In July of 2014, I published an article explaining my concerns about the push to allow prescription privileges for psychologists across the country, after news of the recent legislation in Illinois sanctioning this practice. I cited four main areas of concern, which I will revisit below. More discussion is necessary regarding these issues if we as psychologists, and the general public, are going to be fully informed.
- Our Profession Will Follow the Path of Psychiatry, and Morph from the Practice of Psychology to the Practice of Pharmacology
Those who don’t know history are destined to repeat it.
— Edmund Burke
The Food & Drug Administration (FDA) was founded in 1906 as an independent government agency designed to evaluate the effectiveness and safety of new drugs. One of its primary purposes was to protect the public against new drugs that may do more harm than good. In 1992, a new law was signed by the US government that allowed the FDA to charge drug companies to evaluate their products more quickly. One bill provision stipulated that none of the funds could be used to evaluate the ongoing safety of the drugs, although subsequent reauthorizations have relaxed these provisions. The FDA Office of Drug Safety was subsequently downsized, and focus has shifted from drug safety to drug approval (Kirsch, 2010).
Today, roughly 40 percent of the FDA budget comes from drug company funding. The FDA isn’t alone; about 70 percent of funding from the European Medicine Agency (EMEA) comes from the pharmaceutical industry. This entanglement has raised serious questions about the FDA’s ability to objectively evaluate the efficacy and safety of new drugs. A number of specific concerns have emerged, including reports published by the reports published by the Washington Post that the FDA has advised drug companies to keep negative studies hidden:
The Food and Drug Administration has repeatedly urged antidepressant manufacturers not to disclose to physicians and the public that some clinical trials of the medications in children found the drugs were not better than sugar pills, according to documents and testimony released at a congressional hearing yesterday. Regulators suppressed the negative information on the grounds that it might scare families and physicians away from the drugs, according to testimony by drug company executives. For at least three medications, they said, the FDA blocked the companies’ plans to reveal the negative studies in drug labels.
Today, the FDA only requires at most two adequate and well-controlled clinical studies demonstrating that a particular drug is better than a placebo. Beyond a number of highly criticized methods used to demonstrate efficacy, drug companies are allowed to have as many negative studies (i.e., not showing any benefit over placebo) as long as two studies show efficacy. Many psychotropic drugs are also approved on studies that utilize a period of 8 weeks or less and which provide no information regarding long-term outcomes, including potentially irreversible side effects. Just this past month, the ADHD drug Dyanavel XR was approved for use with individuals 6 and older on the basis of a six week study. In fact, a study by Harvard Researchers in 2014 found that of the twenty ADHD drugs that have been approved by the FDA, the median length of the trial before approval was 4 weeks. Approval for eleven of the drugs occurred after they were only studied in less than a 100 participants. The FDA even approved 7 of the drugs before the sponsors submitted any clinical trial data; these seven drugs had been approved for other conditions, such as obesity. All of these issues raise serious questions about how FDA and drug company entanglement impact a true assessment of the utility and safety of psychotropic drugs.
The American Medical Association (AMA) was founded in 1847. Into the mid-1900’s, the primary focus was on protecting the public. Each year it published a useful drugs book designed to inform the public about the best drugs available that were given its “seal of approval.” In 1951, Congress passed the Durham-Humphrey amendment, which indicated that most new drugs would only be available by prescription from a physician. Suddenly, physicians and drugs became closely aligned to one another. That same year, the AMA and Smith Kline & French coproduced a television program entitled, “The March of Medicine.” In 1952, the AMA stopped publishing its yearly book on “useful drugs”; shortly thereafter, it began allowing advertisements of drugs not approved by its Council on Pharmacy and Chemistry. By 1957, drug revenues reached 1 billion dollars. Physician salaries doubled from 1950 to 1970 (after adjusting for inflation). AMA revenues for drug advertisements in its journals rose from 2.5 million in 1950 to 10 million in 1960 (Whitaker, 2010).
In 2002, Marcia Angell, the editor of the New England Journal of Medicine, wrote an article entitled “Is Academic Medicine for Sale?” In it, she stated the following:
The ties between clinical researchers and industry include not only grant support, but also a host of other financial arrangements. Researchers also serve as consultants to companies whose products they are studying, join advisory boards and speakers’ bureaus, enter into patent and royalty arrangements, agree to be the listed authors of articles ghostwritten by interested companies, promote drugs and devices at company-sponsored symposiums, and allow themselves to be plied with expensive gifts and trips to luxurious settings. Many also have equity interest in the companies.
In 1980, the American Psychiatric Association’s Annual Revenues were 10.5 million. In 1990, they were 24.9 million dollars. By 2008, they had risen to 65.3 million dollars. Meanwhile, during this time, income from member dues showed little change, barely rising to above 10 million dollars in 2008. APA acknowledged that in 2006, 29% of its revenues came directly from the pharmaceutical industry. This did not even include funding received through the American Psychiatric Foundation, created in 1991 as a non-for-profit entity to support the APA (APA annual financial reports, 1980 – 2012).
In the 1990’s, 57 percent of DSM-IV task force members reported ties to the pharmaceutical industry. Sixty-nine percent of DSM-5 task force members report they received reimbursement from the pharmaceutical industry. Ninety percent of APA’s group leaders who authored their guidelines for depression, bipolar illness, and schizophrenia had financial ties to drug companies. At the APA annual meeting in 2008, the 273 speakers collectively had 888 consulting contracts and 483 speaker bureau contracts with the industry.
Do we think somehow we as psychologists will not find ourselves impacted by economics of influence connected with the pharmaceutical industry as other organizations and individuals have?
If we do, then we are ignoring a number of biases that our research has helped to illuminate over the years.
2. Doing No Harm, or, in APA Terms; Nonmaleficence
Beneficence and Nonmaleficence: Principle A in the APA Codes of Ethics
Psychologists strive to benefit those with whom they work and take care to do no harm…Because psychologists’ scientific and professional judgments and actions may affect the lives of others, they are alert to and guard against personal, financial, social, organizational or political factors that might lead to misuse of their influence. -American Psychological Association, 2010
In conjunction with concerns I already voiced in this area, ongoing research regarding the side effects of many psychotropic medications, especially atypical antipsychotic drugs, is revealing huge issues with metabolic, cardiac, neurological, and other physical outcomes; if used chronically, psychotropic drugs often reduce the life expectancy and lead to increased disability and reduced quality of life. These issues are only magnified when medications are started in childhood. A 2014 study published in the British Medical Journal assessed nearly a 100,000 patients, and found those who used anxiolytics and/or hypnotics were three times more likely to die prematurely during a seven year follow-up period than those that did not. As antipsychotic drugs are increasingly being used for almost every psychological ailment, a joint working group of Canadian professionals, including the Canadian Psychiatric Association, indicated that these drugs should not be used as first line treatment for sleep issues. As quoted in the Medscape article, Dr. Chris Wilkes indicated that “these drugs carry significant risk of potential side effects, including weight gain and metabolic disorders.” The serious impact of these and other psychiatric drugs is finally coming to light as well as questions about whether a long-term benefit exists for most.
3. Are Psychiatric Medications Really Helping Us To Be Psychologically Healthier?
In the previous article, I focused on population-based evidence that psychological problems are increasing, not decreasing, as psychiatric drugs are being prescribed more. In this section, I will focus more on outcomes as they relate to specific conditions. It has been well-documented that the long-term results of ADHD medication use in children indicate anything but a clearly advantageous course. As NIMH researchers shockingly found out in Multisite Multimodal Treatment Study of Children with ADHD, physical and psychological outcomes three years and later were worse for those children on ADHD medications than those diagnosed with ADHD who were not. This study was not alone in this finding. But as Robert Whitaker repeated illustrated in Anatomy of an Epidemic, this is just the tip of the iceberg.
In regard to depression, multiple NIMH studies found long-term negative outcomes with use of anti-depressants. In 1990, a large 18-month study, the “stay well” rate was highest for those in regular psychotherapy (30%) and lowest for those on an anti-depressant (19%). In 1995, in a 6 year study of 547 individuals, those treated with antidepressants were 7 times more likely to be incapacitated than those who weren’t. In 1998, WHO published a study indicated that those treated over a year with psychiatric drugs demonstrated worse depressive symptoms and general health than those who weren’t.
In regard to schizophrenia, a 1992 NIMH study found that long-term outcomes were much better in poor countries such as Nigeria and India, where only 16 percent of patients were maintained on antipsychotics, than in developed countries like the U.S. where the rate is much higher. In a 15-year study of patients with schizophrenia, only 5% recovered on antipsychotics compared to 40 percent who were not on these drugs.
Beyond increasing reports of industry corruption within the research and marketing of drugs, there are serious questions about the long-term impact of psychotropic medications
Do we as a profession really want to assume this uncertainty?
4. Logistical Problem of Combining Medical and Psychological Training (and doing both well)
True wisdom is knowing what you don’t know -Confucious
Psychologists are not required to undergo training in basic biological sciences as part of graduate coursework (and certainly most complete only limited coursework in undergrad). This is also not a prerequisite to entering Rx programs. Master’s degrees approved by the APA for prescriptions privileges falls significantly short of that required for other prescribing degrees in this area. They encompass only 20% of average physician training, 33% percent of advanced practice nurses, and 50% of what was required by prescribing psychologists as part of a military pilot program organized in 1991 by the Department of Defense. Standards have gradually been weakened for what is required for psychologists to prescribe (Tumlin and Klepac, 2014).
In 1992, recommendations were put forth by the APA Ad Hoc Task Force on Psychopharmacology that defined 3 levels of training (Smyer et al., 1993). Level 1 was two basic courses in psychopharmacology and biopsychology. Level 2 was focused on preparing CL psychologists for interface with medical personnel. Level 3 was focused on requirements for independent prescription privileges, and would have required four additional years of study in addition to the six years of graduate/postdoc work typically required for clinical psychology, totaling 10 years in all. In 2009, the APA issued revised training standards that are significantly less rigorous than recommended by their own task force.
The Clinical Psychopharmacology Postdoctoral MS Program at Alliant University (through California School of Professional Psychology) is one example of a current Master’s program designed to train psychologists to prescribe. It was established in 1998, as the nation’s first Postdoctoral Master of Science in Clinical Psychopharmacology. It has an APA-approved curriculum, is fully online, and requires 29.6 semester credits. A closer perusal of the class schedule indicates classes with a description that resembles an entire degree program. For example, 2.4 credits total are dedicated to the following study of special populations under the heading PPH Special Populations 1: Child, Geriatric, Chronic Pain, Chronic Medical Conditions, Trauma. The course description states the following:
Topics include: child/adolescent psychopharmacology, geriatric psychopharmacology (dementia, polypharmacy, and interactions between pharmacotherapy and age associated illnesses); developmental disorders; treatment of chronic pain disorders; psychopharmacological issues for individuals with chronic medical illness, victims of trauma, and patients with personality disorders.
Interestingly, the standard RxP model endorsed by APA has failed 183 times in 26 states. Only New Mexico and Louisiana have passed a bill that utilizes the APA model. Even in Illinois, the APA RxP model failed, and it was required that RxP training be at least consistent with what is required by physician assistants, but with the following restrictions in place. Prescribing psychologists can only treat individuals 17-65, can’t treat those who are pregnant, can’t treat those with serious developmental or medical disorders, and are prohibited from prescribing certain benzodiazepines and other drugs.
5. Logistical & Practice-Based Concerns
Finally, we come to the actual logistics of prescribing drugs, and addressing both the potential changes that it may induce in our practice and also managing the sequelae that may result. For psychologists who elect to prescribe, significant questions remain about who will manage side effects (which are often significant) of the medications used. Psychologists are not able and/or qualified to order most medical labs/tests and also prescribe other medications (e.g., GI medications) that might be needed to manage adverse effects. Although certain states may have a collaborative agreement in place, most physicians have difficulty managing their own caseload (and that of a nurse practitioner or other medical professional), let alone another caseload that may require intensive attention. Most primary care physicians refer to prescribing practitioners to manage all the needs and demands that come with medications; significant challenges exist in how this would work with a psychologist who does not have the full privileges at hand of a medical degree. Be certain, too, that rates of prescribing overall will increase, not just be reallocated to different providers, if more psychologists are able to do this.
Beyond the issue of adverse effects, we must also consider the potential of a negative impact on the profession, especially when it comes to the reality of “medication seeking” that exists today. If we as psychologists don’t think that having the ability to prescribe meds would alter the demands we experience, and the clientele that seek us out, we should ask our psychiatric colleagues and fellow primary care physicians about the daily requests they receive. Many patients come with a desire to seek out the best treatment available; some come with the idea that medications are what they need, and are not interested in other options. Right now, we as psychologists are fortunate that even if patients are med seeking, they know we can’t provide a prescription, only a diagnosis that might facilitate the possibility of it (with further effort added). But if patients and hospitals knew that we can prescribe, be prepared that we may feel forced into a mode of practice that makes us uneasy. This might include, but is not limited to, shorter appointments to facilitate seeing more patients and a greater amount of time allocated to enable refills, all without necessarily having a nurse or physician assistant to aid. We would feel increased pressure to prescribe off label as psychiatrists & PCP’s already feel. Personally, I know many medical professionals in these fields who feel that the demands of the agencies that employ them do not allow for thorough, ethical practice.
Ultimately, we as psychologists are left with two questions:
What is best for the general public?
What is best for our profession, which already has tremendous value and responsibility to those we serve?
It is a perspective we must consider, ironically in the shadow of the recent, highly-publicized fallout regarding psychologists’ involvement in the interrogation scandal. On July 30th, 3015, the Los Angeles Times published an article about the interrogation fallout that we all know too well. It was entitled, “How the American Psychological Assn. Lost Its Way.” It began with the line,
“The American Psychological Assn is in a crisis.”
Among many points, two quotes rang clear—not just of the interrogation disgrace—but of the prescription privilege push:
“The APA got into this mess by holding tightly to a deeply flawed assumption: that psychology should embrace every opportunity to expand its sphere of influence.”
“Psychology as a profession should not seek unbridled growth. That view is grandiose and misguided. The effective bounds of our professional ethics and expertise must limit our horizons.”
So, the ultimate question is, “What do we want to guide our profession forward?” Financial gain, marketability, convenience, or a deep consciousness about what is best for the people we serve? Now is not the time to further dilute and stretch what we are doing, making us and the general public only more vulnerable. Now is time to get back to the core of what our profession offers, and strive to do it with the utmost skill and compassion. Millions of people are in need of what we provide. Let us not disappointment them and ourselves.
Whatever your life’s work is, do it well. – Dr. Martin Luther King, Jr.
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Kirsch, I (2010) The Emperor’s New Drugs: Exploding the Anti-Depressant Myth. Basic Books Publishing.
Tumlin, T. R., & Klepac, R. K. (2014). The long running failure of the American Psychological Association’s campaign for prescription privileges: When is enough enough? The Behavior Therapist, 37, 144-152.
Whitaker, Robert (2010). Anatomy of an Epidemic. Crown Publishing.