Establishing a "duty of care" for pharmaceutical companies.
|Publication:||Name: The Hastings Center Report Publisher: Hastings Center Audience: Academic; Professional Format: Magazine/Journal Subject: Biological sciences; Health Copyright: COPYRIGHT 2010 Hastings Center ISSN: 0093-0334|
|Issue:||Date: Nov-Dec, 2010 Source Volume: 40 Source Issue: 6|
|Product:||Product Code: 2834000 Pharmaceutical Preparations NAICS Code: 325412 Pharmaceutical Preparation Manufacturing SIC Code: 2833 Medicinals and botanicals; 2834 Pharmaceutical preparations|
Bioethics has, until now, focused mainly on those who directly
influence human health. It worked to establish guidelines for doctors to
follow when treating their patients, and it provided a backbone for
ethical human research. Bioethics has done a lot of good, but it is time
for the field to branch out to things that affect human health in less
obvious ways. Of the things that bioethics must turn its focus to, one
of the most pressing issues is establishing a duty of care between
pharmaceutical companies and the people they supply.
There has long been a duty of care expected between. doctors and patients. Doctors are expected to have the knowledge and skills necessary to perform their job, and they are expected to exercise that knowledge and skill as well as a reasonably competent professional would in the same situation. (1) In cases where doctors fail to fulfill this duty, patients are within their rights to sue for malpractice. But it is not only doctors who are held to this standard; nurses, dentists, and therapists can be sued for malpractice as well. What establishes the "duty of care" is the fact that the individual is in some way responsible for the well-being of the patient.
If this is the case, then it also seems that pharmaceutical companies, which provide medicines that are key to human health, could reasonably be thought to have a duty of care to their consumers. This duty of care would be a rather unique thing for a company to have. It is widely held that profit is and should be the most important thing for a corporation to think of. Most companies, though, are not as directly responsible for the well-being of their customers as drug companies are. It is time to work at establishing a mentality that places the good of the populace over the good of stockholders.
Duties of care do more than provide a guideline for behavior. They also provide a firm center of responsibility. Health care professionals are directly responsible for patient well-being, and when they lapse in that responsibility, they are held responsible for the repercussions that ensue. This is something that drug companies desperately need.
Marcia Angell, former editor of the New England Journal of Medicine, once put the basic problem this way: "What does an eight-hundred-pound gorilla do? Anything he wants." (2) The pharmaceutical industry is, without a doubt, an eight-hundred-pound gorilla; drugs are a four-hundred-billion-dollar-a-year industry, and they are unlikely to become less popular anytime soon. This means that guiding pharmaceutical companies' behavior is extremely difficult, and power, proverbially, has corrupted. Of the three commonly discussed principles of bioethics, pharmaceutical companies routinely violate all three, often while pretending they don't. This leads to policies that seem clearly to place profit above people.
Let's start with a discussion of justice. To be entirely fair to pharmaceutical companies, they donate extensively to developing nations and have sometimes slashed prices on drugs so that more people may afford them. Unfortunately, while good definitely comes from donations, there are often also problems with them. First, drug companies receive a significant tax cut for donations. Upon the donation of a drug, the company gains the ability to write off on their taxes the entire cost of manufacturing the drug and 50 percent of its wholesale price. (3) This would cause no objections if the companies were complying with the World Health Organization's guidelines for drug donations. According to the activist organization Reseau Medicaments et Developpment, though, companies often donate drugs that are "inappropriate, outdated, or improperly labeled." (4) Additionally, ReMeD adds, the drugs are also often about to expire. Donating these drugs, which would not be marketable in developed nations, allows the pharmaceutical companies to make a bit of a profit on drugs that would have otherwise been a complete waste. Far from aiming to redress imbalances, donating these ineffective drugs actually shows a lack of regard for the people who receive them.
A second principle of bioethics is beneficence and nonmaleficence, best described by Hippocrates in Epidemics: "The physician must ... have two special objects in view with regard to disease, namely, to do good, or to do no harm." (5) Drug companies would argue that their research into drugs is a clear instance of doing good, and they love to extol the virtues of their research, especially in America, where they attribute high drug prices to the necessity for drug research. What they do not mention is that from 2000 to 2004, of the 314 drugs approved by the Food and Drug Administration, only thirty-two were deemed innovative, and of these, only seven came from one of the top drug companies. (6) "Innovative" drugs are those that either treat a previously untreatable sickness or treat it better than the drugs currently on the market. Where drug companies pour money into research, then, is on so-called me-too drugs--that is, drugs that are basically copies of other drugs that have been blockbusters for other companies. They are rarely tested against and shown to be an improvement over the competitor's drug because they rarely are. Pharmaceutical companies seldom invest money in drugs that are not likely to make money. This means that there is little research going into antibiotics because antibiotics are unlikely to be used for more than a single round of treatment. It also means that there is little research into medicines for diseases prevalent in less developed areas, as these areas are unlikely to pay the prices that drug companies prefer.
If drug companies cannot be said to be doing good, it becomes important to examine the other side of the coin, are they doing harm? The simplest answer is yes. The most obvious example is that of Vioxx. Merck, which manufactures the drug, was told that it acted "with wanton disregard for patients taking the drug." (7) Merck kept Vioxx on the market (and some argue put Vioxx on the market in the first place) knowing that it increased the likelihood of a heart attack (as compared to a placebo). More than twenty-seven thousand preventable heart attacks are estimated to have been caused by the drug. (8)
While I was writing this essay, another perfect example came to light. GlaxoSmithKline's diabetes drug, Avandia, was linked to a 43 percent increased risk of heart attacks when compared with placebos or other medicines. (9) Even knowing this, GSK convinced the FDA that the drug was safe. The FDA ruled that there was insufficient evidence to warrant removing the drug from the market. It seems clear from this evidence that drug companies are placing the well-being of their consumers below that of their bottom line.
Finally, there is autonomy. Pharmaceutical companies would argue that they encourage autonomy, primarily through direct-to-consumer advertising, which increases the general public's knowledge of diseases and how to treat them. (10) The basic premise of the ads is that consumers will see them and ask their doctors for prescriptions, and this premise holds true. There are, however, grounds to think that autonomy is not advanced. The ads vastly overshoot the eighth-grade reading level recommended for the general public, and they are written more to guide a decision than to inform it. They overplay the benefits while minimizing the risks, and fewer than one-third provide alternative treatment options, even when there are more effective treatments available. (11) Also, it has long been established that patients have an ethical and legal right to refuse treatment, but they have neither the ethical nor the legal right to demand treatment. These advertisements, though, promote just that.
The image projected by pharmaceutical companies does not square with the reality, which is that profits are more important than people. In the coming years, bioethics must combat this reality by establishing a duty of care for drug companies. If one is in the business of saving lives, then saving lives, not business, must be the goal.
(1.) "Medical Malpractice--Breach of Duty," LouisvilleLaw, 2001, http://www.louisvillelaw.com/ medical/malpractice/ duty.htm.
(2.) M. Angell, The Truth about Drug Companies: How They Deceive Us and What to Do About It (New York: Random House, 2004).
(3.) S. Hillstrom, "Charitable Donations of Drugs by Corporations," Drug Donations, February 11, 2000, http://www.drugdonations.org/ eng/charitable_drug_donations_by_c.html.
(5.) Hippocrates, Of the Epidemics, trans. F. Adams (Whitefish, Mont.: Kessinger Publishing, 2004).
(6.) "Medical Malpractice--Breach of Duty."
(7.) P. Rost, The Whistleblower: Confessions of a Healthcare Hitman (Brooklyn, N.Y.: Soft Skull Publishing, 2006).
(8.) "Vioxx Linked to Thousands of Deaths," MSNBC, October 6, 2004, http://www.msnbc.msn.com/id/6192603.
(9.) M. Calabresi, "After Avandia: Does the FDA have a Drug Problem?" Time, August 12, 2010.
(10.) D. Frosh et al., "A Decade of Controversy: Balancing Policy with Evidence in the Regulation of Prescription Drug Advertising," Health Policy and Ethics (2010): 24-34.
Remy Miller is an undergraduate at Transylvania University studying psychology and biology. She currently coordinates a student-run tutoring program for neighborhood children and after graduation plans to pursue degrees in medicine and bioethics. She also plans to continue efforts to bring reform to the pharmaceutical industry.
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