FDA has launched the Sentinel Initiative to expand and improve medical product risk detection and evaluation. Instead of relying on passive, voluntary adverse event (AE) reports sent to FDA by physicians and pharmacists, the agency would be able to detect safety signals much more quickly through links to health information databases containing information about millions of patients.
Two randomized, double-blind, phase 3 clinical trials demonstrated that raltegravir plus optimized background therapy was more effective than optimized background therapy alone in suppressing resistant HIV-1.
In a nested, case-control study published in the Archives of General Psychiatry, investigators observed that the use of selective serotonin-reuptake inhibitors (SSRIs) increased the risk of upper gastrointestinal (GI) tract bleeding; this increased risk was also observed with the serotonin and norepinephrine reuptake inhibitor (SNRI) venlafaxine. This risk may be increased when the agents are used concomitantly with nonsteroidal anti-inflammatory drugs (NSAIDs) and decreased when used concomitantly with acid-suppressing agents.
The first phase of a double-blind, randomized, parallel-group, multicenter, outpatient study demonstrated that treatment with the combination of etanercept and methotrexate was more effective in inducing both clinical remission and radiographic nonprogression than methotrexate alone in patients with early moderate-to-severe rheumatoid arthritis (RA).
A recent multinational, randomized, double-blind, placebo-controlled clinical trial demonstrated that administration of aliskiren provides additional renal protection to patients with hypertension, type 2 diabetes mellitus, and nephropathy who are already receiving optimal antihypertensive therapy and renal protective therapy with the angiotensin receptor blocker (ARB) losartan.
Among the new data presented at the 68th Scientific Sessions of the ADA were the results of phase 3 trials of the investigational agents liraglutide, ABT-335, saxagliptin, and alogliptin.
Tocilizumab, an investigational agent for the treatment of moderate-to-severe rheumatoid arthritis, is a humanized anti-IL-6 receptor monoclonal antibody. Because tocilizumab contains a mouse monoclonal antibody grafted onto human immunoglobulin, the grafted antibody is less antigenic and has a longer half-life than the mouse antibody. When administered, tocilizumab inhibits IL-6 activity by competing for both the membrane-bound and soluble types of IL-6 receptors, thus eliminating IL-6 transduction into the cell.
In the Antiarrhythmic Trial with Dronedarone in Moderate to Severe CHF Evaluating Morbidity Decrease (ANDROMEDA) investigators observed that dronedarone, an anti-arrhythmic agent related to amiodarone, was associated with increased mortality in patients who were hospitalized for symptomatic heart failure (HF) (New York Heart Association [NYHA] class II, III, or IV) and left ventricular systolic dysfunction.
Recent FDA approvals and indications (through August 2008) related to Concerta, Avodart, Prandimet, Trivaris, Reclast, Requip XL, Aciphex, Aptivus, Kinrix, Pentacel, and Durezol.
New indication: Duloxetine (Cymbalta), an SSNRI, was approved on June 13, 2008, for the management of fibromyalgia
Generic drugs approved by FDA (through August 2008) including risperidone tablets.
Recent FDA action (through August 2008) related to long-acting depot preparation of testosterone, pancrealipase capsules, human papillomavirus (HPV) quadrivalent (types 6, 11, 16, 18) vaccine, recombinant, tolvaptan, etanercept, ustekinumab, and cysteamine hydrocortisone dual-release table.
New indication: Bortezomib (Velcade), an antineoplastic agent, was approved on June 20, 2008, for the initial treatment of multiple myeloma.
Drug Watch: Agents in late-stage development for the treatment of type 2 diabetes mellitus (August 2008)
An important concept surfacing of late is that of patient care navigators, whose goal it is to decrease the number of cancer deaths caused by healthcare treatment disparities.
Employers and health plans are pursuing technologies such as secure email, personal health records (PHR) and home monitoring in hopes of improving compliance with treatment plans and care management programs.
The evolution of consumer-driven healthcare (CDH) has increased the demand for value-added services from health plans. The ability to offer these new services is a prerequisite for those hoping to succeed in the CDH market.
Specialty pharmacy as a managed benefit has arrived at the same place pharmacy benefit management was several years ago (offering open formularies, flat co-pays, etc.). Yet little is being done to address specialty pharmacy as a managed benefit.
National reports - The e-prescribing SureScripts and RxHub network merger reflects the national movement toward interconnected, standards-based technology infrastructures.
Commonwealth Fund State Performance Ranking (2007): 46
Washington, D.C. - Enough Republicans sided with Democrats last month to approve legislation canceling a scheduled 10.6% cut in Medicare fees for physicians.
Consumers want information that's personalized and useful to their specific health problem, according to a recent healthcare consumer study from Deloitte.
E-visits appear to be on the present horizon, but reimbursements are still being worked out.
The continual inability to fall asleep or stay asleep is keeping approximately one-third of the nation up at night. Individuals with insomnia incur $12 billion in direct medical costs and $2 billion in drug costs alone.
Beginning on October 1, 2007, the Centers for Medicare and Medicaid Services (CMS) began posting Corrective Action Plans (CAP) on the public area of its Web site. The goal was to post all review findings for audited conducted on Medicare Advantage and Part D plans for a specific time period that resulted in a CAP.
Personally, I'm concerned about the financial stability of the small physician practices that struggle to cover their costs. Small practices should consider options such as electronic fund transfers or an employment model to streamline financial activities.
The civil False Claims Act is the principal weapon in the government's arsenal to combat healthcare fraud. The Senate and the House are considering bills that would further expand the scope of liability under the Act and eliminate two of the key defenses to meritless lawsuits filed by qui tam plaintiffs.
To improve the quality, safety, efficiency and effectiveness of the healthcare system, the U.S. Agency for Healthcare Research and Quality (AHRQ) is tasked with a mission to gather research and disseminate valuable findings to those who can translate information into practice. Carolyn Clancy, MD, an internist with decades of experience in fact finding and analysis, directs the agency.
In enacting legislation to delay a reduction to Medicare physician fees, Capitol Hill Democrats demonstrated their intent to undermine the role of private insurers in providing care to seniors. Although all sides agreed to avoid a big cut in Medicare payments to doctors, Republicans fought efforts to fund the fees by reducing payments to Medicare Advantage plans.
The US orphan drug program has demonstrated that economic incentives and regulatory flexibility can spur development of treatments for small patient populations. Since enactment of the Orphan Drug Act (ODA) in 1983, FDA has approved >300 medicines for approximately 12 million patients around the world. However, there are approximately 6,000 to 8,000 rare diseases, so “we still have a very long way to go,” commented Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), at a May conference commemorating ODA ’s 25th anniversary, which was sponsored by the Drug Information Association (DIA).
