Patients suffering from obesity often opt for administration of anorexigenic drugs in order to improve not so much their medical condition as the quality of life. Some patients feel chronically hungry and they hope that prescription of anorectics will help them relieve hunger. Is it really necessary to take these favorable weight loss consequences into consideration while calculating the benefit/risk ratio, even knowing that they are unrelated to the medical condition? It is a very complicated matter. There is no doubt that use of such drugs for non-health purposes makes patients think that they truly care for their health, but meanwhile it is very important not to groundlessly promise the patients sustained weight loss. Many patients hope that the treatment will result in considerable weight loss and marked improvement in the quality of life, but later on they get disappointed in therapy that doesn’t live up to their expectations.
It takes talent to maintain, on the one hand, realistic hopes of patients, inspiring their self-confidence, while honestly telling him, on the other hand, all pros and cons of drug treatment for obesity along with its challenges. Only realistic attitude towards hopes and aims will make the patient sign the informed consent form to receive treatment. In a series of clinical trials it was shown that a considerable amount of participants discontinue anorexigenic drugs in 1 – 2 years. The reasons of discontinuation are unknown, but it is possible that losing weight is not as rewarding as the participants thought it would be. Although there is every reason to take quality of life into consideration while calculating the benefit/risk ratio, it might not save the doctor or the patient from disappointment in therapy.
On the other hand, many doctors don’t challenge usefulness of Viagra for the treatment of erectile dysfunction, or the benefit of selective serotonin reuptake inhibitors (SSRIs) for improvement of patients’ quality of life. Doctors take it for granted that such drugs indeed improve the quality of life.
Nevertheless, once the patients experiencing obesity note that without anorexigenic drugs they have a hard time sticking to a diet, the doctors will answer right away: “If you break the diet, administration of drugs will become useless”. It is hardly possible that the doctors will advice the patients to discontinue their anti-diabetic drugs only because the patients fail to stick to the diet. Then why do the same doctors rigidly urge the patients to comply with eating behavior requirements during administration of anorexigenic drugs? Is it really necessary to adhere to certain standards when taking such medicinal agents? If yes, what are the reasons?
Benefit/risk ratio of therapy is assessed not only by the doctor, but by the patient himself. An ethical principle of independence contemplates that the patient is an absolutely competent and independent participant in the treatment process entitled to make crucial health decisions. On the one hand, this principle can be observed in such a way that all doctor-patient decisions will be made solely by the patient. Many doctors rate this approach the best; meanwhile, the doctor is obliged to provide the patient with the information whereby he will be able to make a conscious decision; nevertheless, this is not the case when values and aims of a doctor should substitute those of a patient. The concept of patient independence seems especially essential when there is a hard decision to be made; for example, the decision on discontinuance of life-support therapy in a terminally ill patient. However, since it is possible to reduce the principles of benefit and non-harming to absurdity, there is always a chance that the doctor will be completely deprived of any rights and released of every liability for the therapy by giving all independence to the patient. Unfavorable consequences of absolute patient independence in view of therapy decisions were especially well-defined in the period of popularity of a drug called “fen-phen” (a combination of phentermine and fenfluramine). At that time many patients solicited doctors for prescription of this medicine. Some doctors refused as they believed the drugs were dangerous and not much useful. Other doctors observed the principle of patient independence and informed them on possible complications and treatment efficacy, so it rested with the patients to decide. When side effects of the treatment came to light, such doctors felt dissatisfied with their rightness and uncomfortable having allowed the patients to high-pressure them into prescribing the drugs while paying too little attention to their warnings.
It is possible that the concept of independence means a little more than just acknowledgment of the patient’s right to make individual decisions. In such a case both parties – a doctor and a patient – have the power of veto; the therapy should be conducted only by mutual consent, provided that this therapy has been approved and the benefit/risk ratio is favorable. The doctor has the right to refuse the treatment to the patient if the benefit/risk ratio is unfavorable; moreover, the doctor is to talk the patient out of such a therapy. On the contrary, when the treatment is justified, and when both parties tend to advantageously use their ability to make sound judgments in order to make the decision, then the doctor must insist on conducting the treatment, even if he knows that such treatment might lead to development of certain complications. A doctor together with a patient should jointly evaluate the benefit/risk ratio before such anorexigenic drugs are prescribed, and they should bear joint liability for their decision.
Speaking of benefit/risk ratio, a doctor assumes the most striking moral responsibility when it comes to the process of obtaining informed consent. On a daily basis, each doctor has to obtain informed consent forms of patients for diagnostic and therapeutic interventions; in the majority of cases it can be rather informal. However, in the period of “fen-phen” popularity, many doctors strived to evidence the patient’s visit with a written consent form. Certain documents were drawn up in such a way as to protect the doctor from possible prosecution. The essence of such documents laid not so much in insightful comparison of advantages and drawbacks of drugs, as in the waiver of the patient’s right to impose liability on the doctor for unfavorable outcome of the treatment. In other patient informed consent forms, advantages of the medicine were mentioned only superficially, but the drug-related risk was by all means emphasized. None of the documents releases the doctor from moral responsibility for obtained informed consent. The informed consent document can’t suspend the guilt of the doctor who “bears liability for the patient that places absolute confidence in a doctor and expects adequate care and treatment”. Neither ethical nor moral considerations entitle doctors to disclaim professional responsibility for the recommendations given to the patients. If drug therapy entails any complication, the blame partially rests on the doctor. If a potentially advantageous drug wasn’t prescribed due to incorrect benefit/risk ratio assessment, the doctor can be blamed for that, too. The informed consent document should provide the patient with accurate and reliable information concerning benefits and risks of a drug – no more, no less. There is every chance that the informed consent document is the best means to justify ethical responsibility undertaken by a busy family practitioner before a fully informed patient. Moreover, a doctor can familiarize the patient with the information bulletin, which contains clear and impartial list of drug-related benefits and risks and doesn’t need to be signed.
What impact does the notion of professional ethics have on a decision to prescribe (or not to prescribe) anorexigenic drugs? In the medical field, professional ethics stipulates that the doctor prefers his patient’s interests to his personal interests. Loss of respect for doctors in public consciousness has one cause: doctors put personal financial well-being before patients’ needs. No one understands the primary motive of a doctor better than he does. Any doctor, who prescribes drug therapy for obesity in pursuit of his own income increase, violates professional ethics. Only some doctors practice such an approach intentionally, but it still might have a huge impact on the public opinion.
More often doctors believe that prescribed therapy fully complies with approved indications, but at the same time their practice is built in such a way as to yield as much profit as they can make. Certain methods of obesity treatment, offered by some clinics, do not contravene with professional ethics, but, nevertheless, the motives of attending physicians turn out to be strictly mercantile. For example: distribution of medicine during non-working hours in order to make a profit; reception of too many patients during the day, which makes it impossible to ensure proper doctor-patient contact; prescription of drugs regardless of conventional indications (for example, prescription of thyroid hormones to people with normal thyroid function, or prescription of diuretics solely for the purpose of losing weight); prescription of anorexigenic drugs to the patients that are unlikely to benefit from them (for example, teenagers or people with BMS <25). Such behavior of medical specialists makes us reflect on the true nature of their motivations.
Prescription of drugs in breach of indications and dose regimen
Contrary to the conventional wisdom of many patients, anorexigenic drugs are effective only while they are administered. But if you read package insert for phentermine and other earlier anorectics, you will see that the period of their administration should not exceed three months. In the USA, sibutramine was approved by the FDA for short-term use of no longer than 1 year, although its safety and efficacy had been established for up to two years. Thus, administration of phentermine for longer than 3 months, as well as use of sibutramine for more than 1 year contravenes with the dose regimen of these drugs established in the US. In a number of cases, off-label use of drugs not approved by the FDA USA entailed disease treatment enhancement (for instance, use of ß-blockers in angina or use of methotrexate in rheumatoid arthritis). The drugs are often prescribed in breach of the recommended indications and dose regimen; sometimes it is justified, if the doctor is not trying to grind his own axe, and if the therapeutic effect is conceivable (even if its use is unapproved by the FDA USA). But such drug administration can cause negative attitude of colleagues, and in the event of complications it can even entail prosecution. Prescription of drugs not approved by the FDA USA can be admittedly justified, if such indications are well-thought, clearly explained to the patient and adequately documented.
Some doctors never prescribe anorexigenic drugs. Others prescribe them at short notice. Such approaches are considered to be extreme; none of them should be recognized as true. A doctor should make an attempt to solve such issues based on the principles of professional ethics, identified by Edmund Pelligrino from the Center for Clinical Bioethics at Georgetown University Medical Center (USA) as “suppression of personal interests for the sake of a patient”. If you have any doubts, be sure to discuss them with your dear colleagues. Should they disapprove of your approach, you can enter into discussion in order to get to the heart of your dispute. In the end, every doctor has a moral right to treat the patient as he thinks fit, assuming full responsibility for his actions. The decision-making process is not always clear and simple. However, we can draw lessons from such experience and apply them to prescription of drugs for other medical conditions (although sometimes they are conducted without thinking).
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