PUBLIC health experts have called for an independent body to monitor drug safety after it emerged that young children were more likely to end up in hospital because of side effects from a flu vaccine than they were from the disease itself.
The analysis contradicts government safety advice that the harm did not outweigh the risk and raises concerns about the Therapeutic Goods Administration's assessment of the vaccine.
More than 1000 adverse responses in children under five were reported to the TGA by June this year, including nearly 100 instances of febrile convulsions, a seizure which in a small number of cases has been associated with long-term adverse health outcomes.
The side effects were linked to one of the three seasonal flu vaccines, Fluvax and Fluvax junior, from the drug company CSL, but the TGA maintained despite that, that "the overall risk-benefit balance of both products remains positive".
The Commonwealth Chief Medical Officer claims the advice was intended to indicate the drug should not be withdrawn from the market but said the government would reassess it in light of the research.
But research published yesterday in the journal Eurosurveillance showed Fluvax might have caused two to three hospital admissions due to seizure for every admission from flu it prevented.
The chief executive of the Public Health Association of Australia, Michael Moore, said further examination of risks was needed, at arm's length from the TGA. The government should consider creating an independent centre. "There is a concern … that the TGA is the body that approves vaccines and is also the body that determines what the risks and benefits are when concerns are raised," he said.
Peter Collignon, an infectious diseases expert at the Australian National University, said the vaccination program in children under five did more harm than good. "The TGA made that decision [about risk-benefit] without any evidence to back it up." Professor Collignon questioned the TGA's independence and transparency because some of its advisers had worked for drug companies.
The Chief Medical Officer, Jim Bishop, said the risk-benefit claim indicated the drug should not be withdrawn. The TGA had recommended other vaccines besides Fluvax be used for children under five. He defended the TGA's independence: "There is no evidence the TGA is obligated to drug companies and they have a number of ways to make sure their advice is independent," he said. "I feel comfortable about our investigation [of the vaccine, but] the fact of the matter is there is now new information available and the regulator will take that into account".
Heath Kelly, the study leader and an honorary associate professor at the University of Melbourne, said the government should check for vaccine side effects - not wait for reports. There should also be a national insurance scheme to compensate people if they had a bad reaction. "On very rare occasions, things can go wrong in vaccination programs. The community that recommended and promoted vaccination [should] provide support for any child who suffers serious adverse consequences."
Robert Booy, an infectious diseases expert at the Children's Hospital, Westmead, said that while the rate of seizures was unacceptably high, it was important to remember that continuing complications from them were extremely rare.
While this study indicated there would be more hospital admissions from seizures than would be prevented by the vaccine, children tolerated the other two vaccines well.
A spokeswoman for CSL said: "Extensive investigations are ongoing with international collaborators". It supported recommending that Fluvax should not be used in children under five until it could be confident of preventing problems.
Homeopaths are recommending "unproven" herbal remedies, including belladonna and phosphorus, for whooping cough. A whooping cough epidemic has swept the country, and tragically turned fatal this week when a five-week-old boy died.
Homeopaths say their treatments can prevent and cure whooping cough, while doctors say that is "complete rubbish". Drosera and pertussinum are other herbal remedies commonly recommended.
Australian Medical Association immunity spokesman Dr Rod Pearce said anyone recommending homeopathic "vaccinations" or treatments was illegitimate. He said officially homeopathic organisations admitted people should be conventionally immunised. "It is complete rubbish. If someone misrepresents what they can do, that is a problem. The discussion we've had with them as a whole is that they'll recommend vaccinating.
"There's stuff that's got good evidence and there's stuff that's rubbish. There is total recognition that the only proven way to get protection is to get vaccinated."
SA Health says vaccination is the best way to protect children. It says adults, particularly, should be vaccinated to protect children too young to be immunised. In the wake of the baby's death this week doctors called for vaccinations to be freely available.
Dr Pearce said parents should be vaccinated and should give their child the first vaccination at six weeks.
There have been nearly 4000 cases of whooping cough in South Australia so far this year, but this was the first death in almost a decade. A four-week-old baby died in NSW last year. Dana McCaffery's parents have since become vocal advocates of vaccination. Yesterday, Toni McCaffery posted her condolences to the SA baby's parents on a Facebook page and repeated her plea for the Federal Government to raise awareness and offer free vaccination to everyone.
'I am in tears . . . please Mrs Roxon act on your promise," she wrote. "We have been pleading all year for the government to act and not wait for another death. To the family, we are so, so sorry."