Comments on: FDA Warns Sanofi-Aventis Over Misleading Material http://www.pharmalot.com/2009/10/fda-warns-sanofi-aventis-over-misleading-material/ News, Comment and Conversation Fri, 10 Feb 2012 21:35:18 +0000 http://wordpress.org/?v=2.6.2 By: Justice in Michigan http://www.pharmalot.com/2009/10/fda-warns-sanofi-aventis-over-misleading-material/#comment-442348 Justice in Michigan Thu, 29 Oct 2009 13:38:37 +0000 http://www.pharmalot.com/?p=19375#comment-442348 Compliance Analyst--Fully concur. Look out about saying much about diet and exercise. But at least you didn't mention the "c" word.... Cheerios. Compliance Analyst–Fully concur. Look out about saying much about diet and exercise. But at least you didn’t mention the “c” word….

Cheerios.

]]> By: Compliance Analyst http://www.pharmalot.com/2009/10/fda-warns-sanofi-aventis-over-misleading-material/#comment-442342 Compliance Analyst Thu, 29 Oct 2009 12:03:40 +0000 http://www.pharmalot.com/?p=19375#comment-442342 JiM, I agree for a while DDMAC wasn't doing a whole lot, but when warning letters are sent to cereal companies (see Cheerios) I start to question if warning letters aren't being diluted. Re: My comment about DTD and DTC spending While I am far from the marketing or sales arena (I do compliance for manufacturing), as a consumer, I think the money would be better spent on clinical trials, R&D, and lifecycle maintenance of the product. I would rather see the DTC ad money spent on trade material like medical journals (though I am sure they already spend a lot of money there as well). P.S. I am waiting for a warning letter because I claim eating a balanced diet and exercising could help your lower weight and cholesterol in most populations. :D JiM, I agree for a while DDMAC wasn’t doing a whole lot, but when warning letters are sent to cereal companies (see Cheerios) I start to question if warning letters aren’t being diluted.

Re: My comment about DTD and DTC spending While I am far from the marketing or sales arena (I do compliance for manufacturing), as a consumer, I think the money would be better spent on clinical trials, R&D, and lifecycle maintenance of the product. I would rather see the DTC ad money spent on trade material like medical journals (though I am sure they already spend a lot of money there as well).

P.S. I am waiting for a warning letter because I claim eating a balanced diet and exercising could help your lower weight and cholesterol in most populations. :D

]]> By: cliffintokyo http://www.pharmalot.com/2009/10/fda-warns-sanofi-aventis-over-misleading-material/#comment-442338 cliffintokyo Thu, 29 Oct 2009 07:14:07 +0000 http://www.pharmalot.com/?p=19375#comment-442338 wow: "docs we trust and respect" Now there's a thought. In the USA? I regret to say I have serious doubts. Aren't they (nearly) all queuing up out of med school to do nose jobs and knee surgery on wealthy private insurance patients (instead of treating sick people) because it pays 100x better? I might be more inclined to believe my hard-pressed but (relatively) honest health service doc who follows his solemn oath to 'do no harm' MJ RIP. wow: “docs we trust and respect”
Now there’s a thought.
In the USA? I regret to say I have serious doubts. Aren’t they (nearly) all queuing up out of med school to do nose jobs and knee surgery on wealthy private insurance patients (instead of treating sick people) because it pays 100x better?
I might be more inclined to believe my hard-pressed but (relatively) honest health service doc who follows his solemn oath to ‘do no harm’
MJ RIP.

]]> By: Wow! http://www.pharmalot.com/2009/10/fda-warns-sanofi-aventis-over-misleading-material/#comment-442324 Wow! Thu, 29 Oct 2009 02:21:50 +0000 http://www.pharmalot.com/?p=19375#comment-442324 Jaynesday--I think that's a pretty good list. And it is obviously sad for all of us to have to think/act this way. (Of course, most people won't--because of time, inclination, etc.) In the meantime, what do we do when we're going into surgery and are unlikely (I think) to request a list of the various devices, instruments, and drugs that might be part of the procedure? That's why I think working with docs we trust and respect is a critical piece. It does not solve all, perhaps not even most, of what your responding to. But it helps. Jaynesday–I think that’s a pretty good list. And it is obviously sad for all of us to have to think/act this way. (Of course, most people won’t–because of time, inclination, etc.)

In the meantime, what do we do when we’re going into surgery and are unlikely (I think) to request a list of the various devices, instruments, and drugs that might be part of the procedure?

That’s why I think working with docs we trust and respect is a critical piece. It does not solve all, perhaps not even most, of what your responding to. But it helps.

]]> By: Jaynesday http://www.pharmalot.com/2009/10/fda-warns-sanofi-aventis-over-misleading-material/#comment-442322 Jaynesday Thu, 29 Oct 2009 01:49:36 +0000 http://www.pharmalot.com/?p=19375#comment-442322 Justice, This incident is minor but kind of symbolic of in the sense that critical information was hidden. On purpose? I don't know, but from companies that we rightfully expect the pentacle of professionalism and performance, it appears that in far too many cases we have more along the lines of road side fruit stands. So here is where this outsider truly stands concerning drugs and devices and their manufacturers. If the day comes that I am prescribed a drug or device – I will not take the advice of my doctor (who may be misinformed or bought off) without extensive personal research. I will consider the product label likely to have as much disinformation or missing information than truth. I will consult the FDA’s adverse event database knowing that many events go unreported. I will even consider the FDA's approval of the product as something to question. I will disregard information provided by medical publications as they may only be advertising written by the product's manufacturer. I will consider the reputation and past practices of the pharmaceutical company that provides the product. I will scour the internet to find out what the experiences of others have been with the suggested drug or device. This I will consider to be the most reputable information available. Most importantly - I will continue to take care of my health in an effort to remain as drug free as possible thereby “boycotting” I could care less pharmaceutical companies. Obviously I do not trust them and intent to not put myself in a position that I must rely on them. I will also advise all of my family and friends to do the same. Have I missed the point? I hope someone can convince me that I have. Justice,
This incident is minor but kind of symbolic of in the sense that critical information was hidden. On purpose? I don’t know, but from companies that we rightfully expect the pentacle of professionalism and performance, it appears that in far too many cases we have more along the lines of road side fruit stands.

So here is where this outsider truly stands concerning drugs and devices and their manufacturers.

If the day comes that I am prescribed a drug or device –
I will not take the advice of my doctor (who may be misinformed or bought off) without extensive personal research.
I will consider the product label likely to have as much disinformation or missing information than truth.
I will consult the FDA’s adverse event database knowing that many events go unreported.
I will even consider the FDA’s approval of the product as something to question.
I will disregard information provided by medical publications as they may only be advertising written by the product’s manufacturer.
I will consider the reputation and past practices of the pharmaceutical company that provides the product.
I will scour the internet to find out what the experiences of others have been with the suggested drug or device. This I will consider to be the most reputable information available.

Most importantly -
I will continue to take care of my health in an effort to remain as drug free as possible thereby “boycotting” I could care less pharmaceutical companies.
Obviously I do not trust them and intent to not put myself in a position that I must rely on them.
I will also advise all of my family and friends to do the same.

Have I missed the point? I hope someone can convince me that I have.

]]> By: Justice in Michigan http://www.pharmalot.com/2009/10/fda-warns-sanofi-aventis-over-misleading-material/#comment-442316 Justice in Michigan Thu, 29 Oct 2009 00:13:24 +0000 http://www.pharmalot.com/?p=19375#comment-442316 I see these would now be under the rubric of "help-seeking ads," and appear to be within bounds. A student of mind did, indeed, go to health services and was specifically encouraged to get the Gardasil vaccination. This was within the past month. She was given a flier that was created in 2006 (according to the info on it), a couple of months after Gardasil was approved. It was identified as coming from the CDC and was labeled as an "interim" document. I see these would now be under the rubric of “help-seeking ads,” and appear to be within bounds. A student of mind did, indeed, go to health services and was specifically encouraged to get the Gardasil vaccination. This was within the past month. She was given a flier that was created in 2006 (according to the info on it), a couple of months after Gardasil was approved. It was identified as coming from the CDC and was labeled as an “interim” document.

]]> By: Justice in Michigan http://www.pharmalot.com/2009/10/fda-warns-sanofi-aventis-over-misleading-material/#comment-442315 Justice in Michigan Thu, 29 Oct 2009 00:06:03 +0000 http://www.pharmalot.com/?p=19375#comment-442315 This is a somewhat...tangential question, but in a school (university) newspaper I recently perused, there were four quarter-page ads on four consecutive pages. Each one invoked the dangers of genital warts and HPV infection (although the c word was never used) and advised female college students to go to the university health services and talk it over. None of the print ads mentioned Gardasil. Only the last of the ads included the word "Merck," at the bottom. Does the definition of "reminder ads" include such situations, when even the company that bought the ads need not be identified? This is a somewhat…tangential question, but in a school (university) newspaper I recently perused, there were four quarter-page ads on four consecutive pages. Each one invoked the dangers of genital warts and HPV infection (although the c word was never used) and advised female college students to go to the university health services and talk it over.

None of the print ads mentioned Gardasil. Only the last of the ads included the word “Merck,” at the bottom.

Does the definition of “reminder ads” include such situations, when even the company that bought the ads need not be identified?

]]> By: Christopher http://www.pharmalot.com/2009/10/fda-warns-sanofi-aventis-over-misleading-material/#comment-442305 Christopher Wed, 28 Oct 2009 21:21:11 +0000 http://www.pharmalot.com/?p=19375#comment-442305 ps And I would not be surprised to see less DTC the way we see it now ie TV and print. ps And I would not be surprised to see less DTC the way we see it now ie TV and print.

]]> By: Christopher http://www.pharmalot.com/2009/10/fda-warns-sanofi-aventis-over-misleading-material/#comment-442303 Christopher Wed, 28 Oct 2009 21:17:25 +0000 http://www.pharmalot.com/?p=19375#comment-442303 JiM - Re DTD spending: yes the majority of promotional budgets is spent reaching doctors and other practitioners, just using different media and channels than before. At the same time as reps are finding it harder (impossible) to see docs, an increasing number of docs are using other means to get info, most frequently digital media. That's where the money is going. JiM - Re DTD spending: yes the majority of promotional budgets is spent reaching doctors and other practitioners, just using different media and channels than before. At the same time as reps are finding it harder (impossible) to see docs, an increasing number of docs are using other means to get info, most frequently digital media. That’s where the money is going.

]]> By: Justice in Michigan http://www.pharmalot.com/2009/10/fda-warns-sanofi-aventis-over-misleading-material/#comment-442298 Justice in Michigan Wed, 28 Oct 2009 20:43:29 +0000 http://www.pharmalot.com/?p=19375#comment-442298 Thanks, Compliance Analyst. There was a time, not long ago, when DDMAC wasn't doing much, no? Re: DTD, isn't that still the vast majority of promotional budget, not just via reps but in other communications? Perhaps this has changed. I recall it dwarfing DTC (budgetwise) a few years ago. Thanks, Compliance Analyst.

There was a time, not long ago, when DDMAC wasn’t doing much, no?

Re: DTD, isn’t that still the vast majority of promotional budget, not just via reps but in other communications? Perhaps this has changed. I recall it dwarfing DTC (budgetwise) a few years ago.

]]>