Role of the FDA with Prescription Drugs Essay

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Pharmacy Ethics




The author of this report has been asked to review the legal and ethical considerations in play given the test case scenario surrounding Pharmacare and Compcare. As is quickly apparent while reading the case study, the company engaged in a long and extensive list of ethical and/or legal violations as a means to maximize profit and minimize the legal and other red tape that seems to bother them even though it is there for a very good reason. The ethical issues involved will be touched upon and analyzed. There will also be an exploration and analysis of direct-to-consumer marketing of drugs, whether John is the "investor" of AD23, the arguments about John being a whistleblower and the associated protections he would have if he is and examples of intellectual property theft that have occurred in the last two years or so. While bad things do incidentally happen and crop up when it comes to drugs marketed to the public, there is a clear line between events like this that are incidental and ones that are improper or even criminal in nature.

Analysis




As noted in the introduction, there are a number of legal and ethical issues that abound in the case study. One of the first is the way in which Pharmacare created the wholly owned subsidiary Compcare as a means to bypass scrutiny from the Food and Drug Administration. These barriers and milestones are in place for a reason and Pharmacare is unethical at least and lawless at worst for using a shell company to do their dirty work. However, that part of the overall process with AD23 was just the first way in which they used a secondary company to benefit financially and legally. Indeed, it would be promising and worth exploring whether AD23 could be used to slow down the progress of Alzheimer's. However, the aggressive and entirely too quick way in which Pharmacare reformulated AD23 in a way to maximize the perceived benefits of using AD23 for Alzheimer's led to a rather large number of cardiac issues with patients. Indeed, several hundred people seemingly died as a result of taking the reformulated version of AD23. If the drug reformulation had gone through the proper trials and tests, these cardiac issues almost surely would have been caught before the drug was fully deployed to the marketplace. This is not to say that Pharmacare would escape liability for any cardiac deaths if the drug was approved. However, the way in which they instead went when it came to getting the drug onto the market and the ensuing deaths that happened as a result are going to put Pharmacare into a rather large legal stink even if they cut ties with the company before the legal storm hit. Indeed, the process whereby Compcare skirted the law and got a bad drug (or at least a bad version of the drug) on the market happened while it was owned by Pharmacare. The two prior-related companies also skirted the law when it came to the ban on compounding pharmacies selling in bulk for general use. Indeed, that is not what compounding pharmacies are supposed to be doing as a matter of law but Pharmacare/Compcare pushed forward so as to maximize revenue. To be honest, they were trying to have their cake and eat it too in that they used the different rules for compounding pharmacies to get the drug to market but then they sold it in bulk after getting it ready in violation of what is allowed for in the drug marketplace (Lipworth, Kerridge & Day, 2013).



Perhaps the biggest ethical and legal problem, however, came after the splitting off of Compcare. There were signs just a few weeks after the shift to the new parent that the drug was probably not safe due to the cardiac events that started to arise. Rather than slam the brakes and do a recall or at least slow down the marketing of the reformulated AD23 drug, the company just carried on and continued to sell the drug anyway. This eventually led to John, one of the people that was pivotal in reformulating the drug in the first place, to become a bit of a whistleblower and suggest that things needed to change. It is interesting that John did not seem to say anything until after his wife died after taking the drug. On the other hand, he surely would have told her to not take the drug if he knew about problems ahead of time. In that way, the company is clearly doing the wrong thing while John is trying to do the right thing.

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The corporate decision-makers, both before and after the split, that circumvented the law all need to be brought to the proper ethical and legal authorities, up to and including criminal charges for those that kept pushing the drug despite the dubious and illegal way in which the drug was developed and sold and the way in which it was sold even more even after it was known that there were safety issues with the drug. Indeed, John's wife was taking the drug for diabetes, not Alzheimer's. As such, there seems like there might be a problem with AD23 in any formulation or dosage. As such, any variations or versions of the drug need to be analyzed and pulled from the market if they are indeed not safe (Lipworth, Kerridge & Day, 2013).



One last ethical issue that is perhaps not as obvious in terms but should still be mentioned is that which pertains to paying bonuses for prescription drugs and the amount in which they are sold. To use a better example than AD23, one could point to a drug like Oxycontin. When one looks at the practice of paying people more and more as more and more of the drug is sold, it is a bit unseemly and almost certainly ethically dubious. This is true given that opiate-derived prescription drugs are potentially very addicting and this often ensnares people that are taking the drugs for entirely valid reasons such as back problem and war injuries. Even if the gravity of prescribing a diabetes drug is a little less, the same principle applies. If the drug was developed and marketed in the right and legal ways and the same outcomes (minus the deaths) happened, that would be fine, in the grand scheme of things. However, the company was skirting legal and ethical rules from the word "go" and it would seem the primary and only priority that Pharmacare had was to push the drug as hard as possible to as to enrich themselves and to hell with the consequences that ensue (Das, 2012).



When it comes to direct-to-consumer drug marketing, it is hard to give a definitive answer. However, given the totality of the implications and details involved, it would probably be wise to dial back or even ban the practice from a legal standpoint. At the very least, there are some types of drugs and such where there should be pause before pervasive marketing is allowed. Indeed, having consumers deciding their own fate when it comes to most purchases of life is not a big deal and is accepted to be the norm. However, when one is talking about anti-depressants or drugs for any sort of chronic condition such as diabetes, there should be some different rules. Just as one example, real-life experience tells us that the first-line drug for diabetes has been Metformin and this will likely not change for a while. Regardless, the patient will usually never know as much as a doctor or other trained medical person will know about what drugs are best, which ones should be avoided and why. Beyond that, a lot of the brand name drugs (especially those with a patent still in force, thus precluding a generic) are extremely expensive and there are often drugs that work just fine and are much cheaper. To be sure, there are already situations where drug companies are either limiting themselves or the tenets of corporate social responsibility are taking root. Indeed, one would be hard-pressed to give an example of any drug in the opiate (e.g. Vicodin) or benzodiazepine (e.g. Xanax) being advertised on any sort of widespread basis. Even further, the author of this report does not recall ever seeing ads for either one of those types of drugs. Drugs relating to diabetes and depression, on the other hand, are pervasive. Tresiba, Abilify and a few others are just one example of this. In general, the author of this report would say that while free markets and consumer choice should rule the day, both of those should be tied to informed consent based on timely and proper advice from a physician and not in response to an ad spiel on television. This is not to say that doctors and medical professionals in general are not in….....

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References


Bhardwaj, R., Raju, K. D., & Padmavati, M. (2013). The Impact of Patent Linkage on Marketing of Generic Drugs. Journal of Intellectual Property Rights, 18(4), 316-322.

Das, P. K. (2012). Drug vis-a-vis consumer: a retrospection. International Journal Of Social Economics, 39(3), 200-208. doi:10.1108/03068291211199369

Lee, M. T. (1998). The Ford Pinto case and the development of auto safety regulations, 1893-1978. Business & Economic History, 27(2), 390.

Gordon, S. R., & Clarida, R. W. (2014). Robin Thicke's Legal Battle with Marvin Gaye's Heirs. Entertainment & Sports Lawyer, 31(1), 17-21.

Hammer, A.J. & Kareen, W. (2012. Target Justin; Madonna "Express Yourself" Diss to Lady Gaga?; Who is the Hottest Mama in Hollywood?; SHOWBIZ Viral Video

Showdown. Showbiz Tonight (CNN).

Lipworth, W. L., Kerridge, I. H., & Day, R. O. (2013). Formulating an Ethics Agenda for Drug Development, Regulation, and Utilization. Therapeutic Innovation & Regulatory

Science, 47(1), 46-49. doi:10.1177/2168479012469949 Manap, N. A., Shapiee, R. B., Tehrani, P. M., & Shariff, A. M. (2016). Protecting R&D Inventions through Intellectual Property Rights. Journal of Intellectual Property Rights, 21(2), 110-116.

Peffer, S. L., Bocheko, A., Del Valle, R. E., Osmani, A., Peyton, S., & Roman, E. (2015). Whistle Where You Work? The Ineffectiveness of the Federal Whistleblower Protection Act of 1989 and the Promise of the Whistleblower Protection Enhancement Act of 2012. Review of Public Personnel Administration, 35(1), 70-81.

doi:10.1177/0734371X13508414

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