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Drug Dilemmas

Drug Dilemmas
Case 5.2 Drug Dilemmas
Everyone knows how high the cost of prescription medicines is these days, and many Americans dislike
having to pay significantly more than Canadians or Europeans do for the very same drugs. Many of them
also resent the huge profit margins that drug companies enjoy in comparison with other U. S.
corporations. 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.” 83 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 tax-payer- 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 top- selling 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 one thousand 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 tread-mills 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 off-shore, 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 informa-tion 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 circum-vents 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 prelimi-nary studies of drugs in poorer countries
before formal test-ing 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 com-panies 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 devel-ops 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 every-one,” yet there is
something disturbing about “ parachute research,” in which a company drops into a country, con-ducts
its drug research, and then leaves. “ It raises the ques-tion of what ethical obligation, if any, there might
be to give back and make sure there is access to the drug after the tri-als 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 char-ity, 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
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 corpo-rations don’t have? In your view, are the large U. S. drug companies good corporate
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 develop-ment, either here or overseas? Does the size of the com-pany make a difference? What
would you do if you were Dr. Lange? What obligations, ideals, and consequences should he take into
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 avail-able in poor countries at little or no cost? Explain why or why not. What about effective but
non- life- saving drugs like ranolazine?

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