SUBSPECIALTY NEWS

Dr. Edwin Ryan: Unsung Hero

He linked glitazones to severe DME.

BY JERRY HELZNER, SENIOR EDITOR

■ When retina specialist Edwin H. Ryan, MD, noticed back in 2002 that two of his diabetic patients had ballooned in weight and showed diabetic macular edema out of proportion to their diabetic retinopathy, his interest was piqued and he began to do some detective work.

What he found was that each of the patients had been prescribed glitazone drugs by the physician who was treating them for diabetes.

The purpose of the glitazones — Avandia (Glaxo SmithKline) and Actos (Takeda) — was to maximize the beneficial effects of insulin in regard to controlling blood sugar and cholesterol levels in Type 2 diabetes. At that time, these new drugs were becoming very popular, with Avandia's annual sales eventually reaching more than $3 billion in 2006. (Avandia sales plunged after the drug was linked to heart problems in 2007 and physicians caring for diabetics switched to safer alternatives.)

“After those first two patients, I began to notice other patients who exhibited the same rise in fluid weight and the striking presence of DME,” says Dr. Ryan, who is in practice at VitreoRetinal Surgery in Minneapolis/St. Paul. “I even had an endocrinologist telling me he didn't like using these drugs. I then got together with my colleagues here and we eventually identified 30 cases who had the same DME plus weight gain. All were taking either Avandia or Actos.”

Dr. Ryan presented his findings at the American Academy of Ophthalmology meeting in the fall of 2003. “I had other retina specialists coming up to me saying, ‘Yeah, I think I've seen this in my patients as well.’”

Dr. Ryan said that when he initially approached physicians who were providing basic care to his diabetic patients and asked them to take the patients off of glitazones, he encountered some resistance.

“It was a bit difficult at first because here was an ophthalmologist telling them to take their patients off of the drugs they had prescribed,” says Dr. Ryan. “There was some reluctance with some of those physicians, in part because glucose control was improved. Lately, there hasn't been any pushback when I make that request. Given the recent reports, we have probably saved some lives by getting these patients off of these drugs.”

The good news was that when Dr. Ryan and his colleagues got their patients off of the glitazones, most of them lost significant weight and had a marked reduction in their overall edema.

“My experience is that patients who do the worst on glitazone are the ones who have had diabetes for a long time and have multi-organ involvement, such as kidney problems,” notes Dr. Ryan. “The relatively healthy diabetic patients seem to be able to tolerate the glitazone drugs without getting the edema.”

Dr. Ryan: first to associate glitazones with DME.

With the newer studies in 2007 and then in 2009 associating Avandia with an increased risk of heart disease, there have been increasing calls to take Avandia off the market in the United States.

Whatever the eventual fate of the glitazones medications, the retinal community can take pride in knowing that it was one of their own who raised the first credible warning about the dangers of this class of drugs.

The Appeal of “Key Man” Insurance

A low-priced policy can save a practice.

BY JERRY HELZNER, SENIOR EDITOR

■ In the past few years, two highly respected ophthalmologists in the prime of their lives died tragically, one in a parachuting accident and another in the crash of a private plane. Other ophthalmologists have been forced to stop practicing, either temporarily or permanently, because of illness or disability.

The sudden loss of a productive practitioner can cripple or even spell the end of a practice. This is especially true of retina practices, which tend to have only two or three physicians. However, a practice that buys reasonably priced term life insurance policies on its key practitioners stands a good chance to survive even the death of a partner or principal.

“If it's a solo practice and the doctor dies, it's probably the end of that practice,” says Mark Kropiewnicki, Esq., LLM, CEO of the Health Care Group, Inc., in Plymouth Meeting, Pa. “However, suppose you have a two-physician practice and one dies suddenly. You still have all the expenses and overhead of a two-physician practice. The insurance payment can buy some time and give the practice a fighting chance to bring in another physician and get that doctor up to speed.”

Mr. Kropiewnicki says the simplest and most cost-effective way to get so-called “key man” (or key employee) insurance protection is to buy a 20-year term whole-life policy with a payout in the neighborhood of $300,000.

Premiums on these policies are not tax-deductible and will vary based on the age and health of the person being insured, but Mr. Kropiewnicki says they can be purchased for as little as $1,000 a year.

“Key Man insurance can be very important in maintaining cash flow and providing financial resources to replace a physician,” says James Dawes, chief administrative officer for the Center for Sight in Sarasota, FL. “However, if a group has significant physician capacity with other quality providers who can take over the physician's practice, the need for such insurance is greatly diminished. I would also recommend that if a group chooses to purchase Key Man insurance, that a written agreement is put in place with the group ownership as to how the proceeds of an insurance payment are to be used.”

“Some financial planners will try to tie Key Man insurance in with investments and estate planning but I don't advocate that,” says Mr. Kropiewnicki. “In this instance, the simple, term whole-life policy is the best way to go.”

To protect against a physician's disability, practices can purchase pricier disability insurance or another type of policy called “overhead insurance” that provides payments to keep a practice going during the extended absence of a doctor.

Sustained-Release Treatment for CME

Icon's system begins a phase 1 trial.

■ Icon Bioscience has begun a multisite phase 1 trial of an extended-release formulation of triamcinolone acetonide to treat cystoid macular edema. Its proprietary Verisome drug-delivery system administers a single therapeutic injection that provides extended release for up to a year.

The Sunnyvale, CA company is assessing the safety and efficacy of its lead product, IBI-20089 in the trial. Subjects developed CME following cataract surgery or as a consequence of retinal vein occlusion.

Formulated as a gel, IBI-20089 forms a sphere in the posterior segment after intravitreal injection. This sphere gradually degrades and disappears as the drug is released in a controlled manner.

Icon notes that, with Verisome delivery, instead of having the duration of treatment dictated by the product, physicians will be able to administer consistent levels of a drug directly to the affected site for the duration of treatment they deem clinically appropriate. The system will allow the physician to specifically tailor the therapy for an individual patient.

According to Icon, the Verisome system degrades as the active agent is released over the intended duration of time. Clinically, Icon believes this is highly desirable and unique to IBI's technology as it allows the physician to easily and accurately assess the status of the therapy. As long as the system is visible in the eye, the drug is being released. Additionally, none of the drug-delivery platform exists at the end of therapy. This facilitates the administration of additional doses.

Verisome controlled-release formulations can be designed in a solid, gel or liquid state depending upon the specific clinical requirements. The drug can be delivered with a small 30-gauge needle as a standard intravitreal or anterior chamber injection, without additional devices or surgical procedures. Verisome can incorporate a broad range of pharmaceutical agents including small molecules, nucleic acids, peptides, proteins and monoclonal antibodies.