Or another title as suggested by our guest blogger could be…
“Politicians and reporters make a stink about opioid-induced constipation”
Whatever the title, I’m often asked where I get ideas for blog posts? The simple truth is that all I need to do is wake up in the morning, take a deep breath of politician and media muckraker hypocrisy, and alas, another idea is born. In this case, the resultant diarrhea of the mouth amongst politicians atop a newfound bully pulpit is what made the impact.
Here to enlighten us about some actual and figurative turds is soon to be “Doctor” Kathleen Nicewicz, a recent student that spent 6 weeks studying pain management with yours truly.
Here’s what Dr. Nicewicz has to say…
A new controversy started with an opioid-induced constipation (OIC) Super Bowl television commercial and a new home treatment option: 
Movantik (aka Naloxegol). Some viewers thought the ad was hilarious, while others were outraged and appalled. But perhaps the most important viewer group were those that were comforted to learn that the chronic constipation they’ve been experiencing is a true medical problem with a potentially beneficial new medication option. No matter which group you fall into, this commercial sparked a lot of controversy!
Let’s start with a simplified overview of OIC pathology. Opioids cause constipation by binding to the opioid mu-receptors in the gastrointestinal (GI) tract. These GI mu-receptors are most densely located in the stomach and proximal colon, but they are also located throughout the submucosa and ileal mucosa. Opioids delay GI transit (parastalsis), increase contact time with the GI tract, increase fluid absorption, decrease fluid influx, and decrease anal sphinter tone. This process takes fluid away from the stool making it more difficult to pass through the remainder of the GI tract and be excreted. These effects of opioid use are often avoidable with peripherally acting mu opioid receptor antagonists (PAMORAs) such as naloxegol, a new product known by brand as Movantik. Nevertheless, OIC commercials have caused an uproar all over the country!
Reporters and writers in the media were not shy when voicing their opinions about this advertisement. For example, the LA Times published an article criticizing the ad. The writer felt that pharmaceutical companies were “hoping to profit from a controversial market that has arisen alongside the nation’s opioid addiction crisis”. The article went on to say that the ad has “drawn criticism from federal and local officials for not mentioning the issue of opioid addiction”.
Vermont Governor Peter Shumlin had a lot to spew about this ad. In a letter to AstraZeneca and Daiichi-Sankyo, he wrote: “In the midst of America’s opiate and heroin addiction crisis the advertisement was not only poorly timed, it was a shameful attempt to exploit that crisis to boost your companies’ profits.” He went on to make the following request: “I ask that you immediately pull this advertisement – and others promoting this drug – from the air and instead use the money to fund opiate and heroin prevention efforts.”
This advertisement was not promoting the abuse of opioids, the use of opioids prescribed to someone else, or anything of the sort. The ad never suggested that people should start taking opioids or even ask their doctors if initiating opioids is a good treatment option for them. It was simply addressing a side effect and major problem that chronic opioid-requiring pain patients often experience. Unlike less common opioid side effects, opioid-induced constipation does not improve or lessen over time as the body becomes tolerant to the opioid. Therefore, patients that require chronic opioids who have failed traditional over-the-counter (OTC) products might previously never have escaped this problem. In fact, during my 6 weeks with Dr. Fudin I actually met patients whose lives were so distraught from chronic constipation, that some chose pain over opioids – is that what the politicians are suggesting for their constituents? Often times patients may feel uncomfortable talking about their bowel movements and constipation issues with their medical providers. One goal of this ad was to start an open dialogue between patient and provider. Expressing how common this problem is will hopefully show patients that they are not alone. The way managed care is these days, some clinicians might not broach the topic with their patient when they also have to deal with chronic pain, diabetes, hypertension, anxiety, heart disease, depression, and any number of problems in a 15 minute typical “managed care” visit. It seems that sometimes bowel movements are on the bottom of the bowl so to speak.
There were multiple beer ads during the Super Bowl – where’s the outrage about that? Why aren’t the beer companies such as Anheuser-Busch 
spending their money on an ad demonstrating the dangers of drunk driving, alcohol poisoning, liver toxicity, or alcohol neuritis? Are these not social issues that are directly related to the products advertised (unlike Movantik I might add)?
Similarly, PepsiCo had multiple ads during the Super Bowl (SB). They make products such as Lays potato chips, Gatorade, Quaker, Tostitos, and Pepsi. Should PepsiCo be required to sponsor ads about obesity prevalence in America and associated morbidity and mortality.
It’s absurd to hold one company to this standard and not the others, especially since all but AstraZeneca are actually selling harmful products, while Movantik and other PAMORAs can actually improve quality of life.
Considering 2015 revenue for Anheuser-Busch InBev, the company that owns Budweiser, Stella Artois, and Corona, was $43,604 million USD. For quarter 4, their revenue was $10,723 million USD. PepsiCo’s total 2015 revenue was $63,056 million. Their total revenue for quarter 4 was $18,590 million. AstraZeneca, creator of Movantik aka naloxegol (along with Daiichi-Sankyo), earned $24,708 million of total revenue in all of 2015. They earned $6,399 million in the 4th quarter alone. AstraZeneca made half as much revenue in 2015 as Anheuser-Busch, yet politicians and the media criticized them for spending money on an advertisement. An interesting fact about this outrageous claim is that neither AstraZeneca nor Daiichi-Sankyo make and/or sell any opioid products! Therefore, they are certainly not trying to push their own sales and profits higher by encouraging opioid use. If anything, they would increase their competitors’ profits if they were to promote opioid sales. Last I checked, we live in a autonomous society that encourages Capitalism as discussed in Opioids, Anarchy, Communism, and Pain. Despite what some people are claiming, the first OIC ad did not promote or encourage opioid sales and opioid misuse.
The actor in the SB commercial was a regular guy taking medication to help manage his chronic pain while experiencing a frustrating side effect of said medication. People without chronic pain can never fully understand what it’s like to be in constant, significant pain that impacts quality of life. The mere fact that politicians would even make a connection between substance abuse and the Movantik ad speaks volumes about their lack of understanding and true compassion for their suffering constituents. The last thing a downtrodden opioid-requiring patient needs is commensurate embarrassment when broaching this topic with their prescriber or pharmacist. In fact, while practicing in the pain clinic, I met patients that were afraid to leave their homes because of the potential for explosive diarrhea from non-PAMORA OTC stimulant laxatives, and other patients that were so uncomfortable from several days without a bowel movement and resultant bloating that they were exhausted and depressed with significant angst because of these GI symptoms.
Following the controversy from the OIC SB commercial, two new commercials recently emerged. The first is ‘Paint a Different Picture’ where the main character expresses her struggle to find relief from her chronic constipation. She equates her GI motility to the “crawl” of a snail. Not once during the commercial does she talk about euphoria associated with her pain medications. She also does not encourage other people to try opioids; in fact, just learning about her problems might discourage certain patients from even trying opioids if they were under consideration.
The second new OIC commercial is called ‘Opioid Baggage’. It depicts a woman whose doctor prescribed her opioids for her chronic pain and they are both discussing how opioids are causing her constipation. She receives a prescription for Movantik from her doctor, and then she is able to enjoy her everyday life without the associate angst of ongoing bloat and dicomfort. She still takes her prescribed opioid, but she never says anything even remotely suggestive such as “ask your doctor if opioids are the right pain medication for you”. Instead, she encourages people with this type of constipation to have a conversation with their doctor about this and other treatment options.
To my knowledge, no one has railed against these two new ads – at least not yet! Perhaps media muckrakers sold their quota of stories and politicians exhausted their limelight as opportunist turds were flushed away over time. But more likely than not, we will see loose mouths extruding more rhetoric if the occasion surfaces. It still blows my mind that people had such negative reactions to a constipation commercial when there are so many others on TV today that are more controversial and/or convey questionable messages.
With all of this publicity and discussion, AstraZeneca and Daiichi-Sankyo certainly broke the ice on this important topic. One might even say it had a large impact factor! Thanks to diarrhea of the mouth, these companies actually enjoyed some free press. Moreover, many people will now realize that this is truly an iatrogenic medical problem that has new effective options with a very low relative risk. Hopefully this increased awareness triggers necessary dialogue between patients and their healthcare providers that heretofore were reluctant to openly discuss their bowel habits. In the end, the impact of these commercials was solid!
As always comments are welcome!
Kathleen Nicewicz will be graduating with her PharmD from Albany College of Pharmacy and Health Sciences this month. She is currently under the mentorship of Dr. Jeffrey Fudin as she completes her final advanced practice rotation in pain management. Following graduation, Kathleen has accepted a community pharmacist position in Winston-Salem, North Carolina.
Source for Review of OIC:
- Camilleri M. Opioid Induced Constipation: Challenges and Therapeutic Opportunities. Am J Gastroenterol 2011; 106:835–842; doi:10.1038/ajg.2011.30; published online 22 February 2011 http://gi.org/wp-content/uploads/2011/07/media-ajg201130a_opioid-induced_constipation.pdf
Additional articles regarding the controversy of the Super Bowl ad:
- http://fortune.com/2016/03/01/astrazeneca-moventik-prostrakan/
- http://www.fiercepharma.com/sales-and-marketing/astrazeneca-and-daiichi-sankyo-field-backlash-over-super-bowl-oic-awareness-ad
- http://nationalpainreport.com/bill-mahers-reaction-to-oic-super-bowl-ad-gets-its-own-reaction-8829534.html
- https://www.washingtonpost.com/news/wonk/wp/2016/02/08/this-super-bowl-ad-proved-just-how-much-america-loves-its-opioid-painkillers/
I started using 250 mg of a magnesium supplement for this occasional not chronic problem myself. It works like magic. Many patients on two of my support groups have had the same benefit. Not every problem requires a prescription drug. Just sayin……
Jacqueline; You are absolutely correct.
I cannot understand the disproportionate attention to 18,000 opioid related deaths per year compared to the 80,000 alcoholic liver disease deaths per hear or the 300,000 tobacco related deaths per year (50,000 just from SECOND HAND smoke!). Is the recent attention to opioid deaths related to the fact that now working class whites are dying, capturing the attention of white politicians and pundits, while previously this was a disproportionately African-American problem? Is this the product of an opiophobic society? I don’t know.
I agree that a priority should be eliminating the unsafe prescription of opioids and corralling their diversion, but not at the expense of the hundreds of thousands of those who use them to effect, safely, and appropriately.
Thank you Dr. Nicewicz, for your thoughts on OIC.
I’ve been a patient using opioid treatments for over 30 years, and know first hand about the negative side effects of opioids, including OIC.
In the 1990s, I read an article by University of Chicago pharmacologist JF Foss that told the story of University of Chicago pharmacologist Leon Goldberg and his search for a treatment for OIC and its more severe forms obstipation and ileus. His discovery that methylnaltrexone restored normal GI motility without interfering with analgesia was a major breakthrough for the severely ill patients seen in the oncology department. At the time I read this story, I was naive enough to believe that soon we would have access to an opioid/methylnaltrexone formulation of to treat pain and reduce the side effects of opioid therapy. even though Dr. Foss also wrote that the costs involved with bringing a product to market in America would preclude any further development of this drug as a medicine.
Yet, in the years since that article appeared, we’ve spent billions on creating abuse-resistant opioid formulations.
Some might think, it’s only constipation — live with it.
Last year I noticed a small report out of Chicago titled: Drug for digestive problem can extend survival for many advanced cancer patients (http://www.medicalnewstoday.com/releases/301660.php?tw)
It describes a small study of cancer patients treated with COT, and found that those treated with methylnaltrexone developed fewer GI tumors than those on COT alone.
Is anyone at CDC looking at the incidence of colon cancer in people with chronic pain?
I understand that Relistor, the commercial medication based on methylnaltrexone used to treat ileus in the critically ill has been removed from the forumlaries by both Caremark and Express Scripts. These two PBMS control the pharmacy benefits of 200,000 Americans.
Last year naloxegol, an oral treatment of OIC based on a proprietary naloxone derivative appeared on the scene. A monthly Rx for Movantik costs over $300 in my area. This medication is not included in my insurers formulary.
One reason opioids remain “harmful” is because of OIC, yet, our insurers refuse to pay for treatments that would mitigate this problem.
Attitudes about the people who require opioids is not the only thing that stinks in America.
This needed to be said. The statement you attributed to the Vermont Governor was ignorant, hurtful, and wrong. I hope the Governor has learned something since then.
Thanks Dr. Murphy. You inspired me to send it directly to his office. I’ll keep you posted if I hear anything back.
Excellent article! Also helpful to point out that uncontrolled OIC results in thousands of hospital admissions and in some cases surgeries for chronic pain patients because there constipation can lead to an obstruction or illeus. Last time I checked fast food and alcohol are contributing to health care dollars spent not saving.
Thanks for the great post nearly-Dr. Nicewicz! In my brief time rotating in pain management, I also met patients with similar OIC unresponsive to docusate, senna, PEG, enemas, etc. It boggles my mind that even when there is a true indication for long-term opioids in patient’s who have real pain, people still think of them as drug users rather than compliant patients who are following doctor’s orders for a treatment agreement agreed upon by both parties. While it’s not ideal to use an agent inducing a serious adverse event, it’s not like this is the first time that the medical field has managed side effects of necessary treatment with pharmacotherapy. I suppose when heart failure patients on chronic diuretics develop hypokalemia we shouldn’t provide them with potassium supplementation because it was probably bad health choices that led to the development of HF. And what about the drug manufacturers who profited from antiemetics for chemo patients? Did anyone ever say “gosh, we better let all those chemo patients suffer with otherwise preventable adverse events.” Replace chemo with pain in the previous sentence and that’s exactly what’s happening. Correct me if i’m wrong, but I’m pretty sure Movantik is a prescription drug that requires a prescription from a doctor. I don’t think your typical heroin abuser can walk into a store somewhere and pick this up to support their addiction. I would imagine a prescriber would have some pause if a patient came in requesting Movantik without any pain indication or opioids on file.