Regulatory Focus™ > News Articles > Regulatory Transparency Measures Lead to False Alarms

Regulatory Transparency Measures Lead to False Alarms

Posted 07 August 2012 | By Alexander Gaffney, RAC 

What happens when regulatory databases are made easier to access and understand? In at least one instance of irony, just the opposite of what might be expected.

Australia's Therapeutic Goods Administration (TGA) on 1 August 2012 sent out a media advisory after receiving what it said were reports of a news story indicating influenza vaccines were unsafe. Quite the contrary, said TGA. "In fact, there have been no recorded deaths from influenza vaccine in Australia," regulators wrote. Meanwhile, more than 2,500 Australians die each year from the influenza virus, TGA said.

TGA said the root of the confusion comes from the 1 August launch of its online Database of Adverse Event Notifications (DAEN)-a database of more than 251,000 adverse event reports going back to 1971. The database lists all safety signals received by the agency pertaining to medicines and vaccines as reported by manufacturers, health professionals and consumers.

After the publication of the database, a report in The Australian, a News Corporation company, linked 10 deaths through the database to CSL Biotherapies' H1N1 flu vaccines Panvax and Fluvax Junior. The report goes on to list a number of adverse events, including instances of death and unresponsiveness.

Correlation is not Causation

The problem, explains TGA in a subsequent statement, is twofold. First, not all adverse event reports received by the agency are indicative of a serious reaction or even a causal relationship. As TGA noted in its article, many elderly patients receiving medication can have, "Chronic underlying medical conditions that made them at risk of adverse events, whether they were vaccinated or not."

"In accessing the database we encourage consumers to understand that a report of an adverse event does not necessarily indicate there is a causal link between a medicine and an adverse outcome," TGA explained.

Second, investigations by Australian regulators had failed to substantiate any causal relationship between the vaccines and any of the adverse reactions reported to it.  TGA said it was worried consumers would be misled by unsubstantiated reports of deaths from the flu vaccines and discouraged from receiving the vaccinations in the future, thereby causing unnecessary injuries or casualties.

Regulators urged consumers to appreciate the difference between a safety signal and a confirmed event, and asked them to visit the DAEN database for additional information.

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