Now is the time ...
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...b10010b...
Member # 869
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written Sunday, April 1 2007 14:28
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quote:So change the disclosure rules. Requiring side effects to be categorised by the organ system they affect would be a simple and non-arbitrary way to minimise the number of categories and get a reasonable measure of the overall risk of adverse effects. In the end, the best defence against disinformation is word of mouth. If you want to know people's experiences of a drug, find and talk to a few other people who have been on it. Support groups are a good way to do this. quote:The problem here, surely, is not the regulatory system but the fact that people can be medicated against their will. You can't very well defend the FDA by citing examples of bad things that are happening despite the existence of the FDA. [ Sunday, April 01, 2007 14:35: Message edited by: Thuryl ] -------------------- The Empire Always Loses: This Time For Sure! Posts: 9973 | Registered: Saturday, March 30 2002 08:00 |
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By Committee
Member # 4233
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written Sunday, April 1 2007 16:15
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Thuryl, FDA does have laxer standards for orphan drugs. Because the populations suffering from the diseases, the manufacturers frequently get to skip several rounds of human clinical trials - the idea being that the manufacturers will follow up with post-approval trials. Congress really did step it up with the Orphan Drug Act back in 1983. There are also NGOs like NORD (www.rarediseases.org) that support and are involved in this cause. It's hardly been ignored. Posts: 2242 | Registered: Saturday, April 10 2004 07:00 |
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? Man, ? Amazing
Member # 5755
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written Sunday, April 1 2007 16:31
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I'm no doctor, nor do I portray one in off-Broadway stage, but wouldn't these exotic genetic maladies persist in the population if the effects are treatable? It would seem to be in the best interests of the species to let things like this not continue and to self-direct the evolutionary drift that is always taking place. -------------------- quote: Posts: 4114 | Registered: Monday, April 25 2005 07:00 |
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Councilor
Member # 6600
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written Sunday, April 1 2007 17:02
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The problem with that is that a lot of the conditions we suffer from are either environmental (pollution, poor lifestyle) or appear in middle or late age, after people have children. We're not likely to cure Alzheimer's through evolution any time soon, so we might as well try to cure it. Dikiyoba. Posts: 4346 | Registered: Friday, December 23 2005 08:00 |
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Law Bringer
Member # 6785
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written Sunday, April 1 2007 17:05
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quote:The FDA allows drugs that are only marginally better or sometimes worse than placebos into the system. Their availability means that people get them because of manufactuers pushing them instead of better alternatives. If the FDA kept them out of the system in the first place, then they won't be causing problems. Posts: 4643 | Registered: Friday, February 10 2006 08:00 |
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...b10010b...
Member # 869
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written Sunday, April 1 2007 19:42
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quote:You acknowledge that the FDA allows plenty of bad drugs onto the market. I've provided evidence that the FDA keeps plenty of useful drugs off the market. Given the resounding lack of evidence that the FDA is competent to decide what's a good drug and what isn't, why have an FDA at all? Arguing for the FDA to be made better rings hollow. The FDA can't be made better, because what it's trying to do -- distinguish between useful and useless drugs with 100% accuracy -- is fundamentally impossible. It can either raise its standards and keep more good and bad drugs out (for whatever definition of "good drug" you wish to use), or lower them and let more good and bad drugs in; what it can't do is simultaneously achieve both. Besides, there's no objective standard for deciding what counts as a good or bad drug. A drug that's worse than a placebo for 99% of the patient population may be substantially better for the other 1%; statistical analysis tends to overlook that sort of thing, but it makes a pretty big difference to that 1%. [ Sunday, April 01, 2007 19:46: Message edited by: Thuryl ] -------------------- The Empire Always Loses: This Time For Sure! Posts: 9973 | Registered: Saturday, March 30 2002 08:00 |
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Law Bringer
Member # 6785
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written Sunday, April 1 2007 21:09
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I'd settle for the FDA enforcing regulations. It lets too many drugs on the market under the provision that further clinical trials will be run for adverse effects and the companies never bother or withhold negative results. Some stuff being kept off the market should be allowed after testing to determine why only a small percentage can benefit and how to find them. There is supposed to be DNA testing to see if those people that benefit have a common gene type. Its been shown that having a defective version of some genes increases adverse reactions for hundreds of drugs. The best case is no pain relief from non steroidal anti-inflammatory drugs (aspirin,Tylenol, etc.). They are already testing in cancer patients for the most effective drug treatment using genetic matching. [ Sunday, April 01, 2007 22:32: Message edited by: Randomizer ] Posts: 4643 | Registered: Friday, February 10 2006 08:00 |
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...b10010b...
Member # 869
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written Sunday, April 1 2007 23:13
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I just don't see why the FDA should default to banning a drug unless it's proven safe and effective. The criminal justice system doesn't default to imprisoning people unless they can prove their innocence. -------------------- The Empire Always Loses: This Time For Sure! Posts: 9973 | Registered: Saturday, March 30 2002 08:00 |
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Off With Their Heads
Member # 4045
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written Monday, April 2 2007 05:31
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If every person on trial had a loaded gun pointed at a couple thousand people, innocent until proven guilty might be interpreted slightly differently. Likewise, if medications had feelings or could be harmed by lack of use, we might assume that they were innocent until proven guilty. They don't and they're not, so we don't. [ Monday, April 02, 2007 05:32: Message edited by: Malakos the Freshly-Plowed ] -------------------- Arancaytar: Every time you ask people to compare TM and Kel, you endanger the poor, fluffy kittens. Smoo: Get ready to face the walls! Ephesos: In conclusion, yarr. Kelandon's Pink and Pretty Page!!: the authorized location for all things by me The Archive of all released BoE scenarios ever Posts: 7968 | Registered: Saturday, February 28 2004 08:00 |
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By Committee
Member # 4233
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written Monday, April 2 2007 05:33
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The difference in your analogy is that in the case of a defendant, a crime has already been committed. In the case of the medication, the safety concerns can't occur until the drug is approved. In the very least, Thuryl, I don't think you can argue against an "effective" requirement for medications before they're marketed. Look at the alternative - the dietary supplement market. Statutorially protected from the FDA, it's a multibillion dollar industry that is based largely on anecdotal evidence of effectiveness and frequently outright fraud in marketing. Posts: 2242 | Registered: Saturday, April 10 2004 07:00 |
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Apprentice
Member # 8406
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written Monday, April 2 2007 05:36
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quote:that's a horrible analogy. go take a hike. Posts: 47 | Registered: Thursday, March 29 2007 07:00 |
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...b10010b...
Member # 869
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written Monday, April 2 2007 05:36
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quote:The very fact that it's a multibillion dollar industry and that the anecdotal evidence exists suggests that all those supplements are doing something for the people who buy them, even if it's only providing psychological comfort. We all need our placebos, and it's not always wise to investigate them too closely lest they stop working. I can and do argue against an effectiveness requirement, because it's impossible in principle to prove or disprove effectiveness with certainty, and I don't trust the FDA to decide how much evidence is enough; I'd rather make that decision for myself. (I suppose you're going to ask me whether I think I know better than a panel of experts; that's entirely beside the point. Would you have every family's budgeting and investment decisions made for them by a panel of economists? Protecting people from themselves is ultimately futile, and unlikely to inspire gratitude.) [ Monday, April 02, 2007 05:47: Message edited by: Thuryl ] -------------------- The Empire Always Loses: This Time For Sure! Posts: 9973 | Registered: Saturday, March 30 2002 08:00 |
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? Man, ? Amazing
Member # 5755
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written Monday, April 2 2007 05:57
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All this fussin' and feudin' would not be happening if those medications were paid for by the consumers, rather than indirectly through medical insurance. Isn't that really the issue here? Would a desire to take medication, or the attached feeling of improvement be a little different if out of pocket expenses were 1000% higher? -------------------- quote: Posts: 4114 | Registered: Monday, April 25 2005 07:00 |
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By Committee
Member # 4233
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written Monday, April 2 2007 06:29
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quote:I think that is the point, though. I know that you are very intelligent, but do you really think you have the knowledge to make such determinations, especially where, in the absence of regulation requiring it, pharmaceutical manufacturers wouldn't include relatively comprehensive labelling detailing the effectiveness, duration, and known side effects and their frequency of occurance for a given medication? Because they don't want to share this information. I've personally witnessed a negotiation between a pharmaceutical manufacturer and FDA where they dickered over language that would go into a label; if the pharma's marketing people would have had their way, you'd know practically nothing about the drug. Do you think they would include all the information about side effects and so on and so forth in their nevertheless incredibly effective television advertisements for their brands? Would you really rather take your chances on the company's assertion that the drug will do what they say it will? I think that the development of medications has actually flourished, not been diminished, by the regulation and safeguards put into place by FDA. By mandating stringent levels of disclosure, as well as requiring that drugs be as safe as possible, FDA has significantly reduced risks to consumers, as well economic risks to pharmaceutical manufacturers. Consumers, relatively confident that the government is protecting their health, are more willing to pursue medical treatment; manufacturers, though faced with incredible costs up front, are subsequently better shielded against liability down the road, and encouraged to pursue developing truly effective medication. quote:The distinction is that here, the government isn't protecting people from themselves; it's protecting people from others. Where physical injury or death is concerned, it is the government's role to act, especially when the injury is caused by negligence or actual malice on the part of someone else. Whether there's gratitude involved is beside the point, though personally, I'm grateful. Posts: 2242 | Registered: Saturday, April 10 2004 07:00 |
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Off With Their Heads
Member # 4045
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written Monday, April 2 2007 07:44
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quote:It's not my analogy. Try reading the thread, n00b. :P As for the topic: while I'm not sure that people should be prevented from taking drugs at their own discretion, I'm pretty sure that testing and disclosure are good things. We at least ought to know what these things do — as best we can, whatever that means — before we start giving them to people. [ Monday, April 02, 2007 07:46: Message edited by: Malakos the Freshly-Plowed ] -------------------- Arancaytar: Every time you ask people to compare TM and Kel, you endanger the poor, fluffy kittens. Smoo: Get ready to face the walls! Ephesos: In conclusion, yarr. Kelandon's Pink and Pretty Page!!: the authorized location for all things by me The Archive of all released BoE scenarios ever Posts: 7968 | Registered: Saturday, February 28 2004 08:00 |
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...b10010b...
Member # 869
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written Monday, April 2 2007 23:30
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quote:Why does the fact that I lack the knowledge to make a good decision give anyone else the right to make it on my behalf? I don't object to an independent organisation testing drugs based on its own standards of safety and efficacy. What I do object to is that organisation having the right to ban anything that doesn't meet its standards. Suppose that the FDA didn't have that power; if you wanted, you could choose to only buy drugs that had the FDA seal of approval, and get exactly the same result as under the current system. [ Monday, April 02, 2007 23:33: Message edited by: Thuryl ] -------------------- The Empire Always Loses: This Time For Sure! Posts: 9973 | Registered: Saturday, March 30 2002 08:00 |
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By Committee
Member # 4233
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written Tuesday, April 3 2007 06:35
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If it was just a matter of efficacy, I'd be more amenable to your position; but since it also concerns safety, I have to disagree with you. Do you object when the government moves to recall, say, a large amount of meat some of which has been found to be tainted? Sure, 98% of it is probably fine, but there's no way to know where that other 2% might be. How about other product recalls, like extremely flammable children's pajamas, or the Ford Pinto? Posts: 2242 | Registered: Saturday, April 10 2004 07:00 |
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Apprentice
Member # 8406
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written Tuesday, April 3 2007 08:31
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L's to all involved. Posts: 47 | Registered: Thursday, March 29 2007 07:00 |
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? Man, ? Amazing
Member # 5755
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written Tuesday, April 3 2007 08:43
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quote:How was Thuryl talking about safety across the entire spectrum of medicine applicable to that of a single drug? You specifically say tainted, whereas his question is more about suitability. If 95% of a population would get sick, but 5% would get better, if a drug was administered, shoiuldn't that 5% have access? The 95% could just take a different drug to which their metabolism is more suited. If any of a batch of drugs is tainted, tampered, or otherwise different from labeled or tested, it should be recalled and given to other population groups. Or destroyed. I supposed destroyed is better. -------------------- quote: Posts: 4114 | Registered: Monday, April 25 2005 07:00 |
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By Committee
Member # 4233
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written Tuesday, April 3 2007 14:39
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I used "tainted" in my example about a meat recall as a part of my assertion that we generally don't object when the government intervenes to protect citizens' health, even when the population at risk is actually very small. "Tainted" doesn't come into play when I'm talking about determining drug safety. With drugs, it's actually a matter of whether the drug, as designed, is sufficiently safe for resale to the population. Posts: 2242 | Registered: Saturday, April 10 2004 07:00 |
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Off With Their Heads
Member # 4045
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written Tuesday, April 3 2007 14:45
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quote:The more relevant question is whether the 95% should have access. We're not quite at the point yet — give us a couple more decades on this one — where we can predict individual reactions to a drug. Statistics are all we have, and releasing the drug to the general public is releasing it to the people it will help and the people it will hurt. Progress willing, that won't continue to be the case for much longer, but right now, that's all we've got. -------------------- Arancaytar: Every time you ask people to compare TM and Kel, you endanger the poor, fluffy kittens. Smoo: Get ready to face the walls! Ephesos: In conclusion, yarr. Kelandon's Pink and Pretty Page!!: the authorized location for all things by me The Archive of all released BoE scenarios ever Posts: 7968 | Registered: Saturday, February 28 2004 08:00 |
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...b10010b...
Member # 869
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written Tuesday, April 3 2007 14:55
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quote:You mean you don't object to it. I find it interesting that you used the Ford Pinto as an example, given that its recall is widely recognised in hindsight as a tremendous blunder driven by panic, anecdotal evidence and political pressure. -------------------- The Empire Always Loses: This Time For Sure! Posts: 9973 | Registered: Saturday, March 30 2002 08:00 |
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By Committee
Member # 4233
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written Tuesday, April 3 2007 15:07
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So you do object to mandatory food and product recalls? Thuryl, how do any of these policies really serve to limit the meaningful experiences of your life, other than perhaps by forestalling your death? EDIT: And I don't think the evidence on the Pinto was anecdotal. Even Ford realized how poorly the car was designed, and included the expected costs from legal settlements in their figures before they decided to go ahead with it. Ford wanted the $2000 car, and the $8 or so per car it would have taken to correct the design defects would have put them over that figure. Their error was that they didn't figure on the cost to their good will. [ Tuesday, April 03, 2007 15:14: Message edited by: Drew ] Posts: 2242 | Registered: Saturday, April 10 2004 07:00 |
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...b10010b...
Member # 869
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written Tuesday, April 3 2007 15:32
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quote:I could ask you the same question. What exactly does a mandatory recall achieve that a mandatory notification of risk doesn't? -------------------- The Empire Always Loses: This Time For Sure! Posts: 9973 | Registered: Saturday, March 30 2002 08:00 |
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By Committee
Member # 4233
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written Tuesday, April 3 2007 16:16
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It protects consumers who may not have been aware that the product was put on notice. But beyond that, it's a pretty short step between having retailers post a notice and having them pull the items off the shelf. It's good business sense to begin with, not to mention selling anything that could cause injury is grounds for a tort action in any nation that uses the common law. Posts: 2242 | Registered: Saturday, April 10 2004 07:00 |