Selling Amphetamine-Emblazoned Athletic Shirts Versus Overselling Amphetamines: A Tale of Two Entrepreneurs

The following text, reprinted here with permission of the British Medical Journal (BMJ), originally appeared as one of Dr. Sidney Wolfe’s regular columns in the BMJ.

What could be more tasteless and, possibly, harmful than a Los Angeles boutique selling sweat shirts and tee shirts, looking like football jerseys, with the word “ADDERALL” — a prescription amphetamine for treating attention-deficit/hyperactivity disorder (ADHD) — with a large player type number below it? Beyond the legitimate use of such drugs for treating ADHD, there is no doubt that amphetamine stimulants are used by athletes as performance enhancing drugs and are also misused in other ways. The fact that the product description of the shirts includes “Pop one on and you’ll feel better. Doctors orders” only heightens this concern.[1]

According to an article in the New York Daily News, containing pictures of the shirts and quoting Shire, the manufacturer of ADDERALL, “The use of ‘ADDERALL’ in this fashion gravely concerns Shire as it glorifies the misuse and diversion of a federally controlled prescription drug for the treatment of ADHD. Shire opposes the misuse and diversion of prescription drugs.” The article indicated that Shire was “assessing its options” on how to deal with the unauthorized use of the ADDERALL trademark.[2]

But one answer to what could be more tasteless might be Shire’s own direct to consumer ADDERALL promotional advertisements.

In 2008, the US Food and Drug Administration (FDA) sent a warning letter to Shire asking the company to immediately stop a promotional campaign to consumers that included a webpage and a YouTube video because, in the agency’s words, “Both the webpage and video overstate the efficacy of ADDERALL XR; the video also omits important information regarding the risks associated with ADDERALL XR use. Additionally, the webpage broadens the indication for ADDERALL XR by suggesting uses that have not been approved by FDA.”[3]

Examples of these suggested unapproved uses included the company’s webpage presentation that was “misleading because it implies that ADDERALL XR reduces the likelihood or severity of the ‘difficulties’ and ‘consequences’ of ‘untreated ADHD’ listed above (ie, poor social-emotional development and job success, inability to complete schooling, illegal behaviors, contraction of sexually transmitted diseases, motor vehicle accidents, and physical injury), when this has not been demonstrated by substantial evidence or substantial clinical experience.” In addition to these implied, overstated benefits, “The video . . . entirely omits risk information for ADDERALL XR, including the contraindications, warnings, precautions, and common adverse events associated with the drug.” Examples of documented risks omitted from the video included, according to FDA’s letter, “ADDERALL XR is associated with a number of serious risks, some of which may be fatal. These risks include serious cardiovascular events, hypertension, psychiatric events, aggression, long-term suppression of growth, seizures, and visual disturbances.”

The Shire YouTube video consisted of a testimonial by television star Ty Pennington that also served to overstate ADDERALL’s efficacy. In the video, Pennington said: “Now once I got on medication it’s just amazing the transformation I made. I-It literally changed my life, and gave me the confidence to achieve my goals, like being an artist. As a kid, I never could have imagined I could do it. But with the medicines like ADDERALL XR, it’s truly a transformation. I mean talk about an Extreme Makeover, I’m like living it. Now growing up with ADHD can be a little difficult. It’s not easy to communicate with people, including your own family. So you become kind of alienated. You feel like you’re different, and you don’t really fit in. And that, well, can kind of cause you to feel different, and nobody likes to feel different. So as someone who has had ADHD, and is overcoming it, proper treatment has truly changed my life and made an amazing difference.” (emphasis added)[3]

In its warning letter to Shire about this video, FDA stated “the effect of ADDERALL XR on patients’ total scores . . . , while statistically significant, does not demonstrate an effect that in any way supports the ‘amazing transformation’ claim, nor do the symptoms measured in this rating scale include the outcomes claimed in this testimonial (i.e., fitting in, effectively communicating, not feeling different). If you have data to support these claims, please submit them to FDA for review.”[3] Neither the webpage nor the video (with the urls described in the FDA’s letter) appears any longer on the internet.

In the interests of full disclosure, tees and sweats alternatively emblazoned with “VICODIN,” which contains the narcotic hydrocodone, or with the tranquilizer “XANAX” (alprazolam) — two other highly misused drugs — could also be purchased at the boutique.

The irony of all of this, of course, is that a company such as Shire, while “gravely” concerned that the use of ADDERALL on the shirts “glorifies the misuse and diversion of a federally controlled prescription drug” has been pulled up by the FDA for overstating the benefits of its product in its own direct to consumer advertising campaign. (And what of the irony of broadening the indication for ADDERALL XR by suggesting uses that have not been approved by the FDA?) Further, in the video there is no mention of any of the risks of the drug.

Why don’t these promotional campaigns occur worldwide? Direct to consumer prescription drug advertising in print advertisements and on television is currently only allowed in the United States and in New Zealand, which probably influences manufacturers’ conduct online. Unfortunately, Europe has considered allowing it. Researchers opposing direct to consumer advertising for prescription drugs have stated that “its wider introduction would lead to a ‘pharma knows best’ culture.”[4] I strongly agree.

References

[1] Kitson website (online boutique) www.shopkitson.com/index.php?page=product&id=20370.

[2] Taylor V. Drugmakers may sue LA boutique over Adderall, Vicodin, Xanax T-shirts. New York Daily News 29 August 2013, www.nydailynews.com/life-style/health/drugmakerssue-adderall-vicodin-xanax-shirts-article-1.1440876.

[3] US Food and Drug Administration. Letter to Shire Development Inc. 25 September 2008, www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/ucm053995.pdf.

[4] Mintzes B, Mangin D. Direct-to-consumer advertising of prescription medicines: a counter argument. Future Med Chem 2009;1:1555-60, www.future-science.com/doi/pdfplus/10.4155/fmc.09.136.