Pain as the 5th Vital Sign - Version 1

Is pain (acute or chronic) the 5th vital sign? Should pain be thought of as a vital sign? 30 some years ago the answer was easy, pain was most definitely thought of as the 5th vital sign. By considering it as such, doctors were encouraged and even expected to treat pain with opiates. The use of these medications exploded, after all, because treating pain with opiates was considered compassionate human centered care with the paternalistic doctor looking out for side effects like addiction. Patients were reporting better pain control which in turn validated the idea that pain was the 5th vital sign. Life was good. Enter capitalism.

Although this is somewhat simplified to create intrigue for my post, the above is a great example of the difference between discussing healthcare in the abstract vs the actual practice of health care. To borrow from Mario Cuomo, we discuss and debate healthcare policy in poetry, but we practice health care in prose. The reason for this is simple, no one wants to admit that there is no such thing as a perfect policy. Admitting that someone will be unintentionally hurt by whatever policy is created isn’t good poetry, our bodies are just too complicated to fit into nice clean squares. So, we talk and discus healthcare policy in terms of poetry. Poetry is beautiful, just like life. We speak in broad terms with the best of intentions. Good people wanting to help others, at least that is what we astride to by using the language of poetry.

Here is the classic $50,000 question, where is the line between healthcare advocacy (poetry) and health care implementation (prose)? How might we turn healthcare poetry into practice without hurting others? If we are completely honest, part of the problem is no one can answer this question with any kind of authority. All we can do is practice active listening, accept that failure will happen which is a fancy way of stating someone will most likely get hurt or die, and hope our intention to do good is strong enough so we can become better at the practice of medicine tomorrow than we are today to prevent further pain.

In the spirit of creating a better tomorrow, let’s look at the idea of whether pain should be considered the 5thvital sign. In particular, let’s look at how opioids went from a poetic answer for chronic pain to the implementation of opioids into everyday care. As a chronic pain patient myself, I like to believe that I am the truth for a better tomorrow. However, I don’t have answers yet, all I have is a growing concern that life for all of us will get worse because of the growing misunderstanding of all sides involved in the search for chronic pain poetry.

Beginning in the early 1990’s, there was mounting evidence to suggest that pain was being undertreated. This undertreatment was partially due to pain assessment tools that were available to physicians during that time. To change this trend, Dr. James Campbell, while addressing the American Pain Society in 1995, urged that health care providers treat pain as the “fifth vital sign” (Source Material). Following Dr. Campbell’s speech, the Veterans Health Administration (VHA) introduced a national strategy to improve pain treatment (Veterans Health Administration, 2009) that included mandatory pain screening using the uni-dimensional Numeric Rating Scale (NRS). In simple terms, patient satisfaction surveys would now include pain-related questions. These initiatives were directed at improving pain care for patients with both acute and chronic pain.

Enter a new opiate with a big promise. OxyContin was introduced to the world in 1996. According to Purdue Pharma’s own documents, sales grew from $48 million in the first year to nearly $1.1 billion in 2000. Much of the increase can be attributed too the drug being aggressively marketed and highly promoted. So much so that by 2004 OxyContin had become a leading drug of abuse in the United States (More Source Material).

So, with sales exploding was OxyContin any good at treating the fifth vital sign? According to an article published by the National Library of Medicine, “OxyContin's commercial success did not depend on the merits of the drug compared with other available opioid preparations. The Medical Letter on Drugs and Therapeutics concluded in 2001 that oxycodone offered no advantage over appropriate doses of other potent opioids. Randomized double-blind studies comparing OxyContin given every 12 hours with immediate-release oxycodone given 4 times daily showed comparable efficacy and safety for use with chronic back pain and cancer-related pain. Randomized double-blind studies that compared OxyContin with controlled-release morphine for cancer-related pain also found comparable efficacy and safety. The FDA's medical review officer, in evaluating the efficacy of OxyContin in Purdue's 1995 new drug application, concluded that OxyContin had not been shown to have a significant advantage over conventional, immediate-release oxycodone taken 4 times daily other than a reduction in frequency of dosing. In a review of the medical literature, Chou et al. made similar conclusions.” (Source Material) 

Let’s add some capitalism to this discussion. As the liberalization of opioids increased dramatically from 1996 to 2001, Purdue alone conducted more than 40 national pain-management and speaker-training conferences at resorts. 5,000 plus physicians, pharmacists, and nurses attended these all-expenses-paid symposia, where they were recruited and trained for Purdue's national speaker bureau. In 2001 alone, the company spent $200 million in an array of approaches to market and promote OxyContin. As we all know, there is no such thing as a “free lunch”. It has been proven that these types of conferences influences physicians’ prescribing, even though the physicians who attend such symposia believe that such enticements do not alter their prescribing patterns (Source).

We can also see the effects of capitalism in how Purdue treated their sales staff. In 2001, the average OxyContin sales representative's annual salary was $55,000, annual bonuses averaged out to $71,500, with a range of $15,000 to nearly $240,000. Purdue paid a total of $40 million in sales incentive bonuses to its sales representatives in 2001 alone (Source).

The number of sales representatives on staff for Purdue also underwent huge increases. Purdue increased its internal sales force from 318 sales representatives in 1996 to 671 in 2000. This increase in the number of sales representatives corresponded to an increase in physician call lists that went from 44,500 to 94,000 physicians in the same period. The company, through their sales force, used a patient starter coupon program for OxyContin that provided patients with a free limited-time prescription for a 7- to 30-day supply. By 2001, when the program was ended, approximately 34,000 coupons had been redeemed nationally (Info on the Info). If you count the patients utilizing coupons as quasi sales staff since they were receiving a free prescription, you have one gigantic and influential sales force.

So, what does all this mean? By declaring pain the 5th vital sign, health care was providing legitimacy and credibility to my and millions of others pain. It elevated pain to symptom status instead of a cultural mechanism to judge one’s manhood. In addition, it gave physicians, nurses, providers the authority to treat pain with the same priority as say blood pressure. To control pain was to practice human centered health care. This was poetry to the ears of all who hurt.

In the eyes of patients in pain, opiates provided us with different types of poetry. Haikus are great and powerful, but sometimes we need poetry in the form of Cat in the Hat. Opiates were an effective and cheap way to neutralize the 5th vital sign. Since opiates had been around since the dawn of time, there was also a built-in trust and acceptance. Add to the fact we didn’t fully understand the power of addiction in 1996, the opiate promise grew to heights no one could have anticipated or expect.

Enter the prose of health care. Turns out that by trying to minimize the risk of addiction to accomplish the noble task of reducing pain, we (the collective we) negated much of the pain poetry by creating a foundation for overdoses from both prescription and eventually illegal opioid use. To put it another way, Purdue training its sales representatives to spread the message that the risk of addiction was “less than one percent” was crap, pure crap and they knew it. The actual rate of addiction was around 6-10%, or the same percent as those who are alcoholics. Once again proving the difference between campaigning for healthcare reform and the actual practice of health care reform are two very distinct paths.

To combat the increase in opioid related overdoses, the political and cultural pendulum of change has rapidly moved towards policies of reducing access to legal opiates. Whether it’s anti patient groups like Prop (Prop's Stupidity) who blame patients for not just accepting their pain or new theories like opioid-free anesthesia being sold as a means to combat overdoses, the forces who are advocating for an opiate policy change are strong and growing stronger each day. As the news fails to identify illegal opiate overdoses from overdoses from legal prescriptions (which are much less), the public’s view of this class of drug is changing too. With this change, many are also reexamining the idea of pain as the 5th vital sign.

The problem is with this pendulum change my quality of life has become politicized instead of humanized as it should be. Family, friends, other doctors, and strangers see my bottle of OxyContin as a potential overdose instead of medicine as my eyes see it. With pain no longer seen or accepted as the 5th vital sign, pain patients like me are more prone to judgement and ridiculed for asking for help because of the story of pain as the 5thvital sign over the last 30 some years.

Once upon a time, policy-based nuance for patients like me and healthcare in general meant understanding the difference between every subtle detail it contained. Policy advocates or “nerds” could tell you with great and depending on your interest level, boring detail the possible care options pain as the 5th vital sign would mean for rheumatoid arthritis patients vs those with irritable bowel syndrome for example. It was believed that by understanding these differences to the level only nerds would understand was how to best close unintended loopholes which would ultimately save lives. However, nuance has now been replaced with ideological entertainment. Nuance now revolves around how many ways someone can claim the government is instituting a policy of “genocide” or some other conspiracy theory against patients in pain like me. Yes, you read that right, pain patient advocacy has become a wild ride.

Instead of rapid, and often emotional instead of logical pendulum swings like we are experiencing now, we need a return of nuance. We need the return of policy-based nerds. We need drug companies who work towards better science first and shareholder profit second. We need doctors who understand that hope belongs on Hallmark cards because the real comfort to patients is medical options. Finally, and most importantly, we need more chronic and acute pain stories from patients based on vulnerability and life, not ideological entertainment. This nuance will finally help us bridge the gap between healthcare poetry and prose which will ultimately lead to a higher quality of life for all I have to believe.