Bennison Comment:
In 2000, prescription drugs accounted for 9% to 10% of total health care spending.¹⁹ Drug prices have been increasing at a rate of 5% each year, which is small considering the increasing costs of research and development.¹¹ Pharmaceutical companies devote, on average, 19% of their sales revenues to the research and development of new medicines.²⁰ In 2004, Pfizer spent $7.5 billion on R&D, which represents the largest spending in the industry. These R&D efforts covered 18 therapeutics areas.

The high cost of R&D is one of the principle driving forces in the merger and acquisition wave in our industry. By consolidating, companies can bring efficiency and economics back to manufacturing, marketing and sales. For a research-focused company to be successful, the products being developed have to be numerous and innovative and reach the market quickly. These new drug therapies have contributed appreciably to the extension of life spans and the reduction of hospital stays.²¹

Finding or developing a new drug and bringing it to market costs an average of $800 million. Only 1 in 5 drugs (20% to 23% of new drug entities) that enter clinical studies in humans eventually makes it to market - which makes R&D risky.²² The Waxman-Hatch Act allowed for a patent life extension to 20 years. A product is patented as soon as it is discovered, and bringing it to market may absorb 8 to 12 years of that patent life. This leaves a shortened patent life of 8 to 12 years for the company to recoup the costs of research, development and clinical trials.²³

Bringing innovative new therapies to market has become more costly for three primary reasons. First, a technology shift in the knowledge base for research has occurred. Second, focus has shifted from acute to chronic disorders.²⁴ Research for chronic diseases requires extensive testing for long-term effects and competitive drug comparisons. Drugs that treat acute diseases are developed at a much lower cost. Last, there is less room for me-too drugs. This means that the industry has moved away from modifying the structure of existing drugs. Current patent laws require any change in the chemical structure of drugs to undergo full clinical testing.

As prices rise or the difference between revenues and cost of production increases, R&D funding increases. As drug prices fall, the allocation for R&D decreases.²⁵ A successful pharmaceutical company will quickly bring forth innovative medications to fill therapeutic gaps or offer major improvement over existing therapies.

As far as enhancement drugs, they treat a disease entity, fulfill a patient need and improve quality of life.

The increased costs of research and development have resulted in a corresponding increase in promotional activities to inform providers and consumers about the benefits of newer medications. The main channel for communication of drug information to prescribers is the pharmaceutical representative. In 2001, pharmaceutical companies spent $5 billion on detailing activities and $11 billion on free samples.²⁶ Educating prescribers improves provider-patient relationships and compliance.

The PhRMA code has placed strict guidelines on promotional activities. Pharmaceutical-sponsored educational programs have the dual obligation to inform and to support disease management. Prescriber education is a way of bringing value to the business relationship. Being able to diagnose a problem early or more accurately can have cost benefits. Prescribers report using pharmaceutical materials more than any other patient education source.²⁷

DTC campaigns serve two purposes: They announce the availability of the product, and they educate patients about its appropriate use. Increased consumer awareness stimulates early diagnosis, which is beneficial. Better informed patients are more likely to take the medicines prescribed for them, which improves outcomes. Informed patients improve provider-patient relationships and improve the cost-effectiveness of patient care.

Problem: Prescribers are influenced by interaction with pharmaceutical companies. The companies offer educational programming and gifts that set up a conflict of interest that in turn threatens the integrity of professional decision making. Prescribers' judgments may be influenced, leading to prescriptions that are not in the best interests of the patient or society.

Crigger Comment:
Pharmaceutical programs are supposed to be educational, but in spite of PhRMA guidelines, their content is often biased and presents information that is more promotional than educational. Programs, journal advertisements, written materials and one-to-one sales pitches are often the only source of information a prescriber receives about new medications. Research indicates that the prescribers who use only promotional information about drugs are less likely to prescribe the medications according to patient needs.²⁸ Gifts that represent a larger sum of money, such as air fare, cocktails and expensive dinners, are suspect for influencing providers' judgment to objectively prescribe medications.^29-31

This concern has been addressed by the PhRMA guidelines, but that may not be sufficient. The common sense view that smaller gifts (pens or other inexpensive items) do not influence judgments made about patient care appears to be refuted by the research on gift giving to physicians. Even small gifts can affect prescribing patterns.^32,33 One of the main purposes of commercial advertising is name recognition. Research shows that the effects of gifts can be imperceptible: The greater the incidence of gift acceptance, the less likely the prescriber is to believe that he is influenced by gifts.³⁴

The giving of meals is a particularly powerful gift and often welcomed (or even demanded) as a repayment for time spent with the sales representative. The pleasurable feeling produced by food is projected onto the program and promotional message.²⁸ In both cases, a feeling of reciprocation is the primary psychological response.

Patients respect and value nurse practitioners, and the public trusts NPs to make the best judgments about their care.⁹ Given this privileged position, maintaining public trust is of utmost importance. Recently, the conflict of interest that exists between the NP's role as provider and his or her relationship with the pharmaceutical industry has raised the possibility of ethical misconduct.⁶

The major problem that can lead to misconduct is often referred to as conflict of interest. Although there is no consensus in the literature about the definition of this term, it indicates that an agent has multiple loyalties. When loyalties conflic, the nurse practitioner is to make decisions about patient care based on the good of the patient. For example, in situations involving the pharmaceutical industry, gifts and a nice dinner can affect a prescriber's thinking to be more favorable to a particular method of treatment or a particular drug.³³ Most prescribers deny being influenced, but research shows that even the most insignificant gifts can result in bias.³⁰