HEALTH

FDA panel votes to keep Mevacor statin prescription-only

BY Michael Johnsen

SILVER SPRING, Md. A pair of Food and Drug Administration advisory panels Thursday evening voted 10-to-2 (with one abstention) against the switch of Merck’s Mevacor 20 mg from prescription-only to over-the-counter status, suggesting that a statin will not be switched to OTC in this country.

During its presentation before the committees here Thursday morning on the potential switch of the statin Mevacor to over-the-counter status, Merck and new partner GlaxoSmithKline presented new consumer-usage studies claiming improved self-selection outcomes after implementing several label revisions recommended by the FDA following Merck’s 2005 Mevacor switch application, to be called Mevacor Daily if approved.

It was inadequate self-selection among consumers that was a significant factor in scuttling Merck’s last attempt to switch Mevacor, and it was a major factor in scuttling this attempt as well.

However, Merck’s new studies found that more consumers correctly self-selected as compared to 2005. “For the small fraction that made a mistake” the chance of a serious adverse event is extremely low, noted Edwin Hemwall, Merck’s executive director of worldwide OTC regulatory and scientific affairs. Indeed, consumers approached a 90 percent level in making appropriate decisions regarding the use of Mevacor Daily, Hemwall said.

“We know that Mevacor Daily is indicated for a motivated, [health-conscious] consumer,” commented George Quesnelle, president of consumer healthcare, North America, for GlaxoSmithKline, Merck’s new switch partner. “GlaxoSmithKline has a [proven] track record … for first-in-class switches,” Quesnelle noted, pointing to the company’s successful switch of complicated regimens like smoking cessation products and the diet aid alli. If switched, non-branded education to help raise awareness around statins will be launched into the marketplace, Quesnelle said, long before Mevacor Daily actually hits shelves.

GlaxoSmithKline’s marketing initiatives were submitted along with the application, Quesnelle said.

Some of the label revisions include a highlighted age-exclusion graphic on the front of the package and a stronger warning against the use of Mevacor Daily in women who are pregnant or could become pregnant.

Merck presented usage studies of two labels—one that asked consumers to evaluate whether or not they should take Mevacor Daily based in part on their knowledge of their total cholesterol scores and one that based that evaluation on a consumer’s low-density lipid levels. Merck concluded that consumers were more familiar with their total cholesterol levels.

Merck also proposed selling Mevacor Daily “on the open shelf but only in those stores with pharmacies.” Limiting distribution to stores-with-pharmacies affords the consumer convenient access to a healthcare professional—nurse practitioner, pharmacist—should they have questions.

However, the new studies have not alleviated all of FDA’s concerns over appropriate self-selection. In the usage study based on a consumer’s knowledge of their LDL levels, for example, 98 percent of consumers chose appropriately not to take the medicine, but only 16 percent of those who chose to take the medicine, did so appropriately.

In addition, more than 30 percent of participants who were already taking a lipid-lowering drug stated that they were appropriate to use an OTC statin. Of those, 55 percent would replace their current lipid therapy with the Mevacor Daily and 28 percent would take Mevacor Daily in conjunction with their current statin therapy.

Half of those already on a statin regimen would make the switch to Mevacor Daily based on cost concerns, with the assumption that an OTC medicine would be cheaper than their prescription-drug co-pays; 29 percent cited improved convenience in buying Mevacor over-the-counter; 15 percent said an OTC statin would mean they wouldn’t have to see their doctor as often; and 11.3 percent opined that OTC medicines present fewer side effects than their prescription-only counterparts.

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Study shows Americans prefer OTC cholesterol drug over prescription

BY Michael Johnsen

WASHINGTON According to data released by the National Consumers League Wednesday, Americans with unhealthy cholesterol levels would still be more likely to consider taking an over-the-counter statin option than a prescription product, although the likelihood to purchase an OTC has decreased since the subject was debated in 2005.

Overall, 82 percent of those surveyed responded that an OTC statin would be preferable to a prescription statin. For those respondents who say they are more likely to consider taking the OTC product than an Rx product, the OTC is more appealing largely because of convenience factors.

The general opinion among consumers is that OTC statins would be viewed as safer, more natural, more suitable for someone who takes charge of his or her health, and less likely to cause side effects than Rx statins, despite the fact that those OTC statins would in fact be lower-dose versions of those same Rx statins.

Those who prefer the Rx option have a greater trust in the product and the fact that a doctor prescribed it. The Rx version is generally viewed by at-risk respondents as more effective, more reliable, more trustworthy and more suitable for someone in poor health than is an OTC statin.

Those most inclined to use the OTC statin include individuals with greater levels of concern about cholesterol, those with higher known cholesterol levels, and those who take vitamins or supplements on a daily basis. As many as 98 percent of those who reported being most concerned about their cholesterol indicated that the OTC product would be appropriate for someone with health care needs much like their own. And 94 percent of all respondents reported that the OTC product would be appropriate for someone who takes charge of his or her health.

Appropriately self-selecting was one of the key factors that scuttled the last Mevacor switch application in 2005. Merck is supposed to be updating its customer-usage surveys with better self-selection data to be presented before a Food and Drug Administration advisory committee meeting on Thursday.

The survey also found that people want to know more about OTC statins, and in fact, are more than three times as likely to seek out additional information about the OTC statin than the Rx statin (79 percent vs. 21 percent). They were also much more likely to discuss the OTC product than the Rx product with their doctor (64 percent vs. 36 percent).

Although the survey revealed a strong preference for the OTC option, it found a decline since 2004 in respondents who said they were very or extremely likely to use an OTC statin, from 20 percent in 2004 to 11 percent in 2007, a fact that may reinforce Merck’s updated self-selection usage studies.

“For the more than 100 million Americans who have high cholesterol, the challenge of keeping the bad number low and the good number high is a very real one,” stated Sally Greenberg, executive director of NCL. “In this atmosphere of increasing availability of medications without prescriptions, the introduction of an OTC statin could expand the total number of people getting treated for high cholesterol. Are consumers interested in an OTC statin option? According to our survey, they are.”

The survey was commissioned by NCL and conducted by Harris Interactive between Oct. 25 and Nov. 5. A total of 710 adult Americans at known moderate risk for high cholesterol participated.

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Life Tech introduces fertility supplement

BY Michael Johnsen

NEWPORT BEACH, Calif. Life Tech on Wednesday launched its Fertili-T supplement, a supplement formulated to support fertility, for both men and women.

The comprehensive product line is comprised of programs specifically designed for the varied conditions affecting fertility in approximately one in six American couples, including diagnosis of endometriosis, polycystic ovarian syndrome, uterine fibroids, male factor infertility and unexplained infertility.

“We’ve spent years developing Fertili-T to be effective for both men and women,” stated David Tieman, Life Tech co-founder and lead inventor. “After a development process involving extensive review of the leading published study results, our own ingredient analysis and clinical trials, we are confident that Fertili-T offers an evidence-based approach to preconception with the utmost product quality and safety assurance. …

“As a husband who has experienced the difficulty of infertility firsthand—personally familiar with both In Vitro Fertilization and miscarriage—the development of Fertili-T has become a passion for me,” Tieman said. “I’ve learned that there is no ‘one size fits all’ solution and it’s what has pushed me to use my extensive background in sciences and health to formulate a customized, all-natural line that really improves people’s chances of conception.”

Life Tech’s Fertili-T preconception supplement programs will be available for purchase online at www.Fertili-T.com beginning this month. Available in powder form or daily pill packets, the products are recommended for ages 25-45.

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