/PRNewswire/ -- The chemical dispersants being used to break up the oil leaking into the gulf following the explosion of British Petroleum's Deepwater Horizon offshore oil rig have the potential to cause just as much, if not more, harm to the environment and the humans coming into contact with it than the oil possibly would if left untreated.
That is the warning of toxicology experts, led by Dr. William Sawyer, addressing the Gulf Oil Disaster Recovery Group, a group of lawyers working to protect the rights and interests of environmental groups and persons affected by the Deepwater Horizon disaster. The group represents the United Fishermen's Association and the Louisiana Environmental Action Network (LEAN), among others.
Various publications from the National Academy of Sciences and the National Research Council show that baseline data on the environmental and ecologic fate of petroleum spills and their effects in the marine environment is substantially deficient, said Dr. Sawyer. The lack of substantial research in these areas makes many of the decision-making processes pertaining to successful major spill containment and remediation rife with speculation.
The ongoing discharge of petroleum from the BP site, with a concurrent substantial use of surface and deep-water dispersants, demonstrates an environmental release of toxicants into the marine, marsh and beach environments in an unprecedented way, said Lead Counsel Stuart Smith for Gulf Oil Disaster Recovery Group. Mr. Smith was the first to challenge British Petroleum on the failure of its cofferdam cap on the DEEPWATER HORIZON and has won two successful injunctions requiring British Petroleum to respect fishermen's legal rights and protect their health in all areas impacted by the Gulf oil spill.
"The dispersants used in the BP clean-up efforts, known as 'Corexit 9500' and 'Corexit EC9527A,' are also known as deodorized kerosene," said Dr. Sawyer. "With respect to marine toxicity and potential human health risks, studies of kerosene exposures strongly indicate potential health risks to volunteers, workers, sea turtles, dolphins, breathing reptiles and all species which need to surface for air exchanges, as well as birds and all other mammals. Additionally, I have considered marine species which surface for atmospheric inhalation such as sea turtles, dolphins and other species which are especially vulnerable to aspiration toxicity of 'Corexit 9500' into the lung while surfacing."
The "Corexit 9500" dispersant is designed to breakup the slick at the water's surface, sending the oil into the water column, and from there, to the bottom of the seabed where bottom residing organisms such as shrimp, crabs and oysters reside. One concern with the usage of such dispersants is that, aside from being themselves toxic, they do little more than hide the problem, said Mr. Smith. Many leading experts, doctors and environmentalists have discredited the use of Corexit as a tool for oil spill clean up.
"Toxicity of the petroleum products is increased when it is dissolved into the water by dispersants," said Co-Counsel Robert McKee, Gulf Oil Disaster Recovery Group. "In essence, this activity is making aquatic organisms more exposed to chemicals' harm. The attempt to make these floating tars and oils disappear from view by the use of dispersants increases the likelihood of poisonous effects in these oil polluted waters."
Mr. McKee added, "The use of dispersants, without knowing the cascade of toxic events which may flow from the practice, mandates that those who may be forced to prove their losses in a court of law obtain competent and environmentally knowledgeable legal representatives who can establish the pre-damage baseline ecology now, in order to compare to post-oil spill contamination effects seen later. Without that immediate effort, victims who did not seek that type of early assistance may lose their ability to prove a full accounting of their rightful compensation for losses they actually sustain. The use of dispersants not only hides the amount of oil actually being discharged from view, but also serves to undermine damage proof for the unwary victim who chooses to wait to see what is going to happen."
"What, if any, published testing data has BP used to understand and quantify the long term and short term risks presented to marine environments and fisheries populations by the ongoing spillage of petroleum? What facts supported the decision that dispersants would effectively protect shorelines without significantly impacting the water column and benthic marine populations of the Gulf?" said Mr. Smith. "BP must answer the many questions that arise from the usage of dispersants and be accountable for its actions and the harmful effects they have on marine life, the coastline and the livelihood of those who make their living off the fisheries and tourism industry."
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Showing posts with label gene. Show all posts
Showing posts with label gene. Show all posts
Tuesday, May 11, 2010
Wednesday, April 28, 2010
FDA Warns Users about Faulty Components in 14 External Defibrillator Models
About 280,000 external defibrillators used worldwide in health care facilities, public places, or in the home may malfunction during attempts to rescue people in sudden cardiac arrest, the U.S. Food and Drug Administration warned today.
Sudden cardiac arrest is a condition in which the heart suddenly and unexpectedly stops beating. When this happens, blood stops flowing to the brain and other vital organs, leading to death if not treated within minutes.
External defibrillators can send an electric shock to the heart to try to restore normal heart rhythm when sudden cardiac arrest occurs.
Faulty components in defibrillators manufactured by Cardiac Science Corp. of Bothell, Wash., may cause the devices to fail to properly deliver a shock. In addition to failure to deliver needed shocks, other problems with the affected models may include interruption of electrocardiography (ECG) analysis, failure to recognize electrode pads, and interference or background noise that makes the device unable to accurately analyze heart rhythm.
The 14 models, which include automated and semi-automated devices, are:
• Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E
• CardioVive models 92531, 92532 and 92533
• Nihon Kohden models 9200G and 9231 and
• GE Responder models 2019198 and 2023440.
The FDA recommends that hospitals, nursing homes and other high-risk settings obtain alternative external defibrillators and arrange for the repair or replacement of the affected defibrillators.
For all other users, including those who use the device at home or as part of public access programs, the FDA recommends using alternative external defibrillators if they are available, and arranging for the repair or replacement of the affected models.
If alternative external defibrillators are not immediately available, then FDA recommends continuing to use the affected devices if needed, because they may still deliver necessary therapy. The potential benefits of using the available external defibrillators outweigh the risk of not using any of the affected external defibrillators or the risk of device failure.
“The FDA is issuing this notice so that users can take the proper steps necessary to assure they have access to safe and effective defibrillators,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
Cardiac Science recalled its Powerheart and CardioVive models, manufactured between August 2003 and August 2009, on Nov. 13, 2009. But the FDA has since learned that additional Cardiac Science models, two marketed under the Nihon Kohden name, and two marketed by GE Healthcare as GE Responder have similar problems.
Cardiac Science issued a software update for two of its Powerheart defibrillators in February 2010 and plans to issue similar software updates for other affected devices. However, FDA’s review of the updated software indicates that the software detects some, but not all, identified defects.
Nihon Kohden is based in Tokyo, Japan. GE Healthcare is located in Britain.
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Sudden cardiac arrest is a condition in which the heart suddenly and unexpectedly stops beating. When this happens, blood stops flowing to the brain and other vital organs, leading to death if not treated within minutes.
External defibrillators can send an electric shock to the heart to try to restore normal heart rhythm when sudden cardiac arrest occurs.
Faulty components in defibrillators manufactured by Cardiac Science Corp. of Bothell, Wash., may cause the devices to fail to properly deliver a shock. In addition to failure to deliver needed shocks, other problems with the affected models may include interruption of electrocardiography (ECG) analysis, failure to recognize electrode pads, and interference or background noise that makes the device unable to accurately analyze heart rhythm.
The 14 models, which include automated and semi-automated devices, are:
• Powerheart models 9300A, 9300C, 9300D, 9300E, 9300P, 9390A and 9390E
• CardioVive models 92531, 92532 and 92533
• Nihon Kohden models 9200G and 9231 and
• GE Responder models 2019198 and 2023440.
The FDA recommends that hospitals, nursing homes and other high-risk settings obtain alternative external defibrillators and arrange for the repair or replacement of the affected defibrillators.
For all other users, including those who use the device at home or as part of public access programs, the FDA recommends using alternative external defibrillators if they are available, and arranging for the repair or replacement of the affected models.
If alternative external defibrillators are not immediately available, then FDA recommends continuing to use the affected devices if needed, because they may still deliver necessary therapy. The potential benefits of using the available external defibrillators outweigh the risk of not using any of the affected external defibrillators or the risk of device failure.
“The FDA is issuing this notice so that users can take the proper steps necessary to assure they have access to safe and effective defibrillators,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
Cardiac Science recalled its Powerheart and CardioVive models, manufactured between August 2003 and August 2009, on Nov. 13, 2009. But the FDA has since learned that additional Cardiac Science models, two marketed under the Nihon Kohden name, and two marketed by GE Healthcare as GE Responder have similar problems.
Cardiac Science issued a software update for two of its Powerheart defibrillators in February 2010 and plans to issue similar software updates for other affected devices. However, FDA’s review of the updated software indicates that the software detects some, but not all, identified defects.
Nihon Kohden is based in Tokyo, Japan. GE Healthcare is located in Britain.
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Thursday, March 18, 2010
FDA Committed to Addressing Growing National Overdose Problem
The U.S. Food and Drug Administration (FDA) recognizes the five-fold increase in unintentional drug overdose deaths noted by the Centers for Disease Control and Prevention between 1990 and 2006 as a serious public health concern. Much of this increase follows from increases in the deaths from the use of opioid drugs, which in 2006 accounted for more overdose deaths than heroin and cocaine combined. The agency is also concerned about misuse of benzodiazepines (e.g., Valium and Xanax), which accounted for 272,000 emergency department visits in 2008 (compared to 306,000 for opioids).
FDA is pursuing a variety of programs and initiatives in an effort to strike the right balance between ensuring patients access to important pain medications and mitigating the risks. These efforts include:
* The Safe Use Initiative: The mission of the Safe Use Initiative is to create and facilitate public and private collaborations within the healthcare community. Its goal is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use (see http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm1). Collaborations of this kind are essential for drugs like opioids, given the diverse factors that influence their use (e.g., legal, social, medical) and the many stakeholders working to assure they are used safely and effectively.
* Risk Evaluation and Mitigation Strategies (REMS) for Opioid Drugs: In 2007, Congress provided FDA with the authority to require REMS if that was necessary to ensure that the benefits of a drug outweigh its risks. These can include, for example, requirements for prescriber, pharmacist, and patient education about the risks and appropriate use of a drug, or other tools to better manage a drug’s risks On February 6, 2009, FDA sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a REMS. The affected opioid drugs include long-acting and extended-release brand name and generic products that contain the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone (see http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm2). FDA held a series of public stakeholder meetings in 2009 and opened a docket to receive public comments. FDA continues to accept public comments on the Agency’s approach to opioid REMS and plans to hold a public advisory committee meeting in the summer of 2010 to discuss proposals for this important safety program.
* Efforts on Acetaminophen: Every year in the United States, about 30,000 people are hospitalized with overdoses associated with acetaminophen – approximately half of which are unintentional. In June 2009, FDA convened an advisory committee meeting to provide expert input on options to reduce harm while maintaining access to this effective medication for pain. Potential strategies are currently under review.
* Strategies for the safe disposal of drugs: Certain medicines may be especially harmful and, in some cases, fatal in a single dose if they are accidentally taken. For this reason, FDA lists 26 drugs, including a number of potent opioids, that have special disposal directions indicating they should be flushed down the sink or toilet after the medicine is no longer needed. If disposed of down the sink or toilet, they cannot be accidently used by children, pets, or anybody else (Learn More: Disposal by Flushing of Certain Unused Medicines: What You Should Know3).
* Evaluating the abuse potential of drugs: FDA has entered into a research collaboration with the National Institute on Drug Abuse (NIDA) to assess particular drugs for their abuse potential. The results of this research are provided to the Drug Enforcement Administration (DEA).
* Supporting efforts to identify safer pain medications. Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research recently reviewed this area in the New England Journal of Medicine. See http://content.nejm.org/cgi/content/full/361/22/21054.Exit Disclaimer5
Through these efforts and others, FDA will join with sister agencies, medical professionals, health care institutions, patient organizations and others to reduce the number of overdose deaths.
-----
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FDA is pursuing a variety of programs and initiatives in an effort to strike the right balance between ensuring patients access to important pain medications and mitigating the risks. These efforts include:
* The Safe Use Initiative: The mission of the Safe Use Initiative is to create and facilitate public and private collaborations within the healthcare community. Its goal is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use (see http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm1). Collaborations of this kind are essential for drugs like opioids, given the diverse factors that influence their use (e.g., legal, social, medical) and the many stakeholders working to assure they are used safely and effectively.
* Risk Evaluation and Mitigation Strategies (REMS) for Opioid Drugs: In 2007, Congress provided FDA with the authority to require REMS if that was necessary to ensure that the benefits of a drug outweigh its risks. These can include, for example, requirements for prescriber, pharmacist, and patient education about the risks and appropriate use of a drug, or other tools to better manage a drug’s risks On February 6, 2009, FDA sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a REMS. The affected opioid drugs include long-acting and extended-release brand name and generic products that contain the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone (see http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm2). FDA held a series of public stakeholder meetings in 2009 and opened a docket to receive public comments. FDA continues to accept public comments on the Agency’s approach to opioid REMS and plans to hold a public advisory committee meeting in the summer of 2010 to discuss proposals for this important safety program.
* Efforts on Acetaminophen: Every year in the United States, about 30,000 people are hospitalized with overdoses associated with acetaminophen – approximately half of which are unintentional. In June 2009, FDA convened an advisory committee meeting to provide expert input on options to reduce harm while maintaining access to this effective medication for pain. Potential strategies are currently under review.
* Strategies for the safe disposal of drugs: Certain medicines may be especially harmful and, in some cases, fatal in a single dose if they are accidentally taken. For this reason, FDA lists 26 drugs, including a number of potent opioids, that have special disposal directions indicating they should be flushed down the sink or toilet after the medicine is no longer needed. If disposed of down the sink or toilet, they cannot be accidently used by children, pets, or anybody else (Learn More: Disposal by Flushing of Certain Unused Medicines: What You Should Know3).
* Evaluating the abuse potential of drugs: FDA has entered into a research collaboration with the National Institute on Drug Abuse (NIDA) to assess particular drugs for their abuse potential. The results of this research are provided to the Drug Enforcement Administration (DEA).
* Supporting efforts to identify safer pain medications. Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research recently reviewed this area in the New England Journal of Medicine. See http://content.nejm.org/cgi/content/full/361/22/21054.Exit Disclaimer5
Through these efforts and others, FDA will join with sister agencies, medical professionals, health care institutions, patient organizations and others to reduce the number of overdose deaths.
-----
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Saturday, March 13, 2010
Electronic Cigarettes Are Tobacco Products, States AAPHP
/PRNewswire/ -- The American Association of Public Health Physicians submitted a petition to the US Food and Drug Administration on February 23rd in response to their official stance concerning electronic cigarettes. They cite many concerns, including legal, ethical, epidemiological, medical, and the impact on public health the products could have in the future.
The AAPHP's recent petition dealt with their request that the FDA reclassify the products from a "drug-device combination" to a "tobacco product." They are currently urging all supporters of electronic cigarettes to leave the FDA comments on the docket for their petition so the will of the people may be made known . The AAPHP believes in and promotes harm reduction, unlike other mainstream health organizations who reject the concept.
According to the AAPHP, all tobacco products are "nicotine delivery devices" and that the largest portion of illness and death from conventional cigarettes is due to the products of the combusted tobacco, not the chemicals and other substances found in tobacco cigarettes. The carcinogens are not what cause the majority of the health problems; the smoke causes it when it is inhaled deeply into the lungs and held there.
"E-cigarettes, more than any other tobacco or tobacco-related product, satisfies both the habituation and nicotine addiction," says the organization in their petition. They state that they believe that many smokers struggle with a second addiction to smoking, which is the habit of carrying a pack of cigarettes and lighter, holding the cigarette when it is lit, and the act of smoking it. It is said in their report that there is a significant number of electronic cigarette users who have been successful in switching over to e-cigarette liquid which contains no nicotine while they continue to perform the ritual of "smoking."
Continuing on through the petition, they state that electronic cigarettes, unlike conventional cigarettes, produce no sidestream smoke; that is, smoke that is emitted from a cigarette when it is not being puffed on. The fact that electronic cigarettes also have no combustion is mentioned again, this time in reference to the amount of property damage done every year due to fires caused by lit cigarettes.
The AAPHP states that classifying electronic cigarettes as tobacco products would enable the FDA to impose manufacturing quality regulations, much in the same way pharmaceutical companies are expected to produce their products.
"Objections to FDA approval of e-cigarettes as tobacco products are speculative and largely based on misinformation," states the petition.
-----
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The AAPHP's recent petition dealt with their request that the FDA reclassify the products from a "drug-device combination" to a "tobacco product." They are currently urging all supporters of electronic cigarettes to leave the FDA comments on the docket for their petition so the will of the people may be made known . The AAPHP believes in and promotes harm reduction, unlike other mainstream health organizations who reject the concept.
According to the AAPHP, all tobacco products are "nicotine delivery devices" and that the largest portion of illness and death from conventional cigarettes is due to the products of the combusted tobacco, not the chemicals and other substances found in tobacco cigarettes. The carcinogens are not what cause the majority of the health problems; the smoke causes it when it is inhaled deeply into the lungs and held there.
"E-cigarettes, more than any other tobacco or tobacco-related product, satisfies both the habituation and nicotine addiction," says the organization in their petition. They state that they believe that many smokers struggle with a second addiction to smoking, which is the habit of carrying a pack of cigarettes and lighter, holding the cigarette when it is lit, and the act of smoking it. It is said in their report that there is a significant number of electronic cigarette users who have been successful in switching over to e-cigarette liquid which contains no nicotine while they continue to perform the ritual of "smoking."
Continuing on through the petition, they state that electronic cigarettes, unlike conventional cigarettes, produce no sidestream smoke; that is, smoke that is emitted from a cigarette when it is not being puffed on. The fact that electronic cigarettes also have no combustion is mentioned again, this time in reference to the amount of property damage done every year due to fires caused by lit cigarettes.
The AAPHP states that classifying electronic cigarettes as tobacco products would enable the FDA to impose manufacturing quality regulations, much in the same way pharmaceutical companies are expected to produce their products.
"Objections to FDA approval of e-cigarettes as tobacco products are speculative and largely based on misinformation," states the petition.
-----
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Wednesday, January 09, 2008
Autism Update: Major discovery
A few days ago I wrote a bit about autism and vaccinations (scroll down on the righ to the archive and you'll see the article). Today this bit came across my desk and I thought you might find it interesting. Reading the article I gather this is a major discovery that could have a huge impact on the future of prevention and treatment:
Study: Rare gene change linked to autism
A rare genetic variation dramatically raises the risk of developing autism, a large study showed, opening new research targets for better understanding the disorder and for treating it.
http://news.yahoo.com/s/ap/20080109/ap_on_he_me/autism_gene
Study: Rare gene change linked to autism
A rare genetic variation dramatically raises the risk of developing autism, a large study showed, opening new research targets for better understanding the disorder and for treating it.
http://news.yahoo.com/s/ap/20080109/ap_on_he_me/autism_gene
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