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Changes in Air

A

A federal ban on ozone-depleting

chlorofluorocarbons (CFCs), to conform with the Clean Air Act, is,

ironically, affecting 22.9 million people in the U.S. who suffer from asthma,

Genetic inhaled albuterol, which is the most commonly prescribed short-acting

asthma medication and requires CFCs to propel it into the lungs, will no

longer be legally sold after December 31, 2008. Physicians and patients are

questioning the wisdom of the ban, which will have an insignificant effect on

ozone but a measurable impact on wallets: the reformulated brand-name

alternatives can be three times as expensive, raising the cost to about $40

per inhaler. The issue is even more disconcerting considering that asthma

disproportionately affects the poor and that according to recent surveys, an

estimated 20 percent of asthma patients are uninsured.

B

"The decision to make the change was

political, not medical or scientific," says pharmacist Leslie Hendeles

of the University of Florida, who co-authored a 2007 paper in the New England

Journal of Medicine explaining the withdrawal and transition. In 1987

Congress signed on to the Montreal Protocol on Substances That Deplete the

Ozone Layer, an international treaty requiring the phasing out of all

nonessential uses of CFCs. At that time, medical inhalers were considered an

essential use because no viable alternative propellant existed. In 1989

pharmaceutical companies banded together and eventually, in 1996,

reformulated albuterol with hydrofluoroalkane.

C

The transition began quietly, but as more

patients see their prescriptions change and costs go up, many question why

this bail must begin before generics become available. At least one member of

the FDA advisory committee, Nicholas J. Gross of the Stritch-Loyola School of

Medicine, has publicly regretted the decision, recanting his support and

requesting that the ban be pushed back until 2010, when the first patent

expires.

D

Gross notes that the decision had nothing

to do with the environment Albuterol inhalers contributed less than 0.1

percent of the CFCs released when the treaty was signed. "Lt's a

symbolic issue" Gross remarks. Some skeptics instead point to the

billions of dollars to be gained by the three companies holding the patents

on the available HFA-albuterol inhalers, namely Glaxo-SmithKline,

Schering-Plough and Teva. Although the FDA advisory committee recognized that

the expenses would go up, Hendeles says, it also believed that the companies

would help defray the added costs for individuals, Firms, for instance, had

committed to donating a million HFA inhalers to clinics around the country.

According to Hendeles, GlaxoSmithKline did not follow through, although

Schering-Plough and Teva did. GlaxoSmithKline did not respond to requests for

comment.

E

The issue now, Hendeles says, is that

pharmaceutical-grade CFCs are in short supply, and the public faces the risk

of a shortage of albuterol inhalers if the FDA does not continue promoting

the production of HFA inhalers. He posits that even costs of generics would

go up as CFCs become scarcer. Gross disagrees, saying that the inhaler

shortage and the closure of CFC manufacturing plants are a result of the ban.

F

The HFA inhalers also have encountered

resistance because some asthmatics insist that they do not work as well as

the CFC variety. But, Hendeles says, the differences are in the mechanics and

maintenance—unlike CFC inhalers, the HFA versions must be primed more

diligently and rinsed to accommodate the stickier HFA formulation. They also

run out suddenly without the warning with a CFC inhaler, that the device is

running low. "Pharmacists may not tell people of these things, and the

doctors don't know," Hendeles says.

G

The main public health issue in this

decision may be the side effects of the economics, not the drug chemistry.

Multiple studies have shown that raising costs leads to poorer adherence to

treatment. One study discovered that patients took 30 percent less amtiasthma

medication when their co-pay doubled. In the ease of a chronic disease such

as asthma, it is particularly difficult to get people to follow regular

treatment plans. "Generally speaking, for any reason you don’t take

medication, cost makes it more likely” that you do not, comments Michael

Chernew, a health policy expert at Harvard Medical School.

H

Such choices to forgo medication could

affect more than just the patients themselves. "For example,"

Hendeles points out, "in a pregnant mother with untreated asthma, less

oxygen is delivered to the fetus, which can lead to congenital problems and

premature birth." And considering that the disease disproportionately

strikes the poor, what seemed to be a good, responsible environmental

decision might in the end exact an unexpected human toll.

Question 14-18

Use the information in the passage

to match the people (listed A-C) with opinions or deeds below. Write the

appropriate letters A-C in boxes 14-18 on your answer sheet.

NB

you may use any letter more than once

A Nicholas J. Gross

B Michael Chernew

C Leslie Hendeles

14. Put forward that the increase in the price

of drugs would contribute to the patients' negative decision on the treatment.

15. Spoke out a secret that the druggists try to

hold back.

16. Pointed out that the protocol itself is not

concerning the environment.

17. Demonstrated that the stop of providing

alternatives for CFCs would worsen rather than help with the situation.

18. In public repented of his previous backing

up of the prohibition proposal.

Question

19-22

Do the following statements agree with the

information given in Reading Passage?

In boxes 19-22 on your answer sheet, write

TRUE if the statement is true

FALSE if the statement is false

NOT

GIVEN if the information is not given in the passage

19. It took almost a decade before the

replacement drug for the asthma therapy was ultimately developed by the joint

effort of several drug companies.

20. One of the FDA committee members had a

decisive impact on the implement of the ban on chlorofluorocarbons.

21. As a matter of fact, the emitted

chlorofluorocarbons in asthma treatment took up quite an insignificant amount

at the time when the pact was reached.

22. The HFA and CFC inhalers have something

different regarding the therapeutic effect.

Question 23-27

Complete the following summary of the

paragraphs of Reading Passage, using No More than Three words from the

Reading Passage for each answer. Write your answers in boxes 23-27 on your

answer sheet.

American

people with asthma would be impacted by...23...about chlorofluorocarbons which

would consume the ozone layer. The usually used...24...would be considered

illegal because it needs the propelment of...25.... The...26...would cost the

patients considerably more money. Impoverished people are far more likely to

Suffer from asthma and what makes it even worse is that some of them are in...27...condition.