Statin quo? The pros and cons of direct-to-consumer use

Manufacturers are trying to persuade the FDA to make the popular drugs available without a prescription.

By Susan J. Landers — Posted June 7, 2004

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Millions of people worldwide use statins, and the medication's safety record is admirable, so why not allow sales of these lifesavers without a prescription?

Physicians have varying answers.

Statins should be considered vitamins for the heart, say some, while others remain apprehensive at the prospect of these powerful drugs' over-the-counter sale.

"My gut feeling is that they should not be available over the counter," said Philippe O. Szapary, MD, an internist at the University of Pennsylvania School of Medicine's lipid clinic. "It's not like you just take a pill and you're done. Evaluations are necessary until a patient achieves target cholesterol levels."

But there is also the other side.

"I'm all for it," countered William Clifford Roberts, MD, director of the Baylor Heart and Vascular Institute in Dallas. "I think any method of trying to get more people on statin drugs is useful."

The debate about allowing consumers this direct access is serious. It touches on an important role physicians play in helping patients prevent heart disease by steering them to the correct medications, by determining an effective dose, counseling them on important lifestyle changes and monitoring them for adverse effects. A concern many have about the status change for statins is that much of this function could be lost if patients are able to pluck these medications from store shelves.

The FDA rejected pharmaceutical company requests for OTC availability for low-dose statins in the past, questioning whether the drugs could be safely and effectively used without physician guidance. But firms are gearing up for another try that could occur within the year.

Merck & Co., in partnership with Johnson and Johnson, likely will seek approval for OTC sales of Mevacor, which is already available as the generic lovastatin, and Bristol-Myers Squibb Co. is reportedly considering seeking approval for Pravachol, or pravastatin. Both companies approached the FDA before but were turned down in 2000.

It still could be a tough sell, despite an ever-growing body of evidence that statins are safe and effective. After all, opponents say, we're not talking about runny noses and itchy eyes that can be aided by OTC lotradine, we're talking about coronary heart disease, the leading cause of death in the United States.

Additional proof

The arguments for OTC statins likely will be aided by recent findings demonstrating that high doses of the medications can dramatically drive down low-density lipoprotein cholesterol levels and decrease heart patients' risk of having or dying from a heart attack.

"The story is that people are better off with lower LDL cholesterol levels," said Richard Pasternak, MD, spokesman for the American Heart Assn. and director of preventive cardiology at Massachusetts General Hospital.

Prove-It, a study published in the April 8 New England Journal of Medicine, did just that when it found there was a 16% relative reduction in cardiovascular events among patients who received high doses of statins.

"This tells the sage clinician that for people at very high absolute risk [of cardiovascular disease], getting an additional 16% relative risk reduction is worth it," Dr. Pasternak said.

Many consider certain messages from the study to be clear: "If you have coronary disease, you had to be on statins yesterday," said Thomas Bersot, MD, PhD, associate investigator at the University of California, San Francisco's Gladstone Institute of Cardiovascular Disease.

Still, the question of how low a level is low enough remains to be answered. The National Cholesterol Education Program issued guidelines in 2001 recommending target LDL levels of 100 mg/dL for high-risk patients. But in the Prove-It study, the average LDL level of patients went much lower. Those treated with 80mg of atorvastatin reached levels of 62 mg/dL compared with 95 mg/dL for treatment with 40 mg of pravastatin.

NCEP is examining the study and plans to release findings this summer. But it is unlikely there will be a new recommendation for LDL goals much lower than 100 mg/dL without more evidence, said James Cleeman, MD, NCEP coordinator.

Prove-It and other widely publicized trials, such as REVERSAL (the Reversal of Atherosclerosis with Aggressive Lipid Lowering study) have also caught the attention of patients. The latter trial, published in the March 3 Journal of the American Medical Association, showed that intensive statin therapy reduces the amount of plaque buildup in arteries compared with moderate treatment.

These kinds of reports have triggered a certain degree of patient demand. But this, too, has a downside.

"Everybody is asking about statins," Dr. Pasternak said. And, "Everybody is very confused." Often the studies have been incorrectly depicted as contests between brands rather than demonstrations of the effectiveness of higher doses, he said. Others said media coverage of these studies has led people to want to be on statin therapy even if their cholesterol levels are reasonable, or to request higher doses, even if that's not necessary.

It is this level of confusion that leads some physicians to caution against OTC sales, even though there is considerable agreement that statins should be considered a first-line treatment for almost everybody with high cholesterol. There are other reasons for opposition, too.

For instance, although statins are very safe -- some say safer than pain relievers that are freely available over the counter -- they do have serious side effects, including the destruction of muscle tissue. And higher doses can double the risk of side effects while delivering only marginally more benefit.

Some patients also hesitate to take statins fearing liver damage, a concern that is emphasized in television commercials. In addition, the memory of the Baycol (cerivastatin) recall in 2001 has sparked continuing fears.

Baycol was associated with 31 deaths related to rhabdomyolysis, a rare but dangerous muscle breakdown that can lead to kidney and other organ damage.

After its recall, Public Citizen petitioned the FDA to put a warning of the muscle-affecting side effect on all statin packaging, but the agency declined to do so.

Public Citizen also has issued an alert about the safety of the newest statin, Crestor, or rosuvastatin, which was approved last year. The group opposed the drug's approval, citing the deaths of seven people from rhabdomyolysis in clinical trials.

"For people at high risk [of heart disease] the evidence is that statins are effective," said Sidney Wolfe, MD, director of the Health Research Group of the advocacy organization Public Citizen. "The question is, 'Is Crestor uniquely dangerous?' And the answer is, yes it is, unequivocally."

AstraZeneca, the manufacturer of Crestor, said the charges are misleading and alarmist. "The safety of Crestor was evaluated in over 10,000 patients, more than any other statin prior to approval," said David R. Brennan, the firm's president and CEO. The statin won unanimous approval from an FDA advisory committee last summer.

Meanwhile, physicians who oppose the OTC action point to other drawbacks. For one, patients who purchase their statins at the supermarket or pharmacy would miss one of the main messages of the preventive cardiology community -- the importance of global risk assessment, Dr. Szapary said.

"It's not just your cholesterol level. But also, do you smoke? Are you overweight? Do you have high blood pressure? When you put all these things together you paint a portrait of that particular individual's risk," Dr. Szapary said. "I think patients owe it to themselves to get a full assessment."

"I think in America we like chemistry a lot, but sometimes it's better to try some of the old-fashioned things like diet and exercise," said Joseph Miller III, MD, a preventive cardiologist at Emory University. "They work for a lot of people."

Patients also need to reach a certain target level of cholesterol to attain benefits, and without being properly monitored, taking a low-dose statin might not be enough. Some patients might even need two medications to achieve heart health.

Drug firms are eager to attract the attention of potential statin users, as evidenced by the barrage of television commercials touting their virtues. AstraZeneca recently launched a series of ads for Crestor that are aimed at aging baby boomers, raising the possibility that more patients will be asking about using a statin.

Conquering heart disease

The more people who take statins the better, according to Dr. Roberts, a booster of OTC statins, who is serving on a Merck/Johnson and Johnson advisory board that is working to secure such status for Mevacor. He reported that he does not stand to benefit financially from the drug and, although he has received grants from pharmaceutical companies in the past, he has received none for the past five years.

His support, he explained, springs from a desire to conquer heart disease. He draws a parallel: "Do you want to talk about reducing the risk of measles, mumps, whooping cough, smallpox and polio or do you want to prevent them?" he asked. "I'm on a prevention kick."

About 13 million Americans take statins now, and federal guidelines released in 2001 say that 35 million people should be on a statin or other lipid-lowering drug, he said. "But I think if we are going to make a dent in American health, we need 100 million Americans on these drugs."

Dr. Roberts also has responses to questions raised, including expense. For example, switching to a diet that includes less meat would likely free up enough money to purchase statins, he wrote in the American Journal of Cardiology, of which he is editor-in-chief.

Liver function tests, recommended when a patient begins taking a statin and periodically thereafter, are unnecessary, expensive and often frighten patients, he said. "The evidence that liver failure is ever the result of statin therapy is at best tenuous."

Dr. Roberts also deflects concerns that patients won't attain low enough cholesterol levels if they take a low-dose OTC statin. "Patients going to physicians don't get their LDL levels low enough either."

Meanwhile, Great Britain announced the approval of OTC sales of 10 mg of Zocor on May 13, and Dr. Roberts is pained by his own country's reluctance to do the same. "Great Britain has been the most conservative nation in the Western world in reducing cholesterol and, almost certainly, Zocor [simvastatin] will be approved this year for OTC use," he said shortly before the announcement of the approval.

"That's an embarrassment to the United States as far as I'm concerned," Dr. Roberts said.

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Building a case

Sales of over-the-counter statins have the support of some physicians but not all. The ongoing debate centers on:


Pro: Statins have an admirable safety record.

Con: Statins can have serious side effects.


Pro: Statins are effective at lowering the risk of heart attacks and heart disease.

Con: A healthy lifestyle, low-fat diet and exercise may achieve the same results.


Pro: More people will purchase and use them.

Con: Doses of OTC statins will likely be too low to make a difference.

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External links

National Heart, Lung, and Blood Institute advisory on the use of statins (link)

American Heart Assn. (link)

Food and Drug Administration's heart healthy diet (link)

Johns Hopkins University's patient information on heart health (link)

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