The Herman Cain-Inspired “1-100-0″ Plan for Personalized Medicine?

11/14/11Follow @xconomy

You could feel Herman Cain’s presence last week on the biotech beat. And there was a lot of grousing about it.

Cain, the Republican presidential candidate known for his simple 9-9-9 tax plan and some dubious extra-curricular activities, didn’t attend the Personalized Medicine Conference at Harvard Medical School. But a former advisor to President Obama, Ezekiel Emanuel, was there channeling his inner Cain, delivering a simple, blunt message to top biomedical researchers, business executives, and investors.

The word from Emanuel, the University of Pennsylvania bioethicist and player in the landmark healthcare reform law of 2010, boiled down to this: Personalized medicine is a lot of hype, it will add costs to the healthcare system, and we can’t afford it. What personalized medicine ought to offer, he said, is a “1-100-0″ plan. That means treatments that are truly tailored for a single individual; almost 100 percent effective; and have almost zero side effects.

That’s fantasy, of course, which Emanuel knows quite well. He was being purposefully provocative, and said so. In a roomful of like-minded people having a garden party, he was happily playing the role of the skunk.

Personally, I thought Emanuel gave a brutally honest message that a lot of these people need to hear. It could have been perceived as a rallying cry to come up with new innovations for health that truly reduce, instead of add, costs to the system.

But that’s not how the message was perceived. Everywhere I went the rest of the two-day meeting, people were grumbling about the nerve of this guy. One prominent executive complained that Emanuel shouldn’t have been invited. Emanuel’s not an economist, what does he know? He’s relying on faulty data! What about innovations that improve patient outcomes, helping people live longer and better lives? Isn’t that worth it?

“There seems to be a lot of angst about what’s going on here, but these are still early days,” said Brook Byers, the champion for personalized medicine at Kleiner Perkins Caufield & Byers, during a moderated chat later in the day. “These things take a while. I’ve been doing this long enough to have been through a lot of things in computation, healthcare, and biotech. But personalized medicine is a way of thinking.” And then he made a vague reference to Emanuel that everyone got. “I think the day got started off a little weird,” he said.

Brook Byers (right) pictured with Pascale Witz of GE Healthcare's Medical Diagnostics business, and Raju Kucherlapati of Harvard Medical School

And with that, the room burst out with a round of supportive laughter. It felt to me like a group hug, as if the crowd were saying, “Right On. Tell Him How It Is, Brook.”

Byers didn’t directly attack anything Emanuel said earlier in the day, and he did stress how important it is for entrepreneurs to work closely with payers on measuring the value of new products. But if the crowd of several hundred people in a comfy Harvard auditorium really wants to make a difference in creating innovations for personalized medicine, I’d suggest they’d listen carefully to Emanuel, and a number of health economists who are making basically the same point. The U.S. healthcare system is badly broken, and it can’t go on paying for all these wonderful life science innovations the same way it has for the past 30 years.

As I said in this space a couple weeks ago, I’m inspired by some outstanding personalized medicines that have been approved by the FDA for cancer patients in the past few months. These are superbly effective drugs for small, genetically distinct populations of patients that are worth the hefty price tags they are commanding. These treatments are paving an important road scientifically, and with regulators, which other drugs ought to be able to follow for years to come.

But these innovations need to be taken in context. The U.S. now spends $2.6 trillion a year on healthcare, and that number increases by $100 billion a year, as Emanuel pointed out in one of his recent New York Times columns. That means the U.S. healthcare sector, by itself, is roughly equal in size to the economy of France—the fifth largest economic power in the world. To shave even 1 percent of U.S. healthcare spending per year, you need … Next Page »

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  • Jerry Jeff

    I totally agree, Luke. You have to figure that even in these early days we’re close to the peak for biotech drug pricing.

  • http://www.biotechtranslated.com Biotechtranslated

    I think the truth (as usual) is somewhere in between. I don’t think anyone can argue that Genentech’s herceptin diagnostic isn’t adding value.

    But I would agree that not everything can have a companion diagnostic and in many cases, it adds no value anyways.

    Oncology will be the poster child for diagnostics, but it won’t be “one drug for one person”, it will be a handful of drugs that will allow for specific treatment regimens for specific groups of patients.

    Mike

  • http://Xconomy James Keeney

    I agree, too. With regard to pharmaceutical and biotech therapeutics, this why you have to break the mold of Hatch-Waxman patent expirations and go to a system of “perma-patents” (thank you, Luke, for the term).

    By granting these companies unlimited patent life in return for lower introductory prices for newly marketed compounds, they would benefit by having a longer period with which to realize profits from their $1-2 billion R&D investment per new drug. Competition, not government regulation, would limit their ability to pass along hefty price increases in succeeding years.

    But, companies then would invest more in many more areas of therapeutic R&D than is ongoing today, where cutbacks in marginal areas is the rule of the day. Shareholders in these companies likewise would benefit. With drug patents no longer endangered, finally, you would have a marked increase in dollars being invested in start-up biotech firms.

  • Mark Minie

    These will be the kinds of personalized medicine technologies that will break the cost curve, broaden high quality health care availability and provide highly personalized medicine…

    Scanadu Trailer
    http://www.youtube.com/watch?v=KSwMauCno6o

    The Doctor is Always In
    http://youtu.be/4OT3bDiMWK0

    IBM Watson: Transforming Healthcare
    http://youtu.be/95eF4Dn3CL0

    Biotech/biopharma should be more focused on these approaches now that the currant “pill business model” is broken, while being more open to new emerging biology such as microRNAs as diagnostics and treatments…

    Analytical aspects of microRNA in diagnostics: a review. Anal Chim Acta. (2011)
    PMID: 21704768
    http://www.sciencedirect.com.offcampus.lib.washington.edu/science/article/pii/S0003267011006647

    Antagonism of miR-33 in mice promotes reverse cholesterol transport and regression of atherosclerosis. J Clin. Invest. (2011)
    PMID: 21646721
    http://www.jci.org/articles/view/57275

  • http://amanwithaphd.wordpress.com/ Richard Gayle

    A major shift from personalized medicine will be keeping healthy people healthy, rather than trying to heal sick people. In a few years, everyone will be able to collect a huge database – collected more than daily – of the state of their body. From proteins to metabolites, from DNA to microRNA, labs on a chip connected to mobile devices will catalog what a healthy body not only looks like for every person but also how to perturb it by diet, medication, exercise and emotions. This will make specific therapies to restore the healthy pattern much easier to track and deal with.

    Medications will not be based on statistics, as they currently are but on the specific reaction of individuals to the therapy. I would expect that it is much cheaper keeping healthy people healthy than waiting until they get sick to use a therapy that might at best have some statistical benefit over any harm it might do.

  • http://www.xconomy.com/author/ltimmerman/ Luke Timmerman

    Richard—this is a great point, and similar to what Lee Hood said in his keynote talk at the Personalized Medicine Conference last week. I think there will be great resistance to this movement for a number of reasons.

    The vested financial interests in Big Pharma and Big Hospitals/Delivery right now want to treat people who are sick, not really keep them well. And the evidence-based medicine crowd that believes so strongly in randomized clinical trials will insist that N of 1 experiments are mere anecdotes, and not the basis for making any judgments on how to stay healthy.

    I think it will be fascinating to see if the systems biology and open source biology movements can come up with data that’s compelling enough to overcome these objections.

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