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.
