quote: U.S. advisers are set to decide on Friday whether they will recommend approval for Merck & Co. Inc.'s plan to sell a cholesterol-lowering medicine on drugstore shelves without a prescription.
Allowing Merck's Mevacor to be sold over the counter would be a major shift. Nonprescription drugs generally treat conditions with easily recognized symptoms such as a runny nose. High cholesterol can be detected only with a blood test.
quote: Mevacor's packaging would urge cholesterol testing before and during therapy, and warn against use by people with liver disease or certain other conditions, including pregnancy.
The label also would instruct users to stop taking Mevacor immediately and consult a doctor if they developed "unexplained" muscle pain, weakness or tenderness. Statins can cause life-threatening muscle deterioration in rare cases.
FDA reviewers said users might not follow instructions correctly.
In one Merck study, only 1 percent of those who read the directions and said they could start Mevacor therapy immediately were correct, FDA officials said.
posted
Sort of. I like the idea of people being able to decide their own medication, no matter how risky/foolish, and for people who really do need the medicine it will be more convenient. On the other hand, I wonder about the FDA reviewer's warning that users might not follow instructions correctly. What proportion? Hopefully no one will be stupid enough to give this to their children without a doctor's visit and recommendation. Did Merck purchase any influence? All of the above is predicated on the assumption that the warnings/directions are as complete and accurate as possible.
Posts: 281 | Registered: Aug 2004
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posted
I trust the doctors to do it more than I do. That's not that I'm extremely fond of doctors (and their handwriting, prescriptions are dangarous...), but rather that a professional take care of me. And don't start saying I have east-European Jewish blood!
posted
I do not, but if the relevant information is provided I feel it is the responsibility of the consumer to make rational choices, or at the least accept the risk and responsibility of taking the drug (or food, or chemical that clearly states "Not for human consumption") without the relevant information. It is not the government's job to babysit mentally capable adults. It is only responsible to dependents to insure their guardians are taking adequate care, and to step in if they are not.
It does scare me how many people have asked me if a certain medicine, usually OTC, is safe to drink on. Usually I already know or can find out if they have the bottle, because the warnings and contraindications are clearly printed on it! If I know without looking, it is because I read the bottle before taking it myself. Read the instructions people, two or three times if necessary! It might save you a painful hospital visit, or even your life. If it is serious enough to be there, it is a very real risk.
Posts: 281 | Registered: Aug 2004
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posted
I think it is a bad idea just because many people who have problems will then totally skip the needed doctor's appointments to monitor it (people hate going to the doctor) and if the few people I know who have high blood pressure/high cholestoral are any indication -- most aren't very good at keeping it monitored by themselves.
Sure - there will be some who are responsible about it. But many more who are not.
Farmgirl
edit: (Actually, you would think that Merck would be afraid of being sued by some schmuck that doesn't follow directions and had consequences.)
posted
Insurance companies also have an interest in this sort of thing. Once a drug goes OTC, they don't have to pay for it.
I think this is a very bad idea. These days, there are kits you can get to test your own blood. I can see people misusing this drug, like using it to lower their cholesterol without changing their diet, etc. High cholesterol is a condition that needs to be monitored, even if lightly, and I think people who start using the OTC drug will not be monitored as well. I also think people taking it OTC will be less likely to make their lifestyle more healthy than people who see a doctor to monitor the condition.
I have a genetic problem with high cholesterol. I don't need to take meds for it, but once I do the doctor would actually like me completely unable to get pregnant. He told me that if by the time I need to go on medication that I wasn't planning on having kids, I should have a tubal ligation. This is one of those meds that is very bad for the embryo and fetus and will have an effect even when you don't know you are pregnant.
I understand there can also be some significant liver damage, and this should be monitored as the drug is introducted and checked up on regularly.
My opinion? Bad idea.
Posts: 3495 | Registered: Feb 2000
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As someone that is closely monitored for her cholesterol (it's not bad, but because of family history and having PCOS my doctor keeps an eye on it) I feel much more confident having my doctor in charge of what I take.
Posts: 14428 | Registered: Aug 2001
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posted
It sounds like this could limit the amount of doctor's visits, lowering a family's health care burden. I think this is one of those situations where we should err on the side of individual responsibility.
But this isn't my population. I don't take pills. I have wonderful habits. If everyone ate and exercised like I do, the only people who would need this drug are people with a severe congenital problems or people getting on in years, both populations should be able to get the drug as easily as appropriate.
At some point, we should take the idea of people taking responsibility for the body seriously. But then, I'm one of those guys who likes the government telling people what to do, sticking its nose into everyone's business, but then leaving the individuals to make the appropriate decision.
posted
This makes me think of that latest natural health craze, Tahitian Noni juice. Anyone heard of it? It's one of those things that claims to do everything in the world, prevent colds, cure ADD (impossible I tell you), relieve pain, cure cancer, etc. It's totally unregulated by anything, and if I try and explain that to advocates of it, they just say "Well, it's all natural." So what? I can think of all kinds of "natural" things that are insanely bad for you. Poison ivy, for example.
But the problem is that I KNOW that there are side effects, because a few have been found by people who drink this stuff, but nobody knows what all the side effects are because no one has looked into it in depth. I can't say I'm a huge fan of the FDA or any other form of regulation, but this seriously worries me. I can't help but think of these old Sears & Roebuck catalogs I saw from the 1800s where they had all those "tonics" that cured everything in the world, and turned out to be, essentially, liquied opium.
Posts: 48 | Registered: May 2003
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posted
rivka, I saw this item in my morning paper, and my first reaction was also that it's a really bad idea.
Treating yourself for high cholesterol should not be treated as casually as taking pill for a headache. It requires evaluation and monitoring by a qualified health care professional, which people might be tempted to skip if they decided to start dosing themselves.
Posts: 5771 | Registered: Nov 2000
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posted
I agree that it is a bad idea. High cholesterol is not something for which people should self-medicate. It strikes me as being akin to selling diabetes medication OTC.
quote:If everyone ate and excersized like I do, the only people who would need this drug are people with a severe congenital problems or people getting on in years, both populations should be able to get the drug as easily as appropriate.
Actually, this is not the case. For more than half the high cholesterol population, diet and exercise modification is not enough to lower their cholesterol.
And noni juice - ewwwww! It takes like liquid death!
posted
I tried some. It was kind of like every berry in the world mashed together, along with all the stems and leaves.
Posts: 48 | Registered: May 2003
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quote:If everyone ate and exercised like I do, the only people who would need this drug are people with a severe congenital problems or people getting on in years, both populations should be able to get the drug as easily as appropriate.
How much time and money do those good habits take, Irami? For many workers in the lower income brackets, especially those with kids and long work hours, time and money are barriers to developing a space for regular exercise (30-90 minutes a day is the latest recommendation).
We're not poor, but we're in the "very short on time" category. Still, I have a freer hand in the poor choices I'm currently making than many do.
Posts: 4344 | Registered: Mar 2003
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quote:How much time and money do those good habits take, Irami? For many workers in the lower income brackets, especially those with kids and long work hours, time and money are barriers to developing a space for regular exercise (30-90 minutes a day is the latest recommendation).
It takes time and it takes money, but mostly it takes a shift in priorities. Look, we are quick to get on kids who don't study. I'm just not as sympathetic to adults who think that they ought to be able to eat what they want when they want to. These are issues of judgment and responsibility. We make decisions: failing kids make decisions and fat adults make decisions. We can talk around the problem all we want, but the situation doesn't solve itself until individuals start making a higher priority out of eating better and exercising. I haven't had a doughnut in ten years, and from what I remember, I love a bear claw.
I get a perverse kick out of exercising, but I don't especially like eating as many spinach salads as I do. I love cheese, but I don't eat it. I know it's important and I suck it up, I did the same thing with chemistry when I was in High school. I know that a lot of people's bodies react differently to cholesterol, but I also know that people lack dietary discipline. Hell, I think it's rooted in that American feeling that one should be able to do what they want when they want to do it.
quote:Actually, this is not the case. For more than half the high cholesterol population, diet and exercise modification is not enough to lower their cholesterol.
Yeah, but how did they get themselves there to begin with. I see people eating horribly everyday because they like the taste of food. I'm going to stand up a little bit straighter because I imagine that the whole of hatrack is a little bit softer than they should be: Stop making excuses for yourselves. [/bad cop]
The people who are going to abuse this drug are the same class who want to take a pill to solve all of their problems. The responsible people aren't going to abuse it. I just don't think that we should be legislating against the responsible people, just because we are too lazy to implement serious nutritional public awareness for those who wouldn't know any better.
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