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‘I suspect that you have some urology problem; and you need to see a urologist’‘Sir, Urologists are dangerous; they might kill you’‘What nonsense’‘Sir, my friend went to see a urologist and half-an-hour later he died’.‘Oh ok ok, must be a heart attack; but the doctor is not responsible for that’‘No, no sir; a car accident’‘You must be crazy. How can the doctor be responsible?’‘Sir, the Doctor was driving the car’.Nice WhatsApp humour?But wait, the new directive of the Drug Controller General of India office (CDSCO) says that if a patient included in a ‘Clinical Drug Trial’ (say a new cancer drug) dies because of an unrelated issue like a car accident, the drug manufacturer has to compensate up to Rs. 20 Lakhs (in the same way as he would have been compensated if he died of the experimental drug related side effects).The world of medicine progresses because of Clinical Drug Trials.Aspirin was synthesized by German chemist Felix Hoffman in 1897 and used for long for arthritis.Lawrence Craven in 1950 suspected that it prevents blood clot and might be useful for treatment of heart attack. Large clinical trials were done (half on aspirin and half on placebo) which proved the benefit of aspirin.Now look at the graphs. The top line is where aspirin was not used, had death rate of 11.8% while in aspirin group it was 9.4%. Unless a rigorous clinical trial was undertaken, no doctor could have confirmed or refuted benefit of aspirin. After all, the first 20 patients on aspirin all can die, but the tablet may still be effective. A comment of the doctor that ‘in my experience it works’ has little value.A terminal cancer patient or a severe heart failure patient wants something to hold on to, to keep their simmering lamp of hope burning. Do we have a right to blow it off by scrapping clinical trials in the country; labelling them as unethical considering patients in trials as guinea pigs and doctors who undertake trials as a money-making businessmen whose only intention is to make money out of a misfortune called illness?I myself have stopped asking my patients to partake in clinical trials. Why should I put my reputation at stake, when I have a long appointment list and no time to breathe?The present scenario of clinical trials is dismal. Look at the statistics.(all photo : Google)When my mom was suffering from rapidly progressive non responding dementia, I enrolled her for a new drug trial. The trial failed; but I would get up every morning hoping that I would see a miracle.The state of affairs scares me.

Is she selfish? Childish? Manipulative? Hostile?Does she make you feel like a dirty rag, tattered and warn from being used at her disposal?Does she suffer from some form of addiction? Does she lie frequently? Is she compulsive? Is she promiscuous?==========================================Does she hold down a steady job? Does she have any close friends? Is she close with her family?Have you ever had a successful conversation about your feelings, something thats upsetting you? Is she able to feel remorse? Has she ever apologized for anything shes done to hurt you or other around you?If you answered mostly yeses to the first section, and mostly nos to the second, you are probably dealing with an ASPD (sociopath/psychopath/narcissist). The more yeses/nos the higher on the spectrum.My mother fell around mid mark, she was no murderer. But I suspect only because landing in prison would seriously detract from her ability to do whatever the hell she wanted. She waned from periods of calculative manipulation, to periods of extreme impulsivity. She has done horrible things to the people in her life, yet feels she should be thanked and praised for the sacrifices she has made for the sake of others. Has had regular extramarital affairs, used her husband (my step dad) worse than anyone else. Stolen his money, car, dignity.. Pawned his deceased mothers wedding ring, for money to feed her insatiable gambling addiction.She married my father because she was pregnant with me. Within a year she was pregnant with another man's baby. They divorced and my step dads life long decent into hell began. **This man is an absolute saint.**She was hardly around when my sister and I were growing up. When she was home, she was rumaging through peoples things, looking for anything she could pawn. Or she was entertaining a variety of men. We regularly went weeks without hydro, heat, or food after she cleared the house of money or valuables to go on her adventures. When she came home she would be dancing around the apartment asking how much we missed her. When we said we were hungry she would say “then why don't you eat, silly?” She was oblivious to our suffering. My step dad started leaving my sister and i with his brother out of defeat. Finally heads came to a blow and they seperated for a year. My sister went with her dad, and I with my mother, cause he was not legally in the right to take me.I was 8. And my mother was absent for substantial amounts to time. I was left to fend for myself. I would find money on the ground on my walks to and from school, and I wrote a note saying my mom was sick that i could show to the people at the local corner store or coffee shop and they would give me a soup or some cookies. My mom would pop in for a day here and there, but if i tried to tell her that i was scared and lonely she would just get irritated and leave. While she was gone one time i came down with Impetego. I didnt know what was happening, this big scab was growing over my face. Not knowing what to do, and having no internet back then, i decided to stop doing to school. There was a bus that dropped high school kids off around the time my bus was supposed to drop me off, and i asked one of the girls if she would call the school for me. She did, she also took me to a walk in clinic, which is where i found out it was Impetego. A very contagrious infection. He gave me a note for the school saying that i should be home for a minimum of 8 weeks. The girl brought that for me too, and brought home a bunch of school work. She started coming down to keep me company after she got home from school, for about a week until my mom came home, and almost beat the poor girl up. At this point i had stopped trying to talk to my mom. I just let her do her thing. Then one day my step dad and sister showed up, and saw how i was living and he promised me he would never leave me again. I didnt think he meant hed stay with my mom but i guess she couldn't take me, and she would never let him adopt.. Things were somewhat smooth until I hit grade 6. My hormones were all out of whack due to pubery, and i was feeling so many things. My mom was *trying* to do the mom thing now, but only for apperances. Over the course of the school year i gained a lot of weight.. I went from 110, to 175 pounds. The kids at school were awful. But my mom was worse. I became the focal point of her recent boredom. Every day she would ridicule me, poke me, chase me around the house making pig noises and laughing at me for being fat. No matter where i hid she would find me, and make fun of me for being a big fat baby. I finally snapped one day while in Niagara falls. My step dad thought it would be a good idea to get out as a family. We did the mazes and assorted things, when we went to Ripleys Believe it or Not. I was really busy and slow moving. But we made our way through. Near the end is an exhibit for “fattest man ever” with a giant scale beside to compare .. My moms face lit up.. “Oh guys this looks like fun, lets try it” my family hops on and i tell her i dont want to. She pleads, i ask her to leave me alone. She sways me with “oh come on, ya big baby” on i get.. To see the scale jump by 180 pounds. My mother bursts into laughter yelling in front of everyone “holy shit Jessica, you really need to lose some weight. What happened to my daughter? Did you eat her?” The sea of eyes staring as the words came out of her mouth made me so ashamed. I started crying and ran out of there as fast as i could. My sister and step dad came running after me. We went back to the car, and left my mother to find another way home. After that i barely talked to her. Once i started high school i would stay out as late as possible, and sleep at friends whenever i could. Until second semester of grade 10. I came home for lunch with a friend from school. She had a joint i was going to try for the first time. She lit it, and doesnt my mother come through the gate. It was her 3rd day at probably her hundredth job in the last 2 years, and she had come home cause she couldnt handle the people. She could smell the weed, and smacked the joint out of my friends had and told her to leave. She did. My mom just stared at me for what felt like 20 minutes. I hadnt even taken a puff but i knew that didnt matter. She told me to pack my things and get out of her house. I did. I was glad to. I didnt know i was about to spend 18 months (2 canadian winters) living on the street. The first winter was rough. But i quickly figured out the keys to my success, and im sooo thankful that i didnt break and ask her to let me back in…Fuck sorry this is long, ill be shocked if anybody makes it this far..

At the current time, FDA issues the following types of Export Certificates, although not all certificate types are issued for every FDA regulated product:The "Certificate of Free Sale" (Certificate of Export for Seafood) is for food, including dietary supplements, and cosmetic products that may be legally marketed in the United States. (CFSAN)The "Health Certificates for Food/Feed" currently required primarily by the European Union (EU), are usually consignment-specific and often contain language pertaining to "compliance" of the particular product/consignment with foreign regulations. As a matter of policy, FDA does not issue export certificates that attest to compliance with another country's requirements. Rather, FDA may work with other governments to develop mutually acceptable language for the certificate, e.g., language recognizing "equivalence" rather than "compliance". (Office of Regulatory Affairs-Field Offices)The "Specified Risk Materials of Bovine, Ovine and Caprine Origin Certificate" is used for the export of gelatin that can be legally marketed in the United States. These certificates address concerns on raw material in regard to transmissible spongiform encephalopathies. (CFSAN)The "Certificate of a Pharmaceutical Product" conforms to the format established by the World Health Organization (WHO) and is intended for use by the importing country when considering whether to license the product in question for sale in that country. (CBER, CDER, and CVM)The "Non-clinical Research Use Only Certificate" is for the export of a product, material, or component, for non-clinical research use only, that is not intended for human use and which may be marketed in, and legally exported from, the United States under the Act. These non-clinical research use only materials will be labeled in accordance with 21 CFR 809.10(c)(2) or 21 CFR 312.160, as appropriate, and exported as they are presently being sold or offered for sale in the United States. (CBER and CDRH)The "Certificate to Foreign Government" is for the export of human drugs and biologics, animal drugs, and devices that can be legally marketed in the United States. (CBER, CDRH, and CVM)The "Certificate of Exportability" is for the export of human drugs and biologics, animal drugs, and devices that cannot be legally marketed in the United States, but meet the requirements of sections 801(e) or 802 of the Act and may be legally exported. (CBER, CDRH, and CVM)