News

A review of agents in late-stage development for the treatment of atherosclerosis and thrombosis (June 2006).

Federal Trade Commission (FTC) officials say they are concerned about an increasing trend of pharmaceutical companies paying makers of generic medications to delay marketing competitive products. FTC commissioner Jon Leibowitz, JD, has criticized "reverse payment" settlements, which involve a branded manufacturer compensating a generic medications manufacturer for agreeing to delay marketing efforts for a generic product until the innovator's patent expires.

The blockbuster drugs of the 1990s came off-patent, became generic, and now several of them have become available OTC. Others are expected to join the ranks in the next few years.

A lower dose of the oral retinoid acitretin is effective for moderate-to-severe psoriasis and can minimize adverse effects, according to a study presented at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. Current practice is to administer the maximal tolerated dose of 25 mg to 50 mg acitretin daily.

CNTO 1275, an anti-IL12p40, maintains efficacy in clearing plaque psoriasis for up to 24 weeks after 1 dose, according to results of a phase 2 study presented by researchers at the 64th Annual Meeting of the American Academy of Dermatology in San Francisco. The subcutaneously injected agent targets both interleukin 12 and 23, two key cytokines in type 1 immune responses, said study author Gerald G. Krueger, MD, of the department of dermatology, University of Utah Health Sciences Center, in Salt Lake City, Utah.

A phase 3 study evaluating the histologic and virologic improvement of hepatitis B antigen positive (HBeAg) patients randomized to either lamivudine or entecavir demonstrated that patients treated with entecavir had a significantly higher rate of histologic, virologic, and biochemical improvement. Researchers also observed less viral resistance with entecavir.

Tiotropium use in patients with chronic obstructive pulmonary disease (COPD) exacerbation led to decreased health resource utilization (HRU) and improved airflow limitation, according to a randomized, double-blind, multicenter, parallel group study published in the European Respiratory Journal.

A cross-sectional study of the agendas and transcripts of FDA drug advisory committee meetings from 2001 to 2004 found that conflict of interest disclosures occurred at 73% of the meetings examined, but that the recusal of advisory committee members from decision-making as a result of those conflicts occurred only 1% of the time.

Angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) play a role in the treatment of hypertension (HTN) and heart failure (HF). The literature shows that in patients with HTN with comorbidities, such as HF, myocardial infarction (MI), diabetes mellitus, chronic kidney disease, and stroke, ACE inhibitors and ARBs appear to provide added benefit beyond solely lowering blood pressure. In addition, clinical trials have also demonstrated that ACE inhibitors and ARBs may be beneficial in the prevention of diabetes, atrial fibrillation (AF), and recurrent stroke. This review evaluates the practice guidelines and current literature to assess the implications for the use of ACE inhibitors or ARBs in HTN and HF.

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.

With the nation focused on pandemic flu preparations, federalgovernment officials are calling for a nationwide biosurveillancenetwork to help identify a public health threat in real time. Whilefew doubt biosurveillance can play a critical role in an outbreak,emergency departments are underfunded and overcrowded, pushingbiosurveillance to the bottom of the technology wish list. But acloser look reveals that biosurveillance technology can make animmediate impact on public health, patient care, wait times and thebottom line.

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).