Dr. Forrest Rubenstein MD

GLG News by Dr. Forrest Rubenstein MD, Cardiac, Thoracic and Vascular Surgeon

GLG News is now G+ Insights

G+ is a community for professionals, academics and entrepreneurs to connect through online discussions and in-person meetings. You will continue to see G+ Insights (formerly GLG News) here as well as on the G+ website, where you can share and discuss the G+ Insights you read.

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.

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.

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.

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.

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.

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.

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.

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.  

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.  

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.

Retail Clinics - Healthcare in Evolution

June 28, 2007

Analysis of:Retail clinics: Accepting the inevitable | www.fiercehealthcare.com

   Retail clinics will see a rapid expansion because of the convenience factor.  Patients want to be seen immediately when they have a health issue.  ER's used to fill this need, but the waits there have become worse than the waits in physician's offices and patients have sought a more convenient alternative.  These clinics will only be appropriate for minor complaints and patients (as well as clinic staff) will realize this in a short period of time.  Inevitably, some patients will make a poor choice and the clinic will be stuck caring for a patient above the capabilities of the clinic and this will tie up the clinic staff and expose them to potential liability.  

Ximelagatran effective in stroke prevention

June 11, 2007

Analysis of:Ximelagatran Comparable to Warfarin in Stroke Prevention | www.medscape.com

   Ximalagatran is comparable to coumadin in stroke prevention.  In this analysis of 7000 patients with atrial fibrillation, the stroke rate was less with ximelagatran than with coumadin with a similar bleeding profile.  The combination of aspirin and coumadin did not improve the stroke rate but it tripled the bleeding complication rate.  Ximelagatran was withdrawn from the market for liver toxicity problems, not for lack of efficacy. It is unlikely to be resurrected for a narrow niche market such as this.  This study is important because it shows the utility of oral direct thrombin inhibitors once one is developed that doesn't cause liver toxicity.

Medtronic Endeavor stent - 2nd generation stents are coming online

June 11, 2007

Analysis of:Two-Year Results from the Medtronic Endeavor III Trial Confirm Stent’s Positive Clinical Profile | wwwp.medtronic.com

The Medtronic Endeavor III trial has been completed and the results show similar clinical outcomes compared to the Cypher stent in a controlled trial.  While the angiographic endpoints were somewhat worse for Endeavor than Cypher, the MACE rates and revascularization rates were similar.  Endeavor showed a significantly lower rate of MI and MI +death compared to Cypher in this study although these were only secondary endpoints.  Importantly, there was no reported stent thromboses in the Endeavor group.

DES for Primary PCI

May 1, 2007

Analysis of:Paclitaxel-Eluting versus Uncoated Stents in Primary Percutaneous Coronary Intervention | content.nejm.org

Recent studies have demonstrated higher rates of subacute and late stent thrombosis for DES after discontinuation of Plavix compared to bare metal stents and this calls into question the safety of this trend.

Drug eluting stents account for 90% of stents placed in many institutions in the US and Europe. This is a $5 billion market in the US alone.

The use of DES is supported by studies showing lower restenosis rates, but DES have never been shown to reduce mortality compared to bare metal stents (BMS).

There has never been a study of drug eluting stents (or any stents for that matter) which shows improved long term mortality (5 - 10 years) or quality of life over coronary artery bypass grafting. This needs to be considered in evaluating the best therapy for patients.

This study shows decreased restenosis but no significant survival benefit.

Retrievable filters

May 1, 2007

Analysis of:Breakthrough Clinical Results Reveal Extended Retrieval Times for Cook Medical's Gunther Tulip(TM) Vena Cava Filter | salesandmarketingnetwork.com

 
Pulmonary emboli are a major cause of morbidity and mortality in the US - particularly in post-surgical and trauma patients.

The mainstay of treatment and prevention include anticoagulation, sequential compression devices and vena caval filters.

Filters have been the last resort for patients who could not tolerate anticoagulation or who had recurrent pulmonary emboli because they are more invasive and have more potential complications.

The advent of retrievable filters has altered this algorhythm significantly since they can be removed once the risk is over and the long term complications are greatly reduced.

This will markedly increase the use of these devices for prevention of pulmonary emboli.

Antioxidants - Why don't they work?

May 1, 2007

Analysis of:Antioxidant vitamins increase mortality | www.theheart.org

 
Anti-oxidant vitamins (primarily Vit A and E but to a lesser extent Vit C) have long been touted as cardioprotective agents. There is some logic to this and a large industry of "cardiac health" nutritional agents has sprung up and been heavily promoted by alternative medicine proponents, nutritionists, chiropractors, dieticians, and physicians.

This study shows that there is no benefits to these supplements for cardiovascular protection and that most likely, they actually increase cardiovascular mortality.

Many of these nutritional agents will cease to exist or their use will be dramatically curbed as this information is more widely disseminated.

Tekturna (Aliskiren) - a novel anti-hypertensive with great promise

May 1, 2007

Analysis of:Novartis' New Blood Pressure Weapon | biz.yahoo.com

 
Tekturna is an oral, once daily medication which is the first renin inhibitor on the US market.

It inhibits renin directly and blocks the renin-angiotensin system at its initiation. This prevents buildup of angiotensin I and II and does not interfere with the kinin system.

In clinical trials, Tekturna has been shown to control BP as well as angiotensin receptor blockers and to have a better safety profile than ACE inhibitors.

This agent should see rapid adoption into the antihypertensive regimen of millions of patients whose blood pressures are poorly controlled. 

StomaphyX - a novel device for "natural orifice incisional surgery"

April 19, 2007

Analysis of:EndoGastric Solutions Receives FDA Clearance For First Transoral Surgical Product: StomaphyX(TM) Gets Clearance First | www.medicalnewstoday.com

 
 There has been recent interest in natural orifice surgery as a new type of minimally invasive surgery. This has also been termed incisionless surgery because there are no noticible skin incisions.

This involves inserting surgical instruments via the mouth or anus to perform procedures in a similar fashion to the way endoscopic procedures are performed.

 These new devices are designed around an endoscopic platform but are able to perform more procedures including stapling and cutting as well as a type of suturing.

The stomaphyX device is being utilized to perform a type of bariatric surgery (stomach stapling) for weight loss that may gain popularity if the long term results are proven to be durable.

Endogastric solutions also makes an EsophyX device which can perform a type of anti - reflux procedure known as ELF which is similar to a surgical fundoplication.

Crestor + Zetia achieves LDL goal in 94% of patients

April 16, 2007

Analysis of:Combination Therapy May Help High-Risk Patients Reach Cholesterol Goal | www.medscape.com

Crestor (rosuvastatin) is an HMG CoA reductase inhibitor that blocks endogenous production of cholesterol.

Zetia (ezetimibe) blocks dietary cholesterol absorption from the GI tract.

The combination of these 2 agents has a significantly better result in reaching the recommended and optional ATP III goals than monotherapy with a statin (Crestor) alone.

Crestor is one of the more powerful statins on the market, but the combination of this with Zetia is significantly better than Crestor alone.

This should increase the use of both of these drugs since the combination reaches ATP III goals in 94% of patients and is relatively well tolerated.

FDA drug approvals

April 5, 2007

Analysis of:FDA drug approval at lowest rate | www.nj.com

 
  The Food and Drug Administration approved only 17 new drugs last year compared to the peak of 53 approvals a decade ago.

 This is a direct consequence of the Vioxx controversy after the FDA was heavily criticized for the handeling of the approval and then withdrawal of Vioxx in 2004.

 Drugs and devices are having a harder time being approved in this climate of closer scrutiny to prevent subsequent withdrawals.

 This is the start of a new trend and will likely increase costs and time for approvals of drugs and devices.

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