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Author Topic:   Safety and Effectiveness of Herbs and Pharmaceuticals
purpledawn
Member (Idle past 3479 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 59 of 209 (448260)
01-12-2008 7:04 PM
Reply to: Message 58 by nator
01-12-2008 5:45 PM


Re: Banning Herbals
I agree that any product made available to the general public for consumption should be tested and shown safe and effective for its proposed use. Safe meaning that the benefits, when used properly, outweigh the risks.
To the best of my knowledge the randomized controlled trials are the best system we have for this task. The double-blind trials are better for avoiding bias, but whether double-blind is the only way, I don't know.

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Replies to this message:
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purpledawn
Member (Idle past 3479 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 93 of 209 (554639)
04-09-2010 11:59 AM
Reply to: Message 91 by New Cat's Eye
04-09-2010 11:33 AM


quote:
I like Ibuprofen. If I've done a lot of hard work and have some sore muscles, it works great at getting rid of the pain. What's the alternative there?
I use ginger root. It's an anti-inflammatory. When I injured my knee, it worked great to bring down the swelling. That was the first time I used it. It's my standby for inflammation now.

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purpledawn
Member (Idle past 3479 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 117 of 209 (554821)
04-10-2010 11:09 AM
Reply to: Message 113 by Granny Magda
04-10-2010 9:44 AM


FDA - Labeling
quote:
Attack the source all you like, but the charges of improper sales of medicines that Quackwatch cite were genuinely made by the FDA. Mercola is guilty of lying to his "patients" about the effectiveness of his products, whilst raking in the cash. Meanwhile he accuses mainstream practitioners of greed. He is a quack, a hypocrite and an unreliable source.
The FDA letters aren't saying that the claims on Mercola's site are true or false. They are simply informing him that the claims made on his site about certain items deems them drugs and to be able to continue marketing those items with those claims they must first go through the same channels as drugs or new drugs.
All Mercola has to do is reword his claims, go through the process for drugs, or stop selling the item.
That's why we see this blurp: These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure or prevent any disease.

This message is a reply to:
 Message 113 by Granny Magda, posted 04-10-2010 9:44 AM Granny Magda has replied

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purpledawn
Member (Idle past 3479 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 126 of 209 (554875)
04-10-2010 4:52 PM
Reply to: Message 119 by Granny Magda
04-10-2010 11:37 AM


Re: FDA - Labeling
quote:
Yes, I know that. The fact is though, that any product sold with a medicinal claim carries with it an implication that the product has been tested, that it's alleged effects are real and that it has stood up to the appropriate regulations. Customers are going to assume that he has met any appropriate standards. To carry such boasts without compliance with FDA standards is intrinsically dishonest.
The last letter was 2006. Do you feel his site didn't make the appropriate change?
Are his claims worse than those put out by pharmaceutical companies that also make supplements?
IMO, pharmaceutical companies would be more misleading. Wouldn't the customer assume that a pharmaceutical company would be more likely to test, more reliable?
Wyeth makes Centrum
From Centrum Cardio Bottle
# Corowise Phytosterols, an ingredient derived from soybeans, may reduce the risk of heart disease by lowering LDL (bad) cholesterol.*
# High levels of Vitamins B6 and B12 to support heart health.*
Bayer makes One A Day
Men's Health Formula
One A Day Men’s Health Formula is a complete multivitamin specially formulated for leading men's health concerns. It contains key nutrients to support heart health, healthy blood pressure, immunity and physical energy.*
A Complete Multivitamin with More of What Matters to Men.
Formulated to Support:*
* Heart Health with Vitamins B6, B12, C, E and Folic Acid
* Healthy Blood Pressure Vitamin C, Calcium, Magnesium, and more Vitamin D
* Immunity with Vitamins A, C, E and Selenium
* Physical Energy with Vitamins B6, B12, Pantothenic Acid, Chromium, and Folic Acid
Both carry this statement:
*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
Why wouldn't he cash the checks? Pharmaceutical companies cash their checks regardless of whether their meds cure, maim, kill, or do nothing for an individual.
I feel it is a big mistake to assume any company is looking out for our best interests. Advertisements are designed to make us think they are. Companies push the envelope. Does that make them all dishonest?
It's still a world of buyer beware.

This message is a reply to:
 Message 119 by Granny Magda, posted 04-10-2010 11:37 AM Granny Magda has replied

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purpledawn
Member (Idle past 3479 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 181 of 209 (555914)
04-16-2010 6:44 AM
Reply to: Message 180 by Kitsune
04-16-2010 6:35 AM


Re: Alt med and vaccines
quote:
You are in error that the HepB vaccine is given 6 weeks after birth; the CDC says it should be administered at birth.
When my grandson was born in 2006 he was given the HepB vaccine right out of the oven. I was there and it is listed on his vaccination record. My daughter didn't test positive for any type of Hepatitis.

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purpledawn
Member (Idle past 3479 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 188 of 209 (556279)
04-18-2010 6:58 PM
Reply to: Message 180 by Kitsune
04-16-2010 6:35 AM


Vaccines and our Immune Evolution
quote:
Dr. Wakefield said, quite rightly, that no studies had been done to assess the effects of the full vaccination schedule up to age 2. Remember I said that it's one thing to assess the safety of an individual vaccine, and another to look at them in tandem, in babies and toddlers, because that's who is receiving 24 vaccines by age 1 and 36 by age 2 in the US. I compared this to polypharmacy, where doctors prescribe one or more drugs together though no studies exist to confirm the safety of such a practice (curiously, your only comment on the latter was another guffaw).
I also wonder about how vaccinations affect our immune system and how it will eventually affect future generations.
Historical Medical research on how vaccines affect the immune system.
Vaccination replaces recovery from infections with a rather different type of immunological stimulus. This can have unexpected effects. In the measles system, both vaccination and the infection itself have profound and long-lasting effects on the immune system, but these effects are not the same.
For example, recovery from natural measles infection reduces the incidence of atopy, and of allergic reactions to house dust mite to half the incidence seen in vaccinated children, suggesting a systemic and non-specific switch to Th1 activity.
Are vaccines moving our Th1 driven immune system to a "Th2 driven" immune system?
When a mother is pregnant, her pregnancy is controlled by cytokines, and requires a predominance of Th2 cytokines in order not to reject the baby. (Acta Paediatra 1997; 86: 916-918) A Th1 driven immune system would treat the baby as a graft, thereby miscarrying. Drugs are used to suppress the immune systems of transplant recipients for the same reason.
When a baby is born, it’s immune system is initially Th2-skewed, by virtue of the mother’s immune system. The mother’s immune system changes very quickly, and her breastmilk will help to change the baby’s balance, and will also buffer and assist in the development of the baby’s immune system.
The first years of life if the time when the difference between vaccine and natural immunity is so important, because most diseases promote a Th1 immunity. The portal of entry, and learning pathways teaches and matures the immune system, and helps in the prevention of both allergy-development and auto-immune disease. The antigen is processed, with the help of immunological factors in breastmilk and the baby’s cued-in immune system through the mucous membranes and the various layers of the immune system, producing an end-point called antibodies.
Are we creating weaker humans? Wouldn't it be better to find a way to help children through the diseases instead of avoiding them?
Yes, some people die from disease, but that's part of evolution. Yes, it would bother me if it were my child, but that isn't the issue. If vaccines are supposedly for the greater good, how is it good to weaken mankind's immune system?
I guess we'll only know through hind sight, well the future will anyway.

This message is a reply to:
 Message 180 by Kitsune, posted 04-16-2010 6:35 AM Kitsune has replied

Replies to this message:
 Message 190 by Kitsune, posted 04-20-2010 5:38 AM purpledawn has replied

  
purpledawn
Member (Idle past 3479 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 191 of 209 (556506)
04-20-2010 7:08 AM
Reply to: Message 190 by Kitsune
04-20-2010 5:38 AM


Re: Vaccines and our Immune Evolution
quote:
Erm . . . no. "Survival of the fittest" does not mean that we let the weakest humans die. Surely it is our moral duty to look after each other in the best way possible. My argument here is that vaccines may sometimes do more harm than good. This has got nothing to do with evolution.
I understand your argument, but I do think vaccines impact our evolution. That's why I feel humans would be better served to find a way to help humans survive the disease instead of avoid it. Find a better way to augment a weak immune system. I don't see vaccines as making us stronger from an evolutionary standpoint.
I agree with you that they need to investigate the potential overload of vaccines given to our children.

This message is a reply to:
 Message 190 by Kitsune, posted 04-20-2010 5:38 AM Kitsune has not replied

  
purpledawn
Member (Idle past 3479 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 199 of 209 (556540)
04-20-2010 10:06 AM
Reply to: Message 197 by nwr
04-20-2010 9:38 AM


Smoking Vaccine
quote:
Kitsune writes:
Vaccines for obesity, smoking, diabetes and addictions too?
Is that what the ranting, raving loonies are saying now?
They've been working on them.
Smoking vaccine study underway in Knoxville (8 Apr 2010)
KNOXVILLE (WATE) - East Tennessee smokers may soon have access to an experimental vaccine that takes most of the pleasure out of smoking. It's called Nicvax.
Quitters get a shot in the arm with smoking vaccine
None is yet on the market, but in late September, the National Institute on Drug Abuse (NIDA) released a $10 million stimulus grant to Nabi Pharmaceuticals to help pay for the first Phase III trial — a large study designed to confirm effectiveness and monitor side effects — of a smoking-cessation vaccine. Company spokesman Greg Fries says Nabi, based in Rockville, Md., expects to begin enrolling patients in the NicVax study by year's end. ...
Kim Janda, who has been studying vaccines to treat addiction since the late 1980s, predicts one against nicotine will hit the market within two years. "I think you can make antibodies to any drug of abuse," adds Janda, a chemistry professor at the Scripps Research Institute in La Jolla, Calif.
Scientists Test Anti-obesity Vaccine (2006)
The new vaccine, which is directed against the hormone ghrelin (pronounced "grell-in"), a naturally occurring hormone that helps regulate energy balance in the body, has shown the potential, in animal models at least, to put an end to that risky and often futile struggle.
I didn't find any current info on the anti-obesity vaccine. Maybe it didn't fly.
Swedish Diamyd Medical to apply for diabetes vaccine approval 2011 (For Type 1 Diabetes)

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purpledawn
Member (Idle past 3479 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 204 of 209 (558086)
04-29-2010 6:40 PM
Reply to: Message 203 by Granny Magda
04-29-2010 4:49 PM


Re: Alt-Med Guru Gets a Taste of His Own Medicine
quote:
What really amazes me is that I thought the possibility of vitamin D poisoning was quite well known. You'd think he would have known better.
Never heard of the guy before, but ConsumerLab.com (who is recommended by quackwatch.com) sent me an email concerning the issue. Since one has to subscribe, I can't link to the story on their site.
Vitamin D Overload in Supplement Sickens Users
On April 28, 2010, the New York Post reported that Gary Null, a nutrition promoter, was apparently sickened by his own product, Gary Null's Ultimate Power Meal, due to a manufacturing error that caused an excessive amount of vitamin D to occur in the product. Citing papers filed in a suit by Null against his manufacturer, Triarco Industries, the Post reported that the product contained 2,000,000 IU of vitamin D per daily serving instead of 2,000 IU -- a 1,000-fold increase. (As noted in the ConsumerLab.com Product Review of Vitamin D Supplements, the Upper Tolerable Intake Level for vitamin D is 2,000 IU per day. The Adequate Intake level is 400 IU to 600 IU per day, although 1,000 is often suggested for adults, particularly those with limited sun exposure.) According to the suit, Triarco was responsible for mixing the vitamin D for the product and failed to do proper testing.
He didn't do this to himself by taking too much. It was a manufacturing error. So he wasn't hoisted by his own petard. If the levels had been correct, he would have been fine as far as the Vitamin D goes.
In a response to media reports about the case, Gary Null posted a note on his website on April 28 indicating that only one lot of the product was affected, the product was removed from the market and recalled, and none of the product reached the retail market.
This isn't a case of someone taking too much on their own.
In ConsumerLab.com's view, the case demonstrates the importance of verification of the contents of dietary supplements and the need for consumers to be vigilant if they experience unexpected side-effects when using supplements. Another case of excessive vitamin D in a supplement was reported in 2004, in which a product claiming 400 IU of vitamin D per serving contained 188,640 IU.
Null apparently caught the mistake before it hurt anyone else and the one in 2004 was recalled when the mistake was discovered.
Aloe Producer Recalls Product Due to Toxic Levels of Vitamin D
The recall was initiated after it was discovered that the product contained more than the labeled amount of vitamin D due to an error in manufacturing. The 750 mg dietary supplement was packed 180 capsules per bottle and coded lot number P2207 or P2221. The lot coding can be found on the bottom of the bottle.
Solutions International Inc. reported three complaints received in the past month of customers hospitalized for vitamin D toxicity with hypercalcemia.

This message is a reply to:
 Message 203 by Granny Magda, posted 04-29-2010 4:49 PM Granny Magda has replied

Replies to this message:
 Message 206 by Granny Magda, posted 04-29-2010 7:08 PM purpledawn has replied

  
purpledawn
Member (Idle past 3479 days)
Posts: 4453
From: Indiana
Joined: 04-25-2004


Message 207 of 209 (558189)
04-30-2010 7:25 AM
Reply to: Message 206 by Granny Magda
04-29-2010 7:08 PM


Re: Alt-Med Guru Gets a Taste of His Own Medicine
quote:
He was happy enough to promote completely non-essential vitamin supplements as if they were some kind of healing potion. Now, one of his magic dinners has poisoned him. Bang goes the "natural food supplements are safe" line that Null has been peddling.
So when tainted Tylenol is recalled that means untainted Tylenol is no longer safe?
To be hoisted by one's own petard means one is harmed by something that was intended to harm someone else. Null's supplements weren't meant to hurt anyone. So the idiom doesn't fit.
quote:
I didn't say that it was. The article I quoted makes this quite clear;
The article is clear, but your words imply otherwise.
Granny Magda writes:
Gary Null is one of those kooky nutritionist types who thinks that you can fight disease just by consuming tons of vitamins.
Granny Magda writes:
What really amazes me is that I thought the possibility of vitamin D poisoning was quite well known. You'd think he would have known better.
quote:
Doubtless those people thought that what they were eating was safe. This kind of event encapsulates the reasons why these products should be properly regulated.
I agree it makes a case for proper manufacturing and quality practices as with anything consumed. We assume our food, OTC's, and supplements contain what they say they contain. Errors happen.

This message is a reply to:
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Replies to this message:
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