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Showing posts with label Electric Shocks. Show all posts
Showing posts with label Electric Shocks. Show all posts

Thursday, April 9, 2020

Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior

FDA Press Release
Posted March 5, 2020

Here is an excerpt:

After careful consideration, the U.S. Food and Drug Administration today published a final rule to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated through new or updated device labeling.

“Since ESDs were first marketed more than 20 years ago, we have gained a better understanding of the danger these devices present to public health,” said William Maisel, M.D., M.P.H., director of the Office of Product Evaluation and Quality in the FDA’s Center for Devices and Radiological Health. “Through advancements in medical science, there are now more treatment options available to reduce or stop self-injurious or aggressive behavior, thus avoiding the substantial risk ESDs present.”

ESDs administer electrical shocks through electrodes attached to the skin of individuals to immediately interrupt self-injurious or aggressive behavior or attempt to condition the individuals to stop engaging in such behavior. Evidence indicates a number of significant psychological and physical risks are associated with the use of these devices, including worsening of underlying symptoms, depression, anxiety, posttraumatic stress disorder, pain, burns and tissue damage. In addition, many people who are exposed to these devices have intellectual or developmental disabilities that make it difficult to communicate their pain. Evidence of the device’s effectiveness is weak and evidence supporting the benefit-risk profiles of alternatives is strong. As the risks presented by ESDs meet the agency’s definition of unreasonable and substantial and cannot be corrected or eliminated through new or updated labeling, banning the product is necessary to protect public health.

The act of banning a device is rare and the circumstances under which the agency can take this action is stringent, but the FDA has the authority to take this action when necessary to protect the health of the public. The FDA has only banned two other medical devices since gaining the authority to do so.

This final rule issued today follows a 2016 proposed rule to ban ESDs from the marketplace and takes effect 30 days after publication in the Federal Register. The FDA understands that a gradual transition period may be needed for a subgroup of individuals currently exposed to these devices, to allow time for them to transition to another treatment, so the agency is establishing two compliance dates. For devices in use on specific individuals as of the date of publication and subject to a physician-directed transition plan, compliance is required 180 days after publication of the final rule in the Federal Register. For all other devices, compliance is required 30 days after publication of the final rule in the Federal Register.

The FDA received more than 1,500 comments on the proposed rule, as well as approximately 300 comments submitted to the April 2014 FDA advisory panel meetingExternal Link Disclaimerdocket, which the FDA has associated with this rulemaking action. Comments were received from a variety of stakeholders, including parents of individuals with intellectual and developmental disabilities, state agencies and their sister public-private organizations, the affected manufacturer and residential facility, some of the facility’s employees, and parents of individual residents. State and federal legislators also expressed interest, as did state and national advocacy groups. The overwhelming majority of comments supported this ban.

The proposed rule is here.

Monday, August 20, 2018

Massachusetts allows school to continue with electric shocks

Jeffrey Delfin
theguardian.com
Originally posted July 12, 2108

Here is an excerpt:

The device is not used in what we might call “electroshock therapy” – where small shocks are passed through the brain under anesthesia. Rather, the GED is used as a variation of “aversive conditioning”, in which negative stimulation is applied to a patient when he or she performs an unwanted action. The patient is awake, and feeling pain is the point of the shock.

The GED, when activated, outputs an electric shock that is distributed to the patient’s skin for up to two seconds. Students wear a backpack containing the shocking device, with electrodes constantly affixed to their skin. Staff are able to shock students at any point during the day. Previous attendees at JRC have spoken of up to five electrodes being attached to their bodies. One, Jen Msumba, who blogs about her time at the facility, said electrodes were applied under their fingers or the bottom of their feet to increase the pain.

“We’ve all experienced aversive conditioning. We touch the stove while it’s still hot, it hurts, then we become very cautious about touching it,” says Dr Jean Mercer, the leader of the group Advocates for Children in Therapy, a not-for-profit organization dedicated to ending harmful practices for treating children’s mental health.

The information is here.

Friday, June 1, 2018

The toxic legacy of Canada's CIA brainwashing experiments

Ashifa Kassam
The Guardian
Originally published May 3, 2018

Here is an excerpt:

Patients were subjected to high-voltage electroshock therapy several times a day, forced into drug-induced sleeps that could last months and injected with megadoses of LSD.

After reducing them to a childlike state – at times stripping them of basic skills such as how to dress themselves or tie their shoes – Cameron would attempt to reprogram them by bombarding them with recorded messages for up to 16 hours at a time. First came negative messages about their inadequacies, followed by positive ones, in some cases repeated up to half a million times.

“He couldn’t get his patients to listen to them enough so he put speakers in football helmets and locked them on their heads,” said Johnson. “They were going crazy banging their heads into walls, so he then figured he could put them in a drug induced coma and play the tapes as long as he needed.”

Along with intensive bouts of electroshock therapy, Johnson’s grandmother was given injections of LSD on 14 occasions. “She said that made her feel like her bones were melting. She would say: ‘I don’t want these,’” said Johnson. “And the doctors and nurses would say to her: ‘You’re a bad wife, you’re a bad mother. If you wanted to get better, you would do this for your family. Think about your daughter.’”

The information is here.

Tuesday, December 23, 2014

Harm to others outweighs harm to self in moral decision making

Molly J. Crockett, Zeb Kurth-Nelson, Jenifer Z. Siegel, Peter Dayand, and Raymond J. Dolan
PNAS 2014 ; published ahead of print November 17, 2014, doi:10.1073/pnas.1408988111

Abstract

Concern for the suffering of others is central to moral decision making. How humans evaluate others’ suffering, relative to their own suffering, is unknown. We investigated this question by inviting subjects to trade off profits for themselves against pain experienced either by themselves or an anonymous other person. Subjects made choices between different amounts of money and different numbers of painful electric shocks. We independently varied the recipient of the shocks (self vs. other) and whether the choice involved paying to decrease pain or profiting by increasing pain. We built computational models to quantify the relative values subjects ascribed to pain for themselves and others in this setting. In two studies we show that most people valued others’ pain more than their own pain. This was evident in a willingness to pay more to reduce others’ pain than their own and a requirement for more compensation to increase others’ pain relative to their own. This ‟hyperaltruistic” valuation of others’ pain was linked to slower responding when making decisions that affected others, consistent with an engagement of deliberative processes in moral decision making. Subclinical psychopathic traits correlated negatively with aversion to pain for both self and others, in line with reports of aversive processing deficits in psychopathy. Our results provide evidence for a circumstance in which people care more for others than themselves. Determining the precise boundaries of this surprisingly prosocial disposition has implications for understanding human moral decision making and its disturbance in antisocial behavior.

Significance

Concern for the welfare of others is a key component of moral decision making and is disturbed in antisocial and criminal behavior. However, little is known about how people evaluate the costs of others’ suffering. Past studies have examined people’s judgments in hypothetical scenarios, but there is evidence that hypothetical judgments cannot accurately predict actual behavior.  Here we addressed this issue by measuring how much money people will sacrifice to reduce the number of painful electric shocks delivered to either themselves or an anonymous stranger. Surprisingly, most people sacrifice more money to reduce a stranger’s pain than their own pain. This finding may help us better understand how people resolve moral dilemmas that commonly arise in medical, legal, and political decision making.

The entire article is here.