Tell the FDA: Stop the Shock!

Posted on by S. M. Neumeier

Trigger/Epilepsy warning:

This post talks about torture of disabled children and adults, including a graphic video of a person being restrained and shocked.  The video also flickers and may cause seizures.

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Background
Who Should Comment
Instructions
Talking Points
Sample Comment
Credits

Background

On 22 April 2016, the Food and Drug Administration proposed a ban on electrical stimulation devices used to punish people with intellectual and developmental disabilities with electric shocks.  A ban like this should never have been necessary in the first place.  Unfortunately, it still is.

There’s one program in the country that uses electric shock as a form of punishment.  The Judge Rotenberg Center, a school and treatment facility for disabled children and adults just outside of Boston, has not only done this legally, but has also prevented state agencies in Massachusetts and New York from stopping it for decades.

It’s very likely that the FDA will adopt this regulation, but it isn’t guaranteed.  JRC has been able to mobilize its students’ parents many times now to successfully oppose laws, regulations and court decisions that would even limit its ability to shock its students.  Even if the ban goes into effect, there is a risk that JRC could convince the FDA to let it have a needlessly long transition period during which it can still use its shock devices.   JRC might also convince the FDA to let it continue to shock students who are already there, and only ban the devices going forward — which would be useless, because Massachusetts has already done the same thing.

To make sure that the FDA will follow through and put an end to JRC’s shocks once and for all, we need to send them as many comments on the proposed ban as possible before the comment period ends on 25 July 2016.

Who Should Comment

Everyone who believes that electrically shocking children and disabled people as punishment is wrong should send the Food and Drug Administration a comment supporting the ban.  It doesn’t have to be long — even a couple of paragraphs is fine.

Because earlier comments are already part of the record, it would be particularly helpful to hear from people who didn’t submit a comment for the advisory panel meeting in April 2014.  In particular, it is important for the FDA to hear from:

  • JRC survivors who experienced or witnessed the use of the shock devices
  • Parents of (former) JRC students who oppose the use of shock devices
  • Former JRC staff who now oppose its practices
  • Professionals such as behavior specialists, psychologists, psychiatrists and physicians who work with people with intellectual and disabilities who have significant support needs
  • National disability rights organizations
  • Disability rights organizations from states that send a significant amount of people to JRC such as Massachusetts and New York

Thank you for your help in protecting the human rights of disabled people.

Instructions

To submit a comment electronically, go to http://www.regulations.gov.

To submit the comment by mail, send a paper copy to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852.

All comments must include the Docket No. FDA-2016-N-1111 for “Proposal to Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior.”  You should include your name, contact information, and the name of any organization you represent in your comment.

Comments can be any length, and can include relevant attachments such scientific research, case law, peer-reviewed articles or personal experiences that support your argument.

If you include confidential information in your comment, you should mail two paper copies.  The first copy should be complete and unredacted, with a header or cover page that says, “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.”  The second copy should have the confidential information redacted.  If you want your comment to be anonymous, you should send a cover sheet with your comment that says that you would like your name and contact information to be kept confidential.

To read other comments and materials for ideas, go to http://www.regulations.gov and insert the docket number into the search box.

For further information, contact Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 0993-0002, 301-796-6527.

Again, comments are due by 25 July 2016.

Talking Points

Your comment should say that you support the proposed ban on electrical stimulation devices used to treat aggressive or self-injurious behavior and include your reasons.  You should mention that these devices carry an unreasonable risk of serious injury, because this is the standard for banning a medical device. Here are some ideas for what else to include in the letter.

The shock devices are ineffective and unnecessary

  • There is no peer-reviewed research that shows that electric shock is an effective form of treatment for self-injurious or aggressive behavior.
  • JRC’s in-house research in support of its use of electric shock admits that it had lasting benefits for less than half of the people who participated in the study.
  • Students at the Judge Rotenberg Center are not the only people in the U.S. with dangerous behaviors; hundreds if not thousands of others are treated across the country using humane and effective approaches. Over the last 30 years there have been constant advances in our ability to understand and support people with dangerous behaviors.
  • There are a wide range of methods which are more effective in addressing dangerous behavior, have more lasting effects, and do not inflict pain on or dehumanize people with disabilities.
  • JRC uses electric shock in place of identifying the functions its students’ behaviors serve, providing counseling, offering psychotropic medication when needed, and teaching students coping strategies and alternative behaviors.

The devices are inhumane

  • JRC shocks its students for harmless behavior, such as nagging, keeping their eyes shut, and getting out of their seat, claiming that they could lead to dangerous behavior.
  • Video footage from JRC shows that the shock is a devastatingly painful experience.  The shows Andre McCollins, an 18 year old autistic black man, being shocked for refusing to remove his jacket. The shock causes him to fall to the floor. He is then held down by staff, strapped to a board, and shocked 30 more times over a seven hour period as he screams for help.  The additional 30 shocks were for either screaming or tensing his muscles while being shocked.
  • Two United Nations Special Rapporteurs on Torture have said that the use of electric shock at JRC is torture and violates international human rights standards.  In 2010, Special Rapporteur on Torture Manfred Nowak said that it would not be legal to use the shock device on a convicted terrorist.

The devices are dangerous

  • The shock device used at JRC can malfunction, shocking someone other than the intended target, or shocking someone wearing the device over and over until the wires are disconnected.
  • The weakest device used at JRC is many times stronger than a cattle prod or a dog collar, and both of these devices deliver a shock for only a fraction of a second. The shock delivered by these devices can last for a maximum of two seconds, which is four times as long as the shock from a cattle prod.

The devices cause physical and psychological harm

  • The devices cause first degree burns.  JRC staff have to rotate the electrodes placed on students’ skin to prevent burns, or even take students off the device temporarily to allow them to heal.
  • Experiencing, witnessing and living in constant fear of shock leads to symptoms of post traumatic stress disorder and depression, and can result in learned helplessness.

There is no informed consent

  • There are no meaningful protections for people at JRC. While the use of shock is court approved, it is a rubber-stamp process. There is no informed consent or opportunity to refuse treatment.
  • Parents and guardians of JRC students are not informed about what their children are being shocked for, or how frequent or painful the shocks are. JRC has forced parents to give up guardianship of their children, and then, when they find out what is happening to their children, cannot get them out of JRC without going to court to regain guardianship.

State laws have failed to protect JRC students from the use of shock

  • JRC has prevented Massachusetts and New York from banning the shock devices through lawsuits against both states.  The majority of JRC’s students come from these two states.
  • Both states’ regulations on the use of shock allow JRC to shock students admitted before a certain date.  JRC has sued the state of Massachusetts to overturn its regulation completely so that it can begin shocking newly-admitted students again.
  • State agencies have failed to pull funding from JRC and place its students in other settings.

The ban must be strict

  • The FDA should not allow JRC a long transition period to wean its students off of the shock devices.  JRC has known about a potential ban on the shock devices since the FDA sent them a warning letter in December 2012, and has had time to prepare alternative treatment plans for its students.
  • The ban should not be changed to allow for any exceptions through a grandfather clause.  This would make the ban useless since Massachusetts banned the use of shock on new admissions to JRC five years ago.
  • A long transition period or a grandfather clause would allow JRC to continue to put its students at risk of serious physical and psychological harm.

For more information to use in writing your comment, visit the Judge Rotenberg Center Living Archive.

Sample Comment

[Date]

Dr. Robert M. Califf, MD
Commissioner
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852.

RE:  Proposal to Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior (Docket No. FDA-2016-N-1111)

Dear Commissioner Califf:

I am writing to urge the Food and Drug Administration to adopt its proposed ban electrical stimulation devices used to treat people with disabilities who engage in self-injurious or aggressive behavior.  I am a [self-advocate / parent / professional / concerned citizen / etc.], and  I support the ban because electrical stimulation devices are inhumane and ineffective, and they put disabled people [like me / my family member / my clients] at unreasonable risk of serious injury.  [You may also want to include other relevant information about yourself, your family member or your clients in this paragraph, with the consent of the person you’re writing about.]

The Judge Rotenberg Center (JRC) in Massachusetts is the only program in the United States that uses electrical stimulation devices as a form of punishment.  JRC’s devices are several times more powerful than a cattle prod.  The shocks are extremely painful and can cause first degree burns.  Furthermore, the devices have been known to malfunction by shocking someone other than the intended target or shocking the same person repeatedly until the wires are disconnected.  JRC students who live in fear of experiencing or witnessing the shocks experience symptoms of post traumatic stress disorder and depression, including learned helplessness and thoughts of suicide.  For these reasons, experts from the United Nations have said that the JRC’s use of electric shock is torture that violates the human rights of the people in its care.

[Discuss any personal experience you had with JRC as a student, staff member or family member.]

Meanwhile, educators and service providers across the country use painless and effective forms of treatment every day to meet the needs of thousands of people with serious disabilities.  Research over the last several decades has helped professionals understand why some disabled people engage in dangerous behavior.   Based on this, they have been able to provide positive behavioral supports by adjusting the environment to meet their clients’ needs and helping them develop better ways of coping with stress.  These therapies have been shown to have lasting benefits for disabled people, including those who have significant support needs.  [Discuss your professional experience in working with populations similar to JRC’s, or therapies that were helpful for you or your family in addressing self-injury and aggression.] 

Despite the known dangers of and alternatives to using electric shock as a form of punishment, the states that send the most people to JRC have not been successful in protecting them from it.  JRC has prevented both Massachusetts and New York, which send it the majority of its students, from banning it through litigation.  As a result, both states have had to make exceptions that have allowed it to continue using the device.  Meanwhile, state education and social service agencies continue to fund placements for disabled children and adults at JRC, including those whose treatment plans allow it to continue shocking them.

There are sixty people who are still being shocked with electrical stimulation devices at JRC.  Each shock they experience causes them severe pain, and puts them at risk of further physical injury and psychological trauma.  Therefore, I strongly urge the FDA to adopt its proposed rule banning the devices, and to begin enforcing it as soon as possible without exceptions.

[Explain any documents that you’ve sent in support of your comment.]

Thank you very much for your time and concern, and for taking action to protect the well-being and human rights of people with disabilities.

Sincerely,

[Your name]
[Your title]
[Your organization]
[Your contact information]

Credits

Thank you to Lydia Brown for helping me with the formatting of this post and to Nancy Weiss for coming up with most of the talking points.