The Alarming Confessions of a Pharmageek

The Alarming Confessions of a PharmageekGuest blogger Andrew Rosenfeld writes:

In second grade science, I remember that we were taught about how scientists and engineers tried and failed to create perpetual motion machines. After school I immediately went home and began work on my own. I attached a wheel on a ball bearing and rod to a board and started arranging magnets and metal plates. I thought that, if I arranged the magnets just right, they would attract and the metal plates would block the magnets and the wheel would spin forever. My father found me and saw what I was attempting to do. He coiled a wire around a nail and attached it to a large battery and showed me an electromagnet. I used this, arranging them around the wheel and bent the wires so they would touch at just the right moment. The wheel did spin. Not what I planned in the beginning, but I thought maybe it could be connected to a generator to recharge the battery. My father came by again and cracked open an old blow dryer and showed me that I had created a motor. He told me I could do anything and I believed him.

When personal computers were made available, I learned how to program in Basic on a Commodore VIC-20, then an IBM and Apple II at the age of eight. I had a well-rounded childhood. I played sports and built computers to play the latest ID software games. When it came time to choose a career path, I chose the natural sciences like my father. In organic chemistry class, we studied synthesis and mechanism of classic pharmaceuticals like penicillin and I knew what I was going to be doing.

After college, I obtained an internship at a local cancer hospital doing basic laboratory research In a lab that looked for drug targets in a metabolic pathway. That led to a job in a chemistry lab in that same hospital designing and synthesizing experimental cancer drugs. I worked with graduate students from around the world and some of the best in the field. I was able to do some of the initial in vivo studies on the drugs I created and trained some of the chemists to work in the biology labs.

When the projects there were done and it was time to publish and move on, I ended up at a company that did wood preservation and the chemicals associated. There was a class action lawsuit filed because kids were being poisoned by the chemicals used to treat the lumber that was in the playgrounds at the schools and parks. This company put a team of scientists to work to find the next generation of formulas that were safer. I maintained the mold cultures and helped with the research. The money was great.

The company was acquired and the program was eliminated. 25 high-paying jobs were phased out over a year and it was rumored they hired a lawyer to deal with the lawsuit. Shortly after that came the housing crisis in 2006.

I then went to work for a professor who specialized in a particular HIV protein that acted as the key to get into the white blood cell or T cell. I had heard many times that the HIV virus mutated often and was difficult to eradicate because of this. I found no such evidence in the scientific literature. This key-like protein was heavily protected and there was a robust defense mechanism that seemed to protect it against antibody production and, therefore, a classic vaccine. We were working on a current treatment that would keep an infected person alive. If we could increase the half-life in the body, it would be a better option. This treatment is very expensive and requires daily injections. As I learned more, I brought ideas to my boss about different approaches to stop virus propagation. One day he pulled me into his office and closed the door. He said he appreciated my work, and enthusiasm, and that he was once like me. He then told me that we can do wonderful things in the lab, but if a drug or a treatment does not have potential to make money, it will not become a product.

I moved on to an injectable drug manufacturer with a shaky reputation. Most of the people there had never worked in any other lab and the work was laid out by standard operating procedure (SOP) documents. I was put to work in a quality lab that measures the potency of a newer antibiotic it manufactures. The process involved diluting a known standard and a sample from a lot, and putting it on a Petri dish. The bacteria on the Petri dish created a circle after an incubation and the diameter of the circle was used to calculate the potency of the unknown. After some training, my first test fell slightly below FDA standards and the other two workers in the lab told me that, if I reported this result, I would be crucified and my job security would diminish. They were also involved with the result. They had their hand in preparing standards and calibrating instruments and they told me to shut the computer off without saving the results and run the test again with a calculated adjustment. They said that the lot was safe and this was the best thing for everyone. These men had families to support and great fear of being let go. I agreed and measured the Petri dishes with the adjustments and it did, indeed, pass. Shortly after I became worried about this and similar decisions I had made in the lab. Being a Jewish man, I set myself straight and decided I would take accurate measurements, report data honestly, and perhaps become a positive example and promote change. After five months of work and a few failed lots, they started training me for working in the other labs doing simpler measurements. I was taking samples from different places in the plant and production. I passed the samples through a filter and the bacteria in the sample would stick to the filter and it was simply grown on a Petri dish. I noticed that the standard operating procedure document from which I was working did not include swirling or mixing the sample before taking some. The cells in the liquid are massive compared to molecules, and will settle to the bottom quickly. The sample must be swirled or mixed in order to take a proper sample for an accurate test. Not mixing properly was an amateur mistake common in undergraduate labs. These samples were sometimes sitting for days before testing. I watched others performing the same or similar tests, not mixing their samples, and I told my supervisor what was happening. She looked frightened and didn’t say anything.

An FDA inspection was taking place and the shredding boxes had been stuffed to capacity. A small room and team of people were dedicated to hunting down and shredding documents on command. I watched The federal agents tour the lab and ask questions. A few days later I looked at the SOP documents for the other section of the lab that used this procedure more often. The same step was not in its SOPs and I witnessed scientists there performing the test improperly. I then put everything I knew about this issue in a paper letter and placed it in the department head’s mailbox. Everyone was busy because of the inspection and I thought this was the best way to communicate this. Later that day I walked by the department head in the hallway. She had a worried expression and looked at the floor when we passed. I was soon led down by my boss to human resources to be let go. The HR person said I didn’t fit in and I needed to clean my desk out and leave. I asked my boss why I was being let go and she cited the failed lots I had measured. I explained that I simply perform accurate measurements and report them honestly and that anything else is unethical. She didn’t respond and I was taken to clean out my desk. On the way out we ironically passed the shredding team and then the FDA agents.

I told a few family members what happened and thought about writing the FDA. I’m now married and working in Information Technology. I’m all for a free market, but there needs to be regulation now. The welfare of the people in this country needs to be put before money. I hold no position of power to do anything right now; this is my motivation to publish my story.

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