Merck Shot Down Again For OTC Mevacor
Since 2000 Merck has been presenting the FDA evidence on why they think their statin drub Mevacor should be approved in a low dose for OTC (over the counter sales.)
Fortunately the FDA has denied them once again.
As I have written before and you will find in many printed books, publications and other scientific studies that there is an inherent risk with these statins where individuals should not go unmonitored. Honestly with the practice of prescribing medications these days by most physicians, these risks are still very high because patients are not being properly warned or even monitored.
Aside from all this, statin drugs are only treating the symptom of high cholesterol, and in many cases can be totally avoided, for the patients better welfare.
Oh yeah, almost forgot, cholesterol management still has not been conclusively proven to prevent cardiovascular disease.
It has been said, introducing coffee enema’s to individuals with high cholesterol could bring the statin industry to it’s knees.
So, in Mercks latest attempt to bring Mevacor to the OTC market here are a few comments made from various sides of the issue:
Too many of the wrong people would use the drug if it no longer required a prescription, advisers to the Food and Drug Administration concluded in a 10-2 vote against nonprescription sales of the medication.
“The patients couldn’t figure out whether the drug was for them,” said one FDA adviser, Dr. William Shrank of Harvard Medical School.
Merck argued that offering a low dose of Mevacor on open drugstore shelves, next to the aspirin, would persuade millions of people with moderately high cholesterol levels to take a pill that might prevent a first heart attack.
Health Warrior Comment: They key word here is might prevent, remember this has not been proven and with the inherent risks of depleting coQ10, a necessary nutrient for cardiovascular health, why run the risk. And a quick aside, did you know that Merck has held a patent for a combo of Mevacor and coq10 and has never allowed it to come to market–EVIL!
The FDA’s advisers, however, were struck by how many people, in a study of almost 1,500 potential customers, wanted to buy the drug even though they were bad candidates.
One-quarter of people who wanted the pill did not have a high enough risk of heart disease to qualify, meaning they would face unnecessary side effects.
Worse still, 30 percent of very high-risk people — those who have heart disease or diabetes or had survived a stroke — wanted Mevacor; these are people who should be under a doctor’s care. Merck says many of them are not seeing a doctor and that a little treatment is better than none.
Yet more than 30 percent of patients already taking prescription cholesterol-lowering drugs said they wanted the over-the-counter version. One-half said they would drop the more potent drug in favor of low-dose Mevacor. To the FDA advisers, that raises big questions about previously protected people setting themselves up for a heart attack.
Health Warrior Comment: Please keep in mind, less might not be more when comparing a lower dose to a higher dose. The damage it could cause might be cumulative, regardless of the dose.
“That’s not good,” said Dr. Kenneth Burman of Washington Hospital Center. “They’re not getting monitored, they’re not getting other medications and they’re not getting counseling.”
Health Warrior Comment: Taking into consideration that Mevacor can increase significant stress upon the liver, combinations with other OTC drugs such as acetaminophen (Tylenol) could be tremendous.
Arthur Levin, director of the Center for Medical Consumers in New York, told Merck: “What I keep hearing from you is, ‘It’s good to be on a statin, it’s good to be on a statin.’ Don’t you think that’s a risk, that they may misdiagnose themselves and take too low a dose?”
Health Warrior Comment: The scary thing is it almost sounds like he would be petitioning for a higher dose?
Britain allows nonprescription sale of the cholesterol-lowering statin Zocor, but only if customers get it directly from a pharmacist — meaning behind-the-counter sales.
Health Warrior Comment: This itself is scary for most pharmacists do not know the inherent short and long term risks of statins.
Merck wants Mevacor to be sold over-the-counter, arguing that with heart disease still the nation’s No. 1 killer, people have become sophisticated enough about artery-clogging cholesterol to try.
Health Warrior Comment: Or maybe it is because it can bring them billions at the expense of individuals health?
But others told the advisers that a drug known to have few serious side effects should have a shot at reaching the millions of people now getting no treatment for high cholesterol.
Health Warrior Comment: Few serious side effects? What do they consider serious, or for that matter a side-effect? This is where your health care has gone folks!
“We’re still failing to prevent this epidemic. It’s time to take bolder action, to try new approaches,” said Dr. Valentine Burroughs of New York’s Mount Sinai Medical School, a Merck consultant.
Health Warrior Comment: I agree with the above comment, and this “bolder action” should not be throwing more drugs at people.
“You should put this drug in the drinking water,” said Dr. David Nash of Philadelphia’s Thomas Jefferson Medical College.
Health Warrior Comment: This guy is abvisouly ignorant to the facts, hoodwinked by the biased stats given to him, doesnt read complete studies, or has the pharmaceutical industry padding his pocket. I hope he was joking, and if not, please question such frightening attitudes and comments. And if you know someone who is attending Thomas Jefferson Medical College, give them a gift for the holidays of a nutrition 101 book.
In Health