Januvia is Misbranded - Merck failed to do a follow-up study!

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Anonymous said:
Has to be rodents because you can't cut out a living person's pancreas to perform these studies. Remember the Peter Butler autopsy studies that raised the flag on pancreatic cancer with sitagliptin a couple of years ago. Then later showed metformin somehow helped address the concern supposedly. Wonder if this is the "investigator" study that was proposed to the FDA to satisfy the rodent study requirement, and then the FDA didn't go for it since the investigator was receiving a grant from us to do the study? Also question the three month study proposal since that wouldn't necessarily reflect the years of exposure that an actual human pancreas would be exposed to. Even so, can't imagine this will bode well for the trust and value scores ongoing and the court of public opinion.
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Rodent studies are short with higher doses to simulate exposure over time. It was exactly this type of study that brought to light cancer risks while the PPAR compound was in Phase 2 clinical trials. PPAR got pulled, studies folded and the backup compound studies were expedited. What was that backup compound? MK 0431 - branded names Januvia and Janumet.

Damn those rats!
 




Anonymous said:
Clearly you don't know much about the value of animal studies. It was a frigging test in rats that ended the trials of the forerunner to Januvia while stage 2 human trials were in progress.

This is more than disregarding a request, this is likely the first time they'll have to used what they learned from the bungling of the Enhance results. Prepare for revenue meltdown.
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Actually it was primate studies that showed the skin leisons with the novartis ddp4.
 








Anonymous said:
Rodent studies are short with higher doses to simulate exposure over time. It was exactly this type of study that brought to light cancer risks while the PPAR compound was in Phase 2 clinical trials. PPAR got pulled, studies folded and the backup compound studies were expedited. What was that backup compound? MK 0431 - branded names Januvia and Janumet.

Damn those rats!
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The rodent is a bad model to study and therefore we will not do bad science...FU FDA.
 








Anonymous said:
The rodent is a bad model to study and therefore we will not do bad science...FU FDA.
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Obviously you majored in business, not science. Otherwise you would know that the industry standard for these diabetes pancreas studies is indeed the rat model. You sound like the toddler who stomps away mad when they lose a game saying,"it was a dumb ole game". Bottom line here, you didn't "play" by the rules and have lost the "game".
 








The issue is that Merck had a conditional approval the terms of which were not met. The company's response is hilarious and bizarre.
If I was the FDA I could easily read into that "Houston" there is a serious problem with this company's management.
 




Anonymous said:
Not a mistake at all these are lessons learned from the ENHANCE trial. Make money, lie and suppress data. If we get caught we will deal with it.
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And if we would have played by the FDA rules as requested several years ago now, we wouldn't be in this mess today trying to explain the increase in pancreatic cancer with Januvia. Instead, the years have gone by, we simply paid a simple fine for not completing the rodent study as requested and now we have potentially millions of patients that could be impacted by our decisions to make the almighty dollar.
 




Took my dad off of Janumet XR...his doctor was so clueless...he didn't even know about the pancreatic cancer issue...kind of scary when you, the patient, has to inform the doctor (even if he doesn't see reps, doesn't he read the paper???) Goes to show you that you have to be your own advocate...no one is looking out for you.
 








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