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News
AAO Advocacy Group Holds First Formal Meeting
Early this year, the American Academy of Ophthalmology (AAO) held the first formal meeting of the Ophthalmic Advocacy Leadership Group (OALG) in Baltimore. The OALG, which is made up of leaders from the ophthalmologic subspecialty societies, met to address pressing advocacy issues such as battles over scope of practice, the development of a patient outcomes registry, and Medicare reimbursement.
Cataract & Refractive Surgery Today interviewed Cynthia Bradford, MD, the AAO's senior secretary for advocacy, to learn more about the mission of the OALG as well as the group's plans for attending to these pertinent issues.
"The mission of the OALG is to get the ophthalmologic subspecialty groups' input so that all of ophthalmology is working together when advocating for causes in Washington, DC," said Dr. Bradford, a professor of ophthalmology at the University of Oklahoma. "It is about joining together so that our voices are heard on the federal and state levels."
One of the most important issues that the OALG is currently addressing at the state level is the movement to allow optometrists to perform certain surgical procedures. The American Medical Association (Policy H-475.986) states, "Only licensed physicians with appropriate education, training, experience, and demonstrated current competence should perform surgical procedures." This is the OALG's position as well.
Dr. Bradford is a resident of Oklahoma, the first and only state to allow optometrists to perform laser surgery. In an effort to pass similar legislation in other states, optometrists from Oklahoma are traveling to state legislatures and testifying that they have encounterd no significant complaints from patients or complications, Dr. Bradford explained to CRSToday. Thus far, Oklahoma-based optometrists have reportedly visited West Virginia, North Dakota, South Carolina, and Idaho.
"The OALG wants all ophthalmologists to understand that state statutes define what ophthalmologists and optometrists can do. If we are legislatively active, we can advocate for why ophthalmologists are qualified to perform laser surgery and other highly complex surgeries and why optometrists are not, " Dr. Bradford stressed.
At the federal level, the OALG is tasked with tackling two critical issues: a data registry and Medicare reimbursement. A workgroup from each subspecialty society is evaluating the most effective way to document patient outcomes, complications, and visual outcomes as well as identify cases with a higher risk and complication rate. In a news release, H. Dunbar Hoskins, Jr, MD, executive vice president and chief executive office of the AAO, said that the American Society of Cataract and Refractive Surgery has agreed to join and support this effort.
To address the 5-year review process for reimbursement codes, the OALG has solicited go-to physicians from each subspecialty society to learn the issues and work with the AAO's Health Policy Committee. "When a reimbursement issue arises for a particular procedure, the go-to physician from the appropriate subspecialty group can work with his society to provide the information needed and ensure proper reimbursement takes place," Dr. Bradford explained.
These three advocacy issues will take time and persistence to achieve, Dr. Bradford said. The OALG plans to meet formally again in 2010.
Revised Sunshine Act Stipulates Strict Disclosure Policy
Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) introduced a revised and more stringent Physician Payments Sunshine Act to Congress, according to a news release. If passed, the legislation would require manufacturers and group purchasing organizations to disclose all payments or transfers of value to physicians worth $100 or more.
Under the revised bill, group purchasing organizations or manufacturers that fail to report payments can be fined between $1,000 and $10,000 per infraction, up to a total fine of $150,000 per company per year when failure to report is deemed an oversight. For "knowing failure to report," companies can be penalized up to $1 million.
"The efforts of Senators Grassley and Kohl along with AdvaMed and Pharma protocols are in line with the latest efforts to increase transparency and provide clear and undeniable disclosure of conflicts of interest," John F. Doane, MD, wrote in an e-mail to Cataract & Refractive Surgery Today. Dr. Doane is in private practice with Discover Vision Centers in Kansas City, Missouri, and he is a clinical assistant professor of ophthalmology at Kansas University Medical Center. "The more transparent, the better the transfer of information is for all parties."
Beginning in April 2011, the revised bill will require companies to report payments and other transfers of value for consulting fees, honoraria, gifts, entertainment, food, travel, education, research, charitable contributions, royalty or licensing fees, current or prospective ownership or investment interests, continuing medical education speaker fees and grants, and compensation for other services. When payments are related to marketing, education, or research specific to a covered drug, device, biological, or medical supply, the company will be required to supply that information and the name of the therapy. Furthermore, the legislation will not preempt state laws from demanding further disclosure.
The secretary of the Department of Health and Human Services will be required to establish a disclosure procedure for companies. The legislation includes a clause allowing companies to delay reporting for up to 2 years of payments for clinical investigations or product development agreements regarding new drugs, devices, biologics, and medical supplies.
William L. Rich III, MD, the American Academy of Ophthalmology's medical director of health policy and a senior partner at Northern Virginia Ophthalmology Associates in Falls Church, Virginia, told CRSToday that the Sunshine Bill would not be the last that we hear of legislation on disclosures. "There will be ongoing scrutiny of both doctors and industry to ensure transparency in physicians' decision making when it comes to prescribing medications or choosing a device."
In related but separate news, Pfizer Inc. (New York, NY) plans to disclose the sizeable payments it makes to health care professionals who serve as its consultants, speakers, and clinical investigators. According to a news release from the biopharmaceutical company, this policy will apply to any practicing health care worker who prescribes drugs, major institutions hosting ongoing trials, and principal investigators involved in phase 1 to phase 4 clinical trials "whose aggregate [compensation] exceeds $500 in a calendar year, including the value of nonmonetary items, such as [a] meal, that exceed[s] $25 in value."
Pfizer will publish its first annual report of disbursements on its Web site early in 2010. The listing will include the names of the individuals and institutions that received payments from the company, the services provided by the recipients, and the amount paid since July 1, 2009.
Ista Updates Ophthalmic Pipeline
Ista Pharmaceuticals, Inc. (Irvine, CA), announced that the FDA will review the company's New Drug Application for Bepreve (bepotastine ophthalmic solution). Ista is seeking approval to market an ophthalmic solution of the histamine-1 receptor antagonist for the treatment of ocular itching associated with allergic conjunctivitis.
According to a news release, Bepreve statistically significantly reduced ocular itching in patients who received the drug during phase 3 clinical studies. In addition, Bepreve reportedly had a statistically significant effect on the rapidity of response, and the agent improved other symptoms associated with ocular allergy. Patients who received Bepreve reported no serious adverse ocular effects.
Ista has also released the results of a phase 2b clinical trial of ecabet sodium for the treatment dry eye disease. According to the news release, ecabet sodium increases the quantity of mucin produced by conjunctival goblet cells and corneal epithelia.
The investigators randomized 144 patients to use ecabet sodium or a placebo four times daily for 43 days. At the end of the study, ecabet sodium reportedly nearly had a statistically significantly positive effect on basal tear secretion (as measured by unanesthetized Schirmer testing) compared with placebo. Patients began to show increased tear production by the 22nd day of treatment, and this response demonstrated an upward trend through day 43.
Abbott and AMO Sign Acquisition Agreement
Abbott (Abbott Park, IL) and Advanced Medical Optics, Inc. (AMO; Santa Ana, CA), signed a definitive agreement for Abbott to acquire AMO for $22 per share in cash to equal a total value of approximately $2.8 billion. This amount includes the estimated net debt at the time of closing, which is expected to occur during the first quarter.
Jim Mazzo, AMO's chairman and chief executive officer, will remain with Abbott as the president of AMO. "Joining forces with Abbott will fortify our position as a global ophthalmic medical device leader and enhance our ability to serve eye care practitioners and patients around the world," Mr. Mazzo said in a news release.
According to John M. Capek, Abbott's executive vice president, medical devices, advances in refractive surgery technologies and an aging global population will sustain long-term growth. "With AMO, Abbott will immediately become a global leader in vision," he said.
Phase 1 Trial of Voclosporin-Based Dry Eye Drug Underway
Lux Biosciences, Inc. (Jersey City, NJ), began a phase 1 study to evaluate the safety and tolerability of LX214 for the treatment of dry eye syndrome and other chronic inflammatory ocular surface diseases. LX214 is a topical, clear, aqueous, mixed micellar formulation that contains a high concentration of voclosporin. According to the company, preliminary testing found that LX214 does not cause irritation and requires only once-daily dosing. LX214 is licensed for ophthalmic indications from Isotechnika Inc. (Edmonton, Alberta, Canada). Lux filed for a patent for the formulation in 2007.
Pharmaceutical Companies to Merge
Pfizer Inc. (New York, NY), announced that it will acquire Wyeth (Madison, NJ) for $50.19 per share in a transaction totaling approximately $68 billion. A joint news release from the companies stated that the transaction will be financed through a combination of cash, debt, and stock. A consortium of banks has provided commitments for a total of $22.5 billion in debt.
The Philadelphia Inquirer reported that the merger will help Pfizer replace the approximately $13 billion in revenue it will lose when the patent on its cholesterol-lowering drug Lipitor (atorvastatin calcium) expires in 2011.1 The merger is also expected to bring big job cuts at the combined company (approximately 19,500 jobs over the next 3 years) and may also lead to the closure of Wyeth's corporate headquarters in New Jersey.2
UK Researchers Use Intense X-rays to Map the Cornea
Specially tuned x-rays revealed that a keratoconic cornea does not possess the highly specific fibrous collagen arrangement found in healthy corneas, according to a news release.
Professor Keith Meek, head of the Structural Biophysics Research Group at Cardiff University in the United Kingdom, and colleagues used intense pinpoint beams of synchrotron light x-rays (Diamond Light Source, Oxfordshire, United Kingdom) to map the orientation and thickness of collagen in corneas with and without keratoconus.
The investigators believe that the lack of fibrous collagen arrangements signal the progression of keratoconus and the condition's characteristic conical shape. Furthermore, because the cornea usually has a precise curvature, light passing through a keratoconic cornea is not refracted properly, and therefore the patient's vision is affected.
Synchrotron light x-rays are approximately 100 billion times brighter than those found at a standard hospital, or 10 billion times brighter than the sun, according to Diamond Light Source. Thus, a single cornea can be scanned in just a few hours compared with months using a conventional laboratory source.
"The significance of this research is that with a greater understanding of the structure of the cornea at the molecular level, we are able to suggest methods for improving corneal surgery by increasing our understanding of how physical disruption of the cornea's structure can lead to refractive changes," Professor Meek said in a news release from Diamond Light Source. "Another aspect to the research is that, due to the fact that in many parts of the world the demand for donor corneas far outstrips the supply, the need to develop an artificial cornea has increased. Within a few years, the work will be at a stage where it can feed into the development of artificial biological corneal constructs that mimic the remarkable natural properties of this extraordinary tissue."
Singapore Malay Study Identifies Central Corneal Thickness-Associated Factors
A population-based cross-sectional report from the Singapore Malay Eye Study found that several ocular and systemic factors are associated with central corneal thickness (CCT).1 Investigators used ultrasound pachymetry to measure the CCT of 3,239 individuals aged 40 to 80 years. The mean CCT of patients' right eyes was 541.2 µm. After controlling for age and gender, investigators found CCT was greater in individuals with a higher body mass index (P=.038), greater IOP (P<.001), greater axial length (P=.005), and a greater radius of corneal curvature (P<.001). Patients with systemic conditions, like chronic kidney disease (P=.012) and metabolic syndrome (P<.001), also had greater CCTs.
Phaco Technique Yields Greater Visual Recovery
The rock 'n' roll phaco technique is a safe and fast procedure that reduces ultrasound time by up to 30%, according to a study presented at the European Society of Cataract and Refractive Surgeons Winter Meeting.1
Detlef Uthoff, MD, of Eye Hospital Bellevue in Kiel, Germany, developed the rock 'n' roll technique in 1999. "This is my favorite technique for both mono- and bimanual phacoemulsification," Dr. Utoff said at his lecture during the meeting. "It is characterized by primarily fragmenting or sculpting the nucleus, which is then nudged 180¼ and rotated along its sagittal axis with the help of the phacoemulsification tip. This key step reminds me of rock and roll when dancers throw themselves over each other's shoulders. Next, the nucleus is stabilized by a spatula and then emulsified from its posterior side. During emulsification, the nucleus is held under the iris with a spatula."
The rock 'n roll phaco procedure leads to a greater recovery of vision compared with other techniques, Dr. Utoff stated. He said a learning curve of approximately 100 surgeries is needed to master the technique.
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