Chicago

Anyone who listens to WBBM or WLS radio stations in Chicago or baseball games of the Chicago Cubs has heard them: seemingly incessant jingles selling a drug for an eye condition most have never heard of.

“Slow it down,” tease the ads with a musical lick culled from the 1975 R & B hit by the music group War, Low Rider. "I-Zer-Vay gets GA going slower,” chant the ads, trying to sell the drug IIzervay, which costs $2,220 per treatment without insurance, for the not well known disease of “GA.” (Moreover, the ads target the shrinking demographic of those who remember 50-year-old music hits.)

WHAT IS “GA”?

Geographic atrophy is a condition which can result from dry age-related macular degeneration (AMD)–another eye condition many have not heard of. It has been aggressively publicized by the former Happy Days star Henry Winkler (nee the Fonz) who says he “partnered” with IIzervay manufacturer Astellas Pharma after his father-in-law got the condition.

The ads’ message––or fear signaling––is essentially “Don’t Go Blind” which is a possible but not assured consequence of having GA. Since blindness may result from GA and GA may result from dry AMD, the statistical unlikelihood of listeners having the condition is belied by Astellas’ promiscuous spending on the airwaves.

And there are other contradictions.

MARKETING CONTRADICTIONS

Do radio listeners hear, in safety disclosures, that the ads also admit Izervay may cause wet AMD which can also result in blindness/vision loss? (Pick your poison?)

Do the listeners targeted by the ads realize there are less expensive, non-prescription treatments that can be used for AMD? The American Academy of Ophthalmology has suggested Vitamins C and E, Zinc, Copper and Lutein. But, of course, Vitamin C sellers don’t have radio budgets.

FUNDING CONTRADICTIONS 

Surprisingly, on the basis of its marketing budget, Izervay’s R & D budget was largely funded by you and me, US taxpayers, also known as the National Institutes of Health (NIH).

“The approvals of Syfovre and Izervay represent the culmination of years of NEI-sponsored research, says their press release. “While the drugs were brought to market by the private sector, they represent years of support from the National Eye Institute (NEI) in the form of grants to research campuses around the country.”

Also surprising is Apellas’ aggressive marketing in light of its 2019 agreement to pay $124.75 million over kickback allegations which might produce more humility. The agreement was barely publicized by media, especially those running Apellas’ ads.

https://oig.hhs.gov/fraud/enforcement/two-pharmaceutical-companies-agree-to-pay-a-total-of-nearly-125-million-to-resolve-allegations-that-they-paid-kickbacks-through-copay-assistance-foundations/#:~:text=(Astellas)%20and%20Amgen%20Inc.,companies%20used%20as%20mere%20conduits.

SAFETY AND EFFECTIVENESS QUESTIONS

IIzervay may be minimally effective, suggest experts. Treatments like Izervay “can slow down the rate of progression of geographic atrophy by a small amount,” said Rahul N. Khurana, MD, a retina specialist in an American Academy of Ophthalmology article, but has not “been shown to have any effect on vision” and may cause unwanted side effects. Any improvements should be weighed against the burden of getting monthly injections and possibly severe side effects added Dr. Khurana.

https://www.aao.org/eye-health/tips-prevention/syfovre-izervay-geographic-atrophy-amd-macular-deg#:~:text=Two%20new%20drugs%20%E2%80%93%20Syfovre%20(pegcetacoplan,lead%20to%20significant%20vision%20loss

Another eye specialist also expressed doubts reported the American Academy of Ophthalmology. “What patients care about is how well they see, not some anatomic outcome,” said Jason Miller, MD, PhD, the James Grosfield Endowed Professor and Assistant Professor of Ophthalmology and Visual Sciences at the University of Michigan. There is “a big controversy in our field,” over whether Izervay (and a similar Appellis GA drug, pegcetacoplan, marketed as Syfovre) have enough benefit to warrant the side effect risks, he continued.

https://www.aao.org/eyenet/article/new-geographic-atrophy-drugs

Since commencing marketing, 106 adverse event reactions to Izervay have been reported in the FAERS database including blindness, transient blindness, vitritis and vitreous detachment, retinal harm, worsening of dry AMD, inflammation and glaucoma.

CONCLUSION

Pharma has been accused of “disease mongering” to sell drugs and of selling drugs with problematical efficacy and safety profiles. The poster child for such spurious marketing seems to be Astellas’ Izervay.