The outcome of aggressive marketing efforts by pharmaceutical companies can be lethal for consumers.

I once became a dupe in this process and it taught me some lessons about why “Big Pharma” is so successful at selling their wares to doctors.

The Gathering Storm

It is the summer of 2003. The SARS epidemic is in full swing. Earlier in the year the space shuttle Columbia disintegrated during its reentry over Texas, while not long after the Chinese would launch their first manned spaceflight, heralding the arrival of a new world power. The US is preparing to invade Iraq and talk of weapons of mass destruction is on the tip of everyone’s tongue. Meanwhile, right under our noses, a class of prescription drugs is beginning to lay claim to a rising toll of suffering and death across North America that continues to this day.

The drug was not new by any standards. Opiates are synthetic derivatives of the opium poppy that have been around since the start of the 20th century. They were meant to provide an alternative to morphine and heroin, which had been steadily falling out of favour in America due to their strong side effects and potential for addiction. However, the version known as Oxycodone proved to be equally addictive, and by the mid 90’s was prescribed mainly for the kind of pain associated with terminal cancer. This all changed in 1995 when Purdue pharmaceutical gained approval of a “sustained release” form of oxycodone, which is called Oxycontin. The idea behind sustained release tablets is simple: by adding various chemicals it is possible to slow down the rate of absorption of the drug in your body, spreading out the effects over 12 or more hours, instead of the usual few. Theoretically, this dilutes both the side effect potential and the risk of addiction, while simultaneously providing more sustained pain relief.

By 2001 Oxycontin sales had increased beyond all predictions. Sales had grown a remarkable 2,400% and revenue had topped 1.2 billion dollars. At its peak Purdue was spending 200 million in a single year to promote what had now become its flagship drug (1). Other companies were racing to catch up. Even “last resort” medications like Fentanyl, which had been reserved only for use in intractable pain for patients nearing death were starting to be used for “non-malignant” pain. Realizing that there were huge profits to be made, several more new opiate “analogues” and slow-release versions had appeared on the market. Just about every major drug company had a stake in this process, and across North America vast resources were devoted to changing the way doctor’s prescribed these medications to their patients.

Dr. Shepherd Gets Recruited

In 2003 I was a psychologist with a busy private practice, career oriented physician spouse, and growing family. My wife and I ran our practices out of one wing of our rambling victorian home, and had established a strong collegial network in our community. As part of my work, I had begun developing “treatment manuals” for my clients to go along with some assessment tests that I was developing. These were the early steps in what was to later become Myndplan. This kind of work is typically done in academic settings where researchers can collaborate with one another and are provided extensive resources to support their work. Good research does not just require innovative ideas, it also requires lab space, a ready supply of “subjects” for experiments (usually available through undergraduate students or patients in teaching centres), statistical and computer consultants, research assistants, and various grants and awards to fund the work. Given that I was lacking most of these resources, I had to be creative in my approach and had gotten into the habit of presenting my work at larger conferences in order to get constructive criticism and maintain relationships with the academic world that I had trained in. On the occasion that is the focus of the present discussion, I was presenting a paper on pain management in primary care at the annual American Psychological Association convention in Toronto, Canada.

Overall, the convention was a bust. Toronto was one of the first cities in North America to experience an outbreak of Severe Acute Respiratory Syndrome (SARS). Several people had died, and though the crisis was beginning to fade, the city was struggling. Conference attendance was down, as was tourism throughout the city. My talk was sparsely attended, though warmly received. As I was gathering my things after fielding the final questions from some stragglers in the audience, I was approached by an attractive and very intense woman with a briefcase in hand. She explained that she had a strong interest in education in the field of pain management, and organized events with the support of a major pharmaceutical company. She liked some of the ideas that I had discussed in my talk, and was looking for speakers for a lecture series that a colleague was organizing.

It was difficult not to feel flattered. The usual experience at conference presentations involves a handful of questions from the audience, and perhaps the exchange of a few cards and phone numbers after the talk with colleagues who shared your interests.
Here was someone asking me to serve in a more formal role as an invited, expert lecturer. She worked for a huge multinational pharmaceutical corporation known to spend hundreds of millions of dollars on product research and development. I happily arranged to follow up on her offer.

A few weeks later I was put in contact with another representative. I quickly learned that the company in question had a well established set of “territories” staffed by entire teams of individuals. I was introduced to the manager of my “area” who went over his plans for a weekend-long continuing education event for physicians. I was told that the keynote speaker would be an expert from one of Canada’s top medical schools. I was being asked to contribute my own views on pain management, and would be given free reign as to what that entailed. As a small town therapist with aspirations to academia, how could I refuse? This opportunity could open my professional network to include a wide variety of physicians who were potential referral sources for my practice. It might even lead to financial support for my research endeavors. Plus, unlike professional conferences where I was required to pay large registration fees along with my food and accommodation costs, I was now being offered a princely speaker’s fee and a free meal. It was a no brainer.

The Education Session

I’m sitting in a fancy restaurant but my appetite is flat. Tripe is on the menu. The chef is standing before us, going over the extensive wine list. I don’t drink and had skipped the wine tasting session offered the day before, so I decline. My stomach is churning, but not because I’m hungry. I’m still going over what happened earlier in the day.

My presentation had been a resounding failure. The audience seemed disinterested from the start, and by the time I began describing the therapeutic relationship and its importance to pain management they had become restless. One of the doctors had interrupted me to question whether physicians had time in their busy practices for this kind of “luxury”. I tried to empathize with his need for efficiency. Then I hastily moved on to discuss several intensive behavioral pain management tactics that worked for patients and cautioned against overuse of opiate medications. A physician spoke up and minimized my concerns. He stated that the medications helped a group of patients who were otherwise bereft of treatment options. I was politely corrected by a prominent specialist in pain management. A sales representative from the drug company who was present (commonly called drug “reps” or “detailmen”) joined in the discussion, providing tidbits gleaned from several recent research studies conducted by his company that supported the liberal use of opiates for a variety of clinical uses. I had gone from expert to quack in 20 brief minutes.

My audience was no longer a group of supportive colleagues, but instead had become a patronizing group of family doctors kindly correcting me as though I was yet another of their misinformed patients.

I was woefully underprepared for this shift, and my enthusiasm and confidence wilted. I finished my talk hastily, skipping any further content that might offend my audience. I quavered at the thought that my practice was more likely to shrink due to this event, not flourish. How could things possibly be worse? I reminded myself that as a psychologist I was used to an audience of therapists, not physicians – but this was only a vain effort to salvage my pride.

The “Real” Expert Speaks

Now I’m listening to the keynote speaker talk as I try to swallow some of the tripe that is artfully wound about on my plate in this swanky lakeside restaurant. She is the same specialist who had taken me to task in my talk after I had cautioned my audience about the many harms associated with opiate medication use. She is undoubtedly a busy clinician with a large practice in palliative care, but I’m surprised to discover that she has no research experience and her working relationship to the University is limited to teaching the occasional resident. Nevertheless, she has a lot to say about the use of medication to treat chronic pain, and seems particularly interested in convincing the audience to use opiate medications far more liberally in their practice.

I was astonished at what I learned from her talk. Unlike the dangerous controlled substances that I was familiar with, the opiates that she used in her practice were a physician’s best friend. They were powerful. They saved people from suffering. Most people who used them experienced immediate benefits. The side effects were rare, minimal, and easily managed. She provided helpful hints on how to do the latter. Most importantly, and contrary to everything I had learned in my work, she explained that opiates were not addictive so long as they were used to treat pain. Throughout, we were encouraged to challenge “myths” that had arisen based on outdated, “inferior” research and replace them with “facts” supported by the latest studies. On numerous occasions she mentioned a new patch that delivered the powerful opiate fentanyl in a measured dosage, and discussed its “off label” use.

The term off label is used to describe when doctors give you a medication for a purpose that deviates from its approved purpose. Frequently a drug’s approved uses are very restricted, and apply to a relatively small number of potential patients, such as end stage terminal cancer in the case of the patch. The approval process is very strict, and includes only examples that match extensive controlled studies on large samples of people. Off label uses are broader, based on single case observations or the results of uncontrolled studies with small samples. Off label uses are discouraged and advertising or promoting them is actually against the law in most jurisdictions throughout North America. In the present case, doctors were being encouraged to broaden their use of fentanyl not just to non-malignant as well as malignant cases of cancer, but to use it to treat moderate as well as severe pain.

Judging by the reaction of the audience, the session was a resounding success. By the end the participating physicians were querying about effective dosages, patient histories were being discussed, and tactics for accessing insurance drug plan support were being reviewed. The associate for the drug company sponsoring the event was happy to share his wisdom and arrange follow up meetings to exchange samples and copies of research articles that had been sponsored by the company. The room was buzzing, as was my head.

Is Your Physician Dealing Drugs?

What I did not realize at the time, but would learn over the ensuing years was that this sort of “continuing medical education” event was being orchestrated across North America on a massive scale. Initially, speakers like myself were being recruited loosely, with little or no effort to prepare them for the job.
As things progressed speaker training sessions were provided to help sharpen the message that was being delivered to clinicians across the country. Those who provided content consistent with the drug company’s marketing desires were given regular engagements and large financial payments, those who didn’t perform “well” were not asked to return 1.

To my physician colleagues, it seemed to be a win-win solution. They acknowledged that the drug companies were trying to influence their prescribing practices, but were confident in their ability to discern objective facts from marketing efforts. Continuing education is a mandatory part of a doctor’s life, and pharmaceutical companies provided sessions over lunch hours and on evenings and weekends, making things extremely convenient for professionals whose working day was packed and for whom each working minute represented a billing opportunity. Doctors benefited not just from the chance to brush up on their knowledge base and clinical skills, but to network with colleagues and enjoy a break from their work. Most would take home some new knowledge to share with yet more of their colleagues in hallway consultations. Better yet, it was all free. What could possibly be wrong with that?

The effect of drug promotion and marketing efforts on the use of opiate medications by family doctors has been a resounding corporate success story, however it has also spawned a remarkable public health catastrophe. Over the subsequent years, I would see Oxycontin and other prescription opiate prescriptions skyrocket in the medical clinics where I worked. In most practice groups, at least one doctor would develop exceptionally liberal prescribing habits, and their practices would become burdened with excess numbers of patients addicted to these medications. My therapy groups teaching chronic pain management gradually included more and more patients with opiate prescriptions and all the problems that went with them. It was no longer unusual to see patients in individual counseling who were mainly preoccupied with how to get more prescription medication to feed their habit. In my forensic practice, the roster of clients who had charges stemming from opiate abuse increased with every year. During my discussions with many of these clients, I would learn that most were obtaining their drugs through supply chains that began in the doctor’s office. High school students began to experiment with them too. Before long I was seeing people from all walks of life and of all ages with serious addiction problems.

I was not alone in noticing the spread of the problem. Over the past decade prescription abuse and addiction has continue to worsen across the country. In emergency departments throughout the nation overdose deaths involving opiate medications have become common 2, and now more powerful synthetic opiates such as fentanyl are beginning to show similar patterns of abuse both within medical practices and on the street 3.

While for many years these drugs could be traced back to patient prescriptions, increasingly they are being supplied through online sources that originate in overseas labs. It seems that a problem that was made in Canada and the United States is now being manufactured in China…

I would never hear back from the drug company that hired me for that education session back in 2003. Plus, the experience ruined my appetite for drug lunches and dinners. The reality of the situation was hard to swallow, and my pride was wounded. Instead of launching my career as an expert educational advisor, I experienced only a very brief career as a “hired gun” at an event promoting the more liberal use of opiate medications to my clients. The thought of this still makes my heart sink.

Since this fateful day, I vowed never to attend another drug event. This is not an easy feat when your spouse is a physician and is receiving constant invitations that include dinner at a fancy restaurant with many of our colleagues, or better yet, all expense paid vacations at five star hotels. It is also hard to swallow when you choose to close the very door that gives you unfettered access to the best referral source available – physicians with busy practices. Companies also go to great lengths to minimize or even conceal their sponsorship of events (read my next post for an example of how far they can go to do this). Then there are lesser known benefits – grants for research available even to those with no academic affiliations, free tests and treatment manuals for use in clinical practice, and sophisticated web based consumer information services for my clients.

Because I was engaged in building my own psychological services company this kind of support would have been enormously helpful to the success of the venture. Instead of having tens of thousands of dollars at my disposal with little or no oversight, I was reduced to begging favours from colleagues, expanding my line of credit with the bank, and donating many long hours of work to the cause. Nevertheless, I did not regret taking this fork in the road, as I could sleep better at night knowing that I was not selling out my clients in order to cash in on my business. My enthusiasm for alerting my colleagues to the risks that marketing effects can have on practitioner behaviour and consumer outcomes would eventually lead me to take a more active role in addressing the problem. It would also result in some serious fallout, including the loss of my job. But that is the subject of yet another post later this month…