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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.

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).

A single day of famciclovir started within 6 hours of a genital herpes outbreak shortens the duration of recurrent genital herpes lesions, said Fred Y. Aoki, MD, at the 45th ICAAC meeting in Washington, DC.

The use of acid-suppressive drugs, particularly proton pump inhibitors (PPIs), was associated with an increase in the risk of community-acquired Clostridium difficile-associated disease (CDAD) in the United Kingdom, reported Sandra Dial, MD, MSc, at the 45th ICAAC meeting in Washington, DC.

A study analyzing pharmacy claims among patients who receive chronic medications via 3-tier prescription drug plans found that patients who were prescribed generic or preferred medications by their physicians were the most likely to adhere with their treatments.

A study of 155 patients examining the effects of statins on patients diagnosed with acute coronary syndrome (ACS) suggests that statin therapy may increase survival rates and potentially extends the results of larger, recently performed randomized trials to those with low-density lipoprotein cholesterol (LDL-C) levels of 80 mg/dL and below.

Rheumatoid arthritis patients, hindered by an inadequate response to tumor necrosis factor-alpha (TNF-alpha) inhibitors, may find some relief in the form of a drug that belongs to a new class of selective costimulation modulators.

A prospective, double-blind, randomized, controlled trial comparing the effectiveness of levofloxacin and moxifloxacin in treating community-acquired pneumonia (CAP) among 394 hospitalized elderly patients (aged 65 years and older) demonstrated that moxifloxacin resulted in faster recovery than levofloxacin.

Topiramate safely decreases body mass, hypertension. Topiramate reduces body weight and blood pressure with generally mild-to-moderate adverse effects, according to a randomized, placebo-controlled trial involving obese subjects with hypertension.

A recent meta-analysis published in the Journal of the American Medical Association (JAMA) found that statins have no effect on cancer risk. The finding is in contrast with at least 7 retrospective analyses that suggest that statins reduce the risk of developing cancer.

Colesevelam/fenofibrate combination boosts efficacy in treatment of hyperlipidemia. Fenofibrate significantly reduced low-density lipoprotein cholesterol (LDL-C) in patients with mixed hyperlipidemia when used in combination with the specifically engineered bile acid sequestrant (SE-BAS) colesevelam, according to a study published in Current Medical Research and Opinion.

Two recent studies in The New England Journal of Medicine (NEJM) focused on the breast cancer drug trastuzumab, a recombinant monoclonal antibody (Herceptin, Genentech/Roche).

Tight glucose control for a mean period of 6.5 years produces long-lasting cardiovascular benefits in patients with type 1 diabetes, according to a study published in the New England Journal of Medicine (NEJM).

Isradipine capsules 2.5 and 5 mg (equiv to Dynacirc capsules)

Hepatitis B immune globulin (HepaGam B, Cangene) was approved for the treatment of acute exposure to blood containing the hepatitis B surface antigen (HbsAg), perinatal exposure of infants born to mothers who are positive for HbsAg, sexual exposure to individuals who are HbsAg-positive, and household exposure to individuals with acute HBV infection.

By increasing intestinal fluid secretion, lubiprostone increases motility in the intestine, thereby increasing the passage of stool and alleviating symptoms associated with constipation. Lubiprostone was approved on January 31, 2006, for the treatment of chronic idiopathic constipation (CIC) in adults.

The anti-anginal and anti-ischemic properties of ranolazine are not dependent on reductions in heart rate or blood pressure. Ranolazine was approved on January 27, 2006, for the treatment of chronic angina. Because ranolazine prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other anti-anginal drugs.

Pipeline Preview

A review of agents in late-stage development for the treatment of Parkinson disease (March 2006).

The challenges of medical versus pharmacy benefits faced by payers are unique and vary by category, say industry watchers (See Desktop Resource, March 2006). Some of the following drug classes can fall under both benefit arrangements.

Putting consumers in charge is both the good and the bad of consumer-directed healthcare (CDHC). For those who know how to make good choices, CDHC is great.

Implementing an Electronic Medical Records (EMR) system is more critical and more complicated than most physician practices expect.