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	<title>An Inconvenient Woman &#187; Prescription Drug Side Effects</title>
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			<item>
		<title>Gardasil Economics</title>
		<link>http://iconicwoman.com/gardasil/gardasil-economics/</link>
		<comments>http://iconicwoman.com/gardasil/gardasil-economics/#comments</comments>
		<pubDate>Thu, 23 Apr 2009 06:43:43 +0000</pubDate>
		<dc:creator>H. Sandra Chevalier-Batik</dc:creator>
				<category><![CDATA[Gardasil]]></category>
		<category><![CDATA[Big Pharma Watch]]></category>
		<category><![CDATA[Cervical Cancer]]></category>
		<category><![CDATA[Children's Health]]></category>
		<category><![CDATA[Follow The Money]]></category>
		<category><![CDATA[Gardasil®]]></category>
		<category><![CDATA[Gynecology]]></category>
		<category><![CDATA[Health Advisory]]></category>
		<category><![CDATA[Health Care Costs]]></category>
		<category><![CDATA[HPV Vaccine]]></category>
		<category><![CDATA[Merck Consumer Pharmaceuticals Company]]></category>
		<category><![CDATA[NVIC]]></category>
		<category><![CDATA[PAP SMEAR]]></category>
		<category><![CDATA[PAP Test]]></category>
		<category><![CDATA[Prescription Drug Side Effects]]></category>
		<category><![CDATA[Reproductive Health]]></category>
		<category><![CDATA[STD Vaccination]]></category>
		<category><![CDATA[Vaginal Cancer]]></category>

		<guid isPermaLink="false">http://iconicwoman.com/?p=608</guid>
		<description><![CDATA[Part of public health policy is determining the best use of funds - to save or protect the most lives with the fewest resources. With all the demands on health care from heart disease, diabetes, AIDS, and other types of cancer, the economics for Gardasil don't add up.]]></description>
			<content:encoded><![CDATA[<p>On April 21st, 2009, Nick Batik posted this comment in response to a <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3NjZXB0aWNvbi53b3JkcHJlc3MuY29tLzIwMDkvMDQvMDMvZ2FyZGFzaWwvIA==" target=\"_self\">New Zealand-based Blog </a>that advocated the use of Gardasil noting that  “…there are considerable benefits to the vaccine and that there seem to be no significant drawback.”</p>
<p>I thought Nick’s response warranted reposting here. In the spirit of full disclosure, Nick Batik is my husband and partner in <a title=\"Pleiades Services.com\" href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5wbGVpYWRlc3NlcnZpY2VzLmNvbQ==" target=\"_blank\">Pleiades Publishing Services</a> and the designer of the <a title=\"Iconic Woman\" href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5pY29uaWN3b21hbi5jb20=" target=\"_self\">Iconic Woman</a> and  <a title=\"Holy Hormones\" href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5ob2x5aG9ybW9uZXMuY29t" target=\"_self\">Holy Hormone</a> sites.</p>
<h2><em>Gardasil, By The Numbers</em></h2>
<p>I view the question of Gardasil more from and economic prospective:</p>
<p>US 2000 Census places girls age 10-14 at 6.9% of the total female population of 151,627,727.<br />
That would be 10,462,313 girls.</p>
<p>Gardasil is currently on the market for $120 per single dose. Three doses are required over a 6-month period, making the total cost for the HPV vaccine $360. On top of that, some doctors are charging office visit fees when the vaccine is given.</p>
<p>That would be a total expenditure of $3,766,432,680 not including office visits. In your article you state that 11,070 cases of cervical cancer were reported in the US. Assuming that 100% of those could be prevented by Gardasil (which it cannot &#8211; it only affect 4 of the 72 variations) that would be a cost per case of $340,238.</p>
<p>If you look at the 11,070 reported cases, 3,870 resulted in death. If you measure the cost of Gardasil based on the lives saved (again assuming 100% save rate), that would be $973,238 spent per life. It should be noted that 7,200 (65%) did not die, and that had nothing to do with Gardasil.</p>
<p>Recent congressional reports indicate that an increasing number of cancer related deaths are due to “lack of access” to health care, as opposed to the failures of current treatments. The relatively high cost of the vaccine is just as much a barrier to the poor and uninsured &#8211; those most at risk.</p>
<p>The World Health Organization states that there are a number of low-cost, highly effective diagnostic screening options (e.g. PAP test &#8211; avg. $27 USD<span style="color: #993300;">*</span>) and that cervical cancer is one of the most treatable (with access to health care).<br />
<span style="color: #993300;">*NOTE:  Using PAP Test Recommended guidelines for most women from:<br />
<a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy53b21lbnNoZWFsdGguZ292L2ZhcS9wYXAtdGVzdC5jZm0jcGFwMDQ=" target=\"_self\">http://www.womenshealth.gov/faq/pap-test.cfm#pap04</a><br />
</span></p>
<ul>
<li><span style="color: #993300;">If you are younger than 30 years old, you should get a Pap test every year.</span></li>
<li><span style="color: #993300;">If you are age 30 or older and have had 3 normal Pap tests for 3 years in a row, talk to your doctor about spacing out Pap tests to every 2 or 3 years.</span></li>
<li><span style="color: #993300;">If you are ages 65 to 70 and have had at least 3 normal Pap tests and no abnormal Pap tests in the last 10 years, ask your doctor if you can stop having Pap tests.</span></li>
</ul>
<p><span style="color: #993300;"><strong>It would be a reasonable expectation for a woman to have 25 PAP test throughout her lifetime</strong>. <strong>At $27 USD per test, a woman would invest $675 USD for a life time cervical cancer prevention plan.</strong> </span></p>
<p><span style="color: #993300;">Lets be real clear here — even with the Gardasil HPV vaccine the current medical direction is to continued with your regular PAP test schedule. So why risk the possible side effects of the vaccine?</span></p>
<p>One great unanswered question: increasing outbreaks of diseases though to be eradicated or under control has shown that the efficacy of inoculations given to school age children diminishes over time. Since cervical cancer does not manifest in most women until after age 40, will the Gardasil treatment still be effective, or will it need to administered again?</p>
<p>Considering the number of high-death rate diseases, is this REALLY the best use of our limited health care resources?</p>
<p>Resources:<br />
<a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL2ZhY3RmaW5kZXIuY2Vuc3VzLmdvdi9zZXJ2bGV0L1NUVGFibGU/X2JtPXkmYW1wOy1nZW9faWQ9MDEwMDBVUyZhbXA7LXFyX25hbWU9QUNTXzIwMDdfM1lSX0cwMF9TMDEwMSZhbXA7LWRzX25hbWU9QUNTXzIwMDdfM1lSX0cwMF8=">http://factfinder.census.gov/servlet/STTable?_bm=y&amp;-geo_id=01000US&amp;-qr_name=ACS_2007_3YR_G00_S0101&amp;-ds_name=ACS_2007_3YR_G00_</a></p>
<p>&copy;2012 <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL2ljb25pY3dvbWFuLmNvbQ==">An Inconvenient Woman</a>. All Rights Reserved.</p>. <img src="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?view=1&post_id=608" width="1" height="1" style="display: none;" />]]></content:encoded>
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		<item>
		<title>HPV Vaccine, Not Immune to Controversy</title>
		<link>http://iconicwoman.com/gardasil%c2%ae/hpv-vaccine-not-immune-to-controversy/</link>
		<comments>http://iconicwoman.com/gardasil%c2%ae/hpv-vaccine-not-immune-to-controversy/#comments</comments>
		<pubDate>Wed, 07 Jan 2009 18:16:12 +0000</pubDate>
		<dc:creator>H. Sandra Chevalier-Batik</dc:creator>
				<category><![CDATA[Gardasil®]]></category>
		<category><![CDATA[Big Pharma Watch]]></category>
		<category><![CDATA[Cervical Cancer]]></category>
		<category><![CDATA[HPV Infection]]></category>
		<category><![CDATA[HPV Vaccine]]></category>
		<category><![CDATA[Prescription Drug Side Effects]]></category>

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		<description><![CDATA[The introduction of Gardasil (Merck &#038; Co, Whitehouse
Station, NJ, USA) as a vaccine to the human papillomavirus
(HPV) has received much media attention worldwide since its
approval by the US Food and Drug Administration in 2006.
From the United States to the United Kingdom, New Zealand,
and Malaysia, news headlines have highlighted various issues
and controversies surrounding the HPV vaccine. ]]></description>
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<p>&copy;2012 <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL2ljb25pY3dvbWFuLmNvbQ==">An Inconvenient Woman</a>. All Rights Reserved.</p>. <img src="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?view=1&post_id=345" width="1" height="1" style="display: none;" />]]></content:encoded>
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		</item>
		<item>
		<title>More Questions About Gardasil®</title>
		<link>http://iconicwoman.com/gardasil%c2%ae/more-questions-about-gardasil%c2%ae/</link>
		<comments>http://iconicwoman.com/gardasil%c2%ae/more-questions-about-gardasil%c2%ae/#comments</comments>
		<pubDate>Mon, 13 Oct 2008 14:51:23 +0000</pubDate>
		<dc:creator>H. Sandra Chevalier-Batik</dc:creator>
				<category><![CDATA[Gardasil®]]></category>
		<category><![CDATA[STD Infection]]></category>
		<category><![CDATA[adverse event]]></category>
		<category><![CDATA[Big Pharma Watch]]></category>
		<category><![CDATA[Cancer]]></category>
		<category><![CDATA[Centers for Disease Control and Prevention]]></category>
		<category><![CDATA[Cervical Cancer]]></category>
		<category><![CDATA[CNN]]></category>
		<category><![CDATA[FDA Failure To Protect]]></category>
		<category><![CDATA[federal government]]></category>
		<category><![CDATA[fever]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
		<category><![CDATA[HPV]]></category>
		<category><![CDATA[HPV Infection]]></category>
		<category><![CDATA[HPV Vaccine]]></category>
		<category><![CDATA[Laura Parsons]]></category>
		<category><![CDATA[media outlets]]></category>
		<category><![CDATA[Merck & Co.]]></category>
		<category><![CDATA[Merck & Co. Inc.]]></category>
		<category><![CDATA[Michael McLaren]]></category>
		<category><![CDATA[nausea]]></category>
		<category><![CDATA[pain]]></category>
		<category><![CDATA[pancreatitis]]></category>
		<category><![CDATA[Prescription Drug Side Effects]]></category>
		<category><![CDATA[Questionable Medicine]]></category>
		<category><![CDATA[STD Vaccination]]></category>
		<category><![CDATA[vaccination]]></category>
		<category><![CDATA[vaccines]]></category>
		<category><![CDATA[Woman’s Health]]></category>

		<guid isPermaLink="false">http://iconicwoman.com/?p=259</guid>
		<description><![CDATA[A Recent CNN Article lead with this headline&#8230; Gardasil® Deaths, Gardasil® Side Effects, Gardasil® Paralysis - Is the HPV Vaccine Given to Prevent Cervical Cancer Causing More Medical Problems? A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems. Gardasil® has [...]]]></description>
			<content:encoded><![CDATA[<p>A Recent CNN Article lead with this headline&#8230;</p>
<h2>Gardasil® Deaths, Gardasil® Side Effects, Gardasil® Paralysis -</p>
<p>Is the HPV Vaccine Given to Prevent Cervical Cancer Causing More Medical Problems?</h2>
<p>A vaccine designed to prevent cervical cancer is coming under fresh scrutiny amid thousands of complaints linking it to a range of health problems.</p>
<p>Gardasil® has been the subject of 7,802 &#8220;adverse event&#8221; reports from the time the Food and Drug Administration approved its use two years ago, according to the Centers for Disease Control and Prevention.</p>
<p>Girls and women have blamed the vaccine for causing ailments from nausea to paralysis &#8212; even death. Fifteen deaths were reported to the FDA, and 10 were confirmed, but the CDC says none of the 10 were linked to the vaccine. The CDC says it continues to study the reports of illness.</p>
<p>Gardasil prevents the spread of human papillomavirus, known as HPV &#8212; a sexually transmitted virus that can cause cervical cancer in a relatively small number of girls and women.</p>
<p>The vaccine&#8217;s manufacturer, Merck &amp; Co. Inc., says it has distributed more than 26 million Gardasil® vaccines worldwide, including nearly 16 million in the United States. It estimates that 8 million girls and women have received the vaccine in the United States since June 2006. V</p>
<p>Two girls allege in court that the vaccine made them sick.</p>
<p>One &#8212; Jesalee Parsons of Broken Bow, Oklahoma &#8212; got the shot at age 13.</p>
<p>Jesalee&#8217;s lawyer, Michael McLaren, said she got the shot on February 27, 2007 and soon developed a fever and felt pain. The next day, he said, Jesalee felt pain in her chest and abdomen.</p>
<p>Her mother, Laura Parsons, said Jesalee spent weeks in the hospital and underwent two surgeries after developing pancreatitis. She says the federal government should have studied the drug more before approving its use.</p>
<p>&#8220;I just feel let down by the government,&#8221; Parsons said.</p>
<p>Merck says it could be a coincidence that the girls got sick after receiving the vaccine.</p>
<p>The company said in a statement that an adverse event report &#8220;does not mean that a causal relationship between an event and vaccination has been established &#8212; just that the event occurred after vaccination.&#8221;</p>
<p>Merck said it would continue to evaluate reports of adverse reactions. It said it &#8220;updates product labels with new safety information as appropriate.&#8221;</p>
<p><span class="cnnEmbeddedMosLnk"><img src="http://i2.cdn.turner.com/cnn/.element/img/2.0/mosaic/tabs/video.gif" border="0" alt="Video" width="16" height="14" /> <a onclick=\"CNN_changeMosaicTab('cnnVideoCmpnt','videos.html',true,'/video/health/2008/07/07/cohen.gardasil.cnn');\" href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5jbm4uY29tLzIwMDgvSEVBTFRIL2NvbmRpdGlvbnMvMDcvMDcvY2VydmljYWwuY2FuY2VyLnZhY2NpbmUvI2NublNUQ1ZpZGVv">Watch more on complications linked to Gardasil »</a></span></p>
<p>For Full Article and more video go to:</p>
<p><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5jbm4uY29tLzIwMDgvSEVBTFRIL2NvbmRpdGlvbnMvMDcvMDcvY2VydmljYWwuY2FuY2VyLnZhY2NpbmUv">http://www.cnn.com/2008/HEALTH/conditions/07/07/cervical.cancer.vaccine/</a></p>
<p><em>A sincere thank you to major media outlets, CNN, the Washington Post and the New York Times, for following and reporting the Gardasil® adverse events and asking probing questions about the safety and effectiveness of this aggressively-marketed  Merck product.</em></p>
<p>&copy;2012 <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL2ljb25pY3dvbWFuLmNvbQ==">An Inconvenient Woman</a>. All Rights Reserved.</p>. <img src="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?view=1&post_id=259" width="1" height="1" style="display: none;" /><p><a class="a2a_dd a2a_target addtoany_share_save" href="http://www.addtoany.com/share_save#url=http%3A%2F%2Ficonicwoman.com%2Fgardasil%25c2%25ae%2Fmore-questions-about-gardasil%25c2%25ae%2F&amp;title=More%20Questions%20About%20Gardasil%C2%AE" id="wpa2a_2"><img src="http://iconicwoman.com/wp-content/plugins/add-to-any/share_save_256_24.png" width="256" height="24" alt="Share"/></a></p>]]></content:encoded>
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		<item>
		<title>New Safety Information Identified by the Adverse Event Reporting System (AERS)</title>
		<link>http://iconicwoman.com/adverse-event-reporting-system/new-safety-information-identified-by-the-adverse-event-reporting-system-aers/</link>
		<comments>http://iconicwoman.com/adverse-event-reporting-system/new-safety-information-identified-by-the-adverse-event-reporting-system-aers/#comments</comments>
		<pubDate>Sun, 07 Sep 2008 15:57:00 +0000</pubDate>
		<dc:creator>H. Sandra Chevalier-Batik</dc:creator>
				<category><![CDATA[Adverse Event Reporting System]]></category>
		<category><![CDATA[Big Pharma Watch]]></category>
		<category><![CDATA[Center for Biologics Evaluation and Research]]></category>
		<category><![CDATA[Center for Drug Evaluation and Research]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[FDA Press Release]]></category>
		<category><![CDATA[Food and Drug Administration]]></category>
		<category><![CDATA[healthcare providers]]></category>
		<category><![CDATA[Prescription Drug Side Effects]]></category>
		<category><![CDATA[safety communications]]></category>
		<category><![CDATA[Woman’s Health]]></category>

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		<description><![CDATA[Potential Signals of Serious Risks What is FDA posting? The following reports list any potential signals of serious risks/new safety information that were identified using the AERS database during the indicated quarter. The appearance of a drug on this list does not mean that FDA has concluded that the drug has this listed risk. It [...]]]></description>
			<content:encoded><![CDATA[<h2>Potential Signals of Serious Risks</h2>
<h3>What is FDA posting?</h3>
<p>The following reports list any potential signals of serious risks/new safety information that were identified using the AERS database during the indicated quarter. The appearance of a drug on this list does not mean that FDA has concluded that the drug has this listed risk. It means that FDA has identified a <strong><em>potential safety issue</em></strong>, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.</p>
<p>FDA wants to emphasize that the listing of a drug and a potential signal of a serious risk/new safety information on this Web site does not mean that FDA is suggesting that healthcare providers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider.</p>
<p>FDA will complete its evaluation of each potential safety issue and may issue additional public communications as appropriate.</p>
<h3>Why is FDA posting this information?</h3>
<p>FDA is posting these reports in accordance with Title IX, Section 921 of the Food and Drug Administration Amendments Act of 2007 (FDAAA; <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5mZGEuZ292L2NkZXIvYWVycy9wb3RlbnRpYWxfc2lnbmFscy9kZWZhdWx0Lmh0bSNpbnNlcnQ=">see insert</a>).  FDA will publish a new list of potential signals of serious risks/new safety information identified each quarter.</p>
<table border="1" cellspacing="0" cellpadding="2" width="90%" align="center" summary="Insert: Title IX, Section 921 of the Food and Drug Administration Amendments Act 2007 (FDAAA) (121 Stat. 962) amends the Federal Food, Drug and Cosmetic Act (FDCA) to add a new subsection (k)(5) to section 505 (21 U.S.C. 355). ">
<tbody>
<tr>
<td><a name="insert"></a>Title IX, Section 921 of the Food and Drug Administration Amendments Act 2007 (FDAAA) (121 Stat. 962) amends the Federal Food, Drug and Cosmetic Act (FDCA) to add a new subsection (k)(5) to section 505 (21 U.S.C. 355).</p>
<p>This section in FDAAA, among other things, directs FDA to &#8220;conduct regular, bi-weekly screening of the Adverse Event Reporting System [AERS] database and post a quarterly report on the Adverse Event Reporting System Web site of any new safety information or potential signal of a serious risk identified by Adverse Event Reporting System within the last quarter.&#8221; When a potential signal of a serious risk is identified from AERS data, it will be posted in the required report in the quarter in which it is first identified. A potential signal of a serious risk may in some cases constitute new safety information as defined in FDAAA (newly created section 505-1(b)(3) of the FDCA) which includes, among other things, information derived from adverse event reports about a serious risk associated with use of a drug that FDA has become aware of since the drug was approved or, for drugs that have REMS, since the REMS was required or last assessed. FDA will post each potential signal of a serious risk in the quarter in which it is first identified. If additional new safety information is developed concerning a potential signal that has already been posted, it will be addressed by FDA in new safety communications, but will not appear again as a new quarterly posting.</td>
</tr>
</tbody>
</table>
<h3>How was the list generated?</h3>
<p>FDA staff in the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) regularly examine the AERS database as part of routine safety monitoring. When a potential signal of a serious risk is identified from AERS data, it is entered as a safety issue into CDER&#8217;s Document Archiving, Reporting, and Regulatory Tracking System (DARRTS) or into CBER&#8217;s Therapeutics and Blood Safety Branch Safety Signal Tracking (SST) system. Potential signals of serious risks are normally based upon groups of AERS reports, although a single AERS report could lead to further evaluation of a potential safety issue.</p>
<h3>What information is provided?</h3>
<p>The table in each report lists the names of products and potential safety issues that were entered into the above CDER or CBER tracking systems where the AERS database identified (or contributed to identification of) the potential safety issues.</p>
<p>A new report will be made available each quarter showing newly identified potential signals of serious risks/new safety information identified from the AERS database during the previous quarter. Information from previous quarters will remain available on the website.</p>
<h4>Quarterly Reports</h4>
<ul>
<li><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5mZGEuZ292L2NkZXIvYWVycy9wb3RlbnRpYWxfc2lnbmFscy9wb3RlbnRpYWxfc2lnbmFsc18yMDA4UTEuaHRt">January 2008 to March 2008</a></li>
</ul>
<p align="center"><img src="http://www.fda.gov/cder/templates/graphics/totop_arrow.gif" border="0" alt="to top arrow" width="12" height="19" /> <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5mZGEuZ292L2NkZXIvYWVycy9wb3RlbnRpYWxfc2lnbmFscy9kZWZhdWx0Lmh0bSN0b3A=">Back               to Top</a> <img src="http://www.fda.gov/cder/templates/graphics/back_arrow.gif" border="0" alt="back arrow" width="12" height="14" /> <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5mZGEuZ292L2NkZXIvYWVycy9kZWZhdWx0Lmh0bQ==">Back to AERS</a></p>
<p>Date created: September 5, 2008</p>
<p>&copy;2012 <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL2ljb25pY3dvbWFuLmNvbQ==">An Inconvenient Woman</a>. All Rights Reserved.</p>. <img src="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?view=1&post_id=229" width="1" height="1" style="display: none;" /><p><a class="a2a_dd a2a_target addtoany_share_save" href="http://www.addtoany.com/share_save#url=http%3A%2F%2Ficonicwoman.com%2Fadverse-event-reporting-system%2Fnew-safety-information-identified-by-the-adverse-event-reporting-system-aers%2F&amp;title=New%20Safety%20Information%20Identified%20by%20the%20Adverse%20Event%20Reporting%20System%20%28AERS%29" id="wpa2a_4"><img src="http://iconicwoman.com/wp-content/plugins/add-to-any/share_save_256_24.png" width="256" height="24" alt="Share"/></a></p>]]></content:encoded>
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		<title>FDA Unveils List of 20 Drugs In Side-Effect Probes</title>
		<link>http://iconicwoman.com/adverse-event-reporting-system/fda-unveils-list-of-20-drugs-in-side-effect-probes/</link>
		<comments>http://iconicwoman.com/adverse-event-reporting-system/fda-unveils-list-of-20-drugs-in-side-effect-probes/#comments</comments>
		<pubDate>Sat, 06 Sep 2008 15:15:20 +0000</pubDate>
		<dc:creator>H. Sandra Chevalier-Batik</dc:creator>
				<category><![CDATA[Adverse Event Reporting System]]></category>
		<category><![CDATA[arthritis]]></category>
		<category><![CDATA[AstraZeneca PLC]]></category>
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		<category><![CDATA[cardiac arrest]]></category>
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		<description><![CDATA[Goal Is to Provide Signs of Possibility Of Adverse Effects By JARED A. FAVOLE WSJ.com, September 5, 2008 8:07 p.m. WASHINGTON &#8212; The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care [...]]]></description>
			<content:encoded><![CDATA[<h2>Goal Is to Provide Signs of Possibility Of Adverse Effects</h2>
<p>By <em>JARED A. FAVOLE</em></p>
<p>WSJ.com, September 5, 2008 8:07 p.m.</p>
<p>WASHINGTON &#8212; The Food and Drug Administration on Friday unveiled a report listing 20 drugs that the agency is investigating for potential side effects, as part of a new policy to warn patients and health-care professionals as early as possible.</p>
<p>The list includes a wide array of drugs, from <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL29ubGluZS53c2ouY29tL3F1b3Rlcy9tYWluLmh0bWw/dHlwZT1kam4mYW1wO3N5bWJvbD1sbHk=">Eli Lilly</a> &amp; Co.&#8217;s antidepressant Cymbalta to Purdue Pharma LP&#8217;s painkiller Oxycontin. It also addresses a range of adverse reactions, including cardiac arrest, cancer and Purple Glove Syndrome, which can result in patients having their arms amputated. (<a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5mZGEuZ292L2NkZXIvYWVycy9wb3RlbnRpYWxfc2lnbmFscy9wb3RlbnRpYWxfc2lnbmFsc18yMDA4UTEuaHRt">See the FDA&#8217;s list of drugs that are under investigation.)</a></p>
<p>The FDA has already sent out warnings about a handful of the drugs on the list. The report lists TNF blockers &#8212; such as <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL29ubGluZS53c2ouY29tL3F1b3Rlcy9tYWluLmh0bWw/dHlwZT1kam4mYW1wO3N5bWJvbD1KTko=">Johnson &amp; Johnson&#8217;</a>s Remicade &#8212; as being potentially associated with cancer in children. In June, the FDA said it was investigating the possible link. TNF blockers target a compound known as tumor necrosis factor, which is overproduced in many patients with inflammatory diseases like arthritis and Crohn&#8217;s.</p>
<p>But there appear to be new ones, too. The report lists <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL29ubGluZS53c2ouY29tL3F1b3Rlcy9tYWluLmh0bWw/dHlwZT1kam4mYW1wO3N5bWJvbD1iaWli">Biogen Idec</a> Inc. and <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL29ubGluZS53c2ouY29tL3F1b3Rlcy9tYWluLmh0bWw/dHlwZT1kam4mYW1wO3N5bWJvbD1lbG4=">Elan</a> Corp.&#8217;s multiple-sclerosis treatment Tysabri as potentially being associated with skin cancer. Medical journals have reported cases of melanoma in patients taking Tysabri, but the FDA hasn&#8217;t previously said it was investigating the drug for this side effect.</p>
<p>The list, which the FDA will start issuing quarterly, is aimed at giving consumers and health-care professionals early indications of what the FDA is investigating, but it might end up creating more confusion. Indeed, the agency is concerned &#8220;that people will stop taking a drug inappropriately&#8221; because it is on the list, said Paul Seligman, associate director of safety policy at the agency.</p>
<p>The FDA said it alerted companies whose drugs appeared on the list prior to it being made public &#8212; several companies said they received word late Thursday &#8212; and intends to give drug makers a heads-up in the future as well.</p>
<p>Drug makers said they support the FDA&#8217;s additional efforts to be transparent about drug safety, but some expressed concern that the information was being communicated to patients without context and wondered about what patients might do with the information.</p>
<p>&#8220;It is very, very important that patients and their physicians understand the benefits and the risks of the drug. To speak about one without the other could have an impact on patient perception of their medications,&#8221; said Tony Jewell, a spokesman for <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL29ubGluZS53c2ouY29tL3F1b3Rlcy9tYWluLmh0bWw/dHlwZT1kam4mYW1wO3N5bWJvbD1hem4=">AstraZeneca PLC</a>, whose psychiatric medication Seroquel made the list for the possible safety concern of overdose due to confusing sample-pack labeling.</p>
<p>Companies also cautioned that just because a drug is posted on the site doesn&#8217;t mean a causal relationship has been identified, and it is also risky if patients go off their medications without consulting a physician.</p>
<p>The FDA&#8217;s intention is for patients and doctors to use the list to be aware of potential adverse events and to encourage them to report any problems. The list doesn&#8217;t represent a comprehensive list of drugs the FDA is investigating, the FDA&#8217;s Mr. Seligman said.</p>
<p>The report is generated from the agency&#8217;s adverse-event-reporting database. That compilation consists of voluntary reports from patients and health-care professionals, and is widely considered to capture only a fraction of the actual adverse events associated with any given drug.</p>
<p>Mr. Seligman said the FDA is hopeful the quarterly reports will encourage people to report adverse events.</p>
<p>Write to Jared A. Favole at <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=amFyZWQuZmF2b2xlQGRvd2pvbmVzLmNvbQ==">jared.favole@dowjones.com</a></p>
<p>&copy;2012 <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL2ljb25pY3dvbWFuLmNvbQ==">An Inconvenient Woman</a>. All Rights Reserved.</p>. <img src="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?view=1&post_id=226" width="1" height="1" style="display: none;" /><p><a class="a2a_dd a2a_target addtoany_share_save" href="http://www.addtoany.com/share_save#url=http%3A%2F%2Ficonicwoman.com%2Fadverse-event-reporting-system%2Ffda-unveils-list-of-20-drugs-in-side-effect-probes%2F&amp;title=FDA%20Unveils%20List%20of%2020%20Drugs%20In%20Side-Effect%20Probes" id="wpa2a_6"><img src="http://iconicwoman.com/wp-content/plugins/add-to-any/share_save_256_24.png" width="256" height="24" alt="Share"/></a></p>]]></content:encoded>
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		<title>NY Times Exposes Merck Gardasil® Predatory Advertising Campaign</title>
		<link>http://iconicwoman.com/cervical-cancer/ny-times-exposes-merck-gardasil%c2%ae-predatory-advertising-campaign/</link>
		<comments>http://iconicwoman.com/cervical-cancer/ny-times-exposes-merck-gardasil%c2%ae-predatory-advertising-campaign/#comments</comments>
		<pubDate>Tue, 26 Aug 2008 00:57:57 +0000</pubDate>
		<dc:creator>H. Sandra Chevalier-Batik</dc:creator>
				<category><![CDATA[Cervical Cancer]]></category>
		<category><![CDATA[FDA Failure To Protect]]></category>
		<category><![CDATA[Follow The Money]]></category>
		<category><![CDATA[Gardasil®]]></category>
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		<description><![CDATA[Opportunistic marketing isn’t new. Mass merchandising of tobacco products to minors delivered millions of “Hooked for Life” or at least until premature death ‘users” for BIG TOBACCO. With recent regulations that allegedly limited marketing tobacco to minors, rapacious advertising agencies and armies of mercenaries (lobbyists) have moved to a new, even more, profitable venue —BIG [...]]]></description>
			<content:encoded><![CDATA[<p>Opportunistic marketing isn’t new. Mass merchandising of tobacco products to minors delivered millions of “Hooked for Life” or at least until premature death ‘users” for BIG TOBACCO. With recent regulations that allegedly limited marketing tobacco to minors, rapacious advertising agencies and armies of mercenaries (lobbyists) have moved to a new, even more, profitable venue —BIG PHARMA.</p>
<blockquote>
<p><em><strong>“Merck lobbied every opinion leader, women’s group, medical society, politicians, and went directly to the people — it created a sense of panic that says you have to have this vaccine now.”</strong></em></p></blockquote>
<p style="text-align: right;">— Dr. Diane Harper, a professor of medicine at Dartmouth Medical School</p>
<p style="text-align: left;">
<p>Those who follow BIG PHARM have noticed some interesting trend-lines lurking in the infamous <em>‘9-point Helvetica, grey ink</em>’ Corporate 10-K, Annual Reports. Over the past several years, research budgets trended downward, while “Marketing” expenditures accelerated.</p>
<h3>What would be considered a BIG PHARMA marketing expense?</h3>
<p style="text-align: left;">
<p>Marketing expenses would include clever print and electronic media ads, along with brochures for health professionals. This print material is usually given to Doctors at <em>“Sponsored” </em>events,<em> “Educational”</em> resort-based retreats, private dinners, and that basic and most appreciated pharmaceutical freebee, the “<em>Free Lunch”</em>! On any given day an army of pharmaceutical reps drop off Lunches and other<em> “Goodie packages”</em> to busy practices with free drug samples and good cheer.</p>
<p>Speaking of “good cheer” Marketing expenses also include BIG PHARMA lobbyists spending largest amongst the very representatives “we the people” sent to our local, state, and federal to look after our interest. The amount of cash laid down by MERCK in 2005-2006 to grease the skids for one of the fastest new drug roll outs yet witnessed is staggering. Whoever said you couldn’t buy happiness, hasn’t talked to a MERCK stockholder.</p>
<p>Go to: <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5ueXRpbWVzLmNvbS8yMDA4LzA4LzIwL2hlYWx0aC9wb2xpY3kvMjB2YWNjaW5lLmh0bWw/c2NwPTImYW1wO3NxPSZhbXA7c3Q9bnl0">THE EVIDENCE GAP; Drug Makers’ Push Leads to Cancer Vaccines’ Rise </a></p>
<p><em>August 20, 2008 &#8211; By ELISABETH ROSENTHAL (NYT) &#8211; Front Page –</p>
<p>… DRUG MAKERS’ BIG PUSH A marketing campaign in the United States and Europe by Merck has made Gardasil, its cervical cancer vaccine, a best seller. Cervarix, a similar vaccine from GlaxoSmithKline, has also proved popular, and profitable.</em></p>
<h3>Read the full article and send the link out to anyone who cares about the health issues of women and girls!</h3>
<h2>Inconvenient Women do not get angry…We get ACTIVE!!</h2>
<p style="text-align: left;">
<p><em><strong>The lobbyist/legislator ‘hook-up’ only works if no one is looking. Make sure your representatives know you are watching them and are holding them accountable for the health and wellfare of the nations’ women and girls</strong></em>.</p>
<p>&copy;2012 <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL2ljb25pY3dvbWFuLmNvbQ==">An Inconvenient Woman</a>. All Rights Reserved.</p>. <img src="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?view=1&post_id=204" width="1" height="1" style="display: none;" /><p><a class="a2a_dd a2a_target addtoany_share_save" href="http://www.addtoany.com/share_save#url=http%3A%2F%2Ficonicwoman.com%2Fcervical-cancer%2Fny-times-exposes-merck-gardasil%25c2%25ae-predatory-advertising-campaign%2F&amp;title=NY%20Times%20Exposes%20Merck%20Gardasil%C2%AE%20Predatory%20Advertising%20Campaign" id="wpa2a_8"><img src="http://iconicwoman.com/wp-content/plugins/add-to-any/share_save_256_24.png" width="256" height="24" alt="Share"/></a></p>]]></content:encoded>
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		<title>Skip The Drugs&#8230;Change Your Food Sources</title>
		<link>http://iconicwoman.com/big-pharma-watch/skip-the-drugschange-your-food-sources/</link>
		<comments>http://iconicwoman.com/big-pharma-watch/skip-the-drugschange-your-food-sources/#comments</comments>
		<pubDate>Thu, 21 Aug 2008 17:14:33 +0000</pubDate>
		<dc:creator>H. Sandra Chevalier-Batik</dc:creator>
				<category><![CDATA[Big Pharma Watch]]></category>
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		<description><![CDATA[Deficit Hyperactivity Disorder (ADHD) I was doing some research for a fiend whose child had just been “diagnosed&#8221; Deficit Hyperactivity Disorder (ADHD) by a school nurse who suggested drug therapy. My first thought was a Kindergarten version of ‘One Flew Over the Cuckoo&#8217;s Nest’…dazed and compliant preschoolers. In the past decade, ADHD, ”Deficit Hyperactivity Disorder, [...]]]></description>
			<content:encoded><![CDATA[<h2>Deficit Hyperactivity Disorder (ADHD)</h2>
<p>I was doing some research for a fiend whose child had just been “diagnosed&#8221; Deficit Hyperactivity Disorder (ADHD) by a school nurse who suggested drug therapy. My first thought was a Kindergarten version of<em><strong> ‘One Flew Over the Cuckoo&#8217;s Nest’</strong></em>…dazed and compliant preschoolers.</p>
<p>In the past decade, ADHD, ”Deficit Hyperactivity Disorder, a neurobehavioral developmental disorder has become one of the most commonly diagnosed conditions of childhood, and is being increasingly diagnosed in adults. ADHD is characterized by a persistent pattern of inattention and/or hyperactivity, as well as forgetfulness, poor impulse control or impulsivity, and distractibility. The pharmaceutical medical industrial complex currently considers ADHD a “persistent and chronic condition for which no medical cure is available. Methods of treatment usually involve some combination of medications, behavior modifications, life style changes, and counseling. <em><strong>(BTW side effects aside, MEDICAL TREATMENT is spelled with two-cha-chings!)</strong></em></p>
<p>So how do most ‘school nurses’, Physicians’ assistants and doctors come up with the very common ADHD diagnosis? Most medical professions use the <em><strong>“Desk Reference to the Diagnostic Criteria From DSM-IV-TR®”</strong></em>, compiled by American Psychiatric Association. Available in a spiral-bound book, and online accessible by computer, or PDA, the diagnostic criteria from DSM-IV-TR® is one of the most commonly used tools used by Physicians and other “prescribing” health care professions. Another ‘tool’, Desk Reference (PDR), which includes every prescription drug package insert. The guides serve as ‘medical cliff notes’, listing symptoms, probably diagnosis, suggested drug protocols, prescription drug side effect information and possible drug interactions.</p>
<p>Guidelines issued by the American Academy of Pediatrics recommend medications like <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5jb25jZXJ0YS5uZXQvY29uY2VydGE=">CONCERTA®</a>  among first-line therapies for children with ADHD as part of a comprehensive treatment program.  Go to the <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5jb25jZXJ0YS5uZXQvY29uY2VydGE=">CONCERTA® website</a>(1), READ the SIDE EFFECTS.</p>
<p>What rational person would suggest a little kid’s developing brain be put at risk, to assure social compliance? I knew there had to be a better way to deal with “the fidgets” so I did what Inconvenient Women do best, I looked stuff up, and sent the results out to a few thousand of my closets friends.</p>
<p>In September of 2007, <em><strong>William Atkins</strong></em> did a brillant, if little noted, piece on hyperactivity in children. I found it on <strong>IWIRE</strong> one of my favorite obscure resource sources. For the full article go to: <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5pdHdpcmUuY29tL2NvbnRlbnQvdmlldy8xNDM5OS8xMDY2Lw==">http://www.itwire.com/content/view/14399/1066/</a></p>
<h3>Study links hyper kids with artificial preservatives and colorings</h3>
<p><strong>Sodium benzoate and other food preservatives and colorings have been linked with hyperactivity in children. Although such ingredients have been thought in the past to produce adverse behavior in children, this study is considered the first scientific evidence of its kind.</strong></p>
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<p>The British study from researchers at the University of Southampton, England, has found that the food preservative sodium benzoate (also called benzoate of soda, with chemical formula C<sub>6</sub>H<sub>5</sub>COONa), when found with food dyes and colorings, can increase hyperactive behavior in children. <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL21vbmV5LmNubi5jb20vMjAwNy8wOS8wNy9uZXdzL2NvbXBhbmllcy9zb2RpdW1fYmVuem9hdGUvP3Bvc3R2ZXJzaW9uPTIwMDcwOTA3MTg=" target=\"_blank\">Jim Stevenson</a>, psychologist at the University of Southampton, and lead researcher of the study states, <em>“We now have clear evidence that mixtures of certain food colors and benzoate preservative can adversely influence the behavior of children. We have now shown that for a large group of children in the general population, consumption of certain mixtures of artificial food colors and benzoate preservative can influence their hyperactive behavior.&#8221;</p>
<p></em></p>
<p>Food colorings and preservatives&#8211;which are often found in sweets such as ice cream, candy, and soda, what children love to eat&#8211;were studied. For six weeks over one hundred fifty randomly three-year-olds and over one hundred forty randomly eight-year-olds, in Southampton, England, were studied as to their diet.</p>
<p>The children displayed behaviors previous to the study ranging from normal to hyperactive.</p>
<p>They were provided food that was free of additives. Each day they were given one drink, either fruit juice or one of two mixtures of sodium benzoate preservative and food colorings. One mixture contained sodium benzoate and sunset yellow, tartrazine, carmoisine, and ponceau. The other mixture contained sunset yellow quinoline yellow, carmoisine, and allura red. They were not told which they were given, the fruit juice or one of the two mixtures.</p>
<p>The children who were given the benzoate preservative and food coloring mixtures showed, in some cases, more hyperactive behavior than the children given fruit juice. However, the increases in hyperactive behavior were not consistent between the two mixtures. The researchers contend that the hyperactive behavior may be linked to sodium benzoate and one or more of the specific artificial colorings, rather than to all of the colorings.</p>
<p>The U.S.$1.5 million study was funded by the British <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5mb29kLmdvdi51ay8=" target=\"_blank\">Food Standards Agency</a> (FSA) and written up on September 6, 2007, in the journal <em>The Lancet</em>.</p>
<p>From the <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5mb29kLmdvdi51ay9uZXdzL25ld3NhcmNoaXZlLzIwMDcvc2VwL2Zvb2Rjb2xvdXJz" target=\"_blank\">website of the Food Standards Agency</a> comes this advise, <em>“Parents of children showing signs of hyperactivity are being advised that cutting certain artificial colours from their diets might have some beneficial effects. The colours – Sunset yellow (E110), Quinoline yellow (E104), Carmoisine (E122), Allura red (E129), Tartrazine (E102) Ponceau 4R (E124), and Sodium benzonate (E211) – were studied as part of new FSA-commissioned research.”</em></p>
<p>Within the Friday, September 7, 2007, FSA article “Agency revises advice on certain artificial colours”, Andrew Wadge, the FSA’s Chief Scientist, said: <em>“This study is a helpful additional contribution to our knowledge of the possible effects of artificial food colours on children’s behaviour.&#8221;</em></p>
<p><em>“After considering the COT’s </em>[Committee on Toxicity (COT)] <em>opinion on the research findings we have revised our advice to consumers: if a child shows signs of hyperactivity or Attention Deficit Hyperactivity Disorder (ADHD) then eliminating the colours used in the Southampton study from their diet might have some beneficial effects.”</p>
<p></em></p>
<p><em>“However, we need to remember that there are many factors associated with hyperactive behaviour in children. These are thought to include genetic factors, being born prematurely, or environment and upbringing.”</p>
<p></em></p>
<p><em>“The Agency has shared these research findings with the European Food Safety Authority (EFSA), which is currently conducting a review of the safety of all food colours that are approved for use in the European Union, at the request of the European Commission. This review is being undertaken because of the amount of time that has elapsed since these colours were first evaluated.”</p>
<p></em></p>
<p><em>“If parents are concerned about any additives they should remember that, by law, food additives must be listed on the label so they can make the choice to avoid the product if they want to.”</p>
<p></em></p>
<p><em><strong>[William Atkins' note: When buying foods, always LOOK at the labels. What you don’t read may hurt you and your loved ones when you consume such foods.]</strong></em></p>
<p>Inconvenient Women take action. If you know a mom who is drugging their child at the suggestion of a school nurse or family doctor, ask her to take this or other nutritional research to them and at least try to change their child&#8217;s diet before resorting to the BIG PHARM option.</p>
<p>If the child is a little girl, get her to a female pediatrician, specializing in precocious puberty. Girls as young as four and five years old are experiencing what their moms dealt with at twelve and thirteen. (See precocious puberty in IconicWoman article archive and go to: <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5Ib2x5SG9ybW9uZXMuY29t">http://www.HolyHormones.com</a>)</p>
<p>Explore every option before “medicating” compliant behavior.</p>
<p><em>(1) CONCERTA® and OROS® are registered trademarks of ALZA Corporation</p>
<p>© Ortho-McNeil-Janssen Pharmaceuticals, Inc. 2008. All rights reserved.</p>
<p>This site is published by McNeil Pediatrics™, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., which is solely responsible for its contents.</p>
<p>This site and its contents are intended for USA audiences only.</em></p>
<p>&copy;2012 <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL2ljb25pY3dvbWFuLmNvbQ==">An Inconvenient Woman</a>. All Rights Reserved.</p>. <img src="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?view=1&post_id=201" width="1" height="1" style="display: none;" /><p><a class="a2a_dd a2a_target addtoany_share_save" href="http://www.addtoany.com/share_save#url=http%3A%2F%2Ficonicwoman.com%2Fbig-pharma-watch%2Fskip-the-drugschange-your-food-sources%2F&amp;title=Skip%20The%20Drugs%26%238230%3BChange%20Your%20Food%20Sources" id="wpa2a_10"><img src="http://iconicwoman.com/wp-content/plugins/add-to-any/share_save_256_24.png" width="256" height="24" alt="Share"/></a></p>]]></content:encoded>
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		<title>Fentanyl (Duragesic) Patches Recalled</title>
		<link>http://iconicwoman.com/big-pharma-watch/fentanyl-duragesic-patches-recalled/</link>
		<comments>http://iconicwoman.com/big-pharma-watch/fentanyl-duragesic-patches-recalled/#comments</comments>
		<pubDate>Tue, 06 May 2008 16:36:16 +0000</pubDate>
		<dc:creator>H. Sandra Chevalier-Batik</dc:creator>
				<category><![CDATA[Big Pharma Watch]]></category>
		<category><![CDATA[Breast Cancer]]></category>
		<category><![CDATA[Prescription Drug Side Effects]]></category>
		<category><![CDATA[FDA Press Release]]></category>
		<category><![CDATA[Health Advisory]]></category>
		<category><![CDATA[Questionable Medicine]]></category>

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		<description><![CDATA[What are fentanyl skin patches? FENTANYL (Duragesic®, E-TRANS® Fentanyl) relieves moderate to severe chronic pain. Fentanyl patches are commonly used to treat pain associated with cancer. Once the patch is applied, the medicine is slowly absorbed through your skin into the bloodstream to help control your pain. Generic fentanyl skin patches are available. FDA Recalls [...]]]></description>
			<content:encoded><![CDATA[<h2>What are fentanyl skin patches?</h2>
<p>FENTANYL (Duragesic®, E-TRANS® Fentanyl) relieves moderate to severe chronic pain. Fentanyl patches are commonly used to treat pain associated with cancer. Once the patch is applied, the medicine is slowly absorbed through your skin into the bloodstream to help control your pain. Generic fentanyl skin patches are available.</p>
<h3>FDA Recalls and Safety Alerts</h3>
<p>Actavis recalled all remaining lots of Fentanyl transdermal patches as a precautionary measure. This is an expansion of Actavis’s February 2008 recall of fourteen lots of Fentanyl patches. For more details, see “Additional Information” below.</p>
<p>Several brands of fentanyl transdermal patches are being recalled because they may have defects that could allow the fentanyl gel to leak out of the patch. If the gel touches patient&#8217;s or caregiver&#8217;s skin, it could cause respiratory depression and possibly death.</p>
<p>One recall affects all U.S. lots of 25 mcg/hr Duragesic patches sold by PriCara, and its generic equivalent sold by Sandoz. All these patches are manufactured by the ALZA Corporation and have expiration dates of December 2009 or earlier. Anyone who has the recalled Duragesic patches should call 800-547-6446 for instructions on how to return them. Those who have the recalled Sandoz fentanyl patches should call 800-901-7236.</p>
<p>The second recall affects over a dozen lots of Actavis fentanyl patches in all strengths. [See UPDATE above.] Note that the pouch containing the fentanyl patch may have an Abrika Pharmaceuticals label, whereas the outer carton has the Actavis logo. Lot numbers can be found under &#8220;Additional Information&#8221; below. Anyone who has Actavis patches from the recalled lots should call 1-877-422-7452 for information on how to return them.</p>
<p>If you have a defective patch, dispose of it immediately by flushing it down the toilet, but be sure not to handle it directly. Anyone who comes in contact with fentanyl gel should rinse the exposed skin thoroughly with water. Do not use soap, because this could increase the drug&#8217;s absorption through the skin.</p>
<p>As a reminder, fentanyl is a very strong opioid narcotic. The patches should only be used by opioid-tolerant patients with chronic pain that is not well-controlled by other shorter-acting analgesics.</p>
<p>In addition, patients and caregivers should be educated about the signs and symptoms of fentanyl overdose, which include respiratory distress, shallow breathing, fatigue, sleepiness, confusion, dizziness and fainting. And be sure that patients understand how to use the patches properly, including how often to apply the patch, reapplying a patch that&#8217;s fallen off, replacing a patch, and disposing of the patch.</p>
<p>Finally, remember to tell patients that heat can increase absorption of the drug to dangerous levels, and so they should avoid heating pads, electric blankets, hot baths, sunbathing and other heat sources while the wearing the patch. And they should be cautioned to contact their doctor immediately if they develop a temperature above 102 degrees.</p>
<h3>Additional Information:</h3>
<p><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5mZGEuZ292L21lZHdhdGNoL3NhZmV0eS8yMDA4L3NhZmV0eTA4Lmh0bSNGZW50YW55bA==">FDA MedWatch Safety Alert</a>. Fentanyl transdermal system CII Patches. March 3, 2008.</p>
<p><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5mZGEuZ292L21lZHdhdGNoL3NhZmV0eS8yMDA4L3NhZmV0eTA4Lmh0bSNEdXJhZ2VzaWM="> FDA MedWatch Safety Alert.</a> Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches. <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5hY3RhdmlzLnVzL2VuL21lZGlhK2NlbnRlci9uZXdzcm9vbS9hcnRpY2xlcy9mZW50YW55bCtyZWNhbGwrZXhwYW5zaW9uLmh0bQ==">Actavis Press Release</a>. Actavis Recalls Remaining Fentanyl Patches in the U.S. as Precaution.</p>
<p>&copy;2012 <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL2ljb25pY3dvbWFuLmNvbQ==">An Inconvenient Woman</a>. All Rights Reserved.</p>. <img src="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?view=1&post_id=143" width="1" height="1" style="display: none;" /><p><a class="a2a_dd a2a_target addtoany_share_save" href="http://www.addtoany.com/share_save#url=http%3A%2F%2Ficonicwoman.com%2Fbig-pharma-watch%2Ffentanyl-duragesic-patches-recalled%2F&amp;title=Fentanyl%20%28Duragesic%29%20Patches%20Recalled" id="wpa2a_12"><img src="http://iconicwoman.com/wp-content/plugins/add-to-any/share_save_256_24.png" width="256" height="24" alt="Share"/></a></p>]]></content:encoded>
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		<title>Just Say &#8220;Know&#8221; to Prescription Drugs!</title>
		<link>http://iconicwoman.com/prescription-drug-side-effects/just-say-know-to-prescription-drugs/</link>
		<comments>http://iconicwoman.com/prescription-drug-side-effects/just-say-know-to-prescription-drugs/#comments</comments>
		<pubDate>Tue, 26 Sep 2006 20:48:36 +0000</pubDate>
		<dc:creator>H. Sandra Chevalier-Batik</dc:creator>
				<category><![CDATA[Prescription Drug Side Effects]]></category>
		<category><![CDATA[Your Body/Your Self]]></category>
		<category><![CDATA[Questionable Medicine]]></category>

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		<description><![CDATA[Coalition of Advocates Launch Just Say &#8220;Know&#8221; to Prescription Drugs Campaign &#8211; Declaring October &#8220;Just Say Know month,&#8221; effort aims to get one million people to take a second look at the drugs they are taking. A coalition of 10 organizations, advocates, healthcare professionals, academics and concerned citizens have launched a campaign to get one [...]]]></description>
			<content:encoded><![CDATA[<p><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5wc3ljaHRydXRoLm9yZy9KdXN0U2F5S25vd0Zvcm00LmRvYw=="><img src="http://www.psychtruth.org/JSN2.gif" /></a></p>
<p><strong>Coalition of Advocates Launch Just Say &#8220;Know&#8221; to Prescription Drugs Campaign &#8211; Declaring October &#8220;Just Say Know month,&#8221; effort aims to get one million people to take a second look at the drugs they are taking.</strong></p>
<p>A coalition of 10 organizations, advocates, healthcare professionals, academics and concerned citizens have launched a campaign to get one million people to go to their healthcare providers and ask,</p>
<p><em>&#8220;What am I really putting into my body?&#8221;</p>
<p>&#8220;What are the side effects?&#8221;</p>
<p>&#8220;What are the alternatives?&#8221;</em></p>
<p>The effort is called <em><strong>Just Say &#8220;Know&#8221; to Prescription Drugs</strong></em> and is driven by increasing evidence that many people are uninformed about the potential side effects of their prescribed medication and are not aware of less-risky alternatives.</p>
<p>The advocates are declaring October &#8220;Just Say Know to Prescription Drugs Month&#8221; and have scheduled a conference in Washington D.C. on October 7th to officially launch the campaign.</p>
<p>The conference will report that virtually all people are inadequately informed to assess the genuine risks of the drugs&#8211;or combination of drugs&#8211;they are taking and will suggest <em><strong>&#8220;informed consent as the solution.&#8221;</strong></em> Leading up to the event and throughout the month of October, the campaign coalition will unveil a national effort to get a million people to download a form that allows them to evaluate the drugs they are taking. The form collects specific information from their prescribing physicians, requiring the physician&#8217;s signature attesting that they have fully informed their patient of the risks and benefits of the prescribed medication as well as non-drug alternatives.</p>
<p>&#8220;Informed consent in the prescription of drugs is one of the most critical but missing pieces in the healthcare system today,&#8221; said Dr. Dominick Riccio, psychologist, Executive Director of the International Center for the Study of Psychiatry and Psychology, Inc, and chairman of the &#8220;Just Say Know&#8221; Campaign. <strong>&#8220;Every day intelligent people are taking prescription drugs that they simply don&#8217;t understand and the consequences of not knowing are increasingly dire,&#8221;</strong> said Riccio.</p>
<p>The campaign is being launched on the heels of a $500,000 national AARP campaign to gain public support for the purchase of drugs from foreign countries. The bill that AARP is backing was written by Sen. Byron Dorgan, D-N.D., has bipartisan support and would allow consumers to buy U.S. made prescription drugs from Canada and eventually from other countries. &#8220;This is an important initiative aimed at reducing the cost of prescription drugs. But the corollary is that many people are spending hundreds of dollars a month on prescriptions for which there may be low cost or no cost non-drug alternatives,&#8221; said Dr. Greg Tefft, co-founder of the Just Say Know to Prescription Drugs Campaign.</p>
<p>Organizations and individuals who want to participate may go to any of the following websites, look for the Just Say Know to Prescription Drugs logo, and download the sheet titled &#8220;Take This Form and Sign It.&#8221; Instructions will be provided on each form.</p>
<p><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5pY3NwcC5vcmc="><strong>International Center for the Study of Psychiatry and Psychology, Inc.</strong></a></p>
<p>Dominick Riccio, Ph.D.</p>
<p><strong><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3RydXRodHJ1c3Rjb25zZW50LmNvbQ==">The James Nayler Foundation</a></strong></p>
<p>Robert Johnson, MD.</p>
<p><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5wc3ljaHJpZ2h0cy5vcmc="></p>
<p><strong>The Law Project for Psychiatric Rights</strong></a></p>
<p>Jim Gottstein, J.D.</p>
<p><strong><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5vcnRob21lZC5vcmc=">Journal of Orthomolecular Medicine</a></strong></p>
<p>Abram Hoffer, MD.</p>
<p><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5zZWxmZ3Jvd3RoLmNvbQ=="></p>
<p><strong>SelfGrowth.com</strong></a></p>
<p>David Riklan</p>
<p><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=dHRwOi8vd3d3Lm1lc2ljc2ZpdG5lc3MuY29t"><strong>MESICS Fitness</strong></a></p>
<p>Jim Manganiello, Ed.D.</p>
<p><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5leGVyY2lzZWdyb3VwLmNvbS8="><strong>Natural Bodybuilding &amp; Fitness Magazines</strong></a></p>
<p>Steve Downs, Editor-in-Chief</p>
<p><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5wc3ljaHRydXRoLm9yZw=="><strong>Psych Truth.Org</strong></a></p>
<p>Laurence Simon Ph.D.</p>
<p><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5kcm1pY2hhZWxzaWViZXJ0LmNvbQ=="><strong>Dr. Michael Siebert</strong></a></p>
<p><a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL3d3dy5rcG5jcmFkaW8uY29t"><strong>KPNC Radio</strong></a></p>
<p>Dr.Greg Tefft</p>
<p><em><strong>&#8220;It&#8217;s time for all us to take more responsibility for our own health and to demand that our healthcare providers be more accountable to ensure that we are informed enough to make responsible choices,&#8221; said Dr. Laurence Simon, psychologist and vice chairman of the campaign. &#8220;Take two of these pills and call me in the morning is no longer acceptable,&#8221; said Simon.</strong></em></p>
<p>&copy;2012 <a href="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?url=aHR0cDovL2ljb25pY3dvbWFuLmNvbQ==">An Inconvenient Woman</a>. All Rights Reserved.</p>. <img src="http://iconicwoman.com/wp-content/plugins/wordpress-feed-statistics/feed-statistics.php?view=1&post_id=112" width="1" height="1" style="display: none;" /><p><a class="a2a_dd a2a_target addtoany_share_save" href="http://www.addtoany.com/share_save#url=http%3A%2F%2Ficonicwoman.com%2Fprescription-drug-side-effects%2Fjust-say-know-to-prescription-drugs%2F&amp;title=Just%20Say%20%26%238220%3BKnow%26%238221%3B%20to%20Prescription%20Drugs%21" id="wpa2a_14"><img src="http://iconicwoman.com/wp-content/plugins/add-to-any/share_save_256_24.png" width="256" height="24" alt="Share"/></a></p>]]></content:encoded>
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