Conventional and unconventional innovations in medicine are frequent, and welcome, but they must be scientifically sound and responsibly evaluated. Legislative overrides to that process, especially when they might be motivated by cronyism, campaign donations, lobbying contracts, or anything other than scientific merit, are bad medicine.
Cranston chiropractor Victor Pedro is in the headlines again, this time as the subject of a subpoena for records by the Rhode Island United States Attorney’s office. Pedro gained public scrutiny after journalist Steve Ahlquist flagged a state budget line item for a million dollars to fund his alternative medicine technique, “Cortical Integrated Therapy (CIT).” Described as an “innovative” therapy for brain injuries and a wide array of neuropsychiatric disorders, it was reportedly developed single-handedly by Pedro and available only at his private practice. According to his website, this technique “accurately pinpoints and identifies the injured or under-performing areas of the brain” and a variety of activities are used to “repair brain pathways for more effective and longer-lasting outcomes.” The problem? Medical experts are skeptical of these claims. Not a single published research study documents them. No granting agencies have supported research into the technique – except Rhode Island taxpayers, who began underwriting Pedro’s efforts in 2004, and have spent an estimated $1.9M to date.
In 2004, a $150,000 Rhode Island legislative grant funded a study that treated 10 children with Attention Deficit Hyperactivity Disorder using this technique. The unpublished study, available online, was authored by collaborator James Paicopolos, identified as a school psychologist. No scientific references were included. Subjects were recruited by promotion on television, and no control group of untreated children was included. All children received individualized treatment using vaguely described “sensory therapies,” so the study could not be replicated by other researchers. The same person apparently administered outcome rating scales and treatments. No mention was made of any Institutional Review Board (IRB) approval or human subjects protections. No statistical analysis was conducted; subjective descriptions and testimonial letters alone illustrate results. Reputable medical journals will not publish studies without adequate methodology, IRB approval, informed consent after full disclosure of risks and benefits, placebo control groups, blind raters who administer rating scales without knowing whether or not the patient was in the treatment or control group, and well-described, replicable methodology. This study violated many accepted practices of good science. It also violated guidelines for good clinical care, allowing children to be treated using an unreviewed experimental technique with no published data on safety or efficacy at all.
Proponents have argued that it’s necessary for government to support innovative techniques, as other avenues do not fund them. Not so: a variety of funding streams and mechanisms are available for new medical techniques, including public health agencies, private foundations, university and hospital internal funding, and industry-supported funding streams. Many avenues specifically fund new, innovative pilot projects including an entire branch of the National Institutes of Health called the National Center for Complementary and Integrative Health which focuses on evaluation of unconventional techniques. None of these agencies funded research into CIT, and the United States Centers for Medicare and Medicaid Services (CMS) declined a request by the Rhode Island Executive Office of Healthcare and Human Services to fund its use.
Their August, 2017 letter noted, “As proposed, the CIT treatment is broadly described, with very few parameters for cost or quality control for the specific array of services billed, the intensity of the services, the length of therapy, or the clinical indications for each service. The state has not provided scientific evidence verifying the efficacy of CIT, nor any indication that CIT was subject to such evaluation. CMS does not grant authority, under a section 1115 demonstration, for clinical interventions that have not demonstrated clinical safety and efficacy through standard clinical evaluation processes, and ideally through a rigorous randomized controlled trial. These trials and similar demonstrations could more appropriately be covered through grants available from the National Institutes of Health or other private and public funders of clinical research. We recommend the state look in to these opportunities.”
CMS made it clear that this technique should undergo the standard evaluation process. It didn’t. Instead, the General Assembly turned to Rhode Island taxpayers, taking resources away from evidence-based treatments, and prompting many questions: What are the billing parameters for unique treatments? Since no data exist on the length or scope of treatment that might be necessary, can treatment go on indefinitely with unlimited billing? Can doctors just make up treatments, and provide them to the public, including children, with no efficacy or safety data? Can we do this in any specialty that we choose? Brain injuries and illnesses do not fall within the typical scope of practice for a chiropractor. Is a “chiropractic neurologist” adequately qualified, and what is the requisite amount of education and training to treat patients with brain disorders? Neurologists and neuropsychologists train for 11-12 years, working directly with patients for at least 3 years. Per the American Chiropractic Neurology Board, a “chiropractic neurologist” must complete 300 hours of postdoctoral training. That’s 7.5 weeks at a 40-hour work week. Is that sufficient to treat brain injuries?
In one neurologist’s opinion, “Chiropractic neurology appears to me to be the very definition of pseudoscience – it has all the trappings of a legitimate profession, with a complex set of beliefs and practices, but there is no underlying scientific basis for any of it.” – Steven Novella MD, Neurologist, Yale University School of Medicine, in Science-Based Medicine, November 16, 2011.
It’s understandable that the General Assembly might not be familiar with professional training requirements or accepted practices for scientific research; they are not medical doctors or scientists, for the most part. What is not understandable is why – in a state hosting one of the best medical schools in the country, the Warren Alpert Medical School of Brown University – they would not seek expert advice on these issues. When the budget item was exposed, two dozen medical experts (neurologists, psychiatrists, and neuropsychologists) immediately denounced funding the non-evidence-based technique. Why weren’t they asked?
I urge the General Assembly to let the peer review process vet innovative ideas rather than subvert this process in future budgets. Conventional and unconventional innovations in medicine are frequent, and welcome, but they must be scientifically sound and responsibly evaluated. Legislative overrides to that process, especially when they might be motivated by cronyism, campaign donations, lobbying contracts, or anything other than scientific merit, are bad medicine.