My heels thumped methodically against the back of the waiting room chair in the doctor’s office. My father had warned me not to fidget, but I could not help it; my seven-year old mind was nervous about my visit and the several shots I knew I was to receive. To distract myself, I resorted to kicking the back of my chair while watching the other patients come and go. The office was quite busy today. I noticed several men exit the back room of the doctor’s office, but I paid them no mind. My father, in an attempt to calm me down, commented. “Anastasia, do you know who those men are?” I shook my head as he continued to speak. “They work for the companies that make medicine. They visit doctors to try and sell them their brand of medication.” I looked up at my dad, now interested. We often had business-related conversations, and he frequently asked me for my advice on new business ideas for the pizza restaurant that he owned in town. He tried to cater to the many different types of people that enjoyed his pizza each week. “Did you know that I get an order from men like them at least twice a month? They send pizza to the doctors so that later, when they ask doctors to prescribe their medicine to patients, the doctors are happy to. What do you think about that?” Even as a child, I was uncomfortable with the idea of my father’s pizza influencing the medicine my doctors prescribed to me. I knew that there was something inherently wrong with this-- that no type of food or gift should influence medical care.
As I grew older, I learned more about the complexity of the medical field and how pharmaceutical companies sought to increase their monetary gain by expanding their power over its functioning. In order to maximize their profits, these companies recognized the need to sell their drugs to as many customers as possible. Over time, the companies started to become very creative with their marketing strategies, giving gifts such as pens, pads, food, and even vacations to doctors that signed a contract with them (Katz). The public, outraged with the implications of these actions, began movements to prevent this form of manipulation. Groups of pharmaceutical companies stepped up and began “self-regulation,” creating sets of rules for all companies to follow (Bettelheim). By the 1980s, pharmaceutical companies had ceased giving extravagant gifts such as vacations, but the smaller, seemingly inconsequential gifts continued (Katz). In more recent years, doctors themselves have attempted to cut down on the effects of the unsavory marketing techniques (Katz).
Despite these efforts, little has changed. Gift giving continues, and although it is only with small gifts, companies are still able to use this style of marketing to sway the prescription choices of doctors. After considering the lack of success the medical field has had through allowing pharmaceutical industries to regulate themselves, it has become clear that only a combination of state and federal government regulation, coupled with the continued efforts from medical practitioners and the pharmaceutical industry, will truly be successful in improving the medical field’s quality of care.
This paper explores the policies that have already been implemented by corporations, medical professionals, and the government and then assesses their effectiveness. I begin by considering the nature of the problem and the actions that have been taken by doctors and the pharmaceutical industry itself. I then shift my focus to a discussion about why government regulation of the pharmaceutical industry is the best way to reform the field and what exactly must be done in order for medical professionals to start prescribing medications to patients for the right reasons. I argue that self-regulation and other previously implemented means should be used as a supplement to any government regulations put in place in the future.
The issue of pharmaceutical company influence on the medical field entered the public eye in the 1990s (Bettelheim). As mentioned, the drug industry was becoming increasingly important to medical practice and companies were developing devious strategies to maximize their profits, including giving small and large gifts to doctors (Bettelheim). While the public generally overlooked the small, inconsequential gifts, most citizens did not approve of the companies giving doctors larger gifts, like lavish vacations to sign a contract. More critical commentators did not even approve of the small gifts, citing the influence of the psychological phenomenon known as “reciprocity,” in which a person receiving a gift feels obligated to give something in return (Katz). Dana Katz, a researcher at the University of Pennsylvania, notes the influential strength of even small gifts: “Food, flattery, and friendship are all powerful tools of persuasion, particularly when combined. Individuals tend to be more receptive to information when it is received while eating enjoyable food” (41). This issue, brought to the forefront of discussion in the medical field in the 1990s, led the medical community to move towards some form of regulation. Over the past two decades, this regulation was attempted through two primary means: self regulation of the pharmaceutical industry and the education of medical professionals.
With the public outraged over the pharmaceutical industry’s marketing strategies, groups of both medical practitioners and manufacturers began forming guidelines for the pharmaceutical industry to follow. In 1998, the American Medical Association released a document titled “Ethical Guidelines for Gifts to Physicians from Industry,” which listed voluntary regulations for manufacturers to follow when marketing to medical practitioners. Several years later, in 2002, the Pharmaceutical Research and Manufacturers of America, created another set of guidelines modeled after the AMA’s document (Chimonas 2). These guidelines are known as the PhRMA code and are still in place today, although they have been recently revised (PhRMA). The PhRMA code currently urges manufacturers to keep the amount of gifts given to a minimum, recommending a maximum total of $100 for all gifts (Grande). In addition, the new version of the PhRMA code prohibits non-educational gifts (Grande). This addition to the code is an attempt to prevent manufacturers from giving practitioners gifts such as luxurious vacations that are obvious attempts to simply bribe them to prescribe their medications. Although it is a voluntary code, it has made a substantial impact over the past years. Many manufacturers, both involved in the PhRMA association and independent of it, have pledged to follow this code. As of 2010, 54 companies have pledged to follow the voluntary guidelines of the code (PhRMA). This compliance is certainly a great step forward for the regulation of marketing within the medical field, but unfortunately, it is not enough. As long as these guidelines are voluntary, patient care will always be influenced by these unfair marketing strategies until all companies follow the same standards. In order to truly prevent the manipulation of the medical field by pharmaceutical companies, government regulation must be put in place in order to have a blanket of regulation over all companies in the field.
While manufacturers were developing and attempting to strengthen their voluntary guidelines, the government was also working to regulate the medical field as much as possible. While there have not been many laws passed dealing with pharmaceutical regulation, the Office of the Inspector General (OIG), which is a part of the US Department of Health and Human Services, has issued its own guidance for manufacturers. Susan Chimonas discusses the significance OIG’s document: “[The guidance] addressed not only patently illegal practices but also the "gray areas" of physician-industry relations, including consultancies, conference grants, and gifts. Although these exchanges were not illegal, they carried ‘significant potential for abuse’ under the anti-kickback statute” (2). In addition, the document also endorses the PhRMA code, urging all manufacturers to follow its guidelines. Although the OIG guidance is only a list of recommendations, its endorsement of the PhRMA code shows that the government is becoming more and more active on this issue. More importantly, the guidance demonstrates that the government and manufacturers have a chance at coming to an agreement; their opinions are in line with each other, and the two have the potential to one day create a set of mandatory regulations that are agreeable. Although the PhRMA code is weak in and of itself, if it is accompanied by laws, it will become much stronger, and the focus on the entire medical field will turn towards the interests of the patients once more.
Many groups of medical practitioners have also recognized the importance of keeping the interests of their patients at the forefront of medicine, and they are working towards achieving medical field regulation in their own way. Many practitioners believe that if the majority of drug prescribers in the US agree upon accepted behaviors when dealing with pharmaceutical industries, these industries will be forced to comply with their guidelines in order to sell their drugs at all. Other medical ethicists who are working towards resolving this issue intend to create a new generation of doctors that have been trained to recognize the manipulative marketing of manufacturers (Dresser 2). Those in charge of continued education classes for medical professionals have been working toward developing courses that demonstrate the influence of the marketing styles first hand (Raad).
Many medical field ethicists that oppose the use of government regulation insist that the aforementioned strategies need only be strengthened in order to transform the medical field. Many of these ethicists emphasize the importance of educating current practitioners. Raad and Applebaum, researchers at Cornell and Columbia, respectively, discuss how “[a] study of family medicine residents found that after a 2.5-hour educational intervention, residents were more likely to think that drug samples, free meals, small gifts, and industry-sponsored [continued medical education] were ethically inappropriate, and they reported less intention to accept them in the future” (Raad 7). Putting doctors through workshops may change their views on these medical field norms, slowly beginning to transform the way the field functions. This chance, however, is not guaranteed and would be slow at best, since there is no way to require that all medical professionals take part in such educational sessions.
Another barrier to effective industry self-regulation is that, while some medical practitioners now recognize the influence that the marketing of drug manufacturers can have on them, other doctors insist that they are personally not as effected. As a result, doctors who believe that changes are necessary have encountered difficulties in convincing other doctors to join their cause (Raad). What is worse, however, is that the doctors who don’t see changes as necessary view the gifts as benefits of the job that they are entitled to (Katz). Doctors with this view are resistant to the idea of changing the medical field. This resistance, in turn, encourages companies to continue their use of gift-related marketing strategies.
Over the next several decades, doctors who have gotten used to accepting gifts from medical manufacturers will begin to retire and new doctors who have trained under PhRMA will take over their practices (Dresser 2). As these transitions happen , the marketing strategies used by manufacturers will become more and more unpopular. In this way, these small movements may eventually help to make marketing more ethical, but this process will be much faster if the government passes its own regulations. Over the past decade, the government has become increasingly involved in attempting to regulate the marketing of pharmaceutical industries. In addition to the endorsement of the PhRMA by the OIG, several states have passed mandatory regulations for industries to follow and national regulations have just recently been passed and are expected to be implemented soon. The involvement of the government has had direct influence on the reform of the medical field. As this involvement grows, whether through the action of state governments or the federal government, the mandatory regulations will work with the recommendations already in place to transform the field.
Several state governments have begun to recognize the importance of mandatory regulation and have passed laws that have transformed guidelines into requirements. California has been the most active with these movements. In 2005, the state of California made it mandatory for manufacturers to follow the guidelines set by OIG in the document published in 2003. In addition to this requirement, as noted by Rebecca Dresser: “The California statute also requires companies to set a specific dollar limit every year on the value of gifts and incentives provided to individual health professionals” (Dresser 2). In this way, California currently has the strictest regulations for pharmaceutical companies. This state, however, was not the first to pass laws to regulate unsavory marketing. In 2001, Vermont passed the Gift Disclosure Law, which requires manufacturers to report gifts of any nature to the Attorney General each year (Dresser 2). Other states, such as Maine and Minnesota, have also shown promising movement towards strong regulatory laws. These laws follow virtually the same ideals that have been set by groups of pharmaceutical industries and doctors, reflecting that all three groups can regulate this cause together.
In the past two years, there have been strong developments towards governmental regulation of the field. The changes that the Obama administration made to the medical field in past years included mandatory “physician payment sunshine” rules (Woodward). These rules are consistent with what has been recommended by others for years; as of this year, companies are required to report gifts given to doctors that total over $100 (1). This information will be compiled over the next year, and starting in 2013, it will be released to the public (1). While these requirements are certainly not foolproof, they indicate that the government is beginning to take a stronger role in the field’s regulation.
Many critics of government regulation within the medical field claim that even if mandatory regulations were passed, there would always be loopholes that drug manufacturers would slip through (Grande). It is conceivable that, even now, the industries have developed marketing strategies within the laws and guidelines set for them that still have a way to influence doctors unfairly. Because of this potential, the only true solution to the issues within the medical field is if pharmaceutical industries, medical professionals, and the government work together to regulate the field. In this way, even if government mandates have loopholes, these weaknesses can potentially be strengthened by the actions of doctors and manufacturers. It is only through the combination of all three groups, with the government in the lead, that the medical field can be healed.