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Unit 1
Medicine
1. Read, translate and give the summary of the text ―A Dearth of New
Meds‖.
A Dearth of New Meds
Drugs to treat neuropsychiatric disorders have become too risky
for big pharma
Schizophrenia, depression, addiction
and other mental disorders
cause suffering and cost billions of dollars every year in lost productivity.
Neurological and psychiatric conditions account for 13 percent of the
global burden of disease, a measure of years of life lost because of
premature mortality and living in a state of less than full health, according
to the World Health Organization.
Despite the critical need for newer and better medications to treat a
range of psychiatric and neurodegenerative diseases, including
Alzheimer‟s and Parkinson‟s, drugs to treat these diseases are just too
complex and costly for big pharmaceutical companies to develop. The
risk of spending millions on new drugs only to have them fail in the
pipeline is too great. That‟s why many big drug companies are pulling the
plug on R&D for neuropsychiatric and other central nervous system
(CNS) medicines.
Our team at the Tufts Center for the Study of Drug Development has
arrived at this conclusion after conducting surveys of pharmaceutical and
biotechnology companies about the drug development process. These
surveys allow us to generate reliable estimates of the time, cost and risk
of designing new drugs. Our analyses show that central nervous system
agents are far more difficult to develop than most other types.
One of the problems with neuropsychiatric drugs is that they take so
long to develop. A CNS drug, we have found, will spend 8.1 years in
human testing
– more than two years longer than average for all agents.
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It also takes more time to get regulatory approval
– 1.9 years, compared
with an average of 1.2 years for all drugs. Counting the six to ten years
typically spent in preclinical research and testing, CNS drugs take about
18 years to go from laboratory bench to patient.
Few compounds survive this gauntlet. Only 8.2 percent of CNS drug
candidates that begin human testing will reach the marketplace,
compared with 15 percent for drugs overall. Failures also tend to occur
later in the clinical development process, when resource demands and
costs are at a peak. Only 46 percent of CNS candidates succeeded in
late-stage (phase III) trials, compared with 66 percent on average for all
drugs. As a result, the cost of developing a CNS drug is among the
highest of any therapeutic area.
What makes these drugs so risky? Assessing whether or not a
candidate for, say, a new antibiotic works is relatively straightforward
–
either it kills the bacterium or it doesn‟t – and a course of treatment
typically lasts a few days, which obviates the need for long-term testing
for safety and efficacy. CNS compounds, in contrast, have it a lot
tougher. It is difficult to judge if a reduction of schizophrenic episodes or
a cognitive improvement i
n Alzheimer‟s patients is the result of a drug or
a random fluctuation in t
he patient‟s condition. Treatment periods can
last as long as a patient‟s lifetime. It is no wonder success rates are low.
Some help is on the way. The Coalition Against Major Diseases, made
up of government agencies, drug companies and patient advocacy
groups, has developed a standardized clinical trials database that will
allow researchers to design more efficient studies of new treatments,
initially for Alzheimer‟s and Parkinson‟s. President Barack Obama‟s
health reform law also contains several provisions that could provide
incentives for innovation in areas of unmet medical need. One is the
Cures Acceleration Network, which authorizes the National Institutes of
Health to help academic researchers screen for promising compounds.
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Ultimately, making new CNS medicines may depend on a networked
approach to innovation, in which many organizations share in the risks
and the rewards. It is clear that the challenges of developing new
neuropsychiatric medicines are greater than any one company,
institution or organization can bear alone.
From Scientific American (August 2011),
by Kenneth I.Kaitin and Christopher P.Milne.
2. Use the clues below to fill in the spaces of the crossword puzzle. The
answer to each clue starts in the box with the same number as the clue.
If the clue is under
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