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This Week's Question!!!!
This question from one of the young charges whose minds I am corrupting....
When was it that DTC ads began to mention "diet and lifestyle" as relevant to treatment, and was this by regulation, self-regulation, or some combination?
I vaguely remember Hank McKinnell doing this for Lipitor just before he parachuted away.
Anyway, the winner, as always, will get a free subscription to PharmaLittle and a Degree of Marketing Historiography (suitable for framing) from the PharmaLittle School of Advanced Reflection.
Go for it!.
Friday, January 30, 2009
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Statin labeling typically includes the following clause or something similar: 'Before implementing drug therapy, an attempt should be made to control high cholesterol with appropriate diet, exercise and weight loss for obese patients and treatment of any underlying medical problems.' Also in the indication section of the labeling, statins are specified as being an adjunct to diet.
ReplyDeleteDDMAC requires advertising to be consistent with the labeling, thus it would make sense that diet and lifestyle mentions are included.
Indeed. Ny student was wondering when this first began to appear on statin advertising. I may not recall, but I don't think it was always there - certainlty not as "audibly."
ReplyDeleteThus, I wonder whether this was mandated by DDMAC or a PhRMA initiative. And when.
JiM
ReplyDeleteDuring 2001, Pfizer was called to task by the FDA for failing to adequately display information in their print ads which would inform potential patients that lipitor should only be used when 'diet and exercise' are not enough. The following link has the FDA letter and a sample of the advertisemnt that was called into question.
http://www.fda.gov/cder/warn/2001/9607.pdf
Following is additional background:
The following language is from the FDA's "Guidance for Industry" advertising guidelines dated 1999. As you note the Agency strongly encourages sponsors to provide non-promotional consumer friendly information in the language of the broadcast and cites the Patient Label as a source for this information.
"The Agency strongly encourages sponsors to consider the benefits of also providing consumers with nonpromotional, consumer-friendly product information in the language of the broadcast ad (e.g., FDA-approved patient labeling or accurate, consumer-friendly translations of product labeling information)."
The following information comes from the current (2006) Pfizer patient information and there is a clear reference that lipitor should be used when diet and exercise are not enough.
"LIPITOR is a prescription medicine that lowers
cholesterol in your blood. It lowers the LDL-C
("bad" cholesterol) and triglycerides in your
blood. It can raise your HDL-C ("good"
cholesterol) as well. LIPITOR is for adults and
children over 10 whose cholesterol does not
come down enough with exercise and a low-fat
diet alone."
I do not know if this demonstrates why the Lipitor ads now specifically include a reference to diet and exercise as the admonishment on Pzier's print ads are 8 years old; there may have been further correspondence from the FDA to Pfizer on this issue which brought the Broadcast Ad to the FDA's attention but I thought if I looked for it and found it, I might win that free subscription to Pharmalittle and it might have lost me my EIC status with the IRS.
JimK
Just one more addition; in 2005 Pfizer presented the attached Power Point Presentation to the FDa and in the presentation they state that the benefits of diet and exercise should be promoted. So maybe it was voluntary.
ReplyDeleteI dont if the first link will work but the second link will get yoo to the page featuring the Power Point Presentation.
www.fda.gov/cder/ddmac/dtc2005/Kelly.ppt - 11-09-2005 - Text Version
http://google2.fda.gov/search?access=p&entqr=0&output=xml_no_dtd&sort=date%3AD%3AL%3Ad1&ie=UTF-8&lr=&client=FDA&q=lipitor&as=GO&ud=1&site=cder&oe=UTF-8&proxystylesheet=FDA&ip=67.189.204.214&start=50
Jim-Thanks so much. Very interesting and will be very helpful to my student.
ReplyDeleteMy guess would be that p-point part of compliance activity, but perhaps something can be dug up.
Again, much thanks,
JiM
ReplyDeleteMy guess is the answer may be found in what exactly prompted the Pfizer presentation to the FDA. Salmon or Former would probably have a much better handle on the reason for the presentation as it may have just been a routine presentation required by all drug companies.
JimK
PS:
Pfizer was also called on the carpet for overstating the benefits of Lipitor in their advertisements(prior to the PP presentation).