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.

Nuremberg Trials

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.

A 1962 law slowed drug development. Changing it could slash drug prices

This article was originally published by STAT on October 1, 2018.

After signing the Drug Amendments Act of 1962, President Kennedy presented a pen to those observing the event, including Dr. Frances O. Kelsey.

 

During my 19 years as a research scientist at the Upjohn Company, the regulatory burden imposed by the open-ended Drug Amendments Act of 1962 was mushrooming. My coworkers and I joked that because of this dramatic change to the mission of the FDA, made largely as a response to the European thalidomide crisis, we spent so much time meeting the FDA’s development demands that we had little time to discover new drugs.

Like most gallows humor, such comments masked the very real concern that instead of finding drugs that would save lives, we were checking regulatory boxes. We never dared to hint at these concerns in public for fear that the FDA might retaliate by dragging its feet to delay our company’s drug approvals.

The amendments gave the FDA the authority to require proof of effectiveness — not just safety — before approving a new drug. It could dictate which manufacturing standards needed to be met before animal testing, which animal tests needed to be done before clinical trials, and which human studies were needed for approval. The amendments also gave the FDA jurisdiction over advertising and labeling.

Before 1962, a drug company submitted its data on a new drug to the FDA and could market the drug after six months if the agency didn’t object. The amendments required a “sign off” by an individual regulator, putting that person’s neck in the proverbial noose. Whether the amendments have improved the drug-development process and protected the public’s health continues to be questioned.

In a series of studies stretching from 1979 to the present, Joseph A. DiMasi, Henry G. Grabowski, and Ronald W. Hansen confirmed what my co-workers and I already knew: the cost of taking a new drug, often referred to as a new molecular entity, from the lab bench to the market has soared in the last several decades, primarily due to increasing regulatory demands, as shown in the graph below. These costs must be passed on to consumers as higher prices at the pharmacy if drug companies are to remain solvent.

Did the additional work required by the FDA give us more safety? The evidence is hardly compelling. Using data from several published sources (references available upon request), I calculated that the rate at which FDA-approved drugs were withdrawn from the market because of unacceptable side effects averaged 2.5 percent from 1947 to 1961 and 3.3 percent from 1962 to 2011. Indeed, properly prescribed drugs may now be the fifth largest cause of death in the United States.

Are drugs more effective now than they were before 1962? Researchers have estimated that the 1962 amendments might have saved consumers at most 10 percent on their pharmacy bills by keeping ineffective drugs off the market, while increasing drug costs in the neighborhood of sevenfold to eightfold. In other words, ineffective drugs didn’t survive in the pre-amendment marketplace even without the regulatory requirement that effectiveness be documented by placebo-controlled studies.

In a 1975 analysis, University of Chicago economist Lester G. Telser showed that drug prices adjusted for inflation decreased 32 percent from 1949 to 1961. Yet in the decades after the 1962 amendments, drug prices increased as development costs rose in response to the ever-growing regulatory demands.

Between 1948 and 1961, pharmaceutical companies took an average of about four years to take a new drug to market. By the 1980s, the development time had increased to 14 years and still averages 10 to 15 years.

Some people can’t wait that long for new treatments. In the late 1980s and early 1990s, AIDS patients hired chemists to make the same drugs the pharmaceutical industry was working on. By the time the FDA gave companies permission to start clinical trials, many AIDS patients in the United States who wanted these drugs had already gotten them via the black market and developed resistance to them, similar to what we see now with antibiotics.

Desperate patients are still taking matters into their own hands rather than die waiting as new drugs creep through the lengthy development process. Today, patients with amyotrophic lateral sclerosis are making in their kitchens drugs that look promising, and do-it-yourself kits are being developed for home manufacture of drugs for asthma, hepatitis C, and other diseases.

Innovation is lost as funds are shifted from the discovery of new drugs to the development of those in the pipeline. About half of new drugs that are abandoned in mid- to late-stage development are lost for economic reasons because the companies feel they won’t be profitable enough to justify taking the drug to market — sometimes even for drugs that hold clinical promise. Manufacturers are rapidly abandoning essential research in antibiotics, for example, as they realize their short treatment window makes cost recovery, let alone profits, unlikely.

Many more new drugs are abandoned even before clinical studies begin. The FDA once contacted me to support the development of prostaglandins for liver disease after seeing my patent filing for that indication. For truly novel approaches, like prostaglandins for liver disease, the unknowns are great enough that a mistake in dose, duration of treatment, treatment schedule, number of patients, and the like can mean that effectiveness studies might not have the statistical significance the FDA demands. If these studies, which last for years, have to be repeated, the patent may expire and cost recovery becomes virtually impossible. Even with the enthusiastic support of the FDA, Upjohn management decided it was too risky to even attempt development of prostaglandins for liver disease.

The drug development system that emerged from the 1962 amendments, which were intended to increase drug safety and effectiveness, have given us minimal benefit at great cost, not just in money but in lives. Using estimates of how many lives are saved by the drugs on the market today, I calculate in my latest book, “Death by Regulation,” at least a five-year loss in life expectancy, primarily due to longer development times after 1962 and loss of about 50 percent of our innovations, assuming that they save only 25 percent as many lives as today’s drugs do. Excess regulation has side effects that are just as deadly as bad drugs. All of us — regulators, politicians, drug company employees, patients, and doctors — are affected.

Reversing the 1962 amendments could slash new drug costs virtually overnight, stimulate innovation, and add years to our lives. The amendments demand that drugs be safe and effective, but apparently don’t meet these same standards themselves. Perhaps deadly regulations should be withdrawn, just as unsafe drugs are.

Mary J. Ruwart, Ph.D., is a former research scientist with The Upjohn Company and currently chairs a for-profit institutional review board. She consults for nutraceutical firms, biotech startups, and occasionally testifies as an expert witness. She is also the author of “Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It” (SunStar Press, 2018).

How Liberty Saves the Environment (Part 3: Restitution Is the Pollution Solution)

The last two blog posts explained how libertarians would eliminate sovereign immunity so that victims of the country’s greatest polluter—government—would have recourse. Secondly, libertarians would privatize land and beast to save endangered species, preserve our parks, and protect our forests. In addition, libertarians would couple these powerful reforms with restitution, to prevent pollution before it starts.

Restitution focuses on restoring the victim to the fullest extent possible. Restitution is “punishment” that fits the crime and is the most effective deterrent known.

For example, if I dumped garbage on your lawn, you would expect me to clean it up. Obviously, the expense and hassle of cleaning up your lawn far outweighs any benefit I’d get for dumping garbage on your lawn in the first place. Having to restore what I “polluted” would deter me from doing it.

Environmental restoration is costly and difficult. Restitution therefore becomes an incredibly onerous punishment and the most effective deterrent known. Let’s examine a real-life example of how restitution, coupled with privatization, can protect our waterways.

In Britain, individuals have property rights in the rivers that run through their land. If someone upstream pollutes the water and harms the fish, the downstream owners don’t have to wait for a bureaucratic commission to study the issue. Instead, they immediately sue the polluters to protect their valuable property and claim restitution for damages. As a result, would-be polluters are effectively deterred from damaging the environment.

Waterways that don’t have a private protector fare much worse. When I lived in northern Kentucky, a citizen’s action group contacted me because they were concerned about businesses dumping toxic chemicals into the neighboring Ohio River. Because the government claims stewardship of this waterway, individuals have no ownership rights on which to base a suit. They must wait until bureaucrats decide to take action. If the businesses contribute to the campaign chests of powerful politicians, nothing may ever happen.

Even when the government does decide to move against a corporate polluter, restitution is seldom required. Instead, the business usually pays a fine. Sometimes the fine is small enough that the business finds it cheaper to pollute and pay. Private owners would seldom be willing to let their property polluted for a small sum, because the decrease in property value would be a devastating financial blow.

Our air can be protected from pollution with restitution, private ownership and environmental restoration. For example, in a libertarian society, the roadways would be privately owned. If neighbors complained of pollution, the road company might offer monetary compensation. Most likely, however, the neighbors would want the pollution to stop. Since 80% of emissions’ pollution is caused by 20% of the cars, the road company might deny access or charge much higher user fees to polluting vehicles. Given these alternatives, most of the owners would probably buy a newer car or get their emission system upgraded. Such measures would reduce pollution until the neighbors were no longer bothered by it.

Similarly, if a product polluted the air, victims could sue the product maker, who in turn would pass the costs of restitution onto the consumer. Higher prices would discourage use and decrease pollution.

Instead of using environmental restoration or restitution to alter the usage of potentially damaging products, government today simply bans them. For example, the insecticide DDT eradicated insects that carried malaria, yellow fever, sleeping sickness, typhus, and encephalitis, especially in Third World countries. Pressured by the ban placed on this chemical by the U.S. government, Sri Lanka (then Ceylon) abandoned spraying DDT in 1964. Malaria rose from less than two dozen cases per year to over 2 million. The victims had no recourse because governments have sovereign immunity.

Without sovereign immunity, victims of bans or harmful laws could sue for restitution. The threat of such suit would encourage lawmakers to consider the adverse effects of their actions. Today, because of sovereign immunity, our politicians literally get away with murder.

In today’s society, polluters might simply declare bankruptcy and walk away. However, in a libertarian society, a victim could not be forced by government to give up their claims for damages. Polluters who couldn’t pay immediately would most likely have to make monthly payments until their debt and the interest on that debt was paid in full.

No system is perfect, of course.  Restitution can’t bring back victims who are killed by pollution, for example. However, because of its deterrent effects, it protects the environment better than bureaucrats who aren’t held accountable for their actions.

How Liberty Saves the Environment (Part 2: Privatizing Land and Beast)

Governments, both federal and local, own over 40% of the U.S. land mass. Unfortunately, government’s stewardship over our land is gradually destroying it.

For example, the Bureau of Land Management controls an area almost twice the size of Texas, including nearly all of Alaska and Nevada. Much of this land is rented to ranchers for grazing cattle. Because ranchers are only renting the land, they have no incentive to take care of it. Not surprisingly, studies as early as 1925 indicated that cattle were twice as likely to die on public ranges and had half as many calves as animals grazing on private lands.

Obviously, owners make better environmental guardians than renters. If the government sold its acreage to private ranchers, the new owners would make sure that they grazed the land sustainably to maximize profit and yield.

Indeed, ownership of wildlife can literally save endangered species from extinction. Between 1979 and 1989, Kenya banned elephant hunting, yet the numbers of these noble beasts dropped from 65,000 to 19,000. In Zimbabwe, however, locals had property rights in the elephants in their area; parts could be legally “owned” and sold. Between 1979 and 1989, the number of elephants there increased from 30,000 to 43,000. By 2006, Zimbabwe had 84,000 elephants and their numbers are still increasing. Once they could make a profit from the elephants, the locals became fiercely protective of their “property.” Poachers didn’t have a chance!

Similarly, commercialization of the buffalo saved it from extinction. We never worry about cattle becoming extinct, because their status as valuable “property” encourages their propagation. The second step libertarians would take to protect the environment and save endangered species would be to encourage private ownership of both land and beast.

Environmentalists were once wary of private ownership, but now recognize that establishing the property rights of native people has become an effective strategy to save the rainforests. Do you remember the movie, Medicine Man, in which the scientist played by Sean Connery discovers a miracle drug in the rainforest ecology? Unfortunately, this life-saving compound is literally bulldozed under when the government turns the rainforest over to corporate interests. The natives that Connery lives with are driven from their forest home. Their homesteading rights are simply ignored by their own government!

Our own Native Americans were driven from their rightful lands as well. Similarly, our national forests are turned over to logging companies, just as the rainforests are. By 1985, the U.S. Forest Service had built 350,000 miles of logging roads with our tax dollars, outstripping our interstate highway system by a factor of 8! In the meantime, hiking trails declined by 30%. Clearly, our government serves special interest groups instead of protecting our environmental heritage.

Even our national parks are not immune from abuse. Yellowstone’s Park Service once encouraged employees to trap predators (e.g., wolves, fox, etc.) so that the hoofed mammals favored by visitors would flourish. Not surprisingly, the ecological balance was upset. The larger elk drove out the deer and sheep, trampled the riverbanks, and destroyed beaver habitat. Without the beavers, the water fowl, mink, otter, and trout were threatened. Without the trout or the shrubs and berries that once lined the riverbanks, grizzlies began to endanger park visitors in their search for food. As a result, park officials had to remove the bears and have started bringing back the wolves.

Wouldn’t we be better served if naturalist organizations, such as the Audubon Society or Nature Conservancy, took over the management of our precious parks? The Audubon Society’s Rainey Wildlife Sanctuary, partially supports itself with natural gas wells operated in an ecologically- sound manner. In addition to preserving the sensitive habitat, the Society shows how technology and ecology can co-exist peacefully and profitably.

Our environment is too precious to be a political football. We can best protect it and the environment by privatizing land, taking it away from the Bureau of Land Management and giving private rangers a financial incentive to take care of their property. Bureaucrats’, on the other hand, can only profit by turning it over to special interests who exploit it.

How Liberty Saves the Environment (Part 1: Ending Sovereign Immunity)

Who’s the greatest polluter of all? The oil companies? The chemical companies? The nuclear power plants?

If you guessed “none of the above” you’d be correct. Our government, at the federal, state, and local levels, is the single greatest polluter in the land. In addition, our government doesn’t even clean up its own garbage!

In 1988, for example, the EPA demanded that the Departments of Energy and Defense clean up 17 of their weapons plants which were leaking radioactive and toxic chemicals-enough contamination to cost $100 billion dollars in clean-up costs over 50 years! The EPA was simply ignored. No bureaucrats went to jail or were sued for damages. Government departments have sovereign immunity.

The U.S. military has become the greatest toxic threat to all of us. Thousands of sites at home and abroad are now highly contaminated by the heavy metals used in bombs and bullets, jet fuel, toxic chemicals, and radioactive waste. Groundwater at military bases and surrounding metropolitan areas (e.g., Minneapolis, Cincinnati, Denver, and Sacramento) are so contaminated that perchlorate, a toxin used to make the military’s solid rocket fuel, is now found in high concentrations in over 90% of the country’s lettuce and human breast milk.

The U.S.military is the largest single owner/renter/leaser of land in the world. The contamination on military bases has caused popular resistance to U.S. troops. The aquifer in Germany supplying Frankfurt’s water has been contaminated by 300,000 gallons of toxic jetfuel leakage. Poisoning the wells of our allies won’t win us many friends. In 2001, the people on the Puerto Rican island of Vieques voted to evict the U.S. military. The Navy left behind thousands of barrels and compressed gas cylinders, which were sunk close to the island’s coral reefs. The toxins are now leaking into the North Atlantic and have been found in the marine life there.

In 1984, a Utah court ruled that the U.S. military was negligent in its nuclear testing, causing serious health problems (e.g. death) for the people exposed to radioactive fallout. The Court of Appeals dismissed the claims of the victims, because government employees have sovereign immunity. By 1997, more than 250,000 Americans had been exposed to dangerous levels of nuclear fallout, and up to 75,000 may face an early death from thyroid cancer as a result.

Hooker Chemical begged the Niagara Falls School Board not to excavate the land where Hooker had safely stored toxic chemical waste. Hooker had sold the land to the School Board for $1 when it threatened to condemn the property. The school board ignored Hooker’s warnings. Consequently, taxpayers had to foot a $30 million relocation bill when health problems arose. The EPA filed suit, not against the reckless school board, but against Hooker Chemical! Government officials have sovereign immunity.

Government, both federal and local, is the greatest single polluter in the U.S. This polluter literally gets away with murder because of sovereign immunity. Libertarians would make government as responsible for its actions as everyone else is expected to be. Part of the libertarians plan to protect the environment is to abolish sovereign immunity.

What’s Next After “Right to Try”?

 

The Right to Try bill, which gives terminally ill patients quicker access to new medicines, passed Congress earlier this year.  The Goldwater Institute initially promoted the passage of this bill state-by-state. Over 40 states passed Right to Try before it before it was signed into federal law by President Trump, who championed the bill himself.

Right to Try got its start after cancer patients sued the FDA for the right to try drugs that were not yet FDA approved.  Te court initially ruled in their favor until the FDA asked them to reconsider.  In 2007, the federal court reversed its initial ruling and told cancer patients that they had no constitutional right to save their lives with drugs that had not been FDA-approved.  Right to Try was fashioned after  the requests made by the cancer patients, which would have allowed the terminally ill to negotiate directly with the manufacturer once a drug had gone through Phase 1 safety testing, but before its effectiveness had been demonstrated.

In many cases, patients will continue to be disappointed. Most pharmaceutical companies aren’t able to ramp up manufacturing until after FDA approval, so the supply of drug might not be enough to give or even sell to patients while continuing the FDA-mandated testing. Without such testing, the drug might never become available to all of the patients who need it; in addition, drugs have to continue in their development in order to qualify for Right to Try.

No one still employed or involved in the industry is likely to admit publicly their concern that the FDA will punish them if they negotiate directly with patients and go around the agency.  The FDA has a history of  dragging its feet at crucial decision points in the regulatory process, saddling companies it dislikes with additional studies, or refusing an approval altogether.

Right to Try has brought national attention to the 10-14 years that it now takes for a drug to go from the lab bench to the pharmacy.  From the late 1940s to 1962, it took about 4 years, but the Amendments to the Food & Drug Act incentivized the FDA to increase the number and complexity of studies. Even so, safety hasn’t increased: the pre-Amendment withdrawal rate was about 2.5%; post-Amendment withdrawals have held steady at 3.3% and properly prescribed prescriptions are now the fifth leading cause of death in the United States. Meanwhile, about 15 million people—10 times as many who have died in all wars since our countries founding—have died waiting for drugs that might have saved them.

Perhaps this is why a new initiative from the Heartland Institute called “Free to Choose Medicine” is in the works. Unlike Right to Try drugs, those entering the Free to Choose Medicine tract don’t need to continue in the FDA approval program. Consequently, drug companies won’t have fewer disincentives o entering the program.

Free to Choose Medicine does require a more comprehensive data sharing program, which could concern drug companies (learn more at FreetoChooseMedicine.com). However, the ability to leave the FDA regulatory requirements after the requisite first Phase 2 study might be enough to offset this concern.  Having a two track development system, FDA approval vs. Free to Choose Medicine, will tell us if the current lengthy regulatory requirements can be safely scraped. Given that these requirements haven’t improved safety discernibly, it’s highly likely.

What about effectiveness?  After all, most of the late phase studies are highly focused on efficacy.  Once again, the data suggests that the extra regulatory studies put into place after 1962 have saved the consumer—at most—about 10% from ineffective drugs.  On the other hand, post-Amendment studies probably increased development costs—and drug prices—20-40 fold.  Being able to remove even part of these costs would not only lower the prices we pay at the pharmacy, but would stimulate innovation.  Innovation is vital, since none of us can buy cures that have not yet been discovered. Taking medicine, even medicine as expensive as it is today, is almost always less costly than surgery or hospitalization.

Free to Choose Medicine may give us better drugs, faster, and at lower cost. Because of its data sharing, we will learn how these benefits compare to the regulatory system we have today.  Shouldn’t the FDA’s requirements be tested to be sure that they are as safe and effective as the new drugs they regulate?

Rising Development Costs Are Causing Drug Companies to Abandon Antibiotic Research

This week, Novartis announced that it would be ending its research program designed to discover new antibiotics. The announcement was greeted with great concern, as “superbugs” resistant to our current arsenal of antibiotics, are a growing threat.

In the early 1900s, infection was the primary cause of death. After improvements in sanitation, nutrition, and the introduction of antibiotics, fatalities plummeted. Cardiovascular disease, cancer, and stroke became the top three killers and remain so today. Without new antibiotics in the pipeline, “superbugs” may become difficult to stop and infection may become as deadly as it once was.

What is driving companies to abandon research in these much needed drugs? The answer is simple: as the FDA demands more involved regulatory studies, pharmaceuticals meant to treat disease for a short period of time can’t recover their out-of-pocket development costs, as shown in the Figure below. If a company can’t recover its development costs, and continues to lose money by developing a certain class of drugs, it will go out of business.  Antibiotics are especially vulnerable because new ones are used sparingly and usually only in desperate cases in order to prevent further resistance in the “superbugs.”

The data points shown in the Figure above come from several studies by Tufts University. They indicate that increased complexity of clinical trials designed to show effectiveness, as well as the number of patients needed to complete them, are at fault. If these increased costs gave us safer and more effective drugs, we might be willing to pay these extra costs, but studies show no improvements in either of these measures. For example, about 3.3% of FDA-approved drugs are withdrawn after serious side effects are seen; this rate of withdrawal has been constant since the 1970s. The best way to stimulate research in antibiotics and other life-saving drugs is to lower the development costs by getting rid of the excess regulation that drives up development cost without compensating benefits.

Figure and statistics taken from my new book, Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It.

Mr. President, You Can Slash Drug Prices Virtually Overnight Without Destroying Life-Saving Innovation

On July 9, President Trump lashed out at Pfizer for increasing prices of 41 drugs and lowering prices for 5. According to a Trump tweet, “Pfizer and others should be ashamed that they have raised drugs prices for no reason. They are merely taking advantage of the poor… We will respond!”

Just a day later, Pfizer agreed to defer these prices hikes that went into effect last week after meeting with Trump, who had talked to Pfizer chief executive Ian Read and Alex Azar, Secretary of Health and Human Services, after a discussion of how to deal with rising drug prices.

Ian Read could have told the president that there is a very good reason for ever-increasing prices. He could have told Trump that the soaring regulatory demands of the FDA makes these price hikes inevitable, but probably didn’t dare. Drug companies are well aware that the FDA can “punish” those who speak out against the agency by dragging their feet on upcoming approvals or any steps along the way. Consequently, you’ll rarely hear a complaint about the FDA from drug company executives. The FDA has kept life-saving drugs off the U.S. market to teach companies that criticize it a devastating lesson.

Lowering drug prices by fiat will destroy pharmaceutical innovation by decreasing the amount of money available for research and development. No matter how much money someone has, they can’t buy a cure that hasn’t been invented. People who might have been saved by that cure will die without knowing that their premature death was totally avoidable. However, there is a way to slash drug prices, virtually overnight, by removing the waste from the regulatory red tape.

As you can see from the following figure, prescription drug prices rise as the cost of regulatory-driven research and development do. According to studies done by Tufts University, the increasing costs are due to the FDA’s demands for more elaborate clinical studies. Without these studies, the agency will not approve new drugs for marketing in the United States.
We might be willing to pay the higher costs of regulation and the soaring pharmaceutical prices that they engender if drugs were safer and more effective. By any measure that we use, however, this doesn’t appear to be the case.

 

The rate at which newly approved drugs are withdrawn from the market when side effects occur hasn’t changed much in the last several decades, but is steady at about 3.3%. Indeed, the biggest drug disaster in U.S. history was FDA-approved Vioxx. By the agency’s own estimates, Vioxx was responsible for at least 140,000 heart attacks and 60,000 deaths. Properly prescribed drugs are now the 5th leading cause of death in the United States.

In many ways, the finding that all of these extra studies don’t improve drug safety is not surprising. Most “bad” drugs get to market because our science isn’t good enough to detect side effects that affect a subset of the population.

Effectiveness hasn’t gotten better either. Most drugs only work in some, but not all, patients. If we aren’t improving safety and effectiveness with regulations that increase every year, we could slash pharmaceutical prices virtually overnight by getting rid of this waste. The data suggests that drug prices would be about 5-10% of what they are now if we rolled back regulations that don’t give us more safety and effectiveness. Innovation would soar!

Don’t expect drug companies to tell President Trump how to slash drug prices, while stimulating innovation, though. They can’t afford to anger the FDA. Maybe someone should educate our president and Alex Azar before they destroy life-saving pharmaceutical innovation in a vain attempt to control drug prices.

Figure and statistics taken from my new book, Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It.

Dr. Norman Horn Reviews “Death by Regulation”

Longtime Libertarian writer and activist Dr Mary Ruwart has a must-read book: Death by Regulation: How We Were Robbed of a Golden Age of Health and How We Can Reclaim It.

This book draws on her years as a medical researcher for Upjohn Pharmaceuticals, her knowledge of libertarian philosophy, and her passion for liberty to explain how the 1962 Amendments to the Food and Drug Act, which gave the FDA the power to keep a drug off the market if it didn’t meet the FDA’s idea of effectiveness and safety. It not only stripped individuals of the ability to make their own health care decisions, but enriched big pharmaceutical companies. The FDA has literally killed people.

For example, the FDA prevented Americans from learning of how aspirin can help those with heart problems for a couple decades. This knowledge could have saved about 1.7 million lives. The FDA continues to delay and deny Americans from reviving life-saving cures and knowledge about how minor adjustments to their diets can help avoid certain illnesses.

Campaign for Liberty Chairman Ron Paul, who wrote the foreword for the book says, “While I was serving in Congress, Dr. Ruwart was working at Upjohn, a drug company known for its ground-breaking research. Step-by-step, she shows how the Amendments, even today, are re-shaping the FDA, the drug industry, and the field of medical practice, while shifting us away from a prevention paradigm to a treatment-based one.” You’ll want to read this book carefully: your life may depend on it.

It’s time we were all learned the truth!

Corruption, Power and Dirty Politics

Power corrupts. When we give someone authority over us, it will likely become abuse. For example, when we gave the government power of eminent domain to construct roads, it began using it to condemn private homes so that corporate developers could build malls. When we gave the government the power of civil forfeiture (taking property and money without trial) from known criminals, it began to take cash from innocent people.

When we gave the government the power to regulate industries, presumably for consumer protection, it drove the mom-and-pop shops out of business and became a way for Big Business to destroy its smaller competitors Thankfully, the libertarian Institute for Justice is fighting against these abuses pro bono. Ultimately, however, only lessening the authority of government can stop the abuse.

Remember: less authority to abuse means less abuse of authority.

We usually think that making a law makes it so, but just the opposite is usually true. When we try to legislate virtue, we end up harming the very people we intended to help. That’s why prohibition, whether of drugs or alcohol, does more harm than good. That’s why outlawing prostitution or gambling only drives it underground. That’s why regulations intended to protect the consumer usually harm them instead. Using government to force peaceful people to act as we think that they should backfires. Bad means result in bad ends, not good ones.

Most people feel politics is dirty, even if they can’t tell you why. The “why” is that government is allowed to do things that the rest of us would be thrown in jail for. Politicians and regulators often enjoy sovereign immunity for actions that would land us in prison for decades. Government officials have become a privileged class, just like the monarchs of old. Isn’t it time that they have to obey the same laws that we do?

We defer to these authority figures because they are supposed to know more than we do. If a mistake is made, it’s easy to lay the blame at their feet. Ultimately, however, we are responsible for choosing the authority figure we defer to.

Power, as in political power, is used to bend others to our will. No one who seeks to take away the liberty of others can legitimately claim to love their neighbors. Liberty, on the other hand, is consistent both with self-love and love of others, since we must be willing to grant liberty to others to have it for ourselves.