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Encouraging Evidence-Free Enterprise: Business on a Bed of Sand

Feature

Brian D. Engler and Eugenie V. Mielczarek

Skeptical Inquirer Volume 39.5, September/October 2015

Our previous analyses of awards to medical schools and alternative medicine schools by the former National Center for Complementary and Alternative Medicine (NCCAM)1 and its parent National Institutes of Health (NIH) revealed that, from 1999 to 2013, more than $2 billion in taxpayer money was used to convince Americans that non-evidence-based protocols, such as acupuncture and chiropractic spine manipulation, are medical procedures. Our analyses also showed that violations of the laws of basic science, such as the claims that underlie homeopathy and distance healing, are considered acceptable interventions even within a hospital structure and fall under the Affordable Care Act (ACA).

Our previous analyses covered awards designed by NIH’s NCCAM to install non-evidence-based medicine courses into respected academic schools such as Harvard, Michigan, and Yale, and to beef up schools of alternative medicine such as the College of Oriental Medicine and Bastyr. The fact that the staff at a center at NIH does not distinguish between fantasy and evidence is troubling at best and represents ignorance and misuse of scarce health resources at worst.

In addition to the nearly $3 billion spent on complementary and alternative medicine (CAM) research grants (Mielczarek and Engler 2012), and the nearly $76 million spent on CAM training and education (Mielczarek and Engler 2013), and the funding of schools of oriental medicine and naturopathy (Mielczarek and Engler 2014), another pair of federal programs has been active in the alternative medicine sphere. These two are the U.S. government’s Small Business Innovation Research and Small Business Technology Transfer (SBIR/STTR) grant programs. NIH is one of the five federal agencies that collectively account for nearly all SBIR funding (National Research Council 2009), and NCCAM, along with other NIH centers and institutes, actively participates in the program (see http://grants.nih.gov/grants/funding/sbir.htm).

The two business grant programs, SBIR and STTR, were created to encourage “domestic small businesses to engage in Federal Research/Research and Development (R/R&D) that has the potential for commercialization” and to expand “funding opportunities in the federal innovation research and development (R&D) arena,” respectively. Each has similar goals, with the SBIR program focusing on meeting federal research and development (R&D) needs while fostering “innovation and entrepreneurship by socially and economically disadvantaged persons” whereas the STTR program focuses on fostering “technology transfer through cooperative R&D between small businesses and research institutions” and “private sector commercialization of innovations derived from federal R&D.”

Grants are divided into phases, with Phase I “to establish the technical merit, feasibility, and commercial potential” of the effort usually limited both in duration and funding, and Phase II “to continue the R/R&D efforts initiated in Phase I” allowing more time and funds for promising work. For health-related funding, Phase III usually requires a clinical trial (further details on both programs, including the phases defined for each, can be found at http://www.sbir.gov/). In 2003, the SBIR/STTR programs reached a peak with over 7,400 grants totaling in excess of $1.8 billion. In 2013, the last year reported, the number of grants was nearly 5,100, but the total cost approached $2.0 billion (https://www.sbir.gov/sbirsearch/award/all). Applications exceeded grants universally across all federal agencies authorized to make them. Success stories for both programs abound online, and both are popular.

The very nature of these programs means that individual grants tend to rely on cutting-edge technology. This isn’t a bad thing as long as the technology is grounded in some evidence of efficacy. However, scientific substantiation seems to be in short supply in many of the projects we examined.

Using the publicly available NIH RePORTER tool (http://project
reporter.nih.gov/reporter.cfm), we found that over the past fourteen years, NIH has awarded 167 SBIR/STTR grants to seventy-eight organizations totaling over $40 million via NCCAM, largely for questionable (to put it charitably) endeavors. Our research reveals that small companies received awards focused on alternative medicine for a variety of reasons: to invent some rather remarkable devices, to search for medically useful botanicals, and to archive data and develop media presentations. Thus SBIR/STTR programs present an opportunity for the business community to take advantage of 
NCCAM’s tendency to provide legitimacy to non-evidence-based medicine in nourishing a $33.9 billion annual business (Nahin et al. 2009) itself fed by current societal mythologies.

We reviewed all NCCAM-funded small business grants since 2000 and discovered that the majority tend to fall into three broad categories that as shorthand we term Devices, Botanicals, and Data. In this article, we address a few of what we consider to be the least justifiable grants to shine a light on yet another area in which the NIH’s NCCAM is wasting taxpayer dollars.

Figure 1 displays only those organizations that have received $500,000 or more over the period of time for which data were available to the authors. Easily recognizable are fifteen companies that received funds of over $1 million. Focusing on these fifteen recipients of NCCAM’s largest SBIR/STTR awards, we find all three broad categories represented: three recipients (Advanced Medical Electronics, Bahr, and Stromatec) are publicized on their own websites as medical device companies; eleven sell botanical supplements; and one (Sociometrics) is a social research institution. Much of the money shown in Figure 1 is dedicated to developing devices to monitor adherence to Tai Chi, measuring the incidence of hot flashes, quantifying acupuncture needling, and searching botanicals in an attempt to discover natural products that can be marketed as supplements. Because the data-focused grants were unremarkable and not CAM-specific, this paper will concentrate on the devices and botanicals categories.

chart Figure 1. A graphic representation of individual organizations that received $500,000 or more in NCCAM SBIR/STTR grants between 2000 and 2013.

We used data from NIH RePORTER to track selected NCCAM SBIR/STTR grants to learn whether any had produced inventions or pharmaceutical discoveries.

Devices

Imagine you are a concerned scientist or physician hoping to affect American health. Your expertise and concerns have been noted, and you are asked to serve on a federal committee. The committee’s function? Prioritizing funding of NCCAM’S SBIR/STTR grant proposals for devices. Match your concept of appropriate funding for proposed devices with those of NCCAM’s SBIR awards.

  1. Hot flash monitor devices measuring menopause symptoms:

    • a) Over $3 million

    • b) Between $2 and $3 million

    • c) Less than $2 million

  2. Wearable devices measuring adherence to mind-body protocols of Tai Chi and Yoga positions:

    • a) Over $3 million

    • b) Between $2 and $3 million

    • c) Less than $2 million

  3. Devices measuring acupuncture torque:
    • a) Over $3 million

    • b) Between $3 and $2million

    • c) Less than $2 million


See Figure 2 for the answers.



pie chart Figure 2. A graphic depiction of $9.1 million in NCCAM SBIR/STTR grants for three types of devices–specifically, those designed for hot flash monitoring, wearable exercise monitoring, and acupuncture needling.

Two “device” firms have received funds exceeding $2 million: Stromatec and Advanced Medical Electronics. Stromatec’s website advertises its Acusensor 2 for teaching and quantifying acupuncture needling (see http://www.stromatec.com/acusensor2/). Presumably this invention was possible through the SBIR awards Stromatec has been given for three clinical trials testing its sensors. The test for its torque sensor was to have involved 169 persons. It’s not clear whether the device tested in this clinical trial is its web-advertised Acusensor 2 or something similar. The trial is listed as completed, but no study results are posted. Some respected academic medical schools list acupuncture as an elective, offering a prospective sales market for Stromatec’s Acusensor 2.

Our search of NIH NCCAM records from 1999–2014 shows an expenditure of $188 million for 561 projects by NCCAM to study the efficacy of acupuncture.2 Over this same time period, for all NIH centers, NIH RePORTER lists expenditures for acupuncture totaling $251 million (760 awards). NCCAM’s active projects (as of this writing) related to the efficacy of acupuncture total thirty-one projects at $12 million. NIH’s clinical center employs an acupuncturist (http://www.acupuncturesolution.com/index.html); however, studies that compare the success of trained acupuncturists with untrained ones finds no difference between claims of success by trained over the untrained (http://www.sciencebasedmedicine.org/nc/).

NIH has indulged in a tenacious pursuit of medical credence for a protocol based on the concept that mammals are threaded by undefined “energy meridians.” Criticisms of NIH’s studies of and endorsements for acupuncture, and of acupuncture itself, have been posted in numerous places online (e.g., http://edzardernst.com/2013/12/
acupuncture-its-a-placebo-isnt-it/; http://theness.com/neurologicablog/index.php/another-acupuncture-fail/; http://www.sciencebasedmedicine.org/reference/acupuncture/) as well as in books (Novella et al. 2013; Offit 2013; Singh and Ernst 2009). Even so, NIH incorporates acupuncture as part of its online education, although when accessed July 15, 2014, its webpage was annotated as “. . . an historical document . . . that may be out of date” (https://nccam.nih.gov/training/videolectures/acupuncture.htm).

NIH’s continued examination and even endorsement of acupuncture in the face of all scientific evidence to the contrary is an inexplicable use of taxpayer funds for questionable medical research.

The mystique of a Tai Chi exercise program is reflected by 118 awards from NCCAM that total $38 million. The awards include Research and Training and SBIR grants totaling $400,000 (2012–2014) to develop a three-sensor inner sole attached to a wireless platform that is supposed to record adherence to Tai Chi exercises. The device is currently being tested in a clinical trial at Spaulding Memorial Hospital in Boston (https://clinicaltrials.gov/ct2/show/NCT01687023).

Popular hopes for medically effective “alternative” protocols drive SBIR awards that include examining the misconception that physiologically generated electrical phenomena are a separate field of study unrelated to known physical science. These misconceptions of electromagnetism continue to fuel hopes of CAM practitioners and have generated millions of dollars of grants from NIH’s NCCAM. It is surprising that in view of the National Academy of Sciences report (National Research Council 1997) and the FTC’s Operation CURE.ALL that an SBIR review committee could ignore established science.

pie chart Figure 3. A graphic depiction of $8.8 million in NCCAM SBIR/STTR grants for botanicals, broken out by the condition for which the research was intended and its botanical focus, where these were discernable from the NCCAM project descriptions.

Botanicals

To be clear, we do not find fault in general with appropriate research into medical uses of botanicals. The problem we noticed during our SBIR/STTR research has been that many of these grants to small businesses to commercialize plant products for medical or health purposes seem to presuppose efficacy that either has not yet been proven or that has been disproven.

As shown in Figure 3, conditions considered for botanical focus include cancer, mental disorders, and even sickle cell disease, an inherited anemia. Products advertised by the businesses to combat these conditions include feverfew, goldenseal oil, red lettuce, black raspberries, green tea, saw palmetto, various Alaskan plants, and Chinese herbs. 
One example of a botanical that was claimed to have medical potential is goldenseal oil (Hydrastis canadensis). SBIR/STTR awards total $1.4 million, the majority of which was awarded to a single source (http://www.prweb.com/releases/2012/6/prweb9652644.htm). Goldenseal, or more correctly some alkaloids in it, most notably berberine, is purported to combat inflammation and infection. Goldenseal also is one of the most popular dietary supplements in the United States. However, 
NCCAM’s own website states: “Few studies have been published on goldenseal’s safety and effectiveness, and there is little scientific evidence to support using it for any health problem” (https://nccih.nih.gov/health/goldenseal). NCCAM has spent more than $1 mill­ion in SBIR/STTR funds principally for “development of research-grade goldenseal” ostensibly “to facilitate clinical studies.” NCCAM-funded research projects received a total of over $700,000 in 2013 and 2014 to “explore an alternative strategy for combating bacterial infections” employing goldenseal as a potential “treatment or preventative for bacterial infections such as methicillin-resistant–Staphylococcus aureus (MRSA)” (http://projectreporter.nih.gov/project_info_history.cfm?aid=8443080&icde=0). We have yet to see those studies bear fruit. 
A general search of clinical trials for botanicals, irrespective of funding source, listed sixty-six trials, apparently none of which demonstrated any efficacy (https://clinicaltrials.gov/ct2/results?term=botanical). Of the sixty-six, only two report that they “Have Results.” Of these two, one has published negative results (http://www.ncbi.nlm.nih.gov/pubmed/23553159?dopt=
Abstract) and the other only a trial bulletin to date (http://trialbulletin.com/lib/entry/ct-00556504). Some of the more non-surprising results: Don’t depend on a handful of herbs to eliminate a blood clot or red lettuce to control insulin levels. This is a discouraging indicator for commercial success.

Again, we do not claim that such research cannot be useful, but we do question, as we have in previous articles, why a separate “alternative” therapy-focused center, namely NCCAM, is needed when so many other disease- or infection-specific institutes and centers within NIH already can do the work. For example, the half billion dollars of NIH research related to MRSA very logically has been placed under the direction of the National Institute of Allergies and Infectious Diseases (NIAID). If goldenseal or extracts from it prove to be of value against MRSA, it will be considered medicine—not “complementary” medicine—so, once more, why does NIH need a separate center for CAM? 
You are invited to test your socially informed perceptions against the results of the clinical trials by visiting the ClinicalTrials.gov home page (https://clinicaltrials.gov/ct2/home) and searching for your favorite brand of woo (http://rationalwiki.org/wiki/Woo).


Notes

  1. Last December, NCCAM changed its name to the National Center for Complementary and Integrative Health, NCCIH (see “NCCAM’s Name Change Fails to Impress,” SI, May/June 2015). Since all our previous analyses and this new one were completed while the center went under its previous name, in this article we will continue to refer to “NCCAM.” If you prefer, you may substitute “NCCIH.”
  2. The numbers cited regarding efficacy of acupuncture include all grants, including research and training, not solely SBIR/STTR.

References


Topics: National Center for Complementary and Alternative Medicine
Subjects: Alternative Medicine