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The SkeptVet vs Dr. Shawn—A Paradigmatic Kerfuffle
Posted: 21 February 2010 07:03 PM   [ Ignore ]   [ # 61 ]
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mckenzievmd - 21 February 2010 05:26 PM

I see your point. I would hope that safety as well as efficacy rules could be strictly enforced, so even without specific label claims the manufacturers of CAM remedies would have to prove safety. If they could do so, I don’t suppose it would necessarily be such a problem if they continued to sell something like garlic pills. I realize that, as you imply, anything which could establish an efficacy claim for one indication could easily be misused for others for which there is no evidentiary support, and yet we wouldn’t be able to ban something that did have a legitimate use on this basis either. I guess I’m trying here to be realistic about the fact that irrational self-medication and outright quackery aren’t ever going to be eliminated, I’d just like to see a better job of minimizing the damage.

Of course, the distinction is largely moot since the will and resources to pass and, more importantly, effecttively enforce strict labeling regulations isn’t present and likely won’t be in the forseeable future. *sigh*

Right, unfortunately.

As I wrote above re. GRAS food sources, basically everything in the present food chain is considered to be safe, although very little of it has actually been tested for safety. As I understand it, the only materials routinely tested for safety are new chemical compounds, e.g., like new drugs, which have no particular track record.

So assuming these (“herbal” in the broader sense) compounds are already part of the GRAS food chain, or that they have been demonstrated safe, I don’t see any way that they could be banned outright, and I believe they should be available for sale, since people could want to use them for other purposes than medication. So long as they have NO misleading labeling or other marketing information along with them, I believe they should be available. The government should put its efforts into cracking down on false advertising. Of course, to repeat your point, the chances of anything like that really happening is highly unlikely in an age where money buys political influence with extreme ease.

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Posted: 22 February 2010 05:44 AM   [ Ignore ]   [ # 62 ]
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I am sorry to have to disagree yet again Doug but I think it is a bit of a copout, and inviting a comment of conspiracy theory, when you palm this ‘problem’ off to ‘money buys political influence’. It has nothing to do with money - it has to do with the desire of ordinary people in almost every society to have access to non-scientific, alternative, medicines - for whatever irrational or illogical or silly reason they may chose. I have seen this in Europe where a European Parliament effort to clear the shelves of CAM shops a few years ago was swamped by an outcry by people across Europe.

Contributors to this forum might be interested in an answer given to a Question on this subject in the European Parliament in 2009.
http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=E-2009-3421&language=EN

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Posted: 22 February 2010 06:04 AM   [ Ignore ]   [ # 63 ]
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scepticeye - 22 February 2010 05:44 AM

I am sorry to have to disagree yet again Doug but I think it is a bit of a copout, and inviting a comment of conspiracy theory, when you palm this ‘problem’ off to ‘money buys political influence’. It has nothing to do with money - it has to do with the desire of ordinary people in almost every society to have access to non-scientific, alternative, medicines - for whatever irrational or illogical or silly reason they may chose.

This is incorrect. Firstly, to repeat for the nth time (I really do have to wonder whether you are reading what I write), nothing that I discuss would remove access to the materials for alt med. All they would remove is the misleading or false marketing of them.

As for the question about “consipiracy theory: see for example HERE from Consumer Reports:

Q: Does the government regulate supplements?
Just barely—under DSHEA most supplements get less scrutiny from the FDA than a pack of cough drops. The 1994 law, whose passage was secured in part through heavy lobbying from the supplements industry, restricts the FDA’s authority over supplements, as long as companies are careful not to claim that their products treat, prevent, or cure disease. The law has left consumers without the protections surrounding the manufacture and marketing of over-the-counter or prescription medications.

Drugmakers must spend millions on clinical tests to show that a product works and is safe before the FDA will allow it on the market. Supplement manufacturers can launch products without any testing at all just by sending the FDA a copy of the language on the label. In fact, DSHEA makes it the FDA’s responsibility to prove that a supplement on the market isn’t safe; so far, that’s happened just once, with the hazardous weight-loss and energy supplement ephedra.

And HERE from Time Magazine. (Unfortunately the page displays very poorly on my browser. I’ve cleaned up the formatting in my quote):

How can the health foods industry switch, willy-nilly and with such impunity, to other stimulants that also pose dangers to consumers? Why can’t the FDA, especially with its current activist commissioner, Dr. Mark McClellan, act further to protect the public?

The answer lies in ill-conceived and reprehensible legislation approved by Congress in 1994 after a massive lobbying campaign by the health food industry. It’s called the Dietary Supplement Health and Education Act (DSHEA) and, as I’ve written before, it gives the industry virtually free reign to market products defined as ‘dietary supplements,’ while severely limiting the FDA’s ability to regulate them.

<snip>

Ephedra is a case in point. Although its dangers have been evident for years, the FDA’s recent ban of the herb is the first such action the agency has been able to take in the decade since enactment of DSHEA, an act that the New York Times bluntly characterizes as ‘a formula for covering up problems and ensuring regulatory inaction.’

This harmful and duplicitous legislation was co-sponsored by Utah Senator Orin Hatch, who has been rewarded with nearly $140,000 in campaign contributions from the health food industry, and Representative Bill Richardson, now governor or New Mexico. As recently as 1999, Hatch opposed an FDA proposal that for safety reasons would have allowed ephedra to be sold only in doses of eight milligrams or less. ...

And HERE from Quackwatch:

In the early 1990s, Congress began considering two bills to greatly strengthen the ability of federal agencies to combat health frauds. One would have increased the FDA’s enforcement powers as well as the penalties for violating the Food, Drug, and Cosmetic Act. The other would have amended the Federal Trade Commission Act to make it illegal to advertise nutritional or therapeutic claims that would not be permissible on supplement labels. During the same period, the FDA was considering tighter regulations for these labels.

Alarmed by these developments, the health-food industry and its allies urged Congress to “preserve the consumer’s freedom to choose dietary supplements.” To whip up their troops, industry leaders warned retailers that they would be put out of business. Consumers were told that unless they took action, the FDA would take away their right to buy vitamins. These claims, although bogus, generated an avalanche of communications to Congress. ...

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Posted: 22 February 2010 07:10 AM   [ Ignore ]   [ # 64 ]
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Jeez Doug you have way too much time on your hands tongue rolleye

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Posted: 22 February 2010 07:18 AM   [ Ignore ]   [ # 65 ]
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scepticeye - 22 February 2010 05:44 AM

I am sorry to have to disagree yet again Doug but I think it is a bit of a copout, and inviting a comment of conspiracy theory, when you palm this ‘problem’ off to ‘money buys political influence’. It has nothing to do with money - it has to do with the desire of ordinary people in almost every society to have access to non-scientific, alternative, medicines - for whatever irrational or illogical or silly reason they may chose. I have seen this in Europe where a European Parliament effort to clear the shelves of CAM shops a few years ago was swamped by an outcry by people across Europe.

Contributors to this forum might be interested in an answer given to a Question on this subject in the European Parliament in 2009.
http://www.europarl.europa.eu/sides/getAllAnswers.do?reference=E-2009-3421&language=EN

scepticeye, there’s a huge difference between Europe and the USA, and it ain’t just the water of the Atlantic. Many - most? - people here are not as well-informed as you imply Europeans are, who understand that CAM is unproven and unreliable. Here, the advertising is taken at face value. CAM is believed by its adherents to be even more safe, reliable, and guaranteed therapeutic than scientific medicine. The stories from Mackenzie that you don’t believe about people forsaking scientific medicine in favor of CAM to their detriment and sometimes death, are indeed true, and increasingly common. A lot of people are skipping the “complementary” part of CAM and making it their sole medicine. Faith-based “medicine” is as prevalent in the US as faith-based religion, and it’s NOT being chosen by well-informed consumers as part of a balanced breakfast.

Now, I’m not in favor of banning everything outright, either - if everyone had the attitude towards CAM that you describe, I wouldn’t be worried. But that’s not the case here, or in many other parts of the world. No, the answer is in educating the public about CAM, and the most effective way of doing that is in regulating what CAM practitioners or purveyors can claim about it. I’d like to see more news attention paid to the ample studies disproving this or that, but they won’t get the attention of everyone that they should, especially if the practitioners so disproved are allowed to continue making their claims.

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Posted: 22 February 2010 01:53 PM   [ Ignore ]   [ # 66 ]
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I believe we are all in agreement that deceptive practices in any area must be discouraged by law or public information.
But I read somewhere that the reason big pharmaceutical companies do not include more natural products in their inventory is due to the fact they cannot be patented and thus do not yield the profits that can be generated with exclusive patented products. If that is true, then it is appropriate for ethical smaller niche pharma’s to market beneficial “supplements”, as long as sufficient information is available for an informed choice. Swanson and Puritan are such ethical pharmas and they provide clear and detailed descriptions of ingredients and recommendations for use.
Personal anecdote. I have moderate arterial schlerosis and slight shoulder arthritis.  I use HA, Arginine, and concentrated freeze dried veggie capsules as supplements to my diet. HA for its beneficial joint properties and Arginine for blood circulation (via nitric oxide), the veggie concentrations to supplement my daily vegetable intake. My doctor seems ok with that (he recommended the veggie supplements), and if anything they make me feel healthier than without.
But if anyone can prove that these substances are harmful to me, I would be grateful.

[ Edited: 22 February 2010 02:08 PM by Write4U ]
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Posted: 22 February 2010 02:05 PM   [ Ignore ]   [ # 67 ]
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Write4U - 22 February 2010 01:53 PM

I read somewhere that the reason big pharmaceutical companies do not include more natural products in their inventory is due to the fact they cannot be patented and thus do not yield the profits that can be generated with exclusive patented products.

This is an important, though complex, point. As you pointed out earlier, many currently existing pharmaceuticals had their origins in plant-based or “natural” products, so it isn’t true that such companies avoid “natural products” in general. What is true is that testing is expensive, and so testing of a new compound for a particular disease is more complicated, and rarer, if the compound cannot be patented.

Nevertheless there have been numerous tests of so-called “herbal” remedies, and numerous tests of CAM remedies, virtually all showing no relevant effects, and some showing harm.

There are also several large pharma companies that produce “generic” pharmaceuticals, which are compounds that have gone off patent. These compounds are economically identical to so called “natural” products, in that neither can be patented; and indeed many large pharma companies are now producing CAM as well. CAM is a multi-billion-dollar worldwide business.

What is “HA”?

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Posted: 22 February 2010 02:11 PM   [ Ignore ]   [ # 68 ]
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What is “HA”?

Hyaluronic acid.

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Posted: 22 February 2010 02:59 PM   [ Ignore ]   [ # 69 ]
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Doug is right that the argument about big pharmaceutical companies avoiding natural products isn’t a very reliable one. In fact, big companies are aggressively marketing vitamins and supplements, sometimes alongside coventional medicine. Things like viitamins, glucosamine, fish oils, and so on are hugely lucrative products, and big businessness are motivated to prevent the government from imposing the kind of safety and efficacy testing for these that are required for mainstream drugs. I always grimace when I hear CAM presented as an alternative to the misdeeds of Big Pharma, because the very same misdeed, often by the same companies, are involved in both areas. There’s nothing about alternative medicine that changes or avoids the greed and other sins of for-profit medicine, the only real difference is that CAM is currently smaller (but growing) and less reglated.

As for specific supplements you listed, here is a quick review, with the usual caveats that I’m not an MD and that I can’t guarantee completeness:

1) HA- Several studies have investigated injection of HA into the knee with mixed results. Only one study has reported oral use and there was some subjective perception of improvement. This constitutes weak evidence sufficient to justify further study. No apparent harmful effects from oral supplementation have been reported.

2) Arginine-Studies for use in prevention of complications from atherosclerosis in animals and in humans are mixed, with some showing beenfit and others not. A toxicology reviews suggests safety is pretty certain up to 20g per day, and higher levels may be safe but the data isn’t clear.

3) I’m not sure what’s in the “veggie supplement,” but in general some vitamins are safe and some or not safe depending on dose, health status, other drugs being used, and so on. Several large studies on routine multivitamin use in healthy people eating a typical western diet have found no benefits. Obviously, specific vitamins for specific conditions or deficiencies are often beneficial.

So overall, I’d agree that what you’re taking is unlikely to be harmful, and there’s no solid reason to think it will be helpful. As lng as you are ok with that, I agree with scepticeye that it’s your body and your money. And as long as the people selling you these supplements don’t make claims for them that the evidence doesn’t support, I have no objection to their selling them to you.

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Posted: 22 February 2010 05:08 PM   [ Ignore ]   [ # 70 ]
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mckenzievmd

So overall, I’d agree that what you’re taking is unlikely to be harmful, and there’s no solid reason to think it will be helpful. As lng as you are ok with that, I agree with scepticeye that it’s your body and your money. And as long as the people selling you these supplements don’t make claims for them that the evidence doesn’t support, I have no objection to their selling them to you.

Thank you Brennan, for taking time to research. I value your professional input. grin

[ Edited: 22 February 2010 05:10 PM by Write4U ]
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Posted: 23 February 2010 12:41 AM   [ Ignore ]   [ # 71 ]
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Write4U - 22 February 2010 01:53 PM

But I read somewhere that the reason big pharmaceutical companies do not include more natural products in their inventory is due to the fact they cannot be patented and thus do not yield the profits that can be generated with exclusive patented products.

Not true. The pharmaceutical company will synthesize the active ingredient and patent it as a brand name. Examples are:

THC from marijuana and Digoxin (which of course is now a generic medication).

Opioids which come from poppies are constantly being synthesized to make them better and more effective, an example is fentanyl,  I used to know the names of about a half dozen, but I no longer work in the PICU to use these medications.

Epogen is a natural hormone which was synthesized, and is a boon to patients undergoing chemotherapy and those with kidney failure.Epogen stimulates the bone marrow to make red blood cells. It decreases the need for blood transfusions.  I’m sure it is a BIG money maker for the company which markets it.

Heparin is a natural product made by(if memory serves me correctly) your kidneys. It has been synthesized for decades. It is one of the most useful medications we have.

The Cefazolins were synthesized from a bacteria found in a sewer pipe (in Samoa if my memory is correct). I think we are on the fifth generation now.

Cyclosporin, one of the most important and profitable immunosuppressives was isolated from a fungus found in a Norwegian soil sample.

.... and this list just came off the top of my head after about 15 minutes of thought. If I were to really think about it, I’m sure I could come up with many, many more!

[another one] taxol, the breast cancer drug which has been a life saver came from the yew tree.

[ Edited: 23 February 2010 02:46 PM by asanta ]
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Posted: 28 October 2011 05:47 AM   [ Ignore ]   [ # 72 ]
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The ability to synthesize some drugs is what makes them available in the quantities needed. Synthesis is often a good thing.

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Posted: 12 February 2012 12:44 PM   [ Ignore ]   [ # 73 ]
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