Read Case 5.2 – Drug Dilemmas EVERYONE KNOwS HOw HIGH THE COST of prescription m

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Read Case 5.2 – Drug 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 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 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 every- one,” 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 miserably. 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?

Explanation / Answer

1) The US physician endorsed sedate costs don't mirror the activity of a reasonable and aggressive market. It appears the administration does not control the business as it does in different nations, purchasers are helpless before the pharmaceutical organizations. First, there are numerous reasons that remedy costs are so costly in the U.S., as indicated by businessInsider.com, here a the main six reasons:

There aren't any value controls. The US government does not manage the costs of medications, not at all like different nations have government organizations arrange costs for each medication.

The patent process and patent life expectancy. Licenses last longer in the U.S. than in different nations, generally giving a medication's creator selectiveness that keeps rivalry for a long time from when the patent is issued. Since licenses are documented while drugs are still in testing, that clock begins ticking some time before the medication goes at a bargain. Ordinarily, new medications wind up cornering the market for about twelve years. The pharmaceutical organizations often climb up their costs each year, by around at least 5%.

For numerous medications, there isn't sufficient rivalry to hold down costs. Numerous more seasoned nonspecific medications were estimated too low to be in any way gainful, so some medication creators quit making them. Once just a single organization or two organizations make a medication, the cost as a rule shoots up. For more seasoned, mark name sedates that treat conditions excessively uncommon, making it impossible to draw in various makers, the sole creator has a true syndication. Besides, huge overabundance of nonspecific medications anticipating US administrative endorsement implies that for some off-patent medications, just single or two nonexclusive forms have been affirmed. That points of confinement decreases from the brand.

Little Markets, many new medications are for uncommon conditions or growth subtypes including a specific hereditary change, so they may encourage only thousands or several patients. To recover innovative work costs, medicate creators set high costs, however they offer numerous patients money related help.

Development and creation costs, Research is ending up progressively costly. Industry bunches say it can take in regard to 10 years and well over $1 billion to get another medication affirmed, however that incorporates advancement costs for the numerous medications that don't work out. The most-over the top new medications are biologics, delivered by living cells under exact conditions, which costs much more than blending synthetic compounds to make pills.

Fewer generics, after an enormous influx of patent lapses from 2011 through 2013 that brought nonspecific adaptations of medications taken every day by a large number of patients, the quantity of well-known medications going off patent has declined. That has added to add up to US spending on drug rising.

2) It is hard to state regardless of whether pharmaceutical organizations have distinctive moral duties because of the idea of their items. A limited feeling of corporate social duty would state that, by and large, the organizations were mindful to their investors and to making a benefit. A more extensive definition would contend that, by testing in nations and networks abroad, the organizations have entered in an understood contract with the public and must respond inside the network. Because of the potential advantages of their items, pharmaceutical organizations are held to higher moral norms and do have moral duties that different enterprises don't have. It is critical to understand that, for instance, the organizations are as of now offering or giving endlessly sedates in minimum created nations. Since this is accomplished more from societal weights and not a feeling of obligation, it tends to be reasoned that substantial U.S. tranquilize organizations are bad corporate natives. The unmitigated basic necessitates that human nobility and correspondence are both maintained. Nonetheless, neither of these parts of the basic are being satisfied by huge organizations' abroad trying practices. Once the tests are finished, a significant number of the organizations don't offer their medications in the testing nations. On the off chance that they do, few can manage the cost of them. U.S. tranquilize organizations are characterizing corporate social obligation in the limited sense and, through abroad practices, are not genuinely being great corporate natives.

3) They are not liable of cost gouging or of charging an out of line or exploitative cost for their products. Since they spend parcel of material assets and labor on their items, and they are not the profound pocket that helps each one. They imagine that they are not lacking sympathy, but the financial aspects are intense, they don't have a commitment to everybody in the preliminary or to everybody in the network, the territory, the country, the locale, or the world. I figure, Americans should be permitted to import drugs from Canada or different nations. Since however the monetary is tough, treating the patients is as yet an ethical issue. Canada's level of medications is great, bringing in can not only create local restorative level, yet in addition be useful for local patients.

4) It appears as if, what persuades drugs organizations is benefit. In a perfect world, if a pharmaceutical organization was persuaded by doing admirably for those that are trying the medication and they would keep on making the medication accessible after the testing is over that would be considered ethically supported. Nonetheless, considering the data for the situation contemplate, drug makers are spurred by the minimal effort of testing abroad, less administration, and a populace that is more than willing to be test subjects.

5) It isn't illicit not to do as such. In any case, it isn't moral. These individuals have each to no cash and as of now went out on a limb of the testing and ought to be compensated with the new medication.

6) No, it isn't moral for pharmaceutical associations to diminish the offer of significant meds considering the way that they can benefit exhibiting diverse solutions that are simply more by and large required. A drug that can be useful should ethically be open to an overall population paying little personality to the advantages they could make with simply more extensively required prescriptions. Utilitarianism can apply to this moreover, in consent to oversee utilitarianism. Standard utilitarianism still executes the decide that exercises are right in case they convey most noteworthy ecstasy and wrong in case they don't, yet in this kind of utilitarianism, exercises are not individualized, to some degree held to a moral code or standards set that will make most outrageous happiness. The moral code and principles would be for pharmaceutical associations to allow the meds that can be profitable to people to be sold and coursed in the overall population. It would not be all in all correct to not offer a helpful medication because of the money related advantages the association would get. It is moreover corrupt for associations to not offer an accommodating prescription in remote countries considering the way that they can benefit promoting someplace else. Any pharmaceutical should be available to all people of social requests that it will offer help. It is a medicine association's moral pledge to give obliging meds to all without affect from money related issues. Rawls states that any move that is made should focus on giving the most favourable position to the base advantaged people of the overall population. So it would be fundamental for associations to give these medicines not simply to the people who can deal with its expense, anyway to the base great position people of the overall population which would be needy individuals.

7) They are socially in charge of assisting the destitute whether it is an existence sparing or non-life-sparing medication. Nonetheless, regardless of whether these pharmaceutical organizations sold these doctor prescribed medications at a much lower rate or even chose to furnish these nations with the medications, we can't state that the demonstration was done only for the correct sort of reasons which is helping the poor. Or maybe, it may be more through the demonstration of self-intrigue which makes it unmoral.

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