이 중 5100만 달러(약 510억 원) 정도는 식품의약품안전청과 의회 로비를 위해 쓰였고, 2013년 한 해에만 400만 달러(약 40억 원)가 학회 등 의료계를 위해 쓰였고, 500만 달러(50억 원)가 직접적으로 의사들의 여행비, 식사비, 강연비 등으로 지출되었음.

직접적으로 의사들에게 지출된 500만 달러(50억 원)는 2013년 하반기 단 5개월 동안의 지출 액수.

끊이지 않는 제약회사와 정부, 정치인, 의료계와의 검은 거래를 탐사한 보고서

The international response to the influenza pandemic: WHO responds to the critics

Pandemic (H1N1) 2009 briefing note 21

출처 : WHO 10 JUNE 2010
http://www.who.int/csr/disease/swineflu/notes/briefing_20100610/en/index.html

Background

10 JUNE 2010 | GENEVA — On Friday 4 June 2010, the BMJ, formerly British Medical Journal, and the Parliamentary Assembly of the Council of Europe (PACE) simultaneously released reports critical of the World Health Organization’s handling of the H1N1 pandemic. WHO takes the issues and concerns that were raised seriously and wishes to set the record straight on several points.

Is this a genuine pandemic?

The outbreaks of infection with the new H1N1 virus, which have been confirmed in virtually every country and territory in the world, differ from seasonal influenza in distinct ways. These differences meet the criteria for an influenza pandemic.

1. The first human infections with the new H1N1 virus were confirmed in April 2009. Analysis of laboratory samples showed that the new virus had never before circulated in humans. This is a virus of animal origin with a unique mix of genes from swine, bird, and human influenza viruses. The genetic composition of this virus is distinctly different from that of the older H1N1 virus that has been causing seasonal epidemics since 1977.

2. As the virus spread, it demonstrated epidemiological patterns not seen during seasonal epidemics of influenza. Widespread, high levels of infection with the new virus occurred during the summer in the northern hemisphere in multiple countries, followed by even higher levels during the fall and winter months. In countries with a temperate climate, seasonal epidemics typically taper off in the spring and end before summer.

3. The pattern of illness and death caused by the H1N1 virus differed in striking ways from that seen during seasonal influenza. During seasonal epidemics, more than 90% of deaths occur in the frail elderly. The H1N1 virus affected a younger age group in all categories: those most frequently infected, those requiring hospitalization, those requiring intensive care, and those dying from their infection.

A frequent cause of death was viral pneumonia, caused directly by the virus and difficult to treat. During seasonal epidemics, most cases of pneumonia are caused by secondary bacterial infections, which usually respond well to antibiotics. While many of those who died had underlying medical conditions associated with a higher risk, many others who died were previously in good health.

4. The new H1N1 virus rapidly crowded out other circulating influenza viruses and appears to have displaced the older H1N1 virus. This phenomenon is distinctly seen during pandemics.

5. Early studies showed that antibodies to H1N1 seasonal influenza did not protect people from infection with the new virus. This finding provided critical evidence that the virus was new to the human immune system. Later studies in some countries determined that around one third of people older than 65 years had some immunity to the virus. Younger people, however, had no such protective immunity.

Did WHO remove severity from the definition of a pandemic?

WHO regards severity as an important feature of pandemics and a critical factor when deciding on which actions to take. However, WHO has not required a set level of severity as part of its criteria for declaring a pandemic. Experience shows that all pandemics cause excess deaths, that severity can change over time, and that severity can vary according to location and population.

WHO has published three definitions of an influenza pandemic in the context of phases of pandemic alert. These definitions were contained in broader guidelines for pandemic preparedness issued in 1999, 2005 and 2009. Research on influenza pandemics and pandemic viruses increased considerably following the first human cases of infection with the H5N1 avian influenza virus in 1997. Definitions changed over time in line with this evolving knowledge and the need to increase the precision and practical applicability of phase definitions.

The 2009 guidelines, including definitions of a pandemic and the phases leading to its declaration, were finalized in February 2009. The new H1N1 virus was neither on the horizon at that time nor mentioned in the document.

The media make frequent reference to a 2003 document, available on the WHO web site, stating that an influenza pandemic results in “enormous numbers of deaths and illness”. At the time, this was considered a likely scenario should the highly lethal H5N1 avian influenza virus develop an ability to spread readily among humans, but it was never a formal definition.

Did WHO exaggerate the threat?

When WHO Director-General Dr Margaret Chan announced the start of the pandemic, on 11 June 2009, she expressed the view that the pandemic would be of moderate severity. She further noted the relatively small number of deaths worldwide, and clearly stated that “we do not expect to see a sudden and dramatic jump in the number of severe or fatal infections.”

In every assessment of the pandemic, WHO consistently reminded the public that the overwhelming majority of patients experienced mild symptoms and made a rapid and full recovery, even without medical treatment.

WHO also noted, early on, that influenza viruses are unstable and can undergo rapid and significant mutations, making it difficult to predict whether the moderate impact would be sustained. This uncertainty, which persuaded WHO and many national health authorities to err on the side of caution, was further enforced by the behaviour of past pandemics, which varied in their severity during first and second waves of international spread.

Were any WHO pandemic decisions made to increase industry profits?

No. Allegations that WHO declared a pandemic to boost the profits of the pharmaceutical industry arise from WHO’s use of expert advisers and the way declarations of interest from these experts are handled. No evidence of any specific instance of wrongdoing has emerged from recent enquiries.

What safeguards are in place to guard against conflicts of interest?

Potential conflicts of interest are inherent in any relationship between a normative and health development agency, like WHO, and profit-driven industry. Advice from top experts is sought by industry as well as by agencies like WHO that need to issue guidance based on the best expertise. Many experts who advise WHO have ties with industry, and these ties can range from funding to conduct research, to paid consultancies, to participation in conferences sponsored by industry.

WHO has systems in place to protect the Organization from advice biased by commercial interests. WHO requires all expert advisers to declare their professional and financial interests when they participate in advisory groups and consultations. WHO assesses declared interests to determine whether a potential conflict or a potential perception of conflict exists. Where necessary, WHO requests more detailed information and then decides on the appropriate action to be taken.

The publication of summaries of relevant interests following meetings is inconsistent and needs to be made routine. WHO further acknowledges that safeguards surrounding engagement with industry need to be tightened, and is doing so.

What is the function of the Emergency Committee and why have the names of its members not been disclosed?

The International Health Regulations (IHR) contain a set of requirements that are legally binding for WHO and the 194 States Parties of the IHR. The IHR call upon the WHO Director-General to convene an Emergency Committee, drawn from a standing roster of IHR experts, to provide WHO with independent guidance during public health emergencies of international concern, such as an influenza pandemic. The IHR came into force in 2007.

The emergence of the new H1N1 virus prompted the first convening of an Emergency Committee under the IHR. At that time, WHO debated whether or not to publicly disclose the names of members, and faced a dilemma. On one hand, the names of members of other advisory groups are made public after they meet; the identification of persons offering guidance adds transparency to their advice and subsequent WHO decisions. On the other hand, experiences during the SARS outbreak demonstrated the considerable economic and social disruption caused by some public health emergencies, meaning that experts could well be lobbied or pressured for commercial or political reasons, potentially compromising the objectivity of their advice.

After considering these issues, WHO decided to apply its usual practice of disclosing the names of experts after an advisory body has completed its work. The members themselves welcomed this decision as a protective measure, and not as an attempt to veil their deliberations and decisions in secrecy. However, given the duration of the pandemic, the Emergency Committee has held a number of meetings over more than a year, rather than a single meeting like most advisory groups, thus delaying even further the release of the names of its members.

WHO is now fully aware that this decision has fostered suspicion that the Committee might be providing guidance shaped by commercial interests or pressures. Names of members and a summary of relevant declarations of interest will be made public when the Committee advises that the pandemic has ended. Procedures for revealing names of members of future Emergency Committees are under review.

What evidence supports a role for antiviral drugs during an influenza pandemic?

Given widespread population vulnerability to infection, an influenza pandemic presents health authorities with a significant challenge in finding ways to protect populations. From the outset, WHO has recommended a wide range of measures, including hand washing, respiratory hygiene, and not travelling or going to work when ill, and has offered advice on the clinical care of patients and the use of antiviral drugs and vaccines.

At the start of the pandemic, data from the Centers for Disease Control and Prevention (USA) showed that the new virus was sensitive to oseltamivir and zanamivir. Prior to the pandemic, WHO had developed guidelines for the treatment of severe influenza infections caused by the avian H5N1 influenza virus. These two factors allowed WHO to rapidly issue guidelines for use of antivirals in the context of H1N1 pandemic influenza, with emphasis on the treatment and prevention of severe illness.

Over the course of the pandemic, an increasing volume of clinical data has been published in peer-reviewed medical journals. These studies confirm that prompt use of antivirals correlates with improved recovery from illness and fewer deaths. Evidence shows that antivirals have been especially effective for treating patients at increased risk of developing complications from H1N1^[1].

Was a WHO meeting held in 2002 on influenza vaccines and antiviral drugs influenced by industry?

In 2002, WHO convened a consultation with experts to develop a document, WHO guidelines on the use of vaccines and antivirals during influenza pandemics, which was published in 2004. Some critics have alleged that certain experts who participated in the meeting and the drafting of the guidelines had ties with industry interpreted as conflicts of interest. In line with WHO policy, all experts who participated in this meeting were required to submit a declaration of interest form and all such forms were duly reviewed by WHO. However, a summary of relevant interests was not issued together with the publication. WHO regrets this oversight.

Since that time, a number of administrative and legal changes have been implemented to strengthen procedures for addressing potential conflicts of interest that might influence the advice provided to WHO. WHO is committed to tightening these procedures further and ensuring their more consistent application.

^[1] See for example: Siston et al. Pandemic 2009 Influenza A(H1N1) virus illness among pregnant women in the United States. Journal of the American Medical Association, 2010, 303: 1517-1525


===============

WHO 사무총장, `신종플루 음모설’ 부인

| 기사입력 2010-06-08 23:05

(제네바=연합뉴스) 맹찬형 특파원 = 세계보건기구(WHO) 마거릿 찬 사무총장은 8일 신종플루 대유행(pandemic)을 처리하는 과정에서 몇몇 과학자들이 제약회사와 부적절한 유착 관계를 맺었다는 의혹을 강하게 부인했다.

찬 사무총장은 이날 브리티시 메디컬 저널(BMJ)에 보낸 서한을 통해 “어떤 경우에도, 단 한 순간도 내가 의사 결정을 하는 데 있어서 상업적 이해관계를 고려한 적은 없었다”고 말했다.

BMJ는 최근 비영리조사단체인 언론조사국(BIJ)과 공동으로 실시한 조사에서 지난 2004년 WHO의 신종플루 관련 가이드라인 작성에 참여한 과학자 세 명이 대형 제약업체들로부터 이전에 돈을 받은 적이 있었다는 내용의 보고서를 유럽의회를 통해 지난 4일 발표했다.

보고서는 WHO 가이드라인의 저자인 프레드 하이든, 아널드 몬토, 칼 니컬슨 등은 타미플루 제조사인 로슈와 레렌자 제조사인 글락소스미스클라인(GSK)으로부터 다른 사안으로 돈을 지급받은 일이 있으며, 신종플루 대유행을 결정한 WHO의 16인 비상위원회 위원 중에서도 지난해 GSK로부터 돈을 받은 사례가 있다고 폭로했다.

이에 대해 찬 사무총장은 비상위원회에 참여한 전문가들의 이름은 상업적 영향으로부터 보호하기 위해 철저하게 비밀에 부쳐지고 있다고 반박했다.

찬 사무총장은 또 WHO가 신종플루에 대해 과장된 공포를 불러일으켰다는 BMJ 등의 지적에 대해, 자신이 신종플루 대유행을 선언할 때 치사율이 낮다는 점을 분명히 밝혔고 그것이 기록에 남아있다는 점을 강조했다.

하지만 WHO 외부 전문가위원회 위원장인 하비 파인버그 미국 국립의학연구소(IOM) 소장은 지난 7일 BJM의 보고서를 환영한다면서 신종플루 대응 실태를 평가하는 데 있어서 보고서의 내용을 충분히 고려할 것이라고 말했다.

외부 전문가위원회의 최종 검토 보고서는 내년 초에 발간될 예정이며, 제약회사 결탁설 등이 사실로 드러날 경우 큰 파장이 일 전망이다.

mangels@yna.co.kr


====================

WHO ‘신종플루 과잉대응’ 내홍

독립기구 국제보건규정검토위원 2명 사임

오애리기자 aeri@munhwa.com | 문화일보 기사 게재 일자 : 2010-06-23 14:20 http://www.munhwa.com/news/view.html?no=20100623010326320710020

세계보건기구(WHO)가 신종 인플루엔자 A(H1N1·신종 플루) 과잉대응 논란 속에 내홍을 겪고 있다.

22일 AP통신은 신종 플루 대응조치의 타당성을 평가하기 위해 구성된 독립기구인 국제보건규정검토위원회(IHRRC)의 29명 위원 중 2명이 WHO와의 밀접한 관계 때문에 사임했다고 보도했다.

하베이 파인버그 IHRRC 위원장은 이날 발표한 성명을 통해 “그동안 위원으로 활동해온 존 매킨지 박사와 앤서니 에번스 박사가 WHO와의 관계 때문에 IHRRC의 독립성을 훼손할 우려를 피하기 위해 자진사퇴 결정을 내렸다”고 발표했다.

호주 커틴대 교수이자 열대질병 전문가인 매킨지와 국제민간항공기구(ICAO) 의료팀 책임자인 에번스 박사는 지난해 신종 플루가 전세계를 휩쓸었을 당시, WHO의 자문기구인 비상위원회 위원장과 위원으로 각각 활동하면서 가이드라인을 만드는 데 중요한 역할을 했던 인물들이다.

지난 1월 마거릿 챈 WHO 사무총장의 제안에 따라 구성된 IHRRC에 이들이 포함된 것을 두고 전문가들은 “WHO의 대응과정에 대한 객관적 평가가 어려워 면죄부를 줄 가능성이 높다”며 비난해왔다.

최근 영국의 권위있는 의학전문지 브리티시 메디컬 저널(BMJ)은 신종 플루 대처 가이드라인 작성에 관여한 WHO 전문가들 중 일부가 제약사로부터 보수를 받는 등 이해관계에 연루됐던 사실을 폭로해 파장을 일으켰다.

이들이 의약품과 백신의 대량구매를 촉구하는 WHO 권고안에 영향을 주어, 연관된 제약사의 이익을 추가시켰을 가능성이 있다는 것이다. 이에 대해 챈 사무총장은 “WHO 의사결정에 상업적 이해관계가 절대 개입될 수 없다”는 입장을 고수해오고 있다. IHRRC는 내년초쯤 신종 플루에 관한 보고서를 발표할 예정이다.

오애리 선임기자 aeri@munhwa.com

=================

WHO 사무총장, `신종플루 음모설` 없다

출처 :매일경제 2010.06.09 08:59:35 입력 http://news.mk.co.kr/outside/view.php?year=2010&no=296413

세계보건기구(WHO) 마거릿 찬 사무총장은 8일 신종플루 대유행(pandemic)을 처리하는 과정에서 몇몇 과학자들이 제약회사와 부적절한 유착 관계를 맺었다는 의혹을 강하게 부인했다. 찬 사무총장은 이날 브리티시 메디컬 저널(BMJ)에 보낸 서한을 통해 “어떤 경우에도, 단 한 순간도 내가 의사 결정을 하는 데 있어서 상업적 이해관계를 고려한 적은 없었다”고 말했다. BMJ는 최근 비영리조사단체인 언론조사국(BIJ)과 공동으로 실시한 조사에서 지난 2004년 WHO의 신종플루 관련 가이드라인 작성에 참여한 과학자 세 명이 대형 제약업체들로부터 이전에 돈을 받은 적이 있었다는 내용의 보고서를 유럽의회를 통해 지난 4일 발표했다. 보고서는 WHO 가이드라인의 저자인 프레드 하이든, 아널드 몬토, 칼 니컬슨 등은 타미플루 제조사인 로슈와 레렌자 제조사인 글락소스미스클라인(GSK)으로부터 다른 사안으로 돈을 지급받은 일이 있으며, 신종플루 대유행을 결정한 WHO의 16인 비상위원회 위원 중에서도 지난해 GSK로부터 돈을 받은 사례가 있다고 폭로했다. 이에 대해 찬 사무총장은 비상위원회에 참여한 전문가들의 이름은 상업적 영향으로부터 보호하기 위해 철저하게 비밀에 부쳐지고 있다고 반박했다. 찬 사무총장은 또 WHO가 신종플루에 대해 과장된 공포를 불러일으켰다는 BMJ 등의 지적에 대해, 자신이 신종플루 대유행을 선언할 때 치사율이 낮다는 점을 분명히 밝혔고 그것이 기록에 남아있다는 점을 강조했다. [뉴스속보부]

WHO Director-General’s letter to BMJ editors

출처 : WHO Statement  8 June 2010
http://www.who.int/mediacentre/news/statements/2010/letter_bmj_20100608/en/index.html

Below you will find a copy of the letter Dr Margaret Chan, Director-General of the World Health Organization (WHO) sent to the editors of the BMJ, formerly British Medical Journal, in reference to their article on conflicts of interest at the WHO.

To the Editors,

In the editorial accompanying the feature on conflicts of interest at WHO, the author notes that it is “almost certainly true” that the mildness of the H1N1 pandemic, compared with the severity long expected from a virus like H5N1, has contributed to the current critical scrutiny of WHO’s decisions. As the editorial further states, this reality does not make it wrong to ask hard questions.

We fully agree. Good investigative journalism brings problems, and their potential consequences, into sharp focus and identifies the need for remedial action. Potential conflicts of interest are inherent in any relationship between a normative and health development agency, like WHO, and profit-driven industry. WHO needs to establish, and enforce, stricter rules of engagement with industry, and we are doing so. However, let me be perfectly clear on one point. At no time, not for one second, did commercial interests enter my decision-making.

I take issue with the assumption that WHO simply dismisses these hard questions as unfounded. In January 2010, I suggested that a review committee, an independent mechanism under the International Health Regulations, be used to evaluate WHO’s performance during the influenza pandemic. This recommendation was accepted by members of the WHO Executive Board, and the Review Committee’s work began on 12 April 2010. The Committee agreed to address criticism currently being levelled at WHO as part of its evaluation. I have publicly expressed my desire to see a critical, independent, and transparent assessment of WHO’s performance.

The implication that WHO provoked unjustified fear also needs to be addressed. The record is otherwise, and not a matter of interpretation. On 11 June 2009, when I announced the start of the pandemic, I drew attention to the fact that the worldwide number of deaths was small, and clearly stated that we did not expect to see a sudden and dramatic jump in the number of severe or fatal infections. In every assessment of the pandemic, WHO consistently reminded the public that the overwhelming majority of patients experienced mild symptoms and made a rapid and full recovery, even without medical treatment.

Concerning the members of the Emergency Committee that advised WHO on the pandemic, including phase changes, the names will be released when the Committee finishes its work, as has always been intended. Our decision not to make these names public was motivated by a desire to protect the experts from commercial or other influences. The members themselves welcomed this decision as a protective measure, and not as an attempt to veil their deliberations and decisions in secrecy. Records of all Emergency Committee meetings were kept, and these and all other documents pertaining to WHO’s pandemic decisions and actions have been placed at the disposal of the Review Committee.

Without question, the BMJ feature and editorial will leave many readers with the impression that WHO’s decision to declare a pandemic was at least partially influenced by a desire to boost the profits of the pharmaceutical industry. The bottom line, however, is that decisions to raise the level of pandemic alert were based on clearly defined virological and epidemiological criteria. It is hard to bend these criteria, no matter what the motive.

Accusations that WHO changed its definition of a pandemic in order to accommodate a less severe event (and thus benefit industry) are not supported by the facts. The current pandemic preparedness plan, which includes phase definitions, was finalized in February 2009 following two years of consultations. A new strain of H1N1 was neither on the horizon nor mentioned in the document.

A full record and timeline of events leading to the publication of the 2009 plan have been placed at the disposal of the Review Committee. Should this Committee decide that the current definition of a pandemic and the phases leading up to its declaration need to be tightened or otherwise revised, this will be another recommendation that we will welcome, and act on.

Dr Margaret Chan
Director-General
World Health Organization

For further information, please contact:

Christy Feig,
Director of the Department of Communications,
WHO Geneva
Telephone: +41 79 251 70 55
E-mail: feigc@who.int

Gregory Hartl,
Spokesperson for H1N1,
WHO Geneva
Telephone: +41 79 203 6715
E-mail: hartlg@who.int

H1N1 media line:
Telephone: +41 22 791 5000
E-mail: flumedia@who.int

================

WHO 사무총장, ‘신종플루 허위 대유행설’ 강력 부인

“상업적 이해관계를 고려한 적 없다”

뉴스 한국 2010-06-09 11:34:47 [ 황윤경 기자 ]
http://www.newshankuk.com/news/news_view.asp?articleno=t2010060911344719755

WHO의 돼지독감(신종플루) 바이러스 대응을 검토하는 전문가 패널의 대표를 맡고 있는 하비 파인버그 박사가 200명의 패널 조사단 중 29명이 이해관계의 상충에 따라 이 문제를 다룰 것이라는 우려를 밝혔다는 AP통신의 4월 14일자 보도입니다.

하비 파인버그(Harvey Fineberg) 교수 현재 독립적인 비영리 기구인 의학연구소(the Institute of Medicine, http://www.iom.edu/) 소장을 맡고 있습니다. 하버드 의대 학장으로 재직했으며,  미국 국립보건원장을 역임한 바 있습니다. 1976년 미국의 돼지독감 사태에 대해 미 보건복지교육부 보고서 『돼지 독감 사태: 허깨비 전염병에 대한 의사결정과정(The Swine Flu Affair: Decision-Making on a Slippery Disease, U.S. Department of Health, Education, and Welfare)』, (Neustadt, Richard E, Fineberg Harvey V, 1978)의 저자 중의 한 명으로 유명합니다. 

그는 매커릿 찬(Margaret Chan ) WHO 사무총장이 임명하 200명의 조사단 가운데 적어도 10명은 과거나 현재 WHO에 자문을 하였던 적이 있으며, 24명의 위원은 정부에 고용된 적이 있기 때문에 궁극적으로 편향된 성향을 나타낼 수 밖에 없을 것이라는 우려를 밝혔습니다.

런던에 기반을 둔 국제정책네트워크(International Policy Network)라는 단체의 필립 스티븐스(Philip Stevens)도 일반적으로 봤을 때 WHO가 자신의 정책을 재검토하는 위원회에서 결론을 미리 정해놓고 그 결론에 짜맞추는 것 같은 방식으로 일처리를 했던 역사를 가지고 있다는 비파적 견해를 제시했다고 합니다.

결국 이러한 우려들은 ‘WHO의 가짜 신종플루 대유행 스캔들 조사’가 제대로 이루어질 수 없다느 비관적 현실을 반영하는 것이라 생각합니다.

현재 전세계 각국 정부들이 신종플루 위험성을 과대평가하여 지나치게 많은 백신을 주문하여 비축함으로써 사용하지 못한 백신이 너무 많이 남았다는 대중들의 비난이 쇄도하고 있는 상황입니다.

WHO의 권고가 이러한 문제를 초래했는데요, 로슈, GSK,  노바티스 등 다국적 거대 제약회사들의 이윤을 위해 WHO가 가짜 신종플루 대유행 경고를 발령했다는 의혹이 제기되어 조사가 진행되고 있는 상황입니다.

1918년 인플루엔자(속칭 스페인독감)의 대유행으로 5천만명의 사람이 사망한 것에 비해 이번 2009 돼지독감(신종플루) 바이러스에 의한 사망자는 1만8천명에 불과합니다.  해마다 계절성 독감으로 사망하는 사람이 35만명 가량 되었던 사실에 견주어 볼 때, 신종플루는 위험은 지나치게 과장된 것이 틀림없습니다.

WHO는 거대 제약회사와 유착의혹으로 스스로의 권위를 땅에 떨어뜨렸는데요, 결국 이러한 피해는 전세계 가난한 국가의 민중들에게 고스란히 전가될 것입니다.

과연 전세계 어느 누가 가난한 국가들의 질병을 경감시키기 위해 재정적 지원을 요청하는 양치기 소년 WHO의 말을 따르겠습니까?

전문가 조사패널의 보고서는 2010년 5월에 WHO 회원국가들에게 제출될 예정이고, 최종보고서는 내년에 출판될 예정이라고 합니다.

================================

Chair seeks to tackle bias in WHO swine flu review