EPA and FDA put ecology above kids

0 Comments | Insight on the News, Oct 20, 1997 | by John Berlau

Children with asthma have become a lachrymose concern for the Environmental Protection Agency, or EPA, and its supporters in the battle for costly new air-quality standards. The President's Council of Economic Advisers has estimated that the stringent restrictions to reduce particulates and ground-level ozone would cost industry and consumers $60 billion a year, but EPA administrator Carol Browner, assuring that the regulations could reduce asthma attacks, has firmly declared, "When it comes to protecting our kids, I will not be swayed."

At the same time the EPA is invoking asthmatic children to expand its regulatory reach, it also is pushing for a policy that patient-advocacy and medical organizations say will endanger children with asthma and other respiratory problems. In the name of protecting the ozone layer, a scientifically debatable problem at best, the EPA and the Food and Drug Administration, or FDA, have developed a plan to ban most of the metered-dose inhalers that many patients literally couldn't live without, because they contain chlorofluorocarbons, or CFCs. "It's another cynical exploitation of kids for the sake of environmental correctness," says Robert Goldberg, senior research fellow at George Washington University's Center for Neuroscience, Medical Progress, and Society. He points out that inhalers account for less than 1.5 percent of the atmospheric chlorine believed by some to deplete the ozone layer.

Science and health writer Michael Fumento says, "Children are just weapons in the EPA's ideological war," that it's about power and environmental correctness. In his new monograph Polluted Science, published by the American Enterprise Institute, Fumento questions whether the EPA's air-quality standards, which are being challenged in Congress before they can go into effect, would be helpful to asthmatics since U.S. asthma rates have increased while the levels of air pollutants have decreased. He also notes that comparisons of high-polluting countries, such as East Germany and Poland, with nations that have strong pollution-control measures, such as West Germany and Sweden indicate higher rates of asthma in the countries with less pollution.

Ben Lieberman, a policy analyst at the Washington-based Competitive Enterprise Institute, points out that government may be partly responsible for the asthma increase by mandating and subsidizing energy-efficient buildings, which have ventilation systems that create more indoor air pollution by concentrating dust on the inside.

The causes of asthma may be elusive, but there is a medical consensus that the inhalers to be banned are essential in treatment and prevention of asthma attacks. In a letter to the FDA, the American Medical Association, or AMA, explained that inhalers "can relieve symptoms, prevent emergency-room visits, and, in many cases, they can be lifesaving."

Alan Lloyd, a 68-year-old retired mechanical engineer who lives in Kailua, Hawaii, developed asthma when he was six. He says his life improved dramatically after he began using inhalers when they first came on the market some 35 years ago. "I now can hike mountain trails because my asthma is under control," he says. Lloyd, who uses a CFC-powered inhaler twice a day as a treatment, and another one as needed to stop asthma symptoms, tells Insight, "I feel very threatened that a government agency I pay taxes for wants to take my medication away." His story may be typical.

Yet under the Montreal Protocol, a U.N.-sponsored treaty the United States ratified in 1988, it was agreed to phase out the production of CFCs and other substances believed by some to harm the stratospheric ozone layer. But medical devices deemed "essential uses," such as inhalers, were exempted. Last month, however, a U.S. delegation sent by the Clinton administration to a U.N. meeting in Montreal on the protocol successfully pushed through a treaty policy to require signatory countries to develop strategies for phasing out CFC production for inhalers as well.

Drusilla Hufford, the acting director of the EPA's stratospheric protection division, tells Insight, "The problem for the ozone layer is that if the U.S. were to argue that our remaining uses are so small that we ought be allowed to continue using them indefinitely, it's likely that a lot of other countries would make similar arguments about their uses, and the result of that kind of change would be a problem for the ozone layer."

But Sallie Baliunas, an astrophysicist at Harvard University and the George Marshall Institute, says, "The amount of CFCs in inhalers is minute, so banning them won't make any improvement, and not having them will have a detrimental effect on some children." Never mind. In March of this year, four months after approving the first non-CFC inhaler, the FDA, at the prodding of the EPA, issued an advanced notice of proposed rule-making that set criteria for banning inhalers containing CFCs. The proposal would ban all CFC versions of an inhaler with the same active chemicals, or moiety, if one non-CFC substitute has been approved, and would ban an entire therapeutic class of CFC inhalers if three, representing at least two different moieties, were approved.