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	<title>Comments on: Regulatory Placebo</title>
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	<description>Science Blog from Freelance Science Writer David Bradley</description>
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		<title>By: David Bradley</title>
		<link>http://www.sciencebase.com/science-blog/regulatory-placebo.html/comment-page-2#comment-498371</link>
		<dc:creator>David Bradley</dc:creator>
		<pubDate>Fri, 01 Aug 2008 07:51:47 +0000</pubDate>
		<guid isPermaLink="false">http://www.sciencebase.com/science-blog/?p=1731#comment-498371</guid>
		<description>Interesting point Sheryl, yes it would be very helpful for us to have our own personal SNP profile either when our GP signs a scrip for us or when we buy some alt medication. In fact better still, have a simple lookup system available to all that lists all drugs and herbals that are known to be contraindicated for our personal genome either because of safety issues or efficacy.</description>
		<content:encoded><![CDATA[<p>Interesting point Sheryl, yes it would be very helpful for us to have our own personal SNP profile either when our GP signs a scrip for us or when we buy some alt medication. In fact better still, have a simple lookup system available to all that lists all drugs and herbals that are known to be contraindicated for our personal genome either because of safety issues or efficacy.</p>
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		<title>By: Sheryl Torr-Brown</title>
		<link>http://www.sciencebase.com/science-blog/regulatory-placebo.html/comment-page-1#comment-498226</link>
		<dc:creator>Sheryl Torr-Brown</dc:creator>
		<pubDate>Fri, 01 Aug 2008 05:17:10 +0000</pubDate>
		<guid isPermaLink="false">http://www.sciencebase.com/science-blog/?p=1731#comment-498226</guid>
		<description>Paracelsus decreed that all drug are poisonous save for the dose.  That was several hundred years ago but the fact remains that all drugs are poisonous still today.  As good as science is, it cannot predict all adverse effects, although SNP profiling holds some promise in highlighting individuals at particular risks of side effects or poor efficacy.    I don&#039;t have an answer to whether we should regulate herbals, or not, but one aspect to consider is who would pay for the trials required?  Large trials are only conducted for substances that stand to recoup the cost of the trial (and more) and that are regulated.   We have to create a better system to assess the risk profiles of drugs or herbals at the individual level using SNP and phenotypic profiling.    Large scale human trials are expensive and not as effective as they need to be (hence Vioxx for eg), so asking herbal manufacturers to do the same for the sake of regulation is not the way to go.  Smaller, cheaper, more target trials for traditional and alternative approaches is likely to be better for all in the long run.  How we do that, I&#039;m not sure but SNPs to ID those at risk of severe adverse effects is a good place to start.</description>
		<content:encoded><![CDATA[<p>Paracelsus decreed that all drug are poisonous save for the dose.  That was several hundred years ago but the fact remains that all drugs are poisonous still today.  As good as science is, it cannot predict all adverse effects, although SNP profiling holds some promise in highlighting individuals at particular risks of side effects or poor efficacy.    I don&#8217;t have an answer to whether we should regulate herbals, or not, but one aspect to consider is who would pay for the trials required?  Large trials are only conducted for substances that stand to recoup the cost of the trial (and more) and that are regulated.   We have to create a better system to assess the risk profiles of drugs or herbals at the individual level using SNP and phenotypic profiling.    Large scale human trials are expensive and not as effective as they need to be (hence Vioxx for eg), so asking herbal manufacturers to do the same for the sake of regulation is not the way to go.  Smaller, cheaper, more target trials for traditional and alternative approaches is likely to be better for all in the long run.  How we do that, I&#8217;m not sure but SNPs to ID those at risk of severe adverse effects is a good place to start.</p>
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		<title>By: David Bradley</title>
		<link>http://www.sciencebase.com/science-blog/regulatory-placebo.html/comment-page-1#comment-494496</link>
		<dc:creator>David Bradley</dc:creator>
		<pubDate>Mon, 28 Jul 2008 11:38:36 +0000</pubDate>
		<guid isPermaLink="false">http://www.sciencebase.com/science-blog/?p=1731#comment-494496</guid>
		<description>Sorry to grieve you Pat...yes, as I was writing this post Vioxx and dozens of other serious issues with pharma products came to mind, but I thought I&#039;d leave it to readers to bring those up. Yes, hundreds of thousands of patients suffer ADRs due to approved products, I wrote about that issue for ChemWeb.com almost ten years ago. I&#039;m not sure where I&#039;d draw the line. What I don&#039;t like, is the fact that the herbalists can allude to curative effects for some serious illnesses (here, diabetes, for instance) and yet a pharma product with similar aims and claims would have to go through many years of trials and regulatory tribulations. Yes, good point about coffee, maybe it is time such stimulants were taken more seriously, there are health issues associated with ingesting large amounts of caffeine.</description>
		<content:encoded><![CDATA[<p>Sorry to grieve you Pat&#8230;yes, as I was writing this post Vioxx and dozens of other serious issues with pharma products came to mind, but I thought I&#8217;d leave it to readers to bring those up. Yes, hundreds of thousands of patients suffer ADRs due to approved products, I wrote about that issue for ChemWeb.com almost ten years ago. I&#8217;m not sure where I&#8217;d draw the line. What I don&#8217;t like, is the fact that the herbalists can allude to curative effects for some serious illnesses (here, diabetes, for instance) and yet a pharma product with similar aims and claims would have to go through many years of trials and regulatory tribulations. Yes, good point about coffee, maybe it is time such stimulants were taken more seriously, there are health issues associated with ingesting large amounts of caffeine.</p>
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		<title>By: Pat</title>
		<link>http://www.sciencebase.com/science-blog/regulatory-placebo.html/comment-page-1#comment-494456</link>
		<dc:creator>Pat</dc:creator>
		<pubDate>Mon, 28 Jul 2008 11:12:26 +0000</pubDate>
		<guid isPermaLink="false">http://www.sciencebase.com/science-blog/?p=1731#comment-494456</guid>
		<description>Dear David

You write &quot; I suggested that it would make sense from a safety perspective to bring herbal remedies under the same regulatory umbrella as regular pharmaceutical products.&quot;

Now would that be the same regulatory umbrella that OK&#039;d both vioxx for human use and thalidomide in an earlier generation?

Would you put, say, valerian through these trials when it has been known in herbals for literally hundreds of year and has no record of unsafe usage though for a small portion of people it agitates rather than calms? Hardly dangerous. 

More than 8,000 people die per year in Britain of paracetamol poisoning yet the government (quite rightly) does not propose to ban it because it is generally a very well tolerated pharmaceutical painkiller used properly even though it is known to cause damaging effects to the liver at comparatively low levels. But you would, where there are not even hundreds let alone thousands of deaths, impose imperfect tests on substances that have been known and used for thousands of years? I&#039;d lay odds that you&#039;d be happy to ignore the potential hepatotoxicity of paracetamol whilst restrict the potentially hepatotoxic root of comfrey even though it is the pharmaceutical which wreaks far more damage annually to the population.

Yes some plants can be dangerous, but most are already regulated in Britain from regulation in the 1960s and 1970s. Remember, technically even coffee (caffea arabica) is a stimulating herb - would you demand it for that? For chamomile tea? Where exactly would you draw the line?

Some herbs gain their therapeutic effects from a synergistic action, say Hawthorn, so demanding that certain substances be removed from them or that they are standardised to certain levels might will damage the overall balance of the natural plant extract which has an exceptionally good health record.

I&#039;m sure you&#039;re not paid by big pharma but  it grieves me when a comparatively intelligent writer applies standards to herbal products when it&#039;s the pharmaceutical products that can be the real danger to the average citizen:

&quot;A medical report in 1998 estimated that adverse reactions to prescription drugs are killing about 106,000 Americans each year -- roughly three times as many as are killed by automobiles.[1] This makes prescription drugs the fourth leading killer in the U.S., after heart disease, cancer, and stroke. The report included only drugs that were given properly and under normal circumstances, excluding drugs that were administered in error or taken in attempted suicides. (When errors of administration are included, the death toll may be as high as 140,000 per year.[2] ...&quot;
Source: The Consumer Law Page @ http://consumerlawpage.com/article/drugs_that_kill.shtml</description>
		<content:encoded><![CDATA[<p>Dear David</p>
<p>You write &#8221; I suggested that it would make sense from a safety perspective to bring herbal remedies under the same regulatory umbrella as regular pharmaceutical products.&#8221;</p>
<p>Now would that be the same regulatory umbrella that OK&#8217;d both vioxx for human use and thalidomide in an earlier generation?</p>
<p>Would you put, say, valerian through these trials when it has been known in herbals for literally hundreds of year and has no record of unsafe usage though for a small portion of people it agitates rather than calms? Hardly dangerous. </p>
<p>More than 8,000 people die per year in Britain of paracetamol poisoning yet the government (quite rightly) does not propose to ban it because it is generally a very well tolerated pharmaceutical painkiller used properly even though it is known to cause damaging effects to the liver at comparatively low levels. But you would, where there are not even hundreds let alone thousands of deaths, impose imperfect tests on substances that have been known and used for thousands of years? I&#8217;d lay odds that you&#8217;d be happy to ignore the potential hepatotoxicity of paracetamol whilst restrict the potentially hepatotoxic root of comfrey even though it is the pharmaceutical which wreaks far more damage annually to the population.</p>
<p>Yes some plants can be dangerous, but most are already regulated in Britain from regulation in the 1960s and 1970s. Remember, technically even coffee (caffea arabica) is a stimulating herb &#8211; would you demand it for that? For chamomile tea? Where exactly would you draw the line?</p>
<p>Some herbs gain their therapeutic effects from a synergistic action, say Hawthorn, so demanding that certain substances be removed from them or that they are standardised to certain levels might will damage the overall balance of the natural plant extract which has an exceptionally good health record.</p>
<p>I&#8217;m sure you&#8217;re not paid by big pharma but  it grieves me when a comparatively intelligent writer applies standards to herbal products when it&#8217;s the pharmaceutical products that can be the real danger to the average citizen:</p>
<p>&#8220;A medical report in 1998 estimated that adverse reactions to prescription drugs are killing about 106,000 Americans each year &#8212; roughly three times as many as are killed by automobiles.[1] This makes prescription drugs the fourth leading killer in the U.S., after heart disease, cancer, and stroke. The report included only drugs that were given properly and under normal circumstances, excluding drugs that were administered in error or taken in attempted suicides. (When errors of administration are included, the death toll may be as high as 140,000 per year.[2] &#8230;&#8221;<br />
Source: The Consumer Law Page @ <a href="http://consumerlawpage.com/article/drugs_that_kill.shtml" rel="nofollow">http://consumerlawpage.com/article/drugs_that_kill.shtml</a></p>
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		<title>By: David Bradley</title>
		<link>http://www.sciencebase.com/science-blog/regulatory-placebo.html/comment-page-1#comment-494422</link>
		<dc:creator>David Bradley</dc:creator>
		<pubDate>Mon, 28 Jul 2008 09:44:54 +0000</pubDate>
		<guid isPermaLink="false">http://www.sciencebase.com/science-blog/?p=1731#comment-494422</guid>
		<description>Many thanks for the follow-up comments Slevi, very useful as always.</description>
		<content:encoded><![CDATA[<p>Many thanks for the follow-up comments Slevi, very useful as always.</p>
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		<title>By: Slevi</title>
		<link>http://www.sciencebase.com/science-blog/regulatory-placebo.html/comment-page-1#comment-492085</link>
		<dc:creator>Slevi</dc:creator>
		<pubDate>Fri, 25 Jul 2008 10:59:41 +0000</pubDate>
		<guid isPermaLink="false">http://www.sciencebase.com/science-blog/?p=1731#comment-492085</guid>
		<description>Thanks for the mention. I definitely agree that some sort of regulation on herbal products should be in place, for two reason:

- Making sure it&#039;s safe to use, although the entire idea of herbal products come from nature so it must be good is nice... it simply isn&#039;t always good. Nature is filled with toxins and one mans love might be another mans toxin. And definitely by the moment it begins affecting roughly 5% of the users such as happened with Chinese herbal teas developing Chinese herb nephropathy it should get a big, red stamp saying unsafe to use. Also the results of using it in combination with medicine should be tested, such as whether it&#039;d make the medicine more or less effective and potentially even dangerous for one&#039;s health.

- Proof that it works. I see this as secondary on herbal products, as once you are sure that its safe and you have the proof that it works you&#039;ve essentially gotten yourself a pharmaceutical product. And even though it&#039;d be great in case it actually worked, the placebo effect it might have otherwise doesn&#039;t have to be bad in certain circumstances.

I like the idea of education on things like this, but I don&#039;t think it&#039;s going to work really without regulation on the products. Unless you come with a completely biased form of education which either states all herbal treatment is bad and stay far away from it or it&#039;s all good, use it but alongside your regular meds.

There&#039;s just too many herbal products and other forms of alternative medicine out there for patients to become familiar with, the best you can get is simply teaching them on what different sort of alternative medicine and with that what kind of herbal treatments there are, what form of effectiveness they have, whether its tested or not and the advise to not replace normal medication for it and consult their doctor when they want to use it. But you can&#039;t expect a patient to get to ever know herbal treatment as you&#039;d expect a doctor to know pharmaceuticals, and heck even doctors need the regulation.</description>
		<content:encoded><![CDATA[<p>Thanks for the mention. I definitely agree that some sort of regulation on herbal products should be in place, for two reason:</p>
<p>- Making sure it&#8217;s safe to use, although the entire idea of herbal products come from nature so it must be good is nice&#8230; it simply isn&#8217;t always good. Nature is filled with toxins and one mans love might be another mans toxin. And definitely by the moment it begins affecting roughly 5% of the users such as happened with Chinese herbal teas developing Chinese herb nephropathy it should get a big, red stamp saying unsafe to use. Also the results of using it in combination with medicine should be tested, such as whether it&#8217;d make the medicine more or less effective and potentially even dangerous for one&#8217;s health.</p>
<p>- Proof that it works. I see this as secondary on herbal products, as once you are sure that its safe and you have the proof that it works you&#8217;ve essentially gotten yourself a pharmaceutical product. And even though it&#8217;d be great in case it actually worked, the placebo effect it might have otherwise doesn&#8217;t have to be bad in certain circumstances.</p>
<p>I like the idea of education on things like this, but I don&#8217;t think it&#8217;s going to work really without regulation on the products. Unless you come with a completely biased form of education which either states all herbal treatment is bad and stay far away from it or it&#8217;s all good, use it but alongside your regular meds.</p>
<p>There&#8217;s just too many herbal products and other forms of alternative medicine out there for patients to become familiar with, the best you can get is simply teaching them on what different sort of alternative medicine and with that what kind of herbal treatments there are, what form of effectiveness they have, whether its tested or not and the advise to not replace normal medication for it and consult their doctor when they want to use it. But you can&#8217;t expect a patient to get to ever know herbal treatment as you&#8217;d expect a doctor to know pharmaceuticals, and heck even doctors need the regulation.</p>
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