The Conversion of Our Protector

Not long ago, what we as American citizens ingested in ourselves may have been at
times dangerous due to flaws in the process of producing food and drugs in
particular. With the absence of regulation of the manufacturers, American citizens
could not be assured in what they may take to eat or restore their health was safe
for them, and this was understandably concerning for many people.

Nearly 100 years ago, one man changed the fears and concerns of American
Citizens regarding what they may eat, or what medicine they may be given to
restore their health. And this man simply improved the way things were by writing
a book.

The Food and Drug Administration originated in its primitive form several decades
ago to ensure the health and safety of the citizens of the United States in regards to
what they consume. The administration was created to regulate the manufacturers
who make items people do consume to ensure the safety of the American citizens.

The man responsible for the development of the Food and Drug Administration was
a socialist named Upton Sinclair, who was a writer. One particular book he wrote
several decades ago, while fictional, addressed the working conditions in a meat
packaging company that were quite shockingly described by Upton in this book.
Called, “The Jungle”

The one particular issue in his book regarding the lack of food safety is what caught
the attention of the public who read his book, and this included the U.S. president.
The impact caused by this book on others is what led to the development of the
FDA.

However, and with great disappointment, the purpose and function of the FDA
seems to have changed in the past few decades. The FDA appears to have decided
to ensure the health of the pharmaceutical industry, an industry the FDA was
designed to regulate. This is one of many disturbing flaws and concerns expressed
by others regarding the FDA.
One example is the large amounts of money the pharmaceutical industry gives the
FDA for various reasons created recently. These amounts of money are so large
that this money given to the FDA accounts for nearly half of the FDA’s entire
budget.

An example of stated reason by the FDA for receiving such funds is due to what is
known as the PDUFA ( the prescription drug user fee act), which began in 1992.
Basically, the drug industry has been authorized and is now required to pay the FDA
for faster approval of their medications awaiting approval by the FDA.

The FDA also accepts from this industry over a million dollars from certain drug
companies in order to give their pending new drugs a priority review of 6 months
instead of a year, along with a creating an etiology for this urgency as it happens,
others have said.

Results of this relationship, which some have called collusive and pathologically
intimate between the FDA and the drug industry, may have something to do with
the actual removal of newly approved drugs due to safety reasons. The lack of
regulation and monitoring required by the FDA of the pharmaceutical industry has
resulted in such dangerous safety concerns, one could safely say.

The FDA and the drug industry continues to attempt to validate and explain often
what many others have questioned about the FDA and its lack of focus on the safety
of the public- the public the FDA is suppose to protect to assure their safety. Yet the
focus of the FDA and the purpose of their creation seems to be absent.

The presumed intimacy between these two organizations, the pharmaceutical

industry and the FDA, does in fact seem to continue to worsen. For example, and
recently, the FDA announced they were allowing the pharmaceutical industry to
allow their promoters of their branded drugs they market to discuss these products
for disease states not studied or evaluated by the FDA.

This process use to be mandatory before a drug company could claim that their
drugs were beneficial for a particular disease state. Many remained shocked on
this decision made by the FDA.

Yet the FDA claims that this proposal would enhance the education and knowledge
of the prescriber by the pharmaceutical representative of the marketer of a
particular medication, which remarkably mirrors the premise and objective of this
industry already.

So this strategy, void of any protection of the public health, allows for potential
dangers associated with this practice. This autonomy of the FDA illustrates once
again the present state of the FDA and its need for reform.

A prescriber, upon their own discretion, can in fact prescribe a drug off-label, and
they do so based upon their own discretion. Historically, a pharmaceutical drug
promoter was legally forbidden to suggest to a health care provider to use their
promoted drugs for disease states not approved by the FDA already.

In fact, it was a federal offense for such drug representatives to speak off-label
about the drugs they promoted for their employers. In the past, drug companies
have had to pay settlements to the DOJ when they fractured these laws regarding
off label promotion of medications.

This off-label FDA protocol for drug representatives that has been allowed by our
FDA with presumed encouragement by the pharmaceutical industry is called, “Good
Reprint Practices.” This overt and absurd benefit for the pharmaceutical industry is
that now they can have their pharmaceutical sales representatives, unregulated
themselves, speak about their promoted medications to health care providers
essentially in any way they choose.

Furthermore, this proposal is flawed in that most pharmaceutical representatives

lack necessary medical and clinical training to discuss the complex considerations a
health care provider is able to do because of their training.

Most drug representatives have little medical or clinical training in any objective
way, and they are not hired with having such a background, usually. So this seems
to further complicate the idea of this off-label authorization by the FDA due to the
ignorance of the representatives to discuss such clinical matters.

In addition, the relaxation of previous restrictions regarding off-label promotion

could prove to be a catalyst for representatives of the pharmaceutical industry to
further embellish statements to prescribers for their own benefit in regards to their
promoted medications they present to them.

In fact recently, a study by Sermo concluded that 90 percent of doctors want clinical
evidence based medicine from educated and trained professionals instead of the
typical pharmaceutical sales representatives that now exist. This study also
concluded that around 80 percent of health care providers prefer not to interact
with pharmaceutical representatives, yet still accept drug samples from them for
their patients. The results are rather understandable considering what we now
know.

So, our previous safety association, the FDA, appears to be evolving into a possibly
harmful association with the pharmaceutical industry by suggesting such practices
that aggravate the existing situation with the lack of protection that was once
offered and required from the FDA.

It is unbelievable this good reprint practices ever came into existence- with the
delusional fallacy that it would be of any benefit to patient health. Furthermore, this
may complicate if not increase existing patient medication errors, such as in the
elderly or dosing for children.

So there are enough problems with prescribing, and adding this FDA seems to be
making the issues with medications in the U.S. worse instead of better. We as
citizens are no longer the concern of the FDA, one could safely conclude, and this is
clearly dangerous to the health of the public.

Perhaps another alternative would be to have clinically trained people discuss such
issues regarding the benefits of medications with prescribers, instead of existing
drug reps who have the sole objective of increasing the market share of their
promoted meds with no regard to the science behind these meds, in large part, or
the consequences of their actions as they promote their drugs in this way.

Because historically, medications have in fact proven to be beneficial for other

disease states other than what a certain drug was initially indicated for upon
approval. Yet this should not be determined by those who promote such drugs.
Now, unfortunately, pharmaceutical representatives are allowed to determine how
they can promote their drugs for their employer’s benefit.
Regardless, awareness needs to happen by the citizens involving these tactics
progressively allowed by the FDA that are dangerous and deceptive to the health of
the public. As citizens, we have the right to insist that the FDA- our FDA- maintains
focus on the safety of the public and their health. Reform of the FDA appears to be
necessary for this to occur to re-establish the FDA as the administration that was
created for our protection, and not to protect others financially.

About half of all drugs approved presently by the FDA have had serious post-
approval side effects that should have already been known or suspected of these
drugs. Well over 100 thousand people die every year from drug reactions or
mistakes. This seems to be a rather significant concern for those who are need to
restore their health.

Dan Abshear