CCHR calls for Congress to investigate the possible conflicts of interest between researchers associated with the ECT devices at NIMH and advising the FDA, and to ensure the FDA maintains a Class III risk classification for electroshock devices.
Los Angeles, California (PRWEB) August 08, 2016
The U.S. Food and Drug Administration (FDA) may soon be deciding on whether or not it will reclassify the electroconvulsive therapy (ECT) device as low risk, which would allow broader use and, therefore, vastly increase the number of children, the elderly and the general population that could receive it. International mental health watchdog, Citizens Commission on Human Rights (CCHR), established by the Church of Scientology and the late Professor of Psychiatry, Thomas Szasz, is requesting that Congress look into any apparent conflicts of interest driving the FDA’s decision. This includes psychiatrists with financial ties to the ECT device makers that could be advising the FDA.
In late June, Jason Chaffetz, Chairman of the House Committee on Oversight and Reform also raised concerns about how the FDA was conducting its review of ECT, writing to Sylvia Matthews Burwell, the Secretary of Health and Human Services, which oversees the FDA.
Chairman Chaffetz posed a number of important questions to the Secretary writing, “Given the complexity of this issue, and your admission that the long-term effectiveness of these devices remains debated,” what are the known dangers for those 18 years and younger receiving ECT, how does the FDA propose to monitor the use of ECT, and what Federal tax dollars have been appropriated to pay for ECT? The lawmaker further requested information about how “information on patient population or use is tracked if at all, and provide the underlying data.” Click here to read the letter.
On July 18, 2016, The Washington Post reported that the FDA determined that for some patients, the use of electroshock—up to 460 volts of electricity through the brain—may be helpful and, therefore, justifies a lower risk classification for the shock device. CCHR, along with thousands of submissions to the FDA opposing such a classification, says that this reclassification could put many thousands of individuals, including vulnerable children and elderly, at risk due to the known side effects. The FDA reports these effects to include:
- Cardiovascular (heart and blood vessels) complications
- Cognition and memory impairment
- Physical trauma
- Dental trauma
- Prolonged seizures
- Worsening of psychiatric symptoms
Right now, the ECT device carries the highest-risk, Class III classification, limiting who can be administered it. Reducing the risk classification could open the flood gates for wider electroshock usage. Yet, to date, the device makers have never submitted any clinical evidence to the FDA to prove that the procedure is safe or effective. If the device remains as Class III, the manufacturers must provide an application to the FDA with clinical trials to prove it won’t cause harm.
CCHR states that the amount of information that has not been made public about the review of the classification of ECT is astounding. For example, the FDA claims that every year 100,000 Americans are administered ECT, but this statistic dates back to the 1990s and the FDA has provided no records to substantiate such limited use, nor has it provided information as to how many children and the elderly are subjected to ECT.
The Washington Post’s article conceded what psychiatrists still admit after 70 years of ECT use, that the beneficial results of electroshock are “for reasons not fully understood” and there’s been no scientific evidence to support if ECT works at all.
Hot on the heels of the Post’s article was a study funded by the National Institute of Mental Health (NIMH) that found ECT to be a key component in maintaining remission in depression in the elderly. The study, called, “Prolonging Remission in Depressed Elderly (PRIDE),” examined 240 patients, over the age of 60, who received electroshock and the antidepressant venlafaxine, the generic of Effexor. Those that apparently “bettered” went on to receive either venlafaxine combined with the mood stabilizer, lithium, or underwent more ECT and venlafaxine.
CCHR says that what neither the above study, nor NIMH, mentions is the potential death rate in the elderly receiving ECT, or the damage the violence of such shock treatment can cause. Consider that in March of this year, a coroner from Sunderland County in the United Kingdom determined that 71-year-old Elsie Tindle died after electroshock triggered an epileptic fit, which caused irreparable brain damage. A government pathologist concluded Tindle suffered a permanent epileptic seizure and the brain was completely starved of oxygen during the prolonged fit in 2015. After the third ECT session, Ms. Tindle fell ill the following day and died 25 days later.
Additionally, in the United States, 60-year-old Peggy Salters was administered electroshock following the death of several close family members, including her husband. The psychiatrist who administered the ECT observed Salters was “confused and disoriented” and stopped the treatment because she was “completely unable to function.” Salters held a Master of Science in Nursing, had a long career as a psychiatric nurse, but lost knowledge of nursing skills and was unable to return to work after the ECT. Salters lost all memories of her husband and the births of her three children. In 2005, a jury in Columbia, South Carolina, awarded Salters $635,177, finding that the loss of 30 years of memory and cognitive impairment was due to ECT.
As for teenagers, in an interview with CCHR, Kenny attests to the potential damage ECT can cause: At age 14, he suffered hypothyroidism while he also had problems at home. He was prescribed a thyroid medicine and an antidepressant. He experienced common adverse effects from the antidepressant, but was prescribed more psychotropic drugs that worsened his symptoms. After more than six years of these drug treatments, he was told he was “treatment resistant” and needed ECT. Kenny received ECT thirty times over the next year. He had neurocognitive tests conducted six months after the shocks and the neurologist compared these to his high school IQ, finding he’d lost 50 IQ points. Kenny also saw a cardiologist for a long time because the shocks left him with heart arrhythmia. He says he suffered from severe headaches for a year and a half and went from being a high school honor student to having to be retaught how to tie his shoes. Seven years later, Kenny still suffers from a constant emotional numbness and apathy and has no memories of his childhood or high school years.
Of great importance, CCHR says that one must also consider what appear to be conflicts of interest associated with the FDA’s pending decision. Furthermore, the NIMH’s PRIDE study fails to fully disclose the conflicts of interest of the researchers, including any past financial links and/or affiliations with the two U.S. electroshock device makers.
CCHR states that there appear to be relationships in this process that need to be reviewed and, while an FDA spokeswoman, Deborah Kotz, explained to the Post that “the agency plans to review all the comments submitted” before a final determination is made, the recent media, along with the PRIDE study lauding praise on ECT, has groups seeing this as a vested push to lower the risk classification. For these reasons and the risks to the public health, CCHR reiterates an earlier call for Congress to investigate the possible conflicts of interest between researchers associated with the ECT devices at NIMH and advising the FDA, and to ensure the FDA maintains a Class III risk classification for the electroshock device.
Read the full article here.
About Citizens Commission on Human Rights: CCHR is a non-profit, non-political, non-religious mental health watchdog. Its mission is to eradicate abuses committed under the guise of mental health and enact patient and consumer protections. CCHR has helped to enact more than 150 laws protecting individuals from abusive or coercive mental health practices.
 Leslie Kux, Associate Commissioner for Policy, “Neurological Devices; Reclassification of Electroconvulsive Therapy Devices Intended for Use in Treating Severe Major Depressive Episode in Patients 18 Years of Age and Older Who Are Treatment Resistant or Require a Rapid Response; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy for Certain Specified Intended Uses,” December 29, 2015, 21 Code of Federal Regulations Part 882, Federal Register Number 2015-32592, regulations.gov/#!documentDetail;D=FDA-2014-N-1210-0001.
 Letter to Sylvia Matthews Burwell, the Secretary of Health and Human Services, from Jason Chaffetz, Chairman of House Committee on Oversight and Reform, June 28, 2016, oversight.house.gov/wp-content/uploads/2016/07/2016-06-28-JEC-to-Burwell-HHS-ECT-FDA-due-7-12.pdf.
 “FDA: Electroshock has risks but is useful to combat severe depression,” The Washington Post, July 18, 2016, washingtonpost.com/national/health-science/fda-electroshock-has-risks-but-is-useful-to-combat-severe-depression/2016/07/18/4a109cbc-2f4e-11e6-9de3-6e6e7a14000c_story.html?postshare=7721468884912250&tid=ss_tw.
 “FDA Executive Summary Prepared for the January 27-28, 2011 meeting of the Neurological Devices Panel,” FDA, fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM240933.pdf.
 “Electroconvulsive Therapy Lifts Depression, Sustains Remission in Older Adults,” National Institute of Mental Health, July 18, 2016, nimh.nih.gov/news/science-news/2016/electroconvulsive-therapy-lifts-depression-sustains-remission-in-older-adults.shtml.
 Petra Silfverskiold, “Electric shock therapy led to Sunderland patient having permanent fit,” Sunderland Echo (UK), March 10, 2016, sunderlandecho.com/news/local/all-news/electric-shock-therapy-led-to-sunderland-patient-having-permanent-fit-1-7786233; Jeremy Armstrong, “Woman died after NHS electric shock therapy was given without consent or second opinion,” Mirror, March 11, 2016, mirror.co.uk/news/uk-news/woman-died-after-nhs-electric-7540901.
 Case 03CP4004797, Richland County, South Carolina, Peggy S. Salters vs. Palmetto Health Alliance, Inc., d/b/a Palmetto Baptist Medical Center; Robt. Schnackenberg, M.D., Individually, Eric Lewkowiez, M.D., Individually, Columbia Psychiatric Associates, P.A.; and Kenneth Huggins, M.D., Individually Filed October 03, 2003, Decided June 17, 2005; “Landmark Decision: Jury awards $635,177 Damages for Memory Loss from Electroshock,” Alliance for Human Research Protection, July 8, 2005, ahrp.org/landmark-decision-jury-awards-635177-damages-for-memory-loss-from-electroshock/.