MinTankesmie

- Flere ønsker åpen tilgang til forskningsresultater

Open access approach to medical research publishing will continue to grow, experts predict (Eksperter mener at flere i tiden fremover vil stille spørsmål om åpen tilgang til medisinsk forskning)
BMJ 2011; 342:d3307 (25 May)
An online, open access approach to publishing scientific and medical research is proving successful and will continue to develop, MPs have been told.

Experts in publishing who were giving evidence to the parliamentary science and technology select committee on 23 May said that the approach used by Public Library of Science (PLoS) One—an online, open access journal for the communication of peer reviewed scientific and medical research—was being increasingly adopted by other organisations.

PLoS One and others such as the BMJ, which had followed its example, were speeding up research and enabling more research to be published, MPs were told as part of their inquiry into peer review. (...)

After Vioxx scandal, NEJM Editor-in-Chief Drazen calls for full data disclosure (Redaktøren for NEJM, Drazen, ber om full offentliggjøring av data etter Vioxx-skandalen)
browndailyherald.com 19.4.2007
New England Journal of Medicine Editor-in-Chief Dr. Jeffrey Drazen spoke about the Vioxx drug trials yesterday afternoon in Salomon 001.

Jeffrey Drazen, editor-in-chief of the New England Journal of Medicine, called on medical researchers to report their data accurately and comprehensively in an address Wednesday afternoon analyzing the lessons learned from the Vioxx case.

Speaking before an audience of both professors and students in the Alpert Medical School's first Alpha Omega Alpha visiting professor lecture, Drazen presented a detailed and incisive look at how researchers for pharmaceutical giant Merck withheld data from a clinical trial published in the New England Journal of Medicine in 2000 that indicated patients using the painkiller experienced a higher incidence of cardiovascular problems. (...)

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

Stadig dyrere tidsskrifter
universitetsavisa.no 3.1.2007
Men nå er grensen nådd. NTNU mister tilgang til 778 fagtidsskrifter på grunn av brudd i forhandlinger mellom universitetsbibliotekene og Blackwell Publishing.

Universitetsbibliotekene har i høst forsøkt å komme fram til en lisensavtale med Blackwell Publishing for tilgang til forlagets elektroniske tidsskrifter.

Dette har ikke lykkes, så heretter vil bibliotekbrukere ved NTNU og de øvrige universitetene i landet ikke lenger ha elektronisk tilgang til 778 tidsskrifttitler som inngår i den tidligere pakkeløsningen med Blackwell. (...)

(Anm: Medisinske tidsskrifter og uavhengighet etc. (mintankesmie.no).)

Another reason for opening access to research
John Wilbanks, executive director
BMJ 2006;333:1306-1308 (23 December)
Inspiration
The idea of open access—that scholarly literature should be "digital, online, free of charge, and free of most copyright and licensing restrictions"—has made significant inroads into scientific and technical publishing.¹ (...)

Authors value free access to research articles (Forfatterne vedsetter fri tilgang til forskningsartikler)
BMJ 2006;332 (18 February)
Fri tilgang til forskningsartikler på bmj.com er en viktig faktor når det gjelder forfatterens beslutning om hvorvidt arbeider oversendesBMJ. I en elektronisk tverrsnittsundersøkelse av Schroter (p 394), svarte over halvparten av de responderende forfattere at det å slutte med fri tilgang til forskningsartikler ville gjøre det litt mindre sannsynlig at de i fremtiden ville oversende sine arbeider til BMJ, og to tredjedeler sa at deres oppfatning av tidsskriftet ville forandre seg dersom tilgangen til artikler ble lukket. Forfatternes kommentarer fokuserte på skuffelse over det de oppfattet som et tilbakeskritt i eraen med åpen tilgang og tap av et karakteristisk trekk for BMJ. (...) (Free access to research articles on bmj.com is an important factor in authors' decision on whether to submit their papers to the BMJ. In a cross sectional electronic survey by Schroter (p 394), over half of responding authors said that ending free access to research articles would make them slightly less likely to submit to the BMJ in the future, and two thirds said their view of the journal would change if it closed access to research articles. Authors' comments focused on disappointment with what they saw as a regressive step in the era of open access publishing and the loss of a distinctive feature of the BMJ.)

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

- Forskere sier FDA øker folks risiko ved å forsinke frigivning av sikkerhetsdata

DRUG STUDY SECRECY PUTS LIVES AT RISK (Hemmeligholdelse av resultater i legemiddelstudier utsetter folk for risiko)
indexoncensorship.org 29.11.2011
Studies to test the safety and efficacy of drugs and medical devices are too often never made public, putting lives at risk. Head of Investigations at the British Medical Journal, Deborah Cohen reports (...)

FDA Should Release Safety Data, Health Affairs Commentary States (Health Affairs uttaler at FDA bør frigjøre sikkerhetsdata)
kaisernetwork.org 7.3.2007
FDA should release more detailed information about clinical trial data so that it can be used by independent researchers for further safety study, according to a commentary published on Tuesday in Health Affairs, Dow Jones reports. The authors, Aaron Kesselheim of Brigham & Women's Hospital and Michelle Mello of Harvard School of Public Health, dispute the belief that releasing more detailed safety data would jeopardize corporate secrets, and in the commentary they recommend "placing a heavier burden of proof on companies to show competitive harm if data are released." Currently, FDA releases a summary of safety issues associated with clinical trials of approved drugs but withholds the raw data over concerns that more detailed information "could enable competitors to more easily copy ... drugs or create similar versions," Dow Jones reports (Brickates Kennedy, Dow Jones, 3/6). (...)

An abstract of the commentary is available online. (...)

(Anm: Statlig legemiddelkontroll (Statens legemiddelverk etc.) (mintankesmie.no).)

Researchers say FDA increases public risks by delaying safety data release (Forskere sier FDA øker folks risiko ved å forsinke frigivning av sikkerhetsdata)
boston.com 6.3.2007
WASHINGTON -- Heart problems that pushed the painkillers Bextra and Vioxx off the market could have come to light earlier had federal regulators given outside researchers speedier access to raw safety data, according to a commentary written by Boston researchers. (...)

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

Analysis: New call for FDA openness
UPI Senior Medical Correspondent
upi.com 6.3.2007
WASHINGTON, March 6 (UPI) -- Two researchers Tuesday urged a change in U.S. Food and Drug Administration policies to allow the scientific community access to pharmaceutical manufacturers' clinical trial data in order to help reveal safety issues with new drugs. (...)

Taking the Wraps Off Drug Safety Data From Clinical Trials
docguide.com 6.3.2007
BOSTON, MA -- March 6, 2007 -- For years, pharmaceutical companies have sought to restrict public access to drug safety data collected in clinical trials on the basis that it is proprietary information, arguing that competitors could use that information in the development of their own products. However, a number of recent cases of drugs found to have dangerous side effects after coming to market, such as the anti-inflammatory drug rofecoxib (Vioxx), have raised concerns about safety data being treated as confidential. (...)

- Editorial policy: The right to medical information

Editorial policy: The right to medical information
CMAJ 2006 (September 12)
In a recent editorial co-published by PLoS Medicine and the Bulletin of the World Health Organization, Barbour and colleagues,¹ employees of the Public Library of Science (PLoS), make the valid point that "print is no longer the most efficient way to disseminate information." They also argue convincingly that publicly funded researchers have a moral obligation to make the results of their research freely available to everyone. Indeed, the Canadian Institutes of Health Research,² indicating in April 2006 their intention of developing policies that support open-access publication, have invited a number of health researchers to form an advisory committee to consider policies on physical products of research, structural and functional data typically deposited in public databases, as well as peer-reviewed published results. The US National Institutes of Health implemented a similar policy in February 2005, asking that NIH-funded researchers, upon acceptance of their manuscript for publication, voluntarily submit a digital final copy for posting on NIH's PubMed Central.³ (...)

- Holder legemiddelfirmaer tilbake ufordelaktig informasjon om nye produkter?

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

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

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

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

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

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

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

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

Lost in Transmission — FDA Drug Information That Never Reaches Clinicians (pdf) (Borte på veien - FDA-informasjon som aldri når frem til leger)
NEJM 2009 (October 21st)
(...) The most direct way that the FDA communicates the prescribing information that clinicians need is through the drug label. Labels, the package inserts that come with medications, are reprinted in the Physicians’ Desk Reference and excerpted in electronic references. To ensure that labels do not exaggerate benefits or play down harms, Congress might have required that the FDA or another disinterested party write them. But it did not. Drug labels are written by drug companies, then negotiated and approved by the FDA. (...)

Pharmaceuticals (Legemidler)
Absence of evidence (Mangel på bevis)
economist.com 27.11.2008 (From The Economist print edition)
Holder legemiddelfirmaer tilbake ufordelaktig informasjon om nye produkter? (Do drug firms suppress unfavourable information about new products?)

RICHARD FEYNMAN, a Nobel-prize-winning physicist, declared in a speech in 1974 that science requires “a kind of utter honesty”. He insisted that researchers must publicise all the outcomes of their work, and “not just the information that leads to judgment in one particular direction or another”. To judge by the mounting evidence of publication bias involving studies on new drugs, his words have not yet reached the pharmaceuticals industry.

A study published this week in PLoS Medicine, an online journal, confirms what many have suspected and what previous studies have hinted at: drug companies try to spin the results of clinical trials. If this were done merely in marketing materials, it might be tolerable. What Lisa Bero of the University of California, San Francisco, and her colleagues found, however, was troubling evidence of suppression and manipulation of data in studies published in (or often withheld from) peer-reviewed medical journals. (...)

Bias, Spin, and Misreporting Time for Full Access to Trial Protocols and Results
PLoS Med 2008;5(11): e230 (25.11.2008)
Although randomized trials provide key guidance for how we practice medicine, trust in their published results has been eroded in recent years due to several high-profile cases of alleged data suppression, misrepresentation, and manipulation [1–5, 39]. While most publicized cases have involved pharmaceutical industry trials, accumulating empiric evidence has shown that selective reporting of results is a systemic problem afflicting all types of trials, including those with no commercial input [6]. These examples highlight the harmful potential impact of biased reporting on patient care, and the violation of ethical responsibilities of researchers and sponsors to disseminate results accurately and comprehensively. (...)

Lisa Bero and colleagues review the publication status of all efficacy trials carried out in support of new drug approvals from 2001 and 2002, and find that a quarter of trials remain unpublished.

New Evidence
In a new study published in PLoS Medicine, Lisa Bero and colleagues make an important contribution to the growing body of evidence that the randomized trial literature is skewed towards reporting favorable results [9]. The researchers identified trials from 33 new drug applications (NDAs) for new molecular entities approved by the United States Food and Drug Administration (FDA) in 2001–2002, and compared information from FDA reviews with journal articles. By including all NDAs from a variety of specialty fields, their findings have broad generalizability to pharmaceutical trials.

Overall, a substantial amount of primary outcome data submitted to the FDA was found to be missing from the literature. One quarter of trials in their sample were unpublished—predominantly those with unfavorable results. Not only were data suppressed for the unpublished trials, but an additional quarter of primary outcomes were omitted from journal articles of published trials. These findings are consistent with two recent reviews of FDA documents and journal articles [10,21], one of which was published in PLoS Medicine in September 2008 [21]. (...)

- Tidsskrift trakk artikkel etter klager fra legemiddelfabrikanter

Forskere bekymrede for bivirkninger ved Novo-medicin
business.dk 31.8.2011
En gruppe amerikanske forskere opfordrer til yderligere undersøgelser af bivirkningerne ved blandt andet Victoza efter en kontroversiel analyse af bivirkningsindberetninger i USA. Novo Nordisk har forsøgt at bremse artiklen, men uden held.

En analyse af amerikanske rapporter om bivirkninger ved den lægemiddelgruppe, som Novo Nordisks storsælgende Victoza tilhører, har skabt opstandelse i diabeteskredse både herhjemme og i det store udland.

Analysen, blev offentliggjort i form af en artikel i det anerkendte amerikanske tidsskrift Gastroenterology i juli i år, bygger på data fra den amerikanske lægemiddelmyndighed FDA’s officielle database over indberetninger af bivirkninger i perioden 2004 til 2009.

Konklusionen i artiklen er, at analysen ”antyder”, at der kan være alvorlige bivirkninger forbundet med de to undersøgte lægemidler, Byetta fra amerikanske Eli Lilly og Januvia fra amerikanske Merck. Den amerikanske forskergruppe, som står bag artiklen, har blandt andet fundet en øget rapportering af betændelse i bugspytkirtlen for patienter, der har taget de to lægemidler. Analysen rejser bekymring for en forhøjet risiko for kræft i bugspytkirtlen i forbindelse med de to lægemidler og for kræft i skjoldbruskkirtlen i forbindelse med Byetta.

Diskussionen om de mulige bivirkninger ved de to typer diabetesmidler, er langt fra ny, og forskerne, der tager en lang række forbehold for, hvad man rent faktisk kan bruge tallene i databasen til, er meget forsigtige i deres konklusioner.

Alligevel har medicinalindustrien med Novo Nordisk i spidsen været helt oppe på mærkerne, og har direkte forsøgt at få bremset artiklen, der allerede midt i februar blev offentliggjort på Gastroenterology’s hjemmeside.

Det fremgår af en gennemgang af sagen i dagens udgave af Berlingske Business. (...)

(Anm: Victoza (liraglutide; liraglutid) (en.wikipedia.org).)

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

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

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

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

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

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

Legemiddelfirmaer ønsker ikke full åpenhet?

Transparency in drug studies
The Denver Post Editorial Board
denverpost.com 28.5.2007
A recent study that concluded the diabetes drug Avandia causes serious increased cardiac risk came about because of an unusual transparency in the drug industry, one that has sparked debate about how such information is used.

At issue is a study released last week showing Avandia, which is used by 1 million people in this country, increased the risk of heart attack by 43 percent and cardiac-related death by 64 percent.

The study was done by Dr. Steven Nissen, who used what is known as a "meta analysis." To reach their conclusions, he and colleagues analyzed 42 previously conducted clinical trials involving 28,000 patients.

Nissen had found the results of the prior studies on a website that the makers of Avandia - GlaxoSmithKline - had been required to post as part of a settlement of a lawsuit filed by the state of New York over Paxil, another Glaxo drug. (...)

30 second guide to… Meta-analysis
thisismoney.co.uk 23.5.2007
The Daily Mail's City team examine the studies that scientists conduct into pharmaceutical drugs – and why it can make big companies like GlaxoSmithKline nervous. (...)

For Drug Makers, a Downside to Full Disclosure (Full åpenhehet, en ulempe for legemiddelfirmaer)
nytimes.com 23.5.2007
When GlaxoSmithKline settled a lawsuit three years ago with the State of New York over the antidepressant medication Paxil, the company agreed to take an unusual step: publicly disclosing the results of its clinical trials for Paxil and other drugs.

The company, which was criticized at the time for failing to publicize all pediatric trials of Paxil, not just the positive ones, made good on its promise. The first posting on a new Web site was about 65 studies involving its popular diabetes drug, Avandia.

This week, GlaxoSmithKline learned what that greater disclosure could mean.

A cardiologist at the Cleveland Clinic, Dr. Steven Nissen, stumbled onto the Glaxo Web site while researching Avandia last April. He and a colleague quickly analyzed the data, and on Monday, The New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk.

“It was a treasure trove,” Dr. Nissen said about the Web site.

GlaxoSmithKline has disputed the journal’s interpretation. Officials with the Food and Drug Administration said they were reviewing whether to take any action on Avandia. (...)

“We are committed to the principle of transparency,” Dr. Krall added. “But we knew that when starting this, by putting the data in the public, many things could happen, some of which could be trouble.”

Some experts also believe that releasing the results of hundreds of studies involving drugs or medical devices might create confusion and anxiety for patients who are typically not well prepared to understand the studies or to put them in context.

“I would be very concerned about wholesale posting of thousands of clinical trials leading to mass confusion,” said Dr. Steven Galson, the director for the Center for Drug Evaluation and Research at the F.D.A. (...)

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

Har publikum krav på innsyn i legemiddelstudier?

$185M Settlement Mandates Public Access to Drug Trials (Forlik til 185 millioner dollar bemyndiger offentlig tilgang til legemiddelforsøk)
redorbit.com 15.2.2006
Denne artikkelen ble opprinnelig publisert i Lawyers Weekly USA, en annen Dolan Media publikasjon.) (This article was originally published in Lawyers Weekly USA, another Dolan Media publication.)

I et meget omfattende forlik, som inkluderer banebrytende regler for redegjørelse av informasjon om kliniske forsøk, har et av landets største farmasøytiske firmaer samtykket i å betale 185 millioner dollar i et gruppesøksmål angående børssvindel. (In a massive settlement that includes groundbreaking disclosure rules for clinical trial information, one of the nation's largest pharmaceutical companies has agreed to pay $185 million in a class action securities fraud lawsuit.)

Som del av forliket for legemidlet mot høyt blodtrykk, Vanlev, vil Bristol-Myers Squibb på sitt nettstedlegge ut kliniske forsøksresultater for alle sine legemidler godkjent for markedsføring i USA og i utlandet. (As part of the settlement over the hypertension drug Vanlev, Bristol-Myers Squibb will use its website to publicly post clinical trial results for all of its drugs approved for marketing in the United States and abroad.)

Forliket, som ennå ikke er sluttført, er ifølge saksøkers advokat Thomas Dubbs fra New York, en del av en trend, hvor store institusjonelle saksøkere prøver å få til selskapsreformer i tillegg til store utbetalinger. (The settlement, which has yet to be finalized, is part of a trend in which large institutional plaintiffs seek corporate reforms in addition to large monetary awards, said lead plaintiffs' attorney Thomas Dubbs of New York City.)

Med denne overenskomsten, vil enhver som inntar et legemiddel produsert av BMS få direkte tilgang til kritisk informasjon, spesielt sideeffekter, sa Dubbs, som representerte LongView Collective Investment Fund hos Amalgamated Bank. (With this agreement, anyone taking a drug manufactured by BMS will have instant access to crucial information, especially serious side effects, said Dubbs, who represented the LongView Collective Investment Fund of the Amalgamated Bank.)

Han sa at forliket kunne gi fornyet interesse for statlig lovgivning som vil påby farmasøytiske firmaer å offentliggjøre klinisk testinformasjon. Men andre sa det er mer sannsynlig at resultatet blir at industrien tar initiativ til egne reformer for å avverge statlig inngripen. (He said the settlement could renew interest in federal legislation that would make it mandatory for all pharmaceutical companies to provide public disclosure of clinical test information. But others said the more likely result is for the industry to initiate its own reforms to ward off government intervention.)

Klimaet i vårt land for denne type lovgivning er ikke svært sterk, sa Jerome Kassirer, tidligere sjefsredaktør i New England Journal of Medicine og professor ved Tufts University School of Medicine i Boston. Om noe, tror jeg andre farmasøytiske firmaer er med på liknende offentliggjøring bare for å unngå at kongressen blir involvert. (The climate in our country for that kind of legislation hasn't been very strong, said Jerome Kassirer, former editor-in-chief of the New England Journal of Medicine and a professor at Tufts University School of Medicine in Boston. If anything, I think other pharmaceutical companies may go along with similar disclosure just to avoid Congress getting involved.)

Kassirer sa at følgene av BMS-forliket vil avhenge av hvor lett informasjonen er å forstå. For nærværende er der flere frivillige registre for kliniske forsøk hvor informasjon er tilgjengelig, men det klages på kvaliteten på den informasjonen som er gitt. (...) (Kassirer said the impact of the BMS settlement will depend on how easy the information is to understand. Currently there are several voluntary clinical trial registries where information is available, but there have been complaints about quality of the information provided.)

Søkemotorer øker bruk av online-tidsskrifter

Search engines increase online journal use more than open access
BMJ 2006;332:1353 (10 June)
The ability of internet search engines to find journal articles has considerably increased the readership of academic journals, a detailed analysis of the internet use of one particular research journal has found. (...)

Offentlig finansiert forskning i Storbritannia må gjøres fritt tilgjengelig

Publicly funded research in the UK must be freely accessible
BMJ 2006;333:112 (15 July)
Publicly funded research must be made accessible and free of charge to the public, recommended a statement published this week by research councils in the United Kingdom.

The statement said that information derived from publicly funded research must be made available at no charge for public use as widely, rapidly, and effectively as is practical. (...)

Legemiddelfirmaer & leger: En historie om korrupsjon

Drug Companies & Doctors: A Story of Corruption (Legemiddelfirmaer & leger: En historie om korrupsjon)
By Marcia Angell
The New York Review of Books 2009;56(1) (JANUARY 15) (About the Review)
Recently Senator Charles Grassley, ranking Republican on the Senate Finance Committee, has been looking into financial ties between the pharmaceutical industry and the academic physicians who largely determine the market value of prescription drugs. He hasn't had to look very hard.

Take the case of Dr. Joseph L. Biederman, professor of psychiatry at Harvard Medical School and chief of pediatric psychopharmacology at Harvard's Massachusetts General Hospital. Thanks largely to him, children as young as two years old are now being diagnosed with bipolar disorder and treated with a cocktail of powerful drugs, many of which were not approved by the Food and Drug Administration (FDA) for that purpose and none of which were approved for children below ten years of age. (...)

- Tilbakevisning av Marcia Angell argumenter

På Legemiddelindustriforeningens hjemmeside (lmi.no) (november 2004), var det lagt ut en rekke linker til såkalte "internasjonale rapporter," som ifølge nevnte hjemmeside kunne bestilles, herav bl.a. rapport ”24561. EFPIA. Rebuttal of Marcia Angell arguments. Ref: 59.946”. (24561. EFPIA. Tilbakevisning av Marcia Angell argumenter. Ref: 59.946").

Ved forsøk på bestilling per e-post av den nevnte rapport, opplyste imidlertid LMI at disse rapporter kun er forbeholdt de som har passord til LMIs hjemmeside, dvs. de er ikke offentlig tilgjengelige.

Den nevnte rapport viser imidlertid at EFPIA (Den europeiske føderasjonen av farmasøytisk industri og foreninger) utarbeider såkalte internasjonale rapporter, for internt bruk, som tilsynelatende beskriver hvilken strategi legemiddelindustriforeningene bør bruke for å imøtegå argumenter fra de som måtte stille kritiske spørsmål om legemiddelindustrien; i dette tilfellet den tidligere sjefsredaktør i det anerkjente tidsskriftet The New England Journal of Medicine (NEJM), dr. Marcia Angells. (...)

Legemiddelfirma forsøker å hemmeligholde interne notater

Drug company seeks to suppress internal memos (Legemiddelfirma forsøker å hemmeligholde interne notater)
BMJ 2007;334:59 (13 January) (British medical Journal)
The drug maker Eli Lilly instigated legal action against a number of doctors, lawyers, journalists, and activists over hundreds of internal corporate documents and emails said to have been obtained by them regarding the antipsychotic drug olanzapine (Zyprexa). Eli Lilly obtained a court injunction on 29 December ordering 16 individuals and organisations to stop publishing the documents and to remove any copies posted on the internet. (...)

"Sicko"

Jakten på sannheten
morgenbladet.no 30.11.2007
Michael Moore angripes av sine egne i en ny dokumentarfilm. (...)

I likhet med Moore vinkler de filmen subjektivt, men fremhever hele tiden sine noble motiver om å få frem sannheten. Da foretrekker jeg nesten Moores slue talent, og det faktum at han sjelden legger skjul på sin agenda (som i Fahrenheit 9/11 var å få den sittende presidenten ut av Det hvite hus).

Derfor blir På sporet av Michael Moore en forspilt sjanse. Filmskaperne tilhører riktignok ikke det hysteriske hylekoret av dokumentarer fra amerikansk høyreside som går til frontalangrep på Moore. Dette er en «drittpakke» fra Moores egne på venstresiden. De hyler ikke «Michael Moore hater Amerika!». De jamrer isteden: «Michael Moore hater den venstresiden som har båret ham frem!» (...)

Mildere og moden Moore
PER HADDAL
aftenposten.no 3.10.2007
Michael Moore er en kruttsterk blanding av ellevill gjøgler, besnærende propagandist og bedrevitende lærer. (...)

Overbevisende.
For én gangs skyld er det besværlig å hisse seg opp over Moores mange manipulerende tricks, for filmen handler om virkningene av den private amerikanske syketrygden. 50 millioner mangler syketrygd. De faller utenfor. Selv de som tror seg forsikret, har problemer med å få noe utbetalt. For det sitter leger i forsikringsselskapene og hindrer slikt, mener Moore i "Sicko", en vennligere film enn hans tidligere. Om det er tøv, anekdoter? (...)

Amerikansk selvpisking
Per Haddal Filmkritiker
aftenposten.no 20.7.2007
UJEVNT. Selv ikke eksvinnere av Gullpalmen er alltid like treffsikre når de driver amerikansk selvpisking.

RABULISTEN Michael Moore (”Fahrenheit 9/11”) og de svarthumoristiske brødrene Coen (”Barton Fink”) har iveren, viljen og talentet. Men prestasjonene er og forblir ujevne.

Av sinn og metode er Moore propagandamaker, med skrudde ideer. Han får mange billige og riktige poenger rett i fanget når han i den polemiske dokumentaren ”Sicko” stiller diagnosen på det amerikanske helsevesenet. (…)

(Anm: rabulist; (av lat. rabula, 'dårlig sakfører, høyrøstet taler'), politisk oppvigler; bråkmaker, uroelement.) Kilde: Store norske leksikon.)

Pharmaceutical Research and Manufacturers of America: "You won't get that from Michael Moore"

Healing Our Sicko Health Care System
Jacob S. Hacker, Ph.D.
NEJM 2007;357(8):733-5 (August 23)
There is a scene in Sicko — Michael Moore's controversial new film about U.S. health care — that captures both the power and the limits of Moore's cinematic polemic. (...)

Moore's exposure of the rot at the core of U.S. health insurance drives home the pressing need for action. (...)

PRO-CON: Does Michael Moore’s documentary Sicko’ accurately reflect U.S. health care? Yes
kansascity.com 28.7.2007
Michael Moore’s film “Sicko” shows us that there’s a better way to pay for our health care than relying on the private insurance industry. (...)

CNN vs. SiCKO
fair.org 7.7.2007
Filmmaker Michael Moore appeared on CNN's Situation Room on July 9 to talk about his new film Sicko—but ended up having an animated discussion with host Wolf Blitzer about a CNN "fact check" of the film that made several embarrassing errors. (...)

Actually, Moore was much closer than Gupta: according to the Department of Health & Human Services, U.S. per capita healthcare spending was projected to reach $7,092 in 2006, and $7,498 for this year. (...)

Google i modvind
comon.dk 3.7.2007
En ansat ved Google mente, at Michael Moores kritik af den amerikanske sygesikringsindustri i filmen »Sicko« var en god lejlighed til at sælge annoncer. (...)

»Når som helst sygesikringsindustrien ønsker at tilbagevise anklager i Mr. Moores film, og når som helst Mr. Moore ønsker at udfordre sygesikringsindustrien, er annoncering en meget demokratisk og effektiv måde at deltage i den offentlige debat på,« skriver hun og tilføjer, at dette er Googles holdning. (...)

Lauren Turners oprindelige argument gik på, at branchen burde tage til genmæle:

»Mens lovgivere, advokater og patientgrupper bliver begejstrede, er der andre blandt os, der bliver ængstelige. Og hvorfor skulle de ikke blive det? Moore angriber forsikringssælgere, udbydere og medicinalfirmaer ved at forbinde dem til isolerede og følelsesladede historier om systemet, når det er værst. Moores film beskriver industrien som drevet af penge og marketing, og formår ikke at vise sygesikringens interesse for patienternes tilstand og omsorg.« (...)

Google Health Ads Blog Backs Off Sicko
webpronews.com 2.7.2007
A Google blogger posted a pro-healthcare industry item that criticized filmmaker Michael Moore's new film, while suggesting Google ads as a way to counter negative publicity.

Upon first seeing this item appear on the Google Health Advertising blog over the weekend, I thought Google's blogs had been hacked. It has happened before, and considering the crass, cynical content, it's a bit of a shock coming from the "don't do evil" search advertising company.

Here's an excerpt of the post by Lauren Turner, listed as an account planner for Google health ads: (...)

Analysis: 'Sicko' numbers mostly accurate; more context needed
cnn.com 30.6.2007
STORY HIGHLIGHTS
Analysis: Numbers cited in "Sicko" are accurate for the most part
Assertions could use more context to flesh out comparisons of health care
Health-care experts focus more on film's errors of omission than incorrect facts (...)

Whether it's dollars spent, group coverage or Medicaid income cutoffs, health care goes hand in hand with numbers. Moore opens his film by giving these statistics, "Fifty million uninsured Americans ... 18,000 people die because they are uninsured." (...)

(Anm: New CDC Report Documents Percentage of People Without Health Insurance. cdc.gov 25.6.2007.)

US health professionals demonstrate in support of Sicko
BMJ 2007;334:1338-1339 (30 June)
Doctors, nurses, and health workers across the United States are demonstrating in support of Sicko, Michael Moore's film attacking the US healthcare system. They are calling for a single payer system to replace the US private insurance programme, which leaves about 46 million people, or 16% of the population, uninsured. Health care is a hot issue in the coming presidential campaign. (...)

Newspapers Examine Release of Health Care Industry Documentary, 'Sicko'
kaisernetwork.org 29.6.2007
Several newspapers on recently published features and opinion pieces discussing "Sicko," filmmaker Michael Moore's documentary about the health care industry. Headlines and summaries of the articles appear below. (...)

Michael Moores milliardkupp
na24.no 28.6.2007
Den kjente dokumentarskapren er styggrik.

Filmprodusenten er for tiden aktuell med filmen «Sicko» som handler om det amerikanske helsevesenet. Mannen bak har blitt en milliardindustri, ifølge DinaPengar.se. (...)

'Sicko' Likely To Have Broad Political Impact on Health Care Debate, Experts Say
kaisernetwork.org 25.6.2007
Some elected officials and policy experts last week said that "Sicko," the new documentary on the health care industry directed by Michael Moore, likely will have a "broad political impact," the New York Times reports. In the film, which opens nationwide on June 29, Moore calls for a single-payer health care system in the U.S. Both supporters and opponents of Moore predict that the film will "crystallize the frustration that is a pre-existing condition for so many health care consumers," according to the Times. (...)

For Filmmaker, ‘Sicko’ Is a Jumping-Off Point for Health Care Change
nytimes.com 24.6.2007
Michael Moore appearing with House members last week on Capitol Hill, where he is promoting his film and a plan to guarantee health care. (...)

CBSs 'Sicko' Spin
fair.org 25.6.2007
Americans Don't Want Single-Payer Health—Except They Do

On the June 22 broadcast of CBS Evening News, reporter Jeff Greenfield's critique of Michael Moore's documentary Sicko relied on a single premise: that the U.S. public and its political leaders do not embrace Moore's preferred solution (a single-payer system, where medical care is provided by private doctors and hospitals but paid for by the government). But that argument is at odds with the available evidence. (...)

Michael Moore is toning down his act. Will his critics buy it?
usatoday.com 22.6.2007
(...) Michael Moore may be the only filmmaker whose target audience is people who despise him.
He became one of the most polarizing figures in America after his 2004 documentary, Fahrenheit 9/11, which portrayed the Bush administration as bumbling and corrupt in handling the war on terrorism. He was a heroic truth-teller to some, a loudmouth instigator to others. At White House news briefings, "Michael Moore" became a metaphor for pushy liberalism. (...)

Documentary 'Sicko' Debuts on Capitol Hill, Filmmaker Moore Calls for Single-Payer Health System
kaisernetwork.org 21.6.2007
Capitol Hill Watch | Michael Moore's health care industry documentary "Sicko" debuted in Washington, D.C., on Wednesday and the film maker held a press conference on Capitol Hill to galvanize support for the creation of a single-payer system in the U.S., CQ HealthBeat reports. The press conference featured clips from "Sicko," which compares the U.S. health care system to Canada's single-payer system, as well as testimony from individuals featured in the documentary and from lawmakers who support greater government regulation of health care. (...)

Sykdom, show og suksess i Cannes
morgenbladet.no 25.5.2007
(...) Michael Moores Sicko tar for seg det amerikanske velferdssystemet og den darwinismen som har fått prege det. Med enkle virkemidler viser Moore hvordan tusenvis av mennesker dør eller dumpes som søppel fordi de ikke har råd til sykeforsikring. Som vanlig er det ikke plass til mange nyanser i Moores univers, men jeg savnet ikke nyansene så mye denne gangen. Moore har rettferdigheten helt og holdent på sin side, og han vet det. Sicko er et lidenskapelig innlegg for medmenneskelighet, og Moore spør hva det er som gjør at Amerika har så liten empati med de utslåtte og svake. Så får det ikke hjelpe at han mot slutten må ty til litt for mye showmanship og billige triks for å gi filmen den ekstra underholdningsverdien den kommersielle kinofilmen gjerne krever. (...)

New York Times Examines Potential Effect of Michael Moore Documentary About Problems With Health Care Industry On Health Care Debate
kaisernetwork.org 22.5.2007
The New York Times on Tuesday examined how some health insurance industry officials and policy experts are saying that Michael Moore's new documentary "Sicko," which chronicles the U.S. health care industry, "taps into widespread public concern that the system does not work for millions of Americans." The film, which premiered at the Cannes Film Festival on Saturday, "received many favorable reviews," according to the Times.

America's Health Insurance Plans President Karen Ignagni said that the film might encourage the government to provide more funding for health care for the uninsured. Ignagni said, "If the movie results in members of Congress and governors putting this issue squarely on the table as the No. 1 priority, we will be part of that discussion and will welcome it." (...)

Michael Moore's Health Industry Documentary 'SiCKO' Debuts
kaisernetwork.org 21.5.2007
(...) When Moore started working on the documentary, some drug companies sent warnings to employees not to speak with him. The Pharmaceutical Research and Manufacturers of America already has prepared a statement in response to the film, though no one at the organization has seen it. PhRMA Vice President Ken Johnson said, "No one should be surprised that Michael Moore is making baseless accusations designed to drum up publicity for his movie." He added that "SiCKO" was not on his organization's "top 10 list of concerns." (...)

Ga tusener til mannen som hater ham
side2.no 20.5.2007
Michael Moore ga mannen som driver den største hatsiden mot ham 72.000 kroner. (...)

Hadde mistanke
Jim Kennefick la lørdag ut beskjeden fra Michael Moore på hjemmesiden og sa han hadde mistanke om at giveren var Moore før beskjeden kom. (...)

- Takk Michael, jeg setter pris på hjelpen og det har jeg alltid gjort. Jeg håper Cannes-visningen går bra, men enda mer så håper jeg at du har sagt sannheten denne gangen. Jeg ville bli veldig glad for å støtte denne filmen ettersom jeg også er motstander av private helseforsikringsselskaper.
(...)

Amerikansk selvpisking
Per Haddal Filmkritiker
aftenposten.no 20.7.2007
UJEVNT. Selv ikke eksvinnere av Gullpalmen er alltid like treffsikre når de driver amerikansk selvpisking.

RABULISTEN Michael Moore (”Fahrenheit 9/11”) og de svarthumoristiske brødrene Coen (”Barton Fink”) har iveren, viljen og talentet. Men prestasjonene er og forblir ujevne.

Av sinn og metode er Moore propagandamaker, med skrudde ideer. Han får mange billige og riktige poenger rett i fanget når han i den polemiske dokumentaren ”Sicko” stiller diagnosen på det amerikanske helsevesenet. (…)

(Anm: rabulist; (av lat. rabula, 'dårlig sakfører, høyrøstet taler'), politisk oppvigler; bråkmaker, uroelement.) Kilde: Store norske leksikon.)

Provoserende "Sicko"
aftenposten.no 20.7.2007
Amerikanske myndigheter etterforsker filmregissøren Michael Moore, etter at han brakte amerikanere til legehjelp på Cuba i forbindelse med sin nyeste dokumentarfilm. (...)

Moore godt mottatt i Cannes
vg.no 19.5.2007
Dokumentarfilmen "Sicko" som omhandler det amerikanske helsevesenet, ble godt tatt imot under Cannes filmfestival. Men filmskaper Michael Moore er klar for å bli refset når han kommer hjem til Amerika. (...)

Slankere Michael Moore takker Bush
dagbladet.no 19.5.2007
CANNES (Dagbladet.no): I dag ble Michael Moores nye film «Sicko» vist fram for pressen for første gang under filmfestivalen i Cannes. Og filmskaperen takker Bush-administrasjonen for uvurderlig PR-hjelp når han nå blir etterforsket for en av sekvensene i filmen. (...)

- Det har kommet så mange filmer som er anti-Michael Moore nå, at jeg vurderer å lage en egen filmfestival. Jeg mener min CV taler for seg selv. Først lagde jeg en dokumentar som var kritisk til General Motors, som nå er på konkursens rand. Så lagde jeg om våpen, og skoleskytinger er stadig aktuelt. Deretter lagde jeg en om Bush-administrasjonen, og jeg har nå amerikanere flest med meg på at det var dumt å invadere Irak. Jeg håper nå at folk vil la meg være litt mer i fred. (...)

Michael Moore Film Project Rattles Health Care Giants
adage.com 21.8.2006
Trade Groups on the Defensive; Pharma Companies Allege Bias

NEW YORK (AdAge.com) -- The health-care industry is worried sick over "Sicko." Pharmaceutical companies have told their employees not to talk to documentary filmmaker Michael Moore, whose next project, 'Sicko,' looks at health care in the U.S.

Few details have emerged about the 2007 documentary from Michael Moore, the filmmaker who ripped apart Detroit automakers with "Roger and Me" and now has his sights set on the $1.5 trillion pharmaceutical and health-care industry. But it's still enough to mobilize health-care trade groups who are trying to discredit the film.

No balance from Moore
"A review of America's health-care system should be balanced, thoughtful and well-researched to pin down what works and what needs to be improved," said Ken Johnson, senior VP for the Pharmaceutical Research and Manufacturers of America. "You won't get that from Michael Moore."

Added a spokesman for one of the top 10 pharma companies: "We expect it will be one-sided and biased, just like his other documentaries."

Several other pharmaceutical makers did not return calls for comment. But Pfizer, AstraZeneca and GlaxoSmithKline all advised their employees last year not to speak to Mr. Moore when he began his research for "Sicko." It is not known whether any HMOs or drug companies will appear in the film.

"We were approached, but declined," said a spokeswoman for a second top-10 drugmaker. "Frankly, as much as we felt like we wanted to get our message across, in the end we didn't want to subject ourselves to the editing process." (...)

PR's 'pit bull' takes on open access

Publishers hire PR heavyweight to defend themselves against open access
BMJ 2007;334:227 (3 February)
A new public relations campaign to be launched by the American Association of Publishers will equate open access to scientific journal articles with government censorship.

Email messages leaked to the journal Nature describe a meeting last summer, arranged by the association's professional and scholarly publishing division. The meeting was between employees of the publishing houses Elsevier and Wiley and the American Chemical Society and the public relations consultant Eric Dezenhall (Nature, www.nature.com, 10.1038/445347a).

Mr Dezenhall, author of several novels and of Nail 'Em! Confronting High-Profile Attacks on Celebrities and Businesses, specialises in "marketplace defence" and has been described by an industry publication as the "pit bull of PR." (...)

Rapid Responses to: (...)

"Free access to medical articles" used to be called a library. And New York, luckily, has a number of libraries that offer the "mass of consumers" free access to medical journals.

But if you don't live near such a place, or don't have the time to spend tracking down articles in person, you pay up to $30 to have a copy delivered to your desktop. "The elites" then would be people with paid subscriptions, or who have no problem paying often exorbitent sums for on- line availability.

The idea that the American public should have access to the results of studies funded by their tax dollars (...)

FDA Must Turn Over Vioxx Documents, Judge Rules

FDA Must Turn Over Vioxx Documents, Judge Rules
fdanews.com 17.10.2007
A federal judge denied the FDA’s request to delay turning over documents related to Merck’s Vioxx a lawyer requested under the Freedom of Information Act (FOIA).

U.S. District Court for the District of New Jersey Judge Faith Hochberg will appoint a mediator to create a process for determining which documents the agency must turn over to lawyer Eric Weinberg.

Weinberg made 10 FOIA requests between October 2004 and August 2006, according to his complaint. He alleges the FDA did not respond to five requests, did not produce all documents for three of the requests in a timely manner and did not produce documents for two requests, despite acknowledging receiving the requests. (...)

Weinberg requested information on Vioxx (rofecoxib) including clinical trial data, adverse event reports, Vioxx advertisements and correspondence between the FDA and Merck regarding the drug. (...)

Mer enn halvparten av amerikanske sikkerhetsstudier på legemidler ser aldri dagens lys

More than half of US drug safety studies never see the light of day (Mer enn halvparten av amerikanske sikkerhetsstudier på legemidler ser aldri dagens lys) guardian.co.uk 24.9.2008
Only 43% of the evidence of safety and efficacy that the US Food and Drug Administration uses to approve drugs is published in scientific journals. The authors of the survey say this amounts to "scientific misconduct"

The results of more than half of all clinical trials that demonstrate the safety and effectiveness of new drugs are not published within five years of the drug going on the market, according to an analysis of 90 drugs approved by US regulators between 1998 and 2000.

The researchers, who traced the publication or otherwise of 909 separate clinical trials in the scientific literature, wrote that the failure of drug companies to publish the evidence relating to new medicines amounted to "scientific misconduct". They said it "harms the public good" by preventing informed decisions by doctors and patients about new medicines and by hampering future scientific work.

Sir Iain Chalmers, who is director of the James Lind Library in Oxford and a founder of the Cochrane Collaboration, a respected organisation that reviews medical evidence, said that it was vital that all data on new medicines be made public.

"Patients may otherwise suffer or die unnecessarily," said Chalmers, who was not involved in the work. "The people who participate in a trial have a right to expect that their participation and their data will be made available publicly so that people can take whatever decisions seem appropriate in the light of that information."

The US researchers who carried out the study searched the academic literature for publication of the trials that drug companies relied on to convince the US Food and Drug Administration that their new products were safe and effective and so worthy of market approval. (...)

"In the years immediately following FDA approval that are most relevant to public health, there exists incomplete and selective publication of trials supporting approved new drugs," Prof Ida Sim and her colleagues at the University of California, San Francisco, wrote in the journal PLoS Medicine.

One possible explanation for the scientific data not being published is that drug companies hold back publication of the results that are least flattering to their new drugs. Another possibility is that academic journal editors are less inclined to publish papers on trials that have negative or ambiguous results. (...)

Many Trial Reports on FDA-Approved Drugs Go Unpublished
healthfinder.gov 22.9.2008
TUESDAY, Sept. 23 (HealthDay News) -- More than half of all supporting clinical trials for U.S. Food and Drug Administration-approved drugs remain unpublished five years after permission has been given to sell the drugs in the United States, say University of California, San Francisco researchers. (...)

They said their study findings, published in the journal PLoS Medicine, provide a baseline for monitoring the impact of the FDA Amendments Act 2007. It was introduced to improve the accuracy and completeness of drug trial reporting.
The act requires that all trials supporting FDA-approved drugs be registered when they start and that all outcomes must be posted within a year of drug approval on the U.S. National Institutes of Health's clinical trials Web site.

More information
Here's where you can learn more about the FDA's drug approval application process. (...)

Offentliggjøring av forsøksdata

Making trial data public (Offentliggjøring av forsøksdata)
BMJ 2009;339:b3344 (18 August)
Astronomical data lead the way

Astronomers have been making their raw data publicly available for some time, after a suitable delay to enable those who came up with the idea (and the funding) to perform the first analyses. For example, one organisation releases data to the public 18 months after archiving.¹ Perhaps a suitable time for release of data held by pharmaceutical companies would be shortly after the patent for the drug has expired.²

Secrecy might produce short term gains, but in the longer run it can only hinder progress. (...)

Making information about clinical trials publicly available
Editorials
BMJ 2009;338:b2473 (25 June)
Open access to information on the EudraCT database will improve transparency
Recognition of the commercial and non-commercial benefits of greater transparency within clinical research has increased in the past decade. Public dissemination of the conduct and outcome of all clinical trials, including those performed as part of marketing authorisation applications, will ensure that professionals and patients have more information about how the safety and effectiveness of drugs has been evaluated. This will also prevent unnecessary duplication of research and, by encouraging greater scrutiny of clinical trials, will ensure that their ethical and scientific quality is improved. Wider dissemination of knowledge will also drive innovation and the conduct of further, more relevant, research. (...)

These registers include those of the World Health Organization (www.who.int/ictrp/en/), the US National Library of Medicine (http://clinicaltrials.gov/), the International Standard Randomised Controlled Trials Registry (http://isrctn.org/), and many others. (...)

Groups urge FDA to release info on rejected drugs
reuters.com 24.6.2009
WASHINGTON (Reuters) - The U.S. Food and Drug Administration should make more information available to the public, even on drugs and devices that never make it to the U.S. market, consumer advocates told the health agency on Wednesday.

But industry representatives cautioned that findings or data containing confidential company information could harm competition if made widely available.
While the FDA often provides public details on products that win its approval, doctors and consumers could benefit from similar disclosure on those it rejects, several advocates and former FDA staff reviewers said at a public meeting to discuss ways the agency can make its regulatory decisions clearer. (...)

FDA Pressed for Transparency
online.wsj.com 24.6.2009
WASHINGTON -- Consumers, doctors and scientists told the Food and Drug Administration Wednesday the public deserves to know more about how the agency makes complex scientific decisions about the medicine and food Americans consume.

Consumers said the FDA needs to more rigorously oversee clinical trials to ensure patients get treated fairly; doctors urged the FDA to flag safety concerns with drugs and devices as quickly as possible; and scientists recommended the agency air dissenting opinions by FDA scientists.

These thoughts were balanced, in part, by industry representatives who said that, while they agree the FDA should explain decisions more thoroughly, confidential commercial information shouldn't reach public eyes.

The meeting is part of an FDA effort to counter accusations that it makes decisions without explaining them. The FDA has long faced criticism, some of which was repeated at the meeting, that it sits on safety information that should be public and works too closely with industry.

For instance, the FDA faced criticism that it was too slow to remove the painkiller Vioxx from the market after the drug was linked to an increased risk of heart attacks. The drug was removed from the market in 2004. The agency has been under fire in the last several years for not quickly releasing information showing that the diabetes drug Avandia, made by GlaxoSmithKline, may increase a patients' risk for heart attacks. (...)

- Vitenskapelig æresforfatterskap

Vitenskapelig æresforfatterskap
BO TERNING HANSEN - forsker, Kreftregisteret
aftenposten.no 26.8.2010
Det er ingen tvil om at det er et reelt problem at høyerestående forskere av og til utnytter unge forskere i den vitenskapelige verden, slik Nils Christian Stenseth beskriver i sin kronikk 23. august. Han nevner blant annet æresforfatterskap, hvor enkelte forskere gjennom sin maktposisjon får plass på forfatterlisten uten å ha bidratt, slik reglene for vitenskapelig forfatterskap tilsier. Denne uheldige praksis er utbredt. Forskermiljøene må gjøre mer for å komme dagens stilltiende aksept av juks til livs.

Et sted å begynne kunne vært at alle vitenskapelige tidsskrifter krevde at hver enkelt forfatter selv beskrev sin
rolle i prosessen som ledet frem til det ferdige manuskript. Man kunne da evaluere om den enkelte forfatter oppfyller de formelle krav til vitenskapelig forfatterskap. Eventuelt måtte æresforfatterne selv lyve eksplisitt for å opprettholde dagens praksis. Det tror jeg de fleste ville unngått.

Et annet viktig bidrag for å bekjempe vitenskapelig uredelighet er at vi åpent tør drøfte dette tabuemnet. (...)

Hindrer fri publisering
aftenposten.no 23.8.2010
NILS CHR. STENSETH- professor, Centre for Ecological and Evolutionary Synthesis (CEES), Biologisk institutt, Universitetet i Oslo, Preses, Det Norske Videnskaps-Akademi
Som en etablert forsker ønsker jeg å sette intellektuell trakassering på dagsorden: Både for å forsvare den enkelte og for at samfunnet skal få fullt utbytte av det arbeid som våre forskertalenter utfører, skriver Nils Chr. Stenseth.

- Det er uakseptabelt at folk med «intellektuell makt» misbruker denne til å hindre fri flyt av ideer og resultater.

Det har de siste årene vært mye diskusjon rundt trakassering på jobben – det være seg sosial utestenging, ryktespredning eller seksuell trakassering. Langt sjeldnere trekkes frem hva jeg vil kalle intellektuell trakassering ved universiteter og høyskoler: det vil si situasjoner der veiledere eller andre etablerte medarbeidere styrer prosessen rundt publisering av forskningsresultater etter egen agenda.

Når etablerte forskere blokkerer publisering av forskningsresultater som går mot deres forutfattede mening, eller når de krever å få en mer synlig plass som forfatter på publikasjonene, begår de intellektuell trakassering. (...)

- Forskere føler seg styrt

Forskere føler seg styrt
forskerforbundet.no 25.11.2010
(25.11.10) Forskere ved mer enn hvert tredje forskningsinstitutt sier de er blitt forsøkt styrt av offentlige oppdragsgivere. Det viser en spørreundersøkelse som Forskerforbundet har utført blant sine tillitsvalgte.

– Med henvisning til SINTEF-saken; kjenner du til tilsvarende tilfeller ved eget institutt der offentlig oppdragsgiver har forsøkt å påvirke resultater/konklusjoner i et forskningsoppdrag? var spørsmålet som Forskerforbundet sendte til sine tillitsvalgte.

Vi fikk svar fra 26 forskningsinstitutter. Og av dem var det 11 som svarte bekreftende.

– Jeg synes det er urovekkende høyt, sier rådgiver Jon Wikene Iddeng i Forskerforbundet til Aftenposten.

Les hele saken i Aftenposten: 11 av 26 forskningsinstitutter forsøkt styrt (25.11.10)

Les også: Forskningen må være uavhengig (18.11.10) (...)

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

Diverse artikler

Alle forskningsresultater bør publiseres
Tidsskr Nor Legeforen 2011; 131:2337-8 (29.11.2011)
I Tidsskriftet nr. 19/2011 uttrykker Erlend Hem bekymring over et økende antall «open access»-tidsskrifter og kvaliteten på studiene som publiseres i slike tidsskrifter (1).

Vi mistenker at Hem blander sammen to aspekter ved publiserte studier, nemlig metodologisk kvalitet og nyhetsverdi. Vi trenger nemlig ikke bare de sensasjonelle studiene med positive resultater. Vi trenger også gode studier som repliserer tidligere studier, som kanskje ikke er så spektakulære, men som kan gi et riktigere bilde av problemstillingen. Forskere har dessuten juridiske og etiske forpliktelser til å gjøre forskningsresultater kjent, uavhengig av resultater. Allikevel er det vist at såkalte positive studier har nesten fire ganger så høy sjanse for å bli publisert som negative studier (2). I Tidsskriftet nr. 20/2011 viser Hem selv til saken med bevacizumab i brystkreftbehandling, og skriver at «Medikamentet ble registrert etter én overbevisende studie som viste forlenget effekt på surrogatmarkøren progredieringsfri overlevelse. Senere studier har vist mindre gevinst på slik overlevelse og ingen på samlet overlevelse» (3). Hvilke av disse studiene er «banebrytende», og hvilke er viktige for beslutningstakere i helsetjenesten? (...)

Withdrawal of clinical trials policy by Canadian research institute is a “lost opportunity for increased transparency”
BMJ 2011; 342:d2570 (21 April)
Canadian researchers and academics are puzzled by the Canadian Institute for Health Research’s decision to withdraw its policy on clinical trial registration and results just three months after posting it on its website.

The institute has declined to comment on the decision. A statement on its website says that its policy has been “superseded” by a more general guidance document on the ethics of research involving humans that was prepared for, and approved by, Canada’s three major public funding agencies.

“The CIHR [Canadian Institute for Health Research] policy certainly was leading the drive towards increasing transparency,” said An-Wen Chan, a scientist with the Women’s College Research Institute in Toronto and co-author of the Ottawa Statement on Principles and Implementation of Clinical Trial Registration and Results Reporting (BMJ 2005;330:956-8; doi:10.1136/bmj.330.7497.956). (...)

Eureka! (Et ord norske forskere ikke bruker særlig ofte)
aftenposten.no 29.11.2010
Norske forskere føler seg styrt. I ett opprop forlanger 704 av dem mer penger til den frie forskningen. Og de vil at instituttene ved universitetene skal stå
for utdelingen.

Nypengebinge . For å få skaffe forskere som ikke når igjennom hos Forskningsrådet, flere muligheter, vil Mysterud og Gautestad involvere instituttene ved universitetene. Og de vil resirkulere søknader. Får man nei fra Forskningsrådet skal man kunne søke instituttet i stedet. (...)

Åpen tilgang og Tidsskriftets praksis
Tidsskr Nor Lægeforen 2007; 127:1805 (28.6.2010)
Åpen tilgang innebærer at vitenskapelige publikasjoner gjøres fritt tilgjengelig på Internett. Forfatter beholder opphavsretten til publikasjonen, men gir brukere tillatelse til å lese, laste ned, kopiere, distribuere, skrive ut, søke i eller lenke til fullteksten uten å forlange vederlag. (...)

Nye retningslinjer:
Publiseringsstøtteordning klar for Open Access
forskningsradet.no 25.3.2010
Støtteordningen for publisering fra samfunnsvitenskapelig og humanistisk forskning er revidert. Nye og framtidsrettede retningslinjer åpner for støtte til Open-Access-publisering og elektronisk distribusjon.

Vitenskapelig publisering innenfor samfunnsvitenskap og humaniora foregår i stor grad på norsk, siden mye av forskningen er rettet mot historiske, sosiale og kulturelle problemstillinger i Norge og Norden. Mye av forskningen publiseres også i bokform, sammenlignet med andre vitenskaper. (...)

New studies question FDA's medical approval process (Nye studier stiller spørsmål ved FDAs medisinske godkjennelsesprosess)
examiner.com 31.12.2009
The US Food and Drug Association (FDA) has come under fire once again this week. Two independent studies were published that are critical of the agency's approval process for medical devices. These findings may prove to have long lasting effects in the US justice system. A court case decided in 2008, Riegel versus Medtronic, concluded that approval from the FDA grants companies that produce medical devices free and clear of lawsuits resulting in injuries from their products. (...)

The other study, conducted by researchers from the FDA and Boston’s Beth Israel Deaconess Medical Center, will be published in the upcoming issue of the American Journal of Therapeutics, indicating that about 40% of the studies used to decide what devices are approved lack clear definitions of safety requirements."

These studies follow hot on the heels of other lawsuits with dire consequences that involved FDA approved drugs. Recent headlines featuring tragic birth defects caused by FDA approved antidepressants such as Zoloft and Paxil have shaken consumer confidence in the agency's standards. Even seemingly benign medicine with the FDA's seal of approval is causing grave concern. A good example is the popular denture creams, Fixodent and Poligrip, which are currently facing litigation for zinc poisoning. (...)

FDA corruption in question (...)

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

Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices
JAMA. 2009;302(24):2679-2685 (December 23/30)
Context Medical devices are common in clinical practice and have important effects on morbidity and mortality, yet there has not been a systematic examination of evidence used by the US Food and Drug Administration (FDA) for device approval. (...)

Conclusion Premarket approval of cardiovascular devices by the FDA is often based on studies that lack adequate strength and may be prone to bias. (...)

Bad Drug Test Results Routinely Hidden by Pharmaceutical Companies: Study (Dårlige testresultater for legemidler hemmeligholdes av legemiddelfirmaer)
aboutlawsuits.com 29.9.2009
Drug companies regularly hide the results of bad clinical trials that may have a negative impact on their medications and attempt to only publish studies that show their products in a positive light, according to a new international study.

Researchers from Canada, France and Britain, working with the Ottawa Hospital Research Institute, found that pharmaceutical companies are routinely conducting tests without disclosure that the drug trials are underway, allowing them to cancel studies that may reveal problems with their medications.
According to standard practices for clinical trials, researchers are supposed to announce when any trial is underway and provide information on what the goals are, the researchers pointed out in the Ottawa Citizen.

The examination into drug company practices found that only 50% of drug trials were publicly announced in an appropriate manner, and medical journals are not consistently insisting that the trials first be published on a public register. The researchers concluded that there was a prevalent amount of “selective outcome” reporting of trial results. (...)

German agency refuses to rule on drug’s benefits until Pfizer discloses all trial results (Tysk instans nekter å kontrollere nytteverdi for legemiddel før Pfizer offentliggjør alle forsøksresultater)
Cite this as: BMJ 2009;338:b2521 (22 June)
An independent scientific institute that conducts healthcare research and evaluations mainly on behalf of Germany’s public health insurance regulator has accused the drug giant Pfizer of "concealing" research data on its depression treatment reboxetine.

The Institute for Quality and Efficiency in Health Care, which is based in Cologne and known in Germany as IQWiG, contends that Pfizer has refused to provide a complete list of all published and unpublished trials of reboxetine, which was approved in 1997 in Germany and marketed by Pfizer as Edronax.

If the institute says it is unable to assess the benefit of the drug because of lack of data, it is likely that health insurance companies in Germany may refuse to reimburse its cost. (...)

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

US Congress introduces bill to end free access to federally funded research
Cite this as: BMJ 2009;338:b2199 (1 june)
A bill has been introduced in the US Congress that would end free access to the results of published studies funded by the National Institutes of Health (NIH).
The HR 801 bill, entitled the Fair Copyright in Research Works Act, would, if passed, overturn a public access bill that was passed in October 2007 (BMJ 2007;335:906, doi:10.1136/bmj.39384.638241.DB). This requires researchers to deposit the results of studies with the National Library of Medicine for publication in PubMed Central within a year of publication in a peer reviewed journal. The current law only affects research funded by the National Institutes of Health. (...)

Seroquel user wants judge to unseal papers for FDA
forbes.com 11.3.2009
A patient who claims the psychiatric drug Seroquel gave him diabetes wants a judge to unseal the maker's confidential documents about its side effects before U.S. regulators decide whether to approve a version of the drug for millions of new patients. (...)

Sikrer tilgang til forskningsresultater:
Åpen tilgang til vitenskaplig publisering
forskningsradet.no 6.2.2009
En sentral oppgave for Forskningsrådet er å gjøre forskning tilgjengelig. Dette gjelder forskningsresultater generelt, og forskning finansiert av Forskningsrådet spesielt. Forskningsrådets prinsipper for åpen tilgang til vitenskapelig publisering, vedtatt av Forskningsrådets hovedstyre, er en viktig del av dette arbeidet.

Åpen digital tilgang til publiserte forskningsresultater, vanligvis omtalt som Open Access, er betegnelsen på en stadig viktigere forskningspolitisk målsetting om å sikre åpen tilgang til publiserte resultater av offentlig finansiert forskning. Forskningsrådets prinsipper for åpen tilgang til vitenskapelig publisering er sentrale retningslinjer for å nå denne målsetningen.

Prinsippene slår fast at vitenskapelige tidsskriftsartikler som bygger på FoU-prosjekter finansiert av Forskningsrådet, skal lagres i åpne digitale arkiv og dermed gjøres tilgjengelig for alle interesserte. Forskningsrådet understreker imidlertid at slik arkivering ikke må bryte med forfatteres og utgiveres rettigheter. (...)

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).)

Wall Street Journal Examines Potential Harm in Providing Too Much Drug Safety Information
kaisernetwork.org 9.12.2008
The Wall Street Journal on Tuesday examined how "consumers are receiving a flood of safety information about the drugs they take -- so much that it risks scaring some people." According to the Journal, a recent "series of prescription medication scares" has prompted the media, consumer advocacy groups and FDA to release more information regarding the safety of prescription medications. However, the proliferation of such information "might overwhelm patients and raise undue alarm," according to some medical professionals. The Journal warns that patients "may forget about the benefits of a medication if they focus only on risk," and "the health consequences associated with stopping a medication ... may be far worse than the possibility of a side effect." (...)

Publication bias in clinical trials used for FDA approval
scienceblogs.com 23.9.2008
If there is one difference that defines scientific medicine compared to "alternative medicine" it is the application of the scientific method to health claims. Science and the scientific method require transparency: transparency in methodology, transparency in results, transparency in data analysis. Because one of the most important aspects of science is the testing of new results by other investigators to see if they hold up, the diligent recording of scientific results is critical, but even more important is the publication of results. Indeed, the most important peer review is not the peer review that occurs before publication. After all, that peer review usually consists of an editor and anywhere from one to four peer reviewers on average. Most articles that I have published were reviewed by two or three reviewers. No, the most important peer review is what occurs after a scientist's results are published. Then, all interested scientists in the field who read the article can look for any weakness in methodology, data analysis, or interpretations. They can also attempt to replicate it, usually as a prelude to trying to build on it. (...)

Hemliga papper om Zyprexa blir offentliga
lakemedelsvarlden.se 9.9.2008
Företaget Eli Lilly är föremål för en omfattande utredning i USA. Det handlar om det antipsykotiska läkemedlet Zyprexa och allvarliga biverkningar som företaget anklagas för att ha dolt.

Rättsligt Det är en federal domare i Brooklyn som i fredags beslöt att offentliggöra hemligstämplade dokument om storsäljaren Zyprexa (olanzapin).

Bakgrunden är att ett antal försäkringsbolag, pensionsfondsbolag och fackföreningar har krävt Eli Lilly på stora skadestånd på grund av biverkningar av Zyprexa som företaget dolt. (...)

Keeping the window into drug firms' practices open
boston.com 8.9.2008
IN NOVEMBER, the Supreme Court will hear a case that could make it much more difficult for public officials to expose drug industry practices that put profits ahead of patients. The court could conceivably strip state courts of the right to hear cases challenging the safety and effectiveness of drugs that have been approved by the US Food and Drug Administration. Such state lawsuits have been instrumental in forcing the industry to open its books and reveal embarrassing information.

Recently, for instance, researchers relied on trial documents to shed light on a dubious marketing practice employed by some drug companies: running studies purportedly meant to examine drug safety that in reality are designed to encourage the widespread adoption of a new drug. Such studies are called "seeding trials," and while they are thought to be relatively common, the Aug. 18 report in the Annals of Internal Medicine was the first to investigate these stealth marketing tactics in-depth and raise questions about the ethics of deceiving doctors and patients about the true purpose of these studies.
The report's researchers were able to expose the machinations behind a particular seeding trial - a 1999 study of the painkiller Vioxx by Merck - only because they got their hands on internal Merck documents subpoenaed by plaintiff attorneys. They had sued the firm after Vioxx was withdrawn from the market amid growing evidence that it increased the risk of heart attacks and strokes.

This is not the first time that litigation has provided the public with a glimpse of the lengths to which some drug companies will go to create blockbuster drugs. In 2004, the New York State attorney general's office relied on GlaxoSmithKline's own internal documents to sue the drug company for deceiving physicians and consumers about the safety and effectiveness of its best-selling antidepressant, Paxil. Similar to the Merck case, GlaxoSmithKline's internal documents revealed a rich vein of duplicity among company officials intent on suppressing negative findings about Paxil in treating depression among children and adolescents. (...)

Judge to Unseal Documents on the Eli Lilly Drug Zyprexa
nytimes.com 5.9.2008
A federal judge in Brooklyn decided on Friday to unseal confidential materials about Eli Lilly’s top-selling antipsychotic drug Zyprexa, citing “the health of hundreds of thousands of people” and “fundamental questions” about the way drugs are approved for new uses.

The decision by Judge Jack B. Weinstein of Federal District Court came as part of a ruling that gave class-action status to a case brought by insurance companies, pension funds and unions that want Lilly to repay them billions of dollars they spent on the drug. They contend that Lilly hid the side effects of the drug and marketed it for unapproved uses. (...)

Open access to research
Editorials
BMJ 2008;337:a1051 (31 July 2008)
Increases readership but not citations

This week the BMJ publishes a paper (doi: 10.1136/bmj.a568) that has nothing directly to do with medicine or health care.¹ It does, however, have everything to do with access to research results, a topic that should interest authors and readers in any field. The paper asks whether open access (free full text online publication) increases the chances of an article being read and cited compared with subscription access publication (where articles are accessible only to individuals or institutions who pay to subscribe). (...)

50 millioner nazi-sider åpnes
aftenposten.no 28.11.2007
Enormt nazi-arkiv blir for første gang tilgjengelig for offentligheten.

Allmennheten fikk onsdag for første gang tilgang til enorme mengder hittil ukjent informasjon om Nazi-Tysklands grusomheter i de mange konsentrasjonleirene.

Elleve land har hatt ansvar for arkivet, og har nå ratifisert en avtale om offentliggjøring av det, melder nyhetsbyrået AP.

Det enorme arkivet inneholder informasjon om 17,5 millioner mennesker. (...)

Open Access to Research Funded by U.S. Is at Issue
washingtonpost.com 1.11.2007
A long-simmering debate over whether the results of government-funded research should be made freely available to the public could take a big step toward resolution as members of a House and Senate conference committee meet today to finalize the 2008 Department of Health and Human Services appropriations bill. (...)

Lilly Chief: Share Electronic Records
forbes.com 2.10.2007
INDIANAPOLIS - Eli Lilly and Co. CEO Sidney Taurel is calling for greater cooperation and electronic records sharing in the health care industry to improve drug safety and effectiveness. (...)

The impact of open access upon public health
Bulletin of the World Health Organization (BLT) 2006;84(5):337-424
(...) Increasingly, funders of research also realize the benefit of an open-access model of publishing. The UK’s Wellcome Trust (7) mandates its funded authors to make their work publicly available; the United States National Institutes of Health are encouraging it, (8) and increasing numbers of governments and funding bodies are signing up to declarations on open access. (9) (...)

Transparency in health technology assessments
BMJ 2007;334:594-595 (24 March)
Editorials
Should NICE have the right to refuse access to its modelling data? (...)