Used to treat depression, and other mental illness electroshock therapy is effective and its users are working to have the treatment’s safety risk downgraded.
According to a recent article in the New York Times, federal regulators, psychiatrists, patients, and advocate groups are all sounding off on whether or not to downgrade the risk classification of Electroshock devices.Â These devices are used to administer a controversial procedure called Electroconvulsive therapy, also known as ECT.Â ECT is a procedure in which an electric current is passed through the brain to produce controlled convulsions (seizures) to treat patients with depression, particularly for those who cannot take or are not responding to antidepressants, have severe depression, or are at high risk for suicide.Â ECT is believed to act by a massive neurochemical release in the brain due to the controlled seizure. Â
This debate has stemmed from a Food and Drug Administration Review that was recommended by the Government Accountability Office in 2009.Â Such Review not only targeted ECT devices, but 20 other less controversial medical devices as well, that were grandfathered into F.D.A Regulations in 1976.
As of current, these devices are categorized in the high risk category by the F.D.A, due to the number of risks that are involved with this procedure, but the American Psychiatric Association would like to see this changed.Â They would like them to be reclassified as medium risk.Â The G.A.O, whom recommended the review, believes that the devices should go through the rigorous approval process for high risk devices, or be reclassified as medium or low risk.
For the device manufacturers, a reclassification would be extremely beneficial; but if the F.D.A rules to leave the devices in the current state, then the manufacturers worry that they may also require new testing, and this could come with a hefty price tag.Â Dr. Conrad M. Swartz, cofounder of Somatics, one of the 2 United States manufacturers that market the device used to perform the procedure in question, is quoted in the article as saying, â€œThere is not nearly enough money in this industry to begin to pay for clinical trials that would be substantially larger than those already in the medical scientific literature.â€
The F.D.A. review and reclassification is striking a nerve with many, and has renewed the debate over ECT, and many are using this opportune time to voice their opinion on the therapy itself.
According to a federally financed study in 2007, as well as Psychcentral.com the procedure includes several high risks.Â The risks include; memory loss, concentration and attention problems, general confusion, and other temporary issues, such as nausea, headaches, muscle aches or spasms and vomiting.
Patients apparently have mixed views on this matter.Â Comments received by the F.D.A. and ECT related websites show that many say that it has saved their life, while others say they suffered too much memory loss.
Doctors such as, Dr. Laura J. Fochtmann, says that â€œPeople use it because it works.Â These disorders can be extremely life threatening, and when it works, it can be dramatically effective.â€Â Opponents of ECT include some patient advocacy groups, but the opponents, are clearly outnumbered by physicians.Â Dr. Peter R. Breggin, states, â€œItâ€™s a big money maker.â€Â He further said, â€œDepressed older people can be helped more by a pet or a conversation.â€Â John Breeding, a psychologist and member of the Coalition of Abolition of Electroshock in Texas states, â€œItâ€™s a very strong treatment for despair and hopelessness.Â Itâ€™s a temporary blunting of your feelings, so you feel better for a while, then you feel worse, and now youâ€™ve got the memory loss and brain damage.â€
A ruling by the F.D.A on this reclassification is not expected until later this year.