Controversy
AstraZeneca is a global and science-led bio-pharmaceutical business. They are one of the
world's leading pharmaceutical companies that provide effective medicines.
Their primary focus is on the discovery, development and commercialization of
prescription medicines for gastrointestinal, cardiovascular, neurosciences,
respiratory and inflammation, oncology and infectious disease. AstraZeneca
operates in over one hundred countries. Their innovative medicines are used by
millions of patients worldwide. Seroquel is AstraZeneca’s second best-selling
pharmaceutical drug. It is a drug best known to treat schizophrenia in patients
older than thirteen and bipolar disorder patients older than ten.
According
to GEN Genetic Engineering & Biotechnology News, in 2009, Seroquel made
$4.87 billion in sales. In 1997, the drug was first granted FDA approval for
the treatment of manifestations of psychotic disorders. A few years later, the
FDA suggested narrowing the approval to the short-term treatment of schizophrenia
only. "In January 2004, U.S. approval was also given for the short-term
treatment of acute manic episodes associated with bipolar disorder. Finally, in
2006, the drug was sanctioned by FDA for the treatment of bipolar
depression." The FDA only approved Seroquel to treat and handle only
psychotic disorders, particularly short-term treatments of schizophrenia,
bipolar mania and bipolar depression. The government has made claims that
AstraZeneca deliberately marketed the drug, by a bribery to doctors, for a
variety of illnesses which have never been tested before. Alzheimer's,
aggression, anxiety, anger management, post-traumatic stress disorder and
sleeplessness are all illnesses which were not tested.
According to the acting U.S. attorney
for the Eastern District of Pennsylvania, Seroquel was given to the elderly,
the children, veterans and inmates. They were treated as "test guinea
pigs." ABC News stated that under the Food, Drug and Cosmetic Act,
pharmaceutical firms must identify the intended uses of a medicine in its new
drug application. Before a drug is even approved, the FDA must determine
whether that drug is safe and effective to use by the company. Once that drug
has approval, the drug cannot be marketed or promoted for off-labels uses.
According to ABC News, an individual reported AstraZeneca's illicit activity.
AstraZeneca
actively marketed Seroquel for off-label indications. AstraZeneca denied these
allegations. According to ABC News, the general counsel for the pharmaceutical
company, Glenn Engelmann, said in a statement that: "Moving forward and
resolving the case was in the best interest of the company. While we deny the
allegations, AstraZeneca takes its obligations very seriously under its
agreements with the government. The company is committed to meeting the
expectations and obligations of a leading biopharmaceutical company, while
continuing to provide valuable medicines to millions of patients." AstraZeneca
will pay $520 million in order to resolve the civil suit brought by the federal
and state entities. "The monetary settlement, confirmed by the Departments
of Justice and Health and Human Services’ Health Care Fraud Enforcement Action
Team (HEAT), will be split between the federal government and the state
Medicaid programs and District of Columbia, with the government receiving just
shy of $302 million."
Above, General Counsel and VP Glenn Engelmann |
According to the Washington Post, allegations of
off-label drug marketing have become increasingly common in the past decade.
The drug industry eclipsing all others as the source of fraud-related
settlements with the federal government. Michael L. Levy, U.S. attorney for the
Eastern District of Pennsylvania stated: "People have a legal right to
know that pharmaceutical companies are marketing their drugs only for uses
approved by the FDA and that their doctors’ judgement has not been affected by
misinformation from a pharmaceutical company trying to boost revenues."
Nowadays, doctors are being manipulated into prescribing powerful medicines.
The real issue is the consequences to the health of the people.
Stakeholders
According
to The Case Manual by Heather Salazar, a stakeholder is where a business has no
direct responsibility to any other interest-groups in the context of business.
Employees, suppliers, customers and the societies that the business impacts,
are all examples of stakeholders. The stakeholders in the AstraZeneca Seroquel
controversy are as follows: the patients, physicians, regulators, governments
and payers. Due to AstraZeneca's irresponsible move on the anti-psychotic drug
Seroquel, patients, physicians, regulators, governments and payers suffered
because of AstraZeneca's actions. At first, AstraZeneca denied the allegations
of Seroquel.
Between 2001 and 2006, AstraZeneca advocated the drug Seroquel to psychiatrists and physicians for disorders that were not covered by FDA approval. These off-label indications spanned a broad range of conditions. AstraZeneca promoted Seroquel to physicians who do not normally treat patients with schizophrenia and bipolar disorder. AstraZeneca had a duty and responsibility to the people and public, but they neglected to do so. People who were prescribed Seroquel, had a legal right to know that AstraZeneca was marketing their drug only for uses approved by the FDA. All AstraZeneca cared about at the time was how to boost sales and revenues. They neglected to inform consumers and the public about Seroquel.
Between 2001 and 2006, AstraZeneca advocated the drug Seroquel to psychiatrists and physicians for disorders that were not covered by FDA approval. These off-label indications spanned a broad range of conditions. AstraZeneca promoted Seroquel to physicians who do not normally treat patients with schizophrenia and bipolar disorder. AstraZeneca had a duty and responsibility to the people and public, but they neglected to do so. People who were prescribed Seroquel, had a legal right to know that AstraZeneca was marketing their drug only for uses approved by the FDA. All AstraZeneca cared about at the time was how to boost sales and revenues. They neglected to inform consumers and the public about Seroquel.
Individualism
Individualism is specific to the
business context. The primary values of individualism are the business, the
owner's choices and the profits of the business. The ethical rule of individualism
is that business actions should maximize profits for the owners of a business, but
to do so within the law. AstraZeneca failed to do so within the law. ABC News
stated that AstraZeneca "illegally marketed the anti-psychotic drug
Seroquel to children and elderly patients for uses not approved by the Food and
Drug Administration." They intentionally marketed Seroquel, by
"paying kickbacks to doctors," for various illnesses, which were
never tested before. Basically, the patients were treated as test dummies for
AstraZeneca.
"Under the Food, Drug and Cosmetic Act, pharmaceutical firms must
specify the intended uses of a medicine in its new drug application." Once
again, AstraZeneca failed to follow this law. Before a drug is approved, the
FDA must determine whether it is effective and safe to use. When the FDA
approves it, then the drug may not be marketed or promoted for off-label uses.
These were not victim-less crimes. "Illegal acts by pharmaceutical
companies and false claims against Medicare and Medicaid can put the public
health at risk, corrupt medical decisions by health care providers, and take
billions of dollars directly out of taxpayers' pockets."
Utilitarianism
Utilitarianism states that the best
action is the one that maximizes utility. The primary value of utilitarianism
is the happiness of all conscious beings. It is often interpreted as pleasure
and the absence of pain, but sometimes as the satisfaction of desires. The
ethical rule of Utilitarianism states that business action should aim to
maximize the happiness in the long run for all conscious beings that are being
affected by the business action. In utilitarianism, utilitarians believe the
principles of morality of any given action. Utilitarian’s are concerned about
the long-term costs and benefits of actions. They do this by determining the
overall happiness of all the stakeholders involved.
In the AstraZeneca Seroquel scandal, the stakeholders are not happy. How do we fix this? We need to measure the happiness of all the stakeholders affected by AstraZeneca's behavior and actions. To start off, AstraZeneca paid $520 million in order to resolve the civil suit that was brought about by federal and state entities, according to GEN Genetic Engineering and Biotechnology News. Also, AstraZeneca will pay $68.5 million, as part of a multi-state settlement, according to the Washington Post. The New Jersey Attorney General's Office describing this as the largest multi-state pharmaceutical settlement of its kind. New Jersey will receive $1.85 million from the deal, with thirty-six other states and the District of Columbia as party to the settlement. Since the stakeholder’s happiness was not maximized, a utilitarian would argue AstraZeneca's actions were not ethical.
In the AstraZeneca Seroquel scandal, the stakeholders are not happy. How do we fix this? We need to measure the happiness of all the stakeholders affected by AstraZeneca's behavior and actions. To start off, AstraZeneca paid $520 million in order to resolve the civil suit that was brought about by federal and state entities, according to GEN Genetic Engineering and Biotechnology News. Also, AstraZeneca will pay $68.5 million, as part of a multi-state settlement, according to the Washington Post. The New Jersey Attorney General's Office describing this as the largest multi-state pharmaceutical settlement of its kind. New Jersey will receive $1.85 million from the deal, with thirty-six other states and the District of Columbia as party to the settlement. Since the stakeholder’s happiness was not maximized, a utilitarian would argue AstraZeneca's actions were not ethical.
Kantianism
Weight Gain is a possible side effect from using Seroquel. |
Kantianism is
based on two moral principles. They are motivation and rationality. For any
activity to be considered as rational, it must range with a concept known as
"the formula of humanity," which states "it is wrong to use
people as a mere means to get what you want. Treating someone as a mere means
uses them or exploits them. It disregards their rationality and freedom and
usually it involves an attempt to manipulate them. AstraZeneca did not act with
any respect. They lied and harmed many people in the making. They cared about
their revenues and profit, not if they hurt any people along the way. Instead
of AstraZeneca admitting to their actions, they denied all allegations to
Seroquel. There was evidence on how the drug was marketed, sold and what kind
of side effects Seroquel had on patients and consumers.
Side Effect: High Blood Sugar, which may lead to Diabetes. |
Virtue Theory
Virtue theory analyzes a person's
character. Virtue theory's primary value is to promote wellness or the
flourishing of others within a society. The ethical rule of virtue theory is to
act in a variety of virtuous or good character traits in order to avoid vicious
and bad character traits. Virtue theory asks about a person's character. It
evaluates whether a person is virtuous or not. Having courage, honesty,
insight, care, compassion, leadership and teamwork are just a few of many
virtues that can help business people thrive and be successful. As a
pharmaceutical company, AstraZeneca does not indicate to hold any of these
virtues. AstraZeneca cheated, lied and showed no compassion or care. When they
were called out on their actions, they tried to argue and deny everything, when
there was evidence and proof. AstraZeneca lied to the public and to their
stakeholders. Due to those facts, AstraZeneca as a pharmaceutical company is
not considered ethical or righteous in any way.
Evaluation
I believe AstraZeneca is to be considered an unethical and not virtuous
pharmaceutical company. Their drug Seroquel made $4.87 billion in sales. Those
sales were all based on cheating and lying their way up the ladder to what they
call being successful. They neglected to inform consumers about the side
effects and how the drug properly works and what it's main function was.
In their annual 2011 report, AstraZeneca stated that "we are committed to
acting with integrity and high ethical standards in everything we do and our
goal is always to improve health for patients and bring benefit for our
stakeholders, our business and society." How can a company state something
like this and act so unethically at the same time? When certain pharmaceutical
companies find problems with a particular medicine, they continue to
aggressively push the drug and hope they can make a billion dollars before
someone finds out what is truly going on. That is exactly what AstraZeneca did
with their drug Seroquel.
AstraZeneca targeted its illegal marketing of Seroquel to doctors, who do not typically treat schizophrenia or bipolar disorders. There were some cases where doctors were paid cash and others were sent to lavish resorts, where they were encouraged to market and prescribe Seroquel for unapproved uses. This is a huge problem. It is more than just a financial problem. The main issue here is that these physicians and doctors are being manipulated and played with in order to prescribe strong and powerful medications. With this result, the real problem then is the consequences to the health of the public and people.
AstraZeneca targeted its illegal marketing of Seroquel to doctors, who do not typically treat schizophrenia or bipolar disorders. There were some cases where doctors were paid cash and others were sent to lavish resorts, where they were encouraged to market and prescribe Seroquel for unapproved uses. This is a huge problem. It is more than just a financial problem. The main issue here is that these physicians and doctors are being manipulated and played with in order to prescribe strong and powerful medications. With this result, the real problem then is the consequences to the health of the public and people.
References
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"Drug Giant AstraZeneca to Pay $520 Million to Settle Fraud Case." ABC
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Matthew. "AstraZeneca Paying $68.5M in Seroquel Settlement." The
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<http://www.washingtonpost.com/wp-dyn/content/article/2011/03/10/AR2011031003328.html>.
Salazar, Heather. "The Business
Ethics Case Manual: The Authoritative Step-by-Step Guide to Understanding and
Improving the Ethics of Any Business." The Case Manual (n.d.):
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"US
Court of Appeals Affirms Decision Finding SEROQUEL XR Formulation Patent Valid
and Infringed." AstraZeneca. N.p., 15 Feb. 2013. Web. 31 Mar. 2017.
<https://www.astrazeneca.com/media-centre/press-releases/2013/us-court-appeals-seroquel-patent-descision-15022013.html#>.
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Duff. "AstraZeneca Settles Most Seroquel Suits." The New York
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