Getting Today’s Medicine Today: The Challenge of Clinical Innovation

Dawson Church

Editorial

cost_per_genome2The history of science is littered with examples of technology driving discovery. The Human Genome Project was driven by the availability of gene-sequencing machines. According to a report from the U.S. National Institutes of Health, in 2001, it cost an average of $95,263,072 to sequence the genome of a single human being. In 2014, it cost $4,008 (Wetterstrand, 2014). The accompanying graph shows the reductions in costs. As the technology became available, it was utilized for the scientific enterprise, driving down costs.

Not all technologies have been quickly or widely accepted, and the rapid adoption of new techniques is the exception rather than the norm. The adoption of new therapies such as Energy Psychology has been slowed by the inertia of large organizations. For instance, Emotional Freedom Techniques (EFT) was presented to the Veterans Administration as a treatment for posttraumatic stress disorder (PTSD) soon after the first cohort of veterans began arriving back from deployment in Iraq (Church, Feinstein, Palmer-Hoffman, Stein, & Tranguch, 2014). In 2009, Senator Carl Levin, chair of the Senate Armed Services Committee, wrote a personal letter to then Secretary for Veterans Affairs Eric Shinseki. He enclosed preliminary data on EFT’s efficacy for PTSD and urged investigation by the VA. Shinseki took no action on this request.

Frustration with the lack of progress at the VA, knowledge of the growing research base, and anecdotes by constituents who were veterans prompted members of Congress to write another long and detailed letter to Shinseki in 2010, requesting seven concrete actions by the VA. Copies were circulated among other agencies, such as the National Institutes of Health. Two sets of hearings before congressional committees presented the evidence that EFT could remediate PTSD in six treatment sessions. Again, all this activity produced no interest within the VA in exploring or implementing EFT. This inability to translate scientific discovery into practical patient care is called a “translational gap.”

The U.S. Congress commissioned a report by the Institute of Medicine (IOM) to determine the extent of translational gaps. It found that it takes an average of 17 years for innovations to jump the translational gap (Committee on Quality of Health Care in America, IOM, 2001; Balas & Boren, 2000). Few innovations even make it that far: An analysis found that only 14% of new discoveries are successfully implemented in patient care; the other 86% are lost (Westfall, Mold, & Fagnan, 2007).

The IOM report characterized the translational gap as a “chasm.” The practical consequences of this chasm are that most medical care that patients receive is 14% of what was available 17 years ago.

It’s hard to imagine us, as a society, being content with this level of inefficiency in other parts of our lives. Imagine working on a 17-year-old personal computer, with 86% of its capacity disabled. While we’d be outraged at the detriment to our productivity and life enjoyment entailed by a reduction in our computing capacity, as a society we seem perfectly prepared to accept these limitations when it comes to our health care.

When I address this subject in professional circles, some listeners wonder if there’s a conspiracy by the drug companies to suppress free and effective behavioral cures. Personally, I don’t believe this (or most other conspiracy theories), because there are much simpler explanations. When I was talking to a military psychiatrist, Charles Engel, MD, about adopting EFT, he gave me a reality check. He told me that they can’t even get the psychiatrist at the VA to coordinate care with the psychiatrist who has been treating that same patient while on active duty. Faced with fundamental obstacles like this, training in new therapies seems like a pipedream, no matter how effective those therapies may be.

This type of institutional inertia combines with dogmatic skepticism to produce most of the translational gap. That’s why German physicist Max Planck remarked that science progresses one funeral at a time. Existing “experts” cling to their outdated worldviews, and not till a new generation has displaced them is there a more open intellectual climate in which new ideas can thrive. Highly effective new treatments sometimes overcome the inertia, however, though it might take awhile.

Seventeenth-century Dutch tradesman Anton van Leeuwenhoek was one of my heroes when I was a teenager. Leeuwenhoek perfected the art of grinding magnifying lenses, and began describing the curious microorganisms he saw through them. His curiosity was boundless, and he used his microscopes to examine organisms existing everywhere from ponds to human saliva.

He began reporting his findings to the newly formed Royal Society in England. At that time in history, the Royal Society was the most prestigious association in the world for the advancement of scientific enquiry. Leeuwenhoek’s letters, translated into English, also contained painstaking drawings of the organisms he observed. While contemporary microscopes could magnify to only about 30x, Leeuwenhoek obsessively ground very fine lenses that could magnify an object by up to 200x. He began to see levels of detail in microscopic organisms that had never before been visible to the human eye. However, because these details had never before been observed, many members of the Royal Society greeted Leeuwenhoek’s discoveries with hostile skepticism.

This skepticism has impeded the progress of science for centuries. When Ignaz Semmelweiss in 1850s Vienna discovered that washing his hands between dissecting corpses in the morgue and examining patients in the wards reduced infections by 90%, he was disbelieved. He insisted on hospital workers washing their hands before treating patients. Infections in his ward dropped by 90%, while they remained at the same high levels in other wards. Nonetheless, Semmelweiss was vigorously opposed by his contemporaries, and eventually forced from his job. He died in an insane asylum, and his policies were immediately reversed by his successor. The history of science is littered with similar examples, from Lister to Galileo.
Dogmatic skepticism and anti-scientific superstition are alive and well today, impeding patient care as effectively as did Semmelweiss’s contemporaries. You can read a contemporary example by looking up “EFT” on Wikipedia. Several years ago, a group of skeptics seized editorial control of most of the CAM (complementary and alternative medicine) pages on Wikipedia. Among the topics they control are homeopathy, energy psychology, and acupuncture.

The early articles were written mostly by experts in their fields. The skeptics deleted those articles, and wrote their own. They tag EFT and similar therapies as “pseudoscience,” and whenever experts attempt to correct them, for instance by adding a description of a study newly published in a peer-reviewed journal, the skeptics suppress the amendment. To support their arguments, however, they selectively violate Wikipedia’s own rules by citing skeptical websites and non-peer-reviewed (and non-credible) sources such as the Skeptical Inquirer magazine and Quackwatch.

A popular misconception is that anyone can edit a Wikipedia page; in reality, many entries are controlled by informal committees of editors, who can band together around a common philosophy, such as closed-minded hostility to CAM, or anti-scientific skepticism. The skeptics are organized as Wikiproject Skepticism, and they have vandalized hundreds of entries. In addition, certain pages have been locked to prevent open editing. The EFT page is one of them. These gatekeepers can then dictate what goes on a page, depriving the public using the encyclopedia from reading authoritative, balanced, and objective coverage of a topic, entries written by experienced and qualified experts. Another tactic of the Wikiproject Skepticism editors has been to delete or vandalize the biographies of respected scientists, authors, and researchers in the fields they attack.

Having demonstrated their worldview by tagging EFT as “pseudoscience” in the Wikipedia entry, how do they then deal with the inconvenient fact that there are dozens of clinical trials showing EFT’s “efficacy”. Their solution is to simply not mention them in the article. Research doesn’t support their prejudices, so they ignore it, even though clinical trials are routinely reported in entries for conventional therapies not targeted by the skeptics and in the entries for pharmacological drugs.

Wikipedia allows the reader to peer behind the entry to the history of additions and deletions to the article in the “Talk” pages, and the skeptical editors are perfectly clear, in these discussions, about their worldview. When new studies are published in peer-reviewed medical or psychology journals, the editors state that they should not be included in the Wikipedia article, as this might lend credibility to EFT, which in their eyes it does not have. One of the authors of the EFT entry debates “the best way to demonstrate to the reader that this is bullsh*t!” (http://en.wikipedia.org/wiki/Talk:Emotional_Freedom_Techniques/Archives/2011/May).

There is no mention in the Wikipedia article, or the behind-the-scenes discussions, of the standards for empirically validated therapies published by the Division 12 Task Force of the American Psychological Association, APA (Chambless & Hollon, 1998; Chambless et al., 1998). There is no reference to the evidence-based criteria embraced by the U.S. government’s National Registry of Evidence-Based Programs and Practices (NREPP), or any description of the randomized controlled trials that have demonstrated EFT’s efficacy for PTSD, depression, pain, anxiety, phobias, and other conditions.

Imagine a reputable encyclopedia, perhaps the Encyclopedia Britannica, writing an article by assembling an editorial team with complete ignorance of the topic, hostility to the field, scientific illiteracy, and no relevant academic qualifications. If the article’s topic was the nature of the solar system, the team would contain not a single astronomer, physicist, or geologist. The only requirement would be that every contributor be a member of the Flat Earth Society. Absurd though it may seem, that’s how most Wikipedia entries for CAM are created.

As comedian Tina Fey quipped, “When you’re contemplating open-heart surgery, imagine your reaction to a guy who says, ‘I don’t have any of those fancy degrees from Harvard Medical School. I’m just an unlicensed plumber with a dream. Now hand me the scalpel.

Leeuwenhoek persisted despite the skepticism. Though he never wrote a book, he eventually exchanged hundreds of letters with members of the Royal Society. As the evidence mounted, the nonsensical superstitions of the skeptics were swept away, and Leeuwenhoek gained a secure place in scientific history.

In the same way, I expect the rapidly accumulating evidence for the efficacy of EFT and other evidence-based CAM interventions to overwhelm the efforts of the skeptics to prevent its dissemination. The system that perpetuates the translational chasm is still firmly in place, however, and until public demand for getting today’s medicine today becomes an outcry, it is likely to remain entrenched.

 

References

Balas, E. A., & Boren, S. A. (2000). Yearbook of medical informatics: Managing clinical knowledge for health care improvement. Stuttgart, Germany: Schattauer Verlagsgesellschaft mbH.

Chambless, D., Baker, M. J., Baucom, D. H., Beutler, L. E., Calhoun, K. S., Crits-Christoph, P., . . . Woody, S. R. (1998). Update on empirically validated therapies, II. Clinical Psychologist, 51, 3-16.

Chambless, D., & Hollon, S. D. (1998). Defining empirically supported therapies. Journal of Consulting and Clinical Psychology, 66, 7.18.

Church, D., Feinstein, D., Palmer-Hoffman, J., Stein, P. K., & Tranguch, A. (2014). Empirically supported psychological treatments: The challenge of evaluating clinical innovations. Journal of Nervous and Mental Disease, 202(10), 699-709.

Committee on Quality of Health Care in America, Institute of Medicine. (2001). Cross- ing the quality chasm: A new health system for the 21st century. Washington, DC: National Academy Press.

Westfall, J. M., Mold, J., & Fagnan, L. (2007). Practice-based research: “Blue Highways” on the NIH roadmap. JAMA, 297(4), 403.

Wetterstrand, K. A. (2014). DNA sequencing costs: Data from the NHGRI Genome Sequencing Program (GSP). Retrieved from www.genome.gov/sequencingcosts.