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Jerome Bettis, an asthmatic, cautions lawmakers on phaseout of CFC inhalers

'Mr. Bus' goes to Washington

Thursday, May 07, 1998

Judy Packer-Tursman, Post-Gazette Washington Bureau

WASHINGTON -- Trading in his No. 36 black-and-gold football jersey for a conservative gray suit, Steelers running back Jerome Bettis urged lawmakers yesterday to ensure that regulators don't rush most asthma inhalers off the market until they approve enough alternatives to meet people's needs.

All but one inhaler now on the market contain a propellant believed to damage the atmosphere.

Bettis, 26, was diagnosed with asthma at age 15 and carries an inhaler at all times. "It's something I can't get away from," he said of his asthma. And yet, he wants to offer children with asthma a message that "it's not the end of the world."

In his first trip to Capitol Hill, he told a House Commerce panel on health and environment that an inhaler represents more to children than a medical device. "You take not only the medicine away, but you take the hope and you take the dream to strive and to be a competitor away from that child," he said.

Bettis sat beside a 9-year-old asthmatic boy from New Jersey who minutes earlier had testified about his need to use three CFC-propelled inhalers to help him breathe.

The Steelers star nicknamed "The Bus" came to Capitol Hill at the request of Rep. Ron Klink, D-Murrysville, to participate in the first annual "Asthma Awareness Day." The event, co-sponsored by more than 100 members of Congress, aimed to educate the public about the seriousness of a disease that strikes an estimated 15 million Americans.

The Food and Drug Administration and the Environmental Protection Agency have proposed banning metered-dose inhalers that contain chlorofluorocarbons, or CFCs. These compounds are thought to harm the Earth's ozone layer, a natural shield in the stratosphere against much of the sun's damaging ultraviolet radiation.

Nationwide, about 30 million Americans have obstructive lung diseases, including 10 million with chronic bronchitis and as many as 5 million with emphysema. They likely use one or more of nearly 30 types of CFC-based inhalers, containing 17 active drug ingredients.

So far, the FDA has approved only one inhaler that uses an alternative to CFCs as its propellant. But a manufacturers' consortium estimates that at least 11 alternatives will be available in the United States by 2000 and 35 options by 2005.

At yesterday's lengthy and at times contentious hearing, Congress again put the Clinton administration on alert that lawmakers are watching regulators' actions carefully.

An FDA official insisted to the House panel that his agency is not rushing to phase out CFC-based inhalers, but expects to publish a proposed rule early next year. He said unfounded rumors have "unnecessarily frightened" doctors and their patients about the proposed regulatory ban.

"Let me emphasize that FDA has no intention of taking actions to put people at risk," said John Jenkins, a pulmonologist who directs the FDA's division of pulmonary drug products. "I am saddened that ... patients and physicians have been needlessly frightened. I want this testimony to reassure people that FDA has no plans to place the health and safety of people with asthma at risk."

Rep. Michael Bilirakis, R-Fla., the subcommittee chairman, replied that he was "somewhat bolstered" by Jenkins' testimony. "I know the FDA would never do anything knowingly," he said, but "what good is trust" if an asthmatic needs a product that is no longer available in the marketplace?

A State Department official testified that the Montreal Protocol, which aims to phase out CFCs by an unspecified date -- but unofficially by 2005 -- is working. "We hope for a complete recovery of the ozone layer by the middle of the next century," he said, assuming full compliance by the 160 signatory nations.

Last year, the EPA obtained an exemption for asthma inhalers as "essential-use" products, this time allowing their use through 1999. Agency spokesman Dave Ryan said yesterday that the agency will continue to seek exemptions until there are safe and effective alternative products "for all who need them."

While environmental groups have praised regulators' efforts, their work is also causing consternation. The Washington Post reported yesterday that British-based Glaxo Wellcome PLC, trying to protect its share of a respiratory drug market estimated at nearly $3 billion in annual sales, mounted a campaign to play on the public's fears and to prompt legislation blocking the FDA from acting against CFC-propelled inhalers.

Klink is pushing a bipartisan bill to limit EPA authority under the federal Clean Air Act to ban CFC-based inhalers. Regulators would have to certify to Congress that the market has safe, effective options of comparable cost and availability before a ban could take effect.

Introduced last fall, Klink's bill has gathered 30 co-sponsors. But it and another bill to halt the FDA rule-making process remain stalled in the Commerce panel, as lawmakers wrangle over whether to act to ensure that the agency writes a policy protecting all patients or instead wait for regulators to finish their rule.

Last month, at a Senate Labor and Human Resources Committee hearing on the matter that featured many of the same witnesses, the panel chairman said he wasn't convinced that legislation is needed. But if FDA cannot answer its critics, Congress will act.

No Senate bill appeared until Friday, when Sens. Mike DeWine, R-Ohio, who is asthmatic, and Tim Hutchinson, R-Ark., introduced legislation. It would require that any type of non-CFC-based inhaler the FDA approves must meet the needs of all patient groups, including children and the elderly.

Yesterday, Rep. Tom Coburn, R-Okla., a physician who serves on the Commerce panel, urged colleagues not to "overemotionalize" the matter. "We can scare a whole lot of people on this issue, and it's irresponsible of us to do it," he said. "... You have to recognize there are multiple ways to deliver drugs."

Rep. Patrick Kennedy, D-R.I., a lifelong asthmatic who co-sponsored Klink's bill, agreed that medications can be delivered in many ways. But he cautioned that their affordability and availability are also important points to consider. At a news conference earlier in the day, Kennedy noted that his asthma medicines cost $112 every month. But he said he is fortunate because his health plan bears much of the expense.

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