DƯỢC LÍ Goodman & Gilman's The Pharmacological Basis of Therapeutics 12th, 2010

formal techniques. However, the system also serves to monitor
changes in the nature or frequency of adverse drug reactions due to
aging of the population, changes in the disease itself, or the introduction
of new, concurrent therapies. The primary sources for the reports
are responsible, alert physicians; other potentially useful sources are
nurses, pharmacists, and students in these disciplines. In addition,
hospital-based pharmacy and therapeutics committees and quality
assurance committees frequently are charged with monitoring
adverse drug reactions in hospitalized patients, and reports from
these committees should be forwarded to the FDA. The simple forms
for reporting may be obtained 24 hours a day, 7 days a week by calling
800-FDA-1088; alternatively, adverse reactions can be reported
directly using the Internet (www.fda.gov/medwatch). Health professionals
also may contact the pharmaceutical manufacturer, who is
legally obligated to file reports with the FDA. With this facile reporting
system, the clinician can serve as a vital sentinel in the detection
of unexpected adverse reactions to drugs.
PUBLIC POLICY CONSIDERATIONS
AND CRITICISMS OF THE
PHARMACEUTICAL INDUSTRY
There is no doubt that drugs can save lives, prolong
lives, and improve the quality of people’s lives. Like
adequate nutrition, vaccinations and medications are
important for public health. However, in a free-market
economy, access to safe and effective drugs (or any kind
of healthcare, for that matter) is not equitable. Not surprisingly,
there is a substantial tension between those
who would treat drugs as entitlements and those who
view drugs as high-tech products of a capitalistic society.
Supporters of the entitlement position argue that the
constitutional right to life should guarantee access to
drugs and other healthcare, and they are critical of pharmaceutical
companies and others who profit from the
business of making and selling drugs. Free-marketers
point out that, without a profit motive, it would be difficult
to generate the resources and innovation required
for new drug development.
The media tend to focus on public policy with
regard to the ethics of drug testing, the effectiveness of
government regulations, and conflicts of interest on the
part of researchers, physicians, and others who may
have a personal stake in the success of a drug. In addition,
high-profile legal battles have been waged recently
over access to experimental (non-FDA-approved) drugs
and over injuries and deaths resulting from both experimental
and approved drugs. Clearly the public has an
interest in both the pharmaceutical industry and its
oversight. Consequently, drug development is not only
a scientific process but also a political one in which attitudes
can change quickly. Little more than a decade ago
Merck was named as America’s most admired company
by Fortune magazine seven years in a row—a record
that still stands. Today, Johnson and Johnson is the only
pharmaceutical company in the top 50 of the mostadmired
list, and this likely reflect their sales of consumer
products, such as band-aids and baby oil, rather
than pharmaceuticals. The next sections explore some
of the more controversial issues surrounding drug
invention and development and consider some of the
more strident criticisms that have been leveled at the
pharmaceutical industry (Angell, 2004).
Mistrust of Scientists and Industry
Those critical of the pharmaceutical industry frequently
begin from the position that people (and animals) need
to be protected from greedy and unscrupulous companies
and scientists (Kassirer, 2005). They can point to
the very unfortunate (and highly publicized) occurrences
of graft, fraud, and misconduct by scientists and
industry executives, and unethical behavior in university
laboratories and community physicians’ offices.
These problems notwithstanding, development of new
and better drugs is good for people and animals. In the
absence of a government-controlled drug development
enterprise, our current system relies predominantly on
investor-owned pharmaceutical companies that, like
other companies, have a profit motive and an obligation
to shareholders.
Pricing and Profitability
The price of prescription drugs causes great consternation
among consumers, especially as many health insurers
seek to control costs by choosing not to cover certain
“brand name” products. Further, a few drugs
(especially for treatment of cancer) have been introduced
to the market in recent years at prices that greatly
exceeded the costs of development, manufacture, and
marketing of the product. Many of these products were
discovered in government laboratories or in university
laboratories supported by federal grants. The U.S. is the
only large country in the world that places no controls
on drug prices and where price plays no role in the drug
approval process. Many U.S. drugs cost much more in
the United States than overseas. The result is that U.S.
consumers subsidize drug costs for the rest of the
world, including the economically developed world,
and they are irritated by that fact.
As explained earlier, the drug development process is long,
expensive, and highly risky (Figure 1–1 and Table 1–1). Only a small
fraction of compounds that enter the development pipeline ever make
11
CHAPTER 1
DRUG INVENTION AND THE PHARMACEUTICAL INDUSTRY