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A recent report in The New York Times indicated that the Food and Drug Administration (FDA) is holding a rare “all-hands meeting” to discuss strategic issues in the medical device division of the agency is a further indication that safety approval of medical devices has been compromised, putting patients’ health and safety at risk.  The meeting shows that the FDA sees an urgent need for reform in the agency especially when it comes to medical devices that have seen massive recalls and no recourse of litigation for those injured by these devices.

The American Association for Justice (AAJ) has been working with a large coalition of consumer and patient safety groups to pass the Medical Device Safety Act (MDSA), legislation that would restore the rights of medical device patients to seek justice in state courts when they have been harmed by unsafe medical devices. 

Diet and nutrition counseling for virtually all overweight and obese women of childbearing age can reduce health risks linked to excess weight for mothers and children alike, as per a newly released position paper from the American Dietetic Association and the American Society of Nutrition.

The position, reported in the recent issue of the Journal of the American Dietetic Association, represents the associations' official stance on obesity, reproduction and pregnancy outcomes:

Given the detrimental influence of maternal overweight and obesity on reproductive and pregnancy outcomes for the mother and child, it is the position of the American Dietetic Association and the American Society for Nutrition that all overweight and obese women of reproductive age should receive counseling previous to pregnancy, during pregnancy and in the interconceptional period on the roles of diet and physical activity in reproductive health, in order to ameliorate these adverse outcomes.

The joint ADA/ASN position and accompanying paper were written by Anna Maria Siega-Riz, PhD, RD, LDN, assistant professor of maternal and child health at the University of North Carolina; and Janet C. King, PhD, senior scientist at Children's Hospital and Research Center, Oakland, Calif.

An estimated 33 percent of U.S. women are obese, as per the authors, who write that a long-term goal of health professionals must be to reduce the number of women who become pregnant while obese. They add that the effect of a woman's nutritional status previous to pregnancy is an issue of great public health importance.

"Among obese women, who already have aberrations in glucose and lipid metabolism, the further adjustments induced by hormonal changes in pregnancy create a metabolic milieu that enhances the risk for metabolic disorders such as gestational diabetes mellitus and preeclampsia," as per the position paper.

Infants born to obese mothers have "a higher prevalence of congenital anomalies than do offspring of normal-weight women, suggesting that maternal (obesity) alters development in the sensitive embryonic period." The authors note neural tube defects such as spina bifida and anencephaly are about twice as common among children of obese women. "Other birth defects more frequent in offspring of obese women include oral clefts, heart anomalies, hydrocephaly and abdominal wall abnormalities."

Objectives of the new ADA/ASN position are to provide guidance to nutrition professionals in becoming aware of risks and possible complications of excess weight and obesity for fertility, course of pregnancy, birth outcomes and short and long-term maternal and child health; and to commit ADA and ASN to identifying gaps in scientific research needed to improve knowledge of risks and complications and develop effective strategies "that can be implemented before and during pregnancy as well as during the interconceptional period," the authors write.

The American Dietetic Association is the world's largest organization of food and nutrition professionals. ADA is committed to improving the nation's health and advancing the profession of dietetics through research, education and advocacy. Visit the American Dietetic Association at www.eatright.org/.


Posted by: Evelyn    Source

The National Transportation Safety Board (NTSB) recently concluded driver fatigue, and the lack of federal safety standards protecting passengers on buses, contributed to the death and severity of the injuries sustained in the 2008 Utah bus rollover which killed nine and injured 43.  In response, the American Association for Justice (AAJ) is calling on transportation regulators to review pending pre-Obama administration regulations and open new rule making proceedings to enhance commercial transportation safety measures for both trucks and buses.

You can read more on the American Association for Justice's website here.
 

I recently received the February 2009 issue of the Archives of Clinical Neuropsychology.  The opening article is a position paper of the National Academy of Neuropsychology which is entitled “Secretive Recording of Neuropsychological Testing and Interviewing: Official Position of the National Academy of Neuropsychology”.  The authors of this position paper are Shane S. Bush, Patricia A. Pipental, Ronald M. Ruff, Grant L. Iverson, Jeffrey T. Barth and Donna K. Broshek.
 
There, NAN has taken the position that neuropsychologists do not and should not encourage, condone or engage in the secret recording of neuropsychological interviews or testing as such practice is both deceptive and inconsistent with ethical principles.  The paper also notes, in addition, that such a recording may affect the behavior of the examiner. 
 
Obviously, the issue of secretive recording of neuropsychological evaluations most frequently, if not always, arises in the context of forensic neuropsychological evaluations for litigation purposes.  Further, in most instances, the secret recording would be requested by the plaintiff’s attorney who was concerned about the impartiality of the defense neuropsychologist who is conducting the evaluation. 
 
While the position paper indicates that the examiner’s behavior may be affected, there is no support in the position paper nor any research cited in support of this statement. 
 
Furthermore, as has been indicated in other published papers, many defense neuropsychologists are paid tens of thousands of dollars to serve as a defense neuropsychologists.  Certainly, the payment of large sums of money to serve as a defense forensic expert would have a greater effect on the examiner’s behavior than that examiner recording the neuropsychological evaluation.
 
Finally, it is noteworthy that at the bottom of the position papers as well as all of the other papers published in this issue contain a section entitled “Conflict of Interest”.  In the position papers, all of the authors have indicated that they have no conflict of interest.  While I do not know any of the authors personally and assume and presume that they have undertaken their study with total integrity, it would seem that since this position paper as well as many papers that are published in the Archives involve forensic issues, that where an author is involved in forensic litigation, that neuropsychologist disclose his or her involvement in such litigation and how much of such litigation is on behalf of plaintiffs and/or defendants.  Certainly, if a neuropsychologist earns a great deal of his or her income from forensic litigation matters that a conflict of interest may arise and the readers of the Archives should be aware of such.

The Brain Injury Association of New Jersey will offer two regional seminars this month focusing on the long-term effects of brain injuries on a patient's mental health. The seminars will address the needs of individuals with brain injuries served by health and human service workers throughout New Jersey.

The seminars were created in an effort to increase awareness of brain injuries among health and human service professionals. Since the first series of regional seminars were held in 2003, over 300 health and human service professionals from a wide variety of agencies throughout the state of New Jersey attend the seminars every year.

You can access additional information on the seminars, as well as dates and times for the seminars, online here.