An Asfaliogenic Complication Arising From Profit-motivated Decision-making

Abstract

To the Editor. The recent debate over health care reform has focused on ways to allocate care to the greatest number of individuals despite a limited pool of resources. Third-party insurers who pay for prescriptions have looked at ways to cut costs, especially for patients with chronic illnesses who may require fairly expensive medications for prolonged periods of time. The substitution of generic products has been an accepted means of reducing cost, yet proof of therapeutic equivalence is required if these products are to be used.1 We report a case of a 7½-year-old boy with cystic fibrosis (CF) who developed distal intestinal obstruction syndrome (DIOS) after his health insurance carrier substituted generic for proprietary pancreatic enzymes despite evidence in the medical literature and expert opinion on their nonequivalence. We propose the term asfaliogenic(Greek–asfalia–insurance) for complications resulting from profit-motivated, business decisions by third-party insurance payers.From birth, our patient was treated with proprietary pancreatic enzyme supplements (Creon, Solvay Pharmaceuticals, Marietta, GA), multiple vitamins, and vitamin E supplements. Approximately 2 months before admission, the patient's third-party insurer denied payment for proprietary pancreatic enzyme supplements and substituted a generic formulation (Encron, Rugby Laboratories, Inc, Norcross, GA).Shortly after this change in medication, the patient developed abdominal pain, and he subsequently became obstipated. Upon presentation to our emergency department, physical examination revealed a distended, tense, silent abdomen that was mildly tender in the right upper quadrant where a firm loop of bowel was palpable. A rectum full of firm, pasty stool was also noted. Abdominal radiograph showed prominent small bowel loops filled with inspissated material, consistent with DIOS (formerly called meconium ileus equivalent). A gastrograffin enema was administered and was both diagnostic (demonstrating a colon full of inspissated stool and free reflux of contrast into the terminal ileum), and therapeutic, resulting in multiple bowel movements and resolution of his signs and symptoms. He was discharged the following day.Although the etiology of DIOS remains obscure, inadequate enzyme supplementation, a change in diet, and relative dehydration have been implicated.2 Our patient's admission urinalysis and electrolytes were not consistent with dehydration, and he had no change in his usual intake before the onset of his symptoms. We suspect that this patient's DIOS was directly related to the inadequacy of the generic pancreatic enzymes that his third-party insurer, not his physician, recommended.Treatment failures after substitution of generic pancreatic enzymes in patients with CF have been reported previously.3 Memos circulated to cystic fibrosis center directors have also documented lack of equivalence of generic products. The United States Pharmacopeia does not have a potency testing standard for enteric-coated microcapsules, and it has been recommended that physicians prescribe proprietary products until such a standard is devised.3The health care system is undergoing a plethora of administrative and economic changes driven by financial exigency, political agendas, and governmental deregulation.45 A quality-of-caresystem is rapidly being replaced by a profit-orientedsystem. Proponents for these for-profit changes argue that an investor-owned, for-profit health care system “will strive to provide the highest quality, most cost effective care to consumers” (patients).5 We disagree. In this case, hospital costs for our patient's medical care (exclusive of physician fees) were approximately $4800. The patient's mother reported that her co-payment would have been $40/month above and beyond her insurance coverage, if she chose to purchase proprietary rather than generic enzymes. Furthermore, despite an extensive and unreimbursable amount of time spent educating the third-party insurer about documentation in the medical literature and consensus among subspecialists, a profit-motivated, business decision was made that directly affected medical care of a patient. Insurers deny that their policy decisions are medical decisions. In their view, if a physician deems a treatment necessary, the patient should shoulder the cost, whether or not it is a covered benefit. In reality, many patients accept whatever medical care the insurer covers because they are unable to pay the additional out-of-pocket cost, and they trust that the insurer will adhere to the physician's credo, “First, do no harm.” Asfaliogenic complications are inevitable when medical decisions are made by parties whose credo is, “First, make a profit.” We suspect that we will see more asfaliogenic complications in this era when the bottom lineis the bottom line, not patient care.