Merck & Co. is taking more steps to sell the granddaddy of the famed cholesterol-lowering statin drugs in the U.S. without a prescription.
The Food and Drug Administration is deliberating if it is time to let Mevacor become the first over-the-counter statin, with a low-dose version sold on open US drugstore shelves right next to the aspirin.
Twice since 2000, the FDA has said no. The worry: That too many of the wrong people would use Mevacor, the seriously ill who should see a doctor instead of self-medicating - or people not sick enough to need a drug who thus would unnecessarily risk side effects.
Thursday, Merck brought its case before FDA's scientific advisers, again. It argued that of 20 million Americans with moderately high cholesterol who qualify for statin treatment, only 6 million now are treated - and that a nonprescription option would encourage many more to give it a try.
"This is a real opportunity," Merck's Dr. Edwin Hemwall told the panel.
He acknowledged that letting Mevacor move over the counter would mark a big shift in national health policy - it would in many ways be the most complex nonprescription product available. But Merck contends consumers have become sophisticated enough about heart-clogging cholesterol to use an OTC statin properly.
"This is a significant step. We commit to do it responsibly," Hemwall said.
But FDA scientists pointed to red flags in Merck's study of almost 1,500 potential customers, who read label warnings to decide if they were proper candidates.
Merck said most ultimately made the right choice.
But the FDA said a quarter of people who thought they were good candidates in fact did not have a high enough risk of heart disease for Mevacor.
Worse, 30 percent of people who already have heart disease, diabetes or had survived a stroke wanted to buy over-the-counter Mevacor - people who are supposed to be under a doctor's care. Merck contends not all are, and that a little treatment's better than nothing.
But more than 30 percent of patients who already take prescription cholesterol drugs said they wanted the over-the-counter version. Most were on much more potent statins than low-dose Mevacor. Yet FDA found more than a quarter of these people planned to take both drugs, increasing their risk of side effects for little if any extra gain.
And more than half said they would replace their more potent prescription statin with the OTC one - begging the question of whether they'd be at increased risk of a heart attack. Some said they thought it would be cheaper and they could skip some doctor visits.
"Should we be concerned?" FDA reviewer Dr. Eileen Craig asked the panel.
Many physicians have concerns, too, although cardiologists are not unanimous about an over-the-counter statin. The American Heart Association is remaining neutral, while the American College of Cardiology opposes it.
Patients require repeat testing to check if their cholesterol is dropping or if they need a higher dose - and studies show that to lower the risk of a heart attack by about 25 percent requires daily statin use for five years, says Dr. Steven Nissen of the Cleveland Clinic.
"Do we really think people are going to take an over-the-counter pill every day for five years, or are they going to take them sporadically?" Nissen asked. "This will not enhance the public health."
Since 2004, Britain has allowed a Mevacor competitor, Zocor, to sell without a prescription as long as a pharmacist directly dispenses it to patients, so-called behind-the-counter sales. It is not clear how much that approach has boosted statin use. Merck wants unfettered over-the-counter sales in the US - but did pledge to sell only in stores that have a pharmacy, not spots like convenience stores, in case customers have questions.
Key to Thursday's debate is how consumers assess if they are good candidates for the drug.
Among the criteria:
-Men must be 45 or older, and women 55 or older.
-They must have so-called "bad" or LDL-type cholesterol levels between 130 and 170.
-They also must have at least one other risk factor, including smoking, a low HDL or "good" cholesterol level, high blood pressure, or a relative with heart disease at a young age.
-Users must not already have heart disease, or have very high cholesterol, diabetes or be a stroke survivor. Those people need a doctor's care.
-They must not have liver disease, be pregnant or breast-feeding, or have had muscle pain from taking any previous cholesterol medicine, all risks for side effects.
The agency scientific advisers will make a recommendation Thursday on the pill's fate, but the FDA is not bound by that advice and it is not clear how quickly the agency will decide the issue.