Our society will benefit from using the best available science for governmental regulation and policy.
John P.A. Ioannidis, “All science should inform policy and regulation.”
Undeniably true. Unfortunately, there is no legal mechanism for requiring all governmental regulation and policy to use the best available science. Dr. Ioannidis was lamenting a proposed EPA regulation limiting the types of research it will consider in making policy, a move that he says will “practically eliminate” science from the decision-making process, leaving regulation to “depend uniquely on opinion and whim”. Pretty much the entire scientific community, as well as some industries the EPA regulates, join him in his concern.
Here at SBM, we are all too familiar with opinion and whim beating out science in legislation and regulations. In addition to the Legislative Alchemy that turns pseudoscience into legalized health care practices, a topic I’ve covered many times, examples of this regrettable lack of a scientific basis for government action abounds. Some examples we’ve covered on SBM:
- State “Right to Try” laws, allowing patient access to drugs that have not passed all safety and efficacy testing required for FDA-approval, based on the dubious notion that there is a plethora of life-saving drugs being suppressed by an unwieldy and unyielding government bureaucracy.
- State laws protecting so-called “Lyme literate” physicians from discipline for substandard practice, forcing insurers to pay for discredited treatments for “chronic Lyme,” and requiring burdensome and misleading disclosures be given to patients about Lyme disease.
- The Dietary Supplement Health and Education Act, passed based on absurd claims from alternative medicine proponents about the health benefits of herbs and vitamins.
- Federal law requiring Medicare coverage for the detection and correction of non-existent chiropractic “subluxations.”
- State laws permitting non-medical vaccination exemptions.
- Veterans’ Health Administration policy adopting quackery like reflexology and reiki in the treatment of veterans.
- State laws promoting auricular acupuncture for substance abuse treatment.
- GMO regulation and labelling.
And some that we haven’t:
- A Department of Justice guideline for interviewing crime victims with communication or cognitive disabilities recommending the thoroughly-debunked technique of facilitated communication as valid.
- The Delaney Clause of the FD&C Act, which says the FDA cannot approve the use of any food additive that has been found to induce cancer in humans or animals at any dose, even if the FDA determines the additive does not pose a risk to public health as normally used.
It is especially appalling that the government, on the one hand, uses taxpayer monies to fund research on, for example, cancer treatments and climate change, then deprives those same taxpayers of the fruits of that research through legislation like the new federal “Right to Try” law and administrative actions like removing climate change information from government websites.
All of this raises the question in my mind: Should there be a way to prevent “opinion and whim”, or even just bad science, in government policy where the best available science counsels otherwise? If so, what form should it take? To afford the most protection, do we need a “right to science”, established in the U.S. Constitution, like due process, freedom of speech, and the right to peaceably assemble? What would that look like? And how would it work?
In fact, a “human right to science” was established in the Universal Declaration of Human Rights in 1948 and the right to enjoy the benefits of scientific progress was incorporated in the International Covenant on Economic, Social and Cultural Rights in 1966. (Unfortunately the article is behind a paywall.) The right, which has not received wide attention and has not been fully explicated, does not specifically include the aspiration that all laws and other forms of government regulation be science-based. In 2012, a report to the UN on the meaning and application of the right did identify as a “core component”:
access by everyone, without discrimination, to the benefits of science and its applications, including scientific knowledge.
“Best available science”
The idea of a constitutional right to science appeals to me because the need certainly exists and I cannot come up with any good reason why legislation enacted by Congress and the states, as well as agency rules, affecting our health, safety and welfare shouldn’t be based on the best available science. Perhaps you can. I also cannot find a single mention of any such proposal in the legal literature, but maybe other lawyers don’t spend as much time as I do contemplating the ill effects of pseudoscience on the nation’s welfare.
However, it is the exact wording that I find problematic. I could not locate an exemplar in the Constitution expressing a remotely similar prohibition, but let’s give it a try anyway:
Neither Congress nor any State shall make or enforce any law unless it is based on the best available science.
(Legally, this would necessarily include agency regulations as well.)
Of course, one might well ask: What does “best available science” mean? To Dr. Ioannidis, in using science as a basis for making policy decisions,
it is essential to examine evidence in its totality, recognize its relative strengths and weaknesses, and make the best judgment based on what is available.
It is worth noting that we’ve worked out the definition of more ambiguous words than “best available science” in our Constitution: due process of law, establishment of religion, freedom of speech, unreasonable searches and seizures, probable cause, equal protection of the laws, and impartial jury, among others.
I’ll leave it there, with no pride of authorship and the conviction that better minds could draft a Constitutional amendment if the political will is there, an issue we’ll return to in a moment.
Wording and politics aside, the government’s experience in actually applying a scientific standard gives me confidence that the competent execution of a right to science is possible. Scientific standards do exist in current statutes and agency rules and are regularly enforced. And the courts, the ultimate arbiters of the constitutionality of legislation and regulations, are experienced in deciding questions of scientific validity (however imperfectly).
For example, the Federal Trade Commission requires the best available science, in the form of “ competent and reliable scientific evidence“, to support health claims in advertising and regularly brings enforcement actions against companies that do not comply. As the agency said in warning letters to marketers of weight loss products:
It is unlawful to advertise that a product causes weight loss unless you possess well-controlled human clinical studies of the product, or a substantially similar product, substantiating that the claims are true. Such studies must be randomized, double-blind, and placebo-controlled, and conducted by researchers who are qualified by training and experience to conduct such studies.
As well, the courts are frequently called upon to assess scientific evidence, as they would be in any challenge to a statute or regulation brought pursuant to our putative Constitutional amendment. First, the Federal Rules of Evidence and case law require that expert testimony on matters of science meet certain reliability requirements. In the Daubert case, the Supreme Court
set forth a non-exclusive checklist for trial courts to use in assessing the reliability of scientific expert testimony. The specific factors explicated by the Daubert Court are (1) whether the expert’s technique or theory can be or has been tested—that is, whether the expert’s theory can be challenged in some objective sense, or whether it is instead simply a subjective, conclusory approach that cannot reasonably be assessed for reliability; (2) whether the technique or theory has been subject to peer review and publication; (3) the known or potential rate of error of the technique or theory when applied; (4) the existence and maintenance of standards and controls; and (5) whether the technique or theory has been generally accepted in the scientific community.
Second, in cases challenging the teaching of unscientific “theories” like creationism as violative of the First Amendment’s Establishment Clause, courts have been required to demarcate science from pseudoscience. For example, in Kitzmiller v. Dover, which challenged the teaching of “intelligent design” in public school science classes, a federal district judge, after hearing extensive testimony from both sides, ruled that intelligent design
is not science and cannot be adjudged a valid, accepted scientific theory as it has failed to publish in peer-reviewed journals, engage in research and testing, and gain acceptance in the scientific community.
While we should be able to draft a reasonable scientific standard against which legislation and regulations should be measured, and while we may already have the legal infrastructure in place to interpret and enforce that standard, it’s very hard to amend the U.S. Constitution. (If you want the details, you can read about it here.) Remember, we haven’t been able to add an amendment guaranteeing the equal rights of women, a proposition that doesn’t seem like it should be all that controversial, but is. (There is no time limit on ratifying an amendment, by the way.) Maybe good science would be an easier sell than my equal rights under the law is now or my right to vote was in the last century. (Ironically, opposition to the latter was in part based on bad science.) However difficult the battle might be, I think a constitutionally-protected right to science is well worth considering.