As a nurse with an MBA, I was quite marketable to the medical industry. I knew both sides of the industry: the customer (hospitals/doctors/nurses) and the business workings (MBA power). I finally was hired by a subsidiary of Pfizer, Inc. called Shiley, Inc. At the time that I arrived on the scene, Shiley was in the mist of a very serious product liability problem. The last mechanical heart valve, called the Bjork-Shiley Heart Valve, the company manufactured was fracturing. It was in the beginning steps of a major recall. Not an easy job when the product that needs to be recalled is an implanted product.
O.K….now back to my story….So I went to the interview with great hopes of being hired to help "bring a product to market." During my interview I was informed about the difficulties the company was having at the time. I eventually ended up being hired by the department that was established to handle all issues regarding the heart valve problem. Initially, I was hired to manage the financial concerns of the department, e.g., consulting contracts, budgets, and advisory panel meetings.
Then one day I was informed by our legal department that there was information, boxes full of company documents, that I was to check out and see if the legal department was to catalog. At the time, the legal department was cataloging all company documents that may be required as evidence in present or future lawsuits. They thought the 80 boxes delivered to me, and left in their holding room, were filled with information that may need review by the attorneys.
To my surprise, when I opened one of these boxes, I found patient type information: lab reports, operating room notes, x-ray results, and so on. I looked at one of the Legal Eagles and asked them what they were doing with patient information. They soon informed me that I was responsible for the documents in those 80 boxes. I was informed that it was a study. A study involving 896 subjects who had been implanted with a tissue heart valve and needed follow-up. Oh my Lord!! Are they kidding??? Where is the chocolate!!! I could not believe my eyes or my ears.
I soon contacted my boss and asked what was going on. Well….it seemed that Shiley in its panic to solve the problem concerning the mechanical heart valves had not completed all outstanding studies. In fact all clinical studies had come to a halt until the problem was to be resolved. Unfortunately, the FDA did not see eye to eye with Shiley regarding this solution. The FDA had found this study, MY STUDY, in their files and wanted the subjects located and followed. The FDA knew that the company had no aspirations to market this valve, but there were 896 people out there walking around with this tissue valve and status regarding their well being and health had be done.
Since I was a nurse, everyone thought I would be the perfect person to "find" all these study subjects. Just because I understood medical terminology did not mean I understood what in the world it took to conduct a study. Where's that Godiva chocolate?!!
Anyway, I was told that a new protocol was to be developed, CRFs were to be designed, the IRB at each institution was to be contacted, and the relationship with each of the PIs was to be re-established. To put it mildly, I HAD NO IDEA WHAT THEY WERE TALKING ABOUT!!!
First of all, I wanted to know how in the world the company "lost" 896 people. Did they take a wrong turn on the turnpike or maybe they were on an endless subway ride through Manhattan? And all those ACRONYMS! I just had wanted someone to speak in a complete sentence without using alphabet soup. To summarize, I was scared to death. I knew the FDA was already disgruntled with Shiley. Now I had to come to the party and do a job and I had do it well. I had visions of me heading to Federal Prison if I screwed up. Does anyone know how to bake a cake? Preferably one with a saw in it.
To say the least, I came into the clinical research area with absolutely no training or experience except for my nursing education. Being a very quiet and demeanor lady (Ha! Ha!), I requested, very loudly, that I needed HELP. To my benefit, I was trained by a former Pfizer Regulatory Director who had just retired from the company after 35 years and was willing to tutor me.
The majority of the time as I was learning I was also doing. I had deadlines and requirements that had to be met. I was not only the project manager, but I had to monitor the sites as well. And by the way, I had 14 sites. There were 2 in Europe, 1 in Canada, and 11 throughout the U.S. Let me tell you if I never see another airport in my life….I won't cry.
Needless to say, I learned. I learned a lot and finally became comfortable working in clinical trials. I not only gained invaluable knowledge but 25 pounds to boot. I don't know how you spell relieve, but I spell it C-H-O-C-O-L-A-T-E and don't you forget it.
During my time at Shiley, my position and its responsibilities changed. Over time I shifted from clinical trials to concentrating full-time to a newly established patient registry. At the time, I do believe that Shiley was the first company to establish this type of registry. We were searching for patients who had received one of the problem heart valves and was requesting information regarding their valve. Registries of this type are now strict requirements for all companies who manufacture implantable products.
Well…The best part of all that craziness was that I survived and my experience even though at times was very stressful, it was in many ways extremely remarkable. I now do contract work regarding clinical trials and I teach (the best part of my professional life.)
Life at Shiley gave me the opportunity to see first hand what can happen to a company that has made mistakes, what regulatory agencies demand and what their expectations are, how the medical industry supports one another and, most importantly, how the public perceives a troubled company.
Fundamentals of Clinical Trials - Lesson 1 - Topic 1 - Page 1 of 2