Every morning Rep. Patrick J. Kennedy (D-R.I.) does what an estimated 15 million Americans do: He lifts an aerosol can to his mouth and takes a few puffs of medicine.
To the 30-year-old Kennedy, a lifelong asthmatic, the inhalers he carries with him each day have become "my lifeline." Thanks to these sprays, Kennedy says he has been able to reduce his dependence on asthma pills, some of which have serious side effects. The result for Kennedy -- and other asthmatics in similar situations -- has been a changed life and an unswerving devotion to their inhalers.
But last year the federal government declared those inhalers -- called MDIs, or metered-dose inhalers -- must be reformulated. Under a 1987 international treaty, the chlorofluorocarbons (CFCs) that propel the sprays have been banned from every commercial use in the United States -- refrigerators, air conditioners, everything except the MDIs, which for now have been declared essential. Scientists believe CFCs are responsible for the destruction of the ozone.
The Food and Drug Administration has proposed regulations that would effectively ban further use of the CFC-propelled sprays once alternative inhalers become widely available. But Kennedy and thousands of other asthmatics don't trust the FDA to find a new drug that is as good as what they now take. Kennedy is slated to testify before a congressional panel today against the FDA proposal.
"It's trust me, trust me, trust me and, then if things don't work out, we've got a problem," says Kennedy in a mocking tone.
The asthmatics' fears, some environmental and health lobbyists say, have been heightened by a cynical lobbying campaign by drug company lobbyists concerned about their company's share of a respiratory drug market estimated at nearly $3 billion a year in sales.
At least one company, British-based Glaxo Wellcome PLC, has launched an expensive, frenetic, sometimes secretive lobbying war on Capitol Hill that critics say has played to those fears and prompted congressional proposals to block the FDA from moving against the inhalers. Glaxo has hired some big-name help, including Vice President Gore's former press secretary, Marla E. Romash, to help push the issue.
"It's gotten way out of hand and a lot of it is driven by the industry, most of it by Glaxo," says Corinna Gilfillan, a lobbyist for Friends of the Earth, an environmental group.
Glaxo produces the best-selling U.S. inhalers under the names Serevent and Ventolin, but it is facing unexpected problems producing new, non-CFC inhalers. Other drugmakers also have raised objections to the FDA plan, but 3M Pharmaceuticals, maker of the only approved non-CFC inhaler, and a number of environmental and health groups are applauding the FDA's policy.
As Glaxo's critics tell it, Glaxo and its operatives stirred widespread fear among asthmatics and their physicians last summer by funding a misleading campaign that accused the FDA of racing to ban inhalers.
They charge that the company has used generous campaign contributions, mostly to Republicans, to win support on Capitol Hill. Kennedy has not received Glaxo money.
Glaxo officials deny the charges of buying legislative support and say the company fully supports the FDA's goal of removing CFCs from its inhalers. But they acknowledge that Glaxo is resisting the agency's MDI plan, calling it "too aggressive."
Spokesmen at the company's U.S. headquarters in North Carolina also concede that Glaxo was the principal financial supporter of a short-lived, New Jersey-based committee that last year got thousands of asthmatics to protest the planned phaseout of CFC inhalers.
"The Emergency Committee to Save MDIs" mailed letters to asthmatics suggesting that the government was on the verge of banning their inhalers. The FDA received 9,600 letters protesting the plan.
The MDI committee was run by Gail Safian, a New Jersey public relations executive who has spent much of her career in the drug industry. "We roiled the waters. That was really my objective," she told the Associated Press last summer. The news agency was the first to report the committee's ties to Glaxo. Safian did not return telephone requests for an interview.
Glaxo spokeswoman Ramona Jones rejected allegations that the MDI committee attempted to instill panic among asthma patients. "The efforts of the committee were very limited," Jones said.
But the defunct committee has been only one of the drug company's efforts to influence opinion on the MDIs. Through gifts to a Northern Virginia group, Glaxo has helped underwrite the costs of "Allergy Awareness Day," a Capitol Hill event scheduled for today and sponsored by 83 House members and 14 senators, many with asthmatics in their families. The event will be followed by a hearing on the FDA plan by the health and environment subcommittee of the House Commerce Committee.
The drug company also has given an "unrestricted grant" to the Fairfax-based Allergy and Asthma Network/Mothers of Asthmatics, a group that is sponsoring the Capitol Hill event and has opposed the FDA phaseout plan.
Nancy Sander, an asthmatic who heads the group, has made no secret of the Glaxo funding, disclosing it in her group's publications and in a filing with the FDA.
Sander, who has emerged as one of the leading spokeswomen for patient groups, says she would not have taken the money if the company had attempted to dictate the group's position. "Those people do not tell me what to say or when to say it," she said.
The FDA's Stance
The FDA, Sander says, has itself largely to blame for the outpouring of anger from asthmatics over its "advance notice of proposed rulemaking" (ANPR). The notice, published in the Federal Register, was "very difficult to understand," she said.
"It's clear that the message of what we put out in the ANPR didn't communicate very well to patients and doctors," says John Jenkins, head of the FDA's pulmonary drug products division. He says the FDA's intentions were "misinterpreted and misrepresented. . . . I don't know if it was intentional."
FDA officials have said their critics fail to note the agency's repeated commitment not to ban CFC inhalers until several substitutes are on the market and accepted by asthma patients. They have promised repeatedly that the FDA's top priority will be the health of asthma patients.
"At a fundamental level, these drugs are very important to these people's lives," Jenkins says.
Since inhalers were introduced 40 years ago, MDIs have become the preferred way of treating the nation's growing number of asthmatics. "It's the safest and most effective way of treating asthma," says Albert L. Sheffer, a clinical professor at the Harvard University Medical School.
After the United States signed a treaty in Montreal in 1987 calling for an end to CFC production and use, many pharmaceutical researchers expected they could easily change the inhalers: just add another gas to propel the medicine out.
Struggle for a Substitute
Glaxo researcher Tushar Shah says it hasn't worked that way. The new gases have interacted with the medicines, forcing drug companies to reconsider every element of the MDI, from the gas to the liners of the small cans to their O-rings.
"Yes, we are having difficulties," says Shah, who heads the company's respiratory research efforts.
Thus far, the FDA has approved only one non-CFC-based inhaler, created by 3M Pharmaceuticals, a unit of Minnesota Mining and Manufacturing Co. It introduced Provential HFA, which uses HFA-134a as a propellant, in August 1996 and has had the non-CFC market to itself. The inhaler is marketed by Schering-Plough, and company officials say they expect to introduce other sprays soon.
"It is doable," says Douglas Patton, business manager for 3M's drug delivery systems. He says some companies, which he wouldn't name, chose not to try to reformulate their products to a non-CFC format, perhaps hoping that the government would continue to regard inhalers an "essential use" for CFCs.
When questioned about their own company's activities, Glaxo spokeswomen noted that 3M helped the EPA last year mail out a notice on the availability of Provential to health maintenance organizations. EPA officials said the agency regularly notifies the public of environmentally friendly products but that its inspector general suggested that it may have gone too far when it allowed 3M to supply a mailing list of HMOs.
Lawmakers say it's not the company's political giving that has stirred them to action, but the concerns of asthmatics. Sen. Tim Hutchinson (R-Ark.), whose 87-year-old mother uses an inhaler, says he, like Kennedy, does not accept the FDA's assurances.
"I'm very skeptical. I'm skeptical of regulatory agencies in general," says Hutchinson, a sponsor of legislation to prevent the FDA from banning the CFC inhalers. He says he was unaware that Glaxo's political action committee had given $2,000 to his last campaign.
To Kennedy and his allies, the amount of CFCs that inhalers emit into the atmosphere is so tiny -- about 1.5 percent of all CFCs, according to EPA witnesses at a recent Senate hearing -- that environmentalists have overstated the issue of what do to with the inhalers.
"It's such a minuscule amount that it's really crazy to be thinking about the need for exemptions for CFCs," Kennedy says.
Environmentalists argue that the rise in skin cancers due to the depletion of the ozone is proof that continued CFC use -- at any level -- poses a public health threat as serious as what asthmatics face.
The FDA's foes came close last year to attaching a provision to a bill that would have halted the agency's replacement scheme. "Dad's going to make sure it's part of the conference committee report," Kennedy told CQ Monitor in October. Dad, Sen. Edward M. Kennedy (D-Mass.), failed to attach the measure, a spokesman for Rep. Kennedy noted.
What the drug industry, environmentalists and government officials now seem to have agreed on is that there will be new inhalers reaching the market, perhaps as many as 11 to 24 in the next 5 to 10 years. If these perform as well as the current inhalers, most say, asthmatics will have better drugs than they now have.
As Fran DuMelle, director of the Lung Association's D.C. office, puts it: "The first couple of companies to the marketplace will own it."
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