As psychiatrist Grace Jackson observes in her 2005 book, Rethinking Psychiatric Drugs: A Guide for Informed Consent, the potential for informed consent to allow for meaningful patient choice “must logically depend” upon “a supply of adequate information.” As knowledge regarding withdrawal from psychiatric medication accumulates in online forums, it becomes more and more critical for prescribers to provide that information to patients. If prescribers fail to do so, they are not providing informed consent.
Unfortunately, prescribers do not typically draw upon online knowledge, and their own information sources are often inadequate. These sources include methodologically-deficient randomized clinical trials of psychotropics and the suspect guidelines, statements, and processes of pharmaceutical companies and the medical establishment. Relying on these sources, prescribers have a potentially incomplete and perhaps warped understanding of withdrawal.
To rectify this situation, it is essential, as Jackson suggests, to hold prescribers accountable when they fail, inadvertently or intentionally, to provide patients with accurate information about withdrawal. It is also essential to continue to acquaint prescribers with the wealth of material available on online withdrawal forums by bringing such information into the psychiatric mainstream. Only then “will clinicians and patients be free to participate in the exchange of an authentically informed consent to care.”
A historically imperfect safeguard
In the field of psychiatry, the patient-clinician relationship has long featured an anemic informed consent process. When, at a workshop in 1991, David Cohen presented a detailed informed consent template for use when prescribing psychiatric medication, patients and ex-patients responded “that not a single point mentioned on the form was ever discussed with them by their prescribing doctors.”
That deficiency has been difficult to overcome. Recognizing the persistence of the problem, Cohen and David Jacobs released a revised version of that form in 2015 and again advocated for a more genuine informed consent process. While the process is routinely weakened by prescribers’ failure to provide comprehensive information on many aspects of psychotropic medication use, the lack of information conveyed about withdrawal is particularly glaring. In 2018, a New York Times reporter described how many individuals who are trying to quit experience “withdrawal symptoms they were never warned about.”
Likewise, in 2020, researcher John Read, surveying 3200 people on antidepressants in New Zealand and internationally, found “that only 1 percent recalled being told anything about withdrawal effects when first prescribed the drugs.”
The problem was not limited to the initial conversation about the medication, but continued even when patients, trying to discontinue a drug, reported their distress to a prescriber.
Whether the result of purposeful decisions or simple lack of knowledge, prescribers’ widespread failure to provide information about withdrawal during informed consent is profoundly troubling. To challenge the status quo, advocates should look to the legal requirements of informed consent.
Evolving law regarding informed consent supports greater disclosure
Federal and state law regarding informed consent provides a key tool to ensure that prescribers educate patients on the withdrawal risks associated with psychiatric medication. Although the law regarding informed consent differs to some extent state by state, the direction that case law is moving should benefit patients.
In the U.S., the duty to give informed consent originally could be adequately discharged if physicians merely shared information that those in their profession customarily disclosed. However, in the seminal 1972 case Canterbury v. Spence, the U.S. Court of Appeals for the District of Columbia rejected that standard. The Court instead required doctors to disclose all the information that a “reasonable patient” would want to know before undergoing the treatment at issue.
While there continues to be variation by jurisdiction as to what must be disclosed, courts now widely recognize this standard. Information about withdrawal must be divulged even if that information does not derive from sources physicians traditionally rely upon.
Since Canterbury, state and federal courts have interpreted its requirements regarding informed consent. In these cases, we see evolution of the law in ways that could better prepare patients to make treatment decisions. Case law applicable to Massachusetts prescribers provides examples of such progression.
In its 1982 decision in Harnish v. Children’s Hospital Medical Center, Massachusetts’ highest court required that, during informed consent, physicians disclose: the condition being treated, the type and probability of risks of the proposed treatment, the reasonably expected benefits, the physician’s inability to predict results (if true), any irreversibility of the treatment, results without treatment, and available alternatives (including risks and benefits).
Agreeing with the D.C. Court of Appeals, the Massachusetts Court held that the fact that others in the profession do not provide information is not a defense to claims of informed consent violations.
The Harnish Court specifically rejected the legal standard being applied at that time in other jurisdictions that physicians need “disclose … only such information as is customarily disclosed by physicians in similar circumstances.” Concluding that this rule did not offer sufficient patient protection, the Court instead required that physicians report
all significant medical information that the physician possesses or reasonably should possess that is material to an intelligent decision by the patient whether to undergo a proposed procedure. The information a physician reasonably should possess is that information possessed by the average qualified physician or, in the case of a specialty, by the average qualified physician practicing that specialty. (Emphasis added.)
The Court subsequently expanded application of the new informed consent requirement from physicians to all medical providers.
Six years later, in Kissinger v. Lofgren, the U.S. Court of Appeals for the First Circuit adopted the Harnish analysis. Reviewing the informed consent standard in the context of surgery, the Court of Appeals looked to what “is known or reasonably should be known by every physician who performs that kind of operation.”
These decisions mean that a Massachusetts prescriber must disclose pertinent information regarding withdrawal that an average qualified prescriber knows or reasonably should know, even if the prescriber or the prescriber’s peers have not been routinely disclosing such information. Doing the same inadequate job that others do is insufficient.
As online forum content increasingly makes its way into mainstream psychiatry, including in the ways discussed in my previous post, it becomes easier to conclude that an average prescriber should know about the risks of withdrawal. Online withdrawal forums extensively document an assortment of risks, of various degrees of severity, associated with discontinuation of psychiatric medications. Such information is readily available and, therefore, must be disclosed during informed consent.
Current law may not guarantee sufficient disclosure of withdrawal risks
While the present legal requirements of informed consent and the growing accessibility of online information favor a robust discussion of withdrawal when prescribing psychiatric medication, disclosures of withdrawal risks remain uncommon. It seems unlikely that current case law alone will remedy this problem.
Psychiatric prescribers’ persistent refusal to disclose important new evidence on another topic central to informed consent, the availability of alternative treatments, provides reason for skepticism.
In a 2015 article regarding a prescribing physician’s duty to disclose safer alternative treatment to psychotropics, law professor Rita Barnett-Rose observes that clinicians often fail to disclose all information that a “reasonable patient” would want to know on this subject. “Prescribing physicians rarely disclose any safer alternative treatment options to psychotropic medication, even where there is persuasive evidence that such safer alternatives exist.”
She cites, as an example of such neglected “persuasive evidence,” randomized, placebo-controlled clinical trials that ADHD might be better treated with a change of diet than with medication.
Moreover, courts do not provide a remedy for prescribers’ omissions, Barnett-Rose explains. When these failures come before the courts, judges decline to enforce the newer legal standard:
[C]ourts in reasonable patient jurisdictions are often indistinguishable from medical community jurisdictions, and often simply defer to the challenged physician or medical community itself to determine which alternatives are “reasonable” or “available” to the patient, regardless of the patient’s own interests. This in turn severely limits disclosure.
The result is that there is little incentive for prescribers to change their habits.
Just as prescribers continue to ignore, despite the emergence of new studies, evidence regarding alternative treatment modalities, prescribers may well ignore evidence regarding the risk of withdrawal, even when faced with evidence from online forums and emerging clinical research. This already appears to be the case.
Prescribers might take notice of courts’ attention to online withdrawal information in suits against pharmaceutical companies
While some patients harmed by psychiatric medication pursue informed consent cases against prescribers, others have sought compensation from the deeper pockets of drug manufacturers. Prescribers disinclined to acknowledge new information regarding withdrawal effects might take notice of references, in such litigation against pharmaceutical companies, to new evidence drawn from online sources.
Traditionally, plaintiffs suing drug companies for such harms tended to rely on evidence of what these companies knew about the risks of their products (often from their own studies) but did not disclose to the public.
As Rachel Aviv explains in The New Yorker, such litigation focused on revealing that “[i]nternal records of pharmaceutical manufacturers show that the companies have been aware of the withdrawal problem.” Records could demonstrate that these corporations “run their studies and manage their data [in a way which serves to] suppress vital information about harms and obscure results that would implicate them.”
In addition, plaintiffs often argued that drug manufacturers pursued selective and biased publication of clinical trials and/or engaged in deceptive marketing. Courts have accepted evidence of all these types.
All these evidentiary sources remain important, but plaintiffs suing drug companies regarding withdrawal effects now have an additional source of proof of what is commonly known about a medication—online forums. For example, in Fisher v. SmithKline Beecham Corp., a 2009 decision regarding the risk of suicide from Paxil, a U.S. District Court in New York noted that plaintiff used internet searches for information regarding Paxil to determine the facts upon which legal action may be based.
Likewise, in Saavedra et al. v. Eli Lilly & Co., plaintiffs relied upon internet forums as a source of authority for their 2012 district court complaint, alleging that “In response to Lilly’s deceptive and unlawful marketing practices, a community of former and current Cymbalta users has emerged to provide mutual support and guidance in dealing with Cymbalta withdrawal.”
Just as plaintiffs can look to information accumulated in online withdrawal forums to support their arguments in litigation against pharmaceutical companies, so too can plaintiffs who raise such claims against prescribers. In either case, plaintiffs can argue that defendants knew of such effects even as they continue to promote medication. After all, this information is not hidden in drug company archives, but is plainly available for all to see, online.
Action is needed to effectuate meaningful informed consent
Given the present uncertain potential for successful enforcement of informed consent laws in judicial forums, those seeking to ensure that prescribers fully disclose withdrawal risks should seek additional patient protections.
One potential source of protection is professional medical organization guidance. Drafted by forward-thinking clinicians, directives requiring discussion of withdrawal during informed consent are emerging. Recent professional standards include the collaborative Guidance for Psychological Therapists and the United Kingdom’s National Institute for Health and Care Excellence Clinical Guidelines regarding Depression in Adults (updated in 2019 to address withdrawal effects).
However, the audience for these new standards remains limited. Guidance for U.S. psychiatric prescribers is needed.
Additionally, advocates should seek public directives to reinforce the requirement of disclosure of withdrawal information as an essential element of informed consent. Advocates might pursue such mandates through state statute, regulation, policy, and model informed consent forms. These types of provisions do not exist in many states.
For example, in Massachusetts, aside from case law, relevant authority regarding informed consent to psychiatric medication is extremely limited. State statute and regulations regarding informed consent do not explicitly address the topic of withdrawal, including those that specifically apply to treatment with antipsychotic medication.
For example, one statute which dictates the administration of psychotropic medication to residents of long-term care facilities, Mass. Gen. L. ch. 111, §72BB, only requires disclosure during informed consent of “any known effect or side effect.”
Relevant Massachusetts agency policies tend to have a narrow scope and pay scant attention to withdrawal. A Massachusetts Department of Public Health (DPH) directive for the use of psychotropics in long-term care facilities, promulgated pursuant to §72BB, requires use of a form that verifies that “risks” of treatment were discussed with the patient.
However, the directive both downplays such “risks” and associates them with the administration of medication, rather than its discontinuance: “These risks may vary; and it is possible that little or no adverse consequences may occur if the medication is administered.” Moreover, the form contains no requirement that a prescriber discuss difficulties associated with medication discontinuance.
Likewise, the Massachusetts Department of Mental Health (DMH) Policy # 14-01, Medication Education, Capacity Assessment, and Informed Consent For Psychiatric Medications, which applies to all DMH-operated and contracted inpatient and outpatient facilities and programs in which psychiatric medications are prescribed, instructs providers to ”address the development of any adverse reactions related to the use of Psychiatric Medication(s)” during the informed consent process, but fails to require prescribers to provide relevant information regarding addiction, dependence, and/or withdrawal issues.
There are good models to guide legislative, regulatory, or sub-regulatory reform. Cohen and Jacobs’ informed consent form for psychiatric drug treatment, discussed above, contains the kind of language regarding addiction and withdrawal that all prescribers should include during the informed consent process. The form is worth quoting at length:
I have been informed, if I am prescribed a tranquillizer like Xanax or Klonopin and I take it regularly for more than three or four weeks, that I run the risk of becoming physically dependent on it. I will then have a good chance of experiencing “rebound” insomnia and anxiety, and many other unpleasant sensations, when I try stopping the drug, or even while I continue to take it. I understand that these drugs are not effective antianxiety or sleep-inducing agents after a few weeks of use. I realize that some people are unable to withdraw and must therefore permanently endure the consequences of daily use. …
I understand that the drug is likely to provoke various unpleasant effects when I stop taking it, especially if I stop too suddenly. I understand that although withdrawal reactions are systematically ignored in psychiatric drug treatment or research, they might represent the worst part of my whole drug-taking episode. I further understand that these reactions will often closely resemble the original symptoms for which the drug was prescribed to me, and are likely to be taken for a return of these symptoms (a “relapse”), rather than for withdrawal effects. I realize that my doctor or the researcher is likely to interpret these reactions as a sign that my “illness” is chronic and that my drug is “effective.”
I also understand that once I have been taking drugs for months or years, I will have much difficulty to find a health professional to assist me in withdrawing prudently and safely from the drugs, if I so wish.
One state does require the use of a specific informed consent template that addresses the topic of dependence. The Wisconsin Department of Health Services employs an informed consent form for Ativan that explicitly describes the potential for physical and psychological dependence. However, this form applies only to the care of individuals with intellectual disabilities in intermediate care facilities serving individuals with intellectual disabilities and not to a broader population.
Reform should encompass legislative change to better compel prescribers to discuss all medication risks, including the potential for withdrawal effects. One bill currently filed in Massachusetts is a good start. Known as the “Benzo Bill,” it requires, among other actions, that practitioners prescribing benzodiazepines and non-benzodiazepine hypnotics use a Massachusetts DPH form to obtain a patient’s written informed consent.
The form would include information on medication misuse and abuse, as well as on the risks of dependence, addiction, and long-term use. (The bill might be improved by explicitly listing withdrawal effects among these topics.) The bill also establishes a commission “to study protocols to safely discontinue the use of benzodiazepines and non-benzodiazepine hypnotics and minimize the patient’s symptoms of withdrawal.”
Advocates might consider legislative proposals that go even further. Professor Barnett-Rose offers one proposal. Given the failure of courts, including those with “reasonable patient standards,” to require physicians to disclose safer alternative treatments, she suggests that “legislatures adopt dignitary-based informed consent provisions that will better ensure both adequate physician disclosure of alternative treatments to psychotropic medication and provide an actual remedy for patients in the event of a physician’s breach.”
As she explains, a “dignitary-based model” is one that recognizes that depriving a patient of information alone constitutes an actual loss: the loss of individual autonomy and the right to determine what should be done to one’s own body. For Barnett-Rose, an effective and appropriate remedy requires liability not only for violations of informed consent that result in harm, but also for violations where no actual injury occurs.
There are a range of ways to encourage disclosure of withdrawal risks during informed consent. Advocates should seek standards that specifically reference withdrawal effects as a required topic during the process. Advocates should consider the utility of practical tools, including protocols and informed consent forms. They can evaluate what resources public and mental health agencies might contribute. They should think about broadening the circumstances in which a plaintiff might be able to seek recourse in the way Barnett-Rose suggests.
Finally, drafters must embrace the wisdom of psychiatric patients/survivors who have been struggling with withdrawal and building online peer responses.
Information regarding withdrawal from psychiatric medication on online sites is wholly relevant to current psychiatric practice. We must seek ways to systematically access and legitimize this information. At the same time, we must press for the inclusion of this information into the informed consent discussions between prescribers and patients, using all available tools to do so. Finally, we must recognize weaknesses in the informed consent process and be creative in the ways we remedy those deficiencies.
- Psychiatric Drug Withdrawal: A Guide for Prescribers, Therapists,
Patients and their Families, http://breggin.com/a-guide-for-prescribers-therapists-patients-and-their-families/
- Harm Reduction Guide to Coming of Psychiatric Drugs, written by Will Hall and published by The Icarus Project & The Freedom Center,https://willhall.net/comingoffmeds/
- Freedom Center, Coming off Psychiatric Drugs, https://www.freedom-center.org/coming-psychiatric-drugs-successful-withdrawal-neuroleptics-antidepressants-lithium-carbamazepine-an.html
- Fireweed Collective, https://fireweedcollective.org/
- The Withdrawal Project, https://withdrawal.theinnercompass.org/
- Surviving Antidepressants, https://www.survivingantidepressants.org/
- The International Institute for Psychiatric Drug Withdrawal, https://iipdw.org/
- The International Antidepressant Withdrawal Project, http://antidepressantwithdrawal.info/
- Benzo Buddies, http://www.benzobuddies.org/
- Benzodiazepine Information Coalition, https://www.benzoinfo.com/
- The Ashton Manual: Benzodiazepines: How They Work and How to Withdraw, https://www.benzoinfo.com/ashtonmanual/
- Mad in America, https://www.madinamerica.com/
Mad in America hosts blogs by a diverse group of writers. These posts are designed to serve as a public forum for a discussion—broadly speaking—of psychiatry and its treatments. The opinions expressed are the writers’ own.
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