AMO/Visx has discontinued installation of the latest version of its Wavescan software and recalled the software from the 150 sites that had received it. The 3.9/3.901 software was approved this year for CustomVue monovision treatments and featured a number of improvements including chromatic aberration adjustments and others. Users will not have to return Wavescan units, but will receive a software upgrade in 2009.

The company declined interview requests but explained that the problem came to light as a result of one case and involved the surgeon's decision to override the system's recommended treatment approach.

Marc Odrich, MD, medical director, explains, "When the Wavefront software generates treatments, we're very careful to ask that the exams be clustered, so they're representative of the patients' refraction and their overall aberrometry. It was an error in the creation of one of the exams that a doctor chose to use for a patient. He selected an exam that our software would not have clustered and did not cluster. So he went outside of our recommendation. We teach that you should use your cluster, let the software determine the four or five suitably similar exams that are representative, and we think you should use this one. The doctor can always override that. However, there may be exams that are not suitably similar. The machine doesn't throw those away. It keeps them because, occasionally such as in a retreatment, one of those not-suitably-similar exams may be useful."

Lou Probst, MD, is medical director for TLC, The Laser Center, which had eight sites using the new software. He estimates some 500 patients received treatments with the software, without any complications. In fact, after analyzing the results, he reports that the rate of cases achieving 20/20 actually rose 8 percent and showed a significant increase in the intended versus achieved refraction.

Dr. Odrich believes the company is simply exercising caution. "It's a safety issue," he says. "If your software can miscreate a treatment even if the doctor is using it differently from the way we intended it to be used, it's still a miscreation; it should still create a treatment that should be safe for the patient. We don't think that's what happened. There will be a review of the way the software treatments are created to try to eliminate that possibility." His experience with 50 to 60 patients treated with the new software produced no unexpected outcomes.

The company is upgrading the software and expects to have a replacement available in 2009.

Economy, Lack of Insurance Affecting Health Choices

A flurry of reports released last month reflect grim times for health care in a faltering U.S. economy.

In the first, researchers affiliated with the Cambridge Health Alliance/Harvard Medical School reported in the August 5 issue of Annals of Internal Medicine their conclusion that millions of U.S. working-age adults with chronic conditions do not have insurance and have poorer access to medical care than their insured counterparts.

The cross-sectional, population-based survey used self-reported insurance and disease status data from the National Health and Nutritional Examination Survey (1999–2004) and included 12,486 patients age 18 to 64 years.

On the basis of NHANES responses, an estimated 11.4 million working-age Americans with chronic conditions were uninsured, including 16.1 percent of the 7.8 million with cardiovascular disease, 15.5 percent of the 38.2 million with hypertension, and 16.6 percent of the 8.5 million with diabetes. After the authors controlled for age, sex, and race or ethnicity, chronically ill patients without insurance were more likely than those with coverage to have not visited a health professional (22.6 percent vs. 6.2 percent) and to not have a standard site for care (26.1 percent vs. 6.2 percent) but more likely to identify their standard site for care as an emergency department (7.1 percent vs. 1.1 percent) (p<0.001 for all comparisons).

The authors note that although many Americans lack health insurance, some policymakers claim that persons without insurance are largely healthy. However, the rates of chronic illness among those without insurance have not been well-documented. Using data from the National Health and Nutrition Examination Survey, the study estimates that more than 11 million working-age Americans with cardiovascular disease, hypertension, diabetes, dyslipidemia, obstructive lung disease or previous cancer do not have health insurance.

On the basis of the responses from NHANES, lead author Andrew P. Wilper, MD, MPH, and colleagues estimated that 20.8 percent of nonelderly adults in the United States did not have insurance (36.4 million), a figure consistent with estimates from the U.S. Census Bureau. Among those reporting insurance coverage, 87.9 percent were covered by private insurance, 3.2 percent by Medicare, 6.7 percent by Medicaid or Children"s Health Insurance Program, and 4.9 percent by other government insurance.

After sex, race or ethnicity, and age were controlled for, chronically ill persons without insurance were more likely than those with insurance to have not visited a health professional in the past year (22.6 percent vs. 6.2 percent) and to not have a standard site for care (26.1 percent vs. 6.2 percent) but more likely to identify a standard site for care as an emergency department (7.1 percent vs. 1.1 percent). Further adjustment for income did not alter these findings.

"The decreasing size of many U.S. companies, the increasing role of service sector jobs, and the decline in manufacturing jobs have steadily eroded employer-sponsored coverage," the authors write. "Increasing premiums discourage companies from offering coverage; discourage uptake among workers required to pay a share of premium costs; and make insurance particularly unaffordable for self-employed persons, especially if they have a chronic illness."

The reality may actually be worse. "Our results, the authors say, "probably underestimate the health problems of persons without insurance because those without insurance are less likely to be aware of their illnesses. We could not analyze depression or other chronic mental health conditions because NHANES does not query participants about them."

In a second report, the Kaiser Family Foundation Kaiser Health Tracking Poll: Election 2008 finds that one in four (24 percent) Americans continues to struggle with paying for health care. Health care ranks as a "serious problem,"above paying for food (18 percent), problems with debt (16 percent), and paying the rent or mortgage (15 percent) and below paying for gas (37 percent) or getting a good-paying job or raise in pay (26 percent).

Among the 24 percent that find paying for health care or health insurance a serious problem, those in the poorest health and those with the most need disproportionately report difficulties.

• Half (50 percent) of the uninsured say paying for health care is a serious problem.

 • About four in 10 of those with annual household incomes under $30,000 (42 percent), those living with someone who requires care (42 percent), those who report their physical health as "fair" or "poor" (40 percent), and the unemployed (37 percent) also report struggling with the cost of health care.

 • Members of two minority groups, Hispanics (39 percent) and African Americans (35 percent), indicate disproportionate problems paying for care.

 • Three in ten of those with two or more hospital overnight stays (31 percent) and two or more emergency room visits (30 percent) in the past year also report problems paying for care.

Finally, a national insurance association finds that in order to save money, many Americans are cutting back on medical care. A national survey of 686 consumers, conducted in July on behalf of the National Association of Insurance Commissioners, found that 22 percent of U.S. consumers say they have reduced the number of times they see the doctor as a result of today's economy. Further, 11 percent of consumers say they have cut back the number of prescription drugs they take or the dosage of those medications to make the prescription last longer.

"Delaying medical treatment and regular physicals puts consumers at risk for potential health issues—and increases overall health insurance costs," said NAIC President and Kansas Insurance Commissioner Sandy Praeger. "It's critical that consumers continue to take responsibility for their health, so that we can all benefit from healthier lives and more affordable health care."


NICE Cites Lucentis As Cost-effective

's National Institute for Health and Clinical Excellence (NICE) has recommended Lucentis (ranibizumab) as a cost-effective therapy for all eligible patients with wet age-related macular degeneration.

The announcement is an important development for patients because NICE determines access to medicines in England and Wales based on agreed standards of cost-effectiveness. The final guidance follows a rigorous review which assessed the potential benefits of Lucentis for patients relative to the cost of the medicine.

The NICE decision was based on data from clinical trials involving more than 7,000 patients, demonstrating that Lucentis enabled patients to read on average an additional four lines (21 letters) on an eye-chart compared to those receiving no treatment. This benefit was sustained for two years.

The review evaluated all medications approved for treating wet AMD in the UK, and heard evidence from health professionals, health economic experts and patient groups. The final NICE guidance includes a reimbursement scheme under which the first 14 injections in each affected eye will be funded by the UK National Health Service, while the drug costs for any subsequent Lucentis injections will be reimbursed by Novartis.

"We are committed to working in partnership with health authorities to ensure that as many patients as possible with wet AMD can benefit from treatment with Lucentis," said Trevor Mundel, MD, head of Global Development Functions at Novartis Pharma AG. "This reimbursement scheme is an important collaboration that will ensure patients living with wet AMD in England and Wales receive the best possible care."

Lucentis has been approved in more than 70 countries and has  received positive health economic assessments in a number of countries including Australia, Belgium, Canada, France, the Netherlands, Scotland, South Korea and Sweden.

FDA OKs POAG Marketing of Canaloplasty

iScience Interventional has received expanded indications for use from the Food and Drug Administration for its microcatheters for specific treatment of primary open-angle glaucoma.

Canaloplasty, a minimally invasive surgical technique, uses a 250-µm microcatheter to access the drainage channels and utilizes the eye's natural drainage system to remove fluid from the eye. This interventional procedure has been performed worldwide for more than three years. Much like its more advanced predecessors in interventional cardiology and interventional neuroradiology, canaloplasty is emerging into a practical alternative to more invasive surgical procedures.

iScience believes that canaloplasty presents the ideal treatment for POAG patients with uncontrolled eye pressure. During the 30-minute procedure, the surgeon inserts a microcatheter through a small incision, enlarges the main drainage channel and places a small suture inside the canal to maintain the opening so it can function normally. Once completed successfully, this procedure rejuvenates the native drainage system, thus lowering the pressure in the eye.

"Microcatheters represent an exciting new frontier for ophthalmology," comments Michael Nash, president of iScience Interventional. "We believe that interventional procedures will significantly alter the treatment paradigm for a wide range of eye diseases and disorders in the future."