November 2006

Medicine blurs line between patients and volunteers

by Dr. Terry A. Rondberg

Chiropractors may not agree with the medical paradigm of health, but when it comes to "professionalism" we often to look to MDs as our role models. We want to be as "legitimate" and "credible" as they are, even if it means wearing a white lab coat and hanging a never‑used stethoscope around our necks. We want to walk like a duck and quack like a duck, without actually being one.

But the fact is, the medical profession is not a particularly suitable one to model ourselves after. Its reputation (never sterling to begin with) has been further tarnished by questionable ethics and a pronounced tendency toward greed. This is not to say that every practicing MD is unethical or greedy, but merely that the industry as a whole, dominated as it is by the pharmaceutical and insurance/HMO industries, is no longer a worthy role model (if it ever was).

In everything we do, chiropractic must strive not to be like the medical industry, but to be better than it is. This means running our practices in a more responsible way, caring for our patients with more compassion and honesty. Unlike MDs, who may prescribe antibiotics when patients insist on them even if they know they're useless and possibly even harmful, DCs must make clinical decisions based on the needs of the patient and not the dictates of the insurance companies.

The same applies to chiropractic research. How often in the past few years have we read about medical researchers who have been "bought and paid for" by drug companies? The vast majority of medical research is merely a marketing tool to sell new drugs and most medical "researchers" are merely drug company shills paid to "discover" how wonderful the drugs are.

In recent years, volunteer/patient recruitment for these "research" studies has become another big business that helps lure millions of people into medical offices and drug centers.

In fact, we've seen the rise of a large number of public relations and advertising companies that actually specialize in volunteer/patient recruitment.

Take, for instance, the company Praxis (gopraxis.com).

The company describes itself as "an innovative clinical services provider specializing in patient recruitment." It says it "provides the pharmaceutical and biotech industries with a wide range of services for patient recruitment and retention for clinical trials including patient profiling, recruitment planning, centralized fulfillment, media relations, advertising and program management." On its website, it claims "You can be a Clinical Research Rock Star."

Another company, called Trial Builder (trialbuilder.com), promises to "design an innovative patient recruitment plan to locate and pre‑qualify patients who fit your criteria." It uses radio and television spots, print media, direct mail, Internet announcements, and public relations in order to "attract patients who match your protocol."

Its website claims that companies can lose a million dollars in profits every day that a major drug research project is delayed.

There are even companies, like Clinical Trial Media (clinicaltrialmedia.com) that specialize in buying media time for patient recruitment ads!

Clearly, medical research is big business and so is patient recruitment. With billions of dollars at stake from the sale of drugs and biomedical devices, and millions of dollars in federal grants on the line, the "marketing" of research studies has become as sophisticated and intensive as the marketing of breakfast cereals and SUVs.

As a result, each year, millions of people volunteer to take part in clinical research studies. Most people assume they get paid for their participation, which sometimes entails risking their health (and their lives) on experimental drugs or procedures.

Surprisingly, that's not the case! In fact, many "volunteers" end up paying for whatever medical care they receive.

For instance, the Mayo Clinic issues FAQ sheets for its research projects. One of the questions is: "Will I need to pay for the tests and procedures?"

The answer is: "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." (emphasis added here and in other examples).

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 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).

The form states that: "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."

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!).

It's obvious that many, if not most, medical research programs routinely differentiate between the services provided as part of the research study and actual treatment given to the volunteer as a patient.

Perhaps that's why the recruitment companies fail to make a distinction between volunteers and patients. They openly recruit patients for the medical industry.

In chiropractic, researchers are more careful about not blurring the line between volunteer and patient, although the basic recruitment techniques remain the same.

If one of our colleges conducts a clinical research study on subluxation and headaches, the researchers recruit volunteers, provide (free of charge, of course) any examinations needed, collect the relevant data from the volunteer, and compile their findings. Volunteers who decide to continue receiving chiropractic care do so as paying patients. The researchers can't possibly be expected to provide such care for free, although they may choose to refer the patient to another DC.

For example, a study conducted at Northwestern involved 26 individuals identified as having chronic back pain with an equal number of pain‑free volunteers (The Journal of Neuroscience, Nov. 17, 2004). What happened to the volunteers who, during the course of the study, decided they wanted to receive chiropractic care? If the researchers were in private practice, would they have refused to care for the volunteers after the study was over? Or would they, like their medical counterparts, explained to them that continuing care was not part of the study but they were welcome to become patients?

RCS (Research & Clinical Science) goes even one step further. RCS Clinical Investigators explain to volunteers at their very first visit that the research study involves only a chiropractic examination and filling out an online Self‑Reported Quality of Life survey. Volunteers will receive a report of findings and a Vitality Wellness Index report, but no chiropractic care.

If they choose to receive care, they may do so as paying patients. The line between volunteer and patient is clearly drawn and explained, just as it is in medical studies conducted by the Mayo Clinic..

In fact, the only significant difference between RCS and medical research institutions is that chiropractic research doesn't receive millions of dollars in federal and private grants to pay for the research. We have to pay for it ourselves (at least for now ... I'm firmly convinced that once we have enough hardcore research to satisfy our critics, the money will begin to flow into the profession from private and public sources.)

Luckily, there are enough doctors who understand the vital need for research that they are willing to pay for it through donations to colleges or research organizations and subscriptions to chiropractic research journals like the Journal of Vertebral Subluxation Research. Even more fortunate for chiropractic is the fact that many doctors are willing to support chiropractic research by becoming RCS Clinical Investigators and compile vital research data from their own offices! The modest fee they pay RCS help fund the research we so desperately need.

It's really just one more way that chiropractic is distinct from medicine. Medicine treats diseases and conditions ... we address subluxations in order to allow the body to achieve optimum wellness. Medicine fails to make a clear distinction between research volunteers and patients ... we are careful not to blur the lines between the two. Medicine receives millions of dollars for research in order to make billions on new drugs ... we pay for research ourselves in order to achieve our goal of a subluxation‑free world.

Vive la difference!