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AAO President Says NEI Funding Is Lagging
Blankenship Asks Congress for 21% Increase in Next Budget.
Noting that federal funding for the National Eye Institute (NEI) has grown only half as much as funding to the
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George Blankenship, M.D. |
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National Institutes of Health (NIH) in the last 15 years, the president of the American Academy of Ophthalmology (AAO) urged Congress to increase the NEI budget by 21% to $620 million in fiscal 2002, which begins Oct. 1.
Appearing before a House appropriations subcommittee, AAO President George Blankenship, M.D., said a 21% increase would put the NEI on a par with other NIH institutes that have benefited from Congress' 1998 pledge to double overall NIH funding by 2003.
"Americans fear blindness more than any other debilitating condition except cancer," Dr. Blankenship told the subcommittee. "As the baby boomer generation ages, this fear will become reality for many of our nation's seniors. If we don't invest in the NEI research budget, a whole generation stands to lose."
In his testimony, Dr. Blankenship pointed out the following recent advances in eye research that benefited from NEI involvement:
- development of drug and laser treatment combinations for the wet form of age-related macular degeneration (AMD)
- development of medications to prevent or slow the onset of cataracts
- improved ability to diagnose and treat glaucoma
- confirmation that blindness from diabetes can be prevented in most cases by laser therapy
- advancement in gene therapy and cell transplantation for molecular- and genetic-based eye disease.
"If more research dollars are invested, we can not only improve our understanding of the nature and course of these diseases, we can also address unmet needs in health services research," Dr. Blankenship concluded.
The subcommittee will make its medical research funding recommendations to the full House of Representatives, with a final decision to be made this summer.
Visudyne
Co-Developer Faces Lawsuits
Sales Forecast Missed Mark.
QLT, Inc. was one of Wall Street's darlings throughout most of last year.
The Canadian company, which co-developed Visudyne, a photodynamic therapy for the treatment of wet age-related macular degeneration (AMD), saw its stock hit highs of around $80 several times during 2000. However, on Dec. 14, the company announced slower-than-expected growth of Visudyne sales due to a lack of reimbursement from governmental health administration authorities, private health insurers and other third-party payers in Europe and the United States.
Though the company said it expected the issues that caused the sales shortfall to be "short-lived," the price of QLT shares fell more than 30% that day.
Since the announcement of the shortfall, about a dozen law firms have either initiated or joined in class action suits against QLT in behalf of shareholders who purchased the stock in the months prior to Dec. 14. One suit, filed by the New York City law firm of Faruqi & Faruqi, charges QLT with issuing "false and misleading" statements in press releases concerning the company's revenue and business prospects. The suit also claims that company insiders collectively sold more than 157,000 shares of QLT stock in the months prior to the warning of the sales shortfall.
QLT said it believes the claims against it are "unfounded." The company said it intends to vigorously defend itself against the litigation.
Florida Fight Focuses on Postoperative Care
Bills Seek to Require Surgeons to Provide All Follow-Up.
Florida has become a battleground state once again, but this time the issue isn't a national election -- it's who should be permitted to provide follow-up care to patients who undergo any type of ocular surgery.
On one side is the Florida Society of Ophthalmology (FSO), the Florida Medical Association, and the Florida College of Emergency Physicians, who contend that only physicians should be allowed to care for post-op patients.
On the other side is the Florida optometry community and ophthalmologists who are members of the International Society of Refractive Surgery (ISRS). They believe that well-trained optometrists have a proven track record of providing high-quality routine postoperative care, particularly for cataract and refractive surgery patients.
The battle is being fought in the Florida Legislature, where bills seek to ban nonphysicians from providing follow-up care to ocular surgery patients. The proposed legislation sailed through preliminary committee votes, but, with lobbying efforts intensifying, final passage later this month is in doubt.
Steve Hull, FSO lobbyist and public relations director, says the legislation was introduced after Florida emergency room physicians complained that they're being overburdened by co-managed postoperative ocular surgery patients who experience complications and wind up seeking help in hospitals.
Ken Franklin, executive director of the Florida Optometric Association, contends that assertion is false.
"We've surveyed emergency rooms across the state and see no evidence of patients who are being dumped after eye surgery," says Franklin. "If there's an issue here, it's with those few ophthalmologists who practice bad medicine and then abandon their patients."
And Jeffrey B. Robin, M.D., executive vice president of ISRS and a refractive surgeon practicing in Orlando, Fla., says: "I don't know of a refractive or cataract surgeon who supports this legislation. We've found no evidence of substandard patient care or patient harm related to co-management."
If the law passes, Florida ophthalmologists who hand off their surgical cases to nonphysicians for follow-up will be subject to disciplinary action.
Missouri Co-Management Bill Is Stalled
Negotiations with Optometrists May Continue.
An attempt by the Missouri Society of Eye Physicians & Surgeons (MOSEPS) to legally regulate co-management lost momentum in the Missouri legislature after the Missouri Optometric Association (MOA) announced its opposition to the proposed legislation.
"We spent a great deal of time with MOA representatives negotiating the final language for the bill and we thought we had an agreement," says Rich Paul, MOSEPS executive director. "I was very surprised when the MOA board decided not to support the bill."
"The MOA believes that the standards for co-management don't belong in statute," says LeeAnn Barrett, O.D., president of the MOA. "We feel the rules to regulate co-management can be set by the governing boards of the professional organizations. We're always willing to talk with MOSEPS."
Paul says the legislation was introduced after MOSEPS members asked for legal standards to govern co-management arrangements.
"The bill we presented is derived from the co-management standards recommended by the major ophthalmological organizations and the federal government," says Paul. "These guidelines form an ethical foundation for co-management. For doctors who are already following these standards, nothing needs to be changed."
agement on a case-by-case basis, and only when the patient decides that the arrangement is in his own best interest. It requires full disclosure to the patient of the proposed co-management arrangement and the patient's signature on an informed consent agreement. The co-managing doctors must establish a written protocol for each co-managed patient, describing each doctor's role in that patient's care. In addition, the doctors must communicate regularly regarding the patient's care and progress, and each doctor can only be compensated for the value of the care provided to the co-managed patient.
IN THE NEWS
- Bankruptcy declared. KeraVision Inc., the manufacturer of Intacs prescription inserts for myopia, has filed for bankruptcy. The company, which conducted limited operations in recent months, intends to auction its inventory, equipment and intellectual property within the next 2 months.
- Trademark battle. Pharmacia has filed a trademark infringement suit against Alcon, claiming that Alcon's new glaucoma drug, Travatan, has a name that could be confused with Pharmacia's Xalatan. Alcon said the suit had no factual basis.
- Medical records privacy. The Bush administration announced it will move ahead and implement federal rules to ensure the privacy of patient medical records. The rules are scheduled to go into effect in April 2003, but some softening of the original strict standards is expected.
- STAAR report. Slow growth in key product lines will probably cause STAAR Surgical Company to report no better than break-even financial results in 2001, according to David Bailey, the company's new president.
- Ophthalmologists prevail. The Georgia state legislature defeated a bill that would have allowed optometrists to prescribe all oral drugs, as well as controlled substances. The American Academy of Ophthalmology and the Georgia Society of Ophthalmology opposed the bill.
- Acquisition completed. Luxottica announced that it has completed the $653 million acquisition of sunglass retailer Sunglass Hut. Stockholders of Sunglass Hut received $11.50 a share in cash.
- "No rub" approval. Allergan's Complete brand multipurpose solution for cleaning and disinfecting soft contact lenses has been approved for "no rub" application by the FDA.
New Mexico Begins Online Vision Testing for Drivers
VisionRx System Will Be Used Statewide.
Because state motor vehicle departments are burdened by numerous administrative tasks, millions of drivers -- including many over the age of 65 -- have their driver's licenses renewed repeatedly without ever being required to take a vision test.
However, New Mexico has taken a step toward more frequent vision testing for motorists.
By partnering with VisionRx, a New York-based vision test software company, the New Mexico Motor Vehicle Division is now conducting comprehensive online eye testing in seven field offices set up for that purpose. The system is scheduled to be implemented statewide this summer. "We can now do vision testing we were never able to do before," says Gordon Eden, director of New Mexico's Motor Vehicle Division. "This gives us a means to promote safer driving."
The VisionRx system is a Web-based, clinical-grade software program specifically designed for use by motor vehicle departments. Proprietary VisionRx technology generates a set of self-administered tests that evaluate visual acuity (distance vision), visual field, contrast sensitivity and color vision. Test sequences are randomized, offering no opportunities to cheat.
"All of our tests have been reviewed by ophthalmologists and are comparable to the tests they use in their own practices," says James Laux of VisionRx.
"It's very simple for anyone to take the test on a computer terminal," concludes Eden. "We get the results immediately, which is important to me both as a motor vehicle director and as a person who wears corrective lenses."
Glaucoma Patients Know Little About Their Disease
A Survey Illustrates the Need for More Patient Education.
A recent nationwide telephone survey of more than 1,400 long-term glaucoma patients age 45 or older shows that a large majority couldn't name the major risk factors for the diseases or identify the type of glaucoma they have.
For example, only 12.5% of survey respondents knew that a family history of glaucoma is an important risk factor, and only 10.1% correctly identified diabetics as at-risk for glaucoma.
Among the other survey results:
- less than 5% knew that African-Americans are six to eight times more likely to get the disease than Caucasians
- only 21.4% were aware that the risk for glaucoma increases greatly with age
- only 25.4% could identify the type of glaucoma they have
- more than 40% weren't familiar with the term IOP (intraocular pressure)
- 50% of respondents knew the association of high IOP with glaucoma, but 80% didn't know the IOP danger level.
"I'm disappointed but not surprised by these results. Glaucoma is a very complicated disease," says Richard Lewis, M.D., president of the American Glaucoma Society. "It's especially alarming that such a small percentage of individuals with glaucoma know that the disease runs in families -- because people with glaucoma can educate family members about the risks for this disease, and urge them to have regular eye exams."
Dr. Lewis says the survey results indicate a need for more and better glaucoma education, particularly with older people and African-Americans.
"Brochures and videos are fine, but they don't click with everyone," says Dr. Lewis. "A celebrity spokesperson who has the disease can often make a bigger impact on public awareness."
The survey was commissioned by Pharmacia Corporation, manufacturer of the glaucoma medication Xalatan.
REFRACTIVE SURGERY UPDATE
- Out of business. Icon Laser Eye Centers has shut down operations at all 28 of its recently acquired Lasik Vision laser vision correction centers and placed its Lasik Vision subsidiary into bankruptcy. The action came after Lasik Vision found itself unable to meet payroll obligations. Icon said it's making arrangements to treat hundreds of former Lasik Vision patients at Icon centers, but there were numerous complaints from inconvenienced patients.
- Vision America. Memphis-based Vision America, which operates laser vision correction centers under joint venture agreements, has filed for bankruptcy.
- ClearVision center. ClearVision, the largest privately owned laser vision correction provider in the United States, has opened a new center in Bellevue, Wash.
- Presbyopia patent. The U.S. Patent and Trademark Office has confirmed SurgiLight Inc.'s rights under the company's "609" patent to develop a new laser technology for the correction of presbyopia. The patent covers a broad range of laser spectra, from ultraviolet to infrared.
- Increased pricing. LCA-Vision says its value-priced LasikPlus laser vision correction centers realized an average price per procedure of $902 during the first 3 months of this year, compared to $877 in the fourth quarter of 2000. The centers performed a total of 25,061 procedures in the first quarter of this year, compared to 12,504 during the same period a year ago.
- Buyout offer. Financier Carl Icahn, who already owns 10.5% of VISX stock, has offered to buy the entire company for about $1.9 billion, or $32 a share. Icahn, who has been urging VISX management to sell the company to a large ophthalmic or pharmaceutical firm, said he hopes his bid starts an auction process for VISX.