The FDA recently made drug company Duchesnay, USA remove this Celebrity Endorsement by Kim Kardashian from her Instagram account for its morning sickness drug Diclegis because it did not list all the possible side effects and thus was "misleading."

The FDA recently made drug company Duchesnay, USA remove this Celebrity Endorsement by Kim Kardashian from her Instagram account for its morning sickness drug Diclegis because it did not list all the possible side effects and thus was “misleading.”

A Drug Commercial Parody exposes an FDA policy as antiquated

“Saturday Night Live” Season 33, Episode 5, February 23, 2008 – “Annuale”

      A 2-minute “Saturday Night Live” (SNL) parody commercial for the fictitious drug, Annuale, hysterically captures the absurdity of the U.S Food and Drug Administration’s (FDA’s) archaic rules regarding the advertisement or endorsement of prescription or over-the-counter pharmaceutical drugs. PLEASE do yourself a favor and click-thru to watch this BRILLANT video which demonstrates in ways I cannot adequately explain with mere words just how far out-of-touch the FDA has become with the way in which our lifestyles are affected by the advertisement of drugs on television or via social media.  In short, this video initially aired during SNL Season 33, Episode 5 on February 23, 2008.  It features 4 women (Tina Fey, Amy Poehler, Casey Wilson and Kristen Wig) fed up with everything having to do with their monthly Menstruation Periods until they discover “Annuale,” a birth control pill which limits females to having a single or “Annual” Menstruation Period.  The “catch” and hilarious “twist” in this drug commercial parody is that this “annual” Menstruation “convenience” comes with a few dangerous side effects such as violent rage, the development of a second vagina and the growth of a leathery tail. The complete voice-over side effect and/or health risk disclaimers are as follows:

“Annuale’s not for everyone. (as the [disclaimer] text scrolls over color footage of the four women screaming [and acting out the various dangerous and bizarre behaviors triggered by taking this fictitious drug]) Do not take if you are using MAIO Inhibitors or if your occupation requires you to operate heavy machinery. Do not take Annuale if you ever plan to become pregnant, as it may turn your baby into a firemonster. In the days around your period, you may develop a leathery tail. Annuale may cause you to develop a second vagina. Notify authorities in your town when your period is imminent as they may want to incarcerate you pre-emptively like a wolfman.”

People are Smarter than Advertisers

think they are 

      Poking fun at something or someone often reveals truths about it or them, which are difficult to put into words.  For example, even when the “threatened” drug side effects and health risk disclaimers are so extreme and vividly demonstrated in a drug commercial, as they are in this SNL parody drug commercial, people still focus on the possible improvement in their lifestyle from the drug without reasonably contemplating any possible deleterious side effects or health risks.  That’s one of the two (2) major points I took away from the SNL parody.  Therefore, a reasonable argument could be made that the accuracy of the drug’s efficacy should be the FDA’s emphasis instead of its close monitoring of the manufacturer requiring the advertiser to include every possible side effect or health risk disclaimer, most of which are created by attorneys who wear belts, suspenders and look in the mirror every 5 minutes to make sure they are still wearing their pants!  Additionally, people inherently understand there is “no free lunch” in all aspects of life and that includes some type of undesired side effect or health risk from a drug which addresses and resolves their specific medical problem.  To that end, people in this “Google” era who often watch television, do so on two (2) screens, with the smaller one at the ready for quick internet research, and are thus very resourceful such that they know to research for a drug’s possible side effects and/or health risks.  And they don’t want their social media platform’s 140-characters to be dominated by unnecessary disclaimers written more to protect drug manufacturer’s from frivolous lawsuits than to inform them of a drug’s dangerous side effects or health risks in the interests of public safety.

The FDA is stuck on “Form” over “Substance”; People need only Substance

      Finally, I think it is fair to say that people tend to ignore verbal or written “scrolled-down” disclaimers which stereo-typically appear toward the end of visual drug commercials and reveal every conceivable side effect and health risk of the drug in favor of continued watching of their visualization of a possible enhanced lifestyle achieved with this drug.  This is where the second of the two (2) takeaway points of this SNL drug commercial parody comes into play.  We now live in a world of “substance” in which people can easily navigate to sources of information of their choice and anything “published” as mandated by “form” is not only antiquated, superfluous and unnecessary but any information included in a drug commercial for “form” reasons, such as verbal or written scrolled-down disclaimers, is most likely going to be ignored by viewers.

      More importantly, given that the FDA presently still places great emphasis on “form” in policing its regimented and outdated rules regarding drug TV commercials, people are either being denied access to commercials which would interest them if only the manufacturer could afford producing a commercial sophisticated enough to include all of the “belt and suspenders” disclaimers required by the FDA or people are being inundated by commercials touting the same drugs from the same manufacturers who happen to be in an advantageous financial position that they can comply with the rigorous but unnecessary drug commercial requirements mandated by the FDA.

The FDA vs. Kim Kardashian & her morning sickness

      As recently as early August, 2015, the FDA again revealed its antiquated focus on “form” over “substance” with respect to the advertisement and/or endorsement of prescription or over-the-counter pharmaceutical drugs when it singled out Reality Television Star/Brand and Businesswoman Extraordinaire Kim Kardashian for her paid promotion of the morning sickness drug, Diclegis, via her popular Instagram social media account.  More specifically, the FDA actually sent a “Warning Letter” to the drug’s manufacturer, Duchesnay, after Ms. Kardashian’s social media endorsement of the drug for her own morning sickness and simply concluded Ms. Kardashian’s statements didn’t say enough about the drug’s potential side-effects and are thus misleading.  In responding to the FDA, Duchesnay respectfully insisted that these side effects are easily obtainable online through numerous websites and that Ms. Kardashian had found the drug through her own doctor to treat her own morning sickness before being approached for this endorsement deal.  But Ms. Kardashian subsequently deleted the Instagram post and in order to comply with the Warning Letter, the drug manufacturer must “correct” Ms. Kardashian’s “misleading” statement to that same Instagram audience.  It is unclear if the drug company intends to comply with this FDA Warning Letter requirement or how they intend to do so, were they to comply.

      If Ms. Kardashian had actually used the morning sickness drug, Diclegis, and presented her own opinion of the drug on her Instagram social media account without being paid or “coached” by the drug’s manufacturer, then the 1st Amendment would have protected her against any repercussions and her actions would not have fallen under the purview of any federal agency.  Similarly, since the drug company would then have no knowledge of Ms. Kardashian’s Instagram post until it was posted by her, the drug company also would face no repercussions.  But once she was paid to make such statements, the drug’s manufacturer has to make sure the information is accurate and the “advertisement” is in compliance with all pertinent FDA rules.  But in the world of social media and ever-evolving mediums, some of which only permit 140-characters, it is unrealistic to list each and every disclaimer, many of which are only listed to protect the rear end of the manufacturer from over-reaching law suits filed by disgruntled customers unhappy with the results or somehow damaged by the drug through no foreseeable liability of the drug company.  Accordingly, some disclaimers are appropriate in terms of warning the general public about reasonably dangerous realistic side effects of the drug but too many disclaimers are created by attorneys donning both belt and suspenders while protecting only the manufacturer.

The Manipulative FDA-approved Drug Commercial – “Humira”

      An example of a drug apparently properly advertised on television in accordance with FDA rules, is “Adalimumab,” better known by its brand name of “Humira.”   In full disclosure, you should know that I’ve taken this drug for treatment of my Severe Crohn’s Disease.  While the drug worked very well and exactly as advertised for a significant period of time (i.e., approximately 3-4 years), I eventually started coming down with unusually severe respiratory conditions which landed me in the hospital.  I started doing some “Google” research on the drug and I discovered that not only were serious (and possibly fatal) respiratory infections a fairly frequent occurrence among some other Humira users but the FDA issued several “Black Box Warnings” to the manufacturer of Humira, Abbott Laboratories, AFTER it was released to the general public. “Black Box Warnings” are essentially drug packaging requirements the FDA requires a pharmaceutical company to include as a bold warning on the packaging and on the patient instruction sheet of a drug if serious or life-threatening risks are associated with the drug.  They are the FDA’s most severe warnings a drug can carry before it is pulled from the shelves.

            Not only were there Black Box Warnings issued to Abbott Laboratories for the possibility of dangerous fungal respiratory conditions such as “histoplasmosis” but there were also Black Box Warnings issued to Abbott for increased risk of cancers in children and for the development of Legionella and Listeria (the Humira drug is now owned and operated by a “spin-off” company of Abbott called “AbbVie”).  There were also written communications to the general public about the serious risks of Humira and the development of the rare T-cell lymphoma, HSTCL.   At that time, a summary of all Warnings of concern to patients taking Humira was also included in a RARE “YouTube” announcement by two (2) prominent executives at the FDA.  This is no longer available on the Web but I have seen it.  I imagine the rationale behind using such a unique and new medium is that autoimmune diseases such as Crohn’s Disease typically affect people in the age range consistent with that of the YouTube user’s age demographic.  Interestingly, when I went to AbbVie’s website in preparation for writing this Post and typed “Black Box Warnings” into the Search Box, it came back with NO RESULTS.  Yet, a doctor was able to devise a very specific time-line for the several Humira-issued Black Box Warnings.  While somewhat difficult to cut through the medical jargon, the FDA’s website supposedly has a list of each Warning it has issued but in my cursory review I was only able to locate two (2) such FDA notices.  But upon closer scrutiny or written request, I am confident each FDA issued Black Box Warning can be obtained.

         The television commercial currently running regarding Humira seemingly within every dinnertime Network News Program and during every major sporting event is embedded below.

      It is approximately 1 minute and 14 seconds in length and the VERBAL side effect and health issue disclaimers begin to run at the 35 second mark and end at the 1 minute and 6 second mark.  Thus, the efficacy of Humira is on screen for approximately 43 seconds while the disclaimers are VERBALLY spoken for approximately 31 seconds.  The potential problem with this apportionment of time is that with this particular drug, especially considering how serious the potential side effects and/or health issues can be, it would seem that the 43/31 Visual to Verbal disclaimer content should be flipped.  Moreover, to more accurately represent the seriousness of the potential side effects, wouldn’t it seem to be a fairer representation of the Humira “experience” if the 31 seconds devoted to the side effect and health issue disclaimers included some VISUAL content equal in font prominence and size as the “Remission is Possible” selling-point?

      Moreover, if the FDA is true to its word about prohibiting “misleading” commercials or endorsements like that of Kim Kardashian’s above, which merely didn’t mention side effects or health issues when EVERYONE knows that EVERY DRUG comes with the potential for SOMETHING, the 31 seconds of Humira side effect and health issue disclaimers should SHOW a Humira patient FREAKED OUT because he or she has just been told they have a potentially lethal fungal lung infection, or they have a strange cancer for their age or lifestyle or that they must begin chemotherapy to treat a severe respiratory condition side effect of Humira, AS I WAS REQUIRED TO DO IN ORDER TO BE ABLE TO BREATHE & TALK AT THE SAME TIME.  After all, the beginning of the commercial SHOWS the viewer a “patient” struggling with the effects of Crohn’s Disease so why can’t the commercial do the same regarding a patient struggling with the potentially serious side effects of the drug being marketed?  The answer is because the opening shots of the woman struggling with Crohn’s Disease lures in similar patients and thus creates a demand for the drug, Humira.  Any visualization of LETHAL or LIFE-ALTERING Humira side effects would NOT HELP SALES. Accordingly, I respectfully contend that the Humira commercial, through no fault of Abbott or AbbVie since they are simply following FDA rules, is MISLEADING.

Conclusion: FDA Rules re: Drug Commercials permit Drug Companies to Legally Manipulate Patients

      The Humira television commercial is in sync with the FDA’s preposterous rules regarding the “form” of drug television commercials and the FDA doesn’t care about the “substance” of these commercials, for if it did, the Humira commercial would show a patient struggling with the side effects of Humira for the same amount of time the commercial portrays the patient struggling with Crohn’s Disease (and thus setting the stage for the miraculous selling points of Humira).  Furthermore, if the FDA truly played its role of being **responsible for protecting the public health by assuring the safety, efficacy and security of human …. Drugs …,” the 31 seconds of VERBAL disclaimers would have more substance to them so that the viewer can’t simply tune them out and focus on what they’ve already seen as the potential for them if they took Humira.  Unfortunately, the result is that many Crohn’s Disease patients then go to see their doctors and request to be put on Humira.  Some patients struggling so badly with Severe Crohn’s Disease who don’t respond to any other treatments are certainly candidates for Humira.  But Crohn’s Disease patients who have cases which are not Severe and which have yet to prove they won’t respond to other treatments are not yet candidates for Humira.  This could create a SERIOUS PROBLEM if their doctors cave into the patient pressure and Humira then becomes a drug of 1st resort when it should be a drug of last resort (with the exception of some pediatric Crohn’s Disease and Ulcerative Colitis cases).

      I don’t blame Abbott or AbbVie for what happens in gastroenterologists’ offices because they are simply taking advantage of the FDA’s rules and doing all they can within the law to market their product.  My problem is with the FDA and their archaic rules regarding drug media commercials which CLEARLY favor FORM over SUBSTANCE.  The FDA thinks it is protecting patients by making sure EVERY conceivable disclaimer is included in a commercial but in practice they should recognize how companies like Abbott and AbbVie legally manipulate these rules and create a potentially DANGEROUS situation for patients whom only care about what they SEE and not what they HEAR.  In that regard, I BEG THE FDA TO REVISE THESE RULES so that patients can no longer be legally manipulated by drug companies.

**From FDA Website

Please leave a comment if you have any thoughts about the FDA's drug commercial policy and/or the actions it took in the recent case involving Kim Kardashian's seemingly well-intended Instagram Endorsement of the morning sickness drug, Diclegis.  Please also feel free to comment about the very funny parody drug commercial by Saturday Night Live for the fictitious drug, Annuale.

Please leave a comment if you have any thoughts about the FDA’s drug commercial policy and/or the actions it took in the recent case involving Kim Kardashian’s seemingly well-intended Instagram Endorsement of the morning sickness drug, Diclegis. Please also feel free to comment about the very funny parody drug commercial by Saturday Night Live for the fictitious drug, Annuale.