Friday, September 23, 2005

More on "More Vioxx Agony"

Regarding the post "More Vioxx Agony", I can add the following opinion regarding Dr. Ed Scolnick.

As my former boss's boss and perhaps the most prodigious individual user of the department I managed, the Merck Reseach Labs (MRL) scientific libraries (other than the remarkable late Dr. Maurice Hilleman, that is), I can opine that I do not believe these emails and actions were presented entirely in context by the newspapers and plaintiffs.

It is my personal belief that Dr. Scolnick would not have let a drug on the market that he truly believed had significant risks. While he was indeed tough-talking (as were many senior people in MRL), in my conversations with him I sensed very strong scientific and medical ethics.

In fact, it was he who expressed concern to me over lunch circa late 2000 that the appx. 6,000 scientists of MRL varied in their ability to use scientific information searching tools, and that this could impair their ability to engage in the best science possible. His belief in conducting the best science was strongly evident in this conversation. Proficiency in using these informatics tools, we both agreed, were essential to scientists staying abreast of the latest developments in their fields. He requested an educational initiative be developed. I suggested a worldwide, intranet-based training program in literature searching proficiency.

As a result of that conversation, my staff and I developed an online training program in scientific literature search proficiency that Dr. Scolnick personally approved and promoted, and I expanded access to the most critical of those tools via a rigorously-researched request for additional departmental funding that he supported. (The non-scientist, non-clinician IT execs controlling my budget were noticably not quite so eager to spend on such 'intangible' assets as informational tools where ROI, while obvious to scientists, was difficult to quantify.)

I believe problems ascribed in the articles and in the courtroom likely originated elsewhere, such as in the scientific approach to the issue of rare adverse event detection itself. In addition, articles like this recent one in PLoS point out that even the best approaches can fail when studying low-incidence events with studies of low positive predictive value. As mentioned in this article, the 'biases' fostered by scientific competition, the profit motive, etc. can make the situation even worse, even in the absence of deliberate errors of omission or commission.

These are personal beliefs, of course.

As far as Star-Ledger accounts of his calling FDA staff "devious," "antagonistic," filled with "bastards" and "grade D high school students," I have little to say other than an anecdotal incident involving a former high-level FDA official that occurred after my time at Merck, when I was seeking new positions. This former official, only recently out of FDA in an adverse events capacity, was now running a pharmaceutical company adverse events data management group. I'd been interviewed by the hiring manager of the department, an Executive Director whose wife I'd worked with years prior at a hospital, and who had found my prior work of great interest to the department. A final interview was set up with his boss, the former FDA official, who worked at a distant branch of the company. My interview was to occur locally, at a company facility near me. However, just prior to the interview the ex-FDA official decided he could not travel due to a family member's illness. I therefore offered to drive the nearly 100 miles to his out-of-town pharma office office instead, and did so.

When I arrived, the former FDA official offered me no thanks or acknowledgement for having gone to the trouble, only asking me with somewhat of a smirk what "I had been doing since being unemployed." (To which I politely withheld the obvious answer "looking for a job, [meathead]...") I began showing him my relevant prior work, e.g., development from the ground up of a comprehensive cardiology dataset of hundreds of data elements, accompanying institutional information system, analytics and reporting system for invasive cardiology device/intervention outcomes and adverse events. This was built for a regional center performing over 6,000 procedures per year and was evaluated by national cardiology figures as "outstanding."

During my explanation of the project, the former FDA official rudely cut me off and stated "we don't need Medical Informatics specialists in our adverse events department." I had to hide my astonishment and dismissed myself from the presence of this SOB. Others told me this former FDA official had interviewed literally a hundred others in the preceding year and hired nobody despite an open position, and was basically devoid of social graces, not even greeting his staff when passing them in the halls.

Devious? Antagonistic? Bastards? Grade D high school students? Sample size of one, but a spectacular example nonetheless. What can I say?

Now, if only Dr. Scolnick had talked equally tough with the computer exec who decided upon laying me off as part of the 4,400-person reduction-in-force in late 2003...

Addendum: I should add that the biggest complaint of several clinicians and statisticians in the pharmaceutical adverse events data management department (the one presided over by the humble, well-mannered former FDA official above) was that access to the global adverse events database was often difficult and basically controlled by non-clinical IT personnel. This interview really ranked up there in the Annals of the Absurd.

-- SS