ph4ever wrote:Hell the FDA doesn't even do research on the meds out now. The research is done by the drug companies who report their findings to the FDA and then the FDA approves the drug. Like the drug companies are going to report adverse sides?
The FDA is a huge joke and a waste of our tax dollars.
The FDA does do research on drugs, but the FDA receives the majority of their funding, not from the federal government but from pharmaceutical companies. That stems from legislation requring the drug companies to fund a portion of the cost of getting their products through the process. Liek so many other government plans, it was a nice idea, but inherently flawed at it's core. No one stepped up and asked about the conflict of interest in having the funding of an agency reliant upon the company which the agency is supposed to monitor.
The Food and Drug Administration's job is to make sure medical treatments are safe and effective for people to use. However, FDA does not develop new therapies, or conduct the clinical trials to demonstrate safety and effectiveness. FDA staff members meet with researchers, and perform inspections of clinical trial study sites to protect the rights of participants and to verify the quality and integrity of the data.
The ratio between FDA staff members vs clinical trials/research is so HUGE common sense should tell you there's no way that every FDA staff member can research the thousands of clinical trials going on. That's why drugs are on the market for sometimes a year or two before the FDA issues warnings or completely pulls the drugs off the market.
Well...(said in my best Bubba voice) I've been on sabbatical.
ph4ever wrote:Has anyone noticed a rise of pertussis in their area?
Several cases of it at Victoria's school last year. I don't know whether it is true or not, but I've heard different people say it is because some parents are choosing not to immunize. However, it isn't the DTaP (diptheria, tetanus, pertussis) shot that seems to raise people's immunization eyebrows, but rather the MMR (measles, mumps, rubella) that has been suspected in some to trigger autism.
But what do I know.
So were the children who did not receive the DTaP vacine the ones who got pertussis? Or the children who had the vaccine? Or was it a mix? If it was the 1st, then the parents of vacinated children have nothing to worry about. If it was the 2nd or 3rd, then maybe we should step back and question the effectiveness of the DTaP vaccine. Or even it's necessity. Or perhaps the vaccine for pertussis was compromised when it was packaged together with Diptheria and Tetanus. Sadly we don't know because the government has never required long term studies of the effects vaccines have on children.
Hell the FDA doesn't even do research on the meds out now. The research is done by the drug companies who report their findings to the FDA and then the FDA approves the drug. Like the drug companies are going to report adverse sides?
The FDA is a huge joke and a waste of our tax dollars.
You'd have been proud of Victoria last night. Some RX commercial came on and she said, "Mom, I'm not sure it is a good idea that there are commercials for prescription medicines."
I thought of you guys last night... There was a story on the news that King Soopers is carrying a whole line of gluten free stuff now.
People do not keep their kids immunizations up to date!
how do they enroll them in school w/o a up to date immunization record?
You don't in OK, or Ga, either one. and both states will refuse to let you even attend the first day w/o it.
You can get waivers in most states. The immunization schedules are flawed. We had the docs vaccinate (not immunize) my daughter against polio. 3 doses. The thrid dose to be given at the 18 month checkup. We were on vacation at that time and so had scheduled it for a few weeks later, almost at the 19 month mark. When we got there the doc looked at the chart and said that she didn't need to the third dose because she was older than 18 months. Our question was "If we had come at the 18 month she would have received it, but now three weeks later she miraculously doesn't need it?" The doc just looked at us and said that it was not her decision, but the law. How does anyone explain that?
Last edited by green1 on July 10, 2008 1:05 pm, edited 1 time in total.
ph4ever wrote:Hell the FDA doesn't even do research on the meds out now. The research is done by the drug companies who report their findings to the FDA and then the FDA approves the drug. Like the drug companies are going to report adverse sides?
The FDA is a huge joke and a waste of our tax dollars.
The FDA does do research on drugs, but the FDA receives the majority of their funding, not from the federal government but from pharmaceutical companies. That stems from legislation requring the drug companies to fund a portion of the cost of getting their products through the process. Liek so many other government plans, it was a nice idea, but inherently flawed at it's core. No one stepped up and asked about the conflict of interest in having the funding of an agency reliant upon the company which the agency is supposed to monitor.
The Food and Drug Administration's job is to make sure medical treatments are safe and effective for people to use. However, FDA does not develop new therapies, or conduct the clinical trials to demonstrate safety and effectiveness. FDA staff members meet with researchers, and perform inspections of clinical trial study sites to protect the rights of participants and to verify the quality and integrity of the data.
The ratio between FDA staff members vs clinical trials/research is so HUGE common sense should tell you there's no way that every FDA staff member can research the thousands of clinical trials going on. That's why drugs are on the market for sometimes a year or two before the FDA issues warnings or completely pulls the drugs off the market.
OK I gotta weigh in on this one, although a bit off thread. The quotation above is exactly correct. The FDA inspects the R&D documntation to ensure that the drug product is safe and effective. It is the responsibility of the manufacturer to deliver all documentation to the FDA, for not only the clinical trials, but all documentation from conception. The clinical trials are but one stop in the process, in fact the clinical trials that everyone talks about are Phase 3 trials. I am currently working on a NDA (new drug application). We completed the Phase III trials early last year. Every protocol, test method, capability study, safety build...etc., etc, etc...is scrutanized. Documentation that fills an entire 40' X 40' room will be inspected, during a PAI (pre-approval inspection). What I'm getting at here is yes, there are flaws in the system, but it work pretty Damn well in the big picture. We've had literally hundreds of people devote nearly 4 years developing a very safe and effective product and will spend at least another year before we will ever sell the first one. WE DO NOT HIDE OR MIS-REPORT ADVERSE RESULTS! It is frankly offensive to me that, one would assume or state otherwise.
ph4ever wrote:Hell the FDA doesn't even do research on the meds out now. The research is done by the drug companies who report their findings to the FDA and then the FDA approves the drug. Like the drug companies are going to report adverse sides?
The FDA is a huge joke and a waste of our tax dollars.
The FDA does do research on drugs, but the FDA receives the majority of their funding, not from the federal government but from pharmaceutical companies. That stems from legislation requring the drug companies to fund a portion of the cost of getting their products through the process. Liek so many other government plans, it was a nice idea, but inherently flawed at it's core. No one stepped up and asked about the conflict of interest in having the funding of an agency reliant upon the company which the agency is supposed to monitor.
The Food and Drug Administration's job is to make sure medical treatments are safe and effective for people to use. However, FDA does not develop new therapies, or conduct the clinical trials to demonstrate safety and effectiveness. FDA staff members meet with researchers, and perform inspections of clinical trial study sites to protect the rights of participants and to verify the quality and integrity of the data.
The ratio between FDA staff members vs clinical trials/research is so HUGE common sense should tell you there's no way that every FDA staff member can research the thousands of clinical trials going on. That's why drugs are on the market for sometimes a year or two before the FDA issues warnings or completely pulls the drugs off the market.
OK I gotta weigh in on this one, although a bit off thread. The quotation above is exactly correct. The FDA inspects the R&D documntation to ensure that the drug product is safe and effective. It is the responsibility of the manufacturer to deliver all documentation to the FDA, for not only the clinical trials, but all documentation from conception. The clinical trials are but one stop in the process, in fact the clinical trials that everyone talks about are Phase 3 trials. I am currently working on a NDA (new drug application). We completed the Phase III trials early last year. Every protocol, test method, capability study, safety build...etc., etc, etc...is scrutanized. Documentation that fills an entire 40' X 40' room will be inspected, during a PAI (pre-approval inspection). What I'm getting at here is yes, there are flaws in the system, but it work pretty Damn well in the big picture. We've had literally hundreds of people devote nearly 4 years developing a very safe and effective product and will spend at least another year before we will ever sell the first one. WE DO NOT HIDE OR MIS-REPORT ADVERSE RESULTS! It is frankly offensive to me that, one would assume or state otherwise.
There now I feel better
sorry you're offended however for every good decent honest research group there are others that do hide the negative sides.
Well...(said in my best Bubba voice) I've been on sabbatical.
People do not keep their kids immunizations up to date!
how do they enroll them in school w/o a up to date immunization record?
You don't in OK, or Ga, either one. and both states will refuse to let you even attend the first day w/o it.
You can get waivers in most states. The immunization schedules are flawed. We had the docs vaccinate (not immunize) my daughter against polio. 3 doses. The thrid dose to be given at the 18 month checkup. We were on vacation at that time and so had scheduled it for a few weeks later, almost at the 19 month mark. When we got there the doc looked at the chart and said that she didn't need to the third dose because she was older than 18 months. Our question was "If we had come at the 18 month she would have received it, but now three weeks later she miraculously doesn't need it?" The doc just looked at us and said that it was not her decision, but the law. How does anyone explain that?
I'm not too sure about a waiver....
I am sure that there are children in both states, OK and Ga, that are refused admittance, even for 1 day w/o what that each state requires for immunization.
My only experience is with the Public School System.
I've no idea how day care regulate their requirements. I know the requirements are the same, and regulated if they received any government monies for child care.
many high school students have a mad rush to get their hepatitis before they can enroll.
When it goes from full to crescent...I move in and out of tune...Everlasting Moon....
Most states, if not all, allow waivers based on religious, medical or in some cases, philosophical beliefs. If a waiver is not in place, students can be excluded from school until it is, just like they can be excluded until their vaccinations are current.
ph4ever wrote:Has anyone noticed a rise of pertussis in their area?
Several cases of it at Victoria's school last year. I don't know whether it is true or not, but I've heard different people say it is because some parents are choosing not to immunize. However, it isn't the DTaP (diptheria, tetanus, pertussis) shot that seems to raise people's immunization eyebrows, but rather the MMR (measles, mumps, rubella) that has been suspected in some to trigger autism.
But what do I know.
So were the children who did not receive the DTaP vacine the ones who got pertussis? Or the children who had the vaccine? Or was it a mix? If it was the 1st, then the parents of vacinated children have nothing to worry about. If it was the 2nd or 3rd, then maybe we should step back and question the effectiveness of the DTaP vaccine. Or even it's necessity. Or perhaps the vaccine for pertussis was compromised when it was packaged together with Diptheria and Tetanus. Sadly we don't know because the government has never required long term studies of the effects vaccines have on children.
Hell the FDA doesn't even do research on the meds out now. The research is done by the drug companies who report their findings to the FDA and then the FDA approves the drug. Like the drug companies are going to report adverse sides?
The FDA is a huge joke and a waste of our tax dollars.
You'd have been proud of Victoria last night. Some RX commercial came on and she said, "Mom, I'm not sure it is a good idea that there are commercials for prescription medicines."
I thought of you guys last night... There was a story on the news that King Soopers is carrying a whole line of gluten free stuff now.
That's awesome. I'd say we do 90% of our shopping at King Soopers. The one nearest our house is so-so for gluten-free, but the next-closest one is the best. Gluten-free foods (like crackers, cookies, cakes, breads, crusts) are fine and very "normal tasting" if you know which ones to buy. Some of them are plain nasty, though.
There's actually a whole gluten-free restaurant in Denver. We went there once and probably won't return because it was so nasty. Not because the gluten-free "replacement" foods were bad, but because the cooking was so poor.
Hubby says I should open a GF restaurant and just not tell people it is gluten-free and they prolly wouldn't know the difference.