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	<title>Comments on: New Drug Approvals Are On The Rise, So Far</title>
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	<pubDate>Fri, 10 Feb 2012 21:26:20 +0000</pubDate>
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		<title>By: clazy</title>
		<link>http://www.pharmalot.com/2008/05/new-drug-approvals-are-on-the-rise-so-far/#comment-357418</link>
		<dc:creator>clazy</dc:creator>
		<pubDate>Wed, 28 May 2008 19:45:15 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13648#comment-357418</guid>
		<description>NMEs may be moribund in the US, but they've been rising in the EU. From 2003 to 2006, the numbers were 36, 45, 39, and 63. In the US, on the other hand, the numbers were 28, 30, 31, 19. (Parexel) I couldn't tell you why.</description>
		<content:encoded><![CDATA[<p>NMEs may be moribund in the US, but they&#8217;ve been rising in the EU. From 2003 to 2006, the numbers were 36, 45, 39, and 63. In the US, on the other hand, the numbers were 28, 30, 31, 19. (Parexel) I couldn&#8217;t tell you why.</p>
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		<title>By: Lilli</title>
		<link>http://www.pharmalot.com/2008/05/new-drug-approvals-are-on-the-rise-so-far/#comment-356869</link>
		<dc:creator>Lilli</dc:creator>
		<pubDate>Fri, 16 May 2008 00:57:39 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13648#comment-356869</guid>
		<description>It is a waste of my time to speak to individuals involved with Big Pharama!

Lilli</description>
		<content:encoded><![CDATA[<p>It is a waste of my time to speak to individuals involved with Big Pharama!</p>
<p>Lilli</p>
]]></content:encoded>
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		<title>By: Dan</title>
		<link>http://www.pharmalot.com/2008/05/new-drug-approvals-are-on-the-rise-so-far/#comment-356867</link>
		<dc:creator>Dan</dc:creator>
		<pubDate>Fri, 16 May 2008 00:34:50 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13648#comment-356867</guid>
		<description>Nathan, thank you

Lilli, you seem concerned.</description>
		<content:encoded><![CDATA[<p>Nathan, thank you</p>
<p>Lilli, you seem concerned.</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Lilli</title>
		<link>http://www.pharmalot.com/2008/05/new-drug-approvals-are-on-the-rise-so-far/#comment-356841</link>
		<dc:creator>Lilli</dc:creator>
		<pubDate>Thu, 15 May 2008 21:10:19 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13648#comment-356841</guid>
		<description>Nathan,
Why do attack Me?

&#60; About Dan Read the following:
 

  Dan Abshear
living in Wentzville, MO      
 
Have spent my working life in various aspects of the health care system for decades. Was a medic in the military in the past. And I'm a health care advocate and legal consultant as well, which I enjoy.

Education/Experience: Columbia, B.A.- Behavioral Sciences

Interests: Writing, Reading, health and legal advocacy/consulting, bicycling, parenting, and questioning authority

Motto: Awareness is a catalyst for reality.

Affiliations: National Physician's Alliance, Community Catalyst, Consultant for New Jersey Star Ledger

URL   Dan Abshear's Favorite Content Producers

Dan 

View All »
Send Dan Abshear a Message
    
  

More about Dan Abshear
Published ContentSlideshowsCommentsFavorite CPsFavorited By
   
 Showing Results 1 - 3 of 3
 Universal Health Care Establishment Reform
An examination of some of the premises stated by those opposed to a Universal Health Care System.
By Dan Abshear  &#124;  Read Article 

Published: Mar 19, 2008
 Journosphere: The Journalistic World of the Blogosphere
The past decade has allowed the advent of blogs to progress significantly while increasing thier awareness of numerous issues with the public as well as silencing the blogger's critics due to thier im...
By Dan Abshear  &#124;  Read Article</description>
		<content:encoded><![CDATA[<p>Nathan,<br />
Why do attack Me?</p>
<p>&lt; About Dan Read the following:</p>
<p>  Dan Abshear<br />
living in Wentzville, MO      </p>
<p>Have spent my working life in various aspects of the health care system for decades. Was a medic in the military in the past. And I&#8217;m a health care advocate and legal consultant as well, which I enjoy.</p>
<p>Education/Experience: Columbia, B.A.- Behavioral Sciences</p>
<p>Interests: Writing, Reading, health and legal advocacy/consulting, bicycling, parenting, and questioning authority</p>
<p>Motto: Awareness is a catalyst for reality.</p>
<p>Affiliations: National Physician&#8217;s Alliance, Community Catalyst, Consultant for New Jersey Star Ledger</p>
<p>URL   Dan Abshear&#8217;s Favorite Content Producers</p>
<p>Dan </p>
<p>View All »<br />
Send Dan Abshear a Message</p>
<p>More about Dan Abshear<br />
Published ContentSlideshowsCommentsFavorite CPsFavorited By</p>
<p> Showing Results 1 - 3 of 3<br />
 Universal Health Care Establishment Reform<br />
An examination of some of the premises stated by those opposed to a Universal Health Care System.<br />
By Dan Abshear  |  Read Article </p>
<p>Published: Mar 19, 2008<br />
 Journosphere: The Journalistic World of the Blogosphere<br />
The past decade has allowed the advent of blogs to progress significantly while increasing thier awareness of numerous issues with the public as well as silencing the blogger&#8217;s critics due to thier im&#8230;<br />
By Dan Abshear  |  Read Article</p>
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	<item>
		<title>By: Nathan</title>
		<link>http://www.pharmalot.com/2008/05/new-drug-approvals-are-on-the-rise-so-far/#comment-356835</link>
		<dc:creator>Nathan</dc:creator>
		<pubDate>Thu, 15 May 2008 20:04:33 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13648#comment-356835</guid>
		<description>Lilli,
Why are you insisting on "picking sides"?  This isn't a battle.  We are all interested in working to better the health of mankind.  We just have different views of how to achieve that goal.</description>
		<content:encoded><![CDATA[<p>Lilli,<br />
Why are you insisting on &#8220;picking sides&#8221;?  This isn&#8217;t a battle.  We are all interested in working to better the health of mankind.  We just have different views of how to achieve that goal.</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Lilli</title>
		<link>http://www.pharmalot.com/2008/05/new-drug-approvals-are-on-the-rise-so-far/#comment-356834</link>
		<dc:creator>Lilli</dc:creator>
		<pubDate>Thu, 15 May 2008 19:52:15 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13648#comment-356834</guid>
		<description>Hi Dan,
I am still not quite sure whose side you are on?</description>
		<content:encoded><![CDATA[<p>Hi Dan,<br />
I am still not quite sure whose side you are on?</p>
]]></content:encoded>
	</item>
	<item>
		<title>By: Dan</title>
		<link>http://www.pharmalot.com/2008/05/new-drug-approvals-are-on-the-rise-so-far/#comment-356824</link>
		<dc:creator>Dan</dc:creator>
		<pubDate>Thu, 15 May 2008 17:41:15 +0000</pubDate>
		<guid isPermaLink="false">http://www.pharmalot.com/?p=13648#comment-356824</guid>
		<description>When Competition Does Not Benefit Consumers

“But corruption is neither need based nor greed based.  It’s simply opportunity based.” -----

Billy Tauzin, president and C.E.O. of PhRMA, the pharmaceutical industry’s most powerful lobbying group, as Mr. Tauzin stated in Boston recently.

It has been said by others that the pharmaceutical industry should not have government regulation or interference from our government at all  because that would drastically limit if not eliminate innovation as well as our health care choices and options, both from the perspective of the doctor and the patient, so the public has been told often by others.  So, according to some,  the public’s health would be limited and possibly harmed.  As with other issues we face as citizens, this is another attempt by these others to apparently install fabricated fear in our minds- void of any proof or reason.

As it has turned out, the pharmaceutical industry’s lack of innovation in particular has happened and they have appeared to do this on their own, overall.
Over the past several years, those few meds created and FDA approved with true therapeutic advantages happened by discovery with government involvement in over half of these meds with clear clinical advantages for certain patients.  Conversely, of the new chemical entities approved lately and developed by drug companies, over 50 percent of these have microscopic therapeutic advantage for patients, so I understand upon information and belief.   This inefficient drug development by the pharmaceutical industry has created what is now the dominant development strategy of drug companies, and this strategy is known as the intentional development of what are phrased,  ‘me too’ drugs. 
 These drugs essentially are small molecular variations of the original molecule in a particular class of medications.  In other words, they tweak the original molecule in order to obtain patent rights for their now new drug project.  This me too objective of drug companies now accounts, I believe, for about 80 percent of the research budgets of drug companies.  And because the FDA only requires a potential med to be superior to a placebo in their mandatory clinical trials, usually these me too meds are approved- regardless of their necessity for others, or the need for such drugs.

And me too drugs are selected by the drug company for their potential blockbuster status as well as the speculated growth of a particular market, which means making over 1 billion dollars a year on such a drug, at least.  For example, statin drugs, for high cholesterol patients, is a multi- billion dollar market.  As a result, there are several statin meds now available for use by doctors to prescribe to their patients.  Yet, arguably, me too drugs are all essentially very similar in regards to safety, efficacy, and cost, regardless of the class referred to so often saturated with me too meds, with few exceptions.  The differences overall are minor once again with most me too drugs.  As aggressive marketers, the makers of these meds are suspected of doing a bit of publication planning, it is suspected, to falsely claim superiority of their newly approved me too drug over all the other drugs in a particular class.  Also, other classes of meds with several me too drugs may include SSRI anti-depressant drugs, as well as those meds for hypertension.  There may be a dozen drugs in a particular class of medications that are all essentially the same in regards to their treatment abilities for patients with such disease states that they treat.

Now, there may be cases where a patient tolerates one drug in a class over another for unknown reasons, so in these few cases, these me too drugs occasionally are beneficial for patients, but should absolutely not be a primary objective of the drug companies to create them as often as they do. Instead, true innovation and discovery should be the focus of pharmaceutical companies, and it does not appear to be the focus of the pharmaceutical industry, presently.  

Further vexing is that competition in the pharmaceutical industry amazingly does not and has not been of any financial benefit for the consumer, as competition normally does create.  This fact is normally demonstrated with other industries and is the apex of business operations.  This pharmaceutical industry model is an exception, and the reason for this remains an unknown, as far as the etiology of being deprived of this costly environment of drug spending.

This progressive marketing paradigm of the pharmaceutical industry, such as the creation of me too meds solely for their own profit, clearly illustrates their focus on these issues over true research and science, so it seems.   Innovation, along with ethics, use to define this industry.  Sadly, it seems this is not the case today, which ultimately and potentially deprives potential treatment methods potentially for the public health.  Yet hopefully, such historical qualities of drug companies will return some time.    

Dan Abshear</description>
		<content:encoded><![CDATA[<p>When Competition Does Not Benefit Consumers</p>
<p>“But corruption is neither need based nor greed based.  It’s simply opportunity based.” &#8212;&#8211;</p>
<p>Billy Tauzin, president and C.E.O. of PhRMA, the pharmaceutical industry’s most powerful lobbying group, as Mr. Tauzin stated in Boston recently.</p>
<p>It has been said by others that the pharmaceutical industry should not have government regulation or interference from our government at all  because that would drastically limit if not eliminate innovation as well as our health care choices and options, both from the perspective of the doctor and the patient, so the public has been told often by others.  So, according to some,  the public’s health would be limited and possibly harmed.  As with other issues we face as citizens, this is another attempt by these others to apparently install fabricated fear in our minds- void of any proof or reason.</p>
<p>As it has turned out, the pharmaceutical industry’s lack of innovation in particular has happened and they have appeared to do this on their own, overall.<br />
Over the past several years, those few meds created and FDA approved with true therapeutic advantages happened by discovery with government involvement in over half of these meds with clear clinical advantages for certain patients.  Conversely, of the new chemical entities approved lately and developed by drug companies, over 50 percent of these have microscopic therapeutic advantage for patients, so I understand upon information and belief.   This inefficient drug development by the pharmaceutical industry has created what is now the dominant development strategy of drug companies, and this strategy is known as the intentional development of what are phrased,  ‘me too’ drugs.<br />
 These drugs essentially are small molecular variations of the original molecule in a particular class of medications.  In other words, they tweak the original molecule in order to obtain patent rights for their now new drug project.  This me too objective of drug companies now accounts, I believe, for about 80 percent of the research budgets of drug companies.  And because the FDA only requires a potential med to be superior to a placebo in their mandatory clinical trials, usually these me too meds are approved- regardless of their necessity for others, or the need for such drugs.</p>
<p>And me too drugs are selected by the drug company for their potential blockbuster status as well as the speculated growth of a particular market, which means making over 1 billion dollars a year on such a drug, at least.  For example, statin drugs, for high cholesterol patients, is a multi- billion dollar market.  As a result, there are several statin meds now available for use by doctors to prescribe to their patients.  Yet, arguably, me too drugs are all essentially very similar in regards to safety, efficacy, and cost, regardless of the class referred to so often saturated with me too meds, with few exceptions.  The differences overall are minor once again with most me too drugs.  As aggressive marketers, the makers of these meds are suspected of doing a bit of publication planning, it is suspected, to falsely claim superiority of their newly approved me too drug over all the other drugs in a particular class.  Also, other classes of meds with several me too drugs may include SSRI anti-depressant drugs, as well as those meds for hypertension.  There may be a dozen drugs in a particular class of medications that are all essentially the same in regards to their treatment abilities for patients with such disease states that they treat.</p>
<p>Now, there may be cases where a patient tolerates one drug in a class over another for unknown reasons, so in these few cases, these me too drugs occasionally are beneficial for patients, but should absolutely not be a primary objective of the drug companies to create them as often as they do. Instead, true innovation and discovery should be the focus of pharmaceutical companies, and it does not appear to be the focus of the pharmaceutical industry, presently.  </p>
<p>Further vexing is that competition in the pharmaceutical industry amazingly does not and has not been of any financial benefit for the consumer, as competition normally does create.  This fact is normally demonstrated with other industries and is the apex of business operations.  This pharmaceutical industry model is an exception, and the reason for this remains an unknown, as far as the etiology of being deprived of this costly environment of drug spending.</p>
<p>This progressive marketing paradigm of the pharmaceutical industry, such as the creation of me too meds solely for their own profit, clearly illustrates their focus on these issues over true research and science, so it seems.   Innovation, along with ethics, use to define this industry.  Sadly, it seems this is not the case today, which ultimately and potentially deprives potential treatment methods potentially for the public health.  Yet hopefully, such historical qualities of drug companies will return some time.    </p>
<p>Dan Abshear</p>
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