Auditing Toolkit to Improve Pharmacovigilance of Traditional Chinese Medicine

[barbc56]

I am posting this as a quality control issue and not about the merit of Chinese Traditional Medicine.
Thanks.

Text broken into paragraphs for readability. No special thanks needed for that!

Globally, there has been an increase in the use of herbal remedies including traditional Chinese medicine (TCM).

There is a perception that products are natural, safe and effectively regulated, however, regulatory agencies are hampered by a lack of a toolkit to audit ingredient lists, adulterants and constituent active compounds. Here, for the first time, a multidisciplinary approach to assessing the molecular content of 26 TCMs is described.

Next generation DNA sequencing is combined with toxicological and heavy metal screening by separation techniques and mass spectrometry (MS) to provide a comprehensive audit. Genetic analysis revealed that 50% of samples contained DNA of undeclared plant or animal taxa, including an endangered species of Panthera (snow leopard). In 50% of the TCMs, an undeclared pharmaceutical agent was detected including warfarin, dexamethasone, diclofenac, cyproheptadine and paracetamol.

Mass spectrometry revealed heavy metals including arsenic, lead and cadmium, one with a level of arsenic >10 times the acceptable limit. The study showed 92% of the TCMs examined were found to have some form of contamination and/or substitution.

This study demonstrates that a combination of molecular methodologies can provide an effective means by which to audit complementary and alternative medicines

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It looks like this method works only on herbs?

Now I'm curious as to what measures are taken by Big Pharma, or would it be the FDA, to check for quality control for conventional medications. What's good for the goose and so on. Something to look into at a later time.

The article mentions that some of the herbs may not be deliberately tampered with but due to laboratory contamination.

Barb

 

[IreneF]

Here's a link to the study published in Nature:
http://www.nature.com/articles/srep17475

Really disgusting what they found. Arsenic, lead, cadmium, pharmaceuticals, animal matter (cat, dog, rat, possibly frog and pit viper, and at least one endangered species). Not only disgusting but possibly dangerous.

Pharma has extremely strict quality assurance due to oversight by the FDA. I know a little about it because someone I know worked as a consultant when a pharma co. had an FDA recall. Supplements and herbs do not come under the jurisdiction of the FDA. I think the exception is when something is thought to be a carcinogen. (But then why are alcohol and tobacco still sold?)

You can get more info. about the FDA at its website fda.gov.

 

[adreno]

Really disgusting what they found. Arsenic, lead, cadmium, pharmaceuticals, animal matter

And what do you think is in the food you buy?

 

[barbc56]

Here's a link to the study published in Nature

Thank you so much! I would've bet money I had included the URL! Thank goodness I'm not a betting person!

And what do you think is in the food you buy?

I have read articles that could put off anyone from eating the food we buy. But because there may be flaws in one system does not justify ignoring the other.

Both have to do with quality control and safety. I'm not a Big Government Intervention enthusiasts but feel that for this situation, it's certainly warranted.

Barb

 

[adreno]

I have read articles that could put off anyone from eating the food we buy. But because there may be flaws in one system does not justify ignoring the other.

I agree, but it does put it into perspective, doesn't it? I haven't done the calculations, but I would expect the amount of arsenic from, for example 500mg of herb, to be negligible compared to say, eating a chicken.

 

[barbc56]

, but I would expect the amount of arsenic from, for example 500mg of herb, to be negligible compared to say, eating a chicken

Eating too much fish can be dangerous.

But expecting is guessing. I want as much assurance as possible, with emphasis on possible. There are no guarantees in life. Sometimes, you have to weigh the benefits vs. the harm such as prescription medications and medical procedures.

I can't help but think of Gary Null. Even though his experience was with supplements, he has permanent kidney damage and almost died. The odds of this being an everyday occurance may be low, I don't really know, but I don't want to take the chance.

I'm not dissing TCH in this thread. and as I said above I prefer to discuss this as a safety issue and posted this as information. How people choose to use this information is a personal choice.

I would've said the same thing if we were discussing food, prescriptions, etc.

Barb

 

[IreneF]

These are the dangers of an unregulated market.

I know that processed food allows for certain things like insect fragments, and that anything that grows in the dirt is going to be dirty, but something sold as medicine ought to be held to a higher standard. Would you knowingly take arsenic or eat an endangered species? Would you give a lead-containing substance to a child?

You have a right to know exactly what it is you're getting.

 

[Hip]

It would have been interesting to see herbal medicines from other areas of the globe analyzed. It is just the Chinese herbs that have high levels of heavy metals?

I wonder how heavy metals get into herbal products. Are the heavy metals found in the soil where the herbs grow?

More concerning is the presence of undeclared pharmaceutical agents in 50% of samples. That presumably must be a deliberate addition.

 

[IreneF]

It would have been interesting to see herbal medicines from other areas of the globe analyzed. It is just the Chinese herbs that have high levels of heavy metals?

I wonder how heavy metals get into herbal products. Are the heavy metals found in the soil where the herbs grow?

More concerning is the presence of undeclared pharmaceutical agents in 50% of samples. That presumably must be a deliberate addition.

Lead, especially, is found in many kinds of traditional medicines:
http://www.cdc.gov/nceh/lead/tips/folkmedicine.htm
It seems to be deliberate, not as a result of soil contamination.

The undeclared drugs seem to be mostly in "men's health" or weight loss products.

 

[perchance dreamer]

Most of my supplements are pharmaceutical grade. I do like knowing that every capsule has the dosage stated on the label.

There are 2 brands I like even though they aren't labeled pharmaceutical grade because I get good results with their products: Gaia Herbs and Jarrow.

 

[Jonathan Edwards]

I think the problem with TCM is that they deliberately put various highly toxic things in. Traditional Western medicine was the same. Heavy metals were very popular, as were toxic plant alkaloids. The same probably applies throughout Asia. At one time the red spice used for Tandoori chicken contained a highly potent carcinogen dye which gave a nice colour. Regulatory bodies in the west did not seem to take much notice since the stuff was sold as a spice. And I think we are talking about seriously carcinogenic levels - way, way above anything you would find in a supermarket chicken, although it looks as if some sausages are pretty toxic with all the processing.

 

[dannybex]

It would have been interesting to see herbal medicines from other areas of the globe analyzed. It is just the Chinese herbs that have high levels of heavy metals?

I wonder how heavy metals get into herbal products. Are the heavy metals found in the soil where the herbs grow?

This might be a major reason:

http://time.com/4155365/china-red-alert-smog/

 

[barbc56]

This might be a major reason:

http://time.com/4155365/china-red-alert-smog/

OMG! That's disturbing.