Retro Relpax Web Site Features Woman Mopping the Floor. Inspirational? Not!

Retro Relpax Web Site Features Woman Mopping the Floor. Inspirational? Not!

The "DDR on DTC" column in the August 2012 issue of MM&M magazine ripped into a print ad that showed a woman migraine sufferer being able to mop the floor after taking the Pfizer anti-migraine headache drug Replax.

"DTC ads used to be over-aspirational," said the author, Deborah Dick-Rath, "we saw relieved arthritis sufferers running marathons or playing Frisbee. With Relpax, the insight seems to be that sufferers just aspire to do such everyday activities as mopping the floor...We hope that Relpax is a success for Pfizer and that migraine sufferers find relief. We also hope they get (strictly aspirationally) excused from swabbing the deck" (see "DDR on DTC: Relpax").

Here's the ad that DDR reviewed:

This is probably the result of Pfizer's conservative view of what modern women aspire to at 11:00 Am in the morning (note the clock).

I couldn't find this ad in a recent issue of People Magazine, which is the publication in which DDR found the above ad. Instead I found this much more politically correct, although still not too inspirational, ad:

In this version, two hours after taking Replax, the migraine sufferer is able to go out and do whatever her business is -- probably commuting to work given that the clock is showing 8;00 AM (or is it PM?).

Perhaps Pfizer read DDR's column and revised the print ad campaign, at least as far as image is concerned. Surprisingly, however, the Replax.com Web site still portrays the woman mopping the floor:

It appears that it takes longer to swap out a Web image that a print ad image.

Pfizer is asking Replax.com visitors to tell their "stories" by submitting photos or video. "Tell us about your experience with migraines by submitting a story," says the promo page (here). "Your story can include a photo or video. If chosen, your submission could be featured on RELPAX.com."

I don't imagine a single submitted photo or video will feature a woman mopping the floor. Do you?

You can tell that pharma marketers are getting desperate when they have to beg consumers to submit stories to compensate for the fact that their image of the modern consumer dates back to the 1950's.

Drug Ads & Coupons: Who's the Decider? The Patient, the Physician, or the FDA?

Drug Ads & Coupons: Who's the Decider? The Patient, the Physician, or the FDA?

The FDA is concerned that the use of sales promotions such as free trial offers, discounts, money-back guarantees, and rebates in direct-to-consumer (DTC) prescription drug ads "artificially enhance consumers' perceptions of the product's quality" while also resulting in an "unbalanced or misleading impression of the product's safety." To test whether or not this is true, the FDA will soon start yet another study focused on Rx print ads: "Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions" (see Federal Register Notice archived here).

[I recently posted about another planned FDA study to determine if disease awareness information in branded ads confuses consumers. See FDA Concerned About Product (eg, Lyrica) Ads That are Too "Educational"]

The history of this study is long and mysterious. I first blogged about it 2006; read "FDA, Coupons, and Sleep Aid DTC Ads." Shortly after that the Federal Register notice regarding the study was "yanked" (see "FDA Backs Down on Coupon Study"). Also, the Advertising Age and Wall Street Journal articles cited in those posts can no longer be found in the archives.

In September, 2011, however, the proposed study re-emerged in the Federal Register (here). Whatever happened between 2006 and 2011 is anybody's guess, but I assume that the Bush era FDA leaders axed the proposed study when they learned of it. By September, 2011, these people were on the way out and the door was open again to propose the study anew.

Anyhoo, I want to focus here on comments that PhRMA made in response to the proposal. Alexander Gaffney (@AlecGaffney), Health wonk and writer of news for @RAPSorg, summarized the general attitude of PhRMA (see "US Regulators Move Ahead With Planned Study on DTC Marketing"):

In its statement to FDA, PhRMA wrote it was “concerned that the study, as currently envisioned, will not yield information that is relevant to FDA’s regulatory responsibilities to ensure that DTC advertising is truthful, accurate and balanced.”

“Although the study may provide interesting information about the effect of promotional offers on consumer attitudes toward a brand,” explained PhRMA, “it likely will provide little information on whether promotional offers create or contribute to false or misleading advertising, particularly under real-world circumstances or whether additional regulatory requirements are warranted.”

PhRMA: The Physician is the Decider
I dug a little deeper into PhRMA comments (here) and was surprised to learn that PhRMA's position is that "it is the physician, not the patient (my emphasis), who ultimately must decide whether the benefits of the advertised drug outweigh its risks for any particular patient." Thus, says PhRMA, "the risks of 'misperceptions' ... should be even lower [PhRMA's emphasis] for prescription drugs than for experience goods [i.e., a product or service where product characteristics, such as quality or price are difficult to observe in advance, but these characteristics can be ascertained upon consumption] because any potential misperception, of necessity, will be quickly corrected prior to use through consultation with the patient's treating physician."

This is a very paternalistic POV in this day and age of social media and patient empowerment. Actually, it is the old "learned intermediary" defense that the drug industry often raises (in the past, less so these days) to shield itself from blame when things go wrong.

FDA must respond to comments submitted, but I couldn't find a direct response to PhRMA's comments cited above. I did find, however, the following comments and FDA's response that addressed the issue of the patient-physician relationship generally:

(Comment 22) Two comments mentioned that the study does not assess how consumer perceptions of product risks and benefits are translated into a discussion with their health care provider. One comment stated that because these products can only be purchased after a discussion with a health care provider, the study be redesigned so that consumer perceptions are measured after a discussion with a health care provider.

(Response) We concur that this study does not address behaviors, such as how ad perceptions are translated into a discussion with a health care provider. As noted previously, one purpose of DTC advertising is to motivate consumers to engage in a discussion with their health care provider about health concerns. Another purpose, supported by research findings (Refs. 20 and 21), is to increase awareness of available treatments. DTC advertising does not exist solely in the confines of a doctor's office; rather, DTC advertising targets consumers outside of a doctor's office, with the goal of prompting consumers to ask their physicians about the product. In deciding whether or not to discuss a particular product with their health care provider, consumers presumably are engaging in some sort of judgment about the product being promoted. Therefore, clear communication of risks and benefits is needed for consumers before a consultation with a physician, and it is valid to measure these impressions.

FDA Concerned About Product (eg, Lyrica) Ads That are Too "Educational"

FDA Concerned About Product (eg, Lyrica) Ads That are Too "Educational"

In a recent Federal Register notice (find it here), FDA outlined a study it plans to do to determine if disease awareness information in branded ads confuses consumers; i.e., if consumers confuse educational information about a disease with specific product claims approved by the FDA. As usual, FDA will only study print ads -- not Internet-based ads.

"Sponsors [pharmaceutical companies] may choose to include disease information in their full product promotions," says FDA. "Such information is designed to educate the patient about his or her disease condition. However, in some cases a full description of the medical condition may include information about specific health outcomes that are not part of a drug’s approved indication... When broad disease information accompanies or is included in an ad for a specific drug," says the FDA, "consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad by making inferences that go beyond what is explicitly stated in an advertisement."

FDA cites as an example a hypothetical ad that mentions "diabetic retinopathy," which is damage to the eye's retina that occurs with long-term diabetes. "...the mention of diabetic retinopathy in an advertisement for a drug that lowers blood glucose may lead consumers to infer that the drug will prevent diabetic retinopathy, even if no direct claim is made. The advertisement may imply broader indications for the promoted drug than are warranted, leading consumers to infer effectiveness of the drug beyond the indication for which it was approved."

I couldn't find a diabetes-related print drug ad that mentioned "diabetic retinopathy," but I did find one in today's Parade magazine that informed me that "Diabetes Damages Nerves." That ad (shown below) promotes Pfizer's drug Lyrica, which is indicated for the treatment of "Diabetic Nerve Pain." It is NOT indicated to prevent nerve damage caused by diabetes.

What I see when quickly glancing at this ad is "DIABETES DAMAGES NERVES" (all caps), then "PAIN," (also all caps) and, finally, "LYRICA" (also all caps). If I were a typical consumer with diabetes, I might think that LYRICA prevents damage to my nerves, which would be an incorrect assumption.

BTW, the ad also says "Lyrica is believed to work on these damaged nerves." What does that mean? Does Lyrica work on repairing the nerves? or does it work on shutting down the nerves so you don't feel pain? And, what does "believed" mean? It's all very mysterious!

This ad probably is not the best example of an ad that FDA has in mind -- it was just the best example I could find at the moment. I'll have to buy a few more consumer magazines to find other, more relevant examples. If you know of one, please point it out to me.

Vast Majority of Drug Ads in Leading Medical Journals Don't Pass MDs' Sniff Test!

Vast Majority of Drug Ads in Leading Medical Journals Don't Pass MDs' Sniff Test!

A study led by Mount Sinai School of Medicine researchers of 192 pharmaceutical advertisements (83 full unique advertisements) in biomedical journals found that only 18 percent (15) were compliant with Food and Drug Administration (FDA) guidelines, and over half failed to quantify serious risks including death. The study was published online on August 17, 2011 in the journal Public Library of Science (PLoS) One (here; also see press release here).

I've had some communication about this study with Dr. Deborah Korenstein, MD, Associate Professor of Medicine at Mount Sinai School of Medicine, lead author of the study, and Joseph S. Ross, MD, Section of General Internal Medicine, Yale University School of Medicine, a co-author of the study.

The major question I had was what "FDA guidelines" did they use to measure compliance against? The article was very non-specific in that regard, but I was sent the "Master Guide for Ad review," which was used to assess compliance with 20 FDA "Guidelines" (find the Guide attached to this post).

Actually, "guidelines" is the wrong term to use because what the authors used to create their assessment "Master Guide" was the original FDA "Regulations" (ie, Code of Federal Regulations Title 21, Sec. 202.1 Prescription-drug advertisements; find it here).

For example, one of the assessment items asks reviewers: "Are there unsupportable efficacy claims related to comparisons with other drugs?" In support of that, the authors cite this language in the Code: "Contains a drug comparison that represents or suggests that a drug is safer or more effective than another drug in some particular when it has not been demonstrated to be safer or more effective in such particular by substantial evidence or substantial clinical experience." This is just one of the reasons that would make an ad "false, lacking in fair balance, or otherwise misleading" according to the regulations.

So, in short, the authors played the role of DDMAC reviewers and, based on THEIR interpretation of the regulations, determined if the ad under review was non-compliant with FDA "guidelines."

I took the liberty of plotting some of their results. Looking at the glass half-full, the following chart shows Percentage of Ads that are completely ADHERENT with FDA "guidelines" according to this study:

When assessing content, the reviewers looked at issues relating to "Safety," "Efficacy," and "References," as well as other content issues.

As can be seen in this chart only 47% of the ads (N=83) were deemed adherent to FDA "guidelines" regarding efficacy. The questions authors asked themselves when reviewing the efficacy claims in ads were:

1. Does the ad quantify benefits?


2. Were appropriate efficacy data or numbers presented?


3. Are there unsupportable efficacy claims related to comparisons with other drugs?


4. Are efficacy claims based on non-clinical data?


5. Are there unapproved efficacy claims?


6. Does the ad make unfounded claims regarding competitor drugs or does it claim inaccurately that advertised drug differs from other drugs?

For each question, the reviewer could check off "Yes," "No," "Not Sure," or "NA." Reviewers used language from the FDA regulations cited above to subjectively decide the answer. For example, in support question 4, the assessment guide quotes this language from the FDA regulations: "Contains ...data or conclusions from non-clinical studies ... which suggests they have clinical significance when in fact no such ...significance has been demonstrated." Ads that fit that description -- as subjectively determined by the reviewer -- were judged "Non-Adherent."

According to the researchers:

"Advertisements were considered adherent if they contained none of the 21 [actually 20 according to their "Master Guide"] features used by FDA to classify advertisements as misleading, non-adherent if they contained one or more of the features used by FDA to classify advertisements as misleading, and possibly non-adherent if there were no features clearly defining a misleading ad but at least 1 of those items for which information was incomplete."

Sometimes, the reviewer was "not sure" if the ad was adherent or not. In the case of efficacy claims, 31.3% of the ads fell into this category, while 21.7% were judged "non-adherent." The remainder -- 47% -- were "adherent" as shown in the chart above.

Well, if the MD reviewer is "Not Sure," maybe an actual FDA reviewer might also not be sure. But in that case, the ad would be put into the "adherent" bin. In other words, an FDA reviewer might consider that 78.3% (47% + 31.3%) of the ads were actually adherent with regard to efficacy claims.

The problem, note the authors, is that the FDA is NOT catching the ads that according to them are obviously non-adherent. Why not? "The limited resources of the FDA's Division of Drug Marketing and Advertising [DDMAC] are a major barrier to successful regulation of the pharmaceutical industry's multi-billion dollar marketing budget," said Dr. Korenstein who notes in the research paper that "DDMAC’s fiscal year 2008 budget of $9 million is dwarfed by the pharmaceutical industry’s $58 billion marketing budget."

"We are hopeful that an update in FDA regulations, with increased emphasis on the transparent presentation of basic safety and efficacy information, might improve the quality of information provided in physician-directed pharmaceutical advertisements," said Dr. Korenstein.