Right Call; Wrong Reason

There were several news stories last week that reported that Pfizer had abandoned its efforts to have its Lipitor brand of atorvastatin made available over the counter, without a prescription. I was never a big fan of OTC statins (more on that later) but I was struck by the reason that Pfizer put out:

The study did not meet its primary objectives of demonstrating patient compliance with the direction to check their low-density lipoprotein cholesterol (LDL-C) level and, after checking their LDL-C level, take appropriate action based on their test results. 

Left unstated (and unclear) in this is exactly what the appropriate action was supposed to be. I guess they were implying that patients were supposed to check how they responded to the drug and then figure out if they should keep taking it, change the dose or seek professional advice about next steps.

Here’s the irony with that. The current practice guidelines of the American College of Cardiology and American Heart Association for the management of high cholesterol no longer advise physicians to check how patients respond to statin therapy, or to adjust the dose up or down to achieve a “target” LDL-cholesterol level. Instead, they suggest that we assess a patient’s overall cardiovascular risk using an online calculator, which includes consideration of the patient’s age, blood pressure and other risk factors, and then prescribe moderate or high-dose statin (or no statin) based on the result. No more checking the on-treatment LDL-cholesterol.

So it seems that Pfizer determined that they should not go forward because patients are not capable of doing what doctors are not supposed to do. Makes no sense to me.

Nevertheless, this strikes me as the right decision for the wrong reason. Despite the low toxicity and high therapeutic value of statins, I don’t think they should be offered OTC. The analogy with other formerly prescription only medications like H2 blockers or antihistamines is poor. Those drugs are useful for episodic use for symptomatic conditions, not continuous treatment of silent ones. Statins may be more like vitamins – something that (if indicated) should be taken regularly. Given the importance of cholesterol management, I believe that if a patient needs the drug, it should be prescribed at a therapeutic dose (higher than what was going to be offered OTC). If the patient doesn’t need the drug, then why take it at all? I also think that the best way to make that determination is in consultation with a physician.

What do you think?

3 thoughts on “Right Call; Wrong Reason

  1. A patient can’t order their own lab work- this whole concept is ridiculous! The best thing one doctor did was to put on the EMR that statin gave me seizures. He bullied me into taking statin for PREVENTION. I kept telling him that nobody in my family had any heart problems-all grandparents lived into their late 90s or longer (103 and physically active-car wreck). He called me a liar. My right Achilles tendon ruptured, I urinated BLACK for over 90 days, etc.
    My current PCP tried to put me on statin on the last visit. I told her that statin made me pee black, my disabled vet son had to help me out of bed and walk- get me out of the bath tub. TG for the EMR- I told her to look at the EMR-drug allergies- it said- Statin- side effects- seizures-Helped that I had one in his office. To me statin = Satan. It ruined my life, I was hiking in the mountains with my hounds. I could control my weight. My legs and feet didn’t hurt all of the time. I didn’t have peripheral neuropathy up to my knees, my feet went twisting from muscle damage. It’s all about meeting NIH, FDA, and Medicare goals for the so called prevention of LDL- At least, I escaped dementia. My current doctor had such a sick look on her face.
    If something makes you sick–injures you–Why do modern doctors tell you to take it again? I wish that I had lied- and said that I was taking it, but put it in the trash. I just had a bad feeling about it- and all of this happened in less than 90 days. I just thought that I’d get a rash or something. Simvastatin 10 mg once a day. I won’t even take a lipid test-as That keeps the fight from spreading. It’s No- absolutely NO- What part of No don’t you understand? I’m in remission for a nose-mouth cancer- never smoked-and this Feb, The reading radiologist declared my scan with contrast didn’t show any plaque on my left side, and negligible on the right side. I’m 73—and my current PCP wouldn’t consider that at all. I’m 73—some of the nurses have told me to tell the naggy doctors that I don’t take sleeping, pain, or nerve pills. My mind is alert, I’m articulate, my BP is normal when my thyroid is controlled, so take care of my sinus infection-talk about my thyroid, but leave the rest of me alone, isn’t it bad enough that I’m lame from being poisoned, that I beat an incurable cancer- at least for now.

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