In an additional article to a multi-part series exposing the dangers of electroshock treatment (ECT), Jan Eastgate, President of the Citizens Commission on Human Rights International (CCHR) calls for an overhaul of the Food and Drug Administration.
In December 2018, the FDA reduced the risk classification of the electroshock device so that it could be more broadly marketed and used for the treatment of mental disorders. The decision has prompted CCHR to call upon the U.S. General Accountability Office (GAO) to investigate the agency.
CCHR says the FDA’s handling of the ECT device, allowing it to stay on the market without clinical trials proving safety and efficacy, is another example of the agency’s long history of approving and allowing dangerous products, including drugs and medical devices, to remain on the market. Accusations leveled at the FDA is that it is compromised by healthcare company dollars and puts industry interests before patient safety.
A ProPublica investigation in 2018 found pharmaceutical companies underwrite three-fourths of the FDA’s budget for scientific reviews. The agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits.[1]
After drug approvals, pharmaceutical manufacturers have needed to add 61 black box warnings to their medications to call attention to serious or life-threatening risks. Drugs used to treat “mental illness” and drugs that went through an accelerated approval process have a higher number of adverse “events,” according to a Journal of the American Medical Association (JAMA) study published in May 2017. As the study noted, the majority of these drugs were trialed in 1,000 or fewer patients to get FDA approval.[2] For ECT, there are no clinical trials proving safety and efficacy because FDA has not enforced this requirement since 1976.
In November 2018, an Associated Press analysis of FDA data showed that since 2012, tens of thousands of injury and death reports have been filed in connection with devices that were cleared through a streamlined pathway that minimizes clinical trial testing.[3]
FDA does not monitor the use of ECT and does not have any accurate information about electroshock deaths. Texas is the only state that reports a death within 14 days of ECT being administered. There were 30 deaths between 1993 and 1998. Based on an average number of Texas ECT deaths in 2013, 2014 and 2016, nationally every year nearly 70 Americans undergoing ECT die. Applied to the estimated 1.4 million people worldwide who receive ECT and that’s upwards of 960 deaths per year.
Psychiatrists and the FDA have downplayed deaths, attributing them to other diverse reasons rather than admit to the damage 460 volts of electricity does to the brain and body.
In 2014, the Texas suicide rate for patients shortly following ECT was also 13 times greater than the state suicide rate for the year.[4]
In 2018, Peter White, a coroner in Victoria, Australia ruled that Melbourne grandfather, Gerard Helliar, died a preventable death when he was administered ECT. Mr. White said there was no evidence that the involuntary electroconvulsive therapy Mr. Helliar endured could have provided him with any relief, and ECT instead imposed further pain, discomfort, stress and a sense of hopelessness. Helliar’s life support was turned off after he attempted suicide in a hospital’s acute inpatient mental health unit. He had refused ECT and told his family and doctors that he hated the treatment and that it affected his memory.[5]
If the FDA and its ECT advisers dismiss permanent memory loss and brain damage as an adverse effect of ECT, they’re unlikely to admit that electroshock can kill people. With such a heavy reliance upon industry funds, FDA cannot afford to alienate its funding sources.
In 2017, Pharma paid 75%—or $905 million—of the agency’s scientific review budgets for branded and generic drugs, compared to 27% in 1993. “The virginity was lost in ’92,” said Dr. Jerry Avorn, a professor at Harvard Medical School. “Once you have that paying relationship, it creates a dynamic that’s not a healthy one.”[6] Between 1992, when the Prescription Drug User Fee Act (PDUFA) was passed, making it the law for pharmaceutical companies to directly pay the FDA to review their applications for drug approvals, and 2015/16, pharma companies contributed $7.67 billion to the FDA.[7]
Medical devices and Radiological Health regulatory activities accounted for another 10% of FDA’s budget (or $570 million); 33% of these activities are paid for by industry user fees (or $188.1 million).[8]
About 55%, or $3 billion, of FDA’s budget is provided by federal budget authorization. The remaining 45%, or $2.6 billion, is paid for by industry user fees.[9]
As far as failing to protect the public, the FDA’s history is legendary.
The FDA has only banned two medical devices since 1976 when these devices came under its jurisdiction: one device implanted artificial hair into the scalp and the other was powdered surgical gloves.[10]
- The hair implant device was banned in 1983 because it failed to stimulate hair growth or conceal baldness as advertised and caused infections and injury where implanted (also facial swelling, severe pain, scarring and permanent loss of remaining real hair).[11]
- The powdered gloves could cause severe airway inflammation and hypersensitivity reactions; powder particles could trigger the body’s immune response, causing scar tissue formation, which can lead to surgical complications.[12]
Compare the above effects to the serious adverse effects of the ECT device that includes manic or worsening of “psychiatric” symptoms; pain/somatic discomfort (including headache, muscle soreness, and nausea); skin burns; physical trauma (including fractures, contusions, injury from falls, dental and oral injury); prolonged or delayed onset seizures; pulmonary complications; cardiovascular complications (cardiac arrhythmias, heart attack, high or low blood pressure, and stroke); permanent memory loss and death.[13]
From December 1978 through February 1981, FDA received 166 complaints about the hair fibers.[14] Regarding the powdered gloves, FDA requested public comments on the proposed rule to ban them and received approximately 100 comment letters. Per the FDA, “A majority of the comments supported the objectives of the rule in whole or in part, while a minority of the comments opposed the objectives of the rule.”[15] The FDA said the gloves posed “an unreasonable and substantial risk of illness or injury to healthcare providers, patients and other individuals who are exposed to them.”[16]
Compare this to the Public Docket on ECT (2009) for which the FDA received more than 3,000 comments, most of which (79%) opposed reclassifying ECT devices as a lower risk device and many called for it to be banned. The number against this proposal was 14 times greater than for those in favor of it. Yet the FDA’s Final Order on the ECT device published in December 2018, put the dangerous device into the same risk classification as contact lens, mercury thermometers, condoms and pregnancy tests.[17]
CCHR has documented some 36 FDA-approved drugs, manufactured by about 27 pharmaceutical companies since the 1970s that were recalled due to adverse reactions. Of these, only five were psychiatric drugs. 13 medical drugs were linked to at least 3,343 deaths with an additional 55,000 deaths from Vioxx, a painkiller—or an estimated total of more than 58,300 deaths.
Another 13 drugs were recalled for adverse effects that included causing low white blood cell count, heart problems, stroke, seizures, fractures and spinal fractures.
In contrast, FDA reported severe memory loss, brain damage and death linked to ECT devices and did nothing.
Consider also that between 2008 and the end of 2017, more than 80,000 incidents related to spinal stimulators were reported to the FDA, including spinal-cord nerve damage and paralysis. As with the ECT device, most of these spinal stimulator devices had been approved by the FDA, with little clinical testing.[18] And in the case of the ECT device, no clinical testing.
Johnson & Johnson and Boston Scientific are among seven companies now paying millions of dollars to resolve the claims of more than 100,000 women about a surgical mesh the companies manufacture. As of 2018, the FDA had received reports of more than 10,000 complaints of serious injury and nearly 80 deaths linked to the pelvic surgical mesh it approved in 2002 for use as a class II moderate-risk device. For years, women and legal advocates tried to persuade the FDA that the implant caused harm. In April 2019, Washington State Attorney General Bob Ferguson announced that J&J would pay $9.9 million to avoid going to trial for misrepresentations and failure to include serious risks in the instructions and marketing materials for surgical mesh devices. [19]
The FDA also does not take into account the questionable history of the manufacturers of devices it approves. With ECT, the device makers were asked several times to submit the appropriate pre-marketing application that requires clinical trials proving safety and efficacy and failed to produce these in 40 years. FDA took no effective action, thereby keeping the device on the market, serving psychiatrists’ and the manufacturers’ interests only.
The FDA’s duty to protect consumers from health hazards is compromised by “who pays” and by vested interests, such as the APA, that insist that their arsenal of treatments, such as ECT, remain on the market, despite the imminent danger to patients.
Chief Counsel, Brigadier General Telford Taylor in his opening statement to the Nuremberg Medical Trials covering Nazi medical experiments stated, “To kill, to maim, and to torture is criminal under all modern systems of law…It is far more important [to the unfortunate victims of Nazi atrocities] that these incredible events be established by clear and public proof, so that no one can ever doubt they were fact and not fable; and that this court, as the agent of the United States and as the voice of humanity, stamp these acts, and the ideas which engendered them, as barbarous and criminal.”[20]
That message still rings true today. Electroshock is an atrocity. The administration of ECT should be made illegal and, thereafter indict any use of it and compensate those already physically damaged from it.
Over 95,000 people have signed CCHR’s online petition to ban electroshock. More are encouraged to sign this and to report any incident of ECT damage to CCHR.
References:
[1] Caroline Chen, “FDA Repays Industry by Rushing Risky Drugs to Market,” ProPublica, 26 June 2018, https://www.propublica.org/article/fda-repays-industry-by-rushing-risky-drugs-to-market
[2] Jen Christensen, “Nearly a third of FDA-approved drugs had problems, study finds,” CNN, 9 May 2017, https://www.cnn.com/2017/05/09/health/fda-approval-drug-events-study/index.html
[3] Matthew Parrone, “At FDA, a new goal, then a push for speedy device reviews,” Associated Press, 27 Nov. 2018, https://www.boston.com/news/politics/2018/11/27/us-goal-to-be-first-on-devices-worries-former-regulators
[4] “Texas Injury Data Brief,” Texas Department of State Health Services, https://www.dshs.texas.gov/injury/EPI/Suicide2016Update.pdf; “Electroconvulsive Therapy Annual Report 2014,” Department of State Health Services, March 2015, https://www.dshs.texas.gov/legislative/2015/ECT-Annual-Report-2014.pdf
[5] https://www.theage.com.au/national/victoria/grandfather-forced-to-undergo-ect-before-preventable-death-20180418-p4zacy.html
[6] Op. cit., Caroline Chen, ProPublica
[7] https://avalere.com/press-releases/fda-has-received-7-67-billion-from-manufactures-to-fund-drug-review
[8] https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance
[9] Ibid.
[10] https://www.fda.gov/MedicalDevices/Safety/MedicalDeviceBans/default.htm
[11] https://www.upi.com/Archives/1983/06/03/Ban-hair-fiber-and-synthetic-hair-implants/5598423460800/
[12] http://www.mocarehealth.com/news.php?id=46
[13] https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of
[14] Op. cit., UPI.com
[15] https://www.federalregister.gov/documents/2016/12/19/2016-30382/banned-devices-powdered-surgeons-gloves-powdered-patient-examination-gloves-and-absorbable-powder
[16] https://www.modernhealthcare.com/article/20161216/NEWS/161219917/fda-bans-most-powdered-medical-gloves-due-to-health-risks
[17] https://www.innovatum.com/2014/12/understanding-difference-class-class-ii-medical-devices/
[18]“Medical devices for pain, other conditions have caused more than 80,000 deaths since 2008,” Stat News, 25 Nov. 2018, https://www.statnews.com/2018/11/25/medical-devices-pain-other-conditions-more-than-80000-deaths-since-2008/
[19] Matthew Goldstein, “As Pelvic Mesh Settlements Near $8 Billion, Women Question Lawyers’ Fees,” The New York Times, 1 Feb. 2019, https://www.nytimes.com/2019/02/01/business/pelvic-mesh-settlements-lawyers.html; “F.D.A. Halts U.S. Sales of Pelvic Mesh, Citing Safety Concerns for Women,” The New York Times, 16 Apr. 2019, https://www.nytimes.com/2019/04/16/health/vaginal-pelvic-mesh-fda.html; https://www.fda.gov/news-events/press-announcements/fda-strengthens-requirements-surgical-mesh-transvaginal-repair-pelvic-organ-prolapse-address-safety
[20] Evelyne Shuster, “Medical Ethics at Nuremberg: The Nazi Doctors and the Hippocratic Oath,” prepared for the Annual Ethics Symposium Fifty Years After the Nuremberg Medical Trail (Are) Forming Institutional Review Boards, Philadelphia Veteran Affairs Medical Center, 24 May 1996.