Flu Jab destroys Lives

JUST hours after a doctor jabbed Sharron Coppin's children with a world-first flu vaccine, her three-year-old daughter Alivia turned purple.

As Coppin raced the shivering Alivia to a Perth hospital emergency ward, her husband called an ambulance for their one-year-old twins, Byron and Lateesha, who had begun convulsing and vomiting at home.

Little did the panicked parents realise that the flu shot, provided free by West Australian health authorities, had never been tested in children through clinical trials.

"No one warned us this could happen," Coppin says of the febrile convulsions that afflicted one in every 110 Australian children injected with Fluvax, which combines three strains of seasonal and swine flu.

"I just took the doctor's word. And the doctor obviously trusted that the government had done all the testing. If I had known it hadn't been tested, I would never have let my kids be used as guinea pigs. I was trying to protect them, not put them in harm's way."

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Coppin is flabbergasted to discover some of the federal Department of Health and Ageing's top immunisation advisers have links with the drug company that created the vaccine that landed her kids in hospital.

"You'd think there'd be something to say that's a conflict of interest," she says.

The Perth mother is not the only one to raise eyebrows over the relationships between Australia's health authorities and the pharmaceutical industry. Some independent researchers are questioning the system in which scientists affiliated with drug companies can also advise the government on matters that affect the pharmaceutical sector.

The WA government's independent review into the seasonal flu vaccine scare has recommended that the DHA "formally review and address any perceived or real concerns in peak bodies with regard to conflict of interest".

The report, by former WA chief medical officer Bryant Stokes, highlights concerns over "perceived conflicts of interest, with expert members of peak bodies in relation to immunisation also being involved in pharmaceutical companies and clinical trials for vaccines".

Fluvax, which triggered febrile convulsions in children at nine times the expected rate, was produced by CSL Ltd, Australia's home-grown pharmaceutical giant. CSL also manufactured the federal government's $131m stockpile of Panvax swine flu vaccine.

The Australian revealed last week that two members of the DHA's Australian Technical Advisory Group on Immunisation are also members of CSL's vaccine advisory board. ATAGI chairman Terry Nolan, foundation professor of the school of population health at the University of Melbourne and deputy chairman of the research committee of the National Health and Medical Research Council, and ATAGI member Peter Richmond, senior lecturer at the University of Western Australia's school of paediatrics, have declared their links with CSL, including honorariums from the company, in scientific journals.

Neither would respond to The Australian's questions about their roles on the CSL advisory board or the value of the honorariums. But CSL yesterday revealed they had belonged to a one-off advisory board that met once in 2007 to advise on the design for a large clinical trial in the elderly. It said "nominal amounts of money" had been paid direct to the public institutions for which the experts work.

Nolan also has declared "travel support" from drug companies CSL, Novartis and GlaxoSmithKline to attend scientific meetings to present research findings.

In addition to his position on government advisory committees, Nolan supervised CSL's clinical trial last year of the swine flu vaccine in 400 Australian children.

The successful trial, in which Richmond also took part, led to the federal government's approval of the vaccine and its stockpiling for free public immunisation.

Then, in March, doctors began offering parents an alternative: CSL's Fluvax, which protects against the swine and seasonal strains of flu. Within weeks, as dozens of children turned up in emergency wards suffering febrile fits, the chief medical officer limited its use in the under-fives, in a decision since copied by US and European drug regulators.

The federal government's health watchdog, the Therapeutic Goods Administration, revealed the vaccine had been triggering febrile convulsions at nine times the normal rate.

Nearly six months later, the TGA still cannot say what went wrong. Its expert investigators, led by Nobel prize-winning scientist Peter Doherty, include Nolan and Richmond. Both researchers insist they have no conflict of interest combining their roles trialling vaccines for CSL, advising the government on vaccine use and investigating problems with a CSL product.

Nolan, who as chairman of ATAGI is entitled to a $36,700 fee, says he did not receive personal payment from CSL for supervising the Panvax trial, as the funding went to the paediatric hospitals involved in the trial.

"I don't believe it is a conflict of interest at all," he tells The Australian. "I'm a scientist, I'm rigorously objective about what I observe, scrupulous about the ethics of what I do."

Richmond says he cares about the children being immunised.

"I don't personally receive any funding," he says. "My loyalties lie with the people who are going to benefit from immunisation. I am an academic, I'm a paediatrician."

Richmond, one of the first experts to blow the whistle on the alarmingly high rate of febrile fits from Fluvax, declares he is "all for transparent processes".

"I think it is important that everyone understands when conflicts of interest might arise and the need for them to be declared," he says. "But I don't think investigators involved in clinical trials are working for CSL."

Richmond wants to see reforms that would prevent a repeat of the Fluvax scare, in which more than 100 children suffered convulsions before the vaccine was suspended.

"We certainly need to evaluate what has happened [in terms of the Fluvax side effects] and how we can improve things," he says.

"We still don't quite understand what has happened. I think we need to have a system where there are safe and effective vaccines we can rely on, and if that's not the case, how do we improve the process?"

ATAGI's official role is to provide technical advice to the Minister for Health on the administration of vaccines in Australia, produce the Australian Immunisation Handbook and consult with other DHA agencies on vaccine safety.

The TGA says it has "worked closely" with ATAGI to undertake and analyse epidemiological investigations into the seasonal flu vaccine scare.

It also has worked jointly with ATAGI to analyse the rate of febrile convulsions associated with Panvax, the vaccine for which Nolan and Richmond conducted CSL's clinical trials. The TGA has revealed 48 reports of febrile convulsions in children vaccinated with Panvax - a rate of between one in 5000 and one in 12,000 doses administered. It also received 11 reports of possible anaphylaxis and, "following advice from its expert advisory committees", concluded that both serious side effects were within the expected range.

The DHA is strongly defending its system on the grounds that ATAGI members are sourced from a "limited pool of experts". Members abide by probity rules that include the declaration of any conflict of interest, which are "taken into consideration" at meetings, a spokeswoman tells The Australian.

"It should be pointed out that such misdirected harassment of such high-quality and honest academic high-flyers will mean that government will get no quality advice in the future."

CSL says it was in the "public interest" to have "the very best medical and scientific experts advising on technical public health matters and collaborating with industry on medical research".

"CSL does not have government immunisation advisers on any ongoing vaccine advisory boards," a CSL spokeswoman says.

The non-profit Consumers Health Forum is calling for a shake-up of the TGA's funding, which relies on cost-recovery from the pharmaceutical and therapeutic goods industries.

The forum's executive director, Carol Bennett, says the TGA "has to demonstrate it puts consumer safety above all other priorities".

"There needs to be a portion of government funding, as in Canada and the US," she says. "It's about the transparency and accountability that goes with that. But if it's 100 per cent funded by the therapeutic goods companies, it does raise questions."

Without impugning the integrity of any individuals involved in advising CSL and the DHA, independent medical experts have questioned the way the system may give rise to perceptions of a possible conflict of interest.

Prominent immunologist Nikolai Petrovsky, founder of vaccine research company Vaxine, describes the system as "incestuous". "Even if the [drug company's] money doesn't go into your pocket, it can still be a potential conflict of interest because there is a benefit to the individual in terms of status, funding to their department, and their research output, and that should all be declared," Petrovsky says.

"There is a complete lack of transparency; you can't ever find who's making the decisions, and who's selecting the people who make the decisions.

"You don't know if there is a conflict if you don't know who they are."

Peter Collignon, head of infectious diseases and microbiology at Canberra Hospital, says the federal government should seek advice from experts who have not had dealings with drug companies for at least five years.

"Whenever we're looking at why adverse events have occurred from a drug or a vaccine, it's important that the people on the committee don't have real or perceived conflicts of interest," Collignon says.

"That means getting people who have the scientific knowledge but are not linked to the companies [that] are manufacturing the drug that caused the adverse effects."

Medical ethicist Paul Komesaroff, director of the Monash Centre for Ethics in Medicine and Society, argues that US drug regulators are more rigorous about separating government from industry.

"We are entitled to more than a bland assurance that everyone is an honest person," he says. "The real question is, are they being pulled in two directions at once?"

http://www.theaustralian.com.au/news/features/a-flu-jab-too-close-for-comfort...
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