At a joint meeting of FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committees on January 30, 2009, advisors voted 14 to 12 that propoxyphene and propoxyphene-containing products should be removed from the market. Propoxyphene (Darvon, Xanodyne; generic propoxyphene) and propoxyphene combinations, including Darvocet (Xanodyne), are used for the treatment of mild-to-moderate acute pain.
In an analysis of fracture risk associated with loop diuretic use among postmenopausal women in the Women's Health Initiative (WHI) study, investigators demonstrated no significant association between loop diuretic use and fractures or changes in bone mineral density (BMD). With prolonged use of loop diuretics, however, the risk of fracture was modestly increased.
Initial results of the Women's Health Initiative (WHI) study demonstrated an increased risk of breast cancer among postmenopausal women treated with estrogen plus progestin. A new long-term analysis of this study published in the New England Journal of Medicine demonstrated that breast cancer incidence decreased markedly after WHI study participants discontinued hormone therapy.
Tom Daschle's (D?SD) withdrawal of his nomination for Secretary of Health and Human Services (HHS) has some speculating whether or not healthcare reform will be derailed. Daschle withdrew after saying that his failure to pay more than $120,000 in taxes could be a "distraction."
Pfizer is discontinuing a phase 3 study of axitinib for the treatment of advanced pancreatic cancer. An analysis by an independent data safety monitoring board demonstrated that there was no improvement in survival among patients treated with axitininb plus gemcitabine versus those treated with gemcitabine alone.
After New York State Attorney General Cuomo's industry-wide investigation of allegations that insurers saddle consumers with too much out-of-pocket costs, UnitedHealth says it will develop a new, independent database. Consultants say this is emblematic of a more persistent problem: the relationship among payers, patients, and providers.
Walgreens’ launch of its employer-centric pharmacy, health and wellness program, exemplifies a move by providers of service innovating their delivery models.
Absent regulatory reform prompts Michigan Blues to make some hard business decisions while groups such as Put Michigan People First say BCBSM wasn't able to get individual insurance reform legislation passed because it failed to compromise with key stakeholders.
After scrutiny by the PID, Highmark and Independence Blue Cross called off their merger. PID argues that the union would have created an insurance monopoly in Pennsylvania. The two companies deny that the combination would not have lessened competition in the market.
Pfizer-Wyeth union is just another example of consolidation in the pharma industry.
Consultants speculate on who President Obama will tap to fill the HHS, FDA and IT Coordinator posts after Tom Daschle announces his withdrawal from the HHS appointment.
MCO execs should be looking at payment changes that are win-win for the payer, consumer
On February 3, the FDA Cardiovascular and Renal Drugs Advisory Committee unanimously recommended that prasugrel (Daiichi Sankyo/Lilly) should be approved for the treatment of patients with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI).
Agents in late-stage development for the treatment of HIV and AIDS
Recent FDA action (through February 2009) related to asenapine, certolizumab, olanzapine long-acting injection, ustekinumab, oritavancin, rotigotine, and vigabatrin
Confusing drug names, or "look-alike/sound-alike names" (LASAs), are among the most common reasons for medication errors worldwide; these errors can lead to both morbidity and mortality. Both technological innovations and better communication can help healthcare professionals track and prevent these medication mix-ups.
Among members of the new administration, congressional leaders, payors, and providers, many are eager to transform the nation's healthcare system to curb unnecessary spending and make coverage more fair and efficient. A chief problem is that the US healthcare bill keeps increasing faster than the rest of the economy, with little to show in the way of quality improvement.
Dronedarone, an investigational antiarrhythmic agent being studied for the management of AF and atrial flutter, has a pharmacologic mechanism of action that is similar to that of amiodarone, but dronedarone lacks an iodine moiety, which may result in less thyroid and pulmonary toxicity. Dronedarone is currently pending FDA approval; the agent was granted priority review in August 2008.
The challenge of controlling HIV in patients with resistance to antiretrovirals has contributed to accelerated research into treatments with novel antiretroviral activity.
New molecular entity: Plerixafor (Mozobil), a hematopoietic stem cell mobilizer, was approved on December 15, 2008, for mobilization of hematopoietic stem cells for autologous transplantation in patients with NHL and MM
New molecular entity: Degarelix, a GnRH receptor antagonist, was approved on December 24, 2008, for the treatment of advanced prostate cancer
New molecular entity: Milnacipran (Savella), a selective norepinephrine and serotonin reuptake inhibitor, was approved on January 14, 2009, for the management of fibromyalgia
Lobbying efforts by the pharmaceutical industry and timing concerns have prevented CMS from requiring that all Part D plans move to pass-through pricing
Measurement tools used by state regulatory bodies evaluate MCO capitalization and investment
Pick your poison. Even with the grand number of proposals on the table, healthcare will still cost the nation trillions.
WellPoint sanctions might be indicative of deeper oversight problems in Medicare.
While numbers show less growth, the $2.2 trillion spent on healthcare is still exceptionally high
Big name insurers are getting smacked with fees and penalties for dropping the ball
Drill into your own data to see whether and to what degree these national inpatient trends are occuring in your own area.
Commonwealth Fund State Performance Ranking: 26