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Everyone runs into troublesome customer service now and then. Youknow how frustrating it can become, and it probably inspires you tobe that much more careful when conducting business with your owncustomers. Certainly as consumers, we know the caveat emptorwarnings, but there is nothing so valuable as great service.

All projections of rising healthcare costs assume that advances inmedical science will add to the cost. This is a reasonableassumption, since it has been uniformly true in the past.Antibiotics are a great advance, but bacteria develop resistanceand newer and more expensive antibiotics must be developed. Peoplewho would have died at home in the pre-antibiotic era now survive,but after the greater cost of antibiotics and, possibly,hospitalization. The same is true for advances in cardiac stents,cancer treatment, imaging with CT scanners and MRIs, etc. Thetechnology can be life-saving but is typically expensive.

If one word describes the nearly 150,000 square miles of Montana,it's "vast." And while Montana residents value their state's openspace and its natural beauty, all that space makes healthcarecoordination and delivery difficult at best, as Tom Brewer with theMansfield Health Education Center (Mansfield Center) in Billings,Mont., explains.

FDA officials said the agency "remains very concerned" that patients who take natalizumab (Tysabri, Biogen Idec/Elan) may develop a rare, potentially fatal brain infection called progressive multifocal leukoencephalopathy (PML). So starts a report from Reuters published on February 15, 2006. Should managed care also be concerned? If so, how should managed care formulary decision-makers respond? What is their role in managing patients who are clamoring for even more products to treat their diseases in an era in which it seems that miracles are a daily occurrence in the world of biotechnology? What role should managed care play in refereeing potentially devastating side effects for a disease that frightens patients as much as multiple sclerosis (MS)?

Last month FDA unveiled a long-awaited list of collaborative projects to streamline and accelerate the development of new medical treatments. Then Health and Human Services (HHS) Secretary Mike Leavitt joined Andrew von Eschenbach, MD, and Deputy Commissioner Janet Woodcock, MD, in urging implementation of the Critical Path initiative. Dr von Eschenbach, who hopes to oversee this effort as permanent FDA head following his official nomination to the position, says he is committed to fully implementing the initiative in order to "dramatically increase the success rate in moving products from the lab to the patient."

Aspirin is the cornerstone of therapy in the treatment and prevention of cardiovascular disease. The potential benefit of aspirin therapy may be significantly reduced in patients with aspirin resistance, creating a clinical and economic burden on the healthcare system. The purpose of this article is to clarify the term "aspirin resistance," describe the proposed mechanisms, review the clinical outcome studies with associated resistance testing, and discuss the potential pharmacologic management of this problem. Literature searches were performed using MEDLINE (January 1966 to January 2006) for review articles on aspirin resistance and antiplatelet activity. Aspirin's primary mechanism of action is to irreversibly inhibit cyclooxygenase-1 (COX-1); however, there are reports of alternative biochemical pathways producing platelet aggregation. The addition of thienopyridines to aspirin should be considered for the management of aspirin-resistant patients. (Formulary. 2006;41:192–201.)

FDA actions in brief

Sodium phosphate monobasic monohydrate/sodium phosphate dibasic anhydrous tablets (OsmoPrep, Salix) were approved by FDA for cleansing of the colon prior to colonoscopy in patients aged 18 years or older.

Despite systemic challenges in caring for stroke patients, a care program developed by the American Stroke Assn. has shown promise in improving outcomes.

The push for electronic health records (EHRs) and their physician-originated counterpart, electronic medical records (EMRs), gained significant momentum in 2005. In fact, today's discussions now include subcategories to distinguish the interests of one group over another. We can expect the implementation of some versions of the EHR?including portable EHRs, payer-based EHRs, ambulatory EHRs and inpatient EHRs?to become more widespread.

When you try to describe a disease management (DM) program offered by an HMO, it is important to realize that there is a large amount of variation from program to program and HMO to HMO, according to industry experts.

About 60 million Americans a year experience insomnia often, or for extended periods of time, leading to problems in job performance and other activities. Insomnia affects about 40% of women and 30% of men.

Oh, to be in that generation that feels immortal--the generation of college students. Unfortunately, that feeling of immunity often can lead students to some poor decisions when considering healthcare benefits. "It is a healthy population without a perceived need for insurance," says Don Atherton, president of Integrated Benefit Solutions in Houston. "They have to be motivated to seek out coverage when they would rather pay the rent than buy health insurance."

Reinsurance is often called "insurance for insurers." It involves a contract whereby one insurer (the reinsurer) agrees, for a portion of the premium, to indemnify another insurer (the ceding company or primary insurer) for losses paid by the ceding company under insurance policies it has issued to its policyholders. Notwithstanding the heavy regulation of insurance and the products that are issued by primary insurers, reinsurance is largely an unregulated business.

Healthcare has been documented as a cottage industry time and time again, and Janet Marchibroda, CEO of Washington, D.C.-based eHealth Initiative, keeps witnessing how well that cottage industry structure has worked to drive the most concentrated effort of all: interconnectivity. Ironically, it's the small groundswell that is driving the massive execution toward widespread, interconnected information exchanges.

More on coed care

John Poelman, student body vice president and a senior at the University of Utah in Salt Lake City, is concerned about the rising cost of healthcare benefits and the number of uninsured who have no safety net if some unforeseen illness or injury should occur. He says that the university would adopt a hard waiver policy if enough students supported the idea.

Type 2 diabetes mellitus is a progressive disease affecting more than 18 million Americans. Incretin mimetics and DPP-IV inhibitors are new classes of antihyperglycemic agents that may improve glycemic control in patients with type 2 diabetes. The incretin hormone, glucagon-like peptide 1 (GLP-1), stimulates glucose-dependent insulin secretion, suppresses inappropriate glucagon secretion, and slows gastric motility. GLP-1 levels are decreased in type 2 diabetes. GLP-1 is rapidly inactivated by the enzyme dipeptidyl peptidase-IV (DPP-IV), resulting in a half-life of <2 minutes. Strategies to increase GLP-1 activity include the development of incretin mimetics that are resistant to DPP-IV degradation and the development of DPP-IV inhibitors. Clinical trials have demonstrated that the incretin mimetics exenatide and liraglutide, as well as the DPP-IV inhibitor vildagliptin, improve glycemic control, reduce weight, and are fairly well tolerated. Exenatide (Byetta, Amylin/Lilly) was approved by FDA in April 2005..

Lubiprostone (Amitiza, Sucampo/Takeda) was approved on January 31, 2006, for the treatment of chronic idiopathic constipation in adults when the cause of the condition is unknown. The agent has a unique mechanism of action compared with current therapies on the market in that it locally activates specific chloride channels (ClC-2) in the lining of the small intestines after oral administration, thereby increasing intestinal fluids and softening bowel movements. In double-blind, placebo-controlled trials, lubiprostone demonstrated efficacy in improving the frequency of spontaneous bowel movements and other related constipation symptoms. Lubiprostone was reported to be well tolerated in clinical trials; the most common adverse effects were mild-to-moderate nausea and headache.

FDA began 2006 by unveiling a long-anticipated final rule that significantly overhauls approved labeling for drugs and biologics. This new rule has been in the works for years, delayed by manufacturer concerns that the revisions will expose companies to more liability suits. Although the new labeling's basic framework came as no surprise, compliance will require significant investments by manufacturers to meet the new design and content requirements, which will double the length of many package inserts (PIs).

Vancomycin may be overused for the treatment of hospital-acquired pneumonia, perhaps because of physicians' perceptions that patients are at high risk for methicillin-resistant Staphylococcus aureus (MRSA), according to a study by Robert H. Eng, MD, and colleagues at the Veterans Affairs New Jersey Health Care System in East Orange, NJ. The study was presented at the 45th ICAAC meeting in Washington, DC.