A Remedy for Unscientific Healthcare Practices
The Campaign for Science-Based Healthcare believes that Floridians should not be subjected to unscientific healthcare practices. This includes both those practices which have no plausible basis in science and those which, even though formerly thought scientifically feasible, have proven ineffective. A proposed Florida statute, set forth below, addresses both types of unscientific practices by requiring licensed health care practitioners to meet a minimum scientific standard.
The statute strictly prohibits scientifically implausible practices unless they have been shown to be effective in good quality scientific studies. Presumably, this would require their being tested before practitioners are permitted to use them on the public. If a practice is based on sound science, it may be used unless and until good quality scientific studies demonstrate that the practice is not effective. As the statute makes clear, these are questions best left to science, and generally accepted scientific principles control these decisions.
The reason for two different standards should be obvious: those practices not based in good science should not be permitted until they are shown to be effective. On the other hand, if a practice is based in sound science, that should be sufficient to permit it until studies demonstrate otherwise.
The Campaign for Science-Based Healthcare believes that these standards should be enforced by the Florida Department of Health, employing the same procedures as the Department uses in fighting the unlicensed practice of healthcare.
In addition, the Florida Legislature should review all current licensed healthcare practice acts to eliminate those diagnostic methods and treatment interventions that are scientifically implausible because their implied mechanisms or putative effects contradict well-established laws, principles, or empirical findings in chemistry, biology, anatomy or physiology. In no other field of state regulation are unfounded claims allowed to be perpetrated on the public and healthcare, of all things, should not be the exception.
Proposed Florida Statute:
The Science-Based Healthcare Practices Act
Proposed Legislative Findings:
Whereas, the Legislature finds that those healthcare practices not based on generally accepted scientific principles and those healthcare practices which have been proven ineffective:
cause unnecessary expenditure of time and money by the public for ineffective treatments; and
expose the public to the risk of delay of appropriate and timely diagnosis and treatment; and
violate nationally and internationally accepted ethical norms; and
pose an unnecessary risk to the public health by exposing the public to treatments that carry risk of harm without a sufficient benefit to justify that risk.
Whereas, the Legislature finds that healthcare practices not based on generally accepted scientific principles misrepresent the sciences of biology, physiology, anatomy, physics and chemistry to the public, which undermines the legitimate public interest in a scientifically literate citizenry;
Therefore, the Legislature finds that it is in the best interest of the public health, safety and welfare to protect the public from healthcare practices which are not based on generally accepted scientific principles or have proven ineffective.
Proposed Sec. 456.51, Florida Statutes
(1) Notwithstanding any other provision of Florida law, no healthcare practitioner licensed pursuant to Title 32, Florida Statutes, shall engage in the diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition if such diagnosis, treatment, operation, or prescription is implausible because its implied mechanisms or putative effects contradict well-established laws, principles, or empirical findings in chemistry, biology, anatomy or physiology, and it is either
(i) not supported, to a reasonable degree of scientific certainty, by good quality randomized, placebo-controlled trials, or
(ii) not supported, to a reasonable degree of scientific certainty, by a Cochrane Collaboration Systematic Review or a systematic review or meta-analysis of like quality.
(2) Notwithstanding any other provision of Florida law, no health care practitioner licensed pursuant to Title 32, Florida Statutes, shall engage in the diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition even if such diagnosis, treatment, operation, or prescription is plausible because its implied mechanisms or putative effects are in accordance with well-established laws, principles, or empirical findings in chemistry, biology, anatomy or physiology, if
(i) good quality randomized, placebo-controlled trials, or
(ii) a Cochrane Collaboration Systematic Review or a systematic review or meta-analysis of like quality, demonstrate, within a reasonable degree of scientific certainty, that said diagnosis, treatment, operation or prescription is not effective for said human disease, pain, injury, deformity, or other physical or mental condition.
(c) Each term in this subsection shall be interpreted according to its generally accepted meaning in the scientific community.
(3) It shall not be a defense to prosecution for a violation of this section that a diagnosis, treatment, operation, or prescription is within the scope of practice, as defined in Chapter 32, Florida Statutes, of a healthcare practitioner accused of said violation.
(4) The department, and not the boards, shall have exclusive jurisdiction over any and all proceedings under this section.
(a) “Department” means the Florida Department of Health.
(b) ”Board” means any board established to regulate a licensed health care profession pursuant to Chapter 32 of the Florida Statutes.
(c) “Good quality, randomized placebo controlled trial,” shall mean a trial meeting the following minimum criteria:
(i) involving the random assignment of participants to a credible placebo control group; and
(ii) employing at least fifty participants per group; and
(iii) losing no more than 25 per cent of its participants over the course of the study; and
(iv) published in a high-impact, peer-reviewed research journal.
(6) The Department shall adopt rules pursuant to the provisions of Chapter 120, Florida Administrative Code, to implement the provisions of this section.
[Note: Subsections (7), (8) and (9) adopt the same enforcement procedures as Sec. 456, Fla. Stat., “Unlicensed practice of a health care profession,” which gives the Department of Health the authority to prosecute unlicensed practice.]
(7) When the department has probable cause to believe that any person has violated any provision of this section or any rule adopted pursuant thereto, the department may issue and deliver to such person a notice to cease and desist from such violation. The issuance of a notice to cease and desist shall not constitute agency action for which a hearing under ss. 120.569 and 120.57 may be sought. For the purpose of enforcing a cease and desist order, the department may file a proceeding in the name of the state seeking issuance of an injunction or a writ of mandamus against any person who violates any provisions of such order.
(8)In addition to the remedies under paragraph (3), the department may impose by citation an administrative penalty not to exceed $5,000 per incident. The citation shall be issued to the subject and shall contain the subject’s name and any other information the department determines to be necessary to identify the subject, a brief factual statement, the sections of the law or rule adopted pursuant thereto allegedly violated, and the penalty imposed. If the subject does not dispute the matter in the citation with the department within 30 days after the citation is served, the citation shall become a final order of the department. The penalty shall be a fine of not less than $500 or more than $5,000 as established by rule of the department. Each day that the violation continues after issuance of a notice to cease and desist constitutes a separate violation. The department shall be entitled to recover the costs of investigation and prosecution in addition to the fine levied pursuant to the citation. Service of a citation may be made by personal service or by mail to the subject at the subject’s last known address or place of practice. If the department is required to seek enforcement of the cease and desist or agency order, it shall be entitled to collect its attorney’s fees and costs.
(9)In addition to or in lieu of any other administrative remedy, the department may seek the imposition of a civil penalty through the circuit court for any violation for which the department may issue a notice to cease and desist. The civil penalty shall be no less than $500 and no more than $5,000 for each offense. The court may also award to the prevailing party court costs and reasonable attorney fees and, in the event the department prevails, may also award reasonable costs of investigation and prosecution.
Sec. 456.51 (1): the standard “is implausible because its implied mechanisms or putative effects contradict well-established laws, principles, or empirical findings in chemistry, biology, anatomy or physiology” was taken from “Illinois Department of Professional Regulation Medical Disciplinary Board (MDB). Board Policy Statement: Complementary and Alternative Therapies. November 1999″ posted in pertinent part at http://www.sciencebasedmedicine.org/?p=235#comment-10074. The level of evidence required in Sec. 456.51(1)(i),(ii) and (2)(i)(ii) is based on R. Barker Bausell, Snake Oil Science: The Truth About Complementary and Alternative Medicine (New York: Oxford University Press 2007), Chapter 11 (“What High-Quality Trails Reveal About CAM”) and Chapter 12 (“What High Quality Systematic Reviews Reveal About CAM”).
Sec. 456.51(8)(c): The definition of “good quality, randomized placebo controlled trial” was taken from Bausell, Snake Oil Science, at 176-178.