Dr. Novack presenting at Grand Rounds, University of Wisconsin, September 2019
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).
NDA Partners LLC, a consultancy of which I am a member, was featured in a news article in Business Worldwide.
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.
At the 3rd Annual Sonoma Eye, meeting, Dr. Novack chaired a symposium on two areas of interest – basic research in ocular inflammation and retinal disease and clinical outcomes. Dr. Novack presented current thinking on endpoints in approvals of novel therapeutics in ophthalmology. He also moderated the discussion on how to best use pre-clinical models to aid in drug development. Including Dr. Novack, there were 3 speakers from the University of California, Davis.
Pinterest recently stated that “..it would no longer return any search results, including pins and boards, for terms related to vaccinations, whether in favor or against them.” The firm noticed the majority of shared images on their site cautioned people against vaccinations. As I wrote in an article in 2017, “Anti-Science in the 21st century”. we have a safe, effective, affordable prevention of a terrible disease. Use it!
The U.S. FDA signaled strengthening of regulation of dietary supplements in remarks by FDA Commissioner Scott Gottlieb, M.D. He notes “…In the 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), the law that transformed the FDA’s authority to regulate dietary supplements, the dietary supplement market has grown significantly. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 – and possibly as many as 80,000 or even more – different products available to consumers.”
FDA “sent out 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases.”
To some of us, the promotion of nutritional supplements by some firms goes beyond that allowed by law. Further, some firms prey upon patients’ unfounded belief that “If it’s natural, it must be safe”.
In a recent editorial in EyeNet on the importance of collaboration in successful research, past-president of the American Academy of Ophthalmology, Ruth Williams, M.D. cites Dr. Novack. Dr. Novack stated “…You cannot be successful unless you realize that you do NOT know everything”. Further she states that “…major breakthroughs usually require a multi-disciplinary approach, ophthalmic researcher must recognize and woo individuals who may not currently be working on vision research”. A prime example of this is the Glaucoma Research Foundation’s “Catalyst for a Cure”.
Please see the first issue of OIS Press with updates on novel ophthalmic therapies. I provide a perspective in recent US FDA approvals (Pages 9 and 11).
Gary D. Novack, Ph.D., was selected to be a fellow of the American College of Clinical Pharmacology (ACCP). ACCP consists of a full spectrum of clinical pharmacology professionals from academia, industry, government and clinical settings who span the scope from research and drug development to patient-related care and who remain dedicated to advancing clinical pharmacology with the ultimate goal of enhancing patient care. ACCP seeks to address the educational needs of its diverse membership and all healthcare professionals, covering a range of topics that span the entire area of the interaction between drugs and humans.