GLG News by Restylane Users (US)

Michael BainWound Care DirectorNewport Nursing and Rehabilitation

FDA issues safety signal on ALCL & breast implants

January 31, 2011

Analysis of:FDA issues safety signal on ALCL & breast implants | www.psnextra.org

http://www.psnextra.org/Articles/FDA-ACLC-Issue.htmlThere is a link between breast implants and anaplastic large cell lymphoma (ALCL).  This very rare tumor has almost no cases in the literature.  There appears that there might be an association between the two.

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER

Starpharma gets US patent for use of VivaGel for protection against STIs

September 29, 2009

Analysis of:Starpharma gets US patent for use of VivaGel for protection against STIs | www.pharmabiz.com

Starpharma's lead product, is a vaginal microbicide gel under development for the prevention of sexually transmitted infections (STIs), including genital herpes and HIV infection. The VivaGel® product concept is designed to offer a safe, convenient and affordable means for women to protect themselves from infection with genital herpes and HIV during sex. Surveys show that there is substantial demand in North America and Europe for such a product with an estimated billion dollar market for STI prevention products in the developed world.

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER

Stelara new Option for Psoriasis

September 26, 2009

Analysis of:Stelara Approved to Treat Moderate to Severe Plaque Psoriasis in Adults | www.webmd.com

The FDA approved Stelara based on three studies of 2,266 patients who either got shots of Stelara or a placebo. Patients who got Stelara were more likely to achieve the studies' benchmark for reduction in psoriasis.In a news release, the FDA notes that because Stelara reduces the immune system's ability to fight infections, the product poses a risk of infection. "Serious infections have been reported in patients receiving the product and some of them have led to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer," the FDA states.

Alan ZaccariaPlastic SurgeonMD ALAN FACS ZACCARIA

A Low Cost EMR System From Wal-Mart?

March 16, 2009

Analysis of:Wal-Mart Plans to Market Digital Health Records System | www.nytimes.com

Wal-Mart is one of the top consumer retailers in the country.  They have already entered the world of competitive, low cost health care delivery with their $4.00 generic prescriptions and their Nurse Practitioner run clinics--so becoming a warehouse for state-of-the-art electronic medical records (EMR's) is a natural progression.  I see this as a great business move for Wal-Mart as they will combine their buying power with Dell's technology expertise, creating an affordable EMR system to revolutionize American medicine.

Alan ZaccariaPlastic SurgeonMD ALAN FACS ZACCARIA

Health Care in America--An Ailing Commodity That Doctors Can't Cure

January 30, 2009

Analysis of:Perspectives on Health Reform, 17th January 2009 | healthaffairs.org

Fixing the health care system in America is like trying to fix the economy.  We keep dumping more and more money into it, only to find ourselves going nowhere.  There seems to be a renewed sense of hope with the emergence of a new administration in Washington, but there are no easy solutions.  We are a country endeared to our ever increasingly expensive technology, which everyone wants, but only few can afford.  We treat everyone who needs medical care, whether or not they can afford it, taking the position that hospitals and doctors will absorb the cost.  Well, hospitals and yes doctors, are going out of business.  Until the actual issues are looked at and tough decisions are made, we will find ourselves in a situation of a government run, nationalized health care system (ala Canada) which will set medicine in America back to the stone ages.

Alan ZaccariaPlastic SurgeonMD ALAN FACS ZACCARIA

High End Medical Devices and Implants Are Not Immune to This Recession

January 22, 2009

Analysis of:Medical devices not immune to recession worries | www.boston.com

As America faces one of the worst recessions in history, all businesses suffer, including the health care industry.  With the steady rise of unemployment, more and more people are losing their jobs, and with it their health insurance.  This has a direct impact on medical device companies, as non-emergent surgical procedures and services are put off as long as possible, thus limiting the usage of their products.

Robert FrankOwnerAria Cosmetic and Reconstructive Surgery

Mentor/J&J deal is long overdue

December 3, 2008

Analysis of:Johnson & Johnson buys medical device maker | www.nytimes.com

The purchase of implant manufacturer, Mentor Corporation, by Johnson and Johnson will level the playing field as Mentor seeks to take market share from Allergan in both the breast implant business as well as facial fillers and competitors to Botox.

Robert FrankOwnerAria Cosmetic and Reconstructive Surgery

Dermatologists? I worry more about the Family practitioners, Ob-Gyns, and Internists...

July 31, 2008

Analysis of:As Doctors Cater to Looks, Skin Patients Wait | www.nytimes.com

As insurance reimbursements decline, everyone suddenly thinks they're a cosmetic surgeon.

Alan ZaccariaPlastic SurgeonMD ALAN FACS ZACCARIA

And yet, another filler? Is this the Holy Grail?

July 8, 2008

Analysis of:FDA Approves EVOLENCE®, a New Generation Collagen-Based Facial Filler | www.investor.jnj.com

Over the past few years, noninvasive cosmetic procedures have skyrocketed.  Soft tissue injectable fillers are among those procedures that are rapidly growing.  Up until now, hyaluronic acid (HA) fillers have been the mainstay.  With the emergence of Envolence, we have a new twist on an old product--collagen.  Since this does not involve skin testing and can be used at the same time as the patient's initial visit, this may prove to be an exciting new product, and may capture a fair share of the injectable filler market place.

Jeffrey WeinbergDirector of Clinical Research - DermatologyST LUKE'S-ROOSEVELT HOSPITAL CENTER

Issues with Ustekinumab

June 23, 2008

Analysis of:Positive news on J&J's ustekinumab diminished by safety concerns - analysts | www.tradingmarkets.com

On Tuesday, the FDA's Dermatologic and Ophthalmic Drug Advisory Panel voted unanimously to approve the use of the injectable drug for the treatment of plaque psoriasis, a severe skin disease. As the FDA usually follows the recommendations of its advisory panels when reviewing new drugs for approval, it is anticipated that the regulatory body will approve the drug in the fourth quarter, analysts said. But concerns over the drug's carcinogenic potential and the panel's recommendation that the drug be administered only by a physician and not directly by the patient could diminish enthusiasm over ustekinumab and lessen the drug's potential market share.

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