I'm making a career change by deciding to go to Law School. I've been out of college for 8 years and I wanted to incorporate what I've been doing into my PS. I haven't seen many other statements like that, so I wanted to post what I've written to see if anyone else can relate. It would also be nice to get any constructive feedback if you have it. It's on the longer side now knowing I can pare it down, most likely by combining and shortening the last two paragraphs. Thanks for reading!
In the summer of 2010, at the height of a national drug shortage crisis, endotoxin was seeping into the purified water system for one of the largest pharmaceutical manufacturers in the country. When this toxin enters the bloodstream, it causes cardiovascular system damage, organ failure, and septic shock, a devastating combination for patients already in need of medicine. As a Microbiologist at this company, I spent weeks analyzing distillation deficiencies and filter failures to ensure safe drugs remained available to patients. In my quest to halt this endotoxin intrusion, I discovered a testing flaw that compromised safety data for over a million doses of drugs on the market.
The intruding endotoxin was a straight-forward problem with a clear solution. The water treatment system needed cleaning and maintenance. I caught this issue before any products were affected. I determined the specific location for maintenance by reviewing the endotoxin test data. I began the tangential testing flaw investigation because a couple unusual data points caught my attention.
Laboratory experience prepared me for this investigation. I set up dilution schemes, perfected pH balances, and inoculated test wells for hours each night. Every five minutes the predictable clicks, grinds, and zips of the kinetic analyzer rang out over the monotonous, whirring vortexers in the lab. The sounds signaled the collection of a new raw data point. I rushed to the monitor for the newest data to forecast my workload for the night. If positive controls were not reacting in unison or a pipette variation caused a hot-well, I was in for a long night of retests.
This raw data was never officially reviewed. It was archived yearly, filed away off site, and forgotten. At the end of each test, the testing machine churned out a final report that simplified the data into pass/fail terms. We used this report to determine the acceptability of each batch of product, but digging though the raw data was the only way to verify the testing flaw.
The unusual data points, both of them generated by a single analyst, showed no resemblance to the raw data from my tests. After further review I noticed a pattern in this analyst’s tests that led to a single conclusion. Over a three month period, the analyst failed to add a critical enzyme to their test samples. To complicate the issue, when the enzyme is not added to a sample, the sample always passes in the report. If endotoxin was in one of these samples, it never would have been detected. My company released batches of product to the market based on those invalid tests.
I pondered how the analyst could make the mistake of not adding the enzyme when the entire test is based on the enzyme’s reaction. Officially, the analyst forgot to add the enzyme in error, but this explanation was hard for me to believe. After poring over three months of data, I was convinced the analyst made calculated steps to fool the test into reporting everything as a passing result. Could the fear of a longer work day really convince someone to compromise the integrity of a patient’s medicine? I want to help my colleagues see the impact of their decisions, and I took on the challenge to retrain this analyst on the test.
I worked overtime with my laboratory team to complete all repeat testing within three days of discovering the issue. I even implemented a review process to prevent the issue from happening again. However, the ethical and legal implications of our response sparked my interest in law. For that three-day period, I knew products were on the market based on false test results. Did the patient’s need for medicine outweigh the risk of contamination? I considered larger scale quality concerns. How extensive (and expensive) must a contamination control program be before the costs make medicine unavailable to a patient? Should we allow international products to supplement the US market during shortages, even if they are made under different manufacturing quality laws?
I believe the answers to those questions require a balance between risk and reward that must be assessed for each situation. I have faith in our legal system to maintain that balance. I realize the impact I have as a pharmaceutical tester is important, but perhaps my impact could be greater if I entered the field of law. My time spent in the laboratory studying intricate and overlooked test details foreshadows my career in the field. I improved pharmaceutical contamination control procedures over the last 8 years. I want to continue to improve the healthcare industry by learning, understanding, and applying the law to keep our patients safe.
I understand the opportunities to combine my experience with a law degree are varied. I can find fulfillment helping an inventor navigate the patent system for error proof test equipment, or working for the government to pass administrative rules regarding laboratory testing. My ultimate goal is to use my extensive quality control experience to become in-house counsel for one of the largest pharmaceutical manufacturers in the country. There, I could combine my science and legal background into drafting and defending compliance policies for all manufacturing and testing procedures. I will maintain open lines of communication with employees to ensure the company upholds the most rigorous guidelines possible – uniting behind the mission to improve public health.
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