Ethical and Legal Issues of Doctors Relationship with Drug Companies - Research Paper Example

Ethical and Legal Issues of Doctors’ Relationship with Drug Companies Origins It was in 1990 that shocking facts on the medical fraternity were published by a paper written by the American College of Physicians, on a conflict related to physician practice and the pharmaceutical industry1. The title of the paper was “Physicians and the Pharmaceutical Industry”, revealing the compromising situation that the medical practitioners were engaging in. Due to the influence that drugs producing companies had on the drug choice and prescription decisions that the pharmacists made, it was found out that ethical issues were arising. Patient care is the ultimate responsibility of the physician, as led by physicians’ professional code of conduct, which was apparently being compromised by the conflict of interest that the drug industry was presenting against the integrity physicians. Background Information The main cause of concern in the practicing of competent pharmacy is the common interest that the two parties (physicians and pharmacy industry) share. While the physicians deal directly with their patients, the pharmaceutical companies deal with the pharmacists with a connection through the products. Pharmaceutical companies target the physicians, with an aim of increasing their products consumption by influencing the prescription patterns and ordering of these products by medical institutions. Drug promotions take a different direction when the conflicting interests of the parties compromise the ethical duties that the physicians have over their patients. Commercial pressure from the pharmaceutical industry is exerted to the drugs end users, creating a serious risk to the quality of health services offered2. Laws Regulating Physician-Vendor Arrangements Government laws include False Claims Act that allows the public to launch legal action against fraudulent pharmacists, in case evidence can be adduced to attest to the claims. The Medicare and Medicaid Patient Protection Act, formerly Antikickback Statute provides for the incrimination of improperly obtained reimbursements from the referral or recommendation for purchase medical goods and services. Stark Law provides for the incrimination of physicians’ patients referrals to certain facilities where they have financial interests. Collateral consequences on pharmaceutical companies failing to comply with the provisions of the Antikickback Act include the imposition of government reimbursements ban for five years. Medical supply companies facing such collateral consequences are technically wiped out of the pharmaceutical industry. Further medical supply contracts to the government by the company are cancelled. The collateral consequences implications to the shareholders have far reaching consequences, which trickle down to its public image and long term profitability. The Prescription Drug Marketing Act provides that pharmaceutical suppliers avail a pedigree prior to drugs distribution. Current Regulatory and reinforcement Environment The state and federal enforcements targeting the pharmaceutical industry have been established across the country. State enforcements for instance regulating the reporting on expenditure incurred for marketing is independently carried out. Spending and gifts by pharmaceutical companies is regulated at the state level, with diversified provisions in the laws. An example of such regulation is that enacted by the State of California in controlling budgets touching on marketing expenditure3. The laws that regulate the interactions between the pharmaceutical companies and physicians can be analyzed as government and professional regulations4. Some of these laws provide that the arrangements made for drug acquisition between the vendor and the physician include; Gifts likely to influence the acquisition of pharmaceutical products are not allowed. For instance, the pharmaceutical company is prohibited from offering entertainment or recreational services to physicians. Meals may be allowed on strict conditions of openness as long as the intentions of the offering company are well laid out to exclude influence. The laws also provide that all the arrangements have a true representation of the fair market value. When the vendors supply free samples from the company to the physician, the physician is obliged not to sell the free samples to patients. Gifts extended to physicians have a ceiling to curb influence intentions from the pharmaceutical companies. Excessive promotion of the pharmaceutical company’s products is termed as lobbying and is prohibited. Luring physicians to offer consultancy services to a pharmaceutical company with an aim of luring influencing them is prohibited by law5. Vendors are not allowed to access patients’ information or deal with them on behalf of the physician. Promotional materials are not allowed in public or patient care areas of a health institution, just as it is illegal to market pharmaceutical products directly to patients. The laws also provide restriction regulations to the vendors, in the distribution of free sample drugs. Certain vendors offer scholarships and other contributions likely to create conflict of interests, which is illegal in many government institutions. Examples of federal laws regulating pharmaceutical business include Foreign Corrupt Practices Act, which touches on non US based pharmaceutical companies dealing in the US market. Drug pricing regulations in the US are also currently used as a control measure by the federal government, with the Congress enacting statutes such as Deficit Reducing Act of 2005 paving the way. Clinical trial regulations affecting reporting were affected since the enactment of Food and Drug Administration Amendment Act in the year 2007. Disclosure and Transparency Guidelines Disclosure Obligations and Transparency Guidelines are provided by the current Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 20106. Section 6001 of the same Act contains regulations of dealing with disclosures of interests that could place physicians in a compromising situation. Section 6002 provides that pharmaceutics dealing companies reports should detail in all information on transfers or any transfers of ten US dollars and above. The section also contains a preemption provision that affects six states, and outlines exceptions of its application. Section 6003 transparency provisions demand that physicians offer advice to patients on an alternative physician other than themselves. Another legislation regulations concerning transparency in pharmacy are included in House Bill 3590. Best Law Compliance Practices Conflict of interest policy can be formulated on the basis of setting and assessment of disclosures of relationships between any transacting parties in the pharmacy industry. Disclosures should be facilitated and solutions of referral of transactions enacted within the pharmacy procurement procedures. Transparency should be cultivated through procedures such as open and competitive tendering under strict procedures. Outside vendors should be dealt with by the relevant procurement authority. Failure to observe the authorization channel should amount to termination of services by either the individual physician or the company or both. A competitively constituted centralized department handling all procurement procedures and relations should be established. Constant review and assessment should be facilitated to ensure that the health institution remains focused on the agenda to fight malpractices in similar dealing at all the time. Thorough reviews and authorization procedures should be enhanced at the internal control stage of regulation. Failure to comply with the internal control standards of procurement procedures should bear tough penalties such as suspension of practicing license. Policy and procedures regarding gifts, drug samples, and meals should be in line with objectivity, transparency and independence. Taking or offering of gifts should be discouraged completely to eliminate flouting of disclosure requirement. Only entire organization gifts should be accepted and by non decision making officials during open forums, at a restricted frequency. Drug samples offered to the physicians should be monitored and disclosures ensured. If the pharmaceutical company cannot label free drugs on the packaging, it should be done through the correct authorities. Discouraging such samples should be coupled with heavy penalties such as would discourage future concealment by physicians. Meals acceptance policies should be under clear circumstances revealing lack of tied strings in the final dealing of the two parties. Banning of meals or other food offers to physicians should be encouraged and implementation supported accordingly7. Ethical Issues Medical Ethics Ethical issues arise when the physician or medical professional fails to ensure; service to humanity, practicing with conscience and dignity, that the patient’s health is the first consideration, confidentiality, maintenance of honor for the medical profession, impartiality, respect human life and not to contradict laws of humanity in practice8. Instances of physicians using specific company’s brands for their own benefits increase negligence and chances of offering substandard drugs and services. Prescription could be skewed towards offering a sales advantage to the accomplices, without offering due care that patients trust physicians for. Vendor Relationships Ethical issues concerning physician-vendor relationships arise when objectivity and patient’s interests are compromised. Where personal interests are vested in the dealings between the two parties, ethical conduct is compromised. Such relationships should always offer information for the betterment of patient interests, support research and offer advice through consultations without strings attached. Flouting ethical relationships between these parties creates chances of offering wrong medication, provided the vendor benefits from the unscrupulous arrangement9. Medical Malpractice Using Specific Brands Undue influence imposed on medical practitioners by the pharmaceutical industry sales men and vendors usually lead to the development of a trend to prefer certain drugs in prescriptions than others. The possibility of free drugs offers making an impact on the doctor’s decision concerning prescription is increased by the frequent visits that the vendors make to health institutions. When the free package offered is more lucrative, the doctors try to fix the right prescription from the specific suppliers’ list. By compromising the physician’s independence in the choice of prescription, the deal aims at maneuvering the actual drug utilization at the health institute to favor the interest of the pharmaceutical company10. Meanwhile, the interests of the doctor are protected by maintaining the job and at the same time the doctor enjoys the offers presented by the drug suppliers. Serving to meet the objective of attaining both interests causes the doctor to rely on a particular drug type throughout his prescriptions. Specific drug use from certain companies develop over the time that the specific individuals in control of procurement and supply remain focused to maintain the relationship. Dangers of using poor quality drug choices threaten the effectiveness of treatment, since the element of competitive procurement is lost by favouritism. Prescribing Wrong Medication Besides developing a preference for products of a certain drugs supplier, the doctor falls in the trap of making the wrong medication from a list of drugs from the favoured supplier. Where the supplier does not supply drugs for a certain line of drugs, the favouritism may force the doctor to flout the medical ethics expected in prescriptions. Doctors are likely to incline drugs usage to fit supplier’s interests of a higher usage without taking the interests of the patient into consideration. Medical ethics provide that the correct medication is used in treatment but is might not happen with the undue influence compromising the independence of the doctor. Cases of Improper Physician-Industry Relations Drug companies in New Jersey were discovered to have offered doctors millions of dollars as a secret token for the promotion of their drugs. State authorization of reviews of the earning and subsequent disclosure of such deals gave shocking revelations. Scott McGregor, Eli Lilly and GlaxoSmithKline offered several million dollars in New Jersey alone to physicians, in return getting promotional services for their drugs. Pfizer Drug Company is on record for having paid out over thirty million dollars in just six months to doctors to promote heir drugs. The government reigned in on the scam and fined the company over two billion dollars for improper promotions. Serono Pharmaceutical Company was charged in 2005 for illegally promoting their brand Serostim that is used in treating AIDs weight loss. Over seven hundred million dollars was paid by the company for using undue influence on medical professional to market their products. Medtronic Incorporation was fined forty million dollars for making payments to medical professional in 2006. The company is said to have used doctors to influence patients to use their spinal products, which is not ethically upright. Conclusion Ethical code of conduct should be well outlined in dealing with outside parties for purposes of ensuring the best interest of the patient is guaranteed. As ethical procedures provide to the medical profession, due care should be guaranteed to the patients by ensuring quality practice. On the other hand, business law protects consumers from unscrupulous practices from commodity and service providers. Ethical issues affected by the compromising situation occasioned by the apparent conflict of interest are physician’s objectivity and the exercise of due care to the patient11. References Coyle, L. Susan. (2002) “Physicians- Industry Relations.” Annals of Internal Medicine, 136(5):396-402 Gorrie, T. M., & Santoro, A. M., (2005) Ethics and the pharmaceutical industry, New York, NY: Cambridge University Press. Meriwether Kathleen, Acosta Ted, & LaMastres Todd, (2008) US regulatory environment warrants close attention. London, UK: Informa Ltd Lewis, Morgan (2010) “Healthcare Reform Law Delivers New Transparency Requirements for the Health Industry.” Retrieved from: http://www.morganlewis.com/pubs/WashGRPP_FDA TransparencyRequirements_LF_29mar10.pdf McCarthy, L. Robert, & Schafermeyer, W. Kenneth, (2007) Introduction to health care delivery: a primer for pharmacists.London, UK: Jones and Barlett Learning Kuchekar, B. S., (2008) Pharmaceutical jurisprudence. Mumbai: Pragati Books Pvt. 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