MinTankesmie

- Legemiddelfirmaer anmodes om å slutte med hemmeligholdelse av resultater i legemiddelforsøk

Pharma firms told to end secrecy in drug trials (Legemiddelfirmaer anmodes om å slutte med hemmeligholdelse i legemiddelforsøk)
nature.com 18.5.2006 (The Nature)
Tidlige testfaser bør gjøres tilgjengelige for publikum, ifølge eksperter i samfunnsmedisin. (Early stages of testing should be made public, say public-health experts.)

Verdens helseorganisasjon (WHO) har avvist anmodninger fra den farmasøytiske industri om å tone ned sine planer om åpenhet rundt legemiddeltesting. (The World Health Organization (WHO) has rebuffed requests from the pharmaceutical industry to tone down its plans for openness in drug testing.)

Industrikonserner hadde bedt om å få utelate detaljer om risiko i kliniske forsøk fra en ny WHO-database, som vil samle informasjon om forsøk rundt omkring i verden og stemple hver studie som godkjennes. De anførte at det å offentliggjøre slike detaljer ville innebære å avsløre forretningshemmeligheter, og at informasjonen kunne misbrukes av desperate pasienter som ønsker å bli friske. (Industry groups had asked for critical details about clinical trials to be omitted from a new WHO database, which will bring together information on trials from around the world and provide each study with a stamp of approval. They argued that making such details public would amount to disclosing commercial secrets, and said that the information could be misused by patients desperate for a cure.)

WHO lar seg fortsatt ikke overbevise av industriens anmodninger. "Vi sa: kom opp med de beste argumentene," sa Ida Sim, ekspert på kliniske forsøk hos WHO som diskuterte organisasjonens plan med industrien. "men det er klart at de beste argumentene ikke er tilstrekkelig til å motsette seg behovet for offentlighet og andre etiske innvendinger." (The WHO remained unconvinced by industry's pleas. "We said: give us your best case," says Ida Sim, a clinical-trials expert at the WHO who discussed the organization's plan with industry. "But it was clear that the strongest case was not sufficient to counter the need for transparency and other ethical arguments.")

Systemet er delvis opprettet fordi store farmasøytiske firmaer er blitt anklaget for å skjule bevis for enkelte nye legemidler, slik som at antidepressiva kan være skadelige. Ved å samle data fra alle kjente forsøk håper WHO å gjøre det vanskeligere for legemiddelfirmaer å begrave forsøk når resultater ikke er som planlagt. (...) (The system is being set up in part because major pharmaceutical firms have been accused of hiding evidence that some new drugs, such as anti-depressants, can be harmful. By bringing together data on all known trials, the WHO hopes to make it harder for drug companies to bury trials when the results do not go as planned.)

Beat Widler er leder for klinisk kvalitetssikring hos Roche, som er et firma hjemmehørende i Basel, Sveits. Han sa at hemmeligholdelse er nødvendig for å stoppe konkurrenter fra å bygge på patentbeskyttet forskning og også forhindre pasienter fra å forsøke å få tilgang til behandlinger før de egnede sikkerhetstester er blitt utført. (Beat Widler is a clinical-quality manager at Roche, headquartered in Basel, Switzerland. He says that the secrecy is necessary to stop rivals from building on proprietary research and also prevents patients from attempting to access treatments before the proper safety tests have been done.)

"Det handler om å vekke falske forhåpninger," forklarer Widler. "Omtrent 80 % av molekyler som er testet kommer aldri på markedet." Han tilla at Roche for nærværende har ingen planer om å imøtekomme WHOs anmodninger på dette punkt. (...) ("It's about eliciting false hopes," Widler explains. "About 80% of molecules that are tested never make it to market." He adds that Roche currently has no plans to comply with the WHO request on this point.)

(Anm: Forskning og ressurser (mintankesmie.no).)

(Anm: Antidepressiva (nytteverdi) (mintankesmie.no).)

- WHO ber om registrering av legemiddelforsøk

WHO urges drug trial registration (WHO ber om registrering av legemiddelforsøk)
bbc.co.uk 19.5.2006
Seks menn ble alvorlig syke etter er forsøk ved Northwick Park Hospital (Six men were left seriously ill after a trial at Northwick Park Hospital)

Verdens helseorganisasjon (WHO) etterlyser økt registrering av kliniske legemiddelforsøk slik at negative resultater ikke kan hemmeligholdes. (The World Health Organization is calling for tighter registration of clinical drug trials so that negative findings cannot be kept secret.)

Verdens helseorganisasjon (WHO) oppfordrer legemiddelfirmaer og forskningsenheter til å registrere alle medisinske studier på mennesker fra starten av. (The WHO is urging drugs firms and research bodies to register all medical studies on humans from the outset.)

For nærværende kan forskerne velge å vente inntil de er godt i gang med sitt arbeide før de rapporterer om resultater. (Currently researchers can opt to wait until they are well advanced in their work before reporting on results.)

Det følger som et resultat av katastrofale legemiddelforsøk ved Northwick Park Hospital i London som gjorde seks menn alvorlig syke. (It follows disastrous drugs trials at London's Northwick Park Hospital which left six men seriously ill.)

Mange leger er bekymret for legemiddelsikkerhet etter en rekke nylige skremmende hendelser. (Many doctors are concerned about drug safety after a string of recent scares.)

En nylig undersøkelse i USA antydet at etter at legemidler, slik som artrittlegemidlet Vioxx som ble fjernet fra markedet på grunn av forhøyet risiko for hjerteanfall, er syv av ti leger mer bekymret omkring forskrivning. (A recent survey in the US suggested that since medicines such as arthritis drug Vioxx were taken off the market because of higher heart attack risks, seven out of 10 doctors were more worried about prescribing.)

Helseorganet med tilhold i Geneve har satt opp en 20 punkts sjekkliste for den type informasjon som skal inkluderes for ethvert registrert forsøk før det starter. (The Geneva-based health body has drawn up a 20-point check list for the kind of information to be included in any registry of trials before they start.)

De planlegger også å gi tilgang til globale legemiddelregistre som drives av selskaper, institusjoner og sykehus, gjennom en ny registerplattform. (It also plans to provide access to drug trial registries run globally by corporations, institutions and hospitals, through a new registry platform.)

Disse ville således måtte imøtekomme visse standarder satt opp av WHO.

Det er håpet at registerplattformen ville gi standardiserte rammer for hva som rapporteres for å registrere et forsøk og lette identifikasjon. (These would then have to meet certain standards set out by the WHO. It is hoped the registry platform would provide standardised framework for what has to be reported to register a trial and ease identification.)

Dr. Timothy Evans, assisterende generaldirektør for WHO, sa: "Registrering av kliniske forsøk og fullstendig åpenhet om nøkkelinformasjon på registreringstidspunkt er grunnleggende for å sikre åpenhet i medisinsk forskning og tilfredsstillende etiske ansvarsforhold for pasienter og studiedeltakere." (Dr Timothy Evans, assistant director general of the WHO, said: "Registration of all clinical trials and full disclosure of key information at the time of registration are fundamental to ensuring transparency in medical research and fulfilling ethical responsibilities to patients and study participants.")

Forretningshemmeligheter (Commercial confidentiality)
Han varslet om at nytt register ikke ville forhindre "uheldige hendelser" knyttet til legemidler og vaksiner, men at det ville gi publikum bedre tilgang til informasjon. (He warned that new register would not prevent "adverse events" associated with drugs and vaccines but that it would provide the public with greater access to information.)

Selv om registrering er frivillig, er presset innen det medisinske samfunn økende hva større åpenhet angår. (Although registration would be voluntary, pressure from within the medical community is growing for greater openness.)

En gruppe redaktører fra 11 prestisjetunge medisinske tidsskrifter, International Committee of Medical Journal Editors, gjør gjeldende at resultater fra kliniske forsøk ikke bør publiseres med mindre forsøket er registrert i et offentlig tilgjengelig register. (A group of editors from 11 prestigious medical journals, the International Committee of Medical Journal Editors, argued that the results of clinical trials should not be published unless the trial had been recorded in a publicly-accessible registry.)

Men noen firmaer opplyste at krav slik som dette ville kunne sette kommersiell og akademisk nytte på spill. (But some firms said requirements such as these could jeopardise commercial and academic advantage.)

Dr. Ida Sim, koordinator for registreringsinitiativet, sa: "Vårt mål er å gjøre klinisk forskning gjennomsiktlig og øke publikums tillit til vitenskap, men vi er opptatt av en rettferdig og åpen prosess for alle interessenter. (Dr Ida Sim, coordinator of the registry initiative, said: "Our aim is to make clinical research transparent and enhance public trust in science, but we are in engaged in a fair and open process with all stakeholders.)

"Vi ser frem til fortsatt dialog om forsøksregistrering og rapportering av resultater idet vi går videre med registerplattformen." (...) ("We look forward to continued dialogue about trial registration and results reporting as we move forward with the registry platform.")

Bulletin of the World Health Organization (BLT) - Rapportering av resultater fra kliniske forsøk: et debattinnlegg

Giving patients better access to trial information (Å gi publikum bedre tilgang til informasjon om forsøk)
Bulletin of the World Health Organization (BLT) 2006;84(6):425-504 (June 2006)
Patients and many other members of the public have much to gain from a global clinical trials registry initiative launched by WHO. On 19 May, WHO unveiled the rules under which pharmaceutical companies and others doing research must disclose 20 sets of data when they register clinical trials they are planning to do (see boxes on pp. 430–431). (...)

Bulletin of the World Health Organization (BLT) - Å gi publikum bedre tilgang til informasjon om forsøk

Reporting the findings of clinical trials: a discussion paper (Rapportering av resultater fra kliniske forsøk: et debattinnlegg)
Bulletin of the World Health Organization (BLT) 2008;86(6):417-496 (June)
When researchers embark on a clinical trial, they make a commitment to conduct the trial and to report the findings in accordance with basic ethical principles. This includes preserving the accuracy of the results and making both positive and negative results publicly available.¹ However, a significant proportion of health-care research remains unpublished and, even when it is published, some researchers do not make all of their results available.² Selective reporting, regardless of the reason for it, leads to an incomplete and potentially biased view of a trial and its results.³ (...)

PUBLIC AVAILABILITY
Clinical trial results should be available to everyone, regardless of where they live. If the results are not made available within a reasonable period, the reasons for delay and a date by which the findings will be available should be submitted to the relevant clinical trials registry. It should be the responsibility of researchers to produce their findings in a format that can be accessed by potential users, and it should be the responsibility of the user to seek these results. The Internet could provide the main means by which this shared responsibility can be satisfied. Access also needs to be considered in terms of the end user’s ability to both view and understand the information obtained. (...)

In the United States of America, such legislation is already in place (available at; http://www.fda.gov/oc/initiatives/HR3580.pdf). This may compromise the ability of researchers to publish trial findings in a peer-reviewed journal. Although some journal editors have acknowledged the changing climate around results registration and reporting (available at: http://www.icmje.org/clin_trial07.pdf), they may have a conflict of interest in that they will probably want the key (and potentially most exciting) messages from a trial to appear first, and perhaps exclusively, in their publication.

CONCLUSION
People making decisions about health care need access to knowledge derived from the findings of clinical trial research. Following on from WHO’s position that all clinical trials must be registered,6 it is proposed that the findings of all clinical trials must be made publicly available. This report is the start of a consultation process on how this goal of transparency can be achieved, with the intention that greater accessibility to the findings of all clinical trials will lead to improvements in health and health care. To contribute to the first phase of the consultation, please visit: http://www.who.int/ictrp/results/consultation. (...)

- Chinese research register joins WHO network, raising hopes for improved clinical trials

Chinese research register joins WHO network, raising hopes for improved clinical trials
Bulletin of the World Health Organization (BLT) 2007;85(9):649-732 (September)
China’s acceptance, along with India, into the new WHO International Clinical Trials Registry Platform will help spur greater transparency and registration of research involving human’s in the world’s most populous country. But much work is needed to bring China’s trial standards up to standard.

But the World Health Organization’s July 2007 addition of recently launched Chinese and Indian registers into its new global clinical trial network has raised hopes that medical research standards would start benefiting from greater scrutiny. (...)

- Nytt WHO-onlineverktøy for å forbedre åpenhet om kliniske forsøk

New WHO online tool to improve clinical trial transparency (Nytt WHO-onlineverktøy for å forbedre åpenhet om kliniske forsøk)
who.int 4.5.2007
GENEVA -- WHO today launched a new web site that will enable researchers, health practitioners, consumers, journal editors and reporters to search more easily and quickly for information on clinical trials. The site works as an entry point or portal into multiple, high quality clinical trial registers with a global search function. (...)

- WHO vill öka öppenheten vid kliniska prövningar

WHO vill öka öppenheten vid kliniska prövningar
Läkemedelsvärlden 2006(7-8 (juli)
Världshälsoorganisationen, WHO, tar nu nästa steg för att öka öppenheten kring kliniska prövningar och startar en webbportal. Enligt WHO:s visioner ska den på sikt ge allmänheten tillträde till information om all forskning på människa.

GRANSKNING Redan för över ett år sedan beslutade European Federation of Pharmaceutical Industries and Associations (EFPIA), till vilket bland annat Läkemedelsindustriföreningen, Lif, och dess medlemmar ingår, att öka öppenheten i kliniska läkemedelsprövningar (se även LMV 6/06, sid 7). Öppenheten gäller en lång rad punkter, som var prövningarna görs, vilken sjukdom det gäller, kön och ålder på deltagare med mera. Den europeiska läkemedelsmyndigheten Emea bygger upp en databas för det syftet, och en liknande finns sedan tidigare i USA.

Men WHO vill ta ytterligare ett steg för ökad öppenhet, och har beslutat att starta en portal, International Clinical Trials Registry Platform, som ska bli en knutpunkt för ett världsomspännande nätverk av register för alla typer av klinisk forskning på människa. Det kan handla om läkemedelsprövningar, men även om exempelvis nya kirurgiska metoder eller psykologiska studier. Också den forskning som bedrivs av universiteten och på sjukhus ska finnas tillgänglig för allmänheten, och för läkemedelsindustrin handlar det om att öppet redovisa prövningar även i fas I, och inte bara fas II och III i enlighet med nuvarande överenskommelser.

- Plattformen ska ange en standard på vad som bör registreras, och vår vision är att såväl företag som nationella och internationella register ansluter sig. Idag finns flera öppna nationella register, bland annat i USA och Sydafrika, och i exempelvis Kina och Indien är register på väg att byggas upp. Vi vill knyta ihop samtliga i ett nätverk och vår portal ska bli en ingång för alla som är intresserade av att få information, säger doktor An-Wen Chan på WHO:s International Clinical Trials Registry Platform i Genève.

Frivillig anslutning
An-Wen Chan menar att det är en rad samverkande faktorer som hänt de senaste åren, som minskat allmänhetens tilltro till framför allt läkemedelsprövningar, och som föranleder WHO att ta det här steget. Han pekar bland annat på turerna kring läkemedlet Vioxx (rofecoxib) som drogs tillbaka från marknaden 2004, och händelsen i London i mars i år då sex personer skadades vid en prövning med en speciell typ av monoklonala antikroppar.

Varje prövning som är länkad till portalen ska redan då den inleds uppfylla 20 punkter i en checklista, med information om sponsor, typ av sjukdom som studeras, vilken substans som prövas et cetera. Via ett tilldelat identifieringsnummer ska besökaren till portalen nå den databas i världen där själva prövningen finns registrerad. WHO ska inte själva föra några prövningsregister.

- Sökportalen ska finnas tillgänglig 2007, men sedan återstår många år innan den är fullt utbyggd. Det finns mycket kvar att göra, inte minst ifråga om kapacitetsuppbyggnad och utbildning i utvecklingsländerna, säger An-Wen Chan.

Anslutningen till WHO:s portal ska vara frivillig. Men beslutet om portalen är ett resultat av diskussioner med industrin, regeringar, patientorganisationer och redaktörer för ledande medicinska tidskrifter, och An-Wen Chan tror att intresset från prövare för att ingå blir stort. För prövarna finns flera fördelar, menar han, bland annat minskar riskerna för att studier dupliceras vilket leder till en effektivare forskning.

Överdriven oro
Det har framförts en viss oro från både industrin och akademin om att WHO:s visioner om öppenhet ska medföra konkurrensnackdelar då information ska redovisas i ett så tidigt skede. Forskare inom universitetsvärlden menar att karriären kan drabbas om nya metoder kopieras och resultat publiceras tidigare av andra, och industrin pekar på risken att kommersiellt känslig information för tidigt avslöjas för konkurrenter. Därför finns olika idéer om att i vissa fall kunna fördröja den öppna redovisningen på någon punkt i checklistan.

Richard Bergström, vd för Lif, tror inte att den risken för industrin ifråga om konkurrensnackdelar är speciellt stor.

- Oron för att man skulle tvingas att röja hemligheter är nog ganska överdriven. Det kommersiellt mest intressanta ofta det som kommer ut vid studier i fas II och fas III, där vi redan idag har överenskommelser om öppenhet, säger Richard Bergström.

- Jag är i stort sett positiv till WHO:s initiativ, och händelsen i England ledde ju till en förnyad debatt som gör den här frågan ännu mer viktig. Vi i Lif medverkar gärna i WHO:s nätverk. Jag är mer tveksam till hur det ska fungera i praktiken. Eftersom det inte är en tvingande medverkan misstänker jag att det främst blir de större företagen som har möjlighet att ingå i nätverket. Läs mer på http://www.who.int/ictrp/. (...)

- WHO innrømmer "inkonsekvenser" i sin politikk på interessekonflikter

Conflicts of Interest and the Future of Financing for WHO
haieuropestaffblog.blogspot.com 18.5.2011
Statement on WHO governance and the Management of Conflicts of Interest and the Future of Financing for WHO.

We write to express our concerns about governance of the World Health Organization (WHO) and other public health bodies, as regards the management of conflicts of interest.

WHO and other public health institutions have complex relations with commercial entities that supply health care products and services. In some cases the commercial entities are subject to or in need of regulation, in order to protect consumers and promote the public interest. Public health institutions are also often engaged in buying goods and services, or providing financial assistance for such purchases.

It is therefore widely recognized that governments and public health institutions like the WHO must avoid conflicts of interest in all aspects of governance. WHO can only respond meaningfully to the challenges of public health through greater transparency and accountability guided by the priorities of Member States and the advance of public interest. However, transparency is a necessary but not sufficient safe guard: there must also be a clear approach and policy to ensure that those representing commercial interests are not part of policy and norm setting decision making. (...)

WHO-eksperter mottok lege-penger
nrk.no 11.8.2010
Eksperter i Verdens helseorganisasjon mottok støtte fra legemiddelindustrien. (...)

5 av 15 eksperter som ga Verdens helseorganisasjon (WHO) råd om svineinfluensaen, har oppgitt at de har mottatt støtte fra legemiddelindustrien.

Ekspertkomiteen ble ledet av den australske professoren John Mackenzie, men navnene på de 14 medlemmene har vært hemmeligholdt fram til nå.

Årsaken var ifølge WHO å beskytte dem fra utidig press fra blant annet legemiddelindustrien mens svineinfluensaen herjet verden.

• Les også: - Svineinfluensaen er over (...)

(Anm: List of Members of, and Advisor to, the International Health Regulations (2005) Emergency Committee concerning Influenza Pandemic (H1N1) 2009 (who.int 12.8.2010).)

Her er WHOs hemmelige svineinfluensaeksperter
vg.no 11.8.2010
(VG Nett) Verdens helseorganisasjon (WHO) har for første gang gått ut med alle navnene i en tidligere hemmelig ekspertgruppe.

WHO har fått kritikk for pandemihåndteringen, og det har vært stilt spørsmål ved om avgjørelsen om å erklære en fullverdig pandemi var riktig.

Listen viser at seks av 16 har oppgitt mulige interessekonflikter. Denne går hovedsakelig ut på at de direkte eller indirekte har hatt finansiell tilknytning til forskjellige legemiddelselskaper.

Tre av dem har hatt tilknytning til GSK, som har laget den første svineinfluensavaksinen, Pandemrix. (...)

GSK for åpenhet
Alle ekspertene som har hatt tilknytning til GSK, har også hatt tilknytning til minst ett annet farmasøytisk selskap.

Administrerende direktør for GSK Norge, Åge Nærdal, sier til VG Nett at han også skulle ha ønsket større åpenhet rundt ekspertene WHO har benyttet. (...)

Professor: Unødvendig pandemi-alarm
aftenposten.no 25.7.2010
Svineinfluensapandemien er ennå ikke over, ifølge WHO-direktør Margaret Chan. Fortsatt er det hemmelig hvem som gir henne råd. Norske eksperter mener det er en gåte hvorfor hun slo full pandemialarm i fjor. (...)

WHO swine flu review committee promises to probe links with drug industry (WHOs evalueringskomite for svineinfluensa lover å granske linker til legemiddelindustrien)
BMJ 2010;341:c36 (7 July)
The chairman of the external expert review committee examining the World Health Organization’s management of the H1N1 pandemic said on 2 July that the panel will probe deeper into allegations that the drug industry may have unduly influenced key outcomes.

Speaking at the end of the second round of hearings at WHO headquarters Harvey Fineberg, the head of the 27 member review committee, told reporters that, "Part of [our] concern is dealing with the accusations of undue influence by pharmaceutical companies on the decisions." (...)

WHO Director-General replies to the BMJ
Margaret Chan, director-general¹
BMJ 2010;340:c3463 (29 June)
In her editorial accompanying the feature on conflicts of interest at the World Health Organization,^{1 2} Godlee 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, such as 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. (...)

Kan vi lenger stole på folkehelsemyndighetene?
Jan Helge Solbakk er professor i medisinsk etikk, UiO og UiB.
morgenbladet.no 18.6.2010
Det omfattende samrøret mellom helseorganisasjonen (WHO) og vaksineprodusentene er nå dokumentert. Vaksineskepsis kan ikke lenger avvises som konspirasjonteori, skriver Jan Helge Solbakk. (...)

3. juni 2010 publiserte det prestisjetunge tidsskriftet British Medical Journal (BMJ) en rapport om disse forholdene (Deborah Cohen, Philip Carter: «Conflicts of Interest: WHO and the pandemic flu 'conspiracies'», British Medical Journal). Rapporten er særdeles lite flatterende lesning for WHO.

Dagen etter presenterte også helsekomiteen i Europarådet sin rapport om WHOs håndtering av svineinfluensaen (Paul Flynn: «The handling of the H1N1 pandemic: more transparency needed»). Også den er knusende i sine konklusjoner.

På en pressekonferanse i Paris samme dag uttalte BMJs sjefredaktør, Fiona Godlee, at WHOs troverdighet nå er så skadet at det kan føre til at organisasjonens nåværende ledelse må ta sine hatter og gå. (...)

WHO admits to "inconsistencies" in its policy on conflicts of interest (WHO innrømmer "inkonsekvenser" i sin politikk på interessekonflikter)
BMJ 2010;340:c3167 (15 June)
The World Health Organization has admitted that its policies governing the publication of conflicts of interests of its expert advisers have "inconsistencies" and that safeguards "surrounding engagements with industry" need to be tightened.

The agency was responding to criticisms of its handling of the swine flu pandemic in an investigation by the BMJ and the Bureau of Investigative Journalism and a report from the Council of Europe published last week. (...)

In a letter to the BMJ Margaret Chan, WHO’s director general, defended the agency’s actions leading up to, during, and following its decision to declare the A/H1N1 flu pandemic in June 2009 (www.bmj.com/cgi/eletters/340/jun03_4/c2912#236800). She said, "At no time, not for one second, did commercial interests enter my decision-making." (...)

Øf øf, sådan tjener man 42 milliarder
politiken.dk 10.6.2010
WHO’s omdømme har taget alvorligt skade af H1N1, skriver Poul Aarøe Pedersen.

I morgen er det præcis ét år siden, at Verdenssundhedsorganisationen, WHO, skred til handling og fuppede en hel verden ved at erklære influenza-epidemien H1N1 for en pandemi, dvs. en global epidemi, den første i 41 år.

Dermed var scenen sat for et skuespil, som i fantasi ikke overgår selv den vildeste konspirationsteori: Ikke alene har det vist sig, at influenzaepidemien ikke blev nær så omfattende og farlig, som WHO-eksperterne forudsagde.

Det har også vist sig, at selvsamme WHO-eksperter var købt og betalt – ja, eller i hvert fald på lønningslisten – hos de to førende vaccinefabrikanter, Roche og GlaxoSmithKline. (...)

WHO Director-General’s letter to BMJ editors (Generaldirektøren i WHO brev til BMJ-redaksjonen)
Statement
who.int 8.6.2010
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 British Medical Journal (BMJ) 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.

Related links -- Editorial: “Conflicts of interest and pandemic flu” BMJ 2010;340:c2947

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. (...)

WHO-kritikk etter svineinfluensaen
nrk.no 4.6.2010
Verdens helseorganisasjons håndtering av svineinfluensaen var sterkt skjemmet av hemmelighold og interessekonflikter med store medisinprodusenter.

Det skriver det medisinske tidsskriftet British Medical Journal (BMJ).

Rapporten er skrevet i samarbeid mellom BMJ og Bureau of Investigative Journalism i London.

- Har brutt egne retningslinjer
Verdens helseorganisasjon (WHO) skal ha brutt sine egne retningslinjer ved å knytte til seg eksperter som samtidig fikk konsulenthonorarer fra de to største produsentene av influensamedisin, Roche og GlaxoSmithKline (GSK). (...)

Troverdigheten svekket
Redaktøren av British Medical Journal, Fiona Godlee, mener WHOs troverdighet er sterkt svekket.
Hun mener WHO kan reparere skaden ved å opplyse om komitémedlemmenes interessekonflikter, og lage strengere regler for samarbeid med den farmasøytiske industrien. På den måten mener hun WHO kan hindre at interessekonflikter skal påvirke avgjørelsene. (...)

Pharma and WHO in the dock over swine flu conflict of interest (Legemiddelindustrien og WHO på tiltalebenken over interessekonflikter angående svineinfluensa)
pharmatimes.com 4.6.2010
Researchers advising the World Health Organisation over preparations for a swine flu pandemic had done paid work for pharmaceutical firms “who stood to gain from the guidance these scientists were preparing”, according to a report released this morning.

The analysis is the result of a joint investigation by the British Medical Journal and The Bureau of Investigative Journalism. It notes that the WHO’s advice led to governments stockpiling billions of dollars of antivirals as part of global pandemic preparedness plans but claims that “despite repeated requests”, the WHO has failed to provide any details about conflict of interests involving the experts consulted “and what, if anything, was done about them”.



The BMJ says its report “echoes a highly critical inquiry by the Council of Europe”, whose findings will also be published later today (full analysis on PharmaTimes World News on Monday), “and will fuel suspicions that the drug industry was able to exert undue influence” on the WHO.

The investigation notes that the WHO’s 2004 guidance on the use of antivirals in a pandemic was prepared by an influenza expert who had received payment from Roche, manufacturers of Tamiflu (oseltamivir) and GlaxoSmithKline, which markets Relenza (zanamivir), for lecturing and consultancy work. That guidance concluded that “countries should consider developing plans for ensuring the availability of antivirals” and that they “will need to stockpile in advance, given that current supplies are very limited". (...)

GlaxoSmithKline Storbritannia svarer

Another question for GSK - WHO and pandemic flu
BMJ 2010;340:c3455 (29 June)
The relation between the declaration of a pandemic and the activation of pandemic vaccine contracts came under considerable attention recently. In the BMJ Cohen and Carter wrote, "It was the declaring of the pandemic that triggered the contracts," ¹ but Nature reports that this is false.² (...)

WHO and the pandemic flu (WHO og influensapandemien)
GlaxoSmithKline UK responds (GlaxoSmithKline Storbritannia svarer)
BMJ 2010;340:c3464 (29 June)
Cohen and Carter explore whether the World Health Organization should have taken advice from experts who had declarable financial and research ties with pharmaceutical companies producing antivirals and influenza vaccines, including GlaxoSmithKline (GSK).¹ Can experts provide advice on public health issues such as pandemic flu, as well as help to develop medicines and vaccines for these same health issues?

It is understandable that WHO and research based pharmaceutical companies would seek the same world experts for their respective purposes. Indeed, expertise could be compromised if those that have worked with industry are not able to advise on public health issues. Similarly, without outside advice the development of drugs to meet patients’ needs and address public health issues would not be possible.

To help manage the potential conflict of interest highlighted by Cohen and Carter, disclosure of financial relationships with industry is clearly important. We agree that transparency over the relationships between industry and healthcare professionals is a must.² (...)

De høye legemiddelkostnadene

The high cost of medicines (De høye legemiddelkostnader)
abs-cbnnews.com 21.6.2006
In the Philippines, there is another cause of high medicine prices, namely, the peculiar practice of using “medical representatives” or drug salespersons to market pharmaceutical products to doctors and hospitals.

The World Health Organization recently released the report of the Commission on Intellectual Property Rights, Innovation and Public Health, a study that may have far-reaching consequences in terms of addressing the lack of access of the world’s poor to important life-saving drugs. The study is revolutionary not because it provides new crucial insights on a problem that has long been borne by the poor particularly in the developing countries, but because it is the first time that a root cause of the problem is being squarely and officially recognized and recommendations are being given to strike at it. (...)

WHO maps out strategy for R&D boost

WHO maps out strategy for R&D boost
pharmatimes.com 11.12.2006
A global strategy to boost the development of medicines to combat diseases that largely affect developing countries and poor people has moved a step nearer with a meeting in Geneva convened by the World Health Organisation.

The Inter-Governmental Working Group on Public Health, Innovation and Intellectual Property was set up earlier this year to address concerns that current R&D efforts are weighted more towards solving the health problems of the prosperous West rather than those, often more life-threatening, diseases which disproportionately hit those living in the developing countries. The group is also examining how poor people can gain better access to medicines. (...)

Å takle dødelig korrupsjon innen farmasøytisk industri

Tackling deadly corruption in Pharma industry (Å takle dødelig korrupsjon innen farmasøytisk industri)
finalcall.com 6.1.2007
DE FORENTE NASJONER (IPS/GIN) - Verdens helseorganisasjon (WHO) påtar seg en av de tøffeste nye oppdrag: tar for seg en mektig motstander i verdens multimilliard-dollar farmasøytisk industri. (UNITED NATIONS (IPS/GIN) - The World Health Organization (WHO) is undertaking one of its toughest new assignments: taking on a powerful adversary in the world’s multibillion-dollar pharmaceutical industry.)

The Geneva-based UN agency, which succeeded in piloting an international convention against the global tobacco industry, says its new initiative is aimed at fighting corruption by promoting greater transparency in the procurement and regulation of medicines.

According to WHO figures, a staggering $50 billion is spent annually on pharmaceutical products— “a market so large that it is extremely vulnerable to corruption.”

“We are aware that corrupt practices take place in various forms in both high- and low-income countries,” says Dr. Guitelle Baghdadi-Sabeti of WHO’s Department of Medicines Policy and Standards. (...)

Profit still trumps public health for ‘Big Pharma’ firms
finalcall.com 8.12.2006
GENEVA (IPS/GIN) - The only concrete result of the 2001 World Trade Organization (WTO) ministerial conference in Doha, Qatar, appeared to be the Declaration on Intellectual Property and Public Health.

But on Nov. 14, the fifth anniversary of the adoption of the agreement that put public health needs above commercial interests, leading global NGOs complained that the declaration has not brought the hoped-for results.

“Rich countries have broken the spirit of the Doha declaration,” said Celine Charveriat, head of Oxfam International’s Make Trade Fair Campaign. (...)

Business with disease: The scourge of prescription drugs
finalcall.com 26.1.2004
(FinalCall.com) - According to a genetics expert from the largest European pharmaceutical corporation in the world, GlaxoSmithKline, 90 percent of drugs only work in 30-50 percent of people. Geneticist Allen Roses said that "drugs in the market work, but they don’t work in everybody." (...)

Activists charge pharmaceutical cartel with being a tool for genocide
finalcall.com 20.1.2004
NEW YORK (FinalCall.com) - "There is an entire industry with an innate economic interest to obstruct, suppress and discredit any information about the eradication of diseases," writes Dr. Mathias Rath MD, a German-based advocate of patients rights and author of the book, "Why Animals Don’t Get Heart Attacks-But People Do." (...)

Pharmaceutical cartel: How does it work?
finalcall.com 4.2.2004
NEW YORK (FinalCall.com) - Perhaps the biggest lie that Americans have bought into is the possibility that there is a pill for every ill, charge critics of the legal drug manufacturing industry. Others say the problem is not just an American one, it is global.

"The people of the world are currently facing one of the largest challenges in human history. The right to health and life for billions of people is being threatened by the financial interests of the largest investment industry on earth—the multi-billion dollar pharmaceutical industry," Dr. Mathias Rath MD, a German physician and activist writes. (...)

"pharmaceutical industry outnumbered those from independent groups by a margin of 2 to 1"

Pharma Links of NGOs in the WHO IGWG process
essentialaction.org 7.11.2007
Essential Action today released a report detailing the brand-name pharmaceutical industry ties of NGOs submitting comments to the second public hearing of the World Health Organization's Intergovernmental Working Group on Public Health, Innovation and Intellectual Property.

The full report is available here: igwg.contributorlinks.rtf

A pdf version of the report is available here: igwg.contributorlinks.pdf

The report finds that, even excluding pharmaceutical trade associations that described themselves as NGOs, NGO submissions from groups with links to the pharmaceutical industry outnumbered those from independent groups by a margin of 2 to 1.

Understanding an organization's ties to affected industries is helpful in assessing the merits of comments submitted. Essential Action urges the WHO in the future to request that all authors disclose their financial ties to corporations, including funding sources and whether the author is a consultant, lobbyist or other representative of private industry. (...)

Diverse artikler

Beneficial drug reactions
BMJ 2012;344:e543 (24 January)
Parle and colleagues highlight some of the many examples of chance findings of beneficial effects of drugs.1 It is already possible to mine pharmacovigilance databases—for example, that of the Uppsala Monitoring Centre, which contains upwards of 6 million reports of suspected reactions pooled from national databases around the world, including the yellow card database of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA). Indeed, Hauben and I have defined a signal of suspected causality in pharmacovigilance as “information that . . . suggests a new potentially causal association, or a new aspect of a known association, between an intervention and an event or set of related events, either adverse or beneficial, which would command regulatory, societal or clinical attention”2; this definition was incorporated, in slightly modified form, into the eighth report of the Council for International Organizations of Medical Sciences (CIOMS).3 One problem in achieving it is that, just as adverse reactions often cannot be predicted at the outset, beneficial reactions are also often unexpected and unpredictable.

Although new indications may be identified through biological or pharmacological plausibility, benefits mediated through other targets are less likely to emerge because new chemical entities are increasingly often intended to affect single targets. If this “targetophilic” approach to drug development were replaced by a systems approach the likelihood of discovering unexpected benefits would be enhanced.4 (...)

WHO vil have færre psykiske sygdomsdiagnoser
b.dk 15.1.2012
Psykiske diagnoser griber om sig og skaber pres på billedet af, hvad der er normalt. WHO er bekymret for sygeliggørelsen.

Verdenssundhedsorganisationen WHO har taget hul på en ømtålelig revision af mere end 200 sygdomskategorier. Det drejer sig bl.a. om depression og ADHD, og målet er at reducere antallet af diagnoser, oplyser leder af projektet, dr. Geoffrey Reed, til Berlingske. Det er første gang, at WHO offentligt taler om projektet, der blandt andet skal imødekomme en - især vestlig - tendens til sygeliggørelse.

»Hvis man som vi har en masse diagnoser, der dækker over et bredt spektrum af menneskelige fænomener i den mindre alvorlige ende, risikerer man at sygeliggøre og medicinere ting, som kan være helt normale følelser og ikke sygelige,« siger Geoffrey Reed.

Med signalet erkender WHO, at antallet af diagnoser har taget overhånd. Resultatet af arbejdet forventes først færdigt i 2015, og endnu er der ikke sat navn eller antal på diagnoser, der skal ud. Men allerede nu kridter WHO banen op i en værdidebat om vores normalitetsbegreb, og Geoffrey Reed bekræfter, at marginalgrænser for diagnoser som depression og ADHD er til diskussion. (...)

Sju miljoner biverkningsrapporter till UMC i Uppsala
lakemedelsvarlden.se 16.12.2011
Uppsala Monitoring Centre, som sköter WHO:s biverkningshantering kring läkemedel, har nu fått in över sju miljoner rapporter till Vigibase-databasen sedan starten 1968.

FARMAKOVIGILANS WHO:s säkerhetsövervakning (farmakovigilans) startade 1968 efter den världsomspännande Neurosedyn-katastrofen. Bara under 2011 har UMC fått in över en miljon rapporter, vilket är den största årliga ökningen någonsin.

– Farmakovigilans handlar om ett ständigt pågående och gnetande arbete med att hitta nya riskgrupper och risksituationer där en förändring av läkemedelsanvändningen skulle göra att problemet kunde undvikas, säger Sten Olsson, chef för WHO:s program för internationell läkemedelsuppföljning vid UMC.

Rapporterna skickas direkt till UMC, via de nationella myndigheterna, från både sjukvården, läkemedelsföretag och patienter. Det handlar om allt från traditionella biverkningar till andra läkemedelsrelaterade problem. (...)

WHO Under Spotlight Over Drug Manual Copyright Dispute
foxnews.com 22.7.2011
Some of Australia's most respected medicine experts, who compiled a doctors' guide to children's drugs published by the world's top health body, were accused of copying dozens of passages from a pre-existing publication, The Australian reported Friday.

The World Health Organization (WHO) launched an investigation into how much material was duplicated from an earlier source in its 528-page WHO Model Formulary for Children.

In a letter sent to the WHO in Geneva, the publishers of the Australian Medicines Handbook (AMH), an independent guide for Australian doctors, said that a comparison turned up 50 instances in which "substantial passages from the WHO Formulary ... are identical to the corresponding passages in the AMH."

"It is difficult to escape the conclusion that the passages referred to were copied from the AMH, especially as we understand the content of the WHO Formulary was prepared in Australia, where the AMH is widely distributed," the letter sent in December said.

The letter also warned the WHO there might be more than 50 examples of copied passages because AMH staff had analyzed only about 60 percent of the WHO guide's pages since being alerted to the problem by an AMH editor who recognized her words in the WHO document.

In the letter, a copy of which was obtained by The Australian, AMH general manager Peter Farrell said that the examples "appear to represent a significant breach of our intellectual property rights." (...)

Copying dispute over drug manual
theaustralian.com.au 22.7.2011
SOME of Australia's most respected medicines experts, who compiled a doctors' guide to children's drugs published by the world's top health body, have been accused of copying dozens of passages from a pre-existing publication.

The World Health Organisation has launched an investigation into how much material has been duplicated from an earlier source in its 528-page WHO Model Formulary for Children.

In a letter sent to the WHO in Geneva, the publishers of the Australian Medicines Handbook, an independent medicines guide for Australian doctors, said a comparison had turned up 50 instances where "substantial passages from the WHO Formulary . . . are identical to the corresponding passages in the AMH".

"It is difficult to escape the conclusion that the passages referred to were copied from the AMH, especially as we understand the content of the WHO Formulary was prepared in Australia, where the AMH is widely distributed," the letter sent last December said. (...)

Letter to the 129th WHO Executive Board on conflicts of interest, WHO reform and the future of financing
keionline.org 24.5.2011
NGO letter on Conflicts of Interest, Future Financing, Reform and governance of the WHO.

Dear Members of the Executive Board,

We appreciate the need for a reform of the World Health Organization (WHO) that involves the reshaping of its financing in order to make it a more effective institution that truly serves the interests of all the member states in their efforts to pursue the highest attainable standard of health. However in so doing, it is important that the nature of WHO as an independent, member state driven institution is assured and reinforced. This will require member states to take an active role in the oversight of both WHO financing and the direction and scope of the reform process. This cannot be left to the WHO secretariat alone or to small informal groups of member states.

We are writing to express our concerns regarding the management of conflicts of interest and the role of private bodies in the financing and the governance of WHO, a multilateral entity and specialized agency of the United Nations (UN) that derives much of its legitimacy from its independence and commitment to serving the public health interests of member states. (...)

Medical errors in top 10 killers: WHO
timesofindia.indiatimes.com 20.4.2011
MUMBAI: Medicine heals, but this fact doesn`t hold true for every 300th patient admitted to hospital. Call it the law of averages or blame human error for it, but the World Health Organization believes that one in 10 hospital admissions leads to an adverse event and one in 300 admissions in death.

An adverse event could range from the patient having to spend an extra day in hospital or missing a dose of medicine, said Dr Nikhil Datar, a gynaecologist and health activist. Unintended medical errors are a big threat to patient safety.

Although there is no Indian data available on this topic, WHO lists it among the top 10 killers in the world. While a British National Health System survey in 2009 reported that 15% of its patients were misdiagnosed, an American study published in the Journal of the American Medical Association in 2000 quantified this problem most effectively. (...)

WHO warns anti-smoking campaigners not to become too close to drug firms
BMJ 2011; 342:d2430 (14 April)
The World Health Organization has warned health professionals working in tobacco control not to become too closely involved with drug companies that produce smoking cessation products.

The warning came last month at a meeting on smoking prevention in Madrid that was hosted by the National Committee to Prevent Smoking, which represents most Spanish anti-tobacco organisations, and which was sponsored by Pfizer, GlaxoSmithKline, and McNeil—all of which make treatments to help smoking cessation.

Armando Peruga, programme manager of WHO’s Tobacco Free Initiative, advised health professionals “to be independent and guided by scientific evidence.”

“We have to keep a distance from the tobacco industry, but we also have to maintain some distance from any other industry that can have a commercial interest in this issue,” he said.

“Today the tobacco industry is starting to joke that we have been sold to the pharmaceutical industry, something we must be aware of,” he added. (...)

WHO Director-General Responds To Draft Report On Agency's Handling Of H1N1 Pandemic
globalhealth.kff.org 29.3.2011
WHO Director-General Margaret Chan on Monday responded to the first results of a probe into the agency's response to the H1N1 (swine flu) pandemic, Agence France-Presse reports. While calling attention to where the external panel committee commended the agency's actions, Chan also addressed the criticisms and recommendations issued in the draft report (3/28). Her comments came as the review committee held its "fourth and final public session" in Geneva to receive "feedback from countries and organizations on its preliminary report," CIDRAP News reports (Schnirring, 3/28). (...)

Good Governance for Medicines
who.int (26.1.2011)
Theft, extortion and abuse …the US$ 5.3 trillion-plus spent on health services

worldwide each year are an obvious target for corruption. In fact, Transparency International estimates that 10 to 25 % of global public health procurement spending is siphoned off and stolen. Life-saving resources are being snatched away from the millions of people that need them most. The pharmaceutical sector, with its US$ 750 billion global market value, is vulnerable to fraud.

The Good Governance for Medicines programme's goal is to improve this situation. Guided by WHO’s Medicines Strategy 2004-2007 and launched in late 2004, the programme is raising awareness of abuse in the public pharmaceutical sector and promoting good governance. Its ultimate aim is to ensure that pharmaceutical spending is not misappropriated and essential medicines reach people - not the black market.

The World Bank has identified corruption as the single greatest obstacle to economic and social development. And as the Good Governance project increases in momentum, more and more public health ministers and national medicines regulatory authorities are taking up the challenge to address it. (...)

WHO Future In Question; Debate Over Industry Representation
ip-watch.org 17.1.2011
A seemingly overworked and impoverished World Health Organization opened its Executive Board session today with calls for reform amid deep concerns about its financial future. Meanwhile, dissension arose over an industry representative named by the WHO secretariat to a new research and development funding working group, sparking the WHO director general to cast doubt on the role of industry in such groups. (...)

Chan, who appeared to be near tears, said the secretariat “diligently” followed the process articulated by the WHA. She demanded to know from members – specifically Thailand – why it would be unacceptable to have a candidate with a pharmaceutical background in the working group and said that it would be naïve to think that all participants in such matters – even the WHO – have no vested interest.

Herrling brings “unique expertise” in this group, she said, and she did not see how “a group of this nature” could totally exclude people with rich experience in the pharma sector. If all people with a pharmaceutical background are unacceptable, in some working groups “we will have nobody,” she said. Two countries proposed that industry representatives such as Herrling should instead be invited to appear before the working group to offer their insights.

Chan’s remark about other working groups prompted commentary afterward among observers that it could be read as an admission that all working groups have conflicts of interest. (...)

Council of Europe condemns "unjustified scare" over swine flu (Europarådet fordømmer "uberettiget skremselspropaganda" over svineinfluensa)
BMJ 2010;340:c3033 (7.6.2010)
The Council of Europe has heavily criticised the World Health Organization, national governments, and EU agencies for their handling of the swine flu pandemic.
The parliamentary assembly of the council—the international organisation that protects human rights and the rule of law in Europe—published a draft of a report that reviewed how the H1N1 pandemic was handled.

National governments, WHO, and EU agencies had all been guilty of actions that led to a "waste of large sums of public money, and unjustified scares and fears about the health risks faced by the European public," says the report.

The conclusion came in the parliamentary assembly’s social, health and family affairs committee report published on 4 June. (...)

The report, The handling of the H1N1 pandemic: more transparency needed, is at: http://assembly.coe.int/CommitteeDocs/2010/20100604_H1N1pandemic_e.pdf (...)

WHO’s Flu Advisors Got Payments From Roche, Glaxo, Report Finds
businessweek.com 4.6.2010
June 4 (Bloomberg) -- Experts who received money from Roche Holding AG and GlaxoSmithKline Plc also served as consultants to the World Health Organization in drawing up plans for dealing with pandemic influenza, the British Medical Journal and the Bureau of Investigative Journalism reported.

The flu expert who recommended using and stockpiling antiviral drugs received payments from Roche, which makes the best-selling antiviral Tamiflu, for lecturing and consulting work when the guidance was produced and published in 2004, according to the report published today in the BMJ. He had also received payments from Glaxo, maker of the second best-selling flu drug Relenza, until 2002, the article said. (...)

Expert panel to view confidential swine flu papers (Ekspertpanel gjennomgår hemmelige sineinfluensadokumenter)
forbes.com 19.5.2010
GENEVA -- An expert panel investigating the World Health Organization's response to last year's swine flu outbreak said Wednesday it wants to see confidential exchanges between the U.N. body and drug companies.

The 29-member panel will seek WHO records and correspondence from before and after the H1N1 strain was declared a pandemic in June, said committee chairman Harvey Fineberg, who is also president of the Institute of Medicine in Washington. (...)

WHO admits shortcomings in handling flu pandemic (WHO innrømmer feil i håndteringen av influensapandemien)
reuters.com 12.4.2010
(Reuters) - The World Health Organization on Monday conceded shortcomings in its handling of the H1N1 swine flu pandemic, including a failure to communicate uncertainties about the new virus as it swept around the globe.

Keiji Fukuda, the WHO's top influenza expert, said the U.N. agency's six-phase system for declaring a pandemic had sown confusion about the flu bug which was ultimately not as deadly as the widely-feared avian influenza. (...)

WHO is accused of "crying wolf" over swine flu pandemic (WHO er anklaget for “å slå falsk alarm” over svineinfluensapandemi)
BMJ 2010;340:c1904 (6 April)
Three separate international inquiries will soon be investigating the World Health Organization’s decision to declare the H1N1 virus a pandemic. The most advanced, being conducted by the Council of Europe, began in January.

Also, support is growing inside the European parliament for members to conduct their own investigation, and WHO itself will set up an independent review committee later this month. (...)

Head of WHO’s vaccines advisory group defends its policy on competing interests
BMJ 2010;340:c987 (17 February)
(...) Asked about a recent case concerning a SAGE member, Juhani Eskola, deputy director general of the Finnish National Institute for Health and Welfare, and the fact that Professor Eskola’s research institution had received research funds from GlaxoSmithKline (BMJ 2010;340:c201, doi:10.1136/bmj.c201), he said that the matter fell under "a non-specific interest," as it concerned the institution and not the person.

"We really investigated the situation to our satisfaction that the person had no benefit and actually was not involved with the settling of the contract," said Dr Duclos. (...)

Hård kritik af WHO's influenza-alarm
politiken.dk 3.2.2010
Overdrev WHO faren ved svineinfluenza? Det mener en række kritikere. (...)

Definition blev ændret
Ifølge den nye definition er en pandemi defineret ved en sygdoms udbredelse og ikke ved dens alvor.

Wolfgang Wodarg henviste på høringen til, at den gamle definition på en pandemi blandt andet fordrede, at der skulle være tale om en ny og værre virus end dem, man allerede kender fra de ordinære udbrud af sæsoninfluenza. (...)

Imidlertid kom kritikken også fra en af WHO's egne folk. Dr. Ulrich Keil, direktør for WHO's center for samarbejde om epidemiologi, kritiserede således WHO for at have »lanceret angstkampagner«. (...)

Vaccinmakare försvarar sig mot kritik
lakemedelsvarlden.se 27.1.2010
Representanter för de stora vaccintillverkarna försvarade sig i går under en offentlig utfrågning. De menar att de inte varit med och skapat en falsk bild av hotet med svininfluensan.

Vid en så kallad publik hearing i Europarådets parlamentariska församling, PACE, på tisdagen nekade läkemedelsindustrin till anklagelser om att de skulle ha spritt en falsk bild av hotet från influensan. Heringen hölls efter att den tyska politikern och epidemiologen Wolfgang Wodarg presenterat misstankar om att industrin påverkat Europas myndigheter. (...)

WHO denies drugs firms swayed its flu decisions
reuters.com 26.1.2010
WHO says its response to flu might have been better

STRASBOURG, France, Jan 26 (Reuters) - The World Health Organisation (WHO) denied on Tuesday that it was unduly influenced by drugs companies to exaggerate the dangers of the H1N1 flu virus.

Pharmaceutical firms picked up multi-million dollar vaccination contracts when the United Nations health agency declared the flu a pandemic last June.

Although many millions around the world have been infected with H1N1, and many thousands have died, the pandemic proved milder than health experts had originally feared.

Accusations from some politicians and media that the WHO relied too much on advice from experts in the pay of the pharmaceutical industry -- who could have a vested interest in dramatising the crisis -- have triggered an internal review by the WHO and an inquiry by the Council of Europe, a European Union human rights watchdog. [ID:nLDE60B16L] (...)

WHO angry at claims swine flu is fake pandemic
pharmatimes.com 14.1.2010
A senior World Health Organisation official has poured scorn on claims that the agency has been influenced by the pharmaceutical industry and overstated the swine flu pandemic.

Keiji Fukuda, special adviser to the WHO director-general on pandemic influenza, told reporters that “the world is going through a real pandemic” and “the description of it as a fake is both wrong and irresponsible”. (...)

Dr Fukuda is not best pleased by that stance, saying that the WHO “has been balanced and truthful in the information it has provided to the public. It has not underplayed and not overplayed the risk it poses to the public”. He added that Dr Wodarg’s allegation that this is not a pandemic “is scientifically wrong and historically inaccurate”, noting that the WHO’s basic definition of the latter “is the same. There is worldwide spread of a disease,” he said.

Dr Fukuda also denied that the agency has been in cahoots with the pharmaceutical sector over H1N1. “Has the WHO been influenced by industry? The answer is, 'no'," he said, adding that to remain free from undue influence it has had in place “routine protections against conflict of interest. This is true for a long time but also during this particular pandemic”. (...)

- Jeg tror ikke WHO har latt seg påvirke
nettavisen.no 8.1.2010
Helseminister Anne-Grete Strøm-Erichsen tok «pandemiskandalen» opp med WHO-sjef Margaret Chan. (...)

- Jeg hadde møte med generalsekretær Margaret Chan. WHO avviser kritikken om at de lot seg påvirke av legemiddelindustrien da de erklærte pandemi i fjor sommer. Jeg forstår også på Chan at WHO er opptatt av åpenhet, og jeg tror ikke WHO har latt seg påvirke, sier Strøm-Erichsen til Nettavisen. (...)

- WHOs influensaplan er en medisinsk skandale
vg.no 6.1.2010
(VG Nett) Sjefen for Europarådets helsekomité mener vaksinebeslutningene rundt svineinfluensapandemien var påvirket av legemiddelindustrien. (...)

- Den falske epidemien var en av tiårets største medisinske skandaler, tordner han, ifølge blant annet bransjebladet Pharma Times og britiske Independent.

Wodarg skal også stå bak en debatt og mulig undersøkelse i helsekomiteen av hvorvidt WHOs dømmekraft har vært påvirket av legemiddelindustrien. Debatten skal foregå denne måneden. (...)

I en artikkel publisert i tungtveiende British Medical Journal nyttårsaften advarer WHO-sjef Margaret Chan mot å tro at pandemien er over.

- Vi må passe oss for likegyldighet, sier hun. (...)

WHO Advisor Secretly Pads Pockets with Big Pharma Money
foodconsumer.org 7.1.2010
A Finnish member of the World Health Organization board, an advisor on vaccines, has received 6 million Euros for his research center from the vaccine manufacturer GlaxoSmithKline.

Although WHO promises transparency, this conflict of interest is not available for the public to see at WHO’s homepage. (...)

According to documents acquired through the Danish Freedom of Information Act, Eskola’s Finnish institute, THL, received almost 6.3 million Euros from GlaxoSmithKline (GSK) for research on vaccines during 2009. GlaxoSmithKline produces the H1N1-vaccine ‘Pandemrix,’ which the Finnish government -- following recommendations from THL and WHO -- purchased for a national pandemic reserve stockpile.

Several other WHO experts also have financial ties to the pharmaceutical industry--a double role that notably is not published by WHO. (...)

Legemiddelindustriens makt i WHO og i Norge - spørsmål nr 216 til skriftlig besvarelse
regjeringen.no 30.11.2009
Det vises til ekspedisjon av 19. november 2009 fra Stortingets president med følgende spørsmål til skriftlig besvarelse fra representanten Geir-Ketil Hansen:
På hvilken måte blir dette tatt opp av regjeringa i WHO, og på hvilken måte jobber regjeringen for å stramme inn overfor legemiddelindustriens makt, i WHO og i Norge? (...)

Experter samarbetar med industrin
svd.se 30.11.2009
PANDEMI. Rader med experter hjälper WHO att hantera hotet från svininfluensan. Men flera av rådgivarna har kopplingar till läkemedels­industrin, visar SvD:s granskning. Kommittén som ger råd om själva pandemin är hemlig. (...)

En central grupp sedan svininfluensans utbrott i våras är WHO:s ”Emergency Committe”. Baserat på information från denna kriskommittée har WHO:s generaldirektör Margaret Chan fattat beslut om olika pandeminivåer. (...)

Vilka är medlemmarna i kommittén?
–Namnen på medlemmarna i kommittén är hemliga. Man vill inte att de ska kunna utsättas för påtryckningar utifrån. De är valda utifrån sina expertkunskaper om influensa, virusspridning och sjukdomskontroll, säger Hartl.

Varför är namnen hemliga? Vilka slags påtryckningar riskerar medlemmarna?

–Jag kan inte gå in på det. Men det viktiga är att medlemmarna i kommittén inte behöver ta hänsyn till någon eller någonting utanför kommittén i sin rådgivning till WHO:s generaldirektör, säger Gregory Hartl.

Har någon medlem i kommittén koppling till eller samarbete med läkemedelsindustrin?

–Jag vet inte vilka medlemmarna är. Jag tror att kontroller görs om de har kopplingar till läkemedelsindustrin.

Bör inte WHO vara transparent när det gäller hur beslut fattas om sjukdomar som berör miljontals människor?

–I kampen mot denna epidemi måste man samarbeta med många parter. Det inkluderar regeringar, frivilligorganisationer och läkemedelsindustrin. Vi måste hitta de bästa lösningarna för att skydda människors liv. Att rädda liv är allra viktigast för oss, säger Gregory Hartl. (...)

Drug industry protests over need to register trial results
BMJ 2009;338:b1652 (22 April)
Drug manufacturers this week expressed their concern about a new requirement of the world’s leading drug trial registry that the outcomes of all clinical trials have to be posted on the register within 12 months of completion of the trial.

Under a US law passed in 2007 ClinicalTrials.gov (www.clinicaltrials.gov), which opened in February 2000, has expanded to include not just the details of trials being set up but also the outcomes of completed trials. The requirement came into effect last September. (...)

Världens största databas för biverkningar i Uppsala
lakemedelsvarlden.se 15.10.2008
Sedan 1978 ligger WHO:s program för internationell rapportering av läkemedelsbiverkningar i Uppsala. Biverkningsdatabasen innehåller fyra miljoner fallbeskrivningar vilket gör den till den största i världen. (...)

Positiva tongångar efter WHO-möte
lakemedelsvarlden.se 28.5.2008
I lördags avslutades WHO:s världsmöte där det bland annat fördes intensiva diskussioner om hur fattiga länder ska få tillgång till läkemedel. Trots stora oenigheter inför mötet enades länderna om ett dokument som ska förändra drivkrafterna för att ta fram nya läkemedel. (...)

Den viktigaste slutsatsen anser Ellen t´Hoen är den att WHO fått mandat att jobba fram alternativa sätt att finansiera nya innovationer inom läkemedelsområdet. Dagens modell, där en innovation betalar sig genom patent som ger dyra läkemedel, innebär ofta ett hinder för fattiga länder. (...)

Misslyckat möte om läkemedel till fattiga
lakemedelsvarlden.se 5.5.2008
Det internationella möte som i förra veckan diskuterade hur världen ska få fram billigare läkemedel till fattiga resulterade inte heller denna gång i några konkreta åtgärder.

globalt En arbetsgrupp från WHO har under två år arbetat med att ta fram förslag på hur man kan främja forskning och utveckling inom medicinska områden som framförallt drabbar fattiga länder. Parallellt med gruppens arbete har man hållit tre internationella möten där förslagen har förhandlats. Det andra mötet hölls i november förra året. Målet var då att enas om en handlingsplan som WHO kunde rösta igenom på nästa World Health Assembly som hålls om några veckor. Men förhandlingarna strandade och länderna kom överens om att ha ytterligare ett möte. (...)

WHO database to include drug trials in China and India
BMJ 2007;335:226-227 (4 August)
Researchers, funders, and patients will soon be able to find out which clinical trials are being held in China and India, the World Health Organization announced last week.

Both countries, which are rapidly becoming key players in medical research, have joined the international network of government backed clinical trial registers, coordinated by WHO.

The network aims to boost accountability and transparency for global health research and to improve the quality of data. (...)