In Major Ruling, Massachusetts Court Orders Biogen to Produce ‘All Medical Records’ of Woman Who Died During Tysabri Clinical Test ‘Immediately’

By Steven DiJoseph

Anita Smith died from a rare, and often fatal, brain disease while participating in a late-stage clinical trial of the MS medication, Tysabri. As it turned out, a number of other patients being treated with the drug also contracted the same disease.

Although she had been diagnosed with multiple sclerosis, an autopsy revealed that Smith never had MS, thereby making her enrollment in the trial problematic at best. Moreover, the unusually high incidence of the brain disease in Tysabri patients raised a serious question as to the drug’s safety.

Although the potentially deadly side-effect caused the hastily approved drug to be pulled from the market on February 28, 2005, after only four months, the effort to have Tysabri re-approved began almost immediately. (more…)

Heavy Smokers Who Quit Still At High Risk for Stroke

While any doctor will tell you that people who quit smoking increase their chances of avoiding serious medical problems, many studies have shown that quitting alone may not be enough to prevent long-term health difficulties.

For example, it was only yesterday that we reported on a study (to be published in the Journal of Dental Research) that found long-time smokers are more likely to get root canals than nonsmokers.

In that study, smokers who had smoked for more than 12 years were most likely to have a root canal. Current smokers who had smoked for fewer years had a lower risk of having a root canal, but they were still more likely than nonsmokers to have one. (more…)

CPSC and Next Marketing Inc. Announce Recall of 22,000 Youth Hooded Fleece with Drawstring that Pose Strangulation Risk

The Consumer Product Safety Commission and Next Marketing Inc., of Wabash, Indiana, have announced the voluntary recall of about 22,000 Youth Hooded Fleeces because the drawstring through the hood poses a strangulation hazard to children.

The agency acknowledged that it was alerted to this serious risk by the state of Wisconsin. Consumers should stop using recalled products immediately.

The recalled garments were manufactured in Pakistan and China and sold at web retailers, college book stores, and department stores nationwide from September 2003 through December 10, 2005 for about $15. (more…)

CPSC Announces Recall of Remote Control Flying Saucers Sold by QVC for Fire Hazard

The Consumer Product Safety Commission and Creative Innovations & Sourcing LLC, of Pittsfield, Massachusetts, have announced the voluntary recall of about 180,000 (Radio Control) Pro Flying Saucers.

The battery charger cord sold with these flying saucers can overcharge and cause the toy to overheat, posing a risk of fire. Consumers should stop using the product immediately.

The Pro Flying Saucers were manufactured in China and sold exclusively by QVC Inc. nationwide from November 2005 through December 2005 for $27 or $30. (more…)

FDA Announces Recall of Galerie Brand Choxie Truffles for Undeclared Peanuts that Could Cause Potentially Fatal Allergic Reactions

Ross Acquisition Co. Inc., doing business as Galerieâ„¢ of Hebron, Kentucky, is recalling all lots of its 4.95 oz packages of CHOXIEâ„¢ brand truffles and balls because they may contain undeclared peanuts or peanut butter.

People who are allergic to peanuts and peanut products run the risk of serious or life-threatening reactions if they consume these products.

Product in this recall is: CHOXIEâ„¢ Double Dark Truffles UPC Code 768395345129. (more…)

Undeclared Sodium-Bisulfite Prompts FDA and Federico’s Bakery to Issue Allergy Alert and Recall of Apricot-Filled Butter Cookies

The FDA has issued an allergy alert and notification of a recall by Federico’s Bakery of Duarte, California, for that company’s “Apricot-filled Butter Cookies.” The apricot filling in that product contains sodium-bisulfite that can cause serious or potentially life-threatening reactions in people who are allergic to sulfites.

The recalled cookies were distributed in California and sold in retail stores. Packages with the following item numbers have been recalled: (more…)

Long-Time Smoking Linked to Increased Rate of Root Canals

 Chalk up another negative effect of smoking. This time, a study to be published in the Journal of Dental Research online edition for March 24, 2006, has found that long-time smokers are more likely to get root canals than nonsmokers.

Dr.Elizabeth Krall Kaye, professor of health policy and health services research at Boston University’s Goldman School of Dental Medicine, reported at a media teleconference organized by the American Medical and Dental Associations that: “”Our study has shown that men have almost twice the risk of having root canal treatments if they smoke cigarettes, compared to men who never smoke.” (more…)

Former Snipermail Owner Scott Levine Sentenced to Eight Years in Federal Prison for Massive Data Theft

Summing up the significance of the conviction and sentencing of Scott Levine, the former principal owner of the e-mail marketing company, Snipermail, U.S. Attorney Bud Cummins (Eastern District of Arkansas) said: “At first blush, downloading computer files in the privacy of your office may not seem so terribly serious,” U.S. Attorney Bud Cummins, of the Eastern District of Arkansas, said in a statement. “But, if you are stealing propriety information worth tens of millions of dollars from a well-established and reputable company, you can expect to be punished accordingly.”

Levine, 46, was charged with the theft of some 1 billion data records in an indictment that that alleged 120 counts of unauthorized access of a protected computer, 2 counts of access device fraud, and one count of obstruction of justice. (more…)

CPSC and Provo Craft & Novelty Inc. Announce Recall of 29,000 Metal Charms that Contain High Levels of Lead

The Consumer Product Safety Commission and Provo Craft & Novelty Inc., of Spanish Fork, Utah, have announced the recall of about 29,000 Art Accentzâ„¢ Changlzâ„¢ Metal Charms because they contain high levels of lead that poses a serious risk of lead poisoning and adverse health effects to young children.

Consumers should stop using recalled products immediately.

The recalled charms were manufactured in China and sold at small craft and scrapbook retails outlets from April 2004 through July 2005, and at Pamida Stores from January 2005 through April 2005, for about $3. (more…)

CPSC and Milton Bradley Announce Recall of 461,000 Party Games after 23 Reports of Injuries

The Consumer Product Safety Commission and Milton Bradley of East Longmeadow, Massachusetts, have announced a voluntary recall of some 461,000 Chicken Limbo Electronic Party Games made in China. Consumers should stop using the recalled products immediately.

“The game’s two side poles do not fit into their bases properly making the game unstable. This can cause the game to completely fall apart if touched, hitting children playing the game as well as bystanders.” (more…)

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