By Omeed M. Memar, Ph.D.
Department of Microbiology and Immunology
and
Kayhan P. Parsi, J.D.
Institute for the Medical Humanities
The University of Texas Medical Branch
Galveston, TX 77555

Informed consent is a richly textured legal and ethical concept. Informed consent involves more than just the legal requirements of disclosure and consent between physician and patient. Beauchamp and Childress have argued that informed consent consists of a five-prong process: 1) competence, 2) disclosure, 3) understanding, 4) voluntariness, and 5) consent. As part of; medical practice, informed consent is fundamental to the establishment of the doctor-patient relationship. In the practice of dermatology, issues of informed consent are common place, especially in chronic treatment of potentially fatal conditions like Pemphigus Vulgaris.

Pemphigus vulgaris is an autoimmune disease manifesting as extensive blisters on skin and mucous membranes. The common treatment includes a regimen of high dose costicosteroids (eg, Prednisone), which has serious side effects. However, failure to control and treat Pemphigus vulgaris, invariably leads to significant mortality. In this review, the elements of informed consent, as they pertain to the treatment of pemphigus vulgaris with life-saving corticosteroid therapy, will be discussed.

Legally, informed consent laws impose tow major requirements on the physician: disclosure; of information concerning illness and treatment options; and acquisition of consent from the patient prior to administration of treatment. The level of disclosure deepens on the standard used: The reasonable physician standard ;the reasonable person standard or the subjective standard. For instance, the state of Texas uses the reasonable person standard, whereby a physician is required to disclose what would influence a reasonable person in deciding to consent to a medical procedure. In order to effectively meet this criteria, the patient should be informed of the purpose of the treatment; the potential risks involved; the anticipated benefits; and alternative therapies. Although some jurisdiction have articulated legal duties to disclose alternative to therapy (Utah, Indiana and Florida), case law and statues are silent about the legal duty to disclose potential treatment benefits. Nevertheless, the physician has an ethical duty to inform the patient of the above risks and benefits. The information regarding risks associated with treatment (and non-treatment) alternatives should be reliable, and the information should be shared in an understandable and meaningful manner to the patient. Finally, the physician must assess the patient's understanding of the treatment, and the patient's "voluntary" consent to treatment.

The purpose of corticosteroid therapy in PV should be clearly explained to the newly diagnosed patient. An effective immunosuppressive agent is needed because pemphigus vulgaris is an autoimmune disease, in which the patient's immune system has targeted components in the patient's epidermis to attack. Corticosteroids have proven to be very effective in causing a generalized immunosuppression that curbs this autoimmune attack.

The stress of being diagnosed with a potentially fatal disease should be recognized by the physician. Avoiding jargon, the dermatologist should explain the regimen of steroid therapy, which normally consists of a high loading dose. This is gradually tapered off in conjunction with other immunosuppressive agents. Clear communication should enhance autoimmunity and well-being. The potential risks of corticosteroid therapy are numerous and the physician should convey them to the patient. The include immunosuppression, fluid retention, electrolyte disturbances, muscle weakness and osteoporosis, gastrointestinal ulcers, impaired wound healing, headaches and vertigo, menstrual irregularities, development of a cushingoid state, glaucoma and other less likely side effects.

The immunosuppression is the most important to convey to the patient because it can potentiate various bacterial, fungal and viral infections. Since the immune system is responsible for surveying the body for malignant cells, a weakened immune system is more likely to miss such cells, allowing the growth of malignancies. Therefore, the physician should inform the patient of such potential side effects. This not only fulfills the requirements of informed consent, it also allows the patient to monitor possible malignancies.

The potential benefits of corticosteroid therapy in PV should be made clear to the patient. Alter all, PV is a fatal autoimmune disease and prednisone is one of the most effective immunosuppressants available to the physician. Before the use of steroids, PV had a 100% mortality rate. Using prednisone in conjunction with other immunosuppressants and procedures (eg, plasmapheresis) the mortality rate of PV has greatly decreased. Furthermore, benefits of treatment include the possibility of spontaneous remission, and development of new, less toxic treatments as a result of active medical research. Therefore, although prednisone has many side effects, the patient should be informed as to the greater benefits of prednisone treatment: extended life, possibility of remission, and potential for development of less toxic and more effective therapy. It should be emphasized that prednisone acts differently in different people, only by starting a therapeutic regimen will the side effect to benefit radio be elucidated.

Alternative treatments for PV, which do not include corticosteroids, are of dubious effectiveness, and potentially dangerous to the patient. However, in mild cases of the disease, alternative treatments can be effective, and each patient is different and responds differently to medicine. The following drugs have been used with prednisone in effective treatment of PV: Methotrexate has been used, but with controversial results. Dapsone has been successful in controlling PV lesions in some patients. Immunosuppressants such as Cyclosporin and etretinate have also been used in the treatment of some cases of PV. Gold has also shown effectiveness in treatment of certain patients with PV. Finally, plasmapheresis and extracorporeal photopheresis have show effectiveness in treatment of PV, but with the obvious inconveniences and at times serious side effects.

Yet, the fact remains that corticosteroid therapy is fundamental to treatment, and the above alternative treatments only serve to lower the dose of prednisone needed to achieve immunosuppression. In mild cases, topical prednisone, which does the negative side effects of high dose systemic corticosteroid therapy is sufficient. The patient should be made to realize the armament of steroid-sparing drugs available in treatment of PV.

After informing the patient, the physician needs to assess the understanding of the patient. Usually, this is best done by the physician asking open-ended questions concerning the patient's; condition and treatment options. Based on the patient's response, the physician can again explain the pertinent information. Many times, patients that refuse treatment have not understood the options or prognosis. In cases where the patient is not competent (eg, psychotic patients) the physician should rely on family members or else proceed according to the patient's best interest.

However, this may be legally questioned, especially in cases where family members disagree with the treatment. In such cases, implementation of advance directives, or consultation with family physician, who know the patient for many years might be warranted .

Since the patient's consent is not valid unless given voluntarily, the physician is obligated to make; sure the patient is truly consenting. It should be realized that the patient still has the right to refuse corticosteroid therapy or any other kind of therapy at any point along the course of treatment.

PV patients should be aware of the dermatologists responsibility to educate them about PV and the therapeutic options. Only after patient consent, can treatment be started and continued. This is a fundamental right of the patient, and is best exemplified by the case of Schoendorff v. New York Hospitalin which it was judged that, "every human being of adult years and sound mind has a right to determine what should be done with his own body..." Consent can be given implicitly or explicitly, but the patient must be aware of the condition of treatment, and it is the physician's irresponsibility to assess the patient's level of consent. Corticosteroid is a miraculous therapy which has saved many PV patients. Still, it has serious side effects which should be made clear to the patient. Through involvement of the patient in more of the decision-making, not only is a wider bridge of communication built between doctor and patient, but quality of care is improved.