Company Background
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| Dr. Herbert Ley, Former FDA Commissioner (1968-69). |
Since 1848, the Food and Drug
Administration, or the FDA, has used chemical analysis to monitor the safety of
agricultural products and has changed along with social, economic, political
and legal changes in the United States. One would think that a federal agency
claiming it is dedicated to protecting and promoting public health would
actually protect and promote health to the public. However, that is not the
case with the Food and Drug Administration of the United States Department of
Health and Human Services.
The Case
Between 2009 and 2015, the FDA Commissioner, Dr. Margaret Hamburg, and her husband, Peter Brown, defrauded customers and conspired with Johnson and Johnson, a pharmaceutical company that manufactures
drugs, while suppressing information about the harmful effects of two
dangerous, even fatal, drugs they manufactured from the public and profited
millions of dollars by allowing the drugs to be sold on the market, causing
thousands of people to die and even more to be permanently ill or disabled for
life.
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Dr. Margaret Hamburg, Former FDA Commissioner (2009-2015).
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A former federal prosecutor, Klayman, was the attorney who filed a lawsuit against the former FDA Commissioner (2009-2015), Dr. Margaret Hamburg and Brown, on behalf of six patients who took the antibiotic
Levaquin. Brown was an investment banker and co-CEO of the hedge fund
Renaissance Technologies LLC, which had a large amount of stock in the Johnson
and Johnson Company during the time his wife was the FDA Commissioner. Dr.
Hamburg and her husband were accused of suppressing information about serious
adverse reactions to two pharmaceuticals, Levaquin and Zohydro, that Dr.
Hamburg approved to be sold on the market. Subsequently, the accusers claim Dr.
Hamburg, Brown, and Renaissance Technologies profited by millions of dollars
from existing and successive investments in the manufacturers (Ray). It also
alleged that if Johnson and Johnson did well while Dr. Hamburg was the
Commissioner of the FDA, her husband (thus, herself included) profited millions
upon millions.
The drug Levaquin is often
prescribed for everything from sinus infections to urinary tract infections yet
has been nothing but a “prescription for pain” (O’Brien). Johnson and Johnson
does
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Former FDA Commissioner Dr. Hamburg and her Husband
Mr. Brown and Other Co-Defendants Over Alleged
Conspiracy to Misbrand and Mislabel the Drug Levaquin. |
not include this on its warning labels. In furtherance of her racketeering
and conspiracy, Dr. Hamburg counseled the FDA to approve another dangerous
pharmaceutical drug that Renaissance Technologies also owns stock in, Zohydro,
despite the fact that 11 of the 13 FDA Advisory Committee members voted 11 to 2
against its approval. Yet, Dr. Hamburg neglected the vote and went through with
approving the drug to be sold to the public. Over 5,000 people died from taking
Zohydro. It is becoming more prominent that “the chemical industry has a long
history of political power and influence. Chemical corporations also control
and manipulate the science by funding research that downplays, contradicts, or
casts doubt on health hazards” (Mercola). The circumstances surrounding its
approval reflects her desire to profit from the drug’s sales and illustrates
the company’s corruption and the unethical measures the company would take to
make profit. Thousands of the drugs’ consumers suffered the terrible side
effects of the drugs Levaquin and Zohydro. The side effects of Levaquin
included mitochondrial toxicity, nervous system adverse events, and various
multi-system disabilities related to taking the drug, among over 15 other side
effects (Nathan). As for Zohydro, it is essentially a concentrated,
timed-release form of hydrocodone (a highly addictive opiate used for pain
management) containing five to ten times more of the drug than Vicodin (Ray). A
drug being this easily addictive makes it another potentially fatal drug.
One may say that in certain
situations, the public is in great need of a drug for an epidemic outbreak,
which is indeed true, however that is rarely the case and the public would be
totally fine waiting a bit longer for new, yet just as effective cough medicine
or foods that were grown using fertilizer with a microscopically-altered
formula. The FDA sacrifices quality testing of safety by
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Statistics from the Centers for Disease Control and
Prevention - Over Half of Drug Overdose Deaths in
Entire Nation are Result of Prescription Painkillers.
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speeding up food and
drug testing just to move on to the next tests they have, putting the public’s
safety at risk of long-term side effects of food and drug products. Michael
Elashoff, an ex-FDA biostatistician, told The People’s Chemist that “The people
in charge [FDA officials] don’t say ‘Should we approve this drug?’ They say
‘Hey, how can we get this drug approved?'” and a former senior consultant to
the FDA, Paul Stolley, also told them “The agency [the FDA] neglects drug
safety in its rush to speed the drug-approval process because current laws and
policies let the drug industry influence FDA decisions,” meaning that drug
industries, like Johnson and Johnson and Gilead Sciences, have influential
power over the FDA and “influence” the FDA to approve the safety of their
products so that the can profit from sales in the market. The unethical actions
of Dr. Hamburg and her husband conspiring with FDA coworkers and Johnson and
Johnson proved disastrous and fatal for thousands of stakeholders who consumed the
drugs. Stakeholders consisted of those who consumed the drugs, their families
and friends, and businesses for whom the people worked for because now those
businesses have employees who are either disabled, severely ill, or whose
positions need replacing because the drugs’ side effects were fatal. A broad area
of stakeholders of this case is health care and emergency health care
organizations, such as hospitals and doctors’ offices, because they financially
gain from all the additional visits and doctor appointments being made with
more ill people coming in with the serious medical conditions produced by the
drugs’ adverse side effects.
Individualism
According to Milton Friedman’s
Individualist beliefs, Dr. Hamburg and her husband were ethically fine to
profit off of the selling of the dangerous drugs Levaquin and Zohydro because
it profited them greatly and approving the drugs was within Dr. Hamburg’s power
as the FDA Commissioner. Friedman’s Individualism focuses on the importance of
how the only goal of business is to maximize profits for itself and for its
stockholders. In this case, Dr. Hamburg and her FDA conspirators were ethically
justified in conspiring with Johnson and Johnson and approving the dangerous
drugs to be sold on the market. An individualist would in fact consider it
clever because it proved highly lucrative and greatly benefited Dr. Hamburg. The
theory also would not deem her and her husband responsible for the nationwide
harm they’ve caused because does not affect them, only the profiting off of the
drugs does. The theory deems the consumers of the drugs to be responsible for
conducting research for themselves before deciding to consume drugs because
that is included in the effort of benefitting one’s health. Essentially, all
individuals are accountable for whatever happens to them and should only focus
on profiting for themselves because nobody is responsible for anything but for
the actions they make in attempt to profit themselves.
Utilitarianism
From a Utilitarian perspective,
the actions of Dr. Hamburg and her husband were entirely unethical because of
the major and fatal consequences it causes many of the FDA’s stakeholders.
Utilitarians believe that people should aim to maximize the happiness and
pleasure of themselves and of all beings capable of feeling it simply because
happiness is valuable and there is no difference morally-speaking between one’s
own happiness and another’s (Salazar). Dr. Hamburg’s approval of the drugs to
be sold on the market was unethical because not listing their warnings or
dangerous long-term side effects on their labels endangered everyone who could
possibly consider buying either drug, proven by the several thousand deaths it
caused as a severe consequence. Since Utilitarianism focuses on maximizing the
happiness of the overall population, the conspirers in the FDA were ethically
wrong to approve the drugs and withhold the drugs’ important warning
information on the labels, resulting in the devastation, harm, and deaths of
thousands of people’s lives. A Utilitarian would say that Dr. Hamburg should
have considered all the possible risks and consequences approving the dangerous
drugs would have on the population and should have chosen the path that would
not have harmed or endangered the population at all: to not approve of either
of the two drugs. It would also be said that the FDA should from now on include
each and every warning and side effect information on drugs’ labels and push
Johnson and Johnson to develop better, safer formulas for the drugs or else
they would not be approved.
Kantianism
Based on Kantian beliefs, the
actions of Dr. Hamburg and the company were incredibly unethical. As declared
by Immanuel Kant, there are four basic principles of Kantianism:
1.
Act rationally - don’t
act inconsistently in your own actions or consider yourself exempt from the
rules.
2.
Allow and help people
to make rational decisions.
3.
Respect people, their
autonomy, and individual needs and differences.
4.
Be motivated by Good
Will, seeking to do what is right because it is right. Actions that come from
Good Will are both right/rational and rightly motivated (Salazar).
There are also three formulations
of the Categorical Imperative, or the Law of Rationality, which includes the
Formula of Humanity: “act in such a way that you treat humanity, whether in
your own person or in the person of another, always at the same time as an end
and never simply as a means” (Salazar). Kant meant that people should not
merely use people to get to places, but rather treat people as valuable beings
in themselves (Salazar). When looking at the actions of Dr. Hamburg and her
husband as they conspired to profit off of the sales of dangerous drugs, their
actions heavily endangered people because not listing the dangerous and
long-term harmful side effects of the drugs on their labels exploited consumers
and put them at an unfair disadvantage and prevented them from making rational
decisions, which violates the fourth basic principle of Kantianism: “allow and
help people to make rational decisions” (Salazar). Unlike Utilitarianism’s
perspective, a Kantian would consider that it was ethically fine for Dr.
Hamburg to approve of the drugs, yet would believe that Dr. Hamburg should have
included all the warning and side effects information on the labels to allow
customers to rationally decide whether they want to take the risks of consuming
the drugs. She also violated the fourth basic principle of Kantianism, which
was to be motivated by good will, by simply by being motivated by the millions
of dollars’ worth she was going to profit. So, a Kantian would consider the
former FDA Commissioner’s actions to be unethical because she exploited the
customers and prevented them from being able to make rational decisions in
assessing whether buying the drugs is worth the dangerous risks that follow. Kantians
would say she should have included all the warning and side effects information
on the drugs’ labels to allow customers to rationally decide whether they want
to risk consuming the drugs. Also, by the Formula of Humanity and from the
right motivation, to treat others as an end as opposed to a means Dr. Hamburg
should have been motivated by doing the right thing because it was her duty as
the FDA Commissioner.
Virtue Theory
According to the Virtue Theory,
Dr. Hamburg’s actions were unethical because they put the drugs’ consumers at
an unfair disadvantage when she was dishonest with them when withholding the
warning and side effect information from being printed on the drugs’ labels.
This violates three of the 4 Main Virtues of Character of the Virtue Theory,
which are courage, honesty, temperance, and justice. Instead of being brave
enough to take the step to do the right thing, Dr. Hamburg indulged in greed of
profiting and approved the drugs to be sold on the market. Needless to explain,
withholding the crucial information from the drugs’ labels was outright
dishonest and unjust to customers. Overall, the actions of Dr. Hamburg and
those in the FDA who conspired with her were entirely unethical from a Virtue Theorist
point of view due to how their actions were entirely greedy, dishonest, and
unfair to the drugs’ customers. A Virtue Theorist would consider that the best
course of action Dr. Hamburg and the FDA employees could have done instead
would be if they had not approved the drugs at all in the first place and had
sought a way to improve the drugs’ formulas to make them safe to use, more
effective so that they could fulfill their functions of curing the ailments,
and to sell them for the right reasons, which are to help cure people’s
ailments or illnesses as opposed to selling them just to make a large profit
off them as they conspired to do.
Conclusion
The Food and Drug Administration had the responsibility for ensuring the safety and effectiveness of drugs, along with
the safety of the nation’s food supply, cosmetics, and other processes. The
nation has trusted the FDA with fulfilling its responsibility, however it has
become corrupt through conspiring, racketeering leaders within the company, such as
the case of Dr. Hamburg and her Husband conspiring with Johnson and Johnson to
profit millions from putting the nation’s health in fatal danger. The FDA’s
unethical actions have caused the deaths of over 5,000 people, among
permanent illnesses and lifelong multi-system failure for tens of thousands
more consumers of the dangerous drugs Dr. Hamburg had approved in order to
financially gain from her husband’s stock in the drug’s manufacturer’s company,
Johnson and Johnson. From now on, the company should include every side effect and warning on the labels of
products it approves and cease acts of bribery with drug manufacturers.
The article of the lawsuit can be found in this link:
http://www.larryklayman.com/article.php?id=5
These
analyses of facts are based on a research paper by Katalinn Cooper, "The
Ethical Corruption of the FDA: Former FDA Commissioner Guilty of Conspiracy and
Racketeering (2009-2016)."
References
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<https://thepeopleschemist.com/two-reasons-not-to-trust-the-fda/>.
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<https://holisticprimarycare.net/news/1796-former-fda-head-faces-racketeering-lawsuit.html>.
Heyes, JD. “Corruption at the FDA Is
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NaturalNews.com,
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Lawsuit against Former FDA Commissioner Hamburg, Johnson and Johnson and Others
Sued for Alleged Racketeering and Other Claims
over Dangerous Drug Levaquin.” PR Newswire: News Distribution, Targeting and
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<https://www.fda.gov/aboutfda/whatwedo/default.htm#mission>.
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In the sense of individualism, or considering personal benefit to be the most important factor when making a decision, the focus is on that of single person rather than the whole. While at first glance it may seem like there is no driving force of individualism within this ethical dilemma, there ultimately is a reason that people create these counterfeit helmets. However, this can be viewed as a very negative implementation of individualism. These vendors make a large profit directly off these helmets that are made for a very cheap price. On an individualist scale, the creator and vendors of these helmets only see the money they make rather than the possible detrimental effects on others. This level of personal benefit is the basis of individualism- economic Darwinism. Applying the theory of utilitarianism to this topic offers an interesting perspective in the sense that the theory itself it the determination of right from wrong through focusing on the outcomes a certain situation. This moral framework has been used to justify the social correctness of many issues. This can be applied to the selling of counterfeit helmets in the sense that the proof of its unethically is rather blatant; one person’s desire for wealth should allow them to “play God” in the sense that they can potentially severely injure or even kill another human being who believes they are in safe hands. The theory of Kantianism focuses on that of fulfilling a given duty. One can look at this situation as Amazon merely doing what it was created to do: sell goods to the desired audiences via the internet. However, this point of view is a great disservice as the true focus should be on the idea that the creators and vendors, including Amazon, are in no way fulfilling their allotted task of creating a helmet that protects humans from injury in case of emergency.
However, while this system has remained flawed for this long, at a certain point it sadly must become a “buyer beware” situation, despite the fact that it should be necessary for every single manufactured bicycle helmet to be checked for safety and authenticity. For this reason, they must do even more to guarantee that the necessary guidelines are met when creating these helmets. It is important for companies such as Amazon to make sure they are ensuring quality products as it can truly save lives.
