Ridiculous cost of clinical trials hinder new bug repellant

[Justforfun000]

This is insane. When you have a product that is known to be three times as effective and far more desirable since DEET stinks and is the only major repellant out there, it's pretty annoying that these hurdles should cost so much money and take so much time. That's gross inefficiency. Obviously safety trials and proof of product needs to be done before new products make it to market with valid claims, but this is ridiculous. Why is there any NEED for the costs to be so astronomical? Somewhere along the line, somebody or something is charging far too much for a service.

Article URL: http://www.medicalnewstoday.com/articles/160829.php

The Buzz On An Amazing New Mosquito Repellent: Will It Fly?
17 Aug 2009

After searching for more than 50 years, scientists finally have discovered a number of new mosquito repellents that beat DEET, the gold standard for warding off those pesky, sometimes disease-carrying insects. The stuff seems like a dream come true. It makes mosquitoes buzz off three times longer than DEET, the active ingredient in many of today's bug repellents. It does not have the unpleasant odor of DEET. And it does not cause DEET's sticky-skin sensation.

But there's a fly in the ointment: The odds may be stacked against any of the new repellents finding a place on store shelves this year or next - or ever.

Ulrich Bernier, Ph.D., lead researcher for the repellent study, said the costly, time-consuming pre-market testing and approval process is a hurdle that will delay availability of the repellents, which were discovered last year. The results of his team's work were presented at the 238th National Meeting of the American Chemical Society (ACS) by Maia Tsikoli, Ph.D., a post-doctoral researcher working with Bernier.

"Commercial availability of topical repellents can take years and a significant investment to achieve that end goal," Bernier said. "The cost will be several hundred thousand dollars. Once you determine that the repellent works through some screening process, we then have to go through a toxicological hazard evaluation involving numerous toxicological tests."

Provided the repellents continue to work well when tested in the laboratory on human skin, and if they pass the battery of toxicological tests, they would still face a series of tests to prove their effectiveness in making mosquitoes bug off, Bernier said.

"Clearly, the odds are stacked against new repellent products making it to market," he noted.

Bernier and his team discovered the repellents with what they say is the first successful application of a computer model using the molecular structures of more than 30,000 chemical compounds tested as repellents over the last 60 years. Using 11 known compounds, they synthesized 23 new ones. Of those, 10 gave about 40 days protection, compared to 17.5 days for DEET, when a soaked cloth was worn by a human volunteer. When applied to the skin, however, DEET lasts about five hours.

Bernier routinely participates in repellency studies, which involve about 500 mosquitoes trying to land on his arm and bite through a repellent-soaked cloth. "If the mosquitoes don't even land, we know the repellent is surely working," he explained. "If they walk around on the cloth-covered-arm, they are on the verge of being repelled. If they bite… on to the next repellent."

Overall, in addition to lasting longer than current products, including DEET, the new repellents don't have the stickiness or unpleasant smell common with today's insect sprays and liquids, said Bernier. He said that extended studies are now evaluating the effectiveness of the repellents against flies and ticks.

"This was quite an ambitious project," Bernier said. "The USDA historical archives and repellents database we used consisted of more than 30,000 chemical structures tested over the past six decades."

To search for the best repellents, the team devised software that recognized structural features of a chemical that would make it effective in keeping the bugs away. They trained it by feeding it the molecular structures of 150 known repellents. Based on this information, the program learned to identify the chemical traits of a good repellent without the chemists even having to know what those traits were. For example, the team checked out 2,000 variants of a compound found in black pepper that repels insects.

This study was partly supported by the Deployed War-Fighter Protection (DWFP) Research Program, funded by the U.S. Department of Defense through the Armed Forces Pest Management Board (AFPMB).

Source:
Michael Bernstein
American Chemical Society
--------------------------------------------------------------------------------



Main News Category: Tropical Diseases

Also Appears In: IT / Internet / E-mail,

[Alyrium Denryle]

This is insane. When you have a product that is known to be three times as effective and far more desirable since DEET stinks and is the only major repellant out there, it's pretty annoying that these hurdles should cost so much money and take so much time. That's gross inefficiency. Obviously safety trials and proof of product needs to be done before new products make it to market with valid claims, but this is ridiculous. Why is there any NEED for the costs to be so astronomical? Somewhere along the line, somebody or something is charging far too much for a service.

They are doing toxicological screens, they first had to start with non-humans, then human trials. Insurance for the human trials etc etc etc. It takes time because you have to do the work for long enough to make sure there are not problems with chronic exposure. Why? Because biochemistry is complex, and a drug that has one known effect could have several dozen effects that are not known until they cause someone cancer 15 years down the line.

[salm]

This is insane. When you have a product that is known to be three times as effective and far more desirable since DEET stinks and is the only major repellant out there, it's pretty annoying that these hurdles should cost so much money and take so much time.

Don´t kow about the US but here you get repellants with Icaridin (For example Autan). They don´t stink, don´t attack your lips and are just as efficient as DEET solutions.

[Justforfun000]

Aly Wrote

They are doing toxicological screens, they first had to start with non-humans, then human trials. Insurance for the human trials etc etc etc. It takes time because you have to do the work for long enough to make sure there are not problems with chronic exposure. Why? Because biochemistry is complex, and a drug that has one known effect could have several dozen effects that are not known until they cause someone cancer 15 years down the line.

Yeah, I know. I know that it's sensible and for the best as to safety concerns especially, but several thousand dollars? It's a topical product and therefore of moderately less complexity compared to the safety trials needed for anything we ingest. It just seems like an inordinately huge expense just to get something off the ground. Long terms effects can never be discovered until you actually USE said product over a span of 10 years +, so as with most pharmaceuticals they pass if they appear to be safe in the short term as a main rule....later on if they discover something then it can always be yanked. But it should be relatively easy to determine the toxicity potential of a topical product. It's mainly of a dermatological concern and only relatively few known substances penetrate the skin significantly enough to cause systemic issues of any serious worry.

You would know I suppose....can't they simply test the skin cells for DNA damage after topical application?

Salm Wrote:

Don´t kow about the US but here you get repellants with Icaridin (For example Autan). They don´t stink, don´t attack your lips and are just as efficient as DEET solutions.

I've never heard of it personally, but that doesn't mean we don't have it. I'll have to check it out. I'm currently working every friday night at a campground and am using DEET repellant weekly and I can't stand the stink of the stuff. I'd love to have an alternative.

[General Zod]

Yeah, I know. I know that it's sensible and for the best as to safety concerns especially, but several thousand dollars? It's a topical product and therefore of moderately less complexity compared to the safety trials needed for anything we ingest. It just seems like an inordinately huge expense just to get something off the ground. Long terms effects can never be discovered until you actually USE said product over a span of 10 years +, so as with most pharmaceuticals they pass if they appear to be safe in the short term as a main rule....later on if they discover something then it can always be yanked. But it should be relatively easy to determine the toxicity potential of a topical product. It's mainly of a dermatological concern and only relatively few known substances penetrate the skin significantly enough to cause systemic issues of any serious worry.

It might seem like they're spending a lot of money now, but imagine how much they'd wind up spending from a class action lawsuit down the line because of side-effects they didn't take the time to properly investigate.

[Stark]

It's hilarious to see someone complain about the horrible costs of actual testing when he's prepared to jump on the bandwagon for any 'alternative therapy' ever, because they make him feel good.

This is science, kids. Safety? Pshaw!

[Justforfun000]

It's hilarious to see someone complain about the horrible costs of actual testing when he's prepared to jump on the bandwagon for any 'alternative therapy' ever, because they make him feel good.

Exaggerate much? Unless you can display a listing of posts that have me promoting everything from ear candling to acupuncture, I think you should retract your slander. Even your secondary point is way off.

Obviously in reference to what you ARE basically needling me about...I never claimed I used particular herbal products because they make me "feel good", I listed specific CLINICAL TRIALS that evidenced strong probability of efficacy and also gave examples of people who had actual personal benefit when running their bloodwork. Sometimes it just takes common sense to see if x number of people all have the same beneficial reaction when taking something specifically predicated for a condition...i.e..preventing liver cytotoxicity, then in all probability, the herbal actually IS beneficial and that's why it's been used for hundreds of years traditionally which as a perfect example milk thistle has been.

It's not good enough evidence for pharmaceutical product or it's claims but then I never argued that it should be did I? I only gave reasons that I feel are good enough for me to have the right to choose. Apparently this decision irks you personally because you really dislike pseudoscience and you feel that this in some way perpetuates it? That's my guess to your reaction..and your free to your opinion but whatever it is don't you think you should stop strawmanning my position and at least be fair in your criticism?

[Justforfun000]

It might seem like they're spending a lot of money now, but imagine how much they'd wind up spending from a class action lawsuit down the line because of side-effects they didn't take the time to properly investigate.

Absolutely. But as I said before, shouldn't skin toxicity be relatively simple to determine? I really can't see why they would need anywhere near the amount of money and time in comparison to consumable substances. Actually that isn't even really my point. What I'm really suggesting is that somebody is charging too much money for services. I'm just going to pull figures out of my ass, but what does it cost to pay one of the researchers to investigate something. Is this costing $10 an hour or $500? It's just one of those fields that I really get irked seeing costs and profits being such a huge part of the equation. It's just like the astronomical cost of AIDS drugs as one example and the justification that a company has to spend so much money on research that it's only fair to recoup their costs. So ultimately there isn't any basis of humanitarianism or altruism in medical research even though it's ostensibly to benefit ALL MANKIND, it's still all about profit first and foremost.

Because of this places like Africa have millions dying because there's no way in hell they can individually afford $1500+ a month for meds. I just wish that medical science was based on the ideal that everyone should have the right to the best care science can provide someone for their most basic right of all. Life. But in practice, it doesn't happen because of the profit factor.

[Akhlut]

It might seem like they're spending a lot of money now, but imagine how much they'd wind up spending from a class action lawsuit down the line because of side-effects they didn't take the time to properly investigate.

Absolutely. But as I said before, shouldn't skin toxicity be relatively simple to determine? I really can't see why they would need anywhere near the amount of money and time in comparison to consumable substances. Actually that isn't even really my point.

You don't have to worry about just the skin, for instance. The chemical will have some penetration of the skin and some of it will be respired. People will use it contrary to its indicated uses (accidentally spray it in their eyes, for instance). So, you have to do full system tests to ensure safety. You have to take sometimes more then a decade to properly test everything and make sure repeated exposures, exposures to large doses, and a lot of other similar contingencies are covered so you know exactly how this newfangled drug or chemical will work and will affect people.

What I'm really suggesting is that somebody is charging too much money for services.

You have to pay legions of technicians, scientists, and office workers salaries for ten years. You have to pay for a decade of equipment and supply costs for things like PCR and other chemical analyses (whose chemicals often cost $100+ per bottle of no more then 500g). Sometimes you need to replace machines that cost over $50,000. You have to pay insurance for test subjects, you have to pay test subjects. You have to pay for animal subjects and everything to maintain them. It adds up.

So ultimately there isn't any basis of humanitarianism or altruism in medical research even though it's ostensibly to benefit ALL MANKIND, it's still all about profit first and foremost.

Some drugs can cost as much as ONE BILLION DOLLARS to get from initial stages to market stage. Yes, you want to be altruistic, but you also can't keep pumping out drugs that take decades to reach the market and cost a billion dollars (this also includes the costs of things that, say, get to the human trial phase and are found to have horrible side effects) without going bankrupt and being unable to continue making drugs for people. Is the current system imperfect? Hell yes, but unless you want to subsidize drug production, this is how it's going to have to work for the time being.

[Stark]

Obviously in reference to what you ARE basically needling me about...I never claimed I used particular herbal products because they make me "feel good", I listed specific CLINICAL TRIALS that evidenced strong probability of efficacy and also gave examples of people who had actual personal benefit when running their bloodwork. Sometimes it just takes common sense to see if x number of people all have the same beneficial reaction when taking something specifically predicated for a condition...i.e..preventing liver cytotoxicity, then in all probability, the herbal actually IS beneficial and that's why it's been used for hundreds of years traditionally which as a perfect example milk thistle has been.

Oh man, you couldn't get through a single explanation of your bias without throwing out nonsense like 'that's why it's been used for hundreds of years traditionally'. This doesn't bolster any of your claims and just makes you look stupid; appeals to tradition are worthless, and since the vast majority of 'traditional' medicine is inferior to actual tested medicine, it exposes your cherry-picking. I'm sure you're in earnest, but you really do come across as an alternative medicine nut, and thus having you complain that making ACTUAL medicine takes so long and is so expensive is ludicrous.

[Justforfun000]

Some drugs can cost as much as ONE BILLION DOLLARS to get from initial stages to market stage. Yes, you want to be altruistic, but you also can't keep pumping out drugs that take decades to reach the market and cost a billion dollars (this also includes the costs of things that, say, get to the human trial phase and are found to have horrible side effects) without going bankrupt and being unable to continue making drugs for people. Is the current system imperfect? Hell yes, but unless you want to subsidize drug production, this is how it's going to have to work for the time being.

I agree with everything you quoted before so I'll just snip the last paragraph for brevity....

Yeah I know it's a pointless rant because I may as well be wishing we had enough food to feed all the hungry and all the water in the world to relieve famine. *sigh*. Still, I just wish the government could do a little more to reduce the costs of these hurdles. As you said, for some things..one BILLION. That is an absolutely astronimical amount of money and I really can't help but feel that it must be seriously hyperinflated in many ways. Nothing should cost that much! It's crazy.

I wonder if a great deal of the cost comes from insane lawsuits where people sue for millions of dollars over some trivialities that are ridiculous. Or should I say when they WIN such lawsuits. Canada actually severley limits that kind of craziness. Even in motor vehicle accidents they have certain caps you can sue for based on loss of limb, eye...whatever particular function of your life is severely compromised. I really believe that's immensely sensible and I think the States should stop allowing that kind of bullshit. It's only the insurance companies that end up being the big winners in the end.

Oh, on a completely unrelated note since it pertains to House insurance in Canada.....anyone here might be very interested to learn of this scam. These bloody insurance companies constantly swindle people out of paying insurance that they consistently dent by their "fine print" bullshit. As one example they gave in the article, a "pre-existing" health condition like hih blood pressure COULD be enough to deny the claim. But get this...they have had a situation where if a doctor even CHECKS your blood pressure by applying the cuff to your arm, that's enough to disqualify you! Imagine. You'd have to read the article to get more of the full story, but it's a good warning out there to anyone to beware:

http://www.cbc.ca/marketplace/in_denial/

The Show
Mortgage insurance: Not always a sure thing

If you have a mortgage on your home, chances are good you also have mortgage insurance. The idea is that if you should become seriously ill or die before paying off the mortgage, the coverage will kick in and pay it off for you. It’s meant to offer peace of mind and to reassure you that your family will be able to stay in your home if anything should happen to you.

The reality falls a little short of that. In this week’s Marketplace investigation, we meet two families who bought the coverage and thought they were protected, only to have their claims denied when they became sick or died. In each case, the insurer said the applicant person had lied on their initial application form.

It turns out a routine test at the doctor could be reason to deny your claim, if you don't mention it. Had a cuff inflated on your bicep? That counts as being tested for high blood pressure.

As Erica Johnson reports, the bank staffers selling mortgage insurance are unlicenced and rarely trained to explain the details and legalities of those insurance products. The result is people who pay premiums and think they are covered, only to realize later that they are not.

February 6, 2008
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How to buy insurance that really will protect you

Be sure you qualify.

* There are many terms and exclusions associated with credit insurance policies. Learn what they mean and how they apply to you.
* Call the insurance company directly (NOT the bank that sold you the coverage) for clarification about pre-existing medical conditions.
* Call your doctor to clarify details of any pre-existing medical conditions you may be concerned about.


Know that you can get out.

* You usually have 10-30 days to review your policy after the initial purchase (this is known as a "cool-down" or "free look" period).
* If you have already purchased your credit insurance you can cancel anytime. Keep in mind, however, that you may lose premiums already paid.


Shop around.

* Consider buying from a licensed insurance broker who will explore any medical issues upfront.
* Consider buying or topping up an individual life insurance policy to cover your mortgage.


Know your coverage.

* You may already have adequate insurance coverage through your work or other policies. Insurance experts say it's better to buy one traditional insurance policy than purchase a number of small policies for a variety of products.


Be sure you need it.

* The purpose of credit life mortgage insurance is to protect your loved ones from making mortgage payments if something were to happen to you. This type of insurance may not be applicable if you do not have any dependents who would need to keep your home if something happened.

February 6, 2008
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[Justforfun000]

Oh man, you couldn't get through a single explanation of your bias without throwing out nonsense like 'that's why it's been used for hundreds of years traditionally'.

What's the matter with you? That's simple statement of FACT. Do you not realize that there are hundreds of herbs that have been used as traditional medicine before science came into the picture? how is that nonsense?

This doesn't bolster any of your claims and just makes you look stupid; appeals to tradition are worthless, and since the vast majority of 'traditional' medicine is inferior to actual tested medicine, it exposes your cherry-picking

That was a very minor point in my entire argument. The fact that you are ignoring all of the clinical studies that I cited as examples of researching the individual ingredients, on my own, and NOT from the company's own promotional material..showing very suggestive benefit is a much more important point to my argument so why you would nitpick on this would seem to suggest that you don't have a good argument against the majority of my point?

And when did I say that traditional medicine wasn't inferior? Of course it is! Does that mean it's worthless? No. Your displaying a very serious bias against this subject with no supporting reason that debunks the heart of the point. These substances ARE being tested and evidenced as potentially having very real benefits. More to the concern is whether or not they are truly SAFE. But that's another part of the issue and it's certainly a valid debate. However I'm only talking about what I personally choose to experiment with because a certain degree of evidence might be good enough for me. What's wrong with that? Since a vast majority of people tend to feel that way, we have here in Canada many advocates wishing to make their own choices regarding medicine even when it's "alternative". Sure there's a lot of bunk. So what? You don't throw the baby out with the bathwater. You just have to use your brain and decide if something has any reasonable evidence behind it. Because many people as well as myself feel that many things are showing enough promise to see the writing on the wall and don't want to wait for all the red tape bullshit before we get to actually USE something. We do have a limited lifespan after all.

I'm sure you're in earnest, but you really do come across as an alternative medicine nut, and thus having you complain that making ACTUAL medicine takes so long and is so expensive is ludicrous.

I don't understand why you'd make such an opinion based on the very specific types of alternative medicine...i.e.. specific herbal products.. that actually have some clinical studies behind them showing some promise. That's hardly in the league of tin foil hats and pyramid power.

As I said above to the other poster, I just feel that the costs are ridiculously hyperinflated. Many things in life are! Housing costs in Canada rose ridiculously within the space of a 3 year period back in the early 1980's. In Toronto, a house that was $75,000 could have been sold for $180,000 the next year, and up to $300,000 in the next. Did it REALLY rise that much in true "value"? Or was this truly just greed because of profit? I'm sure you know the answer...That was the period when immigration doors flew wide open here, and because Toronto was the biggest city in Canada, people flocked here in droves. All of a sudden countless numbers of people couldn't afford to own their own home. Same problem exists today for so many people. It's fucking ridiculous that a simple basic living necessity like your home can be a small bungalow and end up costing you up to a million dollars by the time you pay it off. I'm sorry, but to me that's insane, and I feel that many factors are probably also due to greed in medical research and is similarly hyper-inflated.

That's all I ever said by the way, I never said I don't respect science or allopathic medicine. Far from it! I am very much against pseudoscience, but I haven't been suggesting even REMOTELY resembling a belief in that position.

[Mr Bean]

Also let me point out the "outrageous" costs of the testing of this particular compound even by worst case estimate is just a few million dollars. Which will be far more than what they will make off the sale of the compound. Hell your average mega-corporation spends ten times as much decorating their headquarters then it will cost to run this through proper testing procedures. The main thing it costs is not money but TIME.

[Darth Wong]

Why is there any NEED for the costs to be so astronomical?

Have you ever heard those ads on the radio where they offer you thousands of dollars to come in for a weekend and participate in a medical study? Now think about the fact that you probably want a large number of participants, plus a control group, all of which is being paid four figures per head. All of this will need to be documented by highly paid personnel, supervised by highly qualified (and even better paid) personnel, run by a company which has to do all kinds of certification work and paperwork, etc. And you aren't going to run just one study: you have to run studies on safety, studies on effectiveness, probably for different population types and conditions, etc.

One of the reasons for the high costs of medical studies is the fact that most people are rather reluctant to participate in one, and must be bribed with considerable sums of money to do it. Would you participate in a medical study of a hitherto untested experimental drug? How much money would it take? I wouldn't do it. What if I have some horrible reaction and get fucked up for life?

[Duckie]

Ironically this thread some idiot who is throwing out the basic statistical foundation of scientific medicine as established in the 8th century AD is celebrating the idea that some new untested compound might work better than boring old super-tested DEET.

That is, it's ironic because in a previous thread, DEET was found to be a neurotoxin by a study and requires further testing to see if this is potentially harmful to humans. This new shit could diassociate into perchloric acid and mercuric sulfide when absorbed by the blood stream for all the OP knows, for a vulgar and simple example, which is why clinical studies are done.

[General Zod]

Ironically this thread some idiot who is throwing out the basic statistical foundation of scientific medicine as established in the 8th century AD is celebrating the idea that some new untested compound might work better than boring old super-tested DEET.

That is, it's ironic because in a previous thread, DEET was found to be a neurotoxin by a study and requires further testing to see if this is potentially harmful to humans. This new shit could diassociate into perchloric acid and mercuric sulfide when absorbed by the blood stream for all the OP knows, for a vulgar and simple example, which is why clinical studies are done.

What's even more hilarious is that insects often wind up developing a resistance to lots of these so-called alternatives. So even if they somehow manage to get it to market, if the bugs start becoming immune to the product they spent all that money researching, then they're fucked.

[Duckie]

Oh man, you couldn't get through a single explanation of your bias without throwing out nonsense like 'that's why it's been used for hundreds of years traditionally'.

What's the matter with you? That's simple statement of FACT. Do you not realize that there are hundreds of herbs that have been used as traditional medicine before science came into the picture? how is that nonsense?

Here is why:

"Mercurius Vitae", a mediaeval medicine was used traditionally for centuries before science came into existence. When consumed, it disassociates in your gut into hydrochloric acid and algarot, an emetic which forces your body to purge it by diarrhea and vomiting. While emetics are useful in certain medical cases, it is not a cure-all as was used.

"Flors Stibii/Antimoniae", a mediaeval medicine. It has been used in the much-vaunted 'traditional chinese medicine' for thousands of years. Its true name? Arsenic Trioxide. Currently under investigation to see if it's toxic enough to be useful in treating cancer. This is not what it was used for in mediaeval medicine, though, where it was used for numerous illnesses.

Your noble savage worshipping ideology ignores that science tells us what is medical and what isn't, not the fact that bronze age natives have been using it for some time. Under your stupid system, I'd be taking Mercury of Life for the flu, and instead of Viagra we'd all just take Powdered Tiger Dick, just because the mediaeval italians and ancient chinese did so.

And if you come back and say "Well alchemical medicines don't count" you'll just confirm it, because you accept non-western medicine reflexively then. Western Traditional Medicine is just as valid as Native American or Chinese Traditional Medicine. So drink your Mercurius Vitae and stop complaining.

And if only some medicines work and some don't, as I'm sure you'll protest, maybe we should set up some kind of regulatory body to determine which traditional medicines do and don't work? We could call it a Drug Administration. You eat food too though, so let's fold that in on toxicity checks. Food and Drug Administration. I wish we had one of those.

[Stark]

Oh man, you couldn't get through a single explanation of your bias without throwing out nonsense like 'that's why it's been used for hundreds of years traditionally'.

What's the matter with you? That's simple statement of FACT. Do you not realize that there are hundreds of herbs that have been used as traditional medicine before science came into the picture? how is that nonsense?

I'm just going to respond to this because this whole thing is a hijack. Do you honestly type these things and thing you look sensible? I pointed out that appeals to tradition are useless (ie 'used for ages' doesn't mean 'is any fucking good' or 'better than proper medicine) and that most 'traditional' medicines are useless or inferior (as highlighted in numerous studies, including a series of major ones recently) and you respond by incredulously asking if I didn't realise there were LOTS of (useless, old, etc) herbs that do xyz.

Basically, so what? Throughout history all kinds of stupid shit was considered a 'treatment' based on nothing, voodoo, or broken science. The only thing that matters is results, not age, not tradition, not veneration of your ancestors. Just turns out when they're tested, traditional medicine is generally inferior. The number of those traditional treatments doesn't affect this at all.

And don't tell me you're one of those people who doesn't understand 'herb with xyz active ingredient' and 'drug with xyz active ingredient' are basically the same? This is even ignoring the fact that modern medicine produces better results in most cases than 'traditional' medicine!

[Alyrium Denryle]

Yeah, I know. I know that it's sensible and for the best as to safety concerns especially, but several thousand dollars?

Yes

It's a topical product and therefore of moderately less complexity compared to the safety trials needed for anything we ingest. It just seems like an inordinately huge expense just to get something off the ground.

Um... No. Depending on what the compound is, just because you put it on your skin will not help. If the compound is non-polar it might go right through your skin and into your cells. It is also in aerosol, what about absorption through the lungs or other membranes such as the eyes or inside of the mouth? Then it becomes more than just a topical application (see below)

But it should be relatively easy to determine the toxicity potential of a topical product. It's mainly of a dermatological concern

See above

and only relatively few known substances penetrate the skin significantly enough to cause systemic issues of any serious worry.

HAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAH!!!!!!

have you ever taken an organic chemistry class? We have to switch between different types of gloves because a lot of the common compounds used in synthesis (to say nothing of products) can go right through them and penetrate your skin and kill you. Literally kill you.

You would know I suppose....can't they simply test the skin cells for DNA damage after topical application?

See above, combined with this:

Once something is absobed (either by going through your skin, or being absorbed into the lungs etc) it will not only react with various types of tissue, but may be processed through one or more organs, or get broken down into different compounds by different tissues it comes into contact with. The breakdown products that result must also be tested.

Obviously in reference to what you ARE basically needling me about...I never claimed I used particular herbal products because they make me "feel good", I listed specific CLINICAL TRIALS that evidenced strong probability of efficacy and also gave examples of people who had actual personal benefit when running their bloodwork.

And I seem to remember ripping those examples apart.

I only gave reasons that I feel are good enough for me to have the right to choose.

And you are a great example of why lay people should not be allowed to make those choices

[Alyrium Denryle]

I really can't see why they would need anywhere near the amount of money and time in comparison to consumable substances.

Because they WILL be consumed and absorbed one way or the other. They might also not react well to other things on the skin.

Actually that isn't even really my point. What I'm really suggesting is that somebody is charging too much money for services. I'm just going to pull figures out of my ass, but what does it cost to pay one of the researchers to investigate something.

The average Ph.D holder who does this sort of work makes a base salary of ~50k a year in a university, more in the private sector. Then there are the techs who work under them, support staff, facility overhead... And dont even get me into the cost of equipment, lab subjects (animal and human) reagents, reagents, certification, insurance...

It's just one of those fields that I really get irked seeing costs and profits being such a huge part of the equation.

Most of the drug discovery itself is done in universities. They typically sell the rights to the compounds to a company like Merck, or Dupont.

It's just like the astronomical cost of AIDS drugs as one example and the justification that a company has to spend so much money on research that it's only fair to recoup their costs.

First off AIDS research is VERY fucking expensive. Second off, the drug companies dont typically do the actual research... Universities do, with public grants. Private companies MIGHT do the clinical trials, but the clinical trials AFAIK are actually less expensive than the initial drug discovery process.

So ultimately there isn't any basis of humanitarianism or altruism in medical research even though it's ostensibly to benefit ALL MANKIND, it's still all about profit first and foremost.

The people who do the research have no means of distributing the drugs, and the university has to build new buildings. Dont you dare cast aspersions on the motivations of people who work often 12-16 hours a day trying to fight a disease that evolves faster than we can develop drugs to counter it. Biochemists trying to find steroids that defeat standard tests for athletes get paid more than them.

The clinical trials, believe it or not, are the CHEAP part of drug research.

Because of this places like Africa have millions dying because there's no way in hell they can individually afford $1500+ a month for meds.

Take it up with the middle men

Yeah I know it's a pointless rant because I may as well be wishing we had enough food to feed all the hungry and all the water in the world to relieve famine. *sigh*. Still, I just wish the government could do a little more to reduce the costs of these hurdles

See above. The costs of the research itself really are as low as they can be, and is done on the public dime, even when done by a private company.

Nothing should cost that much!

COme back when you have actually done research.

[Mayabird]

and only relatively few known substances penetrate the skin significantly enough to cause systemic issues of any serious worry.

HAHAHAHAHAHAHAHAHAHAHAHAHAHAHAHAH!!!!!!

have you ever taken an organic chemistry class? We have to switch between different types of gloves because a lot of the common compounds used in synthesis (to say nothing of products) can go right through them and penetrate your skin and kill you. Literally kill you.

Example from me: one lab I worked in, I had to wear no less than three pairs of gloves at the same time to handle some of the chemicals I dealt with, and if I did spill any on me I still had to rip it all off immediately and take a long soak under the safety shower just to make sure I didn't get any on me.

And in another we had a chemical that wasn't harmful in and of itself, but if it got on the skin it would transport any chemicals that one came in contact with (say, wood varnish) into the body. Trying to remember what it was exactly, though I remember one time accidentally jabbing myself with a syringe full of it and asking my prof if I should go to the hospital or something, and he said, "But did you get it on your skin? No? Then you're fine. Don't worry about it."

[fnord]

Dimethyl sulfoxide would be my guess as I've heard it used as a key to get other drugs through the skin, Mayabird.

[Justforfun000]

I just want to address one thing until I have time to answer a lot of the above.

Aly, in reference to this part:

Quote:
Obviously in reference to what you ARE basically needling me about...I never claimed I used particular herbal products because they make me "feel good", I listed specific CLINICAL TRIALS that evidenced strong probability of efficacy and also gave examples of people who had actual personal benefit when running their bloodwork.


And I seem to remember ripping those examples apart.

Quote:
I only gave reasons that I feel are good enough for me to have the right to choose.


And you are a great example of why lay people should not be allowed to make those choices

You didn't exactly rip them apart, you just dismissed them as not good enough for pharmaceutical claims which is why they are sold as a supplement that falls under DSHEA in the States.

Specifically you said:

Looking over that, it looks like some Natural Product Chemists did a bit of bioprospecting, and put their findings out on the market without subjecting it to rigorous testing. They are also not meant as treatments for disease, thus, it is not "alternative medicine" but rather, a supplement you get at a health food store that you HOPE does what it says it does because it is unregulated.

That is what sets herbal medicine apart from pharmaceuticals and the treatment of disease. Many of them suggest preventative and health promoting benefits. Drugs are not generally designed that way, they are more for specific treatment of ailments.

I think it's a little unfair to dismiss the findings just because they aren't as rigourously tested as a pharmaceutical. If they work exactly as they SEEM to evidence in the studies they ran, then they are still beneficial and I still feel I should have a right to choose to use it.

That particular product may not have been the best one to use as an example. It was just a newer one I was currently looking at with interest. Their liver formula that I mentioned as the ones my family and their friends were using with personal results that worked for them had better studies.

For example one ingredient in the formula called Metadoxine has quite a bit of clinical evidence behind it and I'm actually surprised it's not well known and promoted by itself. Metadoxine is an ion-pair between pyrrolidon carboxilate (PCA) and pyridoxine (vit. B6) with the two compounds linked in a single product by salification.

Here's one reference that is certainly more then just suggestive or tantalizing. Do you really feel that these preliminary results can be so blithely dismissed as useless and people should not be able to use such a thing on their own volition? Especially considering that their is NO indication of harm. That's the key point here. If there's no harm, and possible benefit, then why should it not be available and a valid choice for a consumer to benefit their health?

http://www.pubmedcentral.nih.gov/articl ... id=1764726

Copyright © 2006 Guerrini et al; licensee BioMed Central Ltd.
A follow up study on the efficacy of metadoxine in the treatment of alcohol dependence
Irene Guerrini,corresponding author1,2 Claudio Gentili,3 Gloria Nelli,3 and Mario Guazzelli3
1Bexley Substance Misuse Service, South London and Mausdley NHS Trust, London, UK
2Molecular Psychiatry Laboratory, Windeyer Institute of Medical Sciences, Department of Mental Health Sciences, Royal Free and University College London, London Medical School, 46 Cleveland Street, London W1T 4JF ,UK
3Department of Psychiatry, Neurobiology, Pharmacology and Biotechnologies, University of Pisa, Via Roma 67, 56124 Pisa, Italy
corresponding authorCorresponding author.
Irene Guerrini: i.guerrini@ucl.ac.uk; Claudio Gentili: c.gentili@med.unipi.it; Gloria Nelli: g.nelli@med.unipi.it; Mario Guazzelli: m.guazzelli@med.unipi.it
Received April 20, 2006; Accepted December 18, 2006.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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>Abstract
Background
Results
Conclusion
Methods
Competing interests
Authors' contributions
References

Abstract
Background
We carried out a three months follow-up study on the efficacy of metadoxine in a cohort of alcoholics admitted to the Alcohol misuse Long-term Treatment (ALT) Unit – University of Pisa (Italy). We analyzed the clinical data, psychometric tests and blood tests of 160 alcoholics on admission and after 3 months of treatment. We compared 58 pts treated with metadoxine (MET) with 102 pts who did not receive (NULL) any drug as an adjunct to the psycho-educational interventions provided by the ALT Unit.
Results
At follow-up, the patients in treatment with metadoxine showed a significant improvement in the rate of complete abstinence (44.8% vs. 21.6%; chi square: 8.45, df = 1, p < 0.0037). Furthermore, the number of drop-outs at three months of treatment was also significantly lower in the MET than in the NULL group (17% vs. 57%; chi square of 23.22, df = 1, p < 0.001).
Conclusion
Our findings support the use of metadoxine in the management of alcohol dependence. However, randomized clinical trials are necessary to confirm and replicate them. This study raises the importance of identifying new pharmacological compounds effective on the outcome of alcoholism in order to help patients to best adhere to treatment programs and to prevent the development of mental and physical complications due to chronic and heavy use of alcohol.
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Abstract
>Background
Results
Conclusion
Methods
Competing interests
Authors' contributions
References

Background
Alcohol misuse is a common problem in the general population all over the world. Recent surveys reported that alcoholism affects almost 10–15% of the general population in US and 1–5% in Europe [1-5]. There is a general agreement in the scientific community that heavy drinking is largely underestimated by clinicians and that alcohol misusers are often not detected unless and until they develop severe alcohol related pathologies [6,7]. According to Stickel and co-workers (2003) in Europe more than 45 million individuals showed signs of alcohol-related damage, mainly cognitive deficits, liver disease, and myopathies [8-11]. The importance of the nutritional status in the development of alcohol-related organ damage has been postulated by several authors [8,12,13].
A reduction in the blood levels of micro and macronutrients, mainly B-complex vitamins, can impair the cognitive functions and therefore compromise the recovery of alcoholics [14]. In order to prevent brain damage and consequential cognitive impairment, the guidelines for the Accident & Emergency departments in United Kingdom recommend the use of parenteral B vitamins for patients showing evidence of chronic alcohol misuse and suspected of having a poor diet [15]. The B-complex vitamins (i.e. thiamine, pyridoxine etc) are extremely important for the homeostasis of the brain, being key factors in the cell metabolism and trafficking, in the energy production pathways and in the DNA synthesis [16].
Therefore, it is important in the treatment of alcohol misuse to consider an integrated approach that includes pharmacological and psychological intervention, social support and nutritional supplementation.
Several studies have proposed the use of metadoxine in the treatment of acute and chronic alcohol misusers [17-21]. Metadoxine is an ion-pair between pyrrolidon carboxilate (PCA) and pyridoxine (vit. B6) with the two compounds linked in a single product by salification. This process synergistically increases its pharmacological activity [17]. In animal studies metadoxine increases the plasma and urinary excretion of ethanol, inhibits the increased production of fatty acid esters in the liver during chronic alcohol intake, reduces oxidative stress and prevents glutathione depletion in the hepatic tissues [17]. In the brain metadoxine increases the level of GABA and acetylcholine in the frontoparietal cortex of guinea pigs [22]. In mice it increases the level of dopamine in the striatum[23,24].
In human studies, it has also been postulated that metadoxine is effective in maintaining abstinence, in decreasing the craving for alcohol and in improving the cognitive function mainly short-term memory [17,19,20]. The improvement of the short-term memory can be related to the effect of this compound on the cholinergic and gabaergic system reported by Antonelli and coworkers in guinea pigs [22].
Clinical trials showed that in acutely intoxicated patients metadoxine reduces the ethanol blood levels and increases the urinary clearance of ethanol and its metabolites [21]. Metadoxine seems to be effective in the recovery of fatty liver and in improving the laboratory blood tests [18] and, as shown by Shpilenya and coworkers (2002), it seems to ameliorate the clinical and behavioural symptoms during alcohol intoxication [21]. Caballeria and co-workers (1998) reported in a double-blind randomized multicentre study that metadoxine significantly improves the liver enzymes and reduces the rate of steatosis after just a month of treatment [18].
We carried out a follow-up study on the efficacy of metadoxine in a cohort of alcoholics admitted to the Alcohol misuse Long-term Treatment (ALT) Unit at the Institute of Psychiatry University of Pisa (Italy). The purpose of this study is to test the potential benefits of using metadoxine in the management of Alcohol Dependence.
Top
Abstract
Background
>Results
Conclusion
Methods
Competing interests
Authors' contributions
References

Results
The 160 patients were 134 males and 26 females (mean age 44 yrs; SD = 11.) At admission at ALT Unit all the patients were completely detoxified and totally abstinent from alcohol. The fifty-eight patients in treatment with metadoxine received a daily dose of metadoxine of 1000 mg, orally administered three times a day.
The clinical characteristics of the samples are shown in Table ​Table1.1. The alcohol intake refers to the amount consumed before admission to the ALT Unit. The intake is calculated in grams of alcohol according to Italian standards (see Guerrini et al., 2006 as a reference)[5]. The Family History (FH) for Alcohol Dependence was evaluated by two independent clinicians, interviewing the patient and one of his/her first degree relatives. The Age of onset refers to the age in which the individuals started having signs/symptoms of Alcohol Dependence.

[General Zod]

I think it's a little unfair to dismiss the findings just because they aren't as rigourously tested as a pharmaceutical. If they work exactly as they SEEM to evidence in the studies they ran, then they are still beneficial and I still feel I should have a right to choose to use it.

Do you have any arguments that don't ultimately boil down to this ridiculous false dilemma of "right to choose"? Maybe you're not familiar with DDT's rather nasty history. This is why pesticides have to be put through vigorous testing.

In 1962, Silent Spring by American biologist Rachel Carson was published. The book catalogued the environmental impacts of the indiscriminate spraying of DDT in the US and questioned the logic of releasing large amounts of chemicals into the environment without fully understanding their effects on ecology or human health. The book suggested that DDT and other pesticides may cause cancer and that their agricultural use was a threat to wildlife, particularly birds. Its publication was one of the signature events in the birth of the environmental movement. Silent Spring resulted in a large public outcry that eventually led to most uses of DDT being banned in the US in 1972.[4] DDT was subsequently banned for agricultural use worldwide under the Stockholm Convention, but its limited use in disease vector control continues to this day and remains controversial.[5]

[Kaiser Caesar]

I think it's a little unfair to dismiss the findings just because they aren't as rigourously tested as a pharmaceutical. If they work exactly as they SEEM to evidence in the studies they ran, then they are still beneficial and I still feel I should have a right to choose to use it.

The problem is that without rigorous testing how will we, the consumers, know if the results are accurate and not simply flukes of anomalies? Without rigorous testing how will we, know that a study has completely analyzed the effects a chemical or a drug (or, yes, a herb) will have on different groups of a population, i.e. how it will affect males and females, young people and old people, people with preexisting conditions such as diabetes or cancer?

We have rigorous testing standards because they are necessary to ensure a study is accurate and provides enough information.