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	<title>Cancer Treatment Today &#187; Medico-legal Issues</title>
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	<description>Knowledge is Power</description>
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		<title>Leukine recall &#8211; pro</title>
		<link>http://cancertreatmenttoday.org/leukine-recall-pro/</link>
		<comments>http://cancertreatmenttoday.org/leukine-recall-pro/#comments</comments>
		<pubDate>Sat, 01 Sep 2012 19:18:30 +0000</pubDate>
		<dc:creator>M Levin, MD</dc:creator>
				<category><![CDATA[Biologicals]]></category>
		<category><![CDATA[Chemotherapy]]></category>
		<category><![CDATA[Medico-legal Issues]]></category>
		<category><![CDATA[Professional]]></category>
		<category><![CDATA[Supportive Care]]></category>

		<guid isPermaLink="false">http://cancertreatmenttoday.org/?p=6010</guid>
		<description><![CDATA[LEUKINE has been FDA approved for use in multiple indications: For use following induction chemotherapy in older adults with Acute Myelogenous Leukemia (AML) For use in myeloid reconstitution after autologous bone marrow transplantation For use in myeloid reconstitution after allogeneic bone marrow transplantation For use in transplantation (BMT) failure or engraftment delay For use in [...]]]></description>
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<p>LEUKINE has been FDA approved for use in multiple indications: For use following induction chemotherapy in older adults with Acute Myelogenous Leukemia (AML)<br />
For use in myeloid reconstitution after autologous bone marrow transplantation<br />
For use in myeloid reconstitution after allogeneic bone marrow transplantation<br />
For use in transplantation (BMT) failure or engraftment delay<br />
For use in mobilization and following transplantation of autologous peripheral blood progenitor cells.</p>
<p>It is guideline (NCCN, ASCO) recommended for preventing and treatment of febrile neutropenia. ALthough it is an unusual choice (usually Neupogen or Neulasta would have been used), it remains a guideline recommended treatment and, therefore, medically necessary.</p>
<p>On 1/24 Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer.</p>
<p><a href="http://www.fda.gov/medwAtch/safety/2008/Leukine_DHCP_01-23-2008.pdf">http://www.fda.gov/medwAtch/safety/2008/Leukine_DHCP_01-23-2008.pdf</a></p>
<p>nccn.org, neutropenia</p>
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		<title>Bloodless stem cell transplants &#8211; pro</title>
		<link>http://cancertreatmenttoday.org/bloodless-stem-cell-transplants-pro/</link>
		<comments>http://cancertreatmenttoday.org/bloodless-stem-cell-transplants-pro/#comments</comments>
		<pubDate>Sat, 01 Sep 2012 19:16:37 +0000</pubDate>
		<dc:creator>M Levin, MD</dc:creator>
				<category><![CDATA[Allogeneic Stem Cell Transplantation]]></category>
		<category><![CDATA[Autologous Stem Cell Transplantation]]></category>
		<category><![CDATA[Concepts in Oncology]]></category>
		<category><![CDATA[Hematology]]></category>
		<category><![CDATA[Medico-legal Issues]]></category>
		<category><![CDATA[Professional]]></category>
		<category><![CDATA[Religion and Spirituality]]></category>
		<category><![CDATA[Technology Assessments]]></category>

		<guid isPermaLink="false">http://cancertreatmenttoday.org/?p=6008</guid>
		<description><![CDATA[With an estimated 6000000 Jehovah&#8217;s witnesses worldwide, haematologists may encounter patients who decline blood transfusions as a matter of personal belief.The risks of high-dose chemotherapy include life threatening bleeding from thrombocytopenia and profound anemia. Autologous stem cell transplantation is usually associated with the transfusion of 5 to 20 units of red blood cell or platelets, [...]]]></description>
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<p>With an estimated 6000000 Jehovah&#8217;s witnesses worldwide, haematologists may encounter patients who decline blood transfusions as a matter of personal belief.The risks of high-dose chemotherapy include life threatening bleeding from thrombocytopenia and profound anemia. Autologous stem cell transplantation is usually associated with the transfusion of 5 to 20 units of red blood cell or platelets, with the potential side-effects of infectious disease transmission, transfusion reactions, and iron overload. Inabilty ot ransfuse can be accommodates by increasing use of erythropoietin (although this was shown in one study not to change outcomes), minimizing blood collection and blood sparing techniques.</p>
<p>In recent years, several facilites, such as University of Pennsylvania,  have extended their bloodles surgery programs into the area of transplantation. However, this remains supported by case reports abd series only. It might be expected that only successful cases are published since a publication bias applies in this situation. It is also likely that some conditions are less suitable to this approach and this, as well as apropriate patietn selection,  must be explored in clinical trials.</p>
<p>K K Ballen et al,  Case Report  Successful autologous bone marrow transplant without the use of blood product support July 2000, Volume 26, Number 2, Pages 227-229</p>
<p>Estrin JT, Ford PA, Henry DH et al. Erythropoietin permits high-dose chemotherapy with peripheral blood stem-cell transplant for a Jehovah&#8217;s Witness. Am J Hematol 1997; 55: 51-52</p>
<p>Bone Marrow Transplant. 2008 Feb 4 [Epub ahead of print] Links<br />
SCT in Jehovah&#8217;s Witnesses: the bloodless transplant.Sloan JM, Ballen K..</p>
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		<title>Delay in diagnosis of head and neck cancer &#8211; pro</title>
		<link>http://cancertreatmenttoday.org/delay-in-diagnosis-of-head-and-neck-cancer-pro/</link>
		<comments>http://cancertreatmenttoday.org/delay-in-diagnosis-of-head-and-neck-cancer-pro/#comments</comments>
		<pubDate>Wed, 29 Aug 2012 02:13:50 +0000</pubDate>
		<dc:creator>M Levin, MD</dc:creator>
				<category><![CDATA[Head and Neck]]></category>
		<category><![CDATA[Medico-legal Issues]]></category>
		<category><![CDATA[Professional]]></category>

		<guid isPermaLink="false">http://cancertreatmenttoday.org/?p=5706</guid>
		<description><![CDATA[Diagnosis and treatmetn of head and neck cancer is complex and requires co-ordination or providers and resources. Delays in diagnosis is not uncommon. In a Canadian study, median patient, professional and total delays were 4.5 weeks, 11.8 weeks and 22.5 weeks, respectively. Significantly longer delays were found among women(p &#60; 0.01), non-smokers (p &#60; 0.01), [...]]]></description>
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<p>Diagnosis and treatmetn of head and neck cancer is complex and requires co-ordination or providers and resources. Delays in diagnosis is not uncommon. In a Canadian study, median patient, professional and total delays were 4.5 weeks, 11.8 weeks and 22.5 weeks, respectively. Significantly longer delays were found among women(p &lt; 0.01), non-smokers (p &lt; 0.01), patients who were not referred following initial consultation(p &lt; 0.001) and patients who did not visit their dentist (p &lt; 0.05). Delays in diagnosis was a major factor in malparctice litigation in the USA. A 2005 study found that the median delay was 3 months and the patients were responsible for the delay in most cases (n = 319, 81% and n = 160, 78%, respectively). Half the patients in each studies cohort had delayed diagnoses (n = 217, 54% and n = 119, 56%, respectively) and similar percentages (n = 110, 53% and n = 172, 47%) presented with advanced disease (stage III or IV). These were not the same patients for there was no correlation between delay and stage or survival. AN article in the New York Times Health Guide says that &#8220;Approximately 25% of people with oral cancer die because of delayed diagnosis and treatment.&#8221;(<a href="http://health.nytimes.com/health/guides/disease/oral-cancer/overview.html">http://health.nytimes.com/health/guides/disease/oral-cancer/overview.html</a>). However, the literature, particularly several studies from Finland, are contradictory in this regard.</p>
<p>Yu T, Wood RE, Tenenbaum HC. Delays in diagnosis of head and neck cancers.J Can Dent Assoc. 2008 Feb;74(1):61</p>
<p>Goy J, Hall SF, Feldman-Stewart D, Groome PA. Diagnostic delay and disease stage in head and neck cancer: a systematic review. Laryngoscope. 2009 May;119(5):889-98.</p>
<p>http://robotics.me.jhu.edu/~rothbaum/Articles%20to%20read/Medical%20malpractice%20and%20head%20and%20neck%20cancer.pdf</p>
<p>Alho, O.-P., Teppo, H., Mantyselka, P., Kantola, S. (2006). Head and neck cancer in primary care: presenting symptoms and the effect of delayed diagnosis of cancer cases.. CMAJ 174: 779-784</p>
<p>Teppo H, Koivunen P, Hyrynkangas K, et al. Diagnostic delays in laryngeal carcinoma: professional diagnostic delay is a strong independent predictor of survival. Head Neck 2003;25:389-94</p>
<p>Koivunen P, Rantala N, Hyrynkangas K, Jokinen K, Alho OP.<br />
The impact of patient and professional diagnostic delays on survival in pharyngeal cancer.Cancer. 2001 Dec 1;92(11):2885-91.</p>
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		<item>
		<title>Thrombophilias in pregnancy &#8211; pro</title>
		<link>http://cancertreatmenttoday.org/thrombophilias-in-pregnancy-pro/</link>
		<comments>http://cancertreatmenttoday.org/thrombophilias-in-pregnancy-pro/#comments</comments>
		<pubDate>Thu, 21 Jun 2012 14:52:12 +0000</pubDate>
		<dc:creator>M Levin, MD</dc:creator>
				<category><![CDATA[Anti-coagulation]]></category>
		<category><![CDATA[Hematology]]></category>
		<category><![CDATA[Medico-legal Issues]]></category>
		<category><![CDATA[Professional]]></category>

		<guid isPermaLink="false">http://cancertreatmenttoday.org/?page_id=1537</guid>
		<description><![CDATA[The thrombophilias are a group of disorders that promote blood clotting. Most women with a thrombophilia have healthy pregnancies. However, pregnant women with a thrombophilia may be more likely than other pregnant women to develop a Venous thrombosis or certain pregnancy complications. Even pregnant women without a thrombophilia may be more likely than non-pregnant women [...]]]></description>
			<content:encoded><![CDATA[<p>The thrombophilias are a group of disorders that promote blood clotting. Most women with a thrombophilia have healthy pregnancies. However, pregnant women with a thrombophilia may be more likely than other pregnant women to develop a Venous thrombosis or certain pregnancy complications. Even pregnant women without a thrombophilia may be more likely than non-pregnant women to develop a VTE. This is due to normal pregnancy-related changes in blood clotting that limit blood loss during labor and delivery. However, studies suggest that up to 80 percent of pregnant women who develop a pulmonary embolus or other VTE have an underlying thrombophilia. Pulmonary embolus is the leading cause of maternal death in the United States.</p>
<p>The thrombophilias also may contribute to pregnancy complications including:Fetal loss. This may occur late in the first trimester (miscarriage) or in the second or third trimesters (stillbirth). and Placental abruption. In this condition, the placenta peels away from the uterine wall, partially or completely, before delivery. .Some pregnant women with a thrombophilia are treated with low moecular weight heparins, such as Lovenox. However, not all women with a thrombophilia need treatment during pregnancy. A woman and her health care provider should discuss her individual risks of blood clots and pregnancy complications and the severity of her thrombophilia before deciding whether or not she needs treatment.</p>
<p>In general, treatment is not recommended for most pregnant women with one of the less severe thrombophilias (such as factor V Leiden or prothrombin mutations) who have no personal or family history of blood clots or pregnancy complications. The risk of VTE is less than 0.5 percent (1 in 200) in pregnant women with factor V Leiden with no personal or strong family history of VTE.</p>
<p>While MTHFR heterozygosity itself does not increse risk of thrombosis or fetal compications, when combined with the prothrombin mutation, the risk incrases exponentially.</p>
<ol>
<li><em>Lockwood, C.J. and Bauer, K.A. Inherited Thrombophilias in Pregnancy. UpToDate, April, 13, 2006.</em></li>
<li><em>Lockwood, C.J. Preventing VTE: Part 3—The Pregnant Patient. Contemporary Ob/Gyn, May 2005, pages 11-12.</em></li>
<li><em>James, A.H., et al. Thrombosis During Pregnancy and the Postpartum Period. American Journal of Obstetrics and Gynecology, volume 193, number 1, July 2005, pages 216-219.</em></li>
<li><em>American College of Obstetricians and Gynecologists (ACOG). Thromboembolism in Pregnancy. ACOG Practice Bulletin, number 19, August 2000.</em></li>
<li><em>American College of Obstetricians and Gynecologists (ACOG). Antiphospholipid Syndrome. ACOG Practice Bulletin, number 68, November 2005.</em></li>
</ol>
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