Ozone layer vs. inhalers: A tough call

By Marlene Cimons, Times staff writer
Copyright 1998 Los Angeles Times
September 21, 1998

Nancy Sander cares about the environment, particularly the quality of the air she breathes. But when the goal of protecting the ozone layer collides with her family's access to life-saving inhalant medications, she will abandon her environmental ideals in a heartbeat.

Sander--and three of her four children--are caught in the middle of a public policy tug of war that is creating a state of high alarm among many of the 30 million Americans who have asthma, a potentially fatal respiratory ailment.

"When I have an attack, it's like someone is holding a pillow over my head," Sander said. "I reach for my inhaler, all the time saying, 'Thank God, thank God, thank God I have this!' "

But there's a catch: The inhaler propels its life-saving medication into her inflamed lungs with chemicals that destroy the Earth's protective ozone layer, which screens out the ultraviolet rays from the sun that can cause skin cancer.

The U.S. government has signed an international agreement to eliminate these propellants, although it has promised that this will not happen until effective alternatives are developed for life-or-death devices such as inhalers.

International environmentalists and public health experts hope that, by ridding the world of the remaining permissible uses of the propellant used in Sander's inhaler, they can head off a dangerous mixture of diseases, including a predicted jump in the number of potentially deadly skin cancer cases.

But to the nation's asthmatics, the threat posed by depletion of the ozone layer seems abstract and distant compared to their own predicament.

"I consider myself very environmentally aware, but I don't like feeling that the government is putting the environment before my health," said Sander, who heads the Allergy and Asthma Network / Mothers of Asthmatics. "Patients are not very excited about making changes to their medications because of the ozone."

Asthmatics see the greater danger as whether they will still be able to get their medicines--which must be taken for life--delivered as effectively by alternative propellants. For the most part, these alternatives have yet to be developed and tested.

Only one has been approved thus far, HFA-134a, which does not hurt the ozone layer. But experts still are not sure whether it will work for everyone and in all products. Other non-CFC propellants are under development, but it could be several years before they are approved.

Patients and their advocates worry that many years of testing--including studies after the products reach the market--may be required to ensure that alternatives work safely, particularly in children. But officials from the U.S. Environmental Protection Agency and the Food and Drug Administration stress that current CFC-containing products will remain available until there is convincing evidence that the replacements are safe and effective.

"EPA is not taking away asthma inhalers from any asthma sufferer," said Paul Stolpman, the agency's director of atmospheric programs in the office of air and radiation. "We are committed to healthy children and a healthy environment--but to healthy children first."

Chlorofluorocarbons, once viewed as among the most useful and versatile chemical compounds ever developed, were used in thousands of consumer products and industrial processes, from aerosol sprays to sterilizing agents for surgical instruments. They are perhaps best known for their use as coolants in air conditioners and refrigerators.

But scientists eventually determined that the substances were responsible for a frightening reduction in the stratospheric ozone layer, a situation that they believed would lead to increases in skin cancer and blindness, crop failures and disruptions of the marine food chain.

The result was the 1987 Montreal Protocol, signed by more than 130 nations, which set deadlines for stopping production of CFCs and similar chemicals. In the United States, CFCs were banned as of Jan. 1, 1996, except for certain products considered necessary, such as inhalers.

But the reprieve is only temporary--the idea is to phase out these uses of CFCs as soon as alternatives become available. The removal is not imminent--the EPA and the FDA insist that the timetable is flexible--but it is inevitable.

Despite the agencies' reassurances, asthma patients and their doctors are nervous about the transition, prompting Congress to take a look at the issue. The Senate Labor and Human Resources Committee conducted a hearing this past spring and lawmakers are considering whether to initiate legislation to block the planned phaseout by the two agencies.

Patients worry that global pressures to eliminate CFCs may accelerate their removal precipitously, putting patients at risk. They also fear that the cost of developing new propellants will result in their having to pay higher prices for their medicines.

In addition, they oppose plans by the EPA and FDA to group numerous drugs used for the same purpose as a single class and to phase them out at the same time once a certain number of alternatives become available.

Asthmatics rely on numerous types of inhaled drugs. There are two major groups. Preventive medicines such as inhaled cortisones are designed to keep the lungs from becoming inflamed in the first place. Bronchodilators, also known as "rescue medicines," are used to treat acute attacks. Within each group, there are a number of different medications.

Physicians and patients note that differences exist among drugs within the same class--among them, potency and duration of action--and that not all patients respond to them in the same way. Lumping them together could prove risky, the physicians and patients say. The drugs should be tested separately with the new propellants and treated separately, they said.

"Just changing a propellant is not all that easy, since they don't all work well with all drug molecules. Not all propellants are created equal," Sander said.

"Some of these drugs may perform the same function, but different patients respond differently to them," agreed Dr. Daniel Ein, president of the Joint Council on Allergy, Asthma and Immunology. "We think each drug ought to be treated differently.

"Everybody agrees that, ultimately, it is a good thing for the environment to get CFCs off the market and out of inhalers," added Ein, an asthma and allergy specialist in private practice in Washington. "But it's the way they are doing it that concerns us, because we think it ties our hands and potentially puts our patients at risk."

Some opponents of the change have suggested that CFCs in metered-dose inhalers contribute very little to the ozone problem and should be given a permanent exemption for that reason. EPA disagrees.

"Worldwide, they are a significant contributor," said the EPA's Stolpman.

The United States submitted an "essential use" request for about 4,000 metric tons of CFCs in metered-dose inhalers for 1999, an amount that is "larger than uses in all sectors combined for close to 100 of the world's developing countries," Stolpman said.

"If the U.S. were to argue that our remaining uses are small enough to be permitted indefinitely, many countries could make similar arguments about their uses. The aggregate effect on the ozone layer of such a change would be significant."

Moreover, the campaign to exempt inhalers runs counter to America's leadership role in phasing out ozone-depleting chemicals.

"We understand that asthma is a growing problem," Stolpman said. "But continued damage to the ozone layer is not a theoretical matter of concern to environmentalists but has real effects on ordinary people. These are two public health problems, one dealing with skin cancer, one dealing with asthma. The right answer is to solve them both."

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