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Vioxx. Avandia. Vytorin. Fen-phen.</p>
<p>That’s just off the top of my head.</p>
<p>^don’t forget Baycol (for cholesterol) and perhaps zetia (also for cholesterol) will be added to the list of withdrawn, seriously questioned RX.</p>
<p>However, no drug is without side effects and without risk. </p>
<p>I have personally seen few people in their 80’s that I would consider to have a good quality of life. When I meet someone who does, they often have few major medical health issues, and take few or no drugs. However, none of that is scientific.</p>
<p>If she would be able to use the money to improve her quality of life in another way, would that be a benefit? At this point is the money so tight for her? </p>
<p>If it was my own mother, and she was being made sick from rx side effects I would not want her to take it. My own mother gave up on most or all (who knows really, she didn’t really tell me, I just saw what was going on) of her pills in her last year of life, and none of what they treated is what killed her. The drugs would have made no difference. Her quality of life was lousy from 82 on for a few years. This is a very difficult time of life, and not everyone feels that taking every possible pill they can is something that they want to do. </p>
<p>I personally don’t like to take medication, and I have a chronic health issue that might be addressed by a newer rx. When I read the warning label, I decided no pills for me. If it gets worse or there are new reports on the drug, maybe I will change my mind.</p>
<p>Really the issue isn’t the age of the patient, but the overall quality of life.
My dad is 83. Very active, does about 2 hours of outdoor work every morning, keeps house (and you can eat off the floors there), takes a walk most afternoons or evenings. He did slow down for a while earlier this year, he had carpel tunnel surgery. Drove everyone crazy until he could use both hands…and still complains that hand is “weak”. Of course, he’s lifting 25lbs or more a couple of times a week, so I’m not too convinced that there is much impairment.
My MIL is 84. Has not been in good health for a couple of years, on a variety of medications, now diagnosed with Alzhiemer’s Disease.
Two completely different situations–both in their 80’s.
I’d talk to the doctor, and research lifestyle changes (ie fish oil, dietary changes). See if the dosage can be changed, or if a combination of lower dosage and dietary changes can help.</p>
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<p>By insisting on increased life expectancy as the only valid end-point you have made it almost impossible to find worthwhile benefit for any drug for someone in their 80s, since all people in their 80s don’t have much time left. You are creating the statistical challenge of finding significance in small differences between large numbers.</p>
<p>So you’d treat a broken arm? How about a drug that <em>prevents</em> broken arms but can’t be shown to increase life expectancy? Would you give that? </p>
<p>By focusing only on the side effects of the cholesterol drug and the near-impossibility of proving a life extension benefit you are willing to abandon a treatment that may well provide a very significant benefit in preventing a loss of quality of life. Lowering cholesterol has been shown to reduce the risk of stroke. Have you seen the quality of life of an elderly person who has suffered a major stroke? It’s pretty low.</p>
<p>In pretty much all diseases, in fact in pretty much all problems in life, prevention is almost always much cheaper, safer, and easier than cure.</p>
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<p>Yes, Coureur. I’m afraid I have.</p>
<p>My mother had a catastrophic stroke in her 50s. Paralyzed. Aphasic. In a nursing home for over a decade until she mercifully died from complications of a leg amputation.</p>
<p>She arrived at the emergency room the night of her stroke not breathing. They resusitated her and I curse that to this day. All they did was add ten years of pure, unmitigated, utter hell to the woman’s life.</p>
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<p>No. I’m insisting that the drug companies and their salesmen (the doctors) who are trying to sell a product to a customer demonstrate the benefits of that product to sufficiently justify the cost and negative side effects of using that product. Just like a car salesman would have to do. If an 80 year old woman is spending $200 a month on pills that make her vomit every morning of her life, then I think the salesmen have an obligation to demonstrate exactly what good the pills are doing her.</p>
<p>I am concerned about the closed-loop nature of the drug company marketing and the medical industry. For example, the whole reason that doctors believe – oh my god, we’ve got to treat every case of high cholesterol – results from drug company research and years of selling it to physicians to establish high cholesterol as the end all and be all and create a demand for Lipitor, the number one selling drug in the world, at $12.8 billion dollars. I don’t know. My attitude is “you are the salesman; so it’s up to you to sell me…” In other words, I would start from the default of wanting to buy as little of their product as possible, not trying to buy as much as possible. That’s all.</p>
<p>You got to remember it takes two years on market to really flesh out the drug. With that Vytorin study, there are endpoint issues. They did not use the correct ones. They only used surrogate endpoints, i.e. plaque thickness. There are conflicting studies on Avandia. It does appear its sister drug, Actos, does not have the problems. The first drug in their class was already removed when Actos/Avandia were approved. The COX-2 inhibitors always had a theoretical possibility of increasing clots. All NSAIDs have that risk. The thought was it would be removed if you just inhibit COX-2 not COX-1, but that turned out to be not that case. That side effect took time to discover. There were also issues with unlisted continuing studies. That is why laws were beefed up to required all trials to be registered.</p>
<p>I would not want to take any newer drug unless I absolutely have to take it. However, those are the drugs being pushed.</p>
<p>Currently, the drug most in danger of being removed from the marketplace is actually darvocet because it has all the risks associated with an opiate painkiller but with the analgesic power of acetaminophen. </p>
<p>On a good note, it appears FDA might be starting to approve generic biologicals.</p>
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<p>That’s almost impossible to do on an individual basis for preventative treatments. I’ll amend my earlier statement to say that what you are advocating could be used to justify withholding all <em>preventative</em> medical treatments for the elderly. </p>
<p>It has been proven that the cholesterol-lowering medications reduce the risk of stroke. So on the whole, people with elevated cholesterol who take them can lower their risk. But can it be proved by a drug salesman or anyone else that any given individual who took the drugs didn’t have a stroke because of the drugs? Of course not. That would be trying to prove a negative.</p>
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<p>Has it? For 80 year olds? They’ve done studies showing that 80 year olds have fewer strokes taking cholestorol-lowering medications than 80 year olds not taking cholesterol-lowering medications? That doesn’t sound like the kind of study a drug company would do. </p>
<p>How much do the studies show that the incidence of stroke is reduced when an 80 year old takes cholesterol lowering medications? What’s the rate without the drug? What’s the rate with the drug? These the questions I would be asking if I were 80 years old and a medication was making me puke every morning of my life.</p>
<p>I am a physician. It is reasonable for her to discuss the discontinuation of this non-statin medication to lower triglycerides with her own physician. This discussion is appropriate at this age, and given the price and the fact there are no generic alternatives. The risk-benefit ratio is not that heavy on risk, but is VERY LIGHT on benefit at this age. And the cost would cause me to have this very discussion if this were me or a member of my family.</p>
<p>The crux of the issue & questions is what really is the expected benefit?</p>
<p>Is it less plaque on the arteries & veins every day or is it less over 10 years. In other words, if cholesterol meds prevent long term build up of arterial plaque, do you still take them when your long term is shorter- assuming people 85+ have 10-15 years remaining max?</p>
<p>Thanks every one for your input, I do not know the details of her annoyance, her $$ paid, etc. I just know what she has said, but am going to summarize what has been said here so she can talk to her doctor about a decision.</p>
<p>Very few studies for drug approval include people over 65 and people under 18. The FDA has developed incentives for the pediatric population but not the elderly.
The most popular drug for triglyceride lowering is Tricor (fenofibrate). Due to the fact that Tricor was reformulated after being available for several years, some strengths of fenofibrate are generically available and others are not. The other generically available fibrate is gemfibrizol and it has a lot more side effects.</p>
<p>my mother had been on cholesterol lowering medication, it seemed to be associated with nerve/muscle damage.</p>
<p>from NIH
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<p>Very interesting article on cholesterol drugs:</p>
<p>[Do</a> Cholesterol Drugs Do Any Good?](<a href=“Bloomberg - Are you a robot?”>Bloomberg - Are you a robot?)</p>
<p>Another interesting article:</p>
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<p>326 people for one person to see a benefit? Wow.</p>
<p>[High</a> Cholesterol Treatment - What is the Benefit? Understanding Statin Drugs and NNT](<a href=“http://ezinearticles.com/?High-Cholesterol-Treatment---What-is-the-Benefit?-Understanding-Statin-Drugs-and-NNT&id=4696055]High”>http://ezinearticles.com/?High-Cholesterol-Treatment---What-is-the-Benefit?-Understanding-Statin-Drugs-and-NNT&id=4696055)</p>
<p>The first article quoted is amazing. It sums up pretty well what I have been obeserving in the US healthcare.</p>
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So what you are saying is that drugs companies do not know whether their drugs are safe, until they have used the general populace as lab rats for two years.</p>
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<p>Unless you are the one person who avoided the heart attack or stroke, then it seems like a pretty good deal. Trouble is no one knows which category they fall into.</p>
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<p>Sounds like a pretty good plan.</p>
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<p>By that logic, we should just pay to have everyone shadowed by a 24/7 mobile EMT cardiac unit, just in case. We are talking about 356 people each spending $1000 a year. That’s a lot of money to prevent one cardiovascular event.</p>
<p>I just printed the Lipitor article to give to my wife. I think she should discuss with her physician why exactly she is paying 100% out of pocket to take this drug. Thanks.</p>
<p>I think way too many doctors prescribe statins as the first line of defense, rather than using them as the last line when everything else fails. It’s not all the doctor’s fault, though - unfortunately, too many people just want to swallow a pill instead of making the changes they need to get healthier.</p>
<p>The issue is with the rare side effects (<1%) and long term effects. With the rare side effects, you don’t have enough people in the studies to really determine if they are significant. A long drug trial might have 10,000 test subjects. With long term effects, it is an issue of time. Most trials last less than 2 years, most often no more than 6 months to 1 year. These issues are no secret. That is why technically drug companies/FDA continue to monitor side effect reports after the drug is released.</p>