Marketers and PR practitioners are finding that managing perceptions about certain drugs among advocacy groups has become a constant challenge. But working with consumer activists --rather than working against them -- can actually aid in the marketing and medical process of certain drugs --whether they're on the market or under FDA scrutiny.
Advocacy groups can help accelerate FDA submission and drug approval, promote healthy behaviors and help overcome reimbursement obstacles with managed care organizations.
Recently, the ALS Association in Woodland Hills, Calif., participated in an Internet-conducted launch event for a new Lou Gehrig's disease drug at http://www.als.org. ALS, Amytrophic Lateral Sclerosis, is a motor neuron disease whose cause and cure are unknown. But profitably working with advocacy groups takes understanding of their individual agendas. It also requires marketers asking themselves the right questions throughout a brand's market lifecycle, said Julie Wang, president of Wang Associates in New York City.
When you look back 10 years to 1987, consumer activism around specific diseases was uncommon.
But today consumer involvement has increased dramatically. Activism has moved beyond the AIDS arena to cancer, women's health, various chronic disorders, and more.
When a drug firm embarks on phase I and II clinical trials, ready or not, it begins marching into a field of communications challenges, said Susan Newberry, senior vice-president of Ruder-Finn's healthcare division in New York.
Some drug marketers are quickly realizing that managing perceptions about their drug and corporate image with advocacy groups becomes as crucial as getting the drug approved. "Excluding patient groups from drug development and marketing issues is no longer an option," said Newberry. "Today, appropriately mobilized advocacy groups bring a lot to the party."
Accoring to Newberry, working with advocacy groups such as the American Cancer Society, the American Lung Association and the Whitman-Walker Clinic has many advantages:
Patient groups are so strong that some clinical studies have been unblinded by members tapping into active communications networks formed by the advocates, said John Deats, senior VP of healthcare for Lobsenz-Stevens in New York City.
Advocate involvement binds patients, doctors, government agencies and drug companies. It is everyone's responsibility to incorporate these groups into market and strategic planning, said Deats.
Early on in this continuum, drug firms are fielding clinical studies so data can be collected for FDA submission. It's critical that Phase I & II trials are filled with qualified patients to advance research - a goal that is often difficult to achieve for a variety of reasons: orphan diseases with small patient pools, trials with rigorous exclusion criteria, several drugs within that therapeutic category under study competing for patients, etc.
"Patient groups are a rich source of study candidates and can become allies in accrual," said Newberry. "They are one of the best sources to tell you if a protocol, as designed, will in fact appeal to patients."
As drug studies move to Phase II & III, questions about expanded access and compassionate use arise. Here again, involvement of advocates can help mitigate problems regarding access or, in some cases, provide input that improves the program.
At launch, advocacy groups have a vested interest in helping communicate information about a new drug to the public. For example, at the launch press conference last year for a new drug for schizophrenia, the National Alliance for the Mentally Ill (NAMI) presented results of the first self-assessment survey of patients with schizophrenia to evaluate treatment needs. This shows that associations can take an interest and even become a mouthpiece for campaigns.
Once a drug is on the market, advocacy groups don't have the resources or the dollars to implement large-scale programs to educate constituencies about the new option. Often, advocates turn to drug companies to underwrite events or materials because of a mutual benefit.
(ALS Association, 818/34--7500, Lobsenz-Stevens, 212/684-6300, Ruder-Finn, 212/593-6400, Wang Associates, 212/685-1900)