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Re: stasis vs. free flow of information.

By now, most people who watch television are familiar with the following advertisement:

Patient: OK, here's the thing. Doctor, I've been using these over-the counter eye drops several times a day.

Doctor: For how long?

Patient: For quite some time.

Doctor: Have you tried other drops?

Patient: All kinds. Is there something else I can do?

Doctor: I'm writing you a prescription for Restasis.

Patient: Prescription? What do I have?

[Around this time in the ad, the following appears at the bottom of the screen for about 3.6 seconds: "Dr. Tendler is compensated for appearing in this advertisement."]

Doctor: A type of chronic dry eye. Restasis is the only prescription drop to help increase tear production, which may be reduced by inflammation due to chronic dry eye. You'll make more of your own tears and need those other drops less.

Patient: So it works?

Doctor: I use it myself.

Patient (with a look of understated surprise and awe): You use Restasis?

Doctor (with a reassuring smile): Twice a day, every day.

In the interest of equal time for low-cost, safe, and effective natural medicine, the following hypothetical conversation is presented:

Patient: Doctor, my ophthalmologist recommended Restasis for my dry eyes. I can't afford to pay for it out of pocket. The list price is $504 for a 60-day supply. Is there anything less expensive that works for dry eyes?

Doctor: Yes there is. It's called Viva-Drops (Dakola Labs, Mitchell, SD). It contains 0.05% vitamin A and 1% polysorbate 80 (an emulsifier). In a comparison trial published last year in the American Journal of Ophthalmology, 150 patients with dry eye syndrome received Restasis drops twice a day, Viva-Drops 4 times per day, or no treatment (control group) for three months. (1) After three months, both the Restasis and Viva-Drops groups showed significant improvements compared with the control group with respect to blurred vision, tear film breakup time, Schirmer tear test results, and goblet cell density. There was no significant difference in any of these parameters between Viva-Drops and Restasis. However, the frequency of adverse events was higher with Restasis than with Viva-Drops (10% vs. 4%).

[ILLUSTRATION OMITTED]

Patient: So, you're saying that Viva-Drops works as well as Restasis and has fewer side effects?

Doctor: That's what it looks like.

Patient: Is that the only study showing that Viva-Drops works for dry eyes?

Doctor: No. At least four other studies published in the late 1980s and early 1990s found this product to be effective.

Patient: How much does Viva-Drops cost?

Doctor: Less than $10 a month.

Patient: What! How come I've never heard of Viva-Drops?

Doctor: There are two possible reasons. First, the product is so inexpensive that the manufacturer cannot afford a large advertising budget. Second, the FDA has not "approved" Viva-Drops as a treatment for dry eyes.

Therefore, it is illegal for the manufacturer to inform people that the product is effective for that purpose. If the manufacturer does tell people what the product is helpful for, the FDA may deem the product a misbranded drug and remove it from the market. When Viva-Drops was first put on the market, it was called Viva-A drops. However, as told to me by the inventor of the product (now deceased), the FDA banned the sale of Vita-A drops on the grounds that the name constituted a de facto health claim. According to the FDA's way of thinking, there is no reason to put vitamin A in an eye drop other than to treat an eye disorder. The public would know that a product named Vita-A eye drops contains vitamin A, and they would assume that the vitamin was added to improve an eye disorder; ergo, the claim is in the name. After an extended legal battle and tens of thousands of dollars of legal fees paid by the small company, the FDA allowed the product to return to the market under the new name.

Patient: If I understand you correctly, the FDA allows one company to promote an eye drop that costs $250 a month, but it forbids another company from promoting a much less expensive eye drop that works just as well and may be safer. I thought the job of the FDA was to protect the public.

Doctor: Maybe it was.

Alan R. Gaby, MD

Notes

(1.) Kim EC et al. A comparison of vitamin A and cyclosporine A 0.05% eye drops for treatment of dry eye syndrome. Am J Ophthalmol. 2009; 147:206-213. e3.
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Publication:Townsend Letter
Geographic Code:1USA
Date:Oct 1, 2010
Words:748
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