Health > Respiratory diseases >
UK / USA
tightness in the chest,
and shortness of breath.
mild asthma USA
severe asthma > heat treatment / bronchial thermoplasty
the first nonpharmaceutical treatment
for severe asthma
the most common chronic disease
that affects Americans of all ages,
about 40 million people
suffer from asthma
in adults UK
in children UK
mild persistent asthma
asthma attacks USA
air pollution > asthma / asthmatic
hyperventilation FR / USA
Hyperventilation causes the body
to expel too much carbon dioxide,
and “rebreathing” exhaled air
helps restore that lost gas.
https://www.youtube.com/watch?v=qfQBCI5VMyE - 20 May 2015
https://www.youtube.com/watch?v=c7tr76wyRCE - 16 February 2014
respiratory medicine UK
tightness in the chest
The Soaring Cost
of a Simple Breath
October 12, 2013
The New York Times
By ELISABETH ROSENTHAL
OAKLAND, Calif. — The kitchen counter in the home of the Hayes
family is scattered with the inhalers, sprays and bottles of pills that have
allowed Hannah, 13, and her sister, Abby, 10, to excel at dance and gymnastics
despite a horrific pollen season that has set off asthma attacks, leaving the
girls struggling to breathe.
Asthma — the most common chronic disease that affects Americans of all ages,
about 40 million people — can usually be well controlled with drugs. But being
able to afford prescription medications in the United States often requires
top-notch insurance or plenty of disposable income, and time to hunt for deals
The arsenal of medicines in the Hayeses’ kitchen helps explain why. Pulmicort, a
steroid inhaler, generally retails for over $175 in the United States, while
pharmacists in Britain buy the identical product for about $20 and dispense it
free of charge to asthma patients. Albuterol, one of the oldest asthma
medicines, typically costs $50 to $100 per inhaler in the United States, but it
was less than $15 a decade ago, before it was repatented.
“The one that really blew my mind was the nasal spray,” said Robin Levi, Hannah
and Abby’s mother, referring to her $80 co-payment for Rhinocort Aqua, a
prescription drug that was selling for more than $250 a month in Oakland
pharmacies last year but costs under $7 in Europe, where it is available over
The Centers for Disease Control and Prevention puts the annual cost of asthma in
the United States at more than $56 billion, including millions of potentially
avoidable hospital visits and more than 3,300 deaths, many involving patients
who skimped on medicines or did without.
“The thing is that asthma is so fixable,” said Dr. Elaine Davenport, who works
in Oakland’s Breathmobile, a mobile asthma clinic whose patients often cannot
afford high prescription costs. “All people need is medicine and education.”
With its high prescription prices, the United States spends far more per capita
on medicines than other developed countries. Drugs account for 10 percent of the
country’s $2.7 trillion annual health bill, even though the average American
takes fewer prescription medicines than people in France or Canada, said Gerard
Anderson, who studies medical pricing at the Bloomberg School of Public Health
at Johns Hopkins University.
Americans also use more generic medications than patients in any other developed
country. The growth of generics has led to cheap pharmacy specials — under $7 a
month — for some treatments for high cholesterol and high blood pressure, as
well as the popular sleeping pill Ambien.
But many generics are still expensive, even if insurers are paying the bulk of
the bill. Generic Augmentin, one of the most common antibiotics, retails for $80
to $120 for a 10-day prescription ($400 for the brand-name version). Generic
Concerta, a mainstay of treating attention deficit disorder, retails for $75 to
$150 per month, even with pharmacy discount coupons. For some conditions,
including asthma, there are few generics available.
While the United States is famous for break-the-bank cancer drugs, the high
price of many commonly used medications contributes heavily to health care costs
and certainly causes more widespread anguish, since many insurance policies
offer only partial coverage for medicines.
In 2012, generics increased in price an average of 5.3 percent, and brand-name
medicines by more than 25 percent, according to a recent study by the Health
Care Cost Institute, reflecting the sky-high prices of some newer drugs for
cancer and immune diseases.
While prescription drug spending fell slightly last year, in part because of the
recession, it is expected to rise sharply as the economy recovers and as
millions of Americans become insured under the Affordable Care Act, said Murray
Aitken, the executive director of IMS Health, a leading tracker of
Unlike other countries, where the government directly or indirectly sets an
allowed national wholesale price for each drug, the United States leaves prices
to market competition among pharmaceutical companies, including generic drug
makers. But competition is often a mirage in today’s health care arena — a
surprising number of lifesaving drugs are made by only one manufacturer — and
businesses often successfully blunt market forces.
Asthma inhalers, for example, are protected by strings of patents — for pumps,
delivery systems and production processes — that are hard to skirt to make
generic alternatives, even when the medicines they contain are old, as they
almost all are.
The repatenting of older drugs like some birth control pills, insulin and
colchicine, the primary treatment for gout, has rendered medicines that once
cost pennies many times more expensive.
“The increases are stunning, and it’s very injurious to patients,” said Dr.
Robert Morrow, a family practitioner in the Bronx. “Colchicine is a drug you
could find in Egyptian mummies.”
Pharmaceutical companies also buttress high prices by choosing to sell a
medicine by prescription, rather than over the counter, so that insurers cover a
price tag that would be unacceptable to consumers paying full freight. They even
pay generic drug makers not to produce cut-rate competitors in a controversial
scheme called pay for delay.
Thanks in part to the $250 million last year spent on lobbying for
pharmaceutical and health products — more than even the defense industry — the
government allows such practices. Lawmakers in Washington have forbidden
Medicare, the largest government purchaser of health care, to negotiate drug
prices. Unlike its counterparts in other countries, the United States
Patient-Centered Outcomes Research Institute, which evaluates treatments for
coverage by federal programs, is not allowed to consider cost comparisons or
cost-effectiveness in its recommendations. And importation of prescription
medicines from abroad is illegal, even personal purchases from mail-order
“Our regulatory and approval system seems constructed to achieve high-priced
outcomes,” said Dr. Peter Bach, the director of the Center for Health Policy and
Outcomes at Memorial Sloan-Kettering Cancer Center. “We don’t give any reason
for drug makers to charge less.”
And taxpayers and patients bear the consequences.
California’s Medicaid program spent $61 million on asthma medicines last year,
paying more than $200 — not far from full retail price — for many inhalers. At
the Breathmobile clinic in Oakland, the parents of Bella Buyanurt, 7, fretted
about how they would buy her medications since the family lost Medicaid
coverage. Barbara Wolf, 73, a retired Oakland school administrator covered by
Medicare, said she used her inhaler sparingly, adding, “I minimize puffs to
‘A Frustrating Saga’
Hannah and Abby Hayes were admitted to the hospital on separate occasions in
2005 with severe shortness of breath. Oakland, a city subject to pollution from
its freeways and a busy seaport, has four times the hospital admission rate for
asthma as elsewhere in California.
The asthma rate nationwide among African-Americans and people of mixed racial
backgrounds is about 20 percent higher than the average.
Robin Levi, a Stanford-trained lawyer who works for Students Rising Above, a
group that helps low-income students attend college, is black. Her husband, John
Hayes, an economist, is white. Their daughters have allergic asthma that is set
off by animals, grass and weeds, but they also get wheezy when they have a cold.
“That first year, I had to take a lot of time from my job to deal with the
asthma drugs, the prices, arguing with insurers — it was a frustrating saga,”
Ms. Levi said.
For decades, the backbone of treatment for asthma has centered on inhaled
medicines. The first step is a bronchodilator, which relaxes the muscles
surrounding small airways to open them. For people who use this type of rescue
inhaler frequently, doctors add an inhaled steroid as a maintenance drug to
prevent inflammation and ward off attacks. The two medicines are often mixed in
a single combination inhaler for adults, and these products are especially
pricey. In addition, many patients, particularly children, take pills as well as
nasal sprays that calm allergies that set off the condition.
While on medication, neither Hayes girl has been in the hospital since her
initial diagnosis. Their mother tweaks dosing, adding extra medicine if they
have a cold or plan to ride horses.
For most patients, asthma medicines are life-changing. In economic terms, that
means demand for the medicines is inelastic. Unlike a treatment for acne that a
patient might drop if the price became too high, asthma patients will go to
great lengths to obtain their drugs.
For pharmaceutical companies, that has made these respiratory medicines
blockbusters: the two best-selling combination inhalers, Advair and Symbicort,
had global sales of $8 billion and $3 billion last year. Each inhaler, typically
lasting a month, retails for $250 to $350 in the United States.
Asked to explain the high price of inhalers, the two major manufacturers say the
calculus is complicated.
“Our pricing is competitive with other asthma treatments currently on the
market,” Michele Meixell, the United States spokeswoman for AstraZeneca, which
makes Symbicort and other asthma drugs, said in an e-mail. She added that
low-income patients without insurance could apply for free drugs from the
Juan Carlos Molina, the director of external communication for GlaxoSmithKline,
which makes Advair, said in an e-mail that the price of medicines was “closely
linked to this country’s model for delivery of care,” which assumes that health
insurance will pick up a significant part of the cost. An average co-payment for
Advair for commercially insured patients is $30 to $45 a month, he added.
Even with good insurance, the Hayeses expect to spend nearly $1,000 this year on
their daughters’ asthma medicines; their insurer spent much more than that. The
total would have been more than $4,000 if the insurer had paid retail prices in
Oakland, but the final tally is not clear because the insurer contracts with
Medco, a prescription benefits company that negotiates with drug makers for
Dr. Dana Goldman, the director of the Leonard D. Schaeffer Center for Health
Policy and Economics at the University of Southern California, said: “Producing
these drugs is cheap. And yet we are paying very high prices.” He added that
because inhalers were so effective at keeping patients out of hospitals, most
national health systems made sure they were free or inexpensive.
But in the United States, even people with insurance coverage struggle. Lisa
Solod, 57, a freelance writer in Georgia, uses her inhaler once a day, instead
of twice, as usually prescribed, since her insurance does not cover her asthma
medicines. John Aravosis, 49, a political blogger in Washington, buys a few
Advair inhalers at $45 each during vacations in Paris, since his insurance caps
prescription coverage at $1,500 per year. Sharon Bondroff, 68, an antiques
dealer in Maine on Medicare, scrounges samples of Advair from local doctors. Ms.
Bondroff remembers a time, not so long ago, when inhalers “were really cheap.”
The sticker shock for asthma patients began several years back when the federal
government announced that it would require manufacturers of spray products to
remove chlorofluorocarbon propellants because they harmed the environment. That
meant new inhaler designs. And new patents. And skyrocketing prices.
“That decision bumped out the generics,” said Dr. Peter Norman, a pharmaceutical
consultant based in Britain who specializes in respiratory drugs. “Suddenly
sales of the branded products went right back up, and since then it has not been
a very competitive market.”
The chlorofluorocarbon ban even eliminated Primatene Mist inhalers, a cheap
over-the-counter spray of epinephrine that had many unpleasant side effects but
was at least an effective remedy for those who could not afford prescription
As drugs age and lose patent protection, the costs of treatment can fall
significantly because of generic competition — particularly if a pill has only
one active ingredient and is simple to replicate. When Singulair, a pill the
Hayes girls take daily to block allergic reactions in the lungs, lost its patent
protection last year, generics rapidly entered the market. The price of the drug
has already dropped from $180 per month to as low as $15 to $20 with pharmacy
But sprays, creams, patches, gels and combination medicines are more difficult
to copy exactly to make a generic that meets Food and Drug Administration
standards. Each time a molecule is put in a new inhaler or combined with another
medicine, the amount delivered into the lungs or through the skin may change,
even though that often has an imperceptible effect on patients.
“Drug companies can switch devices and use different combinations, and it
becomes quite difficult to demonstrate equivalence,” Dr. Norman said, adding
that inhaler makers have exploited such barriers to increase sales of medicines
long after the scientific novelty has passed.
Obstacles for Generics
A result is that there are no generic asthma inhalers available in the United
States. But they are available in Europe, where health regulators have been more
flexible about mixing drugs and devices and where courts have been quicker to
overturn drug patent protection.
“The high prices in the U.S. are because the F.D.A. has set the bar so high that
there is no clear pathway for generics,” said Lisa Urquhart of EvaluatePharma, a
consulting firm based in London that provides drug and biotech analysis. “I’m
sure the brands are thrilled.”
The F.D.A. acknowledges that the lack of inhaled generic medicines, as well as
topical creams, has been costly for patients, but it attributes that to
“difficult, longstanding scientific challenges,” since measuring drug activity
deep into the lung is complicated, said Sandy Walsh, a spokeswoman for the
agency. Dr. Robert Lionberger, the agency’s acting deputy director in the office
of generic drugs, said that research into the development of generic inhaled
medicines was the agency’s highest priority but that the effort had been stalled
because of budget cuts imposed by Congress.
Even so, experts say, a significant problem is that none of the agencies that
determine whether medicines come to market in the United States are required to
consider patient access, affordability or need.
The Food and Drug Administration has handed out patents to reward drug makers
for conducting formal safety and efficacy studies on old drugs that had not been
so scrutinized. That transformed cheap mainstays of treatment like colchicine
for gout and intravenous hydroxyprogesterone for preterm labor into high-priced
branded products, costing $5 a pill and $1,500 per dose.
For its part, the United States patent office grants new protections for tweaks
to drugs without weighing the financial impact on patients.
For example, with the patent for the older oral contraceptive Loestrin 24Fe
about to expire, the company Warner Chilcott stopped making the pill this year
and introduced a chewable version — with a new patent and an expensive
promotional campaign urging patients and doctors to switch. While many insurance
plans covered the popular older drug with little or no co-payment, they often
exclude the new pills, leaving patients covering the full monthly cost of about
$100. Patients complained that the new pills tasted awful and were confused
about whether they could just be swallowed.
“Drug patents are easy to get, and the patent office is deluged,” said Dr. Aaron
Kesselheim, a pharmaceutical policy expert at Harvard Medical School. “The
F.D.A. approves based on safety and efficacy. It doesn’t see its role as
policing this process.”
For asthma patients in the United States, the best the market has yielded are a
few faux generics that are often only marginally cheaper than the brand-name
versions. AstraZeneca, for example, has an agreement with Teva Pharmaceuticals,
a generic manufacturer, to make an approved generic version of its Pulmicort
Respules, an asthma medicine for home inhalation treatments. Teva paid
AstraZeneca more than $250 million last year in royalties to make a generic,
which sells for about $200 for a typical monthly dose, compared with close to
$300 for the branded product.
Research vs. Marketing
There are good reasons drug companies are feeling threatened. In the last
several years, some best-selling medicines, like Lipitor for high cholesterol
and Plavix for blood thinning, have been largely replaced by cheap generics in a
very competitive market. In 2012, that led to $29 billion in savings for
patients, said Mr. Aitken of IMS, or $29 billion in lost revenues for drug
makers. Eighty-four percent of prescriptions dispensed last year were for
While drug companies generally remain highly profitable, recent trends have
meant tough times for some companies, including Merck, whose profits crashed 50
percent this year primarily because the patent expired on its best-selling
asthma pill, Singulair.
So AstraZeneca has recently spent millions of dollars in court pursuing several
small drug companies for patent infringement after they announced a plan to make
a true cheap generic version of Pulmicort Respules. Though a New Jersey judge
sided with the generic manufacturers this spring, legal appeals by AstraZeneca
will keep the generics off the market for the near future.
As insurance policies require patients to contribute more out of pocket for
medicines, public pressure to curb prices has grown. This year, more than 100
top cancer specialists protested the rising prices of cancer treatments.
Drug companies have long argued that pharmaceutical pricing reflects the cost of
developing and testing innovative new drugs, many of which do not pan out or
make it to market.
“When there’s a really innovative product, you might be able to justify the
price,” Dr. Kesselheim said. “But this is not generally the case.”
Critics counter that drug companies spend far more on marketing and sales than
the 15 percent and 20 percent of their revenues that they devote to research and
In the United States, one of the few Western countries that allows advertising
of prescription drugs to consumers, GlaxoSmithKline spent $99 million in
advertising for Advair in 2012. Despite its financial woes, Merck spent $46.3
million to advertise its steroid spray, Nasonex, according to fiercepharma.com,
a Web site that tracks the industry’s advertising.
Also, the focus of much pharmaceutical research in recent years has shifted from
simple drugs for common diseases that would have widespread use to complicated
molecules that would most likely benefit fewer patients but carry far higher
price tags, in the realm of tens of thousands of dollars.
The newest offering for asthma is Novartis’s Xolair, which is given by injection
in a doctor’s office every two weeks at a cost of up to $1,500, depending on the
dose. Because the drug is so expensive and was deemed to have little or no
benefit over inhalers for a vast majority of patients, the British government
last year announced that it would not make it available through the National
Health Service. It relented this year, agreeing to stock it for limited use,
after the manufacturer offered a confidential discount.
In all other developed countries, governments similarly use a variety of tools
to make sure that drug manufacturers sell their products at affordable prices.
In Germany, regulators set drug wholesale and retail prices. Across Europe,
national health authorities refuse to pay more than their neighbors for any
drug. In Japan, the price of a drug must go down every two years.
Drug prices in the United States are instead set in hundreds of negotiations by
hospitals, insurers and pharmacies with drug manufacturers, with deals often
brokered by powerful middlemen called group purchasing organizations and
pharmacy benefit managers, who leverage their huge size to demand discounts. The
process can get nasty; if mediators offer too little for a given product,
manufacturers may decide not to produce it or permanently drop out of the
market, reducing competition.
With such jockeying determining supply, products can simply disappear and prices
for vital medicines can fluctuate far more than they do for a carton of milk.
After the price of Abby Hayes’s Rhinocort Aqua nasal spray rose abruptly, it was
unavailable for many months. That sent her family scrambling to find other
prescription sprays, each with a price tag over $150.
This year the price of Advair dropped 10 percent in France, but in pharmacies in
the Bronx, it has doubled in the last two years.
In Georgia, Ms. Solod, the freelance writer, found the same thing. “Every time I
get Advair, the price is different,” she said. “And the price always goes up. It
never comes down.”
Twenty years ago, drugs that could safely be sold directly to patients typically
moved off the prescription model as their patent life ended. That brought
valuable medicines like nondrowsy antihistamines and acid reducers to drugstore
shelves. But with profitable prescription products now selling for $100 per tiny
bottle, there is little incentive to make the switch, since over-the-counter
drugs rarely succeed if they cost more than $20.
As a result, a number of products that are sold directly to patients in other
countries remain available only by prescription in the United States. That
includes a version of the popular but expensive steroid nasal spray used by Abby
Hayes, which is available over the counter in London for under $15 at the Boots
“Not only is the cost cheaper, but it doesn’t require a doctor’s visit to get
it,” said Dr. Jan Lotvall, a professor of allergy and immunology at the
University of Gothenburg in Sweden, where steroid nasal sprays are also
available over the counter.
During this high pollen season, Abby had to cut short a gymnastics practice, and
her sister, Hannah, missed one day of school because of breathing problems, the
first time in many years. But with parents who can afford to get the medicine
they require, both are now doing fine.
That is not true of two other sisters from Oakland whom their mother mentors.
With treatment hard to access and drug prices high, Kemonni and Donzahnya Pitre,
19 and 17, simply suffer and struggle to breathe.
As Donzahnya, a high school senior, looked through the Fiske Guide to Colleges
at the Hayeses’ kitchen table one day, she had an unusual selection criterion:
“I worry about going to a college that’s surrounded by a lot of grass.”
The Soaring Cost of a Simple Breath,
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