July 2006

Research funding controversy

by Robert H. Blanks PhD, President, RCS

>>> More than half of all medical studies funded by for‑profit sources

According to a recent article in the Journal of the American Medical Society,[1], biomedical research funding in the United States has doubled, when adjusted for inflation, from $37.1 billion in 1994 to $94.3 billion in 2003.

Among the current funding sources, the majority (57%) is from for‑profit commercial sources. The National Institutes of Health accounts for only 28% and private sources (foundations, voluntary health organizations, and free‑standing research institutes) the remaining 15%.

As we well know, only a small fraction of this amount has found its way into chiropractic. That's why it's important to understand more about the funding base in biomedicine. If we can figure out where the medical industry finds the money for its research, we can apply the same economic model to chiropractic.

No matter what differences chiropractors have, they can all agree on one thing: chiropractic needs more research funding to initiate clinical trials across a wide variety of clinical conditions, and to evaluate the adjustment in non‑condition based areas such as quality of life and wellness.

So far, the funding has not come from government grants. Of the 15,000 plus clinical trials currently registered with the US National Institutes of Health (http://www.clinicaltrials.gov), only five are chiropractic and these have evaluated only musculoskeletal issues (low back pain, three trials; headaches, one trial, and Temporal Mandibular Joint pain, one trial).

So, point one is that we need money to conduct valid, scientific research.

Point two is also one we can all agree upon. We need to tap into a variety of sources for research funding ‑‑ commercial, federal and private entities (college, non‑profit organizations, etc.).

Naturally, accepting funding from different sources can raise many thorny ethical issues. The American Medical Association's Council on Scientific Affairs, for instance, concluded that "studies with positive findings are more likely to be published than studies with negative or null results, and an association exists between pharmaceutical industry sponsorship of clinical research and publication of results favoring the sponsor's products."

Further, they warned that "When control lies with the commercial rather than academic or public sector, bias can also envelop the process through the trial design... Outcome bias can result from the use of unreliable methods or instruments, as well as inadequate sample size or comparison groups."

These conclusions were based on a literature search of more than 2,000 articles published between 1985 and 2003. [2]

Similar findings, published in the American Journal of Psychiatry, were obtained from an evaluation of psychiatric clinical trials, where there was a greater likelihood of reporting a drug to be superior to placebo when the authors reported receiving funding from the pharmaceutical company or other interested party. As many as 60% of the contributing authors surveyed among the 397 trials reviewed reported financial conflict of interest!

In an even larger study of general medical trials, between 30‑50% of authors reported conflict of financial interest. In this survey of 162 randomized, double‑blind, placebo‑controlled studies (as reported in Psychiatric News, Oct. 21, 2005) studies conducted by researchers with conflicts of interest were 4.9 times more likely to find positive results from the intervention.

What's more, being funded by a university or federal grant would insure the absence of study bias doesn't solve the problem. Research results can be substantially biased from academic and institutional pressures and even by the media.

In a now‑classic article entitled, "On the folly of rewarding A while hoping for B," Steven Kerr argues that there is always explicit and implicit bias by investigators and their institutions in conducting research. [3]

Such unconventional conflict of interest arises in academics when faculty members are expected by the organization to be devoted teachers, yet they are primarily rewarded for activities such as research and research publication.

The dichotomy between desired and actual results can create conflicting interests between investigators, the institution and the public welfare. [4]

Kerr and others argue that this dichotomy of interests create conflicts of interest even in the most traditional research environment of the university, and in particular within not‑for‑profit academic health centers, where a large proportion of clinical trails are being conducted [5].

Research grants and contracts are major sources of revenue for institutions and reward individual investigator efforts more than group efforts. These conflicts between scientific opportunities and public needs are not necessarily bad and can be mitigated by careful balancing of competing priorities [6].

Clearly, all research is subject to bias stemming from funding source, as well as other well‑defined issues such as poor experimental design, difficulties with interpretation, and the media treatment of the published findings.

Biomedicine lives in a world of carefully managed conflicts of interest. Researchers have learned to reduce the risk of experimental bias because of the funding source by disclosing the source and by balancing the risk with the possible benefit to society and the patient through discovery of new drugs and technology.

In chiropractic, the research community hasn't yet learned to deal with those inherent risks as well as the medical industry. It still tries to rely solely on government grants and what little money can be raised by the colleges. Even top research leaders admit this isn't nearly enough to conduct the type of research the profession needs.

Yet, there is great resistance to tapping into the potential funding from private‑sector research. Such enterprises are deemed sullied by their for‑profit status, even if a vast majority of that profit is reinvested into building the research infra‑structure.

In one way, this is understandable, since chiropractic has to be squeaky clean in order to avoid criticisms from the medical arena. That's why it's important for any research program, particularly those conducted by for‑profit or private research entities, to be reviewed and approved by an independent Institutional Review Board (IRB). IRBs routinely investigate potential conflict of interest issues, including those arising from funding as well as institutional and investigational bias.

Once the IRB has given a clean bill of health to the program, the fear of conflict of interest should be minimized. After all, the chiropractic profession has a long and proud history of private enterprise to prove that profit can co‑exist with quality. All chiropractic techniques were developed by private, for‑profit companies or entrepreneurial individuals and even chiropractic colleges make profits and pay salaries to their administrators, instructors and researchers.

References

1. Moses III, H, Dorsey ER, Matheson DHM, "Financial Anatomy of Biomedical Research." JAMA 2005 294:11, 1333‑1342.

2. "Influence of Funding Source on Outcome, Validity, and Reliability of Pharmaceutical Research" posted at presented as CSA Report 10 at the 2004 AMA Annual Meeting.

3. "On the folly of rewarding A while hoping for B," by Steven Kerr. Academy of Management Journal, 18(4): 769‑783.

4. "Conflicts of interest in translational research," Parks MR, Disis ML. J Transl Med. 2004;2:28(10), 1479‑5xx

5. "The not‑for‑profit form and translational research: Kerr revisited?" Joiner KA, J Transl Med 2005 Apr 10.1186:1479‑5876‑3‑19.

6. "Scientific opportunities and public needs: improving the priority setting and public input at the National Institutes of Health, Washington, DC, Institutes of Medicine"; National Academy Press, 1998.

(RCS co‑founder and President Dr. Robert Blanks is Professor in the Department of Biomedical Sciences at Florida Atlantic University and a past Professor of Anatomy and Neurobiology at the University of California, Irvine. Prior to this he spent two years at the Max Planck Institute for Brain Research in Frankfurt, Germany and two years in the Department of Anatomy at Harvard Medical School. Dr. Blanks is on the Advisory Board of the International Spinal Health Institute, is a Board Member of the Council on Chiropractic Practice and is actively involved in chiropractic research. To learn more about health outcomes research and RCS, call 800‑909‑1354 or 480‑303‑1694.)

The 100th Monkey: A story about social change
by Ken Keyes Jr.

The Japanese monkey, Macaca Fuscata, had been observed in the wild for a period of over 30 years.

In 1952, on the island of Koshima, scientists were providing monkeys with sweet potatoes dropped in the sand. The monkey liked the taste of the raw sweet potatoes, but they found the dirt unpleasant.

An 18‑month‑old female named Imo found she could solve the problem by washing the potatoes in a nearby stream. She taught this trick to her mother. Her playmates also learned this new way and they taught their mothers too.

This cultural innovation was gradually picked up by various monkeys before the eyes of the scientists. Between 1952 and 1958 all the young monkeys learned to wash the sandy sweet potatoes to make them more palatable. Only the adults who imitated their children learned this social improvement. Other adults kept eating the dirty sweet potatoes.

Then something startling took place. In the autumn of 1958, a certain number of Koshima monkeys were washing sweet potatoes ‑‑ the exact number is not known. Let us suppose that when the sun rose one morning there were 99 monkeys on Koshima Island who had learned to wash their sweet potatoes. Let's further suppose that later that morning, the hundredth monkey learned to wash potatoes.

THEN IT HAPPENED!

By that evening almost everyone in the tribe was washing sweet potatoes before eating them. The added energy of this hundredth monkey somehow created an ideological breakthrough!

But notice: A most surprising thing observed by these scientists was that the habit of washing sweet potatoes then jumped over the sea...Colonies of monkeys on other islands and the mainland troop of monkeys at Takasakiyama began washing their sweet potatoes.

Thus, when a certain critical number achieves an awareness, this new awareness may be communicated from mind to mind.

Although the exact number may vary, this Hundredth Monkey Phenomenon means that when only a limited number of people know of a new way, it may remain the conscious property of these people.

But there is a point at which if only one more person tunes‑in to a new awareness, a field is strengthened so that this awareness is picked up by almost everyone!

(From the book "The Hundredth Monkey" by Ken Keyes, Jr. The book is not copyrighted and the material may be reproduced in whole or in part.)