Dry, irritated eyes can be a real problem for many people. It can interfere with sleep, reading, and just about any activity involving the eyes. In terms of quality of life, one study on dry eye syndrome (the technical name for chronically dry eyes) says that severe cases are as bad as severe angina and dialysis!
Big Pharma markets a chemotherapy drug for dry eye syndrome called Restasis eye drops. But do we really need to put chemotherapy into our eyes to take care of this problem? There should be a better way. And, as you’re about to see, there is.
You’ve probably seen the TV commercials for Restasis eye drops. These ads have not gone unnoticed. Between 2009 and 2015, Restasis made over $8.8 billion! And you have to admit, that’s incredibly impressive for eye drops that contain a chemotherapy drug and almost never work any better than placebo. In fact, it’s so ineffective that it can’t even get approval in the European Union, Australia, or New Zealand. If only drugs worked as well as Madison Avenue!
So, how does such an ineffective drug find its way into your eyes? In a recently published article in the Journal of the American Medical Association, Lisa Schwartz and Steven Woloshin, physician-researchers at The Dartmouth Institute for Health Policy and Clinical Practice, answer that question. They graphically point out just how likely it is for corruption to pop up when billions of dollars are up for grabs.
The makers of Restasis first applied to the FDA for approval in 1999. That application failed when reviewers and a unanimous FDA advisory committee concluded that the drops did not work. Not to be deterred, they tried applying four more times with the same result.
Then in 2003, even though the data clearly shows that Restasis does not improve symptoms any better than a placebo, the FDA approved the drug for sales on the flimsy evidence of a validation study, which showed that the drug improved a test for tear production. So, while it’s not an effective treatment for the symptoms of dry eyes, it is marginally effective in improving a test. Even then, it improved the test in only about 1 in 10 people. Australia's regulatory agency found that the very same data showed “no convincing or sustained benefit to patients who had been treated with the drug.”
So why do Americans pay so much money for a drug that potentially does so little for a condition that many would not even consider to be a disease? Schwartz and Woloshin point to the extensive marketing campaign to sell chronic dry eyes as a disease, and Restasis as the only viable treatment option. Schwartz and Woloshin describe just how effective drug companies have been at labeling everything as a disease that needs a drug.
Restasis makers take the merely unpleasant experience of itching or watery eyes (often caused by allergies, cell phones, weather, or other common irritants) and turn it into a disease. Then they go so far as to warn about all of the potential health consequences of undiagnosed and/or untreated dry eyes.
This is an all too common practice. Just because you have symptoms does not mean that you have a disease. If you have symptoms, work with a naturopath or a medical doctor versed in natural medicine and before you resort to drugs first try and figure out what is causing the symptoms and treat the cause. I guarantee you that it’s never a deficiency of a drug.
The Perfect Drug
From Big Pharma’s perspective, Restasis is the perfect drug. Since it relieves only the symptoms without actually correcting the disorder, you have to take it forever to keep the symptoms at bay. There’s no doubt that a drug like Restasis has the potential to generate sales forever.
But is it safe to take it forever?
Restasis eye drops contain the drug cyclosporine. Cyclosporine is an old drug.
So we already know a lot about it. It’s an immunosuppressant, which suppresses the activity of the immune system. Your immune system eliminates toxins and infections from your body. But cyclosporine interferes with that function.
Here’s how it works for dry eyes. First, something starts to irritate the eyes. This could be something as simple as a reaction to dust, mold, animal dander, or pollen. Or it could be something subtler, such as the fumes from a perfume, a furniture polish, or the smell of new carpets or drapes. The irritation could even come from a food allergy. Or it could be from the radiation and glare of computer screens.
In addition to an irritation source, there’s always an imbalance in the body that prevents your body from adapting to and resolving the irritation. The most common imbalances that can lead to this problem are an insufficiency of the adrenal, thyroid, and/or sex hormones. This is precisely why the condition is so much more common in older women. They usually have a deficiency of all the above.
But other deficiencies also play a role. The most common are deficiencies of vitamin A, zinc, selenium, or the essential omega-3 and omega-6 fatty acids (the kinds that are found in fish oils and evening primrose oil). Very often, all of these factors work together to create a chronic irritation of the eyes.
So How Does Restasis Work?
Your immune system recognizes this irritation and starts to do what it’s supposed to do: It eliminates the irritation. And it uses inflammation to do so. However, the immune system can’t stop the original cause from constantly irritating your eyes. So your immune system just keeps on creating inflammation.
Then, after months or even years, the chronic inflammation causes the eyes to stop producing tears. The lack of tears only worsens the original irritation. And the whole process intensifies. The end result is a patient who complains of irritated, dry eyes that can be relieved only by putting a drop of artificial tears in each eye every one to two hours. That’s where Restasis comes to the rescue.
Restasis contains an immune-suppressive drug. So putting it in your eyes will suppress the immune system, which eliminates the inflammation. The good news is that instead of needing to use artificial tears every one to two hours, you can have the same level of symptom relief by using Restasis only twice a day. The bad news is that since Restasis does nothing to clear up the actual cause of the dry eyes, you must use it forever.
Relief Comes With Terrible Side Effects
Before you decide to use Restasis for the rest of your life, let me suggest that you take a look at the side effects of the drug it contains. Some of the worst are seizures, loss of consciousness, difficulty controlling body movements, changes in vision, confusion, headache, diarrhea, heartburn, muscle or joint pain, breast enlargement in men, and difficulty falling asleep or staying asleep.
That’s an awfully long list of potential problems. And to be fair, in all the studies that I investigated, none of these side effects showed up. The only reported side effects were burning of the eyes in 17% of those using the drops, and redness of the eyes, discharge, eye pain, strange body sensations, itching, stinging, and visual disturbance (most often blurring) occurring in 1-5%. However, please keep in mind that the longest study I could find was only 12 months long. Nobody really knows what’s going to happen after 12 months.
Since you’re supposed to use Restasis indefinitely, I don’t think you should use this drug unless you feel like being a guinea pig for Allergan, Inc.
Correct the Problem Instead
Rather than being a guinea pig, why not just correct the problem that caused the dry eyes in the first place? After all, everything has a cause. This may include hormone replacement therapy (using bio-identical hormones) and/or vitamin supplementation.
As I mentioned earlier, one of the common causes of dry eyes is omega-3 deficiency. And one study found that taking omega-3 supplements can help.
The authors of the study looked at all of the published information on dry eye syndrome and omega-3 supplements between 2007 and 2013. The data included seven different trials involving 790 men and women. All the studies were published between 2007 and 2013. Why omega-3 oils? It's because omega-3 oils are instrumental at decreasing inflammation. And, as I mentioned earlier, inflammation is now understood to be a primary cause in the development of dry eye. The studies they examined looked at two tests for dry eye syndrome.
One test is called the "tear breakup time" (TBUT). Normal tears form a continuously available film on the eyes that prevents them from drying out. Blinking maintains the tear film. However, if you keep your eyes open long enough without blinking, the tear film will start breaking up. Your eyes will feel uncomfortable forcing you to blink. In patients with dry eyes, the tear film is unstable, and breaks up faster. Therefore, the TBUT in patients who have dry eyes is shorter. Their eyes become irritated and they feel the need to blink more often.
The other test they looked at was the Schirmer's test. This test looks at the amount of tears that a person's eyes can produce. People with dry eyes can't produce enough tears, and their Schirmer's test results indicate that. So here is what the researchers found out about omega-3 supplements and dry eye syndrome. It worked pretty well. The supplements increased the TBUT by 61% and the Schirmer's test by 60%. The authors concluded, “Consequently, our findings suggest that omega-3 fatty acid offers an effective therapy for dry eye syndrome.”
So if you suffer from dry eyes, before you go right out and start putting a chemotherapy chemical into your eyes, how about trying something natural like omega-3 oils?
One More Option That Works
I think everyone needs to be taking an omega-3 supplement like Complete Daily Oils to improve the moisture in your eyes. But there’s one other thing you can do. I’ve had great results over the years using a homeopathic eye drop that you can now buy over-the-counter. It’s called Similisan Pink Eye Relief.
These drops contain homeopathic concentrations of belladonna, hepar sulphurius, and euphrasia, and they are very effective at eliminating eye irritation no matter what the cause. They don’t contain any drugs. And they can be safely used even in pregnant and nursing mothers. While the Similisan drops treat the symptoms, you and your doctor can look for and eliminate the factors that caused the irritation in the first place.
You can find Similisan Pink Eye Relief at most health food stores and on the Internet. You can even find it at some Walmart and Target stores.
Lisa M. Schwartz, MD, MS; Steven Woloshin, MD, MS. A Clear-Eyed View of Restasis and Chronic Dry Eye Disease. JAMA Intern Med. Published online January 2, 2018.
Restasis: Why US consumers paid billions for drug deemed ineffective in other countries January 2, 2018, Dartmouth College.
Galatoire, O., C. Baudouin, P.J. Pisella, F. Brignole. “Flow cytometry in impression cytology during keratoconjunctivitis sicca: effects of topical cyclosporin A on HLA DR expression.” J Fr Ophtalmol. 2003 April;26(4):337-43.
NIH web site: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601207.html.
Restasis website: http://www.restasis.com
Stonecipher, K., H.D. Perry, R.H. Gross, D.L. Kerney. “The impact of topical cyclosporine A emulsion 0.05% on the outcomes of patients with keratoconjunctivitis sicca.” Curr Med Res Opin. 2005 July;21(7):1057.