Re: Clinical Trials and the FDA--Reply from Cathy Barnes

From: Cathy Barnes (cbarnes@nc.rr.com)
Thu Jun 7 21:50:03 2001


I am very new to ADHESIONS and I want to introduce myself. I am here because I had a laprasocopic sigmoid colon resection in July 99 that went terribly wrong…I leaked at the staples..peritonitis…emergency surgery…temporary colosotomy (4 months), a takedown (incomplete), an iliostomy (for 5 weeks) and then finally a RECONNECTION!!! –January 2000. Yeah yeah!!

But as the saying goes…nothing is for nothing. I have had 3 episodes in the last 9 months of blockages/adhesions. It is not a pleasant experience as I am sure you are all aware of. I am currently on an ostomy listserv and a dizzinews listserv. The ostomy list is obvious. I am on the dizzinews list is because I was permanently damaged by gentamicin IV and it is called bilateral vestibular dysfunction. I have about 10% remaining of my balance system.

I work full time as an Admin Asst for an education association in North Carolina. I want to work and keep working. If I had to stay home every day, I would go nuts!

I am so happy I found this site because I need to be able to talk with people who are experiencing the same discomfort/pain that I experience periodically. I have about ½ my colon left. I had every complication in the book (so I am told). I unfortunately have times of severe butt burn. I must be very careful not to get constipated. When that happens I am very likely to have a blockage.

I may not be making much sense now. It is rather late in the evening for me. Will write again tomorrow night.

Peace and Love to all, Cathy Barnes, North Carolina

PS I don’t have much faith in the FDA—this gentamicin that has damaged me comes into the USA without regulations on its components. There were instances of tainted components that came in to the USA from Chins in 1999. Interesting----don’t you think?

-----Original Message----- From: adhesions@adhesions.org [mailto:adhesions@adhesions.org]On Behalf Of Helen Dynda Sent: Thursday, June 07, 2001 11:24 AM To: Multiple recipients of list ADHESIONS Subject: Clinical Trials and the FDA

http://www.womenssurgerygroup.com/conditions/Adhesions/clinicalresearch.asp Clinical Trials and the FDA...This is a primer that every woman considering participation in an FDA-approved clinical trial should read and understand. The FDA, short for Food and Drug Administration, is the government agency responsible for ensuring the health and safety of consumers in the areas of drugs, biologics, food, cosmetic products, and medical devices. It is the agency's mission to ensure that these products are safe, effective, and are produced under sanitary conditions. In addition, all product packaging and labeling should be truthful, informative, and not deceptive in any way. The FDA: A Short History...The FDA's roots date back to 1862, when Abraham Lincoln appointed chemist Charles M. Wetherill to serve in the newly created Department of Agriculture. Wetherill's appointment marked the beginning of the Bureau of Chemistry, later the Food and Drug Administration. In 1902, the Biologics Control Act was introduced, which authorized the Public Health Service to regulate and license biological drug laboratories in the production of antitoxins used in vaccines. The catalyst for this act was the death of 10 children after they received a vaccine shot. It was later discovered that the horse used in the production of the antitoxin was infected with tetanus. In 1911, in response to the widespread sales of "snake venom" and other wonder cures, the Sherly Amendment was passed. This amendment made it a crime to make false claims in drug labeling. In 1928, the government formed a separate law enforcement agency, originally called the Food, Drug, and Insecticide Administration. In 1930, the name was changed to the Food and Drug Administration. The foundation of the modern clinical trial process was enacted in 1938 with the Federal Food, Drug, and Cosmetic Act. This was also the first attempt to regulate cosmetics and medical devices. This act required that drugs be proven safe prior to marketing. The manufacturers of drugs now had to provide scientific proof of safety by submitting an Investigational New Drug (IND) filing prior to human trials, and a New Drug Application (NDA) before marketing new drug products. In 1962, the FDA was thrust into public view as a result of the discovery that the use of Thalidomide, a sleeping pill, resulted in thousands of birth defects in western Europe. Because of the FDA's role in keeping the drug off the market in the U.S., the agency received a lot of positive press. Twenty years later, the much publicized deaths of seven people from Tylenol laced with cyanide prompted the passage of tamper-resistant packaging regulations by the FDA in 1982. In 1983, the Orphan Drug Act provided incentives for drug companies to develop drugs for rare diseases. Finally, in 1992, the Prescription Drug User Fee Act was passed, which required drug and biologic manufacturers to pay application and other fees to the agency. This revenue is used to hire more FDA reviewers, and has resulted in increased efficiency in the drug approval process. The Clinical Trial Process Phase 1 Phase 2 Phase 3 Phase 4


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