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Archive for November, 2007

Hospital fined after third botched brain surgery

Tuesday, November 27th, 2007

The Rhode Island Department of Health has fined a hospital $50,000 after a doctor performed brain surgery on the wrong side of a patient’s head.

It was the third such incident at Rhode Island Hospital in Providence, which serves as a teaching hospital for Brown University.

“We are extremely concerned about this continuing pattern,” health department director David Gifford said in a statement Monday.

Gifford said that as far as he knows, this is the first time the department has fined a hospital.

On Friday, the chief resident started operating on the wrong side of an 82-year-old patient’s brain, the health department said. The patient was OK, the health department and hospital said.

In February, a different doctor performed neurosurgery on the wrong side of another patient’s head, said Andrea Bagnall-Degos, a health department spokeswoman. That patient was also OK, she said.

But in August, a patient died a few weeks after a third doctor operated on the wrong side of his brain.

The hospital, owned by the nonprofit corporation Lifespsan, said the latest incident had prompted it to re-evaluate its training and policies.

“We have talented, dedicated professionals working hard to provide the best care to our patients, but we clearly need to do more,” a hospital statement said. “Our policies and procedures cannot be effective unless every person understands them and follows them to the letter.”

Experts urge more cautious use of diabetes drugs

Tuesday, November 27th, 2007

European and U.S. diabetologists called on Tuesday for greater caution in prescribing oral diabetes pills like GlaxoSmithKline Plc’s Avandia, which has been linked to increased heart attack risk.

Glaxo’s Avandia has lost ground to Takeda Pharmaceutical Co Ltd’s Actos in recent months, following publication of a U.S. study in May criticizing its safety record. Both drugs belong to a class of medicines known as thiazolidinediones.

In the light of the latest findings, the European Association for the Study of Diabetes and the American Diabetes Association said they had updated their “consensus statement” on use of oral anti-diabetics in patients with type 2 diabetes.

“New information suggests additional hazards associated with the use of either thiazolidinedione, and rosiglitazone (Avandia) in particular may result in an increased frequency of myocardial infarctions,” the revised statement concludes.

“We therefore recommend greater caution in using thiazolidediones, especially in patients at risk of, or with, congestive heart failure.”

The updated statement, detailing when to use the drugs, was published online in Diabetologia and Diabetes Care (http://www.easd.org/Customfiles/easd/press/thiazolidinediones.pdf).

The move comes two weeks after the U.S. Food and Drug Administration said Avandia should carry a new “black box” warning that it may cause chest pain or heart attacks.

Glaxo will also start a trial comparing Avandia head to head with Actos to see if the risk is unique to Avandia.

Avandia and Actos both already carry strong warnings advising of the risk of heart failure, a chronic condition that affects the heart’s ability to pump blood.

Attorney General Sues New Jersey Company

Wednesday, November 21st, 2007

Attorney General Dustin McDaniel on Tuesday sued a New Jersey-based company and its subsidiaries alleging improper marketing practices.

The lawsuit, filed in Pulaski County Circuit Court, asked that the companies be ordered to repay millions that Arkansas’ Medicaid program paid for what the attorney general contends were unnecessary prescriptions of the drug Risperdal, used to treat bipolar disorder, schizophrenia and autism.

Drug companies named in the lawsuit were Janssen Pharmaceutica Inc., Janssen and their parent company, Johnson & Johnson.

The drug companies “made, and continue to make, orally and in writing, false, misleading or deceptive representations in advertisements, promotions and statements and continue to disseminate, false, misleading or deceptive information to the public, including Arkansas citizens, physicians and the state regarding non-medically necessary uses of Risperdal and the health risks and the benefits associated with Risperdal,” the lawsuit said.

McDaniel alleges the drug was prescribed for uses not approved by the federal Food and Drug Administration.

The suit also accuses the drug companies of not including warning labels on Risperdal bottles about possible side effects, such as diabetes and weight gain.

“Risperdal is the most widely used atypical anti-psychotic in the world,” the lawsuit said. “Crucial to this blockbuster success is aggressive marketing, which consists chiefly of overstating the drug’s efficacy while concealing its life-threatening side effects. As a direct result of marketing efforts, the state has paid millions of dollars for non-medically necessary uses of Risperdal.”

Amber Morley, spokeswoman for Janssen Pharmaceutica in New Brunswick, N.J., said Tuesday the company was aware of the lawsuit but had not reviewed it.

“Janssen has always been committed to the highest ethical standards and responsible behavior,” Morley said, adding the company would vigorously defend itself against the lawsuit.

The drug was first approved by the FDA in 1993 and is used to treat bipolar mania and schizophrenia. In 2006, it became the first FDA-approved medication to treat autism in children and teenagers, Morley said.

The lawsuit does not say how much money the state is seeking, but McDaniel said recently that the state’s Medicaid Program has spent more than $200 million to pay for prescriptions for Risperdal, Zyprexa and Seroquel.

Tuesday’s lawsuit targeted only the makers of Risperdal. McDaniel said lawsuits are also planned against the makers of the other two drugs in question.

In September, McDaniel told the Legislative Council that the firm is one of the most successful law firms in the nation in the area of pharmaceutical litigation.

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