Value of medical writers discussed in top journal

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.

Dr. Novack’s paper among top 100 glaucoma papers

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).

Off-label use: Article in the American Journal of Ophthalmology

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. 

PharmaLogic work contributes to glaucoma therapeutics

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.

Paper published in American Journal of Ophthalmology

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.