Thursday, August 4, 2011

Why OTC Lipitor is a Bad Idea

As reported by the Wall Street Journal, Pfizer, the maker of one the best selling drugs ever, is trying to get the FDA to approve an Over the Counter (OTC) version of their blockbuster Lipitor, not coincidentally on the eve of Lipitor going generic.
Readers of this blog know that I am a big proponent of cholesterol lowering medications like Lipitor (statins) for patients at moderate to high risk of cardiovascular disease.  In particular, I am a fan of the more potent statins like Lipitor and Crestor, because of their increased efficacy with fewer side effects (see Don't Take High Dose Simvastatin).  Finally having a generic version available of Lipitor will be a great thing for many patients.

That said, making Lipitor OTC is a bad move. First, there is a difference between medications like Prilosec and Claritin that have gone over the counter and Lipitor.  Diagnosis for GERD and allergic rhinitis for which those medications respectively treat are made mostly on symptoms alone.  Patients don't need to go to medical school to suspect that they may suffer from heart burn or allergies. Starting treatment without seeing a physician is actually medically sound because more often then not the medications will relieve symptoms avoiding a physician office visit.  In contrast, starting a patient on a statin is much more tricky.  Patients need to know their individual risk for cardiovascular disease.  Though there are tools available online to determine this (I use the NIH's risk calculator daily in my clinic), determining individual risk of disease, benefit of taking a medication and weighing this against potential side effects is best decided by a discussion between a doctor and patient. Secondly, before starting a statin medication, one needs to know their cholesterol levels.  Though there are other methods (health fairs, work screenings) of determining cholesterol levels, getting a blood test usually requires a visit to the doctor's office. In addition, follow up blood work (checking for medication efficacy, liver side effects) is warranted after starting treatment. Thus, the benefit of having a medication OTC is negated.  Finally, Claritin and Prilosec are very safe.  They are as safe or safer then other OTC medications.  Lipitor is also very safe, but is associated with rare, but serious side effects.  Taking Lipitor OTC without consultation with a physician creates the risks of patients developing these side effects without proper warnings and therefore potentially worse outcomes if attention is not sought.

The second main reason that OTC Lipitor is a bad idea is that it will hurt more patients than it will help.  The reason for this is that when a medication goes OTC, insurance companies usually will not pay for them.  Now that Allegra is over the counter, it is virtually impossible for any of my patients to get a prescription version antihistamine.  Though they can easily get this OTC, not having a prescription means they need to pay for it out of pocket.  The cost of an OTC medication, even if the generic OTC version is used, is generally more than the co-pay for a generic prescription.  It is unlikely that generic Lipitor will make the $4 Walmart or Target list, but after six month, the co-pay for generic Lipitor would still likely cost a lot less for most patients then paying for OTC Lipitor out-of-pocket. 

Bottom Line: The reason why Pfizer wants Lipitor OTC is for one reason: to make more money.  They can argue that cardiovascular disease is the number one killer in the US, and by having Lipitor OTC, it will be available to more patients.  However, because statins require blood work and medical consultations, the risk of harm to patients outweighs the potential benefits of greater availability.  In addition, this will result in cost-shifting to patients in order to boost Pfizer's profits. Hopefully, the FDA will say what they said when Merk tried to pull this off: "No."


Michael D. Shaw said...

Here's another reason...

Anonymous said...

Dr. Mintz....amazing blog...great point here. You show why GOOD internal medicine is complex and requires the thought you put into it. I'm taking care of a patient with virulent rhabdomyolysis most probably from a statin....he might not have been diagnosed as even having it if not for bloodwork for an unrelated, probably viral syndrome.

Anonymous said...

Dr. Mintz,

Just read your post. Do you also object to a behind the counter designation?


Dr. Matthew Mintz said...

That's a really good question. In theory, a behind the counter designation could work. Patient could bring in lab values, trained pharmacist could ensure proper usage, refills would not be allowed without documentation of liver enyzme testing. Practically speaking though, I don't think this would work. Behind the counter works for limiting the supply or ensuring preventing inappropriate use by minors. Don't think it would work to the degree it needs to ensure safe proper use.

Ticked said...

This is simply madness...arrogant madness. I have hyperlipidemia and no diet or BMI will change my profile (thanks Dad!). I know my values, how I feel on and off statins, etc. better than any physician I have ever had. I have scoured news sources for all those people injured by a 40 mg Zocor or 10 mg of Crestor or ???? and they don't seem to exist. And yet I am prevented...prevented by profiteers from managing my own health, my own body. How is that ethical, much less legal?

Modern medicine has a LOOOOONG history of unnecessary roadblocks and testing (ladies, oddly enough, get the worst of it..hmmm) and once again, history will not be kind here.

The FDA doesn't serve American consumers / patients. It's doctors looking out for doctors. Enough already. Cannot get sDNA out of the gate. Cannot get home HPV DNA testing out of the gate. Cannot get OTC statins out of the gate.

So now that I've vented my about a compromise? OTC zocor (simvastatin) up to 40 mg? Show me one person injured by such a dose...just one.

Oh the hell with it...I can construct my own cocktail that does what most statins do (Quercetin, D-3, etc). And we know the #s and the pathetically assinine good cholesterol/bad cholesterol model is entirely wrong (Zetia vs. Zocor, HDL drugs causing extra CV events, etc.). It's like having the ugly girl turn you down for the prom....not playing anymore.