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Prior to the meeting, an
ACAAI eNews poll revealed the following opinions among
our membership:
• By a vote of 96-14, ACAAI members think that
epinephrine MDI should not be given an exemption to
remain OTC even though it contains CFCs, and
• By a vote of 83-17, ACAAI members believe that if
epinephrine MDI were removed from the market,
albuterol HFA MDI should not go to OTC status.
Comments generally pointed out the danger of treating
asthma without physician monitoring, the dangers of
overuse of bronchodilators without appropriate
controller drug therapy, and a concern that this would
lead to increased exacerbations, increased emergency
room use and potentially, an increase in the number of
deaths from asthma. Those who said the drug should be
kept on the market argued that it was the only OTC
bronchodilator available, and it was unreasonable to
insist that every asthmatic see a physician to obtain
medications.
Wyeth Consumer Healthcare testimony
According to Dr. Roger Berlin, president, Global
Scientific Affairs, Wyeth Consumer Healthcare,
Primatene Mist MDI was the first
epinephrine-containing inhaler drug approved for
marketing in the United States, in 1956. Since then,
183 million canisters have been sold, which he
estimates equate to approximately 25 billion dosing
episodes. Currently, approximately 4-5 million
canisters are sold per year, used by an estimated 2-3
million people per year.
Dr. Berlin attempted to use the literature to answer
the FDA’s question: “From literature sources, what is
the value of use of the product to the users, and why
do they use it?” However, there are few studies on
epinephrine MDI, and those that exist are based on
very small patient numbers. The most recent study,
“Response to nonprescription epinephrine inhaler
during nocturnal asthma,” by Hendeles et al, published
in the Annals of Allergy Asthma and Immunology, was
based on only eight patients. The paucity of data is
remarkable for a drug that is in its 50th year of use.
At the end of his presentation, Dr. Berlin asked that
the committees vote for a continued exemption for use
of CFC in Primatene Mist MDI and to give the company
time to develop an HFA alternative MDI. The company
proposed a timeline of approximately seven years.
Backgroud on CFCs
It is commonly known that CFC use depletes the ozone
layer in the upper atmosphere, which has a known
deleterious effect on human health and the
environment. By 1974, work by Molina and Rowland was
published in Nature that tied ozone depletion to
degraded CFCs, stable compounds that were generally
inert and lasted for decades in the stratosphere. In
1978, CFCs were banned in spray cans and aerosols by
the U.S. government, except for use in certain defined
situations, including in medicinal products for human
use. In 1987, the Montreal Protocol was signed to
bring international awareness to the issue and
ultimately lead to global eradication of
ozone-depleting substances. This protocol, which now
has more than 180 signatory countries, is regarded as
a model for successful global environmental treaties.
Globally, we continue to try to get CFCs out of our
world, and ongoing use must be justified. Dr. Berlin
stated that, in 2005, U.S. medical consumption of CFCs
was 1,800 tons. Inhaled epinephrine was approximately
4 percent of that total, or about 72 tons of CFC.
Worldwide, he reported that epinephrine MDI accounted
for only 0.04 percent of 180,000 tons used. Details of
the Wyeth presentation and other documents can be
found at the
FDA Web site.
AANMA testimony
During the open public hearing, Sandra J.
Fusco-Walker, from Allergy & Asthma Network, Mothers
of Asthmatics, said, “Asthma is a potentially
life-threatening disease that requires medical
diagnosis and strategic management. Self-treatment of
asthma may lead to inadequate or delayed therapy that
can lead to complications or deaths that could be
prevented.
“Today, this committee is not just reviewing whether
an OTC inhaler with CFCs should continue to be
available, but more importantly, you are reviewing the
way our society deals with critical health issues that
affect all Americans, including the poor. Our job here
is to help patients’ transition, not to create a
population of patients for whom the medical guidelines
don’t apply. What you are deciding here today is if
asthma, which kills almost 5,000 people a year and
affects over 20 million Americans, should be treated
over-the-counter.”
Dr. Bryan L. Martin
ACAAI Board of Regents member |
