miércoles, 30 de octubre de 2019

Falsified drug data is still a big problem

The Readout
Damian Garde

Falsified drug data is still a big problem

Despite the drug lobby’s claims that overseas manufacturers largely comply with U.S. regulations, a new analysis suggests that problems with data integrity are widespread and more alarming than simple errors.

Writing in STAT, Katherine Eban and Sony Salzman detail how their review of thousands of FDA documents revealed persistent violations with manufacturers in China and India. In India, about 25% of the plants inspected committed some sort of data violation, while in China, that figure hovers just above 32%. For U.S. plants, the number is 15%.

To distinguish negligent practices from egregious ones, the researchers isolated key words in FDA’s inspection reports, such as falsification, destruction, and backdating. By that metric, 55% of inspections in India and 65% in China found deceptive practices.

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