll blog about your response(s).

Kennedy mentioned comparative effectiveness as a tool in the health care debate but it was hardly a ringing endorsement. “If we’re going to have a debate about health care cost issues are going to be front and center,” but said “it’s not enough to analyze one treatment for another.” He discussed regional disparities in cost for care, something Congressional Budget Office director Peter Orzag often cites on his personal campaign for a comparative effectiveness infrastructure.

It’s a funny scene seeing Ted Kennedy, arguably the drug industry’s most vocal critic in Congress over the course of the last 30-some years, standing up in front of an AstraZeneca banner essentially saying ‘we’re here to solve America’s health problems together.’ And it’s not just paying lip service. Kennedy is putting words into action by providing a roadmap for the drug industry to get more of their drugs approved at FDA with provisions in the FDA Amendments Act, as well as serving as a driving force for a fair and balanced approach to follow-on biologics.

He's not done either: "I'm committed to enacting genuine health care reform in the coming year."

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