precision medicine

Hope, hype, and $$$ in precision medicine

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In the early days of personalized genomic medicine, skeptics wondered how tailored medical care could be profitable. Who would develop a drug for just one or a few people?

Turns out they were looking in the wrong direction. The answer lies in genetic testing more than drug development. A detailed report in today’s New York Times examines how the promise of personalized or precision medicine is being “tainted” by hype. “Across the industry,” they write,

investors are pumping tens of millions of dollars into clinical laboratories that are developing and selling the genetic tests. President Obama recentlycalled on Congress to spend $215 million next year on personalized medicine, calling it “one of the greatest opportunities for new medical breakthroughs that we have ever seen.” A major use of the federal funds would be to create a research group of a million volunteers that would provide scientists with an enormous collection of data.

Doctors and their patients, finding it hard to resist the promise, are being swept up in the excitement. The number of tests has almost doubled in the last few years, creating a $6 billion industry.

While acknowledging that some genetic tests are proving highly valuable–particularly in diagnosing different forms of cancer, which can respond highly specifically to certain drugs depending on the mutation–they note that many genetic tests are doing more to fatten corporate wallets than they are to improve patient care. The tests often run to $1000 or more.

WIth so much at stake, federal regulators are growing concerned about fraud. Turns out some doctors are ordering and charging for tests that people don’t need!

An internal chart reviewed by The New York Times suggests the company was not shy about pointing out that doctors could amass a substantial income by participating. If a doctor enrolled five patients per day and took 110 swabs per month, that physician could earn as much as $125,400 in compensation from the study over a year.

Shock and awe!

An early use of the term “precision medicine”

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“Precision medicine” has become a biomedical buzzword, largely replacing “personalized” or “individualized” medicine.  In his 2015 State of the Union Address, President Obama announced a “Precision Medicine Initiative.” I first heard the term in May 2013 as an updating ofThis seems to be about the time its use began to take off. Researching a talk, though, I was surprised to find a much earlier use, from 1979. The sense is the same, but the context very different.

In the first issue of volume 7 of the American Journal of Chinese Medicine, Ling W. Wei, an electrical engineer at the University of Waterloo, Ontario, published an article titled “Scientific advances in acupuncture.”[1] At that time, “alternative” or “comparative” medicine was new enough that he felt the need to define acupuncture as a branch of Chinese traditional medicine. He notes that Richard Nixon’s visit to China in 1972 put acupuncture in the spotlight for Westerners, noting that the scientific community was “aloof and apathetic, if not down right scornful” of the technique. Wei proceeds to evaluate acupuncture as scientific medicine.

There’s much to say about this fascinating paper, but I note here just one passage, on pp. 70-71.

The trend of technological advance in acupuncture holds great promise of promoting medicine in three directions,” he writes. These are what he calls the “three P’s”: preventive medicine, precision medicine, and people medicine.” This is remarkably close to Leroy Hood and colleagues’ “P4” medicine (“personalized, predictive, preventive, participatory”), first discussed in 2010. Wei’s formulation captures all the sense of Hood’s, but more concisely (preventive follows from predictive). But where Hood’s P4 medicine is predicated on reductive genomics, Wei imagines an equally high-tech but image-based approach.

Preventive medicine, writes Wei, “can be realized only with the availability of a simple, non-invasive and thorough physical check-up method. Like a TV screen, it should be able to expose the whole picture of the body’s condition in various colors and patterns.” He then goes on to imagine much more than a TV screen. “Precision medicine,” he continues, “requires similar methodology and, furthermore, a great analytical power in technology. For example, two common diseases of modern times, headache and hypertension, have many causes and the precise origin of the symptom is sometimes very difficult to diagnose.” Acupuncture can help. “Acu-points can serve as alarming outposts in internal organs when sick.” Merging ancient Chinese medicine with futuristic Western technology, he writes,

“If the electrical signals from 365 or a selected number of acu-points of the whole body are successively stored and then fed to a specially designed TV monitor, the pattern of this “holography” could tell us the whole story of the person’s health condition and thereby reveal not only the precise origin of the current illness but also perhaps some hidden signs of developing symptoms. To make the interpretations more precise, this holographical pattern could be fed to a “diagnostic computer” and let it be compared to thousands of standard patterns (in storage) of established causes. If a match or near-match is found, then the cause is said to be pinpointed. A man could take a “holography” anytime or once a year and the film can be as small as the palm. If in the future every drugstore had a terminal link (perhaps through telephone lines) to a central computer, one could simply insert his holography film into the machine and get an instant print-out telling his health condition. That day is not too far off; because the technology in opto-electronics and computers is almost ready for this “diagnostic automat” to be within reach.

The precision required in acupuncture is obvious and material: you have to put the needles in exactly the right place. It’s rather stunning how close Wei’s vision is to what contemporary precision medicine is aiming at, by very different means.

[1] Wei, L. Y. “Scientific Advance in Acupuncture.” Am J Chin Med 7, no. 1 (Spring 1979): 53-75.