UPFRONT
Compounding The Problem
“The problem with smart people is that they like to be right and sometimes will defend ideas to the death rather than admit they’re wrong.”
— Scott Berkun
Peter K. Kaiser, MD
The CATT study reported two key findings: monthly Lucentis leads to similar visual results as monthly Avastin; and the safety of these treatments was similar for “known anti-VEGF adverse events.” Other studies have shown comparable results. So this should have put the issue to rest — namely that the two can be used interchangeably. However, throughout the world, the issue is still hotly debated both from an efficacy and, more importantly, a safety standpoint.
In this issue, Abdhish Bhavsar, MD, discusses methods to avoid endophthalmitis gleaned from the DRCR.net studies. To me, this is the key issue in the current debate about Lucentis and Avastin. At the Cole Eye Institute, our pharmacy fractionates Avastin vials into syringes. Each lot is first sent for microbiologic evaluation before being released for patient administration.
In CATT and other comparison studies, Avastin was even more carefully prepared in a sterile, clinical-grade pharmacy, where the drug was placed into single-use vials and sent to the clinical sites. So differences in the sterility and composition between the drugs were similar, and no safety issues arose in the studies. In practice, however, retina specialists do not get this form of Avastin, and that is the main safety issue with the drug.
We hear monthly of recalls of drugs from compounding pharmacies for various reasons, including bacterial contamination, mold, counterfeiting, or other imperfections in the compounded product. Most recently, five patients from the same physician in Georgia developed endophthalmitis after receiving Avastin from the Clinical Specialties Compounding Pharmacy. Obviously, this is a very rare occurrence but one that was not studied in any of the comparison trials because they did not use the same Avastin we use in our patients.
Clinical Specialties’ lead pharmacist, Austin Gore, told the Associated Press the pharmacy produced more than 100,000 doses of Avastin without incident. I doubt that is comforting to the patients in Georgia who developed infections. The need for better federal oversight of compounding pharmacies is reaching a boiling point largely because of these incidents.
Steps to reduce the risk of compounded products are explored in this issue. However, irrespective of these steps, Avastin can never reach the same level of sterility as Lucentis or Eylea. In the future, accountable care organizations and other insurance instruments may mandate the use of the lowest cost treatment.
But until that time, I am in the shrinking minority of retina specialists who use the FDA-approved products over fractionated products for the very reasons outlined above.
| EDITORIAL ADVISORY AND REVIEW BOARD |
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EDITOR-IN-CHIEF Peter K. Kaiser, MD, Cleveland, OH FOUNDING EDITOR COLUMNISTS/SECTION EDITORS Riva Lee Asbell, Fort Lauderdale, FL Steve Charles, MD, FACS, FICS, Memphis, TN Michael Colucciello, MD, Moorestown, NJ Emmett T. Cunningham, MD, PhD, San Francisco, CA Pravin U. Dugel, MD, Phoenix, AZ CONTRIBUTORS Ron A. Adelman, MD, MPH, FACS, New Haven, CT Francesco Bandello, MD, FEBO, Udine, Italy Abdhish R. Bhavsar, MD, Minneapolis, MN Rosario Brancato, MD, Milan, Italy David Brown, MD, Houston, TX Usha Chakravarthy, MD, PhD, Belfast, UK Stanley Chang, MD, New York, NY Emily Y. Chew, MD, Bethesda, MD Kevin Corcoran, COE, CPC, San Bernardino, CA Alan Cruess, MD, FRCSC, Halifax, Canada Donald J. D’Amico, MD, New York, NY Diana V. Do, MD, Baltimore, MD Didier Ducournau, MD, Nantes, France Dean Eliott, MD, Los Angeles, CA Michel E. Farah, MD, Sao Paolo, Brazil Sharon Fekrat, MD, Durham, NC Frederick L. Ferris, MD, Bethesda, MD Donald C. Fletcher, MD, San Francisco, CA Anne Fung, MD, San Francisco, CA Morton F. Goldberg, MD, FACS, Baltimore, MD Julia A. Haller, MD, Philadelphia, PA Seenu M. Hariprasad, MD, Chicago, IL Jeffrey Heier, MD, Boston, MA Allen C. Ho, MD, Philadelphia, PA Frank Holz, MD, Bonn, Germany Tomohiro Iida, MD, Maebashi, Japan Lee M. Jampol, MD, Chicago, IL Mark W. Johnson, MD, Ann Arbor, MI Anat Loewenstein, MD, Tel Aviv, Israel Martin A. Mainster, PhD, MD, Kansas City, KS William F. Mieler, MD, Chicago, IL Timothy G. Murray, MD, Miami, FL Michael D. Ober, MD, Southfield, MI Dennis A. Orlock, CRA, New York, NY Kirk H. Packo, MD, Chicago, IL Carmen A. Puliafito, MD, MBA, Los Angeles, CA Carl D. Regillo, MD, FACS, Philadelphia, PA Gisbert Richard, MD, Hamburg, Germany Richard Rosen, MD, New York, NY Philip J. Rosenfeld, MD, PhD, Miami, FL Reginald J. Sanders, MD, Washington, DC Steven D. Schwartz, MD, Los Angeles, CA Ingrid U. Scott, MD, MPH, Hershey, PA Stephen C. Sheppard, Springfield, MO Jerry A. Shields, MD, Philadelphia, PA Lawrence J. Singerman, MD, Cleveland, OH Richard F. Spaide, MD, New York, NY Giovanni Staurenghi, MD, Milan, Italy Michael T. Trese, MD, Royal Oak, MI George A. Williams, MD, Royal Oak, MI Sebastian Wolf, MD, PhD, Bern, Switzerland Lawrence A. Yannuzzi, MD, New York, NY |
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