Last week, the Kaiser Health Network announced the creation of a database to track donations by pharmaceutical manufacturers to patient advocacy groups. Labeled with the somewhat inflammatory moniker of “Pre$cription for Power,” the creators of the database investigated charitable contributions made to a variety of not-for-profit organizations that advocate for patients suffering from both common and rare disorders. Using data from the most recently available IRS Form 990 (the tax form that all groups organized as 501(c)(3) not-for-profit corporations must file), the Kaiser researchers identified 594 patient groups to whom pharmaceutical manufacturers had donated a total of $116M in 2015—an average of $195,000 per group.
Patient advocacy groups are generally well-intentioned organizations that serve admirable purposes. They provide a network for identifying resources and knowledgeable clinicians and platforms for communication among patients who suffer from chronic, often rare and misunderstood conditions. Well-known diseases like Alzheimer’s, heart failure, diabetes, Crohn’s disease, and stroke are represented, but so are rare developmental disorders like Angelman syndrome, Williams syndrome, and other conditions affecting small numbers of individuals. Particularly in the case of rare disorders, advocacy groups serve a valuable role in educating clinicians who may lack specific diagnostic or therapeutic knowledge about infrequently occurring conditions. These groups can also assist patients in forming supportive networks and organize effective outreach efforts that seek to raise awareness among policymakers and educators.
Unavoidably, some groups have less noble objectives and may be organized for the purposes of promoting sham or miraculous cures or raising funds under the flag of charity that actually go to line the pockets of the group’s leadership. Human predators seek out the desperate and uninformed, and hardly a week goes by without distasteful revelations of fraud perpetuated in the name of charity on those who are unwary or simply gullible.
But what happens when legitimate organizations accept funding from sources whose motives are more conflicted? This is the focus of the Kaiser report. Pharmaceutical companies’ donations to a charitable organization may have beneficial goals, such as expanding awareness about available treatments or subsidizing the cost of expensive drugs. At the same time, these donations may serve to transform the organization into an advocacy arm of the drug firm to pass legislation benefiting the industry and insisting that regulators ease access to drugs in the absence of, or even in spite of, data regarding the safety and efficacy of unproven treatments. To this point, the Kaiser research found that pharmaceutical firms’ expenditures on declared lobbying activities had plummeted while donations to patient advocacy groups had increased substantially. In a Medscape article describing the Kaiser study, it was noted that one firm, Bristol Myers Squibb, had made over $20M in patient advocacy group donations while declaring less than $3M in expenditures on regulated federal lobbying activities. The obvious concern is that the drug company has now created an army of civilian lobbyists who can effectively spread the manufacturer’s message to legislators and the public. Cost-offset schemes to subsidize the price of very expensive drugs have also come under ethical and legal scrutiny. While in the short run these may assist certain patients in accessing medications, they may also mask the true price of drugs and pass costs on to unsubsidized consumers.
But that is not the point of this column. Efforts by Big Pharma to boost drug sales and counter-efforts by regulators to curb unethical practices are no longer newsworthy. In the U.S., medical educators have significantly curtailed the “trinket trade” that, under the guise of free pens and pizza lunches, touted brand-name drugs to medical residents. Drug-company funded physician junkets in the U.S. are largely a thing of the past, although the practice remains robust in other countries. FDA initiatives, such as clinicaltrials.gov as discussed in last month’s column have reduced (but not eradicated) the influence of sponsored research in academic discourse.
The big surprise in examining the list of subsidized not-for-profit groups was not which ones were on the list, but which ones were not—and this was a very big surprise. Out of 594 not-for-profit organizations that received funding from Big Pharma, only 14 (approximately 0.02%) had a mental health focus. Of these 14, the preponderance were organizations devoted to autistic spectrum disorders; others dealt with substance abuse, LGBT issues including mental health, and developmental disabilities (for the purposes of my analysis, I did not count organizations devoted to Alzheimer’s disease or other dementias. They were numerous, but their primary focus is neuropathology, not mental health per se). This is a true sea change from the past several decades, when professional and lay mental health groups were inundated by funding and promotional material from manufacturers of antidepressants and antipsychotics. What happened?
In pharmacoepidemiology, it is almost axiomatic that when a manufacturer stops promoting a drug its utilization declines. Because most psychotropics are now available in generic form and there is little economic incentive for manufacturers to promote them, we would expect that overall utilization of psychotropics would decline. Data indicate that the answer is not so simple. Recent analyses of nationwide utilization patterns suggest that more patients than ever are taking psychotropics. Almost 18% of the American adult population has a recent prescription for a psychotropic, and some, like the anti-anxiety agent alprazolam (Xanax) are consistently on the top-20 lists of most commonly prescribed drugs. But at the same time, the sale of branded drugs has plummeted and over 80% of prescriptions are written for a generic rather than brand-name medicine.
So we cannot necessarily blame an overall reduction in use of psychotropics for lack of external funding to mental health advocacy organizations. My guess is that a more convincing explanation can be found by looking at the drug development pipelines of major pharmaceutical manufacturers, because here we see an almost complete absence of any psychotropic drug. In 2017, manufacturers like Lilly and Pfizer had very limited neuroscience drug development portfolios and were mostly working on drugs for Alzheimer’s or Parkinson’s disease. By 2018, in the face of a number of disappointing clinical trials, most work on even these two conditions had stopped. This is a radical reversal from only a few years ago, where neuropsychiatric drugs were often the largest part of a drug company’s portfolio. Less interest (and profit) from drug manufacturers of course means less interest in and funding for patient advocacy groups, but scale of this abandonment is breathtaking.
Does the lack of industry funding for mental health advocacy groups spell doom for our efforts to keep mental health in the public eye? I think not. Industry funding is not the only source of support for not-for-profit advocacy groups. Purely charitable foundations and private donations will continue to provide less-conflicted revenue streams. But the disappointing clinical trials that led manufacturers to abandon neuropsychiatric drugs have positive implications for all of us. For example, an autism advocacy group may no longer focus on demanding that lawmakers increase the supply of a particular medication, but instead must focus on effective individual, educational, and community interventions that allow better integration of patients with autistic spectrum disorders into the community. Rather than being held captive by the elusive notion of a molecular cure for psychosis, a schizophrenia advocacy group may instead lobby for better housing and treatment of de-institutionalized psychotic patients or funding to study promising multifamily group interventions for psychosis. For a very long time, our paradigms for treating mental disorders had at their heart the goal of cure. Cure is the philosophical bedrock of the medical model of mental health treatment. What we are coming to appreciate is that while cure may be a reasonable goal for cancer, it is a less likely goal for many mental disorders. Better interventions to reduce individual distress and more effectively manage symptoms are far more attainable ends. Evidence continues to mount that pharmacological interventions alone yield less robust long-term outcomes than a combination of medication with targeted psychological interventions. Our campaigns for acceptance and stigma reduction have shown early promise, but much work remains to be done. So the absence of industry funding may be a blessing and not a curse—one that allows advocates for patients with mental disorders to focus on solutions that look not just at the individual patient but at how we as a progressive society view the complex problem of mental illness.
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