June 2005

What RCS has in common with the Mayo Clinic

by Dr. David A. Jackson

Over the past few months, I've talked with many DCs about the new private sector research program, RCS (Research & Clinical Science). Almost all were excited about the program, since it offers two major benefits. It conducts important research to validate chiropractic care for every man, woman and child on the planet. And, it can create a flood of new patients while enhancing a doctor's credibility and prestige.

Yet, a few doctors have expressed concern about the ethics of a research program that also has the potential to generate huge numbers of new patients and create significant incomes for the researchers. Their attitude is that, somehow, making a profit sullies the research effort, that altruism and poverty necessarily go hand in hand. Let me address that issue head on, in case you're one in the minority who thinks its wrong to help yourself while helping the profession.

I cannot emphasize strongly enough that RCS' primary mission is to prove that chiropractic has positive impact on just about every aspect of health and wellness. We want to produce unassailable scientific evidence that chiropractic can boost the immune system, help children be stronger and healthier, improve general quality of life, and alleviate or reduce stress‑related disorders (including allergies, asthma, hypertension, arthritis, addictions, obesity, etc.). You and I already know this to be true. Now, we have to provide the hard-core proof to back us up.

In an ideal world, this research would be funded by multi‑million dollar grants from the National Institutes of Health (NIH) or some other agency or foundation. But this is the real world, so we need to recruit doctors willing to pay about $350 a month to participate in the project.

There is absolutely nothing wrong with these doctors receiving compensation ‑- such as greatly increased practice volume ‑- in return for their participation and dedication. They should be allowed to accept as paying patients, those volunteers who, after learning more about chiropractic, decide for themselves that they want to enjoy the health benefits chiropractic has to offer. RCS doctors cannot be expected to tell volunteers, "Thanks for giving us your time but sorry, I can't offer you chiropractic care ‑- go see someone else." That simply makes no sense.

Although chiropractic generally tries to avoid using the medical profession as a role model, the fact is, RCS is using the same procedures and guidelines followed by most medical research programs. The volunteer recruitment ads we've developed follow the guidelines set by the Mayo Clinic, the Naval Medical Research Center, the University of Maryland School of Medicine, the Massachusetts General Hospital, and the University of Kentucky Chandler Medical Center.

The research procedures themselves are also similar to those of medical research projects. For example, the Mayo Clinic issues FAQ sheets for its research projects and answers the question, "Will I need to pay for the tests and procedures?" as follows:

"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 treatment 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."

Similar procedures govern the research conducted by 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.

Its informed consent form reads (in part):

"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."

Likewise, the Kansas City Clinical Oncology Program, a cooperative effort involving 12 Kansas City area health care organizations, as well as more than 70 medical oncologists, radiation oncologists, surgeons and other specialists, informs volunteers that they will be responsible for paying for treatment, drugs, tests or services received during the research project. It tells them:

"... 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 draw 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."

Let's look at just one more: 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).

"What Are The Costs Of Tests And Procedures?

"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 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 (emphasis theirs).

"You will have to pay for any costs not covered by your health insurer."

As can be plainly seen, most volunteers engaged in medical research are expected to pay for any treatment or drugs they receive (including the drugs they need to combat side effects of the drugs being tested!).

The same guidelines are followed by RCS. Volunteers are never charged for any part of their participation in the research. They are offered free of charge a complete chiropractic examination, including X‑ray  when appropriate and when that's part of the RCS Researcher's normal exam procedures. They are given a copy of their RCS Vitality Wellness Index report, which shows them at a glance how they stack up to everyone else in the database, and even the  results of the doctor's examination. They are told right from the beginning that they may terminate their participation at any time and are under absolutely no obligation to receive care.

Plus, doctors are expressly prohibited from using any coercion to get volunteers to become patients.

But, frankly ‑- and I've worked with chiropractors for a long time ‑- I've never yet seen one "coerce" a person into becoming a patient. DCs educate people about the benefits of chiropractic care and explain what services they offer. That's precisely what RCS doctors do. It's only natural, then, that many volunteers (who, by volunteering have already shown their interest in health) will want to become patients.

If an RCS Authorized Research Site sees 10 volunteers a week, and just one half of them decide to receive care, that's five new patients every week ‑- 260 patients a year (not counting all the family members, friends and co‑workers they refer).

Let's do a bit more number crunching: 5,000 RCS doctors (our estimate of the number of doctors who will be joining us in the initial study period) x 260 patients a year. That's 1.3 Million 520,000 new patients brought into chiropractic annually, just through the research program ‑- and 5,000 highly successful, prospering DCs contributing to chiropractic research.

Whether you're one of those 5,000 RCS doctors, or one of the 55,000 others who end up relying on the research produced by the project, you're going to be a winner. The biggest difference will be that the 5,000 will have directly contributed to the results ‑ and reaped the rewards.

(Dr. Jackson is chief executive officer of Research and Clinical Science (RCS), a private sector research program exploring issues of subluxation correction and chiropractic care as they relate to health and wellness. Previously, he served as president of the Chiropractic Leadership Alliance and Creating Wellness Alliance and was owner/operator of several private practice offices in California and Idaho that specialized in high‑volume, family wellness‑based care. For more information on RCS, call 800‑909‑1354 or 480‑303‑1694, or visit the RCS website at www.rcsprogram.com.)