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Varenicline (Chantix, Pfizer) is a partial nicotine receptor agonist with a high affinity for the alpha-4 beta-2 nicotinic acetylcholine receptors, modulating dopamine levels associated with nicotine addiction and aiding in smoking cessation. Clinical studies have demonstrated favorable cessation rates compared with placebo and sustained-release bupropion, with an encouraging safety profile. The most common adverse effect seen in clinical trials was mild-to-moderate nausea. In November 2005, a New Drug Application (NDA) was submitted for varenicline, and the drug was subsequently granted a 6-month priority review. On May 10, 2006, varenicline became the first oral medication approved for smoking cessation since bupropion, representing an agent with a novel mechanism of action for smoking cessation.

Human papillomavirus (HPV) (types 6, 11, 16, 18) vaccine (Gardasil, Merck) for female patients aged 9 years or older

Thalidomide (Thalomid, Celgene) was approved in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma.

Rasagiline is an irreversible monoamine oxidase (MAO) inhibitor that is thought to exert its effect by specifically inhibiting MAO-B, thereby causing an increase in the extracellular levels of dopamine in the striatum.

A landmark event in our country's history was the passage of theSocial Security Amendments of 1965. These amendments, intended toprovide health insurance coverage for the elderly and disabled,were expanded to establish the Medicaid program for families onpublic assistance and who have children with disabilities.

There is no question in anyone's mind that the increased use of high-tech diagnostic imaging has significantly improved the diagnosis and treatment of patients during the past decade.

With its first phase of certification rolling, the CertificationCommission for Healthcare Information Technology (CCHIT) willconcentrate on maintaining its momentum while moving to the realmof inpatient electronic health records (EHRs) in its secondcertification phase, followed by the evolving EHR networkinfrastructure in phase three.

Insurance companies are constantly on the lookout for innovativeways to reduce risk and reduce costs. From underwriting continuingeducation for insured physicians to providing discounts tohospitals that have implemented risk reduction measures,forward-thinking insurers know that small investments in safetytoday can reap significant future rewards.

Although any change in moving newly released over-the-counter (OTC)medications to benefit designs or formularies is currently beingdriven by health plans, other emerging market factors willinfluence how plans and employer groups think about coverage forOTCs. For example, Blue Cross and Blue Shield of Minnesota has hadnumerous inquiries about OTC coverage, usually from employer groupsthat know Medicaid and some Part D plans can cover OTCs. Inaddition, some states are evaluating their pharmacy practiceguidelines to determine how to revise them to accommodate changesin dispensing OTCs. This change is driven by the addition of OTCsto formularies and by the move to put pseudoephedrines behind thecounter. Another industry trend in some states, includingMinnesota, allows pharmacists to prescribe OTC products for publicprogram recipients.

Privatization of Medicare Part D has led to the emergence of manyplayers, both large and small. Navigating CMS regulations andsubsequent guidance has resulted in some administrative burdens, aswell as the inability to employ many managed care techniques, sayexperts.

A landmark event in our country's history was the passage of theSocial Security Amendments of 1965. These amendments, intended toprovide health insurance coverage for the elderly and disabled,were expanded to establish the Medicaid program for families onpublic assistance and who have children with disabilities.

Building and applying the technology of the electronic healthrecord (EHR) is a decidedly non-magical process far more complexand less instantaneous than just making the paper disappear into awastebasket. Quality concerns about EHR systems must be addressed,which is why the Certification Commission for HealthcareInformation Technology (CCHIT) exists. A voluntary, private-sectorinitiative based in Chicago, CCHIT was established in 2004 tofoster the adoption of robust, interoperable health IT in theUnited States through product certification. In 2005, CCHITreceived a three-year contract from the Department of Health andHuman Services, making it the key entity to develop and evaluatecriteria for the testing and certification of EHR systems in theUnited States.

More than 106 million American adults have borderline or high lipidlevels, which places them at increased risk for heart disease. Whenrecommended changes in diet and exercise do not sufficiently lowerhigh cholesterol levels, national medical guidelines call for theuse of lipid-lowering drugs.

There is no question in anyone's mind that the increased use of high-tech diagnostic imaging has significantly improved the diagnosis and treatment of patients during the past decade.

Mike Leavitt is an idealist with a practical slant. As secretary ofthe Department of Health and Human Services (HHS) since January2005, he would like to establish a national, interoperable healthinformation system. He firmly believes that innovative technologycan improve the quality of care in the United States, better informconsumers about health costs and quality, and slow down thenation's healthcare spending spiral.

At present, laws in 14 states are designed to prohibit the use ofsilent discount arrangements and intended to eliminate so-called"silent PPOs," "ghost PPOs," or "blind PPOs," all of which refer tothe same thing.

Transparency. If that's not the hottest topic in managed caretoday, I don't know what is. So many of the consumer-directedhealthcare advocates I've talked with this year have told me thattransparency will be the big coup for consumers, regardless ofwhich plan design they choose or how much they spend in any givenyear.

According to the Centers for Disease Control, chronic diseases havebecome the leading cause of death and disability in the UnitedStates, account for 7 out of every 10 deaths and affect the qualityof life of 90 million Americans. In 2002, direct medical costsreached $92 billion and indirect costs (including disability, workloss and premature mortality) totaled $40 billion. Perhaps the mostconfounding fact is that although chronic diseases are among themost common and costly health problems, they also are among themost preventable.

A review of selected antibiotics in late-stage development (May 2006).

A Kaiser Family Foundation study examined formularies, drug costs, and utilization management tools in drug plans offered by 14 national and near-national organizations, which encompass 35 unique prescription drug plans that account for 1,222 of the 1,429 packages available to Medicare beneficiaries.

As part of its Critical Path initiative, FDA has released a list reporting 76 high-priority research projects designed to modernize and advance medical product development. This program's goal is to bring medical innovations to patients more quickly and at a lower cost.

In response to ongoing industry and beneficiary concerns about the Medicare Prescription Drug Plan, the Centers for Medicare and Medicaid Services (CMS) is clarifying the rules and reviewing the formularies of insurers who are applying to provide Part D coverage for next year. CMS is simultaneously crafting guidance and procedural improvements that aim to make the program operate more smoothly.

An analysis of data gathered from the National Hospital Discharge Survey (NHDS) shows that Clostridium difficile-associated disease (CDAD) rapidly increased among patients at US hospitals from 2000 to 2003, particularly among patients aged ?65 years.

Early statin use was associated with a lower risk of congestiveheart failure (CHF) development and in-hospital death in patientstreated for acute myocardial infarction (AMI), according to arecent observational study published in the International Journalof Cardiology.

The 55th Annual Scientific Session of the American College of Cardiology (ACC) assembled from March 11 to March 14, 2006, in Atlanta, Ga, to exchange new and continuing research in cardiovascular disease. The program featured more than 1,600 oral and poster presentations of original research and hundreds of invited lectures and interactive sessions, with many offering the opportunity to update attendees' knowledge of available and investigational pharmaceuticals.

Full-length or intact parathyroid hormone [rDNA origin] for injection (PTH [1-84], Preos, NPS Pharmaceuticals) is currently under FDA review for the treatment of postmenopausal osteoporosis. If approved, parathyroid hormone (1-84) will join teriparatide (PTH [1-34], Forteo, Lilly), the truncated N-terminal (1-34) form of the hormone, as the only anabolic therapies available for osteoporosis treatment.

Approvable designations

Naltrexone extended-release injectable suspension (Vivitrol, Alkermes/Cephalon) was approved for the treatment of alcohol dependence in patients who can abstain from drinking in an outpatient setting and who are not actively drinking at the time treatment is initiated.