Balancing Health Reform and Medical Innovation

Obsession with the politics of health reform has diverted attention from a huge issue: the decline of U.S. medical innovation.

In March 2009, A coalition of leaders in research, medicine, patient advocacy, academia, education, labor and business leaders anticipated the harmful effects of this diversion. They formed the Council for American Medical Innovation.

"American leadership in medical innovation must be part of our economic recovery plan," said Former Representative Dick Gephardt, a founding member of the Council ,"It has a direct impact on job growth, U.S. competitiveness and the health of all Americans. The future belongs to those who can create and sustain innovation economies, and we must work now to put policies in place that will nurture medical innovation, protect America's ability to maintain its global leadership position and help us find cures."

The other founding members included Dr. Francis Collins, former director of the National Human Genome Research Institute at the NIH; Dr. Edward Benz, CEO of the Dana-Farber Cancer Institute; Billy Tauzin, President and CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA); and Marc Boutin of the National Health Council,. America's future prosperity, they said, will depend on maintaining a lead role in scientific, technological and medical innovation.

Personal Awareness

I am personally aware of this diversion because my two most recent books Innovation-Driven Health Care (Jones and Bartlett, 2007) and Obama, Doctors, and Health Reform (IUniverse, 2009) and my blog medinnovationblog.blogspot.com address the issue. The slogan for my blog is “Notes of a Medical Innovation Watcher,” but lately all I have talked about is reform.

Obamacare has distracted from innovation by its laser focus on standardization and consistency as a means of system-wide cost control and expanding care to include the uninsured. President Obama rarely mentions innovation as a solution to our health care problems. He focuses instead on savings through prevention, comparative-effectiveness research, disease management, health information technologies, and reduced payments to hospitals and doctors and private Medicare Advantage Plans.

Shayvitz Blog

In a September 18 The Health Care Blog, Dr. Daniel Shayvitz, health care consultant and co-founder of the Pasteur Project, a program to educate Harvard medical students for the future, has captured the essence of the reform vs. innovation problem,

“Our healthcare system is now facing a problem that has plagued business leaders for years: how do you balance consistency and innovation?

The drive for consistency in health care is based upon the fundamental observation that physicians across the country treat similar medical conditions in dramatically different fashions. Sometimes, these different approaches are costly, such as using a more expensive treatment when a less expensive approach might be as effective. In other cases, these practice variations are dangerous – failing to provide patients with treatment the evidence suggests is best.”

“Standardizing the delivery of care -- identifying “best practices,” and then insisting physicians follow these guidelines – could, in theory, save money while improving quality, and is the basis of Obama’s healthcare proposal.”

Obama and his advisors may be right about “consistency and standardization” as a reliable means of achieving “savings and efficiency,” and maybe a more even quality, but consistency and standardization come at a price.

The Price of Consistency and Standardization

From the physician’s point of view, this price includes:

1) being reduced to mere technicians or robots carrying out government policies or blindly following protocols or algorithms of others not present at the patient encounter;

2) losing one’s autonomy to do what one thinks is best based on one’s training and clinical judgment at the point of care;

3) unwanted and usually unneeded interference by corporate or government business interests primarily occupied with saving money based on statistical averages rather than personal nature of the patient’s problems;

4) limiting clinical choices and freedoms of action on the part of both patient and doctor;

5) ignoring the different cultures, practice styles, and different socioeconomic demands and needs in different sections of the country.

A Sharper Point

To put a sharper point on what I’m saying, I do not believe a centralized government can possibly anticipate or dictate what needs to be done or on what is desirable at the point of care using claims or outcome data based on “averages” or by relying on management consistency standards. Medical care is an individual, personal, and emotional thing and does not lend itself to health 2.0 interventions

Shaywitz sums up the problem well,

“At some level, standardized algorithms might be good for medicine, reducing the blatant mismanagement of patients by physicians who have not stayed current, and discouraging doctors from reflexively selecting expensive procedures or medications that have been shown to offer little benefit. In simplifying the physician’s decision tree, such guidelines may also enable doctors to spend more time listening to patients, and less time running through a confusing litany of therapeutic alternatives. “

“At the same time, if medicine lurches in the direction of guidelines and algorithms, two important opportunities may be lost:

“- First, we may lose the chance to individualize care; as Steven J. Gould famously wrote, “The median isn’t the message,” and a treatment ineffective for most patients may be enormously useful for some. A key driver of personalized medicine is the urgent clinical need to identify just which patients are most likely to benefit from a particular drug or intervention. “

“Second, we may lose the opportunity to tinker and innovate – so many powerful discoveries originated with a clinician’s chance observation or slight deviation from standard treatment. If the role of physicians is dumbed down to the point where they are simply expected to mechanically execute on established protocols, the ability to intelligently improvise may be curtailed, thwarting medical progress.”

To put it another way, passive or rigid reliance on evidence-based medicine may come at the cost of producing doctors who rely on technologically-generated statistical averages, rather than on the human beings before them. The practice of medicine calls for creativity and innovation and discernment. not blind reliance on computer-generated data.