At Press Time
Physicians Cutting Back Their Hours
A reaction to reduced reimbursements?
By René Luthe, Senior Associate Editor
■ A recent study in the Journal of the American Medical Association could have implications for how healthcare reform efforts may affect the future physician workforce. Staiger et al. examined trends in hours worked by physicians in the US to determine if there was a connection with national trends in physician fees. Their retrospective analysis showed that mean hours worked per week decreased 5.7% between 1996 and 2008 among nonresident physicians. Trends were examined by residency status, age, gender and work setting.
The decline in hours was from 54.9 hours per week in 1996-1998 to 51.0 hours in 2006-2008 — a 7.2% decrease among all physicians. During the 1977-1997 period, by contrast, physician hours were stable at approximately 55 hours per week. While the decline in hours worked by resident physicians during the study period could be attributed to the imposition of work-hour limits in 2003, the researchers found that the decrease in hours worked was greatest for nonresident physicians younger than 45 (7.4%) who worked outside the hospital setting (6.4%). The decrease was smallest for physicians over the age of 45 (3.7%) and working in the hospital (4.0%).
The researchers used nationally representative workforce information from the Census Bureau's Current Population Survey between 1976 and 2008, and designed an inflation-adjusted physician fee index that depicts how payments made to physicians by Medicare and private insurance changed over time. To ascertain if differences in fees across geographic regions were associated with trends in hours, the researchers used the Government Accountability Office's physician fee index, which indicated how payments to physicians by the Federal Employees Health Benefits program differed across 319 metropolitan areas.
Coinciding with the decrease in physician hours, researchers found, was a decline in physician fees by an inflation-adjusted 25% between 1995 and 2006. In the metropolitan areas with the lowest physician fees, mean physician hours were less than 49 per week, while in other areas, mean physician hours were more than 52 hours per week.
While the authors point out that the evidence of the relationship between fees and hours worked is mixed, they also note that the trend toward lower hours means more difficulty in maintaining or expanding the current levels of physician supply. The stated goals of healthcare reform will likely require an expanded physician workforce.
“Our findings are consistent with the possibility that economic factors such as lower fees and increased market pressure on physicians may have contributed, at least in part, to the recent decrease in physician hours,” the authors conclude. “Further reductions in fees and increased market pressure on physicians may therefore, contribute to continued decreases in physician work hours in the future.”
Statin Use Reduces Cataract Risk
A large Israeli study finds significant benefits.
By Leslie Goldberg, Associate Editor
■ In recent years, a growing body of evidence has emerged suggesting that statins may have anti-inflammatory effects; consequently, it was hypothesized by Heymann et al. in the February 2010 issue of the Annals of Epidemiology that statins may have a preventive effect against cataract formation.
A large retrospective cohort study was carried out on 180,291 new statin users in Israel. Study participants from the Maccabi Healthcare Services, an Israeli HMO, were followed between the years 1998 and 2007 for incidence of cataract or cataract extraction.
The study found that persistent statin use was significantly protective for the incidence of cataract in the cohort of men and women younger than 75 years of age, but not in older subjects. Researchers found that men between 45 and 54 who took statins daily to reduce cholesterol had a 38% lower risk of developing cataracts. Women of the same approximate age reduced their risk by about 18%.
“Because of the wide use of statins and the significant burden of cataract extraction in the Western world, our findings have a great potential for primary prevention of age-related lens opacities, probably due to reduced oxidative stress,” write the study's authors. “The growing number of prospective studies that indicate a similar association suggest that large controlled trials to further explore and confirm this relationship should be considered. Well-planned studies are needed to further explore the relationship between persistent statin use in the elderly and cataract formation.”
“Although our study has shown that use of statins may substantially reduce the risk of cataract, and probably other non-cardiac diseases, statins are currently indicated for hypercholesterolemia for primary and secondary prevention of ischemic heart disease, and thus we urge pharmaceutical companies to initiate clinical trials to further investigate this potentially important association. But it is clear that patients prescribed for statins should take it persistently to benefit the most,” said Gabriel Chodick PhD, MHA, lead author of the study.
Dr. Chodick also said that while his team had found somewhat stronger association between high-efficacy statins and lower risk of cataract, they could not recommend a specific type of statin and that further investigation is needed.
Punctal Plugs to Treat Conjunctivitis
Olopatadine will be placed in the plugs core.
■ QLT, which is already well into a phase 2 clinical trial for delivery of the glaucoma medication latanoprost via punctal plugs (see article on Toward Better Delivery of Glaucoma Meds), will now use the same approach to attempt to treat allergic conjunctivitis.
The second drug selected for the punctal-plug delivery platform is olopatadine, an anti-allergy drug. Olopatadine has been approved by the FDA in an eye drop dosage form for the treatment of the signs and symptoms of allergic conjunctivitis. QLT says the punctal plug platform may be well-suited for olopatadine delivery to the surface of the eye as retention rates of the third-generation punctal plug over six weeks — the intended duration of sustained delivery for this product — are greater than 85%.
A short-term, proof-of-concept study to evaluate the preliminary efficacy and safety of a sustained-release olopatadine punctal plug delivery system for allergic conjunctivitis is expected to begin in the second half of 2010 with results expected by year-end.
Recent findings indicate that QLT has of late achieved an 81% retention rate over 90 days with the latanoprost-treated punctal plugs. That represents an improvement over the 75% retention rate achieved in earlier tests.
The company continues to refine the design of the punctal plugs to generate greater retention rates.
Research Digest
New & Noteworthy Journal Articles
Compiled by Andrew E. Mathis, PhD, Medical Editor
► Just say no. With medical marijuana having been legalized in New Jersey in January and initiatives pending in two states and the District of Columbia, the American Glaucoma Society (AGS) has issued a new position statement on the use of marijuana in treating glaucoma.
In the February 2010 issue of the Journal of Glaucoma, Henry D. Jampel, MD, Odd Fellows and Rebekahs Professor of Ophthalmology at Johns Hopkins and research committee chair for the AGS, writes that, despite conclusive evidence that marijuana has the effect of lowering IOP, the AGS cannot recommend the drug in any form for the treatment of glaucoma. Dr. Jampel cites the very short (three to four hours) duration of action of marijuana and the potentially harmful effects of smoking among the reasons for the AGS's unchanged position.
Dr. Jampel also cites inconclusive evidence in trials of drugs derived from tetrahydrocannibinol (THC), the active ingredient in marijuana, not to mention concerns among members of the AGS that marijuana use may endanger the health of the optic nerve due to THC's tendency to lower blood pressure and thus reduce the blood flow. While local administration of THC derivatives in the form of an eye drop remains a possibility for patients with glaucoma, Dr. Jampel writes, too many dangers and uncertainties still exist for the AGS to advocate marijuana use.
► More glaucoma studies. In an issue dedicated to glaucoma, the March 2010 Current Opinions in Ophthalmology presents two demographic articles — one on gender and glaucoma and the other on glaucoma in the Latino community.
The article on gender and glaucoma, authored by a team from the University of Illinois-Chicago, provides an overview of recent research on glaucoma in the light of gender differences.
For instance, recent studies have concluded that women are at higher risk for angle-closure glaucoma; however, there is also some evidence that female sex hormones may have a long-term protective effect on the optic nerve.
The authors' meta-analysis also suggests that women may be more likely to suffer vision loss from glaucoma due to greater longevity in women and generally lower socioeconomic status.
The article on glaucoma in Latinos presents data from the Los Angeles Latino Eye Study being carried out at the Doheny Eye Institute at the University of Southern California. This study examined 6,142 Mexican-American patients in the Los Angeles metropolitan area. Among the more disconcerting findings was that more than 75% of the patients identified as having open-angle glaucoma had not been previously diagnosed.
Based on this finding, the authors predict that more than 410,000 Latinos in the United States may have open-angle glaucoma, and 310,000 may have ocular hypertension.
► A pox on the eye. While the viruses of the family Herpesviridae are well known for their cutaneous complications, they present a unique challenge for ophthalmic surgeons. An article in the Winter 2010 issue of International Ophthalmology Clinics provides some guidelines from two ophthalmologists at the Massachusetts Eye and Ear Infirmary for refractive surgeons treating patients with recurrent herpes infections of the eye.
First, the authors advise careful preoperative evaluation and counseling because of the corneal scarring and irregular astigmatism common in patients with herpes infections. Use of trypan blue dye can help surgeons better visualize the corneal surface when extensive scarring is present. Furthermore, the prevalence of refractive errors in phacoemulsification of patients with herpes indicates the use of Orbscan or Pentacam topography to optimize intraocular lens calculations.
The study also considers at length the use of acyclovir, with the authors noting that prophylactic use of acyclovir for six months prior to refractive surgery may be effective in preventing recurrence during the postoperative period.
However, they also note that in patients with varicella infections of the eye, caused by the herpes virus associated with chicken pox and shingles, studies examining acyclovir are lacking, and booster vaccination may be warranted.
► Falling in low-vision patients. In what may be a surprising finding, a team of Australian ophthalmologists has found that visual function is not independently associated with falls in patients with low vision. Reporting on a study of 127 patients in the April 2010 issue of Graefe's Archive for Clinical and Experimental Ophthalmology, the authors' statistical analysis of several aspects of low vision, including visual acuity, depth perception, visual field and main cause of visual impairment, did not have a statistically significant association with falling accidents.
The one variable measured by the authors that did demonstrate a statistically significant relationship with a tendency among elderly patients to fall down was nonparticipation in physical activity. This association is believed to be due to physical activity being an indicator of mobility and musculoskeletal function, rather than a correlation between physical fitness and tendency to fall.
Despite the findings of this study, its authors stress that more than 40% of patients with low vision fall annually, even though the statistical analysis may not bear out a significant relationship. The team plans to conduct a larger study in the future that will take into account functional gait, mobility, balance and muscular strength in patients with low vision who fall.
Retina Roundup
Timely and Important Retina News of Interest to All Ophthalmologists
Compiled by Andrew E. Mathis, PhD, Medical Editor
► The coming decade in retina treatment. In an article published online on March 10 by Current Opinions in Ophthalmology, Allen Chiang, MD, and Julia Haller, MD, both of the Retina Service of the Wills Eye Institute in Philadelphia, speculate on emergent technologies in treating vitreoretinal disease in the next decade.
Among the topics addressed by Drs. Chiang and Haller are pharmacologic vitreolysis, drug-delivery innovations (including nanotechnology and sustained-release implants) and genetic therapies. They also discuss retinal prostheses in the essay.
In presenting these new technologies, the authors imply that the scope of treatable retinal diseases is set to greatly expand over the next decade. In particular, transplantation of both stem cells and prostheses for inherited retinal degenerations may promise hope for patients who were previously not able to get relief for their conditions before.
On this topic, two new technologies have received green lights for clinical trials. Icon Bioscience is testing its Verisome intravitreal insert of sustained-release triamcinolone acetonide in a phase 1 trial for cystoid macular edema. Meanwhile, Advanced Cell Technology has been granted orphan drug status by the FDA for a phase 1/2 trial that will test stem cells in the treatment of Stargardt disease. Though the Current Opinions article does not specifically mention these two technologies, Drs. Haller and Chiang do comment on corticosteroid-releasing agents and Stargardt disease therapies.
► Anti-VEGF agents in myopic CNV. Though it is similar to wet AMD, myopic choroidal neovascularization can occur in patients much younger than the typical patient with AMD. The March 2010 issue of Retina features four articles on this retinal condition. All four studies examine the use of anti-VEGF agents in myopic CNV.
The first study, conducted in France, found that intravitreal ranibizumab improved visual acuity and reduced retinal thickness in 32 eyes of 32 patients, with almost half of the patients experiencing a change in visual acuity of three lines or more. The authors said that much larger studies are needed to confirm the data.
The second article, a Portuguese study, presented data from a 12-month study of 34 eyes of 32 patients with myopic CNV treated with ranibizumab. In these patients, three-line improvers comprised 24% of eyes, with a statistically significant decrease in mean central retinal thickness, although patients that had previously undergone photodynamlc therapy (PDT) did not improve as a subgroup.
An Italian study looked at several retinal function variables in 11 patients receiving intravitreal injections of ranibizumab. Notably, this study found that all patients sustained complete resolution of subretinal fluid. Fluorescein angiography also demonstrated absence of leakage.
The last study, conducted in Japan, was the only study of significant size (128 patients) and that compared anti-VEGF therapy to PDT directly. Here, patients treated with both ranibizumab and bevacizumab and/or PDT were retrospectively reviewed. The study authors found anti-VEGF to be superior to PDT in treating myopic CNV No statistically significant differences were seen in patients treated with ranibizumab vs. bevacizumab.
► New risk for anti-VEGF? Reporting on two cases of retinal artery occlusion following treatment with ranibizumab, a team of retinal physicians speculate on whether the anti-VEGF drug caused the complication.
Writing in the March 2010 issue of Acta Ophthalmologica, the Norwegian doctors report on two patients, both with macular edema secondary to central retinal vein occlusion (RVO). In both patients, a single injection of ranibizumab was followed within one month by the occlusion.
Because of the quick onset of vision loss in both cases, the authors of the article conclude that the occlusions were not caused by the rise in IOP typically seen with intravitreal agents. The authors note the increased likelihood of thrombosis seen in the use of systemic anti-VEGF agents; furthermore, they state that, because VEGF has recently been shown to have a protective effect on vasculature, blocking VEGF may leave blood vessels susceptible to ischemia.
While the authors are reluctant to disqualify anti-VEGF agents from use in macular edema secondary to RVO, they do urge caution in using these drugs in patients with the condition.
► Pascal: more tissue-sparing. Surgeons from the Retina Foundation in Ahmedabad, India, have conducted a randomized clinical trial of standard laser vs. the multispot Pascal (pattern scan laser) of 60 patients with diabetic retinopathy finding Pascal showed less collateral damage of retinal tissue and a similar regression of retinopathy to laser, which is the current standard of care. Furthermore, treatment with Pascal was less time consuming and painful.
Reporting their results in the March 2010 issue of Retina, the surgeons found patients who were treated with Pascal had higher average retinal sensitivity in the two innermost zones than patients who eyes were treated with standard laser. Average time per sitting was one-third less (1.43 minutes vs. 4.53 minutes) with Pascal also.
Notably, there was not a statistically significant difference in visual acuity outcome between the two treatments. Furthermore, the fact that the Pascal system is not portable hampers its use in some settings. However, the authors of the study see great potential for such systems in the future. OM
In the News…■ First femtosecond cataract surgery. Stephen G. Slade, MD, of Slade & Baker Vision in Houston, has performed the first laser cataract surgery cases in the United States using a LenSx femtosecond laser. LenSx received the first femtosecond laser clearance for a cataract surgery indication in August 2009 for anterior capsulotomy, followed by a clearance for corneal incisions in December. Dr. Slade performed the surgeries in his office-based ASC in Houston. All patients were counseled and LenSx says that all cases were successfully completed with the implantation of a premium IOL. LenSx reports that 100% of the capsulotomies performed in Houston were perfectly centered and achieved diametric accuracy of ±0.25 mm. Precise corneal incisions were effectively created by the laser and all were self-sealing postoperatively. ■ B+L changes in top management. Bausch + Lomb has named Brent Saunders as its new CEO and a member of the company's board of directors. Fred Hassan, former CEO of Schering Plough, will serve as chairman of the board of directors. Current Chairman and CEO Gerald M. Ostrov is retiring and will serve as a consultant to the new leaders. Mr. Saunders was previously senior vice president and president of Schering-Plough's Consumer Healthcare unit, where he implemented a successful growth strategy including expansion into international markets. Mr. Hassan served most recently as chairman and CEO of Schering-Plough Corporation until its merger with Merck & Co. in November of last year. ■ Cataracts associated with some anti-depressants. Researchers in British Columbia have demonstrated an association between a specific class of antidepressants and cataract formation. The study, reported in the online edition of the journal Ophthalmology, included more than 200,000 Quebec residents aged 65 and older. It showed a link between antidepressant drugs classified as selective serotonin reuptake inhibitors (SSRIs) and a diagnosis of cataracts. Overall, individuals taking SSRIs were approximately 15% more likely to be diagnosed with cataracts than individuals who did not take that class of drugs. However, the incidence of cataracts was highest in the drugs Luvox (51% higher risk) and Effexor (34% higher risk). The study did not account for smoking and other risk factors for cataract that may also be present in subjects. ■ Sustained-release anti-inflammatory. Icon Bioscience, Inc., a biopharmaceutical company developing novel ophthalmic pharmaceuticals, has initi ated a phase 2/3 pivotal clinical trial to assess the safety and efficacy of a sustained-release anti-inflammatory in patients undergoing cataract surgery. The Sunnyvale, Calif., company says its IBI-10090 is based on Icon's proprietary Verisome drug-delivery platform technology, administered as a single injection in the anterior chamber and designed to last approximately two to three weeks. Icon says IBI-10090 reduces the inflammation normally associated with cataract surgery and speeds the recovery of patients without the need for multiple daily topical eye drops. The pivotal trial involves multiple clinical sites throughout the United States and will enroll more than 200 patients. ■ Setback for blepharitis study. Inspire Pharmaceutical's Azasite, which is already approved as a treatment for bacterial conjunctivitis, did not meet statistically significant endpoints in two phase 2 trials for anterior blepharitis. A four-week trial did demonstrate improvement in measured signs and symptoms compared to placebo, but a two-week trial did not. The company says it will use the data obtained from these studies to continue to develop trial parameters using Azasite as a treatment for both anterior and posterior blepharitis. ■ Inspire names new CEO. Inspire Pharmaceuticals has named Adrian Adams as President and CEO and elected him to its board of directors. Mr. Adams, 59, most recently led the growth and corporate development of two publicly traded companies. He served as president and CEO of Sepracor Inc. since 2007. Sepracor was recently acquired by Dainippon Sumitomo Pharma Co. Prior to joining Sepracor, Mr. Adams was president and CEO of Kos Pharmaceuticals, Inc. from 2002 until the acquisition of the company by Abbott Laboratories in December 2006. ■ B+L licenses glaucoma drug. France's NicOx and Bausch + Lomb announced that the companies have entered into a licensing agreement that grants B+L exclusive world wide rights to develop and commercialize NCX 116, a nitric oxide-donating prostaglandin F2-alpha analog for the treatment of glaucoma. The companies report that NCX 116 has completed two phase 2 studies in patients with glaucoma and ocular hypertension that demonstrated promising results. According to that data, the higher doses of NCX 116 demonstrated a clinically significant reduction in diurnal IOP from baseline and the highest dose showed consistently more IOP lowering than Xalatan 0.005% at all study visits and at all individual time points, suggesting a beneficial effect of nitric oxide donation. This drug was previously licensed to Pfizer, which elected not to proceed to a phase 3 trial. ■ Aton launches generic Timoptic-XE. Aton Pharma has launched an authorized generic version of its Timoptic-XE (timolol maleate ophthalmic gel forming solution). Timoptic-XE is a non-selective beta-adrenergic receptor blocking agent for treat ment of elevated IOP in patients with ocular hypertension or open-angle glaucoma. Aton also announced that it will continue to make available branded Timoptic-XE. “Authorized generics are a very effective sales strategy for Aton Pharma's product portfolio,” says Michael G. Wells, CEO of Aton Pharma. ■ Avedro in corneal-crosslinking initiative. Avedro, Inc. of Waltham, Mass., has signed a definitive agreement with Swiss-based Peschke Meditrade GmbH to acquire the rights to its phase 3 studies of corneal collagen crosslinking for the treatment of progressive keratoconus and post-LASIK ectasia. The two randomized, controlled, multi-site clinical trials are designed to assess the safety and efficacy of riboflavin/ultraviolet-A light for halting the progression of these degenerative disorders and the accompanying decline in patient's visual acuity. ■ Tecnis 1-piece multifocal OK'd. Abbott Medical Optics has received FDA approval for the Tecnis Multifocal 1-Piece IOL for cataract patients with and without presbyopia. A 3-piece Tecnis Multifocal previously received FDA approval. The lens has also received presbyopia-correcting IOL status by CMS, providing Medicare beneficiaries with the option of receiving a Tecnis Multifocal 1-Piece lens for an additional fee as part of cataract surgery. ■ New Santen USA CEO. The US subsidiary of Japan's Santen Pharmaceutical Co. has a new CEO and an expanded role. Toshiaki Nishihata, PhD, takes the reins at Santen, Inc. In Napa, Calif. He'll remain head of R&D and use that expertise to expand the company's presence In the U.S. market. Joining him as COO will be Akihlro Tsujimura, who says the moves will enable Santen to “enhance the communication between the US organization and corporate headquarters to accelerate our ability to review and act on the many exciting compounds being developed in the US market.” Dr. Nishihata takes over for Adrienne L. Graves, PhD, a 15-year veteran at Santen who orchestrated three NDA approvals for the company during her tenure; she'll stay on as a consultant. ■ Ista warned on Xibrom claims. The FDA has told Ista Pharmaceuticals that the company must cease making certain unsubstantiated claims in its sales materials for Xibrom. In a March 10 warning letter, the FDA noted unsubstantiated product superiority claims, a broadening of the approved indication, overstatement of efficacy, minimization of risk Information and misleading claims of patient preference. Ista said it will respond to the letter In the time frame specified by the FDA. ■ West Virginia ODs fail in bid to perform laser surgery. Controversial legislation that would have allowed West Virginia optometrists to perform three glaucoma-related laser procedures and give injections that do not puncture the eyeball was amended in conference after passing the state Senate. The amended bill permits no OD-performed surgery. The initial bill, which was opposed by ophthalmologists, would have required that the ODs perform these procedures after proving their ability to do so and in consultation with an ophthalmologist. The new bill was sent to Gov. Joe Manchin ■ Dr. Arnall Patz, ROP pioneer. Arnall Patz, MD, who linked high doses of oxygen given to premature infants to the disease now known as retinopathy of prematurity, has died. The former director of the Wilmer Eye Institute at Johns Hopkins University was 89. Dr. Patz also was instrumental in the development of argon laser photocoagulation treatment, which for years has been used to seal leaking blood vessels to mitgate the vision-robbing effects of macular degeneration and diabetic retinopathy. Before Dr. Patz identified the link between oxygen and ROP, premature infants were given so-called “oxygen therapy” to help them breathe. The medical community initially resisted Dr. Patz's findings. In 2004, Dr. Patz was awarded the Presidential Medal of Freedom. ■ Dry AMD drug fast-tracked. Acucela, a clinical-stage biotechnology company, announced it has received Fast Track designation from the FDA for ACU-4429, an oral therapeutic for dry AMD. ACU-4429 is currently being studied in a phase 2 clinical trial. Currently, there are no approved therapies to treat dry AMD. |