I’m having a hard time understanding how anyone with a conscience could work for a company like Allergan. Transferring patents, rights to a native American tribe to try and circumvent the law and using DTC to market a drug that did nothing, according to JAMA but increase health care costs.
According to the JAMA article:
In a legal maneuver that has left many rubbing their eyes, Allergan recently transferred the 6 patents on its blockbuster “dry eyes” drug Restasis (cyclosporine ophthalmic emulsion, 0.05%) to the Saint Regis Mohawk Tribe, which will exclusively license the patents back to the company. The deal, which may delay the marketing of generic alternatives to Restasis, is under legal challenge, amid calls for Congress to ban the strategy Allergan has sought to exploit.
But wait, it gets worse…
Restasis is not approved in the European Union, Australia, or New Zealand, where in 2001 registration applications were “withdrawn prior to approval due to insufficient evidence of efficacy. But Americans pay for Restasis—a lot: $8.8 billion in US sales between 2009 and 2015, including over $2.9 billion in public monies through Medicare Part D.
The findings of the 2 identical, placebo-controlled pivotal trials were inconsistent: one showed no improvement in either criterion,4 and the other found statistically significant—but not clearly meaningful—improvements at some time points but not others.4 Subsequently, Allergan amended the application 4 times, reanalyzing the same data.
By contrast, in the only other regulatory review of the drug that is publicly available, Australia’s Therapeutic Goods Administration evaluator found “minimal or no benefit over and above placebo at most time points” and that the trials—the same ones submitted to the FDA—showed no “convincing or sustained benefit of 0.05% [or] (0.1%) cyclosporine eye drops vs. vehicle in patients with moderate to severe keratoconjunctivitis sicca treated up to 6 months, using a range of objective and subjective efficacy criteria.”1
Given the scant evidence of efficacy, why does Restasis have more than $2 billion in annual sales in the United States?
An important reason may be the extensive marketing campaign to sell a disease—chronic dry eyes—and its treatment.[inlinetweet prefix=”” tweeter=”” suffix=””] From 2007 to 2016, Allergan spent $645 million on television, magazine, and electronic ads including its mydryeyes.com website.[/inlinetweet]7
The website recasts ordinary unpleasant life experiences as disease: “those who experience stinging, burning, and watering eyes might attribute these symptoms to the weather, allergies, contacts or even their eye makeup, when in fact they may be suffering from Chronic Dry Eye (CDE) disease.” Mydryeyes.com invites people to take a quiz. The results come with a warning: “Don’t wait; over time, CDE disease may get worse and may have potential health consequences for your eyes, including damage to the front surface of the eye, an increased risk of eye infection, and effects on your vision.”
Another Allergan website, Restasis.com,8 calls CDE “a chronic condition with no permanent cure … which reduces your natural tear production.” The results of its Dry Eye quiz warn that over-the-counter artificial tears provide temporary relief but “do not increase your eyes’ ability to make their own tears. Restasis … is the only prescription treatment proven to help you make more of your own real tears.”9
[inlinetweet prefix=”” tweeter=”” suffix=””]Based on the evidence, why should consumers, private insurers, and the federal government spend billions of dollars on a marginally effective drug for a condition that many would not consider to be a disease?[/inlinetweet] Restasis might never have reached blockbuster status if payers, clinicians, and consumers had easy access to independent drug information.
I’m having a really hard time trying to understand how a paycheck to lead to such bad, greedy decisions. And in the end the same people that made these bad decisions and helped the company sell a worthless drug is laying off 1000 people as the drug loses patent protection.
I believe in DTC and its ability to educate and inform people. I understand that people are smart enough to do online research before going to ask about an advertised medication, but then this huge black eye which supports those who call for an end to DTC. Greed and love of paychecks over patients.