Pharmacotherapy, visibility and expectation management
Vox Medica's E. Michael Scott examines lessons learned from the first Vioxx case.
"Medicine is of all the arts the most noble; but, owing to the ignorance of those who practice it, and of those who, inconsiderately, form a judgment of them, it is at present far behind all the other arts." - The Law of Hippocrates, c. 390 BC, as translated in The Harvard Classics, Vol. 38, 1910
Amid the anguish and the gnashing of teeth following events in a small town courtroom in Texas last week, there should be significant concern that the leaders of the global biopharmaceutical industry grasp hold of and act appropriately on two major lessons: (1) "science" is not the same as "truth" and (2) footnotes that explain details do not equal transparency.
Whatever one may think of the merits of the outcome in Angleton, one specific item is clear: even the two members of the jury who voted in Merck's favor apparently felt strongly that the company had been insufficiently forthright about the cardiovascular risks associated with Vioxx. And so that there is no confusion, this writer believes that while the legal decision was seriously flawed, Merck brought this problem on itself through an unwillingness to adhere sufficiently closely to its own corporate mission and values (www.merck.com/about/mission.html).
While Hippocrates never used these words in the Hippocratic Oath, all doctors and vast numbers of consumers are well aware of the dictum "First, do no harm" ("Primum non nocere") used by Galen in his Latin translation of Hippocrates' original Greek. It is a simple argument that because Merck was insufficiently forthright over time about the cardiovascular risks of Vioxx, physicians were unaware of those risks, and large numbers of patients thus were prescribed Vioxx based on poor physician appreciation of the risk/benefit equation. Combine this premise with the aggressive DTC advertising, and it becomes easy to understand how society views the Vioxx situation. The precise legal merits of the case may still be open to discussion and interpretation. Society, however, is highly unlikely to change its viewpoint... and society will rule the day.
Over the next few years, thousands of lawyers and regulatory experts are going to have to advise their biopharmaceutical clients and employers about communications strategies based on the risks associated with the outcome of this case and the many more Vioxx cases to come. Naturally, it will be easiest to take the most conservative and simplistic positions. However, this will be a poor response for the long term. True transparency is the only good answer. Scientists need to be clear about even small but meaningful risks associated with potentially widely-used products (especially when those products are widely used for the chronic care of otherwise relatively well patients). Marketers need to show restraint in their tendency to "push the envelope" in terms of therapeutic claims while using footnotes in 8-point type to ensure compliance with regulatory concerns. Sales personnel need very clear guidance about applying their selling skills to the approved product labeling. Senior executives need to set a corporate tone that is firm about transparency and frank about the corporate need to actually be transparent.
If the global biopharmaceutical industry becomes slightly less profitable as a consequence, this will still be a vast improvement compared to the utter destruction of one of the greatest societal advances of the past 100 years -- the development of a business machine that has produced effective (and relatively safe) therapeutics to treat literally hundreds of different clinical disorders, from common problems like hypertension and acne to the rarest forms of enzyme deficiency disorders.
It has already been suggested (yet again) that Congress should pass legislation that states that once the FDA approves a medication for clinical use, there should be no potential for later legal risk so long as the product is used within the approved labeling by physicians and their patients. Such a suggestion is simply unrealistic. We do not apply such thinking to any other form of regulated product (cars, banks, food, etc.).
What we need to do is re-learn the art of expectation management as it affects drug therapy. Every pharmaceutical and biotherapeutic available today comes with some degree of effectiveness and some degree of risk. Physicians' and consumers' expectations need to encompass and reflect this reality. We all truly need to recognize that the degrees of risk are serious, and sometimes mortal, and manufacturers, regulators, physicians, patients, consumers, and even lawyers all have responsibilities associated with communicating these risks clearly and unequivocally, and then acting appropriately. Last but not least, pharmaceutical and biotherapeutic manufacturers are uniquely positioned to use their actions to communicate appropriately instead of just their words.
E. Michael D. ("Mike") Scott is a principal and executive vice president of Vox Medica. The views expressed in this commentary represent personal opinions of the author and do not necessarily represent the views of his employer.