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Immunity
Useless Drug Used For 10 Years To Treat Sepsis
Date: 18/01/12
Keywords: American Food and Drug Administration (FDA), adverse side effects, Cancer, Alternative medicine, Immunity, Infections, Vitamin C
In October last year, drug maker Eli Lilly, issued a statement to The European Medicines Agency, that it will withdraw its drug Xigris — a medicine which used to treat sepsis.
Sepsis, where blood borne bacteria overwhelm a vulnerable immune system, can lead to septic shock, organ failure, and death... and if you're an elderly patient or an infant the danger that hangs over your head with every hospital stay is even bigger.
For nearly 10 YEARS, many patients and their families pinned their survival hopes on Xigris... only to find out that Xigris had no beneficial effect at all. To put it plainly, the results of a clinical study that started in 2008 showed that 26.4 per cent of patients who took Xigris died compared with 24.2 per cent taking a placebo.
In October last year, drug maker Eli Lilly, issued a
statement to The European Medicines Agency, that it will
withdraw its drug Xigris — a medicine which used to treat
sepsis.
Sepsis, where blood borne bacteria overwhelm a vulnerable immune system, can lead to septic shock, organ failure, and death... and if you're an elderly patient or an infant the danger that hangs over your head with every hospital stay is even bigger.
For nearly 10 YEARS, many patients and their families pinned their survival hopes on Xigris... only to find out that Xigris had no beneficial effect at all. To put it plainly, the results of a clinical study that started in 2008 showed that 26.4 per cent of patients who took Xigris died compared with 24.2 per cent taking a placebo.
Why, oh why, oh why?
This is a great example of a good marketing campaign behind a very bad drug.
When Xigris was approved in the US in 2001 and in Europe in 2002, executives and marketers for Eli Lilly (the maker of Xigris) had to overcome a significant hurdle: Xigris was significantly more expensive than its competitors... we're talking thousands more!
Cleverly, Lilly started a 'Surviving Sepsis Campaign', which was designed to raise awareness about Xigris... and as an incentive to raise this sepsis awareness they offered Xigris free to doctors and hospitals. These guys don't miss a trick, do they?
In 2003, Lilly assembled a group of critical care experts to create new sepsis management guidelines. Lilly provided the funding, of course, and — surprise! — the guidelines promoted Xigris over treatments that cost thousands of pounds less.
Ta-da! Useless drug becomes a wild success!
Luckily, the European Medicines Agency, required additional research and the 2008 study (mentioned above) was started. Although the results were considered "statistically insignificant," the death rate was actually slightly higher in the Xigris group.
Xigris is gone now, but it doesn't remove the fact that Lilly had a solid, lucrative 10-year run for nothing but a dud... that cost the lives of many, which could've been saved with cheaper and much more effective drugs.
The real kicker is that there actually is a super safe, inexpensive vitamin treatment that's been shown to be effective in controlling sepsis. BUT, as always the American Food and Drug Administration (FDA) is waging a war against intravenous ascorbic acid (IAA), which has also been shown to regress certain cancers and effectively treat encephalitis, measles, dangerously advanced cases of the flu, and other conditions.
An alternative treatment like IAA is something Big Pharma DO NOT want to see on the market, and medical authorities are clearly all too happy to sweep it under the rug to make way for harmful drugs that save no lives at all. Zero! Nada!
Bear in mind all the material in this email alert is provided for information purposes only. We are not addressing anyone's personal situation. Please consult with your own physician before acting on any recommendations contained herein.
Sources:
Xigris (drotrecogin alfa) withdrawn worldwide, published online 25.10.11, hc-sc.gc.ca
Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy, published online 25.10.11, ema.europa.eu
"FDA Drug Safety Communication: Voluntary market withdrawal of Xigris [drotrecogin alfa (activated)] due to failure to show a survival benefit" FDA, 10/25/11, fda.gov
"Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis" The Lancet, published online ahead of print 10/27/11, thelancet.com
Back to topSepsis, where blood borne bacteria overwhelm a vulnerable immune system, can lead to septic shock, organ failure, and death... and if you're an elderly patient or an infant the danger that hangs over your head with every hospital stay is even bigger.
For nearly 10 YEARS, many patients and their families pinned their survival hopes on Xigris... only to find out that Xigris had no beneficial effect at all. To put it plainly, the results of a clinical study that started in 2008 showed that 26.4 per cent of patients who took Xigris died compared with 24.2 per cent taking a placebo.
Why, oh why, oh why?
This is a great example of a good marketing campaign behind a very bad drug.
When Xigris was approved in the US in 2001 and in Europe in 2002, executives and marketers for Eli Lilly (the maker of Xigris) had to overcome a significant hurdle: Xigris was significantly more expensive than its competitors... we're talking thousands more!
Cleverly, Lilly started a 'Surviving Sepsis Campaign', which was designed to raise awareness about Xigris... and as an incentive to raise this sepsis awareness they offered Xigris free to doctors and hospitals. These guys don't miss a trick, do they?
In 2003, Lilly assembled a group of critical care experts to create new sepsis management guidelines. Lilly provided the funding, of course, and — surprise! — the guidelines promoted Xigris over treatments that cost thousands of pounds less.
Ta-da! Useless drug becomes a wild success!
Luckily, the European Medicines Agency, required additional research and the 2008 study (mentioned above) was started. Although the results were considered "statistically insignificant," the death rate was actually slightly higher in the Xigris group.
Xigris is gone now, but it doesn't remove the fact that Lilly had a solid, lucrative 10-year run for nothing but a dud... that cost the lives of many, which could've been saved with cheaper and much more effective drugs.
The real kicker is that there actually is a super safe, inexpensive vitamin treatment that's been shown to be effective in controlling sepsis. BUT, as always the American Food and Drug Administration (FDA) is waging a war against intravenous ascorbic acid (IAA), which has also been shown to regress certain cancers and effectively treat encephalitis, measles, dangerously advanced cases of the flu, and other conditions.
An alternative treatment like IAA is something Big Pharma DO NOT want to see on the market, and medical authorities are clearly all too happy to sweep it under the rug to make way for harmful drugs that save no lives at all. Zero! Nada!
Bear in mind all the material in this email alert is provided for information purposes only. We are not addressing anyone's personal situation. Please consult with your own physician before acting on any recommendations contained herein.
Sources:
Xigris (drotrecogin alfa) withdrawn worldwide, published online 25.10.11, hc-sc.gc.ca
Xigris (drotrecogin alfa (activated)) to be withdrawn due to lack of efficacy, published online 25.10.11, ema.europa.eu
"FDA Drug Safety Communication: Voluntary market withdrawal of Xigris [drotrecogin alfa (activated)] due to failure to show a survival benefit" FDA, 10/25/11, fda.gov
"Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis" The Lancet, published online ahead of print 10/27/11, thelancet.com
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