The Food and Drug Administration (FDA) regulations, proper procedure conductivity,
and its existence in itself is a vital essence to the health community, if one wishes to go against it
or find loopholes around it, one must be able to endure any potential consequences from it. This
is exactly the case in regards to PharmaCARE, CompCARE, and the victims of cardiac deaths
from using the non FDA approved drug that is AD23. Now, one cannot put all the blame on
PharmaCARE and CompCARE, at least not initially, since when they first started advertising
and administrating the drug, AD23 seemed like a breakthrough drug that had supporting research
claiming to slow the progression of Alzheimer’s disease. People started getting informed, media
started covering the story behind AD23 and its effects, it generated so much publicity and hope
that Medicare, Medicaid, and Veterans Affairs patients wanted to make use of this drug in order
to prevent the progression of Alzheimer’s diseases, and thus it became a high demand product. It
seemed as if PharmaCARE’s research team wanted to get the drug out there for the benefit and
well-being of the people without any interference or holds from the FDA that wouldn’t allow or
at least make it difficult to give this proactive life changing drug to the masses that could benefit
from it. Where PharmaCARE and its wholly owned subsidiary, CompCARE’s ethical integrity
comes into question is when they knowingly advertised its product directly to consumers and
marketing AD23 directly to hospitals, clinics, and physician offices when they were well aware
that they were not permitted to sell these drugs in bulk for general use. The already generated
and potential profit is the likely culprit behind the motivation to produce significantly more of
this this drug to disperse amongst the people in order to maximize profits. It stops being
questionable and starts becoming a direct violation when CompCARE took it upon themselves to
encourage doctors to “fax lists of fictitious patient names to CompCARE” (so says the prompt)
in order to sell their products with no negative bind to its consumers since they were fictitious.
One must keep in mind that PharmaCARE decided to put AD23 into mass production and
advertise it as a drug that could slow the progression of Alzheimer’s disease based off of research
conducted by PharmaCARE itself that concluded as “AD23 MIGHT also slow the progression of
Alzheimer’s disease”. This alone was reason enough for PharmaCARE’s decision to give the
okay to their research team with the objective of reformulating the drug to maximize the effect
that “might slow the progression of Alzheimer’s disease”. This in itself is irresponsible since
nowhere in their reformulation findings has PharmaCARE stated that they analyzed and could
confirm any long term effects of their reformulated AD23 product. PharmaCARE acted on the
potential that AD23 might be able to slow the progression of Alzheimer’s, reformulated it,
assumed that their product was without flaw and advertised it to the masses via CompCARE to
avoid any “scrutiny” from the FDA as they put it. This is the same drug that is the cause of over
200 reported cardiac deaths and that in itself is a direct violation of “Truth in Advertising” which
was a requirement set forth by the Federal Trade Commission Act that ultimately created the
Federal Trade Commission (FTC) to “enforce the provisions of the act” (Hearst
Newspaper,2015). In short, companies that advertise a product, in this case PharmaCARE and
CompCARE’s reformulated AD23, must be “truthful and not deceptive and not unfair” (Hearst
Newspaper, 2015) which both these companies clearly failed to uphold and adhere to the Truth in
Advertising requirements set by the FTC since they didn’t bother to conduct further research on
long term effects, potential dangers, threats, or warnings, and didn’t even publish any concrete
findings that their reformulated product did what it advertised. The simple findings that the
original, untampered AD23 “might” reduce the progression of Alzhemier’s disease was enough
validation and supporting evidence that their experimental product would perform with those
promised results, however, one could argue that personal accounts of users could account for the
products credibility except for the fact that a significant portion of the experimental drug’s
consumers died of cardiac arrest as direct result of the experimental reformulated AD23
consumption. Not only did PharmaCARE and CompCARE violate FTC’s Truth in Advertising
act, but they violated another act by Advertising Harmful Products (Hearst Newspaper, 2015.)
Now, when it comes to Advertising Harmful Products, countries have several different views in
the sense to when is a consumer personally responsible for potential harm, (i.e. taking twenty
pills of a drug when the recommended amount is two) and what regulations and laws a country
has in regards to what is legal to consume, what is consumable at your own risk and what is
consumable against the law. In the United States, they mandate that a company should “take a
good look at the true nature of their product lines when deciding whether they are acting
ethically as advertisers” (Ingram, Demand Media, 2014). PharmaCARE and CompCARE failed
to “take a good look at the nature of their product” since not only did they neglect to record,
publish, or acknowledge long term effects of their reformulated drug, nor did they state any
potential risk of their product, but also failed to provide public research or private recordings that
their product was even effective at doing what it claims to accomplish besides the one bit of
information that was released, stating that the untampered AD23 “might” slow down progression
of Alzheimer’s disease. So when the question if whether PharmaCARE violated any ethical
issues is posed the only answer is yes, several ethical issues were violated and in the case of an
FTC enforced regulation that mandates a company not advertise harmful products, PharmaCARE
is guilty of direct violation since not only did they not provide physical evidence that it is not
harmful and instead beneficial to its target consumer, but when other research teams published
concrete evidence that PharmaCARE’s experimental, reformulated AD23 seemed to be the cause
of inducing heart attacks to its consumers in an alarming rate PharmaCARE responded by
completely ignoring the findings and continued to file and fulfill large orders.
The Consumer Product Safety Act (CPSA) was enacted in 1972 with the purpose of
giving the CPSA authority to “pursue recalls and to ban products under certain circumstances”
(McCormick, J. 2014.) As discussed earlier, PharmaCARE’s reformulated AD23 is harmful to its
consumers as there is published research supporting these claims and over 200 reported deaths
due to this drug. Because of this, CPSA (under docket 15 U.S.C statute 2061) reserves the right
to take AD23 off the shelves and place a ban on it since it has “reasonable cause to believe is in
violation of any consumer product safety rule” this rule being the failure to meet health standards
under the Consumer Product Safety Act (SAME SITE.) It is in direct violation of several CPSA
regulations and statutes and is just another add to the list of violations PharmCARE has
