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January 31, 2008
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Sanofi Aventis - Ketek: subpoenas ahoy!
Another chapter in the tale of Sanofi-Aventis Ketek has opened with the news that the US Congress is to subpoena documents from members of the government and the Food and Drug Administration in connection with a review of the controversial antibiotic.
The House Energy and Commerce Committees Subcommittee on Oversight and Investigations has voted 12-0 to approve a motion to subpoena FDA officials over clinical trial data for Ketek (telithromycin), which the agency approved in 2004 despite claims that a key safety trial, known as Study 3014, involved fraudulent data.
Reports of severe liver damage and death in some Ketek users emerged in 2006 and the FDA withdrew Ketek's approval for sinusitis and bronchitis in 2007. However, Sanofi still sells the drug as a treatment for pneumonia.
The subcommittee also unanimously approved a subpoena to the Secretary of the Department of Health and Human Resources Michael Leavitt, for documents related to the briefing book and other materials used to prepare FDA Commissioner Andrew von Eschenbach for testimony given on March 22, 2007. John Dingell (Republican), chairman of the Committee on Energy and Commerce, said that officials at the HHS and FDA failed to identify a single legal argument to support their attempt to limit the committees ability to conduct a thorough and fair investigation of the Ketek matter.
Chairman of the subcommittee Bart Stupak (Democrat) added that it is important to ascertain what the FDA and Sanofi knew and when they knew it regarding fraud in the pivotal safety trial for Ketek. The integrity of the drug approval process is at stake.
He added that the accuracy of testimony by Commissioner von Eschenbach last year regarding the approval of Ketek must also be answered, claiming that one would think the Commissioner would be eager to discover the truth, but instead, he has resisted our request for his briefing documents.
Source:PharmaTimesSphere: Related Content
The House Energy and Commerce Committees Subcommittee on Oversight and Investigations has voted 12-0 to approve a motion to subpoena FDA officials over clinical trial data for Ketek (telithromycin), which the agency approved in 2004 despite claims that a key safety trial, known as Study 3014, involved fraudulent data.
Reports of severe liver damage and death in some Ketek users emerged in 2006 and the FDA withdrew Ketek's approval for sinusitis and bronchitis in 2007. However, Sanofi still sells the drug as a treatment for pneumonia.
The subcommittee also unanimously approved a subpoena to the Secretary of the Department of Health and Human Resources Michael Leavitt, for documents related to the briefing book and other materials used to prepare FDA Commissioner Andrew von Eschenbach for testimony given on March 22, 2007. John Dingell (Republican), chairman of the Committee on Energy and Commerce, said that officials at the HHS and FDA failed to identify a single legal argument to support their attempt to limit the committees ability to conduct a thorough and fair investigation of the Ketek matter.
Chairman of the subcommittee Bart Stupak (Democrat) added that it is important to ascertain what the FDA and Sanofi knew and when they knew it regarding fraud in the pivotal safety trial for Ketek. The integrity of the drug approval process is at stake.
He added that the accuracy of testimony by Commissioner von Eschenbach last year regarding the approval of Ketek must also be answered, claiming that one would think the Commissioner would be eager to discover the truth, but instead, he has resisted our request for his briefing documents.
Source:PharmaTimesSphere: Related Content
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How To Realize Your True Self? Here Are The Effective Methods!
You should set realistic goals by considering the necessary skills and standards for those goals.
You should be ambitious to set your goals. You should also know about your limitations and about yourself.
If not you will suffer from failure with lower morale and poorer confidence and this affects on your overall working.
By keeping unrealistic goals, you will feel discontented, restless and aggressive in everything.
For knowing about yourself, you should know about your personality and individuality. You should know about your qualities of weaknesses and strengths. You should have self realization for achieving true inner understanding.
Self realization will help you in entire formation of your mental makeup and controlling your energies towards aims and achievements. You will have better motivation towards your goal. If you are aware of your limitations, then you can be productive and manage things better.
You can keep control over your emotions. You should undergo self realization to create better self perception and to boost overall self confidence.
This will enable your abilities to achieve advanced and improved results, by providing you with meaningful and practical description of yourself along with self esteem.
Analysis methods are not in bias with self realization. These methods are applied only when you question yourself and answer, this analysis method will gain you accurate results.
Realistic and reasonable view can be presented on your life by following this method. By following this, you will become calm and more tolerant.
Meditation helps you know about yourself. Practicing meditation techniques in a quiet relaxing environment will help you to concentrate on your mind and focusing on the past and present situations, which needs to create betterment.
You should keep insight on all the important events and external influences which affect yourself, then set your goals in mind. This focus will help you in thinking positively and to transform problems into solutions.
How beneficial it isto practice meditation?
- The connection between you and spiritual self is done through meditation.
- Meditation helps you to concentrate on your inner mind and on a single thought.
- Practicing meditation will help you to know about yourself.
- Meditation will help you to keep your mind away from negative thoughts.
- Meditation will help you in making constructive decisions. Sometimes you have to face more than one stressor. At that time you should focus on one stressor, this will guide you in making decisions of success.
- You can use meditation for guiding, which tools work on you. These tools will help you in finding the ways to reach your goal and for positive self development.
Psychometric tests and other test will help you in providing pretty analysis. You can know about your subconscious mind by visiting to psychiatrist. These are only for general help and you should take care to remain moderate while seeking help from these tests.
By following any of the above ways, you can realize your true self. These ways will enable you to know what are your virtues and vices. Hence change your life without vices.
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January 30, 2008
Statins - who needs them and why?
The NYT's Tara Parker Pope investigates:
But many statin users dont have established heart disease; they simply have high cholesterol. For healthy men, for women with or without heart disease and for people over 70, there is little evidence, if any, that taking a statin will make a meaningful difference in how long they live.
High-risk groups have a lot to gain, said Dr. Mark H. Ebell, a professor at the University of Georgia who is deputy editor of the journal American Family Physician. But patients at low risk benefit very little if at all. We end up overtreating a lot of patients. (Like the other doctors quoted in this column, Dr. Ebell has no ties to drug makers.)
How is this possible, if statins lower the risk of heart attack? Because preventing a heart attack is not the same thing as saving a life. In many statin studies that show lower heart attack risk, the same number of patients end up dying, whether they are taking statins or not.
You may have helped the heart, but you havent helped the patient, said Dr. Beatrice Golomb, an associate professor of medicine at the University of California, San Diego, and a co-author of a 2004 editorial in The Journal of the American College of Cardiology questioning the data on statins. You still have to look at the impact on the patient over all.
A 2006 study in The Archives of Internal Medicine looked at seven trials of statin use in nearly 43,000 patients, mostly middle-aged men without heart disease. In that review, statins didnt lower mortality.
Nor did they in a study called PROSPER, published in The Lancet in 2002, which studied statin use in people 70 and older. Nor did they in a 2004 review in The Journal of the American Medical Association, which looked at 13 studies of nearly 20,000 women, both healthy and with established heart disease.
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Let's put it another way.
Do you like to gamble?
What if you put 250 people in a room and told them they would each pay $1,000 a year for a drug they would have to take every day, that many would get diarrhea and muscle pain, and that 249 would have no benefit? And that they could do just as well by exercising? asks Jerome Hoffman, professor of clinical medicine at the University of California at Los Angeles.
How many would take that?
How many indeed?
Finally take a look at this:
Dr Malcolm Kendrick is a controversial "cholesterol theory sceptic".
Bottom line. Insider thinks that statins might help some people. But they certainly should not be put in the tapwater!
He also is open to argument and discussion.Sphere: Related Content
But many statin users dont have established heart disease; they simply have high cholesterol. For healthy men, for women with or without heart disease and for people over 70, there is little evidence, if any, that taking a statin will make a meaningful difference in how long they live.
High-risk groups have a lot to gain, said Dr. Mark H. Ebell, a professor at the University of Georgia who is deputy editor of the journal American Family Physician. But patients at low risk benefit very little if at all. We end up overtreating a lot of patients. (Like the other doctors quoted in this column, Dr. Ebell has no ties to drug makers.)
How is this possible, if statins lower the risk of heart attack? Because preventing a heart attack is not the same thing as saving a life. In many statin studies that show lower heart attack risk, the same number of patients end up dying, whether they are taking statins or not.
You may have helped the heart, but you havent helped the patient, said Dr. Beatrice Golomb, an associate professor of medicine at the University of California, San Diego, and a co-author of a 2004 editorial in The Journal of the American College of Cardiology questioning the data on statins. You still have to look at the impact on the patient over all.
A 2006 study in The Archives of Internal Medicine looked at seven trials of statin use in nearly 43,000 patients, mostly middle-aged men without heart disease. In that review, statins didnt lower mortality.
Nor did they in a study called PROSPER, published in The Lancet in 2002, which studied statin use in people 70 and older. Nor did they in a 2004 review in The Journal of the American Medical Association, which looked at 13 studies of nearly 20,000 women, both healthy and with established heart disease.
More
Let's put it another way.
Do you like to gamble?
What if you put 250 people in a room and told them they would each pay $1,000 a year for a drug they would have to take every day, that many would get diarrhea and muscle pain, and that 249 would have no benefit? And that they could do just as well by exercising? asks Jerome Hoffman, professor of clinical medicine at the University of California at Los Angeles.
How many would take that?
How many indeed?
Finally take a look at this:
Dr Malcolm Kendrick is a controversial "cholesterol theory sceptic".
Bottom line. Insider thinks that statins might help some people. But they certainly should not be put in the tapwater!
He also is open to argument and discussion.Sphere: Related Content
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