GLG News by Cardiothoracic Surgeons who Perform Valvoplasty Procedures (US)

Forrest RubensteinCardiac, Thoracic and Vascular SurgeonST. MARY'S HOSPITAL, STREATOR, OF THE HOSPITAL SISTERS OF THE THIRD ORDER OF ST. FRANCIS

Preventing Bariatric Surgery Deaths

January 25, 2008

Analysis of:Pinning Down Mortality Rates After Bariatric Surgery | www.medscape.com

 Bariatric surgery is a major operative procedure that caries significant morbidity and mortality risks due to the comorbid diseases seen in this patient population.  This procedure is increasing in frequency as more patients are willing to have it and more surgeons are becoming proficient. The mortality rate is ~ 1 % at 1 year and 6% at 5 years which is greater than the population at large.

Forrest RubensteinCardiac, Thoracic and Vascular SurgeonST. MARY'S HOSPITAL, STREATOR, OF THE HOSPITAL SISTERS OF THE THIRD ORDER OF ST. FRANCIS

CMS regulations penalize hospitals for taking care of sickest patients

August 28, 2007

Analysis of:New Medicare Regulations Adopted To Reduce Certain Hospital Infections And Medical Errors | www.medicalnewstoday.com

This article presents the new CMS guidelines that deny higher payments for the additional costs associated with treating patients for certain hospital - acquired infections and medical errors. While these are laudable goals, to assume that all infections are the result of poor medical practice is an oversimplification. The development of nosocomial infections also has to do with the patients disease processes such as diabetes, morbid obesity, immunosuppression, tobacco abuse, etc. While few physicians would argue against enforcing these rules for documented mistakes (medication errors, transfusion mistakes, and objects left in patients bodies), most recognize there is a certain baseline of these other infections which cannot be avoided. Hospitals should only be penalized when their risk adjusted incidence exceeds a standardized baseline.

Forrest RubensteinCardiac, Thoracic and Vascular SurgeonST. MARY'S HOSPITAL, STREATOR, OF THE HOSPITAL SISTERS OF THE THIRD ORDER OF ST. FRANCIS

Retail drugstore clinics - filling a niche ?

August 28, 2007

Analysis of:Drugstore Clinics Spread, and Scrutiny Grows | www.nytimes.com

   Several large drugstores are establishing retail medical clinics within their stores much as eyeglass stores have had optomitrists on site.  There is no problem with these clinics per se as long as they practice within the scope of the practitioners license and skill.  There are concerns that those clinics staffed by non physicians will be practicing inferior medicine beyond the scope of the practitioner.  As these clinics become more widespread, they will certainly come under greater scrutiny.

Forrest RubensteinCardiac, Thoracic and Vascular SurgeonST. MARY'S HOSPITAL, STREATOR, OF THE HOSPITAL SISTERS OF THE THIRD ORDER OF ST. FRANCIS

The drug patent "shell game"

August 28, 2007

Analysis of:New antihistamine gets FDA green light.(RX CARE)(Levocetirizine (Xyzal) by UCB Inc. and Sanofi-Aventis ) | www.therapeuticsdaily.com

   Zyrtec (cetirizine) is a second generation nonsedating antihistamine that has enjoyed wide popularity.  Zyrtec will become available generically in late 2007 and the generic form is expected to be significantly cheaper.  To virtually extend the patent, the manufacturer is marketing the active enantiomer, levocitirizine (Xyzal) as a replacement for Zyrtec. This required only a fraction of the R&D costs that developing a new drug would entail.  While this could be a boon to the pharmaceutical companies involved in the release, patients have little to benefit from the increased cost.

Forrest RubensteinCardiac, Thoracic and Vascular SurgeonST. MARY'S HOSPITAL, STREATOR, OF THE HOSPITAL SISTERS OF THE THIRD ORDER OF ST. FRANCIS

FIRE STAR™ Rx PTCA Dilatation Catheter - an incremental improvement, not disruptive technology

August 21, 2007

Analysis of:Cordis Corporation Introduces FIRE STAR™ Rx PTCA Dilatation Catheter | www.medicalnewstoday.com

   Cordis introduced the FIRE STAR™ Rx PTCA Dilatation Catheter to the European market.  This catheter reportedly has a lower profile than other devices on the market which enables it to cross highly stenotic or tortuous lesions.  There are no controlled studies showing device this offers any significant advantage for most angioplasty procedures.  The Fire Star device will likely become a part of the armamentarium of interventionalists but will not be the workhorse catheter unless a true outcome advantage can be demonstrated or the price is competitive with the devices currently available.

Forrest RubensteinCardiac, Thoracic and Vascular SurgeonST. MARY'S HOSPITAL, STREATOR, OF THE HOSPITAL SISTERS OF THE THIRD ORDER OF ST. FRANCIS

Bariatric surgery is a useful adjunct in the management of obese diabetics

July 6, 2007

Analysis of:Bariatric surgery - possible treatment for type 2 diabetes mellitus | www.news-medical.net

   Type II diabetes and the metabolic syndrome are highly correlated with obesity. These diseases are epidemic in our society.  Weight loss has been definitively shown to reduce morbidity and mortality in these patients with complications from their obesity.  Bariatric surgery is a highly effective strategy for treating morbid obesity. It reliably produces greater weight loss than any other treatment.   As these procedures do have risks and potential complications, they should be considered a part of the treatment plan along with diet, exercise, and risk factor reduction.  No single strategy is best for all patients so this therapy needs to be individualized.

Forrest RubensteinCardiac, Thoracic and Vascular SurgeonST. MARY'S HOSPITAL, STREATOR, OF THE HOSPITAL SISTERS OF THE THIRD ORDER OF ST. FRANCIS

Non-stimulant treatment for ADHD - a new alternative

July 6, 2007

Analysis of:Shire Receives Approvable Letter from FDA for INTUNIV(TM) (guanfacine) Extended Release, a Nonstimulant for the Treatment of ADHD | www.pipelinereview.com

   Shire PLC received an approvable letter from the FDA for its nonstimulant treatment for ADHD - Intuniv (guanfacine)   Most of the treatments for ADHD are stimulants (amphetamine derivatives) that can have potentially serious cardiovascular side effects. Unfortunately, to date, no nonstimulant medication has been found to be as effective in controlling the symptoms of ADHD as the stimulants are.   This medication will find a place in the treatment of this very prevalent (and possibly overdiagnosed) disease but its effectiveness for the vast majority of patients has not yet been proven.

Forrest RubensteinCardiac, Thoracic and Vascular SurgeonST. MARY'S HOSPITAL, STREATOR, OF THE HOSPITAL SISTERS OF THE THIRD ORDER OF ST. FRANCIS

Rimonabant - the FDA gets it wrong.......Again

July 6, 2007

Analysis of:FDA Advisory Committee Did Not Recommend Approval of Rimonabant (ZIMULTI(R)) for Use in Obese and Overweight Patients With Associated Risks Factors | www.pipelinereview.com

   The FDA advisory committee unanimously rejected rimonabant because of concerns of an increase in suicidal ideation seen in patients taking the highest dose of the medication (20 mg). This drug has been proven in several large studies to not only induce greater weight loss than other strategies, but also to improve glycemic control and the metabolic syndrome.  Since these are the major risk factors for cardiovascular disease, this drug was poised to be a blockbuster drug for Sanofi and a huge help for millions of obese Americans with complications from their obesity.  Both Sanofi and the American public will be worse off if this drug does not come to market in the US.  

Forrest RubensteinCardiac, Thoracic and Vascular SurgeonST. MARY'S HOSPITAL, STREATOR, OF THE HOSPITAL SISTERS OF THE THIRD ORDER OF ST. FRANCIS

Whats new in hypertension therapy - nothing , sort of

July 6, 2007

Analysis of:Exforge Helps Vast Majority of Patients Effectively Control Their Blood Pressure After Failing on Other Medicines, According to New Clinical Data | pharmalive.com

   Valsartan (an ARB) and amlodipine (a calcium channel blocker) are both useful drugs in treating hypertension and heart failure.  Most patients require more than 1 medication to reach goal in controlling their blood pressure.  Exforge (a combination of valsartan/amlodipine) will help more patients achieve control than either drug individually.  While this combination may be perfect for some patients, it is unlikely to be a major drug for the company since there is no new advantage for the patients.  

Forrest RubensteinCardiac, Thoracic and Vascular SurgeonST. MARY'S HOSPITAL, STREATOR, OF THE HOSPITAL SISTERS OF THE THIRD ORDER OF ST. FRANCIS

Angiogenesis (Growth factors) for peripheral arterial disease

June 28, 2007

Analysis of:Vical Licensee AnGes MG Announces Positive Results of Phase 3 Angiogenesis Trial in Japan | www.pipelinereview.com

   Peripheral arterial disease is a major problem in this country which is only recently being recognized for the epidemic that it has become.  This problem (PAD) coexists with coronary disease (heart attacks) and cerebrovascular disease (strokes) and has been neglected and underdiagnosed as well as undertreated for years.  Angiogenesis is an exciting adjunct for this disease process, but it is no substitute for risk factor reduction ( weight loss, smoking cessation, exercise and control of hypertension, diabetes, and dyslipidemia) or revascularization.  While this will likely improve the symptoms of some patients with PAD, it has never been shown to improve limb salvage or exercise tolerance as the proven therapies listed above have. To suggest otherwise is irresponsible. Many more years of study may be needed before all the potential problems with this approach become apparent.

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