Reframing Our Relationship With Pharma

John J. Miller, MD

FROM THE EDITOR

Imagine if you or a loved one was diagnosed with cancer, and your oncologist had not learned about any new medications related to treatment of this cancer for the past 5 years? What if your family member with a stable psychotic disorder developed severe tardive dyskinesia and, as a result, would not leave their group home due to embarrassment about these involuntary movements, and their prescribing clinician had no knowledge of the two drugs that were FDA approved to treat this movement disorder in 2017?

I love psychiatry, I love biochemistry, and I love learning. These passions collide in the arena of new drug development, which continues to deliver novel drug mechanisms of action throughout the field of medicine. In 1986, as I began my internship at the Medical Center Hospital of Vermont, with the gift of an outstanding psychopharmacology mentor, John Ives, MD, I was able to confidently learn to prescribe all the psychiatric medications in our armamentarium at that time. To be fair, the list was rather short: monoamine oxidase inhibitors, tricyclic antidepressants, benzodiazepines, antihistamines, anticholinergics, antipsychotics, lithium, carbamazepine, valproate, and a few others.

During my internship year, I was taught the pharmacology and FDA approval indications for two new psychiatric drugs: bupropion (which was approved on December 30, 1985 for the treatment of major depression) and buspirone (which was approved for the treatment of generalized anxiety disorder in 1986). These drugs had novel mechanisms of action and immediately were added to the hospital’s pharmacy formulary for the treatment of inpatients.

In my years of adult psychiatry residency at the Department of Psychiatry at the University of Massachusetts Medical Center in Worcester, two additional medications were FDA approved that revolutionized treatment options for many of our patients: fluoxetine and clozapine. A game changer for our patients with schizophrenia, clozapine was FDA approved in 1989 for refractory schizophrenia. Clozapine served as a paradigm shifter, and it remains the most effective treatment for refractory schizophrenia. Additionally, it prompted receptor-directed research on novel agents that would modulate serotonin along with dopamine receptors for the treatment of psychosis and mania. Within months of its FDA approval, under the guidance of my psychopharmacology supervisor, I crossed titrated a patient with refractory paranoid schizophrenia from high dose perphenazine  to clozapine. Meanwhile, my very first educational seminar on how to dose clozapine, and the important risks/benefits/side effects that I needed to understand before prescribing this novel drug, was presented by the pharmaceutical representative from Sandoz, who also provided me with a host of peer-reviewed, published clinical trials and information on clozapine.

The value of keeping up-to-date

In 1995, while an assistant professor of psychiatry at the University of Massachusetts Medical Center, I was invited to join the speakers’ bureau for a pharmaceutical company. During the subsequent 25 years, I have proudly maintained ongoing consultation collaborations with pharmaceutical companies that are focused on developing new medications with novel mechanisms of action as well as medications with improved efficacy and tolerability as compared to similar medications currently available. Once FDA approved, I continue to enjoy educating psychiatric colleagues on information important to any prescriber of a new medication: pharmacokinetics, pharmacodynamics, clinical trial results, approved indications, risks, benefits, and side effects.

Although there are many critics of physicians who collaborate with the pharmaceutical industry, I judge myself based on the feedback from the clinicians to whom I present this information. Of course, I always disclose any potential conflicts of interest when presenting a lecture or authoring a publication, which is essential.

During my tenure as a psychiatrist, I have been impressed and invigorated by the dedicated research and development in the pharmaceutical industry as well as their commitment to further understanding disease states and identifying novel medications that serve to decrease symptoms and improve the quality of life of our patients. A great example was the simultaneous FDA approval of two novel medications in 2017 for the treatment of tardive dyskinesia, a movement disorder caused by chronic exposure in a part of the brain to dopamine-2 receptor blocking agents (including all of the antipsychotics). Although tardive dyskinesia was identified in the late 1950s, and for many of our patients causes significant functional impairment, we had no treatment for it until these two medications were approved. Outside of psychiatry, the specialties of neurology, oncology, hematology, immunology, endocrinology, gastroenterology, and others have had spectacular breakthroughs in novel treatments that literally have been life-saving.

A fire wall withholding new information

As clinicians with the opportunity to prescribe life-changing medications for our patients, I believe it is important to understand our biases, both positive and negative, towards Pharma. One benefit from lecturing around the country is the opportunity to meet and speak with psychiatrists, nurse practitioners, and psychiatric providers of all types, and to hear their experiences and challenges in various treatment settings. As a believer in immediate access to all new information that may improve the quality of patient care, it has been disheartening to consistently hear for more than 15 years about the pervasive culture at many medical centers and health care systems to ostracize the pharmaceutical industry, and not uncommonly, to threaten to fire employed physicians and clinicians who would like to attend educational programs about new medications on their own free time.

Some generalized recurrent themes include:

► Psychiatric residents who sneak out to a lecture on a new drug express frustration that the attending/supervising psychiatrists with whom they work have no knowledge of new medications that have been FDA approved over the past 5 to 10 years.

► A psychiatrist at a major medical center/teaching hospital who was fearful to attend a lecture program about a new medication because they were told that they would be fired if they attended any pharmaceutical industry sponsored educational program-even though it was after hours and on their own time.

► Major medical centers/health care systems banning pharmaceutical company representatives, including highly trained medical science liaisons (usually medical doctors or doctorate level pharmacists who receive no remuneration for any resulting business, rather acting  purely as a scientific resource) from even entering their buildings.

► A student with only two months remaining before completing her psychiatric nurse practitioner program at a New England teaching hospital attended a pharmaceutical company-sponsored program where she first learned about a medication that has demonstrated some unique properties helpful for a sub-population of patients and that was FDA approved more than four years ago.

► Psychiatrists at a busy community mental health center express frustration that when their patients were admitted to several different inpatient psychiatry units, the “newer” medications were stopped, and their patients were discharged on an array of side effect-ridden older medications because they were the only options available on the hospital’s pharmacy formulary.

► Frontline prescribers are not allowed to accept medication samples from pharmaceutical companies at risk of job termination. This is unfortunate for many reasons; in my view, the biggest reason being a lost opportunity to have a month trial, at no cost, on a medication to see if it is effective before providing a prescription that will likely require an accompanying nightmarish prior authorization form.

Time to move forward

When I reflect on the rich learning opportunities and experiences I have had in my role as a consultant and lecturer for various pharmaceutical companies over the past 25 years, I remain befuddled as to why many of our major medical centers/residency training programs/health care systems continue to ban the pharmaceutical industry from having any communication with their treatment providers. The majority of physicians and pharmaceutical companies, myself included, all agree that during the 1990s the relationship between the pharmaceutical industry and prescribers was out of control. Too much money was being thrown around with no clear guidelines and embarrassing conflicts of interest. Appropriately, in the early 2000s, there was a major restructuring of how prescribers and the pharmaceutical industry interfaced. As one would expect, initially the pendulum swung too far in the direction away from collaboration. In my opinion, the tragedy is that it has continued to swing away from ethical and appropriate collaboration to the current culture where the pharmaceutical industry is often demonized and ostracized.

Sadly, the real victims here are our patients. When the faculty that is training the next generation of clinicians intentionally avoid learning about new medications, and do not utilize novel treatments because of some misperception of greedy collusion with pharma or insecurity that they will be judged by their peers as unscrupulous, the standard of care will be steadily lowered and our oaths to “Do No Harm” will be broken.
The United States has always been a fertile field for discovery, research and development, and innovation in all markets, including the pharmaceutical industry, hospital systems, medical device development, and the delivery of quality health care. Many of these markets require a margin of profit to survive in our country’s economic structure. This profit motive is primal and necessary for continued operations, but it does not necessarily equate with sinister motives and rogue manipulations. Every bushel from the orchard is likely to have one rotten piece of fruit, but we do not discard the entire bushel as bad.

Our profession is one of lifelong learning, and that fact creates a responsibility to remain up to date on new and expanding treatments specific to our specialty. Any new treatment is initially vetted by the FDA or other regulatory agencies. Once a novel treatment is available to us frontline clinicians, our due diligence should include an objective appraisal of this new treatment, being mindful of positive as well as negative biases that may intrude into our assessment, so we may determine when and how the new treatment may fit into our constantly evolving armamentarium.

In an ideal world, clinicians would be provided sufficient and mandatory time each week to research and learn about newly available treatments. My observation is that, despite good intentions, the stresses of a busy schedule, onerous documentation, returning phone calls, reviewing lab work, and conducting other patient-related correspondence ultimately collude to exhaust us by the end of the day. In this current climate, spending time with a pharmaceutical representative or attending a lecture program by a physician consultant may provide an efficient vehicle to learn the basic data and FDA-approved facts that we can then ponder, discuss with colleagues, and ultimately make our own informed decision about the potential role of new treatments in our clinical practice.

The current political climate in the United States is teaching us about the dark side of extreme partisanship-such partisanship should not exist in our honorable profession of medicine. I would suggest that it is time to reassess the black and white polarization that many academic and medical systems have erected against the pharmaceutical industry and that we resume collaboration in a manner that provides our patients with the best possible treatments. I wonder how many years would have passed before I prescribed clozapine if I never attended that in-service by the clozapine sales representative during my residency?

Disclosures:

DR MILLER is Medical Director, Brain Health, Exeter, NH; Editor in Chief, Psychiatric Times; Staff Psychiatrist, Seacoast Mental Health Center, Exeter, NH; Consulting Psychiatrist, Exeter Hospital, Exeter, NH; Consulting Psychiatrist, Insight Meditation Society, Barre, MA.