In today’s day and age organizations including hospitals
hire outside consultants to address an issue or challenge that has arisen.
These consultants are considered experts in the subject matter and are usually
independent entities and command large sums of money for their efforts. It is a
very good gig if you can get it as I have benefited from this role many times
myself! Consultants work on their own timelines and upon completion of their
work presents a plan to the senior leadership of the organization. It is pretty
unheard of for senior leadership of an organization not to enact the
recommendations of the consultant. The reasoning is “hey this person is an expert
and we have paid him/her a lot of money, so he/she must be right”.
When you think about hiring external consultants I want you
two remember the cult movie “Office Space”. The company, Initech, had hired
these two ass clowns Bob Slydell and Bob
Porter, “the Bobs”, to decide who would be let go from the company. These guys
were hysterical but you would be hard pressed to say they were effective. In
fact, Milton, one of the fired employees, goes on to burn the business down and
two other loyal fired employees try to steal from the company.
So let me tell you another
funny story about consultants. In 2001 while a Clinical Research Physician at
Eli Lilly and Company I was fortunate to direct the pivotal phase III
registration trial (PROWESS) of recombinant activated human protein C in
patients with severe sepsis. This trial was terminated early by an independent
Data Safety Monitoring Board (DSMB) because of the highly statistically
significant (P< 0.005) reduction in mortality in patients that had received
the active drug. Plans then began in earnest to submit a BLA to the FDA. As the
generic name for the drug was Drotrecogin alfa (activated) a parallel activity
of finding a brand name for the drug was begun. To this end, a large consulting
firm was hired and paid a “shload” of money to perform this task.
I remember the final presentation by this group to the full
Product Team at Lilly as if it was yesterday. They unveiled the new name for
the drug, ZOVANT. I am not kidding. Do the Google search. At the meeting I blurted
out “that dog won’t hunt!” I was questioned about my response and explained
that this name was not acceptable from a safety standpoint as it was spelled
and sounded too much like marketed drugs that were used in ICU patients such as
Zoloft, Zofran and Zosyn. Zovant was an anticoagulant drug with the potential
for bleeding; no small side effect if a patient received the drug
inadvertently. I was reassured that the consulting company could not possibly
be wrong. Lilly had paid them all this money after all.
I will move ahead to the pre-BLA meeting between Lilly and
the FDA. Ahead of this meeting Lilly had provided the agency with a set of
questions to be discussed. One of these questions was if the FDA would accept
the trade name Zovant for the drug. At the meeting the FDA answered this
question with a resounding “No”. When pressed on this matter, agency officials
noted that there were too many “sound alike” medications and there existed a
significant potential for medication errors. I cannot tell you how many evil
looks I received from my Lilly colleagues. Needless to say it was a very lonely
flight home for me on the Lilly charter from D.C. to Indy.
I tell this story not as an exercise in self-aggrandizement.
The point is I had spent years working in hospitals and ICUs. I knew what
medications were used on patients and how a medication error could lead to an
adverse event. I had developed this expertise simply by virtue of past
experience. Similarly, many hospitals and organizations have employees with
vast experience and expertise who are most apt to be able to address and fix
the concerns of the organization. How often are these people passed over in
lieu of paid external consultants? How much money is wasted?
Uh oh, I just realized I may have just cost myself lots of
money in consulting fees! I guess I will just go have bourbon out of my ZOVANT
mug.
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