Position at City of Hope
Why did you decide to go to City of Hope?
The position gives me a chance to return to the academic environment and make use of some of the clinical, administrative, and scientific skills I have garnered at a time when this institution is looking at a very bright and promising future.
City of Hope is an excellent institution of modest overall size but of very high quality in both basic and clinical research and in clinical care. One of the hallmarks of City of Hope is the ability to take a fundamental scientific idea and translate it into a test of clinical benefit in a surprisingly short time and highly efficient manner.
The science that exists on the campus, the skills in stem cell biology, in developmental biology, immunotherapy, and in the fundamental therapeutic development sciences, are very exciting. The clinical skills that exist in the bone marrow transplantation area and in the drug development and new drug testing areas are also very good. The superb bioinformatics are first rate and offer a great opportunity.
And there's a general institutional commitment to the kind of coordinated effort that is likely to result in wonderful science and good patient care.
Can you give an example of what you mean by “a fundamental scientific idea” you will be overseeing as it goes from the lab to the clinic?
“One of our investigators has done some very important work with small interfering RNA (siRNA), which was Science magazine's Breakthrough of the Year last year. We are in the midst of designing a clinical trial using siRNA as a gene therapy application for HIV/AIDS to bring a brand new therapeutic option to these patients. We've done this before—City of Hope was responsible for the first human research activity using ribosomes in patients with AIDS-associated lymphomas in an attempt to treat both the lymphomas and the immunosuppression of the underlying AIDS disease.”
Tell us a little about your role at Pharmacia and how that will fit in with what you will be doing at City of Hope.
I did a few different things in my three years in the pharmaceutical industry, one of which was to directly oversee development plans and the research and development process. Coupled with my experience as a clinical investigator, first at UCSF and later at NCI, where we sponsored a great deal of extramural cancer oncology research, as well as at FDA, where we oversaw product development, my pharmaceutical company experience will hopefully provide some insight into how we can better take advantage of what we are doing at City of Hope.
Over the last year, I diverted more time to policy issues such as how to provide HIV medicines to the poorest nations of the world. I also served as a liaison to PhRMA for bioterrorism and biodefense, helping to coordinate some activities with the various governmental agencies.
PhRMA & Biomedical Preparedness
What did you do as Chief Medical Officer for Biomedical Preparedness for PhRMA?
“The role involved working with the Department of Defense, the Office of Homeland Security, and then the Department of Homeland Security, and the Secretary of the Department of Health and Human Services to identify what was needed for our country to be more fully prepared for possible bioterrorism threats or for naturally occurring infections that could potentially be equally serious and devastating. This was a new position, created after October 2001, when the anthrax post office mailings occurred. At that time, it became clear that there were some serious issues that needed to be addressed.”
By “serious issues,” are you saying we were totally unprepared for bioterrorism?
It's a more complicated question than that. As a nation, we had not really invested in the public health infrastructure and the infectious disease research. We didn't address potential threats at the NIH level, pharmaceutical companies and academic centers had not made this a major priority, our hospital and public health infrastructure wasn't appropriate.
So for many years, we had not paid sufficient attention to this, and therefore we were not sufficiently prepared for either a natural emergency such as SARS, or for a terrorist action, an intentional use of microbes.
After the anthrax attacks, there was a good deal of money invested, including in research, and we're making some significant progress in that regard.
Do you think we would be ready today?
“We're better prepared today than we were a year ago. But you can never be perfectly prepared. As a nation, we need to discuss what are the risks that we are prepared to deal with, knowing that we can't ever reduce the risk to zero.”
Pharmacia & Pfizer Merger
Right after you resigned, Pharmacia merged with Pfizer, which announced major layoffs. Did that play a role in your departure?
“I had the opportunity to stay, but I found it far more appealing to come to City of Hope. I really wanted to return to academic and clinical roots, and the acquisition of Pharmacia by Pfizer provided the opportunity.”
At the FDA
How did you come to be acting commissioner of the FDA?
I was asked to come to the FDA by [then-Commissioner] David Kessler, a very charismatic, talented individual. I had not anticipated going to the FDA, but yet it was a wonderful opportunity.
When Dr. Kessler left unexpectedly about a year or so after I arrived, I was asked by then-HHS Secretary Donna Shalala to serve as acting commissioner. I anticipated a 90-day tenure but when almost two years later it was still going on [laughs], I realized it had not gone quite as quickly as I anticipated. But it was a wonderful, wonderful opportunity to do some really exciting things, to deal with some first-rate people.
For example, the President of the United States signed a special program for approval of cancer drugs using surrogate endpoints.
We also did a number of things that helped public health in ways that are not so visible but are very satisfactory. Take bovine spongiform encephalopathy [BSE], for example. We put in place some very strict rules so the cattleman in the United States wouldn't make the same mistakes that were made in Great Britain and other parts of the world. So far the United States has not had a single case of BSE, and I'm extremely proud of that.
We did a number of food safety initiatives that were extremely worthwhile. A major policy consideration was the approval of direct-to-consumer advertising.
And, we brought back thalidomide for patients with cancer and AIDS. This was a monumentally symbolic action for the FDA, which has been appropriately famous for keeping that product from harming pregnant women and their children. Yet when it was the right time to bring thalidomide back, I'm proud that we did the right thing.
Would you have stayed if asked to formally take on the position of FDA Commissioner?
I don't know if I would have stayed if asked; that's the kind of speculation you can't look back on. I had a longer run in my nearly two years than many commissioners that were formally appointed. I had the best time, the most fun, we accomplished a lot, and it was a thoroughly delightful experience.
At that moment that such an interesting and exciting opportunity became available to me that I felt it was in my best interest to pursue that. And that was the opportunity to work with top scientists at Searle Pharmaceuticals and to really get an industry experience.
Achievements at NCI
Tell us about your achievements at NCI.
I was in the Cancer Therapy Evaluation Program, again working for some wonderful and talented people at an exciting time.
One of the achievements was the ability to bring Taxol from an interesting research project to a commercially available product to a product that would be available in sufficient quantity so that a large number of women with breast cancer would have enough of that product.
Also the identification of promising new products, the attention to the clinical trial system and the streamlining and re-energizing of the cooperative group system were all very important. During my tenure, the NCI and FDA began working more closely together to focus on solving some common problems.
Did you feel pressured to force Bernard Fisher, MD, to resign as head of the National Surgical Adjuvant Breast and Bowel Project after problems with the lumpectomy trial came to light?
“That has been talked about and written about in sufficient detail. This was an episode where different issues were wrestled with—some issues that had to do with how one can best monitor and ensure the quality of some of the most important trials that we do. It was a time when many different considerations were balanced. There is no value in me commenting at this point.”
What are some of the other highlights of your career?
“Before I went to the NCI, I was a faculty member at UCSF where I was responsible for clinical activities at the cancer unit.”
Which of your experiences offered the best year of your life?
This will be the best year of my life; each year will be the best year of my life.
The pleasure is in having a number of different experiences and the privilege to work with so many talented and well-meaning people over the years and then bringing all these disparate elements back and weaving them into a contribution I think I can make at this very fine institution at this important moment in its existence.
I look forward to helping the institution make the transition so that our second hundred years is as meaningful, with contributions as valuable, as our first hundred years.
Fifty years from now, is there any one achievement for which you will be best remembered?
“I couldn't even imagine. I've been very fortunate to have the opportunity to work with some wonderful people at some wonderful times and to try to make what contributions I can under those circumstances.”