Professionalism/Marketing of Pharmaceuticals

The pharmaceutical industry is a marketing giant. They spend twice as much money marketing their products as on developing them. The pharmaceutical industry has more motivation to sell their products than to innovate new treatments that improve quality of life.

In countries where they are allowed to, pharmaceuticals are marketed in a variety of ways intended to affect doctors, patients, and even children. Pharmaceutical companies create incentives for physicians to promote their brand-name drug and to give away free samples. When patients describe a vague set of recurring symptoms that are associated with a condition, they become convinced that they have a condition requiring the use of a particular drug. Tragically, children are often convinced in similar ways -- the TeenScreen program, for example, was funded by pharmaceutical companies to diagnose high school students with certain psychiatric conditions requiring the use of brand name drugs.

In this chapter, we will present the techniques used by pharmaceutical companies to promote and sell their products. We will also discuss the various consequences of these techniques and their ethical significance.

Advertising
Only two countries in the world allow drug companies to market to consumers directly, the United States and New Zealand. In the last two years, advertising dollars spent by drug makers have increased by 30 percent to 4.5 billion dollars.

Food and Drug Administration
The 1997 FDA guidelines that allowed drug companies to greatly expand the scope of their direct-to-consumer advertising required the companies to “present a fair balance between information about effectiveness and information about risk.”

The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) oversee direct-to-consumer advertising, monitoring ads to make sure information is “truthful, balanced, and accurately communicated.”

The FDA has been criticized by the Government Accountability Office (GAO) for its inability to ensure that all ads are reviewed adequately.

Direct-to-Consumer Advertising
There are three types of direct-to-consumer advertising:
 * Help seeking advertisements discuss a particular disease or health condition and advertises to the consumer to “ask your doctor” about the condition if you experience these symptoms. No particular product is mentioned within the advertisement.


 * Reminder advertisements calls attention a particular product, but it does not mention a particular health condition that the product treats. These advertisements target physicians that would recognize the product and be reminded.


 * Product claim advertisements include the product’s name and a therapeutic claim about the specific product.

Product claim advertisements are the most common and most memorable ones in public media, coming in the form of commercials and magazine advertisements. They are also the only type of ads that the FDA directly regulates.

Common techniques used in pharmaceutical commercials include: peaceful happy people, pleasant music, calming animation and colors, “free sample”, etc. These techniques shroud the information or disclaimers presented about the product. These gimmicks are used to entice the consumer rather than educate them about the drug.

“Ask your doctor about...” is a phrase often heard in drug commercials and seen on magazine ads. This phrase turns lay people into their own doctors, self-prescribing a specific drug. As a result, physicians may feel pressured to sign patient prescription requests. Therefore, these physicians are no longer paid for their judgment, but rather their signature.

These commercials and advertisements may also turn “normal people into patients. The ordinary experiences of life become a diagnosis, which makes healthy people feel like they're sick" according to Dr. Lisa M. Schwartz of the Dartmouth Medical School. These ads may magnify problems, implying that if you experience these symptoms, you might need medication. Therefore these direct-to-consumer prescription drug ads may also harm public health by advocating drug use as a primary response to medical conditions that can often be remedied in other ways such as diet, exercise, stress reduction, and other preventive measures.

Ad Disclaimer
A study from the University of Georgia, led by Dr. Wendy Macias, analyzed a week’s worth of direct-to-consumer commercials on broadcast and cable television. They found that the average 60 second commercial contained less than 8 seconds (13% of total ad time) of side effects disclaimer, while the average 30 second commercial contained less than 4.4 seconds (15% of total ad time) of disclaimers, and most of the 15 second commercial devoted no time at all to disclaimers. Almost all commercials disclosed side effect disclaimers in a voice over with 2.2% of commercials providing text form along with the voice over. The rest of the commercial is filled with gimmicks that are used to entice consumers rather than educate them about the drug of the health condition.

Perception of Risk
The information and disclaimers provided during commercials is “often presented in a way that most people aren’t likely to comprehend or even pay attention to.” (quote from Dr. Wendy Macias, associate professor in the University of Georgia, Grady College of Journalism and Mass Communication). Though the FDA is supposed to regulate and review these ads, some physicians ethically criticize these direct-to-consumer advertisements because the information provided obscures information about a drug’s risk, therefore reducing the perceived health risks associated with the drug.

Another case where perception of risk is altered is in the advertising of withdrawal syndrome. Discontinuation syndrome is an alternative term for antidepressant withdrawal. It was renamed in 1996, from withdrawal to discontinuation syndrome after a symposium hosted the drug manufacturer Eli Lilly. Common symptoms include headache, irritability, nausea, blurred vision, sexual dysfunction, brain zaps, and bone pain. These symptoms are common to all of SSRI antidepressants. This renaming of side effects to an unfamiliar name, such as renaming withdrawal to discontinuation syndrome, obscures the information about the drug's risk, therefore reducing the perceived risk associated with the drug.

Fava et al. concluded that 78% of patients who took the SSRI antidepressant Effexor would suffer discontinuation syndrome if they try to stop taking it. When a patient wants to come off Effexor, his or her doctor typically recommends first switching to another anti-depressant with a lower probability of experiencing discontinuation syndrome. It may take months to complete draw down off an SSRI antidepressant. Some patients resume taking their antidepressants due to the severity of the discontinuation symptoms.

Health Care Costs
It is reported that every dollar spent on these pharmaceutical advertisements yields an additional 4.2 dollars in sales. The money spent on advertising prescription drugs is passed on to consumers by raising the price of these drugs.

Reports of pharmaceutical company spending shows that twice as much money is spent on advertisement as on research and development. The top 25 direct-to-consumer advertised prescription brands accounted for 62% of total direct-to-consumer ad spending in 2008. Total pharmaceutical expenses rose from 11.4 billion in 1995 to 29.9 billion in 2006.

Pharmaceutical companies are for-profit business entities whose purpose is to make money. These companies advertise prescription drugs to increase their profits, not necessarily to improve public health. The marketing tactics used in direct-to-consumer advertisements may manipulate, create false impressions, and otherwise mislead consumers instead of educating them about the drug.

Brand Name vs. Generic Drugs
Physicians usually prefer cheaper generic drugs to more expensive name-brand ones, thereby limiting pharmaceutical companies’ ability to influence physicians through traditional marketing tools. In an attempt to regain control of the retail prescription drug market, companies shifted their focus in the late 1990s from direct-to-physician to direct-to-consumer advertising. An ethical argument by critics is that these ads drive up health care costs by steering consumers to costly drugs they may not need when less expensive, generic drugs can often be just as effective.

According to the American Medical Association, direct-to-consumer marketing "inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.” When a patient is visiting a doctor with the purpose of getting a specific prescription, the classic doctor-patient relationship becomes disrupted.  The AMA's official stance is to "encourage" federal regulators to "limit anticompetitive behavior by pharmaceutical companies."  This behavior abuses regulatory incentives and patent protections

Benefits of Direct-to-Consumer Advertising
The results of FDA surveys showed that the proliferation of direct-to-consumer advertising has led many patients to become aware of newly available medical treatments for certain health conditions, motivating patients to ask better questions of the healthcare provider. Surveys established that a positive public health response to the advertising was that patients sought additional information about those health conditions for themselves or loved ones.

Pharmaceutical Sales Representatives
Pharmaceutical sales representatives are salesman for pharmaceutical companies who are trained to pitch a product. The most important detail to realize is that they have absolutely no professional healthcare experience. A sales rep is hired for his/her presentability and outgoing nature. Historically, a sales rep's agenda is to convince doctors to prescribe their employer's drug over a competitor's. Currently there are 81,000 pharmaceutical sales reps in the US, or 1 sales rep for every 8 physicians. This number has risen over the past 20 years and is predicted to keep rising.

Profiling
Health care providers are carefully observed by sales representatives. Sales representatives change their techniques based on profiles. These techniques are cataloged and used by different companies to help sell their product better. The chart on the right is an example of a set of profiles that doctors are categorized into. It details the category of physician and the best strategy by which to make a sale. Profiling is usually used to identify which technique will be most effective for a certain doctor. These techniques often come under question by ethical standards.

Gifting
Gifting is a method by which sales reps earn favor with doctors. The practice used to allow sales reps to provide objects or favors with monetary value in exchange for higher prescription rates. Michael Oldani, a former pharmaceutical sales rep, stated that, "the essence of pharmaceutical gifting is bribes that aren't considered bribes." Reps understand that gifting will often be reciprocated even if unintentionally. As stated in the profile chart, "Gifts are used to enhance guilt and social pressure. Reps know that gifts create a subconscious obligation to reciprocate." . Critics question the ethics of these methods citing the doctors responsibility to operate in a patients best interests. However, the practice is still commonly found even today.

Recently, there have been measures enacted to prevent excessive gifting. Some states have introduced "sunshine laws" in an effort to offer more transparency about gifting. Sunshine laws set thresholds for how much money reps can spend on gifts. Beyond certain limits, reps are required to disclose their expenditures in gifts. However, reps will circumvent these rules by providing gifts in the form of paid vacations and dinners which can't be regulated.

Script Tracking
Pharmaceutical companies use 'prescription tracking' to target their marketing efforts. They purchase prescription records from pharmacies and cross reference these records with Physician Masterfile, which is maintained and sold by the American Medical Association (AMA). With this data, pharmaceutical companies can observe the returns on their detailing investments, as well as identify "high prescribers", or physicians who regularly prescribe their medication. These physicians are first in line for gifts and attention from the drug reps to encourage them to continue prescribing. Pharmaceutical companies also categorize physicians into other categories such as "grower", "spreader", "loyalist", or "niche" physicians. These distinctions give vital information to the drug reps as to how they can persuade each physician to write more prescriptions.

History
The rise of prescription drugs and their current dominance of the pharmaceutical market brought about the massive expenditure on marketing. Before the 1900s, it was a common belief that people should be able to take whatever drugs they wanted and that any negative consequences were their own fault. People mostly medicated with Patent Medicines which had proprietary formulas and ingredients and were given without a prescription. These medications were widely advertised directly to the public in newspapers.

Early Legislation
The Pure Food and Drug Act of 1906 was an act "for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes." Under pressure from constituents after journalists reported on unsanitary conditions in US manufacturing plants, it was passed 240 to 17. Food Drug and Cosmetic Act of 1938 (FDCA) was a series of laws served to regulate patent medications by having them include ingredients. However, companies could still decide for themselves if their drug would be a prescription or over the counter medicine. . This was changed in 1951 with the Durham Humphrey Amendments to the FDCA, which required most drugs to be sold by prescription only. The amendment had a dramatic effect on the growth of the pharmaceutical market. In 1939, the market was around $300M, and had grown $2B by 1959. All but $4M of that growth was in prescription drugs.

Detailmen
Drug companies took notice of this and began employing “detailmen” to describe the details of their drugs to physicians. This is a mostly antiquated term but is sometimes used internally today. Detailmen liked to be thought of as more respectable than the "sleazy salesmen" stereotype. However, they were quite frank when discussing their profession with each other, as can be seen in these quotes from Detailing instructional books. ""Detailing is, in reality, sales promotion and every detail man should keep that fact constantly in mind.""

"“The Professional Service Pharmacist’s job is one of scientific selling in every sense of the word ... he must be a salesman first, last, and always.”"

"“It is apparent that the first qualification for a prospective Professional Service Pharmacist is sales ability, a love for selling, a 'selling heart.'”"

FDA Regulation
In the 1960s, after the US narrowly avoided the fallout from Thalidomide, the FDA was given much more power to regulate prescription drugs. It also gained the power to regulate drug advertising from the FTC. It spent the next several decades fighting direct-to-consumer advertising, with the exception of a regulation in 1990 banning “gifts of substantive value”.

Patent Extenders
In the pharmaceutical industry, the biggest profits are secured from monopolies on brand-name drugs protected by patents. Because of the monopoly on the drug, typical brand-name drugs can be marked up to $4.00 per dosage unit, therefore they are a large profit generator. When the patent expires, the monopoly no long exists and other pharmaceutical manufacturing companies can produce essentially the same drug and sell it at significantly lower price, therefore the brand-name drug loses 85% of the market share.

Therefore it is economically advantageous to create patents and monopolies on pharmaceuticals for the least cost. Patent extenders are drugs which are produced by slightly altering another drug whose patent recently expired. This is typically done by slightly changing the chemical compound of the previous patent expired drug to create a "new" drug for which a new patent can be obtained. These drugs are often marketed as breakthrough drugs with many advantages over the patent expired drug. However, these patent extenders are often similar or even identical to the drugs they replace. This behavior is highly unethical because, while the patient sees no additional benefit in a drug's effectiveness, they are paying a premium price for the new patented drug. As a result, pharmaceutical companies earn large profits without innovating a 'new' more beneficial drug.

There are a number of examples of patent extenders, two of which are presented below.

Pristiq and Effexor
Pristiq is a classic example of the patent extender. In 2008, Effexor's patent expired. Faced with a loss of profit, Wyeth (now part of Pfizer) created Pristiq (desvenlafaxine), which is the active metabolite of Effexor (venalafaxine). Effxor and Pristiq are chemically very similar and when Effexor enters the body, the liver turns (metabolizes) it into Pristiq and then distributed via the bloodstream. That is, once these two drugs are metabolized within the body, they are chemically identical. Nonetheless, Pristiq is can be marked up to as high as $4.00 per unit, whereas the generic version can be priced as low as $0.25 per unit. Moreover, through the use of free samples and direct-to-consumer advertisements, patients are given Pristiq even though Effexor or other generic alternatives may be just as effective.

Ritalin and Concerta
Another strategy used to create patent extenders is the creation of extended release drugs. Ritalin is a psychostimulant containing methylphenidate, while Concerta is simply a capsule form of the very same substance. Nevertheless, Concerta has been patented until 2018 and marketed to parents with children who have ADHD as a superior drug to Ritalin.

Conclusions
Pharmaceutical companies unethically market their drugs with the sole goal of maximizing profits. As business entities, success is measured by financial earnings and profits through pharmaceutical sales, rather than medical breakthroughs that improve overall quality of life. Thus, it is in each pharmaceutical company's interest for people to think they are ill. Pharmaceutical marketing, therefore, attempts to convince consumers that they have an illness and that a particular drug is the solution.