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From the time they were first proposed, the 1962 Amendments to the Foo

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From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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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


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


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.


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


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


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Originally posted by SajjadAhmad on 09 May 2018, 13:21.
Last edited by SajjadAhmad on 20 Nov 2018, 22:25, edited 4 times in total.
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 27 Sep 2018, 20:06

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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 27 Sep 2018, 21:37
Could someone provide explanation of Q4?IMO C.
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 28 Sep 2018, 00:55
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

"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."
Thus C
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 28 Sep 2018, 00:57
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

IMO C.C is nowhere mentioned in the passage.
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 28 Sep 2018, 01:05
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

Firstly amendments to the act are discussed.Drug lag is discussed and then author countered the given arguments.Thus, IMO D.
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 28 Sep 2018, 01:33
Can anyone please explain Q-3 .
From where it is inferred that option A is correct.
Thanks
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 28 Sep 2018, 01:36
guptakashish02 wrote:
Can anyone please explain Q-3 .
From where it is inferred that option A is correct.
Thanks


I got it from POE.
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 28 Sep 2018, 05:47
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prashant6923 wrote:
Could someone provide explanation of Q4?IMO C.


Hi Prashant,

Quoting from the para

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, perhaps five years before the new law was fully effective

The author says that reduction in number of drugs was caused back in 1959 and not in 1962. Author is giving an alternate cause for the reduction in no.of drugs. Hence B.

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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 29 Sep 2018, 08:05
prashant6923 wrote:
Could someone provide explanation of Q4?IMO C.


I think B is a better option than C because C uses the word 'opponent', which is not correct though the author does counter the argument.
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 29 Sep 2018, 08:12
guptakashish02 wrote:
Can anyone please explain Q-3 .
From where it is inferred that option A is correct.
Thanks



The author concludes that the benefits of the act overshadow the drug lag effect.
benefits (in the last line)
drug lag (explained as a whole)
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 04 Oct 2018, 17:06
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please explain Q3.

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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 04 Nov 2018, 20:25
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

Only B and C are contenders ... Both seem credible to me.
B - It does look like an alternative explanation
C- as per the function of the paragraph in the passage as a whole, it seems like he is mentioning the stats to limit the credibility of the arguments made by the critics.

COuld you please explain the difference??
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 04 Nov 2018, 20:28
VeritasKarishma GMATNinja GMATNinjaTwo DmitryFarber @mikemcgaryy broall

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

Only B and C are contenders ... Both seem credible to me.
B - It does look like an alternative explanation
C- as per the function of the paragraph in the passage as a whole, it seems like he is mentioning the stats to limit the credibility of the arguments made by the critics.

COuld you please explain the difference??
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post Updated on: 05 Nov 2018, 20:06
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AdityaHongunti wrote:
as per the function of the paragraph in the passage as a whole, it seems like he is mentioning the stats to limit the credibility of the arguments made by the critics.


I think you nailed it there actually - the author is trying to undermine the credibility of one side of the argument...but that's not that same as attacking the credibility of an opponent (the person making that argument). C falls victim to that precise language...it's not about the opponent, it's about the argument.

And note on this - it's so easy for the testmaker to use our own personal biases against us. We kind of seek out drama (look at reality TV, Twitter trolls, etc.), so we'll gravitate toward "attack," "criticize," etc. in these Function questions (i.e. "the author does X in order to Y"). But that's really rare in the text itself...we get a little bored with the subject matter so we're looking for interpersonal drama, but more often than not the author stays within the scope of the argument and doesn't really attack or criticize the people who make it.
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Originally posted by VeritasPrepBrian on 05 Nov 2018, 17:38.
Last edited by VeritasPrepBrian on 05 Nov 2018, 20:06, edited 1 time in total.
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 05 Nov 2018, 17:43
VeritasPrepBrian wrote:
AdityaHongunti wrote:
as per the function of the paragraph in the passage as a whole, it seems like he is mentioning the stats to limit the credibility of the arguments made by the critics.


I think you nailed it there actually - the author is trying to undermine the credibility of one side of the argument...but that's not that same as <b>attacking</b> the credibility of an <b>opponent</b> (the person making that argument). C falls victim to that precise language...it's not about the opponent, it's about the argument.

And note on this - it's so easy for the testmaker to use our own personal biases against us. We kind of seek out drama (look at reality TV, Twitter trolls, etc.), so we'll gravitate toward "attack," "criticize," etc. in these Function questions (i.e. "the author does X in order to Y"). But that's really rare in the text itself...we get a little bored with the subject matter so we're looking for interpersonal drama, but more often than not the author stays within the scope of the argument and doesn't really attack or criticize the people who make it.



So basically, option C can mean that the author is criticizing the critics themselves and not their arguments... By saying "attacking the credibility of the opponent" , the author is instead trying to criticise the character of the opponent rather than the argument he makes...

Got it... Thank you so much for pointing this out... Ambiguity can be a ..... (You know)

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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 05 Nov 2018, 20:12
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Yep, exactly - and really when it says "opponent" that's talking about the person (or people) and not the argument itself.

I'm always super skeptical about answers that say the author's reason for doing something is to criticize/attack a person (or opponent, scientist, whatever). It's just so rarely justified by the text (and kind of hard to fit in a dense passage that also allows for specific detail questions) but it's so tempting to us when we're non-experts on a subject.

Anyway...you're right that ambiguity can be a ***** but here "opponent" I'd say is pretty specific that it's attacking a person, and that's something to look out for (not that it appears a ton, but when it does it should stand out as a likely trap).
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 20 Nov 2018, 17:30
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

E is the wrong answer. The passage is comparing new drugs in the US and those same drugs in foreign countries and is not comparing number vs number.
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Re: From the time they were first proposed, the 1962 Amendments to the Foo  [#permalink]

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New post 20 Nov 2018, 22:27
Edited, added source and difficulty level.
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Re: From the time they were first proposed, the 1962 Amendments to the Foo &nbs [#permalink] 20 Nov 2018, 22:27
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