GLAXO BEHIND CITIZEN LOBBY EFFORT

By Jim Drinkard

AP 22 Aug. 1997

Washington -- Americans with asthma became unwitting lobbyists for the drug industry earlier this year after they were stirred up by a group quietly backed by pharmaceutical company Glaxo Wellcome with a big stake in the $700 million inhaler business.

The Food and Drug Administration has been inundated with 9,000 letters complaining about a plan to phase out metered-dose inhalers, or MDIs, that use a propellant harmful to the Earth's protective ozone layer.

Most of the letters are handwritten and make poignant personal pitches that a corporate lobbyist could not.

"I want the environment to be a safe place for my children, but I also want to live long enough to help them grow up," wrote Mary Thurston of Greenfield, Ind., one of 15 million Americans with asthma.

Thurston and many of the other writers were spurred into action by a mailing last year from a group called the Committee to Protect MDIs -- a pitch that doctors, patient advocates and federal regulators say was exaggerated and premature.

The group was financed by Glaxo Wellcome, one of the drug companies that commands a large part of the $761 million-a-year inhaler market and is lagging behind a competitor in the race to produce new, ozone-friendly inhalers. Glaxo Wellcome has its U.S. headquarters in Research Triangle Park.

The current generation of inhalers uses chlorofluorocarbon propellants, which erode ozone and increase bombardment of Earth by harmful ultraviolet rays. CFCs already have been banned in products such as hair spray and air conditioners under a 1987 treaty.

The FDA is in the early stages of formulating a plan to replace the ozone-damaging inhaler propellants, a process officials say will take several years. The agency is assuring patients that it won't ban any product until ozone-friendly replacements are available.

The Committee to Protect MDIs, however, left many patients fearing that the government was about to ban inhalers altogether. The group is listed only as a post office box in a suburb of Newark, N.J. Its telephone is answered by a machine, and mainstream patient advocacy groups know little about it.

"They don't have a good grasp of the issues," said Nancy Sander, president of the Allergy and Asthma Network/Mothers of Asthmatics, a 5,000-member patient group. "They are trying to tell people the FDA is going to ban their inhalers. They are being too frightening about it. ... To me, it's a scam."

The group's mailings and newsletters were mentioned in many of the letters FDA received. The group also had an Internet site and a public relations consultant named Gail Safian, who traveled to Washington seeking allies.

Safian said she couldn't remember how she became involved, and declined to answer questions about the group's membership and finances.

The committee has been shut down, she said. "We roiled the waters. That was really my objective," she said.

Glaxo said it underwrote the committee's efforts as part of a broader lobbying campaign aimed at making sure a full range of drugs remains available to people with breathing problems.

"We just want to make sure it doesn't hurt the patients and, as a business, we don't want it to hurt us either," Glaxo spokeswoman Ramona Jones said.

Glaxo's Serevent and Ventolin inhalers command 44 percent of the market for aerosol drugs that dilate the airways leading to the lungs. Any quick transition from the old inhalers also could hurt makers of generic products, such as Florida-based Ivax.

Their primary competitor is 3M Corp., the Minnesota company that has developed an alternative inhaler propellant. The company licensed its new technology to drug maker Schering-Plough, which has the only CFC-free inhaler on the market, called Proventil HFA.

Both sides have aggressively pursued their business interests.

Representatives from 3M have lobbied patient advocacy organizations with elaborate presentations to promote the new ozone-friendly inhalers.

Glaxo, 3M and Schering-Plough also have contributed heavily to physician and patient groups for educational programs and research.