Drug Dilemmas Case Study Presenation

• I’m adding Case 5.2 as a word file
• Read Case 5.2 – Drug Dilemmas (Part 2, Chapter 5, begins on page 186).
• Identify and the main issues found discussed in the case (who, what, how, where, when, and why — the critical facts in a case).
• List all indicators (including stated “problems”) that something is not as expected or as desired.
• Briefly analyze the issue with theories found in your textbook or other academic materials. Decide which ideas, models, and theories seem useful. Apply these conceptual tools to the situation. As new information is revealed, cycle back to sub steps a and b.
• Identify the areas that need improvement (use theories from your textbook)
• Specify and prioritize the criteria used to choose action alternatives.
• Discover or invent feasible action alternatives.
• Examine the probable consequences of action alternatives.
• Select a course of action.
• Create a plan for assessing the action to be implemented taking into account the order request.
• Identify and explore the ethical issues involved.

Note: Question and answer format is acceptable for this presentation case study; however, other organizational structures are encouraged (preferable).

Writing Requirements:

• PowerPoint presentation (10 to 15 slides with speaker notes for individual work)
• APA format, for citations and references
• Use the APA template located in the Student Resource Center to complete the assignment.

Case 5.2Drug Dilemmas
Everyone knows how high the cost of prescription medicines is these
days—for instance, medication to combat leukemia or multiple
sclerosis can cost $5,000 to $10,00 per month, and treatment with
the new pill that cures hepatitis C in nine out of ten patients costs
more than $90,000. Those high prices are at least part of the reason
that year after year, for over two decades the drug industry has been
far and away the most profitable sector of our economy. However,
many people are also inclined to accept high prices as the cost we
must bear for drug research and the development of new medicines.
But, in fact, the prices drug companies charge bear little relationship
to the cost of making or developing them, and those prices could be
cut dramatically without coming close to threatening their R&D
budgets. Less than 15 percent of the sales revenue of the large
pharmaceutical companies goes into R&D, half what they spend on
“marketing and administration.”
Moreover, the pharmaceutical industry is nowhere near as
innovative as most people think. According to Marcia Angell, former
editor in chief of the New England Journal of Medicine, only a handful
of important drugs have been brought to the market in recent years,
and they were based mostly on taxpayer-funded research. She
writes, “The great majority of ‘new drugs’ are not new at all but
merely variations on older drugs already on the market. These are
called ‘me-too’ drugs. The idea is to grab a share of an established,
lucrative market by producing something very similar to a topselling drug.” This is made possible by the fact that the FDA will
generally approve a drug if it is better than a placebo. “It needn’t be
better than an older drug,” Angell says. “In fact it may be worse.
There is no way of knowing, since companies do not test their drugs
against older ones for the same conditions at equivalent doses.” Of
the seventy-eight drugs approved by the FDA in a recent year, only
seventeen contained new active ingredients, and the FDA classified
only seven of those as improvements over older drugs. And none of
those seven came from a major U.S. drug company.
When it comes to research and innovation, the record of the big,
profitable pharmaceutical corporations contrasts poorly with that of
the small biotechnology companies that are responsible for most of
today’s medical advances. CV Therapeutics of Palo Alto, California, is
one such company. Founded by cardiologist Louis G. Lange, it has
developed a new drug, ranolazine, which promises to be the first
new treatment for angina in over twenty-five years. The Journal of
the American Medical Association has praised ranolazine as helping
patients for whom standard therapies have failed. But this medical
breakthrough has brought an ethical dilemma with it. Patients in
Russia and Eastern Europe constituted 60 percent of the 1,000 or so
test subjects involved in the studies that enabled CV Therapeutics to
develop the drug. Now that the drug is ready, does the company have
a moral obligation to make its drug available to them?
Other drug companies today are struggling with the same dilemma.
They frequently test experimental drugs overseas, where there is
less red tape and both doctors and patients are keen to participate in
the tests. In Russia, for example, doctors are eager for the money
they can get as study monitors, traveling to medical offices to make
sure protocols are being followed. They also receive medical
equipment such as treadmills for exercise testing. For their part,
patients see it as a chance to get medications that they cannot afford
to buy and that their government doesn’t pay for. Moreover, says
Richard Leach, the American business manager of a company called
Russian Clinical Trials, “Eastern European and Russian people tend
to be very compliant…. They will follow the trial and they will do
whatever is asked. If they have to keep a diary, they do it. If they have
to make office visits, they do it.”
With at least 40 percent of drug testing now done offshore, critics
worry that drug companies are exploiting their human subjects. In
the United States and other well-to-do countries, experimental
subjects must be given full information about the nature of the
research, and they have a right to refuse to participate without
penalty or consequence for their usual health care. Not so in Africa
and many poor regions, where doctors profit from enrolling their
patients, and local officials sometimes encourage whole villages or
provinces to enroll in research programs. Conducting research
overseas not only saves drug companies, money, but it also
circumvents FDA restrictions, which require companies to gain its
approval before human testing in the United States can begin. The
FDA obliges companies to describe their proposed research in detail
and to file plans for guaranteeing informed consent and for
monitoring the progress of the study. They must set up a review
board to monitor each clinical trial and to ensure that risks to human
subjects are “reasonable in relation to anticipated benefits, if any, to
subjects, and the importance of the knowledge that may reasonably
be expected to result.” In addition, all risk must be “minimized.”
Requirements for foreign research are much looser, and there is very
little oversight. “Companies can conduct preliminary studies of drugs
in poorer countries before formal testing even begins,” writes Marcia
Angell. “Quite literally, the participants are used as guinea pigs,
subjects of research that really should be done on experimental
animals.” And when it comes to formal testing, the FDA may not
learn about it until the company applies for final approval of its new
drug.
These moral issues, however, are not the concern of companies like
Russian Clinical Trials. Nor do they see it as their business to ask
what happens when the studies end. Dr. Alan Wood, general
manager of Covance, another American firm that conducts medical
trials in Eastern Europe, says quite plainly, “What our clients do is
not our affair.”
But what about the drug companies themselves? What, if anything,
do they owe overseas test subjects when their new drugs pan out?
Some companies never even sell their drugs in the poor countries
where they were developed. Others do, but often there are few
patients who can afford them. “This is something that the biotech
industry, as it develops more and more drugs, will have to come to
grips with,” says Carl B. Feldbaum, president of the Biotechnology
Industry Organization. “It’s not that we are lacking compassion, but
the economics are tough.”
“Do we have an obligation to everyone in the trial or to everyone in
the community, the province, the nation, the region, or the world?”
asks Dr. Ruth Faden, director of the Berman Bioethics Institute at
Johns Hopkins University. “We really haven’t figured this out.” She
acknowledges, though, that “many physician investigators feel
uncomfortable with the idea of using patients in studies and then not
being able to continue to help them when the trial ends.” We seem
“to have hit a wall of moral unease,” she says. “I’m not sure exactly
where we ought to end up.”
Dr. Lawrence O. Goskin, director of the Center for Law and the
Public’s Health at Georgetown and Johns Hopkins Universities, is also
troubled. Drug companies, he says, should not be seen as “the deep
pocket that helps everyone,” yet there is something disturbing about
“parachute research,” in which a company drops into a country,
conducts its drug research, and then leaves. “It raises the question of
what ethical obligation, if any, there might be to give back and make
sure there is access to the drug after the trials are over.”
Drug companies are businesses, of course, and they have to decide
whether they can earn enough money in a foreign country to justify
applying for approval to market a new drug there, then setting up a
business office, and hiring a sales force. Even if they decide to
provide the drug to patients free of charge—so-called compassionate
use—things are not so simple. They still have to set up a distribution
system, train doctors to administer the drug, and monitor the
patients who take it. In the case of life-saving drugs, such as those for
combating AIDS, many companies do, in fact, provide them for free
or at low cost in poor countries, especially to patients who were
involved in their development. But with a drug like ranolazine, it’s
more complicated. Angina can cause terrible, crushing chest pains,
and it can make the lives of chronic suffers miserable. Ranolazine can
cut in half the number of angina attacks a patient suffers, but it’s not
a life-saving drug. It improves the quality of patients’ lives, but it
doesn’t extend them.
Dr. Lange, meanwhile, is torn. His company is not a charity, and
because CV Therapeutics is small, it can’t afford to market ranolazine
in countries where few people have enough money to buy it or to set
up the distribution systems necessary to give it away. “We’re not
Merck,” he says. “But we’re concerned.”
Discussion Questions
1. What explains the high price of prescription medicines in the United States?
What if anything should be done about it? Do you believe that in the United
States drug prices reflect the operation of a fair and competitive market?
2. Given the nature of their product, do pharmaceutical companies have ethical
responsibilities that other corporations don’t have? In your view, are the
large U.S. drug companies good corporate citizens?
3. Are the large drug companies guilty of price gouging or of charging an unfair
or exploitative price for their products? Should Americans be permitted to
import drugs from Canada or other countries?
4. Assess the motivations of drug companies that do their testing overseas. Do
you think test subjects are being exploited or taken advantage of? Under
what circumstances, if any, are companies morally justified in testing
overseas?
5. Do drug companies have an obligation to make new drugs available to
patients who were involved in their development, either here or overseas?
Does the size of the company make a difference? What would you do if you
were Dr. Lange? What obligations, ideals, and consequences should he take
into account?
6. Is it ethical for companies to decline to sell a useful drug like ranolazine in a
poor country because they can make more money marketing it elsewhere?
7. When it comes to life-saving drugs, do pharmaceutical companies have a
moral obligation to make them available in poor countries at little or no cost?
Explain why or why not. What about effective but non-life-saving drugs like
ranolazine?