Maybe the title should read “follow the money trail”. The FDA is being grilled by our elected representatives in a manner that has to make us wonder who is receiving contributions for their reelection and from what companies. Maybe this should be investigated by the FBI.
The FDA has been tightening the evidence trail after many recalls for defective devices that had cleared the 510(k) premarket clearance process in error and had to be recalled. This is only natural for the FDA to close the door once the horse is out, but the way our elected representatives are acting, they are backing industry investors to open the door for more horses to escape and more recalls to take place.
Of course there are people on both sides of the issue and again the patients will be subjected to over zealous marketers who care more about profits than they do patient safety. A review never hurts, but the nature of the investigation seems to be headed in the wrong direction and leaves open questions about who is paying into reelection coffers for which representatives.
For years the FDA has been negligent and open to influence when money talks, and we have always known this about government, but the situation is becoming a nightmare for patients who cannot rely on safety. This is especially true if the FDA is forced to cave to device investors who are also contributing to reelection funds of our elected officials.
Read the article here and draw your own conclusions.
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
02 March 2011
28 February 2011
The FDA May Deserve This Black Eye
Yes, there is mounting evidence that the FDA is slacking on the duties they should be preforming. I had read about similar things in the past, but to finally have this documented in a graphic way is upsetting.
But I still have an inquiring mind so I will have to ask some questions not covered by the study as researchers can have agendas as well. There also seems to some large gaps in what the study is about.
The article on the study does not state whether they used drugs that were from the same or near same date of manufacture. Also not stated is where the drugs were selected. If they were selected from different countries, how long had they been in the pipeline and were the boxed warnings needed in those countries. This alone could negate the study.
Now if the study is doing things without an agenda, then the FDA may well deserve the criticism for not doing what its own rules indicate that it should. If, and I must emphasize if, the study is correct, then the FDA does need to be corrected and some charges (yes, maybe even criminal) need to be brought by the U.S. Justice Department.
From the article, I do have suspicions that the study was lacking in methodology that is above an agenda and may not be as useful as it might have been. The FDA spokesperson was fairly clear that the FDA may not be without fault, but clearly asked some questions about the study.
Read the article here.
But I still have an inquiring mind so I will have to ask some questions not covered by the study as researchers can have agendas as well. There also seems to some large gaps in what the study is about.
The article on the study does not state whether they used drugs that were from the same or near same date of manufacture. Also not stated is where the drugs were selected. If they were selected from different countries, how long had they been in the pipeline and were the boxed warnings needed in those countries. This alone could negate the study.
Now if the study is doing things without an agenda, then the FDA may well deserve the criticism for not doing what its own rules indicate that it should. If, and I must emphasize if, the study is correct, then the FDA does need to be corrected and some charges (yes, maybe even criminal) need to be brought by the U.S. Justice Department.
From the article, I do have suspicions that the study was lacking in methodology that is above an agenda and may not be as useful as it might have been. The FDA spokesperson was fairly clear that the FDA may not be without fault, but clearly asked some questions about the study.
Read the article here.
20 February 2011
Why are Bariatric Docs Disappointed?
Apparently the Bariatric doctors are very upset with the latest FDA action. This is the third drug the FDA has turned down in the last year.
One doctor has taken his displeasure to the extreme. It will be interesting to see if he remains on the FDA committee. He states quite bitterly - "I think it does send a very bad message to the drug companies who invested billions of dollars in the drugs and have tried to follow the rules the FDA laid out, and yet when they show up with the data they're rejected,"
Then he went on to say, "We also think it sends a very bad message to patients as well. It says, 'Don't expect any help from the FDA, and don't expect any new medicines, so you better go see the quacks in your neighborhood, because that's all you're going to get."
I am very happy that I do not know this doctor. His actions just reinforce why we are so distrustful of the FDA. We do need good doctors on the FDA committees and in other positions, but when they are overly vocal, maybe it is time for them to resign.
I am just thankful that the FDA has chosen to ask for more trials and data. This is their duty and too many drugs have been allowed that maybe never should have been allowed to pass.
Read the article here.
One doctor has taken his displeasure to the extreme. It will be interesting to see if he remains on the FDA committee. He states quite bitterly - "I think it does send a very bad message to the drug companies who invested billions of dollars in the drugs and have tried to follow the rules the FDA laid out, and yet when they show up with the data they're rejected,"
Then he went on to say, "We also think it sends a very bad message to patients as well. It says, 'Don't expect any help from the FDA, and don't expect any new medicines, so you better go see the quacks in your neighborhood, because that's all you're going to get."
I am very happy that I do not know this doctor. His actions just reinforce why we are so distrustful of the FDA. We do need good doctors on the FDA committees and in other positions, but when they are overly vocal, maybe it is time for them to resign.
I am just thankful that the FDA has chosen to ask for more trials and data. This is their duty and too many drugs have been allowed that maybe never should have been allowed to pass.
Read the article here.
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