TCS Daily

Public Policy Follies

By Henry I. Miller - March 10, 2004 12:00 AM

Federal officials have been shooting themselves in the foot on public health issues -- but it is ordinary Americans who hemorrhage. Secretary of Health and Human Services Tommy Thompson and officials at the department's Food and Drug Administration and Centers for Disease Control have made one bad decision after another. Not ideologically motivated decisions (such as the administration's opposition to stem cell research), necessarily, just unwise ones.

These actions -- by the people who determine much of the Nation's public health agenda -- have discouraged research and development; squandered scarce resources; and deprived citizens of important consumer products, while placing them at risk.

Cases in point:

In January 2004 the FDA unexpectedly rejected an application by Inamed Corporation to return silicone breast implants to widespread cosmetic use. This decision, which ignored a recommendation for approval from an external advisory committee, leaves in place severe restrictions imposed more than a decade ago because of safety concerns -- concerns that although unfounded, virtually destroyed an industry and needlessly terrified tens of thousands of American women. The result is to deprive women, after consultation with their physicians, from assuming the risk of an important medical intervention.

The FDA continues to throw rigid, one-size-fits-all solutions at non-problems. An example is the agency's recent decision to deny any drug company the ability to obtain multiple trademarks for the same drug -- for example, Sarafem®/Prozac®® and Propecia®/Proscar® -- even if they are different formulations for different ailments. Attorney Marc J. Scheineson, former FDA Associate Commissioner for Legislative Affairs, argues that the agency's policy towards multiple trademarks is possibly illegal under several theories, including the absence of required formal notice-and-comment rule-making, interference with constitutionally protected commercial speech, impermissible "taking" of corporate "property," and arbitrary and capricious action.

The FDA has made a colossal mess of the regulation of biotech foods. At the same time that U.S. Trade Representative Robert Zoellick and other senior officials in the Bush Administration were working for more science-based and logical treatment of biotech foods (that is, those produced from gene-spliced, or GM, organisms) internationally, they were outflanked and undermined by European and American -- yes, American -- bureaucrats at the deliberations of the Codex Alimentarius Commission, the food standards program of the United Nations. Codex's task force on gene-spliced foods last year completed work on preposterously unscientific regulations that will hugely inflate the costs of using the most precise and predictable techniques for genetic improvement of plants used for food, and also provide cover for those who wish to regulate agricultural biotechnology into oblivion.

During three years of negotiations by the task force, the Europeans and NGOs (which were permitted full participation) led the assault on technological innovation and free trade. The participants -- including the U.S. delegation, headed by senior FDA food regulator Robert Lake, who apparently sees excessive, unscientific international regulation as a possible (desirable) stimulus to excessive, unscientific domestic regulation -- willfully ignored scientific principles and the basic axiom that the degree of regulatory scrutiny should be proportionate to risk. They chose to disregard the scientific consensus that gene-splicing is an extension, or refinement, of older, traditional techniques of genetic modification, and that it does not warrant discriminatory over-regulation. And they chose to overlook the fact that during a decade of widespread use, the performance of gene-spliced crops has been spectacular, with farmers enjoying increased yields, decreased costs of agricultural chemicals, and lower occupational exposures to pesticides. The environmental benefits likewise have been stunning, with less chemical runoff into waterways and greater availability of no-till farming techniques that reduce soil erosion.

FDA Commissioner Mark McClellan was apprized repeatedly of the collusion between his own minions and the anti-science, anti-biotech Europeans and NGOs, but he chose not to rein in his errant subordinates.

Whatever the shortcomings of Dr. McClellan's FDA, it must be said that it was an improvement over the dismal regimes of his two predecessors, and during the lengthy period 2001-2002 when the agency was without a leader. On February 20th, President Bush announced that Dr. McClellan would be departing to be the administrator ofthe federal Medicare and Medicaid programs, a development that bodes ill for FDA-regulated industry -- and public health.

At the time of the anthrax attacks of 2001, when more than 30,000 possibly exposed persons were treated prophylactically with the antibiotic Cipro®, Secretary Thompson demanded deep discounts from its manufacturer, Bayer, threatening that otherwise the government would overturn their patent. (That would have permitted lower-cost, generic versions to enter the marketplace.)

What kind of message does that send to university researchers who perform applied research, or to drug developers -- such as those seeking a vaccine against HIV, or a cure for Alzheimer's disease -- at a time when bringing a drug to market requires, on average, 12-15 years and costs more than $800 million?

Simple. That a highly valuable product can become the victim of its own success, with the government, in effect, imposing price controls that can make an important discovery worth less, if not worthless.

Ironically, there was no need for such heavy-handedness. There was never a shortage of Cipro®, which in any case was over-used. (It is a more expensive alternative to other, equally effective antibiotics, such as doxycycline, penicillin and amoxacillin, which are in plentiful supply.)

Officials at the U.S. Centers for Disease Control seem likewise not to understand how the government's actions convey important messages to the business community. The CDC -- the largest domestic purchaser of vaccines - uses its buying clout to compel deep discounts for purchases. For example, the CDC rejected Wyeth Lederle Vaccines' proposed price of $58 per dose for its pneumococcus vaccine, demanding (and getting) a discount of $10 per dose. So don't expect Wyeth Lederle to invest much in vaccine R&D any time soon.

The administration's smallpox vaccination program was plagued with problems. The currently available vaccine, made from vaccinia virus (a close relative of smallpox virus), is not very different from the earliest version, introduced in 1796. Impure and crude by modern standards, the smallpox vaccine can provoke life-threatening side effects, including spread from the inoculation site to the face, eyelid, mouth and genitalia, and generalized infection. Approximately one in every 300,000 vaccinations causes encephalitis, which can lead to permanent neurological damage; and between one and three in every million recipients die. A study published last year of 2.4 million patients discharged from New York hospitals two years earlier found that 1.3 million had conditions that could make them susceptible to vaccinia infection from contact with persons who had been vaccinated. Particularly at risk are newborns; patients with cancer, skin conditions, immune system disorders; and those taking immune-suppressing medications.

There has not been a case of smallpox anywhere in the world for a quarter century, and the only two known, legitimate repositories of the virus are at the CDC and in Russia. There is no evidence at all that terrorists have ever gained access to smallpox virus. Moreover, there is known to be significant residual immunity from the smallpox vaccination that all Americans over the age of 30 received as infants.

Inexplicably, federal officials embarked on an aggressive vaccination program. Federal health officials began by vaccinating hundreds of thousands of servicemen and women and then set out to vaccinate 500,000 hospital workers. Later, as many as 10 million police, fire and medical personnel would be offered the vaccine. Finally, it would be made available to the population at large.

In pilot trials of stockpiled smallpox vaccine carried out in five states, physicians were shocked by the severity of the side effects of the smallpox vaccine. Of 200 healthy young adults who received the vaccine, more than a quarter missed at least two days of work or school, 75 had high fevers, and several were put on antibiotics because physicians worried that bacteria had infected the injection site. As military personnel and health workers began to be vaccinated, previously unknown cardiac complications were observed, and more than 100 pregnant women, who should have been excluded, were accidentally vaccinated.

As a result, few health professionals and first responders agreed to be vaccinated, but the grandiose vaccination program inflicted such stress on state and local public health agencies that they were forced to neglect not only highly prevalent, life-threatening diseases such as diabetes, influenza and tuberculosis, but also other bioterrorism threats like anthrax. The anthrax-laced letters sent in 2001 show that weaponized anthrax is available to terrorists, and that a tiny amount of the bacteria can spread panic out of all proportion to the actual risk of disease. (A footnote to DHHS's handling of the anthrax terrorism: When the first case of inhalational anthrax was discovered, Secretary Thompson dismissed it as likely having been contracted during a fishing trip.)

West Nile virus epidemics have become a fixture of America's public health landscape. In 2003, there were more than 8000 serious illnesses and over 200 deaths, but the federal government's response was lethargic and politically correct. Consider the guidance posted on the Web site for the Centers for Disease Control: "avoid mosquito bites," by wearing clothes that expose little skin, using insect repellent, and staying indoors during peak mosquito hours (dusk to dawn); "mosquito-proof your home," by removing standing water, and installing and maintaining screens; and "help your community," by reporting dead birds and checking to see whether there are local mosquito-control programs.

There was no mention of insecticides, widespread spraying, or any kind of coordinated effort to address this threat to public health; anyone curious about the role of pesticides is directed to a maze of other web-sites.

In the absence of a vaccine, elimination of the vehicle that spreads the disease -- in this case, the mosquito -- is the key to preventing epidemics. The most potent tool available is the pesticide DDT, but fundamental shortcomings in public policy have prevented its use. In 1972, on the basis of data on toxicity to fish and migrating birds (but not to humans), the Environmental Protection Agency banned virtually all uses of DDT, an inexpensive and effective pesticide once widely deployed to kill disease-carrying insects. Allowing green politics to trump science, regulators also cited the possibility that DDT posed a cancer risk for humans an assertion based on studies showing an increased incidence of the illness in mice that were fed extremely high doses of the pesticide. (The validity of extrapolating these high-dose animal studies to minuscule exposures in humans was and remains in doubt.)

Not only did government regulators minimize scientific evidence of the effectiveness and relative safety of DDT, they also failed to appreciate the distinction between its large-scale use in agriculture and more limited application for controlling carriers of human disease. Although DDT is a (modestly) toxic substance, there is a big difference between applying large amounts of it in the environment -- as American farmers did before it was banned -- and applying it carefully and sparingly to fight mosquitoes and other disease-carrying insects. A basic principle of toxicology is that the dose makes the poison.

The regulators who banned DDT also failed to take into consideration the inadequacy of alternatives. Because it persists after spraying, DDT works far better than many pesticides now in use, some of which are toxic to fish and other aquatic organisms. Also, the need to spray other insecticides repeatedly -- especially in marshlands and forests, where mosquito-breeding areas are large -- drives up costs and depletes public coffers.

Author, filmmaker and physician Michael Crichton minces no words about the banning of DDT: "I can tell you that the people who banned it knew that it wasn't carcinogenic and banned it anyway. I can tell you that the DDT ban has caused the deaths of tens of millions of poor people, mostly children, whose deaths are directly attributable to a callous, technologically advanced western society that promoted the new cause of environmentalism by pushing a fantasy about a pesticide, and thus irrevocably harmed the third world. Banning DDT is one of the most disgraceful episodes in the twentieth century history of America. We knew better, and we did it anyway, and we let people around the world die and didn't give a damn."

These examples illustrate that there exists a national crisis in public health policy. While smallpox and SARS have occupied the front burners, federal officials have all but ignored America's silent, lethal epidemics of influenza (which kills 36,000 Americans in an average year, but which has been worse than average this winter) and hepatitis C (which is thought to chronically infect upwards of five million). And it is disgraceful that more than five hundred persons outside Pittsburgh, Pennsylvania should have become stricken in a 2003 outbreak of hepatitis A, for which an excellent vaccine is available. The CDC should be aggressively promoting universal vaccination against hepatitis A and B -- and placing development of a hepatitis C vaccine among our highest public health priorities.

The crisis should come as no surprise. For far too long, CDC Director Julie Gerberding defended her smallpox vaccination program like a dog with a bone. And although she discovered belatedly that the United States was in the midst of a major influenza epidemic -- and this winter's vaccine offered only partial protection -- she failed to inform the public about the excellent anti-flu drugs that are available. Persons at high risk -- especially if their family members or co-workers have contracted the flu -- should have been urged to consider taking the drugs.

The U.S. Surgeon General, Richard Carmona, could be a positive force for more intelligent and effective policy - if only he, himself, were more intelligent and effective. Last June, Dr. Carmona testified before the House Energy and Commerce Committee, "No matter what you may hear today or read in press reports later, I cannot conclude that the use of any tobacco product is a safer alternative to smoking." That statement is manifestly untrue. It has been known for almost a decade that switching from smoking to smokeless tobacco is a lifesaver.

All forms of tobacco are not equally risky: Smokeless tobacco causes neither lung cancer nor other pulmonary diseases, nor do its users experience an enhanced risk of heart attacks. Oral cancers are the only important adverse health effect of smokeless tobacco, and they are relatively infrequent -- about four times more frequent in users of smokeless tobacco than in nonusers of tobacco, but only about half as great as in smokers.

Dr. Carmona is also woefully lacking in gravitas and visibility. When I mentioned recently to former Surgeon General C. Everett Koop that I was conducting an informal poll of how many physicians and public health experts could identify the current surgeon general, he quipped, "Have you found one?" (In my survey, only eight of 80 experts in public health and public policy could identify the current surgeon general, and many thought the post had been abolished.)

There are structural problems, too: Since the Clinton era, the pivotal position of Assistant Secretary for Health has been stripped of line authority over key agencies, so there is no scientifically and medically knowledgeable DHHS official who oversees and coordinates the work of agencies like CDC, NIH and FDA.

The making of public health policy can be difficult, to be sure, but many of the Bush administration's serious errors have been avoidable. In order to remedy systematic shortcomings, the administration needs to attack public health problems with the same zeal with which it has taken on the Nation's military enemies. And no small part of that will be the filling of senior positions with people who possess real expertise in science, medicine and public policy -- and who are committed to being effective problem-solvers, not bumbling, bean-counting bureaucrats.

Henry Miller, a physician, is a fellow at the Hoover Institution. He was an official at the NIH and FDA from 1977 to 1994. He last wrote for TCS about California Fruits and Nuts.


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