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A Carton of Milk and a Pack of Statins

Since the FDA's comprehensive review in 1972, a slew of drugs have switched to OTC status, including ibuprofen and other nonsteroidal anti-inflammatory drugs, antihistamines, decongestants, and antifungals.

In 2004, British officials approved OTC sale of simvastatin (Zocor, Merck). But in the U.S. the issue of OTC statins has come before the FDA three times, and three times the agency has said "no."

Proponents suggest that allowing drugs like statins to be sold without a prescription increases the likelihood that people will reduce their health risks. OTC status stimulates competition and could help lower drug prices, they say. Those opposed to the move claim that high cholesterol is difficult for people to self-diagnose and that the statin drugs are not without risk.

DOC News asked:

Should statins be switched to OTC status?

I happen to be unable to take statins because I encountered an adverse reaction to three different statins. In particular, I experienced muscle pain and other pretty serious signs of myopathy. My physician and I agreed that it's not a good idea for me to pursue lipid lowering through statins.

The lesson in that story is if this had been an over-the-counter drug, I may or may not have been able to be monitored closely enough to detect the nature of the problem. The safety record of statins is really very good, and one of the reasons may be the close monitoring available for this prescription drug. Based on my personal experience, I would not recommend over-the-counter purchases to my friends.

Peter Kaufmann, PhD Research Psychology Bethesda, Md.

The short answer is we're not quite there yet. Is there a benefit to statins? Yes, the benefits are well established. Could all Americans benefit from some of the effects, such as decreasing the inflammation of arteries that leads to coronary heart disease, in addition to the cholesterol-lowering effect? Yes. Everybody could benefit from those.

But there still are some questions not answered about long-term effects if everybody at large were to take this. There are some unknowns, and that's why I say we're not quite there yet. For example, what about interactions with other medications people may be taking? I don't have the confidence level yet to say let's put it over the counter and let people buy it and take it off the shelf. We still need some kind of professional management. People might take statins by the handful and then go out and eat anything high-fat or high-cholesterol they want. Part of the control is correct dose coupled with good patient education about diet, exercise, and other healthy behaviors.

Again, I think there is still more to be learned before we put statins out on the shelf for everyone to take. But the more we know about the benefits, and as safety is better documented, we're likely to come to that decision. I don't doubt that. I just think we're not quite there yet.

Patricia Comoss, RN Cardiac Rehabilitation Harrisburg, Pa.

I do not recommend statins go over-the-counter. There are several disadvantages to it:

1. Once the physician tells a patient his cholesterol is high, he will get medication OTC and will be under the belief that his cholesterol is better with the OTC statin, even though the OTC statin may not reach the required goal.
   
2. The statins are not safe for every patient. They can cause increased liver function test (LFT) and creatine phosphokinase (CPK) [abnormalities] in some patients, on small doses as well.
   
3. Some patients may take too many statin OTC pills to get their cholesterol down, like taking Tylenol for a headache, and increase their risk of side effects.
   
4. Lots of patients are scared to inform the physician about the OTC meds they are taking, or the physician forgets to check. And if the physician adds a fibrate like gemfibrosil, it will increase their risk of rhabdomyolysis.
   
5. We have several patients with hepatitis C and other comorbid conditions, and if they take an OTC statin, it may damage the liver more.
   
6. In spite of the warning on the OTC products, several patients do not come to a physician to get their LFT or CPK checked after long-term use due to the cost of the physician visit and lab, making a good medication produce a false sense of security, damage to body, and unreached LDL goals.
   

Seema Maheshwari, MD Internal Medicine Eclectic, Ala.

TALK BACK: GIVE A GRADE TO MEDICARE PART D

The new Medicare Part D drug benefit met with rants and raves when launched in January. Part D has been touted as one of the centerpieces of the Bush administration's second term of office, a test of a free-market model of drug benefits for 21 million eligible Americans.

When unveiled, Part D appeared to be a Byzantine maze. Some 260 private companies provide benefits under Part D, each with its own formularies and policies, resulting in a profusion of options. Some drugs covered under one plan are not covered under another. Many beneficiaries discovered that they were not in federal databases and could not get the drugs they need. Others had to pay much higher co-pays than expected. And a program originally pegged at $400 billion over the next 10 years has mushroomed to nearly $700 billion.

But Bush says beneficiaries will pay about half of what they paid for prescription drugs before the new benefit took effect. Congress and the Centers for Medicare and Medicaid Services (CMS) have promised to fix the glitches. Meanwhile, the rollout continues.

What do you think? How is Medicare Part D helping your patients?

Send your comments to docnews{at}diabetes.org.

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This Article Full Text (PDF) Services Email this article to a friend Similar articles in this journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Search for Related Content Social Bookmarking                What's this?