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Ron Paul and Alternative Medicine
Posted: 18 December 2007 12:23 PM   [ Ignore ]   [ # 16 ]
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While I’m almost always with you on technical issues, Doug and Brennen, Sandy’s right about a push by the FDA a few years ago to ban OTC sales of vitamins and minerals that exceeded, as I recall, very much over the RDA.  Since studies have shown that as we get older our intestines are less permeable and less efficient at absorbing micronutrients.  As as 77 year old, I like the idea of being able to take supplements well above the RDA in one pill rather than taking a handful of them.

Again, while many modern pharmaceuticals have been synthesized, all of the vitamins, minerals, and amino acid supplements are natural.  And many of the synthetic ones are modifications of naturally occurring chemicals, e.g., aspirin, the whole family of synthetic penicillins. 

FDA actions such as their handling of tryptophane can’t help but make the alternate medicine community very suspicious.  Many years ago this naturally occuring amino acid was sold OTC as a sleep aid.  Then a Japanese firm came up with a new, cheaper way to synthesize it.  Unfortunately, they didn’t recognize that a side product caused severe blood problems.  A few people died and the problem was identified.  The FDA pulled tryptophane from the market.  They didn’t just recall what was on the shelves at the time; they didn’t just restrict the manufacturing methods; they didn’t accept the Japanese firms statement that they could modify their procedures to prevent that byproduct, and could test to assure it wasn’t there.  They just banned the sale of tryptophane permanently. 

While I strongly endorse the charter of the FDA, the way it has been taken over, especially in this administration, by the meat and pharmaceutical industries is execrable.

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Posted: 18 December 2007 12:38 PM   [ Ignore ]   [ # 17 ]
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Occam - 18 December 2007 12:23 PM

While I’m almost always with you on technical issues, Doug and Brennen, Sandy’s right about a push by the FDA a few years ago to ban OTC sales of vitamins and minerals that exceeded, as I recall, very much over the RDA.  Since studies have shown that as we get older our intestines are less permeable and less efficient at absorbing micronutrients.  As as 77 year old, I like the idea of being able to take supplements well above the RDA in one pill rather than taking a handful of them.

One should not be taking megadoses of vitamins without a doctor’s order. So these should be taken with prescription. Most people taking megavitamins are either wasting their money or actively damaging their own health. So the FDA is in the right to ban them. At any rate, if one is foolish to wish to take large doses of vitamins, one can take more than one pill.

Occam - 18 December 2007 12:23 PM

Again, while many modern pharmaceuticals have been synthesized, all of the vitamins, minerals, and amino acid supplements are natural.  And many of the synthetic ones are modifications of naturally occurring chemicals, e.g., aspirin, the whole family of synthetic penicillins. 

Sure. And most of the food we eat is natural too. But foods, as well as the vitamins and minerals they contain, are not “medicines”. Most medicines are artificial.

Re. tryptophan. From the UC Berkeley Wellness Letter HERE (I believe this requires subscription, though):

5-HTP (5-hydroxytryptophan), a close relative, has replaced tryptophan in health-food stores and drugstores and on the Internet. The body makes 5-HTP from tryptophan; and like tryptophan, 5-HTP is converted to serotonin in the brain. ... Some small studies suggest that 5-HTP may be as effective as standard antidepressants, but most of these studies were not well designed. And other studies have not found a benefit. ...

Final Thoughts: Some dietary supplements, notably 5-HTP, can influence brain chemicals. As the tryptophan story showed, even though they are marketed as “natural,” they can have serious adverse effects—just like traditional antidepressants. The potential dangers of 5-HTP outweigh any possible benefits.

FYI: Quackwatch Notes on the Tryptophan Disaster. (With links).
And more from Quackwatch on How the Dietary Supplement Health and Education Act of 1994 Weakened the FDA.

[ Edited: 18 December 2007 12:40 PM by dougsmith ]
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Posted: 18 December 2007 12:46 PM   [ Ignore ]   [ # 18 ]
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I think the issue of what is “natural” is a dicey one. First, it is almost always equated with “safe” or “healthy,” which is clearly not true. Secondly, if you extract and purify a substance from a plant, it isn’t a “natural” substance (how many gingko biloba trees grow capsules of purified extract?), so it is really a drug and should be treated as such. So I think whetehr something is “natural” or not is kind of irrelevant to safety and efficacy statements. Belladonna is natural, bungarotoxin is natural, GI parasites are natural, but none of them are good for you. It’s a bit of verbal misdirection that covers up the real question-is something safe and effective for a particular use?

Certainly not all FDA regulation is appropriate or effective, and they make mistakes. But on balance, uncontrolled use of any supplement or snake oil anyone chooses to market is a hell of a lot worse, as I think we agree. The issue with the l-tryptophan is not that the FDA went overboard, but that it was unable to require any safety or efficacy data until after the problem had killed and injured a lot of people. Perhaps the ban was excessive, but the alternative would be regulated prescription use, which I support but which the AM community is fundamentally unwilling to acede to. The fact that, as they kept saying, it occurs naturally in turkey had nothing to do with the safety or efficacy of purified extracts of it, and as these are drugs they should be regulated as such.

And as for megadoses of vitamins and minerals, there are a lot of people not as smart and scientifically educated as you are who would make bad choices, encouraged by marketing. Fat soluble vitamins, in particular (A,D, E, K) can be very dangerous if taken in excess or at certain life stages, and if this potential exists I think regulation of their use is in order. Is it better to require older people to see a doctor to get larger doses of vitamines or to let people give their kids Vit A poisoning by allowing free use of large quantities? I have to say the latter.

I’d recommend reading Natural Causes: Death, Lies and Politics in America’s Vitamin and Herbal Supplement Industry (Hardcover)
by Dan Hurley. It’s a bit gonzo in approach (kind of Michael Moorish), but I think it does a good job showing how really dangerous and venal the supplement/vitamin industry is and why regulation is really appropriate.

[ Edited: 18 December 2007 01:11 PM by mckenzievmd ]
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Posted: 18 December 2007 05:15 PM   [ Ignore ]   [ # 19 ]
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Doug:

One should not be taking megadoses of vitamins without a doctor’s order. So these should be taken with prescription. Most people taking megavitamins are either wasting their money or actively damaging their own health. So the FDA is in the right to ban them. At any rate, if one is foolish to wish to take large doses of vitamins, one can take more than one pill.

Equus excrement.  I’ve had discussions with my internist, my cardiologist, my urologist, and my ENT specialist.  None of them are particularly up to date on nutrition.  I’ve had enough biochemistry courses and have kept abreast of work in the field so I have a pretty good handle on what I’m taking.  You’ll note that over the last fifty years the FDA has first shifted from minimum daily dose to recommended daily dose with an increase, then gradually they’ve increased the RDA of quite a few of the vitamins while lowering the RDA of iron for adult males (about five years after I read the research).  Vitamin E used to be set at 40 I.U.  I see it’s now 60, and heart health studies indicate that 200 I.U. makes more sense.  Vitamin D is still set at 400 I.U., but recent research recommends 1000 I.U. in general and 2000 I.U. for pregnant women in higher latitudes.  Vitamin A RDA is 5000 I.U. but it’s not toxic below 25,000. 

I agree that the alternative medicine gurus seldom know anything about the chemisty of what they are selling, and I pay no attention to them.  And I also agree that many consumers aren’t knowledgeable enough to make decent choices.  Unfortunately, often neither are their doctors.

Brennen, I wasn’t implying that natural is therefore good, only disputing Doug’s strong rejection of Sandy’s comment about natural.  I also realize there’s a spectrum from natural to completely synthetic rather than a sharp demarkation.

BTW, I also was annoyed by Sandy’s extreme libertarian position, but I didn’t feel that was reason to attack her alternative medicine views so strongly. 

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Posted: 18 December 2007 05:41 PM   [ Ignore ]   [ # 20 ]
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Occam,

I wasn’t attacking her AM position because of her libertarianism. As I said about Rocinante’s comments, I have some limited sympathies for civil liberties issues as seen from the libertarian perspective, and I don’t see libertarianism as intrinsically pro AM.  I was attacking her impassioned defense of the crap put on at the conference I linked to because it is crap and it hurts people (did you look at the conference topics?). I admit to a certain passion about the issue since I see both well-meaning but ignorant people and outright charlatans inflict pain and deny true medical care to animals on a daily basis, and my family and friends in human medicine see the same done to people. You may be sufficiently educated to make informed, research-based decisions about vitamins and minerals, but most people aren’t, and her position was that’s just their problem and if they can’t evaluate the info adequately it’s their own fault. Government regulation of medical therapies is not an unreasonable imposition on our civil liberties, it is a reasonable defense of the general public against victimisation.

If you look at the history of the FDA and government regulation, you see a clear pattern of decrease in the number of useless and dangerous bogus therapies and the damage they do as the government gets more comprehensive regulations in place. It may be annoying that the regulations aren’t perfect, and no one likes to be told what to do or not to do, but all I’m defending is that people who sell treatments and preventatives for disease be required to prove to a reasonable standard that what they sell is safe and effective. I can’t see why rational people find that idea so offensive, and I can only attribute it to the notion that “I know what’s best for me,” “Who are those faceless beaurocrats to tell me what I can or can’t give my children when their sick,” or even more extreme notions such as “the medical establioshment is conspiring to hide safe and effective natural cures for disease because their income and power would be threatened by letting people treat themselves.” I hear all of these from the AM lobby. You seem to fall under the first one, at least as far as vitamns and minerals are concerned (I don’t know if you extend that to other kinds of therapies and preventatives). And while you may be right in your own case, but I still don’t think you’re right in terms of the public health at large. Sandy falls into the last category, and as a health care professional I can’t tell you how insulting and pissed off that argument makes me, apart from its intrinsic idiocy.

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Posted: 18 December 2007 09:10 PM   [ Ignore ]   [ # 21 ]
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I’m curious as to how people feel about actual drugs as opposed to the obvious worthless (and sometimes dangerous) supplements and megavitamin mumbo jumbo offered up by new age “healers.”  Personally, I prefer my medicine to actually work!  :grin: 

Anyway, on to the example:  Ciliacaycellsty Acid is a drug currently undergoing clinical trials for pain patients.  So far documented side effects include hemorrhaging in the stomachs of patients with at least 52 deaths and toxicity in children.  But despite those problems it does seem to offer moderate pain relief to certain patients.  So while it has clear and admitted risks, it does deliver, as opposed to “alternative medicine” that has risks but doesn’t deliver. 

I’m going to assume people here wouldn’t want the FDA to ban this drug.  But how do people here feel about its availability – assuming it makes it out of clinical trials and onto the market?  What do people here think?  Should the FDA make it available only by prescription or allow it to be sold over-the counter without a prescription?

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Posted: 19 December 2007 09:46 AM   [ Ignore ]   [ # 22 ]
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Well, we are a very risk averse society, and we expect to get something for nothing. But one area where I agree there is no free lunch is physiology. If it doesn’t have side effects it’s because it ain’t doing anything. The decision when to use a drug given the balance between risks and benefits is a complicated, and not purely medical decision. I’ve had people ready to euthanize their dogs for terrible pain, and I was able to relieve that pain and give the dogs a good quality for several months with very high doses of medication. The price, which we knew we were going to pay, was killing the dog with kidney failure after that time. Some people feel that is appropriate, others don’t.

So while I don’t know anything about the specific drug, I think death is a pretty severe side effect and it takes a thorough understandng of the liklihood of that and the other consequences, balanced with an understanding of the potential benefits and the personal appreciation of how debilitating the pain is and how much risk one is willing to take to relieve it, to make a decision to use such a drug. I think most people would be unable or unlikely to be adequately informed or to see the pros and cons from this sort of risk/benefit perspective clearly without the help of a medical profession, and ideally a doctor they have an established relationship with. And especially when people are making decisions for their children who are in pain, these decisions are often not the most rational. So I think making it available without a prescription would on balance do more harm (through side effects that might be avoided by better choices, such as the use of other drugs or avoidance of concurrent risk factors the patient might not be aware of) than good (greater ease of avilability). Granted, some doctors would prescribe it without proper communication and discussion, but that is a flaw in their practice, not in the basic principle that such discussion should happen before such a drug is used.


I guess I view the general issue of availability of drug therapies as a risk/benefit analysis. If there are significant risks, I think these are most likely to be minimized by requiring involvement of doctors in making the drug available to patients. If the risks are minimal, then freer access and less supervision of use is appropriate. It’s a judgement call.

[ Edited: 28 December 2007 11:42 AM by mckenzievmd ]
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Posted: 20 December 2007 12:13 PM   [ Ignore ]   [ # 23 ]
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With credit to George for posting this, I thought it would go well in this thread.

See Cartoon at End of Page

[ Edited: 20 December 2007 12:15 PM by mckenzievmd ]
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Posted: 24 December 2007 06:43 PM   [ Ignore ]   [ # 24 ]
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mckenzievmd - 18 December 2007 05:41 PM

Occam,
...but all I’m defending is that people who sell treatments and preventatives for disease be required to prove to a reasonable standard that what they sell is safe and effective.

I agree.  But the ironic thing is that real scientific-based medicine is more prone to be attacked via our own legal system than the quack-based alternative “medicine.” 

There’s an old saying that goes, “The only bigger fools than quacks are their patients.”  That translates to the fact that no matter how much the quacks’ snake-oil fails to treat diseases, or even how much damage it does to a person who takes it, most alternative “medicine” proponents won’t say a single bad word about the quacks who sold them the snake-oil and will continue to swear by it, even to their deaths. 

While at the same time, real scientific-based medicine remains in the crosshairs of trial lawyers (and their politically elected partners) because the real medical people have bigger bank accounts than the quacks, even if only in perception.  These trial lawyers and politicians (who are sometimes one and the same) have made a very good living out of bad mouthing the medical community, thus prejudicing the perception of them in the public’s eye.  All it takes is for one trial lawyer to convince 12 or even 6 scientifically ignorant jurors that the big, bad, faceless pharmaceutical company’s product caused any sort of ailment in a single person who took it, to potentially bankrupt that company.  (The connection between the drug-maker’s product and the malady doesn’t even have to be true – think of the big lie of the breast implant hysteria a few years back.)  The result could very well be that every other person in the U.S. (and nearly all other nations) could go without countless other drugs that make everyone’s lives better, because that company can’t or won’t put out certain medicines for fear of juries punishing them for something they may not have even done. 

We could set up a panel of impartial scientific and medical experts that would determine the truth of falseness of any medicine’s claim based on pure science (a good idea, I think), and one trial lawyer and one jury who can be manipulated via nothing more than their emotions would immediately counter everything the experts say.

So in addition to laws against false advertising of medical products, we also need serious tort reform along with possible jury reform.  Stupid people need to be prevented from serving on juries, especially when scientific evidence is going to be presented.  Trial lawyers and politicians do not want this.  Thus, it probably is not going to happen.

And all the while, the quacks will continue peddling their junk to people who will demand it and not speak ill of it.  And the more you try to tell them it won’t work, the more they will believe it does.

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Posted: 24 December 2007 07:42 PM   [ Ignore ]   [ # 25 ]
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Rocinante,

I agree, and it’s a sad state of affairs. The incentives in the legal system are such that truth or scientific fact is the last thing relevant to the outcome of a malpractice or liability suit. And, of course, these monetary factors are exacerbated by a sad lack of scientific literacy among jurors and, as import, judges and lawyers. It becomes about deuling experts, with being charismatic and articulate more important than being right. And I also agree significant reform is unlikely any time soon. I like the idea of judges relying on independant experts appointed by the court, rather than those hired by the parties involved. It might help some, anyway.

And, of course, part of the reason the quackery is less vulnerable than mainstream medicine is precisely because it is not subject to the same legal requirements. Making a uniform standard of safety and efficacy for medical therapy, regardless of meaningless distinctions like “natural” and “artificial” would help some as well. Still, as getting sued is a regular and expected part of my work, and nobody seems too upset about it, I doubt there’s any real base of support for real change. Pity, especially for the patients.

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Posted: 25 December 2007 01:06 PM   [ Ignore ]   [ # 26 ]
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mckenzievmd - 18 December 2007 05:41 PM

Occam,
...but all I’m defending is that people who sell treatments and preventatives for disease be required to prove to a reasonable standard that what they sell is safe and effective.

Sounds reasonable, but then, shouldn’t we require the same of the fast food places, video games, and most TV shows (safe for mental health)?  LOL

Occam

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Posted: 25 December 2007 01:13 PM   [ Ignore ]   [ # 27 ]
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Well, we do require a certain standard of public health safety and accountability for fast food. And people have tried to show harm form TV and video games, in which case perhaps regulation could be justified, but the evidence isn’t at all convincing. SO though I get your humorous point, in reality I agree with the literal idea as well.

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Posted: 28 December 2007 08:28 AM   [ Ignore ]   [ # 28 ]
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Rocinante - 18 December 2007 09:10 PM

I’m curious as to how people feel about actual drugs as opposed to the obvious worthless (and sometimes dangerous) supplements and megavitamin mumbo jumbo offered up by new age “healers.”  Personally, I prefer my medicine to actually work!  :grin: 

Anyway, on to the example:  Ciliacaycellsty Acid is a drug currently undergoing clinical trials for pain patients.  So far documented side effects include hemorrhaging in the stomachs of patients with at least 52 deaths and toxicity in children.  But despite those problems it does seem to offer moderate pain relief to certain patients.  So while it has clear and admitted risks, it does deliver, as opposed to “alternative medicine” that has risks but doesn’t deliver. 

I’m going to assume people here wouldn’t want the FDA to ban this drug.  But how do people here feel about its availability – assuming it makes it out of clinical trials and onto the market?  What do people here think?  Should the FDA make it available only by prescription or allow it to be sold over-the counter without a prescription?

Please accept my apologies.  I fibbed a bit in my previous post.  That’s not the drug’s real name and it isn’t currently in clinical trials.  But everything else is true.  But since only one person replied to it (rather reasonably, too), then it is time to reveal everything. 

Ciliacaycellsty Acid is an anagram for Acetylsalicylic Acid, better known as aspirin.  Sorry.  But I knew many, if not all, of the posters here would know it by its real name.  In order to get unbiased answers, I did it this way.  Sorry. 

But the side effects of aspirin and the deaths from it are all true.  Granted many of those deaths are from suicide gulp (from aspirin?!?!), but not all.  And the 52 number was just for one year.  That’s probably about the average number each year.  And all NSAIDs combined kill about 7,600 Americans each year.   

And it is very dangerous for children, causing many children’s deaths in the past, with Reye Syndrome being perhaps the most deadly to kids. 
   
Presented in the manner laid out above, I would submit most Americans would want Aspirin by prescription only, if not outright banned. 

The reason I did this was to point out the absurdity of demanding zero risk in medicine.  If aspirin were introduced today, the FDA and the nanny-staters would probably not allow it on the market.  Can you imagine how far along we would be—right now—in the fight against AIDS, cancers and other diseases if the pharmaceutical companies weren’t hamstrung by trial lawyers and unreasonable demands of the public and lawmakers who won’t accept any risk?   

Too many lawyers in the FDA and not enough doctors is one of the biggest problems with it.  We will never get anywhere without taking risks.  One of the factors that made the U.S. a great nation was previous generations’ risk taking attitude.  That attitude is long gone today, replaced by frivolous lawsuits and hand-wringing nanny-staters who are convinced they know best how everyone else should live their lives.   

As for the “alternative medicine” true believers, nothing will convince them of the folly of wasting their money at the least and endangering their health at the worst pursuing this avenue of “health care.”  All the laws in the world can’t mandate critical thinking and perfect safety.  No matter what we as a society try to do with education and certain limited legislation regarding the dangers and futility of “alternative medicine” (and we should do our best – within reason), we have to accept the fact that there will always be a group of people who will embrace that pseudoscience and endanger themselves.  At some point, we just have to let them go.  The only bigger fools than quacks are their patients.  Granted, when children are involved it brings up a whole set of different problems and philosophical questions and conundrums with no easy answers by anyone.

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Posted: 28 December 2007 08:46 AM   [ Ignore ]   [ # 29 ]
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Occam - 25 December 2007 01:06 PM
mckenzievmd - 18 December 2007 05:41 PM

Occam,
...but all I’m defending is that people who sell treatments and preventatives for disease be required to prove to a reasonable standard that what they sell is safe and effective.

Sounds reasonable, but then, shouldn’t we require the same of the fast food places, video games, and most TV shows (safe for mental health)?  LOL

Occam

It’s not the same.  What I am personally asking of from all medicine (real or alternative) is truth in advertising.  Report that with multiple, double-blind studies, over x amount of time, Y amount of people who took the medicine being advertised got better and z amount of people did not.  Then I can make a decision on whether to take it or not.  Real medicine does this.  Alternative medicine does not (and cannot!) do this, instead relying on anecdotal testimonials from actors dressed up in white lab coats. 

And besides, there is already truth in advertising with the Big Mac because anyone can get the actual caloric, cholesterol, etc. numbers for the Big Mac and make a determination on whether they want to eat it or not.

If it is a matter of the government stepping in to force people to do what is good for them (even against their will), then by that exact same same rational, the government has the right and duty to force all people to become religious, since religious people are generally healthier than non-religious people. 

The government and the nanny-staters have to realize that there will always be people who will do stupid, unhealthy things!  Most won’t.  Some will.  The nanny-staters need to live their own lives and let the stupid people ruin their’s, as long as it doesn’t harm others.  Truth in advertising for medicine will allow the majority of people to make better decisions.  For the stupid people it won’t matter, but then, nothing will matter for them.

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Posted: 01 January 2008 10:08 AM   [ Ignore ]   [ # 30 ]
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mckenzievmd - 12 December 2007 11:42 AM

... to an alternative medicine conference put on by Lew Rockwell, a paleolibertarian associated with the Ludwig von Mises Institute and completely deluded on the questions of science and medicine.

Did you see Ron Paul’s statement on evolution, too?

It’s funny - if you read Virginia Postrel’s “The Future and Its Enemies” or think of Penn and Teller, you’d get the impression that there is a skeptical vein to libertarianism, but then you also get this side, too.

cheers,
VM

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