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  #1   ^
Old Tue, Dec-11-07, 21:59
2bthinner!'s Avatar
2bthinner! 2bthinner! is offline
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Plan: Paleo Gluten free
Stats: 242/216/130 Female 5'7.5"
BF:too/dang/much
Progress: 23%
Location: Florida
Default OTC Statin??

http://news.yahoo.com/s/ap/20071212...DbX_lv7TzbVJRIF

FDA weighs over-counter cholesterol drug By LAURAN NEERGAARD, AP Medical Writer
1 hour, 7 minutes ago



The government is questioning if too many of the wrong people will take cholesterol-lowering Mevacor if it's sold without a prescription, days before Merck & Co. makes its third try to move the drug over the counter.

Merck says selling a low dose of this long-used medication on drugstore shelves, next to the aspirin, could get millions of people at moderate risk of heart disease important treatment that they otherwise may miss.

A preliminary Food and Drug Administration review released Tuesday agreed that nonprescription Mevacor would be "a reasonably safe and effective" option if consumers used it as directed.

But when Merck tested if consumers could judge who was a proper Mevacor candidate, only 20 percent answered all the questions completely correctly 50 percent if researchers counted people who said they'd check some things with their doctor before purchasing, concluded FDA's lead medical reviewer.

Moreover, about 30 percent of people who already were diagnosed with heart disease, diabetes or had had a stroke wanted to purchase over-the-counter Mevacor, people who need a doctor's care, the FDA documents say.

The studies "have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product," the preliminary assessment concluded.

Merck argues that most people made the right decision on whether they should buy OTC Mevacor even if they missed some answers.

On Thursday, Merck will present its case to the FDA's independent scientific advisers, hoping they will recommend that Mevacor become the first in the family of cholesterol-lowering "statin" drugs to be sold in this country without a prescription. Twice before, FDA has said no.

~~~~~
Heck, we cain't even use chilluns cold medicines right.....


Quote:
But when Merck tested if consumers could judge who was a proper Mevacor candidate, only 20 percent answered all the questions completely correctly 50 percent if researchers counted people who said they'd check some things with their doctor before purchasing, concluded FDA's lead medical reviewer.
The blind leading the blind.....
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  #2   ^
Old Wed, Dec-12-07, 02:02
CVH's Avatar
CVH CVH is offline
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Plan: Carnivore
Stats: 000/200/000 Male 6'2"
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Location: FL, USA
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A business has a right to manufacture something and sell it to people as long as it's legal, they are not responsible for the damage it causes if a person uses it in a wrong way, or if a person doesn't do the research on it and read the warnings/instructions.

Statins don't kill people, Guns don't kill people, pens don't misspell words, matches don't start fires, cars don't kill people, cigarettes don't cause cancer and junk food doesn't make you fat, but when the human factor is beyond retarded, the above happens.

YOU have to make a CHOICE to accomplish the above, when was the last time you saw a gun or match in prison for murder and arson?

Even though I don't agree with their product or their way of marketing, I still know they are not doing anything wrong and I still fail to see where Merck put a gun to someone's head and told them to buy statins.

Until then, it is solely the consumers fault and responsibility.
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  #3   ^
Old Wed, Dec-12-07, 10:09
2bthinner!'s Avatar
2bthinner! 2bthinner! is offline
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Posts: 3,345
 
Plan: Paleo Gluten free
Stats: 242/216/130 Female 5'7.5"
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Progress: 23%
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http://abcnews.go.com/Health/Choles...=3984364&page=1


Public Not Ready for Over-the-Counter Statins
Merck Prepares to Make Third Thrust for OTC Mevacor; Many Physicians Opposed
By DAN CHILDS
ABC News Medical Unit
Dec. 11, 2007


Many cardiologists and other physicians agree that offering a cholesterol-lowering statin drug to consumers without a prescription would be a terrible idea.

But just such a proposal is now being weighed by the U.S. Food and Drug Administration. Thursday FDA advisory committees will evaluate data submitted by drug giant Merck & Co., which supports over-the-counter use of its cholesterol drug Mevacor.

"I think this is a very clear call," said Dr. Steve Nissen, chairman of cardiovascular medicine at the Cleveland Clinic Foundation and immediate past-president of the American College of Cardiology. "I do not think it is a good idea."

"OTC [over-the-counter] statins would be a very bad idea," agreed Dr. John Messmer, associate professor of medicine at the Penn State College of Medicine in Palmyra.

"While it is true that statins are indeed quite safe despite rumors to the contrary ... when a drug is available OTC the user should be able to judge whether it has had the desired effect. The nonmedical person is not in the position to decide if his or her cholesterol is low enough."

Dr. Douglas Zipes, distinguished professor of cardiology at the Indiana University School of Medicine in Indianapolis, agreed that the possible side effects of the drug lend weight to the argument that it should not be available without a prescription.

"I considered these issues when I was president of the American College of Cardiology, and we didn't support the over-the-counter use," Zipes said.

Still, Merck says that offering a low-dose version of the pill on store shelves may help millions without prescriptions ward off a first heart attack. Mevacor was the first cholesterol-lowering statin drug when it was introduced back in the 1980s. Since then, other drugs like Lipitor and Zocor have become available to the estimated 11 million Americans taking such drugs.

It's not yet clear whether Mevacor sold over the counter would cost much less than it does under prescription.

And some doctors cite these potential benefits -- though they also note that the move does not come without its fair share of considerations.

"The benefits are likely to be significant since a much larger base of patients would receive statin therapy than is currently the case," said Dr. Domenic Sica, professor of medicine and pharmacology at Virginia Commonwealth University Health System in Richmond.

Sica said that though such drugs carry "very minimal risk," he added, "the agency is concerned about two issues; the possibility of there being liver damage, and the use of these drugs in females of childbearing age."

This isn't the first time such a proposal has passed before the eyes of FDA advisers. Twice before, the idea has been rejected.

And history could repeat itself this time around. Though FDA reviewers said in a preliminary review released Tuesday that the drug could be a "reasonably safe and effective" option if used as directed, tests conducted by Merck showed that most consumers are ill-equipped to judge for themselves when the drug is needed.

The preliminary review subsequently concluded that consumer comprehension falls short of what would be needed to ensure safe and effective use of the drug in this way.


Cutting Doctors Out of the Loop?
Beyond the side effects of the drug, some worry that having the medicine available without a prescription could dissuade many from the crucial step of seeing a doctor about their condition.

"[The] dangers are that it may prevent people from seeing a cardiologist and not getting a proper evaluation for their heart disease," Zipes said.

"First of all, there are no symptoms of high cholesterol," Nissen agreed. "The only way you know is via a lipid profile, and interpretation of these is not simple.

"Doctors must judge risk, patients cannot."

Messmer added that this potential problem is particularly relevant in the case of statins -- which, unlike some other types of medicine, do not provide patients with noticeable proof of their effect.

"When a nonmedical person has heartburn, they either are getting relief or not," Messmer said. "The same applies to pain meds, cough and cold meds, and other OTC meds.

"It is so clearly the contrary with statins, I find it absolutely amazing the FDA would even waste the time to consider it ... I find it unbelievably ill-conceived that they would put the treatment of a component of one of our largest killers -- atherosclerosis -- into untrained hands."

Cutting doctors out of the picture could also lead to sporadic use, physicians noted.

"In most cases, statins are usually taken for life," said Dr. Jeffrey Brinker, professor of cardiology at Johns Hopkins University School of Medicine in Baltimore. "If one takes OTC medication, there is less psychological motivation to take it consistently."


Doctors Question Drugmaker's Motivation
Amid the concern over patient safety, consumer advocacy groups and physicians alike have lambasted Merck for the move, which they said arises from economic concerns.

Dr. Sidney Wolfe, director of the Health Research Group of the Washington, D.C.-based consumer advocacy group Public Citizen, testified in 2005 against a previous effort to grant Mevacor OTC status. He plans to testify again Thursday.

"For the switch of any statin, in this case lovastatin, none of the conditions are met and it is virtually certain that more harm than benefit would accrue to such an ill-advised regulatory decision," Wolfe said in his 2005 testimony. "Despite Merck and its highly paid academic partners' efforts to paint this switch as something positive, the analysis by FDA, with which I concur, seriously undermines any such conclusion."

The Consumers Union has also taken a stand against prescription-free Mevacor. While Mevacor achieved blockbuster status in its earlier days, sales have dropped since 2001 when its patent expired and generic versions entered the market. Last year, worldwide sales for Mevacor topped out at about $20 million.

Some doctors reacted with outrage at what they feel are money-driven motivations behind the move.

"How craven can the drug companies become?" asked Dr. Michael Good, a family practitioner with ProHealth Physicians in Middletown, Conn. "They should put their efforts to actually inventing something new instead of trying to milk old horses for more money at the public expense."

Associated Press reports contributed to this story.


Copyright 2007 ABC News Internet Ventures
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  #4   ^
Old Wed, Dec-12-07, 11:53
mike_d's Avatar
mike_d mike_d is offline
Grease is the word!
Posts: 8,192
 
Plan: PSMF/IF
Stats: 236/181/180 Male 72 inches
BF:disappearing!
Progress: 98%
Location: Alamo city, Texas
Default

They could add em to eggs then we wouldn't have to throw out the yolks
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  #5   ^
Old Wed, Dec-12-07, 11:56
2bthinner!'s Avatar
2bthinner! 2bthinner! is offline
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Posts: 3,345
 
Plan: Paleo Gluten free
Stats: 242/216/130 Female 5'7.5"
BF:too/dang/much
Progress: 23%
Location: Florida
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Quote:
They could add em to eggs then we wouldn't have to throw out the yolks
Noooo! The yolk's my favorite part!! Let them add it to eggbeaters. They need something to give them some flavor!
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  #6   ^
Old Wed, Dec-12-07, 11:57
BoBoGuy's Avatar
BoBoGuy BoBoGuy is offline
Senior Member
Posts: 1,178
 
Plan: Low Carb - High Nutrition
Stats: 213/175/175 Male 72 Inches
BF: Belly Fat? Yes!
Progress: 100%
Location: California
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Quote:
Originally Posted by mike_d
They could add em to eggs then we wouldn't have to throw out the yolks

Hi Mike,

Do you really throw out the yolks?

Bo

Last edited by BoBoGuy : Wed, Dec-12-07 at 17:41. Reason: sp
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  #7   ^
Old Wed, Dec-12-07, 12:59
ceberezin ceberezin is offline
Senior Member
Posts: 619
 
Plan: Protein Power
Stats: 155/140/140 Male 68
BF:18%
Progress:
Location: Los Angeles, CA
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Here's a disaster in the making! Statins have never been proven to lower heart disease incidence. The claim has been that they lower heart disease risk. What's never discussed in articles like the ones above is that they are using an erroneous notion of risk. Statins may lower LDL cholesesterol, but LDL has nothing to do with heart disease, something the drug companies don't want you to know. Making statins OTC would be like giving someone a gun and telling them, "Don't worry; this gun won't hurt anyone.

CVH, it's not a problem of making a choice, it's a problem of making an intelligent choice. People cannot make an intelligent choice about statins if they don't have the information that statins are useless in preventing heart disease.

Hell, most doctors don't have that information either. Recently, my physician told me she didn't like my LDL numbers. I explained to her that the issue was not LDL, but LDL profile. She agreed with that, but said that since we can't know the LDL profile, it is better to lower all LDL just in case. She did not have the information that LDL profile A, the larger particle, is correlated with low triglycerides and high HDL. Since my triglycerides were 47 and my HDL was 85, I figured I didn't have a problem. My physician just shrugged her shoulders and said, "Well, I guess I can't get you to take statins, then." They can't see the information when it's right in front of them.

Last edited by ceberezin : Wed, Dec-12-07 at 13:08.
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  #8   ^
Old Wed, Dec-12-07, 15:19
ElleH ElleH is offline
Registered Member
Posts: 10,352
 
Plan: PP/Atkins Maintenance
Stats: 178/137/137 Female 5'6"
BF:28%
Progress: 100%
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TEEERRRRIIIBBBLE idea. Truly frightening!
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  #9   ^
Old Wed, Dec-12-07, 18:04
mike_d's Avatar
mike_d mike_d is offline
Grease is the word!
Posts: 8,192
 
Plan: PSMF/IF
Stats: 236/181/180 Male 72 inches
BF:disappearing!
Progress: 98%
Location: Alamo city, Texas
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Quote:
I explained to her that the issue was not LDL, but LDL profile. She agreed with that, but said that since we can't know the LDL profile, it is better to lower all LDL just in case.
I wish on the ABC news "healthy cholesterol news" tonight Charlie had asked Dr. Tim "what about the new VAP test that shows the breakdown of lipid size not just TC?" I would have fallen out of my chair. They just don't do their homework.
Quote:
The VAP (Vertical Auto
Profile) Test, developed by Atherotech, is an
expanded cholesterol test that provides
valuable information that can identify hidden
heart disease risk. In fact, the VAP Test
identifies twice as many people at risk than
routine cholesterol tests, including those
with inherited risk factors who often develop
premature heart disease.
The VAP Test is a better
cholesterol test. Like routine tests, the VAP
Test measures total cholesterol, HDL ("good"
cholesterol), LDL ("bad" cholesterol), and
triglycerides. But the VAP Test also measures
cholesterol subclasses that play important
roles in the development of heart disease.
This additional information allows your
doctor to improve the detection of heart
disease risk from about 40 percent to 90
percent, and provides a foundation for
patient-specific treatment plans.
BTW -- I do eat the yolks-- I was being sarcastic. I also eat red meats and organ meats, sometimes more than twice a week!
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  #10   ^
Old Thu, Dec-13-07, 07:36
renegadiab renegadiab is offline
Senior Member
Posts: 475
 
Plan: Schwarzbein/Bernstein
Stats: 355/240/200 Male 69 inches
BF:
Progress: 74%
Default

Statins are grossly over-prescribed as it is. Doctors don't even know who is the right candidate for statins. They just follow big pharma's propaganda. How can we expect non-medical people to make a rational decision -- with the scare tactics over cholesterol and extensive advertizing??

The drug companies have a multi-billion $$$$$ cash cow in statins. Making them OTC would create a bigger cash cow, but would be a medical disaster.
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  #11   ^
Old Thu, Dec-13-07, 17:29
Daryl's Avatar
Daryl Daryl is offline
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Posts: 7,427
 
Plan: ZC
Stats: 260/222/170 Male 5-10
BF:Huh?
Progress: 42%
Location: Texas
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Quote:
WASHINGTON - Government advisers rejected Merck & Co.'s latest bid for over-the-counter sales of Mevacor, the granddaddy of the famed cholesterol-lowering drugs.

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.

"This is a real opportunity," said Edwin Hemwall, executive director of Merck's worldwide OTC regulatory and scientific affairs.

Risk of unnecessary side effects
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.

"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."

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?"

The nation's No. 1 killer
The FDA is not bound by its advisers' recommendations, but usually follows them. Twice since 2000 the FDA has said no to over-the-counter Mevacor.

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.

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.

If such sales were allowed, Mevacor might become the most complex over-the-counter drug available.

Unlike over-the-counter remedies for headaches or allergies, high cholesterol causes no outward symptoms. People would need a laboratory blood test to know if their cholesterol was high enough to qualify and follow-up tests to make sure the pills were working.

The FDA advisers questioned if people would do that. They also noted that at $1 to $1.50 a day, an over-the-counter version would cost more for the insured than the typical $4 to $15 for a month's supply of numerous statins.

Doctors are divided about the request. The American Heart Association is remaining neutral, while the American College of Cardiology opposes OTC Mevacor, for the same reasons the FDA panel cited.

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.

"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.

"You should put this drug in the drinking water," said Dr. David Nash of Philadelphia's Thomas Jefferson Medical College.


http://www.msnbc.msn.com/id/22246548

Put statins in my drinking water, and I'll put my foot so far up your ass.....
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  #12   ^
Old Fri, Dec-14-07, 09:22
2bthinner!'s Avatar
2bthinner! 2bthinner! is offline
Senior Member
Posts: 3,345
 
Plan: Paleo Gluten free
Stats: 242/216/130 Female 5'7.5"
BF:too/dang/much
Progress: 23%
Location: Florida
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Quote:
people have become sophisticated enough about artery-clogging cholesterol to try.
And yet we're too stupid to know how to give our children cold medicine?

http://www.nationalpost.com/story.html?id=147135
Quote:
The conclusion echoes an FDA expert panel's finding last October that the drugs were useless to children under the age of six, adding that their effects on children require further study. Pre-empting that announcement, major pharmaceutical companies volunteered to pull from Canadian and U.S. shelves several drugs intended for under-two toddlers.
My older daughter is 20. She was given medicine when she had a cold. Now, it didn't take away all symptoms, but it did help.

They must have separate panels for these or they'd know they're making NO sense.

Quote:
Put statins in my drinking water, and I'll put my foot so far up your ass.....
Agree! I'm so glad I have well water. They can't slip fluoride in it. Have you seen all the bottled water for babies with fluoride? That stuff that they can't dump in lakes? So...we feed it to our babies? (Not me!)
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  #13   ^
Old Sat, Dec-15-07, 00:30
CVH's Avatar
CVH CVH is offline
Senior Member
Posts: 299
 
Plan: Carnivore
Stats: 000/200/000 Male 6'2"
BF:
Progress:
Location: FL, USA
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Quote:
Originally Posted by ceberezin
CVH, it's not a problem of making a choice, it's a problem of making an intelligent choice. People cannot make an intelligent choice about statins if they don't have the information that statins are useless in preventing heart disease.

Hell, most doctors don't have that information either. Recently, my physician told me she didn't like my LDL numbers. I explained to her that the issue was not LDL, but LDL profile. She agreed with that, but said that since we can't know the LDL profile, it is better to lower all LDL just in case. She did not have the information that LDL profile A, the larger particle, is correlated with low triglycerides and high HDL. Since my triglycerides were 47 and my HDL was 85, I figured I didn't have a problem. My physician just shrugged her shoulders and said, "Well, I guess I can't get you to take statins, then." They can't see the information when it's right in front of them.


Ok, Let's say Mr. A, has "bad" cholestrol and went to see his doctor, which means he must have money or some sort of medical plan and means to research medical info, now the doctor says take statins, eat lower fat, he does. Nothing happens, they give him more statins, do more changes etc...etc...etc....

Mr. B, has bad cholestrol went to see his doctor, same scenario, but instead using the same means available to Mr. A, he researched nutrition/cholestrol and decided to not take statins and focused on nutrition/exercise.

People have more than enough information to make an intelligent desicion, but the problem is that most of them are not or choose not to, who's fault is that? Merck?

And even your example proves that when providing them with the right info, they still choose to ignore it, I can't feel bad for someone who has all the right pieces yet is too dumb or lazy to put them together.
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  #14   ^
Old Sat, Dec-15-07, 05:25
oakdryad's Avatar
oakdryad oakdryad is offline
Senior Member
Posts: 863
 
Plan: Atkins-ish/IF-ish
Stats: 385/278/180 Female 5'10"
BF:something, maybe
Progress: 52%
Location: MN
Default

Quote:
"[The] dangers are that it may prevent people from seeing a cardiologist and not getting a proper evaluation for their heart disease," Zipes said.

"First of all, there are no symptoms of high cholesterol," Nissen agreed. "The only way you know is via a lipid profile, and interpretation of these is not simple.

"Doctors must judge risk, patients cannot."

Messmer added that this potential problem is particularly relevant in the case of statins -- which, unlike some other types of medicine, do not provide patients with noticeable proof of their effect.

"When a nonmedical person has heartburn, they either are getting relief or not," Messmer said. "The same applies to pain meds, cough and cold meds, and other OTC meds.

"It is so clearly the contrary with statins, I find it absolutely amazing the FDA would even waste the time to consider it ... I find it unbelievably ill-conceived that they would put the treatment of a component of one of our largest killers -- atherosclerosis -- into untrained hands."

Cutting doctors out of the picture could also lead to sporadic use, physicians noted.

"In most cases, statins are usually taken for life," said Dr. Jeffrey Brinker, professor of cardiology at Johns Hopkins University School of Medicine in Baltimore. "If one takes OTC medication, there is less psychological motivation to take it consistently."


Why am I astonished by the arrogance of this statement? There are doctors who can't judge a lipid profile accurately and will prescribe statins based on total cholesterol, apart from all the other statin prescribing issues...like, I don't know, they've been shown to have no real benefit for women. :dry:

Like I'm EVER going to let a doctor be the sole assessor of MY risk in taking any medication. S/he can advise me what s/he thinks is the best course of treatment and then I'll research the situation and decide what I think...after all, I have a brain, internet access and know how to use a search engine. And if worse comes to worse, I can always get a second medical opinion. And then I'll do what I think is best under the circumstances.

It seems to me that at least part of the good doctor's objection is financial. If the statin is sold OTC, patients might not visit as frequently, and he might lose some of his share of the big pharma lolly. Or maybe I'm just cynical.
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