Monday, August 23, 2010

Perils part 3, The Tyranny of Safety

The Tyranny of Safety

The precautionary principle rides atop the wild horse that is our fundamental drive to avoid harm. I readily grant that caution is a perfectly sensible practice to adopt as we go about our lives. We get into trouble only when we elevate caution and cautionary measures to the status of an absolute principle—when we endow it with a crude veto power over all other values and over the use of maximum intelligence and creativity. Caution, like suspicion or anger or confidence, enjoys a legitimate place in our toolbox of responses. But it cannot serve by itself us as a comprehensive, judicious, rational basis for making decisions about technological and environmental concerns.

There’s a simple but telling way to appreciate the threat to progress and human well-being posed by the precautionary principle: Take a look back at the scientific and technological achievements of the past, then ask: “Would these advances have been sanctioned or prohibited by the precautionary principle?” Consider a small sample of historical achievements that have improved human life:

The airplane: Planes crash, don’t they? Serious or irreversible harm results without doubt.

Antibiotics and sulfa drugs: Disallowed due to risk of side-effects.

Aspirin: Along with aspirin’s wide range of beneficial effects come some significant adverse side-effects. Today’s level of regulation—which falls well short of the precautionary principle—might deny approval to aspirin.

CAT scans: Disallowed from the start by precaution due to risk from X-rays.

Chlorine: A tremendous public health boon when used for disinfecting water, producing pharmaceuticals, and making pesticides. It’s also a poison gas.

The contraceptive pill: One of the most powerful forces for social change would have been banned due to its association with an elevated risk of some cancers.

DDT (dichlorodiphenyltrichloroethane): This oft-maligned substance, discovered in 1939 by Paul Hermann Mueller (and for which he won the Nobel Prize in medicine), saved the lives of millions threatened by malaria. Throughout the Mediterranean region, DDT transformed malaria from ugly reality to fading bad dream. In 1970, The National Academy of Sciences declared: “To only a few chemicals does man owe as great a debt as to DDT.”

Digitalis: When William Withering extracted digitalis from the foxglove plant (Digitalis purpurea) in 1780, he delivered the first effective drug in medicine. The precautionary principle might have locked down such a highly toxic substance, never allowing its highly beneficial effects on the heart to see the light of day.

Drugs: Do any medical drugs have a proven absence of side effects?

Electrification: Providing electricity to people across the land requires power plants and transmission lines and creates pollution. Each step of the way clearly violates the precautionary principle.

Energy: Production and use of fire, electricity, microwaves, and all forms of energy contravene the precautionary principle. The causal link between accidents with, or misdirected, energy and resulting harm is clear. To prevent the possibility of harm, the principle would prohibit all forms of energy production capable of powering any useful work. Back to living in caves, without fire!

The Green Revolution: This has enormously boosted food production and averted famine throughout much of Asia and elsewhere. The Green Revolution would have been strangled in its crib by the precautionary principle. Genetically modified crops are running up against the principle, yet GM crops are created through a far more precise process. The crops of the Green Revolution were arrived at by randomly mutating seeds and selecting plants with enhanced characteristics. No guarantee could have been given against any possibility of serious harm to humans or ecosystems.

Knives: Enabled humans to eat, build shelter, and develop tools and cultural artifacts. Can also be used for destructive purposes. Say no more.

Nuclear research: The dangers of radiation, illustrated by Marie Curie’s death, would lead the precautionary principle to block the development of NMR imaging, nuclear power, and nuclear physics.

Open-heart surgery: This life-saving surgery might have been blocked early on, since it obviously carried a risk of causing death and opening a path for infections.

Organ transplants: Early recipients often died—a little sooner than they would have otherwise.

Penicillin: Dr. Gail Cardew of the Royal Institution in London has noted that this “wonder drug”, tested early on a human, turned out to be toxic to guinea pigs. A more precautionary approach at the time probably would not have allowed penicillin to be tried on humans.

The periodic table: Systematizes knowledge that can—and has—been used to make explosives for offensive purposes.

Physics research: Study of the principles of motion culminating in work by Newton might have been prohibited. That knowledge created the basis for ballistics.

Radar: If the precautionary ethos, rather than wartime necessity, had prevailed, we would never had enjoyed the benefits of radar. The microwaves emitted by high-powered radar can harm or kill a person standing in front of the antenna.

Railways: When travel by rail first became a real option, some critics warned that people would die when they exceeded 30 mph. Some early travelers attributed their real or imagined sickness to their railroad trip.

Vaccines for rabies, measles, polio, smallpox: Consider that, for instance, Salk’s polio vaccine was a live culture. The probability of protection brought with it a 5% risk of contracting the disease. All vaccines carry a small risk of harmful infection. If Jenner was experimenting with inoculation today, he would be attacked for transferring tissue across species boundaries, and his work shut down as contravening the precautionary principle.

X-rays: Before safe doses had been determined, early researchers into X-ray medicine died.

Just about every human activity could “raise threats of serious or irreversible harm to human health or the environment.” Had the precautionary principle been imposed throughout history, we would still be living poor, nasty, brutish lives—if humans still existed.

The precautionary principle, if applied to real innovation throughout our past, would have stifled progress. As many of the historical examples indicate, this means not only losing the benefits of creativity, but also suffering the natural harms that would continue and multiply unchecked. We need not look to the past to see harm being done. Patients who could benefit from xenotransplantation continue to suffer because of overblown fears about the possible transmission of porcine retroviruses. Neurological disease continues to run its devastating course while drugs that might help are blocked by people fearing a pharmacological “underclass”. Long term storage of nuclear waste continues to be blocked by groups feeding fears of remote, theoretical risks, while they ignore the current, real problems they keep alive.

Recently, a study was published that found an increased incidence of multiple sclerosis (MS) among people who had received hepatitis B shots in the 3 years prior to disease onset. If advocates of the precautionary principle jump on this result, they could cause much needless suffering and death. The kind of fear that drives the principle will ignore the fact that this result comes from a single, unverified study. It will also ignore the crucial information that MS affects about 2.5 million people, but hepatitis B affects 350 million people.

Whether it’s in the name of the principle, or the simple visceral reaction that has the same effect, scared people turning down the hepatitis B vaccine would be a health disaster. Exactly this kind of unmeasured, fearful response to vaccines has already popped up many times, a recent example being parents who refuse to have their children vaccinated with a new combination vaccine.

Consider the case of the rotavirus vaccine. Rotavirus is the most common cause of severe diarrhea among children. According to the Centers for Disease Control, it results in the hospitalization of 55,000 children annually in the United States, and the death of 600,000 children annually worldwide. That’s the death of one child every minute. These children are pushed over a rocky path on the way to death, enduring vomiting and watery diarrhea along with fever and abdominal pain.

Although the disease was discovered three decades ago, no rotavirus vaccine for this devastating disease was available until 1998. In 1999, after just nine months on the market, Wyeth Laboratories voluntarily pulled their vaccine, RotaShield, because it was associated with a slightly increased risk of intussusception (bowel obstruction). In wealthy countries, this can typically be treated, but in places where it isn’t, the result can be a very severe disease or, occasionally, death.

No rotavirus vaccine was available anywhere for five years, even in the developing world, where one in every two hundred and fifty children dies from the disease. The precautionary agency in this case was the Advisory Committee on Immunization Practices (ACIP). This is a horrifying example of caution that kills. Several years after the withdrawal, it remains unclear whether the Rotashield vaccine really causes additional bowel disorders. Even if it does, the risk is small. According to a report by NIH scientists in the Journal of Infectious Diseases, that vaccine might have led to 1 excess case per 32,000 vaccinated infants. More than ten times that number (around 1 in 3,000 infants during their first year) develop intussusception anyway. This report found an overall decrease in intussusception among infants under a year old during the period of exposure to the rotavirus vaccine. The bottom line in the developing world: the precautionary blocking of a vaccine has killed millions of children.

Another upshot of this episode is noteworthy. For half a century, new pharmaceutical products have been introduced first in the United States and Europe, only later reaching the developing world. This is changing. In planning ahead for the launch of its vaccine, Rotarix, GlaxoSmithKline (GSK) held its half-dozen trials in developing world countries including Mexico, Brazil, South Africa, and Malaysia. GSK plans to make Rotarix available in Mexico right away. When it comes to a rotavirus vaccine, it is now the United States that is the third world country. After Wyeth’s experience (albeit with a differently-derived vaccine), GSK has no plans to request approval from the US food and Drug Administration.

The point here is not that precautionary restrictions are never justified. It is not that unfettered innovation is always best. It is not that environmental concerns are to be dismissed. It is that an excessive focus on preventing one perceived problem can create even worse problems. Nor is this a counsel of despair. Better decision processes are available.

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