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According to agency president Lena Chow,
the transformations wrought by advances in genomics will not only affect medicine, but how future drugs will be marketed, and how information about those drugs will be disseminated.
THE NEW CHALLENGES OF
PERSONALIZED
MEDICINE
With the completion of the first
understanding extends not only to heredi- tary factors of diseases, but also to the genes are brought into action (expressed), leading to disease onset. Just as important, ing important information about individu- alized variations in response to therapeutic agents. This ability to assess predisposition to disease as well as response to therapy provides a powerful basis for targeted diag- nostic and therapeutic development strate- gies that will ultimately lead to highly indi- The 1990s saw the introduction of viral load THE CHALLENGES OF
In this new era of personalized medicine, copies of a virus, to monitor disease pro- MARKETING COMPLEX
gression and therapy effectiveness in the SCIENTIFIC CONCEPTS
— are guided not only by phenotypic infor- mation such as health status and history, therapy was introduced with the launch of field of healthcare. The biotechnologymarket is very complex — frontiers in medicine — andformulating marketing strategy for medicine has far-reaching ramifications for the stakeholders in healthcare: patients, tor receptor 2), which is over-expressed in physicians, payers, the FDA, bio-ethicists, about 25 percent of breast cancer patients politicians, and manufacturers. These fun- and is associated with more aggressive dis- therapeutic selection process portend even cepTest, an immunohistochemical test used greater impact upon marketers of diagnos- tic and therapeutic products. Already, the in the tumor sample, which thus facilitated suited to Herceptin therapy. Since then, the predictive tests that are becoming avail- processes and in turn imposing new and dif- (fluorescence in situ hybridization), which ferent demands on marketing. This article directly measures the number of HER2 gene copies in the tumor cell. Targeting therapy to form of aspirin and low-molecular- weight the dawn of this new era, and offers a view patients who can benefit most from the ther- into a future where personalized medicine apy offers significant benefits in reducing the therapy while achieving a higher level of genetic risk can lead to more vigilant sur- An introduction to
veillance, leading to early detection and personalized medicine
significantly improved outcomes, as in the patient care (preventive, therapeutic, and genetic testing to identify predisposition to third use of genetic testing is in genetic inherited diseases, including cancer, heart counseling and the more controversial pre- basis, taking into consideration a person’s disease, neurological disorders, and con- genetic makeup, medical history, and envi- and BRCA2 genes, the presence of which is Personalized medicine:
testing is an integral part of this medicine.
where it stands today
cancer and ovarian cancer;factor V Leiden, As marketers, we will probably not see the linked to clotting disorders and in particu- accurate monitoring of serum drug levels in lar deep vein thrombosis; and a constella- drug selection and dosing for a few years, the 1980s made it possible for physicians to tion of genes linked to cystic fibrosis.
Often, identification of these genes pro- genetic profiles of patients into clinical trial (for example, digoxin and cyclosporine).
made possible by tailoring the therapy to is brief, but the trade-off is that what the process yields are simply reagents and not ment. Then direct the physician to laborato- diagnostic tests. This severely limits any predispositions is a rapidly growing area.
marketing claims that can be made regard- ing what the results of the test tell the physicians can draw conclusions about clini- cal relevance and take necessary action to include the use of genetic testing (and ulti- accuracy and precision) of the test.
mately the ASRs) in clinical practice.
risks of breast and ovarian cancer. Once a disease-causing gene (a genetic marker) is identified, designing a test for the presence few tools of the past to work with, which in of that gene in an individual is not diffucult.
turn, presents novel challenges for market- Many sophisticated laboratories, especially those in the laboratory — not manufactur- those in large teaching hospitals, have devel- ers — performance data, including those oped their own tests, called “home brews,” The challenge of marketing ASRs
comparing different testing methodologies, and are using them in clinical practice.
Recognizing the
challenges
cians order tests if they know the tests can tion is a tried and tested marketing tactic, cians order only tests that are clinically rel- maximizing the opportunity for linking the evant). So, if marketers cannot discuss the clinical relevance or the accuracy of a par- are not allowed in these “off-label” promo- biotech marketers are considerable and are ticular test, how will they be able get the tions, how does one create the association word out to practicing physicians about the value of the test? This challenge becomes visual cues that are so integral to brand Regulatory factors
and constraints
ment, typography, and other visual cues, it Recognizing the rate at which these tests is often possible to offer a bridge to the nition of performance claims, how will 21st brand and thus “brand” the educational century marketers continue to differentiate tional regulatory review, and at the urging maceutical detail force, trained in present- unlike the oblique approach of off-label pro- ing therapeutic rationales to physicians, motion, and tomorrow’s marketers can cer- can be leveraged to present new diagnostic tainly look to yesterday’s experience in tools to physicians and to field questions off-label promotion for ideas for promoting about the complexities of genetic testing.
ASRs. For example, medical education is a In contrast to in vitro diagnostic (IVD) classical tool in off-label promotion. Here is means the pairing of a screening test with a tests, which require extensive clinical trial the parallel: Educate physicians about the therapy, market success will go to the phar- results and review to demonstrate their rel- genetic markers, not the tests to detect vari- maceutical marketers who are able to bring evance to diagnoses, ASR reviews focus on ants in the markers. Provide scientific evi- clarity to complex and potentially confus- dence on how information about a patient’s ing issues of genetic predispositions and turing practice (GMP). The review process genetic makeup has guided clinical manage- The challenge of securing reimbursement
ers and promulgation of genetic testing usher in the new era of per- Another challenge in marketing ASRs is securing reimbursement.
This challenge is a particularly difficult one considering that the The challenge of communicating complex science
overall cost of this new personalized approach to treatment is typi- The single greatest challenge to current marketers can be found in cally many times the cost of traditional medicines, and payers (man- the complexity of the science that has given birth to personalized aged care organizations, Medicare, insurers) who are already medicine. The difference between marketing the productized out- feeling the squeeze of rising healthcare costs will bear the brunt of comes of personalized medicine and marketing today’s pharmaceu- these increases directly. These higher costs mean that more than tical products can be likened to the differences between the ever, marketing success will be dependent upon acceptance by pay- layman’s understanding of inorganic and organic chemistry. People ers. With toolkits limited by regulation, marketers will be required of reasonable skills in arithmetic can readily grasp inorganic chem- to take an even more aggressive role in demonstrating the value of istry, but organic chemistry is more complex and difficult to grasp.
the test to the payer. To achieve the success that one company, Myr- This comparison esentially rejects the notion that today’s product iad Genetics, recently achieved in obtaining reimbursement by managers and the healthcare advertising agencies that support their Empire Blue Cross and Blue Shield of New York (approximately current market basket of products will be up to the challenge posed $2,500 for a full sequence BRCA1 analysis for members who have a by the advent of personalized medicine. Translating this new, highly heightened risk of ovarian and breast cancer) will require planning complex science into meaningful marketing messages may well require a different breed of 21st century marketer, advancing to the forefront those with intimate understanding of genomics, pro- The challenge of patient privacy
teomics and experience in healthcare marketing. We are already The positive promise of health and healing that genomics and per- starting to see the emergence of highly specialized biotech advertis- sonalized medicine represent is a growing concern among con- ing agencies and a move toward further specialization within them, sumers about the negative impact of uncontrolled genetic and it is likely that this trend will continue.
information. With literally hundreds of genetic- based screening tests now available and hundreds more on the way, consumers are Meeting the challenges in the
understandably concerned that information from these tests may years ahead
be improperly used by employers to discriminate against them and With a veritable explosion of genomic and proteomics research- that healthcare insurers might also use this information to limit cov- based products on the horizon, pharmaceutical marketers will soon be facing challenges all but unknown in previous years. Regulatory Laws in every state currently regulate access to medical records constraints, changing roles of physicians in decision-making posi- and the disclosure of personal medical information. The Health tions, consumer concerns for personal privacy, increasing importance Insurance Portability and Accountability Act of 1996 (HIPAA) cre- of third-party payers and scarcity of biotech-savvy marketing, ated federal guidelines and extended health data protection to all public relations and advertising talent will combine to change the Americans. Directed primarily at insurers, these regulations will face of the pharmaceutical marketing industry as we know it today. ■ not become fully operational until after 2003, and even then regula- tions and laws are at best only promises for the future.
LENA CHOW
The legal debate centers on the adequacy of state and federal laws as they relate to genetic information. What, then, is the role for the healthcare marketer in this debate? Healthcare marketers have an obligation to leverage their knowledge, skills and resources to edu- cializes in the branding of transforma-tional products. She can be reached by cate and inform, with the goal of helping stakeholders take posi- tions based on facts and rationale, not hype and hysteria. This obligation begins today, as the accelerated discovery of new mark-

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