The Pivotal Prescribers

Thanks to managed care's efforts to steer patients into the least intensive treatment settings, primary care practitioners (PCPs) play an increasingly important role in prescribing. A case in point: PCPs write more than 70 percent of the prescriptions for selective serotonin reuptake inhibitors (SSRIs) used to treat depression, according to a September 2002 article in the Psychiatric Annals. Their patient load places PCPs in a pivotal role as major prescribers for many other medications as well. Yet, frequently pharma marketers have only a fuzzy understanding of what makes primary practitioners tick. To successfully target doctors in that desirable group, industry needs to better understand them.

WHAT PCPs VALUE

But they can be difficult to reach. Many PCPs do not belong to the American Medical Association. Only about half are members of a specialty organization such as the American Academy of Family Physicians (AAFP) or the American Osteopathy Association (AOA). And most caregivers who practice on the east and west coasts are employed by managed care organizations that operate as intermediaries, often raising barriers that reduce access to physicians.

The situation frustrates PCPs as much as it does industry. At grand rounds, dinner programs, and other medical meetings, physicians complain of increasing patient loads, reduced time with each patient, reduced authority in determining treatments, and shrinking financial compensation. Many feel like they are on a treadmill, and some fear that they will never be able to regain their focus on what attracted them to a medical career in the first place: protecting the welfare of their patients. This article:

• explains how primary care practices differ from specialty care

• discusses what motivates PCPs

• outlines approaches pharma companies can use to develop relationships with those caregivers

• highlights the potential benefits to industry.

In addition, it presents data from a survey of more than 8,000 PCPs nationwide that reveals the relative value they place on educational programs, services, clinical research, and samples. (See "What PCPs Value," page 64.)

Whole Patient Knowledge

Despite the fertile opportunity, the pharma industry has traditionally harbored biases against primary care that limited PCPs' involvement in research and on advisory boards, according to industry representatives who attended 2001 and 2002 Primary Care Network advisory board meetings.

Currently, only field sales reps routinely develop relationships with primary care physicians. Industry decision makers and policy setters most often consult with "thought leaders" and researchers who live in a world entirely different from that of the busy primary practitioner. That "super specialist" perspective gives industry a distorted view of actual medical practice.

Industry gives tertiary specialists its ear in part because of a mistaken assumption that knowledge and expertise follow the four-level structure of the medical pyramid. (See "Pyramid of Care," page 66.) Industry executives assume that thought leaders know more than tertiary care specialists who know more than specialists who know more than primary care physicians.

Although that hierarchy may be valid in the treatment of a specific disease, the expertise level reverses when it comes to treating a whole patient who has multiple medical conditions. Primary care has more insight into a patient's overall health than the specialists further up the pyramid. Consider, for example, someone with a parathyroid tumor who also has hyperlipidemia, hypertension, a difficult marriage, and a mood disorder. The primary care physician refers the patient to the subspecialist who treats the tumor. However, the PCP retains responsibility for the management and integration of the patient's entire medical, psychiatric, and psychosocial make-up.

US Pyramid of Care

In fact, an increasing number of patients with complicated medical problems are never referred up the pyramid because none of their multiple complaints meets managed care's criteria for subspecialty referral. Moreover, many patients prefer to receive treatment from their family doctor. A depressed person, for instance, may want to avoid the perceived stigma of referral to a mental health professional.

The PCP Difference

Because primary care doctors represent such a large potential market, pharma companies should develop disease management strategies that apply to the family practice setting. Education based on those strategies would help PCPs treat the whole patient and would include nonpharmacalogical as well as pharmacological approaches.

Such strategies also need to recognize three significant differences between primary and specialty practice. PCPs typically have much less time with each patient; only five to seven minutes compared with the specialist's 45–60 minutes. Another major difference is the patient's expectation of the clinical encounter. In one family practice residency program, patients presented an average of 4.3 complaints per visit, while they typically consult with a specialist for a single complaint. Finally, the diagnostic approach often differs between the two clinical settings. PCPs tend to rely on a working diagnosis that they confirm through treatment response, while specialists typically rely upon tests and diagnostic procedures.

It's no wonder that many primary practitioners are slow to adopt new treatments when they hear presentations only from the top of the medical pyramid. Specialists lecture primary care doctors with in-depth details of a specific disease and provide evidence-based treatment guidelines. Those guidelines are often derived from results of clinical trials done with "clean" patient populations, those with the specific disorder under investigation but with no other confounding conditions. PCPs value that clinical information, but when they return to their offices, they need principles of patient management that they can generalize to a wide variety of medical scenarios. Survey respondents considered lectures from their primary care peers nearly as important as clinical trial data.

A 2001 survey of Primary Care Network (PCN) members found that 88 percent of PCP respondents want educators who understand and appreciate the unique nature of primary practice and who can recommend practical solutions to their real-world patient care dilemmas. When they attend medical seminars, they want information they can apply to the next three patients they see with that condition. If those patients respond, PCPs immediately see the value to their practice and will likely change their treatment or prescribing approach.

Involving PCPs in Research

When developing medical research programs, pharma companies typically go to the top of the MD hierarchy. Industry researchers ask thought leaders to write protocols, and they employ specialists and tertiary super-specialists as investigators. Clinical trial subjects typically come from specialty practice populations, and those with co-morbid conditions are excluded. Eventually, the new data trickle down to primary care physicians, but only after undergoing lengthy compilation, analysis, and publication.

It's not surprising then, that PCPs question the relevance of such academic findings to their diverse patient populations, and they may hesitate to integrate new approaches into their practices. Their own experience may conflict with "evidence based" guidelines, and in such cases, primary practitioners will typically follow their own clinical experience.

One way to involve PCPs is for pharma companies to sponsor clinical integration trials-those conducted within a primary practice that test drugs in patients with complex medical problems. Integration trials can answer questions such as:

• Is this new drug safe for patients who have concomitant diseases and use other medications, such as antihypertensives or birth control pills?

• Does this new therapy treat the medical condition in such patients within a reasonable amount of time without many side effects?

• Do patients recognize the drug's value?

In Germany, general practitioners test new therapies in primary care settings in addition to research settings, reports Ulrich Goldman, MD, vice-president of Schering AG. That helps German pharma companies more accurately predict a drug's safety and efficacy and gives PCPs confidence that the medication will work with their patients.

The industry is also coming under regulatory pressure to assess the frequency of adverse events, which means pharma companies in general are becoming more concerned about how pharmaceuticals work in diverse patient populations. As first-line healthcare providers, PCPs are in a unique position to detect treatment outcomes and side effects early, before they become complicated and difficult to manage. Those physicians may be the first to see the benefits of new treatments and to identify treatment opportunities for new drugs. They are also likely to be the first to identify potential complications and patient subtypes at risk for side effects. Identification of both benefits and risks in clinical integration studies conducted early in the drug development process may lead to treatment guidelines that doctors can quickly adopt in real-world medical practices.

Investigator-initiated studies can also increase PCP involvement by enabling physicians to test the validity of a concept or an observation. For example, midwestern primary practitioner Roger Cady, MD, repeatedly heard his patients say that if they "catch the headache soon enough" they could prevent it from building into a full-fledged migraine. Acting on a hunch, he orchestrated a small study in which practitioners studied early interventions. The findings, which were later corroborated in a larger study, showed early treatment enhanced the efficacy of an anti-migraine drug and reduced adverse events and recurrence.

PCPs and Drug Safety

The primary care world is an untapped opportunity for pharma companies. Because PCPs write the majority of prescriptions, they are in an ideal position to monitor adverse events. Because they treat patients with multiple medical conditions, PCPs are in a position to observe possible drug interactions. Primary Care Network has suggested to pharmaceutical executives, managed care, and FDA that a network of PCPs who are trained in drug safety could test newly approved drugs in their own practices.

Research suggests that approach could provide multiple benefits for pharma companies, PCPs, and even regulators. PCPs like getting in on the ground floor and helping to shape research, regulators say they like the idea of sharing the burden of responsibility for drug safety, and pharma companies like the prospect of reducing unanticipated post-approval drug problems.

Industry observers anticipate that significant increases in user fees during the next several years will enable FDA to expand agency oversight of marketed medications. And recently FDA commissioner Mark McClellan expressed interest in ways Medicare and Medicaid programs might collaborate with FDA in the safety surveillance of pharma products. Those events affirm the potential benefits of conducting clinical integration trials in primary care settings before drug approval. It fact, some observers predict that eventually, FDA will require industry to provide patient data from actual medical practices. Pharma companies can take the lead by expanding the role of primary care physicians, who have not previously been involved in assessing the value and risk of prescribed products.

Natural Allies

PCPs' involvement in pre-approval trials could ease FDA's heavy burden, reported participants in PCN's spring 2003 advisory meeting. They also suggested augmenting MedWatch, the form FDA requires that physicians use to report an adverse event. Because filling in the form is so time consuming, only an estimated 1 percent of adverse events ever get reported. By streamlining the form and allowing online completion, FDA could make reporting adverse events easier and thus improve risk management. In addition, involving primary care givers could help communicate various risks to physicians, which, in turn, could modify their prescribing behavior. Perhaps best of all––for industry as well as for regulators––the use of clinical integration studies would clarify appropriate prescribing limitations, thus increasing regulators' options for market approval.

Another way for pharma companies to involve PCPs in product research is to select some thought leaders from the specialty of primary care. Research designs would then more effectively weave clinical experience into the evidence-based studies, making clinical trials relevant to the population that primary care manages. The findings of primary practice can even suggest important research questions. PCPs have observed, for example, that many chronic medical conditions are co-morbid in a minority of individuals. Such a constellation of disorders calls for further medical and product research.

Bob Ingram, vice-chair of GlaxoSmithKline and executive committee member of the Pharmaceutical Research and Manufacturers of America (PhRMA), says that when the industry is criticized for its methods, the public assumes guilt by association and blames healthcare providers as well. That perception makes PCPs and pharma natural allies. Clearly, working more closely with PCPs will provide numerous benefits to industry.

It will increase the likelihood that products succeed in the marketplace while providing a scientific basis for balancing risks with benefits. It could improve pharma companies' image by demonstrating concern for patient care while heightening the public image of new products and the healthcare delivery system. Not only could that collaboration help integrate new patient-care approaches into primary care more rapidly, it would enable pharma companies to identify a medicine's problems earlier in the product lifecycle and allow for earlier development of treatment regimens that reduce patient risk. Equally important is the cultivation of positive relationships with PCPs. By joining forces with primary care, pharma companies can turn a source of criticism into a resource of expertise and support.

Those approaches will also help pharma companies demonstrate that their corporate culture does not match media stereotypes, and they will help build a trustworthy, people-friendly reputation that will help them weather tough times. Public relations consultants tout that kind of systematic approach to reputation management as the best strategy for enhancing shareholder value, attracting and retaining high-quality employees, and minimizing the impact of a crisis on company operations. In the face of increasing market, regulatory, and customer pressures, pharma companies are looking for ways to maximize results. Working more closely with primary practitioners can help build company reputation, prevent expensive surprises, and improve physicians' prescribing behavior.