quote:

About 750,000 people in the U.S. each year get sepsis, and about 225,000 of them die from it.

...

That wasn't always in the case. In 2001 when the U.S. Food and Drug Administration approved Xigris, made by the pharmaceutical company Eli Lilly, hopes were high that it would keep thousands of patients from dying. The company's initial clinical trials of the drug showed that it reduced the chances of dying by 20 percent in patients at risk of developing sepsis.

...

But a new analysis, published Monday in the journal Lancet Infectious Diseases, throws into question whether or not Xigris should have been withdrawn at all. In it, Nebraska's Kalil analyzed the results of more than two dozen studies of Xigris, most performed in the "real-world" of clinics and hospitals, trying to save patients with sepsis.

....

"I was expecting to see a very small effect, close to no effect. I was surprised when we saw these kinds of results," Kalil said.
So should the drug be put back on the market? The answer is uncertain and, as far as Eli Lilly is concerned, unfeasible. Putting the drug back on the market would mean conducting another long, expensive clinical trial to clear regulatory hurdles. Janes said the company has no plans to do that, even in the face of evidence suggesting the drug's effectiveness.

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So, we have a disease that kills 225k Americans each year. We had a drug that was supposedly helpful (not a guaranteed cure, though), butit was taken off the Market.

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And, the company won't be putting it back on the Market because of regulatory hurdles.

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ORIGINAL: mnottertail

Wouldn't scrubbing your ass real good be as effective?

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ORIGINAL: thompsonx

You have failed to tell us why it was removed in the first place.

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SOURCE: RxList.com
Xigris (drotrecogin alfa (activated)) is a recombinant form of human activated protein C. An established human cell line possessing the complementary DNA for the inactive human protein C zymogen secretes the protein into the fermentation medium. Fermentation is carried out in a nutrient medium containing the antibiotic geneticin sulfate. Geneticin sulfate is not detectable in the final product. Human protein C is enzymatically activated by cleavage with thrombin and subsequently purified.

Drotrecogin alfa (activated) is a serine protease with the same amino acid sequence as human plasma-derived activated protein C. Drotrecogin alfa (activated) is a glycoprotein of approximately 55 kilodalton molecular weight, consisting of a heavy chain and a light chain linked by a disulfide bond. Drotrecogin alfa (activated) and human plasma-derived activated protein C have the same sites of glycosylation, although some differences in the glycosylation structures exist.

Xigris (drotrecogin alfa) is supplied as a sterile, lyophilized, white to off-white powder for intravenous infusion. The 5 and 20 mg vials of Xigris contain 5.3 mg and 20.8 mg of drotrecogin alfa (activated), respectively. The 5 and 20 mg vials of Xigris (drotrecogin alfa) also contain 40.3 and 158.1 mg of sodium chloride, 10.9 and 42.9 mg of sodium citrate, and 31.8 and 124.9 mg of sucrose, respectively.

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it appears as though there may be an issue of patients hemorrhaging while on this drug. if i were Eli Lilly, i doubt i would want that liability, especially with only a 20% success rate.

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ORIGINAL: DesideriScuri

** No. No it isn't killing Americans.

Sepsis is killing Americans.

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About 750,000 people in the U.S. each year get sepsis, and about 225,000 of them die from it.

...

That wasn't always in the case. In 2001 when the U.S. Food and Drug Administration approved Xigris, made by the pharmaceutical company Eli Lilly, hopes were high that it would keep thousands of patients from dying. The company's initial clinical trials of the drug showed that it reduced the chances of dying by 20 percent in patients at risk of developing sepsis.

...

But a new analysis, published Monday in the journal Lancet Infectious Diseases, throws into question whether or not Xigris should have been withdrawn at all. In it, Nebraska's Kalil analyzed the results of more than two dozen studies of Xigris, most performed in the "real-world" of clinics and hospitals, trying to save patients with sepsis.

....

"I was expecting to see a very small effect, close to no effect. I was surprised when we saw these kinds of results," Kalil said.
So should the drug be put back on the market? The answer is uncertain and, as far as Eli Lilly is concerned, unfeasible. Putting the drug back on the market would mean conducting another long, expensive clinical trial to clear regulatory hurdles. Janes said the company has no plans to do that, even in the face of evidence suggesting the drug's effectiveness.

So, we have a disease that kills 225k Americans each year. We had a drug that was supposedly helpful (not a guaranteed cure, though), butit was taken off the Market. And, the company won't be putting it back on the Market because of regulatory hurdles.

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ORIGINAL: DesideriScuri

** No. No it isn't killing Americans.

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But the drug's initial performance was somewhat disappointing. Some patients benefited from the drug, others did not, and doctors had trouble defining which type of patient would benefit the most. The drug was also very expensive, so many hospitals put protocols in place that strictly limited when the drug could be given -- usually when all other methods had failed.
Dr. Jonathan Janes, medical director of acute care for Eli Lilly, said the company was encouraged by studies of the drug in real-life clinical settings, which showed that it kept many patients alive.
"We felt encouraged by those results, they seemed to support that the drug worked," Janes said. "Obviously, you need your clinical trial data, but these results were nice to have."
But questions about the drug's effectiveness and safety began to surface. Patients getting Xigris had a slightly increased risk of bleeding. Increasingly skeptical that the expensive drug was actually effective, European regulators asked Eli Lilly to conduct a second clinical trial. The results were the nail in Xigris' coffin -- the trial showed that the drug was little better than placebo. Based on those results, Eli Lilly voluntarily pulled the drug from the market in October 2011.

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ORIGINAL: thompsonx

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So, we have a disease that kills 225k Americans each year. We had a drug that was supposedly helpful (not a guaranteed cure, though), butit was taken off the Market.

You have failed to tell us why it was removed in the first place.

quote:

quote:

And, the company won't be putting it back on the Market because of regulatory hurdles.

What specific hurdles would you like to see removed so you can try out this drug that is,according to your post, 20% effective?

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quote:

ORIGINAL: joether
First off...
Why would a conservative give a shit what happens to his/her fellow Americans from a health care stand point? Because if such a person gets that dreadful disorder, it requires intensive medical care; and even then the victim has a 2/3 chances of survival without the drug in question. The drug in question is, Xigris:

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I guess that leaves the philsophical question: Should we research a medication or cures for something that for-profit companies deem 'not profitable enough'? Yes, because this sort of knowledge helps mankind overcome the problems it faces long term. But seems to me the sort of people that would desire for such a drug/treatment to be develop come from the liberal and some moderate side of the political spectrum. The only time conservatives get involved is either A) They can profit from someone else's misery or the more likely B) They or the direct loved one they know has this dreadful condition, and demand help (but before, were fully against it).

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Again, why would a conservative give a shit what happens to his fellow Americans? Isn't it a 'true conservative' one that ignores the suffering of others, and wishs companies to profit heavily off the suffering of others?

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quote:

Let's see...have a drug that is 20% effective, or have no drug therapy at all. Your call, dude.

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ORIGINAL: Politesub53

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ORIGINAL: DesideriScuri
** No. No it isn't killing Americans.

Were you unable to understand your own link ? The part stating the drug was little better than a placebo ?

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But the drug's initial performance was somewhat disappointing. Some patients benefited from the drug, others did not, and doctors had trouble defining which type of patient would benefit the most. The drug was also very expensive, so many hospitals put protocols in place that strictly limited when the drug could be given -- usually when all other methods had failed.
Dr. Jonathan Janes, medical director of acute care for Eli Lilly, said the company was encouraged by studies of the drug in real-life clinical settings, which showed that it kept many patients alive.
"We felt encouraged by those results, they seemed to support that the drug worked," Janes said. "Obviously, you need your clinical trial data, but these results were nice to have."
But questions about the drug's effectiveness and safety began to surface. Patients getting Xigris had a slightly increased risk of bleeding. Increasingly skeptical that the expensive drug was actually effective, European regulators asked Eli Lilly to conduct a second clinical trial. The results were the nail in Xigris' coffin -- the trial showed that the drug was little better than placebo. Based on those results, Eli Lilly voluntarily pulled the drug from the market in October 2011.

quote:


But a new analysis, published Monday in the journal Lancet Infectious Diseases, throws into question whether or not Xigris should have been withdrawn at all. In it, Nebraska's Kalil analyzed the results of more than two dozen studies of Xigris, most performed in the "real-world" of clinics and hospitals, trying to save patients with sepsis.
The results suggest that Xigris is effective after all. The study found that Xigris reduced patients' risk of dying by 18 percent, similar to the results Eli Lilly had reported in its first study of the drug.

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quote:

ORIGINAL: joether

Why would a conservative give a shit what happens to his/her fellow Americans from a health care stand point?

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But, hey,what do I know? One study showed it to be no better than a placebo. Then there were dozens of studies in clinical settings, with results showing it to be better than a placebo.