Nice response from Seek Truth:
I can understand the valid concern of deaths due to anaphylactoid reactions that must be resolved before Omontys can be reintroduced. However, the article implies that even if the anaphylactoid reactions are resolved, the drug itself remains inherently unsafe, and I take issue with that. The Phase 3 clinical trials in dialysis patients have shown beyond statistical doubt that there were no adverse differences in safety between Omontys and ESAs. Using historic data in an uncontrolled manner to come up with a supposition that Omontys can cause 9x more deaths is totally unscientific, naive, and worst of all, misleading.
There is no way that "Omontys Kills At Least 9x More People Than Epogen" - if so, the drug would not have stood any chance with FDA! Granted that the anaphylactoid issue resulting in death still needs to be addressed.
The Phase 3 dialysis data showed without a doubt that Omontys was not statistically worse than EPO in safety; in fact, if anything, the adverse event profile was slightly better than EPO in dialysis patients.
One simply cannot use historic/anecdotal/pos... data to compare against scientifically-assessed randomized clinical trial data - it is comparing apples to oranges. Is the researcher even aware that the EPO post-marketing adverse event data is extremely confounded, where deaths are not usually reported as the adverse event term per se, and therefore missed, and that causality assessments are not what he/she thinks? Is the researcher saying that there were only 0.0027% deaths in CKD/ESRD patients, when in actuality, only 1 in 5 dialysis patients survive 5 years? Who assigned causality in his assessments?
Check out Alpha Exposure's LAME Response, typical Weasel:
" Even the trial data shows that Omontys is not as safe as Epogen. But that's not what's important. Outside of trials some drugs are found to be inherently unsafe - for instance Vioxx. It's perfectly valid to look at safety data from a real world setting and use it to conclude that a drug is unsafe and should be withdrawn from the market. This is what happened with Omontys. I don't think it ever comes back."
How does he know 'this is what happened with O'? What if there was human error involved or some DNA link? And what about Tylenol? Real world safety data indicates Tylenol murders people but J&J keeps selling it, OTC at that!
Here's the response to Alpha's lame answer:
Seek Truth: "I disagree with your assessment, Alpha Exposure, and am not sure where your data come from. Have you ever been involved in performing clinical trials? If not, you might not know this.
You really need to compare like with like. Since Omontys was approved for dialysis patients only, looking at the Omontys dialysis Phase 3 safety data, where Omontys was compared to EPO, Omontys fared better. In fact, the FDA medical reviewer summarized the dialysis safety data as follows: "For most TESAEs (treatment-emergent serious adverse events), the rates of occurrence were similar or numerically slightly lower in the peginesatide (Omontys) treatment group."
You cannot compare apples with oranges. For example, you cannot compare EPO data from less sick CKD patients against Omontys data from sicker dialysis patients. When you are talking about deaths, you cannot compare adverse event terms of death against actually tabulations of deaths which include all causes of death."