The House of Cards with Informed Consent Standards


I recently submitted a recommendation to Oregon’s mental health officials as they consider revising their clinical standards. My recommendations for these clinical practice standards have to do with providing true informed consent for prescribing psychotropic medications. If they were adopted, they would threaten to bring down a kind of “house of cards” that is the centerpiece of the mental health system.

The state is asking for feedback on what they call administrative rules for behavioral health. These rules provide the practice standards required of service providers. The current rules contain only a very superficial section on how patients are to be informed about the medications. I think that if persons who were about to be prescribed psychiatric drugs had complete and accurate information, they would be very cautious about which ones they take, in what dosages and for how long they would take them.

As most anyone who is likely to be reading this knows, people who come to community mental health programs are told that their treatment with medications is critical to their stability, that they will likely need to be taken for a long time if not the rest of their lives, and that it’s all based on their having a chemical imbalance. This imbalance will be corrected with maybe only a few side effects here and there—minor inconveniences like dry mouth and restless legs, but worth the discomfort. However, those who are about to be prescribed antidepressants, for example, are not told about their well-documented lack of effectiveness nor about the increased risk of suicide and withdrawal syndromes that they can expect if they want to go off the drugs. Similarly, with antipsychotics, they are not likely to be told much about the possibility of tardive dyskinesia—a serious and often debilitating effect of taking the drugs. As an illustration of this, a May 2019 article from the online version of Psychiatric Times points out that “few persons know about the condition and many do not recognize it.” This admission comes after over 60 years of prescribing the drugs that cause it.

By the same token, they are extremely unlikely to be informed that the antipsychotics “are engineered to occupy 70% or more of D2 receptors” as documented by the data-based Institute for Safe Medication Practices (ISMP) in their 2016 QuarterWatch report.1 The same source of information goes on to say, “The problem is that these receptors are widely distributed throughout the brain and central nervous system and mediate a long list of important body functions, including mood, sleep, memory, impulse control, decision-making, muscle movement, appetite, blood pressure, and sexual development.”

It would be surprising if any more than a few prescribers have available the kind of information outlined in the ISMP article referenced above that quotes from a National Institutes of Health (NIH) study of five antipsychotics: “66.7% [of these drugs] showed moderate to severe harms over approximately 18 months of treatment. The drugs may also cause cognitive impairment, sexual dysfunction, and diabetes.”

Adding to the problem of fully informing patients is that there are significant gaps in side effect and adverse reaction information that actually exist for prescribers. A December 4, 2019 STAT article points out that “It’s no secret that the many side effects caused by medicines do not get reported to the Food and Drug Administration, but a new report suggests the magnitude of underreporting is far greater than imagined.” It goes on to say that just 1% of an estimated 276,000 serious adverse events had been reported to the FDA in 2017.

Undoubtedly, most prescribers, including the many primary care physicians who prescribe the full range of psychiatric medications, think that they are providing excellent “informed consent.” They believe they learned how to do this in medical school and their residencies. They further absorbed this belief through a combination of osmosis and adherence to the rather minimal practice standards and regulations to which they are expected to adhere.

To operationalize these practice standards, most publicly funded programs do require an informed consent form and a progress note to put it all in a bow. That usually does it. I think it is fair to say that most of them are lacking critical information and the kind of complete information outlined above so they do not have anything to challenge them as to whether or not they are doing a good job. Their existing clinical standards don’t speak to this in more detail than they deliver.

The basic question then is this: Are conversations with people who are being prescribed psychiatric medications fully informing them about psychiatric drugs? The answer to this question was clear in the series of Mad in America Continuing Education series of webinars on “What Would Real Informed Consent on Psychiatric Drugs Look Like?” We started and ended the series with a panel of people who had been prescribed these drugs to hear what they had experienced. Not surprisingly, none of them had received anywhere near true and complete informed consent. You can see this course here.

So what would a former state bureaucrat turned advocate like me want to do about it now? The answer is in the draft I submitted for a change in practice requirements. Here are my proposed revisions in bold:

(f) Give full and evidence-based informed consent in writing prior to the start of services, except in a medical emergency or as otherwise permitted by law. Full and informed consent for the prescription of psychiatric medications means information provided both verbally and in writing which explains possible side effects, both short- and long-term as well as information based on unbiased, well-constructed research regarding likely short-term, mid-term and longer-term outcomes and what can be expected in terms of withdrawal from the prescribed medications. Information must be provided about alternatives to psychiatric medications. Informed consent must also include information about the benefits and risks of prescribing more than one psychiatric medication.

You can see from the current wording (unbolded) that there’s been a lot left out in the current rule. The substantial additions will not go over well. Once consideration of the proposal starts, the objections will be fast and furious.

The first will likely be that this kind of information is already provided. If that is the case, then there should be no problem at all in placing the additional requirements into the standards so that there is never a doubt about the scope and importance of providing true informed consent.

Another objection will be that psychiatric patients have “anosognosia”—a term borrowed inappropriately from neurology—so they can’t be expected to understand the information. My response is twofold—first, this is a condescending and inappropriate view of patients which disrespects the cognitive capacity of almost every person who is prescribed the drugs. Second, it is the responsibility of the prescriber to make the information understandable, not the patient’s responsibility to ask all the right questions.

Finally, there will be the quite realistic observation that because of the way in which services are structured, there isn’t enough time to do a good job of delivering full and complete informed consent. They will point out that there is very limited time for treatment assessments and the follow-up 15 minute med checks are additional serious limitations. It is also true that the alternatives available to avoid overuse of medications are in extremely short supply. But changing these realities is the responsibility of program designers and funding to make the resources an integral part of every program. The changes in wording I have proposed will require not only major reconstruction of services but also will demand a great improvement in continuing education regarding the actions, effectiveness, and risks of prescribing medications.

Being a realist, I think it is extremely unlikely that Oregon or any other state will have the courage to adopt the proposed revisions and then, just as importantly, follow through with the education and enforcement that will become necessary. However, at the least, this proposal will open the door to a much wider recognition of the role that poorly conducted informed consent plays in the excessive use of psychiatric medications. The existing house of cards built with existing informed consent practices and the systems it reflects will then be in peril as advocates expose the lack of true informed consent and the disrespect it shows to persons who are confronting decisions about whether to take these powerful drugs or not. Of course, I would happily be wrong and see major changes begin sooner rather than later.

Show 1 footnote

  1. Institute for Safe Medication Practices. (January 25, 2017). Perspectives from new adverse event reports  (QuarterWatch 2016 Q2). Horsham, PA: Institute for Safe Medication Practices.


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  1. Well, the psychiatric “thought” leaders and their Pharma Bros. would have kittens if they knew tardive dyskinesia wouldn’t exist if “antipsychotic” tablets had one mg. of manganese added to each and every one. This information has only been around for 30+ years, which hasn’t given the “thought” leaders time enough to test the hypothesis.

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  2. Thank you Mr Nikkel.
    I have a question.
    How does a child get informed and if it is law that you have to inform people, this law only applies to adults?
    Obviously a child has no idea what is being given to them so I guess, the information would be given to parents. But suppose the parents are not educated, or too young? Since most people gain knowledge about societal pitfalls at a later age, many are not aware even if presented with some information.
    It should be illegal to present something to parents as an only option, and in NO way should a child receive drugs. It is one thing to give them to brains that are developed, but a completely barbaric experiment on an innocent child, with a still developing brain.

    I would really like to see this become contested more by those who have retired from the system since it seems few are brave enough to act within the system.

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    • Sam, I am completely embarrassed that I didn’t respond to your question. I think it’s an excellent question and the points you make along with it. I meet regularly with the director of a very large family therapy organization with residential and outpatient services. This past week I brought up the question you raised and we agreed at our next meeting we will talk about it. That’s in 2 weeks. So I will respond a lot sooner than 2 years. Bob

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  3. “Being a realist, I think it is extremely unlikely that Oregon or any other state will have the courage to adopt the proposed revisions”

    Me Too Robert. I can’t imagine that these people who were trained in the Harvey Weinstien School of “never take no for an answer” will want to see any changes made.

    I mean in my country if it is known you will refuse to take stupefying/intoxicating drugs they simply ‘spike’ you with them, and then slander you as paranoid if you should make any complaints about it. Fraudulent documents are distributed to lawyers and you will be “fuking destroyed” (is how the Operations Manager of the hospital put it). Its amazing how much damage can be done by someone in a position of trust when they make a decision to destroy members of the public to protect their non existent reputation. Terrorism i’ve heard this practice called. Coercion is the preferred term for the terrorist.

    The Health Practitioners Regulation Agency has no problem with Community Nurses with no prescribing rights using these ‘spiking’ methods as a means to an end and will use negligence (with plausible deniability) to ensure that nothing is done regarding such criminal actions. The old adage has been stretched here too, if a ‘medical person’ does it, it must be medicine. And how fortunate for these criminals that police can’t find their copy of the Criminal Code and will leave them to tidy up their little problems in the Emergency Departments. (Anti Psychotics/Benzos [chemical restraint] + Morphine from an unknown source [anonymous pain patient] = “nothing to see here” from the Coroner).

    Informed consent guidelines aren’t even considered a joke by doctors in my country, they have carte blanche and zero accountabilty to do whatever they choose and any complaints will be snuffed out via a corrupted complaints process. In some cases quite literally, though they prefer the term unintended negative outcomes to convenience killings.

    Who would have thought how broadly the term “emergency” could be stretched. All the way to someone saying the word “no” it would seem.

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  4. Thank you for pointing this deficit of the medical community out. And I agree, this is a serious societal problem. I, for one, prior to being given powerful, mind altering psychiatric drugs, was out and out lied to by a PCP. I was told a dangerous, mind altering, antidepressant was a “safe smoking cessation med.” And I was told a dangerous, addictive opioid was a “safe pain killer.”

    That’s largely the opposite of being given informed consent, so the doctors are truly behaving extremely badly. Not to mention those drug classes have major drug interactions with each other, so they never should have been prescribed together.

    But we wouldn’t have the opioid epidemic today, if the doctors were not systemically lying to their patients on a massive societal scale, in this manner. Plus, since the antidepressants create the “bipolar” symptoms, which most the doctors deny, but even the DSM-IV-TR at the time, stated is the truth. We also wouldn’t have the iatrogenic “bipolar” epidemic, if the doctors were not out and out, incessantly and systemically, lying to, and misdiagnosing, their patients.

    I’m quite certain appropriate informed consent laws should be implemented and enforced. No doubt, appropriate informed consent laws would have helped prevent the iatrogenic opioid and bipolar epidemics, that our society is dealing with today. Our doctors should be ashamed of creating iatrogenic epidemics, no doubt for profit.

    It’s a shame our medical doctors can no longer be trusted to “first and foremost do no harm,” or even stop participating in creating these iatrogenic epidemics. Merely because creating iatrogenic epidemics is “too profitable,” in the words of a pediatrician who is still actively today participating in creating the iatrogenic “childhood bipolar epidemic,” for profit.

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    • I will say, largely thanks to the psychiatrists taking this medical wisdom OUT of the DSM5.

      “Note: Manic-like episodes that are clearly caused by somatic antidepressant treatment (e.g., medication, electroconvulsive therapy, light therapy) should not count toward a diagnosis of Bipolar I Disorder.”

      Adding the ADHD drugs to that disclaimer should have been done instead. Today’s psychiatrists, and mainstream doctors, need to take some ethics classes, obviously.

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