A previous Croakey post linked to this interview, as well as to other articles related to Dr Jefferson, including a systematic review he and others published in the British Medical Journal recently.

I then asked them each to write about swine flu vaccination for the Crikey bulletin, to examine some of the issues involved. Their articles were not written as part of a debate about the merits of vaccination, although this is how they were inadvertently headlined during the Crikey production process.

I would like to put it on the public record that both authors object to their articles being headlined this way and being framed as part of a debate when they were not written for this purpose.

Their articles follow below.

Maryann Napoli, of the Center for Medical Consumers in New York writes:

“How do we know whether the H1N1 [swine flu] vaccines actually work?  How do we know they’re safe for children, pregnant women and elderly people?  These are the most basic questions consumer advocates and medical journalists usually want answered where it concerns new prescription drugs.

And yet when it comes to new vaccines, that justifiable skepticism is often suspended.  What we get instead is an uncritical version of the classic public health position: Vaccines have saved millions of lives worldwide; therefore all vaccines are good. Vaccines are a major public health triumph and any risks are far outweighed by benefits.

That was made depressingly clear three years ago in the US when Gardasil, Merck’s Human Papillomavirus vaccine, came on the market. Yes, we got a lot of excellent reporting about Merck’s appalling marketing tactics but little about the science behind this vaccination recommended to all girls, age 9 and up.

I recently asked the question about H1N1 vaccine effectiveness of the world’s leading authority on the quality of the evidence supporting influenza vaccines, Dr Tom Jefferson, a medically trained epidemiologist who has been a reviewer for the Cochrane Collaboration for many years.

His answers weren’t reassuring, and there isn’t much to say about safety because the one published study looked only at antigens 21 days after the vaccination.

As for those flu-related death stats meant to hasten flu-shot compliance, they haven’t seemed remotely trustworthy ever since a 2005 study concluded that an accurate assessment of flu-related deaths is virtually impossible because few cases are confirmed with blood tests. And the viral infection is usually cleared from the body before the appearance of complications that cause death.

Things are calm here in New York City (flu-wise, that is). The mayor says he won’t close public schools in the event of another swine flu outbreak, except as a last resort (there were at least five swine flu deaths last winter in NYC).

But perhaps the two-pig cartoon currently making the rounds is a sign of what’s going on elsewhere in the country. It shows a small pig marked, “Swine Flu” side-by-side with a giant pig marked “Swine Flu Hysteria.”

By the end of October, all we need will be a news flash about the death of one child, and people, young and old, will be lining up in droves for the vaccine.

Here’s something that might give them pause: In the wake of the 9/11 tragedy, the U.S. Congress, which is bought and paid for by PHARMA, passed a federal law that allows vaccine companies to be protected from liability if anyone gets hurt.

Authorities need only declare a public health emergency for the protection to go into effect.  Like most Americans I would probably be blissfully unaware of this law were it not for one independent vaccine safety organization, the National Vaccine Information Center.”

**
Dr Tom Jefferson, of the Cochrane Collaboration’s Acute Respiratory Infections Group, writes:

“As winter turns to antipodean spring, the scientific community downunder have a duty to inform their northern counterparts about the ebbing of the current “pandemic”.

The information needs to be as accurate and as comprehensive as possible, but most of all it needs to be free of spin and shroud waving. Both of them have featured prominently in scientific and lay media coverage of the “pandemic” and have obscured reality, like a smokescreen.

Here is what we need to know:

1.    What are the estimates of the incidence and impact of influenza-like illness (ILI) in Oz/Kiwiland since early 2009?
2.    How do these compare with previous years?
3.    What is the estimated slice of ILIs and complications caused by influenza A&B and influenza A/H1N1 since early 2009?
4.    What is the estimate of the co-circulation of other agents?
5.    Can you give us full details of deaths coded as caused by H1N1 including, setting, comorbidites and coinfections?
6.    Can you do the same for all serious cases who survived?
7.    Do you have evidence from seroprevalence surveys of when H1N1 first appeared dowunder?
8.    What does your pharmacosurveillance tell you about harms from the use of antivirals?
9.    Are still serious about mass vaccinating now the epidemic is past?
10.   If so, why?

I know it is a lot to ask for, but we need the information to break the smokescreen and in any case if your public health is as good as we hear it is, you will be able to get the information relatively quickly and in an unbiased manner.”

The interview, conducted by Maryann Napoli from the Center for Medical Consumers in New York, raises many questions about the merits of our mass vaccination program for H1N1.

You can also read more about Jefferson’s views and work in this article from the European magazine, Der Spiegel, in this 2005 news release issued by the University of Oxford, at this Cochrane Collaboration site, and in this recent blog by a Scottish GP, Margaret McCartney, at the Financial Times website.

He is also lead author of this systematic review published a few days ago in the British Medical Journal, examining the use of physical interventions (eg handwashing, masks etc) to interrupt or reduce the spread of respiratory viruses, such as influenza.

It seems like the issues around influenza vaccination generally – and swine flu vaccination in particular – may not be quite as clear cut as they’re often made out to be.

Carol Bennett, executive director of the Consumers Health Forum, is encouraging the public to discuss the pros and cons of vaccination with their health provider, rather than relying on media coverage to inform their decisions.

Here is what she has to say:

“While I do not claim to be an expert on the H1N1 vaccine and the specific risks associated with the vaccination, I think we will need to rely on individual health service providers to be aware of, and inform, consumers about the risks rather than expecting consumers to rely on a broad media discussion of potential risk factors.

I know that the risks of any vaccination vary considerably according to individual characteristics – a preschool child has different risks to a teenager who has different risks to an obese middle aged nurse or an older businessman with pre existing asthma and diabetes.

Knowing there are some risks does not inform individuals about how the risk relates to them personally.

I am not one to support health consumers being treated as mugs, but I am confident most health consumers would prefer to discuss their specific circumstances with their health service provider rather than base their risk assessment on generalised advice provided by media summaries of a Health Minister’s statement about potential side effects.

My reading of the media is that the Health Minister has been transparent in both the advice she has received (including potential risk factors) and the policy that she is adopting.”

Below is a document that the Medical Indemnity Protection Society has sent members, making it clear that they will be covered only if they obtain informed consent from patients. This means discussing the potential benefits and risks of vaccination versus no vaccination.

It is interesting to contrast what the Government is telling the public with what doctors are expected to tell their patients. Quite a contrast.

Now, don’t get me wrong. I am not opposed to vaccination per se, and I am certainly not seeking to inflame anti-vaccination campaigns generally.

What I do want, however, is for those in positions of authority to be upfront and honest with the public – in the way that the health professionals charged with delivering the vaccination program are expected to be.

I’ve been thinking about what Minister Roxon could feasibly say when asked about the pros and cons of vaccination and issues such as the infection control concerns around multidose vials.

Of course she doesn’t want to say anything that will lead to alarmist tabloid headlines. But that doesn’t mean she can’t acknowledge that there are legitimate concerns, and to explain how these are being addressed.

Apart from anything, this discussion might help members of the public play a more active role in their care. I was struck by a comment on the earlier Croakey post, where a reader asked: “Is there anything ‘mug consumers’ of swine flu vaccination can do to minimise their risk of contamination with multidose vials?”

It’s not such a silly question. Ensuring consumers are informed about potential risks is well acknowledged within the broader safety and quality field of being one way to minimise the risk of adverse events or to ensure they are effectively managed if they do arise.

If the Government insists on treating the general public like mugs who are incapable of engaging with these issues in a sensible way, it is missing an opportunity. And so are the health professionals who would prefer all these debates stay firmly behind closed doors.

Anyway, enough ranting from me. Here is the advice from the Medical Indemnity Protection Society to doctors:

SWINE FLU VACCINATION – MEMBER INFORMATION
The Australian Government plans to distribute the swine flu (H1N1) vaccine in the near future. This information from MIPS clarifies the indemnity issues surrounding this vaccination program for members and their employees.

Indemnity for members
MIPS will indemnify its members for administering the H1N1 vaccine however, members are required to:
•    provide patients with adequate informed consent including a succinct summary of the current information needed to make an informed decision about H1N1 vaccination.  This should include information about the risks of the vaccine, the general risks of an injection and risks of electing not to have the vaccine;
•    follow the current draft RACGP Guidelines for the use of multi-dose vials (MDV’s) available at http://www.racgp.org.au/h1n1/33545; and
•    meet MIPS general requirements of appropriate qualifications, training and experience.

Informed consent
Members need to appropriately advise patients of the risks of H1N1 and the risks of having or not having a H1N1 vaccination based on their individual circumstances so that patients can make an informed decision (and therefore provide informed consent to undergo vaccination).
For example this should include:
•    information regarding risks associated with H1N1 compared with seasonal flu;
•    information comparing risks from catching H1N1 compared with risks associated with vaccination;
•    advising that the vaccine is currently undergoing clinical trials; and
•    that it is currently not clear whether one or two doses will be required to achieve immunity.

Although presumed, it is not yet confirmed that the risks of H1N1 are in general much higher than normal seasonal flu and/or the extent that the risks of H1N1 are more serious and/or more likely than the risks associated with vaccination.

According to the Australian Government there have been no concerns raised from early vaccination trial data, however it is possible concerns might be subsequently identified.  Members should also set patient expectations that a second vaccination dose may be required and ensure appropriate recall systems are in place to achieve that.

Ultimately, it is the patient after having been appropriately informed, that must make a decision as to whether they wish to proceed with vaccination or not.

Information material
The Australian Government has advised it will provide health professionals and patients with Pandemic H1N1 Influenza Vaccine Information material and also a “consent” form. These should be used.  Refer www.healthemergency.gov.au.  As for any health service the patient’s medical record must also reflect advice given and the patient decision.

Multi-dose vials
For adults the H1N1 vaccine will be presented in multi-dose vials. Practitioners and patients need to be aware of the steps taken to remove potential risks associated with use of multi-dose vials particularly in relation to vertical transmission of blood borne diseases. Strict adherence to the RACGP Draft “Guidelines for the use of multi-dose vials” is required by MIPS because it will remove that risk and thereby provide confidence to patients when making a decision about H1N1 vaccination.

Other matters
The normal issues associated with seasonal influenza vaccines for e.g. egg allergies/potential issues with preservative, risk of bruising, infection, sterile abscess, nerve damage etc. remain for consideration in respect of H1N1 vaccination.

In addition, strict attention to maintaining the cold chain (especially in view of the huge volume of vaccine and potential vaccinations) provides a greater challenge than for other vaccination programmes.

Indemnity for members, those under members direct supervision and practice staff
For those members whose practices are considering arranging for employed staff such as practice nurses to administer the vaccine, in addition to compliance with the above requirements (e.g. for advice and use of multi-dose vials) it is important to remember under the individual MIPS Insurance medical indemnity policy a MIPS member is covered for vicarious liability claims that arise from the provision of healthcare by others under the member’s direction in accordance with clause 12.1.7 of the member’s medical indemnity policy. The relevance of the clause is the requirement for the member’s appropriate and adequate direct supervision and also for the supervised individual to act within practice protocols. The MIPS Insurance Policy can respond if the member’s practice staff seeks indemnity from the member on the basis that the claim against them is as a result of the member’s actions or inactions but only if all requirements are met.

MIPS Members’ Practice staff and the practice entity are also indemnified in accordance with the terms and conditions of the MIPS Member Practice Entity Policy. (A practice entity is defined as a practice in which a member has a financial interest and the majority of shares are owned by medical practitioners working in the practice). In general terms this policy provides cover for health care errors made by practice nurses, receptionists and other administrative staff who act independently and which may financially implicate the practice and/or the member.

It is important to remember that MIPS requirements (as listed above including consent and use of RACGP guidance for the use of multi-dose vials) will be a pre-requisite in relation to indemnity for any H1N1 vaccination matters that arise.

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.

• a lot of people must be working pretty hard and wondering how on earth they’re going to pull it all off

• we will be hearing and reading plenty of reports emphasising the potential benefits of vaccination and maximising concern about the impact of swine flu.

In one sense, this is what happens whenever there is a roll out of a new health program or intervention; the advocates talk it up. But this time, they will no doubt be even more determined to do this, given the questions that are being asked about the merits of the campaign and its timing.

In light of this second point, you might be interested in this piece calling for a “common sense” response to swine flu, recently published by Healthy Skepticism, a group which is not known for being overly enthusiastic about medical marketing.

It is by Juan Gérvas, a rural GP in Spain, and a Visiting Professor, Primary Care, International Department, National School of Public Health (Madrid), Spain. He is also Honorary Professor, Public Health, School of Medicine, Autonomous University (Madrid).

She wrote an interesting article in Crikey today about the image problem of swine flu vaccination and the need for “full transparency from the authorities” to ensure public confidence.  The public will need to know the data the Government is using to assess the vaccine presented in comparison with data comparing the risks of swine flu in Australia, and that systems for reporting adverse events following immunisation are in place, she wrote.

Those who saw the whooping cough story on the 7.30 Report may be interested in her analysis of related issues.

She writes:

“Vaccination is mostly a technically rational practice but the decision to vaccinate is not usually made with a rational approach to the facts. Trust, desire for protection, good mothering all play a role. Fear is also a powerful motivator. In vaccine promotion terms, Toni McCaffery’s willingness to go public is a blessing. Parents who will do this crop up every few years. In the meantime, vaccination advocates struggle in fighting emotional anti-vaccine stories with doctors delivering dry (in comparison) verbal reassurances.

Often parents who go against vaccination do so with what they believe is lots of evidence (often from Jenny McCarthy’s “University of Google”) They also have entrenched belief systems. This 2% will be almost impossible to win over.

A few media reports lately have suggested we are having a drop in rates. This is a blow-up. There is no sign of this from national rates which remain stable at about 94% for two year olds. I am not aware of a fall in the northern rivers rates. It’s always been poor with about two thirds fully vaccinated.

The current approach to the anti-vaccinationism movement is missing the mark.

Health professionals often seem to think you can just feed vaccine dissenters the facts, educate them and this will correct wayward thinking.

This demonstrates a poor understanding of the anxieties and wider social shifts at the heart of vaccine debates. These include mistrust driven by poorly handled health scares (CJD in the UK), a thirst for discrete causes of idiopathic ills (eg, autism), increasing tendency to question medicine, middle-class “intensive parenting”, and the appeal of natural health practices.

Tactics like The Skeptics’ which seek to demonise antivaccination polarise the issue taking away any room for grey in a complex issue (vaccines are great but not perfect).

They also give the AVN a media profile which would potentially attract fence-sitting new paid-up members who otherwise would not have contacted the once nearly bankrupted AVN.

One has to wonder whether appeals to availing oneself of the truth and facts will work with GenY parents who were raised to value the fundamental truth of the personal narrative. We need to consider new models of addressing vaccine scepticism. This first requires better understanding of the current landscape.

The best strategies will be evidence-based, tailored to parents’ needs and contemporary. They will be resource intensive and require consultation and listening, not lecturing.”

One problem with this view is that is inhibits a discussion that we need to have about the potential costs and benefits of the planned pandemic influenza vaccine roll-out. One infectious diseases specialist told me recently that it felt like the roll-out was something of a juggernaut – relentlessly proceeding in the face of quite widespread concerns about its merits.

The Australian Infection Control Association – critical players in any vaccine roll out, not least because of their role in encouraging vaccination of health care workers – has today come out opposing the vaccination plans because of the potential risks of multidose vials. Their concerns are reported in the Crikey bulletin.

Meanwhile, Professor Peter Collignon, from the ANU Medical School, has written this analysis for Croakey.

He writes:

“A pandemic H1N1 09 (swine flu) vaccine will be rolled out here very soon as the start of a mass vaccination campaign. However, this will be in multi-dose vials made by CSL. Spokespeople from Federal Health and CSL have all been reassuring that this will be safe and that the manufacturing and safety checking processes will be no different to what happens with seasonal flu.

These reassurances fly in the face of reality. Multi-dose vials have transmitted infectious organisms, resulting in deaths and serious illnesses, repeatedly over decades.

In Australia we had the Bundaberg Disaster in 1928. Diphtheria vaccine contaminated with Staphylococcus aureus from multi-dose vials caused the deaths of 12 children and resulted in a Royal Commission.

In Geelong in the late 1960’s, two factory workers died from Streptococcus pyogenes following workplace flu vaccinations from multi-dose vial. The coroner subsequently recommended against the use of multi dose vials. In NSW a multi-use vial was suspected as the cause for HIV transmission in a surgeon’s office.

Infection Control guidelines and multiple international agencies such as the World Health Organization (WHO), recommend as best practice that single-dose vials be used where possible. Preservatives added to multi-dose vials (such as thiomersal – a mercury containing compound) reduce the survival of bacteria, but as WHO notes, they still remain prone to bacterial contamination. Preservatives don’t kill viral contaminants.

Multi-dose vials have frequently been the likely source of outbreaks and some other examples are hepatitis B, hepatitis C and Pseudomonas aeruginosa.

In a WHO document on best infection control practices for needle injections, it noted that each year worldwide, poor injection practices (that includes a contribution from contaminated multi-use vials) cause millions of blood borne viral infections especially with hepatitis B virus.

In Australia by August 28th there were 150 reported deaths associated with H1N1 and 4,398 hospitalizations. Four deaths have been in pregnant women.

NSW Health has the best updated and detailed data available. By August 26th in NSW there had been 1,164 hospitalizations, 181 ICU admissions and 41 deaths. Infections peaked in mid July and now flu is at low seasonal levels of activity. Only 2 deaths (12%) were in those below the age of 40 years.

Surprisingly the age of the groups with the highest admission rates to ICU were in 50 to 60 year olds. Of note the overall rate of hospital admissions was 16.5 per 100,000 people compared with the rate in Australia for seasonal flu of 15.3 per 100,000 (2003 to 2005).

The very young and those over 60 years have had fewer admissions to hospital than normally seen.

We don’t know how many people have been infected in Australia, but in NZ it was estimated to be 10% of the population (similar to most winters with seasonal flu). The overall case fatality rate is less than 0.005% and thus may be lower than what is usually seen in seasonal influenza for most people.

In Australia each year we vaccinate about 8 million people against seasonal flu with mainly single-dose pre-loaded syringes. It is thus hard to see therefore why we should have to take this retrograde infection control step given the obvious unnecessary hazards associated with the use of multi-dose vials.

The only reasons to use multi-dose vials is to save money or else because there is a rapidly evolving emergency with a high death rate (as it is the easiest way to deliver a vaccine rapidly to a population).

Neither of these conditions are currently present in Australia. CSL expects to make $300 million from sales of the swine flu vaccine this financial year. Thus cost cutting should not be a factor.

We passed the peak of this epidemic in most states in Australia in mid July. While some groups are over-represented with higher than expected morbidity (pregnant women and Indigenous groups), overall this epidemic has not been much worse as judged by overall hospital admissions and deaths in comparison to seasonal flu over the last 10 years.

Even if we had to rush vaccine production, why not deliver them in single use ampoules?

We are also very unlikely to see any second waves here till next winter. Thus we have time here to do any vaccination program properly and learn from what happens in the Northern hemisphere in their upcoming winter.

We should not proceed in haste with a mass vaccination campaign using multi-dose vials. We need to ensure all the appropriate and usual steps associated with vaccine licensure have been followed. We know that basic infection-control procedures are not always followed in hospitals, clinics and general practice units in the community.

Although the risk may be judged to be slight, any failures will be disastrous for any individuals infected and if linked back to the vaccine roll out may also undermine confidence in the ongoing implementation of Australian vaccination programmes in general.

In summary, we need careful reconsideration of the implementation of this vaccination strategy.
•    Multi-dose vials have a potential to transmit infectious organisms and should not be used in a mass vaccination campaign.
•    The proposed mass vaccination campaign should be delayed until a safe formulation of the vaccine supplied in single dose vials becomes available.
•    All appropriate processes involved with vaccine licensure need to be followed.
•    We need to have an appropriate surveillance system in place that can quickly detect any increase in rare or unexpected side effects from the vaccine (eg Guillain-Barré syndrome – ascending paralysis, that occurred in about 1 per 100,000 people in the US in 1970’s with the last Swine flu mass vaccination program roll out).

References and further reading

1. Kellaway C, H., McCallum P, Tebbutta H. The fatalities at Bundaberg. Report of the Royal Commission. Med J Aust 1928;ii(2):38.

2. Hutin Y, Hauri A, Chiarello L, et al. Best infection control practices for intradermal, subcutaneous,and intramuscular needle injections. Bulletin of the World Health Organization 2003;81(7):491-500.

3. Katzenstein TL, Jorgensen LB, Permin H, et al. Nosocomial HIV-transmission in an outpatientclinic detected by epidemiological and phylogenetic analyses. AIDS 1999;13(13):1737-1744.

4. Samandari T, Malakmadze N, Balter S, et al. A large outbreak of hepatitis B virus infections associated with frequent injections at a physician’s office. Infection Control & Hospital Epidemiology 2005;26(9):745-750.

5. Dumpis U, Kovalova Z, Jansons J, et al. An outbreak of HBV and HCV infection in a paediatric oncology ward: epidemiological investigations and prevention of further spread. Journal of Medical Virology 2003;69(3):331-338.

6. Hutin YJ, Goldstein ST, Varma JK, et al. An outbreak of hospital-acquired hepatitis B virus infection among patients receiving chronic hemodialysis. Infection Control & Hospital Epidemiology 1999;20(11):731-735.

7. Verbaan H, Molnegren V, Pentmo I, et al. Prospective study of nosocomial transmission of hepatitis C in a Swedish gastroenterology unit. Infection Control & Hospital Epidemiology 2008;29(1):83-85.

8. Germain JM, Carbonne A, Thiers V, et al. Patient-to-patient transmission of hepatitis C virus through the use of multidose vials during general anesthesia. Infection Control & Hospital Epidemiology 2005;26(9):789-792.

9. Kokubo S, Horii T, Yonekawa O, et al. A phylogenetic-tree analysis elucidating nosocomial transmission of hepatitis C virus in a haemodialysis unit. Journal of Viral Hepatitis 2002;9(6):450-454.

10. Silini E, Locasciulli A, Santoleri L, et al. Hepatitis C virus infection in a hematology ward: evidence for nosocomial transmission and impact on hematologic disease outcome. Haematologica 2002;87(11):1200-1208.

11. Trasancos CC, Kainer MA, Desmond PV, Kelly H. Investigation of potential iatrogenic transmission of hepatitis C in Victoria, Australia. Australian & New Zealand Journal of Public Health 2001;25(3):241-244.

12. Massari M, Petrosillo N, Ippolito G, et al. Transmission of hepatitis C virus in a gynecological surgery setting. Journal of Clinical Microbiology 2001;39(8):2860-2863.

13. Widell A, Christensson B, Wiebe T, et al. Epidemiologic and molecular investigation of outbreaks of hepatitis C virus infection on a pediatric oncology service. Annals of Internal Medicine 1999;130(2):130-134.

14. Stetler HC, Garbe PL, Dwyer DM, et al. Outbreaks of group A streptococcal abscesses following diphtheria-tetanus toxoid-pertussis vaccination. Pediatrics 1985;75(2):299-303.

15. Olson RK, Voorhees RE, Eitzen HE, et al. Cluster of postinjection abscesses related to corticosteroid injections and use of benzalkonium chloride. Western Journal of Medicine 1999;170(3):143-147.

16 Chant K. Lowe D, Rubin G, et al. (1993). Patient-to-patient transmission of HIV in private surgical consulting rooms. Lancet. 342:1548-1549.

17 NSW Health. Weekly Influenza Epidemiology Report, NSW. Including H1N1 influenza 09. [Internet]. 2009. [Accessed 30/08/2009, 2009]. Available from:
http://www.emergency.health.nsw.gov.au/swineflu/resources/pdf/case_statistics_270809.pdf

18. M G Baker, N Wilson, Q S Huang, S Paine et al. Pandemic influenza A(H1N1)v in New Zealand: the experience from April to August 2009
Eurosurveillance, Volume 14, Issue 34, 27 August 2009. Rapid communications
http://www.eurosurveillance.org/ViewArticle.aspx?ArticleId=19319

19. Plueckhahn VD, Banks J. Fatal haemolytic streptococcasepticaemia following mass inoculation with influenza vacine. Med J Aust. 1970 Feb 28;1(9):405-11.

20. The Geelong disaster. Med J Aust. 1970 Feb 28;1(9):401-2.

21. Lexi Metherell. CSL ‘maxed out’ on swine flu vaccine production
http://www.abc.net.au/news/stories/2009/08/19/2660597.htm?section=australia
August 19th 2009

22. Letter from Australasian Society of Infectious Diseases to Professor Jim Bishop (Chief Health officer). Use of multi-dose vials for H1N1 09 (“swine flu”) immunization. August 19th 2009.

23. Collignon P. Patient-to-patient transmission of HIV. Lancet. 1994 Feb 12;343(8894):415; author reply 415-6.

Meanwhile, Professor Peter McIntyre, Director, National Centre for Immunisation Research and Surveillance of Vaccine-Preventable Diseases, is concerned that the focus upon swine flu and pregnancy may be distracting attention from the risks of influenza generally for pregnant women. He writes:

“Pregnant women are at risk – not just from swine  influenza, as highlighted in the media in recent days, but from influenza of  any kind.

“Ordinary” seasonal influenza is also still circulating. Both vaccines and antiviral drugs are important.

With respect to vaccines, influenza vaccine has been recommended by  the National Health and Medical Research Council for women in pregnancy for  almost 10 years – but few receive it.

This is  probably related to both lack of familiarity with the whole notion of  vaccines in pregnancy by practitioners caring for pregnant women, as well as reluctance on the part of many, if not most, women to receive any treatment  in pregnancy, either vaccine or drug.

Therefore  it is important to emphasise that there is no theoretical or data-based  reason to expect any adverse effects from vaccines which do not contain  live organisms in pregnancy. In partcular, influenza vaccines are safe in pregnancy. The primary rationale  is to provide protection for the mother but there is accumulating evidence that some protection is probably also afforded to the baby after birth.

Once a swine influenza vaccine is available, pregnant women will be a priority risk group, something which has been emphasised by recent publicity concerning severe cases in pregnant women.

It is important to remember that  vaccines for “ordinary” influenza are available now  and are  recommended for pregnant women, who are especially at risk in the later stages of pregnancy, and that professional and public attitudes to using influenza  vaccines in pregnancy need to change now.

With respect to antiviral drugs, it is important that pregnant women  see their doctor early if influenza is a possibility as anti viral treatment  is most beneficial early. Pregnant women also need to see their doctor if it  is possible that their children have influenza, as this may be an opportunity  for even earlier treatment. Given the potential severity of influenza in  pregnancy, the benefits of treatment clearly exceed the risks.

Regarding risks for Indigenous communities, we know that influenza  rates generally are much higher in Indigenous children and adults, with  hospitalisations for influenza and pneumonia 3.5 times higher than in  non-Indigenous Australians.

The biggest  difference is in 25-49 year olds, where the rates are 8  times higher. This younger adult group is the very group now coming to light  with swine flu but has been evident as an important  risk group in earlier data.  This is  reflected in the recent announcement by the Commonwealth that free influenza vaccine will be provided under the National Immunsation Program for all  Indigenous adults from 15 years of age as well as for all persons from 6  months of age who have conditions placing them at increased of severe  influenza.

This group at increased risk, as mentioned above, includes pregnant women. This is especially so for pregnant Indigenous women, where we know that there are high rates of respiratory and ear disease in babies very early  and that mothers themselves are significantly more likely to have health problems. The  increased risk relates not only to medical conditions, but to general living conditions, and other risk factors such as high rates of  cigarette smoking.

Indigenous people should be a priority  group for access to both antivirals and to vaccine for the swine flu, when it  becomes available. For the whole  community, communication about risks and benefits will be crucial.”

• History of swine flu

The latest issue of The New England Journal of Medicine has two interesting articles exploring the history of swine flu, otherwise known as  influenza A (H1N1) strain (S-OIV). See here and here.

The latter article concludes somewhat poetically:

The 1918 influenza virus and its progeny, and the human immunity developed in response to them, have for nearly a century evolved in an elaborate dance; the partners have remained linked and in step, even as each strives to take the lead. This complex interplay between rapid viral evolution and virally driven changes in human population immunity has created a “pandemic era” lasting for 91 years and counting. There is little evidence that this era is about to come to an end.

If there is good news, it is that successive pandemics and pandemic-like events generally appear to be decreasing in severity over time. This diminution is surely due in part to advances in medicine and public health, but it may also reflect viral evolutionary “choices” that favor optimal transmissibility with minimal pathogenicity — a virus that kills its hosts or sends them to bed is not optimally transmissible. Although we must be prepared to deal with the possibility of a new and clinically severe influenza pandemic caused by an entirely new virus, we must also understand in greater depth, and continue to explore, the determinants and dynamics of the pandemic era in which we live.

• Disasters and vulnerable groups

On a related theme, this article suggests that governments and planners need to pay more attention to protecting vulnerable groups when preparing for disasters. The article is very much focused on the US context but no doubt has wider relevance. It is by Sharona Hoffman, Professor of Law & Bioethics  and Co-Director of the Law-Medicine Center at Case Western Reserve University School of Law.

She argues that the needs of those with physical and mental impairments, the elderly, those with language barriers, children, pregnant women, the impoverished, certain ethnic minorities, and prisoners are often overlooked. “As the Hurricane Katrina experience made clear, preparedness fiascos will result in humiliation and a loss of public faith in the government as well.”

• Progress against obesity?

The latest assessment of America’s progress against obesity reaches dismal conclusions. “F as in Fat: How Obesity Policies Are Failing in America 2009″, a report from the Trust for America’s Health and the Robert Wood Johnson Foundation  found adult obesity rates increased in 23 states and did not decrease in a single state in the past year. Meanwhile, the percentage of obese or overweight children is at or above 30 percent in 30 states.

On a more positive front, there’s a wealth of information and resources about what governments, planners and others can do to encourage healthy eating and physical activity in this toolkit. It is “a collection of current best approaches in healthy eating and physical activity policy”.

• Tracking US health reform

For those with an interest in following developments in US health reform, this interactive website will enable comparative analysis of the various proposals (due to go live on July 20). The National Health Reform Comparative Analysis Project is an intitiative of the George Washington University’s Hirsh Health Law and Policy Program.