Back from the other side

In about 8 weeks, I am going to return to academic practice. I’m 50 years old and a pediatric oncologist. I left The Children’s Hospital of Philadelphia at the end of 1997 to start a new career in the pharmaceutical industry. Twelve years later, I’m returning: this time to the Morgan Stanley Children’s Hospital of New York-Presbyterian, Columbia University Medical Center.

At this moment, I’m wondering what I’m getting myself into.

I left for fairly common and mundane reasons. At the time, I had two young daughters, ages 7 and 4 years, two old cars and concerns about meeting my expenses on an academic salary. There was some unease in academics in Philadelphia at the time. U.S. HealthCare was sweeping through the city, and it was unclear how the hospital and department would deal with the expected decrease in revenues. Rumors of layoffs and pay cuts circulated periodically.

The work rules had also changed, particularly regarding the supervision of residents, documentation in the medical record, and the relationship of both of these issues to billing. It was no longer acceptable to simply co-sign the residents’ notes. Certainly, a new level of paperwork made a small impact on my decision to leave.

Still, personal finances were the biggest motivating factor, and I joined the first of the three companies that I would eventually work for in the pharmaceutical industry.

Moving to industry

I have no regrets about leaving academics for industry. I achieved much of what I set out to achieve by changing careers. Because two of the companies I worked for grew appreciably during my time there, I have achieved a level of financial security that would not have been possible in academics. I also learned a great deal about drug development and the machinations of the FDA.

I had work that was intellectually challenging and had the potential to be of some import. For instance, my work at ImClone Systems contributed to the eventual approval of Erbitux (cetuximab) for the treatment of colorectal cancer and squamous cell cancer of the head and neck.

Michael N. Needle

At another time in my career in industry, I worked on the evaluation of in-licensing opportunities as part of a business development group. In this role, I had some influence on how the company chose to invest assets — both money and human resources — in the quest to develop new products. In theory, making the right recommendations would lead not only to additional growth and profits for the company, but would also ensure that projects with the most promise received adequate funding.

One difficulty in this endeavor, however, is the time it takes to move a compound into the clinic and through the development process — often longer than 10 years. Success is typically measured by the number of deals that are made, with no assurance of how many — if any — will result in a therapeutic advance and how many will prove to be a waste of money and effort.

I also learned quite a bit about Congress and the U.S. legal system because of the controversy surrounding the regulatory history of Erbitux.

Partnerships and relationships

I also learned a lot about partnerships and the relationship between individuals and the organizations they work for. When I joined ImClone, we had a partnership with Merck KGaA to market Erbitux outside of the United States and Canada; later, ImClone entered into a second partnership with Bristol-Myers Squibb to market Erbitux in the United States and Canada.

Partnerships are a wonderful laboratory for the study of the organizational and personal influences on human interactions. At the surface, all three organizations were interested in the same thing: that is, bringing a new drug to market that will improve and prolong the lives of those with cancer, and to make money in the process. However, this superficial view hides considerable subtlety.

The organizations involved were very different. ImClone, my company, was a relatively new company that was in many respects indistinguishable from Erbitux. As Erbitux went, so would go ImClone. Merck KGaA is more than 200 years old, and although it was a publicly traded company, it was largely controlled by the Merck family. Bristol-Myers Squibb is closer to a 100-year-old publicly traded company.

The differences in the companies had a tremendous impact on the ways the employees related to their respective companies.

Prospects for failure

For the ImClone employees, personal, product and company successes were very much intertwined. If Erbitux failed in clinical trials, the company would likely fail. If the drug succeeded, then the company would be acquired by a larger company interested in the asset (ImClone has since been acquired by Eli Lilly).

Many ImClone employees did not expect the company to last as an independent entity. Few employees expected to retire from the company.

Merck employees had a different perspective. Merck considers itself the world’s oldest pharmaceutical company and would likely survive with or without Erbitux. Similarly, Merck employees had reason to look beyond the project; in the event that Erbitux did not reach the market, they would be held in high regard and assured further assignment. In many ways, the Bristol-Myers Squibb employees had a similar outlook.

These different corporate cultures must surely affect employee behavior. For the ImClone employees, the horizon is fairly short and failure is the biggest risk. If the drug fails, employees could well be out of a job, not an unusual occurrence after a drug failure at a small biotech company.

For Merck and Bristol-Myers Squibb employees, there is a tremendous chance for personal advancement if the drug succeeds, but there is also the fallback position of other programs within the company. Here the biggest risk is making a mistake that potentially leads to dismissal. Not surprisingly, risk aversion plays a prominent role in the thought process.

Measures of success

Is it any different in academic medicine? What circumstances in an academic medical center foster or discourage risk-taking?

I have been forced to revisit my curriculum vitae in the process of applying for my new job. I was a reasonably successful academic pediatrician at The Children’s Hospital of Philadelphia. I have published 37 peer-reviewed papers (some based on my work in industry), most of which have multiple authors. On a quick read, I am spread out fairly evenly from first author to middle to last.

I am not sure the world of pediatric oncology would be any worse off if none of these papers were ever published. Not that the work was not of high quality or followed a reasonable path of inquiry; it represents a safe collection of small, manageable projects that could be conducted in such a time as to satisfy the committee on promotions and tenure.

One interesting twist is that I found it difficult to find the right place to report my biggest achievement, the approval of Erbitux. I couldn’t submit the package insert as a paper, and my place on the author list of the related papers is buried to emphasize the contributions of the academic investigators.

Is there a place in academics for an investigator who places all of his efforts on a big bet? Is there a place for someone who comes to the committee of promotions and tenure with five papers, three of which are seminal works? Does the system encourage the pursuit of the lower hurdle, bolstered by quantity? Certainly, if I was asked career advice by a new assistant professor, I would suggest a path similar to my own. It has worked for most of my friends, and I have no example of someone who published a very few seminal works very early on. Who would take the risk?

After more than 12 years in industry, I’m very much looking forward to returning to academics. I’m particularly interested in seeing how academic medicine has changed and how my perspective has changed. Some slow developments may be less apparent to those in the field than to someone who is returning after a long hiatus.

Michael N. Needle, MD, practices at the Morgan Stanley Children’s Hospital of New York-Presbyterian, Columbia University Medical Center.