Agent Orange linked to blood pressure
Fri, 27 Jul 2007 14:06:37 GMTWASHINGTON - Exposure to Agent Orange in Vietnam may lead to high blood pressure in some veterans, but the evidence is limited and only suggestive, the Institute of Medicine said Friday.
The IOM, an arm of the National Academy of Sciences, has been studying the effects of the herbicide Agent Orange on veterans since the early 1990s, and is issuing its seventh update.
Two recent studies of Vietnam veterans who handled Agent Orange and other defoliants indicated that these veterans have higher rates of high blood pressure, the report said.
Hypertension affects more than 70 million American adults and is a major risk factor for heart attack and stroke.
The new findings were consistent with other studies that looked at the health effects of herbicides. However, a new environmental study and an earlier study of workers in a herbicide manufacturing plant did not find evidence of an association between herbicide or dioxin exposure and increased high blood pressure.
Because of the inconsistent results the institute said the evidence is suggestive of, but insufficient to conclude with certainty, that exposure to the herbicide leads to high blood pressure.
The new update also said there is suggestive but limited evidence that AL amyloidosis is associated with herbicide exposure.
A rare condition that affects one person in 100,000, AL amyloidosis is characterized by the accumulation of protein deposits in and around organs.
The committee said AL amyloidosis shares many biological and pathological similarities with multiple myeloma and certain B-cell lymphomas, which have previously been found to be associated with exposure to herbicides.
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On the Net:
Institute of Medicine: http://www.nationalacademies.org/iom
FDA suspends gene therapy study
Thu, 26 Jul 2007 23:24:19 GMTBy LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - The government has suspended a Seattle company's gene therapy study — and is reviewing the safety of 28 others around the country — after learning that a patient died this week.
The Food and Drug Administration didn't reveal the cause of death or any details about the patient, who had enrolled in a study of gene therapy for advanced arthritis. The agency said it was investigating what role, if any, therapy played in the death, which occurred Tuesday.
It marks the third blow since 1999 to the field of gene therapy, as scientists struggle to determine if the viruses they use to deliver new genes may themselves cause serious trouble.
Twenty-eight other gene therapy studies have been reported to the FDA that used, or are using, the same virus, called adeno-associated virus or AAV.
The FDA said Thursday that it was not aware of any serious side effects in any of those studies but that as a precaution, officials were reviewing all the ones still actively treating patients.
Targeted Genetics Corp. notified the FDA of the patient's illness and subsequent death.
The company had enrolled more than 100 people in the study without similar problems, but this patient became ill after a second injection of the therapy directly into an arthritic joint, the FDA said.
The therapy uses AAV to deliver a gene that in turn blocks tumor necrosis factor, a substance that fuels the joint inflammation behind crippling forms of arthritis. Drugs that block TNF already are widely used to treat rheumatoid arthritis and other conditions, but a gene therapy approach is novel.
"We are deeply saddened by the death of an individual enrolled in our clinical trial," company president H. Stewart Parker said in a statement issued Thursday.
The company didn't immediately return a phone call seeking comment.
In 1999, 18-year-old Jesse Gelsinger died in his fourth day of a gene therapy experiment at the University of Pennsylvania. Gelsinger had suffered from an inherited disorder that blocks the body from properly processing nitrogen. The FDA concluded that the gene therapy injection intended to try to cure him instead killed him.
That gene therapy attempt used a cousin to AAV, called adenovirus, to deliver the needed gene.
The only disease ever to be cured with gene therapy is "bubble boy disease," an immune disorder formally called severe combined immunodeficiency, or SCID. But gene therapy attempts are restricted to SCID patients who have no alternative, after doctors in 2003 discovered a few babies saved by gene therapy went on to develop cancer — again, linked to the virus used to deliver the genes.
Reflecting how seriously regulators take this latest death, the National Institutes of Health's advisory committee on gene therapy will meet in September to discuss its potential scientific implications.
Group to issue surgery fires guidelines
Thu, 26 Jul 2007 19:50:54 GMTBy DAVE COLLINS, Associated Press Writer
Flames engulfed Kathleen Osberger's face as she lay sedated on a Chicago operating room table during what was supposed to be a simple procedure to remove two moles from her face. Now, seven years and 18 corrective surgeries later, the 54-year-old clinical social worker is still on disability leave because of the severe burns to her upper lip, nose and nasal passages.
She says doctors have never told her what they think went wrong, but she believes oxygen collected under the surgical drapes and fed a fire sparked by surgical tools. She sued and settled with the hospital, which denied negligence.
"I believe they walked into the operating room trying to help me. However, something massively went wrong," she said.
Surgery fires are rare but serious enough that the American Society of Anesthesiologists plans this fall to issue its first guidelines aimed at preventing them. Health officials aren't required to report surgery fires, but the medical group believes they've increased over the past two decades with the use of lasers and tools that use electric current.
"We think there is a lot of underreporting and a lot of near misses," said Dr. Jan Ehrenwerth, a professor at the Yale University School of Medicine and a member of the society's task force on the issue.
ECRI Institute, a nonprofit health research agency, estimates that there are 50 to 100 fires out of the more than 50 million surgeries performed in the United States each year. Such fires kill one to two people annually, and 20 percent of patients suffer serious, disfiguring injuries, according to ECRI, which investigates medical procedures and devices.
Most fires are caused when oxygen builds up under surgical drapes during the use of electric surgical tools that cut or remove tissue or control bleeding, the institute says.
ECRI's Mark Bruley said too many anesthesiologists are using 100 percent oxygen instead of only what the patient needs.
The proposed guidelines include lowering the concentration of oxygen given to patients during surgery by diluting it with room air when surgical tools that could ignite a fire are in use. Other suggestions are to reconfigure drapes to minimize oxygen buildup and use suction devices to remove excess oxygen from surgery sites.
Ehrenwerth disputes suggestions that anesthesiologists are unnecessarily giving high concentrations of oxygen.
"We have to look at the patient and see what's safe for the patient," he said. "We don't want them to have decreased oxygen to their heart or their brain."
Dr. Richard Greco, a plastic surgeon in Savannah, Ga., had a patient catch fire in 1991. While cauterizing an area during an eyelid procedure, excess oxygen fueled flames that burned his patient's nose.
"I was absolutely astonished that the fire occurred while I was doing everything I was trained to do," he said. "There was obviously a flaw in the system. People weren't considering the risk of fire."
He said patients can be kept stable with an oxygen levels of 30 or 40 percent during the use of electrosurgery tools.
Medical researchers and doctors say concern about surgery fires waned in the 1970s when safer anesthetics replaced ether and other flammable agents used to sedate patients. Today more electrosurgery devices are used and cloth drapes have been replaced with paper drapes, which are more flammable.
Osberger, who lives in Chicago, settled a malpractice lawsuit in 2003 against Weiss Memorial Hospital for $6 million. She's had to wear special masks, had stents inserted into her nasal passages and still has trouble breathing or smiling.
The hospital said in a statement Thursday that it has changed its procedures and follows the recommendations of a hospital accrediting group to prevent surgical fires. Those changes include how patients are prepped before surgery and how oxygen is administered. The surgical staff is also trained to prevent fires and how to respond to them, the hospital said.
Osberger believes one of the ways to decrease surgery fires is to require mandatory reporting of them.
"With the high level of skill you have in the operating room, this is preventable," she said.
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On the Net:
American Society of Anesthesiologists: http://www.asahq.org/
