This is a celebrity-focused story on actress Maria Tomei’s use of Restasis, a prescription drug to increase tear production.
The story is problematic on many fronts. Medically, it fosters confusion about “chronic dry eye,” a problem that includes many different causes of dry eyes, and keratoconjunctivitis sicca, a much less common autoimmune disorder. Journalistically, it’s missing all the basic details that make up solid reporting–there’s no quotes from independent experts, nor any mention of costs, evidence, harms, alternatives, or conflicts of interest. It is essentially advertising.
This is also a classic of disease-mongering and overdiagnosis, and chronic dry eye was used in the 2015 Preventing Overdiagnosis conference as an example of the “formula” for the selling of a disease.
According to the FDA-approved product label, Restasis is “indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.” Keratoconjunctivitis sicca is caused by inflammation that decreases tears and salivary secretions, and may be associated with other autoimmune conditions such as rheumatoid arthritis.
This is not the same as chronic dry eyes, which have many causes, including decreased tear production (most commonly from aging) and contact lens use; and increased tear evaporation (from dry air, diminished oil production with aging by glands in the eyelid, prolonged screen use without blinking, and other conditions). Artificial tears are the first line in treating all these conditions.
It’s hard to imagine that the blurring of these two diagnostic groups–which would expand the potential product users from those with keratoconjunctivitis sicca to everyone with chronic dry eyes–is anything but deliberate.
Also, cyclosporine ophthalamic solutions similar to Restasis have been around more than 30 years, and yet the thrust of this story is to get consumers to go to the manufacturer’s website to take a self-diagnostic test which is the entree to the physician’s office, and hence likely to lead to a new prescription specifically for Restasis.
Costs are not mentioned in this story. A quick internet search shows that two packets of 30 vials of Restasis costs more than $300. For comparison purposes, a bottle of generic artificial tear drops costs about $10. Also, there is no mention of the issue of insurance coverage for the cost of Restasis. Some insurers limit coverage for topical cyclosporine or require cumbersome prior authorization to approve coverage.
We learn that “Allergan’s prescription drug RESTASIS®, works by increasing the eyes’ natural ability to produce tears,” but nothing about how it was tested or how well it actually works.
Nothing in this story discusses any harms, but the product label tells us that “In clinical trials, the most common adverse reaction following the use of RESTASIS® was ocular burning (17%). Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).” The label also says: “reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the vial tip touching the eye during administration).”
No evidence was cited.
There was a systematic review in 2013 of 18 randomized trials of topical cyclosporine; 9 out 9 symptoms evaluated showed improvement, but there was no improvement for patients with dry eyes from surgical procedures such as LASIK or contact lens use.
This is pretty clearly as over-the-top disease mongering as you’ll find, and the helpful-sounding self-diagnostic questionnaire is a huge red flag indicating that people are about to be turned into patients. Also, turning chronic dry eye into an acronym–“CDE”–elevates it to medical jargon status.
Presumably the celebrity in question, Marisa Tomei, is working for the company, but even that detail was not presented.
The article said that the actress Marisa Tomei “turned to RESTASIS® because she didn’t want to keep worrying about constantly using eye drops.” So how does the product compare to standard artificial tears? Again, another lost opportunity to inform. With this drug, according to the product label, you still have to put it in your eyes at least twice a day.
It’s available and as “simple as going to your doctor,” according to the celebrity spokesperson. (But as we discuss in the Costs criterion, it’s not free nor necessarily covered by insurance.)
How does this product differ from the other cyclosporine ophthalmic solutions on the market? This article does not tell us.
The story does not appear to rely solely on the news release, since it includes novel quotes from Marisa Tomei. That would normally merit a Satisfactory rating. However, considering Tomei has a partnership with the drug manufacturer, it’s hard to say this story really goes a step beyond the PR effort. We’ll split the difference and give this a N/A rating.