16 minutes

Fool Me Twice Shame on me

Categories: Ethics
Formats: Ideas
Conversation

Should health care professionals be allowed to accept gifts from pharmaceutical manufacturers?

What happens when you learn that you are an unwitting participant in a corporation’s fraudulent efforts to alter drug prescribing practices. Would you still eat the free lunch? 

The Team

The year is 2008, and over the past several months my private practice has been downsized to a handful of clients. It has been difficult to give up the independence that I’ve cultivated for over 15 years, but overall I’m not disappointed. I’ve managed to secure contracts with three of the first Family Health Teams in Ontario. I’m excited. Family health teams are a new concept in Ontario, and I have the good fortune to be consulting for three of them. The concept borrows heavily from the British public health care model. Patients are rostered, meaning that they sign on with their doctor in exchange for a wider variety of free medical services. As part of the deal they agree to make exclusive use of these services. Doctors are paid a yearly amount for each rostered patient blended with a variety of bonuses and incentives for providing them with preventive counseling, screening, and other services.

The team model was quick to introduce nurse practitioners and physician assistants to the mix of professionals providing services to patients. These are two different sorts of primary health care providers who can do a lot of the work that doctors do. Their scope of practice is a bit more limited, but in practice they are often the ones patients see the most when they come in to visit the “doctor”, and over time they have expanded their activities to include interpreting diagnostic tests, diagnosing problems, writing prescriptions, and even performing simple procedures (in the clinic we call these “lumps and bumps”). The presence of this expanded group of providers relieves a lot of the pressure on physicians to do everything for their patients, giving them more time to address the more complex problems and providing patients with a wider variety of services.

Several other “allied health professionals” are part of the team, and include dieticians, pharmacists, and mental health providers (primarily clinical social workers). There are even a handful of psychologists like myself working in some teams. We all use a shared electronic record. Team members no longer have to struggle to decipher cryptic physician notes scrawled in what can appear to be secret code, or face the alternative of making due with no clinical history. The electronic record also puts an end to the endless stream of forms that is usually required to allow practitioners to share information. Everyone shares, everyone contributes, everything is available in the record.

These are heady times in health care, and the opportunities for positive change seem endless. There are also some unintended side effects. For example, a single Family Health Team that is fully staffed with allied health professionals may serve tens or even hundreds of thousands of patients. Because team members work closely together, suddenly there are many more potential targets for drug marketing efforts, and this brings with it the promise of even bigger returns in terms of influencing prescribing practices. The only question is, how do you get access to all those professionals on the team? Until now, pharmaceutical companies have focused their marketing efforts almost exclusively on physicians, though in the United States legislation has allowed them to begin experimenting with marketing their drugs directly to consumers. Never ones to pass on an opportunity, drug manufacturers were quick to improvise new methods to infiltrate health teams and work to expand their sales.

The Forum

In the winter of 2008 I learned that a ground-breaking conference had been arranged by the Executive Directors of several family health teams. The E.D. for the team that served as my home base was enthusiastic and encouraged all the clinical staff to attend. Unlike the usual “doctor-centric” conferences focused on issues of medical diagnosis and treatment, this event was specifically geared to the needs and interests of allied health professionals including psychologists, clinical social workers, and other mental health therapists. As an added bonus, the event was sponsored by the provincial government and attendance was free.

The “Family Health Team Forum” was billed as an opportunity for learning and “networking towards practical, time-sharing solutions for patient care”. All the promotional material we received emphasized that this event was being organized by Local Health Integration Networks (LHIN’s) and the parent Ministry of Health, agencies that make up the publicly funded health care system in Ontario. Like other members of the health teams that I provide service to, I was very interested in the workshop content that was being offered and enthusiastic about attending. It did not hurt that all of us realized that our bosses were encouraging us to attend, and the focus of the sessions was aligned with the goals of the agencies that paid our salaries. Apparently the powers-that-be were only too happy to funnel tons of government funding into the team model that we were a part of, and I could not help but feel lucky to live in a place where the dream of community based health care was becoming a reality.

My enthusiasm changed to unease when I was greeted at the door of the Forum by a phalanx of Pfizer drug detail sales reps, whose effort to make me feel loved, welcome, and important only increased my discomfort. I was handed a glossy information package including a letter lauding the public-private partnership that Pfizer had engineered with the Ministry of Health in Ontario for all our benefit. I was then guided to a reception hall where an impressive breakfast buffet was waiting at the side and the usual “introductory remarks” would be delivered on jumbo screens scattered throughout the room. Never one to look a gift horse in the mouth, I piled my plate with fresh baked pastries, a muffin, and sliced fruit, and poured myself a glass of fresh squeezed orange juice to help get me through the morning’s events. Then I took a seat with some colleagues to chat while I scanned the agenda for the day.

Along with the handouts for pre and post session lectures, the schedule clearly illustrated Pfizer’s effectiveness at gearing each and every workshop to specific drugs that it was aggressively marketing to physicians in our communities. Furthermore, I noticed that Pfizer was also a generous sponsor of many of the studies, charitable foundations, and associated research supporting the talks we were all about to attend. By now I was feeling irritated with myself for having been conned into attending what was essentially the mother of all drug lunches, but as I was stuck in the conference centre for the day with my colleagues, I decided to carry on with things and try and benefit from what I learned.

The various events were exceptionally well organized, scrupulously timed, bolstered by state of the art projection and presentation technology, and graciously hosted by Pfizer drug reps and their respective marketing material in every room. Overall, I gave my respective sessions top marks on the feedback forms. The afternoon was finished off in style by the keynote speaker, Michael Perley, who is the executive director of the Ontario Campaign for Action on Tobacco. As we all washed down a delicious meal of stuffed chicken breasts with a generous glass of locally produced wine, Michael did a wonderful job of outlining the various methods by which the tobacco industry works to normalize its product and manipulate science for its own profit. I took particular note of his description illustrating how the industry finances political interests, sponsors respected events, places executives in position on university, hospital, and other boards, levers the media, and funds university and other courses that indirectly or otherwise “normalize” and facilitate the marketing of its products. When he finished his talk and someone stepped up to remind us all that the event could not have happened without the generous support of Pfizer, the audience applause was warm and heartfelt. I seemed to be the only one in the room who was aware of the painful irony that Michael’s message held.

Drug Marketing Really Works

It was only as my colleagues and I compared notes for the day and reviewed our experiences that the implications of Pfizer’s involvement in the proceedings really began to set in. Along with a full stomach and some great program ideas, I realized that I was taking home a new respect for the benefits that the smoking cessation drug Champix would offer my patients who were trying to kick the habit, had learned that by introducing a memory clinic to my practice I could treat early signs of dementia with Aricept, and gained a more thorough understanding of the benefits that newer drugs like Celebrex and Lyrica would provide for my chronic pain patients. If I had taken the time to scour the research literature on my own, I would have learned that these medications did not offer any significant benefits over other competing treatments, yet throughout the sessions their names kept popping up. The research articles laid out neatly at the back of each of the meeting rooms were exclusively for studies sponsored by Pfizer and focused on these medications. On several occasions the speaker and a Pfizer sales rep would jointly engage in the audience discussion. On one occasion a lecturer wandered into the topic of off label prescribing, and expanded on some of the the uses for drugs like Lyrica that had not yet achieved federal approval. Audience members who participated more actively were often approached by the sales rep in attendance following the respective session, and offered the opportunity to obtain more information, details on securing samples, or free educational resources for their patients. In countless ways my attitudes and beliefs had been massaged and manipulated into shifting towards a more positive view of Pfizer’s products and how they would benefit my patients, and the sales reps were gaining access to a back door into clinics across the province.

There is considerable research evidence suggesting that gifts from pharmaceutical corporations are anything but benign, altruistically motivated gestures intended to improve health care. Studies have brought attention to the fact that pharmaceutical marketing can exploit collaborative relationships with health authorities 1 – just as when Pfizer talked the Ministry of Health into letting them partner on delivering the Forum. Wazana and others have demonstrated how attending presentations sponsored by and/or given by representative speakers increased prescription rates of the sponsor’s medication as well as increasing “nonrational” prescribing 2. Brennan et al 3 have noted that even with current regulations, many unacceptable practices continue. Moynihan 4 has pointed out that doctors are in the dark about sponsorship, industry suggestions are filtered, and disclosure does not disentangle conflicts of interest – just as most of us at the Forum were in the dark about the implications of Pfizer’s role in our “education”. Brennan et al. call for an end to this kind of sponsorship given the increasing weight of research suggesting that current self-regulation and disclosure practices have proven ineffective in preventing harmful influence with respect to the quality of patient care3. None of this should have been news to us, but in 2008 most health care providers were clueless about the dangers associated with pharmaceutical manufacturer’s marketing efforts.

After learning more about the types of problems that go with drug marketing, I discussed my concerns with some of my colleagues. Most seemed pretty complacent about things. I learned that the clinical social worker for my team was using free educational booklets donated by Pfizer for some of her groups, and that one company had a long history of paying the registration fees so that staff could attend conferences and workshops. Free samples of Champix appeared on the shelves in consulting rooms as plans began to create a more organized smoking cessation program in the clinic. Prescriptions for antiseizure drugs like Pfizer’s Lyrica for the treatment of chronic pain began to slowly increase. We also would introduce a memory clinic for our patients, increasing the use of anticholinergic drugs like Aricept for the treatment of early dementia. The E.D. at our clinic described how helpful drug sales reps from a variety of companies were in providing lunch along with educational speakers for physician “lunch and learn” sessions. The physicians expressed their gratitude for the free samples that filled the cupboards in their consultation rooms. Some of our administration and board members were even in the process of recruiting pharmaceutical companies to sponsor a research facility in our community. Rather than providing everyone with a helpful reminder about ethical care and the risks posed by these kind of conflicts of interest, my inquiries seemed to prompt a lot of defensive posturing. No one seemed to believe that these practices had any potential for harm. Instead, people like me were perceived as worry-warts with a chip on their shoulder against drug companies.

A Shot in the Dark

Having made virtually no progress in raising awareness of the risks of these marketing efforts on our clinic, I penned a letter to the organizers of the Forum. These included officials with the LHINs in our area and the Ministry of Health. Knowing that everyone in these agencies would share the same sense of gratitude and goodwill towards drug companies that I was observing in my clinic, I made sure to heap praise on key individuals for carrying out the forum, and complimented the staff and management of clinics like mine who had collaborated with Pfizer on the project. I reassured everyone that of course they did not intend to help a pharmaceutical company to manipulate and exploit a group of health care providers with impunity. As delicately as was possible, I tried to explain that this is what in fact took place, pointing out how Pfizer was essentially granted unrestricted access to hundreds of naive allied health professionals, whose opinions played a significant role in determining the direction of programs and interventions for at least a few dozen separate teams and ultimately influenced the treatment of hundreds of thousands of rostered patients under their care. I noted that regardless of all the good intentions and the obvious financial benefits to everyone collaborating on the delivery of the forum, this kind of partnership was not in the best interests of health care.

During my graduate studies and through my years of providing therapy to clients, I had learned that attitude change does not come easy for most people. Debating or arguing one cause over another tends to just reaffirm people’s pre-existing beliefs. Criticising someone’s behavior often sets off a defensive reaction that can magnify prejudices instead of reducing them. Being judgmental tends to shut people down and leave them feeling hurt and misunderstood. But simply offering positive strokes and compliments, or writing things off to good intentions is not enough either. In order for it to have a positive impact, criticism needs to be constructive and include clear suggestions for concrete changes in behavior. In other words, to be truly helpful one has to not only get people talking the talk, but walking the walk. You also need to be backed up by good research and solid facts.

In my letters to various officials I carefully reviewed the current research into the topic of drug marketing efforts and the risks associated with it for health care. I stressed that we needed mechanisms to ensure that any work we do alongside pharmaceutical companies was neither pushing the boundaries of ethical behavior and fair marketing nor implicating health professionals in a myriad of conflicts of interest. I suggested that perhaps we could develop a policy among the LHINs or with the MOH to address this issue. I proposed that they generate a formal process for choosing corporate sponsors that was fair and equitable. I inquired about whether the publicly funded agencies that were involved would be willing to introduce measures to prevent drug companies from minimizing or concealing the extent of their involvement during the advertising and registration phase of such events in future. I warned that at the very least we had an obligation to monitor events more carefully to ensure that laws were not being broken, such as those against promoting off label use of drugs. Finally, I suggested that many practitioners like myself would be happy to volunteer their time and energy to organize educational events that did not include corporate sponsorship or any of the problems that went with it.

The silence that followed my entreaties was deafening. As the weeks passed by with nary a word of feedback, I began to wonder whether my missives had somehow got lost in the mail. I heard through the grapevine that a “higher up” on one of our local LHINs shared my concerns and had vowed never to see another Forum take place on his watch. Eventually, I began to reassure myself that while a formal response would not be forthcoming, the powers-that-be who were responsible for the Forum would weigh out the risks and benefits and simply drop the whole affair. After all, I was an experienced professional who was well-respected in my community and well known for my commitment to ethical practice. What I did not consider was the possibility that no one was paying any attention to me, and next year’s forum was already in the planning stages. Confident in my abilities and self-absorbed in my work, I simply assumed that the problems would go away thanks to my brief and relatively trivial effort to raise awareness. As the old victorian art critic John Ruskin once said, “A man wrapped up in himself makes a very small parcel.” In the present case, I had managed to convince myself quite thoroughly of the problems raised by the Forum and of the need for change, but my call in the darkness raised not even an echo.

The Bigger Picture

I did not realize it at the time, but the Forum contained many of the elements that had prompted one of the largest class actions lawsuits in the history of the United States Department of Justice. The suit was launched over the marketing of Pfizer’s drugs Bextra and Celebrex, which were both used to treat pain (Bextra was banned in 2004, Celebrex is still in use across North America). The legal proceedings for this case had been in process for several years by now, and would draw to a close a year later. They involved criminal charges of fraud and included, among other things, allegations that Pfizer was misrepresenting and under-reporting dangerous side effects associated with these drugs. In spite of this fact, Pfizer was continuing unimpeded with many of its dubious marketing practices, and I would soon learn of just how powerful their influence could be not just on marketing their products, but in silencing people like myself who took issue with their methods.

 

Comment

References

1

Freemantle N, Johnson R, Dennis J, Kennedy A, Marchment M. (2000) Sleeping with the enemy? a randomized controlled trial of a collaborative health authority/industry intervention to influence prescribing practice. Br J Clin Pharmacol. 49:174-179

2

Wazana A. (2000) Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 283-373.

3

Brennan T. et al. (2006) Health industry practices that create conflicts of interest: a policy proposal for academic medical centers. JAMA. 2006;295:429-433.

4

Moynihan R. (2008) Doctor's education: the invisible influence of drug company sponsorship. BMJ. 336:416-417.