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What Roxon didn’t tell Fran Kelly about swine flu vaccination

Minister Roxon was spruiking the benefits of swine flu vaccination to Fran Kelly this morning and downplaying any potential risks.

Asked about infection control concerns surrounding the use of multidose vials(as outlined in this Crikey story recently), Minister Roxon said these are “very minimal”.

Does she realise what dangerous territory she’s entering here?

Our national infection control guidelines (you can read them here) state that the use of multidose vials is a “high risk” procedure (p49).

The guidelines cite the Australian Drug Evaluation Committee’s advice that “injectable products packaged in multidose vials should not be used except where products such as insulin are intended solely for the exclusive use of an individual patient”.

The guidelines also state: “When single-dose vials or ampoules are not available, the risk of cross-contamination is high if injectable products are used on multiple patients.” They recommend several measures for controlling this risk.

If the Government and its advisors have decided the potential benefits of a mass vaccination program outweigh the costs, including potential harms, then fair enough. Not everyone agrees with them, but that’s their call.

It’s another matter entirely to mislead the public in an effort to sell their program.

This will come back to bite them on the bum, pardon the language, if history is any guide. You don’t have to look too far back to find an example of the perils of health ministers spruiking pharmaceuticals.

Below follows is an extract from Ten Questions You Must Ask Your Doctor, which I wrote with another health journalist Ray Moynihan. This particular section comes from a chapter urging readers to be more alert to the possibility of side effects from medications and notes that these are often downplayed.

“In June 2000, the then Australian Minister for Health, Dr Michael Wooldridge, issued a most extraordinary media statement. In it, he announced that the first of a new class of arthritis drugs called COX 2 inhibitors would be funded by the Australian Government. He said the drug, celecoxib (sold under the brand name Celebrex), was significantly safer than older types of drugs used to treat arthritis and called it a ‘major breakthrough in arthritis therapy’.

It was highly unusual that a Health Minister would feel the need to single out any one drug for such an enthusiastic plug. It was even more remarkable considering that a careful reading of the scientific literature would have shown there were already rumblings of concern about the safety of COX 2 inhibitors. Over the next few years, these rumblings turned into a roar of alarm and an international scandal damaging public trust in drug regulatory agencies, medical journals and drug companies alike.

We now know that tens of thousands of people around the world paid a very high price – suffering heart attacks and strokes – for following advice to take drugs that they had been assured, wrongly as it turned out, were safer than older types of arthritis drugs.

Taxpayers and patients also paid a very high price for the overly enthusiastic promotion of these drugs, which reaped huge profits for their manufacturers. While safety concerns surround many of the COX 2 inhibitors, including the one so warmly endorsed by Dr Wooldridge, the most alarming case is that of rofecoxib, which was sold under the brand name Vioxx by the drug giant Merck.

The history of rofecoxib reveals how so many different groups failed to protect the public’s safety…”

I am not suggesting that swine flu vaccination will turn into this scale of disaster. I sincerely hope not.

But the point is that there are enough lessons from recent history for Health Ministers to be extremely cautious about how they pitch pharmaceuticals and other health interventions to the public.

We need to be able to have an open and frank discussion about the costs and potential harms of any interventions – including vaccines – as well as their potential benefits.

Comments 10

  1. It does seem a bit foolhardy. The only other swine flu mass vaccination campaign resulted in 500 cases of GBS.

  2. Margaret Bozik says:

    GBS = Group B Strep, a term probably not understood by most people.

    Group B strep (GBS), also known as beta strep, is a common bacteria found in about 1 in 4 pregnant women. Most women who carry GBS do not have symptoms. While usually not harmful to pregnant women, some babies who are exposed to GBS during pregnancy, birth, or after delivery, become sick or even die.

    It’s a concern given that pregnant women are being urged to receive the vaccination!

  3. deccles says:

    Thanks Margaret. I was wondering what GBS stood for. Is there anything mug ‘consumers’ of the Swine Flu vaccination can do to minimise their risk of contamination with multidose vials?

  4. hardworking says:

    GBS also stands for Guillain Barre Syndrome, which is the risk here rather than group B Strep. Information on Guillain Barre Syndrome can be found at http://www.gbs.org.uk and information on group B Strep can be found at http://www.gbss.org.uk.

  5. Croakey says:

    I assumed Ben was referring to Guillain-Barré syndrome? Is that what you meant Ben?

    By the way, David thanks for raising the issue about involving patients in their care. I was thinking along the same lines myself today, and have just put up a related post on this issue
    – Melissa Sweet (Croakey moderator)

  6. Altakoi says:

    Other interesting facts are that the WHO yesterday recommended that the composition of the southern hemisphere 2010 winter seasonal flu vaccine should include:

    an A/California/7/2009 (H1N1)-like virus;
    an A/Perth/16/2009 (H3N2)-like virus;
    a B/Brisbane/60/2008-like virus.

    (see the WHO website).

    This makes it even more interesting as to why one would use a multidose mono-valent H1N1 vaccine when, in about four months time, a single-dose trivalent product will be available in time for next winter. This makes the H1N1 vaccine a sensible choice, I guess, if you are worried about dying of pandemic influenza before next winter but that is hardly the bulk of the population.

    In defence of the multidose vial, one assumes that this was designed for the sort of truely mass vaccine rollout which would be required if H1N1 had turned out to be deadly to healthy people. An influenza pandemic like that is a real possibility which the Health Department has correctly planned for. It just seems that it might be a tad of an overreaction for this particular pandemic.

  7. Sorry everyone, I did mean Guillain-Barré syndrome. The three-letter acronym strikes again.

  8. boots says:

    Also worth considering is the fact that pregnant women are told to avoid all mercury in pregnancy as it is a deadly neuro toxin. It is medically advised not to eat tuna or deep sea fish during pregnancy to avoid any risk of exposure, yet this vaccine contains 24.5mcg of mercury (in the preservative thimerosal) – 49 times more than a grown person should be exposed to in a day – hundreds more then a foetus should receive…

    Thimerosal has already been removed from vaccines in children under 10 in Australia due to concerns (though not proven) as causing an increased risk of autism.

  9. reasonable says:

    @boots. Your comments are incorrect and deceptive. I have my suspicions as to why. The autism link has been thoroughly debunked and Dr Wakefield is now a laughing stock in medical debates. But that’s just another conspiracy, isn’t it.
    Your mercury calculations are also scurrilous.
    @Ben. I believe you are referring to a 30 year old vaccination program. You need to do more research about G-B Syndrome, and its myriad of possible causes before you link it to modern vaccination programs.
    @author of story. Basing a story in fear mongering is not a public service, even if you do it in the guise of “open and frank discussion”. Oh please, Meryl Dorey uses that line all the time. But, when you ask a question, the debate finishes.

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