Drug Discovery

[Dima]

If there is evidence that a plant extract is good for treating Parkisons disease, how do we make this a drug? Are there other ways to make this a mainstream treatment for pd, without making it a drug?

 

Thanks,

 

Dmitriy

[hypervalent_iodine]

If there is evidence that a plant extract is good for treating Parkisons disease, how do we make this a drug? Are there other ways to make this a mainstream treatment for pd, without making it a drug?

 

Thanks,

 

Dmitriy

 

The process from discovery to market is a very long an expensive one. Rather than rehash it all here, you might like to read the following wiki articles:

 

http://en.wikipedia.org/wiki/Drug_discovery

http://en.wikipedia.org/wiki/Drug_development

 

IIRC, it takes close to a billion dollars and anywhere between 10-20 years from start to finish.

 

As for your second question, I'm honestly not sure what you mean. If you are using a chemical in any theraputic sense (be it diagnosis, prevention or treatment), that would make it a drug.

[EdEarl]

I do not know whether there is precise distinction between (food, herb, spice) and drug, except that drugs are extracted from plants and animals by drug manufacturers, patented and required to go through extensive, expensive trials before the public can get them. Whereas, foods, herbs and spices are available to people unless they are declared illegal by the government.

 

If a drug company had discovered the process to make cheese and patented it, we would not be able to eat it without paying outrageous amounts for it.

 

Does anyone know if there is a sane procedure for distinguishing between drugs and (food, herbs and spices)? Or, is it precedent and accident? I.E., accident if someone finds it and makes it public before a drug company patents it.

Edited July 2, 2013 by EdEarl

[hypervalent_iodine]

I do not know whether there is precise distinction between (food, herb, spice) and drug, except that drugs are extracted from plants and animals by drug manufacturers, patented and required to go through extensive, expensive trials before the public can get them. Whereas, foods, herbs and spices are available to people unless they are declared illegal by the government.

 

If a drug company had discovered the process to make cheese and patented it, we would not be able to eat it without paying outrageous amounts for it.

 

Does anyone know if there is a sane procedure for distinguishing between drugs and (food, herbs and spices)? Or, is it precedent and accident? I.E., accident if someone finds it and makes it public before a drug company patents it.

 

 

The definition of a pharmaceutical drug is any chemical that is used therapeutically; that is, for cure, prevention, diagnosis, etc. They are not necessarily derived straight from natural sources. Many and more are entirely synthetic and some are structurally distinct but similar to certain natural products. The difference between that and a straight up herbal remedy is probably best described by this Tim Minchin quote:

 

"“By definition”, I begin “Alternative Medicine”, I continue “Has either not been proved to work, Or been proved not to work. You know what they call “alternative medicine” That’s been proved to work? Medicine.”"

[CharonY]

Essentially if you claim therapeutic effects it has to be be tested for that. Food supplements, i.e. stuff that does not claim that it works tend not to fall under the same rule, for instance.

[EdEarl]

 

"“By definition”, I begin “Alternative Medicine”, I continue “Has either not been proved to work, Or been proved not to work. You know what they call “alternative medicine” That’s been proved to work? Medicine.”"

True. I'm not starting the debate about whether alternative medicine works or not. It is futile.

 

The case of Dr. Burzynski, who has demonstrated a good treatment for cancer (FDA approved for trials for a very long time) has, nonetheless, been denied full acceptance of his treatments, and the government has patented his drugs after he already had patents AFAIK. I am not an expert and cannot make an independent judgement. However, the documentary about Burzynski makes a strong case IMO.

 

I do not believe that the pharmaceutical and medical industries are angelic, and I believe some would do unscrupulous things to prevent competition. Whether that is a fact or not in the Burzynski case, I do not know. Similarly, I cannot say whether or any food, spice or herb that can heal exists, which has not been proved to work as a medicine; IMO it is possible, because of a systemic infection.

 

I am certain that I took blood pressure medicine for about 20 years, and that 2 months after starting a vegan diet I no longer need blood pressure medicine. I was in the hospital when they stopped giving me blood pressure medicine.

Edited July 2, 2013 by EdEarl

[hypervalent_iodine]

True. I'm not starting the debate about whether alternative medicine works or not. It is futile.

The case of Dr. Burzynski, who has demonstrated a good treatment for cancer (FDA approved for trials for a very long time) has, nonetheless, been denied full acceptance of his treatments, and the government has patented his drugs after he already had patents AFAIK. I am not an expert and cannot make an independent judgement. However, the documentary about Burzynski makes a strong case IMO.

 

I do not believe that the pharmaceutical and medical industries are angelic, and I believe some would do unscrupulous things to prevent competition. Whether that is a fact or not in the Burzynski case, I do not know. Similarly, I cannot say whether or not foods, spices and herbs that have not been proved to work as medicines exist or not; IMO it is possible.

 

I wasn't trying to engage debate about alternitive medicine, I just liked the quote. It was more a round about way of saying what CharonY said; herbal remedies and the like, even if they do work, have not been tested or proven. That is really the main difference.

 

I do not know much about the Burzynski case, though I have certainly heard of him. There are other examples favoured by conspiracy theorist crowds such as the Rife machine, sodium bicarb, hydrogen peroxide and DCA. The arguments associated with these are usually baseless and plain silly. In any case, this is off topic, so I'll stop here (I'd gladly discuss them elsewhere, though).

 

Pharma is certainly far from being angelic. I don't think many people would actually claim otherwise, though the extent of this I think is exaggerated by some. There is fairly active and ongoing research in identifying, isolating and testing the efficacy of the active components of various herbal remedies and I would think that this would be in the interest of BigPharma, since the isolated compounds and their associated formulations would be able to be patented and marketed. For instance, aspirin, though no longer patented, is the active ingredient of willow bark, a herbal remedy that had/has been used since antiquity.

 

I am certain that I took blood pressure medicine for about 20 years, and that 2 months after starting a vegan diet I no longer need blood pressure medicine. I was in the hospital when they stopped giving me blood pressure medicine.

I am not sure I see your point. There are obviously things such as blood pressure, obesity and obesity related issues, etc., that are strongly correlated to one's diet. Medication can provide a quick fix for some of these problems, but a change in eating habits and lifestyle is usually the best method for sustained prevention.

[EdEarl]

 

I am not sure I see your point. There are obviously things such as blood pressure, obesity and obesity related issues, etc., that are strongly correlated to one's diet. Medication can provide a quick fix for some of these problems, but a change in eating habits and lifestyle is usually the best method for sustained prevention.

I have not lost weight. In fact, I weigh more now than when I started taking blood pressure meds. To the best of my knowledge my life style has not changed except for diet and age. My point is that diet in my case has gotten me off a medication.

 

See the documentary Forks over Knives for an explanation by Caldwell Blakeman Esselstyn Jr., MD and T. Colin Campbell MD PhD., and other publications by them.

 

There are also books and research by John A. McDougall, M.D.

 

and others

[hypervalent_iodine]

Sorry, I should clarify; I do not see your point in the context of this discussion or as it pertains to the OP?

[EdEarl]

oops

[CharonY]

True. I'm not starting the debate about whether alternative medicine works or not. It is futile.

 

The case of Dr. Burzynski, who has demonstrated a good treatment for cancer (FDA approved for trials for a very long time) has, nonetheless, been denied full acceptance of his treatments, and the government has patented his drugs after he already had patents AFAIK. I am not an expert and cannot make an independent judgement. However, the documentary about Burzynski makes a strong case IMO.

 

I do not believe that the pharmaceutical and medical industries are angelic, and I believe some would do unscrupulous things to prevent competition. Whether that is a fact or not in the Burzynski case, I do not know. Similarly, I cannot say whether or any food, spice or herb that can heal exists, which has not been proved to work as a medicine; IMO it is possible, because of a systemic infection.

 

I am certain that I took blood pressure medicine for about 20 years, and that 2 months after starting a vegan diet I no longer need blood pressure medicine. I was in the hospital when they stopped giving me blood pressure medicine.

 

 

I think the documentary is severely distorting facts (also note that the documentary was produced by Burzynski, so clearly not an unbiased report). The bottom line is that there is no evidence that the treatment actually worked. There were indeed several trials filed to the FDA, but no data has been shown to indicate efficacy of antineoplaston treatment. This is the reason why the treatment has not been approved. Also,a filed phase III trial has not even commenced. In addition, at least one case of severe adverse reaction in a child has been found, which led the FDA to put a halt on treatment of children.

Adding to the fact that no mechanism has been proposed (except some handwaving parts), the absence of serious preclinical data demonstrating efficacy available and some ethical issues in the way people were attracted to the study, it is more likely a case of someone wanting to make money off desperate people rather than some poor philantropist being oppressed by the evil FDA.

 

Edit: wrote that down from memory and realized that i did not included references. I have followed the story on and off and it would take a bit of work to dig everything out. But here is a recent blog article deconstructing the narrative built around the "documentary"

http://scienceblogs.com/insolence/2013/06/03/in-which-the-latest-movie-about-stanislaw-burzynskis-cancer-cure-is-reviewed-with-insolence/

Edited July 2, 2013 by CharonY

[Dima]

Thanks for all the responses guys!

 

There is ample evidence for example in Ayurvedic medicines and other traditional herbal remedies for various diseases, the mechanism of treatment is unknown of course, but it is most likely the result of the specific combination of chemicals (not one or two) that are contained within the plant that work together synergistically with their enzymes.

 

It is also possible to see that an extract has beneficial effects in-vivo/vitro; from here, if this is a life-saving treatment: Why can't you make this extract into an FDA approved medicine that actually heals people?

[CharonY]

You certainly can. You just have to prove that it works through the trials. it should be noted that a whole study section of the NIH has worked on proving the efficacy of alternative medicine, and much to their astonishment they came up with little positive to report. Oftentimes the approaches work on specific individuals but fail if used in larger cohorts (i.e. did not show better outcomes than control groups using placebos).

 

In many cases studies are still lacking, but I am not certain about the current status of ayurverdic approaches. Certainly, any extract that can be proven to have therapeutic effects can be treated as any other drug.

Edited July 3, 2013 by CharonY

[John Cuthber]

Thanks for all the responses guys!

 

There is ample evidence for example in Ayurvedic medicines and other traditional herbal remedies for various diseases, the mechanism of treatment is unknown of course, but it is most likely the result of the specific combination of chemicals (not one or two) that are contained within the plant that work together synergistically with their enzymes.

 

It is also possible to see that an extract has beneficial effects in-vivo/vitro; from here, if this is a life-saving treatment: Why can't you make this extract into an FDA approved medicine that actually heals people?

I only know of one case where two different compounds from plants were used synergistically in traditional medicine and that was a hallucinogen so it's probably not going to get FDA approval.

So, where is this " ample evidence" that shows " it is most likely the result of the specific combination of chemicals (not one or two)"?

Is it real, or is it wishful thinking?

 

There have been a good number of cases of plant extracts being used as the basis for drugs. Artemisinin is one of the better known recent ones.

http://en.wikipedia.org/wiki/Artemisinin

 

But where have they ever found that they needed two (or more) compounds simultaneously from the same plant?

[Moontanman]

True. I'm not starting the debate about whether alternative medicine works or not. It is futile.

 

The case of Dr. Burzynski, who has demonstrated a good treatment for cancer (FDA approved for trials for a very long time) has, nonetheless, been denied full acceptance of his treatments, and the government has patented his drugs after he already had patents AFAIK. I am not an expert and cannot make an independent judgement. However, the documentary about Burzynski makes a strong case IMO.

 

I do not believe that the pharmaceutical and medical industries are angelic, and I believe some would do unscrupulous things to prevent competition. Whether that is a fact or not in the Burzynski case, I do not know. Similarly, I cannot say whether or any food, spice or herb that can heal exists, which has not been proved to work as a medicine; IMO it is possible, because of a systemic infection.

 

I am certain that I took blood pressure medicine for about 20 years, and that 2 months after starting a vegan diet I no longer need blood pressure medicine. I was in the hospital when they stopped giving me blood pressure medicine.

 

 

In the spirit of equal time I suggest you watch this somewhat more objective view of Burzynski...

 

http://www.youtube.com/watch?v=QUkON5hkCTY

If there is evidence that a plant extract is good for treating Parkisons disease, how do we make this a drug? Are there other ways to make this a mainstream treatment for pd, without making it a drug?

 

Thanks,

 

Dmitriy

 

 

Is there any chance you can let us know which plant you are talking about or is this hypothetical?

[EdEarl]

 

In the spirit of equal time I suggest you watch this somewhat more objective view of Burzynski...

That does indeed take the spin off the story, and I will never again mention Burzynski. tyvm for the info

 

Furthermore, I regret mentioning it in retrospect, because it may mislead someone else.

Edited July 3, 2013 by EdEarl

[Dima]

Here is some preliminary evidence for a plant extract called Bacopa monierri; worked in c.elegans. There is a lot more studies like this one.

http://www.ncbi.nlm.nih.gov/pubmed/?term=bacopa+parkinsons

[Moontanman]

Here is some preliminary evidence for a plant extract called Bacopa monierri; worked in c.elegans. There is a lot more studies like this one.

http://www.ncbi.nlm.nih.gov/pubmed/?term=bacopa+parkinsons

Interesting, that is an aquarium plant I often grow..