Medicine dangers ‘held in secrecy’

SERIOUS adverse reactions to medicines including deaths, heart failure and pancreatitis are being hidden from Australian doctors and patients and a new study says it is “unacceptable”.

In the decade between 2007 and 2016 doctors in Canada, the US and the UK received 207 warning letters about medicine serious side effects including possible death, heart failure and pancreatitis.

However, when Sydney University researchers investigated whether Australians had been informed it found our medicines watchdog the Therapeutic Goods Administration (TGA) did not post these letters on its website.

Regulators in the UK, US and Canada do publish these letters.

Things got worse when researchers asked the TGA to provide copies of the letters to show they had been sent to doctors in Australia and they were told the agency had no central file of the letters.

The TGA told them to approach the 39 pharmaceutical companies who manufactured the medicines, says Dr Barbara Mintzes whose research is published in the journal Pharmacoepidemiol Drug Safety.

When they did so they found only four companies were willing to provide proof they had sent out the letters in Australia.

Eleven companies said they did not send out the warning letters to Australian doctors.

Fifteen companies that manufactured 83 drugs with safety warnings did not provide any information at all.

Nine companies that produced 87 drugs subject to safety advisories actively refused to provide researchers with copies of the safety warning letters with some claiming the information was “commercial in confidence”.

These companies were Amgen, Astra Zeneca, Aspen,

THE IDEA THAT A WARNING LETTER THAT HAS GONE OUT ... WOULD BE CONSIDERED CONFIDENTIAL IS COUNTERINTUITIVE

PROFESSOR BARBARA MINTZES

Bayer, Janssen-Cilag, Eli Lilly, Roche, LEO and Pfizer.

“We were certainly shocked to have that response from some companies,” said professor Barbara Mintzes.

“The idea that a warning letter that has gone out to thousands of individual health professionals would be considered confidential is counterintuitive,” she said.

“A secret warning is no warning at all.”

Even if the letters had been sent out they were not enough to protect patients, she said.

Doctors may never open them or forget the details and it was important they were included in a searchable online data base.