Pharmaceuticology 101: A course we should all take seriously

By: Anthony Fleg

 

Medical students learn much about the art of medicine in the clinical years, honing diagnostic and therapeutic skill sets. What you may not realize is the added, non-credit course that you take in the midst of your rotations - "Pharmaceuticology 101." Differing from pharmacology, the study of therapeutic agents and their effects on the body, pharmaceuticology involves the interaction between physicians and the industry that manufactures and promotes these agents. Medical schools do not prepare their students for the onslaught of drug company salespeople or advertisements that immediately vie for the loyalties of us doctors-to-be. Gone are the days from the pre-clinical years when drugs are known by their hard-to-pronounce generic names and complicated mechanism of action; now the medical student is expected to speak in the language of brand names, pill colors and catchy drug slogans.

Pharmaceuticology 101 is a reality of our clinical training, and confronts us with the larger question: What relationship should physicians have with drug companies? I find that many of us, busy learning the practice of medicine, never struggle to answer this question and, by default, conform to the norms of our elder physicians and the current environment which caters to the wishes of the drug industry.

In the first weeks of my 3 rd year of medical school, which for medical students in the United States marks the transition from the classroom to patient care, I realized that I could not simply conform to the status quo on such a critical issue. Therefore, I made a simple decision: I would not take any free food, pens, or other drug company propaganda until I had wrestled with the ethical and practical issues pertaining to my interactions with the pharmaceutical industry. My hope is that as I share what I have learned, my colleagues at various stages in their medical careers would invest time towards exploring these same issues; whatever position you then take towards your relationship with drug companies, it will be one based solidly on personal conviction rather than on the morally unsound justification, "I do what everyone else does."

Question #1: Can physicians interact with drug company representatives without compromising their ethical duties to their patients?

This question begs us to consider the foundation of both disciplines. On one hand, physicians take oaths across the globe in various languages, all of which have the core principle that doctors are ethically committed to doing the best for their patients. Patients' and their well-being is to be the focus of a physician's work. The pharmaceutical industry, meanwhile, has a simple founding economic principle - to maximize profits through the sale of prescription medicines. Dr. Brody, an American family physician writing on this subject, reminds us that this goal "includes persuading physicians to prescribe more the most expensive drugs."

Hard as you might try, it is very difficult to see how physicians who both take gifts and propaganda (including a lunch lecture on the "newest, biggest drug") from pharmaceutical salespersons and who also treat patients do not walk an ethical tightrope. How can we serve our patients' interests and simultaneously keep company with those who see our patients merely as revenue producers?

I took this question to the literature on the subject and found, to my surprise, that doctors have raised the ethical problems in this relationship for decades. Moreover, what struck me in the empirical studies on the influence of pharmaceutical salespersons on doctors are two consistent themes: (1) Doctors will prescribe medicines "in ways favorable to the pharmaceutical industry" in direct proportion to the frequency of contact they have with the sales reps (2) Medical students and doctors overwhelmingly feel that contact with drug reps has little or no potential for influencing their prescribing behavior.

Regarding the first theme, the simple truth that the drug industry spends $13 billion annually on gifts and promotional items, that it has increased its salespersons 50% over the last four years, and that the industry now spends almost three times more on "marketing and administration" than on research and development, implies that the drug industry knows very well that each pen, each lunch, and each "sample" has considerable influence on physicians. A randomized controlled trial looked at the influence on prescribing behaviors amongst resident physicians who either did or did not have access to drug samples. The authors conclude, "Resident physicians with access to drug samples were less likely to choose unadvertised drugs [and] less likely to choose over-the-counter drugs...there was a trend towards less use of inexpensive drugs."

Despite the growing body of evidence, doctors continue to underestimate the influence of drug advertisements on their prescribing behaviors. A recent study in JAMA of medical students revealed that 58% believed that gifts would not affect prescribing behaviors and 80% felt an entitlement to gifts. Further revealing the nonchalant attitude towards drug company influence, a full 60% of these students thought that grand rounds lectures were both "educationally helpful" and "likely to be biased." Interestingly, patients are less convinced according to a study that compared doctors' and patients' attitudes towards pharmaceutical gifts. Patients felt that these gifts "are more influential and less appropriate than their physicians. Moreover, half of the patients were not aware of such gifts and of these, 24% responded that this "knowledge altered their perception of the medical profession."

This paints a utopian picture for the drug industry: doctors that can be persuaded to forgo their ethical principles (to their patients) in favor of the economic principles of the drug companies; moreover, these doctors in a fit of denial and pseudo-oblivion have convinced themselves that there is no such phenomenon. The available evidence makes it hard to argue that physicians' ethical duty to serve the best interests of their patients are not compromised by our current "bosom buddy" relationship between physicians and pharmaceutical reps. Furthermore, as more patients realize the extent of this relationship, they are likely to have less trust and respect in their doctors.

Question #2: Can physicians stay informed about novel medicines without the help of pharmaceutical representatives and their materials?

For medical students and younger doctors, drug reps are seen as a convenient, and even essential source of information regarding the overwhelming number of drugs on the market. However, information provided by these "sources of information" is often biased towards the sponsor, minimizing negative aspects of the drug, and often using selling points that do not relate to clinically relevant, patient-oriented data. Take, as an example the 78 drugs approved by the U.S. Food and Drug Administration in 2002. Only 17 of these contained new active ingredients and the FDA classified 7 as improvements over older drugs. So, the majority of these 78 drugs had little to offer clinicians or their patients above and beyond the current drug choices, yet the drug companies had to find "selling points" for all 78 to convince doctors that these new, expensive medicines had compelling advantages. Paraphrasing a pharmacist who spoke to me on the validity of drug reps' information, she observes that junior physicians and medical students are often quoted erroneous and clinically insignificant, un-substantiated claims; while a pharmacist, whose job it is to know the medicines inside and out, might challenge these claims, she warns that physicians who do not bring substantial knowledge of a drug to the discussion are likely to be misled.

The same problem exists in printed promotional items. One study sought to ascertain the availability of references and sponsorship of "original research" using 438 ads from American medical journals, with a comparison group of 400 references from research articles in these same journals. More than 25% of the ads had no references, and 20% of the references given were "data on file" that is largely unavailable to the public. In addition, 58% of the original research cited in the ads had an author affiliated with the sponsor drug company (vs. 8% of the references in the research articles).

Given this data, it seems that medical students and doctors would do better to spend their valuable time researching competing prescription medicines than to turn to drug reps as trusted sources of information. Dr Ralph Faggotter, a general practicioner affiliated with Healthy Skepticism concludes, "Drug reps nearly always present misleading information in these meetings [with doctors]. If a doctor is up with the latest medical information, then they will pick up on this - but then they wouldn't be wasting their time on the rep in the first place."

Question #3: Does a physician lower the cost of medicines for their patients by taking drug company "samples" and other promotions?

Many doctors feel that drug companies "free samples" help them to care for indigent patients, for whom free samples of an expensive medicine may be the only way to get them this medicine. And, in a sense these physicians are correct. But, let us ask three further questions: Do these patients always need the high-cost, "designer brand" medicines they are prescribed? And what happens when this patient needs a refill of the expensive medicine? Thirdly, do all of these medicines make it to those in most need?

First, we must realize that there is no such thing as a free sample of a prescription drug. Instead, all samples are advertisements for a certain company's drug, no different than a billboard or magazine advertisement. No Free Lunch, in a document ("Where are the free samples") made to educate patients reads,

"Free" samples are promotional. The medications in the "sample cabinet" are always the newest and most expensive medications available. Sales-people want very much to get samples into our closet, because they know that once there, they will be given to patients.

When I tried to find research proving that drug samples save patients money, I came up with no studies that suggested this is the reality. What appears to be the more agreed upon consensus is that patients are given free samples of an expensive medicine and then kept on this medicine long-term, often not offered a similar cheaper (generic) medicine that might work equally well.

I spoke with a family physician in the southern United States about her perspective of the benefits of drug company samples, knowing that she had worked for four years in a clinic with indigent patients. I assumed that she had relied on drug company salespersons to provide medicines to her patients. "Actually, I never saw drug representatives there," she commented. 'In fact, there was only one [sales rep] who came to the clinic regularly." Her statements were all the more powerful in that her current clinic, a more affluent clinic a few miles away from the other had large catered lunches and promotional drugs provided by drug company salespeople every day. Examples such as this illustrate that drug companies make very calculated economic decisions as to where their "drug advertisements" are worth the investment; in a setting of poor patients who will not be able to afford the medicine, the incentive to send salespeople to give medicines to get them "hooked" on the newest, most expensive medicine was not there.

Addressing the third question a bit further, there are another set of reasons that promotional drugs do not reach the most needy patients. In the example above, the poorest clinic was simply excluded from the drug companies radar; however, many other samples are diverted from needy patients by clinical staff and even the salespeople themselves. One anonymous survey of all physicians, resident physicians, nursing staff, and office personnel in a family practice residency revealed that 51 of the 53 (96%) respondents reported having taken samples in the last year, with 4 persons admitting to taking 10 or more medicines. Another survey of 27 drug salespeople revealed equally startling misuse of samples, with 59% providing medicines to individuals other than physicians, 26% had exchanged medicines with other drug reps, and 48% reported self-medicating or providing samples to friends/relatives. Though these infractions may seem minor, the numbers of people in these two samples misusing promotional drugs suggests that much of the enormous costs of providing "sample" medicines within a region's or country's health system is not spent on medicating patients in need, but in medicating those with the easiest access to the medicines. This, taken with the larger body of evidence that discounts the justification that "samples" lower the costs of medications for patients, leads us to look for other means to cut costs for our patients. Indeed, generic medicines, patient assistance programs, and consumer-oriented websites that grade medicines by cost and effectiveness (i.e. Consumer Reports Best Buy Drug : http://www.crbestbuydrugs.org/index.html ) will do more to save your patients money than promotional drugs.

In conclusion, I hope that this article prompts you to study Pharmaceuticology 101 further, to make informed, ethical decisions in your dealings with drug companies and other commercial interests in medicine. Though the U.S.A. has unique problems (i.e. the massive effect of direct-to-consumer marketing), the issues and responsibility to change medicine is shared amongst the global community of physicians-to-be. In light of the evidence that exists, I would urge my fellow colleagues to begin by inverting the current default ("I'll accept drug company gifts unless I am convinced otherwise") to a more honest and ethically sound position - "I will not take such gifts unless I am convinced that there is no potential harm to my patients in my doing so." Join with other medical students to question your school, your doctor mentors, and the medical system around you regarding the need to create a physician-drug company code of ethics that is evidence based and brings medicine back into accord with its simple ethical duty: to serve our patients' interests without bias or conflict of interest.



References

Brody H. The company we keep: why physicians should refuse to see pharmaceutical representatives. Annals of Family Medicine. 2005; 3:82-85

Ziegler MG, Lew P, Singer BC. The accuracy of drug information from pharmaceutical sales representatives. JAMA. 1995; 273:1296-1298.

American Medical Student Association. Marketing versus research and development. (www.amsa.org/hp/RandD.cfm)

Adair RF, Holmgren LR. Do drug samples influence resident prescribing behavior? A randomized trial. Am J Med. 2005; 118(8): 881-4.

Sierles FS et al. Medical students exposure to and attitudes about drug company. JAMA 2005; 294"1034-1042.

Gibbons RV. A comparison of physicians' and patients' attitudes toward pharmaceutical industry gifts. J Gen Intern Med. 1998; 13:151-4.