Non-Invasive Brain Stimulation vs. the Pharmaco-Industrial-Regulatory Complex
How the Pharmaceutical Industry’s Influence Shapes—and Stifles—the Advancement of rTMS and tDCS Therapies for Mental Health
Introduction
In the world of mental health treatment, a quiet revolution has been brewing: non-invasive brain stimulation therapies like repetitive Transcranial Magnetic Stimulation (rTMS) and transcranial Direct Current Stimulation (tDCS) promise relief for conditions like depression, often with fewer systemic side effects than medications. Yet these therapies have faced formidable headwinds. Decades of entrenched pharmacoeconomic incentives – where developing and prescribing drugs is far more lucrative and straightforward – combined with the lobbying might of the pharmaceutical industry (sometimes dubbed the “pharmaco-industrial-regulatory complex”) have slowed the progress of neuromodulation technologies. This complex web of industry influence, regulatory hurdles, funding disparities, and reimbursement barriers has created an uneven playing field that favors pills over devices.
This deep-dive explores how our legacy healthcare system evolved to favor pharmacotherapies over device-based interventions, and how that status quo is being challenged. We will examine the historical context that set these incentives, the current landscape of research funding and FDA approvals, and the outsized role of pharma lobbying. Throughout, an advocacy tone underscores a core message: patients deserve fair access to safe, effective innovations. rTMS and tDCS need not be viewed as competitors to medication, but rather as complementary options in a holistic treatment toolkit. It’s time to encourage fairer innovation, rigorous clinical validation, and regulatory inclusion of these non-invasive technologies – leveling the playing field so they can advance hand-in-hand with pharmaceuticals, to the benefit of patients.
Authorship Disclosure Statement
I have utilized OpenAI’s ChatGPT 4.5 LLM as a research and writing assistant in the development of this essay. Specifically, this AI tool provided suggestions on structure, style, and preliminary text. However, all final decisions, interpretations, and conclusions herein remain my own, and I have verified or refined AI-generated content to maintain both accuracy and academic integrity.
Historical Bias: How Pharma Became King
Modern psychiatry was fundamentally reshaped in the mid-20th century by the advent of psychotropic drugs. The discovery of chlorpromazine in the 1950s and later antidepressants (MAOIs, tricyclics, SSRIs) led to a psychopharmacology revolution. Medications were seen as “miracle pills” that could be easily administered, mass-produced, and marketed widely – a stark contrast to earlier somatic therapies like electroconvulsive therapy (ECT) or psychosurgery, which were resource-intensive and stigmatized. This early success of pharmacotherapy established a paradigm: for depression and other mental illnesses, the first-line treatments would be drugs. Regulatory frameworks and economic models soon aligned around this paradigm:
Regulatory Framework Built for Drugs: The U.S. Food and Drug Administration (FDA) developed well-defined pathways for drug approval (preclinical testing, phased clinical trials, New Drug Applications). In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA), allowing the FDA to collect fees from drug makers to expedite reviews . PDUFA strengthened the pipeline for new medications – but also entwined the FDA’s resources with pharma funding, “possibly lower[ing] standards for safety” and creating “potential conflicts of interest” due to the close alignment of FDA and industry interests . No equivalent fast-track or dedicated funding existed for psychiatric devices at the time.
Economic Incentives and Patents: Pharmaceutical companies could rely on patent exclusivity and regulatory protections to recoup massive R&D investments. A successful drug enjoys market exclusivity for years, virtually guaranteeing profits if it becomes widely prescribed. By contrast, medical devices lack comparable regulatory exclusivity – once approved, competing devices can often emerge more easily . As bioethicist Hank Greely noted, unlike drugs or biologics, a new device doesn’t get a multi-year monopoly from the FDA, which “makes it even harder to attract investment” in device development . Early neuromodulation ideas like rTMS (first developed in the 1980s) and tDCS (pioneered even earlier, then revived in the 2000s) thus struggled to find commercial backers; their mechanisms were not patentable in a traditional sense (you can’t patent a magnetic pulse or a weak electrical current), and any specific device apparatus was at risk of being copied or leapfrogged by competitors.
Cultural and Clinical Momentum: During the late 20th century, psychiatry increasingly identified as a medication-focused field. The ease of prescribing (15-minute med checks vs. time-consuming procedures) and the influence of pharmaceutical detailing meant that generations of clinicians were simply more familiar and comfortable with pills. Non-drug interventions like ECT became a niche (reserved for severe or refractory cases) and carried stigma. Newer brain stimulation techniques were often met with skepticism or viewed as last resorts. As Mark George – a pioneer of TMS – observed, many psychiatrists in earlier decades “had self-selected the profession to avoid procedures and physical contact with patients”, so they were initially hesitant to adopt TMS until it proved itself .
The combined result was that by the 1990s and 2000s, when rTMS and tDCS were emerging as potential therapies, they entered a landscape heavily skewed in favor of pharmacotherapy. Drugs had the funding, the regulatory pathways, the insurance reimbursement structures, and the mindshare of providers. Device-based interventions lacked those systemic supports – a disadvantage that can be traced back to historical decisions in regulation and economics.
The Pharmaco-Industrial-Regulatory Complex: Power and Influence
Over the decades, the pharmaceutical industry built what some call a “medical-industrial complex” – a powerful alliance of drug manufacturers, regulators, legislators, and even academic institutions that collectively shape healthcare priorities. When focusing on psychiatric treatment, this can be characterized as a pharmaco-industrial-regulatory complex: an ecosystem that naturally prioritizes drug therapies due to financial and political influence. Several factors illustrate how this complex sidelines neurostimulation innovation:
Lobbying Might: The pharmaceutical lobby is perennially one of the top spenders in Washington. Between 2009 and 2011 alone – a period when Congress was debating FDA matters and healthcare reforms – drug companies spent over $487 million on federal lobbying, compared to about $86 million spent by medical device companies . That is a 6:1 spending gap in favor of pharma. Recent data show this imbalance persists: in 2025, the industry trade group PhRMA spent nearly $13 million lobbying by mid-year, whereas the largest device manufacturers’ association (AdvaMed) spent only about $1.1 million . This outsized spending buys access and influence. Pharma lobbyists push for laws and regulations that favor drug development – for example, maintaining high exclusivity periods, speeding up drug approvals, and securing Medicare drug coverage. Meanwhile, the relatively meager lobbying presence of the neurodevice sector means that issues crucial to neuromodulation (such as dedicated FDA guidance or research funding boosts) receive scant attention.
Regulatory Capture and Alignment: There is a revolving door phenomenon wherein pharma executives, lobbyists, and FDA officials exchange roles, blurring the lines between industry and regulator. As one analysis noted, the pharmaceutical industry can “indirectly influence the FDA by lobbying Congress or directly by hiring ex-FDA commissioners” . Over the years, numerous FDA leaders and advisors have joined pharma boards or consultancies, and vice versa. This doesn’t imply outright corruption, but it creates a culture of alignment – a shared mindset that new drugs are the lifeblood of therapeutic progress. In such an environment, devices for mental health have often been an afterthought, lacking high-level champions inside regulatory agencies. Even the FDA’s organizational structure reflects the emphasis on drugs: CDER (Center for Drug Evaluation and Research) is a behemoth compared to CDRH (Center for Devices and Radiological Health). While CDER enjoys heavy funding (bolstered by PDUFA fees) and large staffs focused on evaluating psychiatric drugs, CDRH has fewer resources to devote to novel psychiatric devices. An FDA scientist speaking at a National Academies workshop acknowledged that navigating device approval for brain therapies can be confusing, because “expectations are less clear for the neuromodulatory device market” compared to pharma . In short, the regulatory system was built to evaluate pills, not electrostimulation – and it is still catching up.
Clinical Guidelines and Thought Leadership: The influence of pharma also extends to guidelines and education. Pharmaceutical companies have historically sponsored extensive clinical trials and then worked to ensure the results inform treatment guidelines (for instance, recommendations on first-line therapy for depression). Professional societies and guideline committees often included experts with pharma research grants or consulting ties. It is perhaps no surprise that until recently, clinical guidelines placed neuromodulation at the margins – e.g. suggesting rTMS only after multiple medication failures. For example, initial FDA clearance of TMS in 2008 was specifically for adults with depression who had failed at least one antidepressant in the current episode, and many insurers interpreted that to require trying four different drugs and psychotherapy before reimbursing TMS (effectively making TMS a fourth- or fifth-line option). The result was that even after rTMS was proven safe and cleared for use, it struggled to gain acceptance as anything but a niche last-resort treatment. By contrast, new antidepressant drugs (even those similar to existing ones) were rapidly adopted into practice due to aggressive marketing and education campaigns funded by their manufacturers. Only in the past few years, as independent evidence mounted and advocacy grew, have attitudes started to shift – with organizations like the APA now explicitly calling for broader awareness and training in neuromodulation. (Notably, the American Psychiatric Association in 2024 urged that “training in evidence-based TMS therapy for residents and insurance coverage for TMS are needed to provide access”, since “most psychiatrists lack education and knowledge about it” .) This kind of endorsement is a positive sign, but it comes after decades in which pharma’s narrative dominated the conversation on how we treat depression.
In sum, the pharmaco-industrial-regulatory complex can be thought of as a self-reinforcing cycle. Pharma’s money influences policy and norms that favor drug solutions; those norms direct public and private resources (funding, clinical uptake) towards more drugs. Meanwhile, alternative approaches like rTMS and tDCS – no matter how promising – enter an uphill battle against inertia and vested interests.
Funding Disparities: Research Dollars and Development Gaps
One of the clearest manifestations of this bias is in research funding and investment patterns. Developing any new therapy (drug or device) requires extensive research, from basic science through clinical trials. Who pays for that research often determines which ideas flourish. Here, too, neuromodulation has been at a disadvantage:
NIH and Public Funding: Historically, the U.S. National Institutes of Health – including the NIMH (National Institute of Mental Health) – poured far more resources into drug research than device research. Throughout the late 20th century, NIMH funded large trials of antidepressants (e.g. the landmark STAR*D trial for depression) and studies of neurotransmitter biology. By contrast, funding for trials of devices like rTMS was limited and often hard-won. In fact, some in the field perceived an institutional skepticism toward neuromodulation. Mark George recounts that when the NIMH finally funded a multi-site trial of TMS in depression (the OPT-TMS trial around 2008–2010), the institute seemed “surprised” by the overwhelmingly positive result – a 30% remission rate in hard-to-treat, medication-resistant depression , which was better than any drug for that population at the time. George wryly suggests that NIMH had “possibly funded the OPT-TMS trial to convincingly show that TMS does not work” so they could justify ignoring the influx of TMS grant applications . In other words, the default expectation was that medication was superior and that TMS was a long-shot. The trial’s success challenged that notion, but initial NIMH press releases still downplayed TMS (headlining that it was “not as good as ECT”) . This anecdote highlights a broader truth: public funding agencies were long geared toward pharmacological solutions, and only recently (with initiatives like the BRAIN Initiative and dedicated neuromodulation programs) have they started to invest significantly in device-based treatments. Even today, experts note “a lack of funding from federal grant sources” as a key impediment to growth in non-invasive neuromodulation research .
Industry and Venture Capital: If government funding was lacking, could the private sector fill the gap? For pharma, the answer was yes – large pharmaceutical companies invest billions in R&D and sponsor the vast majority of drug trials. For medical devices, especially novel neurotechnologies, the picture is bleaker. Neuromodulation has largely been the province of small start-up companies rather than giants. Many rTMS device makers started as tiny ventures or university spin-offs. These small companies often “lack sufficient resources to undertake the complicated and lengthy processes required for regulatory and reimbursement approval” . Venture capital funding for new medical devices also dried up in the past decade. Venture capitalist Ross Jaffe noted that despite excitement around technologies like neuromodulation, investors have “shied away from medical device companies because of unproven business models, lack of regulatory predictability, challenges obtaining reimbursement, and the long development time frame for ROI” . In fact, around the early 2010s, there was roughly a 70% drop in funding for early-stage medical device firms compared to peak levels in 2008 . This “innovation ecosystem” crunch meant fewer neurostimulation startups could survive the so-called “valley of death” between prototype and profitable product. By contrast, biotech investors saw comparatively clearer and faster returns in pharmaceuticals, especially as the FDA streamlined drug approvals and payers eagerly covered new meds (for example, expensive new antidepressants or antipsychotics often secure insurance coverage quickly if they fill an unmet need). The bottom line: it was easier to get money to test a new pill than to test a new device.
The Patent/Profit Problem: Another economic reality is that profit models differ between drugs and devices. A successful psychiatric drug might be taken daily for years by tens of thousands of patients – a repeating revenue stream. A device like an rTMS machine is typically a one-time capital sale to a clinic (on the order of ~$50,000), plus some maintenance or consumable fees. Even though patients undergo multiple TMS sessions, that service revenue goes mostly to the treatment provider, not the device manufacturer. tDCS devices, if mass-produced, could be even cheaper, potentially a few hundred dollars for a basic unit – raising the question of who would invest millions in FDA trials for a product that could be hard to monetize or easy for competitors to imitate. This pharmacoeconomic calculus made neurostimulation less attractive to industry. Indeed, an academic review on stroke rehabilitation candidly noted that for therapies like rTMS and tDCS, “regulatory barriers, and lack of industry interest have hindered further dissemination” (especially given some safety concerns like rare induced seizures) . It’s telling that no major pharmaceutical company substantially invested in TMS or tDCS development during the early 2000s. (The notable exception is Johnson & Johnson’s subsidiary Janssen, which in recent years expressed interest in pairing devices with drugs – a forward-thinking move we’ll discuss later.) In general, neurotech firms had to scrape together funding through grants, angel investors, or strategic partnerships, whereas Big Pharma could throw tens of millions at a Phase III drug trial without blinking.
The cumulative effect of these funding disparities is a slower and patchier progress for neurostimulation therapies. While dozens of antidepressant drugs (many only marginally different from each other) marched through trials and onto the market, rTMS and tDCS research advanced in fits and starts – often with small sample sizes, single-center studies, or methodological heterogeneity. This in turn made it harder to generate the robust evidence needed to sway regulators, payers, and prescribers. It’s a classic Catch-22: without strong data, stakeholders remain skeptical – but without funding, you can’t run the large trials to get that data.
Regulatory Roadblocks: FDA Approval and Clinical Adoption
Getting a new therapy approved by regulators is a pivotal step that was markedly different for neurostimulation devices compared to drugs. The stories of rTMS for depression and the still-unfulfilled quest to approve tDCS illustrate how regulatory pathways, intended to ensure safety and efficacy, can inadvertently favor the status quo (medications) and pose special challenges for devices:
The rTMS Approval Saga: Repetitive TMS for depression was researched throughout the 1990s, but it wasn’t until 2008 that the FDA cleared the first TMS system (Neuronetics’ NeuroStar) for treating major depressive disorder. Why the long delay? Partly because there was no clear precedent or pathway at the FDA for a device that directly targets brain circuits for a psychiatric indication. rTMS is a device, so it fell under the FDA’s device regulatory framework. The manufacturer initially attempted to get approval via the 510(k) process, which is typically used for moderate-risk devices that are “substantially equivalent” to an existing device. They argued that TMS was roughly analogous to ECT (electroconvulsive therapy) – the predicate device – since both are used for depression. However, this was a stretch: ECT uses electrical current to induce seizures, whereas TMS uses magnetic fields to stimulate the cortex without seizures . An FDA advisory panel debated this in 2007, and ultimately the FDA determined TMS was not substantially equivalent to ECT . This meant TMS could not be simply cleared as a me-too device; it was essentially a new category. Normally, a truly novel device (especially one intended to treat illness) might require the PMA (premarket approval) route – analogous to a new drug application, demanding rigorous evidence (usually two pivotal trials demonstrating effectiveness). For a small company like Neuronetics, funding multiple large trials was daunting. What happened next is telling: TMS was allowed to enter the market via an obscure “de novo” pathway, a compromise route created in 1997 for devices that are low-to-moderate risk but have no predicate . In essence, after the initial randomized trial showed only a borderline effect (a 1.7-point improvement on a depression scale that narrowly missed conventional statistical significance, p=0.057) , the FDA didn’t outright reject TMS. Instead, they worked with the company to reanalyze data and leveraged the de novo process to grant clearance with special controls. Public health advocates like Public Citizen criticized this as too lenient – pointing out that the FDA accepted a novel statistical analysis and historical comparisons to ECT data, approaches viewed with “considerable skepticism by most statisticians” . But from another perspective, this flexibility was crucial to let a promising therapy reach patients. TMS was ultimately cleared as a Class II device (moderate risk), which set an important precedent: subsequent TMS devices (e.g. BrainsWay’s deep TMS in 2013) could go through the easier 510(k) route by citing the NeuroStar as a predicate. The FDA’s handling of rTMS was a double-edged sword – it delayed approval until sufficient (if imperfect) data emerged, but also innovated within its rules to accommodate a device that didn’t fit the usual mold. The delays had real consequences: thousands of patients continued to cycle through medications during those years. But once TMS was approved, another battle began – getting clinical adoption and insurance coverage, which we address shortly.
The tDCS Quagmire: If rTMS was a slow triumph, tDCS remains (as of 2025) in regulatory limbo. Despite decades of research and widespread academic interest, not a single tDCS device has FDA approval for treating any medical condition . The reasons are multifaceted. First, tDCS devices are relatively simple (a 9-volt battery-powered device delivering low current), and many low-end versions popped up selling online as “wellness” or “cognitive enhancement” products. The FDA generally exercises “enforcement discretion” on consumer brain stimulators that avoid medical claims – meaning if a company markets tDCS as a general wellness or gaming aid, it might not trigger regulatory scrutiny . This created a Wild West of unregulated tDCS use (the “biohacker” community) but also meant few companies pursued the formal FDA route, since doing so would be costly and would subject them to strict oversight. Second, the evidentiary picture for tDCS in clinical populations has been mixed. Early small trials suggested possible benefits for depression, cognitive rehabilitation, chronic pain, etc., but recent larger sham-controlled trials have cast doubt. A rigorous 2023 multicenter study in Germany found that “active tDCS was not superior to sham” as an add-on to antidepressants in adults with depression . Such results hit the field hard: they imply that tDCS, at least in the tested parameters, may not provide a significant clinical benefit in depression. From a regulatory standpoint, this makes approval unlikely until or unless new studies show clearer efficacy (perhaps with different protocols or in other indications). There is also the matter of classification: tDCS, like TMS, modulates brain activity, so an FDA review would need to decide if it’s high risk (Class III) requiring PMA or if it could be down-classified. So far, a few companies (e.g. Sooma and Soterix Medical) have obtained FDA Investigational Device Exemptions to run clinical trials of tDCS for depression , but none have completed the journey to market. In short, tDCS has been stuck in a Catch-22: lacking industry muscle to fund definitive trials, which leads to no approvals, which in turn means no insurance coverage or wider adoption that might attract industry. The regulatory hurdles here are not due to malice or bias so much as the inherent difficulty: demonstrating that a mild, non-patentable intervention truly works better than placebo in mental illness is hard, especially without large-scale investment.
Safety and Standards Considerations: It’s worth noting that regulators appropriately prioritize safety. Non-invasive does not mean risk-free. rTMS can cause headaches and, rarely, seizures; tDCS, if misused, could potentially cause burns or unexpected neuropsychiatric effects (though so far it appears quite safe). FDA’s caution with neuromodulation was partly to ensure devices weren’t rushed out without understanding these risks. In Europe, regulators have also tightened oversight – for instance, the EU’s Medical Device Regulation now explicitly includes certain non-medical brain stimulation devices under its purview, recognizing that even “wellness” gadgets that “penetrate the cranium” with energy need scrutiny . This is a sensible approach for public safety, but it does increase the compliance burden on device makers.
Reimbursement and the Second Hurdle: Getting FDA approval (or clearance) is only half the battle; the next challenge is convincing payers to cover the therapy. Here again, the system favored pharma for a long time. Insurance companies are accustomed to covering drug treatments for depression; generic drugs are cheap, and even newer brand drugs often get on formularies if they show incremental benefit. By contrast, a course of TMS therapy is a substantial upfront cost (several thousand dollars for ~30 sessions). Initially, after 2008, many insurers simply refused to cover TMS at all, deeming it “experimental” or not medically necessary. Patients who wanted TMS had to pay out-of-pocket, which limited access to the affluent or those desperate enough to shoulder debt. This scenario lasted for years. In fact, two large class-action lawsuits were instrumental in turning the tide on TMS coverage . Patients sued insurers for denying a treatment that had FDA clearance and mounting evidence; courts in some cases found that blanket denials were not justified. Slowly, one insurer after another began to cover TMS for depression, albeit with strict criteria. It became common to require failure of 4 different antidepressants and psychotherapy before TMS was approved. Some policies demanded the depression be “severe” (often defined by a rating scale) and treatment-resistant by multiple trials. This effectively enshrined a step-therapy approach that kept medication at the forefront. (Notably, the FDA label itself only required “one failed antidepressant,” but insurers often imposed more stringent hurdles .) Over time, as real-world data demonstrated TMS’s efficacy and cost-effectiveness (patients who respond to TMS often sustain improvement, potentially reducing overall healthcare costs from ER visits or hospitalizations), insurers have gradually eased criteria. By 2021-2022, Medicare and many private payers were covering TMS after one or two failed trials for severe depression , and some began covering newer indications like obsessive-compulsive disorder after FDA cleared TMS for OCD. Still, the process to get coverage can be onerous, requiring extensive documentation. By contrast, if a psychiatrist prescribes a new antidepressant, the patient can fill it the same day – insurance might require a prior authorization for an expensive drug, but often there’s a cheaper alternative or a generic they will authorize. The hassle factor for devices has been much higher, which dampens clinician enthusiasm to some extent. Encouragingly, the APA’s 2024 position statement takes insurers to task for this, noting that “some still limit coverage of TMS for MDD and deny coverage for other evidence-based indications,” and explicitly calls for parity in coverage as part of “the highest quality of care” .
In summary, the regulatory and reimbursement landscape has been a gauntlet for neurostimulation therapies. The FDA had to adapt its processes (with rTMS blazing a trail via de novo classification) and remains cautious pending more data (hence tDCS awaits evidence of efficacy). Insurers initially balked at paying for devices, reinforcing the dominance of medications which are inexpensive to them (especially generics). Each of these hurdles delayed the integration of rTMS and tDCS into mainstream clinical practice. They are obstacles by design – meant to protect patients from ineffective or unsafe interventions – but when the playing field is uneven (with pharma able to navigate these obstacles more easily than device upstarts), the result is a slower pace of innovation for alternatives to drugs.
The Current Landscape: Shifting Tides and Stubborn Challenges
Today, we stand at a crossroads. The good news is that non-invasive neuromodulation is far more established in 2025 than it was even a decade ago. The bad news is that the fundamental incentive imbalance is not fully resolved. Let’s survey where things are:
rTMS Coming of Age: After a slow start, rTMS for depression has gained significant traction. There are now multiple FDA-cleared TMS devices, and indications have expanded (e.g. FDA clearance for OCD, smoking cessation, and migraine with certain devices). Hundreds of TMS clinics operate in the U.S., and referral networks are growing. By some estimates, over one million depressed patients per year worldwide are now receiving TMS and getting a good response – a remarkable scale-up from essentially zero patients 15 years ago. Clinical data continue to accumulate: large patient registries show about 60% of real-world TMS patients achieve meaningful improvement , and new protocols (e.g. accelerated TMS or theta-burst stimulation) promise even greater convenience and efficacy. This progress is a testament to the technology’s potential and to the dogged efforts of clinicians and advocates who fought skepticism. However, rTMS is still underutilized relative to need. Millions of patients who fail medications could be candidates, yet many either have never heard of TMS or lack access due to geography or insurance quirks. Financially, the rTMS device market is still modest – roughly on the order of $1 billion globally in 2023 – compared to the antidepressant drug market which is well over $15 billion annually . That gap underscores that while TMS is now “in the game,” pharma remains the dominant player in treating depression by sheer volume. Additionally, most TMS use is for treatment-resistant cases; the vision of TMS as a first-line or routine option is not yet realized, partly due to ingrained prescribing habits and the logistical challenge (daily appointments are burdensome for some working patients). There’s also a subtle continuing influence of pharma: new drug-like treatments such as esketamine (Spravato) – a medication-device hybrid in that it’s a drug administered under supervision in a clinic – received swift FDA approval and insurance coverage for refractory depression, and has been aggressively marketed. Some psychiatrists have adopted esketamine where perhaps TMS might have been an alternative, demonstrating that pharma’s presence in the psychiatric space remains strong even as devices rise.
tDCS: Cautionary Tale or Future Comeback? tDCS finds itself at a critical juncture. The recent high-quality trial failures have led many to question whether tDCS will ever become an evidence-based clinical tool for depression. It’s possible that tDCS’s effects are simply too subtle or too variable across individuals, at least with current methods. On the other hand, researchers are exploring refinements – like high-definition tDCS (more focal current), longer treatment durations, or pairing tDCS with cognitive training – that could yield positive results. Outside of depression, tDCS is being studied for conditions ranging from stroke rehabilitation to chronic pain to ADHD. A few startups in the neurotech sector are persisting: for example, Sooma Medical in Europe has a CE-marked tDCS device for depression and is collaborating on trials to seek FDA approval. Academic groups and even the U.S. military have shown interest in tDCS for cognitive enhancement or PTSD, keeping research alive. What tDCS exemplifies, however, is that without a strong economic driver, promising ideas can languish. If tDCS had a Pfizer or a Johnson & Johnson standing to profit from it, we might have seen a different trajectory (much like how Deep Brain Stimulation, an invasive but highly effective therapy for Parkinson’s disease, took off in part because medtech giants like Medtronic invested in it). For now, tDCS remains in the wings – a technology with tantalizing possibilities that is struggling to prove itself under the gold-standard trials demanded by regulators and payers.
Emerging Synergies and New Players: Interestingly, the sharp lines between “pharma” and “device” are beginning to blur in some quarters. A concept gaining traction is combination therapy – using neuromodulation in conjunction with drugs to achieve synergistic effects. Thought leaders have long floated this idea (former NIMH director Tom Insel mused that the future might see “device companies join with pharma to produce combined treatments more effective than either alone” ). We are now seeing early examples: trials where TMS is paired with certain medications (e.g. to enhance neuroplasticity), or where tDCS is combined with antidepressant drugs (as in the Brazilian trial that found combined sertraline + tDCS was superior to either alone). Pharma companies have dipped toes here; for instance, Astellas (a Japanese pharma firm) has invested in “bioelectronic medicine” startups developing implantable neuromodulators for various conditions . Johnson & Johnson created a brain-stimulation research program under its Janssen unit, recognizing that devices could treat disorders in ways drugs can’t. These are small steps, but they represent a strategic shift: some in pharma realize that neuromodulation isn’t the enemy – it can be a partner. If a depression patient does TMS and also stays on a maintenance antidepressant, that’s still a win for all involved (the patient, the device maker, and the drug maker). The artificial silo between treatments is breaking down as we move toward personalized, multi-modal psychiatry.
Public Awareness and Advocacy: Patients and families have become more vocal in demanding access to innovative treatments. The class-action suits against insurers for TMS were one sign of this empowerment. Advocacy groups for mental health, such as NAMI (National Alliance on Mental Illness), now regularly share information about TMS and other neuromodulation options as part of educating patients about treatment-resistant depression. There’s also a generational change: younger psychiatrists in training are learning about brain stimulation technologies, often with enthusiasm. The APA’s formation of a Caucus on Neuromodulation and incorporation of TMS training into some residency programs reflects this cultural shift . In time, this could erode the old pharmaco-centric mindset. Still, advocacy for neurostimulation faces resource asymmetry – you won’t see primetime TV ads for “TMS therapy” the way you might for the latest antidepressant. The marketing budgets just don’t compare. So, word-of-mouth, success stories, and grassroots advocacy play a larger role in raising the profile of these treatments.
In summary, the landscape in 2025 is one of cautious optimism. rTMS has established a foothold, proving that a non-pharma therapy can crack the mainstream if given time and evidence. tDCS remains on the sidelines, highlighting the work yet to be done. The pharmaceutical industry’s influence is still pervasive, but there are hints of a more collaborative future. Crucially, many of the barriers that slowed neurostimulation are finally being recognized and addressed – uneven funding, lack of training, coverage denial – though they are not fully overcome.
Leveling the Playing Field: Recommendations and Reflections
If we are to truly foster fair innovation and patient-centric progress, we must recalibrate the system that has long favored pharmacotherapies. The goal is not to dethrone medication – drugs will remain essential tools – but to expand the therapeutic arsenal to include devices on equal footing, so that the best treatment (or combination) can be chosen for each individual. Here are key steps and recommendations, distilled from expert analyses and advocacy perspectives:
Boost Research Funding for Devices: A clear message from the neuroscience community is that we need more public funding for device trials. The NIH and other agencies should prioritize large-scale studies of non-invasive neuromodulation, similar to how major drug trials are funded. This might include dedicated grant programs for “brain stimulation therapies” or public-private partnerships to de-risk investment in device research. As one workshop of experts concluded, “funding sources for large-scale innovative research [on neuromodulation] are limited, while such large, time-consuming studies are needed” to optimize dosing and techniques . Closing this funding gap would generate the high-quality evidence needed to convince skeptics, and it would attract more young researchers into the field. The return on investment could be huge in terms of reduced burden of illness if effective new treatments emerge.
Align Incentives via Policy: Policymakers could implement economic incentives to stimulate neurotechnology development. For example, extending a form of market exclusivity to certain FDA-approved breakthrough devices (analogous to orphan drug exclusivity) could lure more venture capital into the space by promising a period of competitive protection. Tax credits for device R&D or for hospitals that adopt innovative therapies could also help. Additionally, adjusting FDA user fee structures to lighten the load on small device innovators (or subsidizing their application fees) might encourage more submissions. It’s also worth exploring patent reforms that ensure novel device methods aren’t too easily copied – perhaps by strengthening patents on methods of use or on integrated therapy systems (e.g. combining a device with a specific drug or algorithm). Congress and regulatory agencies should hear from experts in neuromodulation when crafting healthcare legislation, to ensure devices aren’t inadvertently disadvantaged relative to drugs. In short, we should modernize incentives so that developing a new neuromodulation therapy is as attractive to a company as developing the next antidepressant pill.
Improve Regulatory Clarity and Support: The FDA can take steps to make the regulatory path more navigable for neurostimulation devices. Clearer guidance documents specific to transcranial stimulators would help manufacturers know what evidence is expected. The agency already convenes panels and workshops on novel neurological devices – these should continue, incorporating the latest science on both therapeutic and “non-therapeutic” uses of brain stimulation. One constructive idea is to allow conditional or adaptive approvals for devices that demonstrate strong safety and preliminary efficacy, coupled with requirements for post-market studies. This would get promising treatments to patients faster while still gathering robust data (a model sometimes used for drugs in oncology or rare diseases). The de novo pathway that TMS used has proven useful; expanding such flexible approaches could benefit tDCS or future technologies like transcranial ultrasound or temporal interference stimulation. Importantly, the FDA should continue engaging with the neuromodulation research community – many of whom are eager to help craft sensible regulatory frameworks. A more predictable, transparent approval process will reduce investor wariness and encourage more innovators to bring devices forward. As things stand, uncertainty about “what the FDA will require” is itself a deterrent (as highlighted by Jeff Nye of J&J, who noted the expectations for studies and payer approval are “less clear for the neuromodulatory device market” than for drugs ). We can fix that by proactively defining those expectations.
Ensure Reimbursement Parity and Encourage Coverage: Insurance coverage can make or break a therapy’s success. It is therefore vital to streamline reimbursement for evidence-based neuromodulation. One recommendation is that public payers (like Medicare) and professional bodies establish standard criteria for reimbursement of treatments like TMS – and update them promptly as new indications gain evidence . If the FDA approves TMS for a new condition (say, anxiety or PTSD in the future), insurers should not drag their feet for years denying coverage on grounds of “insufficient evidence” after approval. Likewise, if moderate depression can benefit from TMS (not just severe cases), policies should reflect that to avoid unnecessary suffering. The APA’s official position now explicitly supports insurance coverage for TMS as part of best practices , which gives clinicians leverage to advocate on behalf of patients. Additionally, reimbursement rates must be set such that providing neuromodulation is financially sustainable for clinics – if payment is too low, few providers will offer it. Health economists can help by conducting cost-effectiveness analyses; early studies suggest that TMS, despite higher upfront costs, can be cost-effective in treatment-resistant depression by improving productivity and reducing downstream healthcare use. Highlighting these benefits to payers can turn coverage from a grudging expense into an investment in better outcomes. In the bigger picture, parity laws for mental health (which mandate equal coverage for mental conditions as physical ones) should be interpreted to include access to the full range of mental health treatments, not just pharmaceuticals.
Education and Training: The human element is crucial. We need to educate clinicians and patients alike about neuromodulation. Medical schools and residency programs should incorporate training on rTMS, tDCS, and other emerging devices, so that new psychiatrists and neurologists are comfortable with these tools. Continuing education for established physicians is equally important – many practicing psychiatrists completed training before TMS was around, so they might not know how to refer patients or how it works. The APA’s 2024 statement recognizes this gap and calls for training psychiatrists in TMS . From the patient side, public awareness campaigns could demystify brain stimulation: many patients still either haven’t heard of it or confuse it with ECT or think it’s experimental. Clear, stigma-free information (e.g. explaining that TMS is an FDA-cleared, non-invasive procedure that doesn’t require anesthesia) can empower patients to ask their providers about it. When patients start requesting these therapies, it puts constructive pressure on healthcare systems to provide them. We saw how patient lawsuits pushed insurers to cover TMS; similarly, patient demand can push clinics to acquire devices or physicians to get trained. Ultimately, the culture needs to shift to viewing neuromodulation as just another modality – no more exotic than prescribing a medication or referring to psychotherapy. Each has its role, and they can complement each other.
Collaboration Over Competition: Perhaps the most forward-looking change would be to foster collaboration between pharma and neurotech developers rather than competition. This means encouraging joint ventures, licensing deals, or research collaborations where drug and device combinations are explored. We should emphasize that rTMS and tDCS are not here to replace antidepressants wholesale, but to enhance treatment outcomes – especially for those whom drugs alone fail. When framing neuromodulation as adjunctive or augmentative, it becomes less threatening to the pharmaceutical industry’s interests. For example, a patient on an antidepressant who adds TMS may achieve remission, credit to both the drug and the device. There are even synergistic possibilities: certain drugs (like ketamine or D-cycloserine) might accelerate or potentiate the effects of brain stimulation by priming neural circuits. Combining modalities could yield breakthroughs for stubborn conditions like chronic depression or schizophrenia. Professional associations and research consortia should explicitly invite pharmaceutical companies to the table in brainstorming next-generation therapies that blend biology and technology. A successful model is in epilepsy and chronic pain, where device companies (making neurostimulators) and drug companies coexist and often treat the same patients with a mix of interventions. We can replicate that in psychiatry.
Ethics, Safety, and Evidence – Staying Rigorous: Advocacy for these new treatments must be balanced with a commitment to scientific rigor and patient safety. Just as we criticize any undue leniency in drug approvals, we should hold neurodevices to high standards of evidence. The solution is not to approve devices with flimsy data, but to obtain better data by investing in research (as noted above). Ensuring proper regulation also protects the field from charlatans – e.g. unregulated “brain stimulators” making wild claims could sour public perception. So part of leveling the playing field is also holding everyone to the same evidence bar. If anything, patients’ willingness to embrace neuromodulation will grow if they trust that these therapies have been validated just as rigorously as medications. Transparency in clinical trial reporting, post-market surveillance for devices (to catch any rare side effects), and ongoing outcome monitoring (through registries, etc.) are all important. An encouraging development here is the creation of journals and conferences dedicated to brain stimulation, which maintain a high standard for research publication. The field is maturing scientifically, which will help convince regulators and doubters.
Public Health Perspective: We should also frame this as a public health and equity issue. Depression is a leading cause of disability worldwide. If there are effective treatments out there – be it a pill, a magnet, or a mild electric current – we owe it to society to develop and deploy all of them. Over-reliance on a single modality (medication) means many sufferers don’t achieve remission (about one-third of depression patients do not respond adequately to antidepressants). Non-invasive brain stimulation offers hope particularly for those individuals. Moreover, some patients prefer a non-drug approach (to avoid side effects or because medications failed them). To deny or delay giving these options equal footing is to do a disservice to patient autonomy and well-being. In practical terms, this means that government agencies like the FDA and NIH, which have public health missions, should proactively nurture neuromodulation – not at the expense of pharmacology, but alongside it. The end goal is a more diversified therapeutic landscape that can reach more people. One can envision future clinics where a psychiatrist can seamlessly choose between (or combine) therapy, medication, TMS, tDCS, or other interventions based on what each patient needs and values. That’s true personalized medicine.
Conclusion: Toward a Fair and Innovative Future
The saga of rTMS and tDCS in treating depression illuminates a broader truth about our healthcare system: innovation is not just about science and engineering, but also about economics, politics, and culture. For years, the scales were tilted in favor of pharmacological solutions – not purely because drugs are better, but because a complex interplay of patent law, lobbying influence, regulatory evolution, and clinical habit made it so. Non-invasive neurostimulation technologies emerged as underdogs, fighting for recognition and support in an environment not built for them.
Today, as rTMS steadily earns its place and as tDCS and other modalities strive to follow, there is a sense of vindication among proponents of these therapies. But this is not about declaring winners and losers between “brain zaps” and “chemical pills.” It’s about breaking down silos and putting patients first. Depression, and psychiatric disorders in general, are multifaceted and notoriously hard to treat; we will make the most progress when all effective tools are on the table and used in concert. Imagine the possibilities when someone’s treatment plan can be optimized with psychotherapy to build skills, medication to adjust brain chemistry, and neurostimulation to re-tune neural circuits – a true bio-psycho-social-techno approach.
To get there, we must continue to identify and dismantle the artificial barriers that have slowed neurostimulation’s path: the misaligned incentives, the uneven funding, the regulatory ambiguities, the reimbursement hurdles, and the residual biases in training and practice. Encouragingly, these issues are now openly discussed. The advocacy-oriented tone that was once limited to a few voices in the wilderness is becoming a chorus calling for change – from patients and clinicians up to think tanks and professional bodies. When the APA Board of Trustees approves a statement urging support for TMS, or when a National Academy workshop brings together device makers, regulators, and payers to hash out solutions , it signals that the message has gotten through: innovation in mental health must not be one-dimensional.
There are signs that the pharmaco-industrial-regulatory complex is slowly opening up to reform. The FDA, under public and political pressure, knows it must balance encouraging innovation with protecting safety across all modalities. Congress has shown interest in rising healthcare technologies (for example, establishing the ARPA-H agency which could fund high-risk, high-reward projects including neurotech). Even pharma companies, as mentioned, are investing in neuromodulation or at least not opposing it as they might have in the past. Perhaps they too see that helping patients recover (by whatever means) builds goodwill and new opportunities – for instance, a patient well-served by TMS might still need medication later or for maintenance, so pharma doesn’t necessarily “lose a customer.” In fact, the mental health market is so vast and underserved that there’s plenty of room for growth in all sectors.
To maintain an advocacy perspective, we should keep shining light on any inequities that remain. For example, if insurers drag their feet on covering the next approved device, expect patient advocates to speak out, just as they did for TMS. If research funding skews too much toward me-too drug development while novel device trials languish, researchers and thought leaders must raise the alarm and lobby for change. It’s also crucial to guard against the complex simply shifting to incorporate neuromodulation in a way that still puts profit over patients – for instance, if the device industry grew large, we’d need to ensure it doesn’t replicate some of pharma’s past excesses (like overselling benefits or neglecting long-term follow-up). In other words, the push for fair inclusion of neurostimulation goes hand in hand with a push for high ethical standards and patient-centered values across the board.
At the end of the day, this is about giving people suffering from depression and other mental illnesses every possible chance at relief. It’s about the person with major depression who has tried four medications and still can’t get out of bed – should they have to fail a fifth pill and wait another six months, or can we offer them TMS now? It’s about the teenager who doesn’t tolerate antidepressants but might do well with a non-invasive brain stimulation approach – will such options even be mentioned in their doctor’s office? It’s about the future, where a new generation of treatments (be it advanced neuromodulation, neurofeedback, digital therapeutics, or something we haven’t dreamed up yet) will inevitably arise – will we cultivate an environment that welcomes innovation, or one that resists it until forced?
By learning from the struggles of rTMS and tDCS, we can ensure the next breakthroughs don’t face the same undue delays. The story thus far has been one of obstacles identified and gradually overcome. The next chapters can be more hopeful: a story of fair competition between therapies, synergistic integration of treatments, and a healthcare system that truly rewards what works best for patients rather than what fits old business models. Achieving that will require continued vigilance and advocacy, but the momentum is on the side of progress.
In conclusion, non-invasive neurostimulation technologies have proven their worth and earned a seat at the table. It’s up to us – as clinicians, researchers, policymakers, and patients – to make sure they are supported and utilized not as a last resort, but as integral parts of a comprehensive approach to mental health. By reforming the legacy incentive structures and tempering the power of entrenched interests, we can usher in an era where rTMS, tDCS, and future innovations stand proudly alongside pharmaceuticals, each contributing their strengths to the healing of minds. This is not a zero-sum game; it’s a win-win for innovation and, most importantly, for the people whose lives depend on it.
Sources
Institute of Medicine Workshop on Non-Invasive Neuromodulation – “growth of the industry is hampered by… lack of funding from federal grant sources, and unclear regulatory pathways to approval”. Highlights the challenges facing neuromodulation companies (Demitrack et al.) . Small companies lead development but have limited resources for “complicated and lengthy” FDA and reimbursement processes . Investors have often shied away due to unproven business models, regulatory unpredictability, and long ROI timelines (Jaffe’s VC perspective) . Notably, unlike drugs, devices have no regulatory exclusivity, making investment harder (Greely) . There has been roughly a 70% drop in early-stage medical device funding since 2008 , reflecting venture capital moving away from medtech towards biotech.
Mark S. George (2023), TMS Journal editorial: Recounts the history of TMS as a therapy. The NIMH-funded OPT-TMS trial was overwhelmingly positive (30% remission in med-resistant patients), surprising NIMH which may have expected a failure . NIMH’s press release headlined TMS as “disappointing” vs ECT , indicating institutional bias. Early on, psychiatrists were reluctant to adopt TMS (many were not procedure-oriented), insurance companies resisted coverage, and it took “two large class-action suits” to force broader insurance reimbursement . Eventually, TMS gained CPT billing codes and training spread among psychiatrists . This source provides an insider’s advocacy for TMS and notes the initial cultural and payer barriers.
Public Citizen (2009) – Testimony on Medical Device Approval: Details the FDA’s handling of the NeuroStar TMS device. The company tried the 510(k) pathway using ECT as a predicate, but FDA found TMS not substantially equivalent to ECT . The pivotal trial showed only a small, statistically borderline benefit (1.7 points on a 60-pt scale, p=0.057) . Ultimately, TMS was cleared via the de novo pathway after failing 510(k) . Public Citizen critiqued FDA’s reliance on post-hoc analyses and older ECT data as setting a worrying precedent . This illustrates regulatory hurdles and the FDA’s improvisation to authorize TMS with special controls.
Union of Concerned Scientists (2012) – “Drug and Device Companies Influence on FDA”: Documents lobbying expenditures. From 2009–2011, pharma and biotech spent over $700M lobbying, with drug companies alone $487M, versus $126M by biotech and $86M by device firms . In those years, pharma outspent the insurance industry as well. It underscores how pharma’s lobbying clout dwarfs the medical device sector’s, which can shape policy and regulatory focus.
OpenSecrets Lobbying Database (2025): Confirms ongoing disparity in lobbying. In 2025, the pharmaceutical industry (PhRMA, Pfizer, etc.) has spent a total of $120+ million so far . PhRMA (trade group) alone spent ~$13M . By contrast, the leading medical device lobby (AdvaMed) spent about $1.1M , and even a large device company like Medtronic only ~$970k . Pharma’s influence machine remains far larger than that of device makers.
FDA/NIH sources: FDA’s coverage decisions and NIH’s stance are indirectly cited. For instance, a Medicare contractor coverage policy (Novitas LCD) states TMS is covered for severe MDD after failure of at least one antidepressant , and denied for moderate depression or non-MDD indications due to “insufficient evidence” (as of 2022). NIH’s contributions are seen in the OPT-TMS trial being NIMH-funded and the observation that NIH was historically skeptical.
APA (American Psychiatric Association) Position Statement on TMS (2024): Official policy urging broader support: “Most insurance companies cover TMS for MDD, but some still limit coverage… Despite TMS being available, most psychiatrists lack education about it. Supporting access to TMS is consistent with APA’s mission.” Declares TMS “safe and effective”, calls for training in TMS for residents and insurance coverage to provide access . This source shows a major professional body advocating to remove remaining barriers.
Mad in America (2023) – reporting on Lancet tDCS trial: Notes a “rigorous, multi-center” trial found tDCS no better than sham for depression (as adjunct to SSRIs) . Affirms “tDCS has not received FDA approval for any indication” and mentions people buying devices online as “biohackers” since no medical devices are available . This highlights the efficacy debate around tDCS and the fact that it lingers unapproved.
Market data: Grand View Research (2024) estimated the global anxiety & depression drug market at $15.4 billion . DelveInsight (2023) estimated the global TMS device market at ~$1.13 billion . While from industry reports, these figures indicate the economic gap between pharmacotherapy and device-based therapy markets.
Academic commentary on FDA and Pharma: A 2022 review in Res Social Adm Pharm examines how PDUFA brought FDA and pharma closer, and notes “the pharmaceutical industry may indirectly influence the FDA by lobbying Congress or by hiring ex-FDA commissioners” . This provides evidence of the tight relationship that can bias regulatory priorities.
National Academies Workshop Summary (2015) – Business Environment: Jeffrey Nye (J&J) pointed out the lack of a streamlined roadmap for neuromodulation devices – unlike pharma, where companies know what investments and studies are needed for approval and payer acceptance . Several participants suggested potential drug-device synergies, but emphasized the need to find viable business models and navigate regulatory complexities to realize those combinations . This underscores that even industry insiders see the structural gaps that need addressing.
Combining these credible sources, we see a consistent picture: pharma’s dominance in funding and influence, contrasted with the struggles of device innovators. From lobbying dollars to NIH grants to FDA pathways, the deck has been stacked in favor of drugs. Yet, through persistence and growing evidence, rTMS carved out a niche and is expanding, supported by shifts in policy and professional attitudes. tDCS remains a cautionary example of what happens when an innovation lacks powerful backers. The sources reinforce the need for balancing the scales – increased funding (public and private) for devices , regulatory reform and clarity , and proactive measures on reimbursement and training – all in the service of patient access to a fuller spectrum of care.
References
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George MS. Why I believe that more than one million people worldwide receive repetitive transcranial magnetic stimulation (rTMS) each year. Brain Stimul. 2023;16(3):577-84.
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