Well, it seems that the Federal Drug Administration is willing to admit when it has short comings. But it is going to regulate the latest entry – nanotechnology. Noting the “critical need to learn more” about the impact of nanotechnology on medicines and medical devices, the FDA has asked for help.
Speaking out in support of this action by FDA, is Gang Bao, director of the Center for Pediatric Nanomedicine, a joint project of the Georgia Institute of Technology, Emory University, and Children's Healthcare of Atlanta.
Jamey Marth, PhD, director of the Sanford Burnham Center for Nanomedicine at the University of California, Santa Barbara said that the application of this technology is truly revolutionary.
In nanomedicine it is difficult, but important, to understand the scale of the nano. A nanometer (nm) is a billionth of a meter. For example a single sugar molecule in 1 nm in diameter, the DNA helix is 2 nm in diameter, a typical virus in 75 nm in size and a red blood cell is 7000 nm.
According to Jamey Marth, we have not been able to answer all question about a lot of diseases. These diseases, diabetes, cardiovascular disease, disease of aging, and cancer have some genetic bearing, but this is only part of the answer. With nanomedicine we will be able to identify and discover those processes that are outside our genetic makeup. Nanomedicine give us new tools to treat disease.
The FDA has already approved two cancer drugs based on nanotechnology. Besides better treatment with few side effects, the second generation drugs of this type will carry nanoparticles on their surfaces that not only target the drugs to cancer cells, but also allow them to penetrate deep into tumors.
Marth says that nanomedicine will speed the discovery of biomarkers that identify diseased cells. Once these biomarkers are found, they can be used to bind therapeutic nanoparticles only to the cells that need them, leaving normal cells alone. Bao's team is pioneering another approach: using nanoparticles to repair genetic mutations. Their first target will be the mutation that causes sickle cell disease.
The major task ahead for the FDA will be to set guidelines for demonstrating that new nanomedicines are safe. But Marth says there are both toxic and nontoxic approaches to nanomedicine. Even so, Bao says the FDA guidance will be important, as materials that behave one way on a normal scale can behave quite differently at a nanoscale.
"There might be some unique features of nanoparticles that induce some toxic effects," Bao suggests. "If they could get into the body, stay in the cells, not be cleared, there might be some harmful effects down the road, and we need to understand that. We do not think the particles we use have any intrinsic toxicity, but we need to know this for sure."
Read the article here or a very similar one here.
15 July 2011
12 July 2011
'White Coat Effect” Is For Real
Are you a person that takes your blood pressure at home? If so is it consistently lower than that taken in the doctor's office? If so, you may have “white coat effect” (or syndrome if your prefer) or an alternate problem that you have not been allowed to rest for the five minutes before they take your blood pressure. In some offices and clinics, there is a lengthy walk before arriving at the office where the doctor will see you.
This walk can be just enough to start to raise your blood pressure, and then some nurses insist that they take your BP just as soon as you sit down. So just remember that both can affect you blood pressure and the combination can add to the measurement in the doctor's office. Of course, there is a third alternative for men – the nurse may be very attractive – sorry, we won't go there.
Researchers at Duke University and the Durham, NC VA Medical Center have completed a study that supports the white coat syndrome. The study reports that blood pressure readings were consistently higher in the doctors' offices than those taken at home or even in the research setting. While doctors generally rely on one or two BP readings to determine if the patients need treatment for high blood pressure or if it is controlled sufficiently by patients already on medications. This study points out that changes need to be considered.
The researchers felt that repeated measurements taken at home may help give a more accurate display of blood pressure management that a single reading in a doctor's office. The research findings support the idea that the stress of a medical exam can cause large elevations in blood pressure. The researchers also stated that blood pressure normally fluctuates from hour to hour and from day to day, but even knowing this, they were surprised by the large differences between clinic and home readings.
The message for patients is that it is extremely difficult for doctors to know if BP is in or out of control without having multiple measurements. Because of the large differences between clinic and home readings, it is important to take home readings with you to the doctor as this can help the doctor make better decisions for you. Also be aware the some doctors do not accept home BP readings and will ignore them – possibly to your detriment. So discussion beforehand may be necessary.
Read two separate reports of the study here and here.
This walk can be just enough to start to raise your blood pressure, and then some nurses insist that they take your BP just as soon as you sit down. So just remember that both can affect you blood pressure and the combination can add to the measurement in the doctor's office. Of course, there is a third alternative for men – the nurse may be very attractive – sorry, we won't go there.
Researchers at Duke University and the Durham, NC VA Medical Center have completed a study that supports the white coat syndrome. The study reports that blood pressure readings were consistently higher in the doctors' offices than those taken at home or even in the research setting. While doctors generally rely on one or two BP readings to determine if the patients need treatment for high blood pressure or if it is controlled sufficiently by patients already on medications. This study points out that changes need to be considered.
The researchers felt that repeated measurements taken at home may help give a more accurate display of blood pressure management that a single reading in a doctor's office. The research findings support the idea that the stress of a medical exam can cause large elevations in blood pressure. The researchers also stated that blood pressure normally fluctuates from hour to hour and from day to day, but even knowing this, they were surprised by the large differences between clinic and home readings.
The message for patients is that it is extremely difficult for doctors to know if BP is in or out of control without having multiple measurements. Because of the large differences between clinic and home readings, it is important to take home readings with you to the doctor as this can help the doctor make better decisions for you. Also be aware the some doctors do not accept home BP readings and will ignore them – possibly to your detriment. So discussion beforehand may be necessary.
Read two separate reports of the study here and here.
11 July 2011
Old Guard Insists On Medical Resident's Initiation
I might have known that the old guard medical establishment would not give up easily. When I wrote this blog in January, I accused the old guard of using medical hazing like they were initiating college freshmen. Old habit dies hard, and the old guard has had to give way on first year residents, but after that it appears all bets are off until the next legal battle. In the interim, the initiations must go forward.
Never mind the errors medical residents will make and patients that may have their lives taken or damaged, medical initiation for medical residents must continue. Flying in the face of patient safety and reasonable work hours, effective July 1, 2011, medical residents can be scheduled to work up to 24 hours straight through and then have an additional 4 hours tacked on to their working schedule.
As patients, we can only hope that the teaching hospitals and all hospital with residents have excellent liability insurance and have their premiums paid up-to-date. It is not an, if this happens, but when it happens, patients lives are at risk and medical careers may be ended before even blossoming. But the old guard medical establishment feels this is the only way to teach medical students how to think on their feet and maintain medical initiation rites they had to endure.
Coauthor Lucian Leape, MD, an adjunct professor of health policy at the Harvard School of Public Health in Boston, Massachusetts, in a press release accompanying the article said “the current system amounts to an abuse of patient trust.” Well said doctor! Therefore, any patient entering a teaching hospital must be aware that patient safety is not high on the priority list. The initiation rite of medical residents is top of the list and you as the patient will have your safety put at high risk by residents lacking in sleep and probably not at their best for functioning effectively.
I know that I will be hard pressed to remain in one of these situations once I have reestablished by cognitive abilities if I am taken there in an emergency situation. My wife has been told not to allow this.
What is not clear is how much rest time the medical residents get between 24 or 28 hours tours of duty. This has to be wearing on their psyche as well as a drain on their health.
Read the press release here.
Never mind the errors medical residents will make and patients that may have their lives taken or damaged, medical initiation for medical residents must continue. Flying in the face of patient safety and reasonable work hours, effective July 1, 2011, medical residents can be scheduled to work up to 24 hours straight through and then have an additional 4 hours tacked on to their working schedule.
As patients, we can only hope that the teaching hospitals and all hospital with residents have excellent liability insurance and have their premiums paid up-to-date. It is not an, if this happens, but when it happens, patients lives are at risk and medical careers may be ended before even blossoming. But the old guard medical establishment feels this is the only way to teach medical students how to think on their feet and maintain medical initiation rites they had to endure.
Coauthor Lucian Leape, MD, an adjunct professor of health policy at the Harvard School of Public Health in Boston, Massachusetts, in a press release accompanying the article said “the current system amounts to an abuse of patient trust.” Well said doctor! Therefore, any patient entering a teaching hospital must be aware that patient safety is not high on the priority list. The initiation rite of medical residents is top of the list and you as the patient will have your safety put at high risk by residents lacking in sleep and probably not at their best for functioning effectively.
I know that I will be hard pressed to remain in one of these situations once I have reestablished by cognitive abilities if I am taken there in an emergency situation. My wife has been told not to allow this.
What is not clear is how much rest time the medical residents get between 24 or 28 hours tours of duty. This has to be wearing on their psyche as well as a drain on their health.
Read the press release here.
Subscribe to:
Posts (Atom)