FDA Might Change Electroshock Therapy Risk Classification

The Food and Drug Administration is currently considering changing the risk classification of the electroshock devices which have been used in the medical world for a very long time.

The psychiatrists believe that if the F.D.A will downgrade the risk classification of these devices, they will be used much more often that they have been used in the past. In the more recent years the procedure was no longer used because it was considered to be too dangerous for the human health. The patients who received the electroshock, the majority of them being women, were anesthetized, and then received a small jolt of electricity. The electroshock treatment lasts for a few seconds, but the brain convulsions and seizures last for minutes. The patients who receive this treatment usually suffer from major depression, but it can be administered for other illnesses as well. Currently the electroshock treatments are considered to be high risk, and the leading specialists in the domain such as the American Psychiatric Association stated that the F.D.A should move the procedure to a medium risk state. The decision will be taken this week, and the opinions about it are split.

The debate over this treatment took place for a very long time now. F.D.A wanted to declare the treatment as being safe, in 1990, but they never managed to do it. The reason for that was the fact that they were contested by the opposition, and it is believed that the same thing will happen nowadays, when it comes to this decision. The decision is very important, because it will change the way in which the equipments used for the procedure are being sold. If they are downgraded, then the equipments will be sold without new testing. This means that people would be able to buy these equipments with the same ease with which they can buy syringes, and other similar devices. If the F.D.A will make this decision, it is very likely that they will be contested. The same thing could happen if they will leave them in the high risk category, because the manufacturers of these devices have threatened that they will remove them from the market. Some believe that the F.D.A will introduce them in the medium category, but they believe that they will demand certain tests before they will make the decision. It is a known fact that if they will reduce the risk classification of the therapy, it will be used more often by the various psychologists from the country.

The psychologists seem to favor these devices, as they have stated that they are not as dangerous as they were in the past. They believe that even if the F.D.A demands tests on the devices, they will not be completed, as the tests would be too expensive for the manufacturers. There are many who are against this treatment method, and the majority of them are former patients who have undergone electroshock therapy. They stated that the treatment is much more dangerous than it is believed, and that it can cause memory loss and all sorts of other complications. Vera Hassner Sharav, who is the president of the Alliance for Human Research Protection, stated that the electroshock therapy has not been analyzed, and that they are more of a trial and error. He stated that no one bothered to test if these treatments are safe or not, beneficial or not. He stated that the patients who received the treatment, were used as guinea pigs. There are two companies which make these devices in the United States of America: Somatics L.L.C. of Lake Bluff, Illinois, and the Mecta Corporation of Lake Oswego, Oregon. The meeting where the issue will be debated will take place on Thursday, and the F.D.A has asked these two companies to submit as much information about the devices as possible. They want to see if these devices are safe or not, and to understand more about their effects on the people.

Somatics was founded in 1983 by Dr. Richard Abrams and by Dr. Richard Abrams. They have sent an e-mail to the F.D.A in which they stated that they had more than 10,000 patients who underwent this treatment, and that none of them suffered from memory loss. The two said that the side effects of the treatment are not too big, and that they are not a concern for health. However, they stated that they can not afford conducting a study, because they would need to pay millions of dollars for it. The industry is not lucrative, and it can not afford conducting this study either. The officials from Mecta did not make any comments, but one of the women who answered the telephones at the company said that they have to meet harsh criticism very often. They are being blamed for affecting the health of the people, whereas things are completely different. Some say that these companies can afford paying for the tests, but that they do not want to. The critics have stated that each of these companies make more than $1 million each year. They do not reveal how much they make because they do not have to do it, as they are a private company. The devices sold by the companies can be found in more than 1,000 hospitals from the United States of America.

Dr. Charles H. Kellner, who is a top researcher, professor and chief of geriatric psychiatry at Mount Sinai School of Medicine in New York, said that these devices can save lives, as they are used in the case of the people who suffer from clinical depression. In the majority of the cases they are being used when there isn’t an alternative. The Government Accountability Office recommended the F.D.A to make the reviews for the electroshock devices and for 20 other similar devices used in medicine. The Government Accountability Office stated that these devices which are in the high-risk category for the moment should undergo a revision, and they should be placed in the medium-risk or low-risk category if it is discovered that they are not as harmful as it was believed. The electroshock therapy lasts between two and four weeks in the majority of the cases, and three sessions per week are required. They are expensive, as a single session costs between $1,000 and $2,500. This means that one could pay $30,000 for the complete treatment. The equipment can be purchased for $15,000, and it is durable, as it usually lasts numerous years. The patients who receive the treatment receive a very powerful anesthesia.  However, the anesthesia is very short, as the session lasts two or three minutes.

The muscles of the patients become completely relaxed when he is under the anesthesia. The reason for that is to prevent pain. The patient also receives a mouth guard in order not to bite his tongue. The patient can go home 2 hours after the session, and in 10 minutes after he received the shock he is awake. In 2007, a study financed by the government took place, and it was discovered that there were lots of female patients who suffered from memory loss because of the treatment. 347 patients participated to the study, and the ones who conducted it, stated that the results were worrying. They said that the worrying thing was the fact that each doctor had a different method of conducting these therapies. The time and the voltage used ranged from person to person, as there wasn’t a general guideline regarding the usage of these devices. They said that because of this, lots of problems can arise. If one uses the device too aggressively, the patient can be damaged. On the other hand, if he uses to leisurely, then the patient might not feel the benefits of the treatment.

However, the majority of the doctors have stated that the devices which they use today are totally safe. They said that one of the biggest misconceptions about them is the fact that they are like the ones seen in the movie, such as “One Flew over the Cuckoos Nest”. He stated that those devices which can be seen in the movie, existed in the past, but that they are no longer used. The new devices are represented by the electroconvulsive therapy, or E.C.T, and that it is much more different than the ones from the past. The doctors stated that if these devices would have been useless and ineffective, they would have not been used. Since they are still used nowadays, that is a clear sign that they have their share of benefits. On of the most interesting thing is the fact that the patients feel better after the treatment, and the doctors do not know why. They do not know the way in which the treatment influences the brain, but they know that they are beneficial. They stated that they intend to find out the exact processes which take place in the brain during and after the treatment. There are lots of activities which take place in the brain during the therapy, and the doctors have stated that they do not know for the moment which of those activities are beneficial for the human being and why.

It seems that the patients’ opinions about these devices are split as well, as there are many who said that they did not help them, but on the contrary, that it damaged them, whereas many patients have stated that the treatment saved their lives. Many have said that they are almost 100 percent sure that they would have committed suicide if they would have not received the treatment. The electroshock therapy is not used only in the case of the clinically depressed people, but in the case of the people who need a fast treatment as well. The elder are part of this category, because in the majority of the cases they can no longer take aggressive medications for their illness, as the medication would only make their health condition worse. The suicidal people also receive this treatment, as in their case the doctors need to get them out of that state very fast. They can not afford testing various medications on them. In order to treat depression, various medications must be used, as many of them might not be effective. It is a trial and error process, as the doctor uses various options in order to discover the most beneficial one. Dr. James H. Scully Jr., who is a medical director and chief executive of the American Psychiatric Association, is one of the people who have stated that the treatment is very effective. He has sent a letter to the F.D.A, in which he stated that 80 percent of his patients have benefited from the treatment. He also stated that there is no proof that the therapy causes damage to the brain. He believes that the rumors are false, and that they were used in order to ruin the reputation of these devices.

There are many other doctors who have stated that the electroshock therapy is useful, such as Dr. Laura J. Fochtmann, who is a member of the task force, and a professor and director of the Electroconvulsive Therapy Service at Stony Brook University Medical Center, Long Island. She said that only the people who have very serious conditions will be subjected to the treatment, and in the majority of the cases it works. The people who receive this treatment usually do not have other alternatives. The interesting fact is that there are very few doctors who are against the electroshock therapy, as the majority of the opponents are represented by the doctors. Dr. Peter R. Breggin is one of the few doctors who are against the treatment. He said that the treatment is being used because it is very lucrative. He stated that the patients are usually tricked into it, and that the majority of the people who undergo it are elder people. He believes that the old people who suffer from depression do not need this treatment, but what they need is affection. There are also many other doctors who have stated that the costs for these treatments are too expensive, and that the results are not worth it.

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