In the wake of the cox 2 controversy, exemplified by the recalls of Merck's Vioxx and Pfizer's Bextra, major questions loom: What degree of risk are we willing to accept to cure what ails us?
Who gets to decide what degree of risk is acceptable? And on a related note, what is the role of the pharmaceutical company in helping navigate these waters?
In article after article, patients suffering from crippling arthritis have stepped forward to say that if apprised of cardiovascular risk, many would choose daily mobility over a small but real increase in cardiovascular events. Others have blamed these drugs for death that may or may not be related, loudly proclaiming they never would have gone near these pills had they understood the risks they were taking.
While this has certainly hurt the near-term fortunes of Merck, Pfizer, and other companies with similar drugs in development, the start of this discussion may yet signal something good for the pharmaceutical industry - and a huge opportunity if the industry is forward-thinking enough to seize it.
The pharma company that steps forward to influence the debate around this new kind of risk management has much to gain in this environment if they can walk the fine line between pushing interested - yet perhaps inappropriate - patients away and not scaring off the desired target customer in the process.
Witness the recent attention paid to Johnson & Johnson as it boldly explored this idea with its contraceptive, Ortho-Evra. The company's recasting of direct-to-consumer (DTC) advertising as education is laudable for its intent, as is the company's willingness to step forward into territory some may see as risky and counter to self-interest.
Twenty years later, people in our business still talk about Tylenol and how it set a standard for crisis management, as then-J&J CEO James Burke put consumers first and dramatically pulled Tylenol from the shelves without being forced to do so.
Perhaps counter to current prevailing wisdom, Merck took similar action in pulling Vioxx from the market when it believed that its risks did not merit its continued availability for patients who had other, seemingly safer alternatives available.
Whether that move turns out to reap benefits moving forward remains to be seen, but I think history will be kinder to Merck - a company with plenty of goodwill credit in the reputation bank - than many Monday-morning quarterbacks have been to date.
In the wake of events over the past six months, the pharma company that actively educates both professionals and patients about the benefits and the drawbacks of its therapies, as well as the kinds of patients for whom the pill of the moment is truly merited, has much to gain in terms of corporate reputation. To be effective, this must come to life through images, words, and the actual decision to push potential customers in another direction when the product is not necessary for them.
What does this look like moving forward?
Some might suggest we are in the current environment because of how effective DTC ads are in getting patients to ask for the drug du jour, whether or not it is best for them or medically necessary. Others note a payer system that doesn't do enough to limit the use of valuable therapies to those patients who are most appropriate and who need to take certain risks in exchange for efficacy they can't find in other products. Still others point to an FDA without the wherewithal, budget, or manpower to conduct the surveillance needed to ensure our safety once a drug is on the market.
All of these things are factors in the current environment.
But whether we discuss DTC advertising, what's wrong with managed care or the FDA, or star-driven media campaigns, the bottom line is this: A pharma company that tells its product's story so well that it actually loses some patients in the process may very well triumph in the end as one of the strongest players.