Garcinia Cambogia
Replies
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I do think Oz is full of crap. Who has the money to buy all those holistic produces he pushes. He pushes coconut oil. ALWAYS cooks with it. I am in a nutrition class right now and that is on the list of DON"T use oils.0
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Oprah has been on so many diets she must hold the record. She had that guru to lose weight with exercise. He wrote a book. Why is she fat? She has personal chefs, one who cooked healthy and she still gained weight. Look at all those who Oprah made famous who are full of crap. Dr. Phil being the worst. In one of his books he wrote that you should do what you want in your life to be happy. That sure doesn't include having to work for a living, does it?0
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I'll do anything to get myself Garcinia Cambogia because what I've been eating lately. But my mom won't let me. I might as well sneak my way to get it and hide it lol0
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I go to the gym everyday for 2 hours and eat below my calorie limit. And I take garcinia cambogia as a supplement. I don't think there is a problem with taking a supplement, as long as you are aware that it is a SUPPLEMENT and not a magic pill. You can't expect to see results by not working out and eating correctly. I am all for losing weight in a HEALTHY way, so I just use garcinia cambogia as a boost. I do feel that it works. I'm not quite as hungry throughout the day and I feel that it does aid me in losing an additional .5 pounds during the week.0
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I'll do anything to get myself Garcinia Cambogia because what I've been eating lately. But my mom won't let me. I might as well sneak my way to get it and hide it lol
You're 21. I don't understand this "my mom won't let me" argument.
But I also don't understand why anyone would pay real cash money for GC either, so I guess there's a lot I don't understand in this thread.0 -
I go to the gym everyday for 2 hours and eat below my calorie limit. And I take garcinia cambogia as a supplement. I don't think there is a problem with taking a supplement, as long as you are aware that it is a SUPPLEMENT and not a magic pill. You can't expect to see results by not working out and eating correctly. I am all for losing weight in a HEALTHY way, so I just use garcinia cambogia as a boost. I do feel that it works. I'm not quite as hungry throughout the day and I feel that it does aid me in losing an additional .5 pounds during the week.0
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Not meaning to be shills, it's just the evidence points to the facts that this product only works on rats.
http://www.ncbi.nlm.nih.gov/pubmed/21569551
http://www.ncbi.nlm.nih.gov/pubmed/15680676
http://www.ncbi.nlm.nih.gov/pubmed/15200237
The facts also find clearly that the product has absolutely no benefits for weight loss in humans.
http://www.ncbi.nlm.nih.gov/pubmed/22530711
http://www.ncbi.nlm.nih.gov/pubmed/11134690
http://www.ncbi.nlm.nih.gov/pubmed/18729243
The only positives for the product is that 1) it's safe to take 2) there is an outside chance it helps aid gluconeogenesis in the liver.
http://www.ncbi.nlm.nih.gov/pubmed/15234082
Sorry.
Safe to take?
As I posted in the first page of the thread - there have been cases of liver toxicity. Safe? Maybe not.0 -
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Not meaning to be shills, it's just the evidence points to the facts that this product only works on rats.
http://www.ncbi.nlm.nih.gov/pubmed/21569551
http://www.ncbi.nlm.nih.gov/pubmed/15680676
http://www.ncbi.nlm.nih.gov/pubmed/15200237
The facts also find clearly that the product has absolutely no benefits for weight loss in humans.
http://www.ncbi.nlm.nih.gov/pubmed/22530711
http://www.ncbi.nlm.nih.gov/pubmed/11134690
http://www.ncbi.nlm.nih.gov/pubmed/18729243
The only positives for the product is that 1) it's safe to take 2) there is an outside chance it helps aid gluconeogenesis in the liver.
http://www.ncbi.nlm.nih.gov/pubmed/15234082
Sorry.
Safe to take?
As I posted in the first page of the thread - there have been cases of liver toxicity. Safe? Maybe not.
Can you post the study or PM it to me, as the study I have shows it as safe (based on daily levels of below 2800mg).0 -
Not meaning to be shills, it's just the evidence points to the facts that this product only works on rats.
http://www.ncbi.nlm.nih.gov/pubmed/21569551
http://www.ncbi.nlm.nih.gov/pubmed/15680676
http://www.ncbi.nlm.nih.gov/pubmed/15200237
The facts also find clearly that the product has absolutely no benefits for weight loss in humans.
http://www.ncbi.nlm.nih.gov/pubmed/22530711
http://www.ncbi.nlm.nih.gov/pubmed/11134690
http://www.ncbi.nlm.nih.gov/pubmed/18729243
The only positives for the product is that 1) it's safe to take 2) there is an outside chance it helps aid gluconeogenesis in the liver.
http://www.ncbi.nlm.nih.gov/pubmed/15234082
Sorry.
Safe to take?
As I posted in the first page of the thread - there have been cases of liver toxicity. Safe? Maybe not.
Can you post the study or PM it to me, as the study I have shows it as safe (based on daily levels of below 2800mg).
Already posted - page one of this thread. FDA has published a risk letter.
Also:
http://www.wjgnet.com/1007-9327/15/1786.asp
http://www.ncbi.nlm.nih.gov/pubmed/15680676
http://www.ncbi.nlm.nih.gov/pubmed/24699886
http://www.ncbi.nlm.nih.gov/pubmed/21531369
http://www.ncbi.nlm.nih.gov/pubmed/21197150
The high dose one I'd not really consider.
So, there might or might not be a negative effect.
But, in general, anything with any biological efficacy always carries some risks.0 -
Interesting, but certainly not conclusive.
I would agree that long term taking of the supplement MAY have adverse affects, but then the same can be demonstrated for paracetamol, but I would certainly take a short term course of that when needed.0 -
Interesting, but certainly not conclusive.
I would agree that long term taking of the supplement MAY have adverse affects, but then the same can be demonstrated for paracetamol, but I would certainly take a short term course of that when needed.
Paracetamol is your comparative example?
There are over 100 and over 400 deaths from it every year in the UK and US, respectively and it is a highly regulated product in terms of manufacture and distribution across many countries - the same can't really be said about these supplements. I think the call for stricter evaluation that has been made in many journals has some merit.
To say there is not risk is patently false, to consider the risk accpetable is a personal choice.
Worth reading - re ParacetamolConfidential documents from the US Food and Drug Administration suggest that the agency has avoided a debate on tough new measures to reduce overdoses from painkillers—to avoid offending the pharmaceutical industry. Ray Moynihan reports from Washington, DC.Staff at the Food and Drug Administration's Office of Drug Safety wanted the United States to consider following the United Kingdom's policy of reducing the public's ease of access to paracetamol to try to reduce the number of deaths from overdose, a concern in both these countries.
But the office's views never reached the FDA's non-prescription drugs advisory committee, which met last week to consider the drug's safety. The result was that the advisory committee recommended only that the drug, known as acetaminophen in the United States, carry expanded safety warnings. No change was recommended in how it is sold.
Drug company executives were delighted with the committee's decision. “I felt really very good,” said Dr Anthony Temple, a vice president of the Johnson & Johnson company McNeil, which dominates the market in paracetamol products, taken by almost 50 million Americans a week. “I'm pleased the panel came up with the same concepts we've come up with already.”
The advisory committee was looking at the drug, which is contained in many combination products, in an effort to reduce the accidental liver damage it can cause when taken in overdose. In the United States paracetamol is associated with more than 100000 calls a year to poison control centres, as well as 56000 visits to emergency departments, 26000 hospitalisations, and 450 deaths.
The FDA appoints outside expert members to its advisory committees, and before meetings it provides them with background documents and lists of questions, in an effort to seek informed recommendations on important decisions about drug approval or regulation.
In the case of last week's hearing, after eight hours of what were at times confused, uncertain, and vague deliberations, the FDA advisory committee simply recommended changes to labelling and better consumer education about paracetamol (marketed in the United States as Tylenol). These are initiatives in which the manufacturer is already engaged. Asked whether the recommendations could have been worse, Dr Temple responded instantly: “Absolutely—it could have been a lot worse.”
The FDA advisers did not seriously consider following the lead of the United Kingdom and some other countries, which have introduced measures to restrict the numbers of tablets per pack and replacing bottles full of loose pills with “blister packs.” The option was not even suggested for consideration by FDA officers appearing before the advisory committee despite the fact that tentative evidence indicates that such reforms in the United Kingdom may have significantly reduced the number of drug related poisonings, liver transplantations, and deaths .
The reforms in the United Kingdom have also led to a substantial reduction in annual sales of tablets containing paracetamol and paracetamol compounds, from 123 billion to 84 billion.
Behind the closed doors of the FDA, in the lead up to the meeting, staff from the Office of Drug Safety had suggested that the advisory committee should consider the measures that the United Kingdom took. A confidential draft document reveals that the Office of Drug Safety also wanted the advisory panel to discuss whether the “maximum tablet strength should be decreased,” whether “combination products be reformulated without acetaminophen,” and whether there was “a need to standardize the various paediatric formulations.”
The advisers never saw that draft, however, and none of these key options ended up being clearly presented to the committee by the FDA in the final list of questions they were to consider.
Acknowledging an unusual level of confusion throughout the hearings, the advisory committee's chairman, Dr Lou Cantilena, said in an interview afterwards that the questions supplied by the FDA were too vague. “The committee would have preferred more focused questions,” he said.
According to one FDA insider, the draft questions were dropped because senior FDA managers saw them as too offensive to Johnson & Johnson. Asked about this alleged corporate influence within the FDA, Dr Cantilena smiled and said he did not want to speculate.
In an interview last Friday, FDA spokesman Dr John Jenkins said he was not aware of the draft questions from the Office of Drug Safety but said that FDA managers had opted to give the advisory committee more open ended, rather than yes/no-type, questions.
At one point, when the committee's deliberations drifted towards consideration of the United Kingdom changes, another FDA manager, Dr Charles Ganley, effectively cut off debate by strongly cautioning advisers against such action. “It's very difficult to impose these things,” he warned. Dr Ganley is understood to have been actively involved in rejecting the draft questions before they got to the advisory committee.
More than 200 people attended last week's two day hearing, which focused first on paracetamol and then on aspirin and non-steroidal anti-inflammatory drugs, said to be associated with more than 16000 deaths in the United States every year as a result of gastrointestinal bleeding. As on day 1, the recommendations on day 2 were for minor changes to labels and more education.
Although liver damage from paracetamol is rare, its effects can be devastating. Ms Kate Trunk told the committee meeting that her healthy 23 year old son Marcus had died after an accidental overdose, because he had inadvertently taken several products containing the same drug. “Death is not an acceptable side effect,” she said.
The FDA's apparent timidity over reforming the marketing of the multibillion dollar paracetamol will only add to concerns that the regulatory agency may be too close to the companies that by law now fund half of its drug review work. Rejecting those concerns, Dr Temple said the manufacturer had “shared data with the FDA, worked with them, and talked back and forth” in the lead up to last week's meeting, but the FDA had been “pretty arm's length on this.”
The FDA refused a request by the BMJ for an interview with Dr Ganley.
from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1124220/0 -
Interesting, but certainly not conclusive.
I would agree that long term taking of the supplement MAY have adverse affects, but then the same can be demonstrated for paracetamol, but I would certainly take a short term course of that when needed.
Paracetamol is your comparative example?
There are over 100 and over 400 deaths from it every year in the UK and US, respectively and it is a highly regulated product in terms of manufacture and distribution across many countries - the same can't really be said about these supplements. I think the call for stricter evaluation that has been made in many journals has some merit.
To say there is not risk is patently false, to consider the risk accpetable is a personal choice.
Worth reading - re ParacetamolConfidential documents from the US Food and Drug Administration suggest that the agency has avoided a debate on tough new measures to reduce overdoses from painkillers—to avoid offending the pharmaceutical industry. Ray Moynihan reports from Washington, DC.Staff at the Food and Drug Administration's Office of Drug Safety wanted the United States to consider following the United Kingdom's policy of reducing the public's ease of access to paracetamol to try to reduce the number of deaths from overdose, a concern in both these countries.
But the office's views never reached the FDA's non-prescription drugs advisory committee, which met last week to consider the drug's safety. The result was that the advisory committee recommended only that the drug, known as acetaminophen in the United States, carry expanded safety warnings. No change was recommended in how it is sold.
Drug company executives were delighted with the committee's decision. “I felt really very good,” said Dr Anthony Temple, a vice president of the Johnson & Johnson company McNeil, which dominates the market in paracetamol products, taken by almost 50 million Americans a week. “I'm pleased the panel came up with the same concepts we've come up with already.”
The advisory committee was looking at the drug, which is contained in many combination products, in an effort to reduce the accidental liver damage it can cause when taken in overdose. In the United States paracetamol is associated with more than 100000 calls a year to poison control centres, as well as 56000 visits to emergency departments, 26000 hospitalisations, and 450 deaths.
The FDA appoints outside expert members to its advisory committees, and before meetings it provides them with background documents and lists of questions, in an effort to seek informed recommendations on important decisions about drug approval or regulation.
In the case of last week's hearing, after eight hours of what were at times confused, uncertain, and vague deliberations, the FDA advisory committee simply recommended changes to labelling and better consumer education about paracetamol (marketed in the United States as Tylenol). These are initiatives in which the manufacturer is already engaged. Asked whether the recommendations could have been worse, Dr Temple responded instantly: “Absolutely—it could have been a lot worse.”
The FDA advisers did not seriously consider following the lead of the United Kingdom and some other countries, which have introduced measures to restrict the numbers of tablets per pack and replacing bottles full of loose pills with “blister packs.” The option was not even suggested for consideration by FDA officers appearing before the advisory committee despite the fact that tentative evidence indicates that such reforms in the United Kingdom may have significantly reduced the number of drug related poisonings, liver transplantations, and deaths .
The reforms in the United Kingdom have also led to a substantial reduction in annual sales of tablets containing paracetamol and paracetamol compounds, from 123 billion to 84 billion.
Behind the closed doors of the FDA, in the lead up to the meeting, staff from the Office of Drug Safety had suggested that the advisory committee should consider the measures that the United Kingdom took. A confidential draft document reveals that the Office of Drug Safety also wanted the advisory panel to discuss whether the “maximum tablet strength should be decreased,” whether “combination products be reformulated without acetaminophen,” and whether there was “a need to standardize the various paediatric formulations.”
The advisers never saw that draft, however, and none of these key options ended up being clearly presented to the committee by the FDA in the final list of questions they were to consider.
Acknowledging an unusual level of confusion throughout the hearings, the advisory committee's chairman, Dr Lou Cantilena, said in an interview afterwards that the questions supplied by the FDA were too vague. “The committee would have preferred more focused questions,” he said.
According to one FDA insider, the draft questions were dropped because senior FDA managers saw them as too offensive to Johnson & Johnson. Asked about this alleged corporate influence within the FDA, Dr Cantilena smiled and said he did not want to speculate.
In an interview last Friday, FDA spokesman Dr John Jenkins said he was not aware of the draft questions from the Office of Drug Safety but said that FDA managers had opted to give the advisory committee more open ended, rather than yes/no-type, questions.
At one point, when the committee's deliberations drifted towards consideration of the United Kingdom changes, another FDA manager, Dr Charles Ganley, effectively cut off debate by strongly cautioning advisers against such action. “It's very difficult to impose these things,” he warned. Dr Ganley is understood to have been actively involved in rejecting the draft questions before they got to the advisory committee.
More than 200 people attended last week's two day hearing, which focused first on paracetamol and then on aspirin and non-steroidal anti-inflammatory drugs, said to be associated with more than 16000 deaths in the United States every year as a result of gastrointestinal bleeding. As on day 1, the recommendations on day 2 were for minor changes to labels and more education.
Although liver damage from paracetamol is rare, its effects can be devastating. Ms Kate Trunk told the committee meeting that her healthy 23 year old son Marcus had died after an accidental overdose, because he had inadvertently taken several products containing the same drug. “Death is not an acceptable side effect,” she said.
The FDA's apparent timidity over reforming the marketing of the multibillion dollar paracetamol will only add to concerns that the regulatory agency may be too close to the companies that by law now fund half of its drug review work. Rejecting those concerns, Dr Temple said the manufacturer had “shared data with the FDA, worked with them, and talked back and forth” in the lead up to last week's meeting, but the FDA had been “pretty arm's length on this.”
The FDA refused a request by the BMJ for an interview with Dr Ganley.
from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1124220/
Your post about paracetamol focuses on death by overdoses? Not sure where you are going with that one.?
In regards to GC, I would not advocate anyone take it as clearly the product does not work.
However if someone did take a course of it I have yet to see a conclusive study (the ones that you have posted seem to be mainly observations, as opposed to peer reviewed actual studies) that it in the short term it is harmful.
I did post an actual study claiming it was not harmful in daily volumes of less than 2800mg.0 -
Interesting, but certainly not conclusive.
I would agree that long term taking of the supplement MAY have adverse affects, but then the same can be demonstrated for paracetamol, but I would certainly take a short term course of that when needed.
Paracetamol is your comparative example?
There are over 100 and over 400 deaths from it every year in the UK and US, respectively and it is a highly regulated product in terms of manufacture and distribution across many countries - the same can't really be said about these supplements. I think the call for stricter evaluation that has been made in many journals has some merit.
To say there is not risk is patently false, to consider the risk accpetable is a personal choice.
Worth reading - re ParacetamolConfidential documents from the US Food and Drug Administration suggest that the agency has avoided a debate on tough new measures to reduce overdoses from painkillers—to avoid offending the pharmaceutical industry. Ray Moynihan reports from Washington, DC.Staff at the Food and Drug Administration's Office of Drug Safety wanted the United States to consider following the United Kingdom's policy of reducing the public's ease of access to paracetamol to try to reduce the number of deaths from overdose, a concern in both these countries.
But the office's views never reached the FDA's non-prescription drugs advisory committee, which met last week to consider the drug's safety. The result was that the advisory committee recommended only that the drug, known as acetaminophen in the United States, carry expanded safety warnings. No change was recommended in how it is sold.
Drug company executives were delighted with the committee's decision. “I felt really very good,” said Dr Anthony Temple, a vice president of the Johnson & Johnson company McNeil, which dominates the market in paracetamol products, taken by almost 50 million Americans a week. “I'm pleased the panel came up with the same concepts we've come up with already.”
The advisory committee was looking at the drug, which is contained in many combination products, in an effort to reduce the accidental liver damage it can cause when taken in overdose. In the United States paracetamol is associated with more than 100000 calls a year to poison control centres, as well as 56000 visits to emergency departments, 26000 hospitalisations, and 450 deaths.
The FDA appoints outside expert members to its advisory committees, and before meetings it provides them with background documents and lists of questions, in an effort to seek informed recommendations on important decisions about drug approval or regulation.
In the case of last week's hearing, after eight hours of what were at times confused, uncertain, and vague deliberations, the FDA advisory committee simply recommended changes to labelling and better consumer education about paracetamol (marketed in the United States as Tylenol). These are initiatives in which the manufacturer is already engaged. Asked whether the recommendations could have been worse, Dr Temple responded instantly: “Absolutely—it could have been a lot worse.”
The FDA advisers did not seriously consider following the lead of the United Kingdom and some other countries, which have introduced measures to restrict the numbers of tablets per pack and replacing bottles full of loose pills with “blister packs.” The option was not even suggested for consideration by FDA officers appearing before the advisory committee despite the fact that tentative evidence indicates that such reforms in the United Kingdom may have significantly reduced the number of drug related poisonings, liver transplantations, and deaths .
The reforms in the United Kingdom have also led to a substantial reduction in annual sales of tablets containing paracetamol and paracetamol compounds, from 123 billion to 84 billion.
Behind the closed doors of the FDA, in the lead up to the meeting, staff from the Office of Drug Safety had suggested that the advisory committee should consider the measures that the United Kingdom took. A confidential draft document reveals that the Office of Drug Safety also wanted the advisory panel to discuss whether the “maximum tablet strength should be decreased,” whether “combination products be reformulated without acetaminophen,” and whether there was “a need to standardize the various paediatric formulations.”
The advisers never saw that draft, however, and none of these key options ended up being clearly presented to the committee by the FDA in the final list of questions they were to consider.
Acknowledging an unusual level of confusion throughout the hearings, the advisory committee's chairman, Dr Lou Cantilena, said in an interview afterwards that the questions supplied by the FDA were too vague. “The committee would have preferred more focused questions,” he said.
According to one FDA insider, the draft questions were dropped because senior FDA managers saw them as too offensive to Johnson & Johnson. Asked about this alleged corporate influence within the FDA, Dr Cantilena smiled and said he did not want to speculate.
In an interview last Friday, FDA spokesman Dr John Jenkins said he was not aware of the draft questions from the Office of Drug Safety but said that FDA managers had opted to give the advisory committee more open ended, rather than yes/no-type, questions.
At one point, when the committee's deliberations drifted towards consideration of the United Kingdom changes, another FDA manager, Dr Charles Ganley, effectively cut off debate by strongly cautioning advisers against such action. “It's very difficult to impose these things,” he warned. Dr Ganley is understood to have been actively involved in rejecting the draft questions before they got to the advisory committee.
More than 200 people attended last week's two day hearing, which focused first on paracetamol and then on aspirin and non-steroidal anti-inflammatory drugs, said to be associated with more than 16000 deaths in the United States every year as a result of gastrointestinal bleeding. As on day 1, the recommendations on day 2 were for minor changes to labels and more education.
Although liver damage from paracetamol is rare, its effects can be devastating. Ms Kate Trunk told the committee meeting that her healthy 23 year old son Marcus had died after an accidental overdose, because he had inadvertently taken several products containing the same drug. “Death is not an acceptable side effect,” she said.
The FDA's apparent timidity over reforming the marketing of the multibillion dollar paracetamol will only add to concerns that the regulatory agency may be too close to the companies that by law now fund half of its drug review work. Rejecting those concerns, Dr Temple said the manufacturer had “shared data with the FDA, worked with them, and talked back and forth” in the lead up to last week's meeting, but the FDA had been “pretty arm's length on this.”
The FDA refused a request by the BMJ for an interview with Dr Ganley.
from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1124220/
Your post about paracetamol focuses on death by overdoses? Not sure where you are going with that one.?
In regards to GC, I would not advocate anyone take it as clearly the product does not work.
However if someone did take a course of it I have yet to see a conclusive study (the ones that you have posted seem to be mainly observations, as opposed to peer reviewed actual studies) that it in the short term it is harmful.
I did post an actual study claiming it was not harmful in daily volumes of less than 2800mg.
Parecetamol seems to be a poor comparison - given its risks, it is a much more regulated product, and given it's availability and use it actually generates one of the highest rates of hospitalization and fatalities. It's a strange comparitor to use, paracetamol despite the risk has know effective clinical value. GC having no apparent clinical value but some potential risk and not being currently controlled you might as well have chosen cheeseburgers for the relevancy.0 -
Interesting, but certainly not conclusive.
I would agree that long term taking of the supplement MAY have adverse affects, but then the same can be demonstrated for paracetamol, but I would certainly take a short term course of that when needed.
Paracetamol is your comparative example?
There are over 100 and over 400 deaths from it every year in the UK and US, respectively and it is a highly regulated product in terms of manufacture and distribution across many countries - the same can't really be said about these supplements. I think the call for stricter evaluation that has been made in many journals has some merit.
To say there is not risk is patently false, to consider the risk accpetable is a personal choice.
Worth reading - re ParacetamolConfidential documents from the US Food and Drug Administration suggest that the agency has avoided a debate on tough new measures to reduce overdoses from painkillers—to avoid offending the pharmaceutical industry. Ray Moynihan reports from Washington, DC.Staff at the Food and Drug Administration's Office of Drug Safety wanted the United States to consider following the United Kingdom's policy of reducing the public's ease of access to paracetamol to try to reduce the number of deaths from overdose, a concern in both these countries.
But the office's views never reached the FDA's non-prescription drugs advisory committee, which met last week to consider the drug's safety. The result was that the advisory committee recommended only that the drug, known as acetaminophen in the United States, carry expanded safety warnings. No change was recommended in how it is sold.
Drug company executives were delighted with the committee's decision. “I felt really very good,” said Dr Anthony Temple, a vice president of the Johnson & Johnson company McNeil, which dominates the market in paracetamol products, taken by almost 50 million Americans a week. “I'm pleased the panel came up with the same concepts we've come up with already.”
The advisory committee was looking at the drug, which is contained in many combination products, in an effort to reduce the accidental liver damage it can cause when taken in overdose. In the United States paracetamol is associated with more than 100000 calls a year to poison control centres, as well as 56000 visits to emergency departments, 26000 hospitalisations, and 450 deaths.
The FDA appoints outside expert members to its advisory committees, and before meetings it provides them with background documents and lists of questions, in an effort to seek informed recommendations on important decisions about drug approval or regulation.
In the case of last week's hearing, after eight hours of what were at times confused, uncertain, and vague deliberations, the FDA advisory committee simply recommended changes to labelling and better consumer education about paracetamol (marketed in the United States as Tylenol). These are initiatives in which the manufacturer is already engaged. Asked whether the recommendations could have been worse, Dr Temple responded instantly: “Absolutely—it could have been a lot worse.”
The FDA advisers did not seriously consider following the lead of the United Kingdom and some other countries, which have introduced measures to restrict the numbers of tablets per pack and replacing bottles full of loose pills with “blister packs.” The option was not even suggested for consideration by FDA officers appearing before the advisory committee despite the fact that tentative evidence indicates that such reforms in the United Kingdom may have significantly reduced the number of drug related poisonings, liver transplantations, and deaths .
The reforms in the United Kingdom have also led to a substantial reduction in annual sales of tablets containing paracetamol and paracetamol compounds, from 123 billion to 84 billion.
Behind the closed doors of the FDA, in the lead up to the meeting, staff from the Office of Drug Safety had suggested that the advisory committee should consider the measures that the United Kingdom took. A confidential draft document reveals that the Office of Drug Safety also wanted the advisory panel to discuss whether the “maximum tablet strength should be decreased,” whether “combination products be reformulated without acetaminophen,” and whether there was “a need to standardize the various paediatric formulations.”
The advisers never saw that draft, however, and none of these key options ended up being clearly presented to the committee by the FDA in the final list of questions they were to consider.
Acknowledging an unusual level of confusion throughout the hearings, the advisory committee's chairman, Dr Lou Cantilena, said in an interview afterwards that the questions supplied by the FDA were too vague. “The committee would have preferred more focused questions,” he said.
According to one FDA insider, the draft questions were dropped because senior FDA managers saw them as too offensive to Johnson & Johnson. Asked about this alleged corporate influence within the FDA, Dr Cantilena smiled and said he did not want to speculate.
In an interview last Friday, FDA spokesman Dr John Jenkins said he was not aware of the draft questions from the Office of Drug Safety but said that FDA managers had opted to give the advisory committee more open ended, rather than yes/no-type, questions.
At one point, when the committee's deliberations drifted towards consideration of the United Kingdom changes, another FDA manager, Dr Charles Ganley, effectively cut off debate by strongly cautioning advisers against such action. “It's very difficult to impose these things,” he warned. Dr Ganley is understood to have been actively involved in rejecting the draft questions before they got to the advisory committee.
More than 200 people attended last week's two day hearing, which focused first on paracetamol and then on aspirin and non-steroidal anti-inflammatory drugs, said to be associated with more than 16000 deaths in the United States every year as a result of gastrointestinal bleeding. As on day 1, the recommendations on day 2 were for minor changes to labels and more education.
Although liver damage from paracetamol is rare, its effects can be devastating. Ms Kate Trunk told the committee meeting that her healthy 23 year old son Marcus had died after an accidental overdose, because he had inadvertently taken several products containing the same drug. “Death is not an acceptable side effect,” she said.
The FDA's apparent timidity over reforming the marketing of the multibillion dollar paracetamol will only add to concerns that the regulatory agency may be too close to the companies that by law now fund half of its drug review work. Rejecting those concerns, Dr Temple said the manufacturer had “shared data with the FDA, worked with them, and talked back and forth” in the lead up to last week's meeting, but the FDA had been “pretty arm's length on this.”
The FDA refused a request by the BMJ for an interview with Dr Ganley.
from: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1124220/
Your post about paracetamol focuses on death by overdoses? Not sure where you are going with that one.?
In regards to GC, I would not advocate anyone take it as clearly the product does not work.
However if someone did take a course of it I have yet to see a conclusive study (the ones that you have posted seem to be mainly observations, as opposed to peer reviewed actual studies) that it in the short term it is harmful.
I did post an actual study claiming it was not harmful in daily volumes of less than 2800mg.
Parecetamol seems to be a poor comparison - given its risks, it is a much more regulated product, and given it's availability and use it actually generates one of the highest rates of hospitalization and fatalities. It's a strange comparitor to use, paracetamol despite the risk has know effective clinical value. GC having no apparent clinical value but some potential risk and not being currently controlled you might as well have chosen cheeseburgers for the relevancy.
Your example of risk for parecetamol is based on the risk associated with overdose. Most people take the prescribed amount and have no adverse affects.
Also yes the numbers are high, but based on the millions that consume it weekly, how do the percentages stack up. I should think they are less than peanut related deaths and peanuts are unregulated.
And again apart from some anacdotel observations or studies based on high volume consumption, there is no conclusive proof that CG short term is harmful.0 -
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Well I had to try it. Whether it is like placebos that people take or not, not sure but for the 2 weeks I have been taking it, it is helping me for sure. It was on sale at Costco's and they always have the best products and I trust them so me and my sister tried them.
I have cleaned up my diet for the most part too but feel the rate of weight loss is due to this supplement. I weighed the pros and cons, did the research and I will continue to use the rest of the year for sure since taken moderately no adverse side effects and it is good for you too even if not good for weight loss. A win win in my opinion My sister agrees0 -
garcinia cambogia...
90 capsules(3 months)
3 months for 30.00 AND FREE SHIPPING(:
[snipped]
BOOM!
Reported.0 -
Thanks everyone, you saved me money, not buying it!!!0
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