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FDA adds warning Muscle....1.2 mil impacted

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Anonymous

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When did the bastards at Merck know about this Adverse effects. The trail of this AE signal has been reported in studies going back to the 160, 80, and 40 MG dose study programs which was 10 years ago. MRL and the useless management like with VIOXX looked the other way. IMS data shows that 1.2 million patients are taking the 80 MG dose. All the push marketing to the get patients to goal with higher dose. Yale Mitchell and the MRL team have done a public disservice.
 






Muscle damage and extreme pain with statins has been documented for 10 years in many studies. Merck and other statin makers have looked the other way. Did the same thing with Vioxx signals. FDAs response: "What me worry?" philosophy, kind of like VietNam...an acceptable collateral damage level. Those victims are expendable to Big Pharma.
 








After almost 25 years of statin use, any patient that has a doctor operating so cluelessly as evidenced by being so under-informed that a Merck rep would be the sole enlightenment to this (serious and sometimes fatal) side effect has got bigger problems than just cholesterol management.
 




I don't think Merck has been hiding the data. Every doc in town knows high-dose statin is risky. The familial hypercholesterolemic patients are probably happy to take the maximal dose knowing it is a choice between possible muscle damage versus early death. I know someone with this condition who has two family members died in their 30's. No need to start a conspiracy theory here. The latest changes made it official and that's all. If some of us would exercise more, diet and get active, they will never need to go that high a dose unless it is a familial type. Watching the NBA playoff does not count.
 




Anonymous said:
It is criminal for Merck knowingly promote the use of higher dose by promoting treat to goal messages to physicians when they knew these adverse events happen.
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Treatment to goal is not a Merck proprietary marketing scam unless you are that clueless or new to the industry. Physicians have all these guidelines to manage their patients to reach various goals such as BP, cholesterol, diabetes, IOP, BMD, etc. They don't need us to tell them to keep titrating up to reach the goal; when to stop and add another drug from another class (combo theory approach). They should know most drugs, perhaps except the H2 blockers, have more adverse effects at the max dose. If a physician does not know this and he/she is your family doc...you are in trouble.
 








Anonymous said:
Treatment to goal is not a Merck proprietary marketing scam unless you are that clueless or new to the industry. Physicians have all these guidelines to manage their patients to reach various goals such as BP, cholesterol, diabetes, IOP, BMD, etc. They don't need us to tell them to keep titrating up to reach the goal; when to stop and add another drug from another class (combo theory approach). They should know most drugs, perhaps except the H2 blockers, have more adverse effects at the max dose. If a physician does not know this and he/she is your family doc...you are in trouble.
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These treat to goal campaigns were all about product positioning and not loosing the race to Crestor and Liptor. All marketing and not about doing the right thing for the patients. Why in the world we have 1.2 Mil patients on 80 MG of Zocor when other stains have less of this concern.
 








Anonymous said:
These treat to goal campaigns were all about product positioning and not loosing the race to Crestor and Liptor. All marketing and not about doing the right thing for the patients. Why in the world we have 1.2 Mil patients on 80 MG of Zocor when other stains have less of this concern.
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We have never actively promoted Zocor 80 mg to physicians. Physicians know you get very little incremental increase in LDL lowering by going from 40 mg to 80 mg. Best is to add another drug. Given Zocor is now generic and been out for a long time, physicians on their own have opted to give that dose a try for their patients, knowing the increased risks all along. Since we have a flat pricing scheme for Zocor, there isn't much of an extra profit either. Actually we make more $$ if everyone are on Zocor 5 mg.
 




Anonymous said:
These treat to goal campaigns were all about product positioning and not loosing the race to Crestor and Liptor. All marketing and not about doing the right thing for the patients. Why in the world we have 1.2 Mil patients on 80 MG of Zocor when other stains have less of this concern.
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Don't get too worked up over this. If doctors atually assumed that Merck was always going to do the proper thing that would be something different. The Vioxx debacle ended whatever trust medical professionals had in Merck. Ended it forever. And it seems that Merck behaves as if nothing ever can be done about that sad state and will not invest much in any attempt to rebuild trust.
 




Anonymous said:
Don't get too worked up over this. If doctors atually assumed that Merck was always going to do the proper thing that would be something different. The Vioxx debacle ended whatever trust medical professionals had in Merck. Ended it forever. And it seems that Merck behaves as if nothing ever can be done about that sad state and will not invest much in any attempt to rebuild trust.
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Very true. We lost the credibility factor forever with the Vioxx debacle. Looking back, I wonder if the reason for our excessive greed with Vioxx has something to do with the need to pay all those extra Barbie and Ken models we hired then. The payroll for such an expansion had to be quite high then. Not to mention the cost of liposuction, Botox, GQ clothing, low-cut dresses all charged to the RFM budget.
 




Anonymous said:
When did the bastards at Merck know about this Adverse effects. The trail of this AE signal has been reported in studies going back to the 160, 80, and 40 MG dose study programs which was 10 years ago. MRL and the useless management like with VIOXX looked the other way. IMS data shows that 1.2 million patients are taking the 80 MG dose. All the push marketing to the get patients to goal with higher dose. Yale Mitchell and the MRL team have done a public disservice.
Click to expand...

The FDA issued a warning back in March of this year.
 




Anonymous said:
When did the bastards at Merck know about this Adverse effects. The trail of this AE signal has been reported in studies going back to the 160, 80, and 40 MG dose study programs which was 10 years ago. MRL and the useless management like with VIOXX looked the other way. IMS data shows that 1.2 million patients are taking the 80 MG dose. All the push marketing to the get patients to goal with higher dose. Yale Mitchell and the MRL team have done a public disservice.
Click to expand...

Do you believe in black helicopters, Area 51, and Merck Conspiracy? They have to be some dumb ass docs to claim Merck tricks them into it or they are not aware of the possibility of increased AEs with a higher dose. The 40 mg, 80 mg and 160 mg data are public domain info. Or they can be obtained with a professional information request. I must have done 100's of them over the years for my customers.
 




This shits been in our circular for quite a while...all side effects with every statin is dose related...that's why there is no 160mg Zocor or 160mg Lipitor or 80mg Crestor and most of the 80 mg Simva is broken in half thanks to the VA probably the same with 10/80 Vytorin! However Merck has known this was coming and did not tell us because this study was published in 2010 and we should have been marketing 10/10 and 10/20 Vytorin all along for this very reason! We work for a company of manipulators with MBA's (manipulation by assholes) who keep screwing up this company in the name of marketing! This whole exercise may be a manipulated market event staged by our own idiots!
 












Anonymous said:
when patient safety is important why did it take 15 years and millions days of therapy to translate this AE. No wonder trusting this company is not a good idea.
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I think you are over-reacting. A physician has to be a total dumb ass not to know this for years with any meds at high dose. Merck is doing the fire drill probably as a requirement when the PI is officially changed. Then send a report back to the FDA to say we did our best to communicate the new info to the physicians. The only thing Merck decided to do is if we have to waste all the time to comply, we may as well try to use it to sell other products.

Sometimes it is just compliance. You are reading too much into it as yet another way to screw the reps. With not much to sell these days, may as well look at this fire drill as a glass half full.
 




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