News

On November 3, the US Supreme Court heard arguments in the case of Wyeth v Levine; the ultimate decision of the Court on this case may set a precedent on the issue of pre-emption, a tenet that FDA actions regarding drug approvals and medication safety supersede state laws.

As conflicts of interest between academia and the pharmaceutical industry are again under investigation, several pharmaceutical companies and universities are beginning to change their policies on disclosures and funding.

One month after Merck announced that the company was discontinuing development of taranabant, an investigational selective blocker of the cannabinoid-1 (CB-1) receptor that was being studied for the treatment of obesity, Sanofi-Aventis and Pfizer announced that they were also halting the development of their investigational CB-1 receptor antagonists (rimonabant and CP-945,598, respectively).

On November 7, 2008, a California Intermediate Appellate Court in San Francisco held that the "common-law duty [of Wyeth] to use due care in formulating its product warnings extends to patients whose doctors foreseeably rely on its product information when prescribing metoclopramide, whether the prescription is written for and/or filled with Reglan or its generic equivalent."

A phase 2/3 trial of atacicept in combination with mycophenolate mofetil and corticosteroids for the treatment of lupus nephritis in patients with systemic lupus erythematosus has been discontinued.

Study finds CT colonoscopies to be as effective as standard ones. This may prompt further coverage by health plans, as well as encourage more individuals to be screened for colon cancer.

Johnson & Johnson?s acquisition of HealthMedia Inc., a provider of Web-based behavioral interventions, speaks to the critical need for a dramatic shift in focus toward wellness and prevention.

Consumer-directed health plans (CDHPs) can achieve significant cost savings for employers because these plans encourage employees to take advantage of the preventive benefits offered through these plans, according to a WellPoint study.

More than one-third of small employers don't offer benefit plans because it is too expensive, according to Mercer. Technology can be the key to making healthcare affordable for all by reducing the cost of delivering care.

Lack of access to care has nothing to do with insurance status. A study the Robert Wood Johnson Foundation finds that there is no evidence that, despite perceptions, uninsured adults are primarily responsible for overcrowding in ERs or are using ERs to seek treatment for minor illnesses.

The candidates are generally in agreement that the next administration should work toward reducing healthcare costs, delivering high-quality patient care, placing an increased emphasis on prevention, and providing coverage for an estimated 46 million uninsured Americans, but their proposals differ dramatically.

After spending 4 years laying a foundation that will streamline clinical testing and drug development, FDA leaders are poised to move the agency's Critical Path Initiative (CPI) from concept to implementation. Despite public concerns about drug safety, dangerous imports, and rising pharmaceutical costs, CPI has not fallen by the wayside.

A study published in the Journal of the American Medical Association reported that use of finasteride, a 5-alpha reductase inhibitor commonly used to treat benign prostatic hyperplasia (BPH), does not appear to be associated with an increased incidence of hip fractures in men; in fact, the agent appears to decrease the risk of hip fracture.

An observational retrospective study published in the American Journal of Respiratory and Critical Care Medicine demonstrated that mortality is reduced when patients with chronic obstructive pulmonary disease (COPD) are treated with cardioselective beta-blockers before major vascular surgery.

As a pharmacologic adjunct to stenting in patients with acute myocardial infarction (AMI), bivalirudin monotherapy outperformed the combination of a glycoprotein (GP) IIb/IIIa inhibitor and unfractionated heparin (UFH) over 1 year of follow-up, reported investigators at the 2008 Transcatheter Cardiovascular Therapeutics conference.

A phase 2 study published in the New England Journal of Medicine reported that alemtuzumab was more effective than interferon beta-1a in treating early, relapsing-remitting multiple sclerosis (MS), but the agent was also associated with higher rates of autoimmunity, including cases of immune thrombocytopenic purpura (ITP).

To effectively gauge the potential clinical and economic impact of drug and biologic therapies that are pending FDA approval, the monitoring of pharmaceutical pipelines has become an essential function of pharmacy benefit management (PBM) companies and managed care organizations (MCOs); one source of pharmaceutical pipeline information is subscription-based pharmaceutical pipeline databases. Examples of some of these databases, along with the types of information provided and advantages and disadvantages of such products, are presented.

This article reviews the 10 newly improved or investigational agents evaluated in this year's "Focus on" column and includes an update on the regulatory status of each drug.

Prasugrel is a thienopyridine prodrug under FDA review for the treatment of acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI). Clinical trials have demonstrated statistically significant inhibition of platelet aggregation with prasugrel relative to placebo and clopidogrel; however, this improved efficacy outcome entails a significantly increased rate of bleeding.

Recent FDA action (through November 2008) related to aztreonam lysine, fentanyl buccal, tocilizumab, everolimus, ENB-0040, and artemether/lumefantrine

Generic drugs approved by FDA (through November 2008) including galantamine extended-release capsules and carbidopa/levodopa orally disintegrating tablets

FDA drug approvals

Agents in late-stage development for the treatment of insomnia and restless legs syndrome (RLS)

Unfortunately, healthcare's complex business model, dynamic technology and regulatory changes, and potential for market disruptions render conventional strategic planning processes and financial decision-making tools less effective.

The American Medical Group Assn.'s compensation and financial survey indicates trends among surgical specialties, based on compensation RVUs and gross charges over a four-year period

Insurers are not immune to the financial crisis, but because of a positive cash flow and liquidity, they are stillattractive to investors

Healthcare learned lessons about access to patient data during past natural disasters and now are putting those lessons to work during this year's hurricane season

Insurers follow updated CMS rules regarding financial responsibility for egregious medical mistakes, do not pay list and never events

As goes the national economy, so goes healthcare. Unemployment will cause a rise in uninsured and Medicaid enrollment with higher spending ahead.

HHS is giving HIPAA enforcement efforts more teeth with fees and Corrective Action Plans