The American Glaucoma Society recently sought to identify 100 articles with significant impact on the clinical care of patients with glaucoma. This was based upon citation frequency and the input of members of the Society. The results of this activity was recently published by Drs. Vinod, Gedde and Ramulu in Ophthalmology Glaucoma. One of Dr. Novack’s papers on a new class of topical ocular hypotensive agents was selected (Serle JB et al. Two Phase 3 Clinical Trials Comparing the Safety and Efficacy of Netarsudil to Timolol in Patients With Elevated Intraocular Pressure: Rho Kinase Elevated IOP Treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2). Am J Ophthalmol. 2018;186:116-27).
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.
Gary Novack was honored by the UC Santa Cruz Foundation, an organization of which he is a past president. Together with past Executive Director Ann McCrow and past president Gordon Ringold, ten year ago he helped to execute the Board Opportunity Fund. This fund provides seed funds to initiate or support short-term campus projects through the Board Opportunity Fund (BOF), established in January 2008. The Foundation accepts proposals that allow faculty and staff to take advantage of unique opportunities to support a strategic project aligned with academic priorities. This may be an incentive for further fundraising or a vehicle for raising awareness and visibility for UC Santa Cruz. In the ten year, over 60 projects and hundreds of thousands of dollars have been invested. Many of the recipients have gone on to leverage this investment into 5- and 6-figure subsequent grants, providing support for faculty, students and staff. In particular, Dr. Novack was involved in several astronomy and astrophysics projects.
My article with Michele Lim MD is listed first in the American Journal of Ophthalmology, December 2019 issue. This was my personal patient’s view of retinal detachment, including my atypical presentation of symptoms. Colleague Dr. Lim added a perspective on Electronic Health Records – and why the federal mandate for EHR still does not mean interoperability – and thus why I had to give my patient information so many times in one day.
Dr. Novack returned to the University of Wisconsin to present in the Department of Ophthalmology Grand Rounds. His spoke about what it would take to develop a drug to prevent the development of myopia (nearsightedness) in children. Myopia has reached epidemic proportions around the world, and is a major public health issue. He also spoke to the ophthalmology residents on the topic of drop volume (size) for eyedrops. His work on these subjects has been published in Eye and Contact Lens and The Ocular Surface, respectively.
Academic journals have long worked on the “subscription model”, where print subscribers pay to read articles that, for the most part, authors submit for free. With the advent of digital content, the same model has been used – subscribers pay and author provide content for free. There is a shift to “open access”, which typically means that the authors pay upon submission, and readers view for free. Among the first quality journals adopting this model is PLOS One. Other quality journals are moving in this direction, and we are currently in a mixed model paradigm shift, where authors can pay for non-subscribing readers to have free access (“Open Access”). This is not to be confused with “predatory journals” – technically open access journals – but ones that are of low quality.
Universities, through a special application of the subscriber model, pay a subscription fee to allow their faculty and staff to have access to many journals, including those from Elsevier, Wiley, etc. Academic researchers find this tool of high value. For decades, there has been a symbiotic relationship. UC’s researchers contribute quality research for free to quality journals, which in turn publish the “peer-reviewed” paper, key to academic prestige. UC has paid for subscriptions. However, in the paradigm shift, academic authors are starting to have to pay fees – and thus universities are caught in a financial bind. There’s no increase in income for the Universities – yet universities are paying for both subscriptions and author fees for open access. In particular, this has been an issue for the University of California and one of the largest publishers of medical literature, Elsevier. In short, Elsevier’s view of the fees to be paid by the University of California in this transition phase were greater than what UC thought they should pay. This came to a head in January 2019, when it became public that the two were not able to come to a resolution (as discussed in a piece by University of California, Davis, University Librarian, MacKenzie Smith.
Throughout this period, University of California researchers still had access to Elsevier publications. That changed in early July, with Elsevier announcing that they are now stopping that access.
The impact of this decision has yet to be felt or fully comprehended.
(Disclosure – I am an alumnus and professor of the University of California, serve on the UC Davis Library Leadership Board, and an author, reviewer and on the editorial board for Elsevier journals).
The article notes that the pharmaceutical and medical device industry has the most complex regulations of any industry. They take at the unique consultancy services provided by NDA Partners.
The article notes: “…NDA Partners LLC, which provides product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide, has developed a new model of consultancy – the CDO or consulting and contract development organisation. And it’s a model that is entirely suited to small innovators and SMEs.” “NDA Partners distinguishes itself from other consultancies through its ability to assign top-tier expert consultants on all engagements. It provides the full spectrum of functional expertise needed to conduct complete product development programs from bench to marketing authorization”
NDA Partners includes as consultants:
- Three former US Food and Drug Administration (FDA) Centre Directors
- Fourteen former FDA Director or Deputy Director Division heads
- The former Head of the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
- Three former EU regulatory agency senior staff
- The former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP)
- Dozens of highly experienced former biopharma and medical device industry executives
In the 10 May 2019 issue of Science magazine, Assistant Professor of the University of Florida, Alan H Chambers, writes about his experience with a predatory journal. In a moment of weakness after rejection of a manuscript, he submitted it to a newly launched journal. It turns out it was a “predatory journal” in all aspects of the phrase. He realized his mistake and requested it be withdrawn. With a quality journal, this would be honored immediately. This journal demanded payment. Only with repeated demands from the University was the paper “let go”. The author also suggests ways to test a journal (e.g., look at the editorial board, contact them separately to confirm, etc.). Moral of the story – the pressure to publish are real – but don’t succumb to submitting to these journals.