Whistleblowing

The twenty-first century has seen pharmaceutical companies grow in unprecedented size and strength. Due to the unprecedented growth the larger pharmaceutical companies have gained leverage and power in the prescription drug industry, but they lack innovation to market and they seek ways to help the business continue to increase its profits. The pharmaceutical industry was once ethically sound and was a valuable player in the development of human health. However, overtime with the lack of innovation pharmaceutical companies are becoming an unethical market that exploits patients, doctors and anyone else it can to increase its profitability. With eyes only on profitability this can create a hazard for patients because there

Relators brought a qui tam action on behalf of the United States and various states against Solvay Pharmaceuticals, Inc. (“SPI”) and its affiliates pursuant to the False Claims Act. Relators alleged that SPI had marketed drugs for conditions other than the conditions for which the drugs were approved by the FDA and offered kickbacks to physicians who prescribed these drugs. Relators moved for summary judgment on a number of SPI’s affirmative defenses,

The concept of a whistleblower is that of a person who decides to report unethical or illegal actions of or within their place of employment. From the text, an extension of the previous definition goes on to say, “They may be working for private companies, nonprofit organizations, or for the government. They may disclose information inside or outside their organizations—to supervisors, regulators, or to the media.” (Halbert & Ingulli, 2012, p.47) Based on the definition, anyone of us can be a whistleblower. It doesn’t seem that the information disclosed is limited in anyway. Although, some of the information may not be protected

Another law that imposes liability on healthcare manufacturers is the False Claim Act also known as Lincoln Law. Initially, the law was applied to people who defraud federal programs but in the late 90s the Act commenced to be applied to frauds associated with the promotions of the healthcare goods. The first recognition of off-label promotion was made in 1996 when Franklin v. Parke-Davis lawsuit was filed. Dr. David Franklin filed the False Claim Act case based on his concerns on his former employer’s, pharmaceutical company Parker-Davis, off-label promotion of anti-epileptic drug Neurontin. The proposed claim that off-label promotion complies with the False Claim Act was new and controversial. It took 8 years of legal disputes to attain equally beneficial settlement of $430 million in fines and penalties. The Franklin v. Parker-Davis case set a precedent for numerous off-label promotion cases, which still remain urgent matter for both lawsuits and public debates.

The Pharmaceutical industry has been in the spotlight for decades due to the fact that they have a reputation for being unethical in its marketing strategies. In The Washington Post Shannon Brownlee (2008) states, “We try never to forget that medicine is for the people. It is not for the profits. The profits follow.” This honorable statement is completely lost in today’s world of pharmaceutical marketing tactics. These tactics are often deceptive and biased. Big Pharma consistently forgets their moral purpose and focuses primarily on the almighty dollar. Big Pharma is working on restoring their reputation by reforming their ethical code of conduct.

In an age when accelerated communications contribute to growing perceptions of organizational improprieties, the ethical and legal implications of whistleblowing have become a major topic of discussion. According to Lawrence and Weber (2014), whistleblowing is an employee disclosing apparent organizational misconduct to the government or media; however, this reporting of information should come after attempts at going through proper channels in order to persuade the organization to take appropriate actions has been ineffective.

3. The marketing tactics in the case include payments, gifts and other financial lures to doctors and government officials, off-label uses of drugs, overpricing of the drugs resulting in the higher costs of Medicaid and Medicare programs and false advertisement. All of these marketing tactics have resulted from the desire to increase revenue and profits for the firm. Although the main focus of a business is to maximize profits, these marketing methods have resulted in harm to the society and have resulted in unethical behavior. The direct-to-consumer advertisements can be justified to an extent. Through this the industry educates the public about various drugs and their benefits, it could help educate the general population, and in a world

I aim to explain the drug development process, to explore the legal and ethical implications associated with wrongful off-label prescribing, and provide my recommendations for reform of the pharmaceutical industry. I will consistently refer to the GlaxoSmithKline case to display the maleficent inner workings of the multinational pharmaceutical company. Glaxo was involved in the biggest health care fraud settlement in U.S. history for introducing and encouraging physicians to off-label prescribe their patients six misbranded drugs, Paxil, Wellbutrin, Advair, Lamictal, Avandia and Zofran. Kickbacks were paid to physicians that prescribed those drugs but also for the drugs Imitrex, Flovent, Lotronex, and Valtrex. Glaxo also failed to report safety data to the Food and Drug Administration (FDA) for Avandia, a diabetes drug. I find this issue to be so important because I hope to pursue a career in health law. My health policy major and relevant coursework ignited my interest in the legal issues strewn throughout our health care system.

Pharmaceutical companies are receiving negative allegations due to the “off-label” advertising of drugs. The Federal and Drug Administration require strict regulations for the use of “off-label” drugs in the pharmaceutical industry. “Off-label” practice of drugs are not prohibited, however, promoting the drugs are illegal. The concern of effective treatment is weighing the benefits and risks of “off-label” drugs for the best interest of the patient. In addition, companies who fail to comply with the FDA regulations, face consequences such as costly fines as well as criminal issues. Pharmaceutical companies often settle with the government, due to lack of proper procedures, complying with public health agencies. Modifying the policies of pharmaceutical companies with a different approach will limit the misuse of “off-label” drugs (Ghillyer, 2014).

According to Anderson, pharmaceutical companies have been accused of colluding with chemists, misbranding, bribery, and wrongly promoting different brands of drugs. Anderson also says GSK was fined 490 million for bribery in China. In addition, a recent survey that was observed Anderson’s article found that doctors in the US that were receiving payments from Pharmaceutical companies, were twice as likely to prescribe the drug they are promoting. I didn’t know that the pharmaceutical companies were doing unlawful things. I am concerned that this would cause the doctors to prescribe the wrong medications for a possible benifit on their

In this paper, I will cover ethical issues within the pharmaceutical industry, present opinion on Direct-to-Consumer marketing by drug companies, determine the parties responsible for regulation of compounding pharmacies, PharmaCARE used U.S. law to protect its own intellectual property, summarize at least one current example of intellectual property theft, analyze the potential issues surrounding the death of John’s wife, and lastly present major arguments that John can claim as a whistleblower.

Well, according to Miceli, Nearand and Dworkin (2008), whistleblowing is an act of revealing wrongdoings in an organization by the former or current employees of the very organization. As such, a whistleblower is an individual who reveals wrongdoings within an organization to the public or the senior management. The key characteristics of a whistleblower include, but are not limited to, dissent, accusation, breach of loyalty, altruism, sportsmanship courtesy, conscientiousness and civic culture (Miceli, Near & Dworkin, 2008).

A whistle-blower is a person who exposes illegal or immoral activity that they have witnessed. This can be knowledge of misused public money, law breaking, unethical actions, or activity that pose risk to public safety. Employees who have witnessed immoral or illegal actions often decide to keep quiet.

The number of whistleblowing incidents has increased exponentially in recent years. Two of the most major being Cynthia Cooper and Sherron Watkins (Whistleblowers of both Worldcom and Enron). There has been an increase in exposure of current wrongdoings to the supervisory bodies and enforcement agencies worldwide. (Bowen et al., 2008). It's sometimes said that Ralph Nader came up with the term, but the practice of whistleblowing goes back to the late 19th century. British personnel of the government, in the form of local unarmed police or "bobbies," would "blow the whistle" so that good samaritans could be alerted to help chase and apprehend thieves. (Griscom, 2014). For acts of exposure to be considered "whistleblowing" there

Whistleblowers perform in many careers and are found at all levels of an organization: scientists and secretaries, lawyers and paralegals, managers and staff, security personnel and computer specialists, etc. They are as varied in age, ethnic background, education, profession, sex, and income as the population at large.