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        <title>MedWorm Tags: advisory</title>
        <description>MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'advisory'.</description>
        <link><![CDATA[http://www.medworm.com/rss/search.php?qu=%22advisory%22&t=%22advisory%22&r=Exact&o=d&f=tag]]></link>
        <lastBuildDate>Sat, 03 Sep 2011 02:01:12 +0100</lastBuildDate>
        <item>
            <title>The Pros And Cons Of IPAB And Why It Shouldn’t Be Repealed</title>
            <link>http://www.medworm.com/index.php?rid=5130748&amp;cid=t_107651_87_f&amp;fid=39187&amp;url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-pros-and-cons-of-ipab-and-why-it-shouldnt-be-repealed%2F2011.08.15</link>
            <description>In recent weeks, several Democrats and some health reform advocates including the AMA have joined Republicans in calling for a repeal of provisions in the new health law that create the Independent Payment Advisory Board (IPAB). For these people, IPAB represents the worst aspects of the new law–an unelected, centralized planning authority empowered by government to make decisions about the peoples’ health care. Arbitrary cuts to providers, short-sighted decisions that stifle innovation and rationing of care are sure to follow, they claim.
While it’s true that the rules governing IPAB are flawed and should be fixed, eliminating IPAB altogether would be a mistake. (more&amp;#8230;)

			
			*This blog post was originally published at Pizaazz* (Source: Better Health)</description>
            <author>Better Health</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=5130748</comments>
            <pubDate>Mon, 15 Aug 2011 12:00:44 +0100</pubDate>
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            <title>Research Investigates A Percutaneous Option For Aortic Valve Replacement</title>
            <link>http://www.medworm.com/index.php?rid=5050577&amp;cid=t_107651_87_f&amp;fid=39187&amp;url=http%3A%2F%2Fgetbetterhealth.com%2Fresearch-investigates-a-percutaneous-option-for-aortic-valve-replacement%2F2011.07.21</link>
            <description>To ensure rational and responsible dissemination of this new
technology (transcatheter aortic valve replacement [TAVR]), government,
industry and medicine will need to work in harmony.”
- David R. Holmes, Jr., MD, FACC
President, American College of Cardiology
Today, Edwards Lifesciences’ will request pre-market approval of its SAPIEN Transcatheter Heart Valve from the FDA&amp;#8217;s Circulatory Systems Devices Panel of the Medical Devices Advisory Committee. And for the first time, the groundwork for our complicated new era of health care rationing will be exposed.
To win an expensive technology on behalf of patients these days, there will have to be &amp;#8220;harmony&amp;#8221; between doctors and their professional organizations and government regulators.  If not, patients lose.
At issue is a...</description>
            <author>Better Health</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=5050577</comments>
            <pubDate>Thu, 21 Jul 2011 18:00:00 +0100</pubDate>
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            <title>Congresswoman Schwartz Wins USA Today Face-Off</title>
            <link>http://www.medworm.com/index.php?rid=4872084&amp;cid=t_107651_87_f&amp;fid=38368&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FDisruptiveWomenInHealthCare%2F%7E3%2F-PNnvtaDT_A%2F</link>
            <description>By Mary Grealy. It wasn’t a head-to-head battle, as such, but Congresswoman Allyson Schwartz (D-PA) squared off against the USA Today editorial board yesterday on the subject of the Independent Payment Advisory Board (IPAB), and I believe the lawmaker clearly made the better arguments.
USA Today’s editorial made the point that the IPAB, created as part of the Affordable Care Act to curb Medicare costs, is essential to do the job that Congress won’t in cutting program spending.  The newspaper compared the new board to the base closing commission that successfully shuttered unneeded military installations.
That’s a dubious argument, though, at best.  The base closing commission carefully studied the value and usefulness of military bases before choosing which ones could be closed w...</description>
            <author>Disruptive Women in Health Care</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=4872084</comments>
            <pubDate>Thu, 26 May 2011 13:00:30 +0100</pubDate>
            <guid isPermaLink="false">4872084</guid>        </item>
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            <title>Where Have All The FDA Panelists Gone?</title>
            <link>http://www.medworm.com/index.php?rid=4841984&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FmsrQpBjd9A8%2F</link>
            <description>Four years ago, the FDA issued new rules concerning conflicts of interest for its advisory committees. The idea, of course, was to avoid the possibility that a panel member may have a financial connection of some sort to a company or type of drug to be reviewed (read here). Ever since, some critics charge the rules are too draconian and, worse, the effort amounted to overkill, because finding qualified panelists becomes harder.
Last week, Janet Woodcock, who heads the FDA&amp;#8217;s Center for Drug Evaluation and Research, made the same point. The conflict of interest guidelines made it &amp;#8220;tough to find knowledgeable people&amp;#8221; to serve on advisory committees, she told the Reuters Health Summit. &amp;#8220;It&amp;#8217;s a concern for all our staff&amp;#8230;There is no doubt it is difficult findi...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=4841984</comments>
            <pubDate>Thu, 19 May 2011 11:58:03 +0100</pubDate>
            <guid isPermaLink="false">4841984</guid>        </item>
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            <title>Progressive Counter Point: The IPAB Could Be A Good Thing</title>
            <link>http://www.medworm.com/index.php?rid=4841480&amp;cid=t_107651_87_f&amp;fid=39187&amp;url=http%3A%2F%2Fgetbetterhealth.com%2Fprogressive-counter-point-the-ipab-could-be-a-good-thing%2F2011.05.18</link>
            <description>I shouldn&amp;#8217;t do this. It&amp;#8217;s madness to try to delve into the minds of conspiracy theorists and try to make sense of their ravings. But I can&amp;#8217;t help myself; I&amp;#8217;m drawn like a moth to the flame. It never ends well. I only wind up with a horde of trolls in the comments telling me that I&amp;#8217;m a glib supercilious idiot and should stick to medicine or go die in a fire or something.
Sometimes it&amp;#8217;s too hard to stay away. Maybe it was the personal affront I felt in the false imputation of ill motives onto progressives. Maybe it was the gross errors in fact, sitting there ripe for the plucking. I don&amp;#8217;t know, but I just can&amp;#8217;t resist a rebuttal to Dr Rich at Covert Rationing, who weaves a technocratic cost control body into a paranoid web of fantasy, conclud...</description>
            <author>Better Health</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=4841480</comments>
            <pubDate>Wed, 18 May 2011 21:00:00 +0100</pubDate>
            <guid isPermaLink="false">4841480</guid>        </item>
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            <title>Conservative Viewpoint: The IPAB Is The Frightening Lynchpin Of Obamacare</title>
            <link>http://www.medworm.com/index.php?rid=4841481&amp;cid=t_107651_87_f&amp;fid=39187&amp;url=http%3A%2F%2Fgetbetterhealth.com%2Fconservative-viewpoint-the-ipab-is-the-frightening-lynchpin-of-obamacare%2F2011.05.18</link>
            <description>In the speech President Obama gave responding to Congressman Ryan’s budget plan (the one in which he lured Ryan to sit in the front row in order to be publicly pilloried), the President did something DrRich did not think he would do before the next election. He openly invoked, and openly embraced, the Independent Payment Advisory Board (IPAB) as the chief mechanism by which Obamacare will control the cost of American healthcare.
“IPAB” might be a new term to many Americans, but DrRich pointed his readers to this entity, within a few weeks of the passage of Obamacare, as the lynchpin (and a very scary lynchpin at that) of the whole enterprise.
Until President Obama’s recent “outing” of IPAB, however, this new board has been almost entirely ignored by most commentators. Since the...</description>
            <author>Better Health</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=4841481</comments>
            <pubDate>Wed, 18 May 2011 19:00:30 +0100</pubDate>
            <guid isPermaLink="false">4841481</guid>        </item>
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            <title>Inside Every Leftist Is a Little Authoritarian Dying to Get Out</title>
            <link>http://www.medworm.com/index.php?rid=4753664&amp;cid=t_107651_87_f&amp;fid=36438&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FM-da7bJjngI%2F</link>
            <description>By Michael F. CannonI&amp;#8217;ve been meaning to write about how ObamaCare&amp;#8217;s unelected rationing board — innocuously titled the Independent Payment Advisory Board — is yet another example of the Left leading America down the road to serfdom.  (Efforts to limit political speech — innocuously called &amp;#8220;campaign finance reform&amp;#8221; — are another.)
As Friedrich Hayek explained in The Road to Serfdom (1944), when democracies allow government to direct economic activity, the inevitable failures lead to calls for a more authoritarian form of governance:
Parliaments come to be regarded as ineffective &amp;#8220;talking shops,&amp;#8221; unable or incompetent to carry out the tasks for which they have been chosen. The conviction grows that if efficient planning is to be done, the directi...</description>
            <author>Cato-at-liberty</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=4753664</comments>
            <pubDate>Tue, 26 Apr 2011 20:54:12 +0100</pubDate>
            <guid isPermaLink="false">4753664</guid>        </item>
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            <title>FDA Warns Novartis Over Flu Vaccine Promotion</title>
            <link>http://www.medworm.com/index.php?rid=4478161&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FE4YxlSrSI60%2F</link>
            <description>The use of language is a subtle art. Ask any regulator. And the regulators at the FDA have determined that Novartis was a bit too subtle, perhaps, in trying to promote its Fluvirin vaccine for the flu. The agency recently issued a warning letter that chastised the drugmaker for distributing a sales aid and print advertisement that were deemed misleading.
Specifically, the promotional materials incorrectly characterized a published recommendation by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices and implied the Novartis vaccine can be used in all age ranges covered by the ACIP recommendations, according to the FDA letter, which was issued on February 4.
For the current flu season, the ACIP recommended annual vaccination including infants who ...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=4478161</comments>
            <pubDate>Mon, 14 Feb 2011 13:22:30 +0100</pubDate>
            <guid isPermaLink="false">4478161</guid>        </item>
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            <title>19 Steps To A More Transparent FDA?</title>
            <link>http://www.medworm.com/index.php?rid=4318544&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FvdhD1CZE9KE%2F</link>
            <description>There is nothing like a Byzantine agency - or one that appears so - to create confusion, even among those who toil in its confines. And so the FDA, besieged by nearly all quarters to do everything better, faster and smarter - has just issued a checklist of steps to be taken to improve its performance, help everyone figure out what the agency does and how to find that information.
To wit, the FDA has just released 19 steps to be taken in the quest for the &amp;#8216;T&amp;#8217; word - transparency. Toward that end, the agency actually released the list more than an hour before a media briefing, so there is a little time to digest these moves. Basically, the FDA aims for better communication with industry and importers, which includes revamping its website, and improving outreach and interactions w...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=4318544</comments>
            <pubDate>Thu, 06 Jan 2011 17:24:45 +0100</pubDate>
            <guid isPermaLink="false">4318544</guid>        </item>
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            <title>Obama Fiscal Commission: Let’s Raise Drug Rebates</title>
            <link>http://www.medworm.com/index.php?rid=4159507&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FgWmO3GG6Sl8%2F</link>
            <description>With all the talk of slashing federal budget deficits, guess what the Obama Fiscal Commission wants to put on the table? As the headline indicates, yes, Medicare Part D rebates paid by drugmakers, according to the draft proposal, which which also suggests lowering payments to doctors and lawyers, among other things. Rebates would be required as a condition of participating in Medicare Part D (see page 32 here).
Another suggestion is to strengthen the Independent Payment Advisory Board, which was created to control Medicare costs if Congress fails to act on its own. The panel is supposed to get started in 2015, but drugmakers are fighting to eliminate it before that happens. Not surprisingly, the pharmaceutical industry, which negotiated a health care reform deal with the White House, is an...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=4159507</comments>
            <pubDate>Thu, 11 Nov 2010 17:34:28 +0100</pubDate>
            <guid isPermaLink="false">4159507</guid>        </item>
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            <title>FCC and its Technological Advisory Council: Shut Them Down and Use the Money to Reduce Debt</title>
            <link>http://www.medworm.com/index.php?rid=4097902&amp;cid=t_107651_87_f&amp;fid=36438&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FvGeylL-OA40%2F</link>
            <description>By Jim HarperThe Federal Communications Commission has established a new advisory group called the &amp;#8220;Technological Advisory Council.&amp;#8221; Among other things, it will advise the agency on &amp;#8220;how broadband communications can be part of the solution for the delivery and cost containment of health care, for energy and environmental conservation, for education innovation and in the creation of jobs.&amp;#8221;
This is an agency that is radically overspilling its bounds. It has established goals that it has no proper role in fulfilling and that it has no idea how to fulfill. As we look for cost-cutting measures at the federal level, we could end the pretense that the communications industry should be regulated as a public utility. Shuttering the FCC would free up funds for better purposes...</description>
            <author>Cato-at-liberty</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=4097902</comments>
            <pubDate>Fri, 22 Oct 2010 14:37:38 +0100</pubDate>
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            <title>Protecting Our Children and The Vaccine Program</title>
            <link>http://www.medworm.com/index.php?rid=3954264&amp;cid=t_107651_87_f&amp;fid=39261&amp;url=http%3A%2F%2Fvactruth.com%2F2010%2F09%2F09%2Fprotecting-our-children-and-the-vaccine-program%2F</link>
            <description>Laraine C. Abbey, RN, CNS
09/09/2010
Vactruth.com
Three minute summary presentation to: The Advisory Commission on Childhood Vaccines &amp;#8211; 09/02/2010

 
Vaccine critics are saying we are trading vaccine preventable infectious diseases for chronic health disorders.
How can we reasonably say, “Vaccines don’t cause or contribute to autism” when we don’t know what does cause autism!  And vaccine concerns are no longer just about Autism—they’re about children’s total health.
Armies of parents are reporting that they took a normally developing child to the pediatrician for routine shots and their child’s health or behavior changed&amp;#8211;never to be the same as before that visit.  Thousands upon thousands of parents report similar “coincidental” symptoms related in time t...</description>
            <author>vactruth.com</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3954264</comments>
            <pubDate>Thu, 09 Sep 2010 14:44:17 +0100</pubDate>
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            <title>USA Today Abets ObamaCare Supporters’ Misinformation Campaign</title>
            <link>http://www.medworm.com/index.php?rid=3861999&amp;cid=t_107651_87_f&amp;fid=36438&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2FfrmQO2IL3NA%2F</link>
            <description>By Michael F. Cannon
An article in today&amp;#8217;s The USA Today titled, &amp;#8220;With Many Still in Dark, Groups Shed Light on Health Care Law,&amp;#8221; aims to correct misinformation about ObamaCare.  Ironically, the article is itself a monument to misinformation.
It begins:
True or false: The new health care law will cut Medicare benefits for seniors. It will slash Medicare payments to doctors. It will ration health care.
In three polls conducted last month, large percentages of Americans answered &amp;#8220;true&amp;#8221; to each statement. All three are false.
In fact, two of the three statements are 100-percent true.
First, ObamaCare will cut payments to the private health insurance companies that provide coverage to the 20 percent of Medicare enrollees who participate in the Medicare Advantage ...</description>
            <author>Cato-at-liberty</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3861999</comments>
            <pubDate>Thu, 12 Aug 2010 16:45:39 +0100</pubDate>
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            <title>Day 47:  Succinct Health Care – Is there an app for that?</title>
            <link>http://www.medworm.com/index.php?rid=3786183&amp;cid=t_107651_113_f&amp;fid=36694&amp;url=http%3A%2F%2Fblog.crossoverhealth.com%2F2010%2F07%2F23%2Fday-46-succinct-health-care-is-there-an-app-for-that%2F</link>
            <description>Succinct (sək-sĭngkt&amp;#8217;) adj.

 Characterized by clear, precise expression in few words; concise and terse.
Marked by or consisting of few words that are carefully chosen

The other day I was having a conversation with our Director of Membership Experience Stephen Gaines regarding how ineffective and inadequate the current health care experience is for patients.  As our conversation wound around we ended up discussing some principles from Stephen R. Covey&amp;#8217;s book, &amp;#8220;The Seven Habits of Highly Effective People&amp;#8220;. I suggested that Stephen should purchase the book as it is a great read on alot of levels. Before I could even finish the conversation, Stephen had pulled out his iPhone, typed a few things into his Amazon app, and before I had finished my conversational parag...</description>
            <author>Crossover Healthcare</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3786183</comments>
            <pubDate>Fri, 23 Jul 2010 19:38:43 +0100</pubDate>
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            <title>Which FDA Panels Offer More Endorsements?</title>
            <link>http://www.medworm.com/index.php?rid=3672037&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FaDtTeVMFSSE%2F</link>
            <description>There may be some interesting variables involved in analyzing the results, but we have a winner - the Peripheral &amp;#038; Central Nervous System Drugs Advisory Committee, which has not bounced a new drug in the last 3-1/2 years. The latest endorsement was given to the Novartis multiple sclerosis pill, Gilenia. This is the only advisory committee, however, that doesn&amp;#8217;t know the word &amp;#8216;no.&amp;#8217;
Overall, 70 percent of all applications that made it to an FDA advisory committee for review between 2007 and 2010 won positive recommendations, according to Concept Capital, which only considered new molecular entities and major new indications for existing drugs. Also, only the final voting question on whether a drug should be recommended for approval was tallied.
Some other nuggets: the ...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3672037</comments>
            <pubDate>Wed, 16 Jun 2010 20:35:34 +0100</pubDate>
            <guid isPermaLink="false">3672037</guid>        </item>
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            <title>MS “Pill” Approved</title>
            <link>http://www.medworm.com/index.php?rid=3671890&amp;cid=t_107651_129_f&amp;fid=36038&amp;url=http%3A%2F%2Fwww.everydayhealth.com%2Fblog%2Ftrevis-life-with-multiple-sclerosis-ms%2Fms-pill-approved%2F</link>
            <description>The first oral, disease-modifying MS drug, Fingolimod, was approved for release and marketing by the FDA’s Advisory Committee on Peripheral and Central Nervous System Drugs a few days ago!
I apologize for the delay my reporting such important news, but my travel schedule has been a bit nutty of late.
Data was submitted earlier this year as to the efficacy and safety of the drug and the approval process took a HUGE leap on June 10 this a unanimous, 25-0 vote to allow drug maker, Novartis, to begin the next phase in the long process of bringing new drugs to market.
Contacts at Novartis wouldn’t give a firm date as to the release of the drug to the US market, but it will most assuredly be available before for doctors’ prescriptions by the end of the calendar year.
A .25mg dose of the dr...</description>
            <author>Life with MS</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3671890</comments>
            <pubDate>Wed, 16 Jun 2010 19:26:56 +0100</pubDate>
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            <title>Software Glitch Found in Medtronic's Latest Defibrillator Line</title>
            <link>http://www.medworm.com/index.php?rid=3542630&amp;cid=t_107651_105_f&amp;fid=38964&amp;url=http%3A%2F%2Fdrwes.blogspot.com%2F2010%2F05%2Fsoftware-glitch-found-in-medtronics.html</link>
            <description>From 7thSpace: (Hong Kong) The Department of Health (DH) today (May 5) received notification from Medtronic International Limited (MIL), the local branch of a multi-national medical device manufacturer, that software problems in six of its implantable cardiac devices may risk life-threatening though rare malfunctioning. A DH spokesman said, the affected models are Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG, D234VRC), Maximo II CRT-D (D284TRK) and Maximo II DR/VR (D284DRC, D284VRC).All except Maximo II VR (D284VRC) are distributed in Hong Kong. As of April 19 this year, the manufacturer has received five confirmed reports of defect out of approximately 144 000 devices sold worldwide.However, it is reassuring that no patient injury or death arising from the affected devices has been rep...</description>
            <author>Dr. Wes</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3542630</comments>
            <pubDate>Wed, 05 May 2010 22:26:00 +0100</pubDate>
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            <title>FDA Proposes New Disclosure Rules For Panels</title>
            <link>http://www.medworm.com/index.php?rid=3494550&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FZAyqYFm0i5k%2F</link>
            <description>This is long overdue. In a bid to appear transparent, the agency is issuing a draft guidance that would expand disclosure when a conflict of interest waiver is granted to individuals who participate in its advisory committee meetings. 
The expanded disclosure about waivers would occur prior to committee meetings. Specifically, the FDA proposes to post online the name of the company or institution associated with the financial interest along with the type of conflict of interest. Typically, the agency redacts or omits info so that the nature of any possible conflict is difficult if not impossible to ascertain. There are 49 committees, by the way, and some 600 participants.
This doesn&amp;#8217;t mean the FDA will turn its nose at all conflicts. In a letter to agency staff, FDA commish Margaret ...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3494550</comments>
            <pubDate>Thu, 22 Apr 2010 12:17:01 +0100</pubDate>
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            <title>When Doctors Decide Damages</title>
            <link>http://www.medworm.com/index.php?rid=3494328&amp;cid=t_107651_105_f&amp;fid=38964&amp;url=http%3A%2F%2Fdrwes.blogspot.com%2F2010%2F04%2Fwhen-doctors-decide-damages.html</link>
            <description>In an interesting twist to the ongoing saga of device recalls, the Minneapolis Startribune reported that the two doctors, Robert Hauser, MD and Barry Maron, MD who first brought the Prism II ICD device malfunction to public attention by releasing their story to the New York Times in 2005, wrote a letter to the judge reviewing the plea bargain agreement and told him:We are physicians who cared for Joshua Okrup (eds note: should be &quot;Oukrop&quot;), a 21 year-old college student, who died when his Guidant Prizm 2 implantable cardioverter-defibrillator (ICD) short-circuited and failed to deliver a life-saving shock. His unnecessary death was caused by a product defect that Guidant Inc. had known about for years and failed to inform patients, physicians, and the U.S. Food and Drug Administration. Acc...</description>
            <author>Dr. Wes</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3494328</comments>
            <pubDate>Wed, 21 Apr 2010 03:14:00 +0100</pubDate>
            <guid isPermaLink="false">3494328</guid>        </item>
        <item>
            <title>Day 80: My take on “meaningful use”</title>
            <link>http://www.medworm.com/index.php?rid=3519538&amp;cid=t_107651_113_f&amp;fid=36694&amp;url=http%3A%2F%2Fblog.crossoverhealth.com%2F2010%2F04%2F11%2Fday-80-my-take-on-meaningful-use%2F</link>
            <description>Meaningful (mē&amp;#8217;nĭng-fəl)adj.

 Having meaning, function, or purpose.
 Fraught with meaning; significant:

I grow exceptionally tired of the entire &amp;#8220;meaningful use&amp;#8221; conversation. I see multiple definitions, serious scholarly work, conferences, and an entire industry built up around or attempting to knock down this obnoxious term. Its wearisome . . .particularly when I think the term is meaningless in terms of attempting to get people paid for using specific types of technology. My contention is that the government bureaucrats will never be able to run fast enough to keep up with technology which will outstrip not only their ability to classify it, let alone dictate the terms of its use.
As an example of that, I am using HelloHealth&amp;#8217;s EHR platform. It is not EHR ce...</description>
            <author>Crossover Healthcare</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3519538</comments>
            <pubDate>Sun, 11 Apr 2010 06:46:10 +0100</pubDate>
            <guid isPermaLink="false">3519538</guid>        </item>
        <item>
            <title>Lipodissolve “Too Good to be True”</title>
            <link>http://www.medworm.com/index.php?rid=3453934&amp;cid=t_107651_106_f&amp;fid=36682&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FSutureForALiving%2F%7E3%2FblqJyDzRxYI%2Flipodissolve-too-good-to-be-true.html</link>
            <description>I have long been skeptical of Lipodissolve claims.&amp;#160; Patients would ask about the injections that dissolve the fat without surgery.&amp;#160; How it worked?&amp;#160; How safe is it?&amp;#160; Do you do it?&amp;#160; Do you know anyone who does? The FDA has finally issued a warning   On April 7, 2010, FDA announced it had sent warning letters to six medical spas in the United States—and a cyber letter to a company in Brazil—for making false or misleading statements on their Web sites about drugs used in the procedure, or for otherwise misbranding lipodissolve products.  The U.S. medical spas receiving warning letters make various unsupported claims about lipodissolve, such as assertions that the products used in lipodissolve     are safe and effective    have an outstanding safety record    are su...</description>
            <author>Suture for a Living</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3453934</comments>
            <pubDate>Thu, 08 Apr 2010 17:01:00 +0100</pubDate>
            <guid isPermaLink="false">3453934</guid>        </item>
        <item>
            <title>By Pulling His Punches, Bernanke Shatters ObamaCare’s Credibility</title>
            <link>http://www.medworm.com/index.php?rid=3453888&amp;cid=t_107651_87_f&amp;fid=36438&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FCato-at-liberty%2F%7E3%2Fv4Qyws5guZs%2F</link>
            <description>By Michael F. CannonFederal Reserve Chairman Ben Bernanke gave a speech in Dallas yesterday where he inadvertently discredited claims that ObamaCare would reduce health care costs and the federal deficit.  According to The Washington Post:
Federal Reserve Chairman Ben S. Bernanke warned Wednesday that Americans may have to accept higher taxes or changes in cherished entitlements such as Medicare and Social Security if the nation is to avoid staggering budget deficits that threaten to choke off economic growth&amp;#8230;
While the immediate audience for the speech was the Dallas Regional Chamber, his message was intended for Congress and the Obama administration&amp;#8230;
Bernanke has urged Congress to address long-term fiscal imbalances in congressional testimony before, but usually only when he...</description>
            <author>Cato-at-liberty</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3453888</comments>
            <pubDate>Thu, 08 Apr 2010 16:44:29 +0100</pubDate>
            <guid isPermaLink="false">3453888</guid>        </item>
        <item>
            <title>Boston Scientific Issues New ICD Advisory and Halts Sales of All ICDs</title>
            <link>http://www.medworm.com/index.php?rid=3366223&amp;cid=t_107651_105_f&amp;fid=38964&amp;url=http%3A%2F%2Fdrwes.blogspot.com%2F2010%2F03%2Fboston-scientific-issues-new-icd.html</link>
            <description>Despite the excitement of the American College of Cardiology meeting in Atlanta, Boston Scientific issued a self-reported advisory about all of their high-voltage defibrillators (pacers are not affected) stopping sales until &quot;administrative issues&quot; regarding a change in manufacturing processes and changes of their IS-4 lead connector. This advisory does NOT affect existing implanted devices, but rather halts the sales of further devices:The Company has determined that some manufacturing process changes were not submitted for approval to the U.S. Food and Drug Administration (FDA). At this time, the company has identified two instances of changes that, while successfully validated, were not submitted to the FDA. Boston Scientific has informed the FDA and plans to work closely with the agenc...</description>
            <author>Dr. Wes</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3366223</comments>
            <pubDate>Mon, 15 Mar 2010 15:44:00 +0100</pubDate>
            <guid isPermaLink="false">3366223</guid>        </item>
        <item>
            <title>Grassley Tells PBMs To Disclose Ties To Pharma</title>
            <link>http://www.medworm.com/index.php?rid=3359212&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F1uEtOjqcfck%2F</link>
            <description>In his latest attempt to probe the pharmaceutical industry, US Senator Chuck Grassley has written two big pharmacy benefit managers, as well as a trade group, asking them to provide information about their financial relationships with drugmakers. This week, he sent letters to Express Scripts, CVS Caremark and the Pharmaceutical Care Management Association (click on name to see letters).
In explaining his action, Grassley - who is the ranking Republican on the Senate Finance Committee - wrote that the Medicare Payment Advisory Commission (MedPAC) recommended in a report last year that Congress should require drugmakers to report their financial relationships with pharmacy benefit managers, pharmacies, health plans, and others, but not rebates or discounts (look here). And so he asks for det...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3359212</comments>
            <pubDate>Fri, 12 Mar 2010 15:05:05 +0100</pubDate>
            <guid isPermaLink="false">3359212</guid>        </item>
        <item>
            <title>Boston Scientific Issues 'Soft' Defibrillator Advisory</title>
            <link>http://www.medworm.com/index.php?rid=3059738&amp;cid=t_107651_105_f&amp;fid=38964&amp;url=http%3A%2F%2Fdrwes.blogspot.com%2F2009%2F12%2Fboston-scientific-issues-soft.html</link>
            <description>Boston Scientific recently issued a new device advisory for their current line of Teligen ICD and Cognis CRT-D automatic defibrillator devices. The advisory affects only those devices that are implanted beneath the breast muscle (subpectorally) on the chest wall. It seems two (2) devices implanted (of 77,000 total devices implanted worldwide) in this location experienced weakening of a header bond caused by significant forces applied to the header by the pectoralis muscle to the rib. This resulted in altered lead impedances and the introduction of noise to the defibrillator sensing lead that might inhibit pacing or result in inappropriate tachycardia therapies (shocks). The submuscular implantation location is an uncommon location to implant the devices. It is estimated that only 5% (3850)...</description>
            <author>Dr. Wes</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=3059738</comments>
            <pubDate>Fri, 04 Dec 2009 16:44:00 +0100</pubDate>
            <guid isPermaLink="false">3059738</guid>        </item>
        <item>
            <title>ONC Blog – Federal Advisory Committee – Judy Sparrow</title>
            <link>http://www.medworm.com/index.php?rid=2950810&amp;cid=t_107651_113_f&amp;fid=34634&amp;url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FEmrAndHipaa%2F%7E3%2FtE2kF5Y_eLo%2F</link>
            <description>All I can say is that it&amp;#8217;s very cool that ONC now has a blog. This is probably right up there with when I found past HHS secretary Mike Leavitt&amp;#8217;s blog. Ok, yes I am a complete blog nerd. At least I&amp;#8217;m able to admit it up front.
Basically, Judy Sparrow has just done an introduction post where she talks about the Federal Advisory Committees and their role at ONC. She&amp;#8217;s the ONC liason for these committees and so hopefully she&amp;#8217;ll keep us updated on progress with these two very important committees. She also provides this explanation about the committees in her first ONC blog post:
“FACAs” get their name from the Federal Advisory Committee Act, which lays out the guidelines for such committees. FACAs are advisory and intended to provide external guidance to the ...</description>
            <author>EMR and HIPAA</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=2950810</comments>
            <pubDate>Thu, 29 Oct 2009 16:00:13 +0100</pubDate>
            <guid isPermaLink="false">2950810</guid>        </item>
        <item>
            <title>Boston Scientific's Ultra-Soft Device Advisory</title>
            <link>http://www.medworm.com/index.php?rid=2796464&amp;cid=t_107651_105_f&amp;fid=38964&amp;url=http%3A%2F%2Fdrwes.blogspot.com%2F2009%2F09%2Fboston-scientifics-ultra-soft-device.html</link>
            <description>How do you notify people gently about a device alert that doesn't involve an implanted device, but rather a monitoring device developed for the implanted device? Where does a sophisticated implanted defibrillator device end: with the part that's implanted inside a patient or does it include the peripherals that monitor the implanted device, too?These are the issues that have surfaced with a very recent medical device advisory issued by Boston Scientific on 9 September 2009 in a &quot;Dear Doctor&quot; letter (pdf) I managed to find on their website, and was brought to my attention by an anonymous commenter on this blog:BackgroundBoston Scientific defibrillators include a Daily Measurements feature that conducts several diagnostic tests on a daily basis to monitor the implanted defibrillator and lead...</description>
            <author>Dr. Wes</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=2796464</comments>
            <pubDate>Tue, 15 Sep 2009 12:11:00 +0100</pubDate>
            <guid isPermaLink="false">2796464</guid>        </item>
        <item>
            <title>The Importance of Blogs and Device Advisories</title>
            <link>http://www.medworm.com/index.php?rid=2789001&amp;cid=t_107651_105_f&amp;fid=38964&amp;url=http%3A%2F%2Fdrwes.blogspot.com%2F2009%2F09%2Fimportance-of-blogs-and-device.html</link>
            <description>Yesterday, I reported on this blog the trouble Medtronic had experienced with and earlier batch of defibrillators due to a low-voltage capacitor problem from an outside supplier back in 2005 or 2006. The problem was identified in a relatively small number of devices and has not affected their devices' functionality, but the expected battery life of these batch of devices was discovered to be shorter than they had expected. A root cause analysis was undertaken and the capacitor issue was identified. After consulting their physician advisory panel, they elected to notify all doctors who implant their devices about the issue and provided the patients' names that they were aware of to doctors to help facilitate patient notification.Importantly, there was not a press release.Personally, I think...</description>
            <author>Dr. Wes</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=2789001</comments>
            <pubDate>Fri, 11 Sep 2009 13:58:00 +0100</pubDate>
            <guid isPermaLink="false">2789001</guid>        </item>
        <item>
            <title>A New Medtronic Defibrillator Advisory Issued Today</title>
            <link>http://www.medworm.com/index.php?rid=2789003&amp;cid=t_107651_105_f&amp;fid=38964&amp;url=http%3A%2F%2Fdrwes.blogspot.com%2F2009%2F09%2Fnew-medtronic-defibrillator-advisory.html</link>
            <description>Today, an announcement was issued to doctors implanting Medtronic's Concerto and Virtuoso wireless implantable cardiac defibrillator's (ICDs) that a certain lot of 5,200 devices in the US of the total 158,000 implanted worldwide have demonstrated premature battery depletion due to a faulty battery capacitor containing porous copper. A total of 230 devices returned so far have demonstrated this problem. The capacitor was manufactured by an outside vendor, and more recent models of these devices manufactured reportedly no longer have this capacitor. The notification is not a recall and does suggest any of the devices have failed and no deaths have been reported as a result of this notification. It is recommended that physicians continue the routine follow-up of these devices every three mont...</description>
            <author>Dr. Wes</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=2789003</comments>
            <pubDate>Thu, 10 Sep 2009 17:13:00 +0100</pubDate>
            <guid isPermaLink="false">2789003</guid>        </item>
        <item>
            <title>Health Care Moonshot: The Health Care X PRIZE Development Project</title>
            <link>http://www.medworm.com/index.php?rid=2234316&amp;cid=t_107651_113_f&amp;fid=36694&amp;url=http%3A%2F%2Fblog.crossoverhealth.com%2F2009%2F03%2F02%2Fhealth-care-moonshot-the-health-care-x-prize-development-project%2F</link>
            <description>Moonshot (mūn shŏt) n.

Description of the audacious attempt and the subsequent race to place a man on the moon
Used as an analogy to describe similarly gigantic challenges under competitive influence

The best health care book I have ever read, is ironically the first one I was fortunate to pick up. “Redefining Health: Creating Value Based Competition on Results” literally became a life altering experience for me as I read it at a time when I was seeking to redefine my career path. The notions of health care value (outcomes/price), the organizational principles engendered by this approach (focus on the medical condition across the full cycle of care), the competitive forces that this framework unleashes (virtuous cycles of innovation), and the overall promise for improving our deliv...</description>
            <author>Crossover Healthcare</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=2234316</comments>
            <pubDate>Mon, 02 Mar 2009 11:59:42 +0100</pubDate>
            <guid isPermaLink="false">2234316</guid>        </item>
        <item>
            <title>Personal Health Advisor: The Perfect Care Coordinator</title>
            <link>http://www.medworm.com/index.php?rid=2183549&amp;cid=t_107651_113_f&amp;fid=36694&amp;url=http%3A%2F%2Fblog.crossoverhealth.com%2F2009%2F02%2F12%2Fpersonal-health-advisor-the-perfect-care-coordinator%2F</link>
            <description>Coordinator (kō-ôr&amp;#8216;dn-ā&amp;#8217;shən) n.

The act of coordinating
The state of being coordinated; harmonious adjustment or interaction.

I am finishing up some more of my postings related to the Innovators Prescription, but prior to do so I wanted to highlight a key insight mentioned when evaluating the disruptions required to help the Primary Care system to become more effective:
&amp;#8220;We have concluded that a personal adviser of some sort truly needs to be available to direct patients who may not know where to go, so they can find the care they need, and receive that care through the appropriate business models. Many of those who write and speak about reforming health care have called this adviser an &amp;#8220;Accountable Care Organization&amp;#8220; - one whose perspective enables it ...</description>
            <author>Crossover Healthcare</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=2183549</comments>
            <pubDate>Thu, 12 Feb 2009 21:04:54 +0100</pubDate>
            <guid isPermaLink="false">2183549</guid>        </item>
        <item>
            <title>Launch: Personal Health Advisory Services</title>
            <link>http://www.medworm.com/index.php?rid=2108072&amp;cid=t_107651_113_f&amp;fid=36694&amp;url=http%3A%2F%2Fblog.crossoverhealth.com%2F2009%2F01%2F15%2Flaunch-personal-health-advisory-services%2F</link>
            <description>Crossover (krôs&amp;#8217;ō&amp;#8216;vər) n.

The adaptation of a musical style, as by blending elements of two or more styles or categories, to appeal to a wider audience.
A recording designed to appeal to wide or diverse audience



I have been blogging for just over two years at Crossover Health while also working as a strategic consultant in the area of health care innovation.  I have had the privilege to work with some promising companies, some great people, and some excellent ideas during that time. However, I have also been working on some of my own concepts based on the things that I have been observing.
Crossover Health recently launched its beta version of personal health advisory service to South Orange County residents and employers. Crossover Health provides a new category of hea...</description>
            <author>Crossover Healthcare</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=2108072</comments>
            <pubDate>Thu, 15 Jan 2009 15:20:08 +0100</pubDate>
            <guid isPermaLink="false">2108072</guid>        </item>
        <item>
            <title>A Privacy Framework for Personal Health Records</title>
            <link>http://www.medworm.com/index.php?rid=2153836&amp;cid=t_107651_113_f&amp;fid=38236&amp;url=http%3A%2F%2Fwww.healthcareitnews.com%2Fblog%2Fprivacy-framework-personal-health-records</link>
            <description>When I lecture about the new generation of personal health records such as Google Health and Microsoft Healthvault, I emphasize that these applications are not covered by HIPAA. Google and Microsoft are not healthcare provider organizations and thus their privacy is only as strong as the policies they post on the website. Since Google and Microsoft monetize these sites by attracting search traffic, they are highly motivated to build secure and trustworthy systems. As a member of the Google Advisory Council, I know that the Google privacy policies are stronger than HIPAA. (Source: Healthcare IT News Blog)</description>
            <author>Healthcare IT News Blog</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=2153836</comments>
            <pubDate>Sun, 04 Jan 2009 19:24:25 +0100</pubDate>
            <guid isPermaLink="false">2153836</guid>        </item>
        <item>
            <title>Twittering Scott Shreeve, MD:  What are you doing?</title>
            <link>http://www.medworm.com/index.php?rid=1952609&amp;cid=t_107651_113_f&amp;fid=36694&amp;url=http%3A%2F%2Fblog.crossoverhealth.com%2F2008%2F11%2F11%2Ftwittering-scott-shreeve-md-what-are-you-doing%2F</link>
            <description>Tweet (twēt) n. 

1. A weak chirping sound, as of a young or small bird.
2. A “Tweet” is an individual message (or “update”) posted from Twitter.
Twitter is an interesting application with a very simple premise - your friends and associates are actually interested in knowing “What are you doing”. These “tweets” are constrained to 140 characters and for a wide variety of reasons people are actually interested to follow these micro-updates. As with most technologies, the original somewhat superfluous reason for which it was created has begun to find new uses, in new settings, and to be adopted by an ever expanding base. Interesting to watch and follow.
The premise of Twitter - What Are You Doing - has stuck with me during the last several months that I have been using this n...</description>
            <author>Crossover Healthcare</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=1952609</comments>
            <pubDate>Tue, 11 Nov 2008 10:39:46 +0100</pubDate>
            <guid isPermaLink="false">1952609</guid>        </item>
        <item>
            <title>Help Wanted: FDA Advisory Panel Chairs Needed</title>
            <link>http://www.medworm.com/index.php?rid=1906163&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F430030058%2F</link>
            <description>Hard to believe, but three quarters of advisory committees in the Center for Drug Evaluation &amp;#038; Research do not have a permanent chair, The In Vivo Blog reports. Using simple math, that’s 12 out of 16 committee chairs. Only four - Anethestic &amp;#038; Life Support Drugs, Pharmaceutical Science, Psychopharmacologic Drugs and Reproductive Health Drugs - have a permanent chair, the blog writes.
And FDA is having a hard time finding committee members. Why? The blog points to new conflict of interest rules, which restrict participation based on financial holdings (see here), and unspecified &amp;#8220;downsides&amp;#8221; to serving on a committee. What could these be? We prefer not to speculate, but there is an awful lot of politicking that occurs and complaints from anxious drugmakers. And let&amp;#82...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=1906163</comments>
            <pubDate>Thu, 23 Oct 2008 21:12:49 +0100</pubDate>
            <guid isPermaLink="false">1906163</guid>        </item>
        <item>
            <title>FDA Issues New Rules For Advisory Committees</title>
            <link>http://www.medworm.com/index.php?rid=1679624&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F355455748%2F</link>
            <description>The changes involve conflicts of interest and waivers for panel members; advisory committee voting procedures; the timing of committee briefing materials to be released and the procedures for deciding when an advisory committee meeting should be held. The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. Here is a summary, and you can look here to read the individual guidances.
The most contentious issue has to do with concern over conflicts involving committee members, a hot-button topic that regularly embroils the FDA (see this item earlier today). The FDA has long argued finding experts without financial conflicts is arduous, if not impossible, because many top-flight physicians and academics serve...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=1679624</comments>
            <pubDate>Mon, 04 Aug 2008 15:56:07 +0100</pubDate>
            <guid isPermaLink="false">1679624</guid>        </item>
        <item>
            <title>Cellphone Use, Brain Cancer and UPMC Cancer Center Chief’s Advisory</title>
            <link>http://www.medworm.com/index.php?rid=1652628&amp;cid=t_107651_136_f&amp;fid=36051&amp;url=http%3A%2F%2Ffeeds.b5media.com%2F%7Er%2Fb5media%2FCancerCommentary%2F%7E3%2F344938741%2F</link>
            <description>Wednesday, 23 July 2008 is the day the UPMC Cancer Center and University of Pittsburgh Cancer Institute Director Dr. Ronald Herberman is to issue an advisory (pdf file link of the memorandum) on the possible health risks of cellphone use.
&amp;#8220;Recently I have become aware of the growing body of literature linking long-term cell phone use to possible adverse health effects including cancer.
Although the evidence is still controversial, I am convinced that there are sufficient data to warrant issuing an advisory to share some precautionary advice on cell phone use.&amp;#8221;
The advisory suggests certain measures to limit exposure to electromagnetic radiation emitted by the devices, such as shortening the length of conversations or keeping the phones away from the head by text messaging or us...</description>
            <author>Cancer Commentary</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=1652628</comments>
            <pubDate>Thu, 24 Jul 2008 20:00:57 +0100</pubDate>
            <guid isPermaLink="false">1652628</guid>        </item>
        <item>
            <title>No Chair Throwing Allowed At FDA Panel Meetings</title>
            <link>http://www.medworm.com/index.php?rid=1575640&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F325898482%2F</link>
            <description>Most days, an FDA advisory committee meeting would not be mistaken for an episode of one of those talk shows where the guests - and maybe even the host or audience members - will curse, trade punches and throw things at one another. True, a member of the public can sometimes bring the FDA gathering to tears with harrowing stories of overwhelming side effects. But mostly, these are staid events.
Just the same, a threatening rant by an apparently intoxicated speaker during a May 2007 open public hearing has prompted the FDA to tighten security at its meetings, according to The RPM Report. A formal announcement hasn&amp;#8217;t been made, but John Jenkins, who heads the Office of New Drugs, discussed the new procedures at the Drug Information Association’s annual meeting last week.
&amp;#8220;We ha...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=1575640</comments>
            <pubDate>Thu, 03 Jul 2008 16:04:53 +0100</pubDate>
            <guid isPermaLink="false">1575640</guid>        </item>
        <item>
            <title>Cease and Desist? How about Understand and Resist!</title>
            <link>http://www.medworm.com/index.php?rid=1547296&amp;cid=t_107651_113_f&amp;fid=36694&amp;url=http%3A%2F%2Fcrossoverhealth.wordpress.com%2F2008%2F06%2F25%2Fcease-and-desist-how-about-understand-and-resist%2F</link>
            <description>Desist (dĭ-sĭst&amp;#8216;) v. 
1. To cease doing something; forbear.
2. To abandon, break off, discontinue, give up, leave off, quit, relinquish, remit, or stop.
I have been following health care consumerism for several years now. Particularly, the &amp;#8220;Direct Access&amp;#8221; or &amp;#8220;Direct To Consumer&amp;#8221; laboratory testing market. While analytic lab testing has led out in this area, genetic testing has received all the regulatory attention, national press, and policy efforts (GINA).
So it is no surprise that consumer genetic movement would be the first legal test of the Health 2.0 movement. As reported by Matthew Holt, and a host of national outlets (Wired has had extensive coverage here, here, and here), there seems to be quite a hornets nest unleashed by our friends at the Californ...</description>
            <author>Crossover Healthcare</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=1547296</comments>
            <pubDate>Thu, 26 Jun 2008 05:54:53 +0100</pubDate>
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            <title>Lindsay Lohan’s asthma attack: A wake-up call on albuterol?</title>
            <link>http://www.medworm.com/index.php?rid=1494644&amp;cid=t_107651_117_f&amp;fid=36026&amp;url=http%3A%2F%2Fblog.healthtalk.com%2Fzimney%2Flindsey-lohan%25e2%2580%2599s-asthma-attack-a-wake-up-call-on-albuterol%2F</link>
            <description>I don’t really know if Lindsay Lohan had an asthma attack at 30,000 feet, or whether she spent two hours in an LA emergency room or had to be admitted for treatment, because the news reports are conflicting and unclear as of this writing. But I do know that millions of Americans suffer acute asthma attacks every year (11 million during each year between 1997 and 2004), and that they often require emergency room treatment (1.8 million asthma ER visits for each year between 2001 and 2003) and hospitalization (an average of 500,000 hospital admissions each year). Worse yet, there were about 4,200 deaths from asthma each year between 2001 and 2003. Those alarming statistics come from the Centers for Disease Control (CDC).
What these numbers mean is that a lot of people depend on albuterol-ba...</description>
            <author>Dr. Z's Medical Report</author>
            <type>blogs</type>
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            <pubDate>Wed, 04 Jun 2008 23:06:36 +0100</pubDate>
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            <title>Lindsey Lohan’s asthma attack: A wake-up call on albuterol?</title>
            <link>http://www.medworm.com/index.php?rid=1492360&amp;cid=t_107651_117_f&amp;fid=36026&amp;url=http%3A%2F%2Fblog.healthtalk.com%2Fzimney%2Flindsey-lohan%25e2%2580%2599s-asthma-attack-a-wake-up-call-on-albuterol%2F</link>
            <description>I don’t really know if Lindsey Lohan had an asthma attack at 30,000 feet, or whether she spent two hours in an LA emergency room or had to be admitted for treatment, because the news reports are conflicting and unclear as of this writing. But I do know that millions of Americans suffer acute asthma attacks every year (11 million during each year between 1997 and 2004), that they often require emergency room treatment (1.8 million asthma ER visits for each year between 2001 and 2003), and hospitalization (an average of 500,000 hospital admissions each year). Worse yet, there were about 4,200 deaths from asthma each year between 2001 and 2003. Those alarming statistics come from the Centers for Disease Control (CDC).
What these numbers mean is that a lot of people depend on albuterol-based...</description>
            <author>Dr. Z's Medical Report</author>
            <type>blogs</type>
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            <pubDate>Tue, 03 Jun 2008 19:44:45 +0100</pubDate>
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            <title>FDA Panels: When Is A Conflict Not A Conflict?</title>
            <link>http://www.medworm.com/index.php?rid=1478218&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F300533379%2F</link>
            <description>The agency will hold an advisory committee meeting tomorrow to review Promacta, an experimental med for short-treatment of chronic ITP, which is being developed by Glaxo and Ligand Pharmaceuticals. And as documents show, waivers were granted to two panel members holding conflicts of interest. The agency, of course, is allowed to do so, although the practice is controversial and, in response, the FDA proposed new rules that specify when exceptions can be granted.
In the latest instance, the FDA issued waivers to two people on its Oncologic Drugs Advisory Committee. One is Gary Lyman, director of health services and outcomes research in oncology at Duke University, who earns less than $10,000 annually as a speaker for an unnamed rival, according to the FDA waiver form.
The other is Maha Huss...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
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            <pubDate>Thu, 29 May 2008 12:56:45 +0100</pubDate>
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            <title>The Impossible Dream: FDA Panels Without Conflicts</title>
            <link>http://www.medworm.com/index.php?rid=1030259&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F185336084%2F</link>
            <description>The mere notion of a conflict-free panel is speculative and trying to prove otherwise would cost the FDA time and money. That&amp;#8217;s the finding of a research firm that the agency retained to help develop new policies on granting waivers to advisory panel experts. And while it&amp;#8217;s not surprising, the bottom-line conclusion drawn by Eastern Research Group is bound to be controversial, given the sharply contrasting views over the extent to which qualified experts without financial ties to industry can be found. [This is the new FDA policy, by the way].
&amp;#8220;Our main finding is that standing advisory committee members with higher overall measures of expertise were more likely than other standing advisory committee members to have been granted waivers for financial conflicts of interest...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
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            <pubDate>Thu, 15 Nov 2007 18:07:58 +0100</pubDate>
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            <title>Prominent Docs Urge Senators To Limit Conflicts of Interest From FDA Advisory Panels</title>
            <link>http://www.medworm.com/index.php?rid=867459&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F155643778%2F</link>
            <description>In conclusion, it is important to restore the public’s confidence in the integrity of the FDA’s decisions by having Congress restrict the number of waivers the FDA grants.&amp;#8221;
Share / E-mail (Source: Pharmalot)</description>
            <author>Pharmalot</author>
            <type>blogs</type>
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            <pubDate>Wed, 12 Sep 2007 20:04:17 +0100</pubDate>
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            <title>High Deductible? Try Low Premium!</title>
            <link>http://www.medworm.com/index.php?rid=792800&amp;cid=t_107651_113_f&amp;fid=34657&amp;url=http%3A%2F%2Fscottshreeve.blogspot.com%2F2007%2F08%2Fhigh-deductible-try-low-premium.html</link>
            <description>Deductible (dĭ-dŭk'tə-bəl) n. 1. Something, such as an expense, that can be deducted, as for income-tax purposes.2. A clause in an insurance policy that exempts the insurer from paying an initial specified amount in the event that the insured sustains a loss.I didn't really realize that I was such a stickler for words and the definitions of words. However, perhaps as a result of writing this blog (with my signature of having a definition to lead off each entry), I have become a novice wordsmith of sorts. I have also clearly been influenced by my recent reading of the Founding Fathers and their amazing use of the English language to playfully, persuasively, and powerfully make their point. Words do matter.I have been working a lot with health plans who are attempting to offer a &quot;Consume...</description>
            <author>Scott Shreeve, MD</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=792800</comments>
            <pubDate>Fri, 10 Aug 2007 01:30:00 +0100</pubDate>
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            <title>HIV/AIDS Treatment Forum at Duke University Medical Center</title>
            <link>http://www.medworm.com/index.php?rid=790577&amp;cid=t_107651_135_f&amp;fid=35263&amp;url=http%3A%2F%2Fronhudson.blogspot.com%2F2007%2F08%2Fblog-post_5142.html</link>
            <description>The Community Advisory Board and Staff of the Duke University AIDS Research and Treatment Center are hosting a forum on 22 August, 2007. This forum is to provide an update from this year's International Conference on AIDS and to discuss issues relating to HIV and aging.I know that there are many long-term survivors worldwide who are seeking answers about their specific issues as they continue to face emerging side-effects and disease progression. If anyone has questions that they would like me to ask at this forum, I will do so. Simply email me your questions and I will compile a list for the panel.Please note that the area code for the number to RSVP is 919. Click the invitation to enlarge it for reading. Categories: HIV AIDS HIV/AIDS Duke+University AIDS+Research AIDS+treatment Community...</description>
            <author>2sides2ron</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=790577</comments>
            <pubDate>Thu, 09 Aug 2007 15:34:00 +0100</pubDate>
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            <title>FDA Panels Would End Conflicts Of Interest, According To House Proposal</title>
            <link>http://www.medworm.com/index.php?rid=786023&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F141602918%2F</link>
            <description>That&amp;#8217;s the language attached to an agriculture appropriations bill passed by the House last week after a move by US Representative Maurice Hinchey, Democrat of New York. The funding measure heads to the Senate, where the language faces a tough fight - opponents include Ted Kennedy, the Senator from Massachusetts, The Boston Globe reports.
Hinchey&amp;#8217;s proposal goes further than a rule the FDA itself proposed earlier this year. The agency suggested barring panel members with financial ties to drug and medical device makers that exceed $50,000. Members whose grants or consulting fees totaled less than $50,000 during the previous 12 months would be allowed to serve on panels, but not vote. The FDA is still sifting public comments and has not issued a final proposal.
The issue has com...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=786023</comments>
            <pubDate>Tue, 07 Aug 2007 13:51:25 +0100</pubDate>
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            <title>FDA Tysabri Panel Violates New Conflict Rule</title>
            <link>http://www.medworm.com/index.php?rid=764506&amp;cid=t_107651_150_f&amp;fid=35777&amp;url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F138279447%2F</link>
            <description>You read it here first. Of the 16 voting members of the two committees meeting Tuesday - the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee - three members reported conflicts of interest, and received waivers. One, in particular, appears to violate the FDA&amp;#8217;s own, newly proposed rules for panel members.
First, Carol Koski, a retired neurology professor with the Guillain Barre Syndrome/CIDP Foundation International, reports holding up to $25,000 in stock in a competing company and Jim Neaton, a biostatistics professor at the University of Minnesota, says he is a consultant to a rival that pays up to $10,000 a year. You can read each waiver form here, here and here.
But Terry Davis, a professor of medicine and pediatrics at Louisiana...</description>
            <author>Pharmalot</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=764506</comments>
            <pubDate>Sat, 28 Jul 2007 15:30:18 +0100</pubDate>
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            <title>Reaction to ovarian cancer symptoms advisory</title>
            <link>http://www.medworm.com/index.php?rid=721312&amp;cid=t_107651_87_f&amp;fid=34865&amp;url=http%3A%2F%2Fwww.thecancerblog.com%2F2007%2F07%2F09%2Freaction-to-ovarian-cancer-symptoms-advisory%2F</link>
            <description>Filed under: Ovarian CancerAn interesting article came out this week at the San Diego Union-Tribune by Cheryl Clark discussing the new advisory regarding ovarian cancer symptoms. This advisory was issued in June from the Gynecologic Cancer Foundation, the Society of Gynecologic Oncologists and the American Cancer Society. The advisory lists four symptoms as possible signs of ovarian cancer: bloating, pelvic or abdominal pain, frequent or difficult urination, and feeling full quickly or having difficulty eating.Clark addresses physician reaction to this advisory, which is varied. Some doctors believe that the symptoms are vague and usually harmless and this advisory may cause overtesting or unnecessary anxiety. For example, Dr. Philip Young of Vista, CA said, &quot;This isn't going to save any l...</description>
            <author>The Cancer Blog</author>
            <type>blogs</type>
        <comments>http://www.medworm.com/rss/comments.php?id=721312</comments>
            <pubDate>Mon, 09 Jul 2007 04:00:00 +0100</pubDate>
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            <title>Physician Heal Thyself - Enhanced Role for Physicians as Trusted Advisors</title>
            <link>http://www.medworm.com/index.php?rid=611594&amp;cid=t_107651_113_f&amp;fid=34657&amp;url=http%3A%2F%2Fscottshreeve.blogspot.com%2F2007%2F05%2Fphysician-heal-thyself-enhanced-role.html</link>
            <description>Healing (hēl ng) v. To restore to health or soundness; cure. To set right; repair. To restore (a person) to wholeness.I previously highlighted a recent study by Booz Allen Hamilton regarding the Consumer Empowered movement and physician responses to it. I thought the physician responses were very both unfortunate and very telling:Positive Impact of Consumerism (from physician perspective)90% expect to see an increase in CDH plans over the next 5 years70% believe CDH will lead to greater attention to level of service55% consider CDH to be an enduring trend&gt;50% believe CDH will lead to greater attention to clinical qualityLess than 20% believe that increased consumerism will improve resultsBelieve that CDH wil most positively impact employers, plans, and patients the most benefitNegative Im...</description>
            <author>Scott Shreeve, MD</author>
            <type>blogs</type>
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            <pubDate>Wed, 09 May 2007 23:58:00 +0100</pubDate>
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