March 3, 2016
Legal and Ethical Considerations in Marketing, Product Safety, and Intellectual Property
In the book Pharmaceutical Ethics, Jon Merrills’ defines ethics as:
* Ethics is the systematic study of what is right and good with respect to conduct and character.
* The beliefs and behaviors to which members of the profession subscribe.
* A critical evaluation of assumptions and arguments.
* A discussion about what ought to be done or ought not to be done.
Using Merrill’s’ definitions as a rough guide we can evaluate the legal and ethical decisions of PharmaCARE’s use of the diabetic drug AD23 in slowing the ...view middle of the document...
Although, PharmaCARE’s actions seem unethical in practice those tactics are used by the larger drug manufactures and in some cases on much larger scales.
In November 2013, Christopher Kelly with the FDA had a news release stating Janssen Pharmaceuticals, Inc. to plead guilty and pay over $1.6 billion to resolve allegations of misbranding and filing false claims for is schizophrenia drug Risperdal (Kelly, 2013). The release also had a criminal fine of $400 million and the parent company Johnson & Johnson and JPI were aware that Risperdal posed serious health risk including increased risk of stroke, but that the companies downplayed those risks by combining negative data with other studies in order to support a perception of decreased risk from using the drug. Based on this case PharmaCARE and CompCARE would be also guilty of misbranding a medication for diabetics to use for Alzheimer.
According to a scientist for the U.S. Food and Drug Administration (FDA), Avandia is linked to as many as 100,000 heart attacks. Clinical studies show that the drug increases the risk of heart attack by 43 percent and can double the risk of heart failure after one year of treatment. During clinical trials, more people died as a result of a cardiovascular event taking Avandia than those taking a placebo, studies show. Despite these findings, Avandia’s black-box warning label did not mention an increased risk of cardiovascular death until the FDA warned about the risks in 2007. A two-year investigation by the U.S. Senate Finance Committee revealed GlaxoSmithKline knew of the cardiovascular dangers associated with Avandia for years and tried to stifle concerns noted by several doctors about the medication. Many patients feel that GlaxoSmithKline should have made doctors and the public aware of the cardiac risks associated with Avandia at the time the company knew of the dangers. In an article by Tom Moylan, GlaxoSmithKline plc (GSK) on July 24 said it has reached an agreement in principle with the attorneys general of seven states to pay $229 million to resolve lawsuits relating to the development and marketing of the diabetes drug Avandia, along with a lawsuit by the Louisiana attorney general relating to other GSK products. In addition to Louisiana, the settling states are Kentucky, Mississippi, Maryland, South Carolina, New Mexico, West Virginia and Utah. In a press statement, a GSK spokesperson said, “The Company is settling these matters to avoid the expense and uncertainty of protracted litigation and trial. The company did not admit to any wrongdoing or liability of any kind under these states laws in this settlement (Moylan, 2013).” Based on this case PharmaCARE and CompCARE would most likely settle without admitting liability.
In 2012 Abbott Laboratories had a federal lawsuit accusing it of illegally promoting its cholesterol drug TriCor of uses not approved by regulators, including the prevention of cardiac health risks in patients...