Pharmaceutical Rep Case Study

Pharmaceutical Representatives and Physicians: Defining a New Policy of Regulation

The ethics surrounding the Pharmaceutical Industry in the United States and around the world have long been debated by not only healthcare professional, but the general public as well. Due to their high revenues rates and constant legal battles with the government and consumers, new regulations are constantly being developed. For example, in 2009, new voluntary regulations were put out by The Pharmaceutical Research and Manufacturers of America in order to establish guidelines regarding the relationship between physicians and drug representatives in an attempt to improve patient care as a whole. As stated in the new code, “Interactions should be focused

on informing healthcare professionals about products, providing scientific and educational information, and supporting medical education;” but, as seen so far, neither side is necessarily following through. Therefore, new stricter and involuntary regulations need to be made in order to guarantee that the patients and a high level of care are always the main priorities for healthcare professionals.
The Pharmaceutical Industry in the United States remains the most profitable business with a return of 17% on revenue. The top twenty Pharmaceutical companies brought in over $500 billion dollars in revenue in 2008, with Johnson & Johnson and Pfizer alone pulling in over $110 billion of that. While the industry has been in the decline the past two years due to the worldwide economic downturn, few expect it to decline over the next years. This is due to many factors, but not limited to, the increasing prevalence of diseases, rising healthcare costs and the growing affordability of medicines due to the increasing number of markets. In fact, many experts agree that the Pharmaceutical Industry will grow approximately 6.5%, with the value of the market, as a whole, to reach just shy of $1 trillion dollars by the end of 2013.
In order for pharmaceutical companies to make a sure their drugs are being prescribed by doctors, they employ nearly 90,000 drug representatives to maintain regular contact with practicing physicians across the nation. With currently only 500,000 practicing physicians in the United States, that means that there is almost 1 drug rep for every 5 doctors. Contact with these doctors begins when they are still in medical school and is accelerated when they begin their residencies. A national survey of physicians in 2008 found that meetings with drug reps can range anywhere from 2 a month to 16 times a month. Less than a decade ago, it was not uncommon for pharmaceutical companies to send doctors to elaborate resorts to receives pitches on a variety of drugs. Like many current practices by pharmaceutical representatives, the apparent benefit to patients is hard to justify.
While it is a drug rep’s job to promote and sell whatever drug they are marketing to physicians they are in contact with; there are many problems surrounding their practices.

In order to do this, drug reps simply don’t explain the benefits of the drug, but instead often resort to other means of influencing physicians’ decision. For example, things like food deliveries, free samples, expensive dinners for the whole staff, and tickets to a wealth of sporting events are not uncommon. It is quite plain to see that such gifts and benefits that doctors receive could comprise their ability to make a purely objective decision when deciding which drug to use. For example, “Patients with hypertension that are treated with ‘free’ drug samples are less likely to have their hypertension controlled than are patients whose hypertension is treated by the physicians’ free choice of drugs.” Why is that? The causality here is not clear. Are the drugs less effective? Drug companies believe these gifts and other perks like samples work so well that they devoted $13 billion in the year of 2006 to this practice. Even when pharmaceutical representatives finally do gain access to physicians and are given time to educate them on the benefits of a certain drugs; the information disseminated was often very questionable. “One study found that materials distributed during visits usually made assertions without providing evidence to support them, and sometimes promoted non-approved

uses.”
Another area of concern that is often left unnoticed is the effect of a physician’s interaction and their subsequent behavior. As previously mentioned, drug reps are known to visit physicians up to 16 times a month. This can have a huge impact on the amount of time a physician can now devote to their patients. Even with the constant visits from drug reps, few data has shown that physicians, after informational sessions will actually take the time to research the drug and therefore correct any bias they might have. Also, multiple studies found that the more time a doctor was shown to spend time with a drug rep, the less likely they were to prescribe rationally. (‘prescribe rationally’ requires explanation) Similar studies found that physicians, as a result byof more frequent contact with drug reps, would begin to favor “…the newly promoted drugs despite additional cost and sometimes in the face of evidence suggesting that they were inappropriate; prescribing of competitors’ products and generic drugs decreased.”
Due to many of the problems above, the Pharmaceutical Research and Manufacturers of America (PhRMA) developed a marketing code in 2002 and 2009 to guide the Pharmaceutical Industry’s relationship with doctors and other health care professionals. In 2002, the code focused on making sure drug representatives focus their efforts on informing doctors and health care professionals about products by providing educational and scientific information. To do this the code introduced several voluntary rules for particular activities. For example, drug reps are not to provide physicians with entertainment or recreational activities, such as golf outings or tickets to a sporting event. However, pharmaceutical companies are allowed to provide occasional meals, but they must be related to and conducive to informational meetings. Any gifts given to a physician must be primarily for the benefit of the patient and are not to exceed $100. Things like textbooks, stethoscopes, and practice-related gifts of minimal value—pens, notepads, coffee mugs—are therefore permitted. Lastly, no gift or benefit may be given to a doctor or healthcare professional in exchange for a physician’s agreement to prescribe a product.
In May of 2009, the PhRMA released a revised, but still voluntary, code that updates what denotes a proper relationship pharmaceutical drug representatives and health care professionals. While the foundational principle remained the same between the two codes, pharmaceutical representatives were given further detail into what constitutes a correct relationship with health care professionals. One of the biggest changes was in regards to gifts, especially meals paid for by the drug companies/representatives themselves. Once again, the meals must be modest in nature, but they are now to be restricted to take place only in the office or hospital, where the healthcare professionals actually work. Also, only those who actually attend informational presentations or discussions are allowed to attend. However, “…scientific or medical presentations made on behalf of a company by healthcare professionals engaged as speakers may be held at an appropriate setting outside the office or hospital and a modest meal that is incidental to the presentation may be served.”
Completely contrary to the 2002 code, drug representatives are no longer allowed from giving any non-educational items or gifts, including those of minimal value—i.e. pens with drug brand names on them. This new rule also applies to giving such gifts in a “third-party” setting, such as conferences and professional meetings. Examples of appropriate items include anatomical models, medical textbooks, scientific journal subscriptions and relevant clinical treatment guidelines. The new code does not address anything regarding free samples. Lastly, the new code strengthened their prohibition of any entertainment or recreational items to complete disallowance.
While these new regulations represent a lot of progress in the right direction, there still are many loopholes that need to be addressed. The biggest loophole is the fact that even though almost all pharmaceutical companies have agreed to follow the new policies, they are still voluntary. Currently, there are few governmental regulations that guide the relationship between doctors and drug representatives with most being on the state side. Without these, how can one expect everyone in the industry to truly follow these policies? Similarly, the new code still allows for “modest” meals in the office or hospital—with what constitutes “modest” that is obviously a matter of opinion. It is pretty hard for anyone to turn down a free lunch, even if they may have to listen to a pharmaceutical representative talk about a new medication during it. One of the biggest changes made by the new code was to prohibit gifts of no educational value, specifically the mugs, clocks, and pens. Many argue that these are not the things that truly influence a healthcare professional’s opinion on a certain drug.
Unfortunately the new regulations developed by PhRMA have not been in affect long enough for anyone in the industry to truly see if they have had a positive effect. Regardless, these new regulations still do not do enough to ensure that the all healthcare professionals consistently have patients at the forefront of their minds, not their pizza lunch date with their favorite drug representative. Many in the field have pointed for the need of governmental regulation. In the past couple of years, several states are leading the way in this aspect. In 2008, the District of Columbia passed legislation that required all pharmaceutical sales representatives to be licensed. This meant that had to meet a minimal educational requirement, as well as, adhere to a certain code of ethics developed by the Board of Pharmacy. The new legislation also prohibited any sales representative from “deceptive or misleading marketing” to healthcare professionals. While the intentions may seem good here, providing pharmaceutical sales representative “professional” status by licensing them, bring to the forefront a couple of concerns. This statue would “enhance their standing as educators for physicians and potentially increase the reliance of physicians on industry sources by validating their role.”
Other states have taken a more strict approach towards regulation, such that of Minnesota. In 2006, Minnesota enacted a law that prohibited any gift in excess of $50—this excludes things like drug samples and research consultation however. Following suit, in July of 2009, the state of Massachusetts banned all gifts expect for modest meals in a provider’s practice setting, drug samples, and indirect support for educational programs. This is probably the biggest step forward that any state has taken. As previous shown, there is a tremendous amount of evidence suggesting that a gift of any value has an influence on a physicians’ decision. Massachusetts, on the other hand, is able to “avoid the setting financial thresholds that would define the permissibility of gifts.” However, many would argue that states still need to go further and ban all gifts, including in-practice meals of any kind.
Whether self-regulated or government regulated, there still remains an astonishing amount of loopholes that can be exploited by pharmaceutical companies and their sales representatives. In order for the relationship between healthcare professionals and pharmaceutical companies to progress, stricter regulations by both the government and the pharmaceutical companies themselves need to be established; but where can these new rules come from? Aren’t state /federal regulatory institutions the appropriate sources for such rules/limitations? The NCAA has long tried to protect the student-athlete long before they even arrive to campus. That is why they have developed a strict set of rules, specifically regarding contact with potential recruits, in order to do so. While the healthcare industry and college sports may be two entirely different worlds, many parallels can be drawn between the two. This is why the pharmaceutical industry and the government should take notice of some of NCAA’s policies and apply them to future legislation and regulations.