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

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Very typical of Merck in recent years- they want to inflame the FDA- yet another disastrous step Merck. The line is skinny as it is- keep making it more difficult by taking 2 steps backwards- although many tow the protocol line at Merck, the hierarchy does not follow what it preaches. Failure at the very core...
 








Its about time, I have been telling the brand team the past year or so that things are not matching up. Nobody listened. At least they can change some things now. This will help in the long run to be more fair and balanced during our sales conversations.
 








ouch, that sucks, we don't usually thumb our noses at the FDA when they ask for data we can easily produce within a reasonable time frame. Seriously this was a no brainer, I would love to know why we decided to ignore it - especially given that ever since Vioxx we haven't exactly been on the most favored list. This goes beyond "oops, it got buried in all the crap on my desk". I wonder if someone's on the supreme shit list. I also wonder how this hasn't made it in the press. too many questions on this one....
 












Looks like a reason for a few more compliance tests for the field to me plus an increase in time for the Corporate Integrity Agreement where we are showing them "how to earn trust every day"
 








Another damn CIA, more tests when what they need to do is get rid of half the marketing assholes at WS & UG and hire someone that knows what they're doing! Let's be honest here, a friggin rat test on pancreatitis doesn't prove shit, we're doing a huge human safety and efficacy study and have a patient safety network in place! Sounds like some government idiot at FDA has their head up the ole ass! Merck puts idiots in leadership positions because someone annointed them instead of promoting on merit same as the VP Clubs and S3 fiascos'! Just because they 'dress for success' and kiss ass does not mean they can perform in a meaningful way or even have performed!
 








Anonymous said:
Another damn CIA, more tests when what they need to do is get rid of half the marketing assholes at WS & UG and hire someone that knows what they're doing! Let's be honest here, a friggin rat test on pancreatitis doesn't prove shit, we're doing a huge human safety and efficacy study and have a patient safety network in place! Sounds like some government idiot at FDA has their head up the ole ass! Merck puts idiots in leadership positions because someone annointed them instead of promoting on merit same as the VP Clubs and S3 fiascos'! Just because they 'dress for success' and kiss ass does not mean they can perform in a meaningful way or even have performed!
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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.
 




Read Merck's response....Merck is fully committed to complying with the FDA's requirement blah blah blah. OK in Simple English FDA is stupid to send this warning letter when all is being done or will be done on the rodents. Maybe there are smarter people who can understand this Merck double talk.

Well what about some real patient outcomes study?
 




Anonymous said:
Read Merck's response....Merck is fully committed to complying with the FDA's requirement blah blah blah. OK in Simple English FDA is stupid to send this warning letter when all is being done or will be done on the rodents. Maybe there are smarter people who can understand this Merck double talk.

Well what about some real patient outcomes study?
Click to expand...

Read the FDA warning, Poindexter. Merck may SAY they will cooperate blah blah blah but the warning letter was issued because they failed to do so in the agreed upon timeframe previously and to the previously agreed upon standard. Merck has not even acknowledged why they blew off the initial instruction and reminders from the FDA.
 




This is just one of many examples of Merck being Merck. Lie to the customer, lie to the physician, lie to the FDA, lie to the employees...

This company is vomit-inducing.
 




I spent hours listening to the dumb video explaining how important it is to "stay on label". No integrity at all with upper management. btw I have a feeling that good ole bobbie mac is up to his neck in this one too.
 




Continue with the internal discussions of creating an environment of analysis paralysis and confusion to avoid doing the definite outcome studies....this is exactly how the Zetia program after almost 10 years on the market does not have any good outcome data. How can we sell a product in a disease so debilitating with no outcomes?
Can Merck continue to sell another product without any outcomes?
 




Anonymous said:
Read Merck's response....Merck is fully committed to complying with the FDA's requirement blah blah blah. OK in Simple English FDA is stupid to send this warning letter when all is being done or will be done on the rodents. Maybe there are smarter people who can understand this Merck double talk.

Well what about some real patient outcomes study?
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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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