research fraud

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research fraud

Post by cymbalta on Wed Dec 01, 2010 8:20 pm

(NaturalNews) A psychiatrist on the payroll of GlaxoSmithKline has been sentenced to 13 months in prison after pleading guilty to committing research fraud in trials of the company's antidepressant Paxil on children.

Maria Carmen Palazzo is already serving a sentence of 87 months for defrauding Medicare and Medicaid.

Palazzo was accused by the FDA of enrolling children in a clinical trial even though she knew they did not actually suffer from major depressive or obsessive compulsive disorder, the conditions being studied. Palazzo then falsified records and psychiatric diagnoses.

GlaxoSmithKline, manufacturer of Paxil, paid Palazzo $5,000 for every child she enrolled in the study.

The case's significance goes beyond simple research fraud, as Glaxo is now defending itself against charges that for 15 years it deliberately concealed evidence that Paxil increases the risk of suicide in children.

Glaxo is also defending itself against accusations that it manipulated data to conceal the risks of its diabetes blockbuster Avandia, and that it failed to warn parents that Paxil may cause birth defects if taken by pregnant women. The company has already agreed to pay more than $1 billion to settle roughly 700 birth defect lawsuits; another 100 or so suits are pending.

Although the FDA eventually required Paxil to carry a warning about the risk of birth defects and an even more prominent "black box" warning about suicide risk, many critics allege that the agency acted too slowly.

"There [had] been hints for many years that antidepressants, such as Paxil, when given to children, can cause serious side effects, including suicide, but the FDA delayed taking any action to prevent these drugs from being prescribed for children," writes Brent Hoadley in Too Profitable to Cure.

Palazzo will not actually serve any additional prison time for potentially placing children's safety at risk; her new term will be served concurrently with her first.

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