Pharmaceutical Marketing Scene in the US - Literature review Example

? Legal/ Ethical Issues in Business (Add (Add (Add Legal/ Ethical Issues in Business Introduction Medical sales representatives often face criticism on the grounds of morality and ethics. These days, on any given day, medical representatives offer so many dollars and a car trunk full of promotional gadgets to get a prospect’s time, and to make him prescribe the medicine to a number of patients. This practice of giving and receiving gifts is often considered unethical. However, a deeper look into the issue reaches the age old ‘chicken or egg’ question. Doctors are not to be blamed for the extreme extravagance from the part of medical companies, and medical companies will not offer any gifts if doctors are not ready to receive. However, what happens in practice is that medical companies are ready to give, and doctors are equally ready to receive. The gifts often include visits and pleasure trips to dream destinations, a few dollars as honoraria, lunches and dinners in sunny and warm destinations, and pens and other gadgets emblazoned with the name of the sponsor. It seems that the guidelines from governments and other regulatory bodies are seriously deficient in the matter of drug promotion. A look into the Pharmaceutical Marketing Scene in the US According to statistics (cited in Barfett, Lanting, Lee, Lee, M., Victor & Simkhovitch, 2004), in the United States, an amount of nearly $ 21 million was spent in the year 2002 on marketing by pharmaceutical companies. When this amount is broken down, it is seen that 56% of the amount was spent on providing free samples, and 25% was accepted by physicians in the form of honoraria and gifts. As Reilly (2009) points out, there are nearly 92000 pharmaceutical sales representatives in the United States; that means, there is one pharmaceutical sales representative for every 7.9 doctors. This huge number of representatives has become a burden in the medical fraternity. The doctors are forced to spend a lot of time on the representatives. In a recent development, a person filed a law suit against the Blackstone Medical alleging that the company engaged in such illegal practices as offering monthly payments, payments to development projects, entertainment expenses, and so on and on (“Outpatient Surgery”, 2011). Why Physicians Love Drug Samples A study by Joseph & Mantrala (n.d) looks into the attitude of physicians towards the prescription drug promotion. It is found that physicians favor sampling for two apparent reasons. First of all, most of the time, the new representatives, their explanations, and their glossy pamphlets are the primary source of education for physicians to know about new drugs. So, sampling is often the only way for physicians to see how new drugs work in certain conditions. In addition, it also allows the physicians to observe the negative effects of old drugs for new patients and give fine-tuning of dosage before the full prescription is purchased by the patient. Thus, it gives a relatively safer way to check if the drug suits the patient’s idiosyncratic features. Another benefit is the chance to satisfy the price-sensitive patients, thus playing a public relations purpose. However, the physicians abhor the samples for certain basic reasons like the time and effort required to receive samples. It requires sending signed return receipts, and also requires record keeping and security. The Impact of Drug Samples on Prescription Patterns The study by Chew, O’Young, Hazlet, Bradley, Maynard & Lessler (2000) looked into the impact of the presence of samples on the prescription patterns of 131 physicians under three essential scenarios. The scenarios were: an insured woman with uncomplicated lower urinary tract infection, an uninsured man with essential moderate hypertension, and an uninsured woman with a new onset of depression. In the study, it was found that in all the scenarios, a considerable proportion of the physicians gave up their preferred drug choice and prescribed an available sample. The proportion ranged from 16% to 41%. Thus, the study proves that the free samples and gifts are money well spent (Chew et al, 2000). Similar results were obtained in the study conducted by by Backer, Lebsack, Van Tonder & Crabtree (2000); the study looked into the effect of free samples on the prescription patterns of community-based family practices based on 1588 patient encounters with 53 primary care clinicians. From the study, it became evident that in 20% of the cases, the clinicians offered the available drug samples. Off-label use-the first Negative Impact Off-label use can be defined as the use of drugs by doctors for purposes other than those approved by the FDA. It has become evident from various studies that a considerable proportion of patients are subjected to off-label use. This is so because doctors are free to prescribe any legally marketed device for uses other than the ones allowed by FDA. This is so because Section 906 of the Federal Food, Drug, and Cosmetics Act points out that the Act does not interfere with the authority of a healthcare practitioner to prescribe or administer any legally marketed device for any condition or disease within a legitimate health care practitioner-patient relationship (FDA, n.d). Thus, as a study by Kesselheim, Mello & Studdert (2011) from the Brigham and Women’s Hospital, Boston, points out, there is widespread off-label marketing of medicines in the US which cannot be controlled under the existing laws. The study identified three methods of off-label marketing. They are: expansion of drug use to unapproved diseases, expansion of drug use to unapproved disease subtypes, and expansion of drug use to unapproved dosing strategies that often involves higher doses. To illustrate, in the year 2008, Medtronic revealed that the off-label use of its rhBM-2 was under Department of Justice investigation. Though the InFuse Bone Graft was approved by FDA for very limited uses, it was illegally used in cervical spine surgeries (Off-label marketing of rhBMP and the InFuse Bone Graft). The report reveals that off-label use is so wide in the field that federal government charges billions of dollars from drug companies for using medicines for purposes other than the ones allowed by FDA. Rising Price of Drugs- the Second Negative Impact As already said, the medical companies are spending more on promotion than on research and development. The study by Gagnon & Lexchin (2008) looks into the impact of promotion on price. It is found that firms spend two times more on promotion than on research and development. That means, while the production cost of a medicine is nearly 30%, promotion costs nearly 60%. Now, it is totally irrational to believe that the companies that do not hesitate to engage in such unethical practices will not charge the consumers for the cost of promotion. That means, because of this exceedingly extravagant promotion, patients are made to pay an unjustifiably higher price for the medicines they purchase. Regulations The marketing and distribution of pharmaceuticals in the United States is guided by the Prescription Drug Marketing Act of 1987. In addition, there is the Code on Interactions for representatives issued by the Pharmaceutical Research and Manufacturers of America (PhRMA). The mere fact is that the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA), that is responsible to regulate prescription drug promotion does not offer any effective guidelines on the interaction between representatives and physicians. Instead, the FD & C Act deals with the accuracy of information provided in advertisements and promotional gadgets. According to Part 203, Title 21 of the CFR, manufacturers have the responsibility to see that the recipients of the free samples are licensed by the state. Also, the manufacturers will be held responsible for the medicine they ship to the medical sales representatives. Lastly, they are supposed to ensure the safety and security of the samples provided. However, a closer look reveals that these guidelines have no practical benefit in controlling the nexus between health care providers and pharmaceutical representatives. The PDMA Act only ensures that the free samples provided are properly labeled, samples are provided on request, and that those who receive the free samples are licensed by the government. However, there are no proper regulations regarding the use of gifts and free samples that can evidently affect drug price and prescription patterns. Admittedly, one code that deals with the use of gifts and other such promotional practices is the PhRMA Code on Interactions. According to the Code that came into force from 1 July 2002, the interactions between sales representatives and health care professionals should not take place in such places which are unsuitable for the exchange of scientific information. Such restricted places include golf courses, expensive restaurants, and a number of other venues. In addition, it is pointed out that the gifts offered to the health care professionals should not exceed $ 100, and the gifts that can be offered are very limited like stethoscope, anatomical models and so on. The classical gifts like golf balls, sporting event tickets, and tickets to other entertainment shows are restricted under the guidelines. However, it is possible to provide gifts of minimal value like pens and notepads which are of practical use at the practice site. Similarly, AMA and ACOG have modified their codes to discourage the acceptance of gifts and favors. To illustrate, the AMA Code of Medical Ethics, Opinion 8.061, points out that the gifts accepted should be of primary benefit to the patients, and should not be of substantial value. In addition, it is pointed out that individual gift, when accepted, should be of minimal value, and should be directly linked to the physician’s workplace. Moreover, while it prohibits receiving subsidies in the form of costs of travel, lodging, or other personal expenses, it allows receiving reasonable honoraria and reimbursement for reasonable travel, lodging and meal expenses (American Medical Association, n.d). Similarly, ACOG (2011) points out that the practitioners should be aware of and cautious about commercial promotions of medical products and services. It is advised that the practitioners should be fully aware about the possibility of conflict of interest involved. So, they are supposed to offer such medical advice that is accurate, balanced, and complete, and free from any bias based on the promotions (American College of Obstetricians and Gynecologists, 2011). Doctors’ Attitude towards Free Samples and Gifts A study by Morgan, Dana, Loewenstein, Zinberg and Schulkin (2006) looked into the attitude of doctors towards the so called promotion practices. From the study, it became evident that out of the 393 members of the American College of Obstetricians and Gynecologists took part in the study, 92% believed it is right to accept free drug samples. Those who believed in the justifiability of a free informal lunch constituted 77% of the group, and 53% was happy with getting a hefty consultancy fees. Similarly, 75% thought it was right to receive a gift like an anatomic model (Morgan, et al, 2006). A Look into the Ethical Side From the above discussion, it becomes evident that the industry and the authorities have failed to reach a balance between business and fairness in drug promotion and medical practice. Also, it becomes evident that despite efforts from the part of authorities, there is still a lot of space for unethical practices. So, it is only reasonable to look into the ethical aspects once again. A look into general social norms proves that giving and receiving special favors amounts to bribe, especially when it comes to drug promotion. However, one has to remember the fact the research and development of medicine by private firms is solely aimed at making profit. In other words, when a medicine is developed, the company aims at making profit. So, just like any other product, companies cannot be blamed for giving special offers to healthcare professionals for accepting and prescribing their medicine. Giving golf balls, offering trips to tourist destinations are all such practices aimed at promoting their products. If this is justifiable in other businesses, medical business too should be allowed to do so. Now, looking into the issue from the medical professionals’ point of view, one can see that they too receive a lot of benefits from this practice. Firstly, the representatives and the leaflets they provide act as the primary source of medical education for the busy physicians. They get a chance to know about better medicines without a costly loss of time. Secondly, they cannot be blamed for receiving the money and gifts from drug companies, because, prescribing a new medicine is not an easy task. A treatment that goes wrong or ineffective does have a negative impact on the image and reputation of the physician too. Thus, it is irrational to believe that physicians will resort to prescribing such medicines that are evidently ineffective. Now, looking into the matter from a patient’s point of view, one can see that the patient has the right to receive medicine at a reasonable cost. In addition, the patient has the right not to be subjected to any such experimental medication the result of which is unknown. In addition, they are not supposed to bear the cost of the free golf balls and music programs the doctors enjoy. A Way out of the Quagmire From the analysis, it becomes evident that there is no way out especially when medical research and development lies in private hands. So, the first step is to see that the drugs are not priced too high. To achieve this, the pricing of every new drug should receive the approval of FDA. FDA should, in turn, look into the actual research and development costs and production costs, and set a price accordingly. This will stop the companies from charging patients for the unnecessary extravagance. The second point is the prevention of off-label use. The provisions allowing off-label use should be removed from the law, and possibilities of new applications of any medicine should come from manufactures, and should get the approval of FDA before coming into practical use. In other words, experimentation should not be allowed for doctors. Conclusion In total, it becomes evident that the interaction between health professionals and drug representatives cannot be fully streamlined to avoid bribing because the concept of ethics in business is still not concrete. Also, it becomes evident that the existing rules and regulations are mere guidelines that give a lot of space for practitioners to take independent decisions. However, by controlling pricing and off-label use, it is possible to ensure better protection to patients from such practices. References American Medical Association. (n.d). Opinion 8.061 - gifts to physicians from industry. AMA Code of Medical Ethics. Retrieved from http://www.ama-assn.org/ama/pub/physician-resources/medical-ethics/code-medical-ethics/opinion8061.page American College of Obstetricians and Gynecologists. (2011). Code of professional ethics, 1-4. Retrieved from http://www.acog.org/~/media/About%20ACOG/acogcode.ashx Backer, E.L., Lebsack, J. A., Van Tonder, R. J. N & Crabtree, B. F. (2000). The value of pharmaceutical representative visits and medication samples in community-based family practices, Journal of Family Practices, 49(9), 816. Barfett, J., Lanting, B., Lee, J., Lee, M., Victor Ng & Simkhovitch, P. (2004). Pharmaceutical marketing to medical students: The student perspective, McGill Journal of Medicine, 21-26. Chew, L. D., O’Young, T. S., Hazlet, T. K., Bradley, K. A., Maynard, C & Lessler, D. S. (2000). A physician survey of the effect of drug sample availability on physicians' behavior. Journal of General Internal Medicine, 15(7), 478-483. 2011. Court Green-Lights Whistleblower Lawsuit Against Implant Maker Blackstone Medical. Outpatient Surgery. Retrieved from http://www.outpatientsurgery.net/news/2011/06/23-Court-Green-Lights-Whistleblower-Lawsuit-Against-Implant-Maker-Blackstone-Medical FDA: U. S. Food and Drug Administration. (n.d). Regulatory information. Retrieved from http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterIXMiscellaneous/ucm107212.htm Gagnon, M. A & Lexchin, J. (2008). The cost of pushing pills: A new estimate of pharmaceutical promotion expenditures in the United States. PLoS Medicine, 5(1). Joseph, K & Mantrala, M. K. (n.d). Prescription drug promotion: The role and value of physicians' samples under competition. Retrieved from http://web.ku.edu/~pshenoy/BUS936/Powerpoint/Joseph2003.pdf Off-label marketing of rhBMP and the InFuse Bone Graft. Bernstein Liebhard. Retrieved from http://www.consumerinjurylawyers.com/medtronic-infuse-bone-graft/medtronic-off-label-marketing-infuse-bone-graft.html Kesselheim, A. S., Mello, M. M & Studdert, D. M. (2011). Strategies and practices in Off-label marketing pharmaceuticals: A retrospective analysis of whistleblower complaints, PLoS Med, 8(4). Morgan, M. A., Dana, J., Loewenstein, G., Zinberg, S & Schulkin, J. (2006). Interactions of doctors with the pharmaceutical industry. Journal of Medical Ethics, 32(10), 559-563. Reilly, K. B. (2009). Doctors increasingly close doors to drug reps, while pharma cuts ranks, American Medical News. Retrieved from http://www.ama-assn.org/amednews/2009/03/23/prl10323.htm Read More