Healthy Skepticism Library item: 10908

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Publication type: news

Cresswell A.
Calls for tighter drug monitoring
The Australian 2007 Jul 14
http://www.theaustralian.news.com.au/story/0,25197,22069490-23289,00.htmlhttp://

Full text:

DRUG safety experts have called on the federal Government to tighten monitoring procedures that can detect harmful drug side-effects.

The experts say existing methods remain relatively ineffectual.

More rigorous clinical studies and improved systems for picking up problems that only emerge after a new drug has appeared on the market should all be considered, they say amid claims that a recent controversy over a well-known brand of sleeping pill has exposed flaws in the current systems.

The criticism comes despite a move by the federal Government this week to intervene and save from closure a consumer medicines hotline which provides people with a means to report instances of suspected adverse events while taking drugs.

The Brisbane-based Adverse Medicine Events Line was to close at the end of this month when funding by its current sponsor, the pharmacy umbrella group the Pharmacy Guild, was to run out.

The hotline was mainly responsible for alerting Australia’s medicines regulator, the Therapeutic Goods Administration, to the full extent of the disturbing reactions to the sleeping pill Stilnox.

The TGA’s adverse events monitoring body, the Adverse Drug Reactions Advisory Committee, had put out a bulletin in 2002 saying it had received 72 reports of strange psychiatric effects in people taking the drug in the two years since its Australian release.

But it wasn’t until February this year that ADRAC warned of “bizarre sleep-related effects’‘ linked to Stilnox, prompted by 24 reports of such cases, many of them through the hotline.

The cases reported in the February bulletin – which preceded similar warnings in the US – including cases of patients eating from the fridge or driving cars while asleep. One patient put on 23 kilograms over seven months, and her bemused family only discovered why when she was found eating in front of an open refrigerator while asleep. Another patient woke with a paintbrush in her hand after painting the front door while asleep.

In this week’s announcement the Government said it had agreed to keep the service running for another 12 months, during which time longer-term funding options to keep it going indefinitely will be explored. The cost of the 12-month extension is not yet known.

In a statement, health minister Tony Abbott said the funding would “ensure that consumers are provided with a way to seek help with, or report, adverse reactions to medicines’‘.

Hotline manager and clinical pharmacist doctor Geraldine Moses said the hotline had probably received about 900 calls about Stilnox over a four-month period this year.

She said she was “very grateful and very excited’‘ at the extra funding. Although negotiations on the cost were still under way, the hotline had asked for $400,000 to fund the 12 months of operation, she said.

“It’s a short-term solution,’‘ Moses said. “We are going to be entering negotiations with the National Prescribing Service and the Therapeutic Goods Administration to see if we can come up with some sort of long-term solution. This gives us some breathing-space.’‘

However, drug experts said Australia’s systems for detecting problems with drugs would remain sadly lacking, even after the hotline’s welcome reprieve.

Ken Harvey, Adjunct Senior Research Fellow in the School of Public Health at La Trobe University, said much more rigorous surveillance of drugs was required after they were put on sale, including measures to force drug giants to conduct effective large-scale studies. “It’s good the Government’s doing it (saving the hotline), but more needs to be done,’‘ Harvey said. “I certainly support what Geraldine Moses is doing. But you are still left with (a system of) spontaneous reporting, and we know that’s not good enough.

“There’s a move going on globally to get a much more rigorous post-marketing surveillance of drugs. Drug companies should be encouraged to do better studies, and to get good data, and you really need good population studies.’‘

The February bulletin reporting the bizarre effects of Stilnox attracted massive media publicity, and further reports to the hotline spiked as a result. The TGA says that up until May 25 ADRAC had received 727 reports about Stilnox, with 208 reports concerning “abnormal sleep-related event, sleep walking, and/or sleep talking’‘ – with all but 24 of the latter category coming in after the February bulletin.

“This rapid increase in reported side-effects following media attention on the issue of Stilnox is a phenomenon known as `stimulated reporting’,’‘ says a report on the TGA’s website.

“Regulators must interpret the results of stimulated reporting with great care as the effect of media attention may be to overestimate the number of adverse reactions related to a medicine.

“This in turn may result in an overestimate of the risk side of any risk-benefit analysis conducted by the regulator.’‘

A spokesman for the drug industry umbrella group Medicines Australia said companies already had an obligation to report adverse efffects to the TGA.

“If the TGA had a concern they would work with the company to conduct post-marketing surveillance, and that process can be initiated by the company or by the TGA,’‘ he said.

“Before medicines are allowed to be sold in Australia they have to have been through rigorous clinical trials to make sure the benefit outweighs the risk. These trials won’t necessarily pick up one-in-a-million side-effects, but that’s why companies and the TGA continue to monitor medicines’ safety once medicines are in general use.

“The TGA is certainly moving towards requiring companies to have risk-management plans for new medicines when they evaluate these new medicines, and that’s being introduced now.’‘