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A randomized, double-blind, placebo-controlled trial published in the Journal of the American Medical Association (JAMA) found that women who discontinued alendronate after 5 years demonstrated a moderate decline in bone mineral density (BMD) and a gradual increase in serum markers of bone turnover compared with women who continued taking alendronate for an additional 5 years, but mean levels among patients who discontinued therapy remained at or above baseline levels measured 10 years earlier. In addition, no greater fracture risk other than for clinically detected vertebral fractures was seen in the discontinuation group compared with patients who continued alendronate for 10 years.

The duration of dual antiplatelet therapy (aspirin plus clopidogrel) following drug-eluting stent (DES) implantation has been a source of much recent debate. FDA currently recommends either 3 or 6 months of clopidogrel therapy following DES implantation, depending on the type of stent used.

Approvable designations; Nonapprovable designation; Fast-track designation; Priority review; Orphan drug designations

A review of agents in late-stage development for the treatment of hepatitis (February 2007)

Bronchodilators play an important role in the management of stable chronic obstructive pulmonary disease (COPD). Although bronchodilators do not prevent the decline in lung function in patients with COPD, their efficacy in improving disease-related symptoms, reducing the frequency and severity of disease exacerbations, and improving patients' quality of life has been demonstrated in clinical trials. Arformoterol, the (R,R)-enantiomer of the selective beta2-agonist formoterol, is a potent, highly specific, nebulized long-acting beta2-adrenergic agonist recently approved by FDA for the long-term maintenance treatment of bronchoconstriction in patients with COPD, including chronic bronchitis and emphysema. In 2 large, 12-week, phase 3 studies, arformoterol demonstrated an efficacy superior to that of placebo and comparable to that of salmeterol in patients with COPD. In these trials, arformoterol was well tolerated, with a safety profile similar to that of other inhaled long-acting beta2-agonists when used at..

Last year acknowledged the 25th year since AIDS was first recognized, and to coincide with that anniversary, the U.S. Centers for Disease Control and Prevention (CDC) revised its recommendations for HIV testing for adults, adolescents and pregnant women in healthcare settings. The new guidelines remove the onus of determining who is at high risk for HIV infection and makes testing a routine part of medical care for all patients between ages 13 and 64 years.

As the managed care industry continues to consolidate, not-for-profit and provider-sponsored plans haven't lost their niche in the marketplace. They compete on demonstrated quality and the added value of community accessibility, which would, on the surface, seem to be exactly what politicians and healthcare advocates are begging for.

William Copeland JR.'s assessment of the United States' healthcare system is crystal clear: The system is a financial and structural mess.

The campaign to provide healthcare to all Americans is making headlines once more as business, labor and consumer groups join with healthcare insurers and providers to urge major changes in the nation's healthcare system.

The administrative simplification provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) require the Department of Health and Human Services (HHS) to establish national standards for electronic healthcare transactions. This includes assigning healthcare providers a National Provider Identifier (NPI), a 10-digit numeric provider identifier that will be used in standard electronic transactions, such as healthcare claims. As of a legislated date of May 23, 2007, each participating provider will have one and only one NPI, regardless of practice locations or settings.

WITH changes on Capitol Hill and at the state level after 2006 mid-term elections, experts are expecting more focus on broadening Medicaid coverage.

In America, we assume that we get what we pay for, whether it be food, clothing or healthcare. Given that healthcare consumes 16% of the Gross Domestic Product and we spend more per capita than any other nation on cutting-edge care, we expect improved outcomes and more bang for the buck. However, these expenditures do not rank the United States first, second or even third in terms of life expectancy, infant mortality, immunization, cancer screening and the like.

The most significant pressures facing payers evolve constantly, though they rarely change radically from year to year. While payers strive to lower administrative costs and improve efficiencies, manage healthcare costs and grow the business, recent years have seen substantial change in how they address these issues.

Last year acknowledged the 25th year since AIDS was first recognized, and to coincide with that anniversary, the U.S. Centers for Disease Control and Prevention (CDC) revised its recommendations for HIV testing for adults, adolescents and pregnant women in healthcare settings. The new guidelines remove the onus of determining who is at high risk for HIV infection and makes testing a routine part of medical care for all patients between ages 13 and 64 years.

With Administrative costs accounting for as much as 40% of all healthcare dollars spent, many states are seeking new and innovative ways to eliminate bureaucracy and red tape. One area receiving more attention is the resolution of billing disputes between providers and payers. In 2006, New Jersey and California implemented arbitration programs to resolve the growing aggregation of healthcare payment disputes.

It would seem that any healthcare entity able to introduce lower costs and greater convenience would be welcomed with open arms, if not a genuine ticker-tape parade. Yet, walk-in retail clinics, new players built on low cost and convenience, are struggling to gain a national foothold, and experts aren't sure the new guy will even make it in the end.

The federal False Claims Act (FCA) is the government's primary weapon to combat fraud. It empowers the federal government to file actions against those alleged to have knowingly submitted false or fraudulent claims to the government. Since 1986, the Department of Justice has recovered more than $15 billion under the law.

The new House leadership delivered on one of its prime campaign promises last month by pushing through legislation requiring the Health and Human Services (HHS) secretary to negotiate directly with pharmaceutical companies on prices for medications covered by the Medicare drug benefit. The bill (HR 4) repeals the so-called "non-interference" clause in the Medicare Modernization Act (MMA) and replaces it with a provision requiring the secretary to negotiate prices that manufacturers may charge prescription drug plans (PDPs) and Medicare Advantage drug plans (MA-PDs).

An annual government analysis of healthcare spending indicates that outlays for healthcare rose only 6.9% in 2005, continuing a three-year slow-growth trend. Total U.S. healthcare spending reached almost $2 trillion, or $6,697 per person, but this reflects the slowest growth in outlays since 1999, when "enrollment in more tightly managed care plans peaked," according to analysts at the Centers for Medicare and Medicaid Services (CMS).

Everyone is jumping into the pool-the state-purchasing pool that is. States are beginning to dive into healthcare overhaul with almost artistic creativity, coming up with state-specific, collectively funded plans to fix the leaks in coverage.

When health savings accounts (HSAs) are attached to high-deductible health plans, employers find the accounts' low cost and high employee accountability attractive. They can bring in lower health insurance premiums, reduce payroll taxes and, for employees, serve as tax incentives and an additional source of retirement savings.

CDC's revised HIV recommendations that all people aged 13 to 64 should have routine HIV testing may be effective in the public health setting, but might not be as effective in the privat setting, according to one expert.

A review of agents in late-stage development for the treatment of arrhythmia and heart failure (January 2007).

Schizophrenia is a chronic disease usually diagnosed when patients are in their mid- to late 20s; therefore, patients may receive decades of exposure to antipsychotic agents over their lifetime. Whenever long-term pharmacotherapy is required for a disease, the cardiovascular implications of that therapy need to be considered. This fact was recently highlighted by the removal of the cyclo-oxygenase-2 inhibitors rofecoxib and valdecoxib from the US market because of marked elevations in cardiovascular risk.

In an 80-to-11 vote in December 2006, the US Senate confirmed Andrew von Eschenbach, MD, as commissioner of FDA. The nomination process included multiple holds by members of both political parties, which delayed his confirmation.

Five of the nation's largest employers plan to offer employees access to their own portable electronically based medical records that they can use when they travel, see a new doctor, or change jobs to retain information about their healthcare, including medications.

The chronic and excessive use of alcohol adversely affects the healthcare system, work productivity, and familial and social relationships. Alcohol misuse accounts for 85,000 deaths per year in the United States, and the overall financial costs related to alcohol dependence are more than $100 billion annually. The reduction of alcohol misuse can be measured as an increase in the frequency of abstinence or a reduction in the frequency of relapses. The recommendation for alcohol dependence treatment is a combination of psychosocial support therapy and pharmacologic treatment. Currently, there are only 3 FDA-approved agents for the treatment of alcohol dependence: naltrexone, acamprosate, and disulfiram.

Men who suffer from migraines are at increased risk for cardiovascular (CV) events, according to new data from the Physicians' Health Study. These observations follow similar reports that women with symptoms associated with migraines are at higher risk for CV disease.