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Heart Device Dispute Renews Push for User Registry

February 27, 2009

Conflicting data this week about the failure rate of a critical and widely used Medtronic heart device has set off a debate among researchers who want to understand the discrepancies and the implications for patient care.

 

But some experts say that debate would not be occurring if federal officials, medical device makers and more doctors had thrown their weight more fully behind efforts to develop a national database of patients who get heart devices.

 

The Obama administration has announced plans to pour hundreds of millions of dollars into studies to compare the effectiveness of competing medical treatments and devices. Monitoring patients’ outcomes through registries could be part of that process.

 

Read Article: New York Times

 

Stomach drugs need movement disorder warning

A class of drugs to treat stomach disorders needs a strong warning about the risk of involuntary, repetitive movement on several parts of the body seen with long-term use or high doses, U.S. regulators said on Thursday.

 

The drugs contain the ingredient metoclopramide and are available in various forms including tablets, syrups and injections, the Food and Drug Administration said. Makers include Baxter International Inc (BAX.N) and several generic drug companies. More than 2 million Americans use the medicines to treat gastroesophageal reflux disease and other stomach ailments, the FDA said.

 

Chronic use has been linked to tardive dyskinesia, which causes repetitive movements of the limbs, lip smacking, grimacing, tongue protrusion and rapid eye movements and blinking. The symptoms are rarely reversible but may lessen or resolve after metoclopramide treatment ends, the FDA said.

 

Read Article: Reuters

 

Drug Maker Is Accused of Fraud

February 26, 2009

The Justice Department charged the drug maker Forest Laboratories on Wednesday with defrauding the government of millions of dollars by illegally marketing the popular antidepressants Celexa and Lexapro for unapproved uses in children and teenagers.

 

In a civil complaint filed by the United States attorney’s office in Boston, federal prosecutors alleged that former top executives at Forest concealed for several years a clinical study that showed that the drugs were not effective in children and might even pose risks to them, including causing some to become suicidal.

 

From 2001 to 2004, Forest heavily promoted results from another clinical trial it had financed that showed that the drugs were effective, without disclosing the negative study to those researchers, its own medical advisers or its sales representatives, the complaint said.

 

Read Article: New York Times

 

Woman infected with herpes wins lawsuit

A Riverside County jury has awarded nearly $7 million to a 56-year-old woman who was unknowingly infected with herpes by a 77-year-old man.

 

The lawsuit alleged that Thomas Redmond knew he had genital herpes for more than 25 years but did not disclose it before his sexual relationship began with Patricia Behr and did not use a condom.

 

The lawsuit claimed that Behr suffered unnecessary stress and humiliation as a result of the defendant’s conduct, which it called “outrageous and beyond the bounds of decency.”

Redmond, a resident of Las Vegas, is the founder of Redmond Products Inc., a company that manufactures and distributes hair care products. The company was sold in 1997 to Bristol-Myers Squibb Co. and became part of Clairol, which was sold to Procter & Gamble Co. in 2001.

 

Read Article: San Francisco Chronicle

 

Something Rotten in Drywall, Say Homeowners

George and Brenda Brincku knew they only wanted to use the best products for the third house they built together. She said they learned the hard way by scrimping in the past.

When it came to drywall, they insisted their subcontractors use an American-made product.

 

But the couple started experiencing unusual problems along with a number of owners whose homes were built in 2005 and 2006 when construction materials were scarce. The coils in their high-end air conditioner failed repeatedly. There was a strong odor in a downstairs bathroom.

 

“We knew something was wrong,”said Brenda Brincku. They then read news accounts about houses with similar problems blamed on flawed toxic drywall manufactured in China by Knauff Plasterboard Tianjin and other Asian companies. But the Brinckus’ home near Fort Myers didn’t have Chinese drywall. Their drywall came from U.S. companies including National Gypsum in Charlotte, N.C.

 

Read Article: Law.com

 

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