Pfizer did respond to me in a timely manner, which I appreciate given the current state of media frenzy regarding the resignation -- I mean retirement -- of Kindler, Pfizer's CEO. I'm not sure if Twitter facilitated the process or if my multiple phone calls/voicemails to various media people at Pfizer were responsible. Within a couple of hours, however, Chris Loder, Pfizer's Head of US Media Relations, gave me a call and said he needed some time to research the issue, but promised someone would followup soon.
After Chris called, I sent him this email so Pfizer could respond to a specific issue I was interested in:
Thanks for getting back to me regarding a Lyrica DTC ad in the December 2010 issue of Prevention Magazine ("What's causing your chronic widespread MUSCLE pain?"). I know you have seen my main blog post about this but I'd like to call your attention to this comment I received because it gets to the heart of the matter:About 4 hours after that I got an email from Victoria Davis, Senior Manager, Media Relations at Pfizer. Read what Davis had to say and then tell me your opinion.
"... you can't make up an indication based on your MOA or preclinical data, and I do believe that Lyrica is trying to expand its indication beyond diabetic neuropathic pain and fibromyalgia (which cannot accurately be described merely as chronic muscle pain). There are other non-opioid agents now receiving chronic musculoskeletal pain indications, and I think Lyrica is trying to muddy the waters and gain some additional share of that market without bothering to do the hard clinical research and face the enormous placebo effect that comes with any pain studies."
In regards to your questions regarding the Lyrica ad, please find our statement below.I am particularly concerned with the FDA "pre-clearance" statement made by Davis. This implies that the FDA gave its OK when, in fact, FDA does not commit to approving ads BEFORE they are run. It can still cite ads for violations AFTER they have been submitted on Form 2253. FDA requires these submissions to be made " . . . at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a prescription drug product." Companies can choose to submit materials BEFORE initial dissemination of the ad and get some "opinions" from the FDA. But FDA does not APPROVE any ads BEFORE they are run. Here's the DDMAC FAQ on that:
“The DTC campaign is designed to educate patients about the symptoms of fibromyalgia and encourages patients to have a discussion with a healthcare provider about their symptoms. Through illustration, the ads show how overactive nerves may cause the chronic widespread muscle pain that is characteristic of fibromyalgia. The ads also highlight how Lyrica is believed to work by calming these overactive nerves to provide relief from fibromyalgia pain.
“The elements included in the print ad were included in pre-clearance with the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC).
“The statements that ‘fibromyalgia is chronic widespread muscle pain thought to be caused by overactive nerves,’ and that ‘Lyrica is believed to calm these nerves’ are scientifically supported. Data supporting these and similar statements have been published in many peer-reviewed journals, including Nature Clinical Practice Rheumatology (now re-titled Nature Reviews Rheumatology) and Epilepsy Research.”
Please let me know if you need anything else.
Does FDA "approve" advertisements and promotional labeling before use by the company?In any case, I do not think that Pfizer's response was sufficient to answer my question, which asked for SPECIFIC references to support the claim that Lyrica "calms" over-active nerves. I have responded by email to Davis asking for these specific references.
No, except in rare instances, when FDA may require pre-approval of promotional materials as part of an enforcement action. However, DDMAC provides opinions on proposed advertisements and labeling pieces before use upon request by an applicant. Note that accelerated approval products are under a "presubmission" requirement. The accelerated approval regulations require that applicants submit to FDA copies of all promotional materials prior to the intended date of dissemination or publication.
FOLLOWUP: I sent Davis this followup email:
Thanks for your response. However, I was hoping for something more specific, ie, specific references to the medical studies that support the claims. Can you tell me, for example, if these claims are also made in marketing materials provided by Pfizer to physicians? If so, wouldn't those materials include specific references? If not, why not (ie, why are these claims not made in physician promo materials)?To which she responded:
"Here are the references.The last paper supports the claim that Lyrica "calms" over-active nerves. The abstract states: "The preclinical findings to date are consistent with a mechanism that may entail reduction of abnormal neuronal excitability through reduced neurotransmitter release." But this is a review and not a clinical study and it is not concerned with the mechanism of action, but only "addresses the preclinical pharmacology of pregabalin, and also the biology of the high affinity binding site, and presumed site of action." Furthermore, the author is a Pfizer employee who works at the "Department of CNS Biology, Pfizer Global Research & Development, 2800 Plymouth Road, Ann Arbor, MI 48105, USA. email@example.com"
Staud, R. and Rodriguez, M. “Mechanisms of Disease: Pain in Fibromyalgia.” Nature Clinical Practice: Rheumatology. (2006), Vol. 2, No. 2
Taylor, C. et al., “Pharmacology and mechanism of action of pregablin: The calcium channel (alpha2-delta) subunit as a target for antiepileptic drug discovery.” Epilepsy Research (2007), doi: 10.1016/j.eplepsyres.2006.09.008
This is the end of the road for me as far as investigating the validity of the claims made in the Lyrica ad. I leave it up to you and the FDA to determine if Pfizer has made its case in support of the claims made.