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Part two of the new book preview…

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New Regenexx Book Preview

More of the New Regenexx Book preview, part 2 of the chapter on medical innovation and long-tail medicine…

The Long-tail has always been a part of medicine

Believe it or not, many of the medical miracles you take for granted weren’t developed through the FDA pathway – they were developed by physicians. If doctors are responsible for a large portion of medical discoveries, how does this work? Doctors innovate differently than drug companies and use a process sometimes called Bayesian, or adaptive, research that I call Long-tail medicine. A doctor first notices a problem that doesn’t have a solution, i.e., a patient he can’t help recover. He then consults with the sick patient to learn whether or not he or she wants to try a new or innovative treatment or procedure. The patient gets to weigh the risks and benefits (called informed consent), and if the patient agrees, the new therapy is undertaken. The doctor then observes the results and, over time, makes changes he thinks may improve the outcome for the next patient.

If the new therapy seems to be promising, the doctor then performs a small study which may lead to bigger studies at a later date. The doctor then educates his colleagues about the therapy by giving presentations at medical conferences, and the word spreads. Over time, other physicians test the new therapy by performing more and more research. Eventually, the “new” therapy is found to be either not as promising as initially hoped, or it’s deemed effective and is ensconced into how all doctors practice. As you can see, while frequentist research is a “top down” approach, physician innovation (Long-tail medicine) is a “bottom up” approach, with the physicians in the trenches determining where innovation is needed and presenting solutions.

What are the Bioethics of Long-tail medicine?

Is it ethical for doctors to use care that hasn’t been absolutely shown to work through high levels of rigorous research? If so, what major policy statements support this type of medical care? As you have seen, most of what doctors do isn’t supported by EBM. If we look at that through the lens of bioethics, we see that all of the major documents defining what’s right and wrong in innovative care have supported this concept.

First, what is “bioethics”? The concept that subjects in research studies needed to be protected started after atrocities in World War II. As medicine progressed, all sorts of ethical dilemmas were encountered. For example, once we had the ability with modern respirators and IV feeding to keep someone alive almost indefinitely – should we? The two major policy statements that drove the field were the Belmont Report in the U.S. and the International Declaration of Helsinki.

From a bioethics standpoint, TheBelmontReport supports the general concepts behind Long-tail medicine. Belmont was a document created to help the United States establish a framework for protecting patients involved in research studies that ultimately formed the framework of the current U.S. National Institutes of Health research system. Belmont clearly discusses that when doctors innovate, they do so to help patients recover from disease. This is quite different than traditional frequentist research, where the end goal is often the research itself — and whether or not patients recover may be immaterial to the research study.

Section A of the Report distinguishes between the practice of medicine and medical research. According to the Report, activities defined as research should initially undergo review for the protection of human subjects. However, the report recognizes that many times physicians try new things with patients under the practice of medicine. The report defines that medical “practice” refers to interventions that are designed solely to enhance the well-being of an individual patient and have a reasonable expectation of success. The purpose of medical practice is to provide: 1) diagnosis; and 2) preventative treatment for particular individuals.

The section of the report on research architecture contains a general comparison between clinical practice and frequentist research. In a clinical practice, the primary purpose is always clinical, i.e. intended to benefit the patient. Hence, while research itself may have an end to itself (does drug X reduce cholesterol levels), clinical practice investigation is always focused on the mitigation of suffering and disease.

The other seminal report for defining the bioethics of long-tail medicine is the Declaration of Helsinki, first adopted in the early 1960’s about the time our modern U.S. drug laws were created. It says:

In the treatment of a patient, where proven interventions do not exist or have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorized representative, may use an unproven intervention if in the physician’s judgment it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, this intervention should be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information should be recorded and, where appropriate, made publicly available.

Basically, both the major U.S. and the world document on the bioethics of using new and innovative care support the concept behind long-tail medicine. Doctors have a duty to cure or mitigate suffering in their patients and that extends to things they may suspect to be effective. Their hands are in no way tied by what is established medicine or forced to use care that has high levels of EBM – especially when there are few good options for the patient.

While all of this very complex legalese may be hard to follow, what does this mean to you practically? Just like the example that opened chapter 1, if you’re on your death bed, your doctor is charged with saving your life, even if there isn’t EBM to support his every move or if the FDA doesn’t like it. The same holds true for other situations where your doctor may have a better way to help your problem.

If long-tail medicine has been practiced for centuries, whats the problem?

Cells=drugs throws a monkey wrench into long-tail innovation by physicians. The main problem is that it relegates a large portion of the future of medicine to the sole domain of traditional drug research and the moneyed interests of medicine. If your cells are body parts, then your physician can use these to innovate to treat any one unique patient – i.e. long-tail medicine. However, make those body parts drugs, then only FDA frequentist style trials run by large corporations and universities can produce cures. While the rest of our innovation economy has turned away from centralized top-down approaches with the advent of the information age, your body’s cells will become the property of Big Pharma and you will not be free to use them as you wish for your benefit using informed consent.

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