Når ord "står opp fra de døde" (When Words Come Back From The Dead) (forbes.com 13.12.2005)

Mercks slettede data (Merck's Deleted Data) (forbes.com 8.12.2005)

Merck undersøker om de skal bringe Vioxx tilbake på markedet (reuters.com 8.11.2006)

Om legemidler, sikkerhet, forskning og markedsføring En mengde vitenskapelig litteratur er i disse dager verdiløs... (forbes.com 8.5.2006)

Merck slipper billig (Merck Gets Off Cheap) (forbes.com 9.11.2007)

New York State og City saksøker Merck grunnet Vioxx (nytimes.com 18.9.2007)

Big pharmas venner (Big Pharma's buddies)
Leder (chron.com 1.6.2008)

Vioxx-studier var marknadsföring (lakemedelsvarlden.se 19.8.2008)

Merck Is Expected to Announce Vioxx Settlement of $4.85 Billion (wsj.com 9.11.2007)

- Vioxx skadelig selv etter at pasienter har sluttet å ta det

Vioxx harmful even after patients stopped taking it (Vioxx skadelig selv etter at pasienter har sluttet å ta det)
reuters.com 13.12.2010
(Reuters Health) - Merck's withdrawn painkiller Vioxx may have continued to cause blood clots and perhaps deaths even after patients dropped it, U.S. researchers said Monday.

The drug was recalled by Merck in 2004 after a colon-polyp prevention study showed it increased the risk of heart disease and death in users. But over the five years it was on the market, researchers estimate it caused nearly 40,000 deaths.

The new findings, published in the Archives of Internal Medicine, are based on data made available by Merck during multibillion-dollar litigation against the company.

They show patients taking Vioxx (also called rofecoxib) doubled their chances of having blood clots or dying in the first half-year after discontinuing treatment, confirming earlier results that hinted the effects might last up to one year.

What happens after that is still an open question, said Dr. Joseph Ross of the Yale School of Medicine in New Haven, who worked on the study. (...)

(Anm: Pasientsikkerhet (rettssikkerhet) (mintankesmie.no).)

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

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

(Anm: NSAID; non-steroidal anti-inflammatory drugs; Ikkesteroide antiinflammatoriske midler (no.wikipedia.org).)

(Anm: Cheflæge advarer mod »totalt forkert« kultur i topfodbold, og landsholdsspillere bekræfter den. Tidligere Fifa-boss påpeger systematisk brug af smertestillende medicin i topfodbold. Landstræneren tager ikke afstand fra det. MÜNCHEN — Halvdelen af topspillerne i alle turneringer arrangeret af Det Internationale Fodboldforbund (Fifa) i årene 1998-2014, inklusive VM-slutrunder, tager jævnligt smertestillende medicin for at kunne spille. Medicinen dækker over alt fra brugen af gigtmedicin til smertestillende indsprøjtninger; såkaldte blokader. (politiken.dk 25.3.2017).)

(Anm: Cheflæge advarer mod »totalt forkert« kultur i topfodbold, og landsholdsspillere bekræfter den. Tidligere Fifa-boss påpeger systematisk brug af smertestillende medicin i topfodbold. Landstræneren tager ikke afstand fra det. MÜNCHEN — Halvdelen af topspillerne i alle turneringer arrangeret af Det Internationale Fodboldforbund (Fifa) i årene 1998-2014, inklusive VM-slutrunder, tager jævnligt smertestillende medicin for at kunne spille. Medicinen dækker over alt fra brugen af gigtmedicin til smertestillende indsprøjtninger; såkaldte blokader. (politiken.dk 25.3.2017).)

- «Ufarlige» smertestillende knyttet til økt risiko for hjertestans.

(Anm: «Ufarlige» smertestillende knyttet til økt risiko for hjertestans. 'Harmless' Painkillers Associated With Increased Risk of Cardiac Arrest. Painkillers considered harmless by the general public are associated with increased risk of cardiac arrest, according to research published in the March issue of European Heart Journal - Cardiovascular Pharmacotherapy.1 Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used drugs worldwide and some, including ibuprofen, are available over the counter. (pharmpro.com 16.3.2017).)

(Anm: Combination of NSAIDs and gastric protection can lead to inflammation in small intestine. Patients with inflammatory diseases are often prescribed non-steroidal anti-inflammatory drugs. They are also often recommended to use a proton pump inhibitor to protect their stomach. (news-medical.net 11 .4.2017).)

(Anm: Reseptfrie NSAID-er linkes til økt risiko for hjertestans, ifølge studie. Smertestillende legemidler som anses ufarlige for publikum er assosiert med økt risiko for hjertestans, ifølge forskning publisert i dagens utgave av European Heart Journal - Cardiovascular Pharmacotherapy. (…) Disse inkluderte de ikke-selektive NSAID-er (diclofenac, naproxen, ibuprofen) og COX-2-hemmere (rofecoxib celekoksib). Over-the-counter NSAIDs linked to elevated risk of cardiac arrest, study finds. Painkillers considered harmless by the general public are associated with increased risk of cardiac arrest, according to research published today in the March issue of European Heart Journal - Cardiovascular Pharmacotherapy. (…) These included the non-selective NSAIDs (diclofenac, naproxen, ibuprofen), and COX-2 selective inhibitors (rofecoxib, celecoxib). (news-medical.net 15.3.2017).

(Anm: Ibuprofen er knyttet til 31 % økning i risiko for hjertestans. Ibuprofen linked to 31% increase in risk of cardiac arrest. A study emerging from Denmark has found that the use of over-the-counter pain killer, Ibuprofen, is associated with an increased risk of cardiac arrest. In particular, the research warned against the view of nonsteroidal anti-inflammatory drugs (NSAID) as without risk and advised against people using the pain killers who had pre-existing cardiovascular problems. (…) Of those who were taking NSAIDs, the use of ibuprofen was associated with a 31% increase in the risk of cardiac arrest. As well as this, patients taking diclofenac, another NSAID – only available by prescription in the USA and the UK, were found to have a 50% increase in the risk of cardiac arrest. (pharmatimes.com 16.3.2017).)

(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: 50 % av kvinnelige metadonpasienter startet med reseptbelagte smertestillende. (50% of female methadone patients started with prescription painkillers.) (medicalnewstoday.com 10.11.2015).)

(Anm: Rusproblem blant eldre. Bruk og misbruk av alkohol og reseptbelagte legemidler er et økende problem blant eldre. Bruk, misbruk eller feilbruk av alkohol og psykofarmaka blant eldre vil komme til å utgjøre en stor folkehelseutfordring, skriver artikkelforfatteren. (dn.no 2.8.2016).)

(Anm: Reseptbelagt misbruk av legemidler i Europa er et større problem enn tidligere antatt. (Prescription drug abuse in Europe is a bigger problem than previously thought.) (medicalnewstoday.com 4.8.2016).)

(Anm: Opioider linket til dødsfall annet enn overdoser, ifølge studie. CHICAGO (AP) — Utilsiktede overdoser er ikke den eneste dødelig risiko ved bruk av kraftige reseptbelagte smertestillende — legemidlene kan også bidra til hjerterelaterte dødsfall og andre død

(Anm: Persistence of Cardiovascular Risk After Rofecoxib Discontinuation. Arch Intern Med. 2010;170(22):2035-2036 (Dec 13/27).)

Vioxx - informasjon versus kunnskap og visdom - hvem visste hva?

Merck agrees to $220M settlement of Mo. Vioxx suit (Merck samtykker å betale 220 millioner dollar for å forlike Vioxx-søksmål i Missouri)
pharmatimes.com 2.11.2012 (Associated Press)
Drugmaker Merck & Co. Inc. could pay up to $220 million in the settlement of a class action lawsuit filed on behalf of Missouri consumers of the prescription pain reliever Vioxx.

Attorney for the consumers, Patrick Stueve, says Thursday's agreement settles claims that New Jersey-based Merck violated the Missouri Merchandising Practices Act by promoting and selling the arthritis drug.

Merck removed Vioxx from the market in 2004 after evidence showed it doubled the risk of heart attack and stroke. (...)

Merck pays $1bn penalty in relation to promotion of rofecoxib (Merck betaler 1 milliard dollar i bøter i forbindelse med promotering av rofecoxib (Vioxx))
BMJ 2011;343 (Published 28 November)
The international drug firm Merck agreed with the US Department of Justice on 22 November to pay $950m (£615m; €720m) to resolve criminal and civil charges over the promotion and marketing of its painkiller rofecoxib (Vioxx).

In 2007 Merck paid $4.85bn to settle about 26 000 lawsuits relating to the drug in state and federal courts (BMJ 2007;335:1011, doi:10.1136/bmj.39398.517176.DB).

The recent fines relate to a long Justice Department investigation of Merck’s promotion of rofecoxib. The funds will go to the US government and to the Medicaid federal insurance scheme for poor people, which paid for the drug under its programmes. Merck did not admit liability or wrongdoing but entered a corporate integrity agreement to strengthen the company’s policies on interactions with health professionals.

Bruce Kuhlik, executive vice president and general counsel for Merck, said in a statement, “We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx.” (...)

Merck betalar miljardbelopp för Vioxx
lakemedelsvarlden.se 23.11.2011
Läkemedelsföretaget Merck har valt att betala 950 miljoner dollar för att man marknadsförde det nu indragna smärtläkemedlet Vioxx som behandling för en icke godkänd indikation. (...)

Australian court findings on Vioxx may have global ramifications (Australsk retts kjennelse angående Vioxx kan få globale følger)
BMJ 2010;340:c1485 (16 March)
A court in Melbourne has ruled that the anti-arthritis drug rofecoxib (Vioxx) increased the risk of heart attack, while finding that the Australian subsidiary of its manufacturer engaged in negligent and misleading behaviour.

In a class action judgment delivered earlier this month, the federal court judge Christopher Jessup found that rofecoxib contributed to the heart attack of plaintiff Graeme Peterson.

The judge ruled that Merck Sharp & Dohme "fell short" of what was required in the reasonable discharge of its "duty of care" by failing to warn Mr Peterson’s doctor of the drug’s potential cardiac risk and because sales representatives overemphasised its safety. (...)

Risker med Vioxx kända tidigt
lakemedelsvarlden.se 24.11.2009
Redan fyra år innan det antiinflammatoriska Vioxx togs av marknaden fanns data som visade på risker med läkemedlet. Efter en analys av 30 studier av preparatet menar forskare att tydliga tecken visade att risken för hjärt-kärlrelaterade problem ökade med behandlingen.

Det är amerikanska forskare som har gått igenom 30 randomiserade placebokontrollerade studier av rofecoxib, den aktiva substansen i läkemedlet Vioxx. Preparatet kom ut på marknaden 1999 och marknadsfördes då av Merck som en nytt och säkrare alternativ till traditionella icke-steroida antiinflammatoriska medel. Men efter en tid blev det tydligt att personer som behandlades med rofecoxib löpte högre risk än andra att drabbas av hjärt-kärlsjukdomar och 2004 drogs det på grund av detta bort från marknaden.

Menforskarna bakom den nya analysen, som publicerats i Archives of Internal Medicine, en av JAMA-publikationerna, menar att riskerna med läkemedlet var kända redan flera år tidigare. Analysen innefattar totalt 20 152 patienter och studierna har varat från fyra veckor till fyra år. De doser som getts har varit mellan 12,5 till 50 mg. (...)

(Anm: Bringing the FDA's Information to Market. Arch Intern Med. 2009;169(21):1985-1987 (November 23).)

(Anm: Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data
Arch Intern Med. 2009;169(21):1976-1985 (November 23)
.)

Merck disguised "marketing publication" as medical journal to help promote Vioxx, court hears (I rettsforhandlinger opplyses at Merck maskerte "reklamepubliksajon" som tidsskrift for å promotere Vioxx)
BMJ 2009;338:b1714 (28 April)
The Federal Court in Australia has heard allegations that the drug company Merck produced an entire medical journal as part of its marketing campaign to allay safety fears about Vioxx (rofecoxib), its cyclo-oxygenase-2 inhibitor, which was withdrawn in 2004.

The allegations came during testimony from George Jelinek, an emergency doctor and journal editor. Dr Jelinek was called as an expert witness by lawyers acting for Graeme Peterson, who had a heart attack in 2003 after taking rofecoxib for several years and is lead plaintiff in a class action. (...)

(Anm: Delirium is associated with 5-fold increased mortality in acute cardiac patients. (medicalnewstoday.com 16.3.2017).)

(Anm: Lager dokumentarfilm om legemiddelindustrien og psykofarmaka. Filmskaper Annikken Hoel vil ha svar på hvorfor søsteren plutselig døde. (Dødsårsak ukjent). (tv.nrk.no/serie/dagsrevyen 13.3.2017).)

(Anm: «Dødsårsak: ukjent»: Bør bli pensum for både leger og lekfolk. Viktig og skremmende om legemiddelindustriens makt. (...) Det er klart at regissøren har en agenda. Hun dveler ikke ved konspirasjonsteorier, men forsøker å finne frem til en sannhet. Det er klart at regissøren har en agenda. Hun dveler ikke ved konspirasjonsteorier, men forsøker å finne frem til en sannhet. Samtidig er mye av informasjonen i filmen kjent dersom du har fulgt med på store søksmål i USA. Hun greier likevel å få frem et oversiktlig og skremmende bilde av de sterke og korrupte båndene som eksisterer mellom politikere, byråkrater og de store farmasøytiske selskapene. (aftenposten.no 22.3.2017).)

(Anm: Norsk dokumentar: «Lykkepillen» Ti år i psykiatrien var som ti år med tortur for Silje Marie. Et møte med en sykepleier endret alt. (aftenposten.no 13.3.2017).)

(Anm: Uten obduksjoner begraver sykehusene feilene sine. (Without Autopsies, Hospitals Bury Their Mistakes) (…) Da Renee Royak-Schaler uventet kollapset og døde 22. mai beordret ingen obduksjon. (…) Diagnostiske feil, som studier viser er vanlig, forblir uoppdaget, og tillater at leger kan fortsette sin praksis på andre pasienter med en falsk følelse av trygghet. (…) Mulighetene for å lære om effektiviteten av medisinske behandlinger og progresjon av sykdommer går tapt. Unøyaktig informasjon ender opp i dødsattester, og undergraver påliteligheten for avgjørende helsestatistikk. (propublica.org 15.12.2011).)

Vioxx-studier var marknadsföring
lakemedelsvarlden.se 19.8.2008
En studie som Merck gjorde av biverkningar på Vioxx var i själva verket en del av företagets marknadsföring. Studiens syfte var att öka försäljningen av preparatet. (...)

Merck Vioxx study was for marketing: researchers (Forskere: Merck Vioxx-studie var markedsføring)
reuters.com 19.8.2008
NEW YORK (Reuters) - The primary purpose of a 1999 clinical study that Merck & Co Inc said was done to test side effects of Vioxx was actually to support a marketing campaign before the now-withdrawn painkiller's launch, according to U.S. researchers.

The real aim of the study, called Advantage, was to promote prescription of the new medicine when it became available -- a so-called "seeding" project -- the researchers said on Tuesday. (...)

Merck Vioxx Trial Done to Boost Sales, Study Finds (Update1) (Merck Vioxx-forsøk utført for å øke salget, ifølge studie)
bloomberg.com 18.8.2008
Aug. 18 (Bloomberg) -- Merck & Co.'s marketing department devised a study on the painkiller Vioxx to persuade 600 doctors involved in the trial to prescribe the drug and recommend it to their peers, researchers say.

Their conclusions are based on 100 internal company memos and reports about the study known as Advantage obtained from lawsuits against Whitehouse Station, New Jersey-based Merck over heart risks tied to Vioxx, now withdrawn. The trial of 5,557 patients started in 1999, just as Vioxx was cleared for sale, according to the Annals of Internal Medicine report.

The study, which tested the drug's safety in the stomach, was primarily crafted by Merck's marketing department to get doctors to prescribe Vioxx, the researchers wrote. The report provides some of the first evidence of what is thought to be a widespread practice: recruiting doctors for a study to boost their confidence in a new drug and get them to promote it to colleagues, they said. (...)

'Patients at Risk'
"By publishing this article, we hope to shine a light on a practice that appears to be widespread, that really involves an element of deception because patients aren't told the true purpose of the trial,'' Sox said. "This is one practice that appears to put patients at risk when there may be little or no scientific benefit to the research. Indeed, some patients were injured by the drug.'' (...)

Clinical Trial Said to Have Been Marketing in Disguise (Klinisk forsøk sies å være maskert markedsføring)
medpagetoday.com 18.8.2008
BELMONT, Mass., Aug. 18 -- The ADVANTAGE trial comparing Merck's rofecoxib (Vioxx) with naproxen (Aleve) was designed and executed primarily for marketing purposes, said researchers here, but the company has denied the allegation.

Internal documents made public as part of Vioxx-related litigation show that Merck's marketing department conceived the trial as a way to introduce the drug to primary care physicians and turn them into advocates for the product, reported Kevin P. Hill, M.D., M.H.S., of McLean Hospital, and colleagues in the August 19 issue of Annals of Internal Medicine.

The researchers said it was the first clearly documented example of a "seeding trial," where marketing a drug to physicians is the main goal, rather than responding to regulatory requirements or answering a scientific question. (...)

(Anm: The ADVANTAGE seeding trial: a review of internal documents. Annals of Internal Medicine 2008; 149:251-58.

(Anm: Seeding Trials: Just Say "No". Annals of Internal Medicine 2008; 149:279-80.)

Researchers: Merck Vioxx study was for marketing (Forskere: Merck Vioxx-studie var markedsføring)
money.cnn.com 18.8.2008
Researchers: Merck Vioxx study was designed to market the painkiller; company disputes that (...)

NEW YORK (Associated Press) - A 1999 Merck & Co. study of its since-withdrawn painkiller Vioxx, touted to participating doctors and patients as meant to show whether Vioxx caused fewer stomach problems than another drug, was primarily a stealth marketing strategy, researchers report.

The true purpose was to get lots of doctors and patients in the habit of using Vioxx just in time for its launch, according to doctors who uncovered internal Merck memos discussing the strategy behind the study, called ADVANTAGE. They did so while reviewing roughly a million Merck documents for plaintiffs' lawyers preparing for trials in Vioxx lawsuits. (...)

Using funding from the Robert Wood Johnson Foundation's clinical scholars program, they searched further, uncovering items such as a memo from two top Merck executives nominating the study for an internal marketing award.

"The objectives were to provide product trial among a key physician group to accelerate uptake of Vioxx as the second entrant in a highly competitive new class," the memo states. (...)

Hemmeligholdt dødsrisiko
forskning.no 17.4.2008
Et legemiddelfirma hemmeligholdt risikoen ved en ny medisin. Tester som ble fremstilt som uavhengige, var skrevet av selskapet selv. - Trolig ikke et unikt tilfelle, sier en norsk professor. (...)

Siden har det vist seg at flere titalls tusen amerikanere kan ha dødd av Vioxx. I Norge ble dødstallet anslått til et hundretalls personer.

Nå viser det seg at Merck & Co., lenge før legemiddelet ble trukket tilbake i 2004, var klar over den høye dødsrisikoen bruk av legemiddelet medførte. (...)

- Studiene bekrefter noen antakelser om den farmasøytiske industrien, der store pengeinteresser er på spill, sier professor i etikk, Knut W. Ruyter, ved Forskningsetiske komiteer. (...)

Studien viser at vitenskapelige artikler som ble fremstilt som uavhengige, i realiteten var skrevet av ansatte ved Merck & Co. (...)

Spøkelsesforfattere
Fenomenet omtales som "ghostwriting", fordi de som egentlig har skrevet studien, er "usynlige" for offentligheten og helsemyndighetene. (...)

I følge de amerikanske forskerne har det lenge vært mistenkt at en slik praksis med "spøkelsesforfattere" er relativt utbredt innenfor biomedisinsk publisering. (...)

(Anm: Legemiddelkonsulenter. (mintankesmie.no).)

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

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. (...)

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. (...)

Misleading medical research common: journal editor (Tidsskriftsredaktør: villedende medisinsk forskning vanlig)
reuters.com 15.4.2008
WASHINGTON (Reuters) - Misleading research is often published in major medical journals and doctors are lending their names to it, the editor of the Journal of the American Medical Association said on Tuesday.

Doctors, regulators, publishers and others are all taking money, information and small presents from pharmaceutical companies and being influenced in the process, said Dr. Catherine DeAngelis.

"It goes for all of us," DeAngelis, whose journal is influential nationally and globally, said in a telephone interview. (...)

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. (...)

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." (...)

New Vioxx Study May Cast Doubt On Merck Claims
online.wsj.com (3.7.2007)
In a new blow to Merck & Co.'s defense in the Vioxx litigation, results from a yet-to-be-published study suggest that increased heart risks associated with the painkiller began immediately after patients started taking the drug. (...)

Vioxx Stroke Risk could last for Years (Vioxx-slagrisiko kan vare i årevis)
lawyersandsettlements.com 16.5.2007
New York, NY: Tidligere brukere av Vioxx kan være utsatt for risiko for å utvikle slag i årevis etter at de avsluttet bruken av legemidlet, opplyste en fremstående samfunnsmedisinsk ekspert. (Former users of Vioxx could be at risk for developing strokes for years after they have discontinued using the medication, a prominent public health expert has reported.)

Vioxx, som er brukt av millioner av amerikanere, ble trukket fra verdensmarkedet i september 2004 etter at det ble vist at det doblet risiko for hjerteanfall hos pasienter som tar det i 18 måneder eller lenger. (Vioxx, which was used by millions of Americans, was recalled worldwide in September, 2004 after it was shown to double heart attack risk among patients taking it 18 months or longer.)

"Permanent damage" (Permanent skade)
"Det kan være at Vioxx forårsaker varig skade på det kardiovaskulære system, i form av akselererende aterosklerose eller vedvarende økning i blodtrykket," sa dr. Curt Furberg ved den amerikanske Food and Drug Administrations Drug Safety and Risk Management Advisory Committee. ("It may be that Vioxx is causing permanent damage to the cardiovascular system, accelerating atherosclerosis or a sustained increase in blood pressure," said Dr. Curt Furberg of the U.S. Food and Drug Administration's Drug Safety and Risk Management Advisory Committee.)

De nye bekymringer har økt etter en 107 siders studie på pasienter som ble fulgt i et år etter at de avsluttet bruken av Vioxx. Rapporten slår fast at 28 mennesker i studien hadde hjerteanfall og slag innen et år etter at de sluttet med Vioxx. Dette sammenliknet med 16 pasienter fra forsøket som hadde tatt placebo. (...) (The new concerns have arisen from a 107-page study on patients who were followed for one year after they discontinued taking Vioxx. The report states that 28 people from the study had heart attacks and strokes within one year after they stopped taking Vioxx. This is compared with 16 patients from the trial that had taken placebos.)

Journal studies show more Vioxx safety problems (Tidsskriftstudier viser flere sikkerhetsproblemer ved Vioxx.)
marketwatch.com 12.9.2006
-- Mercks tilbaketrukne smertestillende middel Vioxx har økt risiko for problemer med nyre og hjertearytmi, og kan ifølge to nye analyser publisert i tidsskriftet Journal of the American Medical Association være skadelig når det tas for en kortere periode. (- Merck's recalled pain reliever Vioxx carries an increased risk of kidney and heart arrhythmia problems, and can be harmful even when taken for a short period of time, according to two new analyses to be published in the Journal of the American Medical Association.)

Første studie, utført av forskere ved University of Newcastle i Australia, viste at Vioxx kunne øke risikoen for hjerteproblemer, spesielt hjerteanfall, innen en måneds bruk. (...) (A first study, conducted by researchers at the University of Newcastle in Australia, showed that Vioxx could raise the risks of cardiovascular problems, particularly heart attack, within one month of use.)

Selv om den amerikanske legemiddelkontrollen, Food and Drug Administration, har sagt at Vioxx, også kjent som rofecoxib, kan returnere på markedet med restriksjoner, har Merck ennå tilgode å gjøre det. (...) (Although the Food and Drug Administration has said that Vioxx, also known as rofecoxib, can return to the market with restrictions, Merck has yet to do so.)

Vioxx Anxiety Rises (Tiltagende Vioxx-bekymringer)
forbes.com 17.8.2006
Merck ble i dag truffet av et dobbeltslag i forbindelse med to separate rettsavgjørelser relatert til sin tilbaketrekning av det smertestillende midlet Vioxx. (Merck was hit today with a one-two punch in two separate court decisions relating to its withdrawn pain pill Vioxx.)

For første gang tapte Merck (nyse: MRK - news - people) en Vioxx-sak i føderal domstol. saksøkeren, 62-årige Gerald Barnett, ble tilkjent 51 millioner dollar i kompensasjon og "punitive damages". I den første føderale sak, gikk Merck seirende ut av kampen. (...) (For the first time, Merck (nyse: MRK - news - people) lost a Vioxx case in federal court. The plaintiff, 62-year-old Gerald Barnett, was awarded $51 million in compensatory and punitive damages. In the only previous federal case, Merck had emerged victorious.)

(Anm: punitive damages; en erstatning til skadelidte i tillegg til den alminnelige økonomiske tapsberegning, som skal tjene som en slags straff for tort overfor den som har forvoldt skaden.

Punitive damages, som er en viktig årsak til at begrepet "amerikanske tilstander," er en type erstatning som skal være så høy at den kan virke tilstrekkelig avskrekkende til å forhindre selskaper i å ta forretningsmessige beslutninger basert på forventninger om at de kan takle skadeomkostninger for sikkerhetsrisiko.)

Senator Calls For Probe Of FDA Conduct (Senator ber at den amerikanske legemiddelkontrollen FDA granskes)
cbsnews.com 30.7.2006
I forbindelse med dets handlinger da de gjennomgikk sikkerheten for Vioxx (...) (In Connection With Its Actions As It Reviewed Safety Of Vioxx)

Ifølge korrespondent Sharyl Attkisson i CBS News, gir fremlagte dokumenter i noen av disse saker nye glimt inn i forbindelsene mellom FDA og Merck – et forhold som kritikerne sier er altfor nært. (...) (Now, as CBS News correspondent Sharyl Attkisson reports, documents turned over in some of those cases are providing new glimpses into the relationship between the FDA and Merck – a relationship that critics say was far too cozy.)

En seniorforsker hos FDA, dr. David Graham, hadde i god tid før Vioxx ble trukket fra markedet, signalisert at midlet forårsaket hjerteproblemer. (Well before Vioxx was pulled from the market, an FDA senior scientist, Dr. David Graham had flagged its heart issues.)

Men e-poster og håndskrevne notater gjennomgått av CBS News tyder på at ledelsen i FDA, som var antatt å regulere Merck, gav det farmasøytiske firmaet – og ikke publikum – forhåndsinformasjon om disse sikkerhetsresultater. (But, e-mails and handwritten notes reviewed by CBS News suggest FDA management which was supposed to be regulating Merck was giving the pharmaceutical company – and not the public – advance notice of those safety findings.)

Dr. Graham kranglet med FDA-ledelsen i sitt forsøk på å gå ut med informasjon om risikoer for Vioxx. (Dr. Graham butted heads with his FDA managers in trying to get the word out about Vioxx's risks.)

"Ledelsen i FDA ønsket ikke å gi tillatelse til at jeg presenterte mitt arbeide på en vitenskapelig konferanse, men samtidig ønsket de å være sikre på at Merck hadde en kopi av min vitenskapelige presentasjon," sa dr. Graham. "Så det er godt nok for Merck, men ikke godt nok for det amerikanske folk?" ("The FDA officials didn't want to allow me to present my work at a scientific conference, but at the same time they wanted to be sure that Merck had a copy of my scientific presentation," Dr. Graham said. "So it's good enough for Merck, but it's not good enough for the American people?")

Senator Chuck Grassley sa FDA og Merck gikk så langt som å konspirere sammen for å legge hindringer i veien for dr. Grahams resultater. (Sen. Chuck Grassley said the FDA and Merck went so far as to conspire together to undercut Dr. Graham's findings.)

Senator Grassley sender nå et brev til FDA, hvor han anklager byrået for å la interessene til den farmasøytiske industri gå foran interessene til det amerikanske folk. (...) (Sen. Grassley is sending a fresh letter to the FDA accusing the agency of making the pharmaceutical industry the "FDA's first client" when that client should be the American people.)

Lawyers Like Vioxx Correction (Advokater liker Vioxx-korreksjon)
msn.com 27.6.2006
(...) "Korreksjonen viser at de har løyet om APPROVe-dataene," sa Seeger. ("The correction shows they have been lying about the APPROVe data," Seeger said.)

Seeger anklager Merck for manipulasjon av dataene slik at legemidlet fremstår som sikrere enn det er. (Seeger charges that Merck manipulated the data so the drug would look safer than it is.)

Men Merck sa at de bare gjorde en feil da de beskrev metodetypen for analyser brukt i studien. (But Merck said it simply made a mistake when it described the type of method of analysis used in the study.)

Imidlertid sa redaksjonssjef i New England Journal, dr. Gregory D. Curfman, at når man ser på den 100-sider analyseplanen for data var der ingen referanse til bruk av lineær metode. (However, New England Journal executive editor Dr. Gregory D. Curfman said in looking at the 100-page data analysis plan there was no reference to using a linear method.)

"Du kan ikke se på dataene og deretter avgjøre hvordan de skal analyseres," sa Curfman. "Merck antyder at det er OK å endre (planen). Du må følge dataplanen." (...) ("You can't look at the data and then decide how to analyze it," Curfman said. "Merck is suggesting that is OK to change (the plan). You must follow the data plan.")

Key Vioxx Claim Withdrawn (Nøkkelpåstand om Vioxx trukket tilbake)
forbes.com 26.6.2006
Tidsskriftet som publiserte en nøkkelstudie for Merck har trukket tilbake konklusjonen om at det tar 18 måneder for Vioxx å øke pasienters risiko for hjerteanfall og slag, hvilket er et mulig tilbakeslag for legemiddelfirmaet, både hva omdømme og rettssaker angår. (The journal that published a key Merck study has withdrawn the conclusion that it takes 18 months for Vioxx to increase patients' risk of heart attack and stroke, potentially dealing a blow to the drug company, both in its public image and its legal battles.)

I en korreksjon lagt ut på websiden til New England Journal of Medicine, hvor studien, kalt APPROVe, ble publisert i februar 2005, fjerner tidsskriftet konklusjonen i abstraktet og diskusjonen i deres arbeid om at det tar 18 måneder før risiko viser seg. (...) (In a correction posted on the Web site of the New England Journal of Medicine, where the study, called APPROVe, was published in February, 2005, the journal removes the conclusion that it takes 18 months for risk to emerge from the Abstract and the discussion of their paper.)

(Anm: Correspondence. Time-to-Event Analyses for Long-Term Treatments -- The APPROVe Trial. New England Journal of Medicine (NEJM) (June 26, 2006).)

Post-Vioxx, Drug Industry Eyes More Transparency (Legemiddelindustrien møter krav om større åpenhet etter Vioxx) (Alternativ URL)
Leder
investors.com 16.6.2006 (Investor's Business Daily)
Hvem visste hva, og når visste de det. Det er spørsmål mange innen legemiddelindustrien helst ikke ville høre. (Who knew what, and when did they know it? It's a question many in the drug industry would rather not hear.)

Merck (MRK) har hørt det i årevis, helt siden de ble tvunget til å trekke det smertestillende "blockbuster"-legemidlet på grunn av bekymringer om hjerteproblemer og andre mulige sideeffekter. (Merck (MRK) has been hearing it for a couple of years, ever since it was forced to withdraw the blockbuster painkiller Vioxx due to concerns over heart problems and other potential side effects.)

(Anm: blockbuster; legemiddel med årlig salg over 1 milliard dollar.)

Firmaet møter rundt 13 000 Vioxx-relaterte søksmål. Kjernen i disse rettssaker dreier seg om hva — og når — Merck visste om legemidlets mulige sideeffekter. (...) (The company faces some 13,000 Vioxx-related lawsuits. The core of those suits revolves around what — and when — Merck knew about the drug's potential side effects.)

I juni 2004, saksøkte Spitzer det britiske firmaet GlaxoSmithKline (GSK) for å hemmeligholde data som viser at antidepressivaet Seroxat (Paxil i USA) kunne fremprovosere selvmord hos barn. Glaxo inngikk forlik etter to måneder. (In June 2004, Spitzer sued U.K.-based GlaxoSmithKline (GSK) for suppressing data showing the antidepressant Paxil could provoke suicide in children. Glaxo settled in two months.)

I avtalen med Spitzer, lovet GlaxoSmithKline å legge alle kliniske forsøksresultater, som er tilkommet etter 27. desember 2000, ut på nettet. (...) (Under the deal with Spitzer, GlaxoSmithKline promised to put online summaries of all clinical trial results that took place after Dec. 27, 2000.)

(Anm: Hvorfor offentliggjøres ikke alle forskningsresultater som går på bivirkninger og hvorfor aksepterer kontrollmyndighetene hemmeligholdelse av alvorlige bivirkninger?)

Merck Admits a Data Error on Vioxx (Merck innrømmer datafeil for Vioxx)
nytimes.com 31.5.2006
I en innrømmelse som undergraver et av firmaets kjernepunkter i sitt forsvar av Vioxx-relaterte søksmål, opplyste Merck i går at de hadde feilet da de tidlig i 2005 rapporterte at en vital statistisk test viste at Vioxx kun forårsaket hjerteproblemer etter 18 måneders kontinuerlig bruk. (In an admission that could undermine one of its core defenses in Vioxx-related lawsuits, Merck said yesterday that it had erred when it reported in early 2005 that a crucial statistical test showed that Vioxx caused heart problems only after 18 months of continuous use.)

I går innrømmet Merck at statistiske analysetester ikke støtter firmaets 18-måneders teori om Vioxx. (...) (That statistical analysis test does not support Merck's 18-month theory about Vioxx, the company acknowledged yesterday.)

Pill Pushers (Pillepushere)
On The Cover/Top Stories (På omslaget/vigtigste nyheter)
forbes.com 8.5.2006
How the drug industry abandoned science for salesmanship. (Hvordan legemiddelindustrien oppgav vitenskap til fordel for salgsteknikk.)
(…) I alt 17 legemidler er trukket tilbake det siste tiår. Wyeths tilbaketrekking av slankemidlet Redux i 1997 førte til utbetalinger på 22 milliarder dollar i skadeerstatning og skadeoppgjør (FORBES, Apr. 10). (A total of 17 drugs have been recalled in the past decade. Wyeth's withdrawal of diet drug Redux in 1997 led to $22 billion in damages and counting (FORBES, Apr. 10).)

Vioxx vil likevel kunne overgå dette. Mercks ny-generasjon smertestillende legemiddel -- markedsført med aggressive salgsmetoder til en kostnad på 550 millioner dollar over fem år -- ble trukket i september 2004 da en studie viste at pasienter som tok det i 18 måneder hadde dobbelt så stor risiko for hjerteanfall. I det påfølgende rettslige angrep er 10 000 søksmål tatt ut, som søker skadeerstatninger og anklager firmaet for å ha villedet leger og staten. Sist måned tapte Merck 13,5 millioner dollar på en domsavgjørelse til fordel for en overlevende etter hjerteanfall, firmaets annet tap i fem prøvde saker. Der er flere mulige søksmål hvor disse kom fra. (…) (Vioxx could yet eclipse that. Merck's new-generation painkiller--touted to consumers at a cost of $550 million over five years--was recalled in September 2004 when a study showed that patients on it for 18 months had double the risk of heart attacks. In the ensuing legal onslaught 10,000 suits have been filed, seeking billions in damages and accusing the company of misleading doctors and the feds. Last month Merck lost a $13.5 million verdict to one heart attack survivor, its second defeat in five cases tried. There are more potential lawsuits lurking where these came from.)

De ti største legemiddelfirmaer investerer årlig 42 milliarder dollar på forskning, 14 % av salget -- men de bruker likevel mer enn dobbelt så mye på markedsføring og administrasjon. På et tiår har legemiddelfirmaene nesten tredoblet antall selgere som oppsøker leger, til 100 000, ifølge Verispan. Det er en selger på hver niende lege; i 1996 var det en for hver attende. Ofte oppmuntrer de til uautorisert bruk utenfor preparatomtale eller sponser møter som går på "medisinsk etterutdannelse" for å oppildne til flere forskrivninger og utvide et legemiddels pasientgrunnlag. (The top ten drug firms invest $42 billion a year on research, 14% of sales--yet they plow more than twice that much into marketing and administration. In a decade drug firms have almost tripled the ranks of salespeople calling on physicians, to 100,000, according to Verispan. That's one seller for every 9 docs; in 1996 it was one for 18. Often they encourage unauthorized off-label uses or sponsor "continuing medical education" sessions to stoke more prescriptions and broaden a drug's patient base.)

Selv forskningslaboratorier er mer markedsstyrt enn noen gang. Mer enn 9 milliarder dollar går årlig til kliniske forskningsforsøk på legemidler som allerede er godkjent eller snart vil bli det -- ofte for å finne på nye reklameslogan. Det er en økning på 90 % på fire år, ifølge Goldman Sachs. Noen av disse reklamedrevne forsøk er skjeve fordi de sammenlikner den høyeste dose for sponsorens produkt mot en svakere dose for en rivaliserende pille. Allikevel har legemiddelprodusenter unnlatt å igangsette to tredjedeler av de 1 200 forsøk som er krevet etter at markedsføringstillatelse er gitt av FDA. (…) (Even the research lab is more marketing-driven than ever. More than $9 billion a year in research spending goes to clinical trials of drugs that are already approved or may soon be--often to snare new ad slogans. That is up 90% in four years, says Goldman Sachs. Some of these ad-driven trials are skewed to pit the sponsor's full-strength product against a weaker dose of a rival pill. Yet drugmakers have failed to begin two-thirds of the 1,200 post-marketing trials required by the FDA.)

"Folk kom inn og spurte etter -- stilte krav om [en COX-2 hemmer] -- og noen ganger truet de med å finne en ny lege dersom jeg ikke forskrev det," uttalte lege John Abramson, en klinisk veileder ved Harvard Medical School som har vært konsulent for advokater som representerer saksøkere. (…) ("People would come in asking for--demanding [a COX-2 inhibitor]--and sometimes threaten to find a new doctor if I didn't prescribe it," says physician John Abramson, a clinical instructor at Harvard Medical School who has consulted for plaintiff lawyers.)

"De sammenliknende studier er en vits. De er komiske. En mengde vitenskapelig litteratur er i disse dager verdiløs," sa psykiater Jack E. Rosenblatt. "Hele prosessen er korrumpert," sa den britiske beinforskeren Aubrey Blumsohn. "Det forverres fordi den økonomiske innsats er stigende." ("The comparative studies are a joke. They are comical. A lot of the scientific literature these days is worthless," says psychiatrist Jack E. Rosenblatt. "The whole process has been corrupted," says British bone researcher Aubrey Blumsohn. "It is getting worse as the financial stakes are rising.")

Til tross for sløseriet med tvilsomme forsøk, utfører ofte ikke legemiddelprodusenter livsviktige studier for å sørge for at nye legemidler virkelig er sikre når de introduseres på massemarkedet. (…) (Despite the profusion of dubious trials, drugmakers often don't conduct crucial studies to ensure new drugs are truly safe as they move out to a mass market.)

(Anm: Report: Vioxx risk seen with short-term use. msnbc.msn.com. (Rapport: Risiko registrert ved kortidsbruk av Vioxx) (18.5.2006).

Statliga pengar till läkemedelsindustrin. dagensmedicin.se (2.5.2006).)

Disputes Over Medical Research Growing (Økende strid om medisinsk forskning) abcnews.go.com 22.2.2006
Strid om industrifinansiert medisinsk forskning et voksende problem. (Disputes Over Industry-Funded Medical Research a Growing Problem.)

WASHINGTON - Dr. Aubrey Blumsohn ble sjokkert: Forskningsresultater var innsendt til et vitenskaplig møte i hans navn, men den britiske beineksperten insisterer på at han ikke hadde skrevet eller gjennomgått rapporten, han var ikke sikker på at den var nøyaktig. (- Dr. Aubrey Blumsohn was stunned: Research results were submitted to a scientific meeting under his name yet the British bone specialist insists he not only hadn't written or reviewed the report, he wasn't sure it was accurate.)

Striden ble offentlig kjent da Blumsohn anklaget det amerikanske legemiddelfirmaet, som betalte for studien, for å ha avvist hans forsøk på personlig å analysere dataene. (...) (The incident turned into a public feud when Blumsohn charged that the U.S. drug company paying for the study rebuffed his attempts to personally analyze the data.)

"Disse firmaer bruker forskere, universitetsforskere, til å skaffe sin forskning aktverdighet og troverdighet som hører et universitet til," la han til. ("These companies are using scientists, university scientists, to give their research a veneer of university respectability and credibility," he added.)

When Words Come Back From The Dead (Når ord "står opp fra de døde") forbes.com13.12.2005
I det året som er gått siden farmasigiganten Merck trakk sitt legemiddel mot artritt fra hyllene, er firmaet blitt saksøkt av 7 000 skadede personer – herav en som allerede koster firmaet 253 millioner dollar. Men en egenskap ved Microsoft Word, som ofte brukes feil, kan vise seg å være den lille tuen som velter Merck-lasset. (NEW YORK - In the year since pharmaceutical giant Merck withdrew its arthritis drug Vioxx from shelves, the company has been hit with 7,000 personal injury lawsuits--one of which already cost the company $253 million. But it could be a frequently misused feature of Microsoft Word that turns out to be the straw that broke Merck's back.)

Sist uke, uttalte redaktører i The New England Journal of Medicine at før Merck (nyse: MRK - news - people) sendte inn en større studie til Tidsskriftet for publikasjon i 2000, ble informasjon som linket Vioxx til økt risiko for hjerteslag slettet fra dokumentet. (Last week, editors at The New England Journal of Medicine said that before Merck (nyse: MRK - news - people) submitted a major study to the Journal for publication in 2000, information linking Vioxx to an increased risk of heart attacks was deleted from the document.)

I en redegjørelse lagt ut på NEJMs nettsted, opplyser redaktørene at de ved en gjennomgåelse av studien, "ut fra en PC-diskett fastslo at [relevante data ble] slettet fra VIGOR-manuskriptet to dager før det første gang ble innsendt til Tidsskriftet." (In a statement posted on the NEJM's Web site, the editors said that during a review of the study, they "determined from a computer diskette that [relevant data was] deleted from the VIGOR manuscript two days before it was initially submitted to the Journal.")

Ifølge dr. Gregory Curfman, redaksjonssjef i Tidsskriftet, fastslo NEJM at data hadde blitt slettet, ved å slå på egenskaper i Microsoft (nasdaq: MSFT - news - people) Word kalt "Sporinger av endringer," som lager en fortegnelse over hva som er blitt lagt til og slettet fra et dokument, og tillater brukere å legge til kommentarer i teksten. Det er svært ofte brukt av grupper av mennesker med et felles dokument, siden det tillater dem å gjøre endringer på hverandres arbeid, uten å varig slette eller endre det originale dokumentet. (According to Dr. Gregory Curfman, an executive editor at the Journal, the NEJM determined data had been deleted by turning on a feature in Microsoft (nasdaq: MSFT - news - people) Word called "Track Changes," which keeps a record of what's been added and removed to a document, and allows users to add notes to the text. It's commonly used by groups of people who are sharing a document, since it allows them to make changes to each other's work, without permanently deleting or altering the original document.) (...)

Representanter for Microsoft nektet å snakke om Merck-saken, men sa at egenskapen "Sporinger av endringer" vil bli revidert og ytterligere forbedret for å redusere disse uhell i neste versjon av programvaren. (Representatives for Microsoft declined to comment on the Merck situation but said that the "Track Changes" feature will be revised and further enhanced to reduce these accidents in the next version of the software.)

Ønsker du å spore nyheter fra denne forfatter eller om denne industri? Forbes Attache gjør det enkelt. (...) (Want to track news by this author or about this industry? Forbes Attache makes it easy.)

USAs sikkerhetsbyrå:
Statshemmeligheter lekkes i metadata

digi.no 25.1.2006
- Så mye informasjon lekker som metadata i Word og PDF, at USAs sikkerhetsbyrå NSA tar affære.

Den moderne tekstbehandleren Word tar vare på langt mer informasjon enn det som kommer til syne når dokumentet skrives ut. Under dokumentegenskaper får man vite blant annet når dokumentet ble opprettet, og av hvem. Funksjonen «spor endringer» gjør at man aldri mister noe av det som blir strøket. (...)

Farmasigiganten Merck angrer på en diskett de sendte til New England Journal of Medicine i 2000 med en artikkel i Word om legemiddelet Vioxx. Sporingsfunksjonen viste at de hadde strøket et avsnitt om økt risiko for hjertesykdom, en risiko de siden benektet å ha visst om. Nå er Merck saksøkt, og Word-dokumentets sporingsfunksjon er bevismateriale. (...)

Reform of Drug Regulation — Beyond an Independent Drug-Safety Board (Reform av legemiddelregulering — Et uavhengig sikkerhetsutvalg for legemidler)
New England Journal of Medicine (NEJM) 2005;354:194-201 (January 12)
Nylige tilbaketrekninger av høyt profilerte legemidler fra markedet har ført til en ny undersøkelse av prosessen for legemiddelregulering som gir grunnlag for bekymringer om at nåværende prosess er utilstrekkelig til å beskytte folkehelsen.1,2 Den udugelighet, som er registrert hos Food and Drug Administration (FDA) og den farmasøytiske industri, til upartisk å evaluere legemidler og å reagere adekvat på signaler som indikerer mulige sikkerhetsproblemer, har gitt stor støtte til etableringen av et uavhengig sikkerhetsutvalg.3 Imidlertid, fordi begrensninger av den nåværende prosess omfatter interessekonflikter, foreslår vi mer omfattende reformer designet . . . [Full tekst av denne artikkel]. (Recent withdrawals from the market of high-profile drugs have led to a reexamination of the process of drug regulation and have stimulated concern that the current process is inadequate for protection of the public health.1,2 The perceived inability of the Food and Drug Administration (FDA) and the pharmaceutical industry to evaluate drugs impartially and to respond adequately to signals indicating potential drug-safety problems has created extensive support for the establishment of an independent drug-safety board.3 However, because the limitations of the current process go well beyond these conflicts of interest, we propose more extensive reforms designed . . . [Full Text of this Article])

- Handler om å tjene mest mulig
aftenposten.no 9.1.2006
- Legemiddelindustrien skreddersyr undersøkelser som gir svarene de vil ha. Små detaljer kan bety milliarder ekstra i inntekter, sier Jeffrey M. Drazen.

Legemiddelindustrien forteller i sin iver etter å tjene penger ikke alltid hele sannheten om en medisin, sier professor Jeffrey M. Drazen, redaktør i New England Journal of Medicine.

- Stiller meg undrende til kritikken
Aftenposten 9.1.2006
- Jeg opplever at man i industrien har høy integritet og stiller høye krav til de studiene som blir publisert. Han stiller seg undrende til Drazens påstander om at det er en negativ utvikling. Min erfaring er det motsatte, også i internasjonal sammenheng, sier administrerende direktør Pål Christian Roland i Legemiddelindustriforeningen. Han erkjenner at sakene om Vioxx og Celebra har skadet industriens omdømme, men sier likevel: - Generelt kan både leger og pasienter ha tillit til legemiddelindustrien. (...)

Drug profits infect medical studies (Legemiddelprofitt infiserer medisinske studier)
Los Angeles Times 7.1.2006
FLERE AV VÅRE mest ærbødige vitenskapelige tidsskrifter er nylig blitt besudlet av beskyldninger om vitenskapelig uredelighet. Sjokkerende? Vi bør være akkurat like sjokkert som inspektør Renault da han oppdaget gambling på Ricks kafé i Casablanca. (...) (SEVERAL OF OUR most venerated scientific journals have recently been besmirched by allegations of scientific misconduct. Shocking? We should be just as shocked as Inspector Renault when he discovered gambling at Rick's Cafe in Casablanca.)

Hvorfor bør vi ikke være overrasket? Fordi klinisk forskning over de siste 25 år, i stor utstrekning har blitt privatisert. Trekvart av kliniske studier publisert i de tre mest respekterte medisinske tidsskrifter (New England Journal of Medicine, Journal of the American Medical Assn. og Lancet) er nå kommersielt finansiert. Som et resultat, vokser ikke vår medisinske kunnskap i den retning som best forbedrer vår helse men mot korporativ fortjeneste, som planter vokser mot sollyset. (Why shouldn't we be surprised? Because over the last 25 years, clinical research has been largely privatized. Three-quarters of the clinical studies published in the three most respected medical journals (the New England Journal of Medicine, the Journal of the American Medical Assn. and the Lancet) are now commercially funded. As a result, our medical knowledge grows not in the direction that best improves our health but toward corporate profits, the way that plants grow toward sunlight.)

Det var ikke alltid slik. Før 1980, var de fleste medisinske studier statlig finansiert, og de fleste akademiske forskere foraktet industriell sponsing. Nå, imidlertid, er det store flertall av kliniske forsøk kommersielt finansiert, og med så høye finansielle innsatser, er der økende bevis for at enkelte forskere og selskaper manipulerer sine resultater. (This wasn't always so. Before 1980, most medical studies were publicly funded, and most academic researchers scorned industry support. Now, however, the vast majority of clinical trials are commercially funded, and with the financial stakes so high, there is mounting evidence of individual scientists and corporations manipulating their findings.)

Selv våre mest betrodde tidsskrifter er avhengig av penger fra legemiddelfirmaer. Legemiddelfirmaer kjøper ikke bare annonsering på deres sider. Ifølge Richard Horton, redaktør for Lancet, betaler de også opp til 1,75 millioner dollar for opptrykk av artikler som favoriserer deres legemidler, som salgsrepresentanter deler ut til leger. (Even our most trusted journals are dependent on drug-company money. Drug makers don't just buy advertising in their pages. According to Richard Horton, editor of the Lancet, they also pay up to $1.75 million for reprints of articles favorable to their drugs, which sales reps then hand out to doctors.)

Registries and Registration of Clinical Trials (Registre og registrering av kliniske forsøk)
N Engl J Med 2005;353:2811-2812 (December 29) (PDF)
Argumentene i favør av registreringen av kliniske forsøk er nå velkjente.1,2,3,4 Viktigst av disse er praksisen med selektiv rapportering, hvorved studier som er negative eller skadelige ikke gjøres tilgjengelig for offentligheten, hvilket eksperter på spørsmålet om kliniske forsøk betrakter som en viktig form for vitenskapelig uredelighet.5 Denne praksis, som illustrert i et antall høyt profilerte eksempler, har økt kravet om påbudt offentlig registrering av kliniske forsøk. Registrering av forsøk bør øke kompletteringen, påliteligheten, og kvaliteten på fortolkningen av klinisk forskning. (The arguments in favor of the registration of clinical trials are now familiar.1,2,3,4 Chief among these addresses the practice of selective reporting, whereby negative or detrimental studies are not brought into the public domain, which experts on the subject of clinical trials consider an important form of scientific misconduct.5 This practice, as illustrated in a number of high-profile examples, have increased the demand for the mandatory public registration of clinical trials. Registration of trials should improve the completeness, reliability, and quality of the interpretation of clinical research.)

Dette behov for registrering tvinger frem spørsmålet om hvor forsøk bør være registrert. Det synes åpenbart at, for å unngå interessekonflikter og å øke publikums tillit, bør enhetene som etablerer og forvalter registre imøtekomme bestemte krav. (This need for registration prompts the question of where trials should be registered. It seems obvious that, to avoid conflicts of interest and to increase the public trust, the entities that establish and manage registries should meet certain requirements.)

- Merck slettet Vioxx-informasjon
dn.no 12.12.2005
Nye avsløringer rundt Vioxx-skandalen gir farmasigiganten Merck et forklaringsproblem.

Anerkjente The New England Journal of Medicine sier ifølge Reuters at farmasiselskapet Merck holdt tilbake informasjon om farene ved bruken av smertepillen Vioxx i et nøkkelstudie som ble publisert i journalen i 2000.

Medisinen Vioxx måtte trekkes fra markedet ifjor da det ble oppdaget at smertedemperen som skulle være mildere mot magen ga brukere dobbelt så stor sjanse for hjerteinfarkt og slag. Selskapet har siden fått mer enn 6000 søksmål mot seg på grunn av hjerteanfall og død.

Etter at Vioxx-skandalen ble kjent, så det anerkjente tidsskriftet nærmere på manuset det publiserte i 2000. Mercks omtale i The Journal bidro til å gjøre det nye "vidundermiddelet" kjent i bransjen. Da oppdaget The Journal at Merck hadde strøket omtale av tre hjerteinfarkt blant Vioxx-brukere samt annen relevant data i papirmanuskriptet Merck hadde levert, skriver Reuters.

Manipuleringen av manuset ble oppdaget da The Journal i ettertid sammenlignet manuskriptet med en kopi tidsskriftet hadde fått på diskett. I den digitale versjonen av studiet var nemlig farene ved bruk av Vioxx tatt med.

Merck hevder at kunnskapen om hjerterisikoen ved Vioxx-bruken ikke ble kjent før etter deadline i The New England Journal of Medicine. Merck mener heller ikke at utelatelsen i særlig grad endret konklusjonen i artikkelen.

Tidsskriftet mener derimot at Merck på grunn av utelatelsene i manuskriptet "underrapporterte" faren for hjerteinfarkt.

Det er ventet at The Journals oppdagelse kan styrke saken til de over 6000 saksøkerne i kjølvannet av Vioxx-skandalen.

Ifølge en ny analyse fra Dr David Graham ved det amerikanske Food and Drug Administration kan mellom 89.000 og 139.000 personer i USA dødd i Vioxx-relaterte dødsfall.

Merck head 'misled jury in Vioxx court cases' (Leder i Merck "villedet jury i Vioxx-rettssaker")
timesonline.co.uk 13.12.2005
Lederen for kliniske forsøk hos Merck møter påstander om at hun førte jurymedlemmer bak lyset i nylige rettssaker, etter oppdagelsen av bevis som angivelig viser at legegruppen mislyktes å offentliggjøre alle data vedrørende risiko for hjerteproblemer hos pasienter som tok det nå forbudte smertestillende midlet Vioxx. (THE head of clinical trials at Merck faces claims that she misled jurors in recent court cases, after the discovery of evidence allegedly showing that the drug group failed to release all data relating to the risk of heart problems in patients who took the now-banned painkiller Vioxx.)

Beskyldninger mot Alise Reicin kom idet den siste rettssak, som omhandler en pasient som døde av hjerteslag etter å ha tatt legemidlet, ble erklært resultatløs i føderal domstol i Houston, etter at juryen mislyktes å nå en enstemmig dom etter mer enn 18 timers rådslagning. (The allegations about Alise Reicin came as the latest trial involving a patient who died of a heart attack after taking the drug was declared a mistrial in federal court in Houston, after the jury failed to reach a unanimous verdict following more than 18 hours of deliberation.)

Vioxx Editorial May Bolster Merck Suits (Vioxx-lederartikkel kan styrke Merck-søksmål)
abcnews.go.com 11.12.2005
Medisinsk tidsskrifts lederartikkel om Mercks tilbakeholdelse av Vioxx-bevis kan understøtte saksøkerne. (...) (Medical Journal's Editorial on Merck's Withholding Vioxx Evidence May Bolster Plaintiff Cases.) (...)

En talsmann for tidsskriftet sa dessuten at Merck slettet et diagram, som inkluderte de ekstra hjerteslag, i det manuskriptet som ble fremlagt. (Moreover, a spokeswoman for the Journal said Merck deleted a chart which included the additional heart attacks from the manuscript that was submitted.)

"Jeg tror dette er fryktelig skadelig for Merck," sa Howard Erichson, professor ved Seton Hall Law School. "Det faktum at et fremstående medisinsk tidsskrift anklager Merck for å skjule informasjon om Vioxx, treffer deres forsvar om at de ikke har gjort noe galt, midt i hjertet ." ("I think this is terribly damaging to Merck," said Howard Erichson, a professor at Seton Hall Law School. "The fact that a prominent medical journal is accusing Merck with hiding information about Vioxx goes straight to the heart of their defense that they did nothing wrong.")

Doctor Links Merck Trial to His Demotion (Lege linker Merck-rettssak til sin degradering)
The New York Times 10.12.2005
Mindre enn en uke etter at et videoopptak av hans sterke kritikk av Merck ble avspilt i forbundsdomstolen i Houston, har dr. Eric Topol, en fremstående hjertespesialist, mistet sin tittel som faglig sjef for Cleveland Clinic's medical college. (Less than a week after his videotaped lambasting of Merck was played in a Houston federal courthouse, Dr. Eric Topol, a prominent cardiologist, has lost his title as chief academic officer of the Cleveland Clinic's medical college.)

I retten i går fortsatte jurymedlemmer rådslagning om hvorvidt Mercks smertestillende middel Vioxx hadde forårsaket dødsfallet til en mann fra Florida i 2001. (In the courthouse yesterday, jurors continued deliberating whether Merck's painkiller Vioxx had caused the death of a Florida man in 2001.)

Dr. Topol sa i går at han trodde at hans degradering kunne være relatert til hans vitneforklaring i denne saken, det tredje Vioxx-søksmål som er oppe i retten. Dr. Topol har stilt spørsmål om sikkerheten til Vioxx i flere år og sa i sin vitneforklaring, avspilt i retten sist lørdag, at han trodde at Merck opptrådte uansvarlig og begikk vitenskapelig uredelighet da de promoterte Vioxx. (Dr. Topol said yesterday that he believed that his demotion might be related to his testimony in that case, the third Vioxx lawsuit to reach trial. Dr. Topol has questioned Vioxx's safety for years and said in his testimony, played in court last Saturday, that he believed that Merck acted irresponsibly and committed scientific misconduct when it promoted Vioxx.)

"Det vanskeligste i verden er upartisk å forsøke å fortelle sannheten, gjør du de riktige ting for pasienter, blir du bakvasket," sa han i går. "Ikke å undres at ingen tar til motmæle mot industrien." ("The hardest thing in the world is just trying to tell the truth, to do the right thing for patients, and you get vilified," he said yesterday. "No wonder nobody stands up to the industry.")

Doctors Upset Over Latest Vioxx Revelation (Leger opprørt over seneste Vioxx avsløringer)
abcnews.go.com 9.12.2005
Velrenommert tidsskrift konstaterer at opplysninger om enkelte tilfeller av hjerteslag er utelatt i studie (Prestigious Journal States Some Heart Attacks Not Disclosed in Study)

- Amerikanske leger er opprørt over å høre at forfatterne av en studie i 2000, finansiert av legemiddelgiganten Merck, mulig unnlot å legge frem data om at ytterligere tre pasienter fikk hjerteslag, mens de brukte Mercks populære smertestillende middel, Vioxx. (...) (- U.S. doctors were upset to learn that the authors of a 2000 study funded by the pharmaceutical giant Merck possibly failed to disclose data that three additional patients suffered heart attacks while using Merck's popular painkiller, Vioxx.)

Leger er avhengig av at medisinske tidsskrifter publiserer studier om pasient-trender og behandlinger. Når denne informasjon er uriktig, kan det ha skrekkelige konsekvenser, har mange leger bemerket. (Doctors rely on the medical journals to publish studies about patient trends and treatments. When that information is incorrect, it can have dire consequences, many doctors noted.)

Ærligheten til forfatterne og nøyaktigheten til tidsskrifter er livsviktig for bona fide medisinsk praksis," sa professor i familiemedisin ved Bill Cayley University of Wisconsin i et e-post intervju. (...) ("The honesty of authors and the accuracy of journal is vital to the bona fide practice of medicine," said University of Wisconsin family medical professor Bill Cayley in an email interview.)

(Anm: bona fide; bo´na fi`de lat. i god tro, ærlig og redelig, i uvitenhet om å ha begått en rettsstridig handling (mots. mala fide). Kilde: ordnett.no.)

Dersom vi ikke kan stole på sannferdigheten til publiserte data, eller prosessen som fører til at de blir publisert, da har vi ikke et solid fundament." (...) (If we cannot trust the veracity of published data, or the process by which it comes to be published, then we do not have sound footing.")

Når legemiddelfirmaer har en klar finansiell interesse i studieresultatene, kan det være attraktivt for dem å maskere eller mistolke resultater, bemerket familielege Lee Green ved University of Michigan. (When drug companies have a clear financial stake in the results of the study, it may be appealing for them to mask or misinterpret results, noted family physician Lee Green of the University of Michigan.)

Den eneste måte vi noen gang kan oppnå troverdighet på, sikre forskning på kommersielle produkter mot bias, er at investorene som satser penger ikke har innflytelse på finansiering, design, utførelse, analyse eller publisering av forskningen," sa Green. ("The only way we'll ever get trustworthy, unbiased research on commercial products is to ensure that those whose profits are at stake have no say in the funding, design, conduct, analysis or publication of the research," Green said.)

(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.)

(Anm: Legemiddeletterlevelse (Tas legemidler som foreskrevet?) (Adherence to Medication.) (…) Legemidler virker ikke på pasienter som ikke tar dem. (Drugs don't work in patients who don't take them.)  (NEJM 2005;353:487-497(August 4).)

Ideelt sett, er redaktørene for medisinske tidsskrifter antatt å analysere studier for eventuelle mulige konflikter, spesielt når et legemiddelfirma har støttet en studie som er forelagt for publikasjon. I dette tilfellet, kan redaktørene i New England Journal of Medicine ha en rolle å spille i dette, sa Dr. William Golden, lege og professor i folkehelse ved University of Arkansas. (Ideally, the editors of medical journals are suppose to analyze studies for any potential conflicts, especially when a drug company has supported a study being submitted for publication. In this case, the editors of the New England Journal of Medicine may have some part to play in the matter, said Dr. William Golden, a medical and public health professor at the University of Arkansas.)

Selv om redaktørene har bedt Merck om å fremlegge en korreksjon på VIGOR-studien, betyr ikke det at tidsskriftet ikke bør gis noe av skylden, sa Golden. (Although the editors have asked Merck to submit a correction to the VIGOR study, that doesn't mean the journal should not receive some of the blame, Golden said.)

"Som part i denne katastrofen kan deres usedvanlige lederartikkel være et forsøk på å døyve sin egen skyld," sa han. ("Their unprecedented editorial may reflect an attempt at assuaging their own guilt about being part of this debacle," he said.)

Medical Journal Criticizes Merck Over Vioxx Data (Medisinske tidsskrift kritiserer Merck angående Vioxx-data)
The New York Times 9.12.2005
(…) New England Journal of Medicines beskyldninger kunne spille en kritisk rolle i tusener av søksmål som Merck møter angående Vioxx, et artritt og smertelegemiddel. (The New England Journal of Medicine's allegation could play a critical role in the thousands of lawsuits that Merck faces over Vioxx, an arthritis and pain drug.)

Vioxx er estimert brukt av 20 millioner amerikanere før firmaet trakk det sist år etter en studie linket det til hjerteslag og hjerneslag. I tre søksmål som har kommet opp for retten så langt, har Merck sagt at de omgående la frem informasjon om hjerterisiko for Vioxx. (Vioxx was taken by an estimated 20 million Americans before the company withdrew it last year after a study linked it to heart attacks and strokes. In the three lawsuits that have reached trial so far, Merck has said that it promptly disclosed information about Vioxx's heart risks.)

Men i et intervju i går, kom dr. Gregory D. Curfman, tidsskriftets redaksjonssjef, med skarp kritikk av Merck for den måte de presenterte data fra kliniske forsøk. Studien, kalt Vigor, omfattet mer enn 8 000 pasienter og ble publisert i tidsskriftet i november 2000, nesten fire år før Merck stoppet salget av legemidlet. (But in an interview yesterday, Dr. Gregory D. Curfman, the journal's executive editor, sharply criticized Merck for the way it presented data from the clinical trial. The study, called Vigor, covered more than 8,000 patients and was published in the journal in November 2000, almost four years before Merck stopped selling the drug.)

"De opplyste ikke om det de visste," sa dr. Curfman. "Der er alvorlige negative konsekvenser for folkehelsen som et resultat av det." (…) ("They did not disclose all they knew," Dr. Curfman said. "There were serious negative consequences for the public health as a result of that.")

Men dr. Curfman sa studieforfatterne fra først av hadde inkludert noen ufordelaktige data for Vioxx, og deretter slettet dem. (...) (But Dr. Curfman said the study's authors had originally included some data unfavorable to Vioxx, then deleted it.)

Mercks aksjer falt nesten 5 prosent i går etter at tidsskriftet på sin webside (nejm.org) publiserte lederartikkelen og en separat kunngjøring som kritiserer firmaets atferd . (Shares of Merck fell almost 5 percent yesterday after the journal published the editorial and a separate statement on its Web site (nejm.org) criticizing the company's behavior.)

I lederartikkelen, "Uttrykk for bekymring," opplyser tidsskriftet at forfatterne av studien, to dager før de framla resultatene for publikasjon, hadde slettet noen data om slag og andre vaskulære problemer hos pasienter i Vigor-forsøket. (In the editorial, "Expression of Concern," the journal said that the authors of the study had deleted some data about strokes and other vascular problems suffered by patients in the Vigor trial two days before it submitted the results to the publication.)

Forfatterne, hvor noen arbeidet for Merck, som også underrapporterte antallet hjerteslag blant pasienter som fikk Vioxx, hevdet at der var 17 hjerteslag når der i virkeligheten var 20, anførte tidsskriftet. Forfatterne er blitt bedt om å korrigere studien, ifølge tidsskriftet. (…) (The authors, some of whom worked for Merck, also underreported the number of heart attacks suffered by patients taking Vioxx, claiming that there were 17 heart attacks when there were actually 20, the journal said. The authors have been asked to correct the study, the journal said.)

Christopher Seeger, som representerte saksøker i den andre rettssaken – en seier for Merck i New Jerseys statlige domstol i Atlantic City – sa at han trodde at tidsskriftetes anklager ville gjøre det mindre trolig at jurymedlemmer hadde tillit til firmaet. (Christopher Seeger, who represented plaintiffs in the second trial - a victory for Merck in New Jersey state court in Atlantic City - said that he believed that the journal's allegations would make jurors less likely to trust the company.)

"Det kommer til å endre landskapet for rettstvistene," sa Seeger. "De beskylder Merck for vitenskapelig uredelighet." ("It's going to alter the landscape of the litigation," Mr. Seeger said. "They're accusing Merck of scientific misconduct.")

Sist måned viste en advokat, som representerer mennesker som saksøker Merck, et memo til dr. Curfman fra juli 2000 fra dr. Reicin og en annen vitenskapsmann hos Merck, dr. Deborah Shapiro. Det fremgår av dette memo at dr. Reicin og dr. Shapiro visste om de tre ekstra hjerteslag i Vigor-forsøket før tidsskriftet publiserte resultatene, sa dr. Curfman. De hjerteslag kunne og burde ha vært inkludert i artikkelen, sa han. (…) (Last month, a lawyer who represents people suing Merck showed Dr. Curfman a memo from July 2000 between Dr. Reicin and another Merck scientist, Dr. Deborah Shapiro. That memo showed that Dr. Reicin and Dr. Shapiro knew of the three additional heart attack deaths in the Vigor trial well before the journal published the results, Dr. Curfman said. Those heart attacks could and should have been included in the article, he said.)

Memoet viser også at dr. Reicin og dr. Shapiro visste om slagene og alvorlige vaskulære problemer gjennomgått av pasienter som tar Vioxx, sa dr. Curfman. (…) (The memo also shows that Dr. Reicin and Dr. Shapiro knew of strokes and serious vascular problems suffered by patients taking Vioxx, Dr. Curfman said.)

"Der var enkelte systematiske redigeringer av manuskriptet for å kunne slette data," sa han. ("There was some methodical editing of the manuscript to remove data," he said.)

Informasjonen i memoet synes å motsi vitneforklaringen, som dr. Reicin gav i juli i Angleton, Tex., i det første Vioxx-søksmålet som kom opp for retten, sa W. Mark Lanier, saksøkerens advokat i den saken. Dr. Reicin burde etterforskes for falsk forklaring under avgitt forsiking (ed), sa Mr. Lanier. (The information in the memo appears to contradict extensive testimony that Dr. Reicin gave in July in Angleton, Tex., in the first Vioxx suit to reach trial, said W. Mark Lanier, the plaintiff's lawyer in that case. Dr. Reicin should be investigated for perjury for her testimony, Mr. Lanier said.)

Det knuser Reicin fullstendig som vitne," sa Lanier. "Jeg tror hennes tidligere vitneforklaring vil være en bumerang." (It totally destroys Reicin as a witness," Mr. Lanier said. "I think her testimony in the past is going to really come back and bite her.")

(Anm: Expression of Concern: Bombardier et al., "Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis," N Engl J Med 2000;343:1520-8 / Editorial N Engl J Med 353:2813-2814 (December 29).)

Expression of Concern Reaffirmed.Published at www.nejm.org February 22, 2006 (10.1056/NEJMe068054)

Response to Expression of Concern Regarding VIGOR Study. Published at www.nejm.org February 22, 2006 (10.1056/NEJMc066096.)

Merck's Deleted Data (Mercks slettede data)
forbes.com 8.12.2005
NEW YORK - En toppredaktør i New England Journal of Medicine sa at han ble sjokkert da han fant ut at data som linket Vioxx til kardiovaskulær risiko var slettet fra en stor studie publisert for fem år siden -- og at det synes som om Merck-forskere kan ha slettet disse data. (A top editor of The New England Journal of Medicine says that he was stunned to find out that data linking Vioxx to cardiovascular risk was deleted from a major study his journal published five years ago--and that it appears that Merck researchers may have deleted that data.)

"Det var en mellomting mellom overraskelse og sjokk," sa Dr. Gregory Curfman, redaksjonssjef i Tidsskriftet. "De tillot oss å publisere en artikkel som var mangelfull, unøyaktig og villende på visse punkter, hvilket kan ha bidratt til å skade folkehelsen." ("I was somewhere between surprised and stunned," Dr. Gregory Curfman, executive editor of The Journal, says. "They allowed us to publish an article that was just incomplete and inaccurate in some respects and was misleading and may have contributed to the detriment to the public health.") (...)

Vioxx trial deposition reveals strong words against FDA (Vitneforklaring Vioxx-rettssak avslører sterke utfall mot FDA)
Houston Chronicle 5.12.2005
En tidligere fremstående vitenskapsmann hos Merck kalte statlige kontrollører “bastarder" i en intern e-post, fordi de vurderte å tilføye en advarsel i pakningsvedlegget for Vioxx et år etter at det kom på markedet, og etter at en studie linket det til hjerteslag og hjerneslag. (The former top scientist at Merck called federal regulators "bastards" in an internal e-mail because they were considering adding a warning to Vioxx's label a year after it was placed on the market and after a study linked it to heart attacks and strokes.)

Edward Scolnick, tidligere administrerende direktør for Merck Research Labs, sa i en vitneforklaring avspilt for jurymedlemmer i dag at han var sterkt uenig med Food and Drug Administration om at det burde opplyses om problemer i pakningsvedlegget. (Edward Scolnick, the former president of Merck Research Labs, said in a deposition played for jurors today that he strongly disagreed with the U.S. Food & Drug Administration concerns that the label should be added.)

"Vær sikker, vi vil ikke akseptere dette pakningsvedlegget," sa Scolnick i en e-post til andre ledere hos Merck i oktober 2001. ("Be assured, we will not accept this label," Scolnick said in an e-mail to other Merck officials in October 2001.)

Om kontrollører som ber om tilleggsinformasjon, uttalte han, "De er bastarder." Senere kalte han dem "bedragersk." (Of regulators asking for additional safety information, he said, "They are bastards." Later he called them "devious.")

MERCK ON TRIAL (MERCK TILTALT)
Expert testifies Vioxx can cause deadly clots (Ekspert bevitner at Vioxx kan forårsake dødelige blodpropper)
Houston Chronicle 29.11.2005
Første vitne tar standpunkt i søksmålet angående dødsfallet til mann fra Florida (First witness takes the stand in suit over death of Florida man)

En landskjent ekspert innen farmakologi bekreftet tirsdag at forskrivningen av det smertestilende Vioxx kan forårsake blodpropper lik den som førte til dødsfallet til en fiskematselger fra Florida for fire år siden. (...) (A nationally known pharmacology expert testified Tuesday that the prescription painkiller Vioxx can cause blood clots like the one that led to the death of a Florida seafood salesman four years ago.)

Lucchesi var det første vitne i landets første føderale Vioxx-rettssak. Selv om den amerikanske distriktsdommer Eldon Fallon fra New Orleans leder forhandlingene i saken, er den holdt i Houston på grunn av de skadene som orkanen Katrina forårsaket på rettsbygningen der. (Lucchesi was the first witness in the nation's first federal Vioxx trial. Although U.S. District Judge Eldon Fallon of New Orleans is presiding over the case, it is being held in Houston because of damage Hurricane Katrina caused to the courthouse there.)

"Jeg tror at Vioxx kan forårsake blodpropper," sa Lucchesi. "Jeg tror at Merck enten var oppmerksom eller burde ha vært oppmerksom på at denne muligheten eksisterte." ("I believe that Vioxx can produce blood clots," Lucchesi said. "I believe that Merck either was aware or should have been aware that this potential existed.")

Merck undersøker om de skal bringe Vioxx tilbake på markedet

Merck CEO says any Vioxx settlements years away (Merck uttalte at forlik er mange år unna)
reuters.com 8.11.2006
NEW YORK (Reuters) - Merck & Co. (MRK.N: Quote, Profile, Research) Administrerende direktør Richard Clark sa på onsdag at det kunne gå flere år før de vurderte å forlike tusener av søksmål fra mennesker som hevder de er skadet av det tilbaketrukne atrititt-legemidlet Vioxx. (Merck & Co. (MRK.N: Quote, Profile, Research) Chief Executive Richard Clark said on Wednesday it could be several years before it considers settling thousands of lawsuits brought by people who claim to have been harmed by its withdrawn arthritis drug Vioxx.)

I tillegg opplyste Clark på Reuters Healths toppmøte i New York at Merck undersøker om de skal bringe Vioxx tilbake på markedet. (In addition, Clark told the Reuters Health Summit in New York that Merck was still looking into bringing Vioxx back to the market.)

"Vi evaluerer dette, og førsøker å komme frem til en endelig konklusjon," sa Clark, som tilla at han hele tiden får brev fra pasienter som sier at Vioxx var det eneste som hjalp mot smerten. ("We're still evaluating that, and trying to make a final decision," Clark said, adding that he gets letters all the time from patients saying that Vioxx was the only thing that helped their pain.)

"Deres livsstil er forandret" uten Vioxx, sa han. (...) ("Their lifestyles have changed" without Vioxx, he said.)

Love letters to Vioxx

Despite safety problems, Vioxx still in demand
fiercepharma.com 6.8.2007
Maybe some people still don't know what's bad for them. Patients who once dependent on Vioxx for arthritis relief are still lobbying Merck to get the drug back on the market--despite the documented risk of heart attacks, strokes, even death. Consumer advocates say it might be a case of rose-colored hindsight; patients convinced only Vioxx can help them may simply have exaggerated memories of the drug's effects. But patients say they simply want to make their own choices. Don't smokers say the same thing?

- here's the report from the Star-Ledger (...)

Love letters to Vioxx
nj.com 5.8.2007
Despite risks, some former patients are clamoring for drug's return
Nearly three years after Merck pulled Vioxx off the market because of alarming safety data, patients continue to write letters and send e-mails urging the drugmaker's executives to reconsider their decision. (...)

New York State og City saksøker Merck grunnet Vioxx

New York State and City Sue Merck Over Vioxx (New York State og City saksøker Merck grunnet Vioxx)
nytimes.com 18.9.2007
Seeking to recoup tens of millions spent by government-financed health programs on prescriptions for Vioxx, New York State and New York City joined yesterday in filing a lawsuit against Merck, the drug’s maker, which withdrew the painkiller from the market in 2004 because of dangerous side effects. (...)

New York State, City File Joint Lawsuit Against Merck (New York State, City går til felles søksmål mot Merck)
kaisernetwork.org 18.9.2007
The offices of New York Attorney General Andrew Cuomo (D) and New York City Mayor Michael Bloomberg have filed a joint lawsuit against Merck over allegations that the company concealed information about the cardiovascular risks of the COX-2 inhibitor Vioxx, the Wall Street Journal reports. Merck, which withdrew Vioxx from the market in September 2004 because of safety concerns, faces about 28,000 lawsuits related to the medication in state and federal courts (Won Tesoriero, Wall Street Journal, 9/18). (...)

The lawsuit, filed on Monday in state Supreme Court in Manhattan, seeks restitution for tens of millions of dollars spent on Vioxx prescriptions through the state Medicaid program and state Elderly Pharmaceutical Insurance Program between 1999 and 2004 (Kershaw, New York Times, 9/18). The city paid a substantial share of the cost of the Vioxx prescriptions for residents enrolled in the state Medicaid program. (...)

- Norges Bank mot pillegigant

Norges Bank mot pillegigant
dn.no 2.1.2009
Mener legemiddelgiganten Merck holdt skjult dødelige bivirkninger av medikament. (...)

Vioxx ble godkjent av amerikanske myndigheter i 1999. I løpet av få år ble legemiddelet et av de mest solgte i verden. Også i Norge ble Vioxx hyppig skrevet ut på resept.

30. september 2004 ble legemiddelet brått trukket fra markedet av Merck. (...)

Noen dager senere kunne The Wall Street Journal avsløre at sentrale personer i ledelsen i Merck hadde kjent til bivirkningene helt tilbake til 2000. Dette dokumenterte avisen gjennom å trykke interne e-poster.

Informasjonssjef i Merck, Ronald Rogers, skriver i en epost til DN at de motsetter seg søksmålet. (...)

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

(Anm: Ondskapens filosofi (“rule by nobody”) (mintankesmie.no).)

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

Dyr pillesmell for Gjedrem
na24.no 2.1.2009
Norges Bank krever 340 millioner i erstatning fra legemiddelgigant.

- Slike søksmål er en del av businessen, sier kommunikasjonsdirektør Siv Meisingset i Norges Bank.

Det er Oljefondet, som forvaltes av Norges Bank, som skal ha tapt 340 millioner på aksjene sine i legemiddelselskapet Merck. Svein Gjedrem & Co. hevder Merck-ledelsen i en årrekke skjulte at det smertestillende medikamentet Vioxx hadde dødelige bivirkninger, skriver Dagens Næringsliv. (...)

- Merck slipper billig

Merck Gets Off Cheap (Merck slipper billig)
forbes.com 9.11.2007
A few years ago it looked as if product liability battles might endanger the very existence of drug giants like Merck and Wyeth. Apparently not. (...)

If the deal really is ironclad, it represents a huge win for drug companies in general as they face potential liability on medicines that turn out to have side effects. The deal is estimated to cover perhaps 50,000 heart attacks, and those affected will get, on average, $125,000 each. Treating heart attacks costs far more than that. (...)

(Anm: Sakkyndige legers integritet, partiskhet og habilitet versus løgn.)

Merck Rises on Vioxx Deal
forbes.com 9.11.2007
(...) The widespread use of Vioxx meant the possibility of even greater legal costs. Merck faced lawsuits from 47,000 plaintiffs. Analysts earlier said that the legal liability could reach $50 billion.

Merck, however, was able to improve its bargaining position with strong showings in the courtroom. Of the seventeen cases that have gone to trial and reached a verdict, Merck has won 12. (...)

Merck Agrees to Pay $4.85 Billion in Vioxx Claims
nytimes.com 9.11.2007
Three years after withdrawing its pain medication Vioxx from the market, Merck announced today that it will pay $4.85 billion to settle 27,000 lawsuits by people who contend they or their family members suffered injury or died after taking the drug. (...)

Plaintiffs will receive different settlement payments depending on the severity of their injuries and the length of time they took Vioxx. The deal becomes binding only if 85 percent of all plaintiffs agree to drop their cases and take the deal. (...)

But for Merck, which has already spent more than $1.2 billion on Vioxx-related legal fees, the settlement will put to rest any fears that Vioxx lawsuits might bankrupt the company, or even have a significant financial impact. While eye-popping, the settlement payment represents less than one year’s profits for the company, the third-largest American drug maker.

Investors evidently consider it a good outcome for Merck, sending its shares up more than 2 percent in today’s trading, while many other stocks were down for the day.

For plaintiffs, the settlement will provide a measure of vindication and financial relief. And plaintiffs’ firms will earn nearly $2 billion in fees at their standard rates of 33 percent to 40 percent. (...)

Merck May Pay About $5 Billion to Resolve Vioxx Cases (Update1)
bloomberg.com 10.11.2007
(...) "They've done the calculations and found that buying certainty on these claims for $5 billion is the best way to go,'' said Michael Kelly, a Wilmington, Delaware-based lawyer who has represented other drugmakers in products-liability cases. (...)

The accord would be the largest settlement in the U.S. so far this year, according to data compiled by Bloomberg. It also is among the largest settlements in U.S. legal history.

Rival drugmaker Wyeth has reserved more than $21 billion so far, for example, to resolve litigation over the withdrawn fen- phen diet combination.

Wyeth faced more than 150,000 claims over fen-phen, whose former users argued it damaged their hearts. Merck is facing less than 30,000 claims over Vioxx. (...)

- The Vioxx story really highlights the difference between marketing and informing

Vioxx Problems Known Years Before Recall
healthday.com 23.11.2009
Study points up weaknesses of drug approval process in United States, researcher says (...)

In a statement released Tuesday, Merck officials said this: "Merck believes the article published in The Archives of Internal Medicine in today's issue related to Vioxx used unreliable methods and reached incorrect conclusions."

"The first time Merck observed a difference in a placebo-controlled study was when it learned the results of the APPROVe study in September 2004. We voluntarily withdrew Vioxx from the market within a week of those results," the statement continued.

"Merck acted responsibly -- from researching Vioxx prior to approval in studies with approximately 10,000 patients to monitoring the medicine while it was on the market -- to voluntarily withdrawing the medicine when it did," the statement said. "Our decisions were based on the data from well-controlled clinical trials."
But the authors of the new study believe the Vioxx saga points to a larger problem, one that involves the drug approval process in the United States.

"One of the challenges in health care is to recognize these safety risks early," said lead researcher Dr. Joseph S. Ross, an assistant professor of geriatrics and palliative medicine at Mount Sinai School of Medicine in New York City. (...)

(Anm: Bringing the FDA's Information to Market. Arch Intern Med. 2009;169(21):1985-1987 (November 23).)

Bringing the FDA's Information to Market (Formidling av FDAs informasjon til markedet)
Arch Intern Med. 2009;169(21):1985-1987 (November 23)
Here is a challenge: Imagine you are asked to turn a new prescription drug into a blockbuster. The drug is approved by the US Food and Drug Administration (FDA) to treat arthritis pain. That is good news because the arthritis market is huge. But you face some big challenges. First, there are several over-the-counter drugs available that treat pain equally well and at one-fiftieth of the cost. Your only comparative advantage is that your drug causes less gastrointestinal tract (GI) bleeding than other arthritis pain medicines. But this reduction is not very big and only applies to a very small slice (probably <5%) of the market—people at high risk for GI bleeding. And, oh yes, your drug may triple the chance of myocardial infarction.

Do you think you could get physicians to prescribe your drug to over 20 million Americans? Could you achieve over $2 billion in annual sales? Well, the makers of Vioxx (Merck & Co Inc, Whitehouse Station, New Jersey) did just that—until the drug was pulled from the market.

Ross et al show how a cumulative meta-analysis might have led the FDA to halt sales of Vioxx in 2001, 3 years before Merck voluntarily stopped selling it. Doing so might have prevented thousands of myocardial infarctions. We applaud this study and hope that independent investigators will apply the same methods to other drugs to help answer important safety questions. But the article left us wondering, just how did Vioxx get so big and stay so big for so long?

-Vioxx-historien fremhever virkelig forskjellen mellom markedsføring og informasjon. Dersom leger og pasienter hadde hatt fakta hadde de hatt behov for en alkymist for å gjøre denne gråstein til gull, ikke en markedsføringsavdeling. (The Vioxx story really highlights the difference between marketing and informing. If physicians and patients had had the facts, it would have taken an alchemist, not a marketing department, to turn this lemon into gold.)

The problem is that when it comes to prescription drugs, a lot more effort goes into marketing than informing. It has been estimated that drug companies spend $30 billion to $50 billion a year on drug promotion (advertising, detailing visits, free samples, and other promotion techniques).1 That means that the industry can really get its message out. (...)

Fremstående celecoxib-forsker innrømmer fabrikasjon av data i 21 artikler

Doctor Pleads Guilty to Research Fraud Involving Vioxx and Celebrex (Lege erklærer seg skyldig i forskningssvindel som involverer Vioxx og Celebrex)
pharmpro.com (23.2.2010)
BOSTON (AP) — A doctor accused of faking research for a dozen years in published studies that suggested after-surgery benefits from painkillers including Vioxx and Celebrex pleaded guilty Monday to one count of federal health care fraud.

An attorney for Dr. Scott Reuben said the anesthesiologist will have to repay $361,932 in research grants and forfeit assets worth at least $50,000 as penalty for his conduct following a plea hearing in U.S. District Court. (...)

Massachusetts Doctor Accused of Fraud by Faking Research (Lege fra Massachusetts anklaget for svindel ved å forfalske forskning)
pharmpro.com 15.1.2010
BOSTON (AP) — Federal prosecutors announced Thursday that they have filed a health care fraud charge against a doctor accused of faking research for a dozen years in published studies that suggested after-surgery benefits from painkillers including Vioxx and Celebrex.

Court documents indicate that Dr. Scott Reuben, an anesthesiologist, has agreed to plead guilty in exchange for prosecutors recommending a more lenient sentence of up to 10 years imprisonment, a $250,000 fine and forfeiture of assets worth at least $50,000 that Reuben received for the research.

Prosecutors allege the former chief of acute pain at Baystate Medical Center in Springfield sought and received research grants from pharmaceutical companies but never performed the studies. He fabricated patient data and submitted information to anesthesiology journals that unwittingly published it, court documents allege.

Reuben, a Longmeadow resident, took leave after the hospital said last year that a routine review found that some of his research was not approved by an internal hospital review board. Further investigation found 21 papers published in anesthesiology journals between 1996 and 2008 in which Reuben made up some or all data, the hospital said. Hospital officials said Reuben did not admit to the fabrications. (...)

Juks med studier av postoperative smerter
Tidsskr Nor Legeforen 2009; 129:1658-9 (27.8.2009)
En kjent internasjonal forsker har måttet trekke tilbake 21 av sine mye siterte artikler om medikamentell profylakse og behandling av postoperativ smerte. Hvilken betydning har dette for forskning og klinisk praksis? (...)

US researcher fabricated pain studies (Amerikansk forsker fabrikkerte smertestudier)
pharmatimes.com 12.3.2009
One of the largest cases of academic fraud has come to light after it was revealed that a researcher in the USA fabricated data in at least 21 studies on pain drugs.

The work of Scott Reuben, an anaesthesiologist at Baystate Medical Center in Massachusetts, has been the subject of an investigation since May last year. It now appears that he never conducted the clinical trials that he wrote about in journals.

Specifically, Dr Reuben’s ‘research’ had promoted the notion of shifting from nonsteroidal anti-inflammatory drugs (NSAIDs) to the newer COX-2 inhibitors, such as Merck & Co’s Vioxx (rofecoxib) and Pfizer’s Celebrex (celecoxib), and Bextra (valdecoxib). He had argued that using these drugs in combination with Pfizer’s Neurontin (gabapentin) and Lyrica (pregabalin) could be effective in decreasing postoperative pain and reduce the use of addictive painkillers during recovery. (...)

(Anm: Massachusetts Doctor Accused of Fraud by Faking Research (pharmpro.com 15.1.2010).)

(Anm: NSAID Use Is Associated with Elevated Risk for Bleeding in Patients with Atrial Fibrillation Receiving Antithrombotic Therapy Ann Intern Med 2014 Nov 18; 161:690.)

(Anm: Värktabletter kopplas till hjärtproblem. Det finns ett samband mellan en högre risk för hjärtsvikt och medicinering med värktabletter som Voltaren, Ipren och Magnecyl, enligt en ny stor studie. Studien som publicerats i British Medical Journal visar att personer, som inom de senaste 14 dagarna tagit så kallade NSAID-läkemedel, har en 19 procent högre risk för att tas in på sjukhus för hjärtsvikt, jämfört med personer som tagit tabletterna längre tillbaka i tiden. (dagensmedicin.se 30.9.2016).)

(Anm: Mange NSAID knyttet til hjertefeil. Many NSAIDs Associated With HF. 'A clear risk to some... and tighter regulation is justified'. (…) For the individual drugs, odds ratios ranged from 1.16 (95% CI 1.07-1.27) for naproxen to 1.83 (95% CI 1.66-2.02) for ketorolac, and were significant for the following: Diclofenac – Ibuprofen – Indomethacin – Ketorolac – Naproxen – Nimesulide – Piroxicam – Etoricoxib - Rofecoxib (medpagetoday.com 29.9.2016).)

(Anm: Kardiovaskulære risici ved behandling med nonsteroide antiinflammatoriske lægemidler (NSAID). KONKLUSION NSAID-behandling er associeret med en lang række kardiale komplikationer i form af destabilisering af blodtryksbehandling, hjertesvigt, myokardieinfarkt, atrieflimren, venøs tromboemboli, blødning ved kombinationsbehandling med antitrombotika og pludselig hjertedød. Selv korttidsbehandling synes at være associeret med en øget risiko, og særligt diclofenac har en uheldig risikoprofil. Dertil kommer, at der er en dosisrelateret øgning i de kardiovaskulære risici forbundet med NSAID-behandling, hvorimod den terapeutiske og smertestillende effekt ikke øges tilsvarende. NSAID-behandling frarådes derfor til patienter med hjerte-kar-sygdom, og anvendelse af diclofenac frarådes generelt. Ugeskr Læger 2016;178:V08160612.)

(Anm: Using NSAIDs during a cold may increase heart attack risk. Taking ibuprofen or other nonsteroidal anti-inflammatory drugs to help relieve cold or flu symptoms may seem harmless, but new research suggests otherwise. It could increase the risk of heart attack. Study co-author Dr. Cheng-Chung Fang, of the National Taiwan University Hospital, and colleagues recently reported their findings in The Journal of Infectious Diseases. (medicalnewstoday.com 6.2.2017).)

(Anm: NSAIDs offer little benefit for spinal pain, review finds. Non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen offer little more clinical benefit to patients with spinal pain than a placebo, a systematic review and meta-analysis has found. The review of 35 randomised placebo controlled trials involving 6065 people, published in the Annals of the Rheumatic Diseases,1 found that NSAIDs did provide some relief from pain and disability but found little evidence that they were more effective than placebo. Researchers found that, in every six patients treated with an NSAID, only one would benefit. BMJ 2017;356:j605 (Published 06 February 2017).)

(Anm: Demente rammes i højere grad af hjerte-kar-sygdom. Hjerteforeningen følger ministerens arbejde med handlingsplan om demens, der er essentiel for hjertepatienter også. Demens og hjerte-kar-sygdomme har fælles risikofaktorer, siger forskningschef. (hjerteforeningen.dk 3.10.2016).)

(Anm: NSAID-preparat farligt efter hjärtinfarkt. Antiinflammatoriska läkemedel av NSAID-typen är farligt ihop med blodförtunnare efter hjärtinfarkt. (lakemedelsvarlden.se 25.2.2015).)

(Anm: Vanlige smertestillende «øker risiko for hjertesvikt". (Common painkillers 'increase heart failure risk' (…) The British Medical Journal study looked at 10 million people, aged 77 on average, who took the drugs. (…) 'Use with caution' The British Heart Foundation (BHF) said patients should be on the lowest dose possible of NSAIDs for the shortest possible time.) (bbc.com 29.9.2016).)

(Anm: Vanlige smertestillende knyttet til svak økning i risiko for hjerteinfarkt. Common Painkillers Tied to Slight Rise in Heart Attack Risk. TUESDAY, May 9, 2017 (HealthDay News) -- Commonly used painkillers such as Motrin, Advil and Aleve might increase your risk for heart attack, even in the first week of use, a new study suggests. Overall, these drugs and others known as nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of a heart attack by 20 to 50 percent, compared with not using them, researchers found. (medicinenet.com 9.5.2017).)

(Anm: Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study. (…) Conclusions The risk of hospital admission for heart failure associated with current use of NSAIDs appears to vary between individual NSAIDs, and this effect is dose dependent. This risk is associated with the use of a large number of individual NSAIDs reported by this study, which could help to inform both clinicians and health regulators. BMJ 2016;354:i4857 (Published 28 September 2016).)

(Anm: Gigtmedicin skal bruges med omtanke til hjertepatienter. (…) Læger, der udskriver gigtmedicin af typen NSAID (non-steroide anti-inflammatoriske lægemidler), bør være særligt opmærksomme på, at denne type medicin giver en øget risiko for hjertesygdomme hos patienter. Det drejer sig specifikt om produkterne Diclofenac, Ibuprofen og Naproxen. I produktresumeerne for de nævnte produkter, står det udførligt beskrevet, at disse midler er kontraindicerede ved svær hjerteinsufficiens. (laegemiddelstyrelsen.dk 17.3.2016).)

(Anm: Potential Hazards of Adding Nonsteroidal Anti-inflammatory Drugs to Antithrombotic Therapy After Myocardial Infarction. Time for More Than a Gut Check. JAMA. 2015;313(8):801-802. (February 24).)

Prominent celecoxib researcher admits fabricating data in 21 articles (Fremstående celecoxib-forsker innrømmer fabrikasjon av data i 21 artikler)
BMJ 2009;338:b966 (9 March)
A well known researcher who promoted the use of the non-steroidal anti-inflammatory drug celecoxib has admitted fabricating data in 21 of his 72 articles indexed by PubMed. The case is "among the biggest which has come to light," said Harvey Marcovitch, chairman of the Committee on Publication Ethics, an international forum for publishers and editors of peer reviewed journals.
Scott S Reuben, chief of the acute pain service at Baystate Medical Center in Springfield, Massachusetts, has admitted the fraud, says a notice issued by the centre in late January. (...)

Dr Reuben, who received research grants from Pfizer, the US manufacturer of celecoxib (marketed as Celebrex), and served on its speakers’ bureau, pioneered "multimodal analgesia," the combination of celecoxib with another Pfizer drug, the anticonvulsant pregabalin (Lyrica). The combination, Dr Reuben claimed, was preferable to opioids, and it became a mainstay in pain management.

James Eisenach, editor in chief of Anesthesiology, said that Dr Reuben’s research was central to the claim that celecoxib reduces pain at six and 12 months after surgery. He said that the fraud creates a "hole" in pain research and casts doubt on claims about celecoxib.
Dr Eisenach says in an editorial to be published in the May 2009 issue of Anesthesiology (http://pdfs.journals.lww.com/anesthesiology/9000/00000/99939.pdf) that the retracted articles "have been considerably cited since 2002" and that mere retraction of the articles will not be enough. He says that the journal will use its peer review system "to assure that these articles are no longer cited by our authors." He also calls for "submission of studies reexamining the questions that seemed to be answered by Reuben in the retracted studies." (...)

Diverse artikler

Merck ordered to pay $321 million in criminal Vioxx probe
reuters.com 19.4.2012
(Reuters) - A Boston federal judge on Thursday sentenced Merck & Co to pay a $321 million criminal fine for improperly marketing its Vioxx painkiller a decade ago.

The U.S. drugmaker pleaded guilty in recent months to having illegally promoted Vioxx for treatment of rheumatoid arthritis before it was approved for that use in 2002. The pill, approved in 1999 as a painkiller, was withdrawn from the market in 2004 after it was linked to risk of heart attack and stroke.

Federal prosecutors in Boston said Merck illegally promoted Vioxx for rheumatoid arthritis for three years, continuing to do so after being reprimanded in September 2001 by the U.S. Food and Drug Administration. (...)

J&J, Merck & Co settle Risperdal, Vioxx cases
pharmatimes.com 20.1.2012
Johnson & Johnson has agreed to pay $158 million to settle a lawsuit in Texas which claimed the healthcare giant and its Janssen unit defrauded the state's Medicaid programme through illegal promotion of the antipsychotic Risperdal.

The case stems from a whistleblower lawsuit filed in 2004 which revealed that J&J launched a campaign promoting Risperdal (risperidone) as the superior drug of choice, while downplaying harmful side effects. The company was accused of improperly urging physicians to prescribe Risperdal to children and the elderly for schizophrenia and dementia, despite the fact that the antipsychotic had not been approved by the US Food and Drug Administration for these uses at the time.

Texas attorney general Greg Abbott said the agreement "sends a strong message that the state will pursue those who defraud Texas taxpayers". He added that J&J’s "scheme to profit from the Medicaid programme by overstating the safety and effectiveness of an expensive drug and improperly influencing officials ended up costing taxpayers millions of dollars". The state had originally sought a settlement of $579 million. (...)

Merck settles Vioxx suits from New York, Florida
reuters.com 14.11.2011
(Reuters) - Merck & Co has reached settlements to resolve lawsuits from the states of New York, Florida and South Carolina alleging the company misled state regulators about the dangers of the painkiller Vioxx, according to court filings.

The confidential sums were revealed in a court filing Friday in the U.S. District Court for the Eastern District of Louisiana, where thousands of Vioxx cases have been consolidated. In 2007, Merck had agreed to pay out $4.85 billion to resolve claims from thousands of plaintiffs who said Vioxx caused heart attacks.

A spokesman for Merck declined further comment on the settlements. They were revealed in a court filing from attorneys for the plaintiffs' steering committee in the multi-district Vioxx litigation, which asked the court to set aside 6.5 percent of the state settlements in an escrow fund to pay for plaintiffs' legal fees.

Attorney generals for the state of New York, Florida and South Carolina filed lawsuits against Merck in 2007 and 2008 alleging the company misled state regulators about the dangers associated with Vioxx, which has been linked in lawsuits to increasing users' risk of heart attacks and other serious cardiovascular side effects.
Similar settlements have already been reached in lawsuits from the states of Alaska, Kentucky, Mississippi, Montana, Oklahoma and Utah, according to the filing. (...)

Lawyers in Vioxx case closer to getting paid
reuters.com 18.2.2011
Feb 18 (Reuters Legal) - After battling Merck & Co. (MRK.N) in court for years over the safety of its Vioxx painkiller, lawyers for the plaintiffs are a step closer to finally getting paid. A committee charged with divvying up more than $300 million in attorneys' fees for work on lawsuits against the pharmaceutical company has made its recommendations to a federal judge in New Orleans.

The recommendations were laid out in a little-noticed court filing last month to U.S. Judge Eldon Fallon of the Eastern District of Louisiana, who has been overseeing the multidistrict litigation over Vioxx. The big proposed winners include the law firms Seeger Weiss ($40.9 million); Beasley, Allen, Crow, Methvin, Portis & Miles ($40.9 million); Herman, Herman, Katz & Cotlar ($32.5 million); Lanier Law Firm ($27 million); and Weitz & Luxenberg ($20 million).

After it won 11 of 16 trials, Merck agreed in November 2007 to settle nearly all of its litigation over Vioxx for $4.85 billion. Since then, nearly all of the plaintiffs have received their funds, but their lawyers have yet to be paid. (...)

Merck sales disappoint, takes big Vioxx charge
reuters.com 29.10.2010
(Reuters) - Merck & Co Inc reported disappointing quarterly sales and took an almost $1 billion charge related to a previously disclosed U.S. government probe of its recalled Vioxx arthritis drug, sending its shares 2.1 percent lower. (...)

Third-quarter earnings of the combined company fell 89 percent to $372 million, or 11 cents per share, reflecting merger charges and a charge for setting aside a $950 million Vioxx legal reserve.

The charge relates to an ongoing probe by U.S. prosecutors in Massachusetts of how Merck had marketed Vioxx -- Merck's onetime blockbuster arthritis drug that was recalled in 2004 after being linked to heart risks.

Company spokesman Steven Campanini said Merck continues to have discussions with prosecutors.

"Until they are concluded, there can be no certainty about a resolution, so the company took the (legal) reserve," he said. (...)

Australian court: Vioxx doubled heart attack risk
pharmpro.com 5.3.2010
The once-popular painkiller Vioxx doubled the risk of heart attack and was unfit for consumption, an Australian court ruled Friday, awarding a man leading a class action suit against the drug's maker 287,000 Australian dollars ($259,000) in compensation.

Melbourne Federal Court Judge Christopher Jessup's decision opens the door for claims from 600 other litigants in a lawsuit against U.S. pharmaceutical firm Merck & Co. over its since-recalled drug Vioxx. The painkiller was taken off the global market in 2004 after research showed it raised the risk of heart attacks and strokes. (...)

Merck: Last Vioxx Patient Payouts to be Made Soon
pharmpro.com 2.3.2010
TRENTON, N.J. (AP) — Drugmaker Merck & Co. has made its final, $4.1 billion payment into a fund to settle tens of thousands of U.S. claims that withdrawn painkiller Vioxx caused heart attacks or strokes, the company said in a regulatory filing Monday.

The final payouts to those patients or their survivors, from the $4.85 billion settlement fund, should be made by the end of June, according to the filing with the Securities and Exchange Commission.

About $4 billion of that was reserved for heart attack patients. Their claims have already been processed and either paid or denied. (...)

US high court to decide if Vioxx lawsuits allowed (Amerikansk høyesterett avgjør om Vioxx-søksmål tillates)
businessweek.com 30.5.2009
The U.S. Supreme Court will decide whether shareholders can sue international pharmaceutical maker Merck & Co. because of the failure of its former blockbuster painkiller Vioxx.

The high court agreed Tuesday to review Merck's challenge to a federal appeals court's reinstatement of a class-action securities lawsuit. (...)

Ny chans för läkemedelsskadade
lakemedelsvarlden.se 14.5.2009
Ett nittiotal svenskar som anmält att de skadats av läkemedlet Vioxx får sina fall omprövade.

BIVERKAN De väntar nu på besked om ersättning för sina skador. Vioxx-skandalen kulminerade 2004 med att tillverkaren Merck drog tillbaka läkemedlet från världsmarknaden efter larmen om att den orsakade hjärtinfarkt och slaganfall. (...)

Vioxx ökar risk för hjärtinfarkt också på längre sikt
lakemedelsvarlden.se 14.10.2008
Efter den så kallade Approve-studien drogs cox 2-hämmaren Vioxx in från marknaden 2004 då det visade sig att läkemedlet ökade risken för hjärt-kärlsjukdomar. Nu kommer resultat från en uppföljningsstudie som stärker bevisen. (...)

State sues Merck for deceptive marketing of Vioxx (Stat saksøker Merck for villedende (bedragersk) markedsføring)
bizjournals.com 1.10.2008 (South Florida Business Journal)
Florida Attorney General Bill McCollum has filed suit again Merck & Co. for alleged deceptive marketing and promotion of the prescription drug Vioxx.

The lawsuit claims that Merck repeatedly failed to disclose the drug’s adverse effects while offering it to the state’s Medicaid program as a safe painkiller, in direct violation of Florida’s Deceptive and Unfair Trade Practices Act.

Vioxx was used to treat joint pain until it was removed from the market in 2004 after studies suggested those taking it had an increased risk of heart attack and stroke associated with long-term use.

The lawsuit follows a three-year investigation of Merck’s promotional practices and alleges that, due to the company’s marketing practices, numerous state agencies approved the inclusion of Vioxx as a covered or approved drug, and agreed to pay for the prescription or reimburse its expense.

In a prepared statement, Merck said it acted responsibly and intends to defend the complaint, which is similar to those filed by eight other states and pending in federal and state courts. (...)

Big Pharma's buddies (Big pharmas venner)
Editorial (Leder)
chron.com 1.6.2008
Ankedomstol i Houston kaster ut kjennelse på 26,1 millioner dollar, griper inn i rollen til dommer og jury (...) (In throwing out a $26.1 million verdict, Houston appellate court usurps role of trial judge and jury)

I sin annonsering av anke i Ernst-saken, uttalte advokat Lanier at "aktivistdommere beskytter næringslivsledere og eliminerer rettighetene til enker og ethvert annet offer for korporativ svikt." (In announcing an appeal in the Ernst case, attorney Lanier stated, "activist judges are protecting corporate executives and stripping away the rights of widows and every other victim of corporate misconduct.")

Snarere enn å oppmuntre Merck til å gjøre det som er riktig, risikerer beslutning til 14th Courts i denne saken å oppildne firmaet til å stole på upartiske venner høyt oppe i systemet for å oppheve rettsavgjørelser slik at enker ikke får ett rødt øre. (...) (Rather than encouraging Merck to do what's right, the 14th Court's decision in the case risks emboldening the company to rely on judicial friends in high places to overrule juries and send widows home empty-handed.)

Drug Companies Would Be Held Accountable for Concealing Dangers Under Bill Awaiting California Assembly Floor Vote (Legemiddelfirmaer vil bli holdt ansvarlig for å skjule farer i lovforslag som det venteså stemmes over i California.)
californiaprogressreport.com 19.5.2008
Heavy Lobbying by Big Pharma (...)

The bill passed out of the Assembly Judiciary Committee last month, and is now waiting for a vote on the Assembly floor. Unsurprisingly, Big Pharma is lobbying hard to kill the bill, because they don’t want to be forced to live up to the standards by which every other kind of manufacturer is governed. But these self-serving arguments shouldn’t be allowed to carry the day, and bad-acting corporations should no longer able to hide behind the shield of an outdated doctrine when injured consumers try to call them to account. (...)

Merck & Co extends deadline for Vioxx lawsuit settlement
pharmatimes.com 2.5.2008
Merck & Co says that some 94% of eligible claimants in the USA have chosen to participate in its $4.85 billion proposed Vioxx settlement but has extended the deadline for others to join in. (...)

- Merck holdt tilbake informasjon om farlig medisin
vg.no 16.4.2008
Legemiddelgiganten Merck holdt tilbake informasjon om at giktmedisinen Vioxx kunne være farlig, hevder amerikanske forskere. (...)

Sen. Grassley Sends Letter To Merck Requesting Explanation of Recent JAMA Reports
Kaisernetwork.org 18.4.2008
Sen. Chuck Grassley (R-Iowa) has sent a letter to Merck Chief Operating Officer Richard Clark requesting the company explain a recent report that found the company used employees or paid consultants rather than the physicians listed as lead authors to write several published studies of the COX-2 inhibitor Vioxx, CQ HealthBeat reports. Grassley also requested an explanation for Merck's delay in disclosing data that showed an increased risk of death in Alzheimer's patients who took the drug (Reichard, CQ HealthBeat, 4/16). (...)

94% of patients suing Merck over rofecoxib agree to company’s offer
BMJ 2008;336:580-581 (15 March)
A large enough proportion of the litigants suing Merck after taking the drug rofecoxib (Vioxx) have agreed to the terms of the company’s offer to allow the settlement to go ahead.

Eighty five per cent of claimants had to agree to the settlement to proceed, and by the beginning of this month 94% (44 000 of the 47 000) had done so. The company announced in November a settlement worth $4.85bn (£2.41bn; €3.15bn).

The individual awards, estimated at $150 000 to $200 000 on average, will be calculated in a three step process to assess the severity of injuries. Plaintiffs must provide evidence of a heart attack or ischaemic stroke; proof that they received at least 30 rofecoxib pills; and evidence that they took at least one of the pills within 14 days of injury. (...)

UK Parliament To Merck: Settle Our Vioxx Cases
pharmalot.com 10.3.2008
Members of Parliament are upset that the drugmaker’s Vioxx $4.85 billion settlement extends only to people in the US and are calling for a deal that would compensate UK patients, The Times of London reports.

For now, Merck is refusing to strike similar deals with Vioxx users in 18 other countries, and with just six weeks to go until the cut-off for court action, the prospect of compensation for 500 UK patients is receding. No money is available for legal-aid claims and UK litigants, unlike those in the US, may have to pay Merck’s bills if they lose. “No win, no fee” lawyers have refused to take up the case because they regard it as too risky, the Times writes. (...)

Merck Says Thousands File for Vioxx Payments
therapeuticsdaily.com 3.3.2008
CHICAGO (Reuters) - Merck & Co Monday said more than 93 percent of the 47,000 people who allege the arthritis drug Vioxx caused their heart attack or stroke have submitted claims in the company's settlement offer.

Of some 47,000 people who registered eligible injuries, about 44,000 submitted some or all of the documents that could qualify them for an interim payment in the program to resolve state and federal heart attack and stroke claims filed in the United States, Merck said. (...)

GPs have got Britain 'hooked on painkillers' (Allmennpraktiserende leger har gjort Storbritannia "hektet"på smertestillende preparater)
guardian.co.uk 10.2.2008
• Inquiry slams mis-prescribing of drugs
• Doctors 'ignoring official guidelines'

Doctors are unwittingly fuelling the growing number of Britons hooked on prescription drugs by giving patients dangerously high doses of medicines that can prove highly addictive, a parliamentary inquiry has concluded.

MPs say that 'mis-prescribing' of drugs such as painkillers, sleeping tablets and anti-anxiety pills by some doctors is 'leading to addiction and dependence'. (...)

Miljardförlust efter Vioxx-uppgörelser
dagensmedicin.se 30.1.2008
Det amerikanska läkemedelsföretaget Merck & Co gör en förlust på 1,63 miljarder dollar, motsvarande cirka 11 miljarder kronor, för sista kvartalet 2007. Orsaken är ekonomiska uppgörelser med patienter som drabbats av biverkningar efter att ha använt värkmedicinen Vioxx. (...)

Will The Vioxx Settlement Work?
forbes.com 13.11.2007
To hear Merck executives tell it, the $4.8 billion settlement of Vioxx claims is practically airtight. Of course, that's what American Home Products executives were saying back in 1999, when they sewed up a $4.8 billion settlement of thousands of lawsuits over the dangerous diet drug combination fen-phen.

If previous mass tort "settlements" are any example, Merck (nyse: MRK - news - people) will be spending a lot more than $4.8 billion before it's done. American Home Products, now part of Wyeth, has reserved $21.1 billion so far to pay for diet drug litigation, and the settlement is in its seventh iteration. (...)

Merck köper sig fri från Vioxx-stämningar
lakemedelsvarlden.se 12.11.2007
Amerikanska Merck planerar att betala 4,85 miljarder dollar för att göra upp om Vioxx-stämningar. Företaget anser sig dock inte ha gjort något fel. (...)

Enligt Bloomberg News är uppgörelsen den största i USA hittills i år och en av de största någonsin i USA. Merck har i ett uttalande uppgett att uppgörelsen inte innebär att företaget erkänner att något fel har begåtts. (...)

Saksøkt 27.000 ganger
e24.no 9.11.2007
Tre år etter å ha tatt tilbake sin smertestillende tablett går det nå mot forlik. Merck skal ifølge New York Times ut med over 25 milliarder kroner.

- Dødsfall
De misfornøyde kundene har klaget på alt fra bivirkninger til dødsfall blant familiemedlemmer. På tross av at Merck i tre år har nektet all sammenheng mellom deres smertestillende og de påståtte negative effektene går de nå inn for forlik i saken.

Merck har vunnet de aller fleste sakene som har kommet opp i retten, men tapte en sak og ble dømt til å betale over 1,3 milliarder kroner. Avtalen blir bindende hvis 85 prosent av saksøkerne godtar avtalen. Det er ventet at dette går gjennom ettersom de fleste av de 27.000 søkmålene, som representerer 47.000 personer, står relativt svakt hver for seg. (...)

Merck Is Expected to Announce
Vioxx Settlement of $4.85 Billion

wsj.com 9.11.2007
NEW ORLEANS -- Merck & Co. is expected to announce that it agreed to pay about $4.85 billion to settle a significant portion of the claims over injuries allegedly linked to its Vioxx painkiller, according to a person familiar with the situation, after insisting for years that it would fight all 27,000 cases filed rather than compromise. (...)

But the company has incurred considerable costs from the litigation. In its most recent earnings statement, Merck said it spent $160 million in the third quarter for world-wide Vioxx litigation costs. It also took a charge of $70 million to shore up its litigation coffers, and in the year-earlier period took a charge of $598 million. The company currently has set aside $720 million for its Vioxx legal defense costs, which doesn't include any potential damages to plaintiffs. (...)

Vioxx Trials May Focus on Stroke Victims
forbes.com 29.7.2007
NEW ORLEANS - Next year's federal Vioxx trials may focus on people who had strokes after taking the once popular painkiller, the judge assigned to handle pretrial matters in all 8,575 federal lawsuits said Friday. (...)

Study says Vioxx danger begins earlier than stated (Studie viser at farer ved Vioxx begynner tidligere enn påstått)
today.reuters.com 25.7.2007
NEW YORK (Reuters) - The increased heart risk from Vioxx, Merck & Co's withdrawn arthritis medicine, begins much earlier than after 18 months of use, according to a study that contradicts assertions by the drug maker and its scientists.

The 2,434-patient study, published on Wednesday in the New England Journal of Medicine, was halted early when the medicine was pulled from the market in September 2004.

Although the median duration of treatment was only 7.4 months, the researchers concluded that Vioxx, known generically as rofecoxib, was still associated with an increased frequency of adverse cardiovascular events. (...)

Vioxx CV risk ‘starts before 18 months’ (Hjerterisiko starter før 18 måneder)
pharmatimes.com 26.7.2007
The increased cardiovascular risk from Merck & Co’s now-withdrawn painkiller Vioxx (rofecoxib) is seen before the 18 months previously thought to be the benchmark, according to a new study published in the New England Journal of Medicine. (...)

Median treatment duration just 7.4 months
Despite the median duration of active treatment being just 7.4 months, the investigators still found an increased frequency of adverse cardiovascular events – including fatal and nonfatal heart attacks, strokes, sudden death from cardiac causes, blood clots and chest pain - amongst the 1,167 patients receiving Vioxx. Of the 23 confirmed CV events, 16 occurred among Vioxx receivers during or within 14 days after the treatment period, and six patients died (four in the Vioxx group). (...)

(Anm: 'Sudden Adult Death' May Have Mitochondrial Origin. —Some cases of unexplained sudden death can be traced to a common mitochondrial defect. (medpagetoday.com 22.4.2015).)

(Anm: Mitochondria (mitokondrie) (mitokondriesykdommer) (mitokondrielle sykdommer). (mintankesmie.no).)

(Anm: Linking telomere loss and mitochondrial dysfunction in chronic disease. (…) Drawing a mechanistic connection between telomere function and mitochondria biology will provide a broader perspective for understanding the pathophysiology of diseases and their relation to the aging process, and may provide opportunities for new possible treatments. Front Biosci (Landmark Ed). 2017 Jan 1;22:117-127.)

(Anm: Extreme short and long telomeres linked to increased cancer risk (news-medical.net 5.4.2017).)

(Anm: Scientists discover master regulator of cellular aging. (…) "Telomeres represent the clock of a cell," said TSRI Associate Professor Eros Lazzerini Denchi, corresponding author of the new study, published online in the journal Science. "You are born with telomeres of a certain length, and every time a cell divides, it loses a little bit of the telomere. Once the telomere is too short, the cell cannot divide anymore." (medicalnewstoday.com 13.1.2017).)

(Anm: Betennelser endrer mitokondrier til giftige fabrikker. Å lære hvordan å kontrollere betennelser kan ha store implikasjoner for behandlingen av mange sykdommer. Banebrytende forskning oppdager hvordan makrofager endrer mitokondriene til giftige kjemisk-produserende betennelsespromotører. (Inflammation turns mitochondria into toxic factories. Learning how to control inflammation could have huge implications for the treatment of many diseases. Breaking research discovers how macrophages turn mitochondria into toxic chemical-producing inflammation-promoters.) (medicalnewstoday.com 25.9.2016).)

(Anm: Research may show new ways to repress inflammation at outset. (…) Professor Alexander Weber of the Interfaculty Institute of Cell Biology says the enzyme - Bruton's tyrosine kinase or BTK - is switched on when an inflammation occurs in the body, playing a key role in the inflammation's subsequent development. (medicinenet.com 21.2.2017).)

(Anm: Ørsmå mitokondrier spiller en svært stor rolle mht. menneskets evolusjon og sykdom (Tiny mitochondria play outsized role in human evolution and disease.) (medicalnewstoday.com 25.9.2015).)

Plantestoff kan beskytte røykere mot lungekreft
vg.no 25.11.2005
Et stoff som finnes i flere planter, kan beskytte røykere mot utvikling av lungekreft. Det håper amerikanske forskere. (...)

Rotter i alle tre gruppene utviklet lungekreft i løpet av studiet. Men de som ble behandlet med deguelin underveis hadde færre svulster i lungene. Rottene som fikk behandlingen etter de ble eksponert for de farlige kjemikalene, hadde ingen slik effekt. (...)

Den amerikanske undersøkelsen er publisert i fagtidsskriftet Journal of the National Cancer Institute. (...)

Websidene er designet og tilrettelagt av Hein Tore Tønnesen © 2009