Question

please explain social and business implications of the ethical issue and their impact on society that happens due to pharmaceuticals

Answer 1

social and business implications of the ethical issue and their impact on society that happens due to pharmaceuticals

Medicine is an industry-dominated climate, with physicians and patients relying on pharmaceutical companies to provide the medications needed to adequately address patient health concerns. However, because pharmaceutical companies stand to profit from the drugs they sell, they have an incentive to influence consumers to buy the drugs they manufacture. These efforts introduce a conflict of interest: between the objective of pharmaceutical companies to maximize profits and the need of patients to receive the most safe, effective, and individualized medications at any given time.

Relationships involving medical practitioners and the pharmaceutical industry raise serious concerns and controversy within both the medical profession and the broader community. Within the profession itself views differ sharply, from the conviction that the risks associated with such relationships are minimal to a concern that all contact between doctors and industry involves compromise and should therefore be avoided as far as possible.The relationship between the pharmaceutical industry and the medical profession includes clearly desirable aspects (eg, the cooperative efforts of industry, government and prescribers in trying to achieve quality use of medicines) and less clearly ethically justifiable ones (eg, acceptance of lavish gifts and money for entertainment expenses by doctors).

Misleading practices by a pharmaceutical company (pharmaceutical marketing; conflicts of interest; off-label drug marketing) : A recent court ruling has found a pharmaceutical company guilty of marketing an anti-epileptic drug for inappropriate indications. The drug had originally been approved by the national drug administration for the treatment of epilepsy, but it has gone on to become one of the highest-selling drugs in the world because the drug has also been heavily marketed toward the treatment of psychiatric disorders.

Ethical Question: Should companies market a medication for the treatment of a disorder when the medication has not received formal approval from the relevant national regulatory body?

Possible Answers • Yes, as long as empirical evidence exists that supports the drug’s use toward the treatment of a given disorder, it is the company’s right to make this information known — whether or not national regulatory bodies have formally weighed in on the evidence. • • No, the absence of a formal indication may suggest that there is inadequate evidence that the drug is effective and that it does not have a problematic safety profile. A formal indication by the regulatory body serves as a testimony that a third party, with the patient’s best interests in mind, has examined the drug and found it to be sufficiently effective and safe. Discussion On the one hand, the company has the right — even the duty — towards its shareholders to maximize profits and to expand the potential market 20 The Ethics of Pharmaceutical Industry Influence in Medicine for its drugs. Moreover, some medications that are developed to treat a certain disorder are sometimes found to be beneficial in the treatment of completely different disorders. If a company finds that an existing medication can aid in the treatment of a disorder or disease for which it is not primarily indicated, it is useful and necessary for physicians and patients to be informed about this. On the other hand, when a drug company markets a drug for a certain indication, it is implied that the drug was found to be both effective and safe for the treatment of that indication. The lack of approval by a regulatory body raises serious questions regarding the adequacy of these claims, since expanding the formal indications of the medication is certainly in the economic interest of the drug company. Off-label marketing can be more justified if the medication has received a formal indication in another country, if there is robust accumulated evidence in favor of its usage for that indication, or if the indication is a difficult-to-treat entity with unsatisfactory present treatment options.

Providing drug-risk information in pharmaceutical advertisements (pharmaceutical marketing; communication of drug risk information; misleading portrayal): A pharmaceutical company has just received approval to market its new drug. The company is thinking of launching an extensive advertisement campaign spanning many different media, including television and online social media forums. The drug has several side effects, some of them very serious, and the national drug administration has warned the company to include this information in all of its advertisements. At the same time, the company does not want to discourage patients from buying the drug. The company starts thinking of effective ways to include the necessary drug risk warnings in its advertisements without drawing too much attention to this information. The company’s marketing department thinks that this strategy will improve the company’s marketing success while simultaneously satisfying what it believes are overly strict drug regulation rules.

Ethical Question: Is it ethically appropriate for pharmaceutical companies to use advertising techniques that divert attention from adverse effects and other possible dangers of drugs?

Possible Answers • Yes, because it is the duty of the federal regulator to find a legal balance between the company’s interest to increase sales and the public’s interest to be protected from unnecessary harm. As long as the company’s conduct complies with present laws and regulations, its conduct should be considered ethical.

Downplaying drug risk information in televised pharmaceutical marketing (misleading pharmaceutical marketing; direct-to-consumer advertising; drug risk warnings) A large pharmaceutical company has recently released an advertisement promoting an anti-depressant drug. When people in the advertisement take the drug, they immediately turn from gloomy to happy. Even as the side effects are listed in rapid voice-over, the picture on the screen continues to show a happy, recovered patient, who has already benefited from the drug. The advertisers assume that these scenes of happy patients will draw attention away from the drug risk information, ensuring that viewers only remember the positive aspects of the drug, without also remembering the quickly stated risks of taking the drug.

Inclusion of drug interaction risks in a medication package insert (drug interactions; prescription practices; drug risks; conflicts of interest) An elderly female patient began vomiting and experiencing muscle cramps a couple of days after starting her medication for arthritis pain. She thinks that her medication might be responsible for her symptoms, although she is not completely sure, as her new doctor reassured her that the medication was standard treatment. During a consultation with her doctor, she nervously tells him about her current symptoms and concerns regarding the medication. The doctor is surprised by the news. Although the medication is still relatively new on the market, none of his other patients have complained of bad symptoms. He remembers, though, that the elderly woman’s prescription also included some other basic painkillers. The doctor now wonders whether the new medication cannot be taken in combination with painkillers. When he looks up the risks of the medication in the package insert, however, he finds no warnings about how it may interact with other medications.

Influence of pharmaceutical marketing on a physician’s prescribing behavior (pharmaceutical marketing; off-label prescriptions; incentivizing in drug marketing) During Dr. A’s final year of medical school, he does a rotation at a primary medical doctor’s (PMD) suburban practice. One of the patients there is a 40-year-old man with no history of psychological problems. However, Dr. A discovers that the patient has been taking a powerful antipsychotic for the last couple of months. Dr. A proceeds to question the patient about his psychiatric symptoms, and learns that the patient does not have any symptoms in the major categories of psychiatric disease (i.e., mania, psychosis, depression, and anxiety). The patient complains only of some mood trouble, explaining that sometimes he feels like he is “not himself” and can become more irritable with his wife. Dr. A is surprised by what he learns, and asks the PMD why he had decided to put the patient on an anti-psychotic drug. The PMD explains that, back when pharmaceutical representatives were promoting the drug a lot, he figured it would be a useful drug to help ease the patient’s irritability. Hearing this, Dr. A is even more confident that the patient should not be taking the drug. He is also concerned about the influence that pharmaceutical marketing had on the PMD’s prescription.

concern source

Doctors and the pharmaceutical industry share a number of common interests. For example, both are concerned with encouraging effective and responsible use of existing drugs in treatment and care, monitoring of their use, and innovative research. However, the parties have different emphases and focus on different stakeholders. Doctors are interested primarily in patient care and scientific advance, while industry is interested primarily in commercial outcomes. The primary stakeholder in patient care is the patient, whereas the principal stakeholder in industry is the shareholder. The similarities and differences between participants and their interests create both a need for discourse and the potential for conflict. The contribution made by industry to medical knowledge and practice has been considerable. The cost of development of a new drug is between US$300 and $600 million, most of which is provided by industry. Clinical research is also expensive: last year, in the United States, about US$6 billion was spent on clinical research, of which 70% came directly from industry. The total amount spent on research and development is much larger still. In spite of these clear common interests and benefits of cooperation, concerns of an ethical nature have been expressed by both the medical profession and the community. There are three main concerns:

• The possibility that associations between doctors and drug companies may serve commercial objectives of industry and acquisitive interests of clinicians rather than legitimate care, educational or research goals, thereby compromising the primary ethical obligation of doctors to patients, dividing the loyalties of doctors and undermining the basic trust on which clinical relationships depend;

• The risk that drug promotion will inappropriately influence doctors' decisions; and

• The danger that industry involvement in research will lead to distortions in scientific evidence and prevent independent assessment of data.

  It is common for relationships to be associated with several interests. Interests of medical practitioners include:

• patient welfare;

• community welfare;

• When a doctor is engaged in a relationship with a pharmaceutical company, a duality of interests exists. It can not be assumed that such a duality will constitute a "conflict" in each case — this will depend on the particular circumstances, and often not everyone will agree anyway. Dualities of interest are common; conflicts relatively rare. Further, whereas the distinction between the two is sometimes clear-cut, at other times it may be subtle and depend on the nature of the relationship in question and the values of the community within which it occurs. Dualities of interest constitute "conflicts" only when they are associated with competing obligations that are likely to lead directly to a compromise of primary responsibilities. To establish whether a conflict of interest exists it is necessary for the factual details to be declared and for the community to have the opportunity to scrutinise the issues publicly.

• pecuniary interests (eg, consultancy fees, share holdings, paid employment);

• advancement of career;

• research grants;

• hospitality;

• participation in research.

The current pattern of relationships between doctors and the pharmaceutical industry is the outcome of a long-established culture in which gratuities, gifts and the like are both expected and provided. As a result, change will require a substantial shift in attitudes and values and thus is likely to be slow. Research into the expectations of stakeholders and the impact of the various practices discussed may contribute fruitfully to community debate.