Health Highlights: Oct. 13, 2006
FDA Warns of Fake Glucose Test Strips Methamphetamine Lessens Stroke Damage in Rodent Brains Group Wants FDA Probe of Breast Implant Allegations Vital Data Absent From Drug Study File: Report Colds Survey Nothing to Sneeze At
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
FDA Warns of Fake Glucose Test Strips
Counterfeit test strips for use with Lifescan's "One Touch" blood-glucose monitors are circulating in the United States and may provide false blood sugar readings that could lead to injury or death, the U.S. Food and Drug Administration warned Friday.
False readings could encourage diabetics to inject themselves with too little or too much insulin, the agency said in a statement, although no incidents have been reported so far.
The counterfeit test strips are labeled:
- One Touch Basic/Profile 50-count packages (lot #s 272894A, 2619932 or 2606340).
- One Touch Ultra 50-count packages (lot #2691191).
The strips were distributed to pharmacies and stores nationwide, but primarily in Florida, Maryland, Missouri, New York and Ohio. The distributors were Medical Plastic Devices Inc. (Quebec, Canada) and Champion Sales Inc. (Brooklyn, N.Y.).
Lifescan alerted the FDA to the problem, the agency said. Consumers who have these strips should stop using them immediately and contact a physician.
For more information, call Lifescan at 866-621-4855.
Methamphetamine Lessens Stroke Damage in Rodent Brains
In rat and gerbil brains, low doses of the drug methamphetamine appeared to lessen damage caused by stroke, says a University of Montana study that suggests the possibility that the drug may someday be used to reduce stroke damage in people.
The study will be presented at a Society of Neuroscience conference in Atlanta Oct. 14-18, the Associated Press reported.
"Methamphetamine is a drug that has been shown to exacerbate stroke damage or make it worse when administered before a stroke," Dave Poulsen, a research assistant professor in the university's department of biomedical and pharmaceutical sciences, said in a prepared statement. "But we have seen roughly 80 to 90 percent protection of neurons when administered after a stroke."
The scientists found that low doses of methamphetamine helped reduce brain damage up to 16 hours after a stroke. The current leading clot-busting drug used to treat stroke patients must be administered within three hours of the start of symptoms, Poulsen noted.
In one experiment, Poulsen and his colleagues mimicked stroke conditions in thin slices of rat hippocampus (the part of the brain used for memory and learning). They found that low doses of methamphetamine helped protect the brain slices, while high doses increased stroke damage, the AP reported. Another experiment found that low doses protected the brains of gerbils that had strokes.
This is preliminary research and more work is needed to confirm and expand the findings, Poulsen said.
Group Wants FDA Probe of Silicone Breast Implant Allegations
The U.S. Food and Drug Administration must investigate a whistle blower's charges that a company seeking approval to sell silicone breast implants withheld safety data from federal regulators, the advocacy group Public Citizen says.
Mentor Corp. of Santa Barbara, Calif., is one of two companies seeking FDA approval to sell silicone breast implants in the United States. A former Mentor scientist alleges that the company concealed, misrepresented, or withheld data about durability and leakage in its implants, the Associated Press reported.
"Unless the FDA opens a criminal investigation into Mentor's failure to submit the studies, it will only encourage Mentor and other device manufacturers to selectively send the agency only those studies that put their products in the most favorable light," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group.
A statement released by Mentor said, to the company's knowledge, all questions about the its silicone implants were answered to the satisfaction of the FDA, the AP reported.
Silicone breast implants first went on sale in the United States in 1962, but concerns about cancer and leakage problems led to their removal from the market in 1992. In July 2005, the FDA told Mentor and another company that it would allow them to start selling silicone breast implants if the companies met certain unspecified conditions. Neither company has yet received final marketing approval from the FDA.
Vital Data Absent From Drug Research File: Report
Important information was missing from a company research file given to United Kingdom regulators prior to the start of a drug study that left six men seriously ill, says a report by drug research experts from the Netherlands who investigated the incident.
The missing data may have alerted U.K. officials about the potential harm that the experimental drug TGN1412 could cause study volunteers, BBC News reported.
The man who suffered the worst effects from the drug had his fingers and toes amputated and his health outlook is uncertain.
The Dutch report noted that scientists from the German drug company TeGenero said that the site in the body where TGN1412 binds was identical in humans and monkeys. No detailed data on such a comparison was included in the research file given to U.K. regulators, the report said.
The Dutch investigators did their own research on the binding site and concluded that, in fact, there are clear differences between humans and monkeys, BBC News reported.
The investigators said the file also lacked information about how TGN1412 affects certain human immune cells compared to monkey immune cells.
Drug developers must provide all essential information for regulators to properly evaluate which human drug trials should be approved, the report said.
Colds Survey Nothing to Sneeze At
Nearly three in five (58 percent) U.S. travelers age 30 and over say getting a cold while traveling is as annoying as sitting next to crying child while traveling, says a national survey released Thursday.
The online survey included 1,366 adults, age 30 and over, who took at least one leisure, business, or combined leisure/business trip by plane in the previous year. The survey also found:
- 79 percent said getting a cold while traveling is annoying or very annoying.
- 37 percent said getting a cold has negatively affected their travel experiences.
- 49 percent said they feel dissatisfied with their vacation if they catch a cold.
- 51 percent said they can't perform at their best while traveling if they have a cold.
The survey was conducted by Harris Interactive on behalf of a company that makes a cold remedy.