The WHO continues to issue weekly “updates” and briefing notes as below:
Pandemic (H1N1) 2009 – update 75
Weekly update
20 November 2009 –

As of 15 November 2009, worldwide more than 206 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 6770 deaths.

As many countries have stopped counting individual cases, particularly of milder illness, the case count is likely to be significantly lower than the actual number of cases that have occurred. WHO is actively monitoring the progress of the pandemic through frequent consultations with the WHO Regional Offices and member states and through monitoring of multiple sources of data.

Situation update:

The situation remains similar since the last update. In temperate regions* of the northern hemisphere, the early arriving winter influenza season continues to intensify across parts of North America and much of Europe. However, there are early signs of a peak in disease activity in some areas of the northern hemisphere.

More detail at: http://www.who.int/csr/don/2009_11_20a/en/index.html

Pandemic (H1N1) 2009 briefing note 16
Safety of pandemic vaccines
19 NOVEMBER 2009 | GENEVA –

To date, WHO has received vaccination information from 16 of around 40 countries conducting national H1N1 pandemic vaccine campaigns. Based on information in these 16 countries, WHO estimates that around 80 million doses of pandemic vaccine have been distributed and around 65 million people have been vaccinated. National immunization campaigns began in Australia and the People’s Republic of China in late September.

Vaccination campaigns currently under way to protect populations from pandemic influenza are among the largest in the history of several countries, and numbers are growing daily. Given this scale of vaccine administration, at least some rare adverse reactions, not detectable during even large clinical trials, could occur, underscoring the need for rigorous monitoring of safety. Results to date are encouraging.

Common side effects
As anticipated, side effects commonly reported include swelling, redness, or pain at the injection site, which usually resolves spontaneously a short time after vaccination.

Fever, headache, fatigue, and muscle aches, occurring shortly after vaccine administration, have also been reported, though with less frequency. These symptoms also resolve spontaneously, usually within 48 hours. In addition, a variety of allergic reactions has been observed. The frequency of these reactions is well within the expected range.

Guillain-Barre syndrome
To date, fewer than ten suspected cases of Guillain-Barre syndrome have been reported in people who have received vaccine. These numbers are in line with normal background rates of this illness, as reported in a recent study. Nonetheless, all such cases are being investigated to determine whether these are randomly occurring events or if they might be associated with vaccination.

WHO has received no reports of fatal outcomes among suspected or confirmed cases of Guillain-Barre syndrome detected since vaccination campaigns began. All cases have recovered. WHO recommends continued active monitoring for Guillain-Barre syndrome.

Investigations of deaths
A small number of deaths have occurred in people who have been vaccinated. All such deaths, reported to WHO, have been promptly investigated. Although some investigations are ongoing, results of completed investigations reported to WHO have ruled out a direct link to pandemic vaccine as the cause of death.

In China, for example, where more than 11 million doses of pandemic vaccine have been administered, health authorities have informed WHO of 15 cases of severe side effects and two deaths that occurred following vaccination. Thorough investigation of these deaths, including a review of autopsy results, determined that underlying medical conditions were the cause of death, and not the vaccine.

Safety profile of different vaccines
Campaigns are using nonadjuvanted inactivated vaccines, adjuvanted inactivated vaccines, and live attenuated vaccines. No differences in the safety profile of severe adverse events among different vaccines have been detected to date.

Although intense monitoring of vaccine safety continues, all data compiled to date indicate that pandemic vaccines match the excellent safety profile of seasonal influenza vaccines, which have been used for more than 60 years. http://www.who.int/csr/disease/swineflu/notes/briefing_20091119/en/index.html

Pandemic (H1N1) 2009 briefing note 17
Public health significance of virus mutation detected in Norway

20 NOVEMBER 2009 | GENEVA –
The Norwegian Institute of Public Health has informed WHO of a mutation detected in three H1N1 viruses. The viruses were isolated from the first two fatal cases of pandemic influenza in the country and one patient with severe illness.

Norwegian scientists have analysed samples from more than 70 patients with clinical illness and no further instances of this mutation have been detected. This finding suggests that the mutation is not widespread in the country. The virus with this mutation remains sensitive to the antiviral drugs, oseltamivir and zanamivir, and studies show that currently available pandemic vaccines confer protection.

Worldwide, laboratory monitoring of influenza viruses has detected a similar mutation in viruses from several other countries, with the earliest detection occurring in April. In addition to Norway, the mutation has been observed in Brazil, China, Japan, Mexico, Ukraine, and the US.

Although information on all these cases is incomplete, several viruses showing the same mutation were detected in fatal cases, and the mutation has also been detected in some mild cases. Worldwide, viruses from numerous fatal cases have not shown the mutation. The public health significance of this finding is thus unclear.

The mutations appear to occur sporadically and spontaneously. To date, no links between the small number of patients infected with the mutated virus have been found and the mutation does not appear to spread.

The significance of the mutation is being assessed by scientists in the WHO network of influenza laboratories. Changes in viruses at the genetic level need to be constantly monitored. However, the significance of these changes is difficult to assess. Many mutations do not alter any important features of the virus or the illness it causes. For this reason, WHO also uses clinical and epidemiological data when making risk assessments.

Although further investigation is under way, no evidence currently suggests that these mutations are leading to an unusual increase in the number of H1N1 infections or a greater number of severe or fatal cases.

Laboratories in the WHO Global Influenza Surveillance Network closely monitor influenza viruses worldwide and will remain vigilant for any further changes in the virus that may have public health significance.

http://www.who.int/csr/disease/swineflu/notes/briefing_20091120/en/index.html


The World Epidemiological Record (WER) for 20 November 2009, vol. 84, 47 (pp 485–492) includes Epidemiological summary of pandemic influenza A (H1N1) 2009 virus – Ontario, Canada, June 2009.

http://www.who.int/wer/2009/wer8447.pdf

GAVI announced that its impact on the vaccine market is bringing down prices. The announcement was made “just before the GAVI Partners’ Forum, which unites some 400 participants from all over the world including ministers of health, donors, civil society and industry representatives, researchers and development experts.”  GAVI CEO Julian Lob-Levyt said, “This is the ‘GAVI effect’ at work: encouraging and pooling growing demand from countries, attracting new manufacturers and increasing competition to drive down prices. The price drop has come later than we had hoped and it needs to fall further. But this is a clear indication that our market-shaping efforts work.”

The majority of vaccines financed through GAVI is purchased by Alliance member UNICEF. GAVI said that a recent tender for pentavalent vaccine “has shown a significant price drop with the weighted average price for 2010 falling below US$3.00, a decrease of almost 50 cents per dose on the 2009 price. This will create approximately US$55 million in savings in 2010 and enable GAVI to finance the immunisation of 6.3 million more children.  UNICEF Deputy Executive Director Saad Houry commented, “This price drop is no accident, but rather the result of a strategy to leverage the purchasing power of hundreds of millions of people. Clearly, industry understands and responds to a market, regardless of whether that market is in poor or rich countries. The Alliance’s model is beginning to work, and we are optimistic that the trend will continue, as competition and demand increase over time.”

GAVI said its business model is “based on the expectation that rising demand for immunisation in developing countries induces more companies to produce vaccines, thus creating competition and driving prices down. Through the new data, success becomes evident. Whereas in 2001, there was only one company producing the pentavalent vaccine, now there are four. Two are Indian companies, whose products came on the market in 2008. Today, 50% of the vaccines funded by GAVI are from developing country manufacturers.”

At the Hanoi meeting, GAVI Board Chair Mary Robinson noted that progress in immunisation coverage and price decline must be tempered by the fact that more than 20 million children in the world today continue to go without basic life-saving vaccines.

“Our Alliance is not providing charity but rather securing a basic human right, which is the right to equal access to basic standards of health. It is time to recognise that the availability of life-saving vaccines for children worldwide, regardless of where they live, is not a luxury but a fundamental right.”

http://www.businesswire.com/portal/site/home/permalink/?ndmViewId=news_view&newsId=20091117006382&newsLang=en

The GAVI Alliance Board appointed Dr Jaime Sepulveda, Director of the Integrated Health Solutions Development programme at the Bill & Melinda Gates Foundation, as its new Vice-Chair. GAVI said that Dr. Sepulveda will replace Dennis Aitken of the World Health Organization who has retired, and that Daisy Mafubelu, Assistant Director-General for Family and Community Health, will become WHO’s representative on the board. The Bill & Melinda Gates Foundation will be represented by its alternate member. The announcement said that Dr Sepulveda served for more than 20 years in a variety of senior health posts in the Mexican government. From 2003 to 2006, he was director of the National Institutes of Health of Mexico. He also served as Director-General of Mexico’s National Institute of Public Health and dean of the National School of Public Health. In addition to his research credentials, Sepulveda is an experienced implementer of effective health programmes. As Mexico’s Director-General of epidemiology and later Vice-Minister of Health, Sepulveda designed Mexico’s Universal Vaccination Programme, which eliminated polio, measles, and diphtheria by more than doubling childhood immunisation coverage in two years. He also designed a national health surveillance system and founded Mexico’s National AIDS Council. Dr Sepulveda holds a medical degree from National Autonomous University of Mexico and three advanced degrees from the Harvard School of Public Health. He was a recent member of the Board of Overseers of Harvard University and is a member of the Institute of Medicine of the U.S. National Academy of Sciences.

http://www.gavialliance.org/media_centre/statements/2009_11_17_new_vice_chair.php

The MMWR Weekly (November 20, 2009 / 58(45);1270-1274) includes:

Mumps Outbreak — New York, New Jersey, Quebec, 2009
Mumps is a vaccine-preventable viral infection characterized by fever and inflammation of the salivary glands and whose complications include orchitis, deafness, and meningo-encephalitis (1). In August 2009, CDC was notified of the onset of an outbreak of mumps in a summer camp in Sullivan County, New York. The outbreak has spread and gradually increased in size and is now the largest U.S. mumps outbreak since 2006, when the United States experienced a resurgence of mumps with 6,584 reported cases (2). On August 18, public health departments in Sullivan County, New York state, and CDC began an investigation into the mumps outbreak, later joined by departments in New York City and other locales. As of October 30, a total of 179 confirmed or probable cases had been identified from multiple locations in New York and New Jersey (Figure), and an additional 15 cases had been reported from Canada. The outbreak primarily has affected members of a tradition-observant religious community; median age of the patients is 14 years, and 83% are male. Three persons have been hospitalized. Although little transmission has occurred outside the Jewish community, mumps can spread rapidly in congregate settings such as colleges and schools; therefore, public health officials and clinicians should heighten surveillance for mumps and ensure that children and adults are appropriately vaccinated.

Mumps cases in the United States have been classified according to the 2008 case definition of the Council of State and Territorial Epidemiologists,* and cases in Canada have been classified in accordance with Case Definitions for Diseases Under National Surveillance.† Patients in the United States are considered to have age-appropriate vaccinations for mumps if they are aged 1–6 years and have received 1 dose of a mumps-containing vaccine, aged 7–18 years and have received 2 doses of vaccine, or aged 19–52 years and have received 1 dose of vaccine (3,4). Patients aged 7–18 years who have received 1 dose are considered to have received a partially age-appropriate vaccination.

More at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5845a5.htm

The Lancet
Nov 21, 2009  Volume 374  Number 9703  Pages 1723 – 1792
http://www.thelancet.com/journals/lancet/issue/current

Hajj and 2009 pandemic influenza A H1N1
The Lancet

More than 2·5 million Muslims from over 160 countries will be going on Hajj—a pilgrimage to Mecca, Saudi Arabia—this year during Nov 25—30. Such a mass gathering, with up to seven people per m2, increases the risk of spreading infectious diseases, particularly the 2009 pandemic influenza A H1N1.

In The Lancet today, Ziad Memish and colleagues report several recommendations, based on the current status of this pandemic, for provision of the best health services to pilgrims and to keep disease transmission to a minimum among pilgrims and their contacts at home. These recommendations—which are to be put into practice before and during this year’s Hajj—were made after a consultation in Jeddah during June 26—30, 2009, between global agencies at the invitation of the Saudi Arabian Ministry of Health. They are grouped according to screening and isolation; surveillance, epidemiology, and informatics; laboratory testing; infection control; and treatment of the 2009 pandemic influenza A H1N1 infection.

The most important recommendation is that people at risk of infection—such as those older than 64 years, children younger than 5 years, pregnant women, and immunosuppressed individuals—should not go on Hajj this year. However, because Hajj is one of the five pillars of Islam and should be done at least once in a Muslim’s lifetime, individuals will probably not want to postpone after they have spent much time saving money and planning for this purpose. Some of the other recommendations, such as isolation of pilgrims with influenza-like illness, might not only deter individuals from reporting their illness but will undoubtedly also cause them distress and difficulty reuniting with their companions. Improvement of hand hygiene for infection control might be more acceptable than some of the other recommendations because pilgrims should wash before they pray.

These recommendations are a starting point, but they will need to be assessed. Some recommendations might need to be adjusted or discarded as the pandemic develops. However, pandemic influenza A H1N1 alone is understandably unlikely to dissuade many Muslims from going on Hajj.

Establishment of public health security in Saudi Arabia for the 2009 Hajj in response to pandemic influenza A H1N1

ZA Memish, SJN McNabb, F Mahoney, F Alrabiah, N Marano, QA Ahmed, J Mahjour, RA Hajjeh, P Formenty, FH Harmanci, H El Bushra, TM Uyeki, M Nunn, N Isla, M Barbeschi, the Jeddah Hajj Consultancy Group

Public Health
Establishment of public health security in Saudi Arabia for the 2009 Hajj in response to pandemic influenza A H1N1
ZA Memish, SJN McNabb, F Mahoney, F Alrabiah, N Marano, QA Ahmed, J Mahjour, RA Hajjeh, P Formenty, FH Harmanci, H El Bushra, TM Uyeki, M Nunn, N Isla, M Barbeschi, the Jeddah Hajj Consultancy Group

Summary
Mass gatherings of people challenge public health capacities at host locations and the visitors’ places of origin. Hajj—the yearly pilgrimage by Muslims to Saudi Arabia—is one of the largest, most culturally and geographically diverse mass gatherings in the world. With the 2009 pandemic influenza A H1N1 and upcoming Hajj, the Saudi Arabian Ministry of Health (MoH) convened a preparedness consultation in June, 2009. Consultants from global public health agencies met in their official capacities with their Saudi Arabian counterparts. The MoH aimed to pool and share public health knowledge about mass gatherings, and review the country’s preparedness plans, focusing on the prevention and control of pandemic influenza. This process resulted in several practical recommendations, many to be put into practice before the start of Hajj and the rest during Hajj. These preparedness plans should ensure the optimum provision of health services for pilgrims to Saudi Arabia, and minimum disease transmission on their return home. Review of the implementation of these recommendations and their effect will not only inform future mass gatherings in Saudi Arabia, but will also strengthen preparedness efforts in other settings.

The Lancet
Nov 21, 2009  Volume 374  Number 9703  Pages 1723 – 1792
http://www.thelancet.com/journals/lancet/issue/current

Editorials
20 years on: the clinical importance of children’s rights
The Lancet

Preview
During the past week, the Australian Government apologised for the mistreatment of UK children who were resettled in Australia between 1930 and 1970 as part of the child migrants programme; a similar apology from the UK Government is expected. This forced resettlement of 500 000 children is a reminder of their vulnerability. The 20th anniversary on Nov 20 of the UN Convention on the Rights of the Child (CRC) gives an opportunity to reflect on children’s rights today—and the responsibility of health professionals to respect and defend those rights in all settings, including the clinic.

The Lancet Infectious Disease
Dec 2009  Volume 9  Number 12   Pages 719 – 796
http://www.thelancet.com/journals/laninf/issue/current

Preventing the spread of influenza A H1N1 2009 to health-care workers
Leonard A Mermel

The Lancet Infectious Disease
Dec 2009  Volume 9  Number 12   Pages 719 – 796
http://www.thelancet.com/journals/laninf/issue/current

Reflection and Reaction
Influenza vaccination of children
Terho Heikkinen, Ville Peltola

Preview
In this issue of The Lancet Infectious Diseases, Rogier Bodewes and colleagues state that influenza vaccination is beneficial for infants and young children, but at the same time they urge re-evaluation of vaccine recommendations because the inactivated vaccine available at present does not induce heterosubtypic immunity and might make infants more susceptible to pandemic influenza. Although there are numerous immunological mechanisms related to infection with influenza to be discovered, we feel that the conclusions should be put into perspective.

The Lancet Infectious Disease
Dec 2009  Volume 9  Number 12   Pages 719 – 796
http://www.thelancet.com/journals/laninf/issue/current


The Lancet Infectious Disease
Dec 2009  Volume 9  Number 12   Pages 719 – 796
http://www.thelancet.com/journals/laninf/issue/current

Leading Edge
Vaccine safety: informing the misinformed
The Lancet Infectious Diseases

Preview
At the time of going to press, the first major vaccination campaigns to prevent pandemic H1N1 are getting underway. The vaccine might not have been ready in quite the volume hoped; nonetheless, for the production of vaccine in any substantial quantity in such a short time while still providing seasonal vaccine, those involved—the scientist, the pharmaceutical companies, and the chickens that laid the millions of eggs used—should be applauded.

 

New England Journal of Medicine
Volume 361 — November 19, 2009 — Number 21
http://content.nejm.org/current.shtml

Perspective
Mandatory Vaccination of Health Care Workers
A. M. Stewart

Mandatory vaccination of health care workers raises important questions about the limits of a state’s power to compel individuals to engage in particular activities in order to protect the public. In justifying New York State’s regulations requiring health care workers who have direct contact with patients or who may expose patients to disease to be vaccinated against seasonal and H1N1 influenza, New York State Health Commissioner Richard Daines recently argued, “[O]ur overriding concern . . . as health care workers, should be the interests of our patients, not our own sensibilities about mandates. . . . [T]he welfare of patients is . . . best served by . . . very high rates of staff immunity that can only be achieved with mandatory influenza vaccination — not the 40-50% rates of staff immunization historically achieved with even the most vigorous of voluntary programs. Under voluntary standards, institutional outbreaks occur. . . . Medical literature convincingly demonstrates that high levels of staff immunity confer protection on those patients who cannot be or have not been effectively vaccinated . . . while also allowing the institution to remain more fully staffed.”1

Workers at diagnostic and treatment centers, home health care agencies, and hospices are included in New York’s requirement, although workers who can show that they have a recognized medical contraindication to vaccination are exempt. Each facility will have the discretion to determine the steps that unvaccinated health care workers must take to reduce the risk of transmitting disease to patients (see table).
Many health care workers believe that the mandate violates fundamental individual rights and public health policy, and some have filed court actions. In response, one judge ordered a delay in implementing the regulation, and New York’s governor, David Paterson, suspended the requirement so that the limited supply of H1N1 vaccine currently available can be distributed to the populations most at risk for serious illness and death.

The workers argue, first, that compulsory vaccination violates the Fourteenth Amendment in depriving them of liberty without due process. But in 1905, in deciding the smallpox-vaccination case Jacobson v. Commonwealth of Massachusetts, the U.S. Supreme Court recognized that the “police powers” granted to states under the Tenth Amendment authorize them to require immunization. Police powers are government’s inherent authority to impose restrictions on private rights for the sake of public welfare. Thus, health administrators may develop measures that compel individuals to accept vaccinations in order to protect the public’s health.

Such measures include immunization requirements for school entry, which have been enacted by all states and the District of Columbia. These mandates have been shown to be the most effective method of increasing rates of coverage among school-age children and have withstood multiple legal challenges. In 1922, in Zucht v. King (a case regarding an immunization requirement for school entry in San Antonio, Texas), the Supreme Court endorsed these ordinances, finding that they “confer not arbitrary power, but only that broad discretion required for the protection of the public health.”     Opponents of such requirements argue that they are improper on the grounds that they amount to illegal search and seizure under the Fourth Amendment or that they violate either the equal protection clause of the Fourteenth Amendment (“no state shall . . . deny to any person within its jurisdiction the equal protection of the laws”) or the establishment clause of the First Amendment (“Congress shall make no law respecting an establishment of religion”). Yet on the basis of the principles outlined in Jacobson, the judiciary has consistently affirmed that an individual’s right to refuse immunization is outweighed by the community-wide protection conferred by immunization.

Some health care workers in New York have argued that Jacobson does not apply in the case of influenza because there is no health emergency and because the H1N1 influenza virus is not as serious as smallpox. In 2002, in Boone v. Boozman, an Arkansas court heard from opponents of a school-entry requirement for hepatitis B vaccination, who argued that both Jacobson and Zucht were irrelevant because they were decided during declared smallpox emergencies, whereas hepatitis B presented no “clear and present danger.” The court held that “the Supreme Court did not limit its holding in Jacobson to diseases presenting a clear and present danger.” Furthermore, “even if such a distinction could be made, the Court cannot say that hepatitis B presents no such clear and present danger. Hepatitis B may not be airborne like smallpox; however, this is not the only factor by which a disease could be judged dangerous.” The court concluded that “immunization of school children against hepatitis B has a real and substantial relation to the protection of the public health and the public safety.”

Health care workers in New York also argue that because the regulation offers no possibility for religious exemptions, it violates the “free exercise” clause of the First Amendment, which guarantees that government may not interfere with a person’s religious beliefs. But individuals may not engage in activities that threaten important societal interests and expect to be shielded by the First Amendment. When reviewing state initiatives that hinder religious expression, courts weigh the importance of a claim of religious exercise against the state interest. Courts have upheld school-entry vaccination requirements against objections that they infringed on individuals’ religious principles. States have the discretion to determine whether to permit religious exemptions, and Arizona, Mississippi, and West Virginia do not permit such exemptions. Thus, in the absence of a Supreme Court ruling, it is unlikely that the exclusion of a religious exemption from the New York regulation will be considered to be unconstitutional.

The health care workers also argue that the regulation violates the right to “freedom of contract” between employer and employee, as guaranteed by the Fifth and Fourteenth Amendments. However, states are obligated to protect the public welfare, even when doing so affects economic liberty. Furthermore, the Supreme Court has held that states may promulgate regulations restricting liberty of contract in order to protect community health or vulnerable populations.2,3,4 Although New York’s regulation affects employer–employee relationships, it is permissible because promoting patients’ health and safety is a legitimate state interest. Health care workers must receive other vaccinations as a condition of employment, yet they have not challenged those requirements.

The health care workers further claim that the regulation violates the Fourteenth Amendment right of competent adults to bodily autonomy and the right to refuse medical treatment. Yet the right to refuse treatment is not absolute. In determining whether the regulation violates the personal autonomy of health care workers, courts will, once again, balance individual rights against state interests. The state’s power weakens and the individual’s rights strengthen as the degree of bodily invasion increases and the effectiveness of the intervention decreases.5 Courts will consider the extent to which health care workers cause illness and death among patients by exposing them to influenza. Vaccinating health care workers is the most effective means of reducing outbreaks; health care workers are required to submit to the limited intrusion of vaccination in order to protect both themselves and the patients in their care. I believe that the state’s right to compel health care workers to receive vaccinations will supersede their individual rights because of the state’s substantial relation to protection of the public health and safety.

Certainly, courts must take into account Constitutional guarantees of personal autonomy, freedom of contract, and freedom of religion when reviewing the current lawsuits. These rights, however, have been constrained when they conflict with government measures that are intended to protect the community’s health and safety. Health care workers have a profound effect on patients’ health. Although they have the same rights as all private citizens, it is likely that courts will continue to make the health and safety of patients the priority in permitting exceptions to individual rights.

No potential conflict of interest relevant to this article was reported.

Source Information: From George Washington University Medical Center and George Washington University School of Public Health and Health Services, Washington, DC.
This article (10.1056/NEJMp0910151) was published on November 4, 2009, at NEJM.org.

References

Open letter to health care workers from NY State Health Commissioner Richard F. Daines, M.D., September 24, 2009. (Accessed November 2, 2009, at http://www.health.state.ny.us/press/releases/2009/2009-09-24_health_care_worker_vaccine_daines_oped.htm.)

Williamson v. Lee Optical Co., 348 U.S. 483 (1955).

West Coast Hotel Co. v. Parrish, 300 U.S. 379 (1937).

Muller v. Oregon, 208 U.S. 412 (1908).

Cruzan v. Director, Missouri Department of Health, 497 U.S. 261 (1990

PLoS Medicine
(Accessed 22 November 2009)
http://medicine.plosjournals.org/perlserv/?request=browse&issn=1549-1676&method=pubdate&search_fulltext=1&order=online_date&row_start=1&limit=10&document_count=1533&ct=1&SESSID=aac96924d41874935d8e1c2a2501181c#results

Published 17 Nov 2009
The Unintended Consequences of Clinical Trials Regulations
Alex D. McMahon, David I. Conway, Tom M. MacDonald, Gordon T. McInnes

Summary Points
- Trial regulations are damaging noncommercial research and patients.
- The International Conference on Harmonisation (ICH) version of Good Clinical Practice (GCP) is inapplicable to most noncommercial research.
- ICH GCP is not usually legally binding (as conceded by the regulatory authorities in the UK).
- Other parts of the world should learn a lesson from the misguided trial regulations that have been created in Europe.

Science
20 November 2009  Vol 326, Issue 5956, Pages 1029-1148
http://www.sciencemag.org/current.dtl

Intellectual Property:
Research Centers Promise a Break on Medical Patents in Developing Countries
Sam Kean

More than a half-dozen major U.S. universities and institutes pledged last week to lean on biotech companies when licensing intellectual property to secure more favorable terms for countries in the developing world. Harvard, Yale, and Brown universities, the University of Pennsylvania, and the state universities of Oregon and Illinois, as well as the National Institutes of Health and Centers for Disease Control and Prevention, have signed the pledge, which is sponsored by the Association of University Technology Managers.

Vaccine
Volume 27, Issue 51, Pages 7139-7218 (27 November 2009)
http://www.sciencedirect.com/science/journal/0264410X

[This special issue includes 14 papers and an editorial focused on rabies]
Rabies in the 21st Century – A Global Challenge
Edited by William H. Wunner

Pandemic (H1N1) 2009 – update 74
Weekly update

13 November 2009 — As of 8 November 2009, worldwide more than 206 countries and overseas territories or communities have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 6250 deaths. As many countries have stopped counting individual cases, particularly of milder illness, the case count is likely to be significantly lower than the actual number of cases that have occurred. WHO is actively monitoring the progress of the pandemic through frequent consultations with the WHO Regional Offices and member states and through monitoring of multiple sources of data. More discussion at:

http://www.who.int/csr/don/2009_11_13/en/index.html

Clinical management of human infection with pandemic (H1N1) 2009: revised guidance
November 2009
Full document (15 pages) available at: http://www.who.int/csr/resources/publications/swineflu/clinical_management_h1n1.pdf

Summary
This guidance provides updated information for health care providers managing patients with suspected or confirmed pandemic (H1N1) 2009. It incorporates knowledge gained about clinical features of pandemic influenza through international consultations.

Key topics:
- risk factors for severe disease
- signs and symptoms of progressive disease
- diagnosis
- treatment, both outpatient and in hospitals, and
- clinical care for resource-poor settings.

http://www.who.int/csr/resources/publications/swineflu/clinical_management/en/index.html

CDC Estimates of 2009 H1N1 Cases and Related Hospitalizations and Deaths from April-October 17, 2009, By Age Group

Interim planning considerations for mass gatherings in the context of pandemic (H1N1) 2009 influenza

November 2009

Introduction

Mass gatherings are highly visible events with the potential for serious public health and political consequences if they are not planned and managed carefully. There is ample documentation that mass gatherings can amplify and spread infectious diseases.

Respiratory infections, including influenza, have been frequently associated with mass

gatherings. Such infections can be transmitted during the mass gathering, during transit

to and from the event, and in participants’ home communities upon their return.

Planners of mass gatherings face special challenges during a global influenza

pandemic. The purpose of this document is to outline key planning considerations

for organizers of mass gatherings in the context of pandemic (H1N1) 2009 influenza. It

should be used in conjunction with WHO’s Communicable disease alert and response

for mass gatherings.

This document was prepared during September – October 2009 by WHO staff. It was

reviewed by WHO’s Virtual Interdisciplinary Advisory Group on Mass Gatherings. It is

based on currently available information about pandemic (H1N1) 2009 influenza. As the

pandemic situation evolves and additional information becomes available, it may be

necessary to revise the document. Review of the document is planned in the first quarter of 2010.

http://www.who.int/csr/resources/publications/swineflu/cp002_2009-0511_planning_considerations_for_mass_gatherings.pdf