Malpractice: Fresh from Election, House Republicans Set Vote to Put One Company's Bad Asthma Medicine Back on Shelves

Back for their lame duck session, the House Republican leadership has scheduled a floor vote on the Asthma Inhalers Relief Act of 2012 (H.R. 6190), sponsored by Rep. Michael Burgess (R-TX), a bill designed to put back on the market a 1960’s-vintage over-the-counter product called “Primatene Mist,” which was banned at the end of last year.  

Why was Primatene Mist banned?  Because it contains chemicals that deplete the earth’s ozone layer and a drug that the nation’s top asthma doctors consider ineffective and even dangerous.  

Why do House leaders want to bring it back?  Chalk it up to special-interest lobbying by a drug company and a former Congressman turned lobbyist.

Over the last two years, the House has passed dozens of bills, amendments, and riders to weaken the Clean Air Act and our other environmental laws.  The House majority prefers ideology over science and struggles with basic concepts of physics, medicine, and even arithmetic.  

Now they’re insisting they know better than the nation’s lung doctors how to treat life-threatening asthma attacks. 

H.R. 6190 is a piece of work.  Note that it is the Inhalers, not the Patients, Relief Act.  That’s because the sole purpose of this bill is to put one company’s banned product back on the shelves.  Primatene Mist contains a drug called epinephrine and ozone-destroying chlorofluorocarbons (CFCs).  Both the Food and Drug Association and the Environmental Protection Agency have determined it should come off the market.  Why?  Because epinephrine is no longer considered a safe and effective or essential treatment for asthma, and because CFCs are dangerous to the ozone layer. 

After many years of advance warning, the deadline to stop selling Primatene Mist passed on December 31, 2011.  Primatene’s manufacturer – Amphastar Pharmaceuticals and its Armstrong subsidiary – apparently misjudged the declining market for its product and found itself with stocks of inhalers on its hands after the deadline.  So now, nearly a year after the ban took hold, the company is lobbying Congress to pass a special bill to put those stocks back on the market. 

Meanwhile, other drug companies stepped up to the plate by developing effective asthma inhalers that contain better medicines and no CFCs.  They invested the money for research and testing, got FDA approval, and put their products on the market well before the deadline.  Millions of asthma patients, after seeing their doctors, are relying on them today. 

The nation’s leading lung health doctors oppose this bill because they think it actually would be dangerous for asthma patients to put Primatene Mist back on the shelves.  Here’s what Dr. Monica Kraft, professor of Medicine at Duke University and current president of the American Thoracic Society, said in testimony to an Energy and Commerce subcommittee last summer:

It is my strongly held view and the view of the American Thoracic Society, that returning epinephrine inhalers to the U.S. market, even for a limited time, would be ill advised. 

This view is shared by several other physician organizations including, the American Academy of Allergy Asthma and Immunology, the American College of Asthma Allergy and Immunology, the American Association of Respiratory Care and the National Association for the Medical Direction of Respiratory Care.

The take away message is that in the majority of cases, asthma can be successfully treated by working with health care professionals to find the right combination of safe and effective medications.

Epinephrine is NOT one of the medications that is considered safe for the treatment of asthma.

For years the medical community has recognized the dangerous side effects of epinephrine for the treatment of asthma and has recommended against it use for asthma. In 1999 the American Medical Association 1) urged that warning labels on over the counter epinephrine inhalers be strengthened to warn patients about the dangers of epinephrine use, 2) encouraged FDA to consider removing inhaled epinephrine from the market and 3) requested studies to determine whether the availability of inhaled epinephrine is a risk factor in asthma morbidity and mortality. The American Medical Association again reaffirmed this position in 2009.

The American Thoracic Society strongly encourages any patient who is using over the counter medications--like Primatene Mist CFC--to treat their asthma to see a healthcare provider who can help the patient develop an asthma management plan and recommend more effective and safer medications to manage the asthma. ...

If the intent of the legislation is to restore a safe and effective asthma drug to the market place, then this legislative effort is mis-informed. Inhaled epinephrine is not a safe drug for the treatment of asthma. The adverse side effects of epinephrine are serious and well documented.  No current clinical practice guideline for the diagnosis and treatment of asthma recommends the use of epinephrine. In fact, asthma guidelines specifically recommend against inhaled epinephrine for treating asthma. 

Amphastar/Armstrong professes concern for the poor, saying they need an over-the-counter medicine that doesn’t require a doctor’s prescription.  In fact, there is another over-the-counter alternative containing no CFCs, though the asthma doctors discourage it.  Here’s the response of Chris Ward, past chairman of the Asthma and Allergy Foundation of America, is his testimony:   

Another false assumption is that low income people need these medications because they are low cost. While the price of Primatene Mist may be lower than the total cost of or co-pay for more effective bronchodilators, the relief from these epinephrine devices does not last as long. Thus, the long term cost is actually higher....

[O]ver-the-counter bronchodilators can promote self-diagnoses, which is particularly unsafe for the symptoms of asthma. With proper diagnoses and treatment, people can control their asthma symptoms, avoiding high-cost interventions like emergency department visits and hospitalizations. Cutting out care by qualified medical practitioners could be dangerous for the patient and costly to the healthcare system.

The bill’s sponsor and Primatene’s staunchest promoter, Rep. Michael Burgess, often notes that he is a doctor.  Yes – he’s an obstetrician and gynecologist.  Do you think America’s asthma sufferers should take an OB/GYN’s advice over the nation’s top lung doctors?

The company hopes to get Democratic support too.  For that they hired former Rep. Bart Stupak, who turned lobbyist after serving in Congress from Michigan.  In reaching out to his former colleagues, Mr. Stupak doesn’t talk about the lung doctors’ warnings on epinephrine, about damage to the ozone layer, or about the business mistake his client made in getting stuck with too much stock when the well-advertised deadline finally came due. 

House leaders have put this bill on the “suspension” calendar meant for non-controversial bills to name post offices and the like.  That means it will take a two-thirds majority to pass the House.  Let’s hope there are enough House members of both parties that respect science, medicine, and asthma sufferers to send this nasty little bill down to defeat right now. 

Update Nov.13:  Politico reports: "House Republicans have for now pulled a bill directing the EPA to allow Amphastar Pharmaceuticals to sell leftover stocks of the asthma inhaler Primatene Mist, which was banned at the end of last year because of an international pact on products containing chlorofluorocarbons.  The bill, initially set for a House vote Monday, will be rescheduled after Thanksgiving, a spokesman for House Majority Leader Eric Cantor emailed.  'We have a scheduling issue,' the spokesman said."

Update Dec. 11:  The Primatene Mist bill is baaaack!, scheduled for a House floor vote tonight.  Check back here later to see what happens.

Update Dec. 12:  The Primatine Mist bill failed in the House today.  It fell far short of the 2/3rds majority needed for a bill on the "suspension" calendar, which is usually reserved for non-controversial bills.  The vote was 229-182, with 29 Republicans voting against, and 31 Democrats voting for.

About the Authors

David Doniger

Director, Climate & Clean Air program

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