This landmark report is welcomed. Since many prescriptions drugs are "chemical based," I FULLY expect the forces/money behind them to fight to keep the link drawn between the two. But I say, wake up AMERICA, you are being poisoned by the very institutes charged with keeping your best interest in mind, and placing the patient first.
Consider that Synvisc alone has two highly toxic chemicals, Formaldehyde and Divinyl Sulfone discussed extensively on this blog. And this passed the FDA approval. As someone whose health was destroyed from the moment this product was injected into my body, this landmark 240 page report released on May 6, 2010 warns that "our lackadaisical approach to regulation may have far-reaching consequences for our health."
To read further, go to http://www.nytimes.com/2010/05/06/opinion/06kristof.html to read the New York Post Op Ed New Alarm Bells About Chemicals and Cancer .
The read the President's Cancer Panel's actual report, go to this link:
http://deainfo.nci.nih.gov/advisory/pcp/pcp08-09rpt/PCP_Report_08-09_508.pdf
"The Panel urges you most strongly to use the power of your office to remove the carcinogens and other toxins from our food, water, and air that needlessly increase health care costs, cripple our Nation’s productivity, and devastate American lives."
I would add...pharmacueticals and GMO food.
The truth is, this is NOT NEW. The naturopathic community has been screaming about chemicals and the damage they cause to the human body for years. But I'm thankful that this is hitting the mainstream news FROM the mainstream medical community!
Showing posts with label Medical Research. Show all posts
Showing posts with label Medical Research. Show all posts
Sunday, May 9, 2010
Friday, October 2, 2009
Synvisc Not Systemically Absorbed?
I read this Q&A between a potential patient and a physician at this link
http://www.hopkins-arthritis.org/ask-the-expert/treatment-013003/negative-reactions-to-synvisc-571.html.
Information from the physician claims that Synvisc is not systemically absorbed.
According to the following statement with sources, the resident [joint capsule] half-life is days to a few weeks at the most.
Synvisc® may last for a few days (Fiorentini R. , Proceedings of the US FDA Advisory Panel on Orthopaedic and Rehabilitation Devices, 11/21/96 Fairfax (VA) : CASET Associates, 1996; Berkowitz D., Proceedings of the US FDA Advisory Panel on Orthopaedic and Rehabilitation Devices, 11/20/96 Fairfax (VA) : CASET Associates, 1996).
My question to those reading this blog:
If Synvisc leaves the joint capsule in that time frame, and doesn't go "systemic" or is "not systemically absorbed" ...
Where does it go? I'd really like to know.
http://www.hopkins-arthritis.org/ask-the-expert/treatment-013003/negative-reactions-to-synvisc-571.html.
Information from the physician claims that Synvisc is not systemically absorbed.
According to the following statement with sources, the resident [joint capsule] half-life is days to a few weeks at the most.
Synvisc® may last for a few days (Fiorentini R. , Proceedings of the US FDA Advisory Panel on Orthopaedic and Rehabilitation Devices, 11/21/96 Fairfax (VA) : CASET Associates, 1996; Berkowitz D., Proceedings of the US FDA Advisory Panel on Orthopaedic and Rehabilitation Devices, 11/20/96 Fairfax (VA) : CASET Associates, 1996).
My question to those reading this blog:
If Synvisc leaves the joint capsule in that time frame, and doesn't go "systemic" or is "not systemically absorbed" ...
Where does it go? I'd really like to know.
Monday, September 28, 2009
FDA No Longer Includes Description of Adverse Event / Side-effects
Since I started to post the FDA Adverse Events relating to Synvisc reported to the FDA via patient and/or physician, they have since removed the ACTUAL DETAILS and DESCRIPTIONS of the events!!! They simply say "injury" or "hospitilized" or "intervention required."
Patients have the right to know what COULD happen to them if they take Synvisc or ANY OTHER drug or medical device. The FDA SHOULD be working for the people and that would mean full disclosure and description of adverse events.
I'll let you know if the FDA formate changes for the MAUDE search site and see if this changes with the "technical difficulty" declaration. I'll let you know when and if it does change.
Patients have the right to know what COULD happen to them if they take Synvisc or ANY OTHER drug or medical device. The FDA SHOULD be working for the people and that would mean full disclosure and description of adverse events.
I'll let you know if the FDA formate changes for the MAUDE search site and see if this changes with the "technical difficulty" declaration. I'll let you know when and if it does change.
Friday, July 3, 2009
Increased Reactions / side-effects With Each Synvisc Injection
Note: In an effort to keep the information as accurate as possible on this blog, I've posted links to support the data and some verbatim information. Blogspot has now tagged my blog and will not let me do so. I will suggest searches to help you find the research that backs up my post. Sorry for the inconvience.
Conculsion of one study: This study suggests that it's reasonable to tell patients who've been treated with a course of Hylan G-F 20 [Synvisc] and who want more shots that the likelihood of a painful localized acute reaction to the medical device appears to increase. More studies of the frequency of acute local reactions following repeated injections of Synvisc and study of mechanisms of those reactions are warranted.
The full abstract is found on the NCBI Pub Med gov site. You can google to find "Increased frequency of acute local reactions following repeated course of Hylan G-F 20."
Conculsion of one study: This study suggests that it's reasonable to tell patients who've been treated with a course of Hylan G-F 20 [Synvisc] and who want more shots that the likelihood of a painful localized acute reaction to the medical device appears to increase. More studies of the frequency of acute local reactions following repeated injections of Synvisc and study of mechanisms of those reactions are warranted.
The full abstract is found on the NCBI Pub Med gov site. You can google to find "Increased frequency of acute local reactions following repeated course of Hylan G-F 20."
Saturday, June 20, 2009
Medical Journal Studies on Adverse Reactions / Side-Effects of Synvisc
Here are quotes from research that appeared in peer-reviewed medical journals.
Department of Orthopaedic Surgery, Louisiana State University Health Sciences Center, Shreveport, LA 71130-3932, USA.
The flare reaction after treatment with Synvisc probably is not a Type-1 (antibody-mediated) hypersensitivity reaction, but may be a Type-4 (cell-mediated) hypersensitivity reaction.
http://ortho.sh.lsuhsc.edu/Faculty/Marino/Papers/139CORR2006.pdf.
[Hypersensitivity reactions are typical when the causative agent is a synthetic chemical]
Moreover, some of these drugs based on chemically modified HA, such as Synvisc®, have been involved in reports of sometimes serious adverse events (Hammesfahr JF. et al . , The American Journal of Orthopaedics, 2003, 32:277-283), probably following' the onset of inflammatory processes, especially linked with eosinophil recruitment (Schiavinato A. et al . , Clinical and Experimental Rheumatology, 2002, 20:445-454). Considering the above, new chemical derivatives of HA are being studied that enable the problems linked with both residence time in the joint cavity and the risk of toxicity due to solvents and/or particular chemical agents used in the chemical modification of HA [Synvisc] to be overcome, while maintaining all the characteristics and intrinsic properties of the polysaccharide, unaltered.
From this site http://www.ejbjs.org/cgi/content/extract/85/10/2050
"...Increased Frequency of Acute Local Reaction to Intra-Articular Hylan GF-20 (Synvisc) in Patients Receiving More Than One Course of Treatment" (2002;84:1619-23), by Leopold et al., ... We have seen about 25 similar reactions to hylan G-F 20 [Synvisc] but have not seen such reactions to the naturally extracted sodium hyaluronate, suggesting these adverse reactions are not a hyaluronan class effect. Reactions (painful effusion with cellular infiltrate and negative culture) occurred within 24 hours after an injection, presented in the second series of injections or later, and generally required intervention. Some cases improved within days after intra-articular injection, while others were more prolonged. [Full Text of this Article]
J Rheumatol. 1996 May;23(5):944-5; author reply 946. J Rheumatol. 1996 May;23(5):945-6.
Acute local reactions after intraarticular hylan for osteoarthritis of the knee.
Puttick MP, Wade JP, Chalmers A, Connell DG, Rangno KK.
Department of Medicine, University of British Columbia, Vancouver, Canada.
OBJECTIVE. To describe acute local reactions following intraarticular hylan injection and determine their frequency. .. RESULTS. Twenty-two patients had 88 injections to 28 knees. Six patients had reactions within 24 h of injection characterized by pain, warmth, and swelling, lasting up to 3 weeks. This occurrence was unpredictable. Corticosteroid injections were sometimes required. .... CONCLUSION. Intraarticular hylan [Synvisc] was associated with significant local inflammatory reactions in 27% of patients, or 11% of injections. The mechanism(s) and long term sequelae are unclear.
PMID: 7562764 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/18050181?ordinalpos=4&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
Arthritis Rheum. 2007 Dec 15;57(8):1410-8.
Hylan versus hyaluronic acid for osteoarthritis of the knee: a systematic review and meta-analysis.
Reichenbach S, Blank S, Rutjes AW, Shang A, King EA, Dieppe PA, Jüni P, Trelle S.
University of Berne, Berne, Switzerland.
OBJECTIVE: To compare the effectiveness and safety of intraarticular high-molecular hylan with standard preparations of hyaluronic acids in osteoarthritis of the knee. ... CONCLUSION: Given the likely lack of a superior effectiveness of hylan [Synvisc] over hyaluronic acids and the increased risk of local adverse events associated with hylan [Synvisc], we discourage the use of intraarticular hylan [Synvisc] in patients with knee osteoarthritis in clinical research or practice.
PMID: 18050181 [PubMed - indexed for MEDLINE]
[http://www.wipo.int/pctdb/en/wo.jsp?wo=2006092233&IA=WO2006092233&DISPLAY=DESC ]
Department of Orthopaedic Surgery, Louisiana State University Health Sciences Center, Shreveport, LA 71130-3932, USA.
The flare reaction after treatment with Synvisc probably is not a Type-1 (antibody-mediated) hypersensitivity reaction, but may be a Type-4 (cell-mediated) hypersensitivity reaction.
http://ortho.sh.lsuhsc.edu/Faculty/Marino/Papers/139CORR2006.pdf.
[Hypersensitivity reactions are typical when the causative agent is a synthetic chemical]
Moreover, some of these drugs based on chemically modified HA, such as Synvisc®, have been involved in reports of sometimes serious adverse events (Hammesfahr JF. et al . , The American Journal of Orthopaedics, 2003, 32:277-283), probably following' the onset of inflammatory processes, especially linked with eosinophil recruitment (Schiavinato A. et al . , Clinical and Experimental Rheumatology, 2002, 20:445-454). Considering the above, new chemical derivatives of HA are being studied that enable the problems linked with both residence time in the joint cavity and the risk of toxicity due to solvents and/or particular chemical agents used in the chemical modification of HA [Synvisc] to be overcome, while maintaining all the characteristics and intrinsic properties of the polysaccharide, unaltered.
From this site http://www.ejbjs.org/cgi/content/extract/85/10/2050
"...Increased Frequency of Acute Local Reaction to Intra-Articular Hylan GF-20 (Synvisc) in Patients Receiving More Than One Course of Treatment" (2002;84:1619-23), by Leopold et al., ... We have seen about 25 similar reactions to hylan G-F 20 [Synvisc] but have not seen such reactions to the naturally extracted sodium hyaluronate, suggesting these adverse reactions are not a hyaluronan class effect. Reactions (painful effusion with cellular infiltrate and negative culture) occurred within 24 hours after an injection, presented in the second series of injections or later, and generally required intervention. Some cases improved within days after intra-articular injection, while others were more prolonged. [Full Text of this Article]
J Rheumatol. 1996 May;23(5):944-5; author reply 946. J Rheumatol. 1996 May;23(5):945-6.
Acute local reactions after intraarticular hylan for osteoarthritis of the knee.
Puttick MP, Wade JP, Chalmers A, Connell DG, Rangno KK.
Department of Medicine, University of British Columbia, Vancouver, Canada.
OBJECTIVE. To describe acute local reactions following intraarticular hylan injection and determine their frequency. .. RESULTS. Twenty-two patients had 88 injections to 28 knees. Six patients had reactions within 24 h of injection characterized by pain, warmth, and swelling, lasting up to 3 weeks. This occurrence was unpredictable. Corticosteroid injections were sometimes required. .... CONCLUSION. Intraarticular hylan [Synvisc] was associated with significant local inflammatory reactions in 27% of patients, or 11% of injections. The mechanism(s) and long term sequelae are unclear.
PMID: 7562764 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/18050181?ordinalpos=4&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
Arthritis Rheum. 2007 Dec 15;57(8):1410-8.
Hylan versus hyaluronic acid for osteoarthritis of the knee: a systematic review and meta-analysis.
Reichenbach S, Blank S, Rutjes AW, Shang A, King EA, Dieppe PA, Jüni P, Trelle S.
University of Berne, Berne, Switzerland.
OBJECTIVE: To compare the effectiveness and safety of intraarticular high-molecular hylan with standard preparations of hyaluronic acids in osteoarthritis of the knee. ... CONCLUSION: Given the likely lack of a superior effectiveness of hylan [Synvisc] over hyaluronic acids and the increased risk of local adverse events associated with hylan [Synvisc], we discourage the use of intraarticular hylan [Synvisc] in patients with knee osteoarthritis in clinical research or practice.
PMID: 18050181 [PubMed - indexed for MEDLINE]
[http://www.wipo.int/pctdb/en/wo.jsp?wo=2006092233&IA=WO2006092233&DISPLAY=DESC ]
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