Guest guest Posted December 16, 2004 Report Share Posted December 16, 2004 Hi y'all, There is nothing NEW about this .. its been a matter of discussion for many years now .. and I doubt if the FDA is the only international drug watchdog agency that has problems such as this. Governments don't do all that good a job of monitoring anything .. and usually they bite off more than they can chew. Another good reason .. methinks .. for less government. Watch as the EU Parliament grows .. they must over enforce/overprotect if they are to be effective at all. In time, they will limit the freedom of choice of member countries and force themselves out of a job. That is the nature of government. On the other hand, the major mega-buck, multi-national pharmaceutical companies are slicker than greased owl snot .. they know all the right buzz words .. have a platoon of slick catfish lawyers assisting them to stay just on the " technical " legal side of the fence .. and the AMA and FDA just follow them around and push what they peddle. Y'all keep smiling. :-) Butch http://www.AV-AT.com -- Many FDA Scientists Had Drug Concerns, 2002 Survey Shows By Marc Kaufman Washington Post Staff Writer Thursday, December 16, 2004; Page A01 Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality. The survey of almost 400 scientists also found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they are on the market, and that more than a third were not particularly confident of the agency's ability to assess the safety of a drug. _____About This Series_____ The series identifying and documenting the shadow market for prescription drugs resulted from a yearlong investigation by two Washington Post reporters that included more than 500 interviews and the analysis of 100,000 pages of court filings, regulatory cases, investigative reports and computer records. The results of the survey, conducted by the Department of Health and Human Services' inspector general, appear to support some portions of the controversial Senate testimony last month by FDA safety officer David J. Graham. The 20-year agency veteran told senators that the FDA was unable to keep some unsafe drugs off the market, and that scientists who dissented about drug safety and effectiveness were sometimes pressured and intimidated. Graham's testimony, at a hearing into the sudden withdrawal from the market of the arthritis drug Vioxx, put a spotlight on the FDA's safety and management record. Top FDA officials later criticized Graham's testimony as inaccurate and unscientific, but the survey results indicate that some other agency scientists share similar views. " I think this provides evidence that among the reviewing scientists at FDA, their experiences mirror the testimony I gave before Congress, " Graham said yesterday. " It also shows the unfortunate experience of many mirrors what happened to me when I tried to bring safety issues to my managers and the American public. " The complete survey will be made public today by the Union of Concerned Scientists and Public Employees for Environmental Responsibility, two public interest groups that received the documents through the Freedom of Information Act process. The Washington Post obtained a copy yesterday. When the inspector general's report on the effectiveness of the FDA's drug review process was released in March 2003, administration officials focused on the conclusion that FDA reviewers and drug sponsors " have confidence in the decisions FDA makes. " The report also highlighted the agency's effectiveness in reducing the time it takes to review a new drug approval. The survey was conducted as part of the inspector general's inquiry, but only parts of it were included in the report. The dissenting voices of some FDA scientists were not generally represented in the study, by former inspector general Janet Rehnquist. In a statement, the FDA said yesterday that the study showed that overall, " FDA medical reviewers found their work at the agency to be rewarding -- a result consistent with many other quality of workplace surveys conducted throughout the government which have shown that FDA workers are proud of the agency and the service it provides to the American people. " While the final inspector general's report emphasizes the agency's successes, the survey, conducted at the FDA's request, found underlying concern and discord. For instance, 36 percent of scientists said they were only somewhat confident, or not confident at all, in the FDA's decisions regarding drug safety. When it came to drug effectiveness, 22 percent of scientists said they were only somewhat confident, or not confident at all, in the agency's decisions. As described in the report, drug manufacturers reported significantly greater confidence in both categories. Some of the most dramatic Senate testimony that Graham delivered involved what he described as efforts by FDA supervisors to silence him and pressure him to limit his criticism of the safety of some drugs. In the survey, 63 of 360 respondents -- 18 percent -- said they had been " pressured to approve or recommend approval for a [new drug application] despite reservations about the safety, efficacy, or quality of the drug. " Similarly, 21 percent of survey respondents said the work environment at the FDA's Center for Drug Evaluation and Research either allowed little dissent or stifled scientific dissent entirely. Steven K. Galson, acting director of the center, has acknowledged some problems regarding safety reviews and the handling of internal scientific dissent at his agency but has described them as limited. Nonetheless, the agency last month asked the congressionally chartered Institute of Medicine to look into the FDA's system for assessing drug safety. The FDA drug reviewers were also highly skeptical of the agency's ability to monitor the safety of prescription drugs once they are on the market. In all, 6 percent said they were " completely confident, " 28 percent said they were " mostly confident, " 47 percent said they were " somewhat confident " and 19 percent said they were " not confident at all. " Rehnquist's report found that some FDA reviewers believed that the speeded-up process for reviewing drugs required by Congress was causing morale problems among overworked scientists. More than half of respondents said they did not think there was sufficient time to conduct an in-depth, science-based review in the six months required for drugs given " priority " status. Graham, who participated in the inspector general survey, said he had never seen the complete survey results before. The findings are consistent with a 2001 study conducted by Public Citizen's Health Research Group. 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Guest guest Posted December 19, 2004 Report Share Posted December 19, 2004 Heya: Something else, too. A lot of doctors are over-worked and stretched too thin. I think (I could be wrong) that many of them are at the mercy of what pharmaceutical reps tell them when they come in with their samples, literature, spin, and free pens, notepads, and knick-knacks (do they leave those things in order to remind the doctor to use the stuff they're selling?? It usually has the drug name all over it....just a thought). I don't think a lot of these doctors have time to look up info about the drug, it's effectiveness, etc...if they even have access to it (I would hope so). I only think those things because my p-doc gave me a lot of things that turned out in the long run not to be very effective for people w/ bipolar (and things that made it much, much worse). There is a lot of pressure/money-to-be-made to help people with neurochemical disorders such as depression, bipolar, schizophrenia, and what-not. It's apparent that a lot of stuff got pushed out there before they even proved w/out a doubt that it was really effective in treatment. But it was NEW, BETTER, LESS SIDE EFFECTS...yeah, more expensive (ask me how I know...$15 per pill??? and I need how many?!!!?) Many folk are paying out twice. Plunk-plunk (sound of 2 cents): Drae - Butch Owen 12/16/2004 8:40:46 AM OT: Drug Concerns Hi y'all, There is nothing NEW about this .. its been a matter of discussion for many years now .. and I doubt if the FDA is the only international drug watchdog agency that has problems such as this. Governments don't do all that good a job of monitoring anything .. and usually they bite off more than they can chew. Another good reason .. methinks .. for less government. Watch as the EU Parliament grows .. they must over enforce/overprotect if they are to be effective at all. In time, they will limit the freedom of choice of member countries and force themselves out of a job. That is the nature of government. On the other hand, the major mega-buck, multi-national pharmaceutical companies are slicker than greased owl snot .. they know all the right buzz words .. have a platoon of slick catfish lawyers assisting them to stay just on the " technical " legal side of the fence .. and the AMA and FDA just follow them around and push what they peddle. Y'all keep smiling. :-) Butch http://www.AV-AT.com -- Many FDA Scientists Had Drug Concerns, 2002 Survey Shows By Marc Kaufman Washington Post Staff Writer Thursday, December 16, 2004; Page A01 Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality. The survey of almost 400 scientists also found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they are on the market, and that more than a third were not particularly confident of the agency's ability to assess the safety of a drug. _____About This Series_____ The series identifying and documenting the shadow market for prescription drugs resulted from a yearlong investigation by two Washington Post reporters that included more than 500 interviews and the analysis of 100,000 pages of court filings, regulatory cases, investigative reports and computer records. The results of the survey, conducted by the Department of Health and Human Services' inspector general, appear to support some portions of the controversial Senate testimony last month by FDA safety officer David J. Graham. The 20-year agency veteran told senators that the FDA was unable to keep some unsafe drugs off the market, and that scientists who dissented about drug safety and effectiveness were sometimes pressured and intimidated. Graham's testimony, at a hearing into the sudden withdrawal from the market of the arthritis drug Vioxx, put a spotlight on the FDA's safety and management record. Top FDA officials later criticized Graham's testimony as inaccurate and unscientific, but the survey results indicate that some other agency scientists share similar views. " I think this provides evidence that among the reviewing scientists at FDA, their experiences mirror the testimony I gave before Congress, " Graham said yesterday. " It also shows the unfortunate experience of many mirrors what happened to me when I tried to bring safety issues to my managers and the American public. " The complete survey will be made public today by the Union of Concerned Scientists and Public Employees for Environmental Responsibility, two public interest groups that received the documents through the Freedom of Information Act process. The Washington Post obtained a copy yesterday. When the inspector general's report on the effectiveness of the FDA's drug review process was released in March 2003, administration officials focused on the conclusion that FDA reviewers and drug sponsors " have confidence in the decisions FDA makes. " The report also highlighted the agency's effectiveness in reducing the time it takes to review a new drug approval. The survey was conducted as part of the inspector general's inquiry, but only parts of it were included in the report. The dissenting voices of some FDA scientists were not generally represented in the study, by former inspector general Janet Rehnquist. In a statement, the FDA said yesterday that the study showed that overall, " FDA medical reviewers found their work at the agency to be rewarding -- a result consistent with many other quality of workplace surveys conducted throughout the government which have shown that FDA workers are proud of the agency and the service it provides to the American people. " While the final inspector general's report emphasizes the agency's successes, the survey, conducted at the FDA's request, found underlying concern and discord. For instance, 36 percent of scientists said they were only somewhat confident, or not confident at all, in the FDA's decisions regarding drug safety. When it came to drug effectiveness, 22 percent of scientists said they were only somewhat confident, or not confident at all, in the agency's decisions. As described in the report, drug manufacturers reported significantly greater confidence in both categories. Some of the most dramatic Senate testimony that Graham delivered involved what he described as efforts by FDA supervisors to silence him and pressure him to limit his criticism of the safety of some drugs. In the survey, 63 of 360 respondents -- 18 percent -- said they had been " pressured to approve or recommend approval for a [new drug application] despite reservations about the safety, efficacy, or quality of the drug. " Similarly, 21 percent of survey respondents said the work environment at the FDA's Center for Drug Evaluation and Research either allowed little dissent or stifled scientific dissent entirely. Steven K. Galson, acting director of the center, has acknowledged some problems regarding safety reviews and the handling of internal scientific dissent at his agency but has described them as limited. Nonetheless, the agency last month asked the congressionally chartered Institute of Medicine to look into the FDA's system for assessing drug safety. The FDA drug reviewers were also highly skeptical of the agency's ability to monitor the safety of prescription drugs once they are on the market. In all, 6 percent said they were " completely confident, " 28 percent said they were " mostly confident, " 47 percent said they were " somewhat confident " and 19 percent said they were " not confident at all. " Rehnquist's report found that some FDA reviewers believed that the speeded-up process for reviewing drugs required by Congress was causing morale problems among overworked scientists. More than half of respondents said they did not think there was sufficient time to conduct an in-depth, science-based review in the six months required for drugs given " priority " status. Graham, who participated in the inspector general survey, said he had never seen the complete survey results before. The findings are consistent with a 2001 study conducted by Public Citizen's Health Research Group. 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Guest guest Posted December 19, 2004 Report Share Posted December 19, 2004 Drae, I see your point here but the reason doctors are so overworked and stretched too thin is that they try to see TOO many patients in one day. And of course, $$ is the bottom line here. Please don't take this as a slam, because it is not meant to be, it is just a rant on my part because I am VERY impassioned about the abuses so-called medical community heaps on the citizens in this country! I remember years ago when a doctor had a nice little office, a receptionist and a nurse. You had an appointment, got in to see your Dr on time (most Drs now have a 2 hr wait) he actually knew your name, shook your hand, looked at you (not the file) while you talked about the reason for the visit. Nowadays Drs breeze in, sit down with a file or computer in front of them and never look you in the eyes.... if you are lucky you might get 5 minutes of his *time* in the room with you. Multiply that by 6-8 patients an hour X$$$$$$ and these guys are making money hand over fist....and making people sicker every day. Most people in our small town take on an average 12 scripts per day! That is ludicrous! Senior citizens walk into the Drs office with plastic grocery bags of med bottles to be refilled, and usually walk out with another script or two! This isn't medicine. This isn't healing! This is the bottom-line, gigantic profits for pharma companies and the Drs that do their pimping for them.... As for the drug reps, they get more of the Drs time than you do! It is the responsibility of a Dr to know what the side effects of drugs are that he prescribes to his patients! Drs now rely on Pharmacists to print out little papers to send home with the drugs and to catch any *whoops this won't work with that one you are taking* problems! It is the responsibility of the FDA - after all, this is their job - but they pimp and pander to the Pharma companies......boy has this come back on them big-time in the last few weeks and left them with egg on their face with Vioxx, Celebrex, etc..... People need to take back their power, learn more about their bodies and if they go to a Dr. ask questions when he wants to give a script to them! Go home, look up the side-effects, decide for yourself if this is good for you or not.... cripes, people are such sheeple nowadays! Okay, it's time for me to get another cup of coffee and chill! Sorry for the rant guys, and so early in the a.m. but as an alternative health care professional, it really pisses me off when people come to me in a mess and I see what Drs and drugs have done to people who were healthy! Sandi BlackKat Herbs http://www.blackkatherbs.com > Quote Link to comment Share on other sites More sharing options...
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