Monday, November 26, 2018

Ethical Corruption in the FDA: FDA Guilty of Conspiracy and Racketeering (2009-2016)

Company Background
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.

Dr. Margaret Hamburg, Former FDA Commissioner (2009-2015).

          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
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
Statistics from the Centers for Disease Control and 
Prevention - Over Half of Drug Overdose Deaths in 
Entire Nation are Result of Prescription Painkillers.
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.

          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.

          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.

          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.

          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: 

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)."

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