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July 29, 2002
A: FROM MENTOR KRISTIN TAGHON. TO READ BIO. CLICK
HERE.
Erin,
I asked my friend who is in Quality Control at a pharmaceutical.
She said that
there is a great demand for drug researchers. She said that
advanced education
is definitely needed. You would definitely need a Master's;
a PhD is preferred
in order to gain respect and advance in your career.
July 29, 2002
A: FROM MENTOR DENISE HARBERT. TO READ BIO. CLICK
HERE.
There are many different types of drug researchers. The life
cycle of a drug starting from creation to the time it is no
longer made is very complex and involves thousands of people.
Here is a description of the most common process:
1. A chemist in a laboratory creates a new combination of
substances which have not been put together in that way before.
The ideas for these combinations can be spontaneous or random,
the result of an accidental discovery made while researching
something else, or perhaps an attempt to improve a drug that
already exists by enhancing it. This is the piece I'm not
very knowledgeable about, so perhaps another mentor can talk
more about this.
2. A medical researcher prepares research protocols to get
approval for experimentation on laboratory animals. This involves
a lot of paperwork and background reading. See Mentee Alison
B's question about lab animal experimentation http://www.uic.edu/orgs/gem-set/archive020725q1.htm.
3. If the research protocols are approved, a research team
begins experimenting with the drug on animals. This team would
include at least one person with each of the following areas
of expertise: animal care, veterinary medicine, the disease
or ailment the drug was created to treat or improve, statistics
or biostatistics, funding and grant management, etc. The role
of the statistician/biostatistician is just as important to
the research as the veterinary scientist's. In order to prove
that a drug's efficacy outweighs its side-effects, the research
needs the proper experimental design, randomization, data
collection, and data analysis. Test and control groups must
be created and compared. A test group is a group of animals
that gets the drug and a control group is a similar group
of animals that gets a placebo instead. (A placebo is a pill
that looks the same, but has no drug in it.) Both groups have
the same disease or ailment that the drug is supposed to treat.
That way, statistics can determine whether or not the drug
is effective or has side-effects. If both groups of animals
improve at the same rate, then it is probably because of something
other than the drug, like the animals' natural immune systems.
If both groups vomit frequently, then it is probably not a
side effect caused by the drug. It might be caused by something
like the animals' diets or the disease itself. Without a properly
selected control group, you would not be able to tell the
difference between the drug and other factors.
4. If the experimentation on laboratory animals goes well,
then a medical researcher will prepare research protocols
to get approval for experimentation on humans. This step is
very slow and involves even more paperwork and background
reading than the protocols to experiment with animals. The
Food and Drug Administration (FDA) of the U.S. federal government
is the agency that regulates all drug experimentation on humans.
They have very strict rules about what researchers can and
cannot do in their experiments. First and foremost, their
job is to protect human life. They have the authority to shut
down any drug research if there is any evidence to suggest
that the research could be causing more harm than good. This
human experimentation phase of the drug is referred to as
the "FDA clinical trials". A drug must successfully
pass through several levels of clinical trials before it is
approved. If the drug successfully passes through all phases
of the FDA clinical trials, then the FDA approves it for sale
to any U.S. citizen who has a prescription for it.
5. Next, the pharmaceutical company that created the drug
must figure out how to get U.S. doctors to write prescriptions
for their drug. This involves sales and marketing research.
Many pharmaceutical companies hire outside consulting firms
like the one I used to work for to perform this research.
This involves a team of business people, mathematicians, statisticians,
and computer programmers. The business people discuss "story
problems" in English with the mathematician/statistician,
who then figures out a way to solve those problems by analyzing
data and/or building mathematical models. The mathematician/statistician
then communicates the data and model building process to the
computer programmers who write the code to process the numbers.
The numbers and formulas that come out of that code are then
communicated back through the mathematician/statistician,
business people, and eventually to the pharmaceutical company
that implements the solution. Think of it like this: Have
you ever gotten a free sample of medication from a doctor?
The doctor got that sample from a sales representative who
works for the pharmaceutical company that made the drug. The
sales rep visited the doctor, told him/her about the drug
(what it's used for, how effective it is, what side effects
it has, etc.), gave him/her a sample of the drug, then asked
him/her to consider prescribing it to patients. How did that
sales rep know to go to that particular doctor to talk about
that particular drug? Mathematical and statistical modeling.
Every time someone in the U.S. fills a prescription, it's
entered into a computer. The computer retains the drug type,
the date, and the doctor that prescribed it. A data vendor
then collects that information from pharmacies all over the
country and compiles it into one huge database. A consulting
firm buys the data, then builds models on it to identify doctor
prescribing behavior. They mathematically compute how many
doctors prescribe drugs for different medical problems, how
many times those doctors should be visited, how many free
samples they should be given, and how many sales reps are
needed to visit them. The pharmaceutical company then hires
sales reps and implements the plan.
6. Eventually, after years of sales, the drug's patent will
expire. Most of the time, another pharmaceutical company will
start making a generic version of the drug for much cheaper
than the original. The original lowers in price in order to
compete, and eventually the price is so low that it's not
worth the cost of the sales reps to visit the doctors to promote
the drug. The sales reps are assigned to promote different
drugs, and eventually the original drug stops selling and
the pharmaceutical company stops making it.
Right now, there is a tremendous need for drug researchers,
especially in the clinical trial (4) and sales and marketing
(5) phases. These phases require tremendous expertise and
master's or doctorate level educations. There are simply not
enough people out there who are qualified for and interested
in doing that type of work. That is why most of those professionals
can demand salaries of $100,000+ per year, depending on education
and expertise.
However, the demand and salaries for such positions may change
in the future. One of the great debates going on in the U.S.
Congress right now is whether or not certain Americans should
qualify for free drugs and whether or not the prices of drugs
sold in the U.S. should be regulated by the government. Many
drugs sold in the U.S. cost two to ten times more than the
same drug sold in different countries. Americans with decent
health insurance plans pay $10 to $25 per medication and their
insurance company pays the rest. But people who have no health
insurance (unemployed, part time workers, disabled, retired,
etc.) cannot afford the drugs. They often suffer without the
medical treatment that they need. If the U.S. decides to regulate
this process, then pharmaceutical company profits will go
down and they will not have as much money to spend on researching
and promoting their drugs to doctors. Regardless, as long
as there are diseases on Earth, there will be a need for drug
researchers. If this is a field you are interested in, then
pursue it. Simply be aware that your salary might be lower
in the future than people who are in those professions now.
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