Trust me, I'm a scientist
This article from the Australian newspaper has broken ground for a lot of reasons. For one, unlike most media reports, it doesn't try to explain away the huge incidence of serious reactions after this vaccine. There is no mention of coincidence or benefits outweighing the risks. Instead, there is hard-hitting questioning of just why we subjected Australian families to a vaccine that was completely untested and how it is that those 'experts' the government chose to ensure our safety may have been double agents - beholden to drug companies and therefore, unwilling or unable to do their jobs properly.
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.
Not only was this vaccine dangerous and ineffective (a 40-year retrospective study conducted by the Cochrane Collaboration into the effectiveness of flu vaccinations in children under the age of 2 found that it was completely useless at preventing flu in this age group), but it was also completely untested as far as safety goes. The only people who seemed to be unaware of this situation were the doctors administering the vaccines and the parents whose children were offered up as guinea pigs in a study where the safety results were ignored or covered up and the effectiveness has not even been considered.
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.
Well, most people would think that. A politician isn't allowed to own shares in companies their votes may be linked to; doctors are no longer allowed to get pens or pads of paper from drug companies because that has been found to influence their decision making and prescribing practices; but committees that determine government vaccination policy are stacked with people who have strong financial links with the companies producing the vaccines they are supposed to regulate.
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".
Bryant Stokes' report on this situation doesn't go very far into looking at this situation - how could it when his terms of reference were not broad and the time frame he was operating under was impossibly short. Despite these deficiencies, however, the Stokes report is a damning indictment of a government that ignored its own duty of care to its most vulnerable citizens, and the pharmaceutical companies that have manipulated the regulators to do their bidding.
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.
ATAGI, like just about all government committees and regulators, is composed of hand-picked 'stake-holders' who are supposed to be independent of industry influence. Amazingly, this list of so-called stakeholders does not include any representatives of the group with the most to lose in this situation - the families whose children are targeted with an ever-increasing number of recommended vaccines.
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.
Strange that there is no mention of the Telethon Institute in WA, the organisation that was responsible for the 'testing' of this vaccine in children whose parents were kept in the dark about the experimental nature of this vaccine. This Institute was part of a triumverate composed of the WA State Government, the Institute and CSL and Sanofi Pasteur - manufacturers of the 2 vaccines being studied.
Prof Fiona Stanley, former Australian of the Year and Director of the Telethon Institute, has helped to develop this charity into a very successful commercial enterprise. Not content to just trial drugs and vaccines for other companies, she has helped the Institute form its own drug company, Phylogica, which is now in the process of developing its own treatments.
In a 2005 interview published on the National Health and Medical Research Council's website, Prof Stanley was totally unapologetic about the close relationship she has with Big Pharma. "...we've had a very good relationship with big pharma, some of which has just been, 'Here's the money. We're interested in anything you produce.' That's a very good relation that Pat Holt (the head of Telethon's Division of Cell Biology) has had with GlaxoSmithKline."
The federal government's health watchdog, the Therapeutic Goods Administration, revealed the vaccine had been triggering febrile convulsions at nine times the normal rate.
The normal rate? Were parents told that according to the TGA, one child in one thousand would suffer from seizures because of vaccination? That this was considered to be 'normal' and 'acceptable'? Were they informed of this and if not, why not? As a parent, if I had been told that my child had a 1:1,000 chance of having seizures after vaccination, I would have said, "Thanks. But no thanks." I believe that most parents would do the same. But they were not offered the option and instead of a 1:1,000 rate, the actual risk was 1:110.
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."
As if being a scientist somehow makes a person immune to the pull of money; impossible to corrupt and saintly in both aspect and intention. Poppycock! Scientists are humans and just as susceptible to being corrupted as anyone. In fact, there are articles published on a daily basis in medical journals from around the world describing how scientists are corrupted by their involvement with pharmaceutical companies. It is madness to think that our government doesn't see this.
"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."
I beg to differ. If someone is being paid by CSL, they are working for CSL. And if they are being paid by CSL and the government and if there is a conflict over which one of these two bodies takes primacy, the researcher will have to decide which master they actually are serving - there can't be two loyalties in something this important. It is impossible for anyone, even with the best of intentions, to be objective in this situation. This is why police officers are not able to sit on the jury of cases they have investigated; and judges have to step down if there is any potential conflict on cases they are meant to hear. This is a basic principle which should not require explanation. Justice not only has to be done - it has to be seen to be done.
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."
So, when we question the objectivity of people who are receiving either direct payments or other financial considerations from the very organisations they are supposed to be investigating, that is called harassment? Not only that, but we are being warned that there are only a limited number of 'experts' out there and if we start to question them and expect them to be independent, they will no longer play nice and do what we want them to do. Interesting...considering that there is already a question of how good a job they are doing when, on their advice, vaccinations were approved before being tested and were kept in place even when large numbers of reactions were being reported.
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.
Sorry CSL, but it is in the public interest to have the very best INDEPENDENT medical and scientific experts working cooperatively with consumer representatives to ensure that all drugs and vaccines are safe and efficacious. The emphasis here is on the word independent and the inclusion of consumer representatives.
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."
Were you aware of this? I wrote an article for a recent edition of Living Wisdom about this very issue. For almost 15 years now, the TGA has been 100% funded by the very companies they are supposed to regulate. All of their money comes from licensing fees for drugs and vaccines. No drugs or vaccines licensed - no TGA. How objective would you be when regulating a company if your livelihood relied on that company's good will? In addition, the TGA never does any independent testing of any of the drugs or vaccines they license. All testing is done by the company itself. When complaints are received (adverse reactions), the TGA simply sends the reaction reports to the drug company and there is no follow-up. There is no independent oversight of any of these procedures. The TGA has become nothing more than a facade of respectability and responsibility.
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."
Experts in immunology and infectious diseases can see the conflict; parents can see the conflict; doctors and their peak bodies can see the conflicts; strangely enough though, the government can't seem to see the conflicts.
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."
These experts ARE there - we just need to seek them out.