Xigris pulled from market

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Anonymous said:
its hard to say. maybe none. 26 and 24 were essentially the same. no statistical difference. you mock but the bleeding rate were purportedly lower than in other studies. there may be details disclosed later that illuminate the results. however when you are defining high risk of death just to get enrolled (meaning at minimum a 40% chance of dying upon enrollment)........and the doctors couldnt have previous experience with Xigris. not sure why they bothered even running the trial.
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My understanding is that the EU mandated that Lilly complete an additional trial? I could be wrong, but I believe that they had to do another one. What I cannot believe is that an IRB allowed a double blind trial to take place with the drug.

It is a shame that it has been pulled. The clinician base has used the drug appropriately for several years now, and had figured out the drug's niche population. That just wasn't enough for Lilly, though.
 






"We launched Prozac. I think we know what we're doing," ES in 2001.

CF, who was the original Medical Directer for Critical Care (and I believe his name is on the Xigris patent) must be beside himself. What a shame.
 






It seems that the results are inconsistent from all previous sepsis trials. Shock consistently shows a mortality rate of >40%. When the results are released, it will be interesting to see how the mortality rates by country are explained. EMA did require the study but the FDA cautioned against it. Both agencies said that if the study was a failure, the drug would be pulled. In order to get more patients in a shorter time, the study was opened the to the US. Many IRBs and US physicians were against it. CF knew it was over when BM et al. "lead" the way. A sad day for all who "invested" in Xigris.
 






I love it when a drug doesn't do well in a study the homers that sell it always cry that that the study design was wrong.

Get a grip people- the drug was no better then placebo. And any Dr. that thought otherwise isn't a Dr. that I want taking care of me!
 






























I pre-launched Xigris for 9 months and sold it for another 1 1/2 years before transferring to another Lilly division. I never held greater respect for any product that I sold for the 32+ years that I worked for Lilly than I did for Xigris. Xigris is the only drug where I was introduced to patients who were dying and regained organ function after Xigris administration. What a waste.
 






Anonymous said:
I pre-launched Xigris for 9 months and sold it for another 1 1/2 years before transferring to another Lilly division. I never held greater respect for any product that I sold for the 32+ years that I worked for Lilly than I did for Xigris. Xigris is the only drug where I was introduced to patients who were dying and regained organ function after Xigris administration. What a waste.
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while a lot of mistakes were made from beginning to end, Xigris saved people's lives and proved its efficacy over and over. There were many skeptics but there were many believers. it was not a drug for the timid or faint of heart; it required a gutsy confident clinician who knew how to take quick decisive action when treating a patient who had declined into septic shock. many drugs for critical care and oncology for example remain controversial with equally controversial clinical data. the sad truth is that the drugs that can be billed as out-patient or are cheap generics used and billed in-patient bear far less scrutiny than expensive drugs. if xigris had cost $200 it would still be available today with the same data.
 






Anonymous said:
while a lot of mistakes were made from beginning to end, Xigris saved people's lives and proved its efficacy over and over. There were many skeptics but there were many believers. it was not a drug for the timid or faint of heart; it required a gutsy confident clinician who knew how to take quick decisive action when treating a patient who had declined into septic shock. many drugs for critical care and oncology for example remain controversial with equally controversial clinical data. the sad truth is that the drugs that can be billed as out-patient or are cheap generics used and billed in-patient bear far less scrutiny than expensive drugs. if xigris had cost $200 it would still be available today with the same data.
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I agree with your statement. It is regrettable to have to listen to those whose only experience in working with clinicians, comes from asking them for a signature for Cymbalta samples. It was a fabulous drug. Lilly's greed killed it, though. If they had just left well enough alone, and not kept up the facade that the thing was going to be a 2 billion/year product, it would still be around.
 






Anonymous said:
Hopefully you are one the idiots that are still promoting this placebo drug and are soon to be out of a job.
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I'm not, but then again, I would not expect one whose only true interaction with people who practice medicine is watching them sign a piece of paper through a clinic window, to know anything about how a complex biotech molecule works, or how it is used/utilized in a hospital setting.
 












XIGRIS OBITUARY:

Activated, Drotrecogin (alfa) "Xigris," DOB: 1986 when the first Lilly team formed, DOD: October, 2011. Survivors include creators, BY and CF and numerous supporters including sales representatives, some medical personnel, and several benefactors of Xigris. Xigris began life in the late 1980s and continued to develop throughout the 1990s, finally peaking in 2001 when it was introduced to the world as "Zovant." Xigris, as it eventually became known, lived a short but colorful life, triggering strong emotions in both supporters and detractors. Never one to stand on the sidelines, Xigris was featured at several international meetings and saved many lives. Xigris' life was constantly shadowed by disbelief and questions about integrity; nevertheless, Xigris persevered. Xigris passed away late in October with a cause of death listed as "Corporate Sepsis" a condition characterized by pervasive and persistent greed and arrogance coupled with a a lack of integrity and common sense. "CS" often leads to advancement up the corporate ladder and/or "ostrich syndrome" by which those most responsible for the demise get promoted with many others choosing the bury their heads in the sand by ignoring warning signs. Xigris will be missed by those most attached and committed. To others, Xigris was nothing more than placebo. Regardless of opinion, Xigris lead the way to sepsis disease state recognition and for that, all are grateful. In lieu of flowers, please send donations to the American Sepsis Alliance. Xigris will be interred in a landfill, but forever in our hearts. RIP. Written by ~a recent Lilly defector.
 






Anonymous said:
XIGRIS OBITUARY:

Activated, Drotrecogin (alfa) "Xigris," DOB: 1986 when the first Lilly team formed, DOD: October, 2011. Survivors include creators, BY and CF and numerous supporters including sales representatives, some medical personnel, and several benefactors of Xigris. Xigris began life in the late 1980s and continued to develop throughout the 1990s, finally peaking in 2001 when it was introduced to the world as "Zovant." Xigris, as it eventually became known, lived a short but colorful life, triggering strong emotions in both supporters and detractors. Never one to stand on the sidelines, Xigris was featured at several international meetings and saved many lives. Xigris' life was constantly shadowed by disbelief and questions about integrity; nevertheless, Xigris persevered. Xigris passed away late in October with a cause of death listed as "Corporate Sepsis" a condition characterized by pervasive and persistent greed and arrogance coupled with a a lack of integrity and common sense. "CS" often leads to advancement up the corporate ladder and/or "ostrich syndrome" by which those most responsible for the demise get promoted with many others choosing the bury their heads in the sand by ignoring warning signs. Xigris will be missed by those most attached and committed. To others, Xigris was nothing more than placebo. Regardless of opinion, Xigris lead the way to sepsis disease state recognition and for that, all are grateful. In lieu of flowers, please send donations to the American Sepsis Alliance. Xigris will be interred in a landfill, but forever in our hearts. RIP. Written by ~a recent Lilly defector.
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BY best start playing that fiddle faster....
 






This was a niche drug that Sidney tried to turn in to a blockbuster not with science, but with marketing. There are similarities to the Zyprexa scandal. That's all he knew... marketing. How musch did we pay this 'less than geneius'?
 






The entire Xigris story would make a great book. This would include the developement, launch, and withdrawl of the drug. It could be viewed as a metaphor for the US pharma industry, and even the American economy. The story has a beginning, a middle, and an end. There is a best seller awaiting the right author.
 






Anonymous said:
The entire Xigris story would make a great book. This would include the developement, launch, and withdrawl of the drug. It could be viewed as a metaphor for the US pharma industry, and even the American economy. The story has a beginning, a middle, and an end. There is a best seller awaiting the right author.
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"The Xigris Saga: American Pharma Gone Terribly Wrong"

You heard it hear first. Coming soon.

Only question is, "What's next, guys?" What other placeboes have we been selling?
 












Anonymous said:
The entire Xigris story would make a great book. This would include the developement, launch, and withdrawl of the drug. It could be viewed as a metaphor for the US pharma industry, and even the American economy. The story has a beginning, a middle, and an end. There is a best seller awaiting the right author.
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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.
 






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