Therapeutic Talk: New AHA Cholesterol Guidelines
The American Heart Association released new clinical practice guidelines for treating blood cholesterol. Along with The American College of Cardiology, the AHA states that the guidelines will target those high at risk for cardiovascular diseases caused by atherosclerosis, or hardening and narrowing of the arteries, that can result in a heart attack, a stroke or death.
The guidelines recommend moderate to high statin therapy for four groups of patients:
- Those with cardiovascular disease.
- Those with an LDL cholesterol level of 190 mg/dL or higher.
- Those with type 2 diabetes between 40 and 75 years old.
- Those with an estimated 10-year risk of cardiovascular disease of 7.5% or higher who are between 40 and 75 years old.
The new guidelines are stirring some controversy. A recent article by Time magazine, reported that the number of Americans on cholesterol medicine could be doubled. Time also noted that since heart disease is preventable through proper diet and exercise, doctors may be more reluctant to prescribe cholesterol treatments as proposed under the new guidelines.
Med Device: InTone Promises Incontinence Relief
An estimated 20 million women suffer from urinary incontinence in the U.S., and 25% to 45% suffer with bladder leakage. Typically, a $12,000, often painful Mesh/Sling surgery has been the only solution, and roughly 50,000 class action lawsuits against the surgeries have resulted. This new non-surgical treatment is developed to reduce the risks involved with surgery. InTone has been FDA listed as a Class II Medical Device, and it’s the first effective non-invasive treatment for female urinary incontinence. Studies show that strengthening the pelvic floor muscle (PFM) helps women control urinary incontinence, and InTone claims it is proven 95% effective in achieving positive health benefits through the use of patented muscle stimulation algorithms.
Patient Pages: NCPIE Fights for Patient Adherence
The National Council on Patient Information and Education (NCPIE), a non-profit coalition of diverse organizations working to improve communication on the safe and appropriate use of medicines, recently released a 10-step Adherence Action Agenda that places the spotlight on the costly problem of poor medicine adherence, particularly in those 65 and older.
“Although the challenge of poor medication adherence has been discussed and debated extensively, what is lacking is the clear recognition that prescription medicine use and the rising prevalence of chronic and co-morbid conditions are inextricably linked, and together, represent a major opportunity to address this health threat,” says Ray Bullman, NCPIE’s Executive Vice President. “This report is intended as a wakeup call that action is needed now to confront this combined threat, before the predicted continuing upsurge of chronic conditions overwhelms the healthcare system.”
The agenda consists of 10 priorities for action, including:
- Establish medicine adherence as a priority goal of all federal and state efforts designed to reduce the burden of multiple chronic conditions.
- Accelerate the adoption of new health information technologies that promote medication adherence.
- Address multiple chronic conditions and optimal medication management approaches in treatment guidelines.
Merck provided support for development of the Adherence Action Agenda
Doctor Docs: Cegedim Launches Doctor’s Social Network
Relationship management company, Cegedim, is launching a social network for doctors called Docnet. The online community for doctors was already introduced in the Netherlands, Sweden, Norway and Turkey. It will make its debut in the U.S. in late January of 2014. Although Docnet will be competing against other social networks for doctors like Sermo and Doximity, Docnet will have a few very important key features that make it stand out, according to the company. SAFE Bio-Pharma, is a Cegedim partner that has highly advanced digital identity authentication as well as a method for digital signature. With Docnet, physicians will get all the information they need in one place: The opportunity to network; consultation with medical science liaisons; sample ordering; and co-pay and patient discount cards.
Sales Sector: Global Financial Crisis Effects Pharmaceutical Spending
The Organization for Economic Cooperation and Development (OECD) released a report detailing the global financial crisis’ effect on pharmaceutical spending. Based on a study that included 33 countries, in the years leading up to the financial crisis, pharmaceutical spending was rising. But, of course, in the years just after the crisis, spending declined. These countries reduced spending on prescription medicines through price cuts and promoting generics use, while decreasing coverage and increasing co-pays.
FDA Update
FDA Alert on Meridian Devices
The FDA recently acknowledged that auto-injector devices manufactured by Meridian Medical Technologies, a Pfizer, Inc. company, made to deliver Atropen (atropine), DuoDote (atropine/pralidoxime chloride), morphine sulfate, pralidoxime chloride and diazepam, may have questionable expiration dates. The FDA and Meridian are working together to resolve the possible disruption of supply, but it is unclear how long the disruption will last.
Certain lots of DuoDote, according to the FDA, could actually be used for an additional year beyond the expiration date. Due to an ongoing investigation, the FDA suggests that any products nearing or beyond their labeled expiration dates should be retained until they provide further guidance.
New Approvals
Luzu topical treatment was recently approved for use as an azole antifungal indicated to treat tinea pedis, tinea cruris and tinea carporis—all caused by organisms. The active ingredient in Luzu is luliconazole.
Fluvoxamine Maleate was recently granted FDA approval. The product comes in extended release capsules and is designed to treat symptoms of social anxiety disorder, OCD and depression by inhibiting neuronal reuptake of serotonin in the brain.
Moxifloxacin, a product of Akorn, Inc., was recently approved by the FDA. It is primarily used to treat skin, sinus and stomach bacterial infections.
Cadila Pharmaceuticals recently announced the FDA approval of Acyclovir, intended for the treatment of herpes virus infections, such as shingles, herpes simplex and chickenpox. Though the treatment will not cure the disease, it can be used to prevent herpes outbreaks or sores.
