Tom Daschle To Head Health and Human Services Secretary

<p> He will be busy no doubt looking for directors and managers for the FDA, the CDC, Medicare and Medicaid soon and probably the biggest looming question of all the departments is the FDA, who’s up next?  BD  </p> <blockquote> <p>President-elect Barack Obama has chosen former <strong>US Senate Democratic leader Tom Daschle</strong> to be Health and Human Services secretary. <strong>Daschle, of South Dakota</strong>, was an early Obama supporter, who encouraged the first-term senator from Illinois to make his presidential run.</p> <p>Daschle was also one of the Senators most committed to the failed Clinton health reform plan of the early ’90s.</p> <p><a href="http://www.pharmalot.com/2008/11/obama-picks-tom-daschle-to-head-hhs/">Obama Picks Tom Daschle To Head HHS // Pharmalot</a></p></blockquote>

Tom Daschle To Head Health and Human Services Secretary

He will be busy no doubt looking for directors and managers for the FDA, the CDC, Medicare and Medicaid soon and probably the biggest loomi...

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2 Cancer Drugs show promise for Reversal Of Type 1 Diabetes

<p> It is still at the mice testing stage, but 80% tested had a reversal of diabetes and in other cases it prevented the onset of diabetes.  Side effects, etc. will need to be studied as well, but this looks very promising if in fact the drugs can prevent diabetes for many, especially children if their DNA possibly showed they might have a tendency to develop diabetes.  BD  </p> <blockquote> <p>Researchers at the University of California, San Francisco have reported that two common cancer drugs have been used to block and reverse type 1 diabetes in mice. The JDRF-funded study, published in The Proceedings of the National Academy of Sciences, was led by Jeffrey Bluestone, Ph.D., director of the Diabetes Center at UCSF and an expert in the field of autoimmunity. </p> <p>The drugs - Imatinib and Sunitnib, sold as <a href="http://www.medilexicon.com/drugs/gleevec_699.php">Gleevec</a> and <a href="http://www.medilexicon.com/drugs/sutent.php">Sutent</a>, respectively - are used to treat cancer by blocking tyrosine kinases, an enzyme that modify cells' signaling proteins through a simple biochemical change. </p> </blockquote> <p><a href="http://www.medicalnewstoday.com/articles/130019.php"><a href="http://www.sutent.com/"><img alt="image" border="0" height="52" src="http://lh4.ggpht.com/_v3zjJigoAPE/SSRij9GoVwI/AAAAAAAAJ7w/QyuVO-0XkaY/image%5B9%5D.png?imgmax=800" style="border-right-width: 0px; display: inline; border-top-width: 0px; border-bottom-width: 0px; border-left-width: 0px" title="image" width="146" /></a><a href="http://www.gleevec.com/index.jsp?usertrack.filter_applied=true&NovaId=3350119535142648279"><img alt="image" border="0" height="51" src="http://lh5.ggpht.com/_v3zjJigoAPE/SSRik-LJ9BI/AAAAAAAAJ70/TyfpHfFhx9Y/image%5B10%5D.png?imgmax=800" style="border-right-width: 0px; display: inline; border-top-width: 0px; border-bottom-width: 0px; border-left-width: 0px" title="image" width="137" /></a></a></p> <p><a href="http://www.medicalnewstoday.com/articles/130019.php">JDRF Funded Research Shows Promise For Prevention, Reversal Of Type 1 Diabetes</a></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:1412ea3d-c2f5-41a1-835d-b4e6d4166fdc" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/Cancer" rel="tag">Cancer</a>,<a href="http://technorati.com/tags/Diabetes" rel="tag">Diabetes</a>,<a href="http://technorati.com/tags/R+and+D" rel="tag">R and D</a>,<a href="http://technorati.com/tags/healthcare" rel="tag">healthcare</a>,<a href="http://technorati.com/tags/San+Francisco+University+of+California" rel="tag">San Francisco University of California</a>,<a href="http://technorati.com/tags/personalized+medicine" rel="tag">personalized medicine</a></div>

2 Cancer Drugs show promise for Reversal Of Type 1 Diabetes

It is still at the mice testing stage, but 80% tested had a reversal of diabetes and in other cases it prevented the onset of diabetes.  Si...

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First US FDA office unveiled in Beijing

<p>Here’s the ribbon breaking ceremony picture.  Let’s all hope this is a success and hopefully some new technology will enter the picture as well with remote batch monitoring of products manufactured in China and other locations in the world.  There is only so much an in person visit can cover, so perhaps some nice remote monitoring can be set up to not only keep daily track, but serve to subsidize in person visits to the factories.  <strong>Data management can do it as a less expensive cost once set up.</strong>  </p> <p><a href="http://www.chinadaily.com.cn/china/2008-11/19/content_7221094_2.htm"><img align="left" alt="image" border="0" height="285" src="http://lh3.ggpht.com/_v3zjJigoAPE/SSRYkaTJiJI/AAAAAAAAJ7s/llt-2mbq-5s/image%5B6%5D.png?imgmax=800" style="border-bottom: 0px; border-left: 0px; display: inline; margin-left: 0px; border-top: 0px; margin-right: 0px; border-right: 0px" title="image" width="300" /></a><strong>We meet remotely and have have web meetings today so why not some web monitoring of the factories where product is made, and for that matter the same could be set up for all our factories here too as nobody is beyond fault these days.</strong>  When chemical content is reported back by data systems, an alert to both the FDA and the factory would be initiated.  As we all know there should already be some quality controls somewhere along the line in place and by have an automated data function provide some intelligence, it would also serve to make the in house visits by members of the FDA more meaningful as well.  </p> <p><strong>We have the technology and the question I am guessing at this point is whether or not plans will be made to institute quality control for food and drug products manufactured around the world.</strong>  </p> <p>When it comes to financial data, such as Wall Street, no barriers were barred <strong>there as far as having reporting functions and the algorithms to produce desired results, so to do something healthy with technology that will benefit all would truly be once welcome addition</strong> to our global economy and food and drug safety programs.  I am growing very tired of having to post tainted food and drug products that a little technology could have possibly served to avert the entire situations when technology and reporting functions with business intelligence stand to make us not only better consumers, but better producers as well.  In the related articles below there are also some references to clinical trials and drug developments between partners here in the US and those in China as in the one example, data from Chinese R and D scientists were immediately accepted by the FDA, one item that was a bit of a surprise for all.  BD  </p> <p>（From L to R) Mike Leavitt, US Health and Human Services Secretary, Shao Mingli, head of the State Food and Drug Administration (SFDA), Andrew von Eschenbach, FDA Commissioner and the US Ambassador to China Clark T. Randt Jr. cut the ribbon at the opening ceremony of the FDA Beijing office, November 19, 2008. The US FDA will open three offices in Beijing, Guangzhou and Shanghai this week to help ensure export safety while China is also preparing to station offices in the US. [Asianewsphoto] </p> <p><a href="http://www.chinadaily.com.cn/china/2008-11/19/content_7221094.htm">http://www.chinadaily.com.cn/china/2008-11/19/content_7221094.htm</a></p> <p>Hat Tip:  <a href="http://pharmagossip.blogspot.com/2008/11/fdas-china-office-first-pic.html">Pharmagossip</a></p> <p><strong><u>Related Reading:</u></strong>  </p> <h4><a href="http://ducknetweb.blogspot.com/2008/11/chinese-pharma-and-us-clinical-trials.html"><font size="1"><strong>Chinese Pharma and US Clinical Trials Partnership– HUYA, San Diego and Chipscreen, China</strong></font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/11/fda-to-detain-food-shipments-from-china.html"><font size="1"><strong>FDA to detain food shipments from China – Why not add some technology to the inspection processes?</strong></font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/11/mayo-clinic-says-goodbye-to-clinical.html"><font size="1">Mayo Clinic Says Goodbye to clinical services in the US</font></a></h4> <p></p> <h4><a href="http://ducknetweb.blogspot.com/2008/11/melamine-nightmare-needs-to-be-fixed.html"><font size="1">The Melamine Nightmare Needs to be Fixed – Business Intelligence Could Help</font></a></h4> <h6><a href="http://ducknetweb.blogspot.com/2008/11/mike-leavitt-and-fda-commissioner.html">Mike Leavitt and FDA Commissioner Andrew von Eschenbach go to China for consultations</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/11/fda-to-detain-food-shipments-from-china.html">FDA to detain food shipments from China – Why not add some technology to the inspection processes?</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/11/china-wants-to-make-bricks-from-toxic.html">China wants to make bricks from toxic milk - melamine</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/11/business-intelligence-for-fda-on-way.html">Business Intelligence for the FDA on the way</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/11/broken-agency-china-and-fda.html">A Broken Agency – China and the FDA</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/09/medicine-is-low-tech-business-clinical.html">Medicine is a Low Tech Business - Clinical Studies still done on paper too!</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/fda-will-open-inspection-office-in.html">FDA will open inspection office in China this year</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/chinese-drug-firm-recalls-all-injection.html">Chinese drug firm recalls all injection products after deaths</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/fda-tiny-bit-of-melamine-ok-in-most.html">FDA: Tiny Bit of Melamine OK in Most Foods But we Still need better labeling and shipping documentation</a></h6> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:26f7821b-30f6-487c-859c-0bd6f8626873" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/technology" rel="tag">technology</a>,<a href="http://technorati.com/tags/tainted+food" rel="tag">tainted food</a>,<a href="http://technorati.com/tags/import%2fexports" rel="tag">import/exports</a>,<a href="http://technorati.com/tags/pharma" rel="tag">pharma</a>,<a href="http://technorati.com/tags/food+contamination" rel="tag">food contamination</a>,<a href="http://technorati.com/tags/server+banks" rel="tag">server banks</a>,<a href="http://technorati.com/tags/food+safety" rel="tag">food safety</a>,<a href="http://technorati.com/tags/FDA+inspections" rel="tag">FDA inspections</a>,<a href="http://technorati.com/tags/busines+intelligence+software" rel="tag">busines intelligence software</a>,<a href="http://technorati.com/tags/China" rel="tag">China</a>,<a href="http://technorati.com/tags/outsourcing" rel="tag">outsourcing</a></div>

First US FDA office unveiled in Beijing

Here’s the ribbon breaking ceremony picture.  Let’s all hope this is a success and hopefully some new technology will enter the picture as w...

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New Hampshire Law Will continue to protect patient privacy – Drug information not provided for sales

<p>This indeed makes it much more difficult to pin down and see which physicians are using which drugs, but from their own internal sales information each drug company will have sales from drug stores, so the overall business from a pre set territory can be derived, so perhaps a new curve in Pharma marketing, work the territory and not the doctors, so in essence each physician should be receiving the educational materials needed without other marketing interference.  </p> <p><strong>Many Pharma companies are beginning to outsource their sales force as well, with a 3rd party representing several drugs and perhaps even more than one manufacturer as well.</strong>  </p> <p>From a prior post:</p> <h4><a href="http://ducknetweb.blogspot.com/2008/09/merck-outsourcing-brings-in-contract.html"><font size="1">Merck Outsourcing - Brings in Contract Sales Force</font></a></h4> <p><strong>If this continues in the outsourcing direction then a territory focus would seem to fall right in line with accomplishing sales methodologies and the individual doctor records may not bear perhaps as much importance at they do today, and I make this comment strictly with a marketing twist only.   We will know more as time goes on and observe the next wave.  BD  </strong></p> <p>The federal appeals court in Boston upheld New Hampshire’s law barring the sale of doctor prescribing data, rebuffing the drug industry’s argument that the law infringes free speech.</p> <p>Drug companies buy the detailed information on prescribing histories from companies like IMS Health and Verispan and use it for everything from tailoring doctor-specific sales pitches to calculating compensation for sales reps. The data houses are the ones challenging New Hampshire’s 2006 Prescription Information Law.</p> <p>In a 51-page decision this afternoon, the U.S. Court of Appeals for the 1st Circuit overturned a <a href="http://blogs.wsj.com/health/2007/10/03/drug-info-cos-sue-to-block-rx-privacy-laws/">lower-court decision striking down</a> New Hampshire’s data-mining ban as an unconstitutional violation of free speech. “In our view, the portions of the law at issue here regulate conduct, not speech,” Judge Bruce Selya wrote. </p> <p><a href="http://blogs.wsj.com/health/2008/11/18/new-hampshire-prevails-on-law-guarding-prescription-privacy/">http://blogs.wsj.com/health/2008/11/18/new-hampshire-prevails-on-law-guarding-prescription-privacy/</a></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:54b79e5f-982d-415a-bd7b-3ecc3f878a83" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/Patient" rel="tag">Patient</a>,<a href="http://technorati.com/tags/Privacy" rel="tag">Privacy</a>,<a href="http://technorati.com/tags/Drugs" rel="tag">Drugs</a>,<a href="http://technorati.com/tags/Pharma" rel="tag">Pharma</a>,<a href="http://technorati.com/tags/Records" rel="tag">Records</a>,<a href="http://technorati.com/tags/Pharma+Marketing" rel="tag">Pharma Marketing</a></div>

New Hampshire Law Will continue to protect patient privacy – Drug information not provided for sales

This indeed makes it much more difficult to pin down and see which physicians are using which drugs, but from their own internal sales infor...

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FDA and Face Filler Warnings…

<p> Well perhaps not a moment too soon this device was approved today and perhaps maybe an alternative  treatment.  BD  </p> <h4><a href="http://ducknetweb.blogspot.com/2008/11/fda-clears-dpl-deep-penetrating-light.html"><font size="1">FDA Clears The DPL (Deep Penetrating Light) Therapy System For Over-the-Counter - Home Use</font></a></h4> <p><font size="1">This looks very interesting, as it appears you can have both minor pain relief and work on your wrinkles at the same time, so you have a choice to</font><a href="http://www.ledtechnologies.org/info/products.aspx"><font size="1"><img align="right" alt="image" border="0" height="176" src="http://lh5.ggpht.com/_v3zjJigoAPE/SSL72NbOuHI/AAAAAAAAJ6o/JV7iMs8t9eE/image%5B8%5D.png?imgmax=800" title="image" width="244" /></font></a><font size="1"> strap on the unit or use it on the stand as shown below.</font></p> <p><font size="1">The before and after pictures look pretty good for the treatment of wrinkles.  It certainly appears to be a move to devices from the standard creams and lotions that have been available in the past for both beauty and pain relief.  The special price shown on </font><a href="http://www.ledtechnologies.org/info/Product_DPL.aspx"><font size="1">the web site today is $349.00.</font></a></p> <blockquote>(AP) -- Hundreds of thousands of baby boomer women who think they've found an antidote to aging in cosmetic facial fillers must be better informed of possible risks, government health advisers said Tuesday. A panel of independent advisers urged the Food and Drug Administration to revise the labeling to include the possibility of long lasting reactions such as bumps under the skin, blotches and scars. "It is almost a no-brainer," said Dr. Michael Bigby, a Harvard Medical School dermatologist. "The current label is not adequate." The gel-like fillers, which have become hugely popular in the last few years, are injected into the face to smooth away wrinkles.</blockquote> <p><a href="http://www.physorg.com/news146245592.html">FDA panel: Tell consumers about facial filler risks</a></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:79201ef9-8302-4065-9197-dff86d90a790" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/Face+Fillers" rel="tag">Face Fillers</a>,<a href="http://technorati.com/tags/dermatology" rel="tag">dermatology</a></div>

FDA and Face Filler Warnings…

Well perhaps not a moment too soon this device was approved today and perhaps maybe an alternative  treatment.  BD  FDA Clears The DPL (D...

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Name-Brand Drug Makers Ruled Liable for Injuries From Other Manufacturers' Generics

<p> This court case has been in the news of late and now with the current ruling, it adds on one more layer of responsibility to the Name Brand drug company, in other words when the generic versions come out and are prescribed, they can piggyback the exact same warnings, thus the name brand company is now liable for any generic side effects or injuries incurred by patients.  </p> <p>This could stand to open an entire new area in the legal field for lawsuits down the road.  BD  </p> <blockquote>Drug manufacturers have long had to provide safety warnings for their products. Now they might have to do the same for companies piggybacking on their success. On Friday, San Francisco's 1st District Court of Appeal stunned drug makers by ruling that they can be held liable not only for any harm caused by their own name-brand products, but also for injuries caused by competing companies' generic versions. "As the foreseeable risk of physical harm runs to users of both name-brand and generic drugs," Justice Peter Siggins wrote, "so too runs the duty of care."</blockquote> <p><a href="http://www.law.com/jsp/article.jsp?id=1202425895939">Law.com - Name-Brand Drug Makers Ruled Liable for Injuries From Other Manufacturers' Generics</a></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:8786b0ee-f51c-421d-bcb6-f545ce1f7970" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/Generice+drugs" rel="tag">Generice drugs</a>,<a href="http://technorati.com/tags/Lawsuits" rel="tag">Lawsuits</a>,<a href="http://technorati.com/tags/side+effects" rel="tag">side effects</a>,<a href="http://technorati.com/tags/liability" rel="tag">liability</a>,<a href="http://technorati.com/tags/Pharma" rel="tag">Pharma</a>,<a href="http://technorati.com/tags/heatlhcare" rel="tag">heatlhcare</a>,<a href="http://technorati.com/tags/warnings" rel="tag">warnings</a>,<a href="http://technorati.com/tags/drugs.+name+band+drugs" rel="tag">drugs. name band drugs</a></div>

Name-Brand Drug Makers Ruled Liable for Injuries From Other Manufacturers' Generics

This court case has been in the news of late and now with the current ruling, it adds on one more layer of responsibility to the Name Brand...

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FDA Clears The DPL (Deep Penetrating Light) Therapy System For Over-the-Counter - Home Use

<p> This looks very interesting, as it appears you can have both minor pain relief and work on your wrinkles at the same time, so you have a choice to<a href="http://www.ledtechnologies.org/info/products.aspx"><img align="right" alt="image" border="0" height="176" src="http://lh5.ggpht.com/_v3zjJigoAPE/SSL72NbOuHI/AAAAAAAAJ6o/JV7iMs8t9eE/image%5B8%5D.png?imgmax=800" style="border-right-width: 0px; display: inline; border-top-width: 0px; border-bottom-width: 0px; margin-left: 0px; border-left-width: 0px; margin-right: 0px" title="image" width="244" /></a> strap on the unit or use it on the stand as shown below.</p> <p>The before and after pictures look pretty good for the treatment of wrinkles.  It certainly appears to be a move to devices from the standard creams and lotions that have been available in the past for both beauty and pain relief.  The special price shown on <a href="http://www.ledtechnologies.org/info/Product_DPL.aspx">the web site today is $349.00.</a>  </p> <p>More scientific information can be found <a href="http://www.ledtechnologies.org/info/OtherStudies.aspx">here.</a>    Over the years I have received many such products as gifts during the holidays and I must say the devices are getting “smarter” every year.  I also am curious if this has the potential of replacing botox and other therapy treatments in time.  The technology has been around since 2004.  BD</p> <blockquote> <p>LED Technologies, LLC announced today that the U.S. Food and Drug Administration (FDA) cleared their DPL" Therapy System for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness; temporary relief of minor pain and stiffness associated with arthritis; and to temporarily increase local blood circulation. This clearance launches the way for the DPL" Therapy System to bring temporary pain relief technology directly to the consumer without a prescription.   </p> <p><a href="http://lh3.ggpht.com/_v3zjJigoAPE/SSL73hpeb1I/AAAAAAAAJ6s/ztNkHhTTFnk/s1600-h/image%5B12%5D.png"><img alt="image" border="0" height="153" src="http://lh4.ggpht.com/_v3zjJigoAPE/SSL75FWV5TI/AAAAAAAAJ6w/sJ4aedoZ7Sc/image_thumb%5B2%5D.png?imgmax=800" style="border-right-width: 0px; display: inline; border-top-width: 0px; border-bottom-width: 0px; border-left-width: 0px" title="image" width="208" /></a><a href="http://lh3.ggpht.com/_v3zjJigoAPE/SSL77mqqHbI/AAAAAAAAJ60/hr0GXXvyRhU/s1600-h/image%5B16%5D.png"><img alt="image" border="0" height="146" src="http://lh4.ggpht.com/_v3zjJigoAPE/SSL79TsYWxI/AAAAAAAAJ64/8gMdQVPLffc/image_thumb%5B3%5D.png?imgmax=800" style="border-right-width: 0px; display: inline; border-top-width: 0px; border-bottom-width: 0px; border-left-width: 0px" title="image" width="244" /></a></p> <p><a href="http://www.ledtechnologies.org/info/products.aspx"><img alt="image" border="0" height="108" src="http://lh3.ggpht.com/_v3zjJigoAPE/SSL7-o-qtvI/AAAAAAAAJ68/zLj88aDNBPQ/image%5B13%5D.png?imgmax=800" style="border-right-width: 0px; display: inline; border-top-width: 0px; border-bottom-width: 0px; margin-left: 0px; border-left-width: 0px; margin-right: 0px" title="image" width="222" /></a>The future of the DPL™ Therapy System is extremely bright as its applications expand beyond the minor pain relief field. Currently, LED Technologies, LLC is developing new DPL™ (Deep Penetrating Light) treatments for wrinkle reduction, TMJ, Fibromyalgia, Acne and a variety of other pain and wound healing applications.</p> <p>The system also includes a stand for use on the face and an easily adjustable strapping system which helps you place the panels almost anywhere on your body.</p> </blockquote> <p><a href="http://www.medicalnewstoday.com/articles/129684.php">FDA Clears The DPL (Deep Penetrating Light) T herapy System For Over-the-Counter - Home Use</a></p> <p></p> <p></p> <p></p> <p></p> <p></p> <p></p> <p></p> <p></p> <p></p> <p></p> <p></p> <p></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:c8bd96d7-e0df-4862-8572-3ec31ba428ed" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/Wrinkles" rel="tag">Wrinkles</a>,<a href="http://technorati.com/tags/Pain+Relief" rel="tag">Pain Relief</a>,<a href="http://technorati.com/tags/heatlhcare" rel="tag">heatlhcare</a>,<a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/DPL+therapy" rel="tag">DPL therapy</a></div>

FDA Clears The DPL (Deep Penetrating Light) Therapy System For Over-the-Counter - Home Use

This looks very interesting, as it appears you can have both minor pain relief and work on your wrinkles at the same time, so you have a ch...

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A New era of artificial ankles

<p>Ankle replacements moving main stage and one manufacturer took on the FDA of recent, and it has been so long that the patent has now run out so in effect it appears to be open ball game on the device that is currently used outside the US and has been for years.  BD</p> <p><em><font size="1">“It's not often the little guy takes on the federal government and wins. Endotec, a small South Orange maker of orthopedic devices, did just that this summer after years of fighting with the Food and Drug Administration for permission to legally market its unique ankle joint replacement implant.”</font></em></p> <p>WASHINGTON – What was left of Dan Sivia's ankle simply didn't work. He limped through his 30s by sheer force of will, one foot almost completely immobile from repeated broken bones and surgeries. Then a doctor offered his last hope: An ankle replacement. A what? Sivia knew about hip, knee, even shoulder replacements. But ankles?</p> <p>His confusion is understandable: The first ankle replacements of the 1970s were abandoned when they couldn't withstand the pounding of daily life. A second generation in the '90s lasted longer but never became really popular.</p> <p>Now the nation is embarking on a new generation of artificial ankles designed to work more like the joint you're born with, a move specialists hope finally will offer less pain and more function to thousands who hobble — although it's too soon to be sure.</p> <p><strong>In Europe, doctors also can use a similar but three-piece artificial ankle, where the plastic cushion is free-floating. Amid questions about whether that approach is better or worse, the FDA is evaluating whether to allow it here.</strong></p> <p><strong><u>Related Reading from an earlier post</u></strong></p> <h4><a href="http://ducknetweb.blogspot.com/2008/08/fda-shackled-at-ankles.html">FDA Shackled at the Ankles?</a></h4> <p><a href="http://ducknetweb.blogspot.com/search?q=endotec&x=0&y=0"><u><em>UPDATE:</em></u></a><em>  Endotec urged the agency to lower the classification to eliminate the need for more clinical studies in the past and were never accepted.  Then in 2006 the FDA filed a lawsuit.  Now the patient has expired and the judge stated patients can continue to benefit from the ankle replacement, but what else does this mean?  Well now that the patent protection is gone, other can manufacture such products, for a simple example, DePuy, a division of Johnson & Johnson, is conducting a clinical trial on a similar design.  There were issues with the original clinical trials, but the company still contends the device should have been downgraded and not in the same category as Class III devices, which include heart valves, pacemakers and some joint replacements and require clinical trials.  So where do you go when you need an ankle, out of the country?  BD</em><a href="http://lh5.ggpht.com/DucknetServices/SKoPX_J_ZCI/AAAAAAAAIkg/iMI2q-w9w3A/s1600-h/image%5B7%5D.png"><img align="left" src="http://lh6.ggpht.com/DucknetServices/SKoPZZ1CJ5I/AAAAAAAAIkk/rvQRGaIa_dM/image_thumb%5B5%5D.png?imgmax=800" style="display: inline; margin-left: 0px; margin-right: 0px" /></a></p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <p><a href="http://news.yahoo.com/s/ap/20081117/ap_on_he_me/med_healthbeat_new_ankles_2">http://news.yahoo.com/s/ap/20081117/ap_on_he_me/med_healthbeat_new_ankles_2</a></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:8ee9e756-3739-452d-8a80-a8e74069c6d3" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/Ankles+Endotec" rel="tag">Ankles Endotec</a>,<a href="http://technorati.com/tags/healthcare" rel="tag">healthcare</a></div>

A New era of artificial ankles

Ankle replacements moving main stage and one manufacturer took on the FDA of recent, and it has been so long that the patent has now run out...

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United Therapeutics buying some Cialis-ingredient rights

<p>Eli Lilly sells some ingredient rights to perhaps one day be released in a a product to treat high blood pressure.</p> <p>Side effects are_____________________.  BD   </p> <p>But shares of the biotechnology concern slumped 31% premarket to $62.50, as United Therapeutics is buying the rights for $150 million. It has also agreed to sell $150 million in stock to Lilly. United Therapeutics' market value as of Friday was about $2.3 billion. </p> <p>Tadalafil is better known as the generic name for Cialis, but the drug's active ingredient has also been studied for other potential uses, including the treatment of high blood pressure. Lilly executive Gwen G. Krivi lauded United Therapeutics' experience in that field and said Lilly was "pleased to make a financial investment in a promising and profitable biotechnology company." </p> <p><a href="http://www.marketwatch.com/news/story/united-therapeutics-buying-some-cialis-ingredient/story.aspx?guid=%7B41E23B86%2DB6C1%2D4205%2DAE94%2DE7B37B373333%7D">United Therapeutics buying some Cialis-ingredient rights - MarketWatch</a></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:1e225598-181d-4c91-aa84-4879287330d8" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/Lilly" rel="tag">Lilly</a>,<a href="http://technorati.com/tags/Cialis" rel="tag">Cialis</a>,<a href="http://technorati.com/tags/Tadalafil" rel="tag">Tadalafil</a></div>

United Therapeutics buying some Cialis-ingredient rights

Eli Lilly sells some ingredient rights to perhaps one day be released in a a product to treat high blood pressure. Side effects are_______...

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Wearing your baby – get Motrin for Relief?

<p>This is a very interesting video, if you use one of the baby carriers, it assumes you are going to have some pain and this is where Motrin comes to the rescue?</p> <p> Someone along the line got pretty creative for Motrin, couldn’t be a headache or something else along that line, the baby carrier will create the need.  The generic, ibuprofen, I would guess would work just as well if you have this issue.  (grin).  BD  </p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:5737277B-5D6D-4f48-ABFC-DD9C333F4C5D:e8c44366-4cef-472a-91cd-694fb668b7c5" class="wlWriterEditableSmartContent"><div id="fae7143f-f499-4c58-aa0d-fad7d2de57ce" style="margin: 0px; padding: 0px; display: inline;"><div><a href="http://www.youtube.com/watch?v=Mztymu72l7c&hl=en&fs=1&rel=0&color1=0x3a3a3a&color2=0x999999" target="_new"><img alt="" galleryimg="no" onload="var downlevelDiv = document.getElementById('fae7143f-f499-4c58-aa0d-fad7d2de57ce'); downlevelDiv.innerHTML = "<div><object width=\"270\" height=\"203\"><param name=\"movie\" value=\"http://www.youtube.com/v/Mztymu72l7c&hl=en&fs=1&rel=0&color1=0x3a3a3a&color2=0x999999&hl=en\"><\/param><embed src=\"http://www.youtube.com/v/Mztymu72l7c&hl=en&fs=1&rel=0&color1=0x3a3a3a&color2=0x999999&hl=en\" type=\"application/x-shockwave-flash\" width=\"270\" height=\"203\"><\/embed><\/object><\/div>";" src="http://lh5.ggpht.com/_v3zjJigoAPE/SSDlOcVT7ZI/AAAAAAAAJ6g/9of7ij3SxLg/video4e84215c505f%5B2%5D.jpg?imgmax=800" style="border-style: none"></a></div></div></div> <p></p> <p><a href="http://www.youtube.com/watch?v=Mztymu72l7c">http://www.youtube.com/watch?v=Mztymu72l7c</a></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:84532430-9cff-4ef1-9fc3-42437d6a77f7" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/Motrin" rel="tag">Motrin</a>,<a href="http://technorati.com/tags/Pain" rel="tag">Pain</a>,<a href="http://technorati.com/tags/Headaches" rel="tag">Headaches</a>,<a href="http://technorati.com/tags/Healthcare" rel="tag">Healthcare</a>,<a href="http://technorati.com/tags/ibuprofen" rel="tag">ibuprofen</a></div>

Wearing your baby – get Motrin for Relief?

This is a very interesting video, if you use one of the baby carriers, it assumes you are going to have some pain and this is where Motrin c...

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The Melamine Nightmare Needs to be Fixed – Business Intelligence Could Help

<p><strong> Melamine, a chemical used as a flame retardant is used to make cooking utensils and industrial coatings, is rich in nitrogen; it makes an attractive low-cost additive to milk and other foods;  as nitrogen registers as protein on many routine tests</strong>. This is why it is so popular as at created the impression that the food contains much more protein than it really does. <img align="right" src="http://lh4.ggpht.com/_v3zjJigoAPE/SRnGVCBSiAI/AAAAAAAAJ38/WbfxT39zaZM/image_thumb[1].png?imgmax=800" style="display: inline; margin-left: 0px; margin-right: 0px" /></p> <p><strong>I was speaking the other day to a contractor who does remodeling on kitchens, and yes the counters that go into modern day kitchens too have melamine,</strong> so I guess in a way it could make one think this is almost like munching on the kitchen counter, but also <strong>so durable that in China they are are also considering making bricks from the melamine to recycle,</strong> and then you think the chemical is making it in to our bodies through food products, pretty scary knowing that the product is added on purposes to show a high nutritional food value.  </p> <p>So once again, I will come back around to using technology, <strong>business intelligence to monitor the production of food products,</strong> and as we become more global, we can’t rely on trust unfortunately, anywhere.  When you stop and think about technology monitoring the contents of each lot and reporting both let’s say to the FDA here in the US, and to the local company, this would stand to keep many more honest when it is not as easy to trick the consumers.  Sure it will take some expense and effort to establish, but in reality this is something where every country could benefit, especially knowing what is going to be shipped before it ever takes place, along with labeling product properly with the country, state and city of origin, so recalls when needed can be accomplished before others become ill or die due to tainted food products.<strong>  A bank of servers and a little bit of high tech monitoring would need to be established, and after all, we have it today, so why not set up a practice of monitoring the world’s food suppliers, everyone would benefit.</strong></p> <p><strong><a href="http://ducknetweb.blogspot.com/2008/11/fda-to-detain-food-shipments-from-china.html">Under further reading I went into a little more detail,</a></strong> and if we want to be assured of safe food products worldwide, a bit of<strong> business intelligence will help get the job done,</strong> along with scheduled and non-schedules on premise visits world wide with companies that are producing food products, otherwise we are at the risk of the company producing the products and of recent we are seeing how that is not only costing lives but also creating an environment of not knowing which food products and pharmaceuticals are safe and have been approved by the lot with computers spitting out a quality report to both the manufacturer and to monitoring agencies such as the US FDA and to other monitoring entities outside the US as well.  BD  <img align="left" src="http://lh4.ggpht.com/DucknetServices/SIj9P_nkLTI/AAAAAAAAIV8/aMAtC1YcAlA/fda1_thumb[2].png?imgmax=800" style="display: inline; margin-left: 0px; margin-right: 0px" /> </p> <blockquote> <p>(AP) -- Li Xiaokai died of kidney failure on the old wooden bed in the family farmhouse, just before dawn on a drizzly Sept. 10. Her grandmother wrapped the 9-month-old in a wool blanket. Her father handed the body to village men for burial by a muddy creek. The doctors and family never knew why she got sick. A day later, state media reported that the type of infant formula she drank had been adulterated with an industrial chemical.</p> </blockquote> <p><a href="http://www.physorg.com/news145980387.html">Deaths uncounted in China's tainted milk scandal</a></p> <p><strong><u>Related Reading:</u></strong></p> <h4><a href="http://ducknetweb.blogspot.com/2008/11/mike-leavitt-and-fda-commissioner.html"><font size="1">Mike Leavitt and FDA Commissioner Andrew von Eschenbach go to China for consultations</font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/11/fda-to-detain-food-shipments-from-china.html"><font size="1">FDA to detain food shipments from China – Why not add some technology to the inspection processes?</font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/11/china-wants-to-make-bricks-from-toxic.html"><font size="1">China wants to make bricks from toxic milk - melamine</font></a></h4> <h6><a href="http://ducknetweb.blogspot.com/2008/11/business-intelligence-for-fda-on-way.html">Business Intelligence for the FDA on the way</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/11/fda-to-detain-food-shipments-from-china.html">FDA to detain food shipments from China – Why not add some technology to the inspection processes?</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/11/broken-agency-china-and-fda.html">A Broken Agency – China and the FDA</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/09/medicine-is-low-tech-business-clinical.html">Medicine is a Low Tech Business - Clinical Studies still done on paper too!</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/fda-will-open-inspection-office-in.html">FDA will open inspection office in China this year</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/chinese-drug-firm-recalls-all-injection.html">Chinese drug firm recalls all injection products after deaths</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/fda-tiny-bit-of-melamine-ok-in-most.html">FDA: Tiny Bit of Melamine OK in Most Foods But we Still need better labeling and shipping documentation</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/09/fda-bans-import-of-meds-from-ranbaxy.html">FDA Bans Import of Meds From Ranbaxy</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/04/fda-head-we-boosting-it.html">FDA Head: We're Boosting I.T.</a></h6> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:608b7091-59c0-4dac-a687-1ff40dae53b5" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/China" rel="tag">China</a>,<a href="http://technorati.com/tags/phamaceutical+plant+inspections" rel="tag">phamaceutical plant inspections</a>,<a href="http://technorati.com/tags/FDA+funding" rel="tag">FDA funding</a>,<a href="http://technorati.com/tags/Congress+Pharma" rel="tag">Congress Pharma</a>,<a href="http://technorati.com/tags/Melamine" rel="tag">Melamine</a>,<a href="http://technorati.com/tags/Tainted+Milk" rel="tag">Tainted Milk</a>,<a href="http://technorati.com/tags/Food+Products" rel="tag">Food Products</a>,<a href="http://technorati.com/tags/Business+Intelligence" rel="tag">Business Intelligence</a></div>

The Melamine Nightmare Needs to be Fixed – Business Intelligence Could Help

Melamine, a chemical used as a flame retardant is used to make cooking utensils and industrial coatings, is rich in nitrogen; it makes an a...

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Why not -Stephen Colbert FDA Commissioner - Hilarious

<p>Love the added BeeGees effect and he just really nails hormone therapy for women!</p> <p><embed FlashVars="videoId=210357" src="http://www.comedycentral.com/sitewide/video_player/view/default/swf.jhtml" quality="high" bgcolor="#cccccc" width="332" height="316" name="comedy_central_player" align="middle" allowScriptAccess="always" allownetworking="external" type="application/x-shockwave-flash" pluginspage="http://www.macromedia.com/go/getflashplayer"></embed></p> <p><a href="http://blogs.wsj.com/health/2008/11/15/stephen-colbert-for-fda-commissioner/" title="Hat Tip: WSJ">http://blogs.wsj.com/health/2008/11/15/stephen-colbert-for-fda-commissioner/</a></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:397dc701-2efb-421d-8e9d-0fec245ff766" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/Comedy+Central" rel="tag">Comedy Central</a>,<a href="http://technorati.com/tags/Stephen+Colbert" rel="tag">Stephen Colbert</a>,<a href="http://technorati.com/tags/BeeGees" rel="tag">BeeGees</a>,<a href="http://technorati.com/tags/HRT" rel="tag">HRT</a>,<a href="http://technorati.com/tags/Jupiter+report" rel="tag">Jupiter report</a></div>

Why not -Stephen Colbert FDA Commissioner - Hilarious

Love the added BeeGees effect and he just really nails hormone therapy for women! http://blogs.wsj.com/health/2008/11/15/stephen-colbert...

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Chinese Pharma and US Clinical Trials Partnership– HUYA, San Diego and Chipscreen, China

<p>This was somewhat of a first for the US FDA to trust Chinese data.  Shenzhen Chipscreen Bio sciences Ltd. was also awarded the Most Valued Partner for Roche R&D Center.</p> <p>Oncology drugs are one of their primary focuses, with individuals trained here in the US and returning to China to create their own biotech companies and working in partnership with HUYA here.  Perhaps the shape of R and D for the future as costs continue to escalate here?  BD</p> <p>November 13, 2008 | China plus the drug industry plus newspaper headlines has seldom equaled positive reading. Yet where Pharma is <a href="http://www.huyabio.com/english/products.asp"><img align="right" alt="image" border="0" height="141" src="http://lh6.ggpht.com/_v3zjJigoAPE/SR6RaVQq8bI/AAAAAAAAJ6Y/GMIyiam-6ZA/image%5B4%5D.png?imgmax=800" style="border-bottom: 0px; border-left: 0px; display: inline; margin-left: 0px; border-top: 0px; margin-right: 0px; border-right: 0px" title="image" width="127" /></a>concerned, two things can’t be denied. <strong>First, China has certainly become a key player in global biotech,</strong> especially over the last five years, with its economy loosening up and the<strong> government allowing capitalist-type ventures in parts of the country.</strong> As well, those in Pharma constantly lament the lack of new, high-quality compounds for drug development – a process that isn’t getting any less expensive, while the pool of sources is drying up.  </p> <p>Perhaps it needs to be better recognized that drug manufacturing, and the brainpower behind drug discovery, are really quite distinct. If married in the right way(s) between China and a Pharma powerhouse like the US, the combination could turn out pretty appealing. Such was the observation of Mireille Gingras, president and CEO of San Diego-based HUYA Bioscience International, <strong>who noted that significant numbers of Chinese individuals, after being educated and trained in top US institutions, were returning home to start their own biotech businesses.</strong></p> <p>HUYA then approached<strong> <a href="http://www.chipscreen.com/en/about/aboutus.htm">Chipscreen</a></strong> for licensing rights to the compound, helping the Chinese group to write their Phase I protocol. At the same time, they initiated preclinical development studies in the US.  Not surprisingly, <strong>Newman and the HUYA team were “blown away” when the FDA responded both quickly and positively to their preclinical/Phase I plans. <a href="http://www.chipscreen.com/en/index.php"><img align="left" alt="image" border="0" height="57" src="http://lh3.ggpht.com/_v3zjJigoAPE/SR6RbOkowGI/AAAAAAAAJ6c/Zki45fVu4xM/image%5B9%5D.png?imgmax=800" style="border-bottom: 0px; border-left: 0px; display: inline; margin-left: 0px; border-top: 0px; margin-right: 0px; border-right: 0px" title="image" width="244" /></a> </strong></p> <p>HUYA also lauds the US FDA’s move to set up an office in Beijing by year’s end, to help alleviate concerns about Chinese drugs. “It’s a recognition that major things are happening in China with respect to the pharmaceutical industry,” Newman says. And since HUYA is currently the leader in US/China pharmaceutical co-development,<strong> “we feel we’re positioned to play a role in helping to enhance and generate Western standards [in China].” </strong></p> <p><a href="http://www.pharmaweek.com/Business_and_Markets/feature_11_13.asp">http://www.pharmaweek.com/Business_and_Markets/feature_11_13.asp</a></p> <p></p> <p></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:e4493b4f-a2f2-4b1c-87f9-3858d45da14b" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/Oncology" rel="tag">Oncology</a>,<a href="http://technorati.com/tags/Pharma" rel="tag">Pharma</a>,<a href="http://technorati.com/tags/R+and+D" rel="tag">R and D</a>,<a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/biotech" rel="tag">biotech</a>,<a href="http://technorati.com/tags/biosciences" rel="tag">biosciences</a>,<a href="http://technorati.com/tags/China+pharma" rel="tag">China pharma</a>,<a href="http://technorati.com/tags/HUYA" rel="tag">HUYA</a>,<a href="http://technorati.com/tags/Chipscreen" rel="tag">Chipscreen</a></div>

Chinese Pharma and US Clinical Trials Partnership– HUYA, San Diego and Chipscreen, China

This was somewhat of a first for the US FDA to trust Chinese data.  Shenzhen Chipscreen Bio sciences Ltd. was also awarded the Most Valued P...

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Cerner Incorporates Genomics Into Electronic Medical Records

<p>They have established a coding vocabulary for genetic test results called CBO, or <a href="https://www.clinbioinformatics.org/cbopublic/">Clinical Bioinformatics Ontology</a>.  Genetic test results are associated with the concepts from the CBO, whereas a traditional observation like a pulse or blood pressure might be associated with a SNOMED (Systematized Nomenclature of Medicine) concept. </p> <p><img align="left" src="http://lh3.ggpht.com/DucknetServices/SER-cLF-BPI/AAAAAAAAHaU/Sr7OU4wNQZM/image_thumb[1].png?imgmax=800" style="display: inline; margin-left: 0px; margin-right: 0px" />The CBO codes are open source and can be downloaded by anyone.  SNOWMED and LOINC (Logical Observation Identifiers Names and Codes were evaluated for any duplicates efforts, but little or none were found, thus Cerner decided to create a vocabulary for genomics which began about 6 years ago.</p> <p>The focus has been to make the presentation of the genomic information simple and not complicated and less focus on how the results were determined, which is good as that is what a physician needs is the information in the EHR quickly without the time involved searches on the web as the average office visit does not allow additional time for this.  BD  </p> <p><strong>November 11, 2008 |</strong> Molecular diagnostics laboratories that are doing clinical genomics “try to fit a round peg into a square hole, especially when it comes to workflow,” says Mark Hoffman, director of translational medicine at <a href="http://www.cerner.com/public/">Cerner</a>, the Kansas City-based health-IT player which <img align="right" src="http://lh4.ggpht.com/DucknetServices/SGpXenoTixI/AAAAAAAAH9s/C0gXkEBUW4o/image_thumb[1].png?imgmax=800" style="display: inline; margin-left: 0px; margin-right: 0px" />has been targeting this market since 2005. “They try to use systems that were designed for traditional pathology and shoehorn those into a very unique and contemporary workflow, going into contortions to do that within their information system, especially with infectious disease testing.” </p> <p> Cerner’s genomics solution is <a href="http://www.cerner.com/public/Cerner_3.asp?id=27249">Millennium Helix</a>, an offering that incorporates molecular diagnostic data into the electronic medical record, says Hoffman, who helped develop the bioinformatics system, which he says also streamlines processes and positions labs on the cutting edge of diagnostic medicine.</p> <p>Say a patient has a genetic test for a gene that indicates whether they’re predisposed for an adverse drug reaction, within our architecture,<strong> the system can evaluate medication orders against both the genetic test results as well as other factors like drug allergy and drug interactions.</strong> So it enables us to take a very holistic approach to personalized medicine, where it’s not just genetic, not just allergy, but a combination of any factors that need to be taken into consideration.</p> <p><a href="http://www.digitalhcp.com/2008/11/11/QA-cerner.html">http://www.digitalhcp.com/2008/11/11/QA-cerner.html</a></p> <p><strong><u>Related Reading:</u></strong></p> <h4><a href="http://ducknetweb.blogspot.com/2008/09/cerner-and-international-serious.html"><font size="1">Cerner and The International Serious Adverse Events Consortium to Study Genetic Markers</font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/07/cerner-makes-its-moves-beyond-software.html"><font size="1">Cerner makes its moves beyond software</font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/03/cerner-hill-rom-join-smart-hospital.html"><font size="1">Cerner, Hill-Rom join smart hospital beds with e-medical records</font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/01/new-microsoft-direction-in-health-care.html"><font size="1">New Microsoft direction in Health Care - Partners with Cerner and the Patient gets to play X-Box</font></a></h4> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:5baee154-bdcf-4e43-92ac-aee77fb2a7f5" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/Cerner" rel="tag">Cerner</a>,<a href="http://technorati.com/tags/medical+records" rel="tag">medical records</a>,<a href="http://technorati.com/tags/EHR" rel="tag">EHR</a>,<a href="http://technorati.com/tags/EMR" rel="tag">EMR</a>,<a href="http://technorati.com/tags/genomics" rel="tag">genomics</a>,<a href="http://technorati.com/tags/codes" rel="tag">codes</a>,<a href="http://technorati.com/tags/vocabulary" rel="tag">vocabulary</a></div>

Cerner Incorporates Genomics Into Electronic Medical Records

They have established a coding vocabulary for genetic test results called CBO, or Clinical Bioinformatics Ontology .  Genetic test results a...

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Mike Leavitt and FDA Commissioner Andrew von Eschenbach go to China for consultations

<p>With the backlash the FDA has sustained this last year, a lot of it related to lack of technology and not being up to par, perhaps this will turn out to be a productive trip.  </p> <p>Earlier I posted about <strong><a href="http://ducknetweb.blogspot.com/2008/11/fda-to-detain-food-shipments-from-china.html">remote monitoring and how technology could expand and help</a></strong> with monitoring food products, when you stop and think about it<strong> we remotely meet and monitor many other things in society, so why not</strong>.  When it comes to inspections, why not have the <strong>information on the product sent before it is packaged and goes to market.</strong>  We just need some new algorithms written and servers put in to place, to do a quality test for compliance, <strong>with results being show both at the FDA and at the factor of origin.</strong>  Of course, there would <img align="right" src="http://lh4.ggpht.com/DucknetServices/SIj9P_nkLTI/AAAAAAAAIV8/aMAtC1YcAlA/fda1_thumb[2].png?imgmax=800" style="display: inline; margin-left: 0px; margin-right: 0px" />still be a requirement for on premise visits too, but this would certainly cut to the chase, so perhaps CMS and the FDA might look into using technology to help all of us out.  Write up some <strong>quality control algorithms to</strong> meet for each product and set the standards and start transmitting to the server to run queries and disperse alerts as needed. </p> <p>A bit of <strong>well designed business intelligence</strong> to make this a safer place could not hurt at a time like this when there is very little monitoring going on at all, as there will always be those trying to beat the system when it comes down to money.  BD</p> <p>The release touted next week’s planned visit by HHS Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach to China for consultations with officials there and for ribbon-cutting on the agency’s new offices in Beijing, Guangzhou and Shanghai.</p> <p>Both men, it said, will take part in seminars with Chinese authorities on food and drug “policy and governance,” and, nearer the end, “the latest scientific data on the toxicity of melamine on humans.” Melamine is the poisonous chemical that’s been found in Chinese milk.</p> <p><a href="http://blogs.wsj.com/health/2008/11/14/feds-send-mixed-message-to-china/">http://blogs.wsj.com/health/2008/11/14/feds-send-mixed-message-to-china/</a></p> <p><strong><u>Related Reading:</u></strong>  </p> <h4><a href="http://ducknetweb.blogspot.com/2008/11/business-intelligence-for-fda-on-way.html"><font size="1">Business Intelligence for the FDA on the way</font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/11/fda-to-detain-food-shipments-from-china.html"><font size="1">FDA to detain food shipments from China – Why not add some technology to the inspection processes?</font></a></h4> <h4><a href="http://ducknetweb.blogspot.com/2008/11/broken-agency-china-and-fda.html"><font size="1">A Broken Agency – China and the FDA</font></a></h4> <h6><a href="http://ducknetweb.blogspot.com/2008/09/medicine-is-low-tech-business-clinical.html">Medicine is a Low Tech Business - Clinical Studies still done on paper too!</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/08/fda-reform-planned.html">FDA Reform Planned</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/04/fda-head-we-boosting-it.html">FDA Head: We're Boosting I.T.</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/02/study-calling-for-medical-device.html">Study Calling For Medical Device Information To Better Serve Patients And Doctors from the FDA</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/04/congress-to-industry-need-your-help.html">Congress to industry: 'We need your help'</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/06/fda-approvals-will-outsourcing-and-new.html">FDA Approvals – will outsourcing and new budgets help?</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2007/10/chemicals-flow-unchecked-from-china-to.html">Chemicals Flow Unchecked From China to US Drug Market</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/05/fda-chief-relents-asking-congress-to.html">FDA Chief Relents, Asking Congress to Fund More Foreign Inspections</a></h6> <p></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:640ff558-48f6-4d3e-a45f-295ee675ff7f" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/China" rel="tag">China</a>,<a href="http://technorati.com/tags/phamaceutical+plant+inspections" rel="tag">phamaceutical plant inspections</a>,<a href="http://technorati.com/tags/FDA+funding" rel="tag">FDA funding</a>,<a href="http://technorati.com/tags/Congress+Pharma" rel="tag">Congress Pharma</a></div>

Mike Leavitt and FDA Commissioner Andrew von Eschenbach go to China for consultations

With the backlash the FDA has sustained this last year, a lot of it related to lack of technology and not being up to par, perhaps this will...

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Study Predicts Big Savings from PHRs (Personal Health Records) – Best Kept Secret in Healthcare?

<p> There’s probably no bigger fan of PHRs than yours truly here, but <strong>where’s the awareness and out reach here, it doesn’t exist.</strong> The technology is out there, but what good is it if nobody uses it or realizes the value. </p> <p>Consumers, much less doctors and clinical staff all over have not a clue as to what they are! I know that first hand when talking to them as I mention online health records and I usually get a response like “huh?”. I try to encourage physicians to set up one for themselves so they can see the value, but again we are back to knocking heads around in healthcare with resistance to technology, nothing new there. Who’s going to help the <strong><a href="http://ducknetweb.blogspot.com/2008/11/cms-names-four-phr-vendors-for-medicare.html">seniors on the pilot program</a></strong>, we want them to use and have personal health records but are we going to leave them totally on their own to figure it out?</p> <p> <a href="http://www.healthvault.com/"><img height="40" src="http://lh4.ggpht.com/DucknetServices/SM3q6TdZm-I/AAAAAAAAI90/u04OgRqDvPI/image%5B14%5D.png?imgmax=800" width="96" /></a><a href="https://www.google.com/accounts/ServiceLogin?service=health&nui=1&continue=https%3A%2F%2Fwww.google.com%2Fhealth%2Fp%2F&followup=https%3A%2F%2Fwww.google.com%2Fhealth%2Fp%2F&rm=hide"><img height="38" src="http://lh6.ggpht.com/DucknetServices/SGRPjPR9NVI/AAAAAAAAH30/dA55nv_qrf4/googlehealth%5B1%5D.png?imgmax=800" width="95" /></a></p> <p>We all need health records from the bottom of the totem pole all the way up to the top, so where’s the big executives at the top? Do they have a set of online health records set up? It would certainly help in the education process if we could see some information on how Steve Ballmer is using his, or Mike Leavitt, Bill Gates, Sergie from Google and so on. Just an idea from my very small point of view here. Would really be nice to have some stories on <strong>how they see the value with Personal Health Records</strong>, and it would also have the power to reach the masses.</p> <p>After reading this study on how much can be saved, I think we have motivation, perhaps. I have only found a few others besides myself on the web who are promoting PHRs, Dr. Crounse from Microsoft, Dr. Halamka from Harvard/Beth Israel and various pieces from Kaiser Permanente on the web.<strong> I see PHRs mentioned in other blogs, and again those who talk about their use in their blogs don’t seem to get personal,</strong> in other words, what blogs are for, communicating how technology and other items are helping and adding value to their day to day lives, <strong>what’s their PHR doing for them or do they in fact themselves have one? I</strong> don’t see any other bloggers linking to the PHR websites either, so what’s up with that?</p> <p><strong> I know I have gone on here with a bit of a rant,</strong> but hopefully it might touch some ears somewhere along the line to make a bit of a difference, as if nobody realizes the value and doesn’t speak out,<strong> then</strong> <strong>we are just maybe sitting on one of the best kept secrets and tools in healthcare; falling short once more in the education processes. BD</strong> </p> <p>A new study makes the bold claim that widely adopted personal health records could save the U.S. health care system more than $19 billion annually after expenses.</p> <p>The study, from the Center for Information Technology Leadership at Partners Healthcare System in Boston, bases the big-ticket savings conclusion on several major assumptions.</p> <p>The study concludes that providing interoperable PHRs to 80% of the population would cost $3.7 billion in startup costs and $1.9 billion in annual maintenance costs. And it finds that these PHRs would save more than $21 billion annually, with most of the savings going to payers.</p> <p>The predicted savings break down as follows: <br />* Sharing of complete test results: $7.9 billion <br />* Congestive heart failure monitoring: $6.3 billion <br />* E-visits supported by PHRs: $4.8 billion <br />* Electronic medication renewals: $1.1 billion <br />* Smoking cessation management: $1.04 billion <br />* Electronic appointment scheduling: $170 million <br />* Pre-encounter questionnaires: $72 million <br />* Sharing of complete medication lists: $9.2 million</p> <p>The study was funded by “unrestricted research funding” from three vendors involved in PHRs: Google, Microsoft Corp., and InterComponentWare Inc. Others providing grants included the Healthcare Information and Management Systems Society, Kaiser Permanente and Partners Healthcare System.</p> <p><a href="http://www.healthdatamanagement.com/news/PHRs27281-1.html?CMP=OTC-RSS">Study Predicts Big Savings from PHRs</a></p> <p><strong><u>Related Reading:</u></strong></p> <h4><a href="http://ducknetweb.blogspot.com/2008/11/cleveland-clinic-and-microsoft.html"><span style="font-size:78%;">Cleveland Clinic and Microsoft HealthVault to track chronic diseases at home with Medical Devices</span></a></h4> <h6><a href="http://ducknetweb.blogspot.com/2008/09/healthvault-personal-health-records.html">HealthVault Personal Health Records gets a Facelift - Match records and find clinical trials</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/kaiser-permanente-adds-new-online.html">Kaiser Permanente Adds New Online Health Tools for Chronic Conditions – Personal Health Records with more added value</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/patients-can-order-up-their-own-lab.html">Patients can order up their own lab tests on line with MyMedLab.com with a referring physician and you get a free PHR to boot</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/aetna-and-microsoft-join-forces-members.html">Aetna and Microsoft join forces – Members will now be able to transfer health records to Microsoft Health Vault</a></h6> <p><b></b></p> <p><b></b></p> <h6><a href="http://ducknetweb.blogspot.com/2008/10/american-heart-association-and.html">American Heart Association and Microsoft HealthVault Unite</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/scripps-navigenics-affymetrix-and.html">Scripps, Navigenics, Affymetrix and Microsoft team on groundbreaking health study – Personalized Medicine</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/getting-organized-with-online-medical.html">Getting Organized With Online Medical Records – Personal Health Records</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/patients-can-view-share-health.html">Patients can view, share health information through new Health Record Banks - Washington</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/10/healthvault-has-new-features-including.html">HealthVault Has New Features Including Fax Services for $9.00 a year – Fax to the Vault!</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/06/at-covisint-microsoft-healthvault.html">AT&T, Covisint, Microsoft HealthVault Create Health Information Exchange</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/05/stjude-collaborates-with-microsoft.html">St.Jude Collaborates With Microsoft HealthVault</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2008/06/cvs-to-offer-records-via-healthvault.html">CVS to Offer Records Via HealthVault</a></h6> <h6><a href="http://ducknetweb.blogspot.com/2007/10/personal-health-vault-physicians-arm.html">Personal Health Vault - Physicians arm thyself..</a></h6> <div style="margin: 0px; padding: 0px; display: inline; float: none;" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:aa1de7cd-ba6d-4114-bb4b-da19ffbea356" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/PHR" rel="tag">PHR</a>,<a href="http://technorati.com/tags/Personal+Health+Records" rel="tag">Personal Health Records</a>,<a href="http://technorati.com/tags/Education" rel="tag">Education</a>,<a href="http://technorati.com/tags/Healthcare" rel="tag">Healthcare</a>,<a href="http://technorati.com/tags/Google+Health" rel="tag">Google Health</a>,<a href="http://technorati.com/tags/Microsoft" rel="tag">Microsoft</a>,<a href="http://technorati.com/tags/Microsoft+HealthVault" rel="tag">Microsoft HealthVault</a>,<a href="http://technorati.com/tags/Medical+records" rel="tag">Medical records</a></div>

Study Predicts Big Savings from PHRs (Personal Health Records) – Best Kept Secret in Healthcare?

There’s probably no bigger fan of PHRs than yours truly here, but where’s the awareness and out reach here, it doesn’t exist. The technol...

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FDA to detain food shipments from China – Why not add some technology to the inspection processes?

<p> I don’t think in view of the current events, there was a lot of choice here for the FDA, and we do need to know that the quality of both our food and pharmaceutical products is good.</p> <p>One thing in particular that springs to mind for me here here is perhaps <strong>some use of business intelligence for monitoring.</strong>  This is not a cure all for the entire process, but technology can aid and offer some nice assistance here.  A reporting function would need to be set up to automatically<strong> report back to a central agency on criteria established for each drug or food product</strong>.  At the receiving end, anything out of tolerance would be immediately sent to an alert.  Now granted, this should be done locally from every plant, but when you can’t physically have agents in place at every factory all the time, this could offer some real relief and help.<img align="right" src="http://lh4.ggpht.com/DucknetServices/SIj9P_nkLTI/AAAAAAAAIV8/aMAtC1YcAlA/fda1_thumb[2].png?imgmax=800" style="display: inline; margin-left: 0px; margin-right: 0px" /> </p> <p>With today’s speed of data transmissions, a server farm could be set up to monitor this type of activity and before an over seas factory began to export to the US, this would be a prerequisite to be established.  <strong>Each lot before packaged would send the chemical content back to the central gathering agency and report in,</strong> with both the US agency and the local factory itself having the information at hand.  </p> <p><strong>Again, this comes back to adding some new software and algorithms to the process,</strong> but computers could provide this information in a couple of seconds.  <strong>Audit trails would also be there to allow for checking back on submissions.</strong>  A bank of sophisticated server farms could do the work.  This would also tend to build product credibility as well if everyone knows up front that the chemical content was being reported before the end packaging occurs.  Again, not to replace an actual physical inspection all together, but, it would also stand to make those inspections much more information rich and valuable and create safe consumable products.</p> <p><strong><img align="left" src="http://lh5.ggpht.com/DucknetServices/SEmXRJB3eVI/AAAAAAAAHdk/Mt3vrM50l98/image_thumb[2].png?imgmax=800" style="display: inline; margin-left: 0px; margin-right: 0px" /> We do so much today by remote transmissions with information reporting, why not put in in place and use it where it is vital.  This could also be done globally too,</strong> with each country receiving reports on products they import from other countries.  It would sure beat some of the guesswork we see out there today, not to mention illnesses and death from products that are tainted or contaminated.  With the global economy changing every day, it makes sense to know what we are getting and it is impossible to physically monitor all the systems without using some modern day technology. </p> <p>A secondary thought here too is to ensure that all products carry a label showing the city, country, etc. of where the product was manufactured so we don’t  incur the long time delays in figuring out which lot went where,<strong> no more blind shipping documents</strong> as they exist today.  <strong>Wonder why this process has not been considered yet?  BD  </strong></p> <blockquote>The melamine scandal is now weeks old, but FDA officials said it has taken that long to comply with legal requirements that detention orders be scrupulously backed by evidence. A national poll released earlier this week by Consumers Union found that the public wants foreign food-producing facilities inspected as frequently as domestic ones: about once a month. The FDA has nowhere near the number of inspectors to fulfill that desire, and instead mainly relies on U.S. food companies to require that their foreign supplier maintain high standards.</blockquote> <p><a href="http://www.latimes.com/business/la-fi-china14-2008nov14,0,1796913.story?track=rss">FDA to detain food shipments from China - Los Angeles Times</a></p> <div style="padding-bottom: 0px; margin: 0px; padding-left: 0px; padding-right: 0px; display: inline; float: none; padding-top: 0px" id="scid:0767317B-992E-4b12-91E0-4F059A8CECA8:de8d1fd1-19f0-4e3b-9ac8-f8ad263e4876" class="wlWriterEditableSmartContent">Technorati Tags: <a href="http://technorati.com/tags/FDA" rel="tag">FDA</a>,<a href="http://technorati.com/tags/technology" rel="tag">technology</a>,<a href="http://technorati.com/tags/tainted+food" rel="tag">tainted food</a>,<a href="http://technorati.com/tags/import%2fexports" rel="tag">import/exports</a>,<a href="http://technorati.com/tags/pharma" rel="tag">pharma</a>,<a href="http://technorati.com/tags/food+contamination" rel="tag">food contamination</a>,<a href="http://technorati.com/tags/server+banks" rel="tag">server banks</a>,<a href="http://technorati.com/tags/food+safety" rel="tag">food safety</a>,<a href="http://technorati.com/tags/FDA+inspections" rel="tag">FDA inspections</a>,<a href="http://technorati.com/tags/busines+intelligence+software" rel="tag">busines intelligence software</a></div>

FDA to detain food shipments from China – Why not add some technology to the inspection processes?

I don’t think in view of the current events, there was a lot of choice here for the FDA, and we do need to know that the quality of both ou...

Read more »