Tuesday, November 13, 2007

Zyrtec-D Approved For OTC Use By the FDA

Medscape reports that he FDA has just approved Zyrtec-D for over-the-counter (OTC) use.

Anyone who knows me or my writing knows that I'm very much in favor of free markets. I strongly believe that most economic environments serve people better when government regulation is low or minimal.

In fact at Harbor-UCLA, situated as it is in southern California and having a largely poor and minority patient base, I'm surrounded by very idealistic housestaff and faculty who think I'm an apologist for big pharma, big corporations, and every other "big" thing with negative connotations.

But am I really? Am I a libertarian? No. And here's why.

I see classic libertarians as being almost completely averse to all government functions except for a few things such as minting money, protecting our borders, maintaining a military, and I believe maintaining a civil and criminal judicial system. My attitude is far too hands-on to support such a laissez-faire approach.

Call me hypocritical but there are many government intrusions I whole-heartedly embrace. I don't think, for example, that people should be allowed to lie or make unsubstantiated claims in advertising and I applaud laws preventing such transgressions. But truthfully, such a stance puts me at odds with many"true believers". Likewise, I'm perfectly content to have the government oversee things generally helpful to communities as a whole, such as street cleaning. Why should I pay for street cleaning like most of my neighbors but allow the occasional cheapskate on the block ride for free yet enjoy its benefits? Does that make me a hypocrite? I yam what I yam.

Likewise, I'm also in favor of government intervention when it comes to public safety. Rather than accept a purely libertarian position, I recognize the existence of circumstances in which the government has an overiding public interest.

So what does this all have to do with OTC Zyrtec-D?

I admit that I haven't done a complete review of the world literature on the subtleties of the different non-sedating antihistamines/decongestants on the market. However, no one has ever demonstrated to me (or even suggested) that cetirizine is any better than the others. So why do we need yet another "me too" drug to be approved for OTC use? Why should the FDA want to clog up the market with Zyrtec-D when there are other drugs already out there that do the exact same thing?

Now a true libertarian would welcome the added patient autonomy that OTC's provide (I've heard libertarians argue that there shouldn't be such a thing as the FDA in the first place). To me however, keeping the pharmacy lean and mean and not allowing medications that solve no new clinical problems is beneficial to society and falls under the category of the overiding public concern I mentioned above.

When the market for a particular clinical purpose is fractionated among several different drugs, there is an unfortunate consequence. Adverse reactions and serious side-effects become much harder to monitor. It will be harder to detect truly harmful drugs and remove them from the market. This is so because when smaller numbers of patients are taking them, bad outcomes are more likely to make it under the radar than with more commonly used drugs.

For this reason, I would vote for a more active FDA that demands improved efficacy before approving (or in the case of Zyrtec-D, simply expanding its market to OTC).

I do understand that when more companies are allowed to compete, prices inevitably come down and obviously, this benefits the consumer. But in an era where there are tremendous pressures on the FDA to act on drug applications faster and faster, after-market monitoring becomes increasingly important for safety. To me this concern should take precedent and me-too drugs shouldn't be allowed to expand their markets without real demonstrated advantages over what's already out there.

The one caveat to this would be if a company would formally agree to market a new drug at a substantial discount compared to existing drugs performing the same function. Again, this would result in a substantial benefit to the consumer.

I realize that my positioning of the dividing line that separates the public interest from unfettered free trade is arbitrary and derives from my own personal opinion. I'm willing to live with a certain degree of inconsistency.

And if I were emperor of the world, you would have to as well.

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Anonymous Anonymous said...

I have to disagree. I use myself as an example of someone looking forward to the Zyrtec switch. I use this drug for multi-chemical sensitivity. Did you know that that is a common use for this particular drug, in addition to nasal and seasonal allergies? In my case, I am desperately allergic to formaldehyde. Formaldehyde and formadehyde releasers are virtually omni-present in products such as laundry detergents (I take my own sheets to hotels, and to the hospital when I delivered my child), liquid soaps (try to avoid those), clothing sizers (can't try on anything), dry cleaning solutions (even the "green" ones), adhesives (bye bye band-aids), and second-hand cigarette smoke. I do my best to avoid it, but obviously have ot deal with a certain amount formaldehyde exposure my day to day existence. This results in a almost constant rash, from head to toe. I can't remember very many days in my lifetime when I had clear skin. My allergists have tried multiple drugs - topical and systemic - to combat my reactions. THE ONLY ONE that has any effect at all in mediating my outbreaks is Zyrtec. So I have a prescription. And I pay $60 a month for 30 10mg pills since it is my health plan's highest tier. And I take it every day. I am excited to be able to buy these drugs without worrying about refills. I hope I might see a little financial savings, too.
This drug does solve a clinical problem for me. It solves on for lots of people with chemical sensitivities. The other drugs DO NOT do the exact same thing for us. They don't help at all.

November 24, 2007 11:01 AM  
Anonymous Anonymous said...

Zyrtec is the only allergy Rx that works for me. I have terrible seasonal allergies and have tried every prescription on the market. I have paid dearly for Zyrtec when it has not been paid by my insurance(due to Claritin OTC) by dearly, I mean $60+ per 30 day supply. I welcome not having to go to the doctor and pay a co-pay just to get a Rx that I have used for 10 years.

December 18, 2007 12:51 PM  
Blogger Unknown said...

I agree with the person above who said it works for chemical sensitivity. i think it does. It's OTC now for Zyrtec; once you get over the fatigue and drowsiness it causes, it helps with the chemical sensitivity.

April 14, 2010 2:18 PM  

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