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From the time they were first proposed, the 1962 Amendments to the Food, Drug, and Cosmetic

Act have been the subject of controversy among some elements of the health community and
the pharmaceutical industry. The Amendments added a new requirement for Food and Drug
Administration approval of any new drug: The drug must be demonstrated to be effective by
substantial evidence consisting of adequate and well controlled investigations. To meet this
effectiveness requirement, a pharmaceutical company must spend considerable time and effort
in clinical research before it can market a new product in the United States. Only then can it
begin to recoup its investment. Critics of the requirement argue that the added expense of the
research to establish effectiveness is reflected in higher drug costs, decreased profits, or both,
and that this has resulted in a “drug lag. ”The term drug lag has been used in several different
ways. 

It has been argued that the research required to prove effectiveness creates a lag between the
time when a drug could theoretically be marketed without proving effectiveness and the time
when it is actually marketed. Drug lag has also been used to refer to the difference between the
number of new drugs introduced annually before 1962 and the number of new drugs introduced
each year after that date. It is also argued that the Amendments resulted in a lag between the
time when new drugs are available in other countries and the time when the same drugs are
available in the United States. And drug lag has also been used to refer to a difference in the
number of new drugs introduced per year in other advanced nations and the number introduced
in the same year in the United States. Some critics have used drug lag arguments in an attempt
to prove that the 1962 Amendments have actually reduced the quality of healthcare in the
United States and that, on balance, they have done more harm than good. These critics
recommend that the effectiveness requirements be drastically modified or even scrapped. 

Most of the specific claims of the drug lag theoreticians, however, have been refuted. The drop
in new drugs approved annually, for example, began at least as early as 1959, perhaps five
years before the new law was fully effective. In most instances, when a new drug was available
in a foreign country but not in the United States, other effective drugs for the condition were
available in this country and sometimes not available in the foreign country used for comparison.
Further, although the number of new chemical entities introduced annually dropped from more
than 50 in 1959 to about 12 to 18 in the 1960s and 1970s, the number of these that can be
termed important—some of them of “breakthrough” caliber—has remained reasonably close to 5
or 6 per year. Few, if any, specific examples have actually been offered to show how the
effectiveness requirements have done significant harm to the health of Americans. The
requirement does ensure that a patient exposed to a drug has the likelihood of benefiting from
it, an assessment that is most important, considering the possibility, always present, that
adverse effects will be discovered later.

1. The author is primarily concerned with

(A) outlining a proposal


(B) evaluating studies
(C) posing a question
(D) countering arguments
(E) discussing a law
 ::

Spoiler:

Question 2
2. The passage states that the phrase “drug lag” has been used to refer to all of the
following situations EXCEPT

(A) a lag between the time when a new drug becomes available in a foreign country and its
availability in the United States
(B) the time period between which a new drug would be marketed if no effectiveness research
were required and the time it is actually marketed
(C) the increased cost of drugs to the consumer and the decreased profit margins of the
pharmaceutical industry
(D) the difference between the number of drugs introduced annually before 1962 and the
number introduced after 1962
(E) the difference between the number of new drugs introduced in a foreign country and the
number introduced in the United States
 ::

Spoiler:

Question 3

3. The author would most likely agree with which of the following statements?

(A) Whatever “drug lag” may exist because of the 1962 Amendments is justified by the benefit
of effectiveness studies.
(B) The 1962 Amendments have been beneficial in detecting adverse effects of new drugs
before they are released on the market.
(C) Because of the requirement of effectiveness studies, drug consumers in the United States
pay higher prices than consumers in foreign countries.
(D) The United States should limit the number of new drugs which can be introduced into this
country from foreign countries.
(E) Effectiveness studies do not require a significant investment of time or money on the part of
the pharmaceutical industry.
 ::

Spoiler:

Question 4

4. The author points out the drop in new drugs approved annually before 1959 in
order to

(A) draw an analogy between two situations


(B) suggest an alternative causal explanation
(C) attack the credibility of an opponent
(D) justify the introduction of statistics
(E) show an opponent misquoted statistics
 ::

Spoiler:

Question 5

5. The author implies that the non availability of a drug in the United States and its
availability in a foreign country is not necessarily proof of a drug lag because this
comparison fails to take into account

(A) the number of new drugs introduced annually before 1959


(B) the amount of research done on the effectiveness of drugs in the United States
(C) the possible availability of another drug to treat the same condition
(D) the seriousness of possible unwanted side effects from untested drugs
(E) the length of time needed to accumulate effectiveness research

Those who opine lose their impunity when the circumstances in which they pontificate are such
that generate from their expression a positive instigation of some mischievous act. An opinion
that corn dealers are starvers of the poor, or that owning private property is robbery, ought to
be unmolested when simply circulated through the press, but may justly incur punishment when
delivered orally to an excited mob assembled before the house of a corn dealer, or when handed
about among the same mob in the form of a placard. Acts, of whatever kind, which without
justifiable cause do harm to others, may be, and in the more important cases are absolutely
required to be, controlled by the unfavourable sentiments, and, when needful, by the active
interference of mankind. The liberty of the individual must be thus far limited; he must not make
himself a nuisance to other people. But if he refrains from molesting others in matters that
concern them, and merely acts according to his own inclination and judgment in matters which
concern himself he should be allowed, without molestation, to carry his opinions into practice at
his own cost. As it is useful that while mankind are imperfect there should be different opinions,
so it is that there should be different experiments of living, that free scope should be given to
varieties of character, short of injury to others, and that the worth of different modes of life
should be proved practically, when anyone thinks fit to try them. Where not the person‘s own
character but the traditions and customs of other people are the rule of conduct, there is
wanting one of the principal ingredients of individual and social progress.
It would be absurd to pretend that people ought to live as if nothing whatever had been known
in the world before they came into it; as if experience had as yet done nothing toward showing
that one mode of existence, or of conduct, is preferable to another. Nobody denies that people
should be so taught and trained in youth as to know and benefit by the ascertained results of
human experience. But it is the privilege and proper condition of a human being, arrived at the
maturity of his faculties, to use and interpret experience in his own way. It is for him to find out
what part of recorded experience is properly applicable to his own circumstances and character.
The traditions and customs of other people are, to a certain extent, evidence of what their
experience has taught them—presumptive evidence, and as such, have a claim to his deference
—but, in the first place, their experience may be too narrow, or they may have not interpreted it
rightly. Secondly, their interpretation of experience may be correct, but unsuited to him.
Customs are made for customary circumstances and customary characters, and his
circumstances or his character may be uncustomary. Thirdly, though the customs be both good
as customs and suitable to him, yet to conform to custom merely as custom does not educate
him or develop in him any of the qualities which are the distinctive endowments of a human
being. He gains no practice either in discerning or desiring what is best.

1. Based on information in the passage, with which of the following statements about opinions
would the author most likely NOT disagree?

A. Different opinions exist because people are imperfect.


B. An opinion can be relatively harmless in one context and dangerous in another.
C. Opinions directed specifically against fellow human beings should be punished.
D. All expressions of opinion should really be considered actions.
E. An opinion always has an additional unintended effect

2. The author holds that one should not necessarily defer to the traditions and customs of other
people. The author supports his position by arguing that:

I. traditions and customs are usually the result of misinterpreted experiences.


II. customs are based on experiences in the past, which are different from modern experiences.
III. customs can stifle one‘s individual development.

A. II only
B. III only
C. I and III only
D. II and III only
E. None

Question 2

3. The existence of which of the following phenomena would most strongly challenge the
author‘s argument about ―"conforming to custom merely as custom"?

A. A class in morality taught at a parochial high school


B. An important discovery made by a researcher who uses unconventional methods
C. A culture in which it is traditional to let children make their own decisions
D. A custom that involves celebrating a noteworthy historical event
E. a culture in which only the senior most person takes the important decisions

Forget hostile aliens. According to a forthcoming book by noted astrophysicist Egbert Larson, the
intrepid humans who first attempt interstellar space travel will face far more daunting challenges
before they ever meet the Little Green Men. Larson begins with the problem of relativistic time
dilation. If you travel all the way to Alpha Centauri, you’d like to come back and tell your friends
about it, right? It’s not too likely to happen, though. If Mr. Einstein was right about relativity—
and we’re not going to say he wasn’t—then time slows down when you approach the speed of
light. A person traveling at any velocity near the speed of light will age only days for every week,
month, or even year that passes on earth. Relativity does not present a problem for interstellar
space travel, per se, but it does mean that interstellar civilizations or even just interstellar
communications will require a mind-boggling amount of calendar juggling.

Did we mention that you’d have to travel at near the speed of light? That’s because the distance
between stars is so vast that even if you could travel at the speed of light— which, Larson
reminds us, you can’t—it would take more than four years to reach our closest star neighbors,
Alpha Proxima and Alpha Centauri, and decades or centuries to reach the other stars in our
“immediate neighborhood.” And if you tried to accelerate directly to the speed of light like they
do in the movies, you’d be instantly splattered on the back of your theoretical spacecraft.
Achieving anything close to light speed will require sustained acceleration at a level that human
bodies can withstand—say, a crushing two gravities—for over a year. Better hope somebody
brings some chips. 
Speaking of chips, food is going to be a problem. Since it is economically, if not physically,
impossible to accelerate 200 years’ worth of food to nearly the speed of light, and since you’re
not likely to find any grocery stores along the way, someone will have to figure out how to make
food in space. Keeping a crew alive on the way turns out to be the trickiest part of all. Once
you’ve got the nearly impossible physics of space travel worked out, you still have to figure out
the chemistry and biology of keeping your air and water clean and keeping your crew fed and
safe from radiation and infection, and—did we mention the 200 years?—you’ll probably need
several generations of crew members to complete the trip. Ever been on a bus for more than 24
hours? It’s not a pretty picture.

We applaud Larson for his insightful writing and his scrupulous attention to scientific detail. For
those of you seeking a cold, hard look at the reality of interstellar space travel, this is a stellar
read. But be warned: Larson doesn’t let you down gently. For those of you sincerely hoping to
beam up with Scotty—and you know who you are—you might want to give this one a pass.

1. According to the information given in the passage, if two 20-year-old twins lived
on earth, and one of them left on a journey for Alpha Centauri at very close to the
speed of light, then managed to survive the journey and return to earth having aged
40 years during the journey, what could she expect to find upon her return to earth?

A. Her great-grandmother
B. Her twin at the age of 20
C. Her twin at the age of 40
D. Her twin at the age of 60
E. Her twin’s great-grandchildren

2. Which of the following inventions, if it could be perfected and manufactured at a


viable cost, would address the most challenges to human interstellar space travel, as
presented in the passage?

A. A ram-scoop drive that can accelerate a spacecraft of any size to four-fifths of the speed of
light within 24 hours
B. A cold-sleep capsule that essentially halts the passage of time for human inhabitants while
protecting them from all physical harm
C. A sustainable biosphere that reliably generates healthy food and automatically cleans air and
water
D. A neutrino-based communications system that permits instantaneous communication across
any distance without any relativistic time dilation
E. An impervious force field that protects the ship and its inhabitants from radiation, meteor
strikes, or hostile alien attacks

3. The author of the passage most likely mentions “Little Green Men” in the first
paragraph for what purpose?

A. To poke fun at the ignorance of most science fiction readers


B. To introduce a daunting challenge that will have to be addressed before human interstellar
space travel can become possible
C. To draw a comparison between the attempts of humans to voyage in space and the more
successful attempts of other civilizations
D. To draw an amusing distinction between a supposed danger of space travel, as presented in
the popular media, and the actual challenges posed by interstellar space travel, as perceived by
scientists
E. To suggest that the concept of human interstellar space travel is as much of a myth as the
“Little Green Men” that appear in science fiction movies and television programs

The overarching implications of discursive constructivism are realized in every aspect of reality in
which language is involved, since language manifests our conceptual framework. Because
something is the way it is because we bestow our perceptions onto it via language, examining
the philosophy of language proves itself especially important in feminist discourse. Some
feminists have advanced the notion of formulating a new reality more congenial to women by
which women will liberate themselves from oppressive patriarchal discourses and thrive with
their new found expressive capabilities.

The inherent maleness of language, in light of discursive constructivism, traps women in a


hierarchy of patriarchal social relations in which they are delegated to the lower rungs. Language
often represents maleness as the norm, obscures the existence and importance of women, and
imbeds a male-centric worldview, creating a picture of the world more suited to men than
women. The English language, among many others, engages in what Frye calls the absurd
practice of sex-marking, in which language assigns a critical importance to gender in situations in
which it is, in reality, irrelevant, thereby perpetuating the narrative that men and women are
somehow irrevocably and fundamentally dissimilar.

The patriarchal nature of language cannot be denied as a general force, yet feminists are not
entirely correct to say that the entirety of a language enforces a discriminatory narrative.
Although a plethora of specific terms and usages which stifle women’s equality exist, certain
neutral words are undeniably present which have escaped the male bias which afflicts so much
of our semantic reality. It is important to note that the patriarchal structure of society does not
grant men complete control over language, despite their immense influence in the creation of
dictionaries, grammatical rules and usage guides.

Which of the following best summarizes the contents of the passage?

A. Since many linguistic constructs display no gender bias, the feminist argument that language
creates the male-centric structure of our society that traps women in the lower rungs of a
patriarchal hierarchy has no merit.

B. Feminists consider language, which, they argue, has a male bias and therefore devalues
women, to be of great importance because of language’s effect on how we perceive reality, even
though this critique, although correct in principle, is unfounded in some cases.

C. The feminist argument that language reflects the patriarchal order of society and therefore
relegates women to a lower status has many merits but it is not entirely correct.

D. Discursive constructivism, the concept that language is an active agent in the creation of what
we perceive as reality, is of great concern to feminists, but their concerns, while founded, are
exaggerated.

E. Language imposes a patriarchal discourse biased against women and constitutes a grave
concern to feminists, who, although aware of language as a force which shapes reality, believe it
is only male-centric in certain aspects.

 ::

Spoiler:

Which of the following sentences best exemplifies the use of male-centric language as the
feminists cited in the passage portray it?

(A) A deficit of facts leaves an historian with no recourse but creative imagination or theoretical
constructions, as both allow a reconstruction of events based on the historian's understanding of
the period.

(B) The cognitive performance of teenage boys who consumed certain types of fish exceeded
that of other boys their age, even when experimenters controlled for other facts such as parents'
level of education and socioeconomic class.

(C) Lucrezia Borgia was renowned for her expensive tastes and lewd behavior, earning her a
reputation as one of the most corrupt members of the most corrupt of Renaissance Italy's
dynasties.

(D) In their eyes, the American, and by extension any denizen of the free world, was considered
a fully formed individual while the Soviet was a slave, devoid of the freedom to speak his mind.

(E) The Venetians were energetic and brave sea and land farers and thus brought both riches for
themselves and many technological innovations from the Orient to Europe.

The following is an exchange between two art historians over the recent restoration of the
Sistine Chapel.

Scholar A
I shudder to think what Michelangelo‘s reaction would be if he were to gaze up today at the
famous frescoes he painted on the ceiling of the Sistine Chapel over four centuries ago. He was
a practical man and would not have been surprised by the effects of time and environment on
his masterpiece. He would have been philosophical about the damage wrought by mineral salts
left behind when rainwater leaked through the roof. He would also probably have taken in stride
the layers of dirt and soot from the coal braziers that heated the chapel—if that dirt had not
been removed during the restoration.

Scholar B
The armament of the restorer is no longer limited to artistic sensibility and historical knowledge.
A chemist on the Vatican restoration team identified the composition of the layers swathing
Michelangelo‘s primary hues. Since there was a stratum of dirt between the painting and the first
layer of glaze, it was clear that several decades had elapsed between the completion of the
ceiling and the application of the glaze. This justified the use of cleaning solvents that would lift
off all but that final layer of dirt, which was kept for the sake of protection of the frescoes.

Scholar A
The Vatican restoration team revelled in inducing a colourful transformation in the frescoes with
their special cleaning solvents and computerized analysis equipment. But he would have been
appalled at the ravages inflicted on his work by the restorers.

This effect was not, as they claim, achieved merely by removing the dirt and animal glue (which
was, by the way, employed by earlier restorers to revive muted colours). They removed
Michelangelo‘s final touches as well. The ceiling no longer has its essential quality of suppressed
anger and thunderous pessimism. That quality was not an artefact of grime, not a misleading
monochrome imposed on the ceiling by time. Michelangelo himself applied a veil of glaze to the
frescoes to darken them after he had deemed his work too bright. I think the master would have
felt compelled to add a few more layers of glaze had the ceiling radiated forth as it does now. It
is clear that the solvents of the restorers did not just strip away the shadows. They also reacted
chemically with Michelangelo‘s pigments to produce hues the painter himself never beheld.

Scholar B
The particular solvent they employed, AB 57, was chosen because of the overall neutral action of
its two chemicals on pigments: one temporarily tones them down, but the other livens them up
to the same degree. Thus, the colours that emerged from the shadows are truly what
Michelangelo intended to be seen.

The luminous figures are without doubt the work of a master craftsman who executed typical
Renaissance painting techniques to perfection. This is the source of the difficulty you have with
the restoration: the ceiling of the Sistine Chapel no longer seems to be the fruit of the wayward
genius, defiant of Renaissance fresco-painting protocol, that you always thought Michelangelo
was. You don‘t like the fact that the painter seems, like a vagabond given a good scrubbing, to
be a complete stranger, rational and traditional and devoid of fearfulness and anger. But the veil
that led to the misperceptions of Michelangelo has now been lifted, and we may better acquaint
ourselves with him.

Scholar A
Of course, the restorers left open an avenue for the reversal of their own ―lifting of the veil.‖
Since the layers of animal glue are no longer there to serve as protection, the atmospheric
pollutants from the city of Rome now have direct access to the frescoes. In fact, we‘ve already
noticed significant darkening in some of the restored work, and it‘s only been four years since
the restoration was completed. It remains to be seen whether the measure introduced to arrest
this process—an extensive climatecontrol system—will itself have any long-term effect on the
chapel‘s ceiling.

1. Scholar B‘s argument that the presence of dirt between the painting and the first layer of
glaze justified the use of cleaning solvents to remove the glaze assumes that:
A. the dirt was laid down several decades after the painting‘s completion.
B. the cleaning solvents would never actually touch the frescoes.
C. Michelangelo intended the glaze to be relatively temporary.
D. Michelangelo could not have applied glaze to the ceiling decades after
painting it.
E. dirt is not actually making the painting look more beautiful
 ::

Spoiler:

2. Based on Scholar B‘s claim that Scholar A is unhappy because the ceiling ―no longer seems to
be the fruit of [a] wayward genius, defiant of Renaissancepainting protocol,‖ it is reasonable to
conclude that:
A. Michelangelo was not a fiercely independent thinker.
B. the restoration has jeopardized Michelangelo‘s position in history as a
great artist.
C. darkening colours to produce a gloomy effect was characteristic of
Michelangelo‘s time.
D. historical conceptions of Michelangelo overestimated his negative
traits.
E. Scholar A is not aware of all the aspects of Michaelangelo‘s personality
 ::

Spoiler:

3. In arguing that some of the restored work has already been darkened by pollution, which of
the following assumptions did Scholar A make?
I. Nothing except pollution could have caused the darkening.
II. The darkening indicates that irreversible damage has been done.
III. The atmospheric pollutants are more abundant now than they were
before the restoration.
A. I only
B. I and II
C. II and III
D. I, II and III
E. None of the above

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