FDA Calls For Better Evidence On Health Care Antiseptics

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In this age of increasing HAIs (Hospital Acquired Infections) the number of times a HCW must stop and wash (or sanitize) their hands has grown exponentially over the past decade.   As the chart above illustrates (credit WHO), every patient contact can instigate as many as five hand washings.  

 

It is not unusual for HCWs to stop and sanitize their hands a hundred times during a single shift, often utilizing one of several antibacterial products (alcohol rubs, phenols, Iodine benzalkonium chloride, etc.). 

While these products have been around for decades, and are considered Generally Recognized As Safe & Effective (GRASE)  by the FDA , they’ve never been used by so many people – and applied so many times each day - as they are now.  

 

Yesterday the FDA published a notice that they would like to see evidence of both the safety and effectiveness of a broad range of products – used primarily, but not exclusively – in the Health Care arena.   This is the first major review of these products since the early 1970s.

 

Categories of healthcare antiseptics to be reviewed include:

• Health care personnel hand washes
• health care personnel hand rubs
• surgical hand scrubs
• surgical hand rubs
• patient preoperative skin preparations

 

Not included in this review are common consumer antiseptics, like antibacterial soaps containing Triclosan, which are under a separate review (see FDA Reviewing Safety & Effectiveness Of Antibacterial Soaps). 

Results of this review won’t be available for several years, and in the meantime the FDA recommends that hospital staff continue to use these products as they have been. 

 

FDA News Release

FDA issues proposed rule to address data gaps for certain active ingredients in health care antiseptics

April 30, 2015

The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph.

<SNIP>

Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that health care antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective (GRASE) for their intended use to reduce bacteria that potentially can cause disease. The FDA’s request for more safety and effectiveness data for health care antiseptic active ingredients should not be taken to mean the FDA believes that these products are ineffective or unsafe.

Since the FDA began review of health care antiseptics in the 1970s, many things have changed, including the frequency of use of some of these products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body, the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use.

Emerging science also suggests that for at least some health care antiseptic active ingredients, systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients. The FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.

“Today health care professionals use antiseptic products much more frequently than they used to, in some cases up to 100 times a day,” said Theresa Michele, M.D., director of CDER’s Division of Nonprescription Drug Products. “Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals.”

The proposed rule does not require any health care antiseptic products to be removed from the market at this time. Instead, it requires manufacturers who want to continue marketing health care antiseptic products under the monograph to provide the FDA with additional data on the active ingredients’ safety and effectiveness, including data to evaluate absorption, potential hormonal effects and development of bacterial resistance. Once the proposed rule is finalized, ingredients for which adequate safety and effectiveness data have been provided would continue to be available.

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During the last big review of hospital antiseptics in the early 1970s, the FDA determined that one of the most commonly used antimicrobial products - Hexachlorophene – used in hospitals and in consumer products like bar soaps, cosmetics, and acne medicines – was highly toxic and could produce neurological symptoms and even death.

 

Its non-prescription use was pretty much abolished in 1972. 

 

The fact that hexachlorophene was also used in pesticides might have served as a clue to its toxicity, but this was the middle of the 20th century, when for a time you could buy cigarettes with asbestos filter tips, cribs were coated with leaded paint, kids were encouraged to handle beads of mercury in school, and you could go to a shoe store and have your feet x-rayed for fun.

 

And yet, somehow we still think of them as the good old days.

MMWR: A 2013-14 Flu Season Review

CDC FluView – A Flu Season dominated by H1N1

 

 

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The flu season just ended was notable for being the first H1N1 dominated flu season in the United States since the 2009 H1N1 pandemic virus first emerged.  Since then, the (now seasonal) H1N109 virus had taken a backseat to the H3N2 virus – that is – until last winter.

H1N1 dominated flu seasons are traditionally not as severe, but are more likely to impact younger adults and children, than do H3N2 seasons.   And that is the pattern we saw last year.

 

A look at the P&I (Pneumonia & Influenza) Mortality charts for the past four years shows that the previous year (2012-13) peaked far higher, and far earlier, than did last year. 

 

FIGURE 4. Percentage of all deaths attributable to pneumonia and influenza (P&I), by surveillance week and year — 122 Cities Mortality Reporting System, United States, 2009–2014*

 

If you go back to the 2011-12 flu season, we barely saw a flu epidemic at all – in what was perhaps the lightest flu season in 30 years.   Such is the variability of our yearly influenza epidemic.

Yesterday the CDC’s MMWR published a detailed review of the past flu season, with an abundance of charts and statistical information.  I’ve excerpted some highlights, but follow the link to read it in its entirety.

 

Influenza Activity — United States, 2013–14 Season and Composition of the 2014–15 Influenza Vaccines

Weekly

June 6, 2014 / 63(22);483-490

Scott Epperson, MPH1, Lenee Blanton, MPH1, Krista Kniss, MPH1, Desiree Mustaquim, MPH1, Craig Steffens, MPH1, Teresa Wallis, MS1, Rosaline Dhara, MPH1, Michelle Leon, MPH1, Alejandro Perez, MPH1, Sandra S. Chaves, MD1, Anwar Abd Elal1, Larisa Gubareva, MD1, Xiyan Xu, MD1, Julie Villanueva, PhD1, Joseph Bresee, MD1, Nancy Cox, PhD1, Lyn Finelli, DrPH1, Lynnette Brammer, MPH1 (Author affiliations at end of text)

During the 2013–14 influenza season in the United States, influenza activity* increased through November and December before peaking in late December. Influenza A (H1N1)pdm09 (pH1N1) viruses predominated overall, but influenza B viruses and, to a lesser extent, influenza A (H3N2) viruses also were reported in the United States. This influenza season was the first since the 2009 pH1N1 pandemic in which pH1N1 viruses predominated and was characterized overall by lower levels of outpatient illness and mortality than influenza A (H3N2)–predominant seasons, but higher rates of hospitalization among adults aged 50–64 years compared with recent years. This report summarizes influenza activity in the United States for the 2013–14 influenza season (September 29, 2013–May 17, 2014†) and reports recommendations for the components of the 2014–15 Northern Hemisphere influenza vaccines.

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Another somewhat surprising aspect of last year’s flu season was the near-lack of novel flu detections in the United States. During the previous couple of years we saw several hundred swine variant viruses reported, mostly associated with attendance of state and county fairs where pigs were displayed (see A Variant Swine Flu Review).

One of the things we will be watching for this summer is the possible return of variant swine flu viruses.   Last July, in anticipation of its return,  the CDC Released Updated H3N2v Guidance.

 

But as the MMWR report above states:

 

Novel Influenza A Viruses - During the 2013–14 influenza season, one case of human infection with an H3N2v virus occurred during week 40 (the week ending October 5, 2013) in a child from Iowa with known direct exposure to swine. The child fully recovered, and no additional cases were identified in family members or other close contacts.

 

This year’s flu vaccine will have the same components as last year, but that doesn’t mean if you got a shot last year, you can safely skip this year.  The protection of flu vaccines decreases over time (see BMC Infectious Diseases: Waning Flu Vaccine Protection In the Elderly.) 

 

Since flu shots are generally about 60% protective most years, it makes getting the booster  the smart thing to do every year.

 

Composition of the 2014–15 Influenza Vaccines

The Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee has determined that the 2014–15 influenza vaccines used in the United States have the same antigenic composition as those used in 2013–14. The trivalent vaccines should contain an A/California/7/2009-like (2009 H1N1) virus, an A/Texas/50/2012-like (H3N2) virus, and a B/Massachusetts/2/2012-like (B/Yamagata lineage) virus. The committee also recommended that quadrivalent vaccines contain a B/Brisbane/60/2008-like (B/Victoria lineage) virus (1). These recommendations were based on global influenza virus surveillance data related to epidemiology, antigenic and genetic characteristics, serologic responses to 2013–14 seasonal vaccines, and the availability of candidate vaccine viruses and reagents.

The MMWR report sums up their findings:

 

What is already known on this topic?

CDC collects, compiles, and analyzes data on influenza activity year-round in the United States. Substantial influenza activity generally begins in the fall and continues through the winter and spring months; however, the timing and severity of influenza activity varies by geographic location and season.

What is added by this report?

The 2013–14 influenza season was the first influenza A (H1N1)pdm09–predominant season since the emergence of the virus in 2009, and also had later-season influenza B activity. The highest hospitalization rates were among adults aged ≥65 years, which is consistent with previous influenza seasons; hospitalization rates among those aged 50 to 64 years were significantly higher than in all years since the 2009 pandemic. Nearly all of the influenza virus specimens sent to CDC for antigenic characterization were similar to the components of the 2013–14 Northern Hemisphere influenza vaccine. The Food and Drug Administration has recommended that the 2014–15 influenza vaccines used in the United States have the same antigenic composition as those used in 2013–14.

What are the implications for public health practice?

Influenza surveillance, including for novel influenza viruses, should continue throughout the summer months, and health-care providers should consider influenza as a cause of respiratory illness even outside the typical season. Although influenza viruses typically circulate at low levels during the summer months, timely empiric antiviral treatment is recommended for patients with severe, complicated, or progressive influenza illness and those at higher risk for influenza complications; treatment can be considered for others if it can be started within 48 hours of illness onset.

 

While there is no predicting what kind of flu year lies ahead, influenza has a habit of throwing us curve balls, and its potential impact should never be underestimated.

WHO: MERS Summary & Literature Update – May 9th

Credit WHO report

# 8600

 

The World Health Organization has released their 15th MERS-CoV summary and Literature update (see list) in advance of Tuesday’s meeting of the IHR Emergency Committee on MERS.  This is the first major review since the Jeddah/Riyadh & UAE clusters began in earnest in late March.

 

The 8-page document contains new graphics, a summary of the WHO’s findings during their visit to Saudi Arabia, a country-by-country synopsis of recent cases, and a list of recent studies pertaining to the MERS coronavirus.

 

While there remain many unanswered questions, the WHO’s primary finding from their recent investigation boils down to: `there is currently no evidence of sustained human‐to‐human transmission in the community’

 

The entire document (pdf file) is of interest, but I’ve excerpted the summary and Risk Assessment below:

Middle East respiratory syndrome coronavirus (MERS‐CoV) summary and literature update–as of 9 May 2014

(EXCERPT)

Summary and Risk Assessment

WHO is currently working with the Ministries of Health in Saudi Arabia and other affected countries and international partners to better understand the reasons for the increase in cases reported since March 2014. From preliminary investigations in KSA, it is clear that cases continue to be reported in a number of locations across the country. Importantly, health care workers have been infected across the country, including in Jeddah, Riyadh, Tabuk, Asir and Medina in recent weeks.

The large number of the recently reported cases from KSA reflects infection acquired through transmission in health care settings. The large outbreaks in Jeddah and Riyadh, and the reports of smaller hospital‐associated cases in other parts of the country, emphasise the importance of infection control strategies and practices, not only when caring for suspected MERS‐CoV patients but also – and most importantly ‐ when caring for patients in all circumstances. It is therefore important to emphasize the implementation of standard precautions at all levels and also to apply additional precautions according to the risk assessment.

The WHO mission found that the upsurge in cases in Jeddah is explained by an increase in the number of primary cases, amplified by several hospital‐acquired outbreaks that resulted from a lack of systematic implementation of infection prevention and control measures. The apparent seasonal increase in primary cases occurring for unknown reasons may be related to the weaning of young camels from their mothers in the spring of each year. Recent phylogenetic analysis using three human sequences from Jeddah suggests that the virus has not changed from previously recovered strains.

Based on available information from recent cases in KSA, in particular, from Jeddah, and from all recently affected countries, there is currently no evidence of sustained human‐to‐human transmission in the community. The overall transmission patterns previously observed remain unchanged. WHO bases this assessment on the evidence that:

1. The clinical picture appears to be similar to what was observed previously; secondary cases tend to present with a milder disease than primary cases, and many of the recently reported secondary cases have been mild, or were people whose tests were positive for MERS CoV but were asymptomatic;
2. The recently exported cases to Greece, Malaysia, the Philippines and the USA have not resulted in onward transmission to persons in close contact with these cases on airplanes or in the respective countries outside the Middle East (contact tracing is still ongoing);
3. Intensive screening of MERS‐CoV contacts revealed very few instances of household transmission; and
4. There has been no increase in the size or number of observed household clusters. The increase in the community cases might reflect a seasonal increase in zoonotic infections from an animal population such as dromedary camels. Alternatively, as many of the community cases had no reported animal exposures, it is also possible that such cases reflected either person‐to‐person transmission or exposure to another source. Further epidemiological investigations are urgently needed to confirm or refute these hypotheses.

WHO expects that additional cases of MERS‐CoV infection will be reported from the Middle East, and that it is likely that cases will continue to be exported to other countries by tourists, travellers, guest workers or pilgrims who might acquire infection following exposure to an animal (for example, while visiting farms or markets) or human source (possibly in a health care setting). Until more is understood about the exposures to non‐human sources in the community, or human or environmental exposures in health care settings and implementation of preventive measures, cases will continue to be reported.

Urgent investigations are required to better understand the transmission patterns of this virus. The most urgent needs include detailed outbreak investigations, understanding how humans become infected from animal or environmental source(s) through case‐control studies, identifying risk factors for infection in health care settings, and enhancing community studies and surveillance for community‐acquired pneumonia. Collaboration between human and animal health sectors is essential to understand the risk of transmission between animals and humans.

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Referral: A Review of Human Influenza A(H5N1) Cases in 2013

H5N1 Virus

 

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For several years now, Laidback Al (Editor–Senior Moderator–& Newshound) on FluTrackers – has published  a terrific overview of the previous year’s global H5N1 activity in early January (see H5N1 in 2012: The Year in Review, A Summary Of Worldwide H5N1 Cases in 2011).   Al is well known in Flublogia for  his maps and charts, along with his analysis, and so I’ve featured his work a number of times in the past.

This year, Al has his own blog – called NOVEL INFECTIOUS DISEASES, where he has published his review of H5N1 activity during the year 2013.  You’ll find a permalink on my sidebar to his site.

 

Follow the link to read:

 

Wednesday, January 1, 2014

A Review of Human Influenza A(H5N1) Cases in 2013

In 2013, 38 human cases of Influenza A(H5N1)  were reported from around the world. This number represents an 18% increase over the number of reported cases in 2012. Six countries reported cases in 2013, Bangladesh, Cambodia, China, Egypt, Indonesia, and Vietnam. Cambodia reported about 71% (27) of all cases reported in 2013.   In 2013, children younger than 10 years old represent about 63% of all cases. No human clusters were reported in 2013. Relative to other countries, Cambodia experienced the greatest percentage increase in human infections in a short period of time. The continued low frequency of reported infections does not eliminate H5N1 as a pandemic threat. 

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Every year I download and convert Al’s analysis to a PDF file which I keep on my desktop as a reference.   This year will be no exception.

mBio: MERS-CoV – How Worried Should We Be?

 

Photo Credit WHO

# 7586

 

 

Yesterday the open access journal mBio published a detailed review of what we know about the MERS coronavirus by Stanley Perlman, M.D./Ph.D., Professor of Microbiology at the University of Iowa.

 

Although the future course of this virus remains uncertain, Dr. Perlman warns that while there are fewer than 100 cases so far:  `. . .  the virus has spread from Saudi Arabia to Europe and is likely to spread throughout the world as infected patients travel for medical and other reasons.’

 

I’ve reproduced the abstract below, but by all means, follow the link to read this extensive review in its entirety. 

 

 

The Middle East Respiratory Syndrome—How Worried Should We Be?

Stanley Perlman

ABSTRACT

Ten years after the severe acute respiratory syndrome epidemic, a second coronavirus, the Middle East respiratory syndrome coronavirus (MERS-CoV), has been identified as the cause of a highly lethal pneumonia in patients in the Middle East and in travelers from this region. Over the past 9 months, since the virus was first isolated, much has been learned about the biology of the virus.

It is now clear that MERS-CoV is transmissible from person to person, and its close relationship with several bat coronaviruses suggests that these animals may be the ultimate source of the infection. However, many key issues need to be addressed, including identification of the proximate, presumably zoonotic, source of the infection, the prevalence of the infection in human populations, details regarding clinical and pathological features of the human infection, the establishment of a small rodent model for the infection, and the virological and immune basis for the severe disease observed in most patients.

Most importantly, we do not know whether a MERS-CoV epidemic is likely or not. Infection with the virus has so far resulted in only 91 cases and 46 deaths (as of 29 July 2013), but it is nonetheless setting off alarm bells among public health officials, including Margaret Chan, Director-General of the World Health Organization, who called MERS-CoV “a threat to the entire world.” This article reviews some of the progress that has been made and discusses some of the questions that need to be answered.

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H5N1 in 2012: The Year in Review

 

 

# 6815

 

For several years now, Laidback Al (Editor–Senior Moderator–& Newshound) on FluTrackers – has published  a terrific overview of the previous year’s global H5N1 activity in early January.

 

You’ll find his 2010, and 2011 summaries here, and here.

 

Today Al has posted another detailed and highly informative analysis of the past year’s H5N1 human cases (complete with his signature charts & graphs).

 

This fine piece of work is a `keeper’, and I’ve already saved it to my desktop as a PDF file. I’m sure I’ll refer to it often over the next year or so, as I have with his earlier efforts. 

 

A few excerpts follow, but use the link and download this entire review.

 

H5N1 in 2012: The Year in Review

Laidback Al, Senior Moderator, www.FluTrackers.com
January 1, 2013

Abstract – In 2012, 32 human cases of H5N1 were reported from around the world, the lowest number of reported human cases since the World Health Organization (WHO) began reporting H5N1 cases in 2003. In 2012, six countries reported cases, Bangladesh, Cambodia, China, Egypt, Indonesia, and Viet Nam. More than 60% of the reported cases died, a slight increase in the fatality rate over 2011. Although there were only 32 cases reported in 2012, five are associated with two clusters. The source of infection for all of the cases has been reported as exposure to sick and dying poultry.

 

Also, in 2012, controversy over H5N1 laboratory experimentation erupted, several genetic studies were published, and seroprevalence results were evaluated. Although fewer cases were reported in 2012 than preceding years, an H5N1 pandemic is still a potential worldwide public health threat.

Background

Influenza A(H5N1) (often referred to “bird flu” or avian influenza or HPAI) is a novel influenza virus. It was first detected in humans in Hong Kong in 1997. Since 2003, the World Health Organization (WHO) has been monitoring human outbreaks of H5N1, because of its potential to become a pandemic virus. The current WHO report on Human infection with avian influenza A(H5N1) viruses and associated animal health events was updated on December 17, 2012. Through December 31, 2012, WHO has officially reported a total of 610 confirmed human cases of H5N1. The most recent WHO time line of significant events associated with the H5N1 virus was last updated on June 15, 2012 (link).

 

The following summary of human cases from 2012 is generally organized according to the outlined presented last year in “A Summary of Human H5N1 Cases in 2011”(FT link). Additional discussions of H5N1 topics from 2012 are also presented in this review.

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Highly recommended.

Why You Should Catch `Contagion’

 

 

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Like a lot of infectious disease geeks, I hurried to the theatre last night (with a good flu buddy, of course) for my first look at Steven Soderbergh’s pandemic thriller `Contagion’. 

 

For those hoping for a typical summer blockbuster – with over-the-top CGI special effects, juvenile plot lines, incessant pyrotechnics, and gratuitous gore – Contagion may fail to impress.

 

 

But for the rest of us . . .  Contagion provides a thought provoking and realistic look the nightmare scenario presented by a severe pandemic. Understated and scientifically plausible, this film is designed to make you `think’ as well as feel. 

 

And 12 hours post-exposure (that’s how one feels after watching), the images and themes of this movie continue to haunt.

 

The movie incorporates plot points reminiscent of China’s SARS outbreak of 2002-2003, the Nipah virus outbreak in Malaysia in 1998, and the less well known Melaka Virus family cluster in Malaysia in 2006. 

 

Like SARS, the movie’s fictional MEV-1 virus is initially passed on to the public via unsanitary restaurant practices, and like Nipah, the virus enters the food chain when, as the movie states, `the wrong bat met up with the wrong pig’.

 

The Maleka virus – which was initially reported in a 2007 PNAS article called A previously unknown reovirus of bat origin is associated with an acute respiratory disease in humans, infected a 39 year old man when a bat flew into their Malaysian home.

 

More than a week after he was placed in isolation, two other members of his family came down with the same illness, suggesting H-2-H transmission. 

 

The authors of this report write:

 

Bats, probably the most abundant, diverse, and geographically dispersed vertebrates on earth, have recently been shown to be the reservoir hosts of a variety of zoonotic viruses responsible for severe human disease outbreaks, some with very high mortality (9).

 

In the period from 1994 to 1999, four new viruses in the family Paramyxoviridae were discovered, and all appeared to have bats as a reservoir host.

You can read more about this case in First Bird Flu, Now Bat Flu. 

 

For more background on the Nipah Virus – which this movie’s MEV-1 virus is patterned after – you may wish to revisit:

 

The Scientific Plausibility of `Contagion’

Bangladesh: Updating The Nipah Outbreak

Bangladesh: Mystery Fever Identified As Nipah

The Nipah Virus: An Emerging Infectious Threat

 

 

While movie’s utilizes a fictional MEV-1 virus (created painstakingly by Professor Ian Lipkin) – to borrow once more from the movie:

 

They really didn’t have to design a new virus, the bats are already doing that.

 

In all likelihood the next pandemic will be sparked by a far less-lethal (but still potentially devastating) influenza virus, but the truth is a high CFR (case fatality ratio) novel pathogen can’t be discounted.

 

But I digress  . . .

 

Soderbergh’s Contagion manages to avoid most of the clichés of the genre. Instead of focusing on gratuitous death and destruction, the more horrific events are seen as part of the passing parade, while scientists and doctors race to find a vaccine.

 

While I come away greatly impressed with this movie, and the respect it gives the science of virology and epidemiology, I do have a few  - mostly minor – quibbles.

 

The number of people infected four months into the pandemic seemed low given the R₀ number (basic reproductive number) of the mutated MEV-1 virus was stated to be 6.

 

And the societal disruptions seemed oddly mixed – with grocery stores looted and empty – but with apparently gas for cars and people still going to the airport.

 

Having the CDC send a single EIS officer (Kate Winslet) to conduct a major epidemiological investigation stretches credulity, but adds to the dramatic plot line.

 

The biggest quibble for me, however, was the speed with which a vaccine is developed, manufactured, and starts to be delivered.

 

We’d need to get very lucky indeed, to have a vaccine for a novel non-influenza pathogen in fewer than 6 months.

 

I’ll pass on taking umbrage over the depiction of Internet bloggers as conspiracy nut jobs, only because that dangerous and vocal contingent does exist.

 

It would have been nice if they could have showed the positive side of Flublogia, but I accept it was only an 106 minute movie.

 

Quite commendably, all of the performances were restrained and believable. No one was tempted to `chew the scenery’, even during the most intense moments of the film.

 

Laurance Fishburne was solid and authoritative as always – yet humanly flawed, Matt Damon handled a difficult scene where he is told of his wife’s death with great aplomb, and Jennfier Ehle literally shone as courageous Dr. Ally Hextall, who risks taking an unproven vaccine she is working on and then exposes herself to the virus. 

 

Despite the high powered Hollywood ensemble cast, the real `star’ of this movie was never seen.

 

Soderbergh wisely focused his lens on the mundane surfaces we touch mindlessly hundreds of times every day – door knobs, credit cards, menus, telephones . . . and our faces  – and resists the urge to show us CGI representations of swarming virus particles.

 

The fact that we never see the virus only builds the paranoia. Suddenly, nothing is benign. Nothing is safe. Everything you touch could be contaminated.

 

While those expecting a post-apocalyptic zombie-virus movie may be disappointed, Contagion proves that it is possible to create an intelligent and effective thriller based on solid science and where the government isn’t always the bad guy.

 

The bottom line: Go see it.

 

Who knows?  

 

If Contagion wins at the box office this summer, perhaps the idea of intelligent movie making will go on to infect other studios.

UK Releases Independent Pandemic Review

 

 

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At 182 pages and released within the past few hours, I haven’t even begun to read it.  There is a lot here to absorb. The report, The 2009 Influenza Pandemic, is a 1 Mb PDF File and is now available to download.

 

The executive summary lists 28 recommendations  which you can find summarized on the GemaTEch Website.

 

28 Recommendations From Government’s Official Pandemic Review

At 11am today the government published an Independent Review of the UK response to the 2009 influenza (swine flu) pandemic.

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SKY News has a report on their website on the costs of the pandemic as listed in this report.  

 

While costly, the authors are calling it a `proportionate response’.

 

Follow the link to read it in its entirety.

 

 

£1.2bn Cost Of Swine Flu Pandemic Revealed

1:55pm UK, Thursday July 01, 2010

Ruth Barnett, Sky News Online

Britain spent more than £1.2bn tackling the swine flu pandemic but the response was proportionate, an independent review has concluded.

The report by Dame Deirdre Hine, a former chief medical officer for Wales, concluded that the UK's response to the outbreak was "effective".

 

However, she said Britain had been left with vaccines against the H1N1 virus which it did not need, due to the lack of flexibility in the contracts the Government signed.

 

 

 

• I think we have got to set these figures, which seem enormous, against the potential for saving lives.  -  Report author Dame Deirdre Hine

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Two Experts Exit WHO Review Panel

 

 

# 4668

 

 

In January of this year the WHO (World Health Organization) announced it would conduct a review of how they handled their pandemic response 

 

While an after-action review is normal and expected, this announcement came amid criticisms launched by the COE (Council of Europe), and recently echoed in the the BMJ, calling the pandemic declaration inappropriate and possibly driven by outside interests.

 

To fend off these attacks the WHO set up an expert panel in April to examine their actions.

 

Robert Roos, News Editor of CIDRAP has details of two members of the review panel who have decided to step down, citing concerns over their being an appearance of having conflicts of interest.

 

 

 

Two who helped WHO's pandemic response quit review panel

Robert Roos News Editor

Jun 22, 2010 (CIDRAP News) – Two experts have resigned from the committee reviewing the World Health Organization's (WHO's) pandemic response because their involvement in the response itself may appear to compromise the independence of the review, the WHO said yesterday.

 

The two experts are Dr. John MacKenzie, an Australian virologist who chairs the WHO Emergency Committee, which has been advising the agency on its pandemic response, and Dr. Anthony Evans, chief of the aviation medicine section at the International Civil Aviation Association, based in Montreal.

 

"Two members have withdrawn from the committee due to their concerns that their close association with the work of WHO during the H1N1 pandemic could be perceived as inconsistent with the Committee's role in providing an independent evaluation of this work," the WHO said in an update on the pandemic review committee's work.

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WHO Begins External Review

 

 

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Today an panel of 29 experts from around the world, convened by the World Health Organization, will begin a lengthy review of what went right . . . and what went wrong, with the world’s response to the H1N1 pandemic. 

 

This pandemic post-mortem comes in the wake of much criticism of the WHO, along with big pharmaceutical companies, by a number of entities, particularly coming out of Europe.

 

Helen Branswell, ace medical reporter for the Canadian Press, brings us the details.  Follow the link to read her coverage in its entirety.

 

Panel of external experts starts review of WHO, international response to H1N1

Provided by: Canadian Press
Written by: Helen Branswell, Medical Reporter, THE CANADIAN PRESS
Apr. 11, 2010

TORONTO - A panel of external experts begins the task Monday of critiquing how the World Health Organization and the international community responded to the H1N1 pandemic.

 

The WHO, which was drawing members of the review committee from a list of experts nominated by countries, has insisted on keeping the roster secret until the work begins.

 

Among the 29 committee members is Dr. Arlene King, Ontario's chief medical officer of health. King, who took over the Ontario job last spring, was for years Canada's point person for pandemic planning at the Public Health Agency of Canada.

 

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