Prowess-Shock didn't turn out well- sorry for those still promoting that product through the new bio-venture company.
Xigris pulled from market
- Thread starter Anonymous
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What a damn shame. I launched that drug, and it was obvious years ago that if Lilly had just listened to the clinician base about where it should be used, this could all have been avoided. The CC/pulms figured out in about 8 months where the drug should be used, and it just so happened that the patient population was about 1/10th the size of what Lilly had imagined it to be. So, instead of re-evaluating the drug's potential and listening to the very people who were the experts in the field, they set upon a course to make Xigris a billion-dollar-a year drug, regardless of what anyone thought constituted reality.
Lilly decided to shame/cajole/bully/buy-off/scare the physician base into the belief that they just didn't know how to practice medicine, and that Lilly really knew best how they should treat patients that they had been taking care of for years. It was embarrassing, to be frank.
So the PROWESS SHOCK trial, yet another attempt to try and pull blood from a stone, has ultimately put the nail in the Xigris coffin. So now, that small niche population that received incredible benefit from the drug will no longer have access to it. All because Lilly just would not abstain from being a bunch of greedy, arrogant assholes who thought that they know better than the clinicians who live and breathe this every day.
What an appalling situation, and what an absolute travesty for the next young person that shows up in the in ED with purpura. Hope it was worth it, Lilly. They never learn.
I can NOT agree with you MORE............I sold this drug for the last two years, and I have seen, heard, and listened to those physicians, nurses, and health care providers that did see the benefits from the drug and a company (BioCritica) who truly knew and represented the true passion to market this drug in the right market, and to the right population.
Lilly has demonstrated once again a unwillingness to do whats best for those patients who truly need a drug that will save lives...............I hope that one day those who are responsible for Xigris to be pulled get Septic Shock and die a slow and painful death................Serves the bastards right.................Fuck off Lilly you ruined a good drug, cost hundreds of us our jobs, and more importantly indirectly killed those who really needed this drug...........
Lilly has demonstrated once again a unwillingness to do whats best for those patients who truly need a drug that will save lives...............I hope that one day those who are responsible for Xigris to be pulled get Septic Shock and die a slow and painful death................Serves the bastards right.................Fuck off Lilly you ruined a good drug, cost hundreds of us our jobs, and more importantly indirectly killed those who really needed this drug...........
Sidney was a giant, walking, talking scam. You got scammed to... He got $40M t retire. You got Global Shares, the CIA, and the first mass-layoffs in company history. Sidney was a complete fraud. Someone should deficate at the foot of his portrait.
You obviously have had a steady dose of the LLY koolaid. What's sad is that you think you saved patients lives? The study shows no improvement of survival at all. Earlier studies showed a less than 25% improvement in survival at an egregious cost. This company reaps what it sows.
QUOTE=Anonymous;4122250]What a damn shame. I launched that drug, and it was obvious years ago that if Lilly had just listened to the clinician base about where it should be used, this could all have been avoided. The CC/pulms figured out in about 8 months where the drug should be used, and it just so happened that the patient population was about 1/10th the size of what Lilly had imagined it to be. So, instead of re-evaluating the drug's potential and listening to the very people who were the experts in the field, they set upon a course to make Xigris a billion-dollar-a year drug, regardless of what anyone thought constituted reality.
Lilly decided to shame/cajole/bully/buy-off/scare the physician base into the belief that they just didn't know how to practice medicine, and that Lilly really knew best how they should treat patients that they had been taking care of for years. It was embarrassing, to be frank.
So the PROWESS SHOCK trial, yet another attempt to try and pull blood from a stone, has ultimately put the nail in the Xigris coffin. So now, that small niche population that received incredible benefit from the drug will no longer have access to it. All because Lilly just would not abstain from being a bunch of greedy, arrogant assholes who thought that they know better than the clinicians who live and breathe this every day.
What an appalling situation, and what an absolute travesty for the next young person that shows up in the in ED with purpura. Hope it was worth it, Lilly. They never learn.[/QUOTE]
QUOTE=Anonymous;4122250]What a damn shame. I launched that drug, and it was obvious years ago that if Lilly had just listened to the clinician base about where it should be used, this could all have been avoided. The CC/pulms figured out in about 8 months where the drug should be used, and it just so happened that the patient population was about 1/10th the size of what Lilly had imagined it to be. So, instead of re-evaluating the drug's potential and listening to the very people who were the experts in the field, they set upon a course to make Xigris a billion-dollar-a year drug, regardless of what anyone thought constituted reality.
Lilly decided to shame/cajole/bully/buy-off/scare the physician base into the belief that they just didn't know how to practice medicine, and that Lilly really knew best how they should treat patients that they had been taking care of for years. It was embarrassing, to be frank.
So the PROWESS SHOCK trial, yet another attempt to try and pull blood from a stone, has ultimately put the nail in the Xigris coffin. So now, that small niche population that received incredible benefit from the drug will no longer have access to it. All because Lilly just would not abstain from being a bunch of greedy, arrogant assholes who thought that they know better than the clinicians who live and breathe this every day.
What an appalling situation, and what an absolute travesty for the next young person that shows up in the in ED with purpura. Hope it was worth it, Lilly. They never learn.[/QUOTE]
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There are thousands of people that are alive today that would disagree with you, as well as a large number of MDs that feel the same. The drug was niche, and the studies were designed to show that it was efficacious in a large patient population. There is a difference, but then again, I doubt you would know that since you have no doubt spent your illustrious pharma career bringing lunch to the local GP/FP offices and asking the NP to please sign your little sheet of paper..........
That's ok Einstein, not everybody has the intellectual capability to understand complex things. Maybe in the next life............
I am shocked. I was one of the original Critical Care reps that launched Xigris, and I have always been convinced of its value in the severe sepsis patient at high risk of death. I recently contacted Biocritica about selling Xigris for them. I really am at a loss for words.
We are all in shock. We all feel the same way.
The study failed because of poor study design and monitoring along with arrogance and greed. The FDA cautioned against doing a placebo controlled trial of an already approved drug. Bill and Mark deserve to be uncomfortable and miserable for all of their poor decisions and unscrupulous actions. Should have increased the sample size to 2200+ when given the opportunity. So many design errors that no one should be surprised at the results. The original Prowess study was well designed and managed by internal folks that cared. This study was outsourced and not monitored well, leading to questions about the type of patient enrolled and accurate data collection. The mortality numbers defy all previous studies. Good luck explaining those results to the FDA. A great drug put to death by arrogance, greed and questionable marketing practices by the early marketers who ignored the doctors and advisors. Believers believed and experienced success. The doubters will say "I told you so." Xigris was tainted from the beginning when the seed money was given to the Campaign Guidelines and used for aggressive marketing. I know it worked and helped a lot of people, but the shadow of doubt was cast early. Thank you Elaine, Mitch, Bill (the nerd), Sam C and all the others who lied and convinced others that their actions were ethical. And to the designers that ignored scientific advice of internal scientists who knew what they were doing, a giant f u.
Wow, not a good day for two Lilly drugs. Oh well...............time for a price hike on the rest of the brand names for "cost of inflation" oh and research.
How do you know this is true? i.e could have raised sample size to 2200 ............
Don't know about the sample size BUT do know, from the clinicians coordinating the trial that they were unhappy with the study design all along. But, in typical fashion, they were told that's the way it was gonna be, no input allowed from outside.
How do I know they could have raised the sample size? Because i was a direct part of the in house discussions during the first interim analysis. It was recommended to increase the sample size to 2200 but that would have increased the study duration and cost more money. JL defeated the idea. It may not have made a difference but thats what we recommended at the time to add more power to the study. The external committee made the same suggestion.
We are all sad about this especially those of us who launched Xigris.
We are all sad about this especially those of us who launched Xigris.
re sample size: 1600 seems pitifully small when assessing high risk of death critically ill patients.
...and raising the sample size from 1600 to 2200 would have made exactly what magical difference when the drug had 26% mortality and the placebo had 24% mortality?
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.