The narrow patient population and the bleeding risks from Xigris is why it did not gain wider acceptance. A new blood purification device called Cytosorb from Cytosorbents has the ability to reduce cytokines in patients with severe sepsis. Just received EU approval and will launch in early 2012. No adverse events from their treatments. This would be a safe and effective treatment. Watch for it.
Xigris pulled from market
- Thread starter Anonymous
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Let's not forget that large-molecule therapeutic research has burned trillions of dollars in the past decade. Yet, very few really widespread therapies have resulted, except maybe very rare chemotherapy-related treatments from Amgen.
Legitimate mall molecule research has been thrown under the bus, while billions have been thrown at Imclone. Go figure.
The due dilligence for Imclone said, "Don't buy". The Wall Street pleasing decision made it happen. It's a science company making decisions not based on the science. Classic MBA f*ck-up. (Like a lot of our country today).
I am extremely disheartened to learn that Xigris is being pulled from the market.
Almost 3 years ago my son was admitted to the hospital with Neisseria meningitidis.
The infection had gotten into his bloodstream and he had become septic. He was in respiratory failure, his kidneys and other organs were shutting down and his blood pressure was falling to unsafe levels.
We were fortunate that the doctor that treated him, immediately put him on xigris, along with the antibiotics and pressors/pressers ?? for his bp.
Xigris saved my son's life. Of that I have no doubt. He also did not lose any limbs to amputation( which we were told could happen due to complications from the infection)
People WILL die as a result of Xigris being pulled from the market. Many of them young and vibrant like my son.
Almost 3 years ago my son was admitted to the hospital with Neisseria meningitidis.
The infection had gotten into his bloodstream and he had become septic. He was in respiratory failure, his kidneys and other organs were shutting down and his blood pressure was falling to unsafe levels.
We were fortunate that the doctor that treated him, immediately put him on xigris, along with the antibiotics and pressors/pressers ?? for his bp.
Xigris saved my son's life. Of that I have no doubt. He also did not lose any limbs to amputation( which we were told could happen due to complications from the infection)
People WILL die as a result of Xigris being pulled from the market. Many of them young and vibrant like my son.
Great story. I sold this product for 3 years and it was the product I had the most passion to promote because of stories like yours.
I'm glad your child survived. However a double blind trial in children with xigris showed no benefit.
Drotrecogin alfa: not indicated for paediatric sepsis
Canada - The manufacturer of drotrecogin alfa (Xigris®), recombinant human activated protein C, rhAPC, has informed healthcare professionals of important safety information. Drotrecogin alfa is indicated for the treatment of adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g. as determined by APACHE II score or multiple organ dysfunctions).
The manufacturer has recently stopped enrolment in study EVBP, a randomized, double-blind, placebo-controlled trial of drotrecogin alfa (activated) in paediatric patients with severe sepsis. Interim analysis showed that drotrecogin alfa was highly unlikely to show an improvement over placebo in the primary outcome of complete organ failure resolution over 14 days. There was a numerical increase in the rate of intracranial haemorrhage in the drotrecogin alfa versus the placebo group, primarily seen in patients aged 60 days or less. Drotrecogin alfa is not indicated for use in pediatric severe sepsis.
Table. Efficacy and safety of drotrecogin alfa in paediatric severe sepsis (EVBP): Interim analysis
Xigris ®
N=201 n (%)
Placebo
N=198 n(%)
CTCOFRS (Composite Time to Complete Organ Failure Resolution), mean score standard deviation
9.7 + 5.0
9.8 + 5.1
28-day all-cause mortality
Deaths attributable to hemorrhage by investigator*
34 (16.9)
1 (0.5)
36 (18.2)
5 (2.5)
Intracranial hemorrhage
Days 0-6 (infusion period)
4 (2.0)
1 (0.5)
Days 0-28 (entire study period)
8 (4.0)
5 (2.5)
Serious Adverse Events
Days 0-6 (infusion period)
21 (10.4)
23 (11.6)
Days 0-28 (entire study period)
35 (17.4)
40 (20.2)
Serious Bleeding Events
Days 0-6 (infusion period)
8 (4.0)
7 (3.5)
Days 0-28 (entire study period)
13 (6.5)
14 (7.1)
At least one intracranial hemorrhage event OR died during 28-day study period.
39 (19.4)
38 (19.2)
Major Amputations
4 (2.0)
6 (3.0)
Drotrecogin alfa: not indicated for paediatric sepsis
Canada - The manufacturer of drotrecogin alfa (Xigris®), recombinant human activated protein C, rhAPC, has informed healthcare professionals of important safety information. Drotrecogin alfa is indicated for the treatment of adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g. as determined by APACHE II score or multiple organ dysfunctions).
The manufacturer has recently stopped enrolment in study EVBP, a randomized, double-blind, placebo-controlled trial of drotrecogin alfa (activated) in paediatric patients with severe sepsis. Interim analysis showed that drotrecogin alfa was highly unlikely to show an improvement over placebo in the primary outcome of complete organ failure resolution over 14 days. There was a numerical increase in the rate of intracranial haemorrhage in the drotrecogin alfa versus the placebo group, primarily seen in patients aged 60 days or less. Drotrecogin alfa is not indicated for use in pediatric severe sepsis.
Table. Efficacy and safety of drotrecogin alfa in paediatric severe sepsis (EVBP): Interim analysis
Xigris ®
N=201 n (%)
Placebo
N=198 n(%)
CTCOFRS (Composite Time to Complete Organ Failure Resolution), mean score standard deviation
9.7 + 5.0
9.8 + 5.1
28-day all-cause mortality
Deaths attributable to hemorrhage by investigator*
34 (16.9)
1 (0.5)
36 (18.2)
5 (2.5)
Intracranial hemorrhage
Days 0-6 (infusion period)
4 (2.0)
1 (0.5)
Days 0-28 (entire study period)
8 (4.0)
5 (2.5)
Serious Adverse Events
Days 0-6 (infusion period)
21 (10.4)
23 (11.6)
Days 0-28 (entire study period)
35 (17.4)
40 (20.2)
Serious Bleeding Events
Days 0-6 (infusion period)
8 (4.0)
7 (3.5)
Days 0-28 (entire study period)
13 (6.5)
14 (7.1)
At least one intracranial hemorrhage event OR died during 28-day study period.
39 (19.4)
38 (19.2)
Major Amputations
4 (2.0)
6 (3.0)
You can statistically show whatever you want but Xigris flat out worked when it was used early and appropriately. I sold products for Lilly and Dista for over 32 years and I never saw anything turn peoples lives around like this drug did. It's too bad that it wasn't part of a larger hospital portfolio than a single entity.
The Harvard Business Review did an article on it in 2004 about how NOT to market a drug..........It is even taught as part of an MBA course there. No shit.
Does ES teach the course?
You can show whatever you want with rhetoric and hyperbole, too. I'll take facts and randomized controlled trials.
Ahh the eternal struggle of wills, immovable objects and unstoppable forces, it is a battle of minds.
You know studies show that a person can heal themselves, they just need to think about it. Could it be the drug is allowing them to heal themselves, really doing mostly nothing? Placebo. All pharms don't want you to know this.