Pharmaceutical Drug Research: What the hell do I actually do?

So, what the hell do I actually do?

Since moving, I’ve met a lot of new people. And usually one of the first questions I get asked is “So, what do you do?”. Well actually, the FIRST question is usually, “Are you in the Air Force too?”. I don’t mind when people assume this. On any given outing, 95% of the people I’m with are either in the Air Force or associated with the government in some way. My canned response to the typical career question is simply, pharmaceutical drug research. The top 5 responses I get back include:

1. You test medications on people? (And with this they usually have a weird look on their face as if I tie people down unwillingly and subject to them to torture.)

   2.  You test the drugs yourself, like on you? (No, that would not be OK with the FDA.  You may 
         have heard of them. They have a few regulations.)

3. Do you have access to investigational drugs…? (Yep, but again, regulations. We aren’t giving these away people.)

4. Do you get those paid vacations from the drug reps? (No, but I do get free lunch from drug reps pretty much every day. Not because I’m in research, but because the office I work in has doctors that sit through trainings, new drug updates, and guidance throughout their lunch. )

5. That’s sounds cool. (I agree, and that’s why I like it!)

Jake Gyllenhaal in Love and Other Drugs. I wish my drug reps
danced like this. Most people hated this movie. I appreciated it.

So, what do I really do? In the industry my job title is a Clinical Research Coordinator. Side note: I once told someone that and he responded with “So…you don’t actually really do the research, you just coordinate...” To which I wanted to respond, “So, you actually really have no idea about the industry and shouldn’t try to insult people you are just meeting”. Followed by a promt punch in the face. Anyway, I digress.

Let’s start with the basics. The pharmaceutical industry is a billion dollar industry, but it is not an easy business. Most drugs wills spend approximately 10-12 years in the start-up and research phases before they ever make it to the FDA’s desk for approval. That doesn’t even guarantee approval! A company can literally spend millions of dollars doing research and development that never amounts to anything.

There are many phases in a compound’s life. Initially the compound is tested on animal models, followed by smaller non-risk populations, and finally larger populations (thousands of people in one study). The larger scale studies can last upwards of two years alone to compile data and follow patients.

The studies test the compounds for safety and efficacy, and also against existing medications and even placebo at times. This is where I come in.

I work for a research site that is one of many that pharmaceutical companies go to in order to carry out the different phases of research. Big pharma will come to my company and show us the protocol. The protocol tells us exactly what we have to do during a study (how many visits are needed, what procedures have to be performed, etc). I help decide if we can safely and efficiently execute what they want and if we are interested or have the right access to the patients that will be needed.

After months of paperwork, planning, recruiting potential patients (there are usually upwards of 50 different criteria that people must satisfy to participate in), and a million meetings, I start the study. On a typical day, I will see patients for approximately 10 studies for various illnesses, diseases, and conditions. During the subjects’ visits, I complete vital signs, ECGs, questionnaires, cognitive testing, blood work, administer medication, etc. My site then reports all of this information back to the pharma company including any complaints and reported side effects. Where do you think those laundry lists of side effects come from in the drug commercials? Also, did you know that Viagra was originally indicated  for high blood pressure? During studies they found there was a very common side effect…

I’ve worked on drugs for Depression, Bipolar disorder, OCD, Alzheimer’s (Please eat your Omega-3s. This study was scary beyond belief. Also, check out Lumosity. ), Tourette’s syndrome, Multiple Sclerosis, Tardive Dyskinesia, and Schizophrenia. I’m hoping to work on additional indications in the future such as Parkinson’s and Epilepsy. Last year, a drug I worked on was approved for depression and it was incredibly rewarding to see the commercial on TV and know I had a part in that. I also saw a lot of my patients do very well with it.

Many of the people that participate in studies do so because they are legitimately interested in looking for new ways to treat their condition and are also interested in contributing to science. Sometimes patients are compensated for their time, and sometimes they aren’t. In most cases, the intense care and monitoring done in a clinical study is more extensive than a normal visit to the doctors. For most that is enough for them to want to participate. For others, it’s a way to educate themselves further about their condition.

If you are interested in learning more about clinical trials you can check out all the current active clinical trials at http://www.clinicaltrials.gov/. In addition, there may be clinical research sites located near you if you are interested in participating or have family members that may benefit (Google can help with that).

In the end, I enjoy what I do. It’s a fascinating industry and I have access to a lot of “cutting edge” science (that may not be available for a long time to the general population). It can be incredibly stressful and overwhelming to know your patients are taking investigational drugs or that the FDA can come audit you at any time (yes, I’ve been audited) but, the biggest reward is knowing I’m aiding people in their search for better healthcare and a better quality of life.