CCHR Urges Overhaul of the FDA, Charging Approval of Electroshock Device Creates Harm


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 GAO to investigate the agency.

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 GAO to investigate the agency.

The group charges that the FDA’s duty to protect consumers is compromised by vested interests that insist ECT remains on the market despite dangers to patients.

The FDA’s Final Order on the ECT device in December 2018 put the draconian, brain damaging device into the same risk classification as contact lens, mercury thermometers, condoms and pregnancy tests.”

— Citizens Commission on Human Rights

CLEARWATER, FLORIDA, UNITED STATES, October 21, 2019 /EINPresswire.com/ — Summing up a five-part series of articles exposing the dangers of electroshock treatment (ECT) on its public information blog, TruthAboutECT, mental health watchdog, Citizens Commission on Human Rights International (CCHR) calls for an overhaul of the Food and Drug Administration (FDA). 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. CCHR is urging the U.S. General Accountability Office to investigate the agency’s approval of the ECT device, putting industry interests before patient protection.

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] Drugs used to treat “mental illness” and those 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. [2] 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]

There are no clinical trials proving the ECT device safe and effective. Nor does the FDA monitor the use of ECT or have accurate information about electroshock deaths. Texas is the only state mandated to report a death within 14 days of ECT being administered. Between 1993 and 1998 alone there were 30 deaths. Based on an average number of Texas ECT deaths in 2013, 2014 and 2016, nationally about 70 Americans undergoing ECT may die every year.

The Texas suicide rate for patients shortly following ECT was also 13 times greater than the state suicide rate in a year. [4]

Psychiatrists and the FDA downplay deaths, attributing them to other diverse reasons rather than admit to the damage 460 volts of electricity does to the brain and body.

Jan Eastgate, president of CCHR International says industry funding may play a strong part in this: “With a heavy reliance upon industry funds, FDA cannot afford to alienate its funding sources.” About 45%, or $2.4 billion of the FDA’s budget, is paid for by industry user fees. [5]

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]
Medical devices and Radiological Health regulatory activities, under which the ECT devices fall, accounted for another 10% of FDA’s budget ($570 million); 33% of these activities are paid for by industry user fees ($188.1 million). [7]

As far as protecting the public, the FDA’s history of neglect is well documented and legendary, Eastgate adds.

The FDA has only banned two medical devices since 1976—one that implanted artificial hair into the scalp and powdered surgical gloves. [8]

• The hair implant device was banned in 1983 because it failed to stimulate hair growth, conceal baldness as advertised and caused infections and injury where implanted. [9]
• The powdered gloves could cause severe airway inflammation and hypersensitivity reactions. [10]

Compare these to the serious adverse effects of the ECT that include manic or a worsening of the “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; cardiac arrhythmias, heart attack, high or low blood pressure, and stroke; permanent memory loss and death. [11]

From December 1978 through February 1981, FDA received 166 complaints about the hair fibers. [12] It received approximately 100 public comments on powdered gloves. Yet in 2009, the agency received more than 3,000 comments on the electroshock device, of which 79% opposed it—14 times greater than for those in favor of it. Yet the FDA’s Final Order on the ECT device in December 2018 put the draconian, brain damaging device into the same risk classification as contact lens, mercury thermometers, condoms and pregnancy tests, CCHR reports. [13]

The group charges that the FDA’s duty to protect consumers from health hazards is compromised by “who pays” and by vested interests that insist that ECT, described as torture, remains on the market, despite the imminent danger to patients.

It points to Chief Counsel, Brigadier General Telford Taylor in his opening statement to the Nuremberg Nazi Medical Trials following WWII: “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…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.” [14] (See previous article on ECT used by the Nazis)

Eastgate says: “The FDA is an agent for the U.S. that needs an overhaul. Electroshock is an atrocity that should not remain on the market.”

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.

About CCHR: Initially established by the Church of Scientology and renowned psychiatrist Dr. Thomas Szasz in 1969, CCHR’s mission is to eradicate abuses committed under the guise of mental health and enact patient and consumer protections. L. Ron Hubbard, founder of Scientology, first brought psychiatric imprisonment to wide public notice: “Thousands and thousands are seized without process of law, every week, over the ‘free world’ tortured, castrated, killed. All in the name of ‘mental health,’” he wrote in March 1969. For more information visit www.cchrflorida.org

Sources:

[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,” AP, 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 (DSHS), 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.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance
[6] Op cit., Caroline Chen
[7] https://www.fda.gov/about-fda/fda-basics/fact-sheet-fda-glance
[8] https://www.fda.gov/MedicalDevices/Safety/MedicalDeviceBans/default.htm.
[9] https://www.upi.com/Archives/1983/06/03/Ban-hair-fiber-and-synthetic-hair-implants/5598423460800/.
[10] http://www.mocarehealth.com/news.php?id=46.
[11] https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsive-therapy-devices-effective-date-of
[12] Op. cit., UPI.com
[13] https://www.innovatum.com/2014/12/understanding-difference-class-class-ii-medical-devices/
[14] 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

Diane Stein
Citizens Commission on Human Rights of Florida
+1 727-422-8820
email us here

Electroconvulsive “Therapy” —The Facts about ECT #BanECT


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Animal Wellness Urges U.S. Territories to Wind Down Cockfighting, As Upgraded Anti-Fighting Law Soon Becomes Effective


Cockfighting Match

U.S. Department of Justice Affirms That Cockfighting Is Unambiguously Outlawed in All Five U.S. Territories

The rule of law is a sacred doctrine in the United States.”

— Drew Edmondson

WASHINGTON, DC, USA, October 16, 2019 /EINPresswire.com/ — Top officials at Animal Wellness Action and the Animal Wellness Foundation urged the governors and other top elected leaders of American Samoa, Guam, Northern Marianas Islands, Puerto Rico, the U.S. Virgin Islands to signal to the community of cockfighting enthusiasts that they must cease their staged fights and related activities, including organizing derbies, staging fights, raising birds for fighting, selling animals for fighting, or attending these spectacles.

“The United States has the authority to outlaw staged animal fights in the U.S. Territories, and it has done so,” said Drew Edmondson, the former four-term Attorney General of Oklahoma and co-chair of the Animal Wellness National Law Enforcement Council. “The Congress, the Federal Courts, and the U.S. Department of Justice have been crystal clear on the matter: engage in animal fighting activities and go to prison. All of our political leaders need to remind their constituents of these legal realities.”

Edmondson was attorney general when Oklahoma voters banned cockfighting in 2002. That same year, the Congress upgraded the federal law against animal fighting, banning any interstate or foreign commerce in the animals for fighting. As such, Edmondson has experience in helping Oklahoma transition from a hotbed of cockfighting to a jurisdiction that explicitly outlawed the practice.

“The cockfighting community in Oklahoma challenged our state law and they made efforts to challenge federal law without success,” added Edmondson. “As with both the states and the territories, Congress has the power to outlaw this conduct and exercised that authority in upgrading the law five times in the last 17 years.” All federal legal actions to invalidate the statute have failed.

In recent months, a number of cockfighting practitioners and a business named Club Gallistico de Puerto Rico, sued the federal government some months ago and argued that Section 26 of the Animal Welfare Act forbidding animal fighting is unconstitutional as applied to the territories. The U.S. Department of Justice filed a brief in response earlier this month, emphatically arguing that most animal fighting activities are already illegal in the territories and the upgrade of the law, set to take effect on December 20th, simply builds on the roster of prohibited activities. “Just as courts have unanimously affirmed the ability of the federal government to restrict animal fighting in the fifty states, so too may it do so with respect to the territories.”

According to the Department of Justice in its pleadings, the upgrade in the law stipulated that cockfighters “may not sponsor or exhibit cockfights, just as prior to §12616 they were prohibited from attending cockfights, possessing game cocks, or engaging in other animal fighting practices that were prohibited both in Puerto Rico and nationwide.”

Animal Wellness Action founder Wayne Pacelle recently traveled to Guam and was able to walk into a cockfight in progress, with about 150 people in attendance. “Between now and December 20th, it’s critical that they get the message by December 20th that staging fights, attending fighting, shipping birds or fighting paraphernalia, and even possessing fighting birds are federal felonies,” added Pacelle. “There’s no ‘Get-Out-of-Jail-Free’ card for cockfighters and other perpetrators of malicious cruelty to animals.” Pacelle called on the leaders of all the U.S. territories to affirm in a public way that the law, including the federal law against animal fighting, must be observed.

“The rule of law is a sacred doctrine in the United States,” added Edmondson, speaking on behalf of the 25-member Animal Wellness National Law Enforcement Council. “Defying our laws against animal cruelty is not tolerable, and we’ll be working hard to see that the law speaks in every part of the United States, including the Territories.”

Wayne Pacelle
ANIMAL WELLNESS ACTION
+1 202-821-5686
email us here
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Kansas Mesothelioma Victims Center Now Urges A Navy Veteran or Person in Kansas With Mesothelioma to Call Them for On the Spot Access to Attorney Erik Karst of Karst von Oiste-Get Better Compensation Results


“We think most people with mesothelioma will find talking directly with attorney Erik Karst of the law firm of Karst von Oiste to much more helpful than ordering a ‘free’ book about mesothelioma. ”

— Kansas Mesothelioma Victims Center

WICHITA, KANSAS, USA, October 9, 2019 /EINPresswire.com/ — The Kansas Mesothelioma Victims Center says, “We are encouraging a Navy Veteran or a skilled trades worker such as a plumber, welder, electrician or construction worker with mesothelioma anywhere in Kansas to call us anytime at 800-714-0303 to discuss why it is vital to hire some of the nation’s skilled lawyers-if a person like this expects the best compensation results. We have endorsed the law firm of Karst von Oiste to assist a Navy Veteran or person with mesothelioma because we are certain these remarkable lawyers will get a Navy Veteran or person with mesothelioma in Kansas the best financial compensation results.

“We think most people with mesothelioma will find talking directly with attorney Erik Karst of the law firm of Karst von Oiste to much more helpful than ordering a ‘free’ book about mesothelioma as we would be happy to discuss anytime at 800-714-0303. We can typically have a person with mesothelioma or their family talking directly with famed mesothelioma attorney Erik Karst within an hour.” www.karstvonoiste.com/

Vital Compensation Tip from the Kansas Mesothelioma Victims Center: “If you or a loved one has been recently diagnosed with mesothelioma in Kansas, we are now offering to help you make a list of how, where and when you were exposed to asbestos. As we would like to discuss anytime at 800-714-0303 it is this incredibly important information that becomes the basis for your mesothelioma compensation claim and it is extremely important. Our service is free to a person with mesothelioma or their family.” https://Kansas.MesotheliomaVictimsCenter.Com

The Kansas Mesothelioma Victims Center would like to emphasize theirs is a statewide initiative available to a diagnosed victim anywhere in Kansas including communities such as Wichita, Overland Park, Topeka, Olathe, and Lawrence. www.karstvonoiste.com/

For the best possible mesothelioma treatment options in Kansas the Kansas Mesothelioma Victims Center strongly recommends the following heath care facility with the offer to help a diagnosed victim, or their family get to the right physicians at this hospital. Cancer Center of Kansas Wichita, Kansas: http://www. cancercenterofkansas.com/

High-risk work groups for exposure to asbestos in Kansas include Veterans of the US Navy, power plant workers, manufacturing workers, industrial workers, aerospace workers, plumbers, electricians, welders, auto mechanics, machinists, and construction workers. Typically, the exposure to asbestos occurred in the 1950’s, 1960’s, 1970’s, or 1980’s. https://Kansas.MesotheliomaVictimsCenter.Com

The states indicated with the highest incidence of mesothelioma include Maine, Massachusetts, Connecticut, Maryland, New Jersey, Pennsylvania, Ohio, West Virginia, Virginia, Michigan, Illinois, Minnesota, Louisiana, Washington, and Oregon. Mesothelioma also happens in Kansas. www.karstvonoiste.com/

For more information about mesothelioma please refer to the National Institutes of Health’s web site related to this rare form of cancer: https://www.cancer.gov/types/mesothelioma.

Michael Thomas
Kansas Mesothelioma Victims Center
800-7140-0303
email us here


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