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#1 Guide to the Pharmaceutical Industry

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Kitty Lau

on 8 November 2013

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Transcript of #1 Guide to the Pharmaceutical Industry

#1 Guide to the Pharmaceutical Industry
The Pharmaceutical Industry
Getting a Drug to Market:
The Journey of a Drug

Welcome to the industry!
Today, we will be teaching you how to succeed in the pharmaceutical industry.
Learning Objectives
what is the pharmaceutical industry?
how to maximize your profit
process of getting a drug to the market
how to manipulate data, research reports, experimental structures to maximize perception of drug efficacy
brought to you by: Sophie Ni, Wilson Lee, Kitty Lau
Quick Tips on Maximizing Profit
"... [not] a significant breakthrough in human health, ... merely a breakthrough in making money."
-Ben Goldacre
Step 1
generate an idea for the drug
Phase II
1. Test on a couple hundred people with the relevant illness
this provides proof of concept!
2. Work out the dosage through trials
3. See if its effective or not
Advertise
advertising directly to the public is only legal in the United States and New Zealand
repeatedly shown to increase demand for prescribed drugs
Phase I
the beginning of human trials
1. Collect a small sample of healthy volunteers
does it work? does it kill them?
2. Measure the rate at which the drug is excreted from the body
Step 2
test the drug on animals
does it work? does it kill them?
Phase III
1. Test on hundreds or thousands of people
2. Run a couple of Phase III trials
3. Determine the side effects of your drug
4. Obtain a license
5. After it goes to market, do more trials, are there any unnoticed side effects?
Take caution: many drugs fail at this point.
cute, happy, smiling children
look how chipper these kids are after coming
down with a cold
Tylenol will improve your relationship
with your children
While it's at it, it'll probably also improve all your other social relationships
your kids will look as good as these kids if they take Tylenol
I love Tylenol
Drug Company Bullshit
The Drug Trial
So you've created a drug that you are hoping to sell. It is mediocre at best, passable, but obviously, it needs to look amazing so that you can sell it. Perhaps you can dupe your audience into thinking your drug is better than it is. Unfortunately, your audience is comprised of doctors and medical professionals...
Study it in winners
Do LOTS of placebo-based trials
What do you do?
A Sneaky Trick
If you do have to compare your drug against a competitor, do it your way
The Competitors Drug
Use an inadequate dose
Give a very high dose
Give it in the wrong way
Increase the dose really quickly
Your drug will shine in comparison!
don't sell your drug off license
patent your drugs so no one else can make it, then raise the prices
create "me-too" drugs
copies of existing drugs, with just enough differences to be able to claim your own patent
third most profitable industry, after the Internet and communications companies
$227.5 billion a year on pharmaceutical drugs in 2009
worth more than $800 billion worldwide
$3 billion annually on advertisement and promotion
Manipulating the Data
Now you've done your trial
Despite your best efforts, results came out negatively
What can you do?
Hide the negative results
don't draw attention to the disappointing data; put it on a graph
Only mention it briefly and ignore it when drawing your conclusions
don't publish them at all... or publish them only after a long delay
Manipulate the Data
1. Ignore the protocol entirely
2. Play with the baseline
3. Ignore dropouts
4. Clean up the data
5. The best of 5..no..7..no..9!
6. Torture the data
7. Button mash
Side Effects?
Publish wisely
make sure your trial has a positive result!
Don't ask about them...or if you have to, be careful how you ask
List all the unimportant side effects instead of the really terrible ones
#3
Use a "Surrogate Outcome"
Avoid real world outcomes (ie. death or pain)
Use a "surrogate outcome" in place of a "real world outcome"
publish your trial in the biggest journal you can mange if it is positive
publish your trial in an obscure journal if it is positive but was a completely unfair test
hide your findings away somewhere and cite "data on file" if it is really embarrassing
Do you think mainstream medicine is evil?
Good Results Everywhere!
the good results get published many times...in different places and forms!
now it looks like there were many positive trials, but in reality there was only one
Full transcript