 If the Food and Drug Administration and Congress get their way, it will become much easier for the mainstream psychiatry community to utilize unregulated, dangerous electroshock therapy, even though it has been proven to be ineffective and mentally damaging in the past. An alert sent out by the Citizens Commission on Human Rights International, a mental health watchdog group, says that the FDA is seeking to lower the classification of Electroconvulsive Therapy (ECT) devices from the highest Class III rating to Class II, the same category as air purifiers and contact lenses. 'Any medical experts, healthcare professionals, lawyers, ECT survivors and their families/friends that could provide knowledge of the damage ECT causes should comment and oppose the ECT device being rated as Class II for the treatment of any mental disorder,' says the alert. According to the proposed rule change [ here ], the devices are being reclassified 'for use in treating severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients 18 years of age and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition ... based on new information.' 'The FDA is doing this despite 3,045 people responding to an earlier public docket on ECT in 2009, of which 79% opposed reclassification and only 14% supported it and where 1,857 or 61% of the respondents reported a negative effective from ECT ,' CCHRI stated. What's more, the group said, the FDA is well aware of the health risks in using ECT devices. Meaningless 'special controls' 'The FDA admits in the Proposal that there are risks of irregular heartbeat or ischemia/infarction (i.e., heart attack); high or low blood pressure; cognitive and memory impairment, 'ECT treatment may result in the development of hypomanic or manic symptoms,' prolonged seizures, moderate pain following the induced seizure and Death may result from various complications of ECT such as reactions to anesthesia, cardiovascular complications, pulmonary complications, or stroke,' said the organization. CCHRI said the FDA denies that the devices can cause brain damage, even though patients who had received ECT treatment have testified otherwise. What's more, the FDA's claims that it will impose 'special controls' on the devices is largely meaningless, the group said, noting they were largely 'labeling provisions' to include: -- Disclosure of contraindications, precautions, warnings, and potential adverse effects/complications...and patients can be advised of conditions under which ECT treatment should not proceed; -- Specific device use instructions including information regarding conduct of pre-ECT patient assessments; and information on appropriate patient monitoring during an ECT procedure) to minimize potential ECT procedural complications. The mental health watchdog said the FDA's reclassification of the devices would not include treatment for other mental disorders including schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia. The agency proposes to leave the devices at the Class III level, meaning they would require a Premarket Approval (PMA) within 90 days. However, the watchdog said, the FDA has known since 1979 that 'device manufacturers have refused to [submit PMAs] and the companies and psychiatrists from the American Psychiatric Association claim its 'too expensive' for the manufacturers to conduct clinical trials.' No oversight 'Additionally, the FDA states that it did not find sufficient evidence to show that even with 'special controls' implemented, the device would be safe and effective for these other disorders (but apparently it's OK to administer hundreds of volts of electricity if you are older than 18 with either or both of the specified disorders),' CCHRI said. In addition to the proposed rule change, Medicine.news reported in January that legislation has been introduced in Congress to relax medical device standards. That bill, the 21st Century Cures Act , introduced by Rep. Fred Upton, R-Mich., would essentially allow medical devices to be used on patients without their prior consent. The measure completely 'relaxes scientific standards, virtually guaranteeing insufficiently tested drugs will hit the market only to be recalled after the damage is done,' says Lee Spiller, CCHRI's executive director. Sources: Congress.gov Medicine.news <='' a=''> Science.selfnews.com 