MinTankesmie

- Hvor ofte fremstilles negative forsøk som positive, og hvordan gjøres det?

Industry-paid studies likely to favor company drug (Studier betalt av industrien favoriserer høyst sannsynlig firmaets legemiddel)
reuters.com 2.8.2010
(Reuters Health) - Når legemiddelfirmaene finansierer studier på sine egne produkter er det mye mer sannsynlig at resultatene er positive enn når staten tar regningen, uttalte amerikanske forskere mandag. (- When drugmakers fund studies of their own products, the results are much more likely to be positive than when the government picks up the bill, US researchers said Monday.)

De fant at omtrent 85 prosent av industristøttede studier rapporterte positive resultater, sammenliknet med bare halvparten av de med statlig finansiering. Blant de nesten 550 studier av vanlige legemidler som forskerne undersøkte, var trefjerdedeler av de som hadde blitt publisert i medisinske tidsskrifter støttet av industrien. (They found that about 85 percent of industry-backed studies reported positive outcomes, compared to only half of those with federal funding. Among the nearly 550 studies of common drugs the researchers examined, three-quarters of those that had been published in medical journals had industry backing)

(Anm: Outcome Reporting Among Drug Trials Registered in ClinicalTrials.gov. Ann Intern Med 2010;153:158-166 (August 3).)

Spin found in more than half of abstract conclusions in reports of negative trials (Spin avslørt i mer enn halvparten av konklusjoner i rapportering fra negative forsøk)
BMJ 2010;340:c2873 (2 June)
Short Cuts - All you need to read in the other general journals
JAMA 2010;303:2058-64[Abstract/Full Text]
Hvor ofte fremstilles negative forsøk som positive, og hvordan gjøres det? En studie forsøkte å besvare disse spørsmålene ved å granske alle rapporter av parallelle gruppeforsøk med ikke-signifikante resultater for opprinnelige sluttresultater, som ble publisert i desember 2006 og indeksert i PubMed. I de 72 identifiserte arbeider, 49 (68 %) abstrakter og 44 (61 %) hovedtekster, fant man minst én fordreid presentasjon eller "spin," som ble definert som spesifikke rapporteringsstrategier, uten hensyn til motivet, med det formål å presentere den eksperimentelle behandlingen som nyttig til tross for en ikke-statistisk forskjell i det opprinnelige sluttresultatet, eller målsetning om å lede leseren bort fra ikke-signifikante resultater. (How often are negative trials made to look positive, and how is this done? A study tried to answer these questions by examining all reports of parallel group trials with non-significant results on primary outcomes, which were published in December of 2006 and indexed in PubMed. In the 72 identified papers, 49 (68%) abstracts and 44 (61%) main texts were found to have at least one distorted presentation or "spin," which was defined as the use of specific reporting strategies, regardless of the motive, with the aim of presenting the experimental treatment as beneficial despite a statistically non-significant difference for the primary outcome, or the aim of distracting the reader from statistically non-significant results.)

In 13 articles a spin was found in the title. In abstracts, 27 (38%) results sections and 42 (58%) conclusion sections had at least one spin. In the main texts, this was 21 (29%), 31 (43%), and 36 (50%) for the results, discussion, and conclusions sections, respectively. (...)

Spin kan være tilsiktede forsøk på å villede leseren eller det kan være et resultat av manglende kunnskap eller ikke bevisst bias. (...) (Spins may be a deliberate attempt to mislead the reader or they may be the result of poor knowledge or an unconscious bias.)

(Anm: Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes. JAMA. 2010;303(20):2058-2064. (May 26).)

(Anm: Uredelighet og fusk i medisinsk forskning. (mintankesmie.no/).)

(Anm: bias [baies] -en, - skjevhet i vitenskapelig undersøkelse el. resultat pga. mangelfull systematikk i innsamlingen av data. Etym.: eng., fr. biais helning, tendens. Kilde: ordnett.no.)

(Anm: bias; (...) valg og vurderinger som på systematisk måte avviker fra det som er faktisk korrekt. Kilde: Store norske leksikon.)

Results Are Buried, Study Shows (Resultater begraves, ifølge studie)
newsweek.com 5.8.2010
Results remain unpublished, hard to find.

Investors interested in pharma stocks and patients eager to know if an experimental drug works have one thing in common: they devour stories reporting the results of clinical trials, which assess whether a new drug is safe and effective. Now it turns out they have something else in common: they’re not getting the whole story.

Results from fully one third of the clinical trials of five classes of drugs never see the light of day, finds an analysis published in Annals of Internal Medicine.

The drugs were anticholesteremics, antidepressants, antipsychotics, proton-pump inhibitors (which reduce gastric acid), and vasodilators (which relax blood-vessel walls in order to reduce blood pressure). (...)

Antidepressants like Paxil, shown above, are one of the five classes of drugs for which all clinical trial data are not always available. (...)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

(Anm: Uredelighet og fusk i medisinsk forskning. (mintankesmie.no/).)

- De fleste legemiddelannonser i medisinske tidsskrifter fulgte ikke FDAs retningslinjer

Most Drug Ads Did Not Follow FDA Guidelines (De fleste legemiddelannonser fulgte ikke FDAs retningslinjer)
pharmalot.com 29.8.2011
Last year, the FDA acknowledged the difficulty in policing advertisements aimed at healthcare professionals and consumers by creating its ‘Bad Ad’ program, which the agency recently maintained is having a positive effect (read here). But just how bad were pharmaceutical ads before the FDA launched this program?

To gain some clarity, researchers examined 192 pharmaceutical ads that ran in biomedical journals in November 2008 - less than two years before the ‘Bad Ad’ program began - and found that only 18 percent were compliant with FDA guidelines. And more than half failed to quantify serious risks, including death, according to their study, which was published PLoS One.

To be more specific, of those 192 ads, which were promoting 82 unique meds, only 15 fully adhered to all 20 FDA Prescription Drug Advertising Guidelines (read here). Meanwhile, 57.8 percent of the ads did not quantify serious risks, 48.2 percent lacked verifiable references and 28.9 percent failed to present adequate efficacy quantification. (...)

Many advertised drugs in the sample presented potential risks - 31 contain black box warnings and 33 place patients at risk for death or serious morbidity. And 36 ads, by the way, referenced “data on file” and 40 lacked verifiable references, due either to an absence of any references or to the presence of references only to data on file or the product’s package insert, the researchers found.

Which journals qualified for their review? The Journal of the National Cancer Institute; JAMA; Gastroenterology; Annals of Internal Medicine; Archives of General Psychiatry; Blood; Circulation; Hepatology; Journal of the American College of Cardiology; Journal of Clinical Oncology, and The New England Journal of Medicine (n=35). (...)

“The limited resources of the FDA’s Division of Drug Marketing and Advertising are a major barrier to successful regulation of the pharmaceutical industry’s multi-billion dollar marketing budget,” Deborah Korenstein, lead author of the study and associate professor of Medicine at Mount Sinai School of Medicine, says in a statement (here is the complete study).

(Anm: Legemiddelreklame (legemiddelinformasjon) (mintankesmie.no).)

(Anm: Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing. PLoS ONE 6(8): e23336 (August 17).)

- Hvor pålitelige er vitenskapelige studier?

How reliable are scientific studies? (Hvor pålitelige er vitenskapelige studier?)
The British Journal of Psychiatry (2010) 197: 257-258 (October)
(...) There is growing concern that a substantial proportion of scientific research may in fact be false. A number of factors have been proposed as contributing to the presence of a large number of false-positive results in the literature, one of which is publication bias. We discuss empirical evidence for these factors. (...)

- Forringede medisinske bevis

Evidence debased medicine (Forringede medisinske bevis)
BMJ 2010; 341:c5715 (13 October)
Dagens bevisgrunnlag for nytteverdi og skadelige virkninger for mange behandlinger inneholder mangelfulle og tvilsomme bevis. Denne uken krever Elizabeth Loder og Fiona Godlee at man får saker og ting på plass og presenterer en temautgave av BMJ sent i 2011 for forskning som analyserer ikke fremlagte bevis (doi:10.1136/bmj.c5641). Målet er å gjenopprette tilliten til bevisgrunnlaget, ikke for å rette pekefingre. (doi:10.1136/bmj.c5641). (Our current evidence base on the benefits and harms of many treatments contains incomplete and questionable evidence. This week Elizabeth Loder and Fiona Godlee call for the record to be set straight and announce a BMJ theme issue in late 2011 for research that analyses uncovered evidence (doi:10.1136/bmj.c5641). The aim is to restore trust in the evidence base, not to point fingers.)

This is an early call, but such studies take time because they often depend on freedom of information requests and protracted negotiations with companies. Dirk Eyding, Beate Wieseler, and colleagues from the German Institute for Quality and Efficiency in Health Care (IQWiG) show how it’s done.
Their health technology assessment of the antidepressant reboxetine began in the usual way last year with an extensive literature search for primary and secondary studies (doi:10.1136/bmj.c4737). They found a yawning gap: around 4600 people had taken part in trials of reboxetine, yet adequate data on outcomes had been published for only 1600 or so of the participants (doi:10.1136/bmj.c4942). Over the next seven months the institute issued its preliminary conclusion that no benefit of reboxetine could therefore be proved; Pfizer (the drug’s manufacturer) stated “we provided IQWiG with sufficient data” but then released most of the missing data; and the full assessment showed that, overall, reboxetine had no benefit. At the start, IQWiG had asked the manufacturer to sign an agreement requiring: (1) submission of a list of all sponsored published and unpublished trials investigating reboxetine; (2) submission of documents (generally the clinical study reports) compliant with the CONSORT criteria for all relevant trials selected by IQWiG; and (3) permission for publication of all previously unpublished relevant data. (...)

A theme issue in 2011 on unpublished evidence (En temautgave i 2011 på upubliserte bevis)
BMJ 2011; 342:d2627 (28 April)
The BMJ has long championed efforts to ensure complete publication of clinical trial results. Studies published in the BMJ and elsewhere show that unpublished or selectively reported clinical research findings lead to distorted perceptions of treatment effects.^{1 2} The harm is compounded when the results of individual trials are combined in systematic reviews or meta-analyses. Doctors, patients, and policy makers rely on these evidence syntheses as authoritative summaries of knowledge about clinical questions. But when important evidence is unavailable the conclusions reached by these research summaries may be wrong.

Such evidence syntheses are widely considered to represent the highest form of evidence, but as we have asked in a previous editorial, “is this a tenable world view when so much evidence is missing?”³ The existing flawed clinical evidence base cannot simply be ignored because it forms the basis for future research. The current emphasis on comparative effectiveness research, in which new treatments are compared with established treatments rather than placebo, makes tackling the problem even more urgent. If the evidence base for established treatments is unsound, this has serious implications for the choice of comparators and the findings of such comparative effectiveness studies. (...)

- Manglende medisinske data kan skade pasienter

Missing Medical Data Could Harm Patients (Manglende medisinske data kan skade pasienter)
blogs.scientificamerican.com 4.1.2012
Big clinical trials—to test new drugs or procedures—generate reams of important data about safety and efficacy. Only a fraction of that information sees the light of day, a publishing practice that could put patients at risk, according to a special report published this week in the British Medical Journal (BMJ).

Even though scientific and medical journals are loaded with what might seem like endless reports—and lengthy methodology descriptions–from clinical trails each year, about half of clinical trial results go unpublished, An-Wen Chan, of the University of Toronto’s Women’s College Research Institute, noted in one of the seven new papers in the BMJ special section. Published results typically lack details about how studies were conducted and outcomes for individual participants. Although these particulars might seem negligible or dull to a causal reader, “the overall result is that the published literature tends to overestimate the efficacy and underestimate the harms of a given intervention,” he noted.*

Even major trials for drugs submitted to the U.S. Food and Drug Administration (FDA) contained substantial data holes in their published reports, according to one new analysis. A San Francisco- and Denmark-based team performed meta-analyses that included previously unpublished data for nine drugs that were submitted for FDA approval. With this newly included data, they found that 38 of 41 meta-analyses about these drugs were off: 19 of them overestimated the efficacy of the drug, and 19 of them underestimated it. It can be difficult to get a journal to publish—or a drug company to support publication of—harmful—or null, i.e. “negative”–results from a trial. But, as that paper’s authors noted, “when unfavorable results of drug trails are not published, meta-analyses and systematic reviews that are based only on published data may overestimate the efficacy of the drugs.”

Individual trials are important steps for later analyses—which examine previous studies of the same treatment and are fundamental for determining an intervention’s safety and effectiveness. These important, policy-changing meta-analyses often start with a simple search of the literature through a database such as Medline. But as L. Susan Wieland, of the University of Maryland School of Medicine, and her colleagues reported in their new paper, many of the randomized controlled trials in Medline were not tagged as such. That means reviewers and researchers searching for this key type of trial could miss hundreds of potentially important studies published each year, potentially swaying the final meta-analysis.

In an editorial in the same issue of BMJ, Richard Lehman, of the University of Oxford, and Elizabeth Loder, an epidemiology editor at the journal, called for reform of the “current culture of haphazard publication and incomplete data disclosure.” They advocated for a retroactive disclosure of all clinical trial data as “an important first step towards better understanding of the benefits and harms of many kinds of treatments.” (...)

- Vis oss dataene: hvorfor kliniske resultater betyr noe

Show us the data: why clinical outcomes matter (Vis oss dataene: hvorfor kliniske resultater betyr noe )
Outcomes Data
BMJ 2012;344:e66 (10 January)
The NHS’s use of clinical outcomes data is in its infancy, but accurate and usable measures are crucial to the success of new commissioning groups. Michael Cross maps out the road ahead

Data from the NHS will have a key role in the British government’s plan for national economic recovery. In a well trailed speech last month, Prime Minister David Cameron announced a plan to amend the NHS constitution to make data extracted from health records available for research unless patients actively opt out. Acknowledging “a little bit of controversy” over the issue of confidentiality, he said, “it doesn’t mean anyone can look at your health records, but it does mean using anonymous data to make new medical breakthroughs . . . it is simply a waste to have a health system like the NHS and not to do this kind of thing.” (...)

- Legemiddelindustrien er nå den som svindler staten for mest penger

New image for the drug industry
Drug industry is now biggest defrauder of US government (Legemiddelindustrien er nå den som svindler staten for mest penger)
BMJ 2012;344:d8219 (10 January)
Stephen Whitehead, the new head of the Association of the British Pharmaceutical Industry, thinks that the bad press given to the drug industry is largely undeserved.¹ A paragraph heading calls for collaboration. Facts are clear and this call is frightening because in the US laws exist and are implemented.
Public Citizen has made the diagnosis: “While the defense industry used to be the biggest defrauder of the federal government under the False Claims Act, a law enacted in 1863 to prevent military contractor fraud, the pharmaceutical industry has greatly overtaken the defense industry.” Settlements for criminal and civil monetary penalties reached a total of $20bn (£12.9bn; €15.4bn) during 1991-2010, with three quarters of the settlements and penalties occurring between 2006 and 2010.²

Merck agreed with the US Department of Justice on 22 November 2011 to pay $950m to resolve criminal and civil charges over the promotion and marketing of rofecoxib (Vioxx).³ A few weeks before, GlaxoSmithKline agreed on $3bn to settle civil and criminal investigations into its sales practices for numerous drugs—its fourth case since April 2008. This payment surpassed the previous record of $2.3bn by Pfizer in 2009.⁴

The Foreign Corrupt Practices Act (FCPA; US Bribery Act) is enforced by the Securities and Exchange Commission and the US Justice Department. Recently they have been looking into drug companies’ foreign sales practices. Johnson & Johnson was the first company to pay to resolve FCPA allegations in April 2011 ($70m). Pfizer has just reached agreement in principle to resolve “improper payment” matters outside the US.5 Eli Lilly is close to a settlement. AstraZeneca is working to reach an agreement. Many others are being questioned. (...)

(Anm: Legemiddelindustrien. (mintankesmie.no).)

- For godt til å være sant

For godt til å være sant
Tidsskr Nor Legeforen 2011; 131:2228-9 (15.11.2011)
Overvurdering av effekt, manglende rapportering av komplikasjoner og finansielle transaksjoner er avdekket i det som beskrives som den største skandalen i amerikansk ryggmedisin gjennom tidene.

«Yes, isn’t it pretty to think so,» skrev Ernest Hemingway i The Sun Also Rises.

Det er grunn til å gi honnør til Eugene Carragee, professor i ryggkirurgi ved Stanford University og redaktør av Spine Journal, og hans medforfattere. I en systematisk oversiktartikkel har de kritisk vurdert sikkerhetsprofilen til det beinvekststimulerende preparatet rhBMP-2 (recombinant human bone morphogenic protein-2 (1) over tid, fra de første industrisponsede studiene til senere uavhengige vurderinger av produktet, samt ved en uavhengig gjennomgang av offentlig tilgjengelige forskningsdata. De fant en oppsiktsvekkende mangel på rapportering av komplikasjoner i 13 industrisponsede studier med i alt 780 pasienter. Mens den angitte komplikasjonsraten var 0 % i de publiserte originalstudiene, fant de ved gjennomgang av dokumenter fra FDA (United States Food and Drug Administration) en rate på 10 - 50 %.

Komplikasjoner som kan oppstå ved bruk av rhBMP-2, er løsning av implantat, infeksjon, urogenitale komplikasjoner og retrograd ejakulasjon ved fremre avstivningsoperasjoner i lenderyggen; radikulitt, ektopisk beindanning, beinresorpsjon og dårligere global effekt ved bakre avstivningsoperasjoner i lenderyggen; og i tillegg luftveisobstruksjon ved avstivningsoperasjoner i nakken. (...)

Ortopeder i lommen på industrien
Tidsskr Nor Legeforen 2011; 131:2250-3 (15.11.2011)
Utviklingen av nye ortopediske produkter er avhengig av tett samarbeid mellom ortopedene og industrien. De siste årene er det imidlertid blitt avdekket en rekke tilfeller av økonomisk samrøre mellom industrien og deler av det ortopediske fagmiljø i USA. Dette har aktualisert spørsmålet om i hvilken grad ortopedirelatert forskning og utvikling kan ha vært påvirket av uheldige økonomiske incentiver.

Interessekonflikter oppstår i det øyeblikk ortopeden, eller avdelingen vedkommende arbeider i, oppnår økonomisk fordel av å promotere eller ta i bruk ett bestemt produkt. I sin mest ekstreme form kan det dreie seg om å motta godtgjørelse for konsulentoppdrag, salgsprovisjoner for et produkt man har vært med på å utvikle (royalties), aksjer eller opsjoner i firmaet. I de senere år er det blitt avdekket en rekke eksempler på slike økonomiske koblinger, først og fremst blant ortopeder i USA. Samtidig som samarbeid med industrien er av avgjørende betydning for utvikling, klinisk implementering og evaluering av ortopediske implantater, vil eventuelle interessekonflikter hos samarbeidende ortopeder kunne føre til svekket kvalitetssikring i ett eller flere ledd. Dette kan i så fall tenkes å føre til økt risiko for uheldige behandlingsutfall, også for norske pasienter operert med slikt utstyr. (...)

- Fungerer såkalt ekstern fagvurdering (fagfellevurdering, «peer review»)?

Peer review system needs thorough evaluation, MPs hear (Systemet med fagfellevurdering trenger grundig evaluering, er meldingen til parlamentsmedlemmer)
BMJ 2011; 342:d3046 (16 May)
The peer review system used by many medical journals before they publish new research needs to be thoroughly evaluated to confirm its value, MPs have been told.

Several medical and scientific journal editors appearing before the parliamentary science and technology select committee on 11 May spoke of the many merits of peer review, but they raised some concerns about the variability of its quality and a lack of adequate evaluation of the system.

The committee was holding the second oral evidence session as part of its inquiry into the peer review process in science (BMJ 2011;342:d2858 doi:10.1136/bmj.d2858).

Experts deny claims that peer review system is in crisis (Eksperter benekter påstander om at systemet med fagfellevurdering (peer review) er i krise)
BMJ 2011; 342:d2858 (5 May)
Experts have defended the peer review system used by many medical journals before publishing new research and denied claims that it is in “crisis.”

Witnesses appearing before the parliamentary science and technology select committee on 4 May said the system was not perfect but worked well and helped to maintain the public’s trust in science.

MPs on the committee were holding their first oral evidence session as part of their new inquiry into the current state of the peer review process in science. They were prompted to look into peer review by several factors, said a spokeswoman, including the leaked emails on climate change from the University of East Anglia and the Lancet study by Andrew Wakefield. (...)

MPs asked if fraudulent or incorrect papers damaged the public’s perception of the peer review process, to which Professor Laskey replied: “It damages the public perception of science as a whole which is extremely unfortunate.”

Andrew Miller, Labour MP for Ellesmere Port and Neston and chair of the committee, said some written evidence received so far by the MPs said peer review had a tendency to produce “conservative judgments” and wondered if that was a problem for the progression of science.

John Pethica, physical secretary and vice-president at the Royal Society, also giving evidence, said: “There is always a risk in this process that new ideas may be impeded. It has to be balanced against the fact that the likelihood of really radical breakthroughs is unfortunately rather smaller than exotic ideas that don’t actually work. It’s a difficult balance to achieve.”

The inquiry continues. (...)

Is open peer review the fairest system? Yes
BMJ 2010; 341:c6424 (16 November)
Trish Groves argues that telling authors who has reviewed their paper has helped to make the process fairer, but Karim Khan (doi:10.1136/bmj.c6425) is concerned that it stops reviewers from being completely frank (...)

Why didn’t we adopt double blind review, withholding reviewers’ names and also removing authors’ identity from reviewed articles? Firstly, because evidence, including that from randomised controlled trials, had found no benefit of such blinded review.¹ More importantly, the BMJ’s editors felt strongly that withholding reviewers’ names was an unfair and kafkaesque system that seriously limited transparency. We hoped that unmasked reviewers would rise to the challenge and act as critical friends, unafraid of face to face (virtual) scientific discourse. Dream on, said the critics: if you ask reviewers to sign their reports they will perch on the fence and blandly say nothing much. They were wrong, as a BMJ randomised controlled trial² and now more than a decade’s experience have shown. (...)

Is open peer review the fairest system? No
BMJ 2010; 341:c6425 (16 November)
Trish Groves (doi:10.1136/bmj.c6424) argues that telling authors who has reviewed their paper has helped to make the process fairer, but Karim Khan is concerned that it stops reviewers from being completely frank

Open peer review makes perfect sense in the ideal world. But it is not an ideal world. As editor of a BMJ Group specialist journal, I am concerned that open review provides more scope for power relationships to favour “the great and the good.” (...)

Journals Should Set Tougher Standards, Editors Say (Redaktør sier at tidsskrifter bør sette tøffere standarder)
medpagetoday.com 26.3.2010
Editors of medical journals should unite in requiring independent statistical analyses of industry-sponsored clinical trials, according to the two top editors of the Journal of the American Medical Association.

Such a measure would help prevent any inappropriate influence from the study sponsors on data analysis and reporting, wrote Catherine DeAngelis, MD, MPH, editor-in-chief of JAMA, and Phil Fontanarosa, MD, MBA, executive deputy editor of the journal, in an editorial.

"This approach would add powerful support to the fundamental principle that physicians must first do no harm," they wrote in an editorial in the March 24/31 issue of JAMA.

Steven Nissen, MD, of the Cleveland Clinic, agreed in a commentary in the same issue.

"Although this procedure does not guarantee the integrity of the resulting manuscript, it is an essential step and should be universally mandated," he wrote. "If all journals adopted such a policy, the quality of reporting of industry-sponsored clinical trials would be significantly improved." (...)

(Anm: Ensuring Integrity in Industry-Sponsored Research
Primum Non Nocere, Revisited. JAMA. 2010;303(12):1196-1198.)

Når forskere bedømmer forskere
videnskab.dk 21.9.2009
TEORIBLOGGEN: Hvad afgør, om et givent forskningsprojekt er ’god videnskab’? Teoribloggen går i dag bag om peer review-begrebet, og ser på konceptets opståen – og dets svagheder.

Peer review eller fagfællebedømmelse, som det hedder på dansk, består i nogle få, ret enkle metoder til at evaluere videnskabelige meritter.

Peer review bliver fortrinsvis brugt i vurderingen af videnskabelige artikler og forskningsansøgninger.

Eftersom publikationer og bevillinger er altafgørende for at fremme forskeres egen videnskabelige karriere, er peer reviewet af helt grundlæggende betydning for forskningen og for forskerne. (...)

De fleste forskere priser peer review, ofte som det mindst ringe kvalitetssikringssystem. Mange vil dog også anerkende, at der er problemer forbundet med peer review. (...)

Den første dokumenterede anvendelse af noget, der har mindelser om moderne peer review, finder man i en bog om lægeetik skrevet af den arabiske forfatter Ishap bin Ali Al Rahwi. Han levede år 854-931.

Bogen angiver retningslinjer for, hvordan læger bør udlevere kopier af noter og diagnoser til det lokale lægeråd, som efterfølgende kan gennemføre en faglig bedømmelse af lægernes arbejde (Spier 2002). (...)

Kritikk uten hemninger
P Aavitsland
Tidsskr Nor Legeforen 2008; 128:1377 (12.6.2008)
Tidsskriftets eksterne fagvurderere hjelper forfatterne med å forbedre manuskriptet og redaktøren med å treffe en beslutning om publisering

God vitenskap vokser best der den utsettes for uhemmet kritikk. Tidsskriftets ordning med ekstern fagvurdering (fagfellevurdering, «peer review») er en tilrettelegging for kritikk uten hemninger. (...)

Ekstern fagfellevurdering er vitenskapelige tidsskrifters kjennetegn. For Tidsskriftet er fagvurderernes bidrag, som er ubetalt, en forutsetning for kvaliteten - ved at nokså gode manuskripter blir forbedret og svake manuskripter ikke blir publisert. Fagvurderer, medisinsk redaktør og forfatter danner en troika med det mål å få frem en artikkel med et innhold som er nytt og relevant for Tidsskriftets lesere, en artikkel som bygger på sunn vitenskap, som er presentert på en tiltrekkende måte og som er innenfor reglene for forskning og publisering. (...)

For Sciences Gatekeepers, a Credibility Gap (Et troverdighetsgap for vitenskapens portvakter)
THE DOCTOR'S WORLD (LEGENES VERDEN)
nytimes.com 2.5.2006
Nylige avsløringer om uredelige eller uriktige studier publisert i medisinske og vitenskapelige tidsskrifter har medført at det som aldri før stilles spørsmål ved fordelene ved systemet med fagfellevurdering. (Recent disclosures of fraudulent or flawed studies in medical and scientific journals have called into question as never before the merits of their peer-review system.)

(Anm: peer-review; fagfellevurdering, på engelsk peer review, er en metode for å vurdere riktighet og verdi av forskningsrapporter ved budsjettering før forskningsprosjekter får starte og ved publisering av resultater i tidsskrifter. Kilde: wikipedia.org. Tidsskr Nor Lægeforen 2006;126:3327.)

Systemet er basert på at tidsskrifter inviterer uavhengige eksperter til kritisk å bedømme innsendte manuskripter. Det erklærte mål er å luke ut slurv og dårlig forskning, for å sikre integriteten på det som blir publisert. (The system is based on journals inviting independent experts to critique submitted manuscripts. The stated aim is to weed out sloppy and bad research, ensuring the integrity of the what it has published.)

På grunn av at resultater publisert i fagfellevurderte tidsskrifter påvirker pasientbehandling, samfunnsinteresser og forfatternes akademiske reklamefremstøt, hevder tidsskriftredaktører at ny vitenskapelig informasjon bør publiseres i et fagfellevurdert tidsskrift før den presenteres for leger og publikum. (Because findings published in peer-reviewed journals affect patient care, public policy and the authors' academic promotions, journal editors contend that new scientific information should be published in a peer-reviewed journal before it is presented to doctors and the public.)

Imidlertid har dette budskapet skapt en utbredt feiltolkning om at vedtak om fagfellevurdering er det vitenskapelige motstykke til ”gullstandarden” som godkjennelse. (That message, however, has created a widespread misimpression that passing peer review is the scientific equivalent of the Good Housekeeping seal of approval.)

Praktisk talt alle større vitenskapelig og medisinske tidsskrifter er nylig blitt ydmyket ved å publisere resultater som senere er kommet i vanry. De opprørende episoder har fått mange mennesker til å spørre hvorfor alle forfattere, redaktører og uavhengige ekspertgranskere ikke har lykkes å oppdage problemene før publikasjon. (...) (Virtually every major scientific and medical journal has been humbled recently by publishing findings that are later discredited. The flurry of episodes has led many people to ask why authors, editors and independent expert reviewers all failed to detect the problems before publication.)

- Strid om spøkelsesskriving hjemsøker den amerikanske psykiatriske forening (American Psychiatric Association)

Ghostwriting controversy haunting the American Psychiatric Association (Strid om spøkelsesskriving hjemsøker den amerikanske psykiatriske forening (American Psychiatric Association))
pogoblog.typepad.com 5.4.2011
The blogosphere lit up this morning with several posts on the American Psychiatric Association’s (APA) refusal to print a letter critical of a medical textbook they published with help from the ghostwriting company Scientific Therapeutics Information.

We covered it at POGO here, and Dr. Bernard Carroll wrote about it over at Health Care Renewal. Dr. Carroll hints that other documents may throw more light on the controversial textbook.

documents may well be available if they could be unsealed in pending litigation. Naturally, corporations and their attorneys strive to keep the information hidden. But our general point is that the APA has a different duty – which is to transparency rather than to stonewalling. Did the APA do that? Sadly, no, they did not.

Author and journalism professor Alison Bass writes on her blog that APA’s refusal to publish the letter smacks of “censorship.”

How sad. Can it be that the APA is so fearful of its members' reactions (or more likely, legal threats by Nemeroff and Schatzberg) that it cannot even run a short and well-reasoned letter to the editor? For an organization that represents a profession whose very modus operandi is based on disclosure and transparency, the APA's track record of censorship and secrecy is unacceptable.

Meanwhile, Dr. Danny Carlat writes that the whole affair is like a bad penny that just won’t go away.

I don't think this issue is going away. It's time for the APA to prove to the world that they were not complicit with a drug company in publishing a "textbook" that artfully hid Paxil's side effects. (...)

(Anm: Spøkelsesforfattere (ghostwriters) (mintankesmie.no).)

(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)

- Hva er galt med medisinske tidsskrifter?

'Flawed' infant death papers not retracted ("Feilaktige" publikasjoner om spedbarnsdød ikke trukket tilbake)
Nature 2011;476: 263-264
"Fundamentally flawed": that's how a January 2001 report described ten research papers based on body p arts taken from hundreds of dead children without their parents' consent. Yet more than a decade on, Nature has learned, only one of those papers has been removed from the scientific record.

The lack of action, even in what seems to be a clear-cut case, highlights the reluctance of institutions and journals to retract papers when the authors stand by the results. (...)

Tidsskrifter for alle anledninger
aftenposten.no 17.10.2010
Mette Sagsveen og Sigrid Sørumgård Botheim lever i to helt forskjellige tidskriftsverdener. Den ene skriver for 26 000 abonnenter og får lønn, den andre har kun én og gjør alt gratis.

Der det finnes en samfunnsinteresse, en hobby eller en forening, uansett hvor smalt temaet måtte være, der finnes det også gjerne et tidsskrift. En rekke av dem var representert da Norsk Tidsskriftforening i går arrangerte sin årlige Tidsskriftdag på Litteraturhuset i Oslo. Målet var å vise frem innholdet, engasjementet og bredden i norske tidsskrifter. (…)

Mangfold. – Det skal være en plass for smale tidsskrifter, det er viktig å vise mangfoldet i samfunnet vårt, sier hun.

Kontrasten blir derfor stor til Mette Sagsveen, medisinsk redaktør for Tidsskrift for Den norske legeforening. De utkommer annenhver torsdag, med 24 nummer i året, og med et opplag på 25 900. Av disse sendes 18 750 til leger og 3500 til medisinstudenter. Alle de faste i redaksjonen, et tyvetall medarbeidere er lønnet, samtidig lever de av annonser fra legemiddelindustrien.

– Vi stiller nok i en annen klasse, de fleste andre tidsskrifter omhandler kultur, historie eller litteratur. Men det viser i alle fall litt av mangfoldet i samfunnet, sier Sagsveen. (…)

Hva er galt med medisinske tidsskrifter?
Tidsskr Nor Lægeforen 2007; 127: 2571
Smith R. The trouble with medical journals - 292 s. London: RSM Press, 2006. Pris GBP 20 ISBN 1-85315 -673-6
Medisinske tidsskrifter har for tette bånd til farmasøytisk industri. De er for opptatt av at artiklene skal få oppslag i massemediene, forskningen som publiseres er ofte vanskelig å fortolke og er utsatt for en rekke skjevheter, fagfellevurdering fungerer ikke som kvalitetssikring, forfatterskapskriteriene følges ikke, interessekonflikter oppgis ikke, og mange tidsskrifter er blitt melkekuer for eierne.

Dette er (noen av) hovedproblemene ved medisinske tidsskrifter som drøftes i en ny bok skrevet av Richard Smith. Han arbeidet i det britiske legetidsskriftet BMJ i perioden 1979 - 2004, de siste 13 årene som sjefredaktør.

Boken består av 22 kapitler i sju seksjoner, over 400 referanser og en stikkordliste. Mye av stoffet i boken er kjent fra før, ikke minst har Smith selv skrevet om det i ulike sammenhenger. Samme år som boken kom ut, publiserte han seks artikler i Journal of the Royal Society of Medicine, der mange av hovedpoengene i boken blir presentert. Titlene på disse artiklene er illustrerende for bokens innhold (1 - 6). (...)

Frikjennelse av medforfatterne bekymrer
tidsskriftet.no 10.8.2006
Granskingskommisjonens frikjennelse av medforfatterne i Sudbø-saken er underlig og svært bekymringsfull.

Dersom den blir stående vil mye måtte endres innen forskningen. Det mener både redaktør Charlotte Haug og professor Magne Nylenna, som i hver sine lederartikler i Tidsskriftet kritiserer granskingskommisjonens konklusjon om å frikjenne Jon Sudbøs medforfattere for fusk.

Haugs leder er publisert i dagen utgave av Tidsskriftet, mens Nylennas leder er publiser først på nett, og kommer i neste papirutgave. (...)

Stor feiring av Tidsskriftets 125 første år
Tidsskr Nor Lægeforen (9.1.2006)
Over 300 leger, redaktører og andre fagfolk var samlet i Oslo da Tidsskriftet feiret sitt 125-årsjubileum 9. januar. (...)

Jeffrey Drazen, redaktør av New England Journal of Medicine, deltok i debatten om medisinske tidsskrifter og legemiddelindustrien. (...)

Se alle foredragene på nettvideo

Mange hadde kommet langveisfra for å delta, og flere store navn stod på talerlisten.

Blant dem var sjefredaktørene i tre av de fem største generelle medisinske tidsskriftene:Harold Sox fra Annals of Internal Medicine, Jeffrey Drazen fra New England Journal of Medicine og Catherine DeAngelis fra JAMA. De tre var, i likhet med åtte andre redaktører, i Norge i forbindelse med et møte i den internasjonale komiteen for redaktører av medisinske tidsskrifter – den såkalte Vancouver-gruppen. (...)

Føler seg lurt av industrien
Jeffrey Drazen og Cathy DeAngelis deltok i en debatt om medisinske tidsskrifter og legemiddelindustrien. Begge gav sterkt uttrykk for at de følte seg lurt av legemiddelindustrien. De siktet da særlig til COX- 2-sakene, hvor det har vist seg at medikamentene Vioxx og Celebra verken er så effektive eller ufarlige som man først kunne få inntrykk av. Pfizers CLASS-studie ble publisert i JAMA i 2000 og Mercks VIGOR-studie ble publisert i New England Journal of Medicine samme år. Begge studiene viste seg å være manipulert på ulike måter. Både Drazen og DeAngelis uttrykte bekymring over at legemiddelfirmaene de siste årene har begynt å designe studier for å få resultatene de ønsker og dermed tjene mer penger. (...)

Redaktør av JAMA Catherine DeAngelis sammenliknet forholdet mellom tidsskriftene og industrien som et ekteskap. (...)

- Medisinsk tidsskrift kritiserer Medtronic voldsomt for betalinger til leger

Adverse Events Common With rhBMP-2 Device
medpagetoday.com 28.6.2011
In stark contrast to published reports from manufacturer-sponsored studies of the Infuse spinal fusion device that incorporates a biologic bone-building drug, a new analysis of FDA documents and other data sources suggests that up to half of patients receiving the device may experience adverse events related to the drug, researchers said.

The Infuse device, which delivers recombinant human bone morphogenetic protein-2 (rhBMP-2) to speed vertebral fusion in patients with chronic back pain, has adverse event rates of 10% to 50% depending on the approach, according to Eugene Carragee, MD, of Stanford University's outpatient clinic in Redwood City, Calif., and colleagues.

"This risk of adverse events associated with rhBMP-2 is 10 to 50 times the original estimates reported in the industry-sponsored peer-reviewed publications," Carragee and colleagues wrote online in The Spine Journal, which Carragee serves as editor-in-chief.

The investigators in each of 13 reports of studies funded by product manufacturer Medtronic and published from 2000 to 2009 claimed to find no adverse events attributable to rhBMP-2. (...)

Spine Journal Takes Aim at Infuse Research
medpagetoday.com 28.6.2011
Doctors who received millions of dollars from Medtronic systematically failed to reveal serious complications linked to the company's lucrative back surgery product, Infuse, in 13 papers they co-authored for medical journals over the course of nearly a decade, according to a scathing new review.

The analysis is part of an unprecedented event in medicine: The entire issue of a medical journal devoted to a scientific and financial expose of a product, the practices of the company that markets it, and the financially conflicted doctors who tested and promoted it.

Blame also is heaped on the lax oversight of the Food and Drug Administration and failures by editors and reviewers of medical journals. (...)

The main analysis, which was led by editors of the Spine Journal, found a systematic failure to report serious complications with Infuse, bone morphogenetic protein-2 or BMP-2, which is used in spinal fusion surgery. The researchers found complication rates that were 10 to 50 times greater than the estimated complication rates revealed in the medical literature. (...)

Medical Journal Slams Medtronic Over Payments To Doctors (Medisinsk tidsskrift kritiserer Medtronic voldsomt for betalinger til leger)
blogs.forbes.com 28.6.2011
A major medical journal has taken the dramatic step of publishing a series of articles alleging that side effects were downplayed or omitted in scientific articles about a Medtronic product used in spine surgery.

Instead, authors repeatedly asserted the device, called Infuse, caused few complications, according to the report by The Spine Journal, the official publication of the North American Spine Society. Moreover, the journal says, the authors of those often had received significant amounts of money from Medtronic.

On every large study of Infuse, at least one author had received at least $10 million in royalties, consulting, or other payments from Medtronic, according to Eugene Carragee, the Spine Journal’s editor.

“I was really shocked,” says Carragee, who is also a professor at Stanford University. “I wouldn’t have thought I was very naïve about this stuff. I’ve been doing this for 25 years.” (...)

Richard Kuntz, Medtronic’s chief scientific officer, says he has found no evidence that Medtronic played a role in preparing the papers, aside from answering the questions of the outside academics. There were no ghostwriters, as has appeared to occur with other published studies. (...)

Carragee sees a need for much more disclosure of financial conflicts. Among the steps being taken: instead of disclosing payments from companies as footnotes, The Spine Journal intends to put them in the body of articles. That means that if they are incorrect, it could stand as grounds for retraction. This could also lead readers to take the payments more seriously.

“I think that if you do a service for the company and the service is worth ‘X’ amount of money you should get ‘X’ amount of money,” says Carragee. “But if you’re writing advertising copy it should be in the advertising section.” (...)

(Anm: The Spine Journal 2011 (June 28).)

Journal Blasts Industry-Funded Researchers in Spine Surgery Studies for Flawed Research, Undisclosed Financial Relationships (Tidsskrift kritiserer industrifinansierte forskere voldsomt for mangelfull forskning for ryggoperasjon-studier, og ikke å ha opplyst om økonomiske forbindelser)
JAMA 2011 (June 28)
The financial ties between clinical researchers who conducted studies on a product used in spine surgery and the manufacturer of the product have come under fire, raising questions about the integrity of this industry-sponsored research. (...)

An editorial appearing today in The Spine Journal sharply questions the objectivity of purportedly independent researchers participating in industry-funded studies of a product used in spinal fusion surgery.

The editorial is part of a special issue of the journal that focuses on a product containing synthetic bone growth factor, recombinant bone morphogenetic protein-2 (rhBMP-2), manufactured by Medtronic under the name Infuse Bone Graft. The product is intended to allow surgeons to bypass harvesting bone graft material directly from their patients.

In another section of the special issue, a review article assessed published reports of 13 original industry-sponsored studies of safety and efficacy of rhBMP-2 in 780 patients. In these studies, the researchers reported no adverse events such as unintended bone growth. But the authors of the review, using US Food and Drug Administration data summaries, follow-up publications, and administrative and organizational databases analyses, estimate that between 10% to 50% of patients should have experienced an adverse event, including life-threatening events. The authors also said that as of March 2011, Medtronic had paid the clinical investigators of the 13 studies amounts ranging from $560 000 to $23.5 million per study. (...)

In the editorial, the editor of The Spine Journal, Eugene J. Carragee, MD, of the Stanford University School of Medicine and colleagues wrote that the “choirboy defense”—the belief that theirs is an honest profession with unimpeachable integrity and the highest ethical standards—can no long apply to researchers in the spine community. “It harms patients to have biased and corrupted research published,” they wrote. “It harms patients to have unaccountable special interests permeate medical research. It harms patients when poor publication practices become business as usual.” (...)

Medtronic Surgeons Held Back, Study Says (Medtronic: Kirurger hemmeligholdt informasjon, ifølge studie)
online.wsj.com 29.6.2011
Surgeons who conducted clinical trials to test a Medtronic Inc. bone-growth protein widely used in spine surgery didn't report serious complications that arose in those trials in their research papers, a new study says.

Over the past decade, 15 of those surgeons have collectively received at least $62 million from the medical-device giant for unrelated work, according to a Wall Street Journal analysis of Medtronic documents and of recent disclosures made on the company's website.

Last week, the Senate Finance Committee began investigating whether Medtronic's large payments to the surgeons played a role in the fact they didn't report the ... (...)

Surgeons in Medtronic trials omitted results: report (Kiruger i Meditronic-forsøk utelot resutater, ifølge rapport)
reuters.com 28.6.2011
(Reuters) - Surgeons conducting clinical trials to test a Medtronic Inc bone-growth protein used in spine surgery, some of whom got at least $62 million from the company, failed to report serious complications in their research papers, the Wall Street Journal reported.

Fifteen of the surgeons got at least $62 million from the company over the past decade, the paper said, citing an analysis of Medtronic documents and disclosures on the company's website.

A new study in the Spine Journal said serious complications including cancer, sterility, infections, bone dissolution and worsened back and leg pain, occurred in 10 to 50 percent of patients who were administered Infuse or a sister product in 13 clinical trials funded by Medtronic and conducted by the surgeons between 2000 and 2010, the Wall Street Journal said. (...)

- Rapportering av interessekonflikter i metaanalyser av farmakologiske forsøksbehandlinger

Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments (Rapportering av interessekonflikter i metaanalyser av farmakologiske forsøksbehandlinger)
JAMA 2011;305(10):1008-1017 (March 9)
Context Disclosure of conflicts of interest (COIs) from pharmaceutical industry study funding and author-industry financial relationships is sometimes recommended for randomized controlled trials (RCTs) published in biomedical journals. Authors of meta-analyses, however, are not required to report COIs disclosed in original reports of included RCTs.

Objective To investigate whether meta-analyses of pharmacological treatments published in high-impact biomedical journals report COIs disclosed in included RCTs. (...)

Conclusion Among a group of meta-analyses of pharmacological treatments published in high-impact biomedical journals, information concerning primary study funding and author COIs for the included RCTs were only rarely reported. (...)

- Datatilgjengelighet for industrisponsede forsøk: hva bør medisinske tidsskrifter kreve?

Data availability for industry sponsored trials: what should medical journals require? (Datatilgjengelighet for industrisponsede forsøk: hva bør medisinske tidsskrifter kreve?)
BMJ 2010; 341:c5391 (12 October)
Several recent examples illustrate the problems of trusting drug companies to provide the complete picture about the clinical trials they sponsor. Robert Steinbrook and Jerome P Kassirer propose that there is a strong case for journals defining full access to the trial data and requiring that investigators and journal editors have full access. (...)

Companies have financial interests in the outcome of the studies they sponsor; they own the data, and set the rules for access to the data. Unfortunately, they cannot be relied on to consistently provide dispassionate evaluations of their own drugs and medical devices.¹¹ Moreover, many investigators have notable financial interests with the same sponsors. According to the voluntary principles of the Pharmaceutical Research and Manufacturers of America, “As sponsors, we are responsible for receipt and verification of data from all research sites for the studies we conduct; we ensure the accuracy and integrity of the entire study database, which is owned by the sponsor.”¹² These obligations may be appropriate, but it has become impossible to assess which industry studies are trustworthy. (...)

Medical Journals Are an Extension of the Marketing Arm of Pharmaceutical Companies (Medisinske tidsskrifter er en forlengelse av markedsføringen til farmasøytiske firmaer)
Richard Smith.
PLoS Med. 2005 May;2(5):e138. Epub 2005 May 17.
“Tidsskrifter er gått over til hvitvasking av informasjon for farmasøytisk industri”, skrev Richard Horton, redaktør i Lancet, i mars 2004 [1]. Samme år, skjelte Marcia Angell, tidligere redaktør i New England Journal of Medicine, ut industrien for "primært å ha blitt en markedsføringsmaskin” og inkluderer (mot sin vilje) “alle institusjoner som måtte stå i veien” [2]. Medisinske tidsskrifter var påfallende fraværende på hennes liste over "co-opted" institusjoner, men hun og Horton er ikke de eneste redaktører som stadig oftere er blitt pysete når det gjelder makten og innflytelsen til industrien. Jerry Kassirer, en annen tidligere redaktør i New England Journal of Medicine, argumenterer for at industrien har endret retningen på det moralske kompass til mange leger [3], og redaktørene i PLoS Medicine har uttalt at de ikke vil bli en "del av syklusen med avhengighet… mellom tidsskrifter og den farmasøytisk industri” [4]. Noe som øker betydelig. (...) (“Journals have devolved into information laundering operations for the pharmaceutical industry”, wrote Richard Horton, editor of the Lancet, in March 2004 [1]. In the same year, Marcia Angell, former editor of the New England Journal of Medicine, lambasted the industry for becoming “primarily a marketing machine” and co-opting “every institution that might stand in its way” [2]. Medical journals were conspicuously absent from her list of co-opted institutions, but she and Horton are not the only editors who have become increasingly queasy about the power and influence of the industry. Jerry Kassirer, another former editor of the New England Journal of Medicine, argues that the industry has deflected the moral compasses of many physicians [3], and the editors of PLoS Medicine have declared that they will not become “part of the cycle of dependency…between journals and the pharmaceutical industry” [4]. Something is clearly up.)

Statlig hvitvasking av legemiddelinformasjon
Tidsskr Nor Legeforen 2010; 130:368 (25.2.2010)
Selv om myndighetene hevder at publikum mottar en oppdatert informasjon om legemidler via pakningsvedlegg og preparatomtaler, viser en artikkel i New England Journal of Medicine at informasjon blir borte på veien og at pasienter og leger derfor ikke får den informasjon som er nødvendig for å kunne vurdere nytteverdi og skadevirkninger på en uavhengig og forsvarlig måte (1). Dette problemet er også belyst av redaktøren i BMJ, Fiona Godlee, som bl.a. skriver at man i flere artikler konkluderer med at beviset for at oseltamivir (Tamiflu) reduserer komplikasjoner hos ellers friske mennesker med pandemisk influensa, er usikker og at vi trenger en radikal endring av reglene for tilgang til rådata (forsøksdata) (2). (...)

A cure for public distrust
By Jerome P. Kassirer
boston.com 27.7.2006
RECENT NEWS STORIES have focused on physicians who failed to disclose financial ties to a company whose products they have touted. Journals that failed to warn readers about such arrangements have been disparaged; and so has the Food and Drug Administration, for the same reason. In fact, there is plenty of blame to go around: Companies would prefer such ties to be hidden, doctors don't believe that their financial connections to industry can affect their judgment, and journal editors fail to ask the questions necessary to identify the conflicts. Behind the public outcry for disclosure is a serious misconception, namely that disclosing financial connections solves the problem of conflict of interest and bias. Unfortunately, it does not. (...)

Disclosure is nothing more than an excuse to continue business as usual. The cure for public distrust is to employ people who have opted not to be compromised by money. We must find ways of rewarding academic physicians who decide that patient care and personal integrity is more important than a $10,000 infusion into their bank accounts. One cure is to reward physicians by recruiting those without financial ties to write the review articles and to serve on panels that recommend what devices we use and what drugs we take. Maybe then many will opt not to be bought. (...)

- Medisinens største trussel

Medicine's Biggest Threat (Medisinens største trussel)
forbes.com 4.1.2012
Medicine’s biggest threat is not a highly resistant microorganism or rising costs or an aging population or workforce shortages. It is something less obvious and more dangerous: the issue of missing data.

Doctors, researchers, patients and the public routinely see only some of the evidence that has been produced about drugs and devices and other health care interventions. Many studies are designed, funded, and completed, yet the results remain out of sight and are never put in public view. This, after patients –have consented to participate and allow scientists to study them, often putting themselves at some risk or at least inconvenience. As incredible as it seems, the last step of disseminating the results of the completed study too commonly never occurs or is much delayed. And what is missing matters.

Medicine has promoted the use of systematic reviews of the medical literature. These studies of studies scour medical journals and databases for research about a particular topic and review them thoroughly, often bring together the results in statistical analyses with the intent of providing a verdict on a given approach. Systematic reviews seek to equip practitioners with the best summary of what is known on a particular topic.

We now recognize that there is often a big difference between what is published and what could be known about a medical intervention.

(Full disclosure: I served as a consultant to lawyers who represented patients who took Vioxx and have published articles on the data that was not in public view.)

Litigation over the antidepressant Paxil forced GlaxoSmithKline to release unpublished data that were subsequently used to indicate the risks associated with Avandia, the diabetes drug. The published data could not have supported the same conclusion. These experiences have led to calls for increased data sharing.

Now, this week the BMJ, a prominent medical journal, is publishing a series of articles (including one that I co-authored) that explore the pervasiveness of the problem. In one study, the investigators show that more than half of the trials sponsored by the National Institutes of Health remain unpublished even 30 months after the study is completed. This finding demonstrates that delays or omissions in publishing are not strictly an issue for industry.

In another article, unpublished data were shown to have an important influence on systematic reviews, changing perceptions about the risks and benefits of medical therapies. In this study of drugs, in about half the cases including the missing data made the drug appear more effective and in other half the drug seemed less effective. One could not predict the effect of the missing data. The point is that the missingness is not random – there is a bias in the undisclosed data that skews our perception of medical interventions.

The findings thus far suggest that no areas of medicine are immune from this problem. As a result, even the most diligent expert, reading all that has been published in a field, is handicapped by the lack of access to undisclosed information. (...)

(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)

- Mer sannsynlig at medisinske tidsskrifter med annonser anbefaler legemidler enn abonnementstidsskrifter

Medical journals with advertising are more likely than subscription journals to recommend drugs (Mer sannsynlig at medisinske tidsskrifter med annonser anbefaler legemidler enn abonnementstidsskrifter)
BMJ 2011; 342:d1335 (1 March)
Free medical journals with drug advertising were significantly more likely to recommend specific drugs that were advertised on their pages than were journals that relied upon subscription fees to cover their operating costs.

“Free journals almost exclusively endorse the use of the selected drugs, whereas journals that rely exclusively on subscription fees for their revenue are more likely to recommend against the use of the same drugs,” said lead author Annette Becker, MD, from the University of Marburg, Germany. The study was published in the Canadian Medical Association Journal (CMAJ 2011. Doi:10.1503/cmaj.100951).

The cross-sectional study examined all issues of 11 journals for general practitioners in Germany that were published in 2007. It classified the journals into three categories: “free journals” completely financed by paid advertising; “mixed revenue journals” financed with a mix of subscription fees and paid advertising; and “subscription journals” that were completely funded through subscription fees.

The study focused on continuing medical education articles for nine drugs or drug classes such as glitazones (diabetes), ezetimibe (hypercholesterolaemia), and varenicline (smoking cessation).

Within the data set of 465 issues of the 11 periodicals, the study identified 638 advertisements for the selected drugs, and 297 articles that made recommendations for or against their use. (...)

The association between a journal's source of revenue and the drug recommendations made in the articles it publishes
CMAJ 2011 (Published online ahead of print February 28)
Background: There is evidence to suggest that pharmaceutical companies influence the publication and content of research papers. Most German physicians rely on journals for their continuing medical education. We studied the influence of pharmaceutical advertising on the drug recommendations made in articles published in 11 German journals that focus on continuing medical education. (...)

Interpretation: Free journals almost ex clusively recommended the use of the specified drugs, whereas journals financed entirely with subscription fees tended to recommend against the use of the same drugs. Doctors should be aware of this bias in their use of material published in medical journals that focus on continuing medical education. (...)

- Viten om medisin fordreies av økonomiske interesser

Viden om medicin fordrejes af økonomiske interesser
information.dk 9.1.2011
Videnskabelige tids-skrifter tjener stort på at offentliggøre forsøg sponsoreret af medicinalindustrien, viser ny forskning. Det kan skabe tvivl om troværdigheden af den medicinske forskning og give et fordrejet billede af, hvilken behandling der er bedst for patienterne

Offentliggørelse af forskningsresultater i internationale videnskabelige tidsskrifter er ikke bare vejen til akademisk anerkendelse, men også til big business. Ny forskning viser, at de internationale tidsskrifter har store økonomiske interesser i at offentliggøre forskning, der er sponsoreret af medicinalindustrien. Årsagen er blandt andet, at privatfinansieret forskning bliver citeret oftere end offentlig forskning, og det er med til at gøre tidsskriftet mere prestigefuldt at få sin forskning publiceret i, forklarer Andreas Lundh, der forsker på Nordisk Cochrane Center ved Rigshospitalet.

»Men tidsskrifterne bliver også tilskyndet til at offentliggøre medicinsk forskning sponsoreret af medicinalindustrien, fordi industrien presser eller lokker med køb af op til en million eksemplarer af den videnskabelige artikel om deres egne medicinske forsøg,« forklarer han.

Det giver tidsskrifterne enorme indtægter, når de offentliggør medicinalindustriens forskning, og risikerer i værste fald at påvirke den redaktionelle bedømmelse af, hvilken forskning der er bedst egnet til offentliggørelse, siger Andreas Lundh.

»Det skulle jo helst være sådan, at vurderingen kun har noget at gøre med forskningens relevans og kvalitet, men tidsskrifter mener ikke selv, at det er noget problem, fordi redaktørerne ikke er de samme som de økonomisk ansvarlige,« siger han.

At de store internationale tidsskrifter i højere grad offentliggør forskning sponsoreret af industrien, kan imidlertid også farve vores billede af, hvilken medicin eller behandling der er bedst.

»Det er veldokumenteret, at industriens forskning er meget mere positiv end tilsvarende forskning i det offentlige, fordi industrien ikke publicerer alle de negative forsøgsdata,« forklarer Andreas Lundh.

Når forskningen først er offentliggjort i et stort internationalt tidsskrift, får den en enorm troværdighed, der kan føre til indtægter i milliardklassen for medicinal- industrien, fordi lægerne ofte vil udskrive medicin, der har været omtalt der.

»Udviklingen kan betyde, at lægerne kommer til at overvurdere effekten og undervurdere skadevirkningerne af visse typer medicin, og kan i sidste ende føre til, at patienter får en behandling med lægemidler, der ikke er nær så gode, som vi troede,« mener Andreas Lundh. (...)

- Tidsskrift trakk artikkel etter klager fra legemiddelfabrikanter

Journal withdraws article after complaints from drug manufacturers (Tidsskrift trakk artikkel etter klager fra legemiddelprodusenter)
BMJ 2011; 342:d2335 (11 April)
A paper suggesting that two new antidiabetes drugs could greatly increase the risk of pancreatitis and several cancers has been withdrawn from the website of the journal Gastroenterology after complaints from Novo Nordisk and Merck, the drugs’ manufacturers.

The companies wrote letters to Anil Rustgi, the journal’s editor in chief, after the paper appeared online. They expressed concern that the analysis, which used data derived from the US Food and Drug Administration’s adverse event reporting system, reached conclusions that could not be justified. Merck warned that the paper could have a negative effect on the care of patients, while Novo Nordisk claimed that it could spark an unnecessary health scare. (...)

The two drugs involved are Novo Nordisk’s exenatide (marketed as Byetta) and Merck’s sitagliptin (Januvia). They belong to a class called incretin mimetics or glucagon-like peptide 1 (GLP-1) based therapies and aim to give better control of type 2 diabetes.

In the disputed paper the team responsible (Michael Elashoff, Aleksey Matveyenko, Belinda Geir, Robert Elashoff, and Peter Butler, from the Larry L Hillblom Islet Research Center at UCLA) used the FDA database of adverse events from 2004 to 2009 to compare the number of cases of disease reported by users of the two drugs with the number reported by users of four other antidiabetes drugs.

They concluded that the risk of pancreatitis was increased by 6.8 times in users of sitagliptin (95% confidence interval 4.7 to 10.2) and by 11.8 times (8.5 to 16.6) in users of exenatide. For pancreatic cancer the risk ratios were 2.4 and 2.0, respectively, and for thyroid cancer 3.4 and 7.6. There were 970 pancreatitis events among patients taking exenatide and 131 among patients taking sitagliptin. The number of cases of pancreatic cancer was 72 among patients taking exenatide and 14 among patients taking sitagliptin. The paper did not report confidence intervals for the risk ratios for pancreatic cancer.

They conclude: “These data are consistent with case reports and animal studies indicating an increased risk for pancreatitis with GLP-1 based therapy. The findings also raise caution about the potential long-term actions of these drugs to promote pancreatic cancer.” (...)

- Er forskning trygg i deres hender?

Is research safe in their hands? (Er forskning trygg i deres hender?)
BMJ 2011; 342:d284 (19 January)
MMR and scientific fraud (MMR og medisinsk svindel)

Vi kan ikke stole på vår vitenskap er ren før lærdommem fra Wakefield-sagaen er implementert i vår forskningskultur (We can’t bank on keeping our science clean until the lessons of the Wakefield saga are embedded in our research culture)

I 2009 skrev Marcia Angell: “Det er simpelthen ikke lenger mulig å tro på mye av den kliniske forskningen som er publisert, eller å stole på bedømmelsen til betrodde leger eller offisielle medisinek retningslinjer. Jeg synes denne konklusjonjen, som jeg langsomt og motvillig over to årtier har kommet til som redaktør for New England Journal of Medicine, ikke i det hele tatt er noe hyggelig.”¹ (In 2009 Marcia Angell wrote: “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of the New England Journal of Medicine.”¹)

Even making allowances for the cynicism of former journal editors the integrity of research remains fragile. In 2006, after suspicions were raised about a paper published in the Lancet, an investigation by the Norwegian Radium Hospital in Oslo found evidence of systematic fraud in the publications of Jon Sudbø, a cancer researcher at the hospital. The inquiry published its findings within months of the whistle being blown.² (...)

- Om å oppdage forskningsjuks

Forskningsfronten
Camilla Stoltenberg er lege og assisterende direktør ved Folkehelseinstituttet. (Teksten har også vært publisert i Forskning & Medicin)
morgenbladet.no 14.1.2011
Om å oppdage forskningsjuks

I de stille dagene mellom jul og nyttår i 2005 leste jeg en vitenskapelig artikkel. Jeg arbeidet med et kapittel i en bok, og ville bruke artikkelen som referanse. Førsteforfatteren het Jon Sudbø, og studien var publisert i Lancet i oktober samme år. (...)

Hvordan oppdager man forskningsjuks? For min del handlet det om serendipity – the chance observation falling on a receptive eye. En tilfeldig observasjon som fanges opp av et mottagelig blikk. Jeg så etter noe – en betydningsfull studie som kunne illustrere de fabelaktige vitenskapelige mulighetene som ligger i helseregistre og befolkningsbaserte helseundersøkelser. Og jeg fant noe helt annet. I begynnelsen skjønte jeg ikke hva det var. Ordet juks falt meg ikke inn, da heller noe i retning av slurv. I ettertid har jeg tenkt at det var redselen for medansvar, for skyld, som var avgjørende da jeg varslet. (...)

- Institusjonelle og redaksjonelle feil ved MMR-skremsel

Institutional and editorial misconduct in the MMR scare (Institusjonelle og redaksjonelle feil ved MMR-skremsel)
BMJ 2011; 342:d378 (19 January)
This week, in the last of his series of three articles on the secrets of the MMR scare (doi:10.1136/bmj.c7001), Brian Deer describes the events of 2004 when he first raised concerns about Andrew Wakefield’s research with the Lancet’s editor. Rather than calling for an investigation as Deer had expected, Richard Horton moved quickly—with Wakefield, his co-authors, and their former institution—to publicly deny all but one of Deer’s allegations. Six years later, at an estimated cost of £6m, the General Medical Council found all the allegations to be true.

In his observations column, Harvey Marcovitch asks again why it took so long to uncover Wakefield’s fraud (doi:10.1136/bmj.d284). He compares it with other major scientific frauds whose overthrow took a year or less from whistleblow to disgrace. Deer’s article provides another piece of the puzzle. In Wakefield’s case we were falsely reassured. We were told by authoritative sources—the journal and the institution—that an investigation had been done and had cleared Wakefield of most charges. But as shown by documents obtained under the Freedom of Information Act, there was no proper investigation, merely a 48 hour “scramble” to protect reputations and discredit the story.

It is hard to escape the conclusion that this represents institutional and editorial misconduct, and its impact has been substantial. Wakefield’s influence beyond the UK—in the USA, Russia, and elsewhere—is clear from the extensive international media response to Deer’s first two articles. The spread of this influence happened mainly after 2004. The international damage might have been lessened by earlier definitive action.

Speaking for the institution, UCL’s vice-provosts for health and research say that the mistakes made in this case have prompted a review of research governance (www.bmj.com/content/342/bmj.c7452/reply#bmj_el_247716). The Lancet has not yet commented. The Committee on Publication Ethics considers breaches of its code of conduct for editors, but only those that have occurred since the code’s introduction in 2005 (http://publicationethics.org/code-conduct).

What actions should the scientific community take in the light of what Andy Alaszewski calls “this modern tragedy” (doi:10.1136/bmj.d236)? One urgent need is for progress in research into autism. Without a better understanding of its true causes and potential remedies, parents confronted with this frightening and unexplained experience will continue to seek answers from Wakefield and his like. (...)

- Pasientenes manglende stemme ved rapportering av legemiddelsikkerhet

The Missing Voice of Patients in Drug-Safety Reporting (Pasientenes manglende stemme ved rapportering av legemiddelsikkerhet)
healthcarereform.nejm.org 10.3.2010 (New England Journal of Medicine)
En pasient ønsker å bli informert om hvilke symptomer hun kan få av et legemiddel som inntas. Ved å lese avsnittet “Uheldige reaksjoner” i pakningsvedlegget finner hun et vell av data, men hun er ikke oppmerksom på at denne informasjonen, som i hovedsak er samlet inn i løpet av kliniske forsøk, nesten utelukkende er basert på klinikernes inntrykk av pasienters symptomer — ikke på pasienters rapporteringer av egne erfaringer med legemidlet. (A patient wants to know about symptoms she may have from a prescription drug she is taking. Consulting the label’s “Adverse Reactions” section, she finds a wealth of data. Little does she realize that this information, largely collected during clinical trials, is based almost entirely on clinicians’ impressions of patients’ symptoms — not on patients’ own firsthand reports of their experiences with the drug.)

Den nåværende praksis med pakningsvedlegg for uheldige hendelser er stilltiende basert på den forutsetning at en nøyaktig fremstilling av pasientens subjektive erfaringer alene kan fremskaffes gjennom klinikernes dokumentasjon. Selv om det er en betydelig bevismengde som ikke støtter denne antakelsen, viser det seg at klinikere systematisk undervurderer alvorligheten av pasienters symptomer, at pasienters selvrapporteringer ofte påviser sideeffekter som klinikere overser, og at klinikerne svikter når det gjelder å notere denne type symptomer hvilket resulterer i uheldige hendelser som kunne forebygges.^{1, 2} (...) (The current drug-labeling practice for adverse events is based on the implicit assumption that an accurate portrait of patients’ subjective experiences can be provided by clinicians’ documentation alone. Yet a substantial body of evidence contradicts this assumption, showing that clinicians systematically downgrade the severity of patients’ symptoms, that patients’ self-reports frequently capture side effects that clinicians miss, and that clinicians’ failure to note these symptoms results in the occurrence of preventable adverse events.^{1, 2})

(Anm: Legemiddelstudier, åpenhet, uredelighet og kvalitet. (mintankesmie.no).)

(Anm: Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists. BMJ 2011; 342:c7153 (6 January).)

Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists
BMJ 2011; 342:c7153 (6 January)
Objectives To provide information on the frequency and reasons for outcome reporting bias in clinical trials. (...)

Conclusion The prevalence of incomplete outcome reporting is high. Trialists seemed generally unaware of the implications for the evidence base of not reporting all outcomes and protocol changes. A general lack of consensus regarding the choice of outcomes in particular clinical settings was evident and affects trial design, conduct, analysis, and reporting. (...)

Frequency and reasons for outcome reporting bias in clinical trials: interviews with trialists (Hyppighet og årsaker til rapportering-bias av resultater i kliniske forsøk: intervju med de som utfører forsøk)
BMJ 2011; 342:c7153 (6 January)
Objectives To provide information on the frequency and reasons for outcome reporting bias in clinical trials. (...)

Conclusion The prevalence of incomplete outcome reporting is high. Trialists seemed generally unaware of the implications for the evidence base of not reporting all outcomes and protocol changes. A general lack of consensus regarding the choice of outcomes in particular clinical settings was evident and affects trial design, conduct, analysis, and reporting. (...)

(Anm: bias [baies] -en, - skjevhet i vitenskapelig undersøkelse el. resultat pga. mangelfull systematikk i innsamlingen av data. Etym.: eng., fr. biais helning, tendens. Kilde: ordnett.no.)

(Anm: bias; (...) valg og vurderinger som på systematisk måte avviker fra det som er faktisk korrekt. Kilde: Store norske leksikon.)

Finding studies on reboxetine a tale of hide and seek (Funn i studier på reboxetine en historie om hemmelighold)
BMJ 2010; 341:c4942 (12 October)
Beate Wieseler, Natalie McGauran, and Thomas Kaiser use their experience with the assessment of reboxetine to illustrate how publication bias affects health policy decisions and offer some solutions

The antidepressant reboxetine, a selective noradrenaline (norepinephrine) reuptake inhibitor, has been approved in several European countries (including the United Kingdom and Germany) since 1997. However, approval was declined in the United States in 2001. The German Institute for Quality and Efficiency in Health Care (IQWiG) report on the benefit and harm of newer antidepressants concluded in 2009 that, overall, reboxetine was both ineffective and potentially harmful.^{1 2} (...)

(Anm: reboxetine (Edronax) (felleskatalogen.no).)

Patients and Doctors Are Being Misled by Published Data on Medicines, Germany Study Suggests (Tysk studie tyder på at pasienter og leger er blitt villedet av publiserte data for legemidler)
sciencedaily.com 16.10.2010
ScienceDaily (Oct. 12, 2010) — The drug reboxetine is, overall, an ineffective and potentially harmful antidepressant, according to a comprehensive study of the evidence published online in the British Medical Journal.

The study also shows that nearly three quarters of the data on patients who took part in trials of reboxetine were not published until now, and that the published data on the drug overestimate the benefits and underestimate the harms of treatment -- all underlining the urgent need for mandatory publication of all clinical trial results. (...)

They show that reboxetine is, overall, an ineffective and potentially harmful antidepressant. They found no significant difference in benefit (remission and response rates) versus placebo and inferior benefit versus SSRIs, as well as a higher rate of patients affected by adverse events than with placebo and higher withdrawal rates owing to adverse events than with placebo and the SSRI fluoxetine.

A further comparison of published and unpublished trials shows that published data overestimated the benefit of reboxetine and underestimated harm. (...)

(Anm: reboxetine (Edronax) (felleskatalogen.no).)

Journals mislead public over drugs (Tidsskrifter villedet publikum om legemidler)
presstv.ir 16.10.2010
While drugs should undergo various tests before receiving approval in Europe, pharmaceuticals often mislead consumers and authorities by not publishing the results.

According to an article published in the British Medical Journal, pharmaceuticals only publish the positive points of the trial. The publication bias overestimates the benefits of many medications. (...)

- Legemiddelfirma betalte forfattere for å promotere hormonterapi (HRT)

Drug co. paid writers to promote hormone therapy (Legemiddelfirma betalte forfattere for å promotere hormonterapi (HRT))
reuters.com 8.9.2010
(Reuters) - Drugmaker Wyeth used ghostwriters to play up the benefits and downplay the harm of hormone replacement therapy in articles published in medical journals, a U.S. researcher said on Tuesday.

Dr. Adriane Fugh-Berman of Georgetown University Medical Center in Washington analyzed dozens of ghostwritten reviews and commentaries published in medical journals and journal supplements, many of them using documents from judicial trials.

Hun sa at Wyeth, nå eiet av Pfizer, betalte et medisinske kommunikasjonsfirmapaid kalt DesignWrite 25 000 doaalr for å spøkelsesskrive artikler på kliniske studier, inklusive fire som testet lavdose for Prempro, firmaets kombinerte østrogen/progestin-terapi. (She said Wyeth, now owned by Pfizer, paid a medical communication company called DesignWrite $25,000 to ghostwrite articles on clinical studies, including four testing low-dose Prempro, the company's combination estrogen-progestin therapy.)

She said the articles were intended to mitigate concerns that hormone replacement therapy raises the risk of breast cancer, and to support the unfounded idea that the drugs offer some protection against heart disease. (...)

(Anm: Hormonterapi (HRT-behandling) (Hormon Replacement Therapy) (mintankesmie.no).)

Ghostwritten articles overstated benefits of HRT (Spøkelsesskrevne artikler overdrev nytten av HRT (hormonterapi))
BMJ 2010; 341 (7 September)
Gjennomgangsartikler og kommentarer som var spøkelsesskrevne overdrev nytten av hormonterapi og tonet ned dets skadevirkninger, ifølge en analyse publisert I PLoS Medicine (2010;7(9):e1000335, doi:10.1371/journal.pmed.1000335). (Review articles and commentaries that were ghostwritten overstated the benefits of hormone replacement therapy and downplayed its harms, says an analysis published in PLoS Medicine (2010;7(9):e1000335, doi:10.1371/journal.pmed.1000335).)

Resultatene stammer fra en undersøkelse av 1 500 dokumenter fremlagt i en nylig rettssak mot det store legemiddelfirmaet Wyeth (nå en del av Pfizer) som undersøkte hvordan legemiddelfirmaer bruker spøkelsesforfattere til å plassere markedsføringsbudskap i artikler som publiseres i medisinske tidsskrifter. (The finding is from an analysis of 1500 documents unsealed in recent litigation against the giant drug company Wyeth (now part of Pfizer) that looked at how drug companies use ghostwriters to insert marketing messages into articles published in medical journals.)

Adriane Fugh-Berman, associate professor in the department of physiology at Georgetown University Medical Center in Washington, DC, who led the analysis, calls on the medical profession to take action to prevent the “unscrupulous relationships” between the industry and academia.

“Given the growing evidence that ghostwriting has been used to promote HT [hormone therapy] and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted,” she wrote in the article. (...)

(Anm: The Haunting of Medical Journals: How Ghostwriting Sold “HRT”. PLoS Med 7(9): e1000335 (September 7).)

Rapport ber om begrensninger på medisinsk spøkelsesskriving (ghostwriting)

Medicinska redaktörer beroende av ärliga författare
lakemedelsvarlden.se 1.9.2010
Att säkerställa att vetenskapliga artiklar inte undanhåller negativa resultat eller är skrivna av spökskrivare bygger till stor del på om personerna bakom artiklarna är ärliga. Det menar Sabine Kleinert, redaktör på Lancet.

SPÖKSKRIVERI Diskussionen om så kallade spökskrivna vetenskapliga artiklar blommar upp i Sverige och andra länder med jämna mellanrum. Att läkemedelsindustrin anlitar pr-företag som skriver artiklar och att välkända forskare lånar ut sina namn till studier som de inte varit med att genomföra har visat sig vara ett omfattande fenomen. I juni presenterade den europeiska forskande läkemedelsindustrin, Efpia, ett dokument med syfte att göra publiceringsprocessen ärligare. Där står bland annat att även resultat som är negativa för ett företag ska publiceras.

Sabine Kleinert är medicinsk redaktör på Lancet och har länge arbetat med att öka transparensen inom forskningen och tycker att dokumentet är ett steg på vägen.

- Men man önskar att ett sådant dokument kommit för många år sedan, känslan av äntligen, är den man känner mest, säger hon. (...)

(Anm: Spøkelsesforfattere (ghostwriters) (mintankesmie.no).)

US senator calls for tougher rules on ghostwriting (Amerikansk senator ber om tøffere regler for spøkelsesforfattere)
BMJ 2010;340:c3504 (30 June)
Senator Charles Grassley and the US Senate Committee on Finance have called for tougher rules and better disclosure about ghostwriting of journal articles. In a report issued on 24 June they have asked medical journals, medical centres, and the US National Institutes of Health (NIH) to impose stricter rules.

Senator Grassley, an Iowa Republican, has for years been investigating the ghostwriting of journal articles, funding of continuing medical education, and prominent researchers’ financial conflicts of interest. He is the senior Republican on the Senate finance committee.

The report says that, because journal articles influence medical practice and prescribing, undisclosed funding by drug and device manufacturers through medical communications companies could lead to publication of articles promoting sales of the companies’ products. (...)

Report Urges More Curbs on Medical Ghostwriting (Rapport ber om begrensninger på medisinsk spøkelsesskriving (ghostwriting))
nytimes.com 24.6.2010
Should more light be shed on the relationships between drug makers and certain prominent doctors who publish scientific articles about their medicines?

A new Congressional report calls on medical journals, medical schools and even the National Institutes of Health to take additional measures to ensure the integrity of the scientific articles many doctors rely on to make treatment decisions for their patients.

The report, issued Thursday by Senator Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee, focuses on medical ghostwriting.

Ghostwriting is the practice in which prominent researchers sign on as authors to articles for scientific journals that have been developed by third-party medical education companies at the behest of drug or medical device makers. Influential doctors listed as authors, the report said, have had varied input on articles drafted by industry-financed writers that have been published in medical journals.

Manipulasjon av medisinsk literatur kan føre til at leger forskriver legemidler som koster mer eller kan skade pasienter (...) (“Manipulation of medical literature could lead physicians to prescribe drugs that are more costly or may even harm patients,” the report said.)

The report, issued Thursday by Senator Charles E. Grassley of Iowa, the ranking Republican on the Senate Finance Committee, focuses on medical ghostwriting.

(Anm: Ghostwriting in Medical Literature Minority Staff Report 111th Congress United States Senate Committee on Finance Sen. Charles E. Grassley, Ranking Member
June 24, 2010 (nytimes.com).)

(Anm: Spøkelsesforfattere (ghostwriters) (mintankesmie.no).)

Senator asks US medical schools about rules on ghostwriting (Senator ber amerikanske skoler opplyse om regler for spøkelsesskriving)
BMJ 2009;339:b5013 (24 November)
Senator Chuck Grassley har bedt 10 ledende medisinske skoler om å offentliggjøre sine regler for undervisningspersonale som deltar i spøkelsesskriving. (...) (Senator Chuck Grassley has asked 10 leading US medical schools to disclose their rules on the involvement of their teaching staff in ghostwriting.)

Han beskriver medisinsk spøkelsesskriving, som involverer betaling fra legemiddelfirmaer eller medisinske utstyrsfirmaer, for markedsføring eller utkast til artikler, ledere, eller oversiktsartikler produsert av såkalte medisinske utdanningsfirmaer. (...) (He described medical ghostwriting as involving payment by drug and device manufacturers to marketing or medical education companies that drafted articles, editorials, or review papers.)

"Grassley skriver at firmaene egentlig bruker omdømmet til velrenommerte akademiske forskere og deres institusjoner til å promotere salget av legemidler og utstyr. ("Essentially the companies are using the reputation of prestigious academic researchers and their institutions to promote the sale of drugs and devices," Mr Grassley wrote.)

Senatoren uttalte, "Artikler publisert i medisinske tidsskrifter er i stor grad lest av praktiserende og stoles på som objektive og vitenskapelige. Informasjonen i disse artikler kan ha en signifikant innvirkning på legers forskrivningsatferd, og i sin tur, også amerikanske skattebetalere, slik som Medicare og Medicaid-programmer som betaler milliarder av dollar for reseptbelagte legemidler og medisinsk utstyr. Ethvert forsøk på å manipulere vitenskapelig litteratur, som i sin tur kan villede leger til å forskrive behandlinger som kan være ineffektive og/eller forårsake pasientskader, er svært problematisk." (The senator said, "Articles published in medical journals are widely read by practitioners and are relied upon as being objective and scientific in nature. The information in these articles can have a significant impact on doctors’ prescribing behaviour and, in turn, on the American taxpayer, as the Medicare and Medicaid programmes pay billions of dollars for prescription drugs and medical devices. Any attempt to manipulate the scientific literature, which can in turn mislead doctors to prescribe treatments that may be ineffective and/or cause harm to their patients, is very troubling.")

Senator Grassley sa også at spøkelsesskriving kan være en form for plagiat. Han dro analogien med universitetsstudenter som noen ganger bruker "fabrikkerte" arbeider og presenterer det som sitt eget, hvilket de blir irettesatt/straffet for. "Hva skjer når forskerne på det samme universitetet publiserer medisinske studier uten å erkjenne at de er skrevet av andre?" spurte han. (Senator Grassley also said that ghostwriting may be a form of plagiarism. He drew an analogy with university students who sometimes use papers produced in "paper mills" and present them as their own work, for which they are disciplined. "What happens when researchers at the same university publish medical studies without acknowledging that they were written by somebody else?" he asked.)

Senatoren har bedt medisinske skoler opplyse om hvorvidt de har skrevne retningslinjer for spøkelsesskriving, har gransket påstander om at en ansatt ikke har offenliggjort sin involvering i spøkelsesskriving, og hvorvidt universitetet hadde et synspunkt på plagiat. (...) (The senator has asked the medical schools whether they have written policies on ghostwriting and have investigated allegations that a staff member had not disclosed involvement in ghostwriting and whether the university had a position on plagiarism.)

(Anm: Spøkelsesforfattere (ghostwriters) (mintankesmie.no).)

Spøkelser i spaltene

Spøkelser i spaltene
LEDER
Tidsskr Nor Legeforen 2008; 128:1039 (1.5.2008)
Dokumenter fra amerikanske rettssaker gir en ubehagelig innsikt i hvordan deler av den medisinske forskningslitteraturen blir produsert

«Amerikanske rettstilstander» vekker ikke bare positive assosiasjoner på denne siden av Atlanteren. Men det kan komme noe nyttig ut av rettssakene, nemlig innsikt i og dokumentasjon av forhold man bare kunne ane noe om.

Det er skrevet mye om legemiddelindustriens innflytelse på medisinsk praksis (1), og i enkelte undersøkelser har man forsøkt å kvantifisere og dokumentere påvirkningen på forskningen og forskningslitteraturen (2, 3). To artikler som ble publisert i JAMA 16.4. 2008 står i en særstilling (4, 5). Redaktøren skrev i en ledsagende lederartikkel (6): «The profession of medicine, in every aspect - clinical, education, and research - has been inundated with profound influence from the pharmaceutical and medical device industries. This has occurred because physicians have allowed it to happen, and it is time to stop. Two articles in this issue of JAMA provide a glimpse of one company"s apparent misrepresentation of research data and its manipulation of clinical research articles and clinical reviews; such information and articles influence the education and clinical practice of physicians and other health professionals (6).» (...)

Spøkelsesforfattere

Ghost Busting
JAMA. 2010;304 (October 13)
Senate Finance Committee leaders have responded to complaints by the chair of the American Heart Association's (AHA’s) Scientific Publishing Committee that they had unfairly singled out the AHA's journal, Circulation, for publishing a ghostwritten article (Haffner SM et al. Circulation. 2002;106[6]:679-684). The 2002 article touted the benefits of rosiglitazone for lowering levels of certain biomarkers for cardiovascular risk in patients with type 2 diabetes.

An article about rosiglitazone ghostwritten on behalf of its manufacturer, GlaxoSmithKline, appeared in the journal Circulation, said leaders of the Senate Finance Committee.

Initially, Sen Max Baucus (D, Mont), Finance Committee chairman, and ranking member Sen Chuck Grassley (R, Iowa) warned Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, MD, in a July 12 letter that rosiglitazone was part of a ghostwriting program conducted by the drug's manufacturer, GlaxoSmithKline, and cited as evidence a paper that ultimately appeared in Circulation whose working title prior to publication was "Modifying Cardiovascular Risk in the Type 2 Diabetes Patient." The AHA argued in an August 23 letter to Hamburg that Circulation had not published a review article with such a title and that Baucus and Grassley needed to provide a correction for the record (http://freepdfhosting.com/d3154f434e.pdf). The senators countered in a September 1 letter to Hamburg (http://freepdfhosting.com/b8f1a6c5a6.pdf) that Circulation did indeed publish the ghostwritten article but that its title had been changed to "Effect of Rosiglitazone Treatment on Nontraditional Markers of Cardiovascular Disease in Patients With Type 2 Diabetes Mellitus."

The article's lead author, Steven M. Haffner, MD, of Baylor College of Medicine in Houston, gained notoriety when he was identified as a peer reviewer of a meta-analysis critical of rosiglitazone (Nissen SE and Wolski K. N Engl J Med. 2007;356[24]:2457-2471) who leaked the contents of that study to GlaxoSmithKline prior to its publication. (...)

Medical Publisher to Review Claim About Article’s Writer
NYTIMES.COM 19.12.2008
Elsevier, a medical publisher, said Friday that it would investigate a senator’s recent allegation that one of its journals published an article on hormone replacement therapy that was improperly ghostwritten by a drug company promoting the product. (...)

Senator Charles E. Grassley, Republican of Iowa, had raised questions about the May 2003 “Editors’ Choice” article in Elsevier’s American Journal of Obstetrics and Gynecology. The article, signed by Dr. John Eden, an Australia academic, was among articles Mr. Grassley has cited that were favorable to drugs made by the pharmaceutical company Wyeth. (...)

Sen. Grassley Sends Letters to Wyeth, Medical Communications Firm Seeking Information About Journal Article (Senator Grassley ber i brev til Wyeth og medisinsk kommunikasjonsfirma om informasjon om tidsskriftartikler)
kaisernetwork.org 15.12.2008
Senate Finance Committee ranking member Chuck Grassley (R-Iowa) on Friday sent separate letters to Wyeth and DesignWrite , a New Jersey-based medical communication company, to request information about payments that Wyeth allegedly made to DesignWrite to ghostwrite medical journal articles about its hormone-replacement therapy drug Prempro, the New York Times reports. The letters are a part of a broader ongoing congressional probe into the relationship and influence that the pharmaceutical industry might have on physicians and the health care industry (Wilson, New York Times , 12/13). (...)

(Anm: Spøkelsesforfattere (ghostwriters) (mintankesmie.no).)

Wyeth’s Use of Medical Ghostwriters Questioned (Stilles spørsmål ved Wyeths bruk av spøkelsesforfattere)
NYTIMES.COM 13.12.2008
(...) “Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling,” Mr. Grassley, an Iowa Republican, wrote Friday to Wyeth’s chairman and chief executive, Bernard J. Poussot. (...)

From Agenda Item to Published Medical Article (Fra punkt på dagsorden til artikkel publisert i medisinsk tidsskrift)
NYTIMES.COM 12.12.2008
In the years before a federal study found in 2002 that the drug maker Wyeth’s female hormone replacement treatment Prempro raised a patient’s risk of breast cancer, the company actively solicited medical journal articles favorable to the drug, according to documents obtained in patient lawsuits.

The sequence presented here shows the process by which DesignWrite, a medical writing firm hired by Wyeth, began planning an academic article in 1997 about hormone therapy. The article, eventually published in 1999 in the journal Primary Care Update for OB/GYNs, concluded that supplemental estrogen — an ingredient in Prempro and Wyeth’s other main hormone therapies — actually reduced a woman’s chance of breast cancer. (...)

Drug Maker Said to Pay Ghostwriters for Journal Articles (Legemiddelfirma hevdes å betale spøkelsesforfattere for tidsskriftartikler)
NYTIMES.COM 12.12.2008
Wyeth, the pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its female hormone replacement therapy Prempro, according to Congressional letters seeking more information about the company’s involvement in medical ghostwriting. At least one article was published even after a federal study found the drug raised the risk of breast cancer.

The letters, sent electronically Friday by Senator Charles E. Grassley, ask Wyeth and DesignWrite, a medical writing firm, to disclose payments related to the preparation of journal articles and the activities of doctors who were recruited to put their names on them for publication.

The letters are part of a continuing investigation by Mr. Grassley, a member of the Senate Finance Committee, into drug industry influence on doctors.

“Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling,” Mr. Grassley, an Iowa Republican, wrote Friday to Wyeth’s chairman and chief executive, Bernard J. Poussot.

Phone calls and e-mail messages to Wyeth and DesignWrite were not immediately returned. (...)

- Slutt med spøkelsene

Give up the ghosts (Slutt med spøkelsene)
Nature 2010;468:732 (09 December)
The spectral fingerprints of a big drug company have once again been found all over academic publications. Documents released last week by a watchdog group based in Washington DC raise concerns about the role of writers paid by GlaxoSmithKline (GSK) in works attributed to psychiatric researchers at a number of US institutions. They add to the drumbeat of allegations in recent years indicating that such ghostwriting — in which articles contain substantial portions written by someone who is not listed as an author — is endemic in the biomedical literature.

The documents were made available as a result of litigation over GSK's antidepressant Paxil (paroxetine) and were pounced on by the Project on Government Oversight, which raised concerns about authorship of a research article, journal editorial and textbook. (...)

So, how clear are the rules on ghostwriting? A study last year found that just 10 out of 50 top US academic medical centres had explicit, web-accessible policies that prohibit the practice. Another three banned ghostwriting in practice without naming it as such (J. R. Lacasse and J. Leo PLoS Med. 7, e1000230; 2010). (...)

- Spøkelsesskriving fortsetter i størrre medisinske tidsskrifter

Ghost Writing Persists in Major Medical Journals (Spøkelsesskriving fortsetter i størrre medisinske tidsskrifter)
nlm.nih.gov 1.11.2011
Analysis of 6 journals found 'inappropriate authorship' despite ethical concerns. (Analyser av seks tidsskrifter fant "upassende forfatterskap" til tross for etiske bekymringer)

WEDNESDAY, Oct. 26 (HealthDay News) -- Honorary and ghost authors were involved in 21 percent of articles published in six leading medical journals in 2008, which shows that this type of inappropriate authorship remains a problem, a new study says.

Honorary authors are people named as authors despite not making a substantial enough contribution to take responsibility for the research. Ghost authors are people who play a major role in the research or who participate in writing the article, but are not named as authors.

The lack of transparency and accountability associated with both types of inappropriate authorship has been a concern for decades, according to the study authors.
More than 600 biomedical journals have adopted guidelines for responsible and accountable authorship established by the International Committee of Medical Journal Editors, but previous research has found that the prevalence of honorary authors in articles is as high as 39 percent and the use of ghost authors as high as 11 percent.
In this new study, U.S. researchers compared the prevalence of honorary and ghost authors in articles published in six leading medical journals in 1996 and 2008.
Information from 630 authors who responded to the researchers' survey showed that the overall prevalence of articles with inappropriate authorship fell from 29 percent in 1996 to 21 percent in 2008.

There was no change in the prevalence of honorary authors over that time, but there was a large decline in the prevalence of ghost authors.

Original research articles had higher rates of both types of inappropriate authorship than review articles or editorials.

The study was published online Oct. 25 in the British Medical Journal.

"Increased efforts by scientific journals, individual authors and academic institutions are essential to promote responsibility, accountability and transparency in authorship, and to maintain integrity in scientific publication," the researchers wrote in a journal news release. (...)

(Anm: Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey. BMJ 2011; 343:d6128 (25 October).)

Honorary and ghost authorship in high impact biomedical journals: a cross sectional survey
BMJ 2011; 343:d6128 (25 October)
(...) Objectives To assess the prevalence of honorary and ghost authors in six leading general medical journals in 2008 and compare this with the prevalence reported by authors of articles published in 1996. (...)

Design Cross sectional survey using a web based questionnaire.

Setting International survey of journal authors. (...)

Conclusions Evidence of honorary and ghost authorship in 21% of articles published in major medical journals in 2008 suggests that increased efforts by scientific journals, individual authors, and academic institutions are essential to promote responsibility, accountability, and transparency in authorship, and to maintain integrity in scientific publication. (...)

- Bedrageri som markedsføringsverktøy

Sun Editorial: Deception as marketing tool (Lederartikkel Sun: Bedrageri som markedsføringsverktøy)
lasvegassun.com 24.8.2009
Drug industry writers behind some articles purportedly written by doctors

A student who hands in a term paper under his own name when in fact it had been written by someone else has committed a serious breach of ethics.
The same is true for doctors who allow their bylines to appear above articles published in medical journals when in fact the articles were largely produced by ghostwriters pushing a product.

According to stories published Wednesday by The New York Times and the Associated Press, many doctors have been persuaded by drug companies to cooperate on such articles.

A “sophisticated ghostwriting program” used by London-based drugmaker GlaxoSmithKline to promote an antidepressant pill called Paxil was an example given by AP. Although the company says it has discontinued the ghostwriting program, the news service obtained court documents showing that it had used this marketing tactic. (...)

- Journals Should Require Disclosure, Editorial Says

Journals Should Require Disclosure, Editorial Says
kaisernetwork.org 24.7.2006
Medical journals, which appear to lack the ability to "stop printing articles by scientists with close ties" to pharmaceutical and medical device companies, "should at least force the authors to disclose their conflicts of interest publicly, so that doctors and patients are forewarned that the interpretations may be biased," a New York Times editorial says. According to the editorial, "Many journals have been tightening their disclosure and publication policies in recent years," and both the Journal of the American Medical Association and Neuropsychopharmacology -- which recently published articles that failed to disclose author ties to companies -- "plan further tightening." However, such reforms "are not likely to go far enough," the editorial says, adding, "It seems imperative that more muscle be put into forcing disclosure and publication of conflicts of interest." The editorial says, "If all leading journals agreed to punish authors who fail to reveal their conflicts by refusing to accept further manuscripts from them, a lot more authors would be inclined to fess up. Better yet, journals should try much harder to find authors free of conflicts." The editorial concludes, "That is the best hope for retaining credibility with doctors and the public" (New York Times, 7/23). (...)

- Misvisende kommunikasjon av risiko

Misleading communication of risk (Misvisende kommunikasjon av risiko)
BMJ 2010; 341:c4830 (12 October)
Editors should enforce transparent reporting in abstracts (Redaktører bør innføree transparent rapportering i abstrakter)

In 1996 a review of mammography screening reported in its abstract a 24% reduction of breast cancer mortality¹; a review in 2002 claimed a 21% reduction.² Accordingly, health pamphlets, websites, and invitations broadcast a 20% (or 25%) benefit.³ Did the public know that this impressive number corresponds to a reduction from about five to four in every 1000 women, that is, 0.1%? The answer is, no. In a representative quota sample in nine European countries, 92% of about 5000 women overestimated the benefit 10-fold, 100-fold, and more, or they did not know.⁴ For example, 27% of women in the United Kingdom believed that out of every 1000 women who were screened, 200 fewer would die of breast cancer. But it is not only patients who are misled. When asked what the “25% mortality reduction from breast cancer” means, 31% of 150 gynaecologists answered that for every 1000 women who were screened, 25 or 250 fewer would die.³ (...)

Missing clinical trial data: setting the record straight (Manglende kliniske data: dokumentasjon av påstander)
BMJ 2010; 341:c5641 (12 October)
Urgent action is needed to restore the integrity of the medical evidence base

Like us, you have probably grown accustomed to the steady stream of revelations about incomplete or suppressed information from clinical trials of drugs and medical devices.¹ If so, this issue of the BMJ features a pair of papers that will dismay but not surprise you. Researchers for an official German drug assessment body charged with synthesising evidence on the antidepressant reboxetine encountered serious obstacles when they tried to get unpublished clinical trial information from the drug company that held the data, an experience from which they draw several lessons (doi:10.1136/bmj.c4942).² (...)

(Anm: reboxetine (Edronax) (felleskatalogen.no).)

Medisinske tidsskrifter - deklarering av interessekonflikter

New England Journal of Medicine Alters Policies In Response to Complaints Over Conflicts of Interest
kaisernetwork.org 9.1.2009
The New England Journal of Medicine changed its procedures regarding conflict of interest disclosures after a letter by the Accreditation Council for Continuing Medical Education criticized the publication for not disclosing a study author's financial conflicts of interest, the New York Times reports.

The study in question was conducted in 2006 by Claudia Henschke of Weill Cornell Medical College. The study found that widespread use of CT scans could prevent 80% of lung cancer deaths. According to the Times, the study did not disclose that Henschke's work was funded in part by a $3.6 million grant from the parent company of the Liggett Group, a cigarette maker. NEJM editors said they were unaware of the connection. Henschke did disclose to NEJM that she and her university had licensed a CT-related patent to General Electric, a maker of CT scanners, but NEJM decided not to disclose that information to readers. (...)

Psych Journal Discloses Editorial Board Conflicts (Psykiatriske tidsskrifter offentliggjør redaksjonens konflikter)
pharmalot.com 2.9.2008
Now that a Senate investigation into ties between prominent academic psychiatrists, universities and drugmakers have made national headlines (look here, here, here and here), a leading journal has decided to disclose conflicts of interests held by its editorial board members.

In an editorial, Ronald Pies, the editor in chief of Psychiatric Times, writes “I believe that this policy will help ensure fair and accurate reporting, as well as balanced and scientifically grounded opinion and commentary.” After all, he notes, “it is the editor in chief’s job to know of potential conflicts and to make executive decisions accordingly.”

However, the Integrity in Science Watch program writes that the move “only raises further questions about who is calling the shots at leading psychiatric journals,” and the notes that guidelines from The International Committee of Medical Journal Editors say “editors who make final decisions about manuscripts should have no personal financial involvement in any of the issues they might judge.”

Meanwhile, the ISW points out that top editors of psychiatric journals often have such ties and include - guess who? - Pies. There’s also Robert Freedman, editor in chief of the American Journal of Psychiatry, Jan Fawcett, medical editor of Psychiatric Annals, and Alan Gelenberg, editor in chief of the Journal of Clinical Psychiatry. Click on the links and you’ll find they receive education grants or consulting fees from drugmakers that sell psychiatric meds. (...)

Om leger, forskning og legemiddelfirmaer

Læger tigger luksus hos medicinalindustrien
politiken.dk 27.5.2006
Der er behov for moralsk oprustning i lægestanden, mener formanden for medicinalindustriens etiske nævn.

Danske læger går nu direkte til medicinalindustrien for at blive smurt med kontante pengebeløb til gode middage og selskabelighed.

»Vi kan konstatere at der navnlig blandt lægerne er mange, der er ude med tiggerhuen i hånden«, siger Kaspar Linkis, dommer i Vestre Landsret, og formand for medicinalindustriens etiske nævn - NMI.

Superligaens læger fik middagen betalt
Han har en række eksempler på læger, der beder om penge, så der kan komme mere pomp og pragt over deres møder. (...)

For eksempel hospitalsafdelingen, der bad om et medicinalfirma betale forplejning, mad og drikke til deres årsmøde. Eller Superligaens 14 læger, der bad Merck Sharpe & Dome om 25.000 kr. til et selskabeligt arrangement på et Københavnsk hotel - og fik dem.

Tidligere var det medicinalindustriens virksomheder smurte læger, apotekere og andre kundegrupper med dyre middage og eksotiske udlandsrejser. (...)

Uavhengig journalistikk

Legetidsskrift uten journalister
Journalisten.no 11.2.2004
All journalistisk virksomhet i Tidsskrift for Den norske lægeforening er opphørt. Tidsskriftet har tapt rundt ti millioner annonsekroner.

Tidsskrift for Den norske lægeforening kvitter seg med 3,5 årsverk. Journalistene har fått andre jobber i Legeforeningen.

- Det er synd journalistene blir borte. Men i en såpass dramatisk situasjon, så er man alltid nødt til å gå i kjelleren for å finne ut hva vi må gjøre for å føre tidsskriftet videre. Det er 125 år gammelt. Det er i dag mange som driver helsejournalistikk - også dagspressen. Men nøytral faginformasjon er det bare vi som driver med. Vi er en kilde for journalistikken, sier redaktør Charlotte Haug i Tidsskrift for Den norske lægeforening til Journalisten.

- Utsatt for boikott

Haug sier at tidsskriftet ble offer for en annonseboikott i fjor.

- De seks største legemiddelforeningene gjennomførte rett og slett en annonseboikott fra 1. mars til 1. oktober i fjor. Boikotten var ikke direkte rettet mot driften av tidsskriftet, men det var en slags protest mot norsk legemiddelpolitikk. Vi har på det meste omsatt annonser for 20 millioner kroner, og håpet på at forholdene ville stabilisere seg etter boikotten. Men nå er vi nede i halvparten, sier Haug.

Ingen reportasjer

- Hva skjer nå?

- Vi skal fortsatt utgi tidsskriftet hver 14. dag, med rundt hundre sider fagartikler hver gang. Reportasjene blir borte, men vi satser på å beholde portrettintervjuet. Det blir ikke så veldig store forandringer i bladet. Journalistikk er ikke et vesentlig bidrag til vårt fagblad, sier Haug.

Tidsskrift for Den norske lægeforening har et opplag på rundt 22.000 eksemplarer. (...)

Bør medisinske tidsskrifter inneholde legemiddelreklame - ja eller nei?

Medical schools, take the lead
BMJ 2007;335:172 (28 July)
Journals and drug advertising
It is not only journal editors who need to take leadership in changing the culture of acceptance of drug advertising^{1 2}: medical schools also need to recognise their responsibility. (...)

Beware advertising packages
BMJ 2007;335:172 (28 July)
Journals and drug advertising
In post-Soviet Russia, almost all journals depend mostly on advertisements.^{1 2} The most prosperous journals bring profits for their owners, and the owners then press the journals to raise more money through advertisements. This does not reduce the pressure on the content of the journal but introduces another—the demand for more profits. (...)

Should medical journals carry drug advertising? Yes
BMJ 2007;335:74 (14 July)
Richard Smith, executive director
UnitedHealth Europe, London SW1P 1SB
richardswsmith@yahoo.co.uk
No one can fail to notice the adverts in medical journals but are they really necessary? Richard Smith maintains they are essential to editorial independence, whereas Gareth Williams argues that they undermine a journal's integrity

The central argument for carrying advertising in medical journals is independence. Ironically, the main argument against may also be independence, but you can place greater trust in a journal that carries advertising than one that does not. (...)

Should medical journals carry drug advertising? No
BMJ 2007;335:75 (14 July)
Gareth Williams, dean
Faculty of Medicine and Dentistry, University of Bristol, Bristol BS2 8DZ
Gareth.Williams@bris.ac.uk
No one can fail to notice the adverts in medical journals but are they really necessary? Richard Smith maintains they are essential to editorial

ndependence, whereas Gareth Williams argues that they undermine a journal's integrity (...)

Independence and other things

Independence and other things
BMJ 2007;335 (21 July)
Last week we heard from Richard Smith that revenues from drug advertising may be an important pillar of editorial independence (doi: 10.1136/bmj.39259.472998.AD). His article, and a news story this week, have got me thinking about what independence means, what its limits are—since limits there must be—and what it's for. On the previous page in the print journal (and at bmj.com/bmj/about-bmj if you're online) you'll see some small but crucial words: "The BMA grants editorial freedom to the editor of the BMJ." Why are these words crucial? Because they mean that what you read in the BMJ has been judged by the editor to be in the best interests of science, medicine, and patient care. (...)

NEJM credibilty knocked over Vioxx

NEJM credibilty knocked over Vioxx
pharmatimes.com 6.7.2006
The credibility of the New England Journal of Medicine is at stake after the former Editor of the British Medical Journal, Richard Smith, publicly criticized editorial decisions that he says delayed the publication of corrections to Merck & Co's VIGOR study of the now-withdrawn painkiller Vioxx (rofecoxib).

Writing in the Journal of the Royal Society of Medicine, Dr Smith said: "It is unfortunate that the New England Journal of Medicine waited five years before publishing a correction to its VIGOR study, which was published in November 2000. Concerns about the correctness of the study were raised with the NEJM's editor, Jeff Drazen, as early as August 2001, the drug was withdrawn in 2004 and yet it wasn't until December 2005 that the journal published its first correction."

The VIGOR (Vioxx Gastrointestinal Outcomes Research Study) trial involved some 8,000 patients who were given either the conventional non-steroidal anti-inflammatory drug naproxen or the COX-2 inhibitor Vioxx, and showed those given the newer drug experienced less gastrointestinal side effects than those on naproxen (121 versus 56).

However, VIGOR also came under scrutiny after demonstrating significantly fewer heart attacks in patients taking naproxen compared to those receiving Vioxx. Merck asserted for years that this effect was a result of naproxen's ability to block platelet aggregation and so has a cardioprotective effect, but was forced finally to withdraw the drug in 2004 in light of new evidence from the APPROVe trial showing it in fact doubled the risk of heart attacks and stroke in patients taking it for more than 18 months. Most recently, a new analysis of the APPROVe trial suggests Vioxx may even exert these adverse cardiovascular effects after as little as four months' treatment.

Then, in December last year, the NEJM alleged that the authors of the article deleted pertinent data shortly before submitting the manuscript for publication, which emerged only after they were made public by the US Food and Drug Administration. Merck insisted that the three excluded heart attack cases did not materially affect the conclusions of the study and were reported after the pre-specified cut-off date for the article, while the NEJM has since defended itself by saying the correct data were available to view on the FDA's website.

But Dr Smith says that is not good enough. "Doctors, pharmacists and health professionals do not obtain their information by searching through copious data on the FDA website; they get it from leading journals," he said. "The journal failed its readers. It has damaged its reputation." (...)

Tidsskriftsredaktør hevder hun ble villedet

Journal Editor Again Says She Was Misled
nytimes.com 19.7.2006
CHICAGO, July 18 — Days after announcing a crackdown on researchers who do not disclose drug company ties, the editor of The Journal of the American Medical Association said she was misled again, this time by the authors of a study linking severe migraines to heart attacks in women. (...)

Medical journal claims it was misled again
miami.com 19.7.2006
The editor of the Journal of the American Medical Association said the authors of a study failed to reveal possible conflicts of interest.

CHICAGO - Just days after announcing a crackdown on researchers who do not disclose drug-company ties, the editor of a prestigious medical journal says she was misled again -- this time by the authors of a study linking severe migraines to heart attacks in women.

All six of the study's authors have done consulting work or received research funding from makers of treatments for migraines or heart-related problems. Their research appears in today's Journal of the American Medical Association, a week after the crackdown was announced.

The authors said they did not report their financial ties because they did not believe they were relevant to the study.

Dr. Catherine DeAngelis, JAMA's editor in chief, said journal editors did not know about the ties until The Associated Press brought them to her attention late last week.

''We'll get killed,'' she said, referring to the potential damage to the journal's reputation.

She said she would have published the authors' associations with drug makers had she known about them. ''Let me decide what's pertinent or not,'' DeAngelis said. "The issue is not what can those companies possibly gain; it is the issue of perception.''

Last week, JAMA disclosed that the authors of a depression study failed to report ties to makers of antidepressants. And two months ago, the journal reported similar omissions from authors of a study linking certain arthritis drugs to cancer.

JAMA has long required researchers whose articles it will publish to sign statements disclosing all potential financial conflicts. An editorial last week said JAMA was getting tougher as a result of the recent breaches.

JAMA's new policy, effective in January, requires disclosures even before articles are accepted for publication.

Other leading medical journals, including the New England Journal of Medicine, JAMA's main competitor, have disclosure requirements, but DeAngelis said hers are the toughest. Editors say disclosures are necessary to help readers judge the reliability of research.

JAMA posted a letter online Tuesday from the authors explaining the omissions, DeAngelis' response and a correction.

DeAngelis said they would also be published in an upcoming print edition of the journal.

''Authors should always err on the side of full disclosure,'' she wrote in her response.

Dr. Tobias Kurth, the study's lead author, said the researchers were not trying to mislead the journal. He said they believed their financial ties were irrelevant because the study does not promote drug treatment, but rather reports a potential link between women with severe migraines and an increased risk of heart attacks.

''They do not represent a conflict of interest,'' he said in a telephone interview. (...)

Our Conflicted Medical Journals

Medical Journal’s Policies (1 Letter)
nytimes.com 29.7.2006
To the Editor:
Re “Our Conflicted Medical Journals” (editorial, July 23): We strongly object to your characterization of the Journal of the American Medical Association as a “conflicted medical journal,’’ and to your unfair association of JAMA with an incident at the journal Neuropsychopharmacology. (...)

In fact, we recently tightened this request by requiring all authors to report all of their financial associations in detail in the manuscript at the time of submission.

In a few recent cases in which authors have deliberately failed to disclose relevant financial associations, we have requested and received special investigations by deans, resulting in significant sanctions of the authors. In others, we have freely and openly exposed failures of authors to disclose in special editorials and letters rather than simply publishing corrections in the journal. (...)

Our Conflicted Medical Journals
EDITORIAL
nytimes.com 23.7.2006
Leading medical journals seem to be having a difficult time disentangling themselves from the pharmaceutical and medical device industries. If they cannot stop printing articles by scientists with close ties to these businesses, they should at least force the authors to disclose their conflicts of interest publicly so that doctors and patients are forewarned that the interpretations may be biased.

Two disturbing cases were described in detail by The Wall Street Journal in re