TCS Daily

California's Congressional Pests

By Henry I. Miller - September 9, 2005 12:00 AM

Often I find merit in the quip that we are, indeed, a two-party system -- the Stupid One (Republican) and the Evil One (Democratic). Recently, however, the overwhelmingly Democratic California congressional delegation seems to be poaching on the Republicans' turf.

The issue is a somewhat arcane one: the use of human volunteers to test certain pesticides before they are introduced to the marketplace. Government regulators and public health experts around the globe, along with myriad scientific bodies, support the qualified use of human clinical studies in the approval process for pesticides. However, several scientifically challenged members of California's congressional delegation have intervened to prohibit the Environmental Protection Agency from considering these tests in its evaluation process -- even if the results have already been obtained.

Senator Barbara Boxer (D-CA) and Representatives Henry Waxman (D-CA) and Hilda Solis (D-CA) crafted an amendment to the EPA's appropriations bill that seeks a one-year moratorium on EPA's use of data from human studies. During Senate consideration of the bill, Senator Conrad Burns (R-MT), who represents common-sense farmers and ranchers, sponsored a conflicting amendment that would have mandated EPA to review all human studies under consideration to be certain they had been conducted safely and ethically.

During the conference committee on the appropriations bill, a compromise was reached that would prohibit EPA from proceeding with human studies until the agency produces a final regulation on this issue. As the Agency began circulating its draft rule through bureaucratic channels, enter the intra-EPA guerilla group known as PEER -- Professional Employees for Environmental Responsibility -- which leaked the proposal to the media. PEER claimed the draft rule was ignoring congressional intent and should be trashed.

That provided an entrée for Senator Boxer to complain in a letter to EPA Administrator Steve Johnson that his Agency is advancing "an arrogant Congressional direction." Boxer and her colleagues try to frame this issue as an affront to ordinary, vulnerable people, alleging that pregnant women and children could be exploited by profit-minded industry. This is a grotesque mischaracterization: Only healthy, non-pregnant adult volunteers would ever be considered for testing.

The legislators chose to ignore the findings of the nation's most prestigious scientific body, the National Academy of Sciences, which after an exhaustive study of this issue said in a February 2004 report that it is in the public interest to maintain the availability of products that both ensure an abundant, affordable high-quality food supply and protect public health by controlling disease-carrying pests, such as mosquitoes, ticks and cockroaches. The Academy also observed that human studies are only done when there is a scientific question that cannot be answered by existing data.

Democratic politicians seem to make a habit of being on the wrong side of pesticide issues. Under Senate rules, any senator can put a "hold" on a presidential nominee who requires confirmation, with 60 votes required to overturn it, making it similar to a filibuster. Several months ago, Senators Boxer (D-CA) and Bill Nelson (D-FL) placed holds on the nomination of acting EPA Administrator Steve Johnson for the permanent position, demanding that he cancel a study of the effects of pesticides on infants and babies if he wanted to be confirmed. A day later, Johnson complied. A spokesman for the EPA admitted that Johnson had canceled the study because of the holds on his confirmation.

Some Democratic critics have misrepresented that study as requiring the deliberate spraying of infants with pesticides, with their parents receiving money and other remuneration from the government. But that is another lie.

The truth is that the study would have analyzed the results of exposure to routine household applications of pesticides, with the subjects' parents receiving modest compensation for permitting examinations and measurements. The worthy goal of the study was to ascertain whether routine applications can result in toxic levels of pesticides under normal domestic usage. It would both have benefited the subjects and provided important information to government and industry scientists.

The effect of the senators' ethically dubious actions -- and Johnson's cowardly capitulation to them -- was to derail a useful public health surveillance project.

Moreover, to illustrate the absurdity of this situation, suppose that there were senators on both sides of this issue making conflicting demands on Johnson in order to gain confirmation -- some demanding cessation of the study, others asking for expansion. How do we make a decision on a critical public health issue -- flip a coin?

Provided safeguards are in place and sound scientific principles are used, human testing is ethical and appropriate, and may, indeed, be life-saving. But the Boxers and Waxmans -- ignoring directives established by Congress and EPA and international scientific protocols such as the Common Rule, Declaration of Helsinki and Good Clinical Practice -- think they know better. Or perhaps they're just indulging in demagoguery, one of the few things at which they seem proficient.

The machinations of the California congressional pests (including honorary member Senator Nelson) are an affront to victims of West Nile virus, Lyme disease, or roach-allergy asthma, and also to anyone who is prone to infected insect bites. Their misery might have been prevented, had demagoguing politicians not prevented the testing of new, more effective and innovative products.

Henry I. Miller, a physician and fellow at the Hoover Institution, headed the FDA's Office of Biotechnology from 1989-1993. His latest book, "The Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution," was picked by Barron's as one of the Best 25 Books of 2004.


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