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 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.