(NEW YORK) - Reporters Deborah J. Nelson and Ryan McNeill spent six months exhaustively documenting the behavior of businesses involved in the fight against drug-resistant superbugs. They found that multiple studies supporting the use of antiseptic products containing the chemical chlorhexidine to clean hospital patients were funded or otherwise supported by the companies that make those products, raising concerns about the independence of the research.
But that was only half the story. As in any high impact investigative project, the reporters then set out to show the industry-backed science on chlorhexidine resulted in quantifiable harm to the public.
A break came in February when the U.S. Food and Drug Administration issued a warning about “rare but serious” cases of anaphylaxis – extreme, potentially fatal allergic reactions – linked to the use of chlorhexidine-based products in hospitals across the United States. Reuters turned to the same data used by the FDA. Manufacturers of pharmaceuticals, medical devices and other healthcare-related products generally must submit reports of adverse events – unexpected occurrences such as illness or death – that occur with use of their products.
The task of data mining proved daunting. The FDA doesn’t make its data searchable online, so Reuters downloaded and analyzed the agency’s raw data – millions of records contained in quarterly data releases.
The data aren’t perfect, as FDA officials were quick to point out. The agency does not receive reports of every adverse event. A report doesn’t always mean there’s a confirmed causal relationship between the product and the adverse event. And some details – for example, a field showing how the chlorhexidine was used – were missing in about 30 percent of the records, making granular analysis difficult.
In the end, Reuters sifted through about 8 million case records to find all reports of events where chlorhexidine was considered the primary suspect.
Our analysis yielded enough evidence to show that as use of chlorhexidine products increasesd, supported by industry-funded science, so had reported adverse events associated with the products – evidence of the real harm to humans.