Gardasil - Revision history

Marisa de Andrade at 18:36, 19 August 2009

2009-08-19T18:36:09Z

Claire Robinson: /* Controversy */

2009-08-08T09:38:43Z

Controversy

Claire Robinson: /* Controversy */

2009-08-08T09:36:50Z

Controversy

Claire Robinson: /* Controversy */

2009-08-08T09:28:40Z

Controversy

Claire Robinson: /* Controversy */

2009-08-08T09:24:54Z

Controversy

Claire Robinson: /* Controversy */

2009-08-08T09:24:20Z

Controversy

Claire Robinson: /* Controversy */

2009-08-08T09:23:57Z

Controversy

Claire Robinson at 09:23, 8 August 2009

2009-08-08T09:23:41Z

Claire Robinson: /* Controversy */

2009-08-08T09:22:12Z

Controversy

Claire Robinson: /* Controversy */

2009-08-08T09:21:47Z

Controversy

← Older revision		Revision as of 18:36, 19 August 2009
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−	'''Gardasil''' is a vaccine manufactured by [[Merck]]. ~~It is intended to protect~~ against ~~certain kinds~~ of human ~~papilloma virus~~ (HPV). ~~These~~ strains of HPV ~~are associated with cervical~~, ~~vulvar~~ and ~~vaginal cancers~~ and ~~genital warts~~.	+	{{Template:Pharma_Portal_badge}}
		+
		+	'''Gardasil''' is a vaccine manufactured by [[Merck]] and sold in some countries as Silgard. The vaccine has been approved in 109 countries including those in the European Union, the United States, Canada and Australia. Additional applications are currently under review in other countries. Gardasil protects against four strains – types 6, 11, 16 and 18 - of the human papillomavirus (HPV) virus which has been linked to cases of cervical cancer. It is also approved for preventing genital warts, caused by HPV types 6 and 11. [[Cervarix]], its rival vaccine, protects against two strains of HPV – types 16 and 18.
		+
		+	==Corporate Funding==
		+
		+	In August 2009, the [[Journal of the America Medical Association]] ([[Jama]]) reported that three medical associations promoted the use of Gardasil using funds from its manufacturer, [[Merck]]. The [[American College Health Association]], the [[American Society for Colposcopy and Cervical Pathology]], and the [[Society of Gynecologic Oncologists]] used a promotion strategy similar to the one used by the drug company in its marketing campaign for the vaccine. The three associations received $199,000 (£115,000), $300,000 (£182,000) and $250,000 (£150,000) from Merck respectively in what's being described as an example of 'marketing and medical education [being] blurred'.<ref>Stein, R. [http://www.washingtonpost.com/wp-dyn/content/article/2009/08/18/AR2009081803325.html Medical Groups Promoted HPV Vaccine Using Funds Provided by Drugmaker]. ''The Washington Post''. Accessed 19 August 2009.</ref>

	==Controversy==		==Controversy==

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 On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil as a result of reports of girls fainting and having seizures after receiving the vaccine. In the new label, information about fainting is now included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity.<ref>[http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm Information Pertaining to Labeling Revision for Gardasil], FDA website, accessed 8 Aug 2009</ref>
-Judicial Watch said in its press release of June 2009 that the FDA documented 6,723 "adverse events" related to Gardasil in 2008, of which 1,061 were considered "serious," and 142 considered "life threatening,"  Judicial Watch said.  The group said it obtained the data from  VAERS.<ref>Parker Waichman Alonso LLP, [http://www.yourlawyer.com/articles/read/16678 Gardasil Side Effect Reports Included 28 Deaths, Group Says], 25 June 2009, YourLawyer.com, accessed 8 Aug 2009</ref>
+Judicial Watch said in its press release of June 2009 that the FDA documented 6,723 "adverse events" related to Gardasil in 2008, of which 1,061 were considered "serious," and 142 considered "life threatening". The group said it obtained the data from  VAERS.<ref>Parker Waichman Alonso LLP, [http://www.yourlawyer.com/articles/read/16678 Gardasil Side Effect Reports Included 28 Deaths, Group Says], 25 June 2009, YourLawyer.com, accessed 8 Aug 2009</ref>
 Since last June, 235 cases detailed permanent disability. There were also 29 new cases of Guillain-Barré Syndrome (a type of paralysis), and 147 cases of "spontaneous abortions," or miscarriages, when the vaccine was given to pregnant women, Judicial Watch said.<ref>Parker Waichman Alonso LLP, [http://www.yourlawyer.com/articles/read/16678 Gardasil Side Effect Reports Included 28 Deaths, Group Says], 25 June 2009, YourLawyer.com, accessed 8 Aug 2009</ref>

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 As of June 30, 2008, there had been 9,749 Vaccine Adverse Event Reporting System (VAERS) reports of adverse events following Gardasil vaccination. Of these, 94% were classified as reports of non-serious events, and 6% as serious events.<ref>"[http://www.cdc.gov/vaccinesafety/vaers/FDA_and_CDC_Statement.htm Information from FDA and CDC on Gardasil and its Safety]", Centers for Disease Control website, accessed 5 April 2009</ref>
-In 2009 the conservative advocacy group Judicial Watch reported that in 2008, more than 2 dozen women and girls died after receiving the Gardasil vaccination.   According to a press release issued by Judicial Watch, there have been a total of 47 deaths linked to Gardasil since it was brought to market in 2006.<ref>Parker Waichman Alonso LLP, [http://www.yourlawyer.com/articles/read/16678 Gardasil Side Effect Reports Included 28 Deaths, Group Says], 25 June 2009, YourLawyer.com, accessed 8 Aug 2009</ref>
+In June 2009 the conservative advocacy group Judicial Watch reported that in 2008, more than 2 dozen women and girls died after receiving the Gardasil vaccination.   According to a press release issued by Judicial Watch, there have been a total of 47 deaths linked to Gardasil since it was brought to market in 2006.<ref>Parker Waichman Alonso LLP, [http://www.yourlawyer.com/articles/read/16678 Gardasil Side Effect Reports Included 28 Deaths, Group Says], 25 June 2009, YourLawyer.com, accessed 8 Aug 2009</ref>
 On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil as a result of reports of girls fainting and having seizures after receiving the vaccine. In the new label, information about fainting is now included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity.<ref>[http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm Information Pertaining to Labeling Revision for Gardasil], FDA website, accessed 8 Aug 2009</ref>

← Older revision		Revision as of 09:28, 8 August 2009
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	On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil as a result of reports of girls fainting and having seizures after receiving the vaccine. In the new label, information about fainting is now included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity.<ref>[http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm Information Pertaining to Labeling Revision for Gardasil], FDA website, accessed 8 Aug 2009</ref>		On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil as a result of reports of girls fainting and having seizures after receiving the vaccine. In the new label, information about fainting is now included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity.<ref>[http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm Information Pertaining to Labeling Revision for Gardasil], FDA website, accessed 8 Aug 2009</ref>
		+
		+	Judicial Watch said in its press release of June 2009 that the FDA documented 6,723 "adverse events" related to Gardasil in 2008, of which 1,061 were considered "serious," and 142 considered "life threatening," Judicial Watch said. The group said it obtained the data from VAERS.<ref>Parker Waichman Alonso LLP, [http://www.yourlawyer.com/articles/read/16678 Gardasil Side Effect Reports Included 28 Deaths, Group Says], 25 June 2009, YourLawyer.com, accessed 8 Aug 2009</ref>
		+
		+	Since last June, 235 cases detailed permanent disability. There were also 29 new cases of Guillain-Barré Syndrome (a type of paralysis), and 147 cases of "spontaneous abortions," or miscarriages, when the vaccine was given to pregnant women, Judicial Watch said.<ref>Parker Waichman Alonso LLP, [http://www.yourlawyer.com/articles/read/16678 Gardasil Side Effect Reports Included 28 Deaths, Group Says], 25 June 2009, YourLawyer.com, accessed 8 Aug 2009</ref>
		+
		+	Judicial Watch also documented 62 cases of Gardasil recipients who developed warts after receiving the vaccine. In additional to reports of genital warts, there were 21 reports of girls developing warts on other areas of the body, including face, hands and feet, and in one case, "all over her body."<ref>Parker Waichman Alonso LLP, [http://www.yourlawyer.com/articles/read/16678 Gardasil Side Effect Reports Included 28 Deaths, Group Says], 25 June 2009, YourLawyer.com, accessed 8 Aug 2009</ref>

	==How the vaccine is made and what's in it==		==How the vaccine is made and what's in it==

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 In 2009 the conservative advocacy group Judicial Watch reported that in 2008, more than 2 dozen women and girls died after receiving the Gardasil vaccination.   According to a press release issued by Judicial Watch, there have been a total of 47 deaths linked to Gardasil since it was brought to market in 2006.<ref>Parker Waichman Alonso LLP, [http://www.yourlawyer.com/articles/read/16678 Gardasil Side Effect Reports Included 28 Deaths, Group Says], 25 June 2009, YourLawyer.com, accessed 8 Aug 2009</ref>
-On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil as a result of reports of girls fainting and having seizures after receiving the vaccine. In the new label, information about fainting is now also included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity.<ref>[http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm Information Pertaining to Labeling Revision for Gardasil], FDA website, accessed 8 Aug 2009</ref>
+On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil as a result of reports of girls fainting and having seizures after receiving the vaccine. In the new label, information about fainting is now included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity.<ref>[http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm Information Pertaining to Labeling Revision for Gardasil], FDA website, accessed 8 Aug 2009</ref>
 ==How the vaccine is made and what's in it==

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 ==Controversy==
-In February 2009 it was announced that a batch of [[Merck]]'s Cervical Jab [[Gardasil]] has been withdrawn after two 14-year-old girls in Spain were hospitalized. Health authorities withdrew nearly 76,000 doses of the shot after both girls developed convulsions and at least one lost consciousness soon after the vaccine was administered.
+In February 2009 it was announced that a batch of [[Merck]]'s Cervical Jab [[Gardasil]] had been withdrawn after two 14-year-old girls in Spain were hospitalized. Health authorities withdrew nearly 76,000 doses of the shot after both girls developed convulsions and at least one lost consciousness soon after the vaccine was administered.
 The batch had been distributed all over Spain, to some to pharmacies and others to regional vaccination programs. [[Sanofi Pasteur MSD]], the joint venture of [[Sanofi]] and [[Merck]] that markets Gardasil in Spain, said that a link between the shot and the symptoms has yet to be proved: "In both cases, other medical conditions (in the girls) have been observed and are being investigated which could be the cause of the reported events."<ref>Staton, T. [http://www.fiercepharma.com/story/hospitalized-girls-prompt-gardasil-recall/2009-02-11?utm_medium=rss&utm_source=rss&cmp-id=OTC-RSS-FP0 Hospitalized girls prompt Gardasil recall] Accessed on February,12,2009 </ref>

← Older revision		Revision as of 09:23, 8 August 2009
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−	'''Gardasil''' is a vaccine manufactured by [[Merck]]. It is intended to protect against certain kinds of human papilloma virus (HPV).	+	'''Gardasil''' is a vaccine manufactured by [[Merck]]. It is intended to protect against certain kinds of human papilloma virus (HPV). These strains of HPV are associated with cervical, vulvar and vaginal cancers and genital warts.

	==Controversy==		==Controversy==

← Older revision		Revision as of 09:21, 8 August 2009
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	The conservative advocacy group Judicial Watch reported in 2009 that in 2008, more than 2 dozen women and girls died after receiving the Gardasil vaccination. According to a press release issued by Judicial Watch, there have been a total of 47 deaths linked to Gardasil since it was brought to market in 2006.<ref>Parker Waichman Alonso LLP, [http://www.yourlawyer.com/articles/read/16678 Gardasil Side Effect Reports Included 28 Deaths, Group Says], 25 June 2009, YourLawyer.com, accessed 8 Aug 2009</ref>		The conservative advocacy group Judicial Watch reported in 2009 that in 2008, more than 2 dozen women and girls died after receiving the Gardasil vaccination. According to a press release issued by Judicial Watch, there have been a total of 47 deaths linked to Gardasil since it was brought to market in 2006.<ref>Parker Waichman Alonso LLP, [http://www.yourlawyer.com/articles/read/16678 Gardasil Side Effect Reports Included 28 Deaths, Group Says], 25 June 2009, YourLawyer.com, accessed 8 Aug 2009</ref>
		+
		+	On June 9, 2009, the Food and Drug Administration (FDA) approved a revised label for Gardasil as a result of reports of girls fainting and having seizures after receiving the vaccine. In the new label, information pertaining to syncope (fainting) is now also included in the Warnings and Precautions section, and this section has new information noting that individuals who faint sometimes have tonic-clonic (jerking) movements and seizure-like activity.<ref>[http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm165145.htm Information Pertaining to Labeling Revision for Gardasil], FDA website, accessed 8 Aug 2009</ref>

	==How the vaccine is made and what's in it==		==How the vaccine is made and what's in it==