Who cheats on tests? Some foreign drug makers do. Several dozen companies have been caught in the act, fabricating data used by Health Canada and other regulators to approve drugs for sale in the Canadian, US and European markets.
Western inspectors have found pages of important data buried under rubble. They’ve found evidence of erased computer records and falsified human blood tests. And those are just the examples they’ve witnessed, CBC reported.
The data fraud is happening across the international pharmaceutical manufacturing industry. “Data integrity is a fairly new issue and it’s an emerging issue,” said Etienne Ouimett, Health Canada’s director of drug establishment inspections.
And because 80% of drugs on the Canadian market and almost half of those sold in the US are imported, Health Canada, the US Food and Drug Administration and other health regulators are increasingly trying to crack down.
Raw Data Crumpled on the Floor
In April, the FDA and the World Health Organization independently discovered problems at one private research company in Bangalore, India. Semler Research Center was testing pills, in humans, for a variety of international drug companies.
World Health Organization inspectors reported finding evidence of “deliberate sample manipulation,” which they concluded was “a common practice” and an “indicator of fraud.”
The inspectors also reported finding raw data ripped up and crumpled on the floor.
So far, the FDA has found no evidence of serious safety concerns with drugs approved using Semler data. But the agency demanded all of the tests be repeated by an independent group.
Canadian Connection
Health Canada has identified one Canadian drug company that used data from Semler to have a drug approved for sale inside Canada. That company is Marcan Pharmaceuticals and the drug is moxifloxacin, an antibiotic used to treat sinusitis, bronchitis, pneumonia and other bacterial infections.
Marcan’s version of moxifloxacin is marketed in Canada under five different brand names and it’s an instructive example of the maze that awaits anyone who tries to track the manufacturing chain of a single pill.
Health Canada says Marcan has been able to demonstrate the safety of moxifloxacin using other data.
But it’s almost impossible to find out which drugs are being quarantined and who sells them.
And the entire drug manufacturing chain is shrouded in secrecy, protected by a curtain of corporate confidentiality that Health Canada refuses to lift.
