News

Combination therapy with an antimuscarinic agent (tolterodine extended release [ER]) and alpha1-receptor antagonist (tamsulosin) provided symptomatic benefit in men with moderate-to-severe lower urinary tract symptoms and overactive bladder, according to a large-scale, randomized, double-blind, placebo-controlled study published in the Journal of the American Medical Association (JAMA).

Many Americans suffer from insomnia regularly, but clinicians often do not address this issue. A variety of factors may contribute to insomnia, including medical conditions such as gastroesophageal reflux disease, Parkinson disease, and heart failure. Medications such as amphetamines, theophylline, and beta agonists could also precipitate insomnia.

A public forum scheduled this month will help to solidify proposals FDA unveiled in January for reauthorization of the Prescription Drug User Fee Act (PDUFA). Once public comment from the February 16 meeting is received and incorporated into the finalized proposal, negotiations between the agency and the federal government over the fourth incarnation of this important funding mechanism will be key in determining FDA's fiduciary future.

Researchers at the Infectious Disease Laboratory at Columbia University Mailman School of Public Health and the World Health Organization (WHO) Global Laboratory Network have developed a new diagnostic tool called the "GreeneChip," a glass slide that can rapidly and accurately identify multiple pathogens from different biologic samples (eg, tissue, blood, urine).

Direct-to-consumer advertising (DTCA) of prescription drugs has been a source of debate since its US approval by FDA in 1997. A primary source of debate among experts is the methods advertisers use to attempt to influence the consumer and the consumer's subsequent reaction. Despite the controversy, authors of a recent content analysis of televised DTCA say there has been no systematic analysis of DTCA's influence on consumers to date.

The American Gastroenterological Association (AGA) has issued a consensus statement on the safe and efficacious use of nonsteroidal anti-inflammatory drugs (NSAIDs), including nonselective, nonsteroidal anti-inflammatory drugs (nsNSAIDs), cyclooxygenase-2 enzyme inhibitors (coxibs), and aspirin (ASA).

A cross-sectional study of selective serotonin reuptake inhibitor (SSRI) use by community-dwelling older women aged ≥71 years with or without depression demonstrated that SSRI use in that population was strongly associated with sleep disturbance. The study, which relied on data collected from 4 centers throughout the United States, was recently published in the Journal of the American Geriatrics Society.

Adverse events associated with the use of atypical antipsychotic medications in the management of psychosis, aggression, and agitation in patients with Alzheimer's disease (AD) may outweigh any benefit the treatments provide, according to a double-blind, placebo-controlled study published in the New England Journal of Medicine (NEJM).

Rifaximin has demonstrated global improvement of the symptoms of irritable bowel syndrome (IBS) in patients for ≤10 weeks after the discontinuation of therapy. Rifaximin is a nonabsorbed (≤0.4%), broad-spectrum antibiotic that was approved by FDA in 2004 for travelers' diarrhea.

A post-hoc analysis of the large, randomized, double-blind, placebo-controlled Physicians' Health Study found that the use of low-dose aspirin (ASA) on alternating days reduced the risk of adult-onset asthma by a statistically significant 22%.

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.

In an attempt to reduce healthcare costs, a U.S. company is encouraging its employees to go abroad for necessary medical or surgical care. A recent article in the Christian Science Monitor noted that Blue Ridge Paper Products in North Carolina is sending an employee to India for two surgeries that will cost about $20,000-far less than the estimated $100,000 for comparable procedures in the United States.

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).