Reintroduced MS Drug Cited in Two New Deadly Infections
Two new instances of a dangerous brain infection have been reported among users of Tysabri, a multiple sclerosis drug that was reintroduced two years ago after being pulled from the market because of the same adverse effect.
While the two new cases occurred in Europe, they raised international concern about Tysabri and its connection with the viral brain condition called progressive multifocal leukoencephalopathy (PML). The new cases were confirmed this week, according to the Bloomberg news service, which cited a statement from one of the drug's makers, Massachusetts-based Biogen Idec Inc.
Biogen and co-maker Elan Corp, based in Ireland, voluntarily withdrew Tysabri in February 2005 after three users contracted PML and two of them died. The drug was reintroduced in July 2006.
A Biogen spokeswoman told Bloomberg that additional cases had been anticipated and that pulling the drug again was "not under consideration."
Some 31,800 people were taking Tysabri at the end of June, and the companies had hoped to have 100,000 users by 2010, the news service said. The drug also has been approved in the United States to treat an inflammatory bowel disorder called Crohn's disease.
Of the two new cases of PML, one is recovering at home and the other has been hospitalized, Bloomberg said.
"These incidents of PML are unfortunate and disappointing, and we hope for the best possible outcomes for these individuals and their families," the National Multiple Sclerosis Society said in a news release. "However, their occurrence is within range of the predicted frequency of cases, estimated by a published report and by the FDA, of approximately one in 1,000 people taking the drug."
The society said Tysabri users and their doctors should monitor closely for signs of PML, which could include "worsening neurological symptoms such as any changes in thinking, eyesight, balance, strength and other symptoms."
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Possible Anthrax Suspect Commits Suicide
A senior U.S. government biodefense researcher who may have been linked to a series of anthrax deaths in 2001 committed suicide earlier this week. Bruce E. Ivins, 62, worked at the biodefense laboratories in Fort Detrick, Md. for the past 33 years.
Ivins did not play a role in the anthrax deaths of at least five people and had fully cooperated with investigators, his lawyer told The New York Times.
"The relentless pressure of accusation and innuendo takes its toll in different ways on different people, as has already been seen in this investigation," said Paul Kemp. "In Dr. Ivin's case, it led to his untimely death."
Ivins was regarded as a legitimate suspect and agents were nearing a possible arrest, a federal law enforcement official told the Times.
A few weeks ago, the Justice Department agreed to pay $4.6 million to settle a lawsuit by Steven J. Hatfill, another biodefense researcher at the same facility, who also had been investigated in connection with the anthrax case.
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FDA Rejects Anesthesia Recovery Drug
In a surprise decision, the U.S. Food and Drug Administration said it won't approve the drug sugammadex, designed to help patients recover from anesthesia. The agency said it had concerns about allergic reactions seen in some patients who took the drug, the Associated Press reported.
Thursday's decision was unexpected because an FDA panel of outside experts had recommended approval of the drug. The FDA isn't required to follow the advice of its expert panels, but generally does.
In a statement released Friday, drug maker Schering-Plough Corp. said it would work with the FDA to address concerns about sugammadex.
On Tuesday, European Union regulators approved the injectable drug, which will be marketed under the name Bridion, the AP reported.
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U.S. Senate Passes Bill Banning Lead from Children's Products
The U.S. Senate on Thursday passed a bill that bans lead from children's toys and other products. The measure also bans, either permanently or pending further study, children's goods that contain chemicals called phthalates, which are widely used to make plastic products softer and more flexible.
The Senate passed the bill by a vote of 89-3. On Wednesday, the House passed the measure 424-1. The Bush Administration has objected to certain parts of the bill but a White House spokeswoman said President Bush would sign it, the Associated Press reported.
The Consumer Product Safety Improvement Act would permit only tiny levels of lead in products for children 12 or younger, giving the U.S. the most stringent lead standards in the world.
Last year, lead paint was a major factor in the recall of 45 million toys and other children's items, the AP reported. Many of those items came from China.
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Hypnosis Helps Dementia Patients: Study
Hypnosis slows the progression of dementia, according to results of a U.K. study.
Researchers compared dementia patients who had hypnosis to patients who received standard treatment and those in group therapy that encouraged discussion of news and current affairs, United Press International reported.
Patients in the hypnosis group showed improvements in concentration, memory, socialization, relaxation, motivation, and daily living activities.
"Over the 9-month period of weekly sessions, it became clear that the participants attending the discussion group remained the same throughout. The group who received 'treatment as usual' showed a small decline over the assessment period, yet those having regular hypnosis sessions showed real improvement across all of the areas that we looked at," Dr. Simon Duff, a forensic psychologist at the University of Liverpool, said in a news release cited by UPI.
"Participants who are aware of the onset of dementia may become depressed and anxious at their gradual loss of cognitive ability and so hypnosis -- which is a tool for relaxation -- can really help the mind concentrate on positive activity like socialization," Duff said.
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Performance Anxiety May Increase Risk of Eating Disorders in Female Athletes
Competitive female athletes who worry about their performance may be more prone to eating disorder-related attitudes and behaviors, suggests a University of Denver study that included 274 undergraduate women at a large southeastern university.
The participants included: varsity athletes, who exercised an average of two hours per day; club athletes, who practiced their sport an average of four times per week; independent exercisers, who exercised on their own at least three times per week; and non exercisers, who exercised 0-2 times per week, United Press International reported.
The women had standard assessments for eating disorders, self-esteem, and sports-related anxiety. The researchers found that competitive athletes who are anxious about their performance may be at higher risk for eating disorder symptoms than women who are less anxious about their sports performance and those who aren't involved in competitive athletics.
Coaches and athletic departments should watch for signs of sports-related anxiety in their female athletes, said the researchers.
The study appears in the International Journal of Eating Disorders.
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