September 2005

Fighting against the 'other' billboard attacks

by Dr. Terry A. Rondberg

Last month, The Chiropractic Journal ran the news story about the billboard in Connecticut that blared the warning: "Chiropractic Adjustments Can Kill or Permanently Disable You." We were all proud of the many DCs who took immediate action to force the billboard company to cover up the display. It's obvious that doctors are willing to stand up and do something when they see their profession under attack like this.

But what about the attacks that are less blatant but just as damaging? What are we doing about the "billboards" that say things like:

"There is no scientific evidence that adjustments to bones or vertebrae will correct specific conditions such as asthma, bronchitis, kidney disease or constipation." ("What Chiropractors Can‑And Can't‑Do for You," Tufts University Health & Nutrition Letter, February, 2003)

or this ...

"There is a lack of sufficient evidence to support many of the claims of efficacy (of chiropractic and other alternative health care approaches)." (British Medical Association)

or this ...

"There is no solid scientific evidence for subluxations." ("Chiropractic: A 100 year struggle from pseudoscience to legitimacy," by Mahlon Wagner, PhD)

or this ...

"There is no scientific evidence whatsoever that the so‑called chiropractic spinal adjustment results in any correction to a child's spine. These adjustments are ineffective and useless." (NCAHF Fact Sheet on Chiropractic) ?

I've seen dozens of these kinds of statements in newspapers, magazines and newsletters distributed to millions of people around the world. They're repeated on hundreds of websites throughout the Internet. More people will read these warnings in a single day than the New Jersey sign would have reached in a year.

Why, then, aren't we doing something about these other "billboards" that are scaring off our patients?

The biggest reason is that we don't have the right ammunition to fight back. We can't claim the statements are lies or slander. After all, truth is a defense against slander and our accusers need only look us in the eye and say "show me the research."

And the fact is, we don't have the kind of research we need to shut them up.

I'm not the only one who thinks this way. Just about every chiropractic researcher agrees that we have a tremendous "dearth of good research to prove efficacy," as Newsweek magazine so bluntly put it.

William Meeker, DC, director of the Palmer Center for Chiropractic Research, stated: "Let's face it. We have a massive fact deficit in chiropractic. I fear the profession still doesn't realize it, or how dangerous it is to our future.... the time has come to reassess our professional commitment, our strategies, and our priorities for the science of chiropractic." He said that in a 1996 article in Dynamic Chiropractic.

Here we are, nearly a decade later, and there's been little progress. The World Federation of Chiropractic noted during its Identity Consultation this summer, "There is little existing research or scientific evidence to support chiropractic's role in overall health improvement."

During those intervening years, we heard the message repeated many times.

In 1999, the Journal of the American Chiropractic Association (JACA) ran a report by Dr. Cheryl Hawk, an associate professor at the Palmer Center for Chiropractic Research at Palmer College of Chiropractic and this year's Foundation for Chiropractic Education and Research (FCER) "Researcher of the Year." She stated that without research on clinical and economic outcomes, chiropractic will not prosper. "If we could get evidence for what we do, we could definitely treat many more types of problems and many more types of patients in years to come," she said.

In a 2002 JACA article, Ronald J. Feise, the president and a faculty member of the Institute of Evidence‑Based Chiropractic and research director of the American Chiropractic Scoliosis Foundation, noted: "Although the importance of chiropractic research in professional practice is widely accepted, and using research to guide chiropractic practice has been a long‑standing goal of the profession, the actual integration of research into practice is not yet widespread. This lack of research utilization is threatening the integrity of the profession."

With all due respect to those researchers who are working hard to produce evidence of chiropractic's efficacy and safety ‑‑ and they're producing some excellent work ‑‑ it's not enough. We aren't compiling the kind of irrefutable data using large scale population studies that will convince our critics and the public. We're still focusing too much on back pain relief studies and failing to use modern public relations methods to interpret the findings so that laypeople can understand them.

The profession also hasn't responded to the continual pleas for financial support for research efforts.

In the Spring/Summer 2005 issue of the FCER publication Advance, Dr. Meeker complained, "there are not many more people doing chiropractic research now than there were 10 years ago." He admitted that, in a way, his article was an "indictment of this profession's inability to grow its research enterprises... We can't even find jobs for promising young scientists in our institutions. Only a small number of grant applications are submitted to the National Institutes of Health, even though manipulation research is explicitly on their scientific agenda. Our peer‑reviewed scientific journals are in chronic financial trouble."

He warned that "our profession's research capacity must take a significant leap forward, and all chiropractors must understand and apply the fruits of scientific evidence," but added, "It takes people with curiosity, knowledge, skills, motivation, time, and lots and lots of money."

Well, Dr. Meeker is no doubt relieved and pleased to read about the introduction of RCS ‑‑ Research & Clinical Science ‑‑ a private sector research company that is filled with people with just those attributes. RCS is embarking on what will be the largest outcomes research project ever conducted in chiropractic, and possibly in medicine. It will definitely "grow" chiropractic's research enterprises, help turn the profession into an army of clinical investigators, make it easier to receive grant funding, and spur a renewed interest in chiropractic research within the profession itself.

Most critically, it will compile subjective and objective data on hundreds of thousands of people around the globe, analyze and correlate that data, and identify specific chiropractic outcomes. It will provide the scientific evidence that chiropractic can be used to address a variety of health issues and improve general wellness levels.

To do that, RCS has developed its research protocol so meticulously that it will be impossible for critics to refute or ignore the results.

For example, the program itself and all of its principle investigators have undergone rigorous examination by an independent Institutional Review Board (IRB), a federal requirement for all human subject studies. Every detail of the program ‑‑ including the way in which volunteers are recruited, the data collection process, the integrity and security of the database, and even the financial arrangements between RCS and its investigators ‑‑ was carefully scrutinized and approved.

In addition, every doctor of chiropractic who becomes an RCS Authorized Clinical Investigator, must go through that same process and become an IRB‑approved researcher. Every legitimate researcher whose investigations involve interaction with human subjects must have this approval and very few doctors of chiropractic outside academia have ever received it.

Yet, RCS will have hundreds of IRB‑approved chiropractors working from their offices, collecting data on volunteers and existing patients. These RCS doctors will also have to complete an online training course by the National Institutes of Health and a two‑day training session held by RCS on the campus of the University of California‑Irvine. They'll emerge having earned a Fellowship in Health Outcomes Research.

Every RCS doctor is to be carefully monitored by RCS, which was founded by David Jackson, DC, past president of the Chiropractic Leadership Alliance and Creating Wellness Alliance; Matthew McCoy, DC, director of the Office of Sponsored Research and Scholarly Activities at Life University's College of Chiropractic, and editor of the Journal of Vertebral Subluxation Research; and Robert Blanks, PhD, 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.

They'll be required to use only those volunteer recruitment methods and materials developed by RCS following guidelines based on those of the Mayo Clinic, the Naval Medical Research Center, the University of Maryland School of Medicine, Massachusetts General Hospital and the University of Kentucky Chandler Medical Center. The wording and even the design of the ads and flyers were approved by the IRB. Doctors will also use informed consent forms written by the IRB itself, in order to fully protect all volunteers.

RCS Authorized Clinical Investigators will also be regulated as to how they handle volunteers who choose to become patients. Volunteers will be clearly informed of which services (such as the initial examination, data collection, and Vitality Wellness Index report) are provided free of charge and which (such as actual chiropractic care) are not part of the research program.

In this, RCS has again adopted guidelines similar to medical research institutions. The Mayo Clinic, for example, tells volunteers:

"You and/or your health plan will need to pay for all tests and procedures that are part of this study because they are needed for your regular medical care. The study drug will be given to you at no cost. However, you may need to pay for the preparing of the study drug. You or your health plan might also have to pay for other drugs or treatments which are given to help you control side effects. Before you take part in this study, you should call your health insurer to find out if the cost of these tests and/or procedures will be paid for by the plan. Some health insurers will not pay for these costs. You will have to pay for any costs not covered by your health insurer."

The Kansas City Clinical Oncology Program has similar policies. It informs volunteers that "... medical care costs including laboratory tests, radiology procedures, and medications that are specifically required prior to and during this clinical research study shall be your responsibility unless specified. You have been given the opportunity to discuss the expenses or costs associated with your participation in this research activity.... As part of the evaluation of this treatment, you will be asked to regularly submit blood samples and undergo regular physical examination and x‑ray studies. Almost all of these studies are routinely obtained as part of the general follow‑up and surveillance of patients, and are not part of the investigational aspect of this study.... You and/or your health plan will need to pay for all costs associated with administration of this treatment. The blood drawn for research purposes will be done at the same time as the blood draws needed for your regular medical care. Baseline MUGA scan/echocardiogram will be paid for by you or your health plan as these are clinically indicated tests when receiving AC treatment. ... You or your health plan might also have to pay for other drugs or treatments that are given to help you control side effects."

The University of Michigan Medical Center's General Clinical Research Center, one of 79 NIH‑funded clinical research centers at leading hospitals throughout the United States, includes this statement on its informed consent form:

"If the subject is receiving care for a condition or illness, and is seen in a protocol that involves an accepted form of treatment, either the patient, or the insurance company representing that patient, is responsible for the costs of that medical care. The NIH grant pays for only those tests and procedures performed for research purposes; room charges and standard treatment costs are charged to the participant's insurance."

The Bryanlgh Medical Center Saint Elizabeth Regional Medical Center's consent form for its "Phase I/II Trial Of Pyrazoloacridine And Carboplatin In Patients With Recurrent Gliomas (Study 3) noted:

"You understand you are responsible for all expenses incurred during your hospitalization including supply costs (e.g., IV solutions) and preparation costs for preparing your treatment. You will not be billed for any investigational agents provided at no charge to the hospital.

"The Division of Cancer Treatment and Diagnosis of the National Cancer Institute will give the PZA free of charge for this study. Should PZA become commercially available during the course of the study, however, you may be asked to buy the remaining doses of the medicine.

"... Other costs such as pharmacy charges, the cost to administer the drugs, and the use of medications or other types of treatment to help control side effects could result in added costs to you and/or your health plan. You and/or your health plan will need to pay for all tests and procedures that are part of this study because they are needed for your regular medical care. Before you take part in this study, you should call your health insurer to find out if the cost of these tests and/or procedures will be paid for by the plan. Some health insurers will not pay for these costs. .. You will have to pay for any costs not covered by your health insurer."

RCS doctors will be free to choose whether they wish to accept these volunteers as patients or refer them to other practitioners.

Most impressive of all is the caliber of the RCS International Scientific Advisory Panel, made up of world‑class researchers including: Margaret V. Ames, PhD, a nationally recognized expert in health promotion as well as disease prevention communication activities who serves in federal government health department; Yoshimi Shibata, PhD, associate professor, Department of Biomedical Sciences, Charles E. Schmidt College of Science, Florida Atlantic University; Isaac Ogwel Opole, MD, PhD, resident, Department of Internal Medicine, Kansas University Medical Center; and James Fallon, PhD, professor, Department of Anatomy & Neurobiology, University of California‑Irvine, College of Medicine. (To learn more about the Panel, visit the RCS website at www.rcsprogram.com).

When this group of scientists begins putting together the scientific papers that will be submitted to major peer‑reviewed medical and chiropractic journals, the world will sit up and take notice!

Realizing it was time to try something new and innovative, to take research out of the ivory tower realm and into chiropractic offices, RCS managed to solve the problem of chronic under‑funding of chiropractic research ‑‑ by eliminating the need to rely on (and continuously beg for) donations from the profession. In making research a private enterprise and giving the doctors enough benefits to make it well worth their while to pay to become an RCS Authorized Clinical Investigator, RCS has put chiropractic research on the same playing field as medical research, which is conducted in great part by businesses such as drug companies.

Actually, it's more than innovative. It's revolutionary. But it will take a revolution to beat back our profession's critics as they continue to label chiropractic "unscientific" in order to keep us subservient to the medical and drug industries. And I can't think of any company or group better qualified to lead this revolution than RCS.

If you'd like to get a packet of information that tells you more about RCS and the research it's conducting, you can call 800‑909‑1354 or 480‑303‑1694, or visit the RCS website at www.rcsprogram.com. Doctors of chiropractic may log on to a special limited‑access area of the site by using the username TRguest and password RESEARCH.