Hyperbole in the Age of Pharma

Hyperbole in the Age of Pharma
The internet has exacerbated a pervasive problem in the news media—a tendency to PROCLAIM A CURE! This is most evident in retina for the treatment of age-related macular degeneration (AMD), but is certainly endemic in other fields. When I was a high school student, I remember reading about the cure for AMD—laser photocoagulation. This cure was short-lived. Fortunately, another cure arrived during my fellowship—verteporfin photodynamic therapy. Five years later, another cure—pegaptanib sodium. One year later, two new cures—bevacizumab and ranibizumab. Now it seems that the pharmaceutical industry is getting smarter, because reports of new cures are coming weekly—small interfering RNA, VEGF-trap, mammalian target of rapamycin, topical VEGF approaches, oral VEGF approaches, endostatin, even radiation. Why so many cures? Clearly, these cures must be suboptimal.

What bothers me is the hyperbole. Lucentis has been a paradigm-shifting therapy for AMD. Bevacizumab appears to offer many of the benefits of Lucentis at a fraction of the cost. That’s all we can really say, and then we enter into the swamp of the unknown—Phase 1, Phase 2, and Phase 3 enrolling trials. Featured recently on this very website was pre-clinical data on endogenous endostatin where the editor of FASEB, Gerald Weissman is quoted as saying “This research provides hope for those at risk for blindness, and it gives everyone another glimpse of how investments in molecular biology will ultimately pay off in terms of new treatments and cures.” Really! How many hundreds of drugs are in development for treatment of AMD? How many of these will make it to the marketplace, demonstrate efficacy, and be affordable? How is he able to make such a blanket statement from one pre-clinical study in MICE? Seems to me that I recall similar hyperbole surrounding the drug pegaptanib sodium after the preclinical data was reported, and I cannot recall the last time I heard of anyone using that medication.

Typically, the company that is manufacturing a medication or therapy will issue a terse press release stating that Phase I/II/III results demonstrated that they met/exceeded primary endpoints. This is then picked up local/national/international news media who scramble to their address books to find if any of the authors are listed. If so, modest appraisals of the study are usually proffered, with great hope for the future results. If not, then some talking head who is in the address book is secured for a quote, usually very complimentary, occasionally disparaging, but either way very preliminary and usually misleading based on the available data.

Let’s face it, if anyone could predict what the clinical efficacy of these drugs would be, there would be no need for clinical trials. Unfortunately anything can happen in a biological system, much of it unanticipated. To borrow a phrase from sporting, “That’s why they play the game.” The real purpose for the hyperbole appears to follow into one of 3 categories: 1) economic gain, 2) grandstanding, 3) and playing to the patients. Economic gain is straightforward—the companies are in business to make money, the more the better. They are usually small and are looking to appease and/or attract investors, and the best way to do that is with a promising result. More mature companies have reporting requirements, hence the terse, dare I say it, clinical statements. Grandstanding, everybody understands—it helps the company get a moment of glory, it gives the commentator their moment in the sun, validating their position as an EXPERT talking head. Playing to the patients is just a crock. It promises two things: 1) false hope and 2) that our (retina community) phones will be ringing off the hook for 7-10 days later. PLEASE lay off on the grand pronouncements and let the market and the science determine what is or (more likely) is not a PROMISING NEW CURE!

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