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Marjorie and Rita, IN spite of my agreement with you on most things I have to take issue with you on the FDA The FDA is imperfect and my need some reorganization but to privatize the FDA is opening it up to even more abuses than it may be subject to now. The pressure to rush untested drugs to the market by drug companies will be unbelievable as will the pressure from we consumers pushed on by high expectations of the manufacturers. Remember Tocapone and the fact that that got on the market even after testing. For those of us feeling desperate I suggest getting involved in a study. Be one of the first people to try a new drug or procedure prior to its general release to the public.is admirable and necessary.. But putting a drug on the market with less knowledge than we have now in the hands or ill trained and ill-prepared MD's invites disaster. Many MD's get the majority of their information about a new drug from the drug manufacturer and will not monitor a new drug adequately, The issue of the release from Rush about Kordower's research with the monkeys and use of viral vectors to produce GNDF is a preliminary step in the research process. It may or may not bear fruit. A monkey and a person certainly are different from each other and the monkey model of PD is also different. It would be ridiculous to fan our hopes by stating that a cure for PD has been found, but it is promising research. There have been deaths involved with research into this area of genetic therapy. It is not innocuous. But Marge and Rita if you want to participate in a clinical trial and you meet the criteria I want to encourage you to contact a major PD research center and make it known that you wish to participate in drug or surgical trials. (I have taken part in one drug study and 2 surgery protocols. ) I think it is better to get a new drug or procedure in controlled conditions than expose the public to the risk of premature release and perhaps tragic results. I am not saying that the FDA is doing the best job that can be done but in their absence, I am not prepared to trust the Drug and equipment manufacturers to be objective or do the right thing by the public. In spite of the fact that I hold some stock in Medtronic - like most multinational corporations I have more trust in them to take care of my interest as a stock holder more than my interest as a user of their product. Unless a drug is potentially life-saving 18 months is not too long to wait to maximize safety and efficacy. IMHO, if the participation in the safety and efficacy studies are open to those that want to participate. Just my random thoughts about a few items being discussed here on the list. Charlie ps Rush website www.rush.edu At 11:25 AM 11/2/00 -0500, you wrote: >No Rita, >Not Gratis, > In all reality everyone who purchases >a drug pays twice, once as a taxpayer,and once as a consumer. >Do away with the FDA ,as an entity under US Department of Health >and Human Services, and set it up with a group of scientists or as >a private enterprise, using the funding currently paid to the FDA. > Drug Companies pay >to have drugs tested too, get them in on a re-evaluation of the FDA. >There just has to be a better way,and the history of the FDA > proves they are too slow!!! > >The average time for approval from the FDA is 18 months, >All PWP's know what 18 months does to their bodies, >especially after they have had it a number of years. >How many new drugs do you think are sitting there waiting >for FDA approval which would be of use to us now? > >Things have changed since the FDA was set up in 1906 , and if >one reads the History of the FDA you'll see it takes them too >long to get anything done, always has! > >I'm including this for persons who don't have research capabilities: >This is from Encarta 1998, which I have in my computer. >There are many, many books written on the history of the FDA >is someone cares to read more about it, go to your favorite library. >If they don't have a book on it, they will be happy to do an >ILL (inter library loan) for you, and they will gladly find titles >of books for you on the History of the FDA. > > ><SNIP> >The Federal Food, Drug, and Cosmetic Act was enacted in 1938 requiring that >new drugs be safe for humans; however, it did not require that >manufacturers prove their drugs' effectiveness. It would be 24 years before >legislation was passed that would require proof of the efficacy of new >drugs (the Kefaver-Harris Amendments, 1962). Enforcement of this law was >entrusted to the FDA. >Two laws enacted in the 1960s strengthened the FDA's efforts to reduce drug >abuse. The Drug Abuse Control Amendments of 1965 provided penalties for the >illegal sale or possession of stimulants, sedatives, and hallucinogens, and >the Narcotic Addict Rehabilitation Act of 1966 set up a federal program for >addicts that provided them with the option of receiving treatment for their >drug problems in place of a prison sentence. >In 1970 the Comprehensive Drug Abuse Prevention and Control Act established >rules for manufacturing and prescribing habit-forming drugs. It stipulated >that physicians can prescribe all drugs, but a special license is required >to prescribe drugs with a high abuse potential. This license is issued by >the Drug Enforcement Administration. >The Anti-Drug Abuse Acts, signed into law in 1986 and 1988, set up funding >for the treatment of drug abuse and for the creation of law-enforcement >programs to fight the illegal sale of drugs. These acts also detailed >severe punishments for individuals selling and possessing drugs illegally. >Harsh penalties for using anabolic steroids (hormones that promote the >storage of protein and the growth of tissue that are sometimes abused by >competitive athletes) were included in the 1988 act, along with the >requirement that all alcoholic beverages be labeled with warnings about >alcohol's potentially dangerous effect on the body. The 1988 act also >established the Office of National Drug Control Policy to develop an action >plan that would involve the public, as well as private agencies, in >eliminating the illegal sale of drugs; in helping individuals who use drugs >to stop; and in preventing nonusers from ever starting to use drugs. >The U.S. government and its regulatory agencies continually monitor the >development and use of all drugs sold in the United States to ensure that >the American public has access only to drugs that are safe and effective. >Recently, the FDA introduced legislation requiring warning labels on all >over-the-counter medication after research indicated that the nonaspirin >pain reliever acetaminophen can cause liver damage when taken in high doses >with large quantities of alcohol. > >END> > >Maybe it's possible that the FDA has too much to do, and not enough help, >but it certainly >needs to be brought up to speed, 18 months for approval is unacceptable in >this century. > >just me, >Marjorie >68/58/55 > > > > >At 09:39 AM 11/02/2000 -0500, you wrote: >>Marjorie said....... >> >>"MOHO, the FDA gives a new meaning to the expression "Slower than molasses >>on a cold day in January". Also in my own humble opinion, the FDA should=20 >>be removed from >>Federal Control and turned over to a private group of scientists!!!!! But=20 >>then no >>one ever asked me for my opinion!" >> >>and Rita asks.......Who is going to pay for the FDA program if the taxpayers >>don't? >>Someone must foot the bill.....where will the private group of scientists get >>the money?.......or is this just to be a "gratis" thing that is added on to >>the research platter? >> >>Rita Weeks 56/11 > >Charles T. Meyer, M.D. >Middleton, WI >PD DX 12 years (at age 44) >Age 56