David's New Book

Monday, May 10, 2010

Life in Big Pharma


In October 2001 I was the Vice President for Infectious Diseases and Co-leader (with a marketing colleague) of the anti-infectives therapeutic area for Wyeth.  I was happy (relatively).  Tigecycline, our most advanced antibiotic, was moving through the clinic and results were looking good (aside from some nausea and vomiting – don’t laugh).  We had placed a new drug for hepatitis C in clinical trials along with our partners at ViroPharma.  Our new program to find novel broad-spectrum B-lactamase inhibitors was showing astounding early success.  I had been at a meeting in Boston and was about to take the slow road home to New Jersey by driving through some great country for Fall colors. 
As I got in the car, my cell phone rang. It was the President for Research and Development at Wyeth (Dr. R.) – my boss’s boss.  He rarely called and when he did, it was usually for some problem.  He said that he had been watching the rapid abandonment of antibiotics research by other big pharmaceutical companies like Lilly, Roche, Bristol Myers Squibb and others.  He wondered why Wyeth should stay in the area.  The ground fell from under me.  I babbled some sort of response.  Dr. R. said that he had already discussed the question with his superiors (the upper stratosphere at Wyeth) and they were interested in reviewing the question.  Having found my footing, I posed my own question.  Why were we in the anti-inflammatory field?  The only drug we produced since Advil came from outside – not from our own efforts.  Why were we still in Neurosciences – we had produced nothing since Effexor?  At least in Infectious Diseases we had a blockbuster antibiotic - piperacillin-tazobactam - whose sales were continually increasing.  He didn’t exactly agree with me. 
Our call did not end on a happy note, but I didn’t hear anything more from him for another month or so.  The next call from Dr. R came towards the end of the year and was a proposal to carry out a review of all the therapeutic areas.  The ID review was ultimately scheduled for May of 2002.  This caused a flurry of activity for the entire anti-infectives therapeutic area team.  Marketing got into high gear.  We studied the entire market backwards and forwards. We then made risk adjusted market predictions for tigecycline and our emerging B-lactamase inhbitors as well as our Hepatitis C program. It was a great learning experience for me.  All this resulted in a presentation to top management in May of 2002.  The result was an assurance and a handshake agreement with the CEO of Wyeth that anti-infectives was here to stay.  The next month, I left to take on a new job at Idenix, a small antiviral biotech in Cambridge, Mass.  By the summer of that year, Wyeth lost a large part of their sales revenues because of issues around their Premarin birth control franchise.  By November, Infectious Diseases research at Wyeth was history.  They kept about 10 people out of almost 100 to support tigecycline, which was starting its Phase III trials.  A few others were employed in other areas of Wyeth and many were simply “let go.”  So much for process, fairness and hand shakes.
In spite of this, tigecycline went forward and has achieved good success both clinically and in the marketplace.  The hepatitis C program failed in the clinic over the course of almost 6 drug candidates – still championed by the ViroPharma partnership that Wyeth maintained. The B-lactamase inhibitor program lingered in purgatory with no one in a position of power to champion the program for 6 years until the company finally decided to go forward with the lead compound into the clinic.  That lead compound was synthesized back in 2001 or 2002!  I understand the program has now been put on hold once again at Pfizer (after their purchase of Wyeth last year). Most of the folks involved with tigecycline from marketing and the few left in the research area to support the drug took early retirement or were dismissed during the Pfizer takeover. Pfizer, the proud owners of Wyeth, still has an antibiotics program, but in their announcements over the last several years, has not included antibiotics among its “core” areas – always a bad sign.
I wish I could say that my experience was unique or somehow atypical for large pharmaceutical companies. But I fear that the opposite is more likely to be true.  These large behemoth companies focus on their bottom line from one quarter to the next.  Anything that increases the risk for the bottom line can become a target for the number crunchers.  All the meetings, data, presentations and the work to prepare it all count for little when the financial push arrives.  Yet, these large companies are very fond of process and meetings both low level and high level.  The process and meetings slow decision-making and make the companies unwieldy in a rapidly changing world.  At the same time, when a decision has to be made rapidly, the result is frequently, and not surprisingly, poorly considered as was the jettisoning of antibiotics research by Wyeth.