When companies interact with governmental bodies, issues related to the Public Information Act frequently arise. It is imperative for those companies to understand the Public Information Act as well as the internal procedures that may be developed to handle open records issues.
I had the honor of joining 40 executive delegates for a week to observe the Irish healthcare system. While spending in the Irish healthcare system is just 7.2% of GDP, the public hospitals are filled to the gills.
Commonwealth Fund State Performance Ranking (2007): 2
Adding zoledronic acid to anastrozole or tamoxifen therapy decreased recurrence by 35% and increased disease free survival by 36% in premenopausal breast cancer patients, according to results of the Austrian Breast and Colorectal Cancer Study Group Trial 12 (ABCSG-12). The multicenter, Phase III trial is the first large trial to demonstrate the significant antitumor benefit of zoledronic acid, said Michael Gnant, MD, Medical University of Vienna. "Adjuvant treatment with zoledronic acid should be considered in order to improve the standard of care in premenopausal breast cancer patients," he said.
Modafinil appears to reduce the severity of chemotherapy-induced severe fatigue, reported Gary R. Morrow, PhD, MS.
Vaginal brachytherapy is as effective as external beam radiation therapy in preventing the recurrence of higher-risk endometrial cancer but with fewer side effects and results in superior quality of life, according to a Phase 3 study presented by Remi A. Nout, MD.
Adherence to a four-point Individualized Sleep Promotion Plan (ISPP) intervention consisting of stimulus control, sleep restriction, relaxation therapy, and sleep-hygiene practices significantly lowered fatigue and increased sleep quality for patients undergoing adjuvant chemotherapy. Fatigue and sleep disturbances are the most frequently reported symptoms during adjuvant chemotherapy for breast cancer. One-third of breast cancer patients report persistent fatigue and abnormal sleep/wake cycles, said Ann M Berger, PhD, RN, professor, College of Nursing, University of Nebraska Medical Center, Omaha.
Routine cardiac monitoring is suggested for patients receiving sunitinib, as cardiotoxicity, particularly left ventricular (LV) dysfunction, is common, said Melinda Telli, MD.
Everolimus, an experimental oral agent that targets the mTOR protein, may represent an effective second-line option for patients with metastatic renal-cell carcinoma whose disease has progressed despite treatment with a tyrosine kinase inhibitor.
Phase 3 trial results show that adding bevacizumab to docetaxel as first-line therapy for newly diagnosed HER2-negative, locally recurrent, or metastatic breast cancer resulted in significantly less disease progression. "This shows that the antiangiogenic approach to treating breast cancer is effective, regardless of which taxane drug it is combined with," said lead author David Miles, MD, professor, Mount Vernon Cancer Center, Middlesex, UK. Previous studies have shown that the combination of bevacizumab to paclitaxel doubled progression-free survival among patients with metastatic breast cancer.
Cancer is an independent predictor of increased vulnerability, functional limitations, geriatric syndromes, frailty, and fair or poor health status among older Medicare beneficiaries. "Up until now, a lot of this has been more opinion rather than numbers," said Gary R. Morrow, MD, professor of radiation oncology, University of Rochester Cancer Center. "This gives us a method to let us know if we have changed anything.
National News-Small businesses are less likely to offer employee health benefits, especially if they’re the new kid on the block, according to a recent report from the Kaiser Family Foundation. Analysis finds that among firms with nine employees or fewer, those in business for 20 years or more are more likely to offer benefits.
Cleveland-Cleveland Clinic has its own electronic personal health record system for patient viewing, and now it plans to pilot information-exchange capabilities with GoogleHealth, an online PHR platform.
Oakland, Calif.-Nearly 9 million Kaiser Permanente members in nine states are now on the books with the plan’s HealthConnect electronic medical record system, which completed a four-year rollout recently. Installation cost $4 billion, including $1 billion for maintenance.
National News-Wal-Mart will offer generic medications for $10 for a 90-day supply, which previously cost $4 for a 30-day supply, offering more over-the-counter medications at $4. About 350 generics are covered. At the same time, Target’s prescription drug program now includes an expanded assortment of $4 prescription drugs, 90-day supply of these medications for $10 and OTC medications for $4 or less.
Washington, D.C.-There’s a lot of talk in Washington about the importance of enacting legislation to establish a pathway for FDA to approve “similar” or “follow-on” versions of biotech drugs. Biopharmaceutical companies have been pushing for compromise legislation this year, that is aligned with health insurers, pharmacy benefit managers, and public and private payers, who envision big savings.
Istradefylline, a highly selective adenosine A2A receptor antagonist, is a new agent being investigated for the adjunctive treatment of the motor signs and symptoms of idiopathic Parkinson disease.
Treatment options for osteoporosis include calcium, vitamin D, estrogen plus progesterone, calcitonin, and bisphosphonates.
Generic drugs approved by FDA (through May 2008) including amifostine for injection, clobetasol foam, granisetron oral solution, calcium acetate capsules, and irinotecan injection.
Recent FDA action (through May 2008) related to ceftobiprole, sugammadex, romiplostim, Gardasil, and amrubicin.
NME: Bendamustine (Treanda), an alkylating agent, was approved on March 20, 2008, for the treatment of chronic lymphocytic leukemia (CLL).
Experts urged a “return to statins” after hearing the final results of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial, which demonstrated no slowing of carotid atherosclerosis progression with the addition of ezetimibe to simvastatin therapy.
Antibiotics in deveopment for the treatment of complicated skin and skin structure infections, community-acquired pneumonia, and infectious diarrhea
According to results from the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET), the angiotensin receptor blocker (ARB) telmisartan is as effective as the angiotensin-converting enzyme (ACE) inhibitor ramipril in preventing adverse cardiovascular events in high-risk patients with cardiovascular disease but without heart failure.
At a March 5, 2008, commission meeting, the Medicare Payment Advisory Commission (MedPAC) discussed the feasibility of requiring pharmaceutical companies and medical product manufacturers to report financial relationships and gifts to physicians on a national basis.
Approximately 1.7 million healthcare-associated infections (HAIs) occur in US hospitals each year. These HAIs, which include pneumonia, bloodstream infections (BSIs), and urinary tract infections (UTIs), account for approximately 99,000 deaths and $5 billion in additional healthcare costs.
Much to the surprise of most close FDA observers, Janet Woodcock, MD, agreed in March to resume control of the Center for Drug Evaluation and Research (CDER). Dr Woodcock headed CDER for 10 years before becoming deputy commissioner and, more recently, FDA’s chief medical officer. But when CDER director Steven Galson, MD, MPH, left last year, Dr Woodcock served as the temporary CDER chief. Now, after a long search for a replacement, she has decided to accept the position herself.
Recent Milliman analysis of employer programs that offer employees a choice of consumer-directed health plans or non-CDHPs, shows that when offered as a new choice, CDHPs deliver a modest 1.5% in savings beyond non-CDHPs based on typical risk- and benefit-adjustment factors.
The enrollment process offers opportunities to engage employees, but the tools themselves are not enough, according to one industry expert.
How much attention is being paid to abuse of prescription drugs? One group, pharmacy benefit managers, are beginning to take a closer look by creating programs to identify members who may be abusing prescription drugs.
