Small Practices Slow to Adopt EMR
Initial Costs are High but New Incentives Could Help.
BY JERRY HELZNER, SENIOR EDITOR
■ Despite the efficiency and convenience offered by today's improved electronic medical records (EMR) systems, fewer than 20% of US doctors are using EMR as part of their everyday routine.
Although more than half of the physicians working in large practices (50 or more doctors) are now using EMR, adoption is moving much more slowly in smaller practices (1 to 3 doctors) where fewer than 9% have implemented computerized records. Because of their specialized nature, most retina-only practices tend to be relatively small.
The findings are from a national survey of more than 2600 physicians undertaken by the US Department of Health and Human Services. The survey results were reported recently in the online edition of the New England Journal of Medicine.
Physicians in smaller practices cite the approximately $15,000 to $20,000 per doctor initial cost of EMR implementation as a major obstacle to adoption. They also fear that the conversion from paper to computer records will disrupt their practices and cause them to see fewer patients.
Because wider adoption of EMR will create efficiencies throughout the entire spectrum of the healthcare community, the federal government is now moving to assist smaller practices in making the conversion. A new Medicare pilot program will initially help 1200 physicians nationwide convert to EMR by offering increased-payment incentives of up to $58,000 per doctor over a 5-year EMR implementation period
In another government nudge toward wider EMR adoption, the Medicare pay-for-performance (P4P) program, offering small bonuses to practices that are able to accurately report on specific measures of patient care, is now in its second year. Practices that have EMR are in a better position to collect this data than those that do not have computerized records.
The good news for expanded future adoption of electronic records is that the great majority of those physicians now using them say the systems are helpful in improving their practice of medicine. More than 80% of these doctors cite EMR for improving the quality of clinical decisions, avoiding medication errors, and assisting in the delivery of preventive care.
OPKO: Bevasiranib Reaches Target Cells
Data Support Wet AMD Treatment.
■ OPKO Health Inc. said that a study recently published in the peer-reviewed journal Molecular Vision demonstrates that bevasiranib, its small interfering RNA (siRNA) agent for the treatment of wet AMD, is distributed throughout the eye, including extensive uptake into the retina.
In 2 tissue-distribution and pharmacokinetic studies in rabbits, results showed that bevasiranib was present in the retina and in targeted retinal pigment epithelium (RPE) cells following intravitreal injection. Bevasiranib is a gene-silencing agent designed to shut down the production of vascular endothelial growth factor (VEGF), a primary cause of neovascularization associated with the wet form of AMD. The efficacy and safety of bevasiranib are currently being assessed in the COBALT study, an international phase 3 trial.
"Importantly, these data indicate that following intravitreal injection, bevasiranib distributes to the ocular structures relevant to the VEGF-induced neovascularization associated with vision loss in wet AMD, and we believe these animal data provide support for the use of bevasiranib in our ongoing pivotal phase 3 trial for the treatment of wet AMD," said Samuel Reich, executive vice president of OPKO Ophthalmics. "It is noteworthy that bevasiranib was distributed to the RPE cells, since we believe that even a fraction of the tissue-associated bevasiranib entering the RPE cell is likely to be effective in specifically suppressing VEGF production."
Alcon Sale: All Parties Will Benefit
Deal Should Be Completed in 2010.
BY JERRY HELZNER, SENIOR EDITOR
■ When the huge Swiss food company Nestlé decided that its highly profitable long-term investment in eyecare leader Alcon was not a part of its strategic plans, it set into motion a sequence of events that should ultimately benefit Nestlé, Alcon, and pharmaceutical giant Novartis, which now intends to purchase Alcon in a 2-step transaction.
Nestlé recently announced that it is selling a 24.85% stake in the eyecare company to Novartis for $11 billion. Nestlé is also giving the diversified pharmaceutical company an option to purchase its remaining 52% of Alcon for approximately $28 billion in 2010. The deal is subject to regulatory approval.
With the billions it will realize from the sale of Alcon, Nestlé can pay off debt, buy its own shares, and expand its already considerable presence in packaged food. Nestlé's packaged food portfolio already includes such brands as Nescafé coffee, Perrier water, Stouffer's frozen foods, Purina pet foods, and Baby Ruth candy bars.
A large stake in Alcon will allow Novartis to expand its presence in the high-growth eyecare area, where the company already has the CIBA Vision contact lens business and international rights to 2 drugs for the treatment of wet AMD, Lucentis and Visudyne.
Having a parent company with an established presence in eye care should help Alcon, as well.
"Eye care will continue to grow dynamically, as there is a growing unmet medical need driven primarily by the world's aging population," said Novartis CEO Daniel L. Vasella, MD, "The margins are higher than those in our pharma business and are obviously very attractive."
Nestlé purchased Alcon in 1977 when Alcon had only about $80 million in annual sales. Over the years, Nestlé has allowed Alcon management to operate in a relatively independent manner under the Nestlé umbrella, probably because Nestlé senior management was made up of "food people" who understood that they didn't possess the specialized knowledge required to build a major vision care business.
Meeting Focuses on Artificial Vision
"The Eye and the Chip" Held in Detroit.
■ The world's most well-attended congress related to visual neuroprosthetic device development was held for 3 days in mid-June in Detroit.
The fifth "Eye and The Chip" meeting brought together 34 of the world's leading authorities on artificial vision, co-organized by Joseph Rizzo, MD, of the Harvard Medical School, and Philip Hessburg, MD, of the Detroit Institute of Ophthalmology.
The field of visual devices for the blind and those afflicted with vision-robbing retinal diseases, such as retinitis pigmentosa, has grown, perhaps exponentially, over the past decade. Dr. Rizzo points out that 10 years ago he and Dr. Hessburg had difficulty putting together a full panel for the first congress. Today, however, the every-other-year meeting is accepted as the "gold standard" for those interested in the field.
The Detroit Institute of Ophthalmology has in its database pertinent papers, presentations, and manuscripts from at least 52 major programs in 19 countries. These programs list more than 200 cooperating institutions, corporations, governmental bodies, and academic departments, suggesting that there is now a critical mass of investigators working in the field.
Virtually all of the major research programs presented at the "Chip" congress. Of special interest was a presentation by Bernard Lepri, OD, MS, MEd, of the Food and Drug Administration (FDA), titled "Is Visual Acuity Enough?" Dr. Lepri described a many-pronged algorithm around which a template can be constructed to assist groups seeking regulatory approval for artificial vision devices. The talk included Dr. Lepri's thoughts about visual acuity, visual fields, and contrast sensitivity, coupled with functional effectiveness, quality-of-life assessment, and patient-reported outcome measures. The final template will ultimately be created by a yet-to-be-named committee of advisors to the FDA.
Phil Troy, PhD, of the Illinois Institute of Technology, offered an insightful and challenging review of the ethics of device development, testing, implantation, evaluation, volunteer recruitment, informed consent, and long-term (decades not months) follow-up for implanting organizations. The discussion periods, a highlight of "Eye and The Chip" congresses on artificial vision, were spirited.
Reviews of all of the major groups implanting experimental devices in humans, as well as in pigs, sheep, cats, rats, and monkeys were presented, representing numerous initiatives in the United States, Korea, Australia, England, Germany, Spain, China, and Japan.
The meeting validated the fact that investigators are now working on artificial vision all over the world. What remains unclear, however, is which materials to use (silicon, iridium, gold, polyimide, platinum, titanium nitride, parylene), where the implants should be placed (epiretinal, subretinal, suprachoroidal, cortical, optic nerve), and whether these implants should be smooth, penetrating, or micro-electrode-laden with multiple electrical contact points.
All of the sessions were recorded in high definition by the Thornton Group of Dallas, Texas. The set of 11 DVDs is available at (313)-824-4710, or at www.EyesOn.org for $750.
The next "Eye and the Chip" Congress will be held in Detroit in June 2010. Those interested in artificial vision, or the related car show EyesOnDesign, presented at the same time, should mark their calendars.
|■ OSI to sell Macugen franchise. OSI Pharmaceuticals said that it has a potential buyer for its wet AMD treatment Macugen and that a deal could be announced this summer. Macugen got off to a strong start after FDA approval in late 2004, but was soon surpassed by Genentech's Lucentis, which is more effective in the vast majority of patients.|
OSI is carrying Macugen on its books as a discontinued operation and has incurred significant losses in supporting the drug. In the first quarter of 2008, OSI lost $2.4 million in supporting the Macugen franchise.
Macugen was originally developed and commercialized by Eyetech Pharmaceuticals and its marketing partner Pfizer. OSI bought Eyetech in 2005.
■ Allergan retina drug approved. Allergan Inc. said that the FDA has approved Trivaris (triamcinolone acetonide injectable suspension) 80 mg/mL, a synthetic glucocorticoid corticosteroid with anti-inflammatory action. Delivered via intravitreal injection, Trivaris is indicated for sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
"Retinal diseases are currently the leading cause of blindness in developed countries and represent a significant unmet need in eye care," said Scott Whitcup, MD, Allergan's executive vice president, Research and Development. "Trivaris marks the first approval for Allergan resulting from our strategic focus on the development of therapies for back-of-the-eye diseases, and we remain committed to bringing forth innovative new treatments for patients suffering from retinal diseases."
In the May 2008 issue of Retinal Physician, 2 errors require clarification. First, in the article "Intraocular lens implantation from the vitreoretinal perspective" by Annie C. Lee, MD, and Sharon Fekrat, MD, FACS, figures 2 and 3 are incorrectly placed and should have been reversed. Second, in "Endophthalmitis prophylaxis for intravitreal injections" by Ingrid U. Scott, MD, MPH, and Harry W. Flynn, Jr., MD, an incorrect percentage was provided. Where the article reads "2 of 277 (0.07%)," the correct percentage would be 0.007%. Retinal Physician's editors regret these errors.
■ Santen/MacuSight collaboration. Santen Pharmaceutical Co. Ltd., and MacuSight Inc. have entered into a research and development collaboration and license agreement for the development and commercialization of sirolimus in Japan and Asia for the treatment of ocular diseases and conditions, including wet AMD and diabetic macular edema (DME). Sirolimus, originally known as rapamycin, is a highly potent, broad-acting compound designed to combat a broad range of diseases and conditions. MacuSight is currently initiating a phase 2 clinical trial of sirolimus in DME, and preparing to initiate a phase 2 study in wet AMD in the second half of 2008.
Under the terms of the agreement, Santen receives the rights to develop and commercialize sirolimus for ocular diseases and conditions in Japan and Asia. RP