Pharma’s Cutting Edge

Whither J&J? Still held forth to business school students as an example of the benefits of “doing the right thing” even when it adversely affects short-term profits (viz the Tylenol tampering incidents), J&J is now the subject of criticism from some of its most important customers–academic medical opinion leaders. The charge? Failure to “do the right thing” regarding Natrecor, the natriuretic peptide approved several years ago as an acute treatemnt for CHF. As this article describes, J&J has taken a year (so far) to implement a large study that would address a gap in the safty signature of this once-promising therapy. I have no excuses to offer on J&J’s behalf.

I was surprised when Natrecor was first approved (I later learned from a former high-ranking FDA official involved with Natrecor’s FDA review that it barely passed muster then and would never be approved in a climate similar to today’s). As a then-employee of J&J, I was displeased with Chris Poon’s public pronouncements of a potentially large market for Natrecor in the near future, despite its narrow approved use. She was right, of course. Is it because she knew, as J&J’s chief drug marketer, that J&J was going to push Natrecor hard with clinicians not initmately familiar with its marginal efficacy and questionable safety but eager to have a new billable infusion therapy for their outpatient CHF clinics? I’m just wondering.

I’m sure the business case for the proposed Natrecor safety study is looking pretty bleak, perhaps with a high likelihood of negative NPV. If so, what will J&J do? I know the right thing to do. If the business case for the large safety study is decidedly negative, withdraw Natrecor from the market now and restate J&J’s commitment to discovering and developing more promising CHF treatments. If there’s a decent chance, even if it’s small, of recovering the cost of the study eventually, then do it. Do it soon. Involve the opinion leaders and all of the clinicians that prescribed Natrecor in its early days. Allow it to run largely independent of J&J. Use your influence and money to make sure its the best-run CHF study ever. And when its over, act humbly regardless of the outcome. Thank the participants heartily for their patience, guidance and participation. Publish the results quickly. And make sure everyone knows that although you were slow out of the gate, in the end J&J came through and did the right thing.