Restasis has such a small beneficial effect that every country except the US rejected it. What’s wrong with us that we pay billions for crap meds?
The very best research that Allergan could create showed that Restasis increased tear production slightly in 15% of people in the test, vs. the 5% who perceived a benefit with a placebo.
Restasis performed better than artificial tears (cheap OTC eye drops) only 1 time in 9 trials. That does NOT mean that Restasis is 3x better than a placebo. It means it barely works on hardly anybody.
Because Restasis generates huge profits — funded in part by payments from Medicare Part D — Dartmouth researchers Lisa Schwartz and Steven Woloshin conducted an In-depth analysis of the studies provided to the FDA by Allergan. Their findings have been published in JAMA Internal Medicine.
Restasis Squeaks Through the Approval Process
It was not easy for Restasis to get approved by the FDA, observed Schwartz and Woloshin. Allergan filed for approval in 1999 and had to amend its application 4x before approval in 2003. Using the same research, Restasis has not been able to get approval in the European Union, Australia or New Zealand. Canada approved it, but with such weak proof of meaningful benefit that the Canadian health drug plans don’t pay for it.
So why does the US spend $2 billion in insurance payments and personal money on Restasis? Mostly because of advertising convincing the public that chronic dry eye syndrome is a real disease (it’s not a thing, really) and doctors who are either unwilling to tell patients the truth or unwilling to take the time to read the research themselves, so they depend on the pharma rep literature. Dry eyes are an ordinary, slightly unpleasant life experience. Restasis is approved by the FDA to increase tear production, not to cure a disease.
$645 million of advertising buys a lot of eyeballs, as advertising viewers are termed in the business. For every $1 spent on advertising, Allergan took in about $3 — or more than $2,000,000,000 last year. What could you do with $2 billion? We know what Americans did: spent it on trying to fix something that they had been fooled into thinking was an actual disease. (It’s worth noting that only the US and New Zealand allow direct-to-consumer advertising of pharmaceuticals.)
The ‘Allergan Access’ program paid ophthalmologists to prescribe a drug you may not have needed. If your ophthalmologist wrote a prescription for Restasis, you may want to consider a new eye doctor.
Allergan has been criticized from many directions on its handling of Restasis. There have been allegations of sham lawsuits designed to slow generic competitors and a class action suit on Restasis pricing.
In July 2017 Allergan agreed to settle kickback allegations by paying $13 million to the federal government and 19 states. (I covered this in my blog post Crying over Dry Eyes.) The lawsuit alleged that the primary purpose for the “Allergan Access” program, promoted to ophthalmologists, was “to induce doctors to write prescriptions for Allergan’s eye care products, many of which had less expensive treatment alternatives.” In plain English, this program paid ophthalmologists to prescribe a drug you may not have needed. If your ophthalmologist wrote a prescription for Restasis, you may want to consider a new eye doctor.
And Then There Was the Mohawk Tribe Gambit
Allergan tried to circumvent the entire US patent process by selling its Restasis patents to the Saint Regis Mohawk tribe in upstate New York. “By doing so, it [Allergan] aims to sidestep what’s called inter partes review, a type of patent challenge that is easier and faster to file than a lawsuit. As a sovereign tribal government, the Saint Regis Mohawk tribe claims immunity in inter partes review proceedings.”
Allergan’s move to give the patents to the Saint Regis tribe is now moot because the patents protecting Restasis have been invalidated on the basis of “obviousness.”
Allergan made more than $8.8 billion in sales on Restasis between 2009 and 2015. One can hardly blame the company for fighting ferociously to protect this bounty. But what is wrong with us, in the US, who keep buying what the ads are selling?
Thanks for advising me about Restasis because I have what they call Dry eyes!
I was told by eye doctors to take Restasis for years but I don’t see any great results. It is costly and my eyes have a blurry look after I have taken it. I have tried to go off of it a few times and then I look at those boxes of vials that I paid dearly for and go back on it.
chronic dry eye most definitely IS “a thing, really.” Wait until you’ve had ocular surface damage, sometimes permanent, all the way up to blindness from that “not a thing” chronic dry eye, no matter what the underlying reason for the condition.
Restasis may not work, and that’s a major issue, but don’t “dis” a condition that affects many people, has caused ocular damage for many people and cannot always be address by OTC drops. Patients with chronic dry eye experience vision problems, sensitivity to sunlight/bright light, eye pain (burning, feeling of sand in the eye), and corneal erosions/scarring/ulcers, the last of which are what can lead to blindness. I’ve had to be on corticosteroids, including on an emergency basis when there was a possibility of losing my eyesight, and have had my life pretty well altered just with the eyes (never mind the underlying condition) by needing moisture chamber glasses, constant humidification, Xiidra, OTC drops every two yours, and sleep goggles, among other things.
No doctor or pharmaceutical company talked me into believing that chronic dry eye was a “thing.” I only knew my vision (didn’t experience discomfort/pain when it started) was erratic, from sharp to “can’t see a doggone thing,” which turned out to be from fluctuating tear film. By the time I was diagnosed, I produced NO tears in one eye and “might as well be none” (doctor’s words) in the other and had the corneal erosions noted above. Just lucky treatment started before there was permanent scarring.