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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

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January 4, 2008

Plants For Cancer?

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Posted by Derek

A reader sends along this article from the New York Times about Chris Kilham, an ethnobiotanist from U. Mass - Amherst looking for medicinally active plants in Peru. The article has lots of local Peruvian color, but it doesn’t neglect the money involved:

” Products that once seemed exotic, like ginseng, ginkgo biloba or aloe vera, now roll off the tongues of Westerners. All told, natural plant substances generate more than $75 billion in sales each year for the pharmaceutical industry, $20 billion in herbal supplement sales, and around $3 billion in cosmetics sales, according to a study by the European Commission.”

It’s worth noting, though, that none of those three once-exotic plants (exotic when – twenty-five years ago?) are the source of any major revenue for the pharmaceutical industry, unless you count aloe-vera sunscreen line extensions and the like. Kilham himself has some definite opinions on the value of plant-derived drugs:

Mr. Kilham believes multinational drug companies underutilize the medicinal properties in plants. They pack pills with artificial compounds and sell them at huge markups, he says. He wants Westerners to use the pure plant medicines that indigenous peoples have used for thousands of years.

“People in the U.S. are more cranked up on pharmaceutical drugs than any other culture in the world today,” Mr. Kilham said. “I want people using safer medicine. And that means plant medicine.”

Unpacking those statements is a chore, though. Just to pick a big one, “pure plant medicine” is a tricky concept, as any natural products chemist will tell you. Are we talking ground whole plants here (and if so, which parts, grown where?) Extracts (and if so, which fractions?) Purified single compounds?

Moving to the next difficulties, would these plant medicines somehow not be sold at such huge markups? Take a look at the herbal supplement industry for a reality check on that one. And if we in the drug industry could get such drugs with less trouble and effort than our “artificial” ones, why wouldn’t we do so – especially if they have fewer side effects? (Side effects cost us money, too, you know). Finally, are those natural compounds really safer than the nasty artificial ones? Not as far as I’ve ever seen – they come out the same in genotoxicity studies, for one thing. The whole “artificial” versus “natural” division is generally a sign of lazy thinking, in my experience. There’s no wholesome Gaia-derived goodness to be found in a plant-derived natural products, and they weren’t somehow made for us to use as medicines. Some are harmless, some are toxic – same as everything else.

Then there’s this interesting part:

“So-called bioprospectors can make their fortunes by bringing those advantages to the attention of companies who identify the plant’s active compound and use it as a base ingredient for new products that they patent.

Some 62 percent of all cancer drugs approved by the Food and Drug Administration come from such discoveries, according to a study by the United Nations University, a scholarly institution affiliated with the United Nations.”

Hmm. Examples? The only “bioprospector” that I can recall making a fortune in this way was Russell Marker, the founder of Syntex, who realized that Mexican yams contained an excellent starting material for steroid synthesis. Mind you, that was in 1944. If anyone has a more recent example of an Indiana Jones figure stumbling out of the jungle clutching a profitable wonder root, please do let me know. Whole companies have been founded on the idea of cashing in on active natural products and indigenous medicines. None of them, as far as I can tell, have made any fortunes yet, and some of them have done the reverse. Shaman Pharmaceuticals is the obvious example. I know someone who was right in the middle of their drug discovery effort. It wasn’t pretty, and it sure wasn’t profitable.

Besides, the Times reporter should have asked Kilham himself about cancer therapies. Here's a 2005 interview with him:

"I don't see the cancer herb category becoming a major category any time soon. I believe that the majority of people who get cancer are still going to turn to a conventional medical doctor. I think the greatest majority will. . ."

And that study by the UN doesn’t appear to have dug all that deeply. (It should be noted up front that oncology and anti-infectives are the two areas where natural product-derived compounds are by far the most well-represented). That 62 per cent figure for cancer drugs would seem to come directly from this 2003 paper in the Journal of Natural Products, from a group at the Natural Products branch of the National Cancer Institute. A closer look at the figures show that they list 140 drugs available over the years 1981-2003 (note that many of these are no longer first-line therapies). The 62% figure comes from excluding all the antibodies, proteins, and vaccines (10% of the total) and counting straight natural products (14%), semisynthetic compounds derived from them (26%) and synthetic compounds whose active pharmacophore came from a natural product lead (14%).

You can draw the line wherever you like, but by rigorously crunchy standards only that first 14% qualifies. If we’re going to draw some line between “natural” and “artificial”, everything else is on the other side of it. There’s no denying that natural products are and have been a great source of active compounds and structural leads, of course. But the vast majority of drugs come from us chemists, cranking out the man-made (and man-improved) structures.

The other problem with that number is that, if anything, it may represent a peak. The kinase inhibitors that have been approved in recent years are all completely synthetic compounds, and the antibody and vaccine ranks are swelling, too. Ranked by sales, there are 19 oncology drugs in the most recent top 200 list I can find, and only one of them is a straight natural product (taxol, at #169). Taxotere, at #37, is a semisynthetic derivative of taxol, and irinotecan at 122 is a semisynthetic as well. But to my eyes, that’s about it. Getting data by usage is harder (without paying for it!), but the older natural products would come out looking better ranked by total prescriptions filled. In most cases, though, they’re no longer first-line therapies.

So natural products aren’t dead, by any means. But they aren’t an untouched gold mine, either. Someone tell the Times.

Comments (38) + TrackBacks (0) | Category: Cancer | Drug Development | Drug Industry History


COMMENTS

1. Prof. Socrates on January 4, 2008 10:55 AM writes...

C'mon! It's from a plant! It's got to be good for you!

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2. milkshake on January 4, 2008 11:00 AM writes...

One runs into this kind of New Age gorp often, from people who are unhappy with the healhcare, and who think the Big Pharma is to blame (partially true) but who have absolutely no knowledge of specific, such as how the medicine and drug discovery works. They just have the hope there must be a better alternative. This dirves them into scented snake oil, herbal supplements and homeopatics. Which does not bother me until they start rant about it.

Wolfbane aconitine, mold aflatoxins and deathcap phalloidine are all common and perfecly natural scary substances.

There was a reason why most major pharma companies halted their natural product collection programs.

There is money to be made in natural products, as the Taxol and Epothilone story shows (and the Etinascidin and Dicsodermolide story does not) but the drug development done on a natural compound is slower, more difficult and more risky.

Also I worked in a company right next to Shaman. And I felt sorry for them. It was a tiny place and it looked awfully underfinanced.

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3. Jose on January 4, 2008 11:26 AM writes...

Mmmm, thujone!

Why can't the NY Times do a better job, dammit?

Anyone know the status of Ect 743?

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4. Tom on January 4, 2008 12:36 PM writes...

He does have a point.. The 62% figure is there to point out the fact that most approved drugs over the recent decades are somehow derived from or related to natural products. The point of the JNP paper in my opinion was to simply point out that HTS of wholly synthetic compounds hasn't yielded the results one would have imagined.

The big pharma are obviously in a bit of a tight spot with respect to their money makers coming off patent. Perhaps they outta figure out a way of using their big fancy HTS to go through thousands of collected plant samples.

On a side note...
Combretestatin A4 is an interesting example of a natural product which will most likely come to the market within the next decade(Its prodrug to be precise). (OXiGENE)

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5. milkshake on January 4, 2008 1:22 PM writes...

My friend was working on Ect 743 analogs. Later when I was worjing at Celera in SSF they bought rights to develop Andy Mayers Saframycine analogs. So I asked the Saframycine group at that time what was the status on PharmaMar competition, Ect 743 and Phtalascidine. I was told that Ect 743 was going nowhere because of problems in clinical trial but that ParmaMar was pursuing the Phtalascidine simplified semisynth analog.

That was 4 years ago, and soon after Celera SSF closed and sold all their medchem projects.

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6. clazy on January 4, 2008 1:42 PM writes...

New age types like to think plant medicines materialized out of the air, handed out freely by local deities to the natural people who deserve them, but it really comes down to millenia of curious people (and lunatics) -- Derek's antecedents, if I may be so bold. I look at something like gingko biloba or Kilham's maca, and I see an endless line of people dead or crippled for lack of a scientific method and controlled trials.

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7. Morten on January 4, 2008 2:15 PM writes...

Aren't antibodies more natural than anything you can juice out of a plant..? Unless "natural" can't exist inside a house of course.
Less toxic too (if we ignore that one horrible event that clearly demonstrated how awesome the human immune system is).

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8. Jan on January 4, 2008 4:13 PM writes...

As a pure chemist (whatever that meens, but far from biology) I feel that this article is a improvement in the perception of chemistry. I stumbled over arguments in discussions and ads where the main point was not the distinction between natural or artificial but things with or without chemistry. (Bakery advertised a bread without chemistry, I wonder what they use instead of oligosacharides).
Only loosly related to the topic but I wondered that it didn't show up in this blog (maybe I overlooked it):
http://www.spiegel.de/wissenschaft/mensch/0,1518,526363,00.html
http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371%2Fjournal.pmed.0050001&ct=1&SESSID=97f0b18f53acbab233689aaf2a056dcb
an article about the pharma industry. $57,5 billion for advertisment and only $31,5 billion for research. For an industry that is selling a feeling (fashion, media) that might be reasonable but for a research centered industry?

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9. Handles on January 4, 2008 5:24 PM writes...

Tom,

Here is a group that figured out a way to do HTS on natural products. Not being involved, I dont know why AZ pulled the plug at the end of last year, but I heard speculation that they just didnt find much...

http://www.eskitis.org.au/platform/npd.html

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10. flash on January 4, 2008 5:34 PM writes...

What I am most concerned about is the intellectual property end of it and how indigenous peoples are being compensated for their knowledge. I still don't see a lot of justice on this end of the biopharm debate.

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11. Hap on January 4, 2008 7:50 PM writes...

1) Testing costs an awful lot of money, and I don't see how the testing process is any cheaper for natural product-derived drugs than unnatural ones, unless you just slap "supplement" on them, and sell them anyway.

2) It would seem that natural products might have advantages, but I don't exactly see how safety is one of them - after all, the natural products we want to use and reengineer were evolved to kill competing species, so they aren't harmless to lots of living things, including perhaps us.

3) The level of marketing expense reported in Jan's article (Pharmalot has a summary) seems high relative to R+D, but it would be nice to know what other industries spend on both of those - it might not be disproprtionate relative to similar industries (whateer those are). The overselling of drugs (both in overselling their claimed benefits and in expanding their markets beyond those who can benefit from them without undue harm) might be a larger problem.

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12. Hap on January 4, 2008 7:52 PM writes...

1) Testing costs an awful lot of money, and I don't see how the testing process is any cheaper for natural product-derived drugs than unnatural ones, unless you just slap "supplement" on them, and sell them anyway.

2) It would seem that natural products might have advantages, but I don't exactly see how safety is one of them - after all, the natural products we want to use and reengineer were evolved to kill competing species, so they aren't harmless to lots of living things, including perhaps us.

3) The level of marketing expense reported in Jan's article (Pharmalot has a summary) seems high relative to R+D, but it would be nice to know what other industries spend on both of those - it might not be disproprtionate relative to similar industries (whateer those are). The overselling of drugs (both in overselling their claimed benefits and in expanding their markets beyond those who can benefit from them without undue harm) might be a larger problem.

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13. Polymer Bound on January 4, 2008 11:42 PM writes...

I bet if you cut out the natural product/natural product derived drugs which act as cytotoxins, the list gets even shorter.

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14. As You Lean on January 5, 2008 1:33 AM writes...

I've done some work with natural products and screening them is no easier than it is with any other chemicals, possibly even worse because with synthetics you at least have some idea of what the heck it was that you put in the assay to begin with. A lot of natural product work is figuring out what it was in the methanol extract of the roots of plant X which had its interesting activity. This combined with seasonal variations in compound levels and the possibility that they were produced by some endophytic species makes screening for natural products kind of a pain.

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15. TNC on January 5, 2008 11:06 AM writes...

Frequently, proponents of natural products argue that they are pre-optimized for bioavailability. What do people think of this argument?

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16. SRC on January 5, 2008 2:21 PM writes...

I wish the New Age types would be consistent in what is and isn't "natural." In other contexts anything that involves any remote human intervention (e.g., vitamin C) is no longer "natural," but in this context the converse is true. Consistency, please!

As for the "it's natural, it comes from plants, therefore it's good for you" nonsense, my favorite counterexamples are the alkaloids the public is familiar with (e.g., curare, strychnine). Never got a good response to that.

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17. aaaa on January 5, 2008 6:32 PM writes...

The pipeline of the big pharma is empty, they would grab anything promising now from anyone at any price (I am in the business, know it is true). HTS has shown its problems, and lets admit - a drug like Taxol, would not be discovered EVER (far too complex, medchem R&D do not come close to 1/10th of this molecular complexity), if we would just follow the fully synthetic drug discovery approach. I think we should not brag how smart we are and how stupid nature is, instead, we should look more and more into natures molecules. Look how complex the chemistry in our body is, and we want to influence it in a selective way with drugs that look ridiculously simple in comparison. I think pharma will soon reach a point where finding new synthetic drugs that are better than the existing ones will not be economically viable. For example, AZ shut down their gastrointestinal research lab in Sweden for one simple reason - they decided - there is no need for a better drug than their Nexium, and it would cost far too much for not much back to find anything better.
Big pharma will have to look into nature more and more. At the moment cancer is the top of the line, because according to ChemEngNews, some 70 or 80% (do not remember the actual figure) of the anticancer drugs registered by FDA in the last 10 years come from natural products. Other areas will follow.

Permalink to Comment

18. aaaa on January 5, 2008 6:35 PM writes...

The pipeline of the big pharma is empty, they would grab anything promising now from anyone at any price (I am in the business, know it is true). HTS has shown its problems, and lets admit - a drug like Taxol, would not be discovered EVER (far too complex, medchem R&D do not come close to 1/10th of this molecular complexity), if we would just follow the fully synthetic drug discovery approach. I think we should not brag how smart we are and how stupid nature is, instead, we should look more and more into natures molecules. Look how complex the chemistry in our body is, and we want to influence it in a selective way with drugs that look ridiculously simple in comparison. I think pharma will soon reach a point where finding new synthetic drugs that are better than the existing ones will not be economically viable. For example, AZ shut down their gastrointestinal research lab in Sweden for one simple reason - they decided - there is no need for a better drug than their Nexium, and it would cost far too much for not much back to find anything better.
Big pharma will have to look into nature more and more. At the moment cancer is the top of the line, because according to ChemEngNews, some 70 or 80% (do not remember the actual figure) of the anticancer drugs registered by FDA in the last 10 years come from natural products. Other areas will follow.

Permalink to Comment

19. SNP on January 5, 2008 9:03 PM writes...

Looking at the publications on the potato they're researching, they have some efficacy data on healthy rats, no disease model, no human data and no tox data. And they're selling the stuff now! If pharmas adhered to the same standard -- believe me, our pipelines would be humming along, too.

What I am most concerned about is the intellectual property end of it and how indigenous peoples are being compensated for their knowledge. I still don't see a lot of justice on this end of the biopharm debate.

We've hashed through that issue here a number of times (and I really dislike when people preemptively identify their own position as "justice" in a question as murky as this.) That said, unlike cases where a natural product serves as the starting point for development of a drug that emerges a billion dollars later, I'm a lot more sympathetic to the natives' claims when the product being sold has essentially no intellectual contribution beyond theirs, as is the case here.

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20. Chris Kilham on January 6, 2008 12:34 AM writes...

I'm gratified to see so much comment on the article in the New York Times. As it turns out, a large body of double-blind, placebo-controlled, human clinical studies handilly demontrates the efficacy and safety of many plant=based medicines in their whole or extracted multi-compound form. That's the point. The days of vague claims are way over if you pay attention to the vast medical science that has sprung up around herbs. Just make a sober appraisal of the World Health Organizations' excellent published materials on herbal medicine if my own decades of experience in the field won't do it for you. Or consider that approx 3000,000 people in the US die each year from the proper use of OTC and prescription drugs, and that in most years, there are absolutely no reported deaths attributable to herbs. If you are going to understand the issue, then reviewing the real science, and not just pretending it doesn't exist, is the only credible path. And if you dog down the mortality data, pharmaceuticals compare poorly against herbs. The landscape is by no means perfect, and many herbal products are of poor quality in any number of ways. But the reason that herbal or plant-based medicine is the number one category of medicine used globally is that these agents work. Keep up the lively banter. Happy trails- Chris Kilham, Medicine Hunter

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21. philip on January 6, 2008 8:39 AM writes...

If Chris Kilham really believes that "3000,000 people in the US die each year from the proper use of OTC and prescription drugs", then, no, his "own decades of experience in the field won't do it for" me.

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22. jose on January 6, 2008 2:51 PM writes...

"And if you dog down the mortality data, pharmaceuticals compare poorly against herbs."

Statistics must work a little differently on the "Medicine Hunter's" happy little planet.

Seriously, statements like this are simply an insult to the hundreds of thousands of professional scientists working in the field.

Permalink to Comment

23. TNC on January 6, 2008 6:17 PM writes...

Stunningly, Derek doesn't mention the most interesting thing about Mr. Kilham's drugs: they're not. They're supplements sold at WalMart. Good God -- this guy's not a medicine hunter, he's a direct-to-consumer quack.

Childish insults aside, I challenge Mr. Kilham to subject his medicinal herbs and his clinical studies to the FDA for approval as drugs. If they're approved, you won't have to sell books and supermarket supplements anymore, you'll be a billionaire.

Permalink to Comment

24. TNC on January 6, 2008 6:34 PM writes...

For good fun, I've excerpted Mr. Kilham's website explanation about plant medicines. This is great stuff. For extra laughs, I suggest Mr. Kilham's article in Discovery Health titled "Herb Sex Boosters."

"Plant Medicines, Safer and Time-tested

Plant medicines are far and away safer, gentler and better for human health than synthetic drugs. This is so because human beings have co-evolved with plants over the past few million years. We eat plants, drink their juices, ferment and distill libations from them, and consume them in a thouand forms. Ingredients in plants, from carbohydrates, fats and protein to vitamins and minerals, are part of our body composition and chemistry.

Plants and Humans Share Similarities

Some compounds perform the same functions in plants and in the body. Natural antioxidant phenols in plants, for example, protect plant cells from oxidation, and often perform the same function in the human body. Our bodies recognize the substances that occur in plants, and possess sophisticated mechanisms for metabolizing plant materials.

Synthetic Drugs Are Foreign To The Body

The same cannot be said about synthetic drugs. These agents are most often alien to the chemistry of the human body, and are separate and apart from the careful crafting of evolution. Synthetic drugs often act in the body as irritants and toxins, upsetting the balance of whole systems, producing side effects that can be lethal. By contrast, the regular and judicious use of herbs to protect and promote health and as medicines to help treat common ailments is an enlightened approach to personal well-being.

Plants Can Be Dangerous Too

Plants can also pose a danger to human health. Drink a tea made from oleander leaves or chew a mouthful of foxglove and and you'll be dead in a hurry. On the other hand, if you use any of the thousands of healthful herbs that have been utilized as traditional medicines over the past few millenia, in dosage ranges that have been determined by centuries of trial and error, you are likely to benefit without side effects."

Permalink to Comment

25. SNP on January 6, 2008 7:06 PM writes...

As it turns out, a large body of double-blind, placebo-controlled, human clinical studies handilly demontrates the efficacy and safety of many plant=based medicines in their whole or extracted multi-compound form. That's the point. The days of vague claims are way over if you pay attention to the vast medical science that has sprung up around herbs.

Chris, if I've misrepresented the safety and efficacy data around your maca products, I'd welcome any correction. (In fact, I do see a pair of placebo-controlled trials of maca underway at MGH, but no results reported yet anywhere.)

Permalink to Comment

26. SRC on January 6, 2008 8:53 PM writes...

Chris, thanks for your post. We don't get many laughs around here.

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27. jose on January 6, 2008 10:12 PM writes...

To echo TNC, I heartily suggest everyone check out Chris' website, http://www.medicinehunter.com/.

Truly an eye-opening experience!

Permalink to Comment

28. milkshake on January 6, 2008 11:00 PM writes...

Chris Kilham served for 3 years as a "Honorary Consul to the United States for the Republic Of Vanuatu"

There is a famous speech from Dick Feynman, about pseudoscience and scientific integrity:

https://netfiles.uiuc.edu/mragheb/www/Cargo%20Cult%20Science.pdf

Permalink to Comment

29. bcpmoon on January 7, 2008 4:57 AM writes...

The view "Natural = Good" is quite narcisstic, because it implies that nature is there for humans. At the end it is a religious view: Its good because it was made for us. Not so, and the co-evolution argument is only the same view in a sciency wording. First of all, humans have not co-evolved with plant-toxins, being on the same planet at the same time does not mean that we have adapted to them: Snake venom will kill me and a lions teeth are not healthy when applied by a lion.

Permalink to Comment

30. Kaltha on January 7, 2008 9:14 AM writes...

In case you wanted any bioprospecting examples;
Cyclosporin should be a prime candidate. It was found in a fungi from the soil of a remote part of Norway by some clever swiss people working at Novartis.

Permalink to Comment

31. Liquidcarbon on January 7, 2008 10:57 PM writes...

Don't forget about the Cherokee hair tampons...

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32. Petros on January 8, 2008 3:30 AM writes...

Didn't MErck buy an island or two to find drugs in its flora. Got them a K channel blocker lead I think.


On a related note the British Government has fallen for the line spun by Prince Charles resulting in the following"
"The Medicines and Healthcare Products Regulatory Agency has already changed its rules to allow homeopathic remedies to be sold for the first time with labels advertising the diseases they are supposed to cure. This was despite strong objections from the British Pharmacological Society, some of the Royal Colleges and the Royal Society itself. Professor Michael Baum protested that "this is like licensing a witches' brew as a medicine so long as the batwings are sterile".

http://www.guardian.co.uk/commentisfree/story/0,,2236975,00.html

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33. TFox on January 8, 2008 6:16 PM writes...

@TNC:

Frequently, proponents of natural products argue that they are pre-optimized for bioavailability. What do people think of this argument?

I dunno. Plants make a lot of compounds, not all of them soluble, or bioavailable from a simple extract, but that doesn't stop other compounds present from working. An ex-employer tried to turn this around, arguing that the bioavailable compounds were more likely to be responsible for the efficacy (which was simply assumed to be present). It didn't work, in the sense that the company wasn't able to make money. The real problem is regulatory: DSHEA makes selling herbs legal, but ensures that a) there's no IP, and no incentive to test claims and b) virtually all marketing claims are illegal, but rarely enforced. As a result, science is selected out of the herbal industry genepool by regulators and market pressures, leaving only fly-by-night hucksters.

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34. srp on January 9, 2008 8:43 PM writes...

Back in the 1970s, when the "natural" marketing craze started, I remember Consumer Reports used to show funny pictures of oddball products proclaiming their wondrous natural qualities. My favorite was a bottle of natural rat poison.

Permalink to Comment

35. srp on January 9, 2008 8:49 PM writes...

Back in the 1970s, when the "natural" marketing craze started, I remember Consumer Reports used to show funny pictures of oddball products proclaiming their wondrous natural qualities. My favorite was a bottle of natural rat poison.

Permalink to Comment

36. gary on January 10, 2008 12:35 PM writes...

Interesting to read through the above discussion! It seems that the scientific approach put into the manufacture of medicine puts more weigh on its ability to cure. But then again, we cannot disregard the fact that herbal remedies do have medicinal properties and the potential to heal despite the mentioned difficulty in screening plant compounds.

Permalink to Comment

37. kam choo choo on March 19, 2008 10:34 PM writes...

I grow a plant for cancer. The main stem has many thorns. The Chinese call it the cancer plant with 8 thorns. I do not know the English name. Can anyone help me?

Cheers to good health.

Choo Choo from Singapore.

Permalink to Comment

38. Jane Yao on July 17, 2012 6:22 PM writes...

Screen our Newly Isolated compound library to generate new drug leads

Take a look at our unique sample library containing low hanging fruits, and consider screening it in your next drug lead discovery?

We (usahealthresource.com) provide over 12,000 non-commercially available compounds and fractions obtained by column separation of worldwide chemically untapped natural products.

Thanks

Jane
Health Resource Pharmaceuticals LLC

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