What does the FDA drug side actually do?

Uploaded by anubis2814 on 26.08.2011

I've had a few people respond to my regulations video ask me why if the FDA trusts scientists
to make the drugs, then why don't they trusts the scientists to ensure that the drugs are
safe? Well they actually don't trust the scientists to make or test the drugs.
Let's go through the stages of clinical testing, as most people are unaware of how they work.
The science field starts with pre-clinical trials. These trials work on in-vitro or test
tube human or animal cells or in-vivo used on animal models, they they work under the
scrutiny of the scientific process. In Universities, there are strict ethics panels to ensure the
lowest level of animal suffering on the animal models. This is less true in terms of drug
companies. The pre-clinical trials are a lot of trial and error, every group working on
the most promising ideas as the science is very expensive. From these studies they can
assess the toxicity, efficacy or quantified effects and Pharmicokinetics which is the
understanding of what the drug is doing and why it has the effect that it does. Once this
information is compiled, the FDA gives the drug the status of investigational new drug
This drug then moves into phase zero which is a new stage using micro-dosing. Phase zero
and one are designed to determine side effects and toxicity of the drug in humans. They don't
even test to see if the drug does in humans what it does cells or animals, just to make
sure it wont kill you. Remember mice and other animal models tested are not little humans.
What may work in a animal may work completely different in a human. Humans would be the
perfect models to do scientific testing on but there are massive ethics reasons that
we don't, so there could be drugs that don't work well on our animal models but would work
great on humans. An example of how the holistic community takes
advantage of people's lack of understanding of clinical trials is in a chemical called
resveritrol. It appears naturally in red wine, and red grape skins as well as blueberries
and other sources. It increased the lifespan of rats by three times and boosted their metabolism
like crazy. Several people noted the obesity in french and Italians from American even
though they had some pretty high carb diets in bread and pasta. They linked to the high
quantity of red wine they consumed. Soon the supplement released concentrated resveritrol.
I bought into the idea back in the day as well. Since then, the trials on humans have
shown to be pretty disappointing, and they have very little conclusive proof that concentrated
resveritrol has much effect at all on weight in humans. Eating it in grapes and other foods
is the best way to get it if you want try try something like this. Most of the herb
and supplement business is set up to take these cell and animal studies that most people
don't understand cannot be translated to human studies. The FDA just ensures they aren't
dangerous and then lets people eat them at their own discretion. University and non-profit
science groups using contributions and government grants will then move the most likely herbs
to phase 2 and 3 stages. An example of an herb that is making it through clinical trials
and showing serious chance of being a cheap alternative drug is tumeric, which has shown
to have good evidence that Curry eating populations have lower instances of alzheimer's.
Phase zero gives micro-dosing dosing to the patients and tracks how the body reacts to
the drug in general. Whether it is absorbed at the speed and to the same locations as
the animal model and it gets flushed out at the same rate. This is a new stage added to
increase the speed of the drugs passage, if the drug shows to be too toxic or doesn't
work the way it did in the animal, then the clinical trials will be a lot more expensive
and complicated. Sometimes the drug will go to completely different areas of the body
than the animal model or just get flushed out of the person through urine, which will
require going back to pre-clinical trials trying to find an animal model that will match
the same effect, or if it flushes out, trying to modify the drug to see if it changes the
effects and makes it more toxic. An easy way to find out if the drug is getting dumped
is to test the urine to see if its less than the amount taken in. Phase zero saves the
company or university a lot of money and the FDA a lot of time.
Next we go to phase 1 trials also under the intense scrutiny of the FDA. From here on
out I'm just going to read segments from the wikipedia page on the subject because it gets
long an complicated. Phase I trials are the first stage of testing in human subjects.
Normally, a small (20-100) group of healthy volunteers will be selected. This phase includes
trials designed to assess the safety, tolerability,ápharmacokinetics, andápharmacodynamicsáof a drug. Phase I
trials most often include healthy volunteers. However, there are some circumstances when
real patients are used, such as patients who haveáterminalácancer oráHIVáand lack other
treatment options. Volunteers are paid an inconvenience fee for their time spent in
the volunteer centre. These go through working up the ranges and
levels of the dose until they find side effects and often combined effects like it the drug
interacts with food or other drugs. If it passes this stage it can then move on to phase
2 áPhase II trials are performed on larger
groups (20-300) and are designed to assess how well the drug works, as well as to continue
Phase I safety assessments in a larger group of volunteers and patients. When the development
process for a new drug fails, this usually occurs during Phase II trials when the drug
is discovered not to work as planned, or to have toxic effects.
Phase II studies are sometimes divided into Phase IIA and Phase IIB.
Phase IIA is specifically designed to assess dosing requirements (how much drug should
be given). Phase IIB is specifically designed to study
efficacy (how well the drug works at the prescribed dose(s)).
Phase III studies are randomized controlledámulticenter trialsáon large patient groups (300ľ3,000
or more depending upon the disease/medical condition studied) and are aimed at being
the definitive assessment of how effective the drug is, in comparison with current 'gold
standard' treatment. Because of their size and comparatively long duration, Phase III
trials are the most expensive, time-consuming and difficult trials to design and run, especially
in therapies foráchronicámedical conditions. It is common practice that certain Phase III
trials will continue while the regulatory submission is pending at the appropriate regulatory
agency. This allows patients to continue to receive possibly lifesaving drugs until the
drug can be obtained by purchase. Once a drug has proved satisfactory after
Phase III trials, the trial results are usually combined into a large document containing
a comprehensive description of the methods and results of human and animal studies, manufacturing
procedures, formulation details, and shelf life. This collection of information makes
up the "regulatory submission" that is provided for review to the appropriate regulatory authorities[3]áin
different countries. They will review the submission, and, it is hoped, give the sponsor
approval to market the drug. Most drugs undergoing Phase III clinical trials
can be marketed under FDA norms with proper recommendations and guidelines, but in case
of any adverse effects being reported anywhere, the drugs need to be recalled immediately
from the market. While most pharmaceutical companies refrain from this practice, it is
not abnormal to see many drugs undergoing Phase III clinical trials in the market
Phase IV trial is also known asáPostmarketing surveillanceáTrial. Phase IV trials involve
the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after
it receives permission to be sold. Phase IV studies may be required by regulatory authorities
or may be undertaken by the sponsoring company for competitive (finding a new market for
the drug) or other reasons (for example, the drug may not have been tested for interactions
with other drugs, or on certain population groups such as pregnant women, who are unlikely
to subject themselves to trials). The safety surveillance is designed to detect any rare
or long-term adverse effects over a much larger patient population and longer time period
than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase
IV trials may result in a drug being no longer sold, or restricted to certain uses. The FDA
is involved at every step of the way, because it's a hell of a lot cheaper than burdening
the courts with tons of complicated and expensive to prove lawsuits. It also reduces and prevents
deaths from occurring to begin with. During every step of the trials, GLP or good laboratory
procedures is use which requires Nazi level bureaucracy and signatures and dates and initials
on mistakes then making annotations of those mistakes, and if you make a mistake doing
the annotations of those mistakes you have to date and initial then annotate those mistakes
somewhere else. This ensures that when something goes wrong in the drug trial they can trace
the problem directly back to the person who made the mistake. By the time a drug reaches
the market there is nearly a tractor trailer truck of paperwork taken to the FDA. Why?
Because a) the number of mistakes that can occur in clinical lawsuits are high, and B)
the incentive to cheat due to the lucrative amount of money to be made off the drug is
even higher. Since the 90's, drug companies have realized that working with the FDA instead
of trying to lie to them is actually in their best interest as they don't lose nearly as
much money on lawsuits or from a bad name when a drug shows negative side effects that
could have been prevented if they had just worked with the FDA. Any time something poorly
tested slips through to the market, just like in the scientific community the FDA will modify
its trial technique to prevent that from happening. Think of the drug side of the FDA as a mix
of a scientific journal and a court, where the court is holding the case before a crime
is committed and therefore the crime never happens. Its possible what the FDA does could
be done by a private regulation system, but the number of lawsuits that regulation system
would have to face the price it would need to get off the ground is insurmountable. The
FDA isn't perfect, but its a hell of a lot safer and better for the health of our nation
than the lazzez-faire ideas that libertarians claim, mostly because they really don't understand
how and what the FDA does in terms of food.