In May, Dr. Novack was part of a UC Davis Department of Ophthalmology & Vision Science weekend Continuing Medical Education course in Napa. He presented issues surrounding off-label use and compounded medications in ophthalmology. He also discussed generic vs. branded products.
Dr. Novack was featured in a spotlight on ARVO members in a May 2022 posting of The Ophthalmologist entitled “Captain’s Log”, the reported focused on Dr. Novack’s answer to a query about an analogy for his work. Novack said “…like Captain James T. Kirk in the Star Trek Original Series “Corbomite Maneuver”, episode, I use available information to take strategic directions and optimize resources. He also gives to his “…parents, who were first generation to college, for providing me the education (together with the University of California) to enable me to reach my adolescent goal of being a scientist. I also credit my family for giving me support and fulfillment throughout my life.”
Dr. Gary Novack presented two posters at the May 2022 ARVO conference in Denver. One of these was presented in the Cornea section on preclinical data on a new investigative potential treatment for dry eye disease. The other was presented in the retina section on Phase 3 studies of a new topical anesthetic for use in the office for various procedures including intravitreal dosing.
Gonzalez VH, Wirta DL, Uram M, Schupp A, Widmann M, Novack GD. Two Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Studies of the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution 8% (AG-920)
Park LC, Gharat L, Park, K, Alam J, Yu Z, Hu Y, de Paiva CS, Novack GD. Pflugfelder SC. Dry Eye: Evaluation of novel YP-P10 Peptide in animal models of inflammatory dry eye disease.
With a recent product approval, Dr. Novack has now made substantial contributions to 60 approved products during his career. As he noted in an editorial, half of “Pharmacology” is “Therapeutics” – providing better ways to treat patients. Please see “Key Roles” on the PharmaLogic website.
The issue of ethics of professional medical writers engaged by pharmaceutical firms was discussed in novel oncology therapies.
In a recent article in JAMA Oncology on the use of surrogate endpoints in oncology, del Paggio et al identified industry funding for nearly all. They further highlighted the use of medical writers in papers published on this work to be of concern, suggesting that medical writers may unduly influence the interpretation of trials. In a letter, leaders of three professional medical writing organizations, the American Medical Writers Association, the European Medical Writers Association and the International Society for Medical Publication Professionals, refute this point, stating that the authors have no data to support this premise. Further, the medical writers make reference to Good Publication Practices guidelines,and ethical standards for medical writers. They cite a paper by Hamilton et al showing the opposite – that the involvement of medical writers in preparing manuscripts improves several outcomes.
Glaukos announced that 200 papers published on their glaucoma product, the iStent. . We’re pleased to say that Dr. Novack was the medical writer for lead authors Dr. Thomas Samuelson and L. Jay Katz on the first one, in Ophthalmology. This demonstrates one of our principles – publications in quality journals have a long lasting benefit.
The American Academy of Ophthalmology reported (June 2021) a shortage of bevacizumab as used off-label, aliquoted, for ophthalmic indications in the U.S. The issue surrounding off-label and compounding pharmacy use, particularly with this class of products, were discussed in a recent editorial by Dr. Novack and UC Davis colleague, Ala Moshiri MD, Ph.D. in an article in the American Journal of Ophthalmology. Such use is at risk for many reasons – including availability.
Together with UC Davis Ophthalmology faculty member, Ala Moshiri, M.D., Ph.D., I published a commentary in the American Journal of Ophthalmology regarding the challenges to making off-label use of products a standard of care in retina therapies in ophthalmology. This continues a theme from a previous paper regarding this issue with antibiotics in cataract surgery. While off-label use and compounding medications on a patient by patient basis is supported by U.S. code, a more general policy for standard of care creates a narrow ledge for patients and physicians.
The American Academy of Ophthalmology recently updated its Glaucoma Practice Pattern. In this document, also published in the AAO’s Journal Ophthalmology, the Committee, headed by Steven J. Gedde, M.D., glaucoma is defined as a chronic, progressive optic neuropathy. The document then further describes the best practices for diagnosis, follow-up and therapy. Dr. Novack’s work on the issues of treatment adherence (patients taking their medication as prescribed) and performance (challenges to patients to properly use eyedrops). His work on novel therapeutics drugs and devices is also cited.