It’s almost unthinkable that in an era preoccupied with “evidence-based” medicine and “best practice” advice, one of the worst drug problems in the United States flows right out of our health care system. Unlike other major epidemics such as those connected to methamphetamine, crack cocaine or other illegal drugs, our prescription opioid problem is full of irony and agony, because it has been fueled, to a certain extent, by the actions of well-intended medical doctors.  Physician-prescribed opioid medication misuse is multifactorial in its origins and has proved an equally complex puzzle for those who are working to find a solution.

But we do need to find a solution. But where did this problem begin?

As recently as the early 90s, a patient would have to present with cancer or a painful, terminal illness before physicians would write a prescription for ongoing opioid pain medication. Although these drugs were commonly used for short term, acute pain connected to a procedure, surgery or injury, prescribing them long term was considered a bad idea.  For example, in 1992, a physician survey found only 12% of physicians believed that giving patients opioids for chronic pain was a “lawful and generally acceptable medical practice.” In other words, almost 90% believed it was unacceptable. How that changed is a fascinating tragedy.

Ironically, this public health disaster begins with physicians wanting to help their patients, specifically their patients with chronic pain, which millions of Americans live with on a daily basis. The reason that physicians had always been reluctant to use powerful opiates to treat these kinds of chronic pain- arthritis, bad knees and backs, was because the risk-benefit analysis involved in putting somebody on long-term opioids was considered a losing proposition. Doctors knew that their patients would become physically dependent on a morphine-based drug, with all of the well-known side effects (sedation, constipation, sexual dysfunction, etc) and that they would need larger doses over time as tolerance to the drug developed. They knew that after a not-very-long period of time, if their patients wanted to go off the medications, they would suffer the misery of opioid withdrawal.  So it just didn’t add up- better to cope with the pain without using morphine derivatives than to start one’s patient down a predictable road of addiction.

The equation started to shift about a decade ago, when a movement to more adequately treat patients for pain gained momentum in the medical establishment. Doctors became more concerned about adequate pain management as a cornerstone of good practice and were broadly encouraged to take their patients’ reports of pain more seriously. They were told to stop viewing pain as an inevitable symptom of primary illness or aging but instead to look at pain as a primary issue in its own right that deserved the most robust treatment possible. As Dr. Anna Lembke noted in a recent article published in the prestigious New England Journal of Medicine, ”in contemporary medical culture, self-reports of pain are above question, and the treatment of pain is held up as the holy grail of compassionate medical care.”

At the same time, Dr. Lembke points out, a paradigm shift was also happening in the larger culture. On a global level, it has become more and more of an accepted notion that there is a pill for any ailment or discomfort, and that all less-than-optimal situations, difficulties or disturbances can and should be alleviated pharmacologically.  So the pain pill epidemic should also be viewed in context, in this case a nation where over 20% of American women are on an antidepressant and many millions of men, women and children can’t live without their daily Xanax, Ambien, Adderall or other forms of pharmaceutical life-support.

So now the patient, now viewed by some as “the health care consumer,” is bombarded by television commercials for an array of pills that can fix any problem—shyness, sleeplessness, fibromyalgia or pain. Patients who walk into their physician’s office now arrive with a culturally validated expectation of relief. To add to the dilemma, doctors who refuse to deliver the goods, even if they are doing so in the best interest of their patient, know that their average patient rating on Yelp.com, and perhaps ultimately their practice, may take a hit, since these ratings frequently include questions about how well the doctor responded to the patient’s reported pain. As Dr. Lembke notes, “health care providers have become de facto hostages of these patients, yet the ultimate victims are the patients themselves.”

Unfortunately, along with the additional training and focus on pain management, there was no commensurate attention given to helping physicians understand, screen for, and treat addiction. Had there been a push to manage pain along with a corresponding effort to help doctors understand the nuances, complexities and dangers of addiction, we would likely be looking at a very different landscape.

How did it happen? Ask Big Pharma

The other necessary element in the pain medication debacle is the development and marketing of opioids and opioid research by drug manufacturers that were unbelievably well-received by not only physicians but also the Food and Drug Administration. As described in a recent Washington Post article, drug manufacturers, particularly Purdue Pharma, the maker of Oxycontin, and the researchers that they hired,  put out a variety of scholarly articles that seemed to alleviate many of the concerns that the medical profession had long accepted as common knowledge.

Their research, which was published in the most prestigious, peer reviewed journals, including the New England Journal of Medicine, indicated that there were “inconsequential” risks of addiction, dependence or withdrawal symptoms from the long term use of opioids with true pain.  The FDA-approved labeling for Oxycontin included the following language:  “The development of addiction to opioid analgesics in properly managed patients with pain has been reported to be rare” (the language was removed from the label in 2008).  Physicians were told that patients with legitimate pain wouldn’t experience, and crave, the euphoria that opiates can generate, because the pain interferes with the euphoric response to the drug.

The take home message that was inculcated into the physician community was essentially that people in legitimate pain, under the proper care of a physician, will not develop the same kind of addiction problems that other people taking the same drugs inevitably would. Illogical as it sounds, and untrue as we now know it turns out to be for millions of patients, the message took hold, and the mantra of the profession shifted. Now, the thinking went, if these medications, properly prescribed, to the right kind of patient, will not cause the kinds of problems we thought they would, why would a physician fail to adequately care for patients’ pain?  This shift in focus has inadvertently caused a tremendous amount of misery. And, despite all we now know, the battle for turf in the opioid market goes on, with new,  and stronger opiates vying for market share and generic formulations of Oxycontin on their way.

Additionally, there are important problems in the supply chain that is responsible for safely distributing these powerful medications, with numerous opportunities along the way for drugs to be inappropriately diverted. At the same time,the Drug Enforcement Administration is petitioning the FDA to categorize Vicodin as a Schedule II drug, which would impose significant new barriers to patients.

How bad is it? 

Now that we have a basic understanding of how this problem arose- how bad is the problem? Extremely bad. First of all, we had a huge drug problem before the pain medication crisis: “Addiction is the largest preventable health problem in the United States- affecting 16 percent of the population- more than heart disease, cancer or diabetes”, says Susan Foster, CASAColumbia’s Vice President and Director of Policy Research. And then, into that addiction continuum, where many misuse multiple substances, add prescribed opioids, which are particularly troubling because the risk to each user is enormous:

• Vicodin and Oxycontin are the two most misused prescription drugs in the country.
• More people are addicted to prescribed opioids (somewhere between 2 million and 2.4 million) than to heroin and cocaine combined, and prescription drug misuse “remains the fastest-growing drug problem in the United States,” according to the Centers for Disease Control and prevention.
• More people die of drug overdoses than by any other cause of accidental death, with the majority, about 15 million people, dying each year from prescribed opioids. One reason for this is that as tolerance develops to the pain relieving effects of the opiate, users take higher and higher doses to achieve the same pain relief. But the users’ respiratory system doesn’t develop the same level of tolerance as the dosages get  higher. Eventually, the user is on such a high dose that breathing can slow down to the point that it stops. This scenario is common in opiate dependence in part because the user may be sedated and confused, unable to monitor dosages properly and likely to make medication errors.  For the first time since records have been kept, more people are dying of accidental drug overdose than in car accidents.
• Opioid addiction, pound for pound, is the most dangerous addiction. Setting aside the sheer number of opiate-addicted citizens, the risk of death to any one user is higher than for any other drug. People who are addicted to opiates are almost 6x more likely to die than they would be if they were not addicted to opiates- making opiate addiction more dangerous than addiction to methamphetamine (#2) and other drugs and alcohol.
• The number of infants born dependent on opioid painkillers and diagnosed opiate withdrawal upon delivery has tripled in the last decade, to 13,000 in 2009.
• Certain regions of the country, Florida is famously one, parts of Appalachia another, are simply devastated by frightening rates of addiction to pain medications. In these regions, up to ten percent of infants are born addicted to opiates. In Florida, in 2009, death by overdose of prescription drugs was about four times that attributed to illegal drugs.

Where do we go from here?

Now that we have a pretty clear sense of the basic forces that have led to the problem, and the extent of it, two essential questions are raised. First, what should be done for the two million people who are addicted to prescribed opioids. Second: what can be done to prevent more people from finding themselves in the same situation. Where do we go from here? What needs to change? We’ll tackle those questions in Part II of this article, which will be coming soon.

Richard Juman is President, Insight BusinessWorks, Inc. and blogs at The Fix.