ER Patients Given Ketamine, Antipsychotics in Clinical Trials Without Their Consent, FDA Finds

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From STAT: “At least three of the studies cited by the FDA inspectors involved people brought to [Minneapolis’s Hennepin County Medical Center’s] emergency room with ‘severe’ agitation, as assessed by emergency technicians using criteria developed by the researchers. The study leaders apparently persuaded the IRB that such patients could not provide informed consent, and so could be swept into the trial unknowingly.

In fact, such patients are considered ‘vulnerable,’ said bioethicist Leigh Turner of the University of Minnesota, who signed the Public Citizen letter. According to federal law, they are supposed to receive special safeguards, such as having a family member or other representative give or decline consent. That did not happen. […]

In the first study cited by the FDA inspectors, researchers injected either ketamine or haloperidol into people taken to the ER, to reduce their ‘agitation.’ Ketamine is not approved by the FDA for that use. The unwitting participants were treated not according to clinicians’ best judgment but according to the study’s protocol: Those arriving during certain months got ketamine and those arriving in other months got haloperidol.

Among the trial’s results was that some patients given ketamine suffered breathing problems; 39 percent required intubation, compared to 4 percent given haloperidol. Before the trial began, its leaders had warned in a 2013 paper that ketamine can impair breathing and so should be reserved for only the most severely agitated patients.”

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3 COMMENTS

  1. I read the article: it is appalling. A group of crazy scientists doing secret experiments on non-consenting patients, risking the death of 39% of patients in the experimental group by respiratory depression, and publishing their article in a peer-reviewed journal just like that.

    This is the real madness: psychiatrists out of control, violating the FDA’s prohibitions and who are not subject of any criminal investigation. Let these monsters be condemned and put out of action: they are dangerous.

  2. “In July, Public Citizen and 64 bioethicists, physicians, and other scholars submitted a complaint about two of Hennepin’s ketamine studies to the FDA and HHS’s Office of Human Research Protections. In August, FDA sent inspectors to the hospital.”

    “Public Citizen” is a political group that wants “widespread assisted outpatient treatment programs” The is them working with The Treatment Advocacy Center promoting forced drugging. https://www.citizen.org/sites/default/files/2330.pdf Page 12.

    https://www.madinamerica.com/forums/topic/public-citizen-forced-drugging-assisted-outpatient-treatment-widespread/

    Human rights and informed consent are exactly not on the top of this groups priority list.

  3. This business of injecting people with Ketamine and anti psychotics is a direct result of all the benzo bashing as they are looking for an alternative to those “evil benzodiazepines” that work better on ‘severe’ agitation then any other drugs in widespread use.

    “Fifty acutely anxious and\or agitated patients requiring immediate sedation were treated with intravenous lorazepam. Most patients responded to a dose of 5 to 10 mg. (average 7.5 mg.), and the sedative-hypnotic effect became apparent within 5 minutes of injection, except in severe cases. In these patients, dosage was increased to 15 to 20 mg., and even to 30 to 40 mg. in those with delirium tremens, who proved difficult to treat with lorazepam alone. Side-effects were minimal and not troublesome, and there was no evidence of respiratory depression or cardiovascular effects, even in the elderly patients treated. Local tolerance of the injection was very good. https://www.tandfonline.com/doi/abs/10.1185/03007997509113687