Sanofi Says Proposed FDA DTC Guidelines Would Effectively Kill TV Drug Ads

PhRMA is itching to challenge FDA's authority to regulate DTC advertising in front of the Supreme Court, arguing that recent "Draft FDA Guidance on PreDissemination Review of TV Direct-to-Consumer Ads" (find it here) violates the Free Speech Clause of the First Amendment because pharmaceutical marketing is a form of free speech (see "PhRMA Demands that FDA 'Cabin' Its Discretion to Regulate DTC Ads").

Sanofi, on the other hand, in a comment submitted to FDA (see here) argues that "the process presented in the draft guidance would potentially require the sponsor [ie, Sanofi and other pharma companies] to cease the use of TV ads as a vehicle to educate consumers due to significant production challenges as a result of the draft proposed process."

The "process" that Sanofi is talking about is the requirement to submit a "final recorded version [of the ad] in its entirety." Sanofi is concerned that if the ad needs to be changed -- reshot and re-edited -- as a result of FDA pre-review, it be too costly and "resource intensive" for the sponsor.

Not all ads, however, will require FDA review before airing (see "Focus on Drug Safety Communication & TV DTC Advertising" for details) and it is not clear how much it would actually cost to redo the production to comply with FDA comments. Sanofi should have included some specific estimates of these costs and "resources" to bolster its case.

Sanofi offered a compromise. Instead of submitting a "final recorded version" of the TV ad "in its entirety," Sanofi suggests that sponsors submit an "annotated storyboard or animatic [animated?] version of the advertisement."

FDA already reviews storyboards submitted prior to ads being run. In at least one case, however, a violative ad was aired months after FDA had a storyboard in its possession. Only after the ad had run its course did the FDA issue a notice of violation (see "FDA and YAZ: Is FDA Helping Marketers Work Around Regulations?").

Sanofi also submitted a comment regarding FDA's requirement for "verification that a spokesperson who is represented as a real patient [in a TV ad] is indeed an actual patient." Sanofi asked that FDA clarify what type of verification would be needed. Would a "signed testimonial from an actual patient" be enough?

Snaofi may be planning to use more real patients in its TV ads as have other pharma companies (eg, Pfizer use of real patients in Chantix TV ads). I've documented one instance where Sanofi has used a real patient in a video ad on YouTube (see "Method Acting for Real Patients Who Play Themselves on Pharma YouTube Channels") but do not recall any TV ads for Sanofi products that used real patients.

Regardless of what verification FDA requires for TV ads, the guidelines only apply to TV ads and NOT to ads that run on YouTube. Hence, although these new guidelines may "kill" TV drug ads, they may be a boon for YouTube ads such as the Sanofi YouTube video mentioned above.

Amgen's Prolia Website Features Stories from "Typical" But Not "Actual" Women Like You

You've probably been seeing DTC TV ads for several different osteoporosis drugs these days. No longer does Sally Field dominate the airwaves hawking Genentech's Boniva. AMGEN's twice-per-year injectable Prolia, for example, is now competing with once-per-month injectable Boniva.

Unlike Boniva, however, Prolia does not have a celebrity spokeswoman. What it has are "Women Like You."

The Prolia website prominently displays the option titled "Stories from women like you." Below is a screen shot of that option showing Karen, 71, who talks about Prolia.

Unfortunately, neither Karen nor any of the other "women like you," is an actual patient. Their stories, AMGEN claims, are "examples of typical patients--not the experiences of actual patients." Maybe it's difficult to get real patient stories for a new drug. I've heard from posts on CafePharma that sales of Prolia suck big time because few GPs want to prescribe a new, unproven biologic that remains in the body for a whole year. Plus there are re-imbursement issues.

Karen tells her story AS IF she were a real patient and provides details of how she fractured her left wrist. "I should be glad it wasn't my right [wrist]," says Karen. "My doctor said, 'Karen, you didn't get a fracture from being clumsy. You got a fracture from weak bones.'"

[BTW, I love the new age music in the background!]

Karen mentions that she is doing "everything my doctor told me to do to strengthen my bones." At first -- within the first two minutes of the video -- she only mentions getting a "shot every six months," which she "likes" and says"works for me." Later on, Karen does mention calcium pills, exercise, etc.

While Karen doesn't mention specific side effects, some specific side effects do pop up in the video frame in mouse-sized type that is difficult to read -- especially, I imagine, for older women. The last 2 minutes of the video highlights the important safety information using a scrolling text screen and a voiceover.

Perhaps, over time AMGEN will collect stories from ACTUAL patients to replace Karen and other "not actual patients" on its website. Meanwhile, I remain queasy about actors portraying "typical" patients in drug ads. Has the FDA issued any guidelines regarding what constitutes a "typical patient" in drug ads? FDA has issued warning letters about actors whose dialogue overstates benefits or downplays risks, but I don't recall any letter that questioned whether or not the portrayal is "typical."

Suppose, instead of a typical patient, AMGEN had a video of a "typical" physician? Would the FDA (or AMA for that matter) rise up and challenge the concept of a typical physician?

It seems to me that allowing drug marketers to use actors to portray what is labeled a "typical patient" is worse than using actual patients who tell real stories stories, even if those stories are not typical. At least we can challenge the veracity of "real" stories versus "typical" stories.

Is Phil Mickelson Shilling for Enbrel?

The golf world was stunned by Tiger Woods' recent poor performance. Another bit of "stunning" news hit the golf world yesterday when the #2 ranked duffer Phil Mickelson announced that he suffers from Psoriatic Arthritis and is being treated with Enbrel. See "Phil Mickelson Arthritis: Will Play At PGA Whistling Straights".

The New York Times also ran a story: "Immune Disorder Could Be an Enduring Test for Mickelson".

Both these articles mentioned that he was being treated with Enbrel, a drug jointly marketed by AMGEN & PFIZER. The first article I cited includes the subtitle "PGA Championship 2010, Whistling Straits: Phil Mickelson Has Psoriatic Arthritis - Uses Enbrel To Help Manage Condition" and includes this quote from Phil: "I have no aches and pains. My back feels great. I feel stronger and more flexible than I've ever been."

Quite an "unsolicited" celebrity endorsement! Amgen/Pfizer could never quote what Phil said on its Enbrel website as in the following completely fabricated (by me) screen shot:

By the way, although you probably cannot see it in Phil's press conference image shown above, his eyes are completely BLOODSHOT, which indicates to me that he is taking something other than Enbrel to ease the pain (see larger image here).

The New York Times helped Enbrel's cause by supplying the following dire statistics about this medical condition: "As many as 7.5 million people in the United States have psoriasis, according to the National Psoriasis Foundation, and about 30 percent of those with psoriasis develop psoriatic arthritis. While psoriasis often appears between the ages of 15 and 25, the arthritis symptoms usually appear later, often between 30 and 50. When it does, there is no rhyme or reason as to which joints will hurt at any given time."

I am willing to bet that this bit of information came straight from AMGEN/PFIZER's PR people.

It probably did NOT come from the "nonprofit Psoriasis Cure Now" group, which issued a press release entitled "Phil Mickelson's Arthritis Shocks Golf World, Psoriasis Cure Now Says a Reminder That Psoriatic Arthritis Is a Serious Disease." That group, which includes Amgen and Pfizer as sponsors, claimed ONLY 1 million people (less than half the number cited in the NYT article) in the US have psoriatic arthritis. "... cases range from mild to what Phil Mickelson described this week. Fortunately, the man on the edge of being ranked the world's number one golfer is taking Enbrel, a biologic treatment that has transformed the lives of many people with psoriasis, psoriatic arthritis, rheumatoid arthritis and other immune system diseases."

My question is this: Is Phil Mickelson being paid as a spokesperson by Amgen or Pfizer either directly or through Psoriasis Cure Now?

I have surveyed readers about the "Use of Patient Testimonials in DTC & Social Media Advertising" (see survey here) and have also written about it in Pharma Marketing News (see "Real Patient Testimonials: An Effective Social Media Marketing Strategy"; use code 'SMOD239' to download it FREE).

P.S. Does Phil have a Twitter account? Will he do branded tweets like racecar driver Charlie Kimball has done for Levemir? (see “Novo Nordisk's Branded (Levemir) Tweet is Sleazy Twitter Spam!”).

P.P.S. Before you go off on a rant, let  me just say that I admire Phil Mickelson -- unless, of course, he is having an extramarital affair we do not know about! I also like Charlie Kimball and Sally Field and each and every pharma celebrity product endorser!