Ethics Responsibility or Sustainability in the pharmaceutical industry

This is a phrase I heard in my undergrad yearss whilst analyzing to be a physician. It is apparent that the infirmary industry serves as a good subject for an ethics treatment, nevertheless the industry reflected in the quotation mark above is the pharmaceutical industry. So why the pharmaceutical industry? This is something I hold close to my bosom after something I learnt about chest malignant neoplastic disease intervention in the concluding twelvemonth of my degree plan. We were told about the battles faced by Dr. Dennis Slamon in order to acquire the chest malignant neoplastic disease drug, Herceptin into the market ( book and film on this issue every bit good ) . The battle involved deficiency of support to taking truly difficult determinations during clinical tests. Herceptin could hold been launched a few old ages before, salvaging 1000000s of lives had it non been for the sudden backdown of support. For more inside informations on the Herceptin instance see Appendix A. I was incognizant of such patterns being carried out by the pharmaceutical companies and since so these issues have ever bothered me. Some more issues that I came across in the class of some research were those of selling of drugs to doctors, expensive drugs being sold to people below the poorness line, contribution of drugs to developing states which are nearing their termination day of the month or crossed it. These drugs are non merely harmful but are besides expensive to dispose, hence adding more force per unit area to the developing states economic system. Pharmaceutical companies besides focus on the development of drugs that would make good commercially and non needfully concentrating on drugs to bring around prevailing diseases like HIV, malaria etc. Hence several inquiries arise refering moralss. Why do these companies focus chiefly on life manner diseases which are more prevailing in the developed states, whilst the biggest slayers in this universe travel unnoticed? This essay nevertheless would concentrate on the monetary value of the drugs and the ethical quandary attached to the pricing and besides the selling of these drugs to doctors, which has been regulated to some extent, nevertheless, non plenty for it to non be a job. As one of the most monolithic and successful concern sectors, the pharmaceutical industry is a powerful force for good in the community, being one of the subscribers to assist increase life anticipation by 20 old ages in developed states, this industry still has a tarnished image and its behavior is often questioned.

So how did this image come to be developed? This would be covered in this essay by first turn toing the one of the most of import issues of the drugs being excessively expensive and how everything bowls done to merely being a money doing industry with moralss taking the back place. With most of the population of the universe in developing states the cost of medical specialties has become a major concern. In the war between human life and profitableness, profitableness seems to be winning. $ 800 Million – $ 1 Billion are spent on research and development entirely, in conveying a new drug to the market. ( Martin, E, 2010 ) . Due to these big sums spent by the pharmaceutical companies and finally the end being acquiring a return on their investing, they are ‘forced ‘ to bear down high monetary values for the medical specialties they have developed. The word ‘forced ‘ has been really carefully chosen. Albeit, there may be many private companies which are merely concerned with doing money, pharmaceutical industry on a whole does something baronial. It saves 1000000s of lives and gives everybody a opportunity to take a better life. These companies need to bear down higher monetary values non merely for net income grounds but besides to be able to hold the money to develop more drugs, which in bend would finally profit world. However, these companies besides use patents in order to avoid competition that would bring forth cheaper and more readily available drugs. The patents allow the companies to acquire a few old ages of competitory advantage where they charge a premium for the drug until the patent runs out and cheaper options are available in the market. These patents run several old ages and the hapless who can non afford expensive medical specialties suffer. This was seen in South Africa when a major pharmaceutical company opened a case against the South African authorities to claim that their belongings and patent rights were put at hazard when they started importing Ciprofloxacin, one of the drugs used in the therapy of AIDS, from India, which was 13 times cheaper. 27 million people are HIV positive and were exposed to a monetary value 13 times more expensive due to the protection by patents. This case was nevertheless finally withdrawn as the media examination became such that the menace to the companies reputes became greater than the economic loss caused due to dispute to the patents. ( Salek, S, 2002 ) This brings me to an ethical quandary. As the companies spend the sum they do in developing new drugs the money they make gets ploughed back into development of new drugs. If they do non do net incomes so developing new drugs would come to a deadlock. They charge the premium to retrieve the costs they incurred. But how far can this be justified? Agreed that some drugs can be charged a premium but what about drugs that cure malignant neoplastic disease or other diseases. Should n’t these be subsidised inspite of the costs they incur? This is the quandary. Millions of people are deceasing due to the drugs being expensive and people non being able to afford intervention and the pharmaceutical companies need to bear down more in order to be able to develop more drugs. So, how can one happen a solution to this barbarous rhythm? With the cognition I have about this industry I am presuming the authorities should assist in this affair and besides the FDA must be more proactive as any holds in attesting the drug adds on to its cost exponentially. Besides included in this issue is that pharmaceutical companies are keener on developing commercially profitable drugs whilst the intervention for HIV, malaria vaccinums and drugs are enduring. It was estimated that merely US $ 300 million was dedicated to research for vaccinums for HIV/AIDS and merely US $ 100 million to malaria research. These are diseases with the highest mortality and morbidity rates in the universe, and turn out devastating in developing states. However companies believe it would be more profitable to develop a drug designed to heighten sexual public presentation for males than to develop a medical specialty designed to handle or forestall malaria.

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These cases reflect an ethical dilemma- whether to supply cheaper drugs and non do net incomes, therefore halting the development of new drugs or charge higher and maintain the research traveling. To explicate the moralss behind this industry one can do usage of the teleological moralss theory or the consequentialist theory which states that the rightness or goodness of an action is non intrinsic to that action but can merely be judged by its effect. Adam Smith states that due to egoism, actions that these companies follow are morally right if the determination shaper is prosecuting his ain involvements. However, this industry is besides involved with salvaging 1000000s of lives and hence it can be safely assumed that the Utilitarian attack which holds that “ actions are right if it consequences in greatest sum of good for the greatest sum of people affected by the action ” is besides being followed. ( Modern definition, Crane, Matten 2004 ) . However this definition of the useful theory is rather different from Jeremy Bentham ‘s definition stating, “ the rule of public-service corporation approves or disapproves of every action whatsoever, harmonizing to the inclination it appears to hold to augment or decrease the felicity of the party whose involvement is in inquiry: or, what is the same thing in other words, to advance or to oppose that felicity. ” This definition to me has a few defects, as it seems excessively subjective, the portion ‘tendency it appears to hold ‘ suggests that it refers to cipher in peculiar and the word ‘tendency ‘ shows a divergence and uncertainness in the definition. We need something more concrete to establish moralss on. Besides, Bentham ‘s definition is for a choice group of people whose involvement is in inquiry, and even the modern definition depicts people affected by the action and ignores people who would hold been affected if a different action had been carried out. With respects to this the most suited definition would be the simplest one by Mill ‘s, “ Actions are right in proportion as they promote felicity, incorrect as they produce the contrary of felicity ” . Utilitarian theory besides assumes the measure and quality of felicity can be weighed based on strength, continuance, certainty, extent etc. Cost benefit analysis is an of import tool in this theory as it measures non merely the direct costs and benefits to an administration but besides the societal costs and benefits. For illustration it can be measured by the nest eggs on medical intervention, the overall economic productiveness due to intervention, improved quality of life. The tangibles can be measured easy as costs of drugs would be known. Harmonizing to Karl Marx the theory of public-service corporation is true by definition and therefore does non truly add anything meaningful. For Marx, a productive enquiry had to look into what kinds of things are good for people. Second, he says that Bentham fails to take history of theA changingA character of people, and therefore the altering character of what is good for them. Marx argues thatA human natureA is dynamic, so the construct of a individual public-service corporation for all worlds is unidimensional and non utile. He decries the deduction that society, and people, have ever been, and will ever be, as they are now. ( Das Kapital )

In contrast to this theory a expression at the virtuousness theory could besides be interesting to understand this industry. Virtue theory does non take moral regulations or effects into history. Virtue moralss implies that morally correct actions are those undertaken by virtuous people and hence formation of virtuous character is first measure towards morally correct behavior ( Crane, A, 1968 ) . We can see how this theory contradicts the useful attack, as under the latter the industry is ethical as its action sum to the greater good no affair what the action was, nevertheless harmonizing to the virtuousness theory the actions need to be good and this would in bend make the industry good. This is less seen in pattern as many a times in order to better profitableness the industry takes the incorrect action and does non stay virtuous, unlike in the useful theory, where even a incorrect act is justified if it leads to the greater good, which in the instance of the pharmaceutical industry in peculiar, it normally does. ( Kelman, S, 1981 )

The other issue that fusss me is the selling of prescription drugs to doctors. Medical gross revenues representatives frequently visit doctors, advancing new drugs of the pharmaceutical companies. Doctors are frequently offered non merely corrupt, and kickbacks but besides all disbursal paid trips, season tickets etc to advance their drugs. Other than this the purchasing groups may besides hold vested involvements as they may keep stock in the provision company. These determinations are sometimes taken unconsciously by the doctors, due to the relationship edifice that was being done. All this raises the issues of struggle of involvement as the doctor is non able to transport his responsibility with all equity as sworn in the Hippocratic Oath. They fail to populate up to their professional duty when opportunism bias their opinion and compromise their service to their patients. All this has an impact on professional and scientific unity and quality of wellness attention. It ‘s all about selling. Merchandises are meant to be sold in ‘too-good-to-be-true ‘ bundles and doctors are persuaded by all the benefits demonstrated. Some companies do non even unwrap al the possible side effects of the drug, in fright of it non being accepted by the doctor. Hence, rather a batch of information is kept hidden while overstating the benefits. All this once more leads to a barbarous rhythm as when a doctor is convinced that a peculiar drug option is better, he might alter the intervention options of his patients to this extremely hazardous and more expensive drug than before unaware of the harm it might make. Drug which are insecure are being brought into the market. These led to rigorous ordinances being laid between the relationships of these companies with the FDA.

A pharmaceutical company has a commercial involvement in denying or playing down medical hazards and in being slow in look intoing these hazards. These companies are wrongly motivated. Agreed all stakeholders need to profit, but the patients are besides of import stakeholders who are frequently ignored. Harmonizing to the stakeholder theory stockholders are but one of the of import stakeholders. The companies get involved in bureau hazards in which the directors merely focus on increasing stockholder wealth at the disbursal of the assorted other stakeholders. Stakeholders are “ those groups without whose support the organisation would discontinue to be. ” This is a slightly radical position got from the Stanford memo in 1963. Harmonizing to R. Edward Freeman, the stakeholders are the 1s “ that can impact or are affected by the accomplishment of an administrations aims. ” This attack can help directors by advancing analysis of how the company fits into its larger environment, how its criterion operating processs affect stakeholders-shareholders, employees, patients devouring the medical specialty, doctors ordering them, clinical research workers, medical diary editors, wellness attention policy shapers, authorities etc. Hence, the most of import issues that arise are the quality and cost of medical attention and the unity of medical professionals. ( Weber, L.J, 2006 ) Again, the contrast with Friedman ‘s position should be apparent: if the corporate director looks merely to maximise stockholderA wealth, A other stakeholders can easy be overlooked. ( Mayer, D, ) In a normative sense, stakeholder theory strongly suggests that overlooking these other stakeholders is unwise and ethically undue and in an instrumental sense they can look into if it is good to the administration to take the stakeholders involvements into history, as this is what would take to success and competitory advantage. ( Bailur, S, 2006 ) Hence, these companies possibly dedicated to safety of the patients ( stakeholder ) but there is a struggle of involvement nowadays, between safety and sale of the drug. ( Weber, L.J, 2006 ) This was what was seen in the Merck and Vioxx instance where people died due to the company being slow to move in retreating the drug whilst the grounds of unacceptable hazards was mounting. For more inside informations on the Merck-Vioxx instance, see Appendix B.

This industry is frequently faced with the issues of corporate administration and trust. Due to the assorted drug call dorsums that have happened over the recent old ages trust in pharmaceutical industry has decreased, it is merely being considered a money devising machine. This has non merely led to bad promotion taking to drop in gross but besides increased costs of monitoring and control procedures. ( Salek, S, 2002 ) The function of being a corporate citizen varies from active impression of citizenship to inactive credence. In a universe where directors face improbably intense force per unit area sing fiscal public presentation, it is wholly excessively easy to lose sight of the broader corporate citizenship docket which places concerns steadfastly within the context of the societies in which they operate. ( Waddock, S, 2003 ) . In marketing to consumers the companies should supply accurate and clear information on the benefits and hazards of the drug. Harmonizing to Garriga & A ; Mele, ( 2005 ) , the most recent theories to back up the construct of corporate societal duty are fundamentally focused on four countries, run intoing aims that produce long term net incomes, utilizing concern power in a responsible manner, incorporating societal demands and eventually, lending to a good society by making what is ethically right. 4 groups that arise out of this attack are the instrumental group, where the corporation is seen as an instrument for wealth creative activity and this implies its whole societal duty. The 2nd group is the political theory group, which emphasizes the societal power of the corporation vis a vis its relationship with society and its duty in the political sphere. The 3rd group is the integrative theories, which emphasizes the fact that concern depends on society for its continuity, growing and being. The last is the ethical theories which postulates that the relationship between concern and society is embedded with ethical values. The pharmaceutical industry falls into the political theory group as its societal duty lies in the benefit of world, and this duty arises due to the sum of societal power they have. ( Theophilius, A, 2007 ) However, due to a few whistling blowing incidents seen in the pharmaceutical industry, many issues have been made cognizant to us which we would hold non known otherwise. One of the most celebrated instances was Pfizers colony at $ 2.3 billion in 2009. For more inside informations see Appendix C. Had people died inspite of Pfizer cognizing the drugs side effects and non informing the people concerned, it could hold been sued for corporate manslaughter.

This paper hence covers assorted ethical issues of the pharmaceutical industry and application of assorted theories with an analysis of the assorted attacks of old writers to the different theories. All in all, like every industry, the pharmaceutical industry besides has a good and a bad side. The universe today is a capitalist driven, market based economic system. Pharmaceutical companies besides chiefly concentrate on their net income coevals. If we view the sustainability issue from the consequentialist position, we can deduce statements that both support and condemn environmental development. Harmonizing to this theory environmental development by the pharmaceutical industry could be justified if it finally leads to the larger good. However, what would go on to other industries or resources if the environment is exploited? How does the useful attack explain the harm done to several lives. What would be the tradeoff? The pharmaceutical industry should look at the ternary underside line which includes the societal, environmental, and fiscal public presentation which involves duties to the assorted stakeholders, these should be measured, calculated, audited and reported. In order for the ternary bottom line coverage to drive maximal value, it is indispensable that the information reported aligns with concern scheme and aims and accurately reflects the focal point of company activity in these peculiar countries. ( Schubert. J, 2003 ) The pharmaceutical industry is an industry which is based on profiting world, nevertheless the barbarous rhythm of R & A ; D costs and developing new drugs is an of import portion in it being expensive and using for long patents. Thinking about it, it is non ethically incorrect, it becomes incorrect when it limits itself to merely being a money devising industry, working the hapless when there is an option available to supply cheaper drugs to those who truly necessitate it and can non afford them and therefore burying the larger image.


Story behind Herceptin-

So, what was the narrative behind the Herceptin? Dr. Dennis Slamon, UCLA Medical Centre, LA, develops the experimental drug, Herceptin, which harmonizing to him was a large discovery to handle breast malignant neoplastic disease. He needed to run tests on adult females with chest malignant neoplastic disease in order to see its effectivity and farther to acquire the blessing for the launch. He worked indefatigably on this get the better ofing many obstructions. I wondered how far were these obstructions ethically correct. First, one of the pharmaceutical companies stops funding for research, which was really of import as it was merely an experimental drug, nevertheless a few altruists show involvement and the research finally gets funded by drug companies. The other obstructions being the tests that the drug had to undergo. Tests were done on adult females with the malignant neoplastic disease and who were explained the hazards and results beforehand. However, a few adult females were excluded out of the tests as they did non run into the ‘protocol ‘ . Even though Dr. Slamon knew this drug would profit even those who did non suit the protocol and inspite of all the attempt put by him the adult females had to be rejected. Finally after 8 long old ages of confronting the obstructions and about giving up, the drug proved to be a success and was given the FDA ( nutrient and drug disposal ) blessing. The inquiries this raised for me was- it took 8 long old ages to establish a drug which could hold been launched in less than half that clip hence salvaging 1000000s of adult females and besides the protocol issue and my ethical quandary. I do understand as a physician that following protocol is of import, nevertheless giving those adult females the drug would hold jeopardised the whole test. I assumed the adult females could hold been given the drug without affecting them in the test, once more salvaging lives. On researching more thenceforth, I came across many other ethical issues which were more prevailing and were distributing like the pestilence in the current universe we live in.

Vioxx- hurting slayer or merely killer? ?

Vioxx which was a hurting slayer to handle conditions like arthritis was on the market for 5 old ages and had reaped one million millions in net income already. Evidence of it increasing the opportunities of doing shots and bosom onslaughts was increasing, nevertheless, Merck was still contending off jurisprudence suits to support the drug alternatively of taking the drug off. The whole narrative was evidently ill-defined as to whether Merck knew of all the side effects, as, if they knew it merely means they marketed it as a ‘super-drug ‘ under wholly false pretensions.


This happened when they approached a head-shrinker, Dr. Stefan Kruszewski, to sell him an anti psychotic drug for kids and an off-label usage of handling dementedness in grownups. He did no agree to it and on farther research found that the drug, Geodon, had serious cardiac side effects which were non metioned by the gross revenues reps, who called it a safe drug. The head-shrinker blew the whistling on this and took Pfizer to tribunal. Pfizer had to settle for 2.3 billion out of which 14.3 million were given to Dr. Kruszewski. Many such instances have been seen and the whistle blowers motive to make this could be the moralss behind the state of affairs or the pecuniary motive of acquiring returns from the colony. ( Lowe, 2009 )

Use of Kohleberg ‘s model-

Even harmonizing to the Kohlberg theoretical account they get off by showing pre-conventional morality which means they are oriented to obeisance and penalty. They follow the regulations by the book in making research, clinical tests etc. This is what jurisprudence requires them to make. Again, this is where the differentiation between jurisprudence and moralss would come into image. ( Crane, 1985 ) Legally, there have been many regulative limitations on the pharmaceutical industry in footings of criterions for quality, safety and efficaciousness. These have been developed over several old ages. There are many Torahs and ordinance impacting the industry, refering for illustration the pricing of medical specialties, the behavior of clinical surveies, the wellness protection of workers and concern for the environment. In some Fieldss it is so barely possible to keep criterions through ordinance. This is where the function of moralss comes into the image. ( Duke, 2005 )



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