An Ethicist Asks “Is Regulation Unethical Human Experimentation?”

Summary:  For the last 10 years, I have chaired a for-profit Independent Review Board (IRB) that reviews the information that subjects of human testing receive explaining their rights and responsibilities. These internationally-adopted standards for human experimentation, which evolved from the atrocities of Nazi Germany and unethical experiments in the United States and elsewhere, are routinely violated by regulations governing human behavior.  While practicing ethicists rarely challenge such behavior, voluntarists and libertarians generally are willing and able to do so. Since professionals with diverse backgrounds can be labeled as “ethicists,” voluntarists and libertarians may wish to bring their expertise to bear on questioning whether regulatory practices are a form of unethical human experimentation. Indeed, taking such an approach may be timelier and more effective than promoting liberty as a “moral” choice.

History of Ethical Human Experimentation Standards

After World War II, the criminal war trials of prominent Nazis brought to light human experimentation that was universally condemned on ethical grounds. The prosecution put together what is now known as the Nuremburg Code which defined the basic requirements for ethical conduct of human research. The Code required ethical human experimentation to follow ten principles, including voluntary and informed consent, a favorable risk/benefit ratio, and the right to withdraw without penalty.

The Worldwide Association of Physicians subsequently issued the Declaration of Helsinki, which extended the Nuremburg Code to include oversight by an “independent committee.” These are known as Institutional Review Boards (IRBs) in the United States, Research Ethics Boards (REBs) in Canada, and other variations of “ethical review board” in other nations. An important focus of the Declaration was its insistence that “concern for the interests of the subject must always prevail over the interests of science and society.”

Consequently, most human experimentation today is conducted only after a review by an ethical review board whose primary mission is to protect the rights and welfare of the research subjects being enrolled. Biomedical studies, social studies, and pharmaceutical studies, which are often undertaken solely for regulatory purposes, are all reviewed by IRBs prior to their instigation to make sure they meet certain criteria.

Private companies, government institutions (such as National Institutes of Health (NIH)), independent physicians and researchers, as well as public entities (such as most universities), are all required to inform experimental subjects of their rights prior to undertaking the research. U.S. IRBs review both what subjects will be told, as well as why the study is necessary, before the study begins. If certain informational standards and protections are not included in this “informed consent,” the research is considered unethical, won’t be approved, and can’t legally proceed.

Regulation as Human Experimentation

Why should regulation be thought of as human experimentation and subject to its rules? Historically, we often do think of legislation and regulation just that way.

Referring to the newly crafted government of the United States, George Washington remarked:  “The preservation of the sacred fire of liberty… is finally staked, on the experiment entrusted to the hands of the American People.” In more recent times, John Foster Dulles reaffirmed this perspective:  “Our nation was founded as an experiment in human liberty.”

President Herbert Hoover once referred to Alcohol Prohibition as “the great social and economic experiment, noble in motive and far reaching in purpose.”  The designation of alcohol prohibition as the “noble experiment” stuck and can be found in many historical accounts of alcohol prohibition’s passage and repeal. Drug prohibition, as well as its re-legalization, is often referred to as an “experiment” as well.

Consequently, precedent suggests that new government structures, laws and regulations are frequently regarded as experiments.  Whether they fail and are rescinded, or succeed and are retained, is irrelevant to their designation as experiments.

Components of Ethical Human Research

Voluntarists will likely find the approval criteria used by ethical review boards to be in alignment with the ethical (moral) principle of non-aggression (NAP). Regulation, however, apparently violates, not just the NAP, but the standards set by IRBs and other ethical review boards. Thus, regulation may very well be classified as unethical human experimentation.

Today’s ethicists generally focus on how much regulation is acceptable, instead of asking whether regulation itself violates the internationally-agreed upon principles of ethical human experimentation. Voluntarists, generally more sensitive to the potential moral and ethical hazards of modern day regulation, may therefore have a pivotal role to play in such discussions.

The approval criteria for ethically-conducted human experimentation include, but are not limited to:

1. Using an experimental design that will test the hypothesis being proposed;
2. Informing the subjects, both verbally and in writing, of their rights and responsibilities;
3. Giving the subjects a forum to have all of their questions answered;
4. Reassuring subjects that participation is voluntary and that no one can force them to be in the study;
5. Making sure that subjects know that they can withdraw from the study at any time without penalty for any reason;
6. Letting subjects know of other possibilities (treatments) that they might undertake rather than being in the study;
7. Sharing any new information that might come to light and influence the subjects’ desire to continue in the study;
8. Protecting vulnerable subjects (e.g., children, prisoners, illiterate, mentally incapacitated, terminally ill), if they are to be enrolled, by having a legally authorized representative (LAR) evaluate and agree to the research on their behalf;
9. Making sure that the compensation for participating is not so much as to exert undue influence in the subjects’ decision to enter or continue in the study against their own best interests;
10. Apprising subjects of potential risks of the study;
11. Informing subjects of any remedial actions that will be taken if they are harmed;
12. Insuring that investigators do not have unmanaged conflicts of interest.

Without these and related protections, the research is considered unethical human experimentation and won’t be approved by the ethical review board. Since virtually all of these elements are missing when governments institutes regulations, one might question whether regulation is unethical human experimentation.

Regulations Have Poor Experimental Design

In a strict research sense, almost all regulations would be regarded as “uncontrolled” experiments, since there is no subset of the population that is not subject to them. Without a comparator group, the experimental design cannot test the hypothesis that the regulations do what they are intended to do.  Consequently, an ethical review board probably wouldn’t approve such an “experiment.”

Regulators Promise Effectiveness Prior to Its Demonstration

IRBs make sure that investigators who test new therapies don’t imply that the subjects will experience beneficial treatment effects.  After all, the study is being conducted to determine if the new drug actually works!

However, regulations assume positive outcomes (e.g., consumers will be protected) when, in fact, the opposite may be true.  Legislatures and regulators assume that making a law intended to do something will actually achieve it, even if no evidence exists to back up their claim. In many cases, the only evidence available actually suggests that the regulations do the opposite of what their supporters intend.

For example, states which have more stringent licensing laws for electricians, optometrists, or dentists have more accidental electrocutions, a higher incidence of blindness, and poorer dental hygiene respectively.  As requirements go up, prices do too, making some services unaffordable.  Consequently, although licensing laws are assumed to provide more quality service, there is actually less quality service delivered as many consumers are priced out of the market. Consumer protection, the desired result, is not achieved. Indeed, the opposite appears to be true.

Regulations Aren’t Evaluated for Effectiveness

When conducting human research, investigators are required to devise a way to actually determine the true impact of the “treatment.” In a drug study, for example, investigators must have enough subjects to actually do a meaningful comparison between a drug treatment and a placebo group, must make sure that both groups are similar to start with, etc.

Not only do legislatures and regulators assume a positive outcome for regulations that they propose or enforce, they make little or no attempt to verify that the regulations work as expected.  The possibility that regulations are hurting people instead of helping them is never tested.

In attempting to conduct such verification, most non-governmental researchers have found that regulations harm, instead of help. Indeed, some agencies can’t meet the standards that they themselves set. For example, researcher Dale Gieringer commented, “FDA regulation certainly cannot be proved ‘safe and effective,’ thereby flunking its own approval criterion.” His conclusion was further verified in my book, Death by Regulation. In addition, the IRS’s bookkeeping is so poor that it would likely fail its own audit.

Regulation Violates a Subject’s Right to Withdraw

Arguably, the most important feature of the ethical protections afforded human subjects in research studies is their informed consent. The informed consent document affirms that subjects have the right to refuse to participate and can withdraw at any time for any reason. However, regulation does not provide this option, even if it might save the life of the patient.

For example, the average time to take a drug from the laboratory bench to the U.S. marketplace is 10-14 years, primarily due to FDA-mandated testing. Terminally-ill patients have frequently asked to withdraw from the “protection” of this regulation in order that they might take potentially life-saving drugs that have not yet been FDA-approved. Although such “compassionate use” exemptions are often granted, valuable time is lost filling out applications and waiting for the FDA to reach a decision. By the time their request is approved, dying patients may be too far gone to benefit. Sometimes, such requests are simply denied.

For example, 21-year-old Abigail Burroughs was terminally ill from a type of cancer for which a new drug had shown great promise (Erbitux).  Although it was not yet FDA-approved, Abigail’s doctor encouraged her to see if she could get a compassionate use exemption after she failed conventional treatments. Unfortunately, she was not permitted to have the medication when she requested it and died in 2001.  Three years later, the drug was approved and considered a breakthrough for patients with Abigail’s cancer type. Unfortunately, Abigail’s story is not unique.

Regulations Don’t Put the Individual First

IRBs are required to shut down a study, if, in their judgment, the subjects are put at too great a risk relative to the benefit for the individual subject. In the case of a terminally ill patient, who has no other viable options, “opting out” of the regulatory regime may not only be appropriate, but potentially life-saving. Regulatory refusal to allow withdrawal is a violation of the ethical codes applied to human experimentation. Indeed, withholding a viable treatment option might be construed by some legal codes as malpractice or even manslaughter. Doctors, for example, can be sued if they don’t provide appropriate treatments to their patients. Regulators, though, have sovereign immunity.

Regulators Have Unmanaged Conflicts of Interest

Abigail’s family and other concerned citizens sued the FDA to give terminally ill patients the right to try new drugs that had safety, but not effectiveness testing, in humans. The grounds of the suit were constitutional in that the “right to life” should allow patients trying to save their lives access to drugs that might assist them.

In 2006, the US Court of Appeals ruled in favor of the Abigail Alliance, but the FDA asked for a rehearing and the Court reversed itself.  The Supreme Court refused to hear the case, leaving the FDA regulations intact.

The FDA could have argued that terminally ill patients were vulnerable, and that regulators were acting as their LARs in protecting them from unproven therapies. Instead, the thrust of their position was that future patients wouldn’t want to participate in clinical trials where they might get placebo instead of active drug if they could obtain these drugs prior to approval. In other words, the FDA argued that if patients were allowed to “opt-out” of their regulatory “protections,” that the regulations, or at least the way the regulations were implemented, would be compromised. Instead of putting the individual’s interest first, as required by the Declaration of Helsinki, the FDA put its regulations and future patients’ interests first.

The FDA wasn’t acting primarily to protect the rights and lives of today’s patients, which was their supposed charge; they were acting to protect their ideas of how drugs should gain approval.

In trying to maintain its way of doing things, the FDA has an undeclared conflict of interest between any claim as a legally authorized representative, whose charge is to protect vulnerable populations, and its position as a regulatory body intent on continuing its way of doing things.

IRBs or ethical review boards must decide if such a conflict is managed appropriately or shut down the study. In this case, the conflict was apparently not managed, since regulatory preference was used to deny terminally ill patients access to drugs that might have saved their lives.

Coercive Compensation Killed Millions in the Third World Nations

By 1946, the insec­ticide DDT (dicholordiphenyl tricholororethane) had been recognized as one of the most important disease-preventing agents known to humans. Used exten­sively in the tropics, DDT eradicated the insects that carried malaria, yellow fever, sleeping sickness, typhus, and encephalitis.

In Sri Lanka (then Ceylon), with 2.8 million malaria sufferers and over 7,000 malaria deaths per year, 15 years of DDT spraying reduced these numbers to 17 cases a year and no malaria deaths at all! Fatalities in India dropped from 750,000 per year to 1,500, thanks to DDT. The Nobel Prize was awarded to DDT’s discover in 1948.

Human side effects from DDT were rare, even though thousands had their skin and clothing dusted with DDT powder or lived in dwellings that were sprayed repeatedly. DDT replaced the more dangerous and less effective pesticides, some of which contained the poison, arsenic.

Fears that the bird population was being harmed, that DDT remained too long in the environment, and that it might cause cancer led the U.S. Environmental Protection Agency to ban DDT in 1972, even though its own hearings concluded that “The uses of DDT under the regulations involved here do not have a deleterious effect on freshwater fish, estuarine organisms, wild birds, or other wild­life.”

Third World nations had to stop using DDT if they wanted to continue receiving foreign aid. An IRB would have considered such a demand to be an example of “coercive compensation,” which is an offer to pay subjects so much that it tempts them to disregard threats to their own safety should they enroll in or remain in a study.

In this case, heads of state were loath to give up the large infusions of money associated with foreign aid. They elected to accept the aid and the restrictions on DDT.

As a result, malaria cases once again skyrocketed in the poor countries of the tropics. Within six years, 800 million cases were being reported each year and over 8 million died in the affected countries.

Frustrated by expensive and ineffec­tive alternatives, developing nations finally started spraying homes with DDT once again. Even this limited use resulted in dramatic drops in malaria deaths. DDT used in this manner was just a fraction of its former agricultural use, but saved millions of lives.

Conclusion

Legislation and regulations are often acknowledged as “experiments.” Such experiments often, if not always, violate several of the international standards for human experimentation.

Therefore, voluntarists and libertarians could make a case that regulations are a form of unethical human experimentation in order to encourage mainstream ethicists and the American public to consider a broader perspective in their evaluation of regulations.

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