In reply to Phylla

"Two things that weren't made clear (I tried to read the last two commentators thoroughly, but could have missed a point) to the average reader: it is not the PawPaw(Asimina triloba) *fruit* that has the action in question, it's an extract from the seeds and bark. So, the obvious pleasure of ripe pawpaw fruit, enjoyed for a long time, is not the basis of safety issues. I think that's an important distinction."

In the present product from the company in Utah where Dr. McLaughlin was involved for four years, the product is a twig extract. It is biologically standardized.

The seeds were the source for acetogenins in the product from Eli Lilly in the nineteenth century.

In considering the content of acetogenins in the various plant parts, the amounts vary by plant part and by season. That is one tricky thing about raising paw paws for market. The grower must wait for a sufficient ripeness on the tree so that the acetogenin content will be tolerable in the fruit to the one consuming it. So it is conceivable that humans and animals have consumed fruit at times when the acetogenin content was high enough to matter. That is why the fruit consumption is a reasonable thing to consider when looking at long term use issues, along with other tests, like Ames tests for mutagenicity and ascending toxicity tests.

"Second, the fact that Pawpaw seeds and twigs were used as a vermifuge, and have an emetic action, indicate that is a "heroic" herbal medicine. Like Taxol, these herbs are not to be used casually, but under the guidance of an experienced practitioner."

To be clear, this is the way that Dr. McLaughlin described this class of molecules in the Invited Review article in the Journal of Natural Products from the American Chemical Society.
"The Annonaceous acetogenins are now one of the most rapidly growing classes of new natural products and offer exciting anthelminitic, in vivo and cytotoxic antitumor, antimalarial, antimicrobial, antiprotozoal, and pesticidal activities and special promise of becoming new chemotypes for antitumor and pesticidal agents."

I am not sure of the meaning of "heroic" in your comment. Most of the people that I have interviewed who have taken it have serious conditions. Dr. McLaughlin always has answered the question concerning using paw paw as a preventive for cancer with the analogy that a person would use an antibiotic only when they had an infection and so would use paw paw extract for a condition, not prevention.

The presence of paclitaxel in the yew tree is very low in concentration, according to my reading. If I recall correctly, to obtain enough for one dose, the extraction required the bark of three trees. So this is the reason that Weyerhauser was planting yew groves.

I agree that paw paw is not a casual product. I find it interesting to consider the effects of the formulation from Donald Yance because I do not know the methods of standardization he uses. I know that even in paw paw plant parts collected at the "right" time that individual samples have varied in activity by about 1000 times. So even if a person collects the right plant parts at the right time from the same group of trees, biological standardization is a very important feature.

The brine shrimp lethality assay, used by Dr. McLaughlin for plant extract screening and biological standardization, could by used for many other herbal extracts. Perhaps someone will further this work so that we may obtain more consistent products in the future.

I believe that I made reference to Native American use of paw paw tea extracts for medicinal use. Steven Horne, another respected member of AHG, reported to me that one of his Native American sources had revealed to him that use. So it is another source of information about human use.

There is another product that is presented using paw paw from the Utah company that is intended as an anti-parasite product.

I also find other products that use Yew source materials in the marketplace. I was given samples of a capsule product and a tea bag product at a trade show.

I looked at Donald Yance's site. It appears that the blend of herbs that you mentioned is sold to practitioners only.

I sort of laughed when I found myself at the end of 100 posts. I guess I could have claimed to have the last word by manipulating the postings, but I am not that bright. So now I see that I don't have to worry about having the last word.

Go for it, Dr. Eric

Richard

Just two questions for Richard.

After numerous posts on the subject (including comments minimizing side effects, and encouraging people to take such drugs with other chemotherapy agents), you are only now acknowledging that paw paw extract is not something to be "casually" used. Do the products your company sells (or plans to sell) include paw paw drugs, and do you or will you sell them without a prescription?

In the American Chemical Society journal article you mention above, Dr. McLaughlin is quoted as saying that paw paw extracts show "special promise" of being useful as antitumor agents.
Since even your prime source for information on these drugs says only that they show "promise", don't you think it's time to back off on suggesting that the drugs should be taken now to treat cancer, and concede that a lot of hard work needs to be done before marketing them to the public as an effective and safe treatment?

As to Donald Yance, he does sell a variety of products on the Natura website, marketed with vague promises like "builds vitality", "elevates performance", "detoxifies", "renews sexual essence" and "enhances libido". One of them, Botanabol, has a name and description that's supposed to make you think it's a replacement for anabolic steroids, so maybe athletes are a target market.

There are no supporting studies for any of these products listed on the website.

Martha Stewart is quoted as praising him on the basis of one of his books, though, so I guess we should rush out and buy. :)

Hello Dr. Eric,

I know that you have limited your information to what is published, so it is not possible for you and I to be on the same page on these matters. Based on the information available to me to date, I feel that for those who wish to purchase paw paw and use it for their own use, they should be free to do so. The current law controlling paw paw dietary supplements is DSHEA.

In the act of selling this product, I do not, nor does the manufacturer, make claims beyond these:

Description: Paw Paw XXXX-XXX [Immune] selectively targets specific cells to enhance the overall health of the body. Paw Paw twigs contains acetogeninsÂactive compounds that modulate the production of ATP in mitochondria of specific cells, which affects the viability of specific cells and the growth of blood vessels that nourish them.

A recent clinical study with over 100 participants showed that the paw paw extract, containing a mixture of acetogenins, supports the body's normal cells during times of cellular stress. Paw Paw XXXX-XXX is a valuable tool in strengthening and supporting the immune system. This patent-pending product is the only standardized acetogenin product available to regulate specific cells.
Benefits:
 Selectively affects specific cells.
 Modulates the production of ATP in mitochondria of specific cells.
 May help modulate the growth of blood vessels near specific cells.

The current manufacturer is a Natural Products Company. It would require a completely different business model for them to offer prescriptions, so I do not think that they will apply for an Investigational New Drug application. They are a company that readily complies with FDA directives, as shown by their compliance with Red Rice Yeast product changes, elimination of ephedrine alkaloids from their products, and recent changes in their product lines to reflect the desires of the California Attorney General for them to come into compliance with our Prop 65, regarding heavy metal issues. (A side note, California fruits and vegetables are exempt, even though tomatoes sold in California grocery stores have tested up to 2700 times the allowable amount of lead for dietary supplements.)

Should paw paw extract be granted over the counter status as a drug in the future, then the manufacturer would probably continue to sell it, as they do certain topical products for pain relief.

I can foresee foreign drug applications at some future date because the cost for drug development and the time required in some countries is more reasonable. This is only my surmise. I have not heard of any plans from anyone.

Personally, I don't sell drugs, except the as noted topical. I always use the sentence, "Paw paw is not a cure for cancer" in my reponses to inquiries. I feel that it has helped some fight it.

I would recommend other products for cancer prevention. Green tea extract comes to mind, also I would suggest flax seed oil with lignans or just the ground flax seeds. I am sure that you might have several other favorites, along with a sensible diet, regular exercise, good sleep patterns, reduction of bitterness and stress in one's life, and removing inflammatory foods and excess weight. Paw paw is not on my list for that.

If we had really won the war on cancer, I could see that a person might not need to try complementary and alternative approaches. But, in today's environment, I still think it is a reasonable thing to try for that type of condition. One of the reasons I made the educational site was so that people could get the available facts from the principle researcher. I have not used testimonials to date, but I can see that people would like to hear them from the letters that I get. My selling efforts will not have links to testimonials for now, either. But maybe I will need to use them to fulfill my business card's listing of my role as a snake oil salesman.

Paw paw is marketed now. Graviola products also contain acetogenins. And there are many sources for those. What I would decide will not control the marketplace. Since I have seen some good from the use of acetogenins in people and no evidence of harm, I still advocate the availability of these compounds. I want every person who decides to try them to make an informed decision about them after consulting their health care professional's advice. But the decision is their's.

I hope that further scientific investigation continues until we really win the war on cancer.

Richard

No wonder people are bewildered by the current marketing of supplements under DSHEA - it's basically impossible to get a straightforward description of what the seller intends and what the products are supposed to accomplish.

On the one hand, supplement dealers provide glowing descriptions along vague lines of "supporting" the health of certain organs, "strengthening" the immune system etc. But then, because the manufacturer needs to stay within the limits of the law (and is not willing to expend the money and effort necessary to actually qualify his product as a drug), there's always a disclaimer about how the supplement isn't intended to prevent, treat or cure any disease.

So everybody involved in sales does a sort of dance to indicate the product helps cancer patients, fixes thyroids, boosts energy, peps up the immune system, eliminates constipation and improves skin tone - but never really promises anything, because the best "evidence" available is testimonials and one could wind up having to pay a big fine and then go do the same thing all over again with a new miracle product.

We need to reform the system so fewer people waste money and lives on false hopes.

Hello Dr. Eric,

Well said. You have hit the nail on the head.

The disclaimer is there because it is required by law. There is a practical issue of expense in the selling of products. If we only had drugs or food with no intervening category, the supplements would either be black market, really expensive, or home made. I would prefer to have a system where the buyer would be able to hear what the seller thought was true, but I concede that in our history of selling products, extravagant claims are made. Part of the resistance to seeking drug approval is the cost and the level of proof required, as well as the time.

DSHEA was a compromise. Under it, we are supposed to be limited to making structure and function claims. Very rarely do the regulators allow disease statements. It seems that of late the green tea extract is allowed to make some comment about reducing cancer risk, for example. Fish oils high in Omega 3 are just now being allowed to make limited claims. The regulators are very tough on proof. You might make a good one if you were not so dedicated to your practice.

So we see words about products that have 1,3 beta D glucans that talk about supporting the immune system, a part of the body. This is a function claim. We might hear words about mineral supplement that makes reference to structural support or a structure claim. Or we see that products that help control blood sugar (e.g. nopal- although I know that you may not consider it to be well supported) and they are described by the words, "may help to maintain blood sugar levels already within a normal range." Even if nopal brought down high blood sugar to normal (and we are not saying that is proven), because the condition of high blood sugar is related to a disease state, it is outside of compliance to say that it does that.

Little companies (or the grab and run bigger companies) might get away with making claims because of the lack of enforcement due to low funding. I see on Spanish language television here in Los Angeles ads all the time that say the new elixir is effective for treating cancer, diabetes, and heart problems. I imagine that we have even fewer regulators that speak Spanish.

We all saw a guy named Kevin interview another guy named Bob on night after night for two years saying that we just needed to use a mineral from coral to cure our diseases. I know through sources that they were shipping a lot of product. And I am sure were getting wealthy. Finally the Feds caught up with them. Now Kevin is back, selling a book. He is forbidden to sell the mineral, if I get the story straight. So we have some bad apples in the natural products industry. What I am asking you to consider is that there are some good apples too.
This past week an acquaintance of mine told me he had been to the FDA with his product. He had been looking at doing an Investigational New Drug application. He had heard that there was a program for "orphan drugs." This applied to drugs that were intended for diseases that had fewer victims than were necessary for economic investment by Big Pharma. What he learned was that the money and time were really not different. So he gave up and came back to California, deciding to go ahead with marketing as a supplement. I will wait to ask about safety testing and all that because I don't know much yet. I know that you will want to know.

Anyway, there are big companies and little ones. The big ones can do some things that the little ones cannot. Currently, the dominance of staffing in Big Pharma is in synthetic chemists. I hope that someday we will see a return of pharmacognosy to Big Pharma.

Richard

The "good apples" in the supplement business, such as there are, are the ones who sell a standardized, dependably potent product that fulfills the claims made for it and is backed by solid science.

You'd think the good elements in the industry would support strengthening the current minimal regulation and lax enforcement, to help drive some of the scammers that infest the field out of business and give consumers a break. The answer is not to open things up even wider to con men and false claims.

Regarding DSHEA:
One of the parts of the law that was passed and put into effect on 15 Oct 1994 is the establishment of "Good Manufacturing Practices" (GMP) for the dietary supplements. This would put standards into effect regarding the methods of product collection and formulation that could go part way, at least, to helping make dietary supplements at least capable of what they are proved to do in the published literature. We have to wait for the FDA to act. It is indicative of a large beauracracy with many hands pulling in opposite directions.

Being in the industry, I look forward to meaningful, logically based standards. I also want to make sure that personal collectors and simple honest herbalists who serve certain communities (e.g. Amish or LDS) would still be able to operate without getting a degree in chemistry or buying an HPLC setup.

In general, the industry does have trade organizations and other ways of promoting good practices. We tend to not directly attack our competitors as a whole because we prefer a marketplace that is respectful and friendly. Many industries have similar codes of conduct.

Personally, I try to encourage the companies that I have relations with to focus on science. There are many voices, some who base their decisions on other means. So it is hard to turn a ship of this size.

Regulators depend on complaints to generate inquiries. I believe that most sellers of dietary supplements keep adverse events reports. Those reports are the basis for a confirmation that the process of manufacture has succeeded. The careful examination by manufacturers of raw materials and making sure the manufacturing line is doing what they should is the job of management.

Almost every company assures its customers of quality and safety in manufacture. There are reasonable watchdog groups like supplementwatch and consumer reports that give independent data on supplements. More of this is needed.

One problem in the industry is the fierce price competition. This pushes some manufacturers to do less than what might be necessary to ensure that their products actually get absorbed or have the proper amounts of the key molecules. Price ranges of 10 to 1 are not uncommon. So the consumer who is interested in price gets served, but not always well.

So we hope for help with the GMP standards. Meanwhile, those who do not grow their own must buy. And although the labels are supposed to be telling the absolute truth, sometimes they do not reflect the whole story.

Perhaps this forum will continue to provide stimulating education about sources and methods. Of course, purchased advertising is needed to comply with the rules, but sound advice can still be given within the restrictions.

MLM can be a red flag, but it should not always be considered a negative. It is a method of distribution that can be used correctly and can be abused. Read the advertising copy. Look at independent sources from people like Memorial Sloan Kettering. Then ask your friends for recommendations.

Richard

"We have to wait for the FDA to act."

Supplement companies and their allies in Congress have been fighting effective regulation tooth and nail. The responsible firms will not wait for things to change; they should act on their own to assure consumers of a reliable product, regardless of whether this causes friction with competitors.

"I believe that most sellers of dietary supplements keep adverse events reports."

Which they are not required under DSHEA to submit to the FDA or otherwise make public. Consumers remain in the dark until some scandal erupts.

More on drawbacks and scams associated with multilevel marketing. The FTC and other advocates for consumers also have good tips online on how to avoid getting sucked into these schemes.

Hello Dr. Eric,

In regard to the FDA's responsibility to Congress to implement DSHEA, I am sure that supplement companies responded with comments when the call for public comments. Would you give evidence please that the supplement companies have been fighting effectve regulation tooth and nail?

The company that I do most of my dietary business with are acting responsibly in my opinion. I know that you do not agree, of course.

Adverse event reports are proprietary. They are kept by responsible companies. One reason, of course, is to provide data if something goes wrong or if a question of safety is raised legally. When the question of safety of ephedrine alkaloids came up, the company that I mentioned could demonstrate an excellent record with all of their ephedrine products for many years. They elected to not combine it with caffeine, which can be a poor combination and increase risk. Careful label instructions included warnings about excess use and the amounts contained were appropriate for the use intended.

Drug companies, of course, immediately warn everyone when they have problems with a drug. No one died from using Vioxx, Celebrex, or other COX2 inhibitors, did they?

By the way, the understanding that I have of forum use is that we are not to promote selling sites. I noticed that on the landing page of the link that you gave last post contained an offer to sell books. Although I have recommended a book in another thread, I tried to recommend finding it in a library.

The books of the Psychiatrist's site are many and cost money. Did you mean to post these titles?

"Quackwatch Home Page ::: Order Form

Recommended Consumer
Protection Publications
(There follows a list of 35 books, some of which are authored or edited by the man who has this site. I would see this as self -serving, unless it is made clear that it is a commercial enterprise, not an educational site)

(I did find two listings that are significant and are good books, in my opinion. It is interesting that they are authored by Varro "Tip" Tyler, Dr. Jerry McLaughlin's mentor.)

THE HONEST HERBAL (1999)
Fourth edition of this referenced analysis of more than 100 herbs and related substances. By Varro E. Tyler, Ph.D., a leading expert on pharmacognosy. Hardcover, 460 pages, $35.00 [List price $54.95]. Softcover $17 [List price $24.95)

HERBS OF CHOICE (1999)
Second edition of Tyler's guide to the therapeutic use of herbs, arranged by problem. Softcover, 297 pages, $15.00 [List $19.95]

HOW TO ORDER
To above prices, please add $2.50 for first book + $1.00 for each additional book for postage & handling. (Canadian orders add $4.00 for the first + $2.00 for each additional book.) Other countries add $5.00 for the first + $2.50 for each additional book. Please enclose payment with order. Send orders to Quackwatch, P.O. Box XXXX, XXXXXXXXX, PA XXXXX. Pennsylvania residents should add 6% for sales tax. NCAHF members can deduct 10% from book prices. Canadian & overseas checks must be in U.S. dollars. We cannot process credit card orders. Please use our order form and include your email address.

Recommended Periodicals ::: Downloadable Order Form
Quackwatch Home Page
This page was revised on December 13, 2001."

Not only is the author pitching his own stuff, but he is also trying to attract members by offering commercial discounts.

Not exactly pure motives? Or do you see his economic activity morally superior because he takes your viewpoint?

Additionally, what makes the Psychiatrist an expert on trade? What is his training in the ins and outs of business models and what is his training that gives him an edge on the value of herbs?

Richard

Vioxx deaths, horrible http://www.kansas.com/mld/eagle/living/health/10220598.htm?template=contentModules/printstory.jsp

celebrex more deaths http://www.consumeraffairs.com/news04/celebrex_canada.html

huge drug recall scary
http://www.ablelabs.com/investors/press/pr011603.html

I believe there are safer herbal alternatives.

"Medicine BAD!" does not address the subject of whether paw paw extracts are either safe or effective for treating conditions such as cancer.

Continued research and evaluation have turned up concerns about certain painkilling drugs. Shouldn't we give the same attention to supplements, which under current law are exempted from similar oversight?

"Continued research and evaluation have turned up concerns about certain painkilling drugs. Shouldn't we give the same attention to supplements, which under current law are exempted from similar oversight? "

No, because unlike the abovementioned drugs, people are not being killed, nor suffering from the terrible side effects of herbs. If they were, we'd give then the same attention.

John

John, we've been through this before, and you know that unsafe dietary supplements do kill and severely injure people. Examples have included ephedra, comfrey, chaparral and aristolochia. Supplement companies have been involved in major recalls. What also needs to be considered is delay in seeking or avoidance of proven therapies in favor of ineffective supplements, wasting lives and money.

Wouldn't it be something if we could discuss an herb or dietary supplement on its merits, without attempts to sidetrack the issue with general diatribes against mainstream medicine?

To Richard: Pharmaceutical companies are required to report all adverse events of which they are aware to the FDA. Supplement companies are not required to report such problems under current law.
Attempts to reform the law and make the supplement companies more accountable are fought by the supplement lobby and its allies in Congress, including Senators Tom Harkin and Orrin Hatch.

It's good that you remind forum users of rules on the GardenWeb prohibiting posters from trying to sell their products here. It's a form of exploitation that also deprives GW of ad revenues.
As for non-GW health sites, the least credible ones are those that tell about the supposed wonders of certain products, and also sell such products on-site. As for Quackwatch (which really seems to annoy you), its target is healthfraud involving a wide range of practitioners including physicians, naturopaths, chiropractors etc. and numerous ineffective and dangerous products. It does not sell diagnoses or therapeutic aids, so your complaint seems irrelevant. I am unaware of any legal or ethical constraint against offering books for sale which probably help defray the cost of running the website and researching fraud. And as you note, he offers books by a noted herbalist, Varro Tyler, whose work is widely respected in part because he valued scientific documentation on the effectiveness of herbs.
There's big money in pushing supplements, but I've never heard of anyone getting rich by fighting health fraud.

And by the way, I haven't said anything about your company or how responsibly it may do business (it is only recently that you've acknowledged commercial connections). My concern has been over premature hyping of paw paw extracts in this forum and secondarily to clarify whether some of the drug's promoters stand to benefit financially through its sale.

Eric I think theres a big difference between medicine and and VIOXX.Paw Paw aleast has some history of healing,whats VIOXX ever done but kill people,and there are safer alternatives.

"Would you give evidence please that the supplement companies have been fighting effectve regulation tooth and nail?"

One additional example: it was reported recently that a number of Ayurvedic medicines imported into the U.S. contain dangerous levels of heavy metals. The Journal of the American Medical Association called for mandatory testing of imported supplements for heavy metals to assure that consumers are protected. The American Herbal Products Association opposed this idea, arguing that testing should be voluntary for its members.

Nowhere in that article does the AHPA oppose heavy metal testing of imported herbs. Rather they state their support of current US laws that make such illegal, and further encourage practitioners to test product again before prescribing.

This is another example of why it is hard to converse with Eric, who distorts and manipulates information to discredit herbalism in favour of drug therapy, a theme flowing continually throughout his posts over many years.

When we review past posts and statistically analyse percentages of text Eric actually devotes to discussing herbs, as opposed to discrediting them, or natural medicine, or talking about drugs, we get a better picture of his real motives.

I doubt you'd talk about herbs for therapeutic use any more than 10% of the time Eric, so stop giving forum members the "Wouldn't it be something if we could discuss an herb or dietary supplement on its merits, without attempts to sidetrack the issue with general diatribes against mainstream medicine?" rubbish.

The AHPA link makes clear that they oppose mandatory testing for toxic heavy metals in favor of letting their clients test only if they want to. This is just one example of the supplements industry fighting regulation that would benefit consumers.

There are a couple of standard responses made in this forum in an attempt to stifle discussion or distract attention away from herbs, supplements or treatments that don't work and/or are hazardous.

Examples:

"Treatment X has been discredited, and it has been shown to damage the liver."

Response: "Well, what about Vioxx? Medical mistakes? Mainstream medicine is BAD."

"This herb has shown some promise in test-tube applications against cancer cells, but it is way too premature to recommend that people take it before clinical studies of safety and efficacy have been carried out."

Response: "You're a poopy-head."

Since we have participated in some good discussions in the past, John, I'm disappointed in seeing you take the latter tack, and calling a statement you disagree with "rubbish." I have disagreed with you previously, but in a civil manner.

Feel free to document any "distortions" or "manipulations" you claim I've made. Since this discussion is (nominally at least) about paw paw extracts, you can start there. Or continue name-calling; it's up to you.

rubbish Eric, the AHPA does not oppose mandatory heavy metal testing of herbs. Nowhere in the linked article is that stated, and only a malicious interpretation on your behalf to discredit the herbalism industry, leads you to post such nonsense.

Again, you are incorrect. It's right there in the link, as follows: "No change in the law (i.e. mandatory testing) is required, though manufacturers, importers and retailers need to assure that the products they manufacture, import and sell are free of adulteration. AHPA encourages its members to test products for heavy metals." (bolding added)

In other words, voluntary testing is suggested, mandatory testing is opposed. What could be clearer?

Personal attacks do not obscure this point.

There is no change needed in the law becuase the law already exists. People are breaking the the existing law, so therefore the AHPA has to advise members to test product for themselves.

The AHPA clearly states its position on additives, pesticides,adulterants and related issues within it's code of ethics published for all to read on its website, which is conveniently overlooked by Eric, who has a chip on his shoulder about natural medicine organisations, including the AHPA it seems.

From time to time I shall continue to pop in and keep the forum balanced by sharing the facts. If I was to take up that cause with the many other selective half truths and misrepresentations you make so often on this forum to discredit herbalism and natural medicne I would be embarking upon a full time job.

There is an American law against selling products adulterated with heavy metals. The law did not protect consumers in this country who bought imported Ayurvedic medicines containing high levels of heavy metals. Therefore the author of the JAMA article called for mandatory testing of imported products. As I have stated and is made clear on the American Herbal Products Association website link provided earlier, the AHPA opposes mandatory testing in favor of a voluntary approach.

First you deny this vehemently, amid accusations of "distortions", "manipulations" and "rubbish". Now you appear to recognize that I was correct but claim there is no need for a change in regulations, and continue making unfounded accusations.

If you want to be a forum truth squad, it would be useful to be accurate, to concede error when you are wrong, and to stop with the ad hominem accusations when they backfire on you.

You are making up stories Eric, and in the process are digging your hole deeper.

American law does protect people against Ayurvedic herbs that contain heavy metals. That is clearly stated in the article, even the specific legislation is referenced.

You are wrong, and cannot admit it. This is not the first time you have been wrong and have not admitted it, and probably won't be the last. And that Eric, is why conversations with you are so difficult.

"U.S. law already makes it unlawful to import or sell products that are adulterated with high amounts of heavy metals. No change in the law is required, though manufacturers, importers and retailers need to assure that the products they manufacture, import and sell are free of adulteration. AHPA encourages its members to test products for heavy metals."

What part of the above qouted text from the article don't you understand Eric?

Let me explain this to you yet again.

Dangerous levels of heavy metals have been found in Ayurvedic medicines. These products reached store shelves in the U.S. despite the presence of a law prohibiting heavy metal contamination. Obviously, the Indian and Pakistani manufacturers of these products are not being affected by U.S. law, and the U.S. importers aren't taking sufficient precautions to protect consumers. The authors of the JAMA article argue in favor of mandatory testing for heavy metals in such products (which hopefully would include stiff fines for noncompliance), as an added means of insuring that consumers don't get poisoned. The AHPA is clearly against this, in favor of voluntary testing, which hasn't worked.

You may wish to argue that if supplement makers ignored the existing regulation against heavy metal adulteration, they'll just go ahead and ignore any new regulation too. This is a somewhat defensible position (though it would put you in the position of saying that these companies are total scofflaws who'd place profit over responsibility to their customers).

You seem to have moved beyond claiming that the AHPA doesn't oppose mandatory testing (because they clearly do), but you are still misrepresenting my statements.

John, you used to be much more reasonable in previous discussions. What's the reason for all the misplaced hostility now?

"The AHPA is clearly against this, in favor of voluntary testing, which hasn't worked."

This statement is incorrect, and I fail to why you continue to propose it when I presume you have both read (and understood) the article, along with the AHPA charter on their website.

Please show me any evidence you may have that the AHPA is against the testing of herbal products for heavy metals. bear in mnind that such a position would defy all commonsense and alienate many members of the herbal industry.

If you have misinterpreted the article Eric, re- read it. If you are blindly sticking to your stance to protect your pride, then I think it's time to reflect a little deeper.

It would be ludicrous for the AHPA to state to the media that they oppose mandatory heavy metal testing of imported herbal products when it blatantly contradicts their code of ethics as stated publicly on their website.

Could a better explanation for your apparent misinterpretation of the article (and the facts) be your underlying motivation to use this forum as a means to undermine and discredit herbal medicine and natural therapies in favour of orthodox western medicine?

It's right in your own quote from the AHPA website:

"No change in the law is required (i.e. no mandatory testing as the JAMA article urged), though manufacturers, importers and retailers need to assure that the products they manufacture, import and sell are free of adulteration. AHPA encourages its members to test (i.e. voluntary testing) for heavy metals."

I'll make one last possible allowance for your misunderstanding here, though Australia shouldn't pose an impenetrable language barrier. Mandatory testing means mandated by law. There is no such regulation currently. That is the "change in the law" the AHPA is opposing.

Any more denial of the obvious?

By the way, the claims about my supposed attempts to "undermine and discredit herbal medicine" are getting old, and quite obviously untrue. You will find on this forum page alone (in the threads on treating menopausal symptoms and allergies) statements I made in support of two useful herbs, black cohosh and butterbur).

Your hostility is difficult to explain merely on the grounds that I do not support every claim made for herbal and other alternative therapy, and speak out against quackery. Come to think of it, are you fuming in this way because I made comments earlier in support of Quackwatch, and as a naturopath you resent Quackwatch'sanalysis of naturopathy?

Here's a link to the actual JAMA article about heavy metal content in Ayurvedic medicines, which includes the following:

"Ayurvedic HMPs containing heavy metals are readily available in most of the South Asian grocery stores in Boston, recommended for adults and children, and relatively inexpensive. One of 5 available Ayurvedic HMPs contained lead, mercury, and/or arsenic....Our findings support calls for reform of DSHEA that would require mandatory testing of all imported dietary supplements for toxic heavy metals."

The supplements industry has been fiercely protective of DSHEA (which has been a cash cow for them), so it is not surprising that the AHPA would oppose this reform.

And before we get the response that the American Medical Association (which publishes JAMA) is just picking on herbal/alternative remedies - it is clear that JAMA routinely reports on toxicities and side effects associated with certain pharmaceutical drugs as well.

Nowhere in that article does the AHPA oppose mandatory testing of imported herbs. You have implied they do, you are wrong.

Where's your supposting evidence for suggesting black Cohosh as a menopausal herb Eric?

Please share with the forum why you have suggested this herb, what signs/symptoms you hope to apply it to, how long it might take to work, what form you might prescribe, suggested dosages, and evidence to back up your claims.

John, obviously nothing more can be done to shake your insistence that the-Emperor-really-does-have-new-clothes.

Eric may want to familairize himself with the terrible side effects of Black Cohosh that his senior clinicians outline before recommending it on the basis of a small pilot study.

Makes chilling reading.

John may wish to familiarize himself with all of the clinical studies and other research supporting the use of black cohosh for menopausal symptoms, before dismissing this data as solely based on "a small pilot study". A simple Pub Med search would suffice.

We may also wonder why John now passes himself off as vehemently anti-black cohosh, after he himself recommended it in another recent discussion on herbs and menopause. (Of course, John also dismissed menopause itself as a mere "stage" women go through, in yet another thread).

It is good though that John found a case study* which reminds us that herbs are drugs, that any drug may have deleterious side effects, and that we must balance these effects against the good to be gained, as demonstrated by clinical studies. I believe that to this date black cohosh (also validated by a major obstetric and gynecologic physicians' organization) has passed this test. Paw paw extracts have not.

*even pointless vendettas can yield facts of interest to the forum at large, even if much time is wasting in getting to them.

Perhaps Eric can now review his opinion that herbs should be freey available over the counter. He might also apply his newfound open-minded evaluation of effect vs adverse effect to herbs generally.

This gets increasingly bizarre.

First John said "Could a better explanation for your apparent misinterpretation of the article (and the facts) be your underlying motivation to use this forum as a means to undermine and discredit herbal medicine and natural therapies in favour of orthodox western medicine?"

Now he says "Perhaps Eric can now review his opinion that herbs should be free(l)y available over the counter."

So which is it, John? Either I'm the enemy of all things herbal, or I want all herbs regardless of safety sold willy-nilly over the counter? :)

Do you think we could return now to a rational discussion of paw paw extracts?

"Do you think we could return now to a rational discussion of paw paw extracts? "

if you can find someone to continue the discussion with Eric

Just a small note about Quackwatch and Stephen Barrett. Some of us in the natural products industry that have to defend ourselves in court from time to time may find it funny to see this fellow asking for fees for expert testimony. That is the real issue with him. If he were a Varro Tyler or a Mark Blumenthal or a Tierona Low Dog, he would deserve to get his fees and be listened to. But, so far, his actual credentials in herbal medicine seem lacking. He knows the industry in general, but I find his actual training and experience lacking.

You will be happy to hear that the California law requiring the labeling of dietary supplements in regard to "heavy metals" is finally being enforced. The company that I sell products for is complying and has altered formulas where necessary. Some formulas had to become concentrated extracts in order to comply.

What is funny here is that grocery store tomatoes have been found to have as much as 2700 times the lead per serving as are allowed in supplements.

Federal regulation of importation of supplements currently requires FDA registration of foreign facilities which includes inspection and identification of the actual place of growing of the ingredients, as much as can be identified. This is not part of DSHEA, but of the Home Land Security legislation. This is done to insure food safety.

An interesting point about Siddha medicine, Indian, but unrelated to Ayurvedic tradition, includes metals like mercury in the formulas. A very interesting study was done on Rasagenthi Lehyam, a popular and effective (as reported by the researchers in interviews with 96 men who used it in India) treatment for Prostate Cancer. The product had 38 herbal ingredients and eight minerals, if my memory is correctl I have a copy of the paper from the author at Kentucky U, so you find him willing to send it to those interested.

The testing done for the paper was not on humans. They just did interviews.

I am not advocating for or against the California law or the RL Siddha medicine. I am just mentioned these as bits of information to add to your body of knowledge.

Of course, everything that I said is probably wrong, so I will just save Eric the trouble of correcting me.:)

Richard

No trouble at all, Richard. :)

"You will be happy to hear that the California law requiring the labeling of dietary supplements in regard to "heavy metals" is finally being enforced. The company that I sell products for is complying and has altered formulas where necessary."

It took regulatory enforcement to get your company to take action on heavy metal levels in supplements? Not voluntary action?
This suggests that the mandatory testing the supplements industry opposes on a national basis is needed to protect consumers. Any law that merely inspects the place where foreign ingredients for supplements are grown, is not going to have any effect on deliberate insertion of heavy metals.

I can't find anything online regarding your claim of high lead levels in grocery store tomatoes. Do you have a link?

You can probably find testimonial support for just about every treatment offered. We've even seen it in support of using caustic ointments to burn off skin tumors. As someone who's referred to scientific studies here, I hope you are not equating interviews with "satisfied customers" with evidence from clinical trials.

Quackwatch really seems to have gotten under your skin, Richard. Is there a story here?

The issue is whether Prop 65 limits are achievable in a powdered plant product. The limits for daily consumption for lead under Prop 65 is 0.5 micrograms per day. Unpublished data indicates that a cup of tomatoes from a California grocery store that was tested had 2700 times that amount.

The company whose products I sell has tested for heavy metals for many years and never sends out contaminated products. But the nature of herbs means that there is some wood fiber content- cellulose and lignans- that will contain some lead, no matter how well it is grown. So the company revised less than 20 products to comply by eliminating the fiber by extraction of herbs. They also have decided that they cannot achieve Prop 65 levels with about 15 more at this time and so have discontinued to sell those in California until they can achieve it. This is out of more than 600 products that they sell. Less than 10% did not meet the strictest standards in the world.

So they did what they could to change them and are acting honorably about any that cannot.

Dr. Chendil of Kentucky University will probably not like your comments about his paper on Rasagenthi lehyam. He was kind enough to send me a full copy of his paper. Perhaps he would do the same for you, Dr. Eric. Then you can read about the 96 interviewed who had prostate cancer.

Prop 65 limits do not apply to fruits, vegetables, and water in California. But Big Ag had nothing to do with it. California consumers demanded that they be exempted because we like our heavy metal in the food. It improves the taste so much.

I am starting a new MLM selling specially selected California drinking water to be sold to people from Ohio who just can't stand the pure water that their own governments insist that they drink. Maybe you could start a new downline, Dr. Eric?

Richard

I would ask you to document that odd claim that California consumers are demanding heavy metals in their food. But since you couldn't support your claim about high lead levels in tomatoes, I'm not expecting much.

"They also have decided that they cannot achieve Prop 65 (lead abatement) levels with about 15 more (supplements) at this time and so have discontinued to sell those in California until they can achieve it."

I see. So they're perfectly happy to sell those to unsuspecting consumers in the rest of the country?

Your link to the "Cancer paper" doesn't provide anything more than a summary of an article on a preliminary test-tube study on cancer cells. Sounds like a mountain of work is ahead for those researchers, trying to figure out which, if any of those "38 botanicals" might have significant anti-cancer activity in humans, or if the observed anti-cancer cell action is due instead to the "inorganic" components (?toxic heavy metals?).

Are there any publishable human trials in the works involving paw paw extracts?

Hi Dr. Eric,

So you are not able to discern between bone and marrow?

My line about California consumers demanding heavy metals was a joke.

We do have a bad reputation in some parts of the country, but I thought you might get it. Sorry. I won't quit my day job.

You obviously have checked the US Pharmacopeia for allowable lead content. What is it? I would expect a physician to have easy access to this data.

.5 micrograms. That is ten to the minus ninth, I think. Is that correct?

Regarding the paper on Rasagenthi lehyam:
I am not responsible to ask an author of a paper to send you a copy. I provided the link to the free abstract. I talked about the paper and what it said. I accurately reported that. Maybe you could also do what I did which is to ask the author for a copy of the full text so that you could read it. We have intellectual property laws that protect publications. So I cannot just publish the entire text here for you. If you want to know, ask the author. If you just want to attack my argument without checking the paper, go ahead. It just does not become you. You are a better person than that.

I absolutely agree with you that there is much work to do to evaluate this formula. I have talked with the author and find him to be a good researcher. He is just going to need another pile of money. He did a recent paper on the photosensitizing by curcumin of prostate cancer cells to radiation. As you are well aware, radiation of PCa is not effective in some cases. His work may lead to better medical treatments down the road. He is Dr. Chendil of Kentucky University.

The authors of the one paper reporting on a human trial with 94 people using paw paw twig extract that has been written have not succeeded in having it received for publication to the best of my knowledge. If I become aware of publication, I will try to inform you.

There is one interesting case reported by Dr. Steven Martin, an immunologist. His research group is called Grouppe Kurosawa. He reports on the efforts of "Anna" who started with a 10 cm breast cancer tumor 3 cm thick and has managed to reduce it to a few small nodules. Although his site is not a peer reviewed journal, so you won't be interested in what she reports, others may wish to read it. Very interesting application of EGCG and paw paw by topical means and per os using coconut milk as a carrier to avoid absorption by the chylomicron method and going directly into the lymph.

Before you disregard Dr. Martin's site, I should mention to the readers that Alexa.com lists it as number five in the world for web traffic under the heading of immunology. So he is no crackpot.

Happy sniping.

Richard

What a sad story.

This is a breast cancer patient who did not seek diagnosis or medical treatment for what might have been a curable lesion early on, but allowed it to progress to an advanced stage while seeking "alternative" treatments. Then, when she finally receives a drug (Herceptin) known to have anti-cancer effects, she credits not the drug but the "Grouppe Kurosawa" potions for retarding the spread of the cancer.

"Grouppe Kurosawa", as Richard notes, appears uninterested in having its claims and products reviewed by the scientific community and instead is depending on direct pitches over the Internet and on unreliable testimonials.

Why would you post such a thing?

And as Richard the supplement dealer knows, I was not attacking his argument without checking the paper (on the Ayurvedic product). I pointed out the obvious - that it is a test tube study that does not validate the product for use in humans, something even the researcher involved surely recognizes. The only reason I can see for Richard posting the abstract, is to demonstrate that Heavy Metals Are Good For Us. ;)

And by the way, as the folks in Lexington would want me to mention, it is not "Kentucky University" but the University of Kentucky.

Hi Dr. Eric,

You are correct in the reason for the post. The formula mentioned used 10 mg of mercury. The California prop 65 level is .3 micrograms per day. The other reason for mentioning this is the notion that the lead content in Indian herbal products measured to be dangerously high might actually be intentional.

As a reminder, I am not supporting the use of Rasagenthi lehyam by anyone. I just bring it up for a point of discussion. I am interested in seeing more research done if money becomes available of course.

I still wonder if you could fill us in on what the USP says about heavy metal content. What are the daily limits that are suggested?

I am happy that you have found another error in my post. I guess that I need a sound trouncing for getting the name of the school wrong. I stand corrected.

Grouppe Kurosawa is free for the reading. They do solicit a $100 donation for forum membership. I am a member of its forum.

I am thinking about what you said about heavy metals. How does "Things go better with Cadmium cola" sound?

Richard

".5 micrograms. That is ten to the minus ninth, I think. Is that correct? "

That is ten to the minus sixth.

RE: Question: Pawpaws in Shade? etc.

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* Posted by njbiology Zone 7(/6b); NJ (My Page) on
Wed, Apr 1, 09 at 21:50

Hi,

I have a set of Pawpaw issues for anyone whose had some direct experience with growing Pawpaws.

I have a situation with regard to location.

-In one location, it will only receive sunlight when the sun is directly overhead through the second half of the day (but only receiving light on foliage 15' above ground. A large tree which faces directly east will block it from the sun in the first half of the day and a 15' garage will block is directly to the west; since the tree grows higher then 15' (when reaching for light) and may grow around 30', the tree should have good light when it grows tall enough to tower over the garage. Will this location enable the tree to receive an ample amount of light for good fruiting.

-In another location it will have a tree block it from the West from all sunlight and filtered light comes from the light canopy above and full light to the entire profile of the tree for the first half of the day. The ground is a little shallow here - will this allow for fruiting?

-If I plant two varieties of pawpaw ('Sunflower' & 'Wells', in my case) only 3" apart, will the trunks expand and, as I suspect, fuse (inosculate) together to for a solid trunk where one side is one cultivar and the other side the other? I worry about this arrangement more then with most fruit trees because the pawpaws I've seen have a single trunk, completely vertical and pine-tree shaped; if the trunks don't fuse and divert, that may weaken the tree?

-Will pawpaw fruit more as a single specimen (perhaps 15'wide) or a patch of pawpaws (each small) that spans 15'?

-Pawpaw is, along with insecticidal, piscidical, being toxic to fish. I'm afraid to plant this too close to my pond... I wonder if this is not a real issue, I hope.

Steve

Well, this is a blast from the past, as I was the OP of this thread, but others made it fascinating. Waffling on posting to the above reply, as it's off topic, really. But, this year, folks are wanting to plant edibles in an effort to grow their own food, so, gonna do it. Hope the denizens of this forum are OK with it.

I grow pawpaws from seed to sell at my nursery. They are rather slow growing, and not at all like, say, apples, in production, so, first off, you won't get a huge harvest of fruit in a few years, They can reach 25 feet, but, that takes awhile. Here in the South, they are found as an understory tree along riverbanks, and kind of zigzag up amongst the canopy. They can be grown in full sun though, and this gives better fruit set. You would want to help them along, though, by giving exrtra water while establishing during the hot months.

Pawpaws are not self-fertile, and require two geneticallly different trees to set fruit, so two of the same cultivar won't work. See the link below for an explaination.

That link is to Michael McConkey's Edible Landscaping nursery, specifically his pawpaw info page.He's been doing that for 30 years, ahead of the current trend.The question about "fusing" two trees together sounds messed up to me horticulturally, but, who knows, I could be wrong. McConkey would be the guy to ask, and he is a passionate sweetheart, so I wouldn't be shy to ask that.

My two pawpaws (one of which started bearing fruit this past year) get only half-day sun and seem to be doing well.
I'd avoid planting them too close together. Rather than trunk fusion you'd probably get branches rubbing and damage, as well as mutual shading that would inhibit flowering and fruiting.

Holy cow, it's a question related to my bonsai knowledge! Although Pawpaw's are not typically used in Bonsai partially due to the large leaves, but more than that due to the brittle wood.

If you were trying to fuse the trees together the first thing to do would be to remove all of the branches and most of the roots from one side of the trees, I'd think trees about 4-6 feet tall would be ideal. Then put them close to each other, facing the right way (and probably east west rather than north south, or put the stronger one on the north side). After that wrap the suckers together, eventually they will probably fuse, change the wrapping every 6 months or so to avoid scaring the tree(s) and be sure not to cover the buds on the leader so that they can grow out rather than being held against the trunk.

You will have two apical meristems (unless you are a very talented botanist and manage to graft them together directly, in which case you will have a hybrid apical meristem for a node or two then one will win out), and with luck the bottom few feet of your "tree" will fuse and the top will branch out like a "Y". stay on top of pruning the branches that grow in, to keep them from rubbing, and either cable the two diverging trunks together, or if you get a branch growing straight at the other trunk you can try to graft some of the branches together ala living fence.

This is probably a wast of two good tree's, but if it works it will be really cool, and thats what is important isn't it?

It just occurred to me that pawpaws are typically grafted, knowing this I would think it would be easier to clip off the leader and either hope two leaders form and graft scions to them, or do some chip/bud/bark/thread grafting to put on the branches you want.

very often i see lot of gimmick products with tall claims:innocent consumer-lured by advertisements,victims of:however,if the product do not stand to satisfy the buyer..well that is the end of the road for the product& the company.
k.pathi
pathiplans@sify.com