- Kongressrapport ber om begrensninger (nytimes.com 24.6.2010)

- Industrien bruker spøkelsesforfattere (Tidsskr Nor Lægeforen 2005 (27. april))

Slutt med spøkelsene (Nature 2010;468:732 (09 December))

Forskerne sier spøkelsesforfatterskap (Ghost authorship) er vanlig for industrifinansierte forsøk (BMJ 2007;334:223 (3 February))

Om den ikke-skrivende forfatter (gjestespøkelsessyndromet) Den ikke-skrivende forfatter, som kanskje ikke er involvert i forskningen og er blitt anmodet om å forfatte for å øke artikkelens prestisje, har den endelige kontrollen over manuskriptet. Men mange av disse forfatterne er travelt opptatt og kan kanskje ikke gjennomføre en grundig gjennomgang. Dette gjestespøkelsessyndromet (31,32) er et voksende fenomen, spesielt i den kommersielle sektor, hvor de allmennpraktiserende leger som driver forskning har liten interesse i forfatterskap. (N Engl J Med 2000;342:1539-44)

Hold gjesteforfattere av spøkelsesskrevet forskning ansvarlig for svindel, sier jurister (BMJ 2011; 343:d4955 (3 August))

Tidligere ble publikasjoner skrevet av studiens ledende forsker

Men i det siste har det utviklet seg en praksis som en kanskje skulle benevne som ikke-skrivende forfatter-ikke-forfatter skriversyndrom. (N Engl J Med 2000;342:1539-44)

Mercks Vioxx-spøkelser (BMJ 2008;336:849 (19 April))

Krever uberettiget forfatterskap (etikkom.no 10.1.2007)

- Ubehagelige allianser – kliniske forskere og den farmasøytiske industri

Uneasy Alliance - Clinical Investigators and the Pharmaceutical Industry (Ubehagelige allianser – kliniske forskere og den farmasøytiske industri)
N Engl J Med 2000;342:1539-44
(...) Hvor stor innflytelse har industrien på arbeidet og produkter i forskningssamfunnet? Kan allmennpraktiserende leger stole på den informasjon de mottar om de legemidler som de forskriver? Gir skiftet fra akademisk til kommersiell forskningssektor industrien for mye kontroll over legemiddelstudiene? (...) (How much influence does industry have over the work and products of the research community? Can practicing physicians trust the information they receive about the medications they are prescribing? Does the shift from the academic to the commercial research sector give industry too much control over clinical drug trials?)

Authorship (Forfatterskap)
Tidligere ble publikasjoner skrevet av studiens ledende forsker. Men i det siste har det utviklet seg en praksis en kanskje skulle benevne som ikke-skrivende forfatter-ikke-forfatter skriver-syndrom. Mange intervjuer gjennomført for denne rapporten bekreftet den store utbredelsen av dette syndromet i publikasjonen av rapporter fra legemiddelforsøk, lederartikler og oversiktsartikler. Syndromet har to særtrekk: en profesjonell medisinsk forfatter (”ghostwriter”) som arbeider for et legemiddelfirma, CRO, eller medisinsk kommunikasjonsfirma, som er betalt for å skrive en artikkel men som ikke er navngitt som forfatter; og en klinisk forsker ("gjesteforfatter”), som fremstår som forfatter men som verken analyserer dataene eller skriver manuskriptet. (28,29,30) Spøkelsesforfattere skriver en artikkel utfra en liten pakke materiale som de mottar; hvor de kanskje blir instruert til å inkludere et hovedbudskap som favoriserer firmaets produkt. (...) (In the past, publications were written by a study’s principal investigator. More recently, a practice that one might call the nonwriting author-nonauthor writer syndrome has developed. Many interviews conducted for this report confirmed the wide prevalence of this syndrome in publications of drug-trial reports, editorials, and review articles. The syndrome has two features: a professional medical writer (”ghostwriter”) employed by a drug company, CRO, or medical communications company, who is paid to write an article but is not named as an author; and a clinical investigator ("guest author"), who appears as an author but does not analyze the data or write the manuscript. (28,29,30))240,241,242 (Levy D. Ghostwriters a hidden resource for drug makers. (Ghostwriters typically receive a packet of materials from which they write the article; they may be instructed to insert a key paragraph favorable to the company’s product.)

(Anm: (28,29,30) USA TODAY 25.09.1996; Larkin M. Whose article is it anyway? Lancet 1999;354:136; Editorial. Ghost with a chance in publishing undergrowth. Lancet 1993;342:1498-9.)

(Anm: CRO; Contract-Research Organizations; kontraktforsknings-organisasjoner.)

Den ikke-skrivende forfatter, som kanskje ikke er involvert i forskningen og er blitt anmodet om å forfatte for å øke artikkelens prestisje, har den endelige kontrollen over manuskriptet. Men mange av disse forfatterne er travelt opptatt og kan kanskje ikke gjennomføre en grundig gjennomgang. Dette gjestespøkelsessyndromet (31,32) er et voksende fenomen, spesielt i den kommersielle sektor, hvor de allmennpraktiserende leger som driver forskning har liten interesse i forfatterskap. (...) (The nonwriting author, who may be uninvolved in the research and have been requested to author the article to enhance its prestige, has final control over the manuscript. But many of these authors are busy and may not perform a thorough review. This guest-ghost syndrome (31,32) is a growing phenomenon, particularly in the commercial sector, where community-physician investigators have little interest in authorship.)

(Anm: (31,32) Rennie D, Flanagin A. Authorship! Authorship! Guests, ghosts, grafters, and the two-sided coin. JAMA 1994;271:469-71) (Brennan TA. Buying editorials. N Engl J Med 1994;331:673-5.)

(Anm: Skiftet fra akademiske til kommersielle legemiddelnettverk (CRO - Kontraktsforskningsorganisasjoner) (mintankesmie.no).)

- Konklusjon: Dekonstruksjon av rettsdokumenter avslørte at protokollspesifikke resultater ikke viste statistisk signifikant forskjell mellom citalopram og placebo. Den publiserte artikkelen konkluderte imidlertid med at citalopram var trygt og betydelig mer effektivt enn placebo for barn og ungdom, med mulige bivirkninger mht. pasientsikkerhet.

(Anm: The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance. OBJECTIVE: Deconstruction of a ghostwritten report of a randomized, double-blind, placebo-controlled efficacy and safety trial of citalopram in depressed children and adolescents conducted in the United States. (…) CONCLUSION: Deconstruction of court documents revealed that protocol-specified outcome measures showed no statistically significant difference between citalopram and placebo. However, the published article concluded that citalopram was safe and significantly more efficacious than placebo for children and adolescents, with possible adverse effects on patient safety. Int J Risk Saf Med. 2016 Mar 16;28(1):33-43.)

(Anm: Cipralex (Lexapro) (escitalopram) - Cipramil (Celexa) (cipramil) (citalopram) - H. Lundbeck A/S (mintankesmie.no).)

(Anm: Media (mediekritikk) (mintankesmie.no).)

(Anm: - Definitivt redaktørmakt. (…) Hva som skal trykkes i en avis er jo gjenstand for en silingsprosess som avisen alene står for. Meg bekjent er det ingen åpenhet hverken i Aftenposten eller i noen andre medier om hvilke standarder som benyttes i utvelgelsen. Er det den redaksjonelle linjen som avgjør? Er det hva som er nyhetsverdig eller er det salgstallene som bestemmer? Eller kanskje avisens politiske orientering? (aftenposten.no 10.11.2016).)

(Anm: NRK og Adresseavisen lot tips om at lærer mobbet egne elever på barneskole i Trondheim ligge. (…) – Svikter barna. (…) Han undrer seg også over at ingen medier stiller kritiske spørsmål til de ansvarlige i kommunen om hvordan mobbingen kunne pågå. (…) NRK og Adresseavisen lot tips om at lærer mobbet egne elever på barneskole i Trondheim ligge. Sjefredaktør Tor Olav Mørseth i Adressa sier det handler om prioriteringer. (journalisten.no 24.2.2017).)

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

(Anm: Språk, språkforståelse og utdanning (mintankesmie.no).)

- Spøkelsesskriving: viktigheten av forklaringer og dens plass i dagens markedsføring av legemidler

Ghostwriting: the importance of definition and its place in contemporary drug marketing (Spøkelsesskriving: viktigheten av forklaringer og dens plass i dagens markedsføring av legemidler)
BMJ 2016;354:i4578 (Published 30 August 2016)
Alastair Matheson beskriver hvordan legemiddelfirmaer søker å legitimere spøkelsesskrevne publikasjoner ved å endre sine forklaringer mens de avleder oppmerksomhet fra sin bredere markedsføringspraksis i sin teoretiske publisering. (Alastair Matheson describes how the pharmaceutical publications industry seeks to legitimise ghostwriting by changing its definition while deflecting attention from wider marketing practices in academic publishing.) (…)

Nøkkelpunkter (Key points)
- Spøkelsesskriving fortsatt utbredt i industrifinansiert medisinsk tidsskriftslitteratur, selv om omdefinering betyr at det ikke alltid er merket som sådan ( -Ghostwriting remains widespread in industry financed medical journal literature, although redefinition means it is not always labelled as such)

- Legemiddelindustriens bruk av medisinske forfattere er bare én av flere midler som akademisk litteratur kan bli påvirket av i markedsføringsøyemed (-The drug industry’s use of medical writers is only one of various means through which scholarly literature may be influenced for marketing purposes)

-ICMJE-reglene bør endres for å sikre at industriens medisinske forfattere blir krediteres med medforfatterskap og for å sikre at industriens at foranlediget litteratur blir bedre forklart og merket ( -ICMJE rules should be modified to ensure that industry medical writers are credited with coauthorship and to ensure that industry instigated literature is better attributed and labelled )

- Standarddefinisjonen på spøkelsesskriving bør gjeninnføres innen medisinen, og at industriens aktiviteter innenfor publiseringsetikk blir gjenstand for etisk studie. (- Standarddefinisjonen på spøkelsesskriving bør gjeninnføres innen medisin, og industriens aktiviteter innenfor publiseringsetikk blir gjenstand for etisk studie.)

(Anm: Medical literature has seen a positive evolution of transparency. BMJ 2016;354:i5043 (Published 20 September 2016).)

(Anm: Journalists: anything to declare? (Journalister: noe å deklarere?) BMJ 2007;335:480 (8 September).)

(Anm: GlaxoSmithKline vil betale uafhængige sundhedsjournalister på eksempelvis Politiken for hjælp til omtale af lægemiddelstudie. »Helt skævt«, siger journalistformand. (politiken.dk 30.1.2016).)

(Anm: Sponsing av journalistikk (mintankesmie.no).)

(Anm Sponsorer gir 40.000 studenter fri tilgang til Schibsteds nettaviser. (…) Nå utvides studentkonseptet til seks nye skoler, med tre sponsorer på laget, BDO, KPMG og Adlibris. Til sammen 40.000 studenter vil nå få fri tilgang flere av Schibsteds aviser. Det er Aftenposten, Bergens Tidende, Stavanger Aftenblad og Fædrelandsvennen. På trappene er også en lansering på den åttende skolen, NTNU i Trondheim. Med NTNU på plass vil Schibsted og partner nå 70.000 studenter.) (kampanje.no 31.10.2016).)

(Anm: Ytringsfrihet og offentlighet. (mintankesmie.no).)

(Anm: Fra fengsling av journalister til det usynlige, økonomiske fengsel. Medieoligarkene brer om seg. (…) Se hva som skjer: TV 2 og staten ble enige. TV 2 skal være en kommersiell allmennkringkaster. Staten legger en solid slump på bordet, oppå bordet. I tillegg ligger det i kortene at staten skal besørge annonsering i hundremillionersklassen hvert år, og skattelovene får finurlige forskrifter som internt i Finansdepartementet kalles Lex TV 2. (medier24.no 7.8.2016).)

(Anm: Thalidomide og media: "Det är utomordentligt viktigt att PR-avdelningen i framtiden anstränger sig ännu mera än hittills för att hålla nära kontakt med framstående vetenskapsmän och opinionsbildare." (Thalidomide and the Power of the Drug Companies. Penguin Books. Stockholm: Bokforlaget Sjöström & Sjöström, 1972 (s. 108)).)

(Anm: Fri tilgang til forskningsresultater? (forskningsdata) (mintankesmie.no).)

(Anm: The hidden side of clinical trials | Sile Lane | TEDxMadrid (youtube.com).)

(Anm: Forvaltningsmakt og kunnskapspolitikk. Sammendrag. Helse- og omsorgsdepartementet benekter at de ønsker å styre forskninga i underliggende etater, og ser ingen problemer med at forskninga ligger under forvaltninga. Rus & Samfunn 05 / 2016 (Volum 9) Side: 33-35.)

(Anm: Frie forskere eller maktens lakeier? Abstrakt. Det går et skisma gjennom den samfunnsvitenskapelige rusforskningen. Ved første øyekast er det vanskelig å forstå hvorfor. Rus & Samfunn 05 / 2016 (Volum 9) Side: 36-40.)

(Anm: Nesten halvparten av alle studier som er gjennomført av store sponsorer i det siste tiåret er upublisert (Nearly half of all trials run by major sponsors in past decade are unpublished.) BMJ 2016;355:i5955 (Published 04 November 2016).)

(Anm: Who's not sharing their trial results? (trialstracker.ebmdatalab.net).)

(Anm: Transparency for patients: How much is too much? (pharmafile.com 11.10.2016).)

(Anm: Parlamentsmedlemmer hører at kliniske forsøk er byråkratiske, uklare, og forvirrende for forskere og pasienter. (…) "Det har vært en rekke kjente tilfeller hvor godkjente legemidler er basert på ufullstendig informasjon — og hvor den informasjonen som senere er stilt til rådighet har vist at legemidlet er ineffektivt eller faktisk skadelig.  (Clinical trials are bureaucratic, opaque, and offputting to researchers and patients, MPs hear.) BMJ 2013;346:f1711 (14 March 2013).)

(Anm: Informasjon versus kunnskap og makt (kommersialisering og monopolisering av kunnskap) (mintankesmie.no).)

(Anm: Lederartikler. Å gjøre pasientrelevant klinisk forskning til en realitet. Forskere, bidragsytere (sponsorer; finansiører) og utgivere har alle et arbeid å gjøre (Editorials. Making patient relevant clinical research a reality. Researchers, funders, and publishers all have work to do.) BMJ 2016;355:i6627 (Published 23 December 2016).)

(Anm: Mer kritisk tenkning blant folk med utdannelse? (…) Kritisk tenkning er vår beste sikkerhetsventil mot maktovergrep, tyrannisering, og overtro. (…) Mer kritisk tenkning blant folk med utdannelse?) (…) Er kritisk tenkning utbredt? I så fall blant hvem? (fritanke.no 14.6.2013).)

(Anm:- Jeg sørger over fattigdommen i vår kritiske tenkning. (I mourn the poverty of our critical thinking.) BMJ 2012;345:e5409 (10 August).)

(Anm: Aage Borchgrevink, forfatter og seniorrådgiver i Den norske Helsingforskomite. Ingenting er sant og alt er mulig. (…) I Russland ligger staten bak, mens amerikanske falske nyheter var en forretningsmodell. (…)  I en tid der det finnes mer informasjon enn noensinne, er folk relativt sett dårligere informert enn før. (nrk.no 5.2.2017).)

(Anm: George Orwells «1984» er en bestselger etter Trump-innsettelse. (…) Boken et en dystopisk fortelling om et fremtidig samfunn der fakta blir forvrengt og undertrykt. Folket overvåkes, opposisjonen forsvinner og historien omskrives. (vg.no 25.1.2017).)

(Anm: Michael Flynn trækker sig: Trumps sikkerhedsrådgiver blev ramt af sin egen løgn. Trump accepterer opsigelse fra sin nationale sikkerhedsrådgiver. Aflytning af den russiske ambassadørs telefon tog Michael Flynn i en løgn. (politiken.dk 14.2.2017).)

(Anm: Skrekken for åpenhet i forvaltning, byråkrati og politisk ledelse er et demokratisk problem (aftenposten.no 25.3.2015).)

(Anm: Margaret McCartney: Bevis i en post-fakta-verden (Evidence in a post-truth world.) Gjør internett oss dummere? Utfallet av det amerikanske presidentvalget vil bli analysert som en skarp case-studie lenge etter at vi alle er døde, men internett må i det minste ta noe av skylden. Vi lever i et post-faktum, post-sannhet, vi har fått nok av ekspert-æraen. (Is the internet making us more stupid? The outcome of the US presidential election will be analysed as a caustic case study long after we’re all dead, but the internet must take at least some of the blame. We’re in a post-fact, post-truth, we’ve-had-enough-of-experts era. BMJ 2016;355:i6363 (Published 28 November 2016.)

(Anm: - De som tror intelligens er fastlåst har selvtillit som overgår deres evner. (…) Forskerne bemerker at overdreven selvtillit er et dokumentert problem hos bilførere, motorsyklister, strikkhoppere, leger og advokater. Journal of Experimental Social Psychology 2016;63:94-100 (March 2016).)

(Anm: Medisinering av psykisk utviklingshemmede (Lørdagsrevyen 12.11.2011).)

(Anm: Tror psykose­medisin tok livet av Renate. Da søsteren til Anniken Hoel døde brått, sto familien uten svar. Til det viste seg at «plutselig død» var en mulig bivirkning av medisinene hun tok. (nrk.no 13.3.2017).)

(Anm: Overmedisinering av eldre (NRK Dagsrevyen) (…) Flere eldre dør av overmedisinering. (...) Vi er kommet dit at vi aksepterer lettere at pasienter dør av bivirkninger av medisiner enn av selve sykdommen. (nrk.no 10.2.2017).)

(Anm: Moren (85) ble syk av behandlingen på sykehjem: – Hadde ikke forventet at de skulle ødelegge et menneske med medisiner. Beboere på norske sykehjem bruker i gjennomsnitt syv medikamenter hver, viser tall fra Regjeringens demensplan 2020. Ofte er tallet mye høyere. (tv2.no 18.5.2017.)

(Anm: Han blei medisinert til døde (nrk.no 12.11.2011).)

(Anm: Havarikommisjoner (undersøkelseskommisjoner) (mintankesmie.no).)

(Anm: Bruk av annengenerasjons antipsykotiske legemidler øker parametre for metabolsk syndrom. (dgnews.docguide.com 17.3.2016).)

- Studien viser sammenhengen mellom metabolsk syndrom og risiko for kognitive sykdommer.

(Anm: Study shows link between metabolic syndrome and risk of cognitive disorders. A study presented at the European Academy of Neurology Congress in Amsterdam has shown that obesity alone is not a risk factor for cognitive disorders, but commonly associated co-morbidities such as diabetes, high blood pressure, and metabolic disorders are. Dementia diseases in patients who suffer from diabetes are often treated inadequately, a new research paper reveals. It has long been supposed that patients with metabolic syndrome are more likely to suffer from cognitive impairment - and to a greater extent. Reasons are thought to include chronic inflammatory processes which can induce neuroinflammatory and neurodegenerative changes. Whether obese individuals without risk factors such as diabetes mellitus, metabolic disorders and the presence of albumin in the urine have an increased risk of cognitive impairment is still little researched. (news-medical.net 27.6.2017).)

(Anm: Metabolic Syndrome Components Are Associated With Symptomatic Polyneuropathy Independent of Glycemic Status. Diabetes Care 2016 (Published online before print March 10, 2016).)

(Anm: Patients With Polyneuropathy Receive Long-Term Opioid Therapy, No Clear Benefit. CHICAGO -- May 23, 2017 -- Polyneuropathy is associated with an increased likelihood of long-term opioid therapy, but therapy does not appear to improve functional status, according to a study published online by JAMA Neurology. Polyneuropathy is a common painful condition, especially among older patients, which can result in functional impairment. (dgnews.docguide.com 23.5.2017).)

(Anm: Prepsychosis links with elevated metabolic syndrome. MADRID – Untreated people at high risk for developing psychosis also showed an increased prevalence of certain components of metabolic syndrome in data collected from 163 German study participants, a finding that gives new insight into the well-documented but poorly delineated link between schizophrenia and metabolic syndrome. (...) He also suggested prescribing antipsychotic medications that pose the lowest risk for causing further metabolic derangements in patients. (clinicalpsychiatrynews.com.com 2.4.2016).)

(Anm: Joachim Raese, MD. Metabolic syndrome is defined by the aggregation of hypertriglyceridemia, low high-density lipoprotein (HDL) levels, elevated fasting glucose, hypertension, and increased waist circumference. Metabolic syndrome confers an increased risk of developing diabetes and of dying from coronary artery disease. Cardiovascular disease is the leading cause of death among patients with schizophrenia, who have a life expectancy about 20 years shorter than the general population. (…) For a more detailed discussion, I suggest watching a YouTube video that we have prepared. (cmeinstitute.com 27.4.2016).)

(Anm: Video Lecture 8: Metabolic Syndrome Lectures 1 (By Dr. Joachim Raese) (youtube.com).)

(Anm: - Lege får 30 år til livstid for drap i sak i L.A. knyttet til pasienters overdoser. (Doctor gets 30 years to life for murders in L.A. case tied to patients' overdoses.) (…) En dommer dømte fredag en lege i Rowland Height til 30 år til livstid i fengsel for drapene på tre av sine pasienter som følge av dødelig overdose, en dom som satte sluttstrek i en "landmark"-sak som enkelte medisinske eksperter sier kan endre hvordan leger i hele landet håndterer forskrivningen av reseptbelagte legemidler. (latimes.com 5.2.2016).)

(Anm: Diskriminering, feilmedisineringer hos mennesker med utviklingshemming og utfordrende atferd (psykofarmaka; antidepressiva, antipsykotika, sovemedisiner) etc. (mintankesmie.no).)

(Anm: På tide å revurdere? (Time to rethink?) Legemiddelbehandlinger hos mennesker med utviklingshemming og utfordrende atferd (Drug treatments in people with intellectual disability and challenging behaviour disabilities) Editorials (Lederartikkel) BMJ 2014;349:g4323 (Published 04 July 2014).)

(Anm: - Slår sovepiller os ihjel? (- Studiet er det største af sin slags på globalt plan og har også undersøgt sammenhængen mellem brug af antidepressiver og antipsykotika og dødelighed. Også her fandt forskerne en overdødelighed.) (videnskab.dk 21.3.2016).)

- Forskerne sier spøkelsesforfatterskap er vanlig for industrifinansierte forsøk

Ghost authorship of industry funded drug trials is common, say researchers (Forskerne sier spøkelsesforfatterskap er vanlig for industrifinansierte forsøk)
BMJ 2007;334:223 (3 February)
Ghost authorship, whereby someone who has made a major contribution to a scientific article as an author is not acknowledged, is a widespread practice, says a study published this week.

In the clinical trials investigated in the study, three quarters of individuals who had made significant contributions to the final paper were not listed as authors (PLoS Medicine 2007;4:e19). In most cases these were statisticians working for the company sponsoring the trial.

"Ghost authorship is a form of research misappropriation, and we believe that this practice serves commercial purposes," said the study's lead author, Peter Gøtzsche, of the Nordic Cochrane Centre in Copenhagen.

"Authorship establishes accountability, responsibility, and credit for scientific articles. If authorship is misappropriated, readers may be misled, and the potential for manipulated analyses and conclusions may increase," he added.
(...)

(Anm: Ghost Authorship in Industry-Initiated Randomised Trials. PLoS Medicine 2007;4:e19.)

(Anm: Peter Gøtzsche: »Én mand kan godt ændre videnskaben«. Han har sammenlignet medicinalindustrien med Hitlerjugend og har fået en stor del af den danske psykiaterstab på nakken, da han for nylig udgav bogen ’Dødelig psykiatri og organiseret fornægtelse’. Mød Peter Gøtzsche; internationalt anerkendt professor, som ikke er bange for at være udiplomatisk. (videnskab.dk 13.11.2015).)

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

- 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. (...)

– Mitt intryck var att alla på mötet ansträngde sig att komma med goda nyheter för företaget Agnovos Healthcare och deras produkt.

USA-företag styrde forskarmöte
liu.se 10.12.2015 (Linköpings universitet)
Ortopediprofessorn Per Aspenberg trodde att han var inbjuden till ett akademiskt möte med världens främsta forskare inom osteoporos, benskörhet. Väl på plats vid Genèvesjöns strand fick han veta att ett amerikanskt företag låg bakom.

– Mitt intryck var att alla på mötet ansträngde sig att komma med goda nyheter för företaget Agnovos Healthcare och deras produkt, säger Per Aspenberg som publicerar en featureartikel i British Medical Journal under rubriken "How I was nearly duped into 'authoring' a fake paper". (…)

Hur dokumenterades mötet?
– Spökskrivaren skulle skriva en ”vetenskaplig” artikel med oss alla som författare. En av deltagarna är redaktör för en inflytelserik osteoporostidskrift där den skulle publiceras. Mitt i juli kom manuskriptet och vi fick kort tid på oss att kommentera. ”Profylaktiska operationer”, i synnerhet Agnovos metod beskrevs i positiva ordalag. Mina synpunkter, bland annat om att riskerna rimligen var större än nyttan, fanns inte med. Artikeln var falsk och jag bad att mitt namn skulle strykas i författarlistan, vilket också skedde. (…)

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

(Anm: How I was nearly duped into “authoring” a fake paper. Academics need to beware of the dangers of flattery, says Per Aspenberg. BMJ 2015;351:h6605 (Published 08 December 2015).)

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

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

- Vioxx-studier skrevet av Merck - brukte spøkelsesforfattere og selektive data i Vioxx-publikasjoner

Merck used ghostwriters and selective data in Vioxx publications, JAMA says (Merck brukte spøkelsesforfattere og selektive data i Vioxx-publikasjoner, ifølge JAMA)
BMJ 2008;336:849 (19 April)
Researchers and editors claim in two papers and an editorial this week that Merck, the makers of the arthritis drug rofecoxib (Vioxx), misrepresented study results and used ghostwriters to prepare manuscripts for journal publication.
The authors of the articles have drawn their evidence from thousands of documents released during lawsuits against Merck over adverse events related to the drug (JAMA 2008;299:1800-12, 1813-7, and 1833-5).

Rofecoxib was withdrawn worldwide in September 2004 after a study showed that it doubled the risk of heart attack or stroke if it was taken for more than 18 months (BMJ 2004;329:816; doi: 10.1136/bmj.329.7470.816-a). (...)

(Anm: Guest Authorship and Ghostwriting in Publications Related to Rofecoxib (Gjesteforfatterskap og spøkelseskrevne publikasjoner relatert til Rofecoxib)
JAMA 2008;299(15):1800-1812.

Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment. JAMA 2008;299(15):1813-1817.

Impugning the Integrity of Medical Science: The Adverse Effects of Industry Influence (Setter spørsmålstegn ved medisinsk forsknings integritet: Den uheldige effekt av industriens innflytelse). JAMA. 2008;299(15):1833-1835.)

(Anm: Vioxx - informasjon vs kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

Vioxx study shows complex researcher involvement (Vioxx-studie viser kompleks forsker delaktighet)
reuters.com 16.4.2008
WASHINGTON, April 16 (Reuters) - Every few months, Stephen Ferris would receive folders of papers with clinical descriptions of patients suspected to have Alzheimer's disease.

Ferris, the Gerald J. and Dorothy R. Friedman Professor of Psychiatry and director of New York University's Alzheimer's Disease Center, would help decide if a patient had developed Alzheimer's disease.

He never saw a patient. Yet his name is listed as second author on the study in the journal Neuropsychopharmacology in March 2005.

Wednesday's issue of the Journal of the American Medical Association alleges this is a clear demonstration of "guest writing." (...)

Merck dolde fakta om dödlig medicin
svd.se 16.4.2008
Kända forskare står med sina namn bakom rapporter från läkemedelsstudier. I själva verket är författarna ofta anställda på läkemedelsföretag eller inhyrda spökskrivare. (...)

Merck Wrote Drug Studies for Doctors
nytimes.com 16.4.2008
The drug maker Merck drafted dozens of research studies for a best-selling drug, then lined up prestigious doctors to put their names on the reports before publication, according to an article to be published Wednesday in a leading medical journal. (...)

Spökskrivare bakom vetenskapliga rapporter
svd.se 15.4.2008
Ett stort antal vetenskapliga rapporter om läkemedel är skrivna av anställda på läkemedelsföretag eller betalda spökskrivare. Men deras namn hålls hemliga. Istället köps ledande akademiska forskare in som författare ibland utan att ha haft något med studierna att göra. En ledande vetenskaplig tidskrift kräver nu ett stopp för "manipulationerna". (...)

Drug giant Merck accused of deaths cover-up (Legemiddelgiganten Merck anklaget for å dekke over dødsfall)
newscientist.com 15.4.2008
It is perhaps the biggest drug scandal of recent years. Before Merck withdrew Vioxx in 2004, the popular painkiller was linked to heart attacks in tens of thousands of people. Now researchers have alleged that Merck knew of the dangers years earlier, but tweaked statistics and hid data so that regulators remained in the dark.

Vioxx was a blockbuster drug for Merck in the 5 years it was on the market, generating billions of dollars in revenue. After it was linked to heart attacks and strokes, the firm pulled its product, and earlier this year Merck agreed to provide almost US$5 billion in compensation to those claiming to have been harmed.

But an analysis of documents released during the litigation process that led to that settlement, carried out by Richard Kronmal, a statistician at the University of Washington, Seattle, who acted as an expert witness in the Merck lawsuits, suggests that company scientists were aware of the problems well before 2004. (...)

Spökskrivare bakom vetenskapliga rapporter
svd.se 15.4.2008
Ett stort antal vetenskapliga rapporter om läkemedel är skrivna av anställda på läkemedelsföretag eller betalda spökskrivare. Men deras namn hålls hemliga. Istället köps ledande akademiska forskare in som författare ibland utan att ha haft något med studierna att göra. En ledande vetenskaplig tidskrift kräver nu ett stopp för "manipulationerna". (...)

Merck dolde fakta om dödlig medicin
svd.se 16.4.2008
Kända forskare står med sina namn bakom rapporter från läkemedelsstudier. I själva verket är författarna ofta anställda på läkemedelsföretag eller inhyrda spökskrivare. (...)

Vioxx-studier skrevs av spökskrivare
lakemedelsvarlden.se 16.4.2008
Amerikanska Merck använde systematiskt spökskrivare och betalade akademiska forskare för att använda deras namn på vetenskapliga studier om Vioxx. Det visar en ny genomgång av företagets interna material som publiceras i JAMA idag. (...)

I en artikel som publiceras i JAMA idag presenterar fyra amerikanska forskare ett antal exempel på hur manipulationen gått till. Forskarna har gått igenom det omfattande material som blivit offentligt i och med rättegångarna som pågår i USA mellan Merck (som i Sverige heter MSD) och Vioxx-patienter. Bland miljontals dokument har de vaskat fram 250 dokument som innehåller diskussioner om vilka forskare som ska stå som författare för de vetenskapliga studierna.

Ett exempel är en klinisk prövning som undersökte om Vioxx fördröjde utbrottet av Alzheimer hos patienter med tidiga symtom. Den kliniska prövningen gjordes av åtta forskare på Merck. I en intern version av studien står de Merck-anställda forskarna som författare. Men före deras namn står det ”External author?”. I slutversionen som sedan publicerades i tidskriften Neuropsychopharmacology har frågetecknet bytts ut mot namnen på tre akademiska forskare. Själva texten och den vetenskapliga analysen skiljde sig inte nämnvärt mellan den första versionen och slutversionen. Det tolkar forskarna som att själva studien, analysen och artikelförfattandet i stort sett var färdigt innan de externa forskarna blev involverade. (...)

Reports: Data on Vioxx was misused (Rapporter: Data på vioxx ble misbrukt)
usatoday.com 16.4.2008
Corporate and government documents from Vioxx lawsuits indicate that the drug's maker, Merck & Co., apparently downplayed evidence showing the painkiller tripled the risk of death in Alzheimer's-prone patients, researchers report today.

A separate analysis of court documents revealed that many Vioxx studies were prepared or written by Merck employees or paid consultants, not the doctors named as the studies' lead authors, researchers say.

Doctors involved in the analyses, published in The Journal of the American Medical Association, some of whom served as plaintiffs' witnesses, say the trove of information that Merck was compelled to produce offers a rare window into the world of billion-dollar drugs and the lengths to which a company will go to advance and protect its interests.

"The drug industry appears to treat scientific data as if they were a marketing tool," says the University of Washington's Bruce Psaty, a co-author of one of the JAMA articles. "That's not appropriate." (...)

Corporate and government documents from Vioxx lawsuits indicate that the drug's maker, Merck & Co., apparently downplayed evidence showing the painkiller tripled the risk of death in Alzheimer's-prone patients, researchers report today.

A separate analysis of court documents revealed that many Vioxx studies were prepared or written by Merck employees or paid consultants, not the doctors named as the studies' lead authors, researchers say. (...)

Impugning the Integrity of Medical Science: The Adverse Effects of Industry Influence (Setter spørsmålstegn ved medisinsk forsknings integritet: Den uheldige effekt av industriens innflytelse)
JAMA. 2008;299(15):1833-1835.
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 articles1-2 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. The direct influence of for-profit companies on education3-6 and clinical practice7-8 has been well documented, so this Editorial deals primarily with clinical research. (...)

Key Vioxx Research Was Written by Merck, Documents Allege (Vioxx grunnforskning ble skrevet av Merck, viser dokumenter)
healthfinder.gov 15.4.2008
Rapporter viser at akademikere ble betalt for å låne deres navn til spøkelsesskrevne studier som overdrev smertestillende legemidlers sikkerhet. (Reports say academics paid to lend their names to ghost-written studies that exaggerated painkiller's safety.)

TUESDAY, April 15 (HealthDay News) -- Industry documents reveal that pharmaceutical giant Merck & Co. paid academics to put their names on Vioxx research published in top medical journals while company employees often ghost-wrote the studies on the controversial cox-2 painkiller.

The company apparently also exaggerated the safety of the medication in published clinical trials, and the academics frequently did not disclose industry financial support, the documents allege.

Two articles detailing these findings, the latest episode in the Byzantine tangle surrounding the former best-selling pain reliever, appear in the April 16 issue of the Journal of the American Medical Association.

The scope of the analysis was significant. The researchers combed through 250 documents that included 24 clinical trials, 72 review articles and numerous editorials to come to their conclusions. The Vioxx articles appeared in more than a dozen medical journals, including the New England Journal of Medicine and JAMA.

"These are extraordinary manuscripts, and they reveal the inner workings of the promotion of a drug that ultimately turned out to be a hazard," said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. (...)

Key Vioxx Research Was Written by Merck, Documents Allege (Vioxx grunnforskning ble skrevet av Merck, viser dokumenter)
healthfinder.gov 15.4.2008
Rapporter viser at akademikere ble betalt for å låne deres navn til spøkelsesskrevne studier som overdrev smertestillende legemidlers sikkerhet. (Reports say academics paid to lend their names to ghost-written studies that exaggerated painkiller's safety.)

TUESDAY, April 15 (HealthDay News) -- Industry documents reveal that pharmaceutical giant Merck & Co. paid academics to put their names on Vioxx research published in top medical journals while company employees often ghost-wrote the studies on the controversial cox-2 painkiller.

The company apparently also exaggerated the safety of the medication in published clinical trials, and the academics frequently did not disclose industry financial support, the documents allege.

Two articles detailing these findings, the latest episode in the Byzantine tangle surrounding the former best-selling pain reliever, appear in the April 16 issue of the Journal of the American Medical Association.

The scope of the analysis was significant. The researchers combed through 250 documents that included 24 clinical trials, 72 review articles and numerous editorials to come to their conclusions. The Vioxx articles appeared in more than a dozen medical journals, including the New England Journal of Medicine and JAMA.

"These are extraordinary manuscripts, and they reveal the inner workings of the promotion of a drug that ultimately turned out to be a hazard," said Dr. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic. (...)

Guest Authorship and Ghostwriting in Publications Related to Rofecoxib (Gjesteforfatterskap og spøkelseskrevne publikasjoner relatert til Rofecoxib)
JAMA 2008;299(15):1800-1812
A Case Study of Industry Documents From Rofecoxib Litigation (...)

Conclusions This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support. (...)

Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment
JAMA 2008;299(15):1813-1817
A Case Study Based on Documents From Rofecoxib Litigation

Sponsors have a marketing interest to represent their products in the best light. This approach conflicts with scientific standards that require the symmetric and comparable reporting of safety and efficacy data. Selective reporting of the results of clinical trials can misrepresent the risk-benefit profile of drugs. We summarize how the sponsor represented mortality findings associated with rofecoxib in clinical trials of patients with Alzheimer disease or cognitive impairment. We reviewed documents that became available during litigation related to rofecoxib involving Merck & Co, including internal company analyses and information provided by the sponsor to the FDA. We also evaluated information in 2 published articles that reported results of these trials. In one article (reporting results of protocol 091) published in 2004, 11 "non-drug related deaths" were reported (9 deaths among 346 rofecoxib patients and 2 deaths among 346 placebo patients). In another article (reporting results of protocol 078) published in 2005, 39 deaths were reported among patients taking study treatment or within 14 days of the last dose (24 among 725 rofecoxib patients and 15 among 732 placebo patients) and an additional 22 deaths in the off-drug period (17 in rofecoxib patients and 5 in placebo patients). However, these articles did not include analyses or statistical tests of the mortality data, and the 2 articles concluded that regarding safety, rofecoxib is "well tolerated." (...)

- Glaxo brukte spøkelsesforfattere (skjulte bidragsytere) til å pushe Seroxat

Summary Box: Glaxo used ghostwriting to push Paxil (Oppsummering: Glaxo brukte spøkelsesforfattere (skjulte bidragsytere) til å pushe Seroxat)
forbes.com 19.8.2009
British drugmaker GlaxoSmithKline PLC used a ghostwriting operation called CASPPER to promote its antidepressant Paxil, allowing doctors to take credit for journal articles mainly written by company consultants, according to court documents.

Here are some details from the memo, which instructs salespeople to approach physicians and offer to help them write and publish articles in medical journals:

_ The company offers to help doctors with everything from "developing a topic" to "writing a first draft."

_ The program's goal is to "strengthen the product positioning and overcome competitive issues."

_ The company expects that "physicians will be eager to participate in CASPPER regardless of their professional stature," adding "less experienced physicians may be interested in building their reputation in the field." (...)

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

Inside GSK's CASSPER Ghostwriting Program
industry.bnet.com 21.8.2009
A look inside GlaxoSmithKline’s CASSPER ghostwriting brochure reveals that Paxil Product Management at GSK expected its drug sales reps to control the process, even with doctors who were clearly unfamiliar with existing published data on the drug.

BNET noted yesterday that GSK (formerly SmithKline Beecham in the U.K.) maintained the program to create ghostwritten medical journal articles about its antidepressant, Paxil. (...)

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

Glaxo used ghostwriting program to promote Paxil (Glaxo brukte spøkelsesforfatter-program for å promotere Seroxat)
google.com/hostednews/ap 19.8.2009 (AP)
WASHINGTON — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

Known as the CASPPER program, the paper explains how the company can help physicians with everything from "developing a topic," to "submitting the manuscript for publication." (...)

Glaxo used ghostwriting program to promote Paxil (Glaxo brukte spøkelsesforfattere (skjulte bidragsytere) til å pushe Seroxat)
google.com/hostednews/ap 19.8.2009 (AP)
WASHINGTON — Court documents show drugmaker GlaxoSmithKline used a ghostwriting program to promote its antidepressant Paxil, letting doctors take credit for medical journal articles written by company consultants.

An internal company memo instructs salespeople to offer to help physicians write and publish articles about their positive experiences prescribing Paxil.

The document was uncovered by the Los Angeles law firm, Baul and Hedlund, which alleges Glaxo downplayed the risks of the drug, including increased suicidal behavior in young adults.

The April 2000 memo states that the program aimed to "strengthen the product positioning and overcome competitive issues," facing Paxil.

A spokeswoman for the British drugmaker had no immediate comment Wednesday afternoon. (...)

GSK Used Ghostwriting to Push Paxil (GSK Glaxo brukte spøkelsesforfattere (skjulte bidragsytere) til å pushe Seroxat)
pharmpro.com 21.8.2009
WASHINGTON (AP) — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press. (...)

Court documents show Glaxo used CASPPER (the friendly ghostwriting program) to promote Paxil
latimes.com 19.8.2009
WASHINGTON (AP) — Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

Known as the CASPPER program, the paper explains how the company can help physicians with everything from "developing a topic," to "submitting the manuscript for publication."

The document was uncovered by the Baum Hedlund PC law firm of Los Angeles, which is representing hundreds of former Paxil users in personal injury and wrongful death suits against GlaxoSmithKline. The firm alleges the company downplayed several risks connected with its drug, including increased suicidal behavior and birth defects. (...)

CASPPER, GlaxoSmithKline’s Friendly Ghostwriting Program
online.wsj.com 23.8.2009
Drug makers have been taking heat for a while now over ghostwritten articles in medical journals. Basically, there have been instances where drug companies went out and found doctors willing to put their names on articles that the company paid someone else to write or make significant contributions to. (...)

Inside GSK's CASSPER Ghostwriting Program
industry.bnet.com 21.8.2009
A look inside GlaxoSmithKline’s CASSPER ghostwriting brochure reveals that Paxil Product Management at GSK expected its drug sales reps to control the process, even with doctors who were clearly unfamiliar with existing published data on the drug.

BNET noted yesterday that GSK (formerly SmithKline Beecham in the U.K.) maintained the program to create ghostwritten medical journal articles about its antidepressant, Paxil. (...)

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

- 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. (...)

- Rapport ber om begrensninger på medisinsk spøkelsesskriving (ghostwriting)

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)
.)

- Spøkelsesforfattere må være mer synlige

Ghost writers need to be more visible (Spøkelsesforfatter må være mer synlige)
Personal views
Keith Dawes, clinical research scientist and medical writer 1 PRA International, Reading
BMJ 2007;334:208 (27 January)
What is a medical writer? A medical writer is a professional writer who is hired to write scientific or medical documents, including manuscripts for publication in peer reviewed journals. Most medical writers are employed by drug companies, contract research organisations, or medical communication agencies, but there are also freelance medical writers and consultants.

Currently medical writers contribute extensively to medical journals, mostly as unheralded "ghost writers." Medical writers also have an important role in medical education, drug development, and drug marketing. Though mostly unseen, unappreciated, and misunderstood, they nevertheless add quite a bit of grease to the wheels of science publishing. It has been claimed that at least 50% of all publications on treatments in the BMJ, Lancet, and New England Journal of Medicine have been written by an unacknowledged ghost writer (BMJ 2004;329:937; 2004;329:1345). (...)

Rapid Responses published: (...)

- Hold gjesteforfattere av spøkelsesskrevet forskning ansvarlig for svindel

Hold guest authors of ghostwritten research liable for fraud, say legal scholars (Hold gjesteforfattere av spøkelsesskrevet forskning ansvarlig for svindel, sier jurister)
BMJ 2011; 343:d4955 (3 August)
Holding the “guest author” of a ghostwritten paper legally liable for fraud may help to curb the practice in the face of the reluctance of universities and journals to act, argue legal scholars in PLoS Medicine (2011;8(8):e1001070, doi:10.1371/journal.pmed.1001070).

Universities and journals “have been slow on the uptake and haven’t done much” to tackle ghostwriting because they often have divided loyalties and don’t want to confront the powerful figures who are recruited as guest authors, the paper’s lead author, Simon Stern, a law professor at the University of Toronto, told the BMJ.
“We propose a solution by an actor outside of the medical community that doesn’t have those divided loyalties,” Professor Stern said.

Using the US legal system as an example, Professor Stern and his coauthor, Trudo Lemmens, write that class action and the Racketeer Influenced and Corrupt Organizations Act laws might both be used to prosecute and seek damages over ghostwriting. (...)

“Guest authors” and journals may accrue a modest financial gain and increased stature in surreptitiously publishing such a paper, but discovery and punishment would constitute a significant deterrent for them both, he said. By comparison, the sanctions likely to be imposed on a drug company would be “a drop in the bucket” for one with a blockbuster drug with sales of more than a billion dollars a year, Mr Stern said. These companies have a much greater incentive to support ghostwriting.

He acknowledged that bringing patients into the mix of plaintiffs might significantly increase the financial penalty of a guilty verdict. But doing so would require proving causality and harm, which are more difficult to do, he said. (...)

(Anm: Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles. PLoS Med 8(8): e1001070 (August 2).)

Challenging Medical Ghostwriting in US Courts (Still medisinske spøkelsesforfattere for amerikansk rett)
PLoS Med 2012;9(1): e1001163 (January 24)
(...) Summary Points
- Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.
- In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
- For example, when an injured patient's physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.
- In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.
- Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.
- Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud. (...)

Key Opinion Leaders Who Lend Their Names to Ghostwritten Medical Articles Should Be Held Legally Liable, Article States
prweb.com 25.1.2012
Prominent physicians who lend their names to ghostwritten, industry-financed medical articles that convey fraudulent misinformation resulting in harm to patients should be held legally liable, according to a new article published today in PLoS. The article was co-written by Baum, Hedlund, Aristei & Goldman attorney Bijan Esfandiari along with Dr. Xavier Bosch from the University of Barcelona and Dr. Leemon McHenry from California State University, Northridge. http://www.baumhedlundlaw.com/drug-injury-press-releases/ghostwritten-medical-articles-liability.php

Baum, Hedlund, Aristei & Goldman reports that the authors of an article published on January 24, 2012 in the medical journal PLoS (Public Library of Science) suggest that prominent physicians (also known as Key Opinion Leaders or “KOLs”) who lend their names to ghostwritten, industry-financed medical articles that convey fraudulent misinformation resulting in harm to patients should be held legally liable.

The article, entitled "Challenging Medical Ghostwriting in the US Courts," was co-written by Baum Hedlund attorney Bijan Esfandiari along with Dr. Xavier Bosch from the University of Barcelona and Dr. Leemon McHenry from California State University, Northridge.

The authors describe the practice of improper medical ghostwriting as, not only infringing on academic standards, but, in many cases, they argue it “contributes to fraud.” They explain the practice as “industry-financed writers generating articles that either promote the sponsor company’s products or discredit competing ones, with eventual authorship credited to academic researchers who provide little or no input, thereby concealing industry involvement and contributing to distorted drug profiles.” Marketing messages are “planted in the ghostwriter’s first draft well before a nominal author is selected,” according to the authors, and often “falsely tou[t] the purported benefits of the drug and fai[l] to disclose the side effects.” They argue the practice, which has “long tainted journal content and jeopardized patient safety,” should be outlawed.

Numerous examples of medical ghostwriting have been uncovered in lawsuits involving drugs such as Neurontin, Paxil, Zoloft, fen-phen, Vioxx and Prempro where courts have unsealed formerly confidential internal company documents. In other cases, the extent of medical ghostwriting remains under court seal (e.g., Avandia, Zyprexa, Seroquel, Bextra and Celebrex). (...)

Prominent physicians who lend their names to ghostwritten articles containing fraudulent representations resulting in harm to patients should be held legally liable. - Bijan Esfandiari (...)

- Kjære lege: Dersom du krediteres for en spøkelseskreven artikkel kan du bli saksøkt

Ghostwriting – how does academic medicine justify it? (Spøkelsesskriving - hvordan rettferdiggjør akademisk medisin dette?)
blogs.plos.org 5.8.2011
We’re always interested at PLoS Medicine in different perspectives on the ghostwriting problem. Following considerable news coverage of our recent Stern and Lemmens paper on legal liability for ghostwriting, another article, this one by Jonathan Leo and colleagues (who have previously written for us on the lack of ghostwriting policies in major US medical schools), has appeared in Society. In it they offer some explanations for why ghostwriting is “allowed” in academic medicine.

The parts I found most intriguing were their examples of how academic medicine is complicit. We all know that in the “publish or perish” environment of medical academia publications are currency, which must help explain why many academic guest authors receive no monetary payment at all for their unethical and dishonest collusion with pharma that allows them to take (academic) credit for papers they didn’t write.

But don’t institutions expect their faculty and members to publish ethically and in the best interest of patients? (...)

Dear Doctor: If you take credit for a ghostwritten article, you could be sued (Kjære lege: Dersom du krediteres for en spøkelseskreven artikkel kan du bli saksøkt)
blogs.plos.org 2.8.2011
Ghostwriting is not only an unethical practice, but it may also constitute legal fraud, according to an article by University of Toronto law professors Simon Stern and Trudo Lemmens, published this week in PLoS Medicine. As such, they argue that medical academics who serve as “guest authors” could be held legally liable.

It’s irrelevant whether publications with academic guest authors are factually accurate, Stern and Lemmens say. What’s important is the false gravitas given to claims of safety and effectiveness through the use of academic authors when these claims–contained in articles ghostwritten by industry but guest authored by academics–are used as scientific evidence in the courtroom. So not only does the dishonest and manipulative practice of ghostwriting undermine the integrity of medical research and patient care (as many previous PLoS Medicine articles have argued), but now we can see how a guest author’s claim for credit of an article written by someone else constitutes legal fraud.

The legal repercussions for the company that sponsored the research reports could be severe. Stern and Lemmens say that patients and others could file class action suits based on the Racketeer Influenced and Corrupt Organizations (RICO) Act, as well as make claims of ‘‘fraud on the court’’ against a pharmaceutical company that has used ghostwritten articles in litigation.

Even though industry personnel write these ghostwritten medical and scientific articles, the academic authors serving as guest authors still receive substantial professional credit for their work. And so, Stern and Lemmens take a hard line, saying that the legal remedy is to charge academics who lend their names with professional and academic misconduct and fraud. (...)

Medical ghostwriters should be sued, lawyers argue (Medisinske spøkelseforfattere bør saksøkes, argumenterer advokater)
toronto.ctv.ca 2.8.2011
Academics who lend their names to medical and scientific articles that they didn't actually write are doing little more than prostituting themselves, according to two law professors at the University of Toronto.

The professors outline their argument in a piece in PLoS Medicine, saying researchers who engage in the practice should be sued for fraud.

Academic ghostwriting is a little-known practice that finally came to the public's attention after some popular drugs like the now-discontinued painkiller Vioxx started showing serious problems.

Lawsuits revealed that studies that suggested the drugs were safe and effective were often not written by the scientists listed as the authors. Instead, they were ghostwritten by writers working for the drug companies that make the medications. The scientists listed as authors were offered payment in return for attaching their names.

The problem of course is that doctors rely on information in the medical literature to make treatment decisions. That's when "ghostwritten" articles can have devastating effects: by swaying doctors to give patients improper and even harmful treatment.

The practice has been widely condemned by scientific journals and most journals now do through reviews to ensure that the scientists who sign off on the studies actually performed the research. And yet, it continues. (...)

Legal Remedies for Medical Ghostwriting: Imposing Fraud Liability on Guest Authors of Ghostwritten Articles (Rettslige skritt mot medisinsk spøkelsesskriving: Innføring av erstatningsansvar for gjesteforfattere i forbindelse med svindel i spøkelsesskrevne artikler)
PLoS Med 8(8): e1001070 (August 2)
Introduction
There are persistent concerns about the influence of the pharmaceutical and device industries on the medical literature, and particularly on the reporting of clinical trials, which can include the distortion of the true evidence base of medical interventions and overestimation of the clinical benefit of a drug used to treat patients [1]. An especially problematic issue involves the industry practice of publishing studies prepared by hired medical writers but signed by academic “guest authors” who are invited to add their names without fulfilling authorship criteria. In this case, “guest authorship” is accompanied by “ghostwriting,” which occurs when a published article fails to acknowledge the original writer or writers' contributions [2]–[4]. Ghostwriting can also occur when an academic research group uses a professional writer to draft an article based on data generated by the group. When the research group retains control of the data and the final analysis, however, there is less of a concern about possible bias in the reporting of the results, and the appropriate remedy in that case is to report explicitly the role and contribution of the medical writer in the article. Here, we concentrate on ghostwriting and guest authorship in industry-controlled research, where several examples have revealed the use of ghostwriters to insert concealed marketing messages favourable to a company's product, and the recruitment of academics as “guest” authors despite not fulfilling authorship criteria [5]–[9]. (...)

Summary Points

  • Ghostwriting of medical journal articles raises serious ethical and legal concerns, bearing on the integrity of medical research and scientific evidence used in legal disputes.
  • Medical journals, academic institutions, and professional disciplinary bodies have thus far failed to enforce effective sanctions.
  • The practice of ghostwriting could be deterred more effectively through the imposition of legal liability on the “guest authors” who lend their names to ghostwritten articles.
  • We argue that a guest author's claim for credit of an article written by someone else constitutes legal fraud, and may give rise to claims that could be pursued in a class action based on the Racketeer Influenced and Corrupt Organizations Act (RICO).
  • The same fraud could support claims of “fraud on the court” against a pharmaceutical company that has used ghostwritten articles in litigation. This claim also appropriately reflects the negative impact of ghostwriting on the legal system. (...)

- Industry Funding and Author-Industry Affiliation in Clinical Trials in Psychiatry

Industry Funding and Author-Industry Affiliation in Clinical Trials in Psychiatry
Letter to the Editor
JOHN H. MONTGOMERY, D.O.
American Journal of Psychiatry 163:1110-a-1111, June 2006
To the Editor: The recent study by Roy H. Perlis, M.D., and colleagues (1) addressed an important relationship between author-industry affiliation and study outcomes in clinical trials. The authors examined funding source and author financial conflict of interest in 397 clinical trials published in four psychiatric journals over a 3-year period. The authors defined conflict of interest as "any report of consulting or speaking fees...stock ownership, or employment by the study sponsor" (p. 1957). Their results suggested that author conflict of interest was prevalent and significantly associated with positive trial outcomes in all of the 162 randomized, double-blind, placebo-controlled studies. Further, the authors stated that in these studies, "industry support itself was not significantly associated with a positive outcome" (p. 1958). (...)

Krever uberettiget forfatterskap

Krever uberettiget forfatterskap
etikkom.no 10.1.2007
To studenter har bedt Forskningsetiske komiteer om hjelp fordi de mener at en prosjektleder krever uberettiget forfatterskap. Komiteene gir studentene rett og er kritiske til universitetets håndtering av saken. (...)

Bidraget må være substansielt
Forskningsetiske komiteer trekker frem tre internasjonalt anerkjente retningslinjer for forfatterskap; Vancouver-reglene, den britiske sosiologiforeningens retningslinjer og manualen til den amerikanske psykologiforeningen. Det er stor overenstemmelse i disse retningslinjene.

- For å kunne være medforfatter må bidraget være substansielt, det må forholde seg til det bestemte prosjektet og forfatteren må ha deltatt i hele prosessen med kritisk refleksjon, oppsummerer Knut Ruyter, sekretariatsleder i NEM. (...)

Universitetet støtter rådende praksis
Studentene mener at prosjektleder ikke oppfyller kravene til forfatterskap. Alle nivåer på universitetet har gitt sin støtte til prosjektleder, uten å ha vurdert de faktiske forholdene. Det påstås også at Vancouver-reglene er så vage at deres bruk er begrenset.

- Dette er problematisk fordi universitetet gir støtte til rådende praksis. Vi er uenig i at disse reglene er vage og ubestemmelige, sier Ruyter.

Gir studentene rett
På bakgrunn av det saksmaterialet Forskningsetiske komiteer har hatt tilgang på, gir de studentene rett i at prosjektleder ikke har bidratt på en måte som berettiger til forfatterskap til den aktuelle artikkelen.

- Det å ha vært prosjektleder er ikke alene nok til å kvalifisere til medforfatter, poengterer Ruyter.

- Vi anbefaler at universitetet ivaretar studenter og juniorforskeres rettigheter gjennom avtaler for tverrfaglig samarbeid, kriterier for forfatterskap og prosedyrer for å løse uenighet og konflikt, avslutter sekretariatslederen på vegne av alle tre komiteene (NEM, NESH og NENT). (...)

Skrivehjelp og ghostwritere

Skrivehjelp og ghostwritere
aftenposten.no 1.12.2005
Bøkene om Nancy Drew ble skrevet av mange. Nå skal Emma Roberts spille Nancy Drew i kommende kinofilm.

Det skal ha skjult seg så mange som 73 ulike forfattere bak bøkene til franske Alexandre Dumas d.e., mest kjent for historiene om De tre musketerer og Greven av Monte Cristo. I høyt tempo ledet han produksjonen av bortimot 250 bøker, men hadde strenge retningslinjer og leste selv gjennom alle tekstene før han satte navnet sitt på bokryggen.

Da det vokste frem et marked for underholdningslitteratur midt på 1800-tallet, ble denne skrivemåten vanlig praksis. Flere hundre skribenter masseproduserte detektiv- og krimbøker under et felles forfatternavn. (...)

I dag er denne skrivepraksisen i stor grad overtatt av TV-mediet. Skaperne av Hotel Cæsar, svenske Peter E. Falck og Christian Wikander, fastlegger de store handlingslinjene to ganger i året, og overlater deretter hotellets intriger til en hel fabrikk av skribenter, der kjente forfatternavn som Niels Fredrik Dahl har vært innom. (...)

- Industrien bruker spøkelsesforfattere

- Industrien bruker spøkelsesforfattere
Tidsskr Nor Lægeforen 2005 (27. april)
Spøkelsesforfattere skjuler seg bak hver tiende vitenskapelige artikkel i de internasjonale tidsskriftene. Nå står en dansk lege frem og forteller om sin erfaring med såkalt ghost writing.

I siste utgave av danske Ugeskriftet står en lege for første gang frem og forteller om det han kaller et forsøk på ghost writing, eller bruk av fiktive forfattere. Overlege Peer Wille-Jørgensen ved Bispebjerg Hospital i København, og to andre overleger, fikk våren 2003 et manuskript fra legemiddelfirmaet AstraZenecas avdeling i Sverige. Legemiddelfirmaet mente de tre legene kunne være interessert i å stå som forfattere på oversiktsartikkelen. Artikkelen konkluderte med at firmaets produkt mot magesår var signifikant mer effektivt enn konkurrentens produkt. (...)

"just sign here, Doc; we've reviewed the data"–––for $20,000 to $40,000 per article"

The Many Faces of Big Pharma's Disease Mongering
opednews.com 4.12.2007
Most people blame Big Pharma and the docs in its pocket for elevating everyday anxiety to depression, depression to bipolar disease and childhood behavior problems to major psychiatric diseases.

But there are others to thank for the national pathology of creating and treating diseases that aren't even there.

There's the 200 US medical education and communication companies (MECCs) who ghostwrite journal articles for Big Pharma––"just sign here, Doc; we've reviewed the data"–––for $20,000 to $40,000 per article. (...)

MECCs (medical education and communication companies)

Are You One of Big Pharma's Lab Animals?
alternet.org 7.12.2007
Most people blame Big Pharma and the docs in its pocket for elevating everyday anxiety to depression, depression to bipolar disease and childhood behavior problems to major psychiatric diseases.

But there are others to thank for the national pathology of creating and treating diseases that aren't even there.

There's the 200 U.S. medical education and communication companies (MECCs) who ghostwrite journal articles for Big Pharma -- "just sign here, Doc; we've reviewed the data" -- for $20,000 to $40,000 per article.

There's Complete Healthcare Communications (CHC), whose phalanx of 40 medical writers, editors and librarians has submitted over 500 manuscripts to journals for clients Pfizer, Sanofi-Aventis, Wyeth, Schering-Plough and AstraZeneca, according to its promotional materials, with an acceptance rate of 80 percent.

And the MECC, which wrote up the Merck-designed and -funded Vioxx trials less the death data, which ran in Annals of Internal Medicine first author of the Advantage study Jeffrey Lisse recounts to The New York Times.
And, of course there are the medical journals themselves which can make $450,000 off one article reprint as Big Pharma disseminates its messages under their masthead ("look, Doc -- it says RIGHT HERE") and untold ad page revenues. (...)

Legemiddelfirma betaler spøkelsesforfattere for å skrive tidsskriftartikler

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. (...)

- Medisinske artikler og studier skrevet av spøkelsesforfattere pushet legemidler

Wyeth använde falska artiklar
lakemedelsvarlden.se 11.8.2009
I samband en rättslig process har tidigare hemliga dokument offentliggjorts som tyder på att företaget Wyeth låtit publicerat falska artiklar om sina storsäljande hormonpreparat Prempro och Premarin. Historien som nu rullar upp visar på manipulerade data och tvivelaktig marknadsföring.

FALSKSPEL Av dokumenten som blev offentliga i början av augusti framgår att det amerikanska läkemedelsföretaget Wyeth använt spökskrivare till ett 30-tal artiklar.

Artiklarna, som stöder användningen av hormonersättningsmedel hos kvinnor, har publicerats i flera tunga vetenskapliga tidsskrifter som The American Journal of Obstetrics and Gynecology och The International Journal of Cardiology. I artiklarna framhävs de positiva effekterna av hormonterapier, HRT, samtidigt som biverkningarna tonats ner. (...)

Medical Papers by Ghostwriters Pushed Therapy (Medisinske artikler og studier forfattet av spøkelsesforfattere pushet terapi)
nytimes.com 4.8.2009
Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.

The articles, published in medical journals between 1998 and 2005, emphasized the benefits and de-emphasized the risks of taking hormones to protect against maladies like aging skin, heart disease and dementia. That supposed medical consensus benefited Wyeth, the pharmaceutical company that paid a medical communications firm to draft the papers, as sales of its hormone drugs, called Premarin and Prempro, soared to nearly $2 billion in 2001.

But the seeming consensus fell apart in 2002 when a huge federal study on hormone therapy was stopped after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer, heart disease and stroke. A later study found that hormones increased the risk of dementia in older patients. (...)

The documents on ghostwriting were uncovered by lawyers suing Wyeth and were made public after a request in court from PLoS Medicine, a medical journal from the Public Library of Science, and The New York Times. (...)

Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their prescribing habits after reading certain articles, unaware they were commissioned by a drug company. (...)

- Senatet: Ledende medisinsk utstyrsfirma spøkelsesskrev artikler, betalte leger

Det amerikanske senat: Medtronic skrev tidskriftartikler
medwatch.dk 29.10.2012
Ifølge en ny rapport fra det amerikanske senat har medico-giganten være involveret i at skrive videnskabelige artikler og betalt læger for at gøre det.

Det amerikanske senats finanskomité skriver i en rapport d. 26. oktober, at Medtronic hemmeligt har forfattet artikler i medicinaltidskrifter, samt betalt millioner af dollars til læger i ”konsultationsgebyrer.”

Medtronic er et af medicoindustriens førende selskaber og verdens største producent af hjerterytmeprodukter.

Rapporten handler primært om bekymringer vedrørende Medtronics håndtering af InFuse, et redskab der bruger et genetisk fremstillet protein til at skabe knoglevækst ved operationer i rygsøjlen.

Redskabet, der blev godkendt i 2002, var en kæmpesucces for Medtronic og indbragte selskabet i omegnen af 800 mio. dollars om året. Salget er siden faldet drastisk, eftersom en række artikler i tidsskriftet The Spine Journal har dokumenteret, at InFuse øger risikoen for sterilitet, infektioner, og kræft.

Senatets rapport konkluderer, efter at have gennemgået 5000 af Medtronics dokumenter over 16 måneder, at selskabet har været ”stærkt involveret i at skrive, redigere, og udforme indholdet af artikler til medicinske tidsskrifter.” Artikler, som konstaterede, at InFuse ikke havde nogen bivirkninger.

Dokumenter udgivet af de amerikanske sundhedsmyndigheder FDA viser dog, at patienter, der deltog i testforsøg med InFuse, oplevede smerter, cyster, infektioner, samt andre komplikationer.

Rapporten konstaterer endvidere, at Medtronic betalte 210 mio. dollars til læger i perioden fra november 1996 til december 2010.

Læs resten af historien, samt Medtronics svar på anklagen, hos Medical Daily. (...)

U.S. Senate: Leading Medical Device Company Ghost-Wrote Articles, Paid Physicians (Senatet: Ledende medisinsk utstyrsfirma spøkelsesskrev artikler, betalte leger)
medicaldaily.com 25.10.2012
Medtronic spøkelsesskrev og redigerte artikler utgitt i medisinske tidsskrifter, og betalt leger millioner av dollar i "konsultasjons"-avgifter, uttalte United States Senate's Finance Committee i en rapport i dag. (Medtronic ghost-wrote and edited articles released in medical journals, and paid physicians millions of dollars in "consulting" fees, the United States Senate's Finance Committee stated in a report today.)

The United States Senate's Finance Committee released a report today, which stated that Medtronic ghost-wrote and edited articles released in medical journals, and paid physicians millions of dollars in "consulting" fees.

Medtronic is a leading company in the medical device industry, and is the world's largest maker of heart-rhythm products. The report mostly concerns Medtronic's care of the InFuse device, which uses a genetically engineered protein to create bone growth for spinal fusion surgery along with a fusion device. For a time, the InFuse device, which was approved for use in 2002, was a huge moneymaker for Medtronic, garnering the company $800 million a year. Its sales have since plunged since a series of articles written in The Spine Journal showed that InFuse elevated risk for infertility, infections, and cancer. Since then, sales of the device are a fraction of what they once were, at $141 million during the second quarter of 2011. (…)

Diverse artikler

Ghostwriting Policies in High-Impact Biomedical Journals: A Cross-Sectional Study
JAMA Intern Med. 2013;173(10):920-921.
Although sound authorship of biomedical journal articles relies on personal and professional integrity and accountability, recent controversies concerning ghostwriting and guest authorship have shown that this approach has limitations.1

Ghostwriting and guest authorship are often linked to academic-industry collaborations. Typically, industry-sponsored professional writers prepare complete articles, which are then presented to senior, often expert, academics who submit the article in their own name (perhaps after some editing) and are often reimbursed.1

Although biomedical journals have led the way in drawing up editorial policies, ghostwriting policies have not been analyzed. We aimed to assess the prevalence and content of ghostwriting policies in the most influential biomedical journals. (...)

Only about 10% of journals provided explicit definitions of ghostwriting, less than 6% had detection and response procedures, and only about 17% mentioned ghostwriting or ghostwriters in nonspecific statements such as “ghostwriting constitutes an inappropriate practice.” This might indicate that the problem is not taken seriously or that journals may be influenced by revenue from industrial sources, including advertising and the selling of reprints, possibly for off-label promotion.3-4

Some editors' and medical writers' associations have specific, clearly positioned policies on ghostwriting.5-7 Likewise, a Committee on Publication Ethics flowchart advises on how to proceed when ghost, guest, or gift authorship is suspected.8

CMOs, CROs will Report Payments to Doctors Under Final 'Sunshine' Rule
in-pharmatechnologist.com 5.2.2013
CMOs and CROs must notify sponsors of payments made to physicians on their behalf under long-awaited US 'Sunshine' rules published last week (...)

Ghostwriting part 3: psych drug Paxil – and conclusion
healthnewsreview.org 25.1.2013
The GlaxoSmithKline psychiatric drug Paxil is the topic of the third and final part of a series of unsolicited guest blog submissions by Jonathan Leo, PhD, and Jeffrey Lacasse, PhD. (...)

Ghostwriting – how does academic medicine justify it? (Spøkelsesskriving - hvordan rettferdiggjør akademisk medisin dette?)
blogs.plos.org 5.8.2011
We’re always interested at PLoS Medicine in different perspectives on the ghostwriting problem. Following considerable news coverage of our recent Stern and Lemmens paper on legal liability for ghostwriting, another article, this one by Jonathan Leo and colleagues (who have previously written for us on the lack of ghostwriting policies in major US medical schools), has appeared in Society. In it they offer some explanations for why ghostwriting is “allowed” in academic medicine.

The parts I found most intriguing were their examples of how academic medicine is complicit. We all know that in the “publish or perish” environment of medical academia publications are currency, which must help explain why many academic guest authors receive no monetary payment at all for their unethical and dishonest collusion with pharma that allows them to take (academic) credit for papers they didn’t write.

But don’t institutions expect their faculty and members to publish ethically and in the best interest of patients? (...)

Author of Ghostwritten Study Runs for Parliament in Canada (Forfatter av spøkelsesskrevet studie stiller i kanadisk parlamentvalg)
pogoblog.typepad.com 12.5.2011
The night before I spoke last week at the University of Toronto conference on corporate funded ghostwriting in medicine, the university held a dinner at a French bistro for the conference speakers. It was election night in Canada and everyone at the table was buzzing about Dr. Stan Kutcher, a psychiatry professor at Dalhousie University who was running for Parliament.

Under legal threat from Dr. Kutcher, The Coast, a small Canadian newspaper, retracted and then apologized for a story that investigated a study Dr. Kutcher published on Paxil. Known as “Study 329,” this clinical trial was funded by GlaxoSmithKline (GSK) and concluded that Paxil is "generally well tolerated and effective for major depression in adolescents."

Unfortunately for Dr. Kutcher, GSK was sued in the United States for hiding evidence of the link between Paxil and suicide. Numerous internal emails and documents are public and Study 329 now pops up in most discussion whenever experts talk about corruption in medical research.

Warning to readers: hold your nose. Study 329 really stinks.
If you’re new to the issue, corporate funded ghostwriting involves a pharmaceutical company that hires a PR firm to write medical studies. The PR firm then presents the manuscript to academic physicians to sign their names on as authors. Sometimes, the authors make only minor changes. The professors get credit for a publication to add to their CVs, and the pharma company gets a study that is “authored” by physicians who are leading researchers in their field and appear to be independent.

The practice of ghostwriting drives up the costs of healthcare, because these studies trick doctors into prescribing drugs that may be more costly, and sometimes less safe. These studies can also be used to seek approval by the FDA and payment from federal healthcare programs.

In the case of Study 329, GlaxoSmithKline used the study as a tool to market Paxil for use on children, until both the FDA and its British counterpart warned doctors to stop prescribing Paxil to children because it could cause them to commit suicide.

Last November, POGO sent a letter to National Institutes of Health (NIH) asking why taxpayers were funding researchers involved in Study 329 when it was ghostwritten and flawed. (...)

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

(Anm: Restoring Study 329. Scientific Integrity Through Data Based Medicine (study329.org).)

(Anm: Study 329 continuation phase: Safety and efficacy of paroxetine and imipramine in extended treatment of adolescent major depression. (…) CONCLUSIONS: The continuation phase did not offer support for longer-term efficacy of either paroxetine or imipramine. Relapse and adverse events on both active drugs open up the risks of a prescribing cascade. The previously largely unrecognised hazards of the taper phase have implications for prescribing practice and need further exploration.Int J Risk Saf Med. 2016 Sep 17;28(3):143-61.)

(Anm: Study 329: Big Risk. Study 329 seems to fit the classic picture. It has Big Pharma ghostwriting articles, hiding data, corrupting the scientific process and leaving a trail of death, disability and grieving relatives in its wake. (davidhealy.org 16.11.2015).)

(Anm: Letters. Restoring Study 329. Retraction of biased journal articles. Study 329 may be the most infamous example of biased reporting within psychiatry, but this practice is widespread. (…) For example, our analysis included trial STL-N/S-95-003 (sertraline for social phobia). A memo in the FDA review stated: “Since the sponsor acknowledged that this was a negative study . . . they needed to submit only a summary report.” However, this trial was published as a success. (…) Although our papers clearly identified biased articles, none has since been retracted. BMJ 2015;351:h5497 (Published 21 October 2015).)

(Anm: Restoring Study 329. Paroxetine and Study 329: what we already knew and when. (…) More disturbing than the results of the Study 329 re-analysis is the continued prescribing of drugs such as paroxetine in populations for which there is no evidence of benefit. BMJ 2015;351:h5411 (Published 14 October 2015).)

(Anm: Study 329: The Timelines (davidhealy.org).)

NIH Takes on Ghostwriting
JAMA. 2011;305(16):1646 (April 27)
The National Institutes of Health (NIH) appears poised to take a tougher stand on investigators who accept payments to be named as authors of articles written by others, suggests a letter from Director Francis S. Collins and proposed rules for conflicts among NIH-funded investigators.

Clinical investigators who are paid to have their names listed as authors of ghostwritten articles may be subject to conflict-of-interest disclosures under new federal rules.
Such ghostwritten articles have received increasing scrutiny from government regulators and journals. In a letter (http://tinyurl.com/4uzj5r5) to Paul Thacker, an investigator at the watchdog group Project on Government Oversight, Collins states that the agency does not condone ghostwriting and outlines various ways the NIH might deal with investigators who engage in this practice. For example, Collins noted the agency might consider an investigator involved in ghostwriting as being in violation of agency policies regarding plagiarism.

Additionally, as part of proposed rules regulating investigator conflicts of interest (http://tinyurl.com/4ffxbxv), the agency has added paid authorship to the list of potential financial interests investigators must report. With this, “the NIH is sending a clear message to institutions and investigators alike that we support the principles of transparency and accountability in research,” Collins stated in the letter. (...)

Hunting Ghosts (Spøkelsesjakt)
sciencecareers.sciencemag.org 18.3.2011
After Science Careers published an article last November on the hazards of medical literature ghostwriting, an industry representative sent an e-mail suggesting that our research was out of date. "This article does not reflect current industry practices," wrote Carl Rios, a medical affairs manager at Nycomed, a pharmaceutical company based in Zurich, Switzerland. "It is not fair-balanced as it leaves the reader believing that the pharmaceutical industry has not taken action to avoid medical ghost-writing, which in fact, it has."

Still, according to researchers such as Adriane Fugh-Berman of Georgetown University Medical Center in Washington, D.C., and Leemon McHenry, a medical ethicist at California State University in Northridge, the practice of industry ghostwriting persists. "Pharmaceutical and medical communication companies have just found more clever ways of concealing their activities," Fugh-Berman says. (...)

Invisible influence
Ghost authorship occurs when an unacknowledged author makes substantial contributions to an article that appears under the names of other scientists, who may contribute little. Accounts from court records reveal instances of pharmaceutical companies paying medical communications companies to draft articles favorable to their products, then hiring well-known academics to publish the papers under their own names without disclosing the papers' origins.

The earlier Science Careers article highlighted a case involving the pharmaceutical company Wyeth, which paid ghostwriters to write dozens of papers on hormone replacement therapy. Published in medical journals between 1998 and 2005, the articles exaggerated the benefits of the therapy while minimizing its risks.

And in 2009, documents uncovered by a law firm representing users of the antidepressant Paxil showed that GlaxoSmithKline paid ghostwriters to write journal articles promoting the drug and downplaying its risks. An internal memo showed that the company instructed salespeople to offer assistance to physicians writing and publishing articles describing the drug's benefits.

Such activities taint the contents of the medical literature by injecting messages that benefit the sponsor, says Fugh-Berman, who directs PharmedOut, "a university-based project that empowers physicians to identify and counter inappropriate pharmaceutical promotion practices." (...)

Yale Paxil Study Alleged Promotional Scheme
newsomelaw.comn 15.12.2010
A Yale Daily News article explains that a “School of Medicine faculty member has been accused of signing her name to a ghostwritten study” for a report on the antidepressant, Paxil. According to the news article, this is “a practice that many believe amounts to plagiarism and undermines scientific integrity.”

The Yale Daily News goes on to explain that “The nonprofit watchdog Project on Government Oversight (POGO) claims that School of Medicine associate professor Kimberly Yonkers signed her name to work that was not her own in a 2003 report.” POGO contacted the National Institutes of Health, which funds some of Yonkers’ research, “identifying about four separate cases of alleged ghostwriting,” the Daily News alleges.

According to the article, “One of these was Yonkers’ study, which POGO claims was part of a promotion scheme by pharmaceutical company GlaxoSmithKline to increase Paxil sales.” The Yale newspaper explains that Yonkers denied these accusations, saying she was “extensively involved in writing and editing the report.” (...)

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

Yale Medical Professor Accused of Ghostwriting Paxil Side Effects Study
lawyersandsettlements.com 14.12.2010
New Haven, CT: A professor at Yale's School of Medicine has been accused of signing her name to a ghostwritten study on Paxil side effects, the Yale Daily News reports.

The Project on Government Oversight (POGO), a nonprofit watchdog, claims that associate professor Kimberly Yonkers signed her name to work that was not hers in a 2003 report on Paxil, an antidepressant drug, the news source said.

POGO claims that Yonkers's alleged ghostwritten study was a part of a promotional scheme by GlaxoSmithKline to increase the sales of Paxil. Yonkers, however, claims she was very involved in the report's writing and editing, according to the news provider. (...)

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

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). (...)

Med prof accused of ghostwriting
yaledailynews.com 3.12.2010
A School of Medicine faculty member has been accused of signing her name to a ghostwritten study, a practice that many believe amounts to plagiarism and undermines scientific integrity. (...)

Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say (Legemiddelprodusent skrev bok under to legers navn, ifølge dokumenter)
nytimes.com 2.12.2010
Two prominent authors of a 1999 book teaching family doctors how to treat psychiatric disorders provided acknowledgment in the preface for an “unrestricted educational grant” from a major pharmaceutical company.

But the drug maker, then known as SmithKline Beecham, actually had much more involvement than the book described, newly disclosed documents show. The grant paid for a writing company to develop the outline and text for the two named authors, the documents show, and then the writing company said it planned to show three drafts directly to the pharmaceutical company for comments and “sign-off” and page proofs for “final approval.”

“That doesn’t sound unrestricted to me,” Dr. Bernard Lo, a medical ethicist and chairman of an Institute of Medicine group that wrote a 2009 report on conflicts of interest, said after reviewing the documents. “That sounds like they have ultimate control.” (...)

GSK Hired Ghostwriters to Pen Scientific Papers (GSH hyret inn spøkelsesforfateere for å skrive vitenakspelige dokumenter)
By Marian Wang ProPublica
2 Dec | ProPublica – This isn’t news but according to newly released documents from GlaxoSmithKline, the pharmaceutical company often paid ghostwriters to pen medical studies, editorials and even a textbook that listed physicians as the authors.

The documents — some of which date back to late 1990s — were recently unsealed in litigation over a GlaxoSmithKline product. We saw them after they were attached to a letter released this week by a nonprofit watchdog group urging the National Institutes of Health to crack down on ghostwriting in medical academia. The documents and the letter by Project on Government Oversight together outline several examples of how a major drug company contributed to the funding, writing and approval of material published in medical journals and elsewhere. (...)

Professor, APA dispute ghostwriting allegation
stanforddaily.com 1.12.2010
A watchdog group this week urged the National Institutes of Health to put an end to “ghostwriting,” alleging that scientific publications by some federally funded researchers were actually written by drug and marketing companies — including one book co-written by Stanford psychiatry professor Alan Schatzberg.

The Washington group, Project on Government Oversight, bases its allegations on documents made public in a lawsuit against GlaxoSmithKline related to the drug Paxil, as The New York Times first reported on Tuesday.

The documents include a draft of the book “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” which was published in 1999 by American Psychiatric Publishing, Inc. (APPI), a branch of the American Psychiatric Association (APA). The draft was “developed” by two writers for the medical publishing company Scientific Therapeutics Information (STI) of New Jersey under an “educational grant” from drug company SmithKline Beecham Pharmaceuticals (now GlaxoSmithKline), according to the document. Schatzberg and Charles Nemeroff, at the time chairman of psychiatry at Emory University, are the book’s authors, the draft said.

Also among the documents was a 1997 letter from STI editor Sally Laden to Nemeroff describing the company’s timeline for completing the book. The timeline included several dates when drafts of the book would go to the co-authors and the “sponsor” for comments, “sign-off” and “final approval.”
“You and Alan [Schatzberg] are in good hands with Diane [Coniglio, an STI writer],” Laden wrote to Nemeroff. (...)

POGO Letter to NIH on Ghostwriting Academics
pogo.org 29.11.2010
The Project On Government Oversight (POGO) is a nonpartisan independent watchdog that champions good government reforms. POGO’s investigations into corruption, misconduct, and conflicts of interest achieve a more effective, accountable, open, and ethical federal government. We take a keen interest in strengthening the integrity of federally funded science, and have particular concerns involving the National Institutes of Health (NIH), which receives around
$30 billion a year in federal taxpayer dollars to fund biomedical research.[1]

We are writing to urge that NIH curb the practice of ghostwriting in academia. As the Director of the world’s largest and most prestigious funding source for biomedical research, you must set policies that require NIH-funded academic centers to ban ghostwriting to strengthen scientific integrity. (...)

The GlaxoSmithKline Ghostwriting Documents, Part Two
psychologytoday.com 1.12.2010
How the NIH Can Stop Ghostwriting in Commercial Research

On Tuesday, the New York Times reported on how SmithKline Beecham paid a marketing company, Scientific Therapeutics Information (STI), to ghostwrite a medical textbook on psychopharmacology for family physicians, with Charles Nemeroff and Alan Schatzberg then signing off as authors of that textbook. The Project on Government Oversight (POGO), which is a non-profit group that seeks to "expose corruption" in the federal government, first fleshed out this story, posting documents on its website, and those documents tell of a ghostwriting enterprise that supported the selling of Paxil for more than a decade. This also was an enterprise that involved a number of prominent academic psychiatrists, who -- as the POGO documents reveal -- continue to receive large grants from the National Institutes of Health.

According to the documents posted by POGO, in early October 1993, STI laid out a ghostwriting plan to help SmithKline Beecham market its new antidepressant, Paxil. This would begin, STI proposed, with a meeting of SmithKline's "Psychiatrist Advisory Board" on November 5-7 in Palm Beach, Florida. STI had recruited ten well-known psychiatrists for the board, which was to be chaired by Nemeroff, and STI promised to recruit ten more. All of the psychiatrists on the advisory board were to be flown first class to Florida, and paid between $2,500 and $5,000 for the weekend event.

At the opening session, STI promised, Nemeroff would discuss how to "generate information for use in promotion/education" of Paxil. (...)

A Ghostwritten Psychiatric Book Hints at a Much Larger Problem
psychologytoday.com 30.11.2010
The Story That Is . . . and Isn't Told in Psychiatric Textbooks

The report by the New York Times today that a 1999 medical text authored by Dr. Charles Nemeroff and by Dr. Alan Schatzberg was ghostwritten and financed by a pharmaceutical firm seems—at first glance—to tell of a new level of corruption within American medicine. “To ghostwrite an entire textbook is a new level of chutzpah,” former FDA commissioner David Kessler told the New York Times. “I’ve never heard of that before.” (...)

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. (...)

Spökskrivare fortsatt vanligt
lakemedelsvarlden.se 11.8.2010
Förekomsten av så kallade spökskrivare och vetenskapliga artiklar som sponsrats av industrin utan att det framgår har inte minskat de senaste åren. Det visar en rapport som sammanställts av den amerikanska senaten.

MANIPULERAT De ansträngningar som gjorts för att ha bättra koll på vilka som ligger bakom vetenskapliga artiklar i medicinska tidskrifter har än så länge inte haft någon stor genomslagskraft. Det visar en rapport som gjort på uppdrag av den amerikanska republikanska senatorn Chuck Grassley enligt tidningen Scrip.

Rapporten bygger på en undersökning från 2009 som granskat 630 forsknings- och reviewartiklar, ledare och debattartiklar som publicerats i sex ledande medicinska tidsskrifter under 2008. Undersökningen visade att 26 procent av artiklarna hade betalda författare, 8 procent hade spökskrivare och 2 procent hade båda delarna. Undersökningen visade att siffrorna inte ändrats speciellt mycket sedan 1996 då en liknande undersökning hittade 19 procent betalda författare, 11 procent spökskrivare och 2 procent med bådadera.

Rapporten från senator Grassley manar till tydliga och skarpa regler som garantera att samtliga skribenter till en vetenskaplig artikel uppfyller kraven om oberoende. Han har även vänt sig till den amerikanska hälsovårdsmyndigheten NIH och efterlyst tydligare regler för de studier och kliniska prövningar som görs med statliga medel. (...)

Medical publication ghostwriting report gets a mixed review
orthosupersite.com 22.7.2010
Medical publishing was the latest industry to be put under the microscope in the push for greater transparency in many fields when the office of United States Senator Charles Grassley released a new report on medical ghostwriting on June 24, but at least one medical publishing association is questioning some of its contents.

The staff report of the Committee on Finance on the practice of medical ghost writing followed a 2-year review of the role that pharmaceutical and medical device companies play in developing articles for publication in medical journals. According to a press release from the senator’s office, Grassley has urged the National Institutes of Health (NIH) to incorporate the report’s findings in its new, final disclosure guidelines for federal grant recipients. (...)

Ghostwriting and Academic Medicine
chronicle.com 19.7.2010
Pharmaceutical companies are masters of marketing, as witnessed by their impressive ability to create blockbuster drugs. Unfortunately, those include medicines like Vioxx (which was withdrawn from the market in 2004), Paxil (whose use in young people is being questioned), Fen-phen (the diet drug that was recalled), Zoloft, (which requires a "black box" warning about side effects), Zyprexa, (for which Eli Lilly agreed to pay up $500-million to settle lawsuits), hormone-replacement therapy, (which has come into question), and the now much-debated Avandia. (...)

(Anm: Avandia (rosiglitazone) - informasjon versus kunnskap og visdom - hvem visste hva? (mintankesmie.no).)

Grassley Calls on NIH to Stiffen Ghostwriting Rules
medpagetoday.com 8.7.2010
Institutions receiving research grants from the National Institutes of Health should be required to do more to police industry-sponsored ghostwriting of medical journal articles, Sen. Charles Grassley (R-Iowa) said in a letter to NIH Director Francis Collins, MD, PhD.

The senator -- a frequent critic of the pharmaceutical and medical device industries and their relationships with academia -- also released a report on medical and scientific journal ghostwriting, compiled by Senate Finance Committee staff. Grassley is the panel's senior Republican.

"Public dollars and public trust are at stake in research and the practice of medicine," Grassley said in a statement announcing the committee report. (...)

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. (...)

Läkemedelsindustrin tar fram regler mot spökskrivande
dagensmedicin.se 10.6.2010
Den internationella föreningen för forskande läkemedelsföretag har tagit fram regler för hur medlemsföretagen ska presentera resultat från kliniska prövningar.
Läs reglerna:

”Joint Position on the Publication of Clinical Trial Results in the Scientific Literature” (i PDF-format)

Läkemedelsindustrin kritiseras ofta för att köpa forskare som kan stå som författare till spökskrivna artiklar. I vilken utsträckning det förekommer är föremål för diskussion.

Som ett svar på kritiken lanserar i dag den internationella föreningen för de forskande läkemedelsföretagen IFPMA nya regler för hur resultat från kliniska prövningar ska presenteras. (...)

Ghostbusting in Paxil Birth Defect Litigation
healthsentinel.com 3.3.2010
A month before the first Paxil birth defect trial against GlaxoSmithKline was set to begin, the Associated Press ran the headline, "Glaxo Used Ghostwriting Program to Promote Paxil," in reporting on a program called "CASPPER," which allowed doctors to "take credit for medical journal articles mainly written by company consultants."

"Drug companies frequently hire outside firms to draft a manuscript touting a company's drug, retain a physician to sign off as the author and then find a publisher to unwittingly publish the work," the Associated Press said on August 19, 2009. "Drug company salespeople often present medical journal articles to physicians as independent proof that their drugs are safe and effective."

Between 2000 and 2002, articles from the CASPPER program appeared in five medical journals. On August 21, 2009, Jim Edwards on BNET, described the CASSPER ghostwriting brochure. The document shows that the intent of CASSPER was to flood the market with ghostwritten information, he said. It stated: "Paxil Product Management has budgeted for 50 articles for 2000."

The trial in Kilker v Glaxo ended on October 13, 2009, with a jury in Philadelphia finding that Glaxo "negligently failed to warn" the doctor treating Lyam Kilker's mother about Paxil's risks and the drug was a "factual cause" of Lyam's heart defects. The family was award $2.5 million. (...)

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

Norge vill sätta stopp för spökskrivare
lakemedelsvarlden.se 15.2.2010
Den senaste tidens avslöjanden att artiklar om läkemedelsstudier allt som oftast författas av andra än de som utfört forskningen och att dessa andra är spökskrivare betalda av läkemedelsföretagen har väckt debatt i Norge. Nu väntar tydligare regler mot spökskriveri i grannlandet. (...)

Anledningen är en amerikansk undersökning som nyligen publicerades i PLos Medicine som visar att få amerikanska forskningsinstitutioner har några regler mot de spökskriverier som läkemedelsföretag visat sig inte på något sätt vara främmande för.

Bara ett fåtal av de akademiska institutionerna hade enligt undersökningen regler som uttryckligen förbjuder detta. Hur spökskriveriet går till och hur utbrett det är beskrivs i senaste numret av Läkemedelsvärlden.

– Den här okulturen som vi nu fått inblick igenom de amerikanska rättstvisterna mot läkemedelsföretag innebär att systematiska kunskapssammanfattningar och begreppet evidensbaserad medicin förorenas, säger Jørund Straand till tidningen.

– Kanske är det dags att sluta tro på resultat från läkemedelsprövningar sponsrade av företagen. (...)

(Anm: Ghostwriting at Elite Academic Medical Centers in the United States
PLoS Med 7(2): e1000230 (February 2)
.)

Most leading US medical schools lack rules on ghostwriting (De fleste amerikanske medisinske skoler mangler regler for spøkelsesskriving)
BMJ 2010;340:c799 (8 February)
A survey of the top 50 US medical schools found that only 13 have policies prohibiting ghostwriting of scientific articles, a new report has found.

Last year the US Institute of Medicine recommended that US academic medical centres prohibit ghostwriting by their teaching staff.

One of the paper’s coauthors, Jeffrey Lacasse, from Arizona State University in Phoenix, told the BMJ, "This is one of the most pressing problems in evidence based medicine . . . Nobody has ever been sanctioned [for cooperating in ghostwriting]." (...)

(Anm: Evidence based medicine: a movement in crisis? BMJ 2014;348:g3725 (13 June 2014).)

Ghostwriting at Elite Academic Medical Centers in the United States
PLoS Med 7(2): e1000230 (February 2)
(...) Of the 50 academic medical centers that we examined (Box 1), ten (20%) explicitly prohibit ghostwriting. Of these ten, seven (14%) include some definition of ghostwriting in their policy, while three (6%) prohibit ghostwriting without defining the term. Many schools have an authorship policy that does not clearly ban all aspects of ghostwriting (n = 13, 26%); the most common reason is a failure to require that all qualified authors be listed. Three academic medical centers (6%) have stringent authorship policies that prohibit it in practice (by requiring both a substantive contribution to qualify for authorship and that all who qualify for authorship be listed) but do not mention ghostwriting by name (Table 1). (...)

Conclusion Top
Medical ghostwriting is a threat to public health which currently takes place only due to the cooperation of researchers employed at academic medical centers. Although there is growing awareness of the danger posed by medical ghostwriting, we find that few academic medical centers have public policies which prohibit this behavior, and many of the existing policies are ambiguous or ill-defined. We have proposed an unambiguous policy which defines participating in medical ghostwriting as academic misconduct akin to plagiarism or falsifying data. By adopting and enforcing this policy, academic medical centers would adhere to the norms of science followed across the rest of the University, and would no longer facilitate clandestine industry influence over the peer-reviewed scientific literature. By prohibiting medical ghostwriting, academic medical centers have a rare opportunity- to significantly reduce a major threat to public health with the stroke of a pen. (...)

NIH chief: Researchers may have to disclose funding sources
blogs.usatoday.com 21.12.2009
National Institutes of Health chief Francis Collins said Monday that new ethics rules governing biomedical researchers will be proposed next month.

In an interview taped for the cable television's CSPAN "Newsmakers" show (Sunday at 10 a.m and 6 p.m. EDT), Collins says the "Proposed Rule" notice would require disclosure of financial connections between medical firms and NIH-funded scientists, and forbid "ghostwritten" studies, authored by drug firms but attributed to researchers. (...)

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).)

Medical Schools Quizzed on Ghostwriting
nytimes.com 17.11.2009
Senator Charles E. Grassley wrote to 10 top medical schools Tuesday to ask what they are doing about professors who put their names on ghostwritten articles in medical journals — and why that practice was any different from plagiarism by students. (...)

Ghost-writers Hired by Drug Companies Write Journal Articles, Then Find the Medical Authors
virginiabeach.injuryboard.com 28.10.2009
An amazing series of documents were unsealed by a court in a dangerous drug injury case involving Prempro, a hormone drug. Injured plaintiffs argue that the drug causes breast cancer and other medical problems, but the bomb drop is not the allegations, but what drug giant Wyeth did to "help" create medical journal articles about the safety of its drug.

But the court documents reveal scandalous email and correspondence which purportedly shows that Wyeth "fraudulently and intentionally polluted the scientific literature related to hormone therapy in general and their hormone drugs in particular" in that Wyeth hired ghostwriter physicians or scientists to “author” biased scientific and medical journal articles-but the articles were largely written before the “author” was on board.

A medical journal PLoS Medicine posted about 1,500 of the documents on a website (www.plosmedicine.org/static/ghostwriting.action). It was through the action of the medical journal and the New York Times that the court decided to unseal a massive number of documents which reveal exactly how the ghostwriting was done for the drug manufacturer-reaching the suggested conclusions well before a “reputable” doctor was ever part of the “study” findings as the study's author.

As further related in an article in Trial Magazine, American Association for Justice, October 2009, PLoS Medicine editors wrote an editorial that stated. (...)

US survey favours acknowledging medical study ghostwriters
BMJ 2009;339:b3986 (29 September)
Pharma Marketing News, a US online journal, found that three quarters of respondents to a small survey of its readers thought that drug companies’ use of professional writers to write articles for medical journals was acceptable as long as it was clear who wrote the article and who endorsed the content (www.pharma-mkting.com).

John Mack, the journal’s publisher, wrote, "‘Ghostwriting’ in and of itself may not be objectionable, but when sponsored by pharmaceutical companies that distribute medical journal articles on off-label indications to physicians it becomes a huge marketing compliance and ethics concern."
The US Food and Drug Administration earlier this year allowed drug companies to distribute articles about off-label uses (BMJ 2009;338:b187, doi:10.1136/bmj.b187). (...)

Federal Court Grants Public Access to Evidence that Drug Company 'Ghostwrote' Medical Articles About Deadly Hormone Therapy Drug
publicjustice.net 24.9.2009
A federal judge in Arkansas granted public access today to evidence that Wyeth Pharmaceuticals "ghostwrote" medical articles regarding its hormone therapy drug Prempro, which a national study has shown increase a woman's risk of stroke, heart attack, blood clots, cardiovascular disease, and cancer. (...)

Federal Court Grants Public Access to Evidence that Drug Company
'Ghostwrote' Medical Articles About Deadly Hormone Therapy Drug

publicjustice.net 24.9.2009 (News release)
(...) The evidence has been under seal in an ongoing federal lawsuit filed on behalf of victims of Prempro. Public Justice, a national public interest law firm headquartered in Washington D.C., sought access to the evidence on behalf of PLoS Medicine, a medical journal published by the nonprofit Public Library of Science (PLOS). Along with the New York Times, PLOS had moved to
interevene in the case to unseal the ghostwriting documents because the public has powerful interest in knowing the truth about the drug companies' conduct and the safety of their drugs.

"We are thrilled by the Court’s decision to stop Wyeth’s attempt to hide evidence of its ghostwriting,” said Amy Radon, Public Justice's lead attorney for PLoS Medicine. "Public health and safety is put at serious risk when a drug company fails to reveal its role in authoring a medical journal article touting its own product." (...)

Ghosts in the medical machine (Spøkelser i det medisinske maskineri)
philly.com 20.9.2009
Redaktør Christine Laine i Annals of Internal Medicine uttaler at hun ønsker at medisinske forskningssentre forbyr spøkelsesskriving. (Annals of Internal Medicine editor Christine Laine said she wanted medical-research centers to forbid ghostwriting.)

Var legemiddelforskning infisert av spøkelsesforfattere? I Seroxat-søksmål, sier et Chadds Ford-firma at det var etisk. (Was drug research infected by ghostwriters? With Paxil suit in court, a Chadds Ford firm says it was ethical.)

Da markedsførere i GlaxoSmithKline P.L.C. søkte etter leger til å reklamere for sitt antidepressiva Seroxat, kalte de prosjektet CASPPER. (When GlaxoSmithKline P.L.C. marketers looked for doctors to promote the antidepressant Paxil, they called the project CASPPER.)

Navnet var mer enn bare en underlig anerkjennelse av det vennlige spøkelse i tegnefilmserien. Det var et blunk og et nikk til "spøkelsesskriving," en tvilsom praksis hvor forskere setter sitt navn på forskning skrevet av en annen, vanligvis betalt av et legemiddelfirma. (The name was more than just an offbeat tribute to the friendly cartoon ghost. It was a wink and a nod to "ghostwriting," a questionable practice in which scientists put their names on research written by someone else, usually a writer paid by a drugmaker.)

Kritikere av spøkelsesskriving uttaler at det maskerer markedsføringsmateriale som vitenskapelig forskning. (Ghostwriting critics say it disguises marketing material as scientific research.)

Ghostwriting harms patients, said Adriane Fugh-Berman, a doctor and associate professor at Georgetown University and a paid witness in litigation involving complaints over Wyeth's hormone drugs, Premarin and Prempro.

Documents released in connection with 8,000 lawsuits filed against Wyeth over Premarin and Prempro show that the company, which employs several thousand people in Collegeville, paid a medical-writing firm to produce articles from 1998 to 2005 that allegedly downplayed the risks of hormone treatment and emphasized benefits. (...)

Ghostwriting widespread in 6 of top 10 med journals; study
in-pharmatechnologist.com 14.9.2009
By Nick Taylor, 14-Sep-2009
A significant number of articles in six of the top 10 medical journals in 2008 were ghostwritten, according to study by editors of JAMA that found responding authors reported a 10.9 per cent rate in the NEJM.

Ghostwriting has come under increasing scrutiny with figures including Senator Chuck Grassley raising concerns that some articles “may be subtle advertisements rather than publications of independent research”. (...)

Medical Journal Ghostwriting: Time to Do Something?
By Shirley S. Wang
blogs.wsj.com 18.9.2009
Concerns over ghostwritten medical journal articles could lead to tighter rules and more severe punishments from individual journals, reports the New York Times.

In its most extreme form, ghostwriting involves slapping the name of a scientist as an author on the piece who played no role in writing the article. Typically the sponsors of the ghostwritten articles are pharmaceutical companies. Read about a bevy of examples here and here and here.

Sen. Chuck Grassley has been investigating ghostwriting for some time, and some medical journal editors are speaking up as well, saying that voluntary disclosure agreements about industry ties or contributions to the papers aren’t enough, according to the NYT.

For instance, a recent editorial in PLoS Medicine, one of the Public Library of Science journals, urged journals to identify and retract articles that were ghostwritten, and to banish those authors from subsequent publication in the journal.

Here’s an excerpt from the editorial: (...)

More than 20% of articles have a "guest" author, study shows
BMJ 2009;339:b3783 (15 September)
At least a fifth of articles published in medical journals are likely to have a guest (or honorary) author, and journals are not doing enough to tackle the problem, say two studies presented at the Sixth International Congress of Peer Review and Biomedical Publication in Vancouver last week.

A guest author is someone who has not contributed sufficiently to the work but whose name is included in the list of authors. In a survey of corresponding authors of nearly 900 articles published in high impact general medical journals in 2008, 20% of respondents admitted that their paper had at least one guest author. In addition, nearly 8% admitted that their article had at least one ghost author—someone who had written the article or otherwise contributed substantially to the work but was not listed as an author. (...)

Ghosts still present in the medical machine
Nature 2009; 461(7262): 325 (Published online 14 September)
Unattributed authors remain an issue for journals.

The medical literature continues to be haunted by ghostwriting — a practice that, in its most extreme form, involves pharmaceutical companies designing and paying for studies or reviews, then seeking a guest author to be credited while the company goes unacknowledged. The problem persists, said experts last week, despite recent drug-company policy changes and efforts by journals to cut down on the practice (see 'Spectre of industry bias'). (...)

Studie visar att spökskrivare är vanligt
lakemedelsvarlden.se 14.9.2009
Sex av de mest välsedda vetenskapliga tidskrifterna har under förra året flertalet artiklar skrivna av så kallade spökskrivare. Siffrorna som väckt stor förvåning och ilska kommer från en studie genomförd av redaktörer på JAMA.

BLUFF Omkring 8 procent av artiklarna i de mest prestigefylla vetenskapliga tidsskrifterna hade skrivits med hjälp av personer som inte angivits som författare, så kallade spökskrivare. I alla fall om den studie som utförts av redaktörer på tidskriften JAMA visar rätt.

I studien fick författare till 630 artiklar som publicerats i tidskrifterna under 2008 anonymt fylla i ett frågeformulär. Bakgrunden till undersökningen var en växande oror över de rapporter som kommit senaste åren om oredovisade samband framförallt mellan läkemedelsindustrin och vetenskapliga artiklar. (...)

PRC: Study Finds Less Ghost Authorship, Critics Ask Why (PRC: Peer Review Congress Meeting)
medpagetoday.com 11.9.2009
VANCOUVER -- The practice of ghostwriting in major medical journals has declined since the mid-1990s, according to a new study, but critics say the drop could be the result of authors' unwillingness to admit the practice.

The proportion of articles that were ghostwritten fell from 11.5% in 1996 to 7.8% in 2009, said Joseph S. Wislar, survey research specialist for the Journal of the American Medical Association, at a plenary session of the Peer Review Congress here.

"The prevalence is still much higher than we'd like to see," Wislar said.

And it may be underestimated, some researchers say. The confounder is that Wislar and co-authors Annette Flanagin, Phil B. Fontanarosa, MD, and Catherine DeAngelis, MD, MPH, are all editors of JAMA. (...)

Paxil lawsuit uncovers allegations of company-written medical articles (Seroxat-søksmål avdekker anklager om firmaskrevne medisinske artikler)
mail.google.com 10.9.2009
Studies confirming a new antidepressant's safety and efficacy may allay the concerns of users, but the journal articles denying Paxil side effects were not written by the doctors listed as authors, according to reports.

GlaxoSmithKline employed a team of consultants who worked with sales representatives to create new literature combatting concerns about Paxil defects in a program known as CASPPER, according to the Associated Press. The sales representatives would offer to help physicians and psychiatrists write up their positive experiences, and the consultants would then create whatever material the doctors needed.

"We know that GSK has engaged in ghostwriting for many years," said Dr Leemon McHenry, a research consultant for the plaintiff in the Paxil lawsuit. "But to create an internal ghostwriting program and have the gall to name it after a cartoon ghost demonstrates their juvenile attitude and careless disregard for patients." (...)

Drug firms’ manufactured buzz (Legemiddelfirmaers fabrikkerte "buzz")
boston.com 26.8.2009
NO ONE minds much when a champion athlete or Hollywood star uses a ghostwriter. But what if the ghostwriter is writing under the name of a renowned medical researcher and getting paid by the pharmaceutical firm whose new drug the researcher is extolling?

This form of ghostwriting is all too common in the promotion of drugs in the dog-eat-dog world of pharmaceutical blockbusters. Now, Senator Charles Grassley of Iowa, a medical-ethics watchdog, is putting pressure on the National Institutes of Health to do all it can to curb the practice. All medical schools should forbid their personnel from lending their names, and the universities’ prestige, to medical journal articles they did not have a meaningful role in creating. Boston University, Tufts, and Harvard have such policies. By the same token, medical journals should follow the lead of the International Committee of Medical Journal Editors and insist that authors actually write the articles that bear their name or participate in the research described. (...)

Senator Moves to Block Medical Ghostwriting (Senator ønsker tiltak mot spøkelsesforfattelse)
nytimes.com 18.8.2009 (The New York Times)
A growing body of evidence suggests that doctors at some of the nation’s top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies — articles that were carefully calibrated to help the manufacturers sell more products. (...)

Sen. Grassley Wants Tougher Stance Against Medical Ghostwriting (Senator Grassley ønsker hardere virkemidler mot medisinsk medisinske spøkelsesforfattere)
empowher.com 19.8.2009
A U.S. Senator wants stronger action against scientific papers written by ghostwriters who work for drug companies and against doctors at medical schools who attach their names to the papers, which are carefully crafted to boost drug makers' sales.

While medical ethics experts say the practice betrays public trust, many universities don't acknowledge the problem and haven't introduced new ethical rules or held faculty members to account, The New York Times reported.
Last week, Iowa Republican Senator Charles E. Grassley started putting pressure on the National Institutes of Health to get tough on medical ghostwriting. Grassley, who helps oversee funding for medical research, has led a long-running investigation of conflicts of interest in medicine.

The NIH underwrites much of the medical research in the U.S. and many doctors depend on federal grants to support their work. Attaching conditions to those grants could force universities to introduce new ethical standards, The Times reported. (...)

Wyeth paid ghostwriters to draft articles promoting its hormones, PLoS Medicine and New York Times say
BMJ 2009;339:b3288 (11 August)
The drug firm Wyeth has defended itself after court documents seemed to show that it paid a medical communications company to draft articles promoting the use of its hormone replacement therapies.

A news story in the New York Times (www.nytimes.com, 5 Aug, "Medical papers by ghostwriters pushed therapy") said that the documents on ghostwriting were uncovered by lawyers suing Wyeth and were made public after a request in court from the medical journal PLoS Medicine and the New York Times.

The New York Times story said: "The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them, and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest that the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs and other pharmaceutical companies." (...)

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). (...)

Journal Articles on Drug Trials Often Offer Limited Information for Doctors, Study Says (Tidsskriftsartikler på legemiddelforsøk gir leger ofte begrenset informasjon, ifølge studie)
kaisernetwork.org 15.12.2008
According to a study in the current issue of PLoS Medicine, medical journal articles on drug trials often do not provide doctors with complete information necessary to evaluate the potential benefits and risks of new drugs, the San Francisco Chronicle reports.

To obtain approval for a new drug, companies must present FDA with results from various clinical trials. After gaining FDA approval, the companies typically fund written accounts of such trials to appear in medical journals. The firms can employ third-parties to prepare journal articles on newly approved drugs. Such articles can carry the names of doctors who participated in the trials and can be written by drug company doctors who helped develop the drug, the Chronicle reports. Many doctors use the articles to determine whether, and how, they will use the drugs. (...)

(Anm: Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation. Review of Publication and Presentation. PLoS Med 2008;5(11): e217 (25.11.2008).)

Thomas McGarity: Safeguard lawsuits that potentially save lives
dallasnews.com 9.5.2008
A report recently published in the Journal of the American Medical Association should be deeply troubling to the millions of Americans who have taken the blockbuster painkiller Vioxx. The article demonstrated that many of the published scientific studies used to establish the drug’s safety and efficacy had been “ghostwritten” by the manufacturer. (...)

Ghostwriting in medicine: Would the real author please step forward?
DR. CRAIG BOWRON
minnpost.com 6.5.2008
There's an expectation that doctors be of high moral character. An article in the April 16 edition of the Journal of the American Medical Association (JAMA) calls that into question. The white coat may have turned a shade of gray.

The article looked at the practice of guest authorship and ghostwriting in producing research papers for medical journals. These journals are the sounding board of medicine: They bring physicians the latest research and drug trial information. They influence the way we practice medicine, and because health care is so expensive, billions of dollars can tumble this way or that depending on what these journals report. (...)

Research ghostwriting common, insiders say (Spøkelsesskrevet forskning vanlig, ifølge insidere)
baltimoresun.com 18.4.2008
Drug companies seek recognized authors
(...) Researchers and ethicists say scientists are often paid to be listed as authors of ghostwritten studies in scientific journals, a practice they say undermines the public's already sagging confidence in research. (...)

One of the scientists listed as an author has disputed the contention that he did little work - saying that he reviewed the records of almost 200 patients.
An industry group, the Pharmaceutical Research and Manufacturers Association of America, said that "it is essential for clinical trials to be conducted as ethically as possible" but disputed any inference that company-sponsored studies are inherently biased.

The group said the U.S. Food and Drug Administration acts as a check by reviewing protocols, data and conclusions.

It's understandable that drug companies sponsor studies on drugs they developed, DeAngelis said in an interview. "It's the drug companies that discover these drugs, and thank God somebody does," she said.

But she said it's dishonest for companies to hire doctors to lend prestige to studies they had little role in, and to hide the participation of outside firms that do much of the writing and apply the drug company's spin. (...)

The articles struck a chord with Dr. Jean Sealey, a retired professor from Weill Cornell Medical College in New York. Last year, she said, a London-based consulting firm that helps drug companies publish research invited her to "author" an article for a coming conference of the American Society for Hypertension.

Sealey, a noted authority on hypertension, said two things surprised her about the offer: The conference was only a week away, and she had never heard of the drug, much less conducted any research on it:

"I knew nothing about this drug, and I didn't really know how to pronounce it. Clearly they just wanted my name." (...)

At Johns Hopkins, honorary authorship "is unacceptable and should be actively discouraged," according to policy, said Dr. Julie Gottlieb, Hopkins assistant dean for policy administration. (...)

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