[Ip-health] NYT: The Higher Cost of Breathing (Amy Nunn)

[Amy Nunn]

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The Higher Cost of Breathing




By ANDREW POLLACK
<http://topics.nytimes.com/top/reference/timestopics/people/p/andrew_pollack
/index.html?inline=nyt-per>

Published: May 12, 2006

An environmental effort to protect the earth's ozone layer could mean
disruptions for the nation's millions of asthma
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics
/asthma/index.html?inline=nyt-classifier>  patients. Dr. Najib Maalouf
checks Matthew Murillo, 11, at the Breathmobile, a free clinic on wheels, at
an elementary school in Los Angeles.

A federally mandated shift to a more ozone-friendly version of the hand-held
inhalers used to quell asthma attacks is creating spot shortages of the
devices, because production of the older versions has declined even before
producers of the new inhalers ramp up fully. The shift is also giving a few
drug makers the rare chance to introduce brand-name medicine into a market
long dominated by low-cost generics.

The drug at issue is albuterol, the leading prescription treatment used to
open constricted airways during an asthma attack. Because the new inhalers
are covered by patents, they are commanding high prices - $30 to $60 each,
including the drug inside, compared with as little as $5 to $25 for the
older generic versions.

By the end of 2008, which is the federal deadline for phasing out albuterol
inhalers that use an ozone-depleting propellant gas, the nation's annual
cost for these inhalers could be $1 billion higher than now. The main
beneficiaries would be Schering-Plough
<http://www.nytimes.com/redirect/marketwatch/redirect.ctx?MW=http://custom.m
arketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=SGP> ,
GlaxoSmithKline
<http://www.nytimes.com/redirect/marketwatch/redirect.ctx?MW=http://custom.m
arketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=GSK>  and other
drug makers whose asthma inhalers are protected by patents that in some
cases extend to 2017.

For people with drug insurance, price increases may be less a concern than
occasional spot shortages of the devices. In early March the Food and
<http://topics.nytimes.com/top/reference/timestopics/organizations/f/food_an
d_drug_administration/index.html?inline=nyt-org>  Drug Administration issued
an alert about temporary shortages, although an agency official said more
recently that supplies appeared to be "certainly adequate or nearly
adequate."

But some patients like Ross Berry have occasionally had to scrounge. "At
Target here you couldn't get it for weeks," said Mr. Berry, 42, a disabled
veteran in Reston, Va., who is covered by health insurance. " Safeway
<http://www.nytimes.com/redirect/marketwatch/redirect.ctx?MW=http://custom.m
arketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=SWY>  didn't have
it. Finally I found a Giant that had it. It got a little bit scary."

For people with no insurance, high prices might be the big concern. Although
asthma can affect people from all economic strata, it is a disease
disproportionately found among low-income people. Federal officials estimate
that the new policy could mean an additional $95 a year for each of the 1.25
million asthma patients without health insurance.

On the playground of an elementary school in a Hispanic neighborhood of Los
Angeles recently, mothers brought their children for checkups at the
Breathmobile, a free clinic on wheels. None of the women were yet aware of
the inhaler transition, but when told that prices of the devices might
double, some immediately recognized it as a potential burden.

"I guess we have to do our best to buy it even if we have to pay cash," said
Jenny Diaz, a nurse's assistant. She said she had been paying about $20 each
for inhalers for her 9-year-old son and her husband because, while she is
covered by the state's Medicaid program, she has a high deductible. She said
her husband, a pizza deliveryman, needed a new inhaler every two to three
months and her son less frequently.

About 6.4 percent of children with family income below the poverty level had
at least one asthma attack a year, compared with 5.4 percent of all
children, according to a federal survey a few years ago. Asthma prevalence
is particularly high among blacks. Experts say this could be because people
with lower incomes might be exposed to dirtier air and to agents like dust
mites and cockroaches that could set off asthma attacks.

The devices at issue let patients dispense a mist of albuterol to open
constricted airways during an attack. A single inhaler generally provides
200 puffs of medicine, and people may use anywhere from 1 to 12 a year,
according to doctors. In most cases consumers buy a new inhaler each time,
rather than buying a drug refill for an existing inhaler.

The products being phased out use chemicals called chlorofluorocarbons, or
CFC's, to propel a mist of medicine. CFC use is being ended in accordance
with the Montreal Protocol, a 1987 global treaty intended to save the
stratosphere's ozone layer, which protects the earth from some of the sun's
cancer
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics
/cancer/index.html?inline=nyt-classifier> -causing ultraviolet rays.

CFC has already been phased out of heavy-use applications like refrigeration
and air-conditioning. Inhalers, which once accounted for less than 1 percent
of CFC use, are now the major remaining application. But with alternatives
available, the F.D.A. decided last year that the CFC inhalers were no longer
essential and outlawed their sale after Dec. 31, 2008.

Schering-Plough and GlaxoSmithKline, which had developed the new type of
inhalers and were keen to sell more of them, urged the F.D.A. to set the
deadline at the end of 2005. But the F.D.A. chose the later date to ensure
that there would be an adequate supply of inhalers using the new propellant,
called hydrofluoroalkane, or HFA, before the older devices were outlawed.

The agency did express concern about the impact on the uninsured, saying
that higher prices might have some adverse effects on public health by
deterring use of albuterol. But the agency said it could not quantify that
effect.

There was little resistance to the change when the F.D.A. held a public
advisory committee meeting on the issue in 2004. GlaxoSmithKline and
Schering-Plough said then that their patient-assistance programs for
low-income people would help provide the drug to those who could not afford
it. Glaxo also promised to provide two million free samples a year,
something it says it still intended to do after the CFC inhalers were gone.

Asthma patient groups generally supported a more rapid changeover to help
the environment. So did some medical societies, which saw the transition as
an opportunity to reduce use of albuterol, which merely quells an asthma
attack, in favor of drugs like inhaled steroids
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics
/steroids/index.html?inline=nyt-classifier>  that can prevent attacks in the
first place.

"In many ways, treating asthma as a rescue situation is dangerous and is
sort of putting a Band-Aid on the situation," said Dr. Julian L. Allen,
chief of pulmonary medicine at Children's Hospital of Philadelphia.

Debra Mendelsohn of Claremont, Calif., who has two asthmatic children, said
she favored protecting the ozone layer. Ms. Mendelsohn, who described
herself as belonging to the upper-middle class, said the transition would
perhaps mean a few extra dollars a month in insurance co-payments.

"For me that's a small price to pay for a clean environment and for clear
lungs," she said.

But Mr. Berry, the asthma patient in Virginia, said that the small amount of
CFC used by inhalers meant the changeover was "just straining at gnats and,
in so doing, is causing a tremendous burden on people."

The prime reason for the shortage during the transition is that Ivax, which
supplied about 30 percent of the generic CFC inhalers, has cut back
production. The company says it will no longer sell the product after July
1, because the European Union
<http://topics.nytimes.com/top/reference/timestopics/organizations/e/europea
n_union/index.html?inline=nyt-org>  will not allow it to obtain more CFC for
its factory in Ireland, where the inhalers are made.

"We will simply run out of gas, quite literally," said George Barrett, the
head of North American operations for Teva Pharmaceutical Industries
<http://www.nytimes.com/redirect/marketwatch/redirect.ctx?MW=http://custom.m
arketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=TEVA> , which
recently acquired Ivax.

Makers of the HFA inhalers, which so far represent only a few percentage
points of the market, have been hesitant to increase production. The makers
fear they will not be able to sell the new products because generics will
remain available for three more years.

Schering-Plough is the largest supplier of generic CFC inhalers, which it
sells under the Warrick brand. It is also poised to be the major supplier of
the new HFA inhalers, which it sells under the Proventil name; they are
manufactured by 3M.

Julie Lux, a spokeswoman, said Schering-Plough was producing CFC inhalers at
maximum capacity while 3M
<http://www.nytimes.com/redirect/marketwatch/redirect.ctx?MW=http://custom.m
arketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=MMM>  was
increasing output of HFA inhalers. Last November, to prevent hoarding, the
company began allocating generic inhalers to wholesalers.

GlaxoSmithKline, which stopped making a CFC product a few years ago,
voluntarily suspended production of its Ventolin-HFA devices last May to
refine its manufacturing process and to add a dose counter to the inhalers,
a spokeswoman said. Shipments are expected to resume in mid-June.

Armstrong Pharmaceuticals
<http://topics.nytimes.com/top/news/health/diseasesconditionsandhealthtopics
/drugspharmaceuticals/index.html?inline=nyt-classifier> , which is the No. 3
supplier of generic inhalers after Warrick and Ivax, said it had excess
capacity and would increase production. Armstrong is a unit of Amphastar
Pharmaceuticals.

Some health care providers are taking steps to cope with a shortage, or an
anticipated one. Kaiser Permanente, the big health maintenance organization,
said it was providing only one inhaler at a time to each patient.

The supply pressures have resulted in some price increases even for the
older inhalers, although they remain far cheaper than the newer ones. The
Web retailer Drugstore.com recently raised its price for orders of three or
more generic inhalers to $8.99 a device from $6.66.

With more than $1 billion a year in potential extra revenue at stake,
inhaler makers might seem to have an incentive in calling attention to a
shortage to speed the transition.

Sepracor
<http://www.nytimes.com/redirect/marketwatch/redirect.ctx?MW=http://custom.m
arketwatch.com/custom/nyt-com/html-companyprofile.asp&symb=SEPR> , for
example, said in an earnings conference call with analysts in late April
that the shortage of CFC's provided a big opportunity for its asthma drug,
Xopenex.

The company says that Xopenex, available in an HFA inhaler since December,
is an improved, safer version of albuterol - although The Medical Letter,
published by a nonprofit organization that reviews clinical data, recently
concluded "there is no convincing evidence" that Xopenex "offers any
advantage" over albuterol.

Xopenex is even more expensive than the new albuterol inhalers. A single
Xopenex device sells for about $49 on Drugstore.com, compared with about $39
for an HFA albuterol inhaler.

The Zeno Group, a public relations firm hired by Sepracor, has been trying
to get reporters to write about the inhaler supply situation, offering to
set up interviews with doctors and patient groups. It distributed a news
release from the Allergy and Asthma Network Mothers of Asthmatics, a patient
group, urging people with asthma to consider switching to HFA inhalers now,
to avoid being caught short as the supply of CFC devices diminishes. The
press release mentioned Xopenex as the newest HFA inhaler on the market,
though it also mentioned other brands.

Nancy Sander, an asthma patient who also has children with the condition, is
founder and president of the nonprofit mothers group. She said that she
wrote the press release herself and that Zeno helped distribute it only
because her group did not have the money to do it alone.

Ms. Sander has reported owning $25,000 to $50,000 of Sepracor stock in her
retirement account. But she said that did not influence her belief that
asthma patients should start trying to find the best new alternative that
works for them. "For patients to make the transition now is incredibly
important," she said.



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