Wednesday, June 29, 2022

Comments by KDP

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  • I started TMS for other reasons, Fibromylegia, stress, severe body pain, spine degeneration, Osteasthritis and nerve issues. However, working for FDA, especially in device regulatory agency, I was surprised, why I never heard of this device, as I am familiar with most of the devices. I wanted to find positive experience but finding all negative response. So, I read all blogs and now having a second thought. So far, I finished seven sessions and get severe headaches, which I never experienced before. I am not sure if I would continue the treatment at this point. I would like to educate about FDA So, this is what I am addressing 1) This TMS device Neurostar is not “FDA approved”. It is ‘FDA Cleared”. The difference is, FDA approved device require clinical studies and clinical data of the device usage from real patients. FDA Cleared is simply, a device, which is equivalent to the similar device in market, before 1978. For example, if there was a massager for head, which can simply use for the similar function and it was used in 1900, the manufacture can tell that TMS is similar to that device, and FDA can give the clearance. No data are reviewed or required by FDA. 2) FDA inspects device manufacturer but if the device is not very critical, it is not a high priority. Also, each investigator varies and one investigator might not find any issues, next investigator after two years may find issues. So, it depends on how deep the investigation was performed. Therefore, there was nothing I found on TMS. 3) The manufacturer’s promotion of “FDA Approved” is in violation of FDA Act. Some one should complain to FDA about this. It is a misbranded device. 4) FDA require doctors, user, patients and manufacturer to report any “Adverse events” to FDA (Link is http://WWW.FDA.GOV and search Adverse event reporting under CDRH). Anyone can report device malfunction, serious injuries and death to FDA. When an investigator inspects mfr., they review these complaints. However, if manufacture don’t report to FDA, FDA will not know about it. So, I highly recommend all bloggers to report events to FDA. This applies for food, drugs, devices etc.

    Do not think, FDA is your police or protector. You are in charge of your own health, just like don’t think, doctors are your protector or they have magic wand. They are just like you and I , who can also have similar health issues. Just a simple example, if in your house, there are two people who ate same food but one may get sick and the other don’t get sick. Each person reacts differently to the drugs as well. I tried so many antidepressants, pain medicines but nothing helped. Even if you say, drugs are approved by FDA, so it works. You are wrong. I know how drug companies and device companies lobby and have laws in their favor. Same way, do you think, one drug will act to your body the same way, as it was to the other? I am frustrated because there are so many loopholes in our system. Doctors are brainwashed by pharma companies, favored by pharma companies and many times, they are hired by pharma companies to be either on their board, as a consultants, to do clinical research for them etc. The ethics requirement is to pay very nominal amount to the doctors and that is one of the FDA requirement for the doctors who participates in clinical trials. However, there are many other ways, doctors are paid to favor the pharma companies. as I mentioned before. Also, if there is a death or serious injury reported to FDA by the user or other doctor, most of the times, manufacturer blames doctor that he/she did not use the device properly as described, how to use. Many times, they employ or hire doctor as their consultant, who writes investigation report as either it is patient’s condition responsible for the injury, or the patient’s anatomy responsible for the injury and not the device. I have seen enough during my entire career with FDA. Even working for FDA, I myself experienced many adverse events in my family, including the death of a child due to the faulty device and I was frustrated that FDA did not take any action. I have seen legitimate lawsuit by patients but at the end, companies know how to get around proving the patient to be blamed for.