The Federal Practice Group Blog


Posted By smay || 26-Sep-2017


21ST Century Cures Act, the Electroshock Machine, and Veterans

While we have been occupied by the presidential election, there are some impending threats that are not getting enough attention for what they actually are. The 21st Century Cures Act contains provisions that can easily be exploited by psychiatric medical devise manufacturers to avoid standard clinical trials and get unsafe devices on the market. Additionally, the Food and Drug Administration (FDA) is deliberating its Proposed Order, that in plain English, approves “shock therapy” (Electroconvulsive Therapy or ECT), without clinical trial evidence. Shock therapy entails applying electric current to the brain, supposedly to treat mental health conditions which have not improved by psychotropic drugs. The 21st Century Cures Act and the FDA’s Proposed Order, both provide pathways for dangerous brain devices to be used more broadly without requiring that manufactures conduct trials to prove safety and efficacy.

The contraindications or “side effects” of ECT show that “[s]omewhere between one-quarter to two-thirds of people receiving ECT will have memory problems as a result of ECT. Some people will experience trouble forming new memories and remembering things that happen after they start receiving ECT … Some people will experience trouble remembering things that happened to them before they started ECT and this often lasts longer. The risks of ECT are substantial…” The National Alliance on Mental Illness Fact Sheet, July 2012. Other potential side effects include permanent brain damage and death.

At their annual convention May of this year, the American Psychiatric Association promoted ECT as an appropriate option for individuals diagnosed with PTSD. The U.S. Department of Veterans Affairs appears to have also been convinced of its merit and thus started to expend resources in order to procure ECT devices for use on Veterans and active duty service members who may be suffering from PTSD.

The U.S. Department of Veterans Affairs mission statement is “{t}o fulfill President Lincoln’s promise ‘To care for him who shall have borne the battle, and for his widow, and his orphan’ by serving and honoring the men and women who are America’s Veterans.” How is this mission statement supported when this agency is about to begin widespread shock therapy in the face of known contraindications? In October 2011, the VA’s own Inspector General substantiated a number of disturbing findings to the VA’s use of ECT’s which included, “{w}e substantiated the allegation that the machine had not been sent to the manufacturer “in years” for a recommended quality control check.”

The U.S. Department of Veterans Affairs has demonstrated on every administrative level that it fails to possess the appropriate fail-safe systems to manage the agency and ensure timely assistance to our Nation’s Veterans. The U.S. Department of Veterans Affairs has further demonstrated that it is also unable to manage the health care of our growing veteran population. The examples are prolific and horrific. It defies logic that this troubled agency is now going to be given authority to effectively experiment on veterans like mad scientists from a science fiction movie.

Our moral obligation as a Nation is to protect the interests of those who have sacrificed so much for our freedom. The same mental health professionals promoting shock therapy, acknowledge that up to 66% of those treated with ECT will endure memory loss – much of it permanent. In addition, studies reveal that almost all of the individuals who underwent treatment have re-experienced their same debilitating symptoms within months of receiving treatment, now with the added “benefit” of potential brain damage and memory loss. This is what we want to do to our sons and daughters who have sworn to protect our country from enemies both foreign and domestic?

The Honorable Jason Chaffetz, Chairman of the Committee on Oversight and Government Reform is currently seeking clarification from HHS and the FDA. Hopefully, further investigations will be made into the FDA, psychiatric devise industry, the medical device section of 21st Century Cures Act, and the U.S. Department of Veterans Affairs to stop the “lab rat” mentality with which veteran health care initiatives are being pushed through at the expense of taxpayers and of our Nation’s most valuable treasure – our veterans.

Major Eric S. Montalvo, U.S. Marine Corps (Ret.)

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