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The Results of Our Last Question
Will mixing different combinations of presbyopia-correcting IOLs (a different IOL in each eye, such as Crystalens in one eye, Restor in the other, or Crystalens + Rezoom, or Restor + Rezoom) be the best way to achieve better near, intermediate, and distance vision in presbyopic patients??
A. Yes 21%
B. No 29%
C. Unsure at this time 50%
FDA Announces Label Change for Flomax
The FDA has opted to include an additional warning on the labeling of systemic tamsulosin (Flomax; Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT) following the collection of reports from surgeons regarding ocular complications associated with the drug. The incidence of intraoperative floppy iris syndrome, a small pupil disorder, has previously been linked with the use of Flomax according to two studies conducted by David F. Chang, MD, of Los Altos, California and John R. Campbell, MD, of San Rafael, California. Upon the FDA s request, reports tracking cataract patients on Flomax and other prostate drugs were submitted and evaluated, which subsequently led to the label change.
Dr. Chang, CRSToday s Co-Chief Medical Editor, asserted that patients need not cease Flomax use, as it is effective in treating symptoms of an enlarged prostate. However, he stressed that it is imperative that Flomax patients, and those who have received the alpha-1 blocker in the past, notify their ophthalmologists so that they may anticipate and plan for special surgical measures. The new label reads as follows: The patient s ophthalmologist should be prepared for possible modifications to their surgical technique.
In addition, the AAO has urged its members to question their male cataract patients about other prostate medications, such as Hytrin (Abbott Laboratories Inc., North Chicago, IL), Cardura (Pfizer Inc., New York, NY), and Uroxatral (Sanofi-Aventis, Bridgewater, NJ), as the use of these drugs may also be a contributory factor in the occurrence of intraoperative floppy iris syndrome.
Phase 2 Trial to Test OT-551 in Cataract Prevention
Othera Pharmaceuticals, Inc. (Exton, PA), initiated a phase 2 clinical trial evaluating the efficacy of OT-551, its topical eye-drop antioxidant, as a treatment that halts the development or progression of cataracts in patients who have undergone vitrectomy surgery. The double-masked, randomized, placebo-controlled study will be conducted during a 12-month period.
According to the results of a phase 1 trial for OT-551 completed in May, safety and comfort endpoints were successfully met, and treatment was reportedly targeted to the anterior and posterior segments of the eye. OT-551 is a novel small molecule that is topically dosed in an eye drop and has the unique ability to penetrate cell membranes and reach both the front and the back of the eye, stated David S. Joseph, Chairman and CEO of Othera Pharmaceuticals. For this reason, the company is enthusiastic about the agent s potential as a treatment option for dry AMD as well. Othera expects to begin trials for this indication in 2006.
AMO Advises Physicians to Discontinue Endosol Use
Advanced Medical Optics, Inc. (AMO; Santa Ana, CA), issued a safety warning against use of all of its Endosol products manufactured by Cytosol Laboratories, Inc. (Braintree, MA). Lots specifically referenced in the alert were 500mL glass bottles (product code END500), 500mL plastic bottles (product code 0850), and 18mL plastic squeeze bottles (product code 0997).
Toxic anterior segment syndrome, a condition marked by an inflammatory reaction to the presence of a contaminant in the eye during surgery, was observed in postoperative patients who received the agent. This prompted the placement of a shipment hold on all orders for Endosol products on November 4. Orders will be suspended pending completion of an investigation.
In the interim, AMO suggested that physicians use one of two balanced salt solution vendors: Hospira, Inc. (Lake Forest, IL), at (800) 615-0187 (product code 3911-03); and Baxter International, Inc. (Deerfield, IL), at (888) 229-0001 (product code 1A7233P). Additionally, AMO requested that any cases of complications associated with Endosol products be reported by contacting the company at (800) 366-6554.
AAMC Aims to Enhance Clinical Trial Validity
The Association of American Medical Colleges (AAMC) recently released new Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials in order to further demonstrate the credibility of the nation s medical schools and teaching hospitals as reliable sources of research information. Although the standardization of clinical trial reporting has been the focus of various plans proposed in the past, published studies reveal the lack of a uniformly accepted and enforced system for analyzing and presenting results of sponsored clinical trials.
The new guidelines were developed by the AAMC in conjunction with the Centers for Education & Research on Therapeutics and the Blue Cross and Blue Shield Association (Chicago, IL). All clinical trials conducted in academic medical institutions, regardless of the source of their financial backing, will be subject to these standards. According to the principles, researchers are ensured full intellectual participation in studies and are, thus, held responsible and accountable for the results. The AAMC is confident that the provisions in the new initiative will establish a comprehensive process that will prohibit sponsors from evading the release of ineffective or negative study results, a practice that can be detrimental to the reputations of medical institutions where the trials were conducted.
The AAMC will circulate the new principles to promote their widespread adoption by both industry and the entire medical community. To access a copy of the Principles for Protecting Integrity in the Conduct and Reporting of Clinical Trials, visit http://www.aamc.org/research/clinicaltrialsreporting/start.htm.
CMS Reports Improvement in Rate of Improper Claims Payments
The Centers for Medicare & Medicaid Services (CMS) announced that during the past year, the number of improper fee-for-service Medicare claims payments has been reduced by 50%, from 10.1% in 2004 to 5.2% in 2005, representing $9.5 billion in savings. According to a CMS press release, this has occurred despite a growing volume of claims filed and an increase in the complexity of payment processing.
The unprecedented $9.5 billion reduction in improper Medicare payments reflects our commitment to careful measurement and targeted oversight, and we intend to keep building on these efforts, CMS Administrator Mark B. McClellan, MD, PhD stated. We are measuring the accuracy of payments more closely, and that enables us to target our efforts more effectively with Medicare contractors and providers.
The reduction is a result of the efforts of the CMS to implement the Comprehensive Error Rate Testing program, which focuses on educating providers about the importance of responding to requests for medical records and accurate reporting. Payment error rates were significantly improved. The CMS will continue to take steps toward reducing the error rates by incorporating several new measures that provide corrective action plans and identify specific providers who need further education.
The CMS acknowledges Congress support of the fee-for-service oversight program. Due to the success it has achieved thus far, the CMS has requested an additional $80 million in order to apply similar oversight initiatives to programs involving prescription drug plans and other areas of Medicare.
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