MinTankesmie

- 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(Reuters Health) - Merck's withdrawn painkiller Vioxx may have continued to cause blood clots and perhaps deaths even after patients dropped it, U.S. researchers said Monday.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: Persistence of Cardiovascular Risk After Rofecoxib Discontinuation. Arch Intern Med. 2010;170(22):2035-2036 (Dec 13/27).)

(Anm: Interessekonflikter, bestikkelser og korrupsjon (mintankesmie.no).)

- Vioxx-historien fremhever virkelig forskjellen mellom makedsføring og informasjon

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 makedsføring 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. (...)

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

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).)

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. (...)

- Studie: Å ta bare litt for mye paracetamol (Tylenol) hver gang kan være dødelig

Litt for mye Paracet kan være dødelig
nrk.no 23.11.2011
(...) – Folk som tar tabletter for kronisk smerte skjønner kanskje ikke at de tar for mange eller kjenner igjen symptomene ved overdose og leverskade, sier Kenneth Simpson ved Edinburgh University til BBC.

Simpson og hans forskerteam har sett på rundt 663 tilfeller av leverskade grunnet legemiddelet paracetamol og fant 161 tilfeller av det de kaller «forskjøvet» (staggered) overdose.

Paracetamol finnes i vanlige smertestillende tabletter, som Pinex, Paracet og Panodil. (...)

– For lett tilgjengelig
Ved Rikshospitalet kjenner de godt til problemstillingen.

– Etter vårt skjønn er farene ved paracetamol for lite kjent blant folk flest, sier Aksel Foss, overlege og seksjonsleder ved seksjon for transplantasjonsmedisin, der levertransplantasjoner foretas.

– Vi mener paracetamol er litt for lett tilgjengelig, sier Foss.

I Norge seleges pakninger med 20 tabletter paracetamol reseptfritt, også i matbutikker.

Men salget har ikke økt etter at Paracet og liknende legemidler ble tilgjengelig utenfor apotekene, ifølge Steinar Madsen, medisinsk fagdirektør i Legemiddelverket. (...)

Study: Taking Just a Little Too Much Tylenol Each Time Can Be Deadly (Studie: Å ta bare litt for mye paracetamol (Tylenol) hver gang kan være dødelig)
healthland.time.com 23.11.2011 (Time)
Taking just a little bit too much acetaminophen (Tylenol) over the course of days or weeks is more likely to be fatal than taking a single, massive overdose, according to a new study. In part, that's because when people take such a "staggered overdose," physicians aren't always able to identify the problem in time to help.

Acetaminophen is one of the most commonly used drugs in the world, with 28 billion doses purchased in the U.S. in 2005 alone. But its very familiarity can obscure the fact that it is a powerful drug, and that taking only slightly higher than recommended doses can cause potentially fatal liver damage. Tylenol overdose is the leading cause of acute liver failure in the U.S., leading to 26,000 hospitalizations and nearly 500 deaths annually, according to the Food and Drug Administration.

The new study, led by Dr. Kenneth Simpson of the University of Edinburgh in Scotland, followed 663 hospital patients who had suffered from acetaminophen overdose between 1992 and 2008. Of these patients, 161 had taken a staggered overdose, increasingly escalating their use of painkillers containing acetaminophen to treat common pain like toothache, headache and muscle pain. (...)

(Anm: Tylenol, acetaminophen (called "paracetamol" outside North America). (en.wikipedia.org).)

Diverse artikler

Debate Continues Over Aspirin Use to Reduce Cancer Risk
JAMA 2011 (March 21)
Does daily aspirin reduce the risk of developing or dying of certain cancers? Although some new studies add to the evidence base that aspirin may have such benefits, some caution that more data are needed to weigh risks of treatment and determine which patients might benefit.

A pooled analysis of individual patient data, published online in the Lancet in 2010, suggested that daily aspirin reduced death due to cancer among 25 570 patients enrolled in 8 analyzed trials by 21% (327 deaths among 14 035 taking aspirin vs 347 deaths among 11 535 control participants). In February of this year, the Archives of Internal Medicine published a meta-analysis of 9 trials involving more than 100 000 participants suggesting that aspirin did not reduce cancer mortality. But yesterday, 2 studies published in the Lancet and another in Lancet Oncology suggest, once again, that daily aspirin use reduces cancer mortality. (...)

Prescription drugs are the worst of many options for adults with neck pain (Reseptbelagte legemidler er det verste av flere alternativer mot nakkesmerter hos voksne)
All you need to read in the other general journals
BMJ 2012;344:e76 (11 January)
Ann Intern Med2012;156:1-10 FREE Full Text
Most adults report non-specific neck pain at some point in their lives, and possible treatments include drugs, spinal manipulation, mobilisation, and unsupervised exercises. A pragmatic trial comparing these options found little to choose between 12 weeks of spinal manipulation and two teaching sessions to help people mobilise plus exercise at home. Both physical treatments worked significantly better than a doctor’s choice of prescription drugs.

All groups improved during the 52 week trial, but participants treated by chiropractors (spinal manipulation or home exercises and mobilisation) reported greater reductions in pain scores than those given prescription drugs, including non-steroidal anti-inflammatory agents, muscle relaxants, and opioids. The difference between drugs and home exercises was significant at 26 weeks only. All significant differences between treatment groups measured less than one point on a 10 point pain scale. (...)

Prescription Painkiller Overdoses in the U.S. (Overdoser av smertestillende i USA)
cdc.gov 1.11.2011
Overdose deaths from prescription painkillers have skyrocketed in the past decade. Every year, nearly 15,000 people die from overdoses involving these drugs—more than those who die from heroin and cocaine combined.

Overdoses involving prescription painkillers—a class of drugs that includes hydrocodone, methadone, oxycodone, and oxymorphone—are a public health epidemic. These drugs are widely misused and abused. One in 20 people in the United States, ages 12 and older, used prescription painkillers nonmedically (without a prescription or just for the "high" they cause) in 2010. A recent CDC analysis discusses this growing epidemic and suggested measures for prevention. (...)

Information on the proper storage and disposal of medications can be found at www.cdc.gov/HomeandRecreationalSafety/ Poisoning/preventiontips.htm. (...)

AACR-FCPR: Painkillers Tied to Kidney Cancer Risk (AACR-FCPR (American Association for Cancer Research's Frontiers in Cancer Prevention Research): Smertestillende legemidler knyttet til økt risiko for nyrekreft)
medpagetoday.com 28.10.2011
BOSTON – Analgesic use increased the hazard for renal cell carcinoma (RCC) by as much as 33%, depending on the drug class, results of a large meta-analysis showed.

Use of acetaminophen or nonaspirin, nonsteroidal anti-inflammatory drugs (NSAIDs) significantly increased the risk of RCC compared with nonuse. Aspirin use was not associated with an increased risk of the kidney cancer, as reported here at the American Association for Cancer Research Frontiers in Cancer Prevention Research meeting.

"The results are kind of surprising," Eunyoung Cho, ScD, of Harvard and Brigham and Women's Hospital in Boston, told MedPage Today. "Aspirin and NSAIDs have been associated with a reduced risk of several types of cancer, but that does not appear to be the case with renal cell carcinoma." (...)

(Anm: Nyrekreft (nhi.no).)

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

(Anm: Paracetamol (eller acetaminophen) er et legemiddel, brukt smertestillende og febernedsettende. En bør vise litt forsiktighet ved bruken da store doser kan gi varige leverskader. Ved nedsatt leverfunksjon kan toleransen for paracetamol være nedsatt, og moderat til høyt alkoholforbruk kan gi økt fare for paracetamolforgiftning. (no.wikipedia.org).)

Use of nonaspirin nonsteroidal anti-inflammatory drugs during pregnancy and the risk of spontaneous abortion
CMAJ 2011; 183(15) (October 18)
Background: The association between the use of nonaspirin nonsteroidal anti-inflammatory drugs (NSAIDs) during pregnancy and the risk of spontaneous abortion remains unclear because of inconsistent research results and the lack of evidence for an effect due to specific types or dosages of nonaspirin NSAIDs. We aimed to quantify the association between having a spontaneous abortion and types and dosages of nonaspirin NSAIDs in a cohort of pregnant women. (...)

Interpretation: Gestational exposure to any type or dosage of nonaspirin NSAIDs may increase the risk of spontaneous abortion. These drugs should be used with caution during pregnancy. (...)

NSAIDs gir økt risiko for hjertesykdom
legemiddelverket.no 29.9.2011
Ny undersøkelse bekrefter at NSAIDs gir litt økt risiko for hjerte- og karsykdom. NSAIDS finnes i blant annet Voltaren og Ibux. - Vi vil drøfte om det er nødvendig med nye råd om bruken av NSAIDs, sier Steinar Madsen, avdelingsoverlege i Legemiddelverket.

Den nye studien har samlet resultatene fra tidligere undersøkelser. Den bekrefter at de fleste NSAIDs gir en litt økt risiko for hjerte- og karsykdom. Unntaket er naproksen.

-Den nye studien bekrefter det vi har trodd, sier Madsen, og påpeker at Legemiddelverkets råd er at NSAIDs ikke bør brukes i høyere doser eller over lengre tid enn nødvendig. For pasienter med høy risiko for hjerte- og karsykdom bør legen vurdere annen behandling enn NSAIDs. (...)

Smertestillende kan være farlig for hjertet
vg.no 29.9.2011
En omfattende britisk studie som involverte nærmere tre millioner pasienter, viser at det smertestillende legemiddelet diklofenak øker risikoen for hjerteproblemer kraftig.

Britiske forskere ved Hull medisinske universitet har funnet ut at pasienter som bruker diklofenak har 40 prosent høyere risiko for hjerteinfarkt og slag enn pasienter som ikke benytter disse legemidlene.

I 2010 fikk 481 000 norske pasienter utskrevet det risikofylte legemiddelet.

- Vi har lenge vært bekymret for overdreven bruk av denne typen smertestillende, sier medisinsk fagdirektør i Legemiddelverket Steinar Madsen.

Bekymret
Også generalsekretær i Landsforeningen for hjerte- og lungesyke, Frode Jahren, er bekymret over funnene.

- Vi forventer at dette følges av helsemyndighetene og at det vil få konsekvenser for legemiddelbruken, sier han.

Steinar Madsen forteller at Legemiddelverket flere ganger tidligere har rådet norske leger til å bruke lavest mulig dose og kortest mulig behandlingstid av diklofenak. Men nå vurderes en ny innskjerping:

- Det er mulig vi må stramme inn bruken av disse legemidlene ytterligere. Vi vil helt klart ha en diskusjon om det nå, sier han.

Ikke godt nok
Det mye brukte og reseptbelagte legemiddelet Voltaren har diklofenak som virkestoff.

Det er i hovedsak pasienter med leddgikt og slitasjegikt som bruker reseptbelagte Voltaren, men det skrives også ut til pasienter med andre smerteproblemer som ryggsmerter, muskelsmerter og senebetennelse.

- Problemet er at dette er legemidler det ikke finnes fullgod erstatning for. Vi anbefaler paracetamol som alternativ, men for pasienter med store smerter er ikke dette alltid godt nok. Da må man vurdere nytten opp mot risikoen, sier Madsen. (...)

(Anm: Cardiovascular Risk with Non-Steroidal Anti-Inflammatory Drugs: Systematic Review of Population-Based Controlled Observational Studies. PLoS Med 8(9): e1001098 (September 27).)

Painkiller heart alert: Don't stop taking pills, but do talk to your GP, British scientists urge
dailymail.co.uk/ 28.9.2011
• Diclofenac can raise risk by 40 per cent
• Drug is found in Voltarol Pain-Eze tablets - where risk is increased by 22 per cent
• Risk greatest for those already suffering problems

A painkiller taken by millions can increase the risk of heart attack and stroke by 40 per cent, a study has found.

Researchers say that while there is no need for patients to panic, diclofenac should be restricted to prescription only. (...)

(Anm: Cardiovascular Risk with Non-Steroidal Anti-Inflammatory Drugs: Systematic Review of Population-Based Controlled Observational Studies. PLoS Med 8(9): e1001098 (September 27).)

Taking non-aspirin NSAIDs in early pregnancy doubles risk of miscarriage, study shows (Inntak av ikke-aspirin NSAID-er tidlig i svangerskapet dobler risiko for spontanabort)
BMJ 2011; 343:d5769 (9 September)
The risk of miscarriage among women who took any type and dosage of non-steroidal anti-inflammatory drug (NSAID), excluding aspirin, in early pregnancy is more than double that among pregnant women who did not, concludes a new study published in the journal of the Canadian Medical Association (CMAJ doi:10.1503/cmaj.110454).

The principal investigator, Anick Bérard, professor in the Faculty of Pharmacy at the University of Montreal, said, “We consistently saw that the risk of having a spontaneous abortion was associated with gestational use of diclofenac, naproxen, celecoxib, ibuprofen, and rofecoxib alone or in combination, suggesting a class effect. We did not see a dose-response relationship.”

The highest risk was associated with diclofenac alone, and the lowest risk was in users of rofecoxib alone, the researchers said. Naproxen was the most commonly used non-aspirin NSAID, followed by ibuprofen. (...)

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

Common Painkiller Use May Be Linked to Miscarriage Risk (Vanlige smertestillende kan være linket til risiko for spontanabort)
healthland.time.com 8.9.2011 (Time)
A new study from the University of Montreal suggests a possible link between the use of nonaspirin painkillers like ibuprofen (Advil) in early pregnancy and a higher risk of miscarriage.

The researchers looked at more than 52,000 pregnant women in Canada, and found that those who received at least one prescription for a nonsteroidal anti-inflammatory drug, or NSAID, in early pregnancy, were more than twice as likely to have a miscarriage than women who didn't get a prescription.

NSAIDs include prescription drugs like diclofenac, celecoxib (Celebrex) and rofecoxib (Vioxx), a painkiller that is no longer sold in the U.S., as well as over-the-counter painkillers like ibuprofen (Advil) and naproxen (Aleve).

About 4,700 women included in the study had a miscarriage before the 20th week of pregnancy. The researchers compared each of those women to 10 others of the same age who had not miscarried by the same point in their pregnancies. Among women who miscarried, 7.5% (352 women) had filled at least one NSAID prescription, compared with 2.6% (1,213 women) who didn't have a miscarriage.

The risk of miscarriage was independent of the dose of drug that women were prescribed, the study found. "This leads me to believe that women using NSAIDs over the counter, which are known to be lower dosage, are at the same risk as those who are going and getting a prescription," study author Anick Bérard, a professor of pharmacy at the University of Montreal, told WebMD. (...)

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

Common NSAID Painkillers May Increase Risk of Miscarriage, Study Finds (Vanlig NSAID-smertestillende kan være linket til risiko for spontanabort, ifølge studie)
ibtimes.com 6.9.2011
Common anti-inflammatory drugs like ibuprofen and aspirin may increase a woman's risk of miscarriage, researchers found in a new study published Tuesday in the Canadian Medical Association Journal.

The findings concerned non-steroidal anti-inflammatory drugs, or NSAIDs, the most common of which are ibuprofen (Advil or Motrin), aspirin and naproxen. They do not apply to acetaminophen, or Tylenol, a non-NSAID painkiller that is safe for pregnant women.

"We're seeing a 2.4-fold increased risk in spontaneous abortion following early use of NSAIDs during pregnancy," Anick Berard, an epidemiology professor at the University of Montreal and the senior author of the study, told HealthDay.

The risk was strongest for women who took NSAIDs during the first 20 weeks of pregnancy. However, the drugs are known to be dangerous in the third trimester as well, for a different reason: they can cause fetal circulation problems. (...)

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

Chronic NSAID use doubles cardiovascular deaths in the elderly (Kronisk bruk av NSAID dobler dødsfall hos eldre)
pulsetoday.co.uk 27.7.2011
Older patients with hypertension and coronary artery disease who use NSAIDs for chronic pain are at significantly increased risk of cardiovascular events, a new analysis shows.

An observational study found in a cohort of more than 22,000 patients, with a mean age of 66.1, chronic NSAID use was associated with a 47% increased risk of cardiovascular events compared to non-users.

The trial was conducted with data from the hypertension trial INVEST, a trial comparing treatment with and without a calcium channel blocker in patients with hypertension and coronary artery disease.

Researchers asked each patient about their use if NSAIDs at every follow-up visit and patients who reported NSAID use at every visit were identified as chronic users, while all others were identified as non-chronic users. (...)

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

NSAID og kardiovaskulær risiko
irf.dk 17.5.2011 (Institut for Rationel Farmakoterapi (IRF)
Det er i de seneste år blevet kendt, at NSAID, især med stor COX-2-selektivitet, øger risikoen for kardiovaskulære hændelser.

Såvel IRF som Dansk Cardiologisk Selskab har tidligere konkluderet, at patienter med erkendt hjertekarsygdom ikke bør behandles med COX-2 selektive NSAID såsom celecoxib, etodolac og diclofenac, da disse stoffer vurderes at have en højere kardiovaskulær risiko end uselektive NSAID såsom ibuprofen eller naproxen (1,2).

Såfremt NSAID-behandling hos patienter med erkendt kardiovaskulær sygdom er nødvendig, bør der desuden behandles med mindst mulige dosis (eks. naproxen < 500 mg dgl. eller ibuprofen < 1.200 mg dgl.) i så kort en periode som muligt (1,2).

Et nyt dansk kohorte studie af patienter med tidligere AMI har bekræftet, at NSAID er forbundet med en øget risiko for død og nyt AMI i denne højrisikogruppe. Undersøgelsen fandt, at:

• Diclofenac var associeret med øget risiko for død eller nyt AMI fra starten af behandlingen (hazard ratio (HZ) 2,5-3).
• Ibuprofen var associeret med øget risiko for død eller nyt AMI efter >1 uges behandling (HZ omkring 1,5).
• Naproxen var ikke associeret med øget risiko ved < 90 dages behandling men ved > 90 dages behandling (HZ ca. 1,5) (3).

IRF mener:

• Studiet (3) tyder på, at selv kortvarig behandling hos patienter med erkendt hjertekar-sygdom er forbundet med en øget risiko for AMI eller død
• NSAID bør så vidt muligt undgås hos denne patientgruppe
• Såfremt andre analgetika ikke er tilstrækkelige bør vælges naproxen fremfor andre NSAID. (...)

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

Risks: Pain Drugs May Lead to Birth Defects (Risikoer: Smertestillende legemidler kan føre til fødselsdefekter)
nytimes.com 17.3.2011
Women who take codeine, oxycodone and other opioid pain drugs early in pregnancy may be exposing their babies to a higher risk of birth defects, a new government study suggests.

Though the overall numbers were small, babies whose mothers took opioids were considerably more likely than others to have congenital problems, including a potentially fatal syndrome in which the left part of the heart does not develop completely; spina bifida, in which the backbone and spinal canal do not close; and gastroschisis, in which the intestines stick out of the body.

The study, from the Centers for Disease Control and Prevention, was one of the largest to examine the effects of opioid use during pregnancy. It appeared last month in The American Journal of Obstetrics & Gynecology.

It used data from the National Birth Defects Prevention Study about mothers in 10 states who gave birth from 1997 to 2005. Information was drawn from hourlong computer-assisted telephone interviews with the mothers. (...)

NSAID Use Tied to Men's Sexual Performance
medpagetoday.com 5.3.2011
The regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) is associated with higher odds of erectile dysfunction, a cross-sectional study showed.

In a large healthcare system, the rate of erectile dysfunction was 35.2% among middle-age men who regularly took NSAIDs and 24% among those who did not (P<0.001), according to Steven Jacobsen, MD, PhD, director of research at Kaiser Permanente Southern California in Los Angeles, and colleagues.

After adjustment for age, race, ethnicity, smoking, body mass index, and various comorbidities, that worked out to a 1.22-fold greater likelihood of erectile dysfunction in NSAID users (OR 1.22, 95% CI 1.18 to 1.27), the researchers reported online in the Journal of Urology. (...)

(Anm: Regular Nonsteroidal Anti-Inflammatory Drug Use and Erectile Dysfunction. J Urol 2011;185:1388-1393.)

CDC Links Prescription Painkillers in Pregnancy to Birth Defects (CDC linker reseptbelagte smertestillende midler i svangerskapet til fødselsdefekter)
news.yahoo.com 2.3.2011
WEDNESDAY, March 2 (HealthDay News) -- Moms-to-be who take prescription opioid painkillers such as codeine, hydrocodone or oxycodone (Oxycontin) may increase the risk of birth defects in their newborns, according to a new U.S. government report.

Taking these types of analgesics just prior to pregnancy or in the early stages of pregnancy was linked to a modest risk of congenital heart defects in an ongoing population study, according to the U.S. Centers for Disease Control and Prevention.

The risk for spina bifida, hydrocephaly, congenital glaucoma and gastroschisis was also heightened, the report said.

"Women who are pregnant, or thinking about becoming pregnant, should know there are risks associated with using prescription painkillers," said CDC Director Dr. Thomas R. Frieden, in an agency news release. "They should only take medications that are essential, in consultation with their health care provider." (...)

Warnings over regular painkiller use
hc2d.co.uk 15.2.2011
Health experts are warning that taking painkillers should not turn into a part of people's daily lifestyle.

Many people keep packs of paracetamol, ibuprofen or aspirin in their cars, medicine cabinets or handbags, in case they are hit by aches and pains.

Research firm Mintel found recently that more than 80% of Americans use either acetaminophen, aspirin, ibuprofen, or naproxen.

The four major over-the-counter analgesics are a common feature of most people's lives, but few are aware of the potential health risks. (...)

(Anm: Acetylsalisylsyre (Acetylsalicylic Acid). Stoffet brukes mot smerter og feber og finnes under flere varemerkebeskyttede navn, blant annet Dispril, Aspirin og Globoid.(no.wikipedia.org).)

(Anm: Risk of Upper Gastrointestinal Bleeding With Low-Dose Acetylsalicylic Acid Alone and in Combination With Clopidogrel and Other Medications.Circulation. 2011;123:1108-1115 (March 15).)

New uses for existing treatments
BMJ 2011; 342:d907 (9 February)
Two months on from widespread media reports that aspirin reduces deaths from common cancers, are you encouraging your middle aged and older patients to take a daily aspirin? Are you taking one yourself? The reports were based on an impressive meta-analysis published in the Lancet by Peter Rothwell and colleagues (Lancet 2010;376:1741-50). They looked at individual patient data from randomised trials of daily aspirin versus control and found about a 20% reduction in deaths from cancer at five and 20 years.

You may remember that the BMJ’s editorial on the paper was more circumspect (BMJ 2011;342:5-6). In it, Paul Moayyedi and Janusz Jankowski questioned the number of cancer deaths actually prevented and estimated a rather larger number needed to treat of 200. They stressed the need to look at all cause mortality rather than just deaths from cancer, citing among other things the risk of gastrointestinal and other major bleeds. (...)

NSAID kopplas till viss ökad hjärtrisk
lakemedelsvarlden.se 14.1.2011
Att ta vissa typer av smärtstillare dagligen under flera års tid kan innebära en ökad risk för hjärtattack och stroke enligt en schweizisk studie.

LÅNGVARIG Den schweiziska forskargruppen har gått igenom data från 31 publicerade studier för att undersöka kopplingen mellan smärtstillare och en eventuell förhöjd risk för hjärtkärlsjukdom. Resultaten, som publicerats i British journal of Medicine, innehåller uppgifter från över 100 000 patienter och jämför behandling med NSAID som ibuprofen, naproxen, diklofenak och rofecoxib med varandra eller placebo.

Personer som tagit NSAID regelbundet hade enligt forskarnas resultat en två till fyra gånger högre risk att avlida i stroke eller hjärtattack jämfört med de som tagit placebo. De flesta studiedeltagarna var äldre med diagnoser som artrit och som stått på höga doser NSAID dagligen under minst ett år. Ibuprofen var kopplad till den högsta risken för stroke följt av diklofenak. (...)

Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis (Kardiovaskulær (hjerte-kar-) risiko for ikkesteroide antiinflammatoriske midler (NSAID): nettverks meta-analyse)
BMJ 2011; 342:c7086 (11 January)
Objective To analyse the available evidence on cardiovascular safety of non-steroidal anti-inflammatory drugs (...)

Data synthesis 31 trials in 116 429 patients with more than 115 000 patient years of follow-up were included. Patients were allocated to naproxen, ibuprofen, diclofenac, celecoxib, etoricoxib, rofecoxib, lumiracoxib, or placebo. Compared with placebo, rofecoxib was associated with the highest risk of myocardial infarction (rate ratio 2.12, 95% credibility interval 1.26 to 3.56), followed by lumiracoxib (2.00, 0.71 to 6.21). Ibuprofen was associated with the highest risk of stroke (3.36, 1.00 to 11.6), followed by diclofenac (2.86, 1.09 to 8.36). Etoricoxib (4.07, 1.23 to 15.7) and diclofenac (3.98, 1.48 to 12.7) were associated with the highest risk of cardiovascular death.

Conclusions Although uncertainty remains, little evidence exists to suggest that any of the investigated drugs are safe in cardiovascular terms. Naproxen seemed least harmful. Cardiovascular risk needs to be taken into account when prescribing any non-steroidal anti-inflammatory drug. (...)

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

Painkiller use linked to stroke risk
reuters.com 19.8.2010
(Reuters Health) - Common painkillers that have been linked to an increased risk of heart attack may also elevate risk of stroke, a new study suggests.
Researchers found that among nearly 38,000 Taiwanese adults who suffered a stroke over one year, the use of a non-steroidal anti-inflammatory drug (NSAID) in the prior month may have elevated their stroke risk. (...)

NSAIDs are a group of painkillers that include over-the-counter medications like aspirin, ibuprofen (Advil, Motrin and other brands) and naproxen (Aleve), as well as prescription arthritis drugs known as COX-2 inhibitors.

The COX-2 inhibitors were first linked to an increased risk of heart attack and other cardiovascular problems, and two of the drugs -- rofecoxib (Vioxx) and valdecoxib (Bextra) -- were pulled from the market in 2004 and 2005, respectively; a third COX-2 inhibitor, celecoxib (Celebrex) remains on the market.

But subsequent studies also raised concerns about the possible heart risks of some of the older, over-the-counter NSAIDs, including ibuprofen and diclofenac (Voltaren). (...)

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. (...)

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-sagen
gigtforeningen.dk 5.11.2008
(...) Gennem de seneste år har Gigtforeningen været i kontakt med en lang række af de mange danskere, der nåede at blive behandlet med gigtmedicinen Vioxx, inden det blev taget af markedet på grund af alvorlige bivirkninger. I Danmark har 108 anlagt erstatningssag mod det amerikanske medicinalvarefirma, og dommene er nu begyndt at falde. De fleste patienter får afslag. (...)

(Anm: Medicin (gigtforeningen.dk).)

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. (...)

Ibuprofen Use Increases Cardiovascular Risk but Not for All Older Patients
medpagetoday.com 5.9.2008
(...) The patients at increased risk were those 80 and older, those with hypertension, chronic obstructive pulmonary disease, and cardiovascular disease, and those who had previously had a myocardial infarction, Daniel Solomon, M.D., M.P.H., of Brigham and Women's Hospital, and colleagues reported in the August issue of Arthritis Care & Research.

Patients with history of MI had the highest rate of cardiovascular events related to ibuprofen use at 44 events per 100 person-years. Non-users had a rate of 32.6 events per 100 person-years. (...)

Merck & Co gets two more Vioxx rulings overturned
pharmatimes.com 30.5.2008
Merck & Co is celebrating a pair of legal victories after appeals courts in Texas and New Jersey reversed rulings against the firm in liability cases concerning its withdrawn COX-2 inhibitor Vioxx.

The Texas court reversed a 2005 judgment in favour of Carol Ernst, who claimed that her husband's use of Vioxx (rofecoxib) caused his death. In the first Vioxx lawsuit to go to trial, the jury had awarded Ernst $253.4 million in compensatory and punitive damages though that amount was later reduced to about $26.1 million under a state law capping damages.

That judgement has now been overturned and Chief Justice Adele Hedges said in the ruling that “we find no evidence that Ernst suffered a thrombotic cardiovascular event. Accordingly, appellee failed to show that ingestion of Vioxx caused her husband's death." (...)

Side Effect Discovered with New Painkillers (Sideeffekter oppdaget for nye smertestillende legemidler)
ivanhoe.com 17.3.2008
(Ivanhoe Newswire) -- A dark side has been discovered with a new class of painkillers. A new study finds painkillers that block a receptor called TRPV1 may interfere with brain functions, such as learning and memory.

TRPV1 is a pain receptor whose activation causes the pain in inflammation. Drug companies have been testing TRPV1 receptor blockers as a way to treat the pain of inflammation and nerve damage in peripheral nervous system.

Researchers knew that TRPV1 dealt with the nervous system, but were not sure of its function in the brain. (...)

Study authors say these findings may also explain the role of TRPV1 in the reported side effects of the anti-obesity drug, Acomplia. Acomplia is approved in Europe but was denied FDA approval because of concerns that the drug increased a patient’s risk of depression and suicide. (...)

(Anm: TRPV1 Channels Mediate Long-Term Depression at Synapses on Hippocampal Interneurons. Neuron, Vol 57, 746-759, (13 March).)

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'. (...)

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. (...)

Anti-depressants And Painkillers Combined Linked To Gastrointestinal Bleeding
sciencedaily.com 9.10.2007
Science Daily — New research shows that selective serotonin reuptake inhibitors (SSRIs), a group of drugs commonly used to treat depression, may double the risk of gastrointestinal bleeding, according to researchers from Wake Forest University School of Medicine and colleagues. When the drugs are taken with aspirin and other similar pain medications, the risk is more than 600 percent higher. (...)

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. (...)

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.)

Too Many Painkiller Warnings? (For mange advarsler for smertestillende midler?)
ivanhoe.com 27.4.2007
ORLANDO, Fla. (Ivanhoe Newswire) -- One of the most commonly used pain killers in the world should be taken off the market, according to a researcher at Wake Forest University. (...)

Studies have shown diclofenac, sold as Voltaren, increases the risk of heart attack as much as banned medications Bextra and Vioxx, Curt Furberg, M.D., Ph.D., told Ivanhoe. The researcher from Wake Forest University Baptist Medical Center in Winston-Salem, N.C., also serves on the U.S. Food and Drug Administrations Safety and Risk Management Advisory Committee. (...)

FDA whistle-blower shifts Arcoxia fight to Europe (FDA-varslers kamp flyttes til Europa)
usatoday.com 17.4.2007
Food and Drug Administration-varsler David Graham er ikke fornøyd med bare å hjelpe til med å holde Mercks legemiddel Arcoxia utenfor det amerikanske markedet, fordi det er fremdeles 63 land hvor artrittlegemidlet selges. (...) (Food and Drug Administration whistle-blower David Graham isn't content with helping to keep Merck's drug Arcoxia off just the U.S. market, because that still leaves 63 countries in which the arthritis medication is sold.)

(Anm: Arcoxia (felleskatalogen.no).)

FDA scientist: Merck's proposed Vioxx successor a potential 'disaster'
signonsandiego.com 12.4.2007
WASHINGTON – A painkiller proposed as a successor to Vioxx may substantially increase the risk of stroke and heart attack and is no more effective for pain relief than other drugs of the same class, a federal drug safety expert said Thursday.

Safety studies done on the proposed drug, Arcoxia, are neither adequate nor reasonable to support its approval, Food and Drug Administration scientist Dr. David Graham told a panel of agency advisers. Graham has been a leading critic of Vioxx, also known as rofecoxib.

“What you're talking about is a potential public health disaster,” Graham said of Arcoxia. “We could have a replay of what we had with rofecoxib.” (...)

U.S. panel rejects Merck's Vioxx successor
reuters.com 12.4.2007
GAITHERSBURG, Maryland (Reuters) - Merck & Co Inc.'s successor to the recalled pain reliever Vioxx should not be approved, a U.S. advisory panel ruled on Thursday.

The Food and Drug Administration's panel of outside experts voted 20-1 against recommending clearance for the drug, called Arcoxia. (...)

Merck seeking to market a new Vioxxlike drug
philly.com 8.4.2007
Experts will meet Thursday to decide. Many doctors and patients say the pain reliever's risks are worth it. (...)

Experts: New Merck drug won't get OK
money.cnn.com 5.4.2007
Say studies of arthritis drug Arcoxia, meant as Vioxx replacement, reveal unacceptable dangers. (...)

Drugs not always the best way to kill pain
nashuatelegraph.com 25.3.2007
NASHUA - When cardiologist Steven Schwartz talks to patients about using pain medication, he makes one point clear: It isn’t just Vioxx and other cox-2 inhibitors, most of them no longer on the market, that may increase the risk of heart attack and stroke.

All pain medications carry risks, including commonly used over-the-counter medicines such as aspirin and acetaminophen. Furthermore, the dose and the length of time a patient takes a medicine increase the risk of ill effects.

“You have to weigh the risk of not taking medication, which is pain and quality of life,” Schwartz said, ticking off a list of side effects, including kidney failure, that can result when a patient with heart disease uses painkillers. (...)

People in pain caught between rock, hard place
chron.com 11.3.2007
People in pain are caught between a rock and a hard place. On the one hand, they have to deal with sore joints or chronic back problems that make it hard to enjoy everyday activities. On the other hand, the pain relievers they count on to ease their discomfort pose serious risks. (...)

Aspirin, NSAIDs Won't Prevent Colorectal Cancer: Study
healthfinder.gov 6.3.2007
U.S. task force recommendation says potential harm outweighs benefits. (...)

A Chronic Problem
washingtonpost.com 6.3.2007
What New Painkiller Guidelines Mean for You

New guidelines released last week by the American Heart Association, advising doctors to withhold medications to treat chronic pain until other treatment options have been exhausted, have left some patients frustrated and confused, wondering what's safe to take for pain, experts say.

The statement, published in the journal Circulation, suggested that doctors urge patients to try exercise, orthotics, weight loss, physical therapy and hot or cold packs before turning to medication, especially nonsteroidal anti-inflammatory drugs, or NSAIDs (such as naproxen and ibuprofen), and COX-2 inhibitors (Celebrex) to treat chronic pain. The new guidelines follow several years of debate about the value, and potential danger, of such medications.

Wondering how the new recommendations apply to you? We answer some questions below. (...)

FDA panel to review Vioxx follow-up
businessweek.com 2.3.2007
A Food and Drug Administration panel in April will review Merck's Arcoxia, its follow-up to the controversial painkiller Vioxx, which was pulled from the market in 2004 following safety concerns. (...)

Common Painkillers May Cause Hypertension in Men
healthfinder.gov 26.2.2007
Acetaminophen, ibuprofen and aspirin might affect chemicals that help blood vessels relax.

MONDAY, Feb. 26 (HealthDay News) -- Middle-aged men who regularly take the widely used pain pills acetaminophen, ibuprofen or aspirin appear to have an elevated risk of developing high blood pressure.

The three drugs are the most commonly used medications in the United States, according to a study published in the Feb. 26 issue of Archives of Internal Medicine. (...)

Heart Experts Issue Guidelines on Use of Celebrex
healthfinder.gov 26.2.2007
Cox-2 painkiller should be last resort because of cardiovascular risk, American Heart Association says

MONDAY, Feb. 26 (HealthDay News) -- The American Heart Association is weighing in on the potential heart dangers of controversial cox-2 nonsteroidal anti-inflammatory drug (NSAID) painkillers such as Celebrex.

In a statement published Monday in Circulation, the association says these painkillers -- which include two other drugs, Vioxx and Bextra, now withdrawn from the market -- do increase the risk of heart attack and stroke, and doctors need to change the way they prescribe these pain relievers to people with, or at risk for, heart disease. Cox-2 pain relievers are so named because they specifically target the cox-2 enzyme.

However, other, less targeted or "selective" non-cox-2 NSAIDs may also increase the risk, the AHA said. (...)

How safe is Celebrex? (Hvor sikker er Celebrex?)
boston.com 25.2.2007
The FDA has thousands of accounts suggesting the painkiller may be linked to heart attacks. Critics are unsure if flaw is in drug or agency's reporting system. (...)

(Anm: Celebrex (celecoxib; celekoksib); markedsføres under handelsnavnet Celebra i Norge).

Får erstatning etter dødsmedisin
nrk.no 22.2.2007
Ytterligere fem personer får erstatning etter å ha fått alvorlige bivirkninger av medisinen Vioxx. Tre av disse er døde. (...)

New FDA warning labels may slow painkiller sales
whittierdailynews.com 26.12.2006
WASHINGTON - New warning labels for over-the- counter painkillers proposed by the government could reduce sales for Johnson & Johnson's Tylenol, which has enjoyed a higher safety profile compared with its competitors' products. (...)

FDA calls for pain reliever warning
usatoday.com 20.12.2006
Non-prescription pain relievers used by millions of U.S. consumers need stronger health warnings regarding liver or stomach risk, the Food and Drug Administration said Tuesday.

The drugs include some of the most commonly taken in the USA — aspirin, ibuprofen and acetaminophen — and will affect such household brands as Motrin, Advil, Aleve and Tylenol.

While some manufacturers already note the health risks on packages, the FDA wants the warnings to be more specific, standardized and prominent. New labels aren't likely to be required for at least a year, but companies can do so sooner. (...)

Are Your Painkillers Actually Killing You?
abcnews.go.com 20.12.2006
FDA Proposal Aims to Strengthen Warning Labels for Common Over-the-Counter Medicines
Dec. 20, 2006 — - Calls for stronger warning labels for certain over-the-counter (OTC) medications question the safety of products that are a fixture in the medicine cabinets of nearly every American household. (...)

FDA Proposal for Painkiller Warning Is Decades Late
citizen.org 19.12.2006
Dec. 19, 2006
Finally, the Food and Drug Administration (FDA) is proposing to put labels on over-the-counter pain relievers warning of the potential for stomach bleeding and liver damage.

Our major question is: What took the agency so long? (...)

FDA Calls for Tougher Warnings on OTC Painkillers
healthfinder.gov 19.12.2006
Products such as aspirin, Tylenol and Motrin would be affected. (...)

- Smertelindrende kan gi ammeproblemer
vg.no 13.12.2006
Fire av fem norske kvinner ønsker epidural smertelindring ved fødsel. Men ny forskning viser at det kan gi ammeproblemer.

Fødende som får epidural for å redusere smertene, kan få problemer med ammingen, hevder australske forskere. (...)

Skal prioritere smertepasienter
helserevyen.no 4.12.2006
Helseforetakene har fått sterke signaler fra helsemyndighetene om å prioritere pasienter med kroniske smerter, slik at de får den behandlingen de trenger.

Det mener helse- og omsorgsminister Sylvia Brustad (Ap), som ifølge NRK vil legge mer press på helseforetakene.
- Jeg har allerede stilt krav til foretakene, men jeg kommer til å gjenta kravene, sier hun til NRK. (...)

- Smertepasienter må prioriteres
nrk.no 3.12.2006
Helseminister Sylvia Brustad (Ap) vil legge mer press på helseforetakene for at pasienter med kroniske smerter skal få den behandlingen de trenger. (...)

- Ikke lønnsomme pasienter
nrk.no 3.12.2006
Pasienter med kroniske smerter får ikke den hjelpen de trenger, mener sykehusprofessor.

- Sykehusene må først og fremst behandle livreddende og kurativt. Kroniske smertepasienter tjener ikke sykehusene på, sier overlege og professor ved Rikshospitalet, Harald Breivik.

Han hevder at denne typen pasienter alltid kommer nederst på listen.

I går fortalte Dagsrevyen historien om Kjersti og hennes kamp for å få hjelp. (...)

Fikk ikke hjelp – døde
nrk.no 2.12.2006
Personer med kroniske smerter som blir avhengige av smertestillende får liten eller ingen hjelp hvis de ønsker å slutte.

En kvinne som var avhengig av legemidler, og som ikke fikk hjelp, er nå død. Familien er stolte av henne, og vil fullføre hennes ønske om stå frem for å sette søkelyset på en gruppe som faller mellom to stoler.

Kjersti levde med kroniske smerter i mange år, og var avhengig av smertestillende legemidler. Leger skrev i en årrekke ut store mengder medikamenter. (...)

Falt mellom to stoler
Hun havnet med andre ord i et system der kroniske smertepasienter med avhengighetsproblem faller mellom to stoler. Kjersti hadde et så sterkt ønske om og behov for hjelp at hun sendte en e-post til Dagsrevyen en dag i oktober.

«- Helse-Norge 2006 vil ikke vite av meg og sånne som meg. Vi blir avvist uansett hvor vi henvender oss. Jeg lever et stille og rolig liv sammen med min mann, og jeg har aldri gjort noe galt eller kriminelt. Min "forbrytelse" er at jeg har smerter og tar smertestillende medisiner for å klare hverdagen, skrev Kjersti i en e-post. » (...)

FDA Panel Backs Celebrex for Kids With Arthritis
forbes.com 29.11.2006
The panel, a committee of doctors and other specialists, voted 15-1 that the benefits of the drug for children with juvenile rheumatoid arthritis (JRA) outweigh the shortage of proof on its safety.

However, the panel also voted 8-7, with one abstention, that available data doesn't demonstrate that Celebrex is safe in treating JRA and that a registry should be established to track these young patients for 10 to 20 years. (...)

FDA casts doubts on using Celebrex to treat arthritis in kids
usatoday.com 28.11.2006
WASHINGTON (AP) — Pfizer Inc. may fall short in convincing federal regulators that its painkiller Celebrex should receive expanded approval to treat children with a devastating form of arthritis, according to documents released Tuesday. (...)

Painkiller's use in children sought
boston.com 27.11.2006
Pfizer drug has history of risks
WASHINGTON -- Despite Celebrex's well-documented link to higher heart risks, Pfizer Inc. wants permission to sell its painkiller to treat children as young as 2 who have arthritis. (...)

Newly Released Data Stirs Naproxen Debate
forbes.com 17.11.2006
-- Just-released data from a trial that was stopped early in 2004 for safety reasons is re-igniting debate on the safety of two popular painkillers.
The trial suggested the over-the-counter painkiller Aleve boosted heart risks, while another controversial prescription painkiller known as Celebrex did not.
Now, the data from that trial has finally been made available. But that has not silenced one critic, who says this early data is unreliable and questions the reasons the trial was stopped prematurely.

"The trial was improperly stopped by what appears to be political considerations. When you do that, you generate data which we know is unreliable," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic Foundation.

Nissen is author of an accompanying commentary in the Nov. 17 online edition of PLoS Clinical Trials, which has published the data from the Alzheimer's Disease Anti-inflammatory Prevention Trial (ADAPT). (...)

Vioxx successor poses heart risk in study
boston.com 14.11.2006
CHICAGO -- Merck & Co.'s Arcoxia, a successor to the company's withdrawn Vioxx pain pill, posed the same heart risks in a study as an older arthritis medication. The finding may hinder US approval, a top heart doctor says. (...)

Learning from Vioxx
boston.com 14.11.2006
THE RECALL in 2004 of Vioxx after the arthritis pain reliever was found to cause heart attacks and strokes is just one example of a drug that the Food and Drug Administration approved but then failed to monitor closely enough after it was on the market. Providing the agency with the resources and the authority needed to better ride herd on drugs in the marketplace should be high on the to-do list of the new Congress. (...)

Forvirring om abortrisiko og smertestillende medicin
netdoktor.com/dk 8.11.2006
Gravide bør undgå en række smertestillende præparater med nonsteroide antiin-flammatoriske stoffer (NSAID) konkluderer overlæge Steffen Thirstrup og reservelæge Jeanett Borregaard Larsen fra Lægemiddelstyrelsen i en artikel til Ugeskrift for Læger. Alligevel bliver advarselen ikke lagt ved medicinen. Stoffet NSAID findes for eksempel i Kodimagnyl, Ipren, Ibuprofen og Treo. (...)

Panel Clarifies NSAID Benefits and Risks
JAMA. 2006;296:2193.
Most physicians are aware of the positive and negative consequences associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), but the American Gastroenterology Association (AGA) believes clinicians should be more familiar than they currently are about the risks associated with specific NSAIDs, the magnitude of risks, and ways to reduce such risks. (...)

Pain drugs may raise risk of kidney failure (Smertestillende legemidler kan øke risiko for nyresvikt)
reutershealth.com 3.11.2006
NEW YORK (Reuters Health) - The use of nonsteroidal antiinflammatory drugs ("NSAID"), which include pain relievers like ibuprofen (Motrin, Advil) may increase the risk of kidney failure, according to a report in the American Journal of Epidemiology.

"NSAIDs are associated not uncommonly with renal failure," Dr. James M. Brophy from McGill University in Montreal told Reuters Health. "This rate of renal failure is approximately twice that observed for (heart attack). Clinicians should, therefore, be concerned not only about cardiac but also renal adverse effects and, therefore, restrict NSAID use only for those situations where the benefit is expected to outweigh the risks." (...)

(Anm: American Journal of Epidemiology 2006 164(9):881-889.)

Merck Hikes General Counsel Pay to $780K (Merck øker juridisk sjefs lønn til 780 000 dollar)
hegnar.no 30.10.2006
WASHINGTON — Merck & Co. said Monday that it has raised General Counsel Kenneth C. Frazier's salary to $780,000 from $689,400. (...)

Nytt håp for Vioxx-ofre
p4.no 24.10.2006
(P4) Flere av dem som har blitt alvorlig syke av leddgiktmedisinen Vioxx, likevel få erstatning. Det er Norsk Pasientskadeerstatning som nå skal se på 78 saker på nytt igjen etter at det har kommet fram nye opplysninger om medisinen skriver VG. Legemiddelverket frykter at 400 nordmenn kan ha dødd og langt flere har fått skader etter å ha brukt pillene fram til 2004, da de ble trukket fra markedet. (...)

Er paracetamol levertoksisk også i små doser?
Tidsskr Nor Lægeforen 2006; 126: 2633
Paracetamol i terapeutiske doser ga betydelig stigning av alaninaminotransferasenivået (ALAT) hos mange friske forsøkspersoner. (...)

- Det er overraskende at paracetamol 1 g x 4 ga så høy forekomst av markert økning i ALAT-nivå som denne studien viste. Det kan bety at kontinuerlig paracetamolinntak over mange dager øker risikoen for leverskade mer enn tidligere antatt. Den kliniske betydningen av leverenzymøkningen er uklar, men risikoen for mer alvorlig leverskade kan ikke utelukkes, sier seksjonsoverlege Odd Brørs ved Seksjon for klinisk farmakologi, Klinisk-kjemisk avdeling, Ullevål universitetssykehus.

- Behandling med så høye doser bør følges nøyere med blodprøver enn det som har vært vanlig hittil. Det er utvilsomt behov for nye studier for å klarlegge toksisiteten bedre og for å finne eventuelle individuelle faktorer som disponerer for leverskade ved paracetamolbehandling, sier Brørs. (...)

Doctors warned over pain drug use
bbc.co.uk 24.10.2006
NSAIDs are used to treat chronic pain in conditions such as arthritis

Doctors are being warned that high daily doses of common painkillers such as ibroprofen can increase the risk of heart attack and stroke.

The guidance is being issued by the Commission on Human Medicines.

British Medical Journal research published in June found taking the drugs meant an extra three people in a thousand would have such conditions. (...)

(Anm: Press release: Updated safety information for non-steroidal inflammatory drugs (NSAIDs). mhra.gov.uk 24.10.2006.)

Judge Orders Merck to Disclose Lawyers' Fees in Vioxx Case
law.com 19.10.2006
A New Jersey judge has ordered Merck & Co. to release records on how much it spent on a trial involving its Vioxx painkiller.

The information would provide a window into how much Merck spends on its trials, and what its legal defense costs could be in the future. More than 21,000 suits have been filed against Merck, which has vowed to try each case over Vioxx.

So far, Merck has reserved $970 million for legal costs and spent $285 million of that last year. (...)

German Court Rejects Vioxx Claim
chron.com 18.10.2006
— A German court rejected two claims Wednesday over U.S. drugmaker Merck & Co.'s withdrawn painkiller Vioxx, including one seeking euro80,000 (US$100,000) in damages.

A civil court in Berlin said it dismissed both claims against the German distributor of the once-blockbuster drug. (...)

Vioxx cases overload Atlantic County court
courierpostonline.com 11.10.2006
The court charged with handling about 14,000 Vioxx-related cases that have been filed in the last two years has asked for additional help to handle its workload. (...)

Vioxx Patients Lose U.S. Compensation Bid
allheadlinenews.com 6.10.2006
(...) - British Vioxx users who charge that the drug caused them heart attacks have lost their bid to seek compensation in the US. A New Jersey court has decided that patients must filed their case against the U.S. pharmaceutical company Merck in the UK courts. (...)

Sallie Booth, from Irwin Mitchell solicitors, which represents nearly 100 claimants in the UK, said "This is hugely disappointing for UK victims of this drug."

"Whilst they should not be forced to look to a foreign jurisdiction to determine their cases, the restricted availability of funding for claimants in group actions in this country, especially public funding is having the effect of denying these people proper access to justice.

"However we will now carefully review all alternative options for our clients."
"Drug companies must realize the huge responsibility they have to produce safe and reliable drugs. (...)

World: Merck and Vioxx
40,000 claims
canada.com (3.10.2006)
Merck & Co. will face about 40,000 claims over its withdrawn Vioxx painkiller once deadlines for filing lawsuits lapse around the U.S., court records and lawyer estimates show. (...)

Merck sees a rush of Vioxx lawsuits as filing deadline nears
courier-journal.com 30.9.2006
Popular painkiller pulled 2 years ago (...)

So far, well over 21,700 suits, many with multiple plaintiffs, have been filed, up sharply from the 14,200 Merck reported as of June 30. Merck also has at least 5,800 agreements waiving the statute of limitations for other Vioxx users. (...)

Surge of Vioxx lawsuits swamp courthouses
eitb24.com 30.9.2006
(...) So far, well over 21,700 suits, many with multiple plaintiffs, have been filed, up sharply from the 14,200 Merck reported as of June 30. Merck also has at least 5,800 agreements waiving the statute of limitations for other Vioxx users.

The company faces at least 190 potential class action suits by Vioxx users and Merck shareholders. Merck is challenging the one class action already approved, for health insurers and unions seeking to be reimbursed for Vioxx they bought for health plan members - a case that could cost Merck $15 billion ($11.9 billion) if it loses. (...)

Merck Vioxx Litigation Score Card
September 20, 2006 at 09:03:59
In the homestretch leading up to the latest trial in New Orleans, the score in the Vioxx litigation was 5 to 4 in favor of Merck. However, in mid-August, 2006, a New Jersey victory for Merck was thrown out reversing the score to 5 to 4 in favor of plaintiffs. (...)

Mener fotball-død kan skyldes smerte-piller
vg.no 21.9.2006
Dansk dokumentar vekker oppsikt

ODENSE (VG) Over 40 unge fotballspillerne har plutselig og uforklarlig falt død om av hjertesvikt i Europa de siste fem årene. Nå mener en dansk dokumentar å ha en mulig forklaring på de mystiske dødsfallene. (...)

Topspillere falder om af pillemisbrug
ekstrabladet.dk 20.9.2006
FODBOLD: Skader og smertestillende medicin er fundet som fællesnævner med mystiske dødsfald i fodbold. Dansk dokumentar viser, det kan være forklaringen

Fodboldsporten har de senere år været ramt af en lang række mystiske dødsfald. Mere end 40 unge spillere i Europa er faldet om med hjertestop. Danmarks Radio viser onsdag i dokumentaren 'Når døden spiller med', at der kan være en sammenhæng mellem dødsfaldene og brugen af smertestillende medicin.

Programmet ser nærmere på fire dødsfald. Et af dem er Claus Henningsen fra Otterup på Fyn, der faldt om en vinteraften i 2004.

- Der er lavet store undersøgelser, der bekræfter, at der er overdødelighed af pludselig hjertedød, hvis man indtager NSAD-præparater (smertestillende medicin, red.) For eksempel Diclofenac, som Claus Henningsen havde taget, siger retsmediciner Jørgen Lange Thomsen til DR.

I programmet dokumenteres, at Benfica-spilleren Miklos Feher, Rasmus Green fra Næstved og nordmanden Kjartan Ellingsen alle havde været skadet og indtog smertestillende medicin, før de omkom. (...)

Mange superligaspillere på gigtmedicin
ekstrabladet.dk 19.9.2006
FODBOLD: En undersøgelse blandt Spillerforeningens medlemmer viser, at smertestillende medicin som gigtpræparater er en del af dagligdagen (...)

Latest studies reveal more risks with Vioxx
news-medical.net 18.9.2006
The studies appear in the current issue of the Journal of the American Medical Association (JAMA).

An accompanying editorial from Dr. David Graham, a physician who works for the U.S. Food and Drug Administration (FDA) says the results question the safety of another COX-2 inhibitor, Arcoxia (etoricoxib), for which Merck is currently seeking a U.S. licence.

Dr. Graham says that it has been assumed that Arcoxia poses no cardiovascular risk on the basis that it causes around the same number of cardiovascular events as diclofenac, but this latest evidence of a link between diclofenac and heart attacks, now places Arcoxia's safety in doubt.

The findings have been posted online ahead of schedule by JAMA because of their 'public health implications' and are due to appear in the October 4 issue of the journal.

Dr. Graham says in view of recent history the FDA's concerns should now be focused on patient safety rather than corporate profitability. (...)

Latest Pfizer Celebrex Court Ruling 50-50
by Evelyn Pringle
opednews.com 15.9.2006
According to Pfizer, Celebrex is still selling like hot cakes with worldwide sales of $471 million in the second quarter of 2006, representing growth of 17% over the same period last year, with sales in the US of $355 million. (...)

Merck didn't reveal Vioxx risks, professor says
nola.com 13.9.2006
A Harvard Medical School professor who studies prescription drugs told a federal court jury in New Orleans on Tuesday that Merck & Co. didn't level with doctors about the risks and benefits of Vioxx, a painkiller approved for sale in 1999 but pulled off the market in the fall of 2004 after studies linked its use to heart attacks. (...)

Merck Faces New Vioxx Suits
forbes.com 13.9.2006
Pharmaceuticals Merck may see a surge in Vioxx lawsuits after an independent study found an increased risk of kidney-related complications and arrhythmia, a JP Morgan Securities analyst believes. (...)

FDA whistle-blower Graham blasts new Merck arthritis drug
usatoday.com 12.9.2006
The arthritis drug that Merck has developed to compete with Celebrex may be as risky for the heart as Vioxx, writes Food and Drug Administration whistle-blower David Graham in an editorial posted online Tuesday by a medical journal.

In considering whether Arcoxia should be approved, "the FDA, academia, and the medical research enterprise are once again faced with the opportunity to forsake common sense by willfully accepting misdirection and disinformation presented in the guise of science," Graham writes on the Journal of the American Medical Association's website. (...)

Merck's New Painkiller May Have Same Heart Risks as Vioxx Pill
bloomberg.com 13.9.2006
-- Merck & Co.'s experimental painkiller, Arcoxia, may carry the same risk of heart attacks and strokes as Vioxx, according to an analysis of 23 studies comparing side effects of several pain medicines. (...)

Fears over Voltaren causing heart risk
smh.com.au 13.9.2006
AUSTRALIA'S medicine watchdog is reviewing the safety of the common anti-inflammatory drug Voltaren amid fears it could pose the same risk of heart attack as the disgraced drug Vioxx.

The Therapeutic Goods Administration said yesterday it was carrying out an extensive review of non-steroidal anti-inflammatory drugs (NSAIDs), including the need for new warnings about diclofenac, an older NSAID sold over the counter under brand names, including Voltaren.

Research by the University of Newcastle, being published in the Journal of the American Medical Association today, has found it can be harmful, even at commonly used doses.

An analysis of 17 studies on the safety of NSAIDs found diclofenac increased the risk of cardiovascular events by 40 per cent.

While the drug is most commonly sold as Voltaren in the tablet form, it is also known under many other names, either prescription-only or over-the-counter medications, including Clonac, Diclohexal and Fenac. (...)

(Anm: Diklofenak og hjerteinfarkt (legemiddelverket.no 13.9.2006).)

(Anm: Diclofenac; fornorsket: diklofenak; markedsføres under handelsnavn som bl.a. Voltaren, Voltarol, Diclon, Dicloflex, Difen og Cataflam.)

Ky. suit to be part of Vioxx trial
courier-journal.com 10.9.2006
For 14 years after he injured his right knee playing softball in 1988, Garry Smith of Florence, Ky., treated his pain and swelling with over-the-counter medications and a prescription anti-inflammatory drug.
Then, in October 2002, his doctor prescribed the painkiller Vioxx. Smith had knee surgery at the end of that month, but kept taking Vioxx until the following February.

Then he had a heart attack -- which he and his lawyers contend was caused by Vioxx. Drug manufacturer Merck & Co. pulled Vioxx off the market in 2004 after a study found it doubled the risk of heart attacks and strokes. (...)

Celebrex is a threat to the heart
usatoday.com 30.8.2006
(...) Sales of Celebrex are expected to top $2 billion this year.

DRUGS' COMPLICATIONS
Celebrex's heart risks outweigh its potential to prevent colorectal cancers, new studies have found. Analysts used those studies to estimate the effect on 1,000 people with polyps who took Celebrex, aspirin or nothing for three years. According to this projection, those who took aspirin had the fewest complications. (...)

Farmakoterapi har liten effekt mot artrosesmerter
Tidsskr Nor Lægeforen 2006; 126: 2081
Konservativ behandling av artrose har lenge vært dominert av legemidler, men effekten er dårlig. Det viser en norsk metaanalyse. (...)

Dagens høye forbruk av legemidler ved kneleddsartrose skyldes trolig massiv markedsføring som har vektlagt statistisk signifikans på bekostning av klinisk relevans. 90 % av de undersøkte legemiddelstudiene var industrifinansierte med inklusjonskriterier som gir grunn til å stille spørsmål ved overføringsverdien til den kliniske hverdag. Det er typisk å vise til p-verdier og ikke oppgi den reelle effektstørrelsen. (...)

Study Casts Doubt on NSAID Use After Brain Injury
healthfinder.gov 26.7.2006
Injured rats given ibuprofen showed signs of cognitive decline
-- Long-term use of the painkiller ibuprofen after brain injury led to a decline in cognitive abilities in rats, a new study found.

The findings may have implications for the treatment of patients with traumatic brain injury, because they are often prescribed ibuprofen and other nonsteroidal anti-inflammatory drugs (NSAIDs) for chronic pain, said researchers from the University of Pennsylvania School of Medicine.
They published their findings online in the July issue of Experimental Neurology. (...)

Painkiller overdoses 'deadlier' than hard drugs (Overdoser av smertestillende legemidler "dødligere" enn harde stoffer)
netdoctor.co.uk 24.7.2006
Overdoses from prescribed painkiller drugs are responsible for more deaths in the US than that of cocaine and heroin, a new study published in the journal Pharmacoepidemiology and Drug Safety today reveals.

Researchers from the Centre for Disease Control and Prevention, Atlanta, claim that as sales of a group of painkilling drugs classed as opioids, which includes Oxycodone, Hydrocodone, Methadone and Fentanyl, have increased, drug-related deaths have risen in turn. (...)

Opiate Painkiller ODs Now Top Those for Cocaine, Heroin
healthfinder.gov 24.7.2006
-- Opioid prescription painkillers cause more drug overdose deaths in the United States than either cocaine or heroin, a new U.S. study finds.

Opioid painkillers include oxycodone, hydrocodone, methadone, morphine and fentanyl. U.S. sales of these painkillers have increased over the past 15 years, and there's been a parallel increase in the number of deaths from the drugs, say researchers at the U.S. Centers for Disease Control and Prevention. (...)

Painkillers Linked to more Overdoses than Cocaine or Heroin
ivanhoe.com 24.6.2006
-- Prescription painkillers are at the center of a national epidemic that has been going on since the 1990s.

Over the past 15 years, sales of opioids -- or painkillers -- such as oxycodone, hydrocodone, methadone and fentanyl, have increased, and the deaths related to these drugs have mirrored sales. Drug overdoses from opioids have actually surpassed both cocaine and heroin.

In a recent study, researchers compared the death rates of opioids in relation to both cocaine and heroin. Between 1999 and 2002, death certificates mentioning heroin increased by 12.4 percent, and cocaine related deaths increased by 22.8 percent. While these numbers might seem like a big jump, they are nothing compared to the deaths related to opioids. (...)

NSAIDs Pose Death Risk for Heart-Attack Patients
forbes.com 19.6.2006
MONDAY, June 19 (HealthDay News) -- People who have survived a first heart attack have a higher risk of dying or having a second heart attack if they are taking non-steroidal anti-inflammatory drugs (NSAIDs), including the newer class called cox-2 inhibitors.

The research detailing these findings appears in the June 20 issue of the journal Circulation, and was first presented at the 2005 meeting of the American Heart Association. The results of the two studies are almost the same, although the latest study shows an even higher correlation between NSAID use and a second heart attack.

"The evidence is accumulating, and it seems that patients who have already had a heart attack are at even more risk than we thought before, and we are talking about short-term treatment," said study lead author Dr. Gunnar H. Gislason, senior resident at Gentofte University Hospital in Copenhagen, Denmark. (...)

COX 2 inhibitors and some NSAIDs increase the risk of vascular events (Cox-2-hemmere og noen NSAID-er øker risikoen for vaskulære hendelser)
BMJ 2006;332 (3 June)
Use of selective COX 2 inhibitors is associated with a 1.4-fold increase in the risk of myocardial infarction, stroke, or vascular death compared with placebo; large doses of diclofenac and ibuprofen are also associated with an increased risk, whereas large doses of naproxen are not. In a meta-analysis of 138 randomised trials and almost 150 000 participants, Kearney and colleagues (p 1302) didn't have enough data to adequately assess whether the excess risk was dose dependent, but the hazard was not confined to long term use only. (...)

(Anm: Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ 2006 332: 1302-1308.)

Smertefarlig pille
vg.no 24.5.2006
Har du en Ibux liggende i veska i tilfelle hodepine på jobb? Den lille pillen øker risikoen for hjertesvikt.

Noen typer reseptfrie smertestillende medisiner øker risikoen for hjertesvikt. Ikke-steroide antiinflammatoriske midler (NSAID), som Ibux, kan være farlige. (...)

Smärtstillande medel ökar risk för hjärtsvikt
dagensmedicin.se 22.5.2006
Vanliga smärtstillare, så kallade NSAID, ökar risken för sjukhusvård på grund av hjärtsvikt, visar en studie av spanska forskare.

Det är forskare vid spanska Centro Español de Investigación Farmacoepidemiológica i Madrid som gjort undersökningen. Den är baserad på uppgifter från en brittisk databas, General Practice Research Database, med statistik om miljontals personer som behandlats av allmänläkare i Storbritannien.

I den aktuella studien jämfördes 1396 personer som tagits emot på sjukhus för första gången för icke-dödlig hjärtsvikt med 5000 slumpmässigt utvalda kontroller.

Studien visar att den huvudsakliga riskfaktorn för att tas emot på sjukhus med hjärtsvikt var en tidigare diagnos av sjukdomen. Andra riskfaktorer var fetma och rökning.

Men forskarna fann också att de personer som tog smärtstillande NSAID-preparat, till exempel ibuprofen, löpte en liten, men signifikant, ökad risk att drabbas av hjärtsvikt. Om personen ifråga redan hade en konstaterad hjärtsvikt och åt NSAID var risken för att tas in på sjukhus för hjärtsvikt större, med en relativ riskökning på 8,6 procent.

Den vanligaste anledningen till att personerna som ingick i undersökningen tog NSAID-preparat var att de hade artros.

Studien publiceras online i tidskriften Heart. (...)

Vioxx man awarded $9m after heart attack
timesonline.co.uk 11.4.2006
An American jury has awarded $9 million (£5m) in punitive damages to a man who blamed his heart attack on Vioxx, the arthritis drug made by Merck. (...)

A Hopeful Sign For Merck
forbes.com 11.4.2006
Amid today's blaring headlines announcing an award of $9 million in punitive damages against Vioxx maker Merck, there is good news for the drug giant.

Sure, the punitive damages an Atlantic City, N.J., jury awarded to John McDarby, 77, and his wife were a wallop, especially on top of the $4.5 million in damages already awarded for pain and suffering. And the fact that Merck (nyse: MRK - news - people) will appeal is cold comfort to many. (...)

Jury: Medicinal-firma skyld i hjerteanfald
berlingske.dk 6.4.2006
Den amerikanske medicinalvirksomhed Merck skal betale 27,5 mio. kroner i erstatning til en 77-årig mand, der fik et hjerteanfald efter længere tids brug af firmaets Vioxx-piller.

Juryen ved retten i New Jersey fandt, at pillerne bidrog til at fremkalde anfaldet. Dommen siger desuden, at Merck ikke på tilstrækkelig vis har advaret om risikoen for hjerteproblemer ved brug af de smertestillende piller.

Merck trak Vioxx tilbage fra markedet i 2004, hvor det viste sig at risikoen for hjertestop og blodpropper er fordoblet hos patienter, der bruger medicinen i mere end 18 måneder. Vioxx blev blandt andet brugt af gigtpatienter.

Tidligere Vioxx-søgsmål mod Merck er end med frifindelse, begrundet i at klagerne ikke havde brugt medicinen i lang tid. Retssagen i New Jersey er den første, hvor sagsøgerne havde brugt Vioxx i over 18 måneder. En med-sagsøger fik dog ikke medhold i, at pillerne bidrog til hans hjerteanfald.

Der er stadig næsten 10.000 Vioxx-søgsmål, som venter på afgørelse, og med domfældelsen i New Jersey faldt Merck-aktien øjeblikkeligt på børsen. (...)

A 2nd Loss For Merck Over Vioxx
nytimes.com 6.4.2006
— Delivering a sharp blow to Merck, a New Jersey jury found Wednesday that the company had not properly warned patients of the dangers of its drug Vioxx and had caused a heart attack suffered by John McDarby in 2004. The jury awarded Mr. McDarby, who had taken Vioxx for four years, $3 million in compensatory damages and Irma, his wife, an additional $1.5 million. (...)

Merck Shares Fall On Vioxx Verdict
forbes.com 5.4.2006
Shares of Merck fell 3% in after-hours trading after a New Jersey court awarded a former Vioxx patient $4.5 million in damages late Wednesday.

The Whitehouse Station, N.J.-based company was cleared of claims filed by state resident Thomas Cona, 59, who claimed long-term use of the painkiller contributed to his heart attack. (...)

Krever forbud mot smertestillende piller
vg.no 28.2.2006
Smertestillende tabletter skal ha tatt livet av over 2000 amerikanere i løpet av årene 1981 til 1999. Public Citizen's Health Research Group krever nå forbud av disse medikamentene.

De siste årene har flere hundre mennesker tilfeldigvis dødd etter å ha tatt de smertestillende tablettene Darvon og Darvocet, eller lignende medikamenter, hevder gruppen.

Ifølge Public Citizens leder, dr. Sidney Wolfe, er hovedingrediensen i tablettene, propoxyfen, relativt svakt smertestillende, men representerer en uakseptabel risiko for forgiftning for de millioner mennesker som hvert år har fått utskrevet disse preparatene. De har vært i bruk siden 1957. (...)

(Anm: Propoxyphene-Containing Products (fda.gov 21.11.2010).)

Legal Strategy for Vioxx to Test Merck
washingtonpost.com 27.1.2006
Pharmaceutical giant Merck & Co. vowed to fight every claim filed by plaintiffs who say they were injured by the withdrawn painkiller Vioxx. Now, with 11 cases slated for trial in the next five months, the viability of the company's scorched-earth strategy is likely to become clear.

More than 9,200 lawsuits involving 18,250 plaintiff groups have been filed against Merck, which pulled Vioxx off the market in September 2004. Merck took the action because of a study that showed the drug was associated with increased risk of heart attacks and strokes after 18 months of use. So far Merck's courtroom record is mixed -- one win, one loss and one hung jury, all in cases involving relatively short-term use of the pain drug. (...)

The company has set aside $675 million for legal costs but has not established a reserve for paying damages.

"We do not have a reasonable basis for establishing a liability reserve," said Ted Mayer, one of Merck's outside lawyers. "It's not as simple as you try one case and you know what is going to happen in a whole category." He said the company does not believe there is clear scientific evidence that Vioxx causes heart attacks, even after long-term use. "Our story stays the same from case to case. . . . The company acted in the interest of patient safety." (...)

- 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.

Konsekvensen kan være at leger som setter sine pasienter på nye medisiner, ikke kjenner hele sannheten om hvordan medisinen virker og ikke minst hvilke bivirkninger de kan påføre pasientene som får den nye medisinen.

Kraftsalven mot en samlet legemiddelindustri kommer fra Jeffrey M. Drazen ved Harvard Medical School i USA, en anerkjent professor i lungemedisin. Han er redaktør i et av verdens mest prestisjetunge medisinske fagtidsskrifter, New England Journal of Medicine.

I dag holder han foredrag for mer enn 350 leger og fagfolk på jubileumsseminaret til Tidsskrift for Den norske lægeforening, som i dag er 125 år. (...)

Han mener studiene ikke er lagt opp for å gi svar på forhold leger kan være interessert i å vite, blant annet når det gjelder sikkerhet for pasientene, men for raskest mulig å tilfredsstille myndighetenes krav til dokumentasjon for godkjenning av nye legemidler.

- Det handler om å tjene mest mulig penger og kortest mulig utprøvningstid for medisiner før de er på markedet, sier Drazen.

Prøver å kjøpe leger.
Han understreker at legemiddelindustrien driver mye og svært viktig forskning, og behandlingstilbudet til pasienter verden over er avhengig av at nye legemidler forskes frem.

- Leger og forskere må samarbeide med industrien. Det er også viktig for at pasientene våre skal få den best tenkelige behandling. I det store og hele fungerer dette, med høy faglig og etisk standard, men det finnes dessverre stadig flere unntak, sier Drazen.

Han liker imidlertid dårlig det han mener er en holdningsendring mot mer pengetenkning og mindre fag og etikk i den mektige industrien.

- Jeg har selv opplevd å bli kontaktet av legemiddelfirmaer som har gjennomført studier. Den vitenskapelige artikkelen er ferdig skrevet, og jeg får tilbud om å være medforfatter når artikkelen skal sendes til et medisinsk tidsskrift. De vil ha mitt navn som et kvalitetsstempel. (...)

Dette er Vioxx- og Celebra-sakene
aftenposten.no 9.1.2006
Slik fremstiller professor Jeffrey M. Drazen ved Harvard Medical School, og redaktør i New England Journal of Medicine, saken om Vioxx og Celebra: (...)

Judge: Federal Vioxx Case to Be Retried
By KRISTEN HAYS, AP Business Writer
yahoo.com 13.12.2005
A jury's inability to reach a unanimous verdict in the nation's first federal Vioxx trial after more than 18 hours of deliberations prompted a judge to declare a mistrial and aim for a second try.

The nine-member panel was about 20 minutes into its fourth day of deliberations Monday when U.S. District Judge Eldon Fallon called jurors to the courtroom and reminded them they had agreed Saturday to reach a verdict in a "reasonable time." (…)

Two jurors who voted in favor of the drugmaker told The Associated Press that only one of the nine refused to absolve Merck of liability.

One of the jurors, Amanda Toungate, said she didn't believe the drug caused Richard "Dicky" Irvin's death. She also said Merck should have done a better job telling patients about Vioxx's risks.

"He had too many other risk factors," said Toungate.

Merck lead attorney Phil Beck said that he could not confirm the 8-1 jury split because the judge instructed lawyers not to contact the jurors.

" If it is accurate, it's very gratifying; 8-to-1 is good enough to win in almost every state court in the country, including Texas. But in the federal system you need to win 9-0 and hopefully next time we'll get all nine votes," he told the Associated Press. (...)

Hung Jury Leaves Merck Up In The Air
forbes.com 12.12.2005
A hung jury led a judge to declare a mistrial in the most recent trial related to the withdrawn painkiller Vioxx.

That may be a mixed blessing for Merck (nyse: MRK - news - people), the drug's maker, which is facing at least 7,000 lawsuits related to Vioxx that are likely to result in billions of dollars in damages. Vioxx was pulled from the market in September 2004 after a trial clearly showed that it increases the risk of heart attacks and strokes for at least long-term users. (...)

Hung Jury In Federal Vioxx Trial
cbsnews.com 12.12.2005
(CBS/AP) (...) Merck & Co. emerged from its third Vioxx trial Monday with a hung jury when the panel failed, in about 18 hours of deliberations over three days, to side with the drug maker or the widow of a 53-year-old Florida man who died after taking Vioxx for about a month. (...)

Merck was expected to have an edge because federal courts are often viewed as business-friendly and disciplined, and less tolerant of attorney theatrics and flimsy evidence than state courts. (...)

Läkemedelsjätte i nytt blåsväder
n24.se 10.12.2005
Uppmärksamheten kring den pågående skadeståndsrättegången och tidningsavslöjanden om att graverande patientdata plockats bort ur en studie fick Merckaktien att falla 2 procent på New York-börsen.

Problemen fortsätter att hopa sig för amerikanska läkemedelsjätten Merck. Samtidigt som juryn i den tredje skadeståndsrättegången mot bolaget i går överlade i Houston, Texas, anklagar ansedda tidskriften New England Journal of Medicine företaget för att ha plockat bort data om patienter som drabbats av hjärtproblem i en studie om indragna smärtstillaren Vioxx. (...)

Vioxx maker left out bad news on heart risk
seattletimes.nwsource.com 10.12.2005

Merck doctored arthritis drug data
timesonline.co.uk 10.12.2005
The drug giant Merck is facing further trouble after it was alleged that it had deleted data on the safety of its bestselling arthritis drug, Vioxx. (...)

Vioxx Jurors Told to Keep Deliberating
latimes.com 10.12.2005 (Los Angeles Times)
HOUSTON — Jurors considering whether Merck & Co.'s Vioxx contributed to a man's death told the judge Saturday they could not reach a unanimous verdict, but the judge told them to keep deliberating.

The nine-member federal jury so far has deliberated more than 12 hours over three days.

"It is your duty to agree on a verdict if you can do so without surrendering your own conscientious opinion," U.S. District Judge Eldon Fallon told jurors. (...)

Tung medicinsk tidskrift anklagar Merck för fusk
n24.se 9.12.2005
En av världens mest prestigefyllda vetenskapliga tidskrifter, New England Journal of Medicine (NEJM), anklagar läkemedelsbolaget Merck för att ha undanhållet data i det uppmärksammade Vioxx-fallet.

Smärtstillaren Vioxx drogs för ett drygt år sedan in från marknaden efter att det visat sig att preparatet ökar risken för hjärtinfarkt. Merck, som utvecklat och sålt Vioxx, hotas av skadestånd på flera miljarder dollar från före detta användare. (...)

Journal Slams Vioxx Study
latimes.com 9.12.2005 (Los Angeles Times)
Questions about 3 heart attacks not included in data analysis could hurt Merck's legal defense. (...)

Merck Shares Drop on Vioxx Study Report
abcnews.go.com 9.12.2005

Medical journal says Merck deleted Vioxx dangers
reutershealth.com 9.12.2005

Medical journal says Vioxx data withheld
usatoday.com 8.12.2005

Journal: Merck Hid Vioxx Results
cbsnews.com 8.12.2005

Posted December 8, 2005
EDITORIAL: 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.

English claims against Vioxx manufacturer are on brink of collapse
BMJ 2005;331:1292 (3 December)
A compensation claim in the English courts against Merck, the US manufacturer of the withdrawn painkiller rofecoxib (Vioxx), looks set to be abandoned because the 500 claimants cannot get funding. (...)

Doctor: Merck's Habits 'Appalling'
cbsnews.com 4.12.2005
(AP) A prominent cardiologist testifying in Merck & Co.'s federal trial over Vioxx accused the drug maker of engaging in scientific misconduct, suppressing clinical evidence and stifling medical discourse as it promoted the painkiller.

Dr. Eric Topol, chairman of the cardiovascular medicine department of the Cleveland Clinic, called certain aspects of Merck's behavior "repulsive" and "appalling" during a three-hour videotaped deposition played for the jury Saturday. (...)

COX 2 inhibitors may not be safer for the stomach
BMJ 2005;331 (3 December)
Cyclo-oxygenase-2 inhibitors seem no better than conventional non-selective non-steroidal anti-inflammatory drugs in terms of the risk of an adverse upper gastrointestinal event. In a nested case-control study of more than 9000 cases of first peptic ulcer or haematemesis and almost 90 000 controls from 367 general practices throughout Great Britain, Hippisley-Cox and colleagues (p 1310) found that the risk of adverse events was increased with all NSAIDs included, selective and non-selective. Use of ulcer healing drugs reduced the increased risk of adverse events for all NSAIDs except diclofenac. (...)

Most NSAIDs Raise Death Risk After Heart Attack
ivanhoe.com 13.11.2005
By Heather Kohn, Ivanhoe Health Correspondent
Reported November 14, 2005

DALLAS (Ivanhoe Newswire) -- Recent reports have linked the use of COX-2 inhibitors, such as Vioxx, to raising patients' risk of heart attack and death. In the first study to examine patients who take the drugs after suffering their first heart attack, researchers found taking almost any non-steroidal anti-inflammatory drug (NSAID), especially in high doses, raises patients' risk of death.

Excluded from this study is the use of aspirin. Lead study author Gunnar H. Gislason, M.D., of Bispebjerg University Hospital in Copenhagen, Denmark, says, "There is no doubt about the beneficial effects of aspirin among patients after heart attack, which is a cheap and effective treatment -- and the scientific evidence is undeniable." (...)

Painkillers and the risk of myocardial infarction
BMC Medicine 2005, 3:17
Comparing use of traditional non-steroidal anti-inflammatory drugs in patients with myocardial infarction and in healthy controls found that short-term use of NSAIDs has no increased risk, but use of some traditional NSAIDs for over a year has a small increased risk of non-fatal myocardial infarction. (...)

Merck enjoys Vioxx victory
Pharmaceutical Digest
WEEKLY EDITORIAL (8th November 2005)
Edited by Michael Randle

Merck & Co has won an important victory in the ongoing defense of its arthritis and pain drug, Vioxx. A court in New Jersey found that the drug did not cause the plaintiff's heart attack, and also found that the company was not guilty of suppressing concerns about the safety of the drug. It would appear that Merck is confident in its case against the estimated 6,500 pending lawsuits, having set aside just $675 million for legal defense costs, but nothing for jury awards or settlements.

It seems that Johnson & Johnson's derailed $25.4 billion acquisition of medical device maker Guidant Corporation will also be resolved in court, after Guidant sued the healthcare giant in an attempt to force it to complete the acquisition. J&J claims that it is no longer obliged to close the transaction because recent product recalls and associated regulatory investigations into Guidant have damaged the short and long term outlook of the business. (...)

Merck Wins Battle, Faces War
forbes.com 3.11.2005
Merck won a significant decision in a Vioxx lawsuit, emerging victorious on all counts in the New Jersey case of a postal worker and Vietnam veteran who said that two months of Vioxx use caused his heart attack. (...)

"This vindicates that we acted in the right way," said Kenneth C. Frazier, Merck's top lawyer, on a conference call with reporters.

"This is a critical victory for Merck," says Howard Erichson, a professor of law at Seton Hall Law School in New Jersey. "It doesn't end the litigation, but it takes the pressure off of them to start settling some cases right away." (...)

"One case doesn't tell us much," says Carl Tobias, who teaches product liability law at the University of Richmond. The venue, the fact that Merck was fighting in its home state where it employs thousands of people and the particulars of the case all could have affected the decision.

"I continue to think that it's a marathon," says Barbara Ryan, an analyst at Deutsche Bank who rates Merck a "hold." "I think it seemed like, on the merits of this case, they should win. If they couldn't win this case, there was a dismal outlook." (...)

Jury sides with Merck in 2nd Vioxx trial
usatoday.com 3.11.2003
Rallying from its first Vioxx trial loss, pharmaceutical giant Merck (MRK) on Thursday won the second court showdown over its controversial painkiller.
But while the win provided a one-day stock price jump, it's unclear whether the nation's third-largest drugmaker will prevail in what financial analysts and lawyers said shapes up to be a protracted legal war.

On the third day of deliberations, a New Jersey state court jury found Merck not liable for the non-fatal heart attack suffered by an Idaho postal worker who used the drug. The verdict marked a turnabout from the first Vioxx trial in Texas, where jurors returned a $253 million verdict against Merck in August. (...)

Cardiologist testifies in favor of Vioxx
seattletimes.nwsource.com 19.10.2005
ATLANTIC CITY, N.J. — An Idaho postal worker who suffered a heart attack had a buildup of plaque in his arteries that was not caused by the since-withdrawn painkiller Vioxx, a doctor testified Tuesday for the drug's maker during a product liability trial.

Dr. Theodore Tyberg, a New York cardiologist who also teaches at medical schools, told a jury that only minimal plaque buildup is needed to cause the "small, modest" heart attack Frederick "Mike" Humeston suffered in his Boise home in September 2001. (...)

Merck faces surge of new Vioxx lawsuits
boston.com 13.10.2005 (Boston Globe)
--Eight weeks after a Texas jury handed drug maker Merck & Co. a $253 million verdict in its first Vioxx product liability trial, the number of Vioxx lawsuits is rising like floodwater.

More than 1,000 new Vioxx cases have been filed in New Jersey alone since late August, including 800 in September, and over 500 new cases are pending in federal court.

Based on interviews by The Associated Press, Whitehouse Station-based Merck now faces well over 6,500 Vioxx lawsuits, up from about 5,000 in the company's last status report. (...)

Lawyer Grills Vioxx Researcher at Trial
abcnews.go.com 14.10.2005

Testimony by Witness for Merck Disallowed
nytimes.com 8.10.2005 (New york Times)
Merck's defense in the second Vioxx lawsuit to reach trial sustained a serious blow yesterday when the New Jersey judge overseeing the case threw out testimony from the company's first witness and then shouted down a defense lawyer who tried to protest the decision.

"Sit down, Ms. Sullivan! Sit down!" Judge Carol E. Higbee shouted at Diane Sullivan, a lawyer who represents Merck, after deciding to disallow the testimony given on Thursday by Dr. Briggs Morrison, a Merck scientist.

Ms. Sullivan continued to protest angrily as Judge Higbee continued to reprimand her loudly. The lawyer quieted only after the judge threatened to have her forcibly removed from the courtroom. The antagonism could be a problem for Merck beyond this one case, because Judge Higbee is overseeing all 2,400 Vioxx-related suits that have been filed in New Jersey state court. (...)

Medicinsælgere fik forbud mod at tale om bivirkninger ved Vioxx
politiken.dk 1.10.2005
Fortrolige dokumenter afslører, at medicinalfirmaet bag gigtmidlet Vioxx forbød sælgerne at informere læger og sygehuse om risiko for blodpropper.

Sælgerne af gigtmidlet Vioxx fik forbud mod at tale med læger og sygehuse om de forsøg, som viste, at der var bivirkninger og risiko for blodpropper ved at bruge gigtmidlet.

Medicinalfirmaet Merck & Co., som producerede Vioxx, meddelte direkte til alle sælgere, at de i stedet skulle tilbyde læger, der spurgte til bivirkningerne, at de kunne få fremsendt noget materiale om lægemidlet.

Fortrolige dokumenter
Det fremgår af en række normalt fortrolige dokumenter om Mercks salgskampagne for Vioxx, som den amerikanske Kongres har bedt om og fået fremlagt, efter at Merck for et år siden trak Vioxx tilbage fra verdensmarkedet på grund af risikoen for blodpropper.

I august 2001 var det ansete amerikanske medicinske tidsskrift The Journal of the American Medical Association på vej med en artikel om, at Mercks eget forsøg havde vist, at der var øget risiko for blodpropper ved brug af Vioxx. Det kom virksomheden for øre, og direktør Jo Jerman udsendte derfor en »vigtig besked« til firmaets sælgere om, hvad de skulle gøre, hvis læger stillede spørgsmål om risikoen.

»Det er ikke tilladt, at I diskuterer forsøgets resultater«, sagde hun i sin telefonbesked - voice mail. Det var kulminationen på en række tidligere meddelelser om, at sælgerne ikke uopfordret måtte begynde at diskutere den risiko, som forsøg havde vist, og som den amerikanske lægemiddelstyrelse havde bedt en ekspertgruppe se nærmere på.

»Indled ikke diskussioner« om ekspertgruppens gennemgang eller resultatet af forsøget, lød instruksen fra Merck til sælgerne. Og hvis læger uopfordret skulle stille spørgsmål om sikkerheden, fik sælgerne besked på »kun at svare som beskrevet« i informationen. (...)

Dorthe Mikkelsen, der er kommunikationsdirektør i MSD, der er den danske afdeling af Merck, vil ikke kommentere den amerikanske markedsføringskampagne:

»Vi forbyder ikke vores konsulenter at tale om noget. Vi beder dem om at sætte sig ind i de godkendte produktresuméer og gå ud fra det, når de taler med lægerne«, siger hun. (...)

For Merck, second Vioxx trial off to inauspicious start
nola.com 18.9.2005 (The Times-Picayune)
— For Merck & Co., its second trial over failed painkiller Vioxx is another bitter pill. (...)

Then came two doctors testifying on behalf of plaintiff Frederick "Mike" Humeston, the 60-year-old postal worker whose 2001 heart attack is the crux of the suit.

Humeston's personal physician, Dr. Gregory Lewer, told jurors Humeston was a vital, active nonsmoker with no history of heart disease who was stricken two months after he started taking the drug to relieve pain from an old war wound. (...)

The first week of the New Jersey trial climaxed with dramatic testimony from heart expert Dr. Benedict Lucchesi, who fought back tears as he reviewed the texts of e-mail messages and other Merck communiques that discussed health risks posed by Vioxx long before its launch in 1999.

"They're putting profits before lives," Lucchesi told the jury. (...)

Legemiddelgigant beskyldt for å skjule helserisiko
dn.no 15.9.2005
Legemiddelprodusenten Merck skjulte risikoen for hjertefeil ved bruk av den smertestillende tabletten Vioxx, hevder advokaten til en mann som nå saksøker selskapet. (...)

Vioxx judge reprimands Merck lawyer
businessweek.com 15.9.2005
The judge hearing a product liability suit against Merck & Co., the manufacturer of painkiller Vioxx, reprimanded the dug maker's lead lawyer Thursday for violating pretrial instructions barring comments about lawyers in front of the jury.

Threatening to declare a mistrial, Superior Court Judge Carol E. Higbee said Merck lawyer Diane Sullivan had made repeated negative references about attorneys in her opening statement to jurors Wednesday, despite being told beforehand not to do so.

Pharmaceutical Digest WEEKLY EDITORIAL
Pharmaceutical Business Review [info@secure-business-review.com] 23.08.2005
The decision of a US court to find Merck & Co. liable in the death of a man who had used the company's arthritis drug Vioxx could have consequences for the wider pharmaceutical industry. Although the case has set a dangerous precedent for Merck, which is already facing another 4,000 similar lawsuits, investors will be concerned at the product liability risk across the industry.

Pfizer, for example, is almost certain to face an increased legal challenge. Pfizer withdrew its COX-2 inhibitor Bextra from the market in April, while certain research has also linked Celebrex to cardiovascular risks. Novartis and GlaxoSmithKline, meanwhile, will have to make key decisions over the future development of their pipeline COX-2 products. GSK has additional concerns. The company has been forced to defend the safety of Paxil after a study claimed that the antidepressant drug was linked to an increased suicide risk. Several organizations, including the mental health charity Mind, have called for the drug to be withdrawn.

With drug safety issues causing further damage to the industry's already tarnished reputation, the leading pharmaceutical groups may now have to build on recent initiatives, which have included commitments to publicize study data and reform direct-to-consumer advertising. (...)

Pharma industry faces consequences of Vioxx case
the Pharmaceutical Business Review 23.8.2005
In a decision that could have wider implications for the pharmaceutical industry as a whole, a US court has found Merck & Co. liable in the death of a man who had used the company's arthritis drug Vioxx.

- Merck & Co. has been ordered to pay the widow of Robert Ernst $253.4 million in damages. Although these costs are expected to be reduced to 10% of that amount because of a state cap on punitive damages, the case sets a dangerous precedent for Merck, which is already facing 4,000 similar lawsuits.

The verdict against Merck could also have far reaching repercussions for other drugmakers currently facing legal challenges based on the use of their products. Out of court settlements could now be encouraged and Pfizer is likely to be particularly wary of the ruling. Pfizer's Celebrex, which belongs to the same class of drugs as Vioxx, remains on the market.

Although Merck's lawyers say they will appeal the verdict, further would-be plaintiffs are preparing to bring actions against the company. British lawyers, for example, are contemplating bringing a case for a group of around 150 potential claimants, many of which are relatives of patients who died while taking the drug.

Analysts now suggest that negligence claims against Merck could total between $10 billion and $50 billion. The company withdrew Vioxx, which accounted for 11% of last year's sales of $23 billion, in September 2004.

While Merck insists that it acted responsibly during every stage of the drug's development, observers suggest the legal cases against it could generate further evidence of the company's prior knowledge of the health risks associated with the drug. (...)

Merck Knew Vioxx Dangers In 2000 (Merck kjente til Vioxx-farene i 2000)
cbsnews.com 22.6.2005
(AP) Merck & Co. researchers privately sought to reformulate Vioxx in 2000 to reduce its cardiovascular side effects, even as the drug maker was publicly playing down a study that highlighted the pain relief medication's potential heart attack risk, an internal company document shows.

The widely publicized study in March 2000 found that patients taking Vioxx were five times more likely to have heart attacks than individuals using the generic medicine naproxen. Merck insisted at the time that this was a result of naproxen's cardioprotective properties and not any defect in Vioxx.

But behind the scenes, company scientists were considering combining Vioxx with another agent to reduce the risk of heart attacks and strokes, according to a document that was mistakenly provided by Merck to plaintiff lawyers as part of the evidence-gathering process in one of the hundreds of Vioxx lawsuits around the country.

That document, a communication between Merck researchers and the company's patent department, stated that the way Vioxx works to reduce pain might also increase cardiovascular problems. They suggested a patent be sought for a combination drug mixing Vioxx with another agent to lessen the risk.

The document is potentially among the most damaging to emerge since the drug's sales were suspended because it calls into question the bedrock Merck defense that company officials were convinced of the drug's safety. The desire to reformulate the drug suggests a level of urgency that goes beyond previously disclosed internal e-mails that discussed safety risks. (...)

F.D.A. Official Admits 'Lapses' on Vioxx
nytimes.com 2.3.2005
After the Food and Drug Administration insisted for months that it did nothing wrong in its oversight of the withdrawn pain pill Vioxx, a top agency official acknowledged ''lapses'' in the agency's actions before a Senate panel on Tuesday. (...)

The Lessons of Vioxx - Drug Safety and Sales (Lærdommen fra Vioxx - legemiddelsikkerhet og salg)
NEJM (New England Journal of Medicine) 2005;352:2576-2578 (June 23, 2005)
On November 23, 2000, the results of the Vioxx Gastrointestinal Outcomes Research study, known as VIGOR, were published in the Journal. This randomized, controlled trial showed that rofecoxib, an inhibitor of cyclooxygenase-2 that had been marketed as Vioxx since May 1999, was associated with fewer gastrointestinal complications than naproxen, a standard nonsteroidal antiinflammatory drug. Unexpectedly, the VIGOR study also showed that the patients who were given rofecoxib had four times as many myocardial infarctions as those who were given naproxen. (...)

Merck instruerte sine legemiddelkonsulenter til f.eks. kun å gi leger bestemte godkjente resultater. (Merck instructed its sales representatives, for example, to provide only certain approved study results to doctors.) (...)

Kunne Vioxx ha vært trukket tidligere?
Tidsskr Nor Lægeforen 2005; 125: 323-4 (3.2.2005)
30. september 2004 valgte MSD frivillig å trekke Vioxx (rofecoxib) tilbake fra markedet verden over.

Basert på en metaanalyse fra The Lancet i november 2004 ble det i Tidsskriftet (1) hevdet at rofecoxib burde ha vært trukket tilbake før. Etter å ha vurdert de samme data konkluderte det svenske legemiddelverket med at artikkelen i The Lancet ikke inkluderer alle relevante data og at frem til resultatene fra APPROVe-studien ble meddelt MSD 23.9. 2004 «fantes det ingen kontrollerte data som indikerte at rofecoxib var forskjellig fra placebo med tanke på risiko for hjerteinfarkt». Hvordan kan man komme frem til to så ulike konklusjoner? (...)

Vi valgte selv å trekke rofecoxib, og vi gjorde det fordi vi mente at det var til det beste for pasientene. Vi mener at det ville ha vært mulig å fortsette å markedsføre rofecoxib med de nye dataene inkorporert i preparatomtalen. Fordi det finnes alternativ behandling og på grunn av spørsmålene som disse dataene reiste, ble vår konklusjon at det mest ansvarlige vi kunne gjøre var en frivillig tilbaketrekking. (...)

Vioxx trekkes fra markedet
Tidsskr Nor Lægeforen 2004; 124: 2595 (21.10.2004)
Langvarig bruk av Vioxx kan føre til hjerteinfarkt eller hjerneslag. MSD trekker legemidlet ut av markedet over hele verden, med umiddelbar virkning. Det er en ny studie som viser at COX-2-hemmeren rofecoxib (Vioxx fra MSD), kan øke risikoen for kardiovaskulære sykdommer.

- Dette har vært diskutert i fagmiljøet lenge, så helt overraskende er det ikke. Det er imidlertid overraskende at de går til det drastiske skritt å trekke medikamentet fra markedet, sier Olav Spigset, overlege ved avdeling for klinisk farmakologi ved St. Olavs hospital. (...)

Merck Vows to Fight Suits
latimes.com 10.9.2005 (Los Angeles Times)
From Associated Press
On the eve of the second trial over its painkiller Vioxx, pharmaceutical giant Merck & Co. reasserted Friday that it planned to aggressively fight the mounting lawsuits over the withdrawn drug, despite recently saying it might settle some suits.

Kenneth C. Frazier, Merck's general counsel and senior vice president, also tried to reassure investors that liability over Vioxx, estimated by analysts at as much as $50 billion, wasn't a threat to the Whitehouse Station, N.J.-based company.

"We are in this for the long haul. We have both the resources and the resolve to address these cases one by one over many years," Frazier told reporters during a conference call.

Frazier seemed to backpedal slightly on statements he made last month that indicated the company might settle a small number of lawsuits with Vioxx users who had limited heart risk factors and took the drug for 18 months or more. (...)

As Another Vioxx Trial Nears, Merck Vows to Keep Fighting
nytimes.com 10.9.2005
By THE ASSOCIATED PRESS
TRENTON, Sept. 9 - With the second trial over its painkiller Vioxx scheduled to begin next week, the drug giant Merck on Friday reasserted that it planned to aggressively fight the mounting lawsuits over the withdrawn drug. (...)

The Lessons of Vioxx - Drug Safety and Sales
NEJM (New England Journal of Medicine) (June 23, 2005)
"Unexpectedly, the VIGOR study also showed that the patients who were given rofecoxib had four times as many myocardial infarctions as those who were given naproxen." (...)

"Merck instructed its sales representatives, for example, to provide only certain approved study results to doctors." (...)

Skadade av Vioxx ersätts av försäkring
Läkartidningen 2005;102:2382 (31.8.2005)
I Texas, USA, tilldömdes nyligen en patient som skadats av cox 2-hämmaren Vioxx till skadestånd från tillverkaren Merck & Co. I Sverige finns en annan syn på ersättning för läkemedelsskador, genom att alla som fått ett läkemedel utskrivet på recept, eller köpt det på Apoteket, omfattas av Läkemedelsförsäkringen.

Läkemedelsförsäkringsföreningen uppger att man fått in 80 skadeanmälningar från patienter som anser sig ha fått skador av läkemedlet Vioxx. I 6 fall har patienten fått ersättning, i 52 fall har patienten fått avslag och i 22 fall pågår fortfarande utredning. LT

I Texas, USA, tilldömdes nyligen en patient som skadats av cox 2-hämmaren Vioxx till skadestånd från tillverkaren Merck & Co. I Sverige finns en annan syn på ersättning för läkemedelsskador, genom att alla som fått ett läkemedel utskrivet på recept, eller köpt det på Apoteket, omfattas av Läkemedelsförsäkringen.

Läkemedelsförsäkringsföreningen uppger att man fått in 80 skadeanmälningar från patienter som anser sig ha fått skador av läkemedlet Vioxx. I 6 fall har patienten fått ersättning, i 52 fall har patienten fått avslag och i 22 fall pågår fortfarande utredning. (...)

Merck faces ongoing claims after Texan ruling on rofecoxib
BMJ 2005;331:471 (3 September)

Jogging dreper
aftenposten.no 3.9.2005
Lars Fr. H. Svendsen er filosof og førsteamanuensis ved Universitetet i Bergen.

(...) Nylig fant en domstol i Texas legemiddelgiganten Merck skyldig i å ha bidratt til at den 59 år gamle triathleten Robert Ernst døde av hjerteproblemer. Det ble hevdet at legemiddelet Vioxx hadde forårsaket dødsfallet, og Ernsts kone ble tilkjent en erstatning på rundt 1,6 milliarder kroner. Merck har i årevis underslått vesentlig informasjon om at medikamentet kan gi økt fare for hjerneslag og hjerteinfarkt, og slik sett er det vanskelig å ha særlig stor sympati for selskapet. Imidlertid ble det ikke lagt frem et fnugg av bevis for at Vioxx faktisk hadde forårsaket Ernsts død. Hva om det var all treningen som drepte ham? (...)

Jogging beskytter
aftenposten.no 25.9.2005
Av Hans Rostad, dr. med., Oslo Lars Fr. H. Svendsens meningsytring om at «jogging dreper» i Aftenposten lørdag 3.9. september kan ikke stå uimotsagt.

De fleste av hans utsagn er direkte gale. Det foreligger nå en serie medisinske publikasjoner som viser mosjonens gunstige innvirkning på helsetilstanden. Toppidrettsmenns dødsfall under idrettsutøvelse, f. eks. Tour de France, er oftest dopingrelatert, og har intet å gjøre med anstrengelsen i seg selv.

I perioden 1990-97 ble 23 norske idrettsutøvere rammet av plutselig hjertedød. Bare én var kvinne. 22 ble obdusert, og hjertesykdom påvist hos de fleste. Friske, veltrente idrettsutøvere får nesten aldri alvorlige hjertekomplikasjoner. Feidipides, som forfatteren nevner, hadde sannsynligvis neppe et helt friskt hjerte.

New York-maraton er nok et dårlig eksempel fordi det åpenbart i dette løpet er altfor mange utrente mennesker som aldri burde deltatt i et maratonløp. Det er flest dødsfall i golf, antagelig på grunn av det store antall utrente eldre som deltar.

Svendsen hevder at det er overhyppighet av kreft hos dem som trener mye. Feil. I en artikkel i tidsskriftet Medicine and Science in Sports and Exercise konkluderes med at god fysisk form beskytter mot kreft. I et materiale ble 26 000 menn fulgt i 10 år. Resultatet var krystallklart: Sammenlignet med dem i dårlig form hadde de mest veltrente 55 mindre risiko for å dø av alle typer kreft. Mosjon beskytter antagelig mot kreft i lunger, bryst, tykktarm og prostata. Det er også viktig å minne om at god fysisk form beskytter mot diabetes II, som dessverre øker foruroligende i Norge.

At langrennsløpere skal få dårligere hukommelse enn andre, er antagelig det rene tøv.

Det er beklagelig at forfatteren hevder at hans røykende, drikkende og spisende venner praktisk talt aldri er syke mens de såkalte sunne går ned for telling støtt og stadig. Spøker han? Det er jo ikke lenger den minste tvil om at hans venners levesett bidrar til utvikling av de livsstilssykdommer som etter hvert forårsaker overbelastning av våre sykehus. Mosjon er klart den viktigste faktor til bedring av folkehelsen fordi den bidrar til omlegging til en sunnere livsstil. Det er formildende at forfatteren i sitt siste avsnitt synes å innrømme at en viss mosjon generelt er bra for helsen. (...)

Maker of Vioxx Reports Progress of Suits
nytimes.com 26.8.2005
With the number of Vioxx-related lawsuits soaring, the drug maker Merck may consider offering settlements to plaintiffs in a few cases, the company's general counsel suggested yesterday.

Merck had previously said that it planned to defend every personal-injury lawsuit filed over Vioxx, a painkiller and arthritis medicine that has been shown to raise the risk of heart attacks and strokes.

But the general counsel, Kenneth C. Frazier, said in an interview yesterday that Merck would consider settling suits brought by people who took Vioxx for long periods of time and had few other risk factors for heart disease. Nearly 5,000 Vioxx suits have already been filed, and tens of thousands more are expected. (...)

What Was Wrong With Vioxx?
forbes.com 26.8.2005
A year after Merck withdrew the painkiller Vioxx and a week after a resounding defeat for the drug firm in the first product liability trial related to the drug, scientists still don't understand what made Vioxx cause heart attacks and strokes--or how much of that risk extends to other pain drugs such as Celebrex, Advil, Aleve or even Tylenol. (...)

TOP STORY Merck Eases Stance
On Vioxx Suits
The Wall Street Journal 26.8.2005
Drug Maker Indicates
It May Consider Settling Cases
Meeting Narrow Criteria

In a slight softening of its fight-every-case defense strategy, Merck & Co. may consider settling a small number of Vioxx cases if patients who claim they were harmed fit a very narrow profile.

The company's general counsel yesterday stressed that Merck hasn't changed its defense strategy of fighting every case in court. However, in cases where patients took Vioxx for more than 18 months and had no other risk factors for heart attacks or strokes, "we're going to have to carefully look at those cases," a Merck spokeswoman said. The statement suggests for the first time that a settlement of a small number of Vioxx cases may be part of Merck's plan.

The softening comes less than a week after Merck lost the first Vioxx case to go to trial. A jury in a state court in Angleton, Texas, found Vioxx liable for the death of a 59-year-old triathlete who took Vioxx for eight months and awarded his widow $253 million in damages. The award is likely to be reduced to about $26 million under Texas damage caps. More than 20 million people took Vioxx in the U.S. before the drug was withdrawn in September after a Merck-sponsored clinical trial found that Vioxx increased the risk of heart attack and stroke in people who took the medicine daily for more than 18 months. (...)

Vioxx verdict's dark side
Boston Globe 23.8.2005
A TEXAS JURY's Texas-size message to the drug manufacturer Merck last week may mean more than meets the eye. The jury awarded a $24 million base amount for the death of Robert Ernst and $229 million in punitive damages, apparently for Merck's failure to adequately disclose the risk of heart problems from Vioxx. Merck's stock market value declined by $5 billion on Friday. Lawyers say that Merck may face up to 100,000 other Vioxx-related suits.

Ernst's death was a tragedy. Nonetheless, there is cause for concern about the size of the Texas award and about many similar judgments imposed on corporations in this country. The concern is that when corporations have to pay large damage awards, three things happen that may be disadvantageous to us as consumers.

First, the prices that we pay for goods and services will tend to rise. Drug companies have to charge enough to cover their costs, and when these costs include large liability bills, the result is higher prices. For instance, one study found that the price of the DPT vaccine for infants rose 6,000 percent mainly because of potential liability.

The second problem is that products might not be developed, or might be withdrawn from the market, even though they are valuable to us.

Merck halted sales of Vioxx last fall, and Pfizer stopped selling a similar drug, Bextra, shortly thereafter, but the public still needs pain-relieving drugs that are easy on the stomach. Other examples of withdrawn products and services abound: for example, some physicians refuse to deliver babies due to the threat of malpractice liability.

The third difficulty caused by large damage awards is excessive producer caution, adding to costs and prices. A classic example is defensive medicine, such as the ordering of unneeded tests due to the fear of lawsuits.

The jury in the Vioxx case apparently did not have these problems in mind when it decided on its $253 million award. It was probably focusing on the two standard advantages of liability awards: sending a message to companies to reform their behavior and compensating victims of harm.

But does a $253 million message need to be sent to Merck for the death of Ernst? The usual figure courts use to deter wrongful deaths, say, from automobile accidents is rarely more than a few million dollars. Economists have suggested that there is no reason to beef up usual damage awards unless there is a chance that a company can escape liability for harm. If a company covertly dumps pollutants and we happen to catch it, a penalty exceeding the harm done ought to be imposed in order to deter more dumping. But the argument that Merck might escape liability for harm does not seem to apply to Vioxx, for it was sold to millions of individuals, Merck is regulated by the FDA, and epidemiologists and lawyers are on the watch for problems with drugs.

What about compensation for victims? There is no reason to think that Mrs. Ernst has a much greater need for compensation than the surviving spouse of an automobile accident victim, who typically receives no more than several million dollars.

It is also worth noting that our legal system is an extremely expensive way to go about compensating individuals. To deliver $100 to a plaintiff through the legal system costs about $100 in legal expenses. It is as if the fee for withdrawing $100 from an ATM machine was $100. A better way to ensure that people are compensated for losses is to encourage them to buy insurance, or perhaps for the government to supply them with insurance.

In all, the lesson to be drawn from the Vioxx case is that if the Vioxx award is writ large, it will probably do more harm to consumers than good -- presumably not the intention of the Vioxx jury.

Steven Shavell and A. Mitchell Polinsky, who are economists, are professors at Harvard Law School and Stanford Law School, respectively. (...)

Exposed: how drugs giant pushed Vioxx painkiller
Independent 22.8.2005
The growing furore surrounding the painkiller Vioxx could prove to be the most expensive legal action ever faced by a drugs company and raises questions about the marketing tactics used by a multibillion-pound pharmaceutical giant.

Fikk medhold i medisinskadekrav
aftenposten.no 21.8.2005
e norske Vioxx-kravene er under behandling

En norsk kvinne har fått medhold i erstatningskravet sitt etter å ha brukt medikamentet Vioxx. 131 tilsvarende saker gjenstår i Norge.
HELENE MO

Behandlingen av 135 erstatningskrav på grunn av alvorlige bivirkninger ved bruk av de smertestillende tablettene Vioxx har startet i Norge. Foreløpig har Norsk Pasientskadeerstatning (NPE) fattet fire vedtak, der én kvinne har fått medhold.
De tre andre har fått avslag på kravene sine. Legemiddelverket antar at 400 nordmenn har dødd på grunn av medikamentet.

- Foreløpig er det ikke fastsatt noe erstatningsbeløp, sierTorill Stæhr, informasjonssjef i NPE.

Minimumsutbetalingen i pasientskadeerstatningssaker er 5000 kroner, mens de største beløpene har vært på nær 8 millioner kroner. Stæhr regner ikke med at Vioxx-erstatningene blir i den størrelsesorden, men tror at det kan bli snakk om større beløp. (...)

- Slike svimlende summer kommer vi aldri opp i, sier advokat Anne Hazeland. Hun representerer rundt 50 av de i alt 135 erstatningssøkende. Hun anslår 200 000 kr. som en realistisk kompensasjon for de involverte. - Det viktigste i slike saker er ikke pengene, men det prinsipielle, sier hun. Helsemyndighetene tar ansvar for at et tilsynelatende ufarlig medikament ble sluppet løs på det norske markedet, mens det viste seg å ha alvorlige bivirkninger.

Her til lands håndterer NPE erstatningskravene på vegne av Legemiddelforsikringspoolen. Alle som produserer og formidler medisiner, er lovpålagt å være forsikret her. Vioxx-kravene behandles som en serieskade, dermed legges erstatningssummene sammen og dekkes av forsikringen inntil 100 millioner kroner. Ut over dette vil Merck holdes direkte ansvarlig.
I prinsippet kan også norske statsborgere gå til sak mot et utenlandsk firma. Ifølge jusprofessor Ørnulf Rasmussen ved Juridisk fakultet på Universitetet i Bergen, er det uvesentlig hvor den skadelidte kommer fra når ansvar skal plasseres. Han kjenner likevel ikke til at noen nordmenn har prøvd saken sin i USA. (...)

Merck Faces More Challenges in Next Round
ABC 21.8.2005
Merck, Which Lost $253 Million Judgment in Vioxx Trial, Faces

LAKE JACKSON, Texas - Drug-maker Merck & Co.'s blistering defeat in the nation's first Vioxx trial was only round one in a series of expected court battles in the coming months, many of them involving plaintiffs who have some major advantages.

The link between the patients' health problems and Vioxx is already well established. They suffered heart attacks; Merck yanked the drug from the market last year because a study showed it doubled patients' risk of heart attacks and strokes. (...)

Ernst's victory gives lawyers in the upcoming cases something of a playbook for arguing that Merck acted recklessly when it promoted Vioxx. The company's loss is also expected to prompt more lawsuits, on top of the 4,200 already pending. The company's potential liability has already been estimated at up to $18 billion.

Merck does have some strengths in the upcoming litigation that it didn't have in the Texas case.

One of the cases is in federal court, where experts say stricter rules of evidence and testimony may benefit the New Jersey-based drug maker.

Legal experts said some of the testimony allowed in the Texas trial probably would not have been permitted in federal court, especially the surprise testimony from a coroner that a heart attack could have led to the fatal arrhythmia. Merck said its appeals will include claims that the judge erred by allowing testimony from unqualified experts and the undisclosed witness.

The federal case may be Merck's best shot at an early win, and the company desperately needs a victory if it doesn't want to be pressured into settling cases en masse, experts said.

"Federal judges are more cautious about what experts can testify in a case like this (product liability). There are stringent guidelines," said Benjamin Zipursky, a professor at Fordham Law School in New York.

The first federal trial may also present a challenge for the plaintiff because Richard Irvin had only taking Vioxx for about a month before he died of a heart attack in 2001 at age 53.

The study that led Merck to remove Vioxx from the market last year found cardiovascular problems only manifested themselves after 18 months of use. Plaintiff lawyers say other studies point to problems much earlier.

"I expect Merck to make an issue about short-term use, but I'm not worried," said attorney Andy Birchfield , who is representing Irvin's widow. Birchfield said Irvin didn't have any major risk factors for a heart attack, although he was slightly overweight. The case will be heard in federal court in New Orleans in November. (...)

For Merck, Vioxx Paper Trail Won't Go Away
New York Post 21.8.2005
HOUSTON, Aug. 20 - Bad facts. Plaintiffs' lawyers love that term. Merck may grow to hate it.

On Friday, a Texas jury found Merck liable for the death of Robert C. Ernst, who died in May 2001 after taking Vioxx, a painkiller made by the company. After two days of deliberations, the jury said that Carol Ernst, Mr. Ernst's widow, should be awarded $253.5 million.

In interviews after the six-week trial, jurors said they had concluded from the testimony and documents presented by Mrs. Ernst's lawyers that Merck was long aware of Vioxx's potential heart risks but hid those risks from patients. To the jurors, the evidence added up to a mass of damaging bad facts that overwhelmed the company's defense.

Merck's stock price fell almost 8 percent Friday afternoon, although Texas's rules on punitive damages will automatically lower the verdict to $26.1 million and Merck has already said it plans to appeal the case. (...)

Danske gigtpatienter vil føre erstatningssag i USA
Politiken 20.8.2005
Det amerikanske medicinalfirma bag gigtpillen Vioxx skal betale erstatning og bøde på mere end 1,5 milliarder kroner efter amerikansk gigtpatients død.

Danske patienter, der har taget skade af at bruge gigtpillen Vioxx, står nu med gode chancer for at få en betydelig erstatning fra det amerikanske medicinalfirma, der producerede pillen. (...)

Gigtpillen Vioxx blev solgt som smertestillende middel til mange andre end gigtpatienter og var en af de største salgssucceser i verden. Da salget var på sit højeste i Danmark i 2002 brugte 75.000 patienter Vioxx.

Gigtforeningen skønner, at mellem 1.600 og 2.600 gigtpatienter har fået alvorlige men af at tage pillen. Merck & Co. trak selv pillen tilbage fra markedet med dags varsel i september sidste år, da langtidsforsøg havde vist, at patienter, der fik Vioxx, havde dobbelt så stor risiko for at få blodpropper som patienter, der ikke fik medicinen. (...)

»Dommen har været imødeset med spænding, og nu er udsigten til, at danske patienter kan få en erstatning rykket betydeligt nærmere«, siger advokat Anders Boelskifte.

Han har det seneste år samlet et »tocifret« antal sager med danske patienter, som ønsker at føre sag mod medicinalfirmaet i USA. Den danske advokat formidler sagerne videre til en amerikansk kollega i Californien, der vil rejse erstatningskravet ved de amerikanske domstole.

En af de danske patienter er den 62-årige Klavs Johansen fra Sønderjylland. Han fik en blodprop i hjertet, da han i 14 dage havde fået Vioxx som smertestillende middel efter en banal knæoperation. Klavs Johansen har efter flere klager netop fået godt 150.000 kroner i erstatning fra Patientforsikringen, men han mener, at det er rimeligt, at Merck & Co. bliver stillet til ansvar i retten.

»Den erstatning, jeg har fået, svarer slet ikke til de gener jeg har fået. Jeg synes, Merck er sluppet alt for let, og det ser også ud til, at de mener det i USA«, siger Klavs Johansen. (...)

Merck Found Liable in Vioxx Case
Texas Jury Awards Widow $253 Million
Washington Post 20.8.2005
After less than 11 hours of deliberation, a Texas jury yesterday found Merck & Co. responsible for the death of a 59-year-old triathlete who was taking the company's once-popular painkiller, Vioxx. (...)

The verdict also comes as the industry and the Food and Drug Administration that regulates it are struggling to respond to broad criticism that they have not put enough emphasis on the safety of prescription drugs.

Merck and the FDA have defended their actions in evaluating the benefits and risks of Vioxx from before it went on the market in 1999 until it was withdrawn last September. But a 10 to 2 majority of the jury of seven men and five women in a small town south of Houston did not agree and rejected Merck's argument that Robert Ernst died of clogged arteries rather than a Vioxx-induced heart attack that led to a fatal heart rhythm irregularity.

"They know truth, and they know justice," said Mark Lanier, an attorney for Ernst's widow, Carol. "Anyone who said they are too 'small-town' or won't understand -- they are crazy."

Attorneys for Merck said the company will appeal and continue to fight other pending suits. As a result of yesterday's jury decision, many more are expected to be filed.

"We believe that the plaintiff did not meet the standard set by Texas law to prove Vioxx caused Mr. Ernst's death," said Jonathan Skidmore, of Merck's defense team. "There is no reliable scientific evidence that shows Vioxx causes cardiac arrhythmias, which an autopsy showed was the cause of Mr. Ernst's death, along with coronary atherosclerosis." (...)

In the aftermath, the FDA has become more aggressive about publicly identifying emerging risks it finds in drugs and medical devices, and has sought to beef up its drug safety office.

The possible FDA fallout from the trial was quickly evident in a statement from Sen. Charles E. Grassley (R-Iowa), who held a hearing on the drug safety issue last fall.

"The Food and Drug Administration was also negligent in the Vioxx case," said Grassley, who has proposed making the drug safety office more independent. "Those running the nation's public safety agency repeatedly dismissed the concerns of their own scientists and seemed to do everything possible to keep the public in the dark about emerging problems with Vioxx."

Peter Pitts, a former FDA associate commissioner and now a senior fellow at the Pacific Research Institute, said he hopes officials in Washington do not overreact.

"Now is not the time to let lawyers rule," he said. "I hope this verdict will not chill the nascent movement towards more open and transparent sharing of information between the pharmaceutical industry, FDA, physicians and patients."

Merck's stock fell almost 8 percent on news of the verdict, closing at $28.06 a share. Since the company withdrew Vioxx in September, its stock value has been cut almost in half. Merck reported $22.9 billion in sales in 2004, and incomplete 2005 data suggest it is the world's fourth-largest drug company by sales.

The $229 million in punitive damages is likely to be reduced because Texas state law caps punitive damages at twice the amount of economic damages. Under that formula, $26.1 million is the maximum Carol Ernst could receive. (...)

Jury Calls Merck Liable in Death of Man on Vioxx
New York Times 20.8.2005
ANGLETON, Tex., Aug. 19 - In the first verdict of a personal injury lawsuit involving the pain drug Vioxx, a Texas jury found the drug's maker, Merck, liable and said the widow of a man who died in 2001 after taking the drug should be awarded $253.5 million. (...)

In interviews after the decision, jurors said they had made the large punitive award to send a message that drug makers must disclose the risks of their medicines.

"Respect us, that's the message," said Derrick Chizer, a juror. "Respect us."

Ten of the 12 jurors voted for the plaintiff, the minimum number required to make an award under Texas law. Judge Ben Hardin of the Texas District Court announced the verdict at the Brazoria County Courthouse in Angleton, about 40 miles south of downtown Houston.

When Judge Hardin finished reading, Mrs. Ernst, her family, and her lawyers erupted in cheers and began to hug one another.

"The justice system in America works and it works very well," W. Mark Lanier, the lead lawyer for Mrs. Ernst, said outside the courtroom.

In a news conference after the verdict, Mrs. Ernst, 60, said that the case, which began three years ago, had been stressful but that she was pleased with the outcome.

"This has been a long road for me," she said. "I just know that it was a road that I had to run and I had to finish." (...)

Legemiddelprodusent kjent skyldig i dødsfall
Aftenposten 20.8.2005
En domstol i Texas fant fredag at legemiddelgiganten Merck hadde skyldansvar for at en texaner døde etter å ha tatt de smertestillende tablettene Vioxx.

Robert Ernst døde i 2001 av uregelmessig hjerterytme etter å ha brukt Mercks smertestillende tabletter.

Ernsts kone ble fredag tilkjent om lag 1,6 milliarder kroner i erstatning og oppreisning. Merck anket på stedet.

Kjennelsen markerer begynnelsen på en lang rekke søksmål mot Merck. Selskapet blir beskyldt for over 4.200 tilfeller av å ha underslått informasjon om økt fare for hjerneslag og hjerteinfarkt ved bruk av Vioxx.

Vioxx er et smertestillende og betennelsesdempende medikament som ble trukket tilbake fra markedet i september i fjor. Av de 136 kravene om erstatning Norsk pasientskadeerstatning (NPE) mottok de seks første månedene i år, var 103 knyttet til bruk av legemiddelet Vioxx (...)

Troubles Just Beginning For Merck
CBS 20.8.2005
ANGLETON, Texas, Aug. 20, 2005
The huge jury award to a plaintiff in the nation's first Vioxx case is likely to inspire thousands more suits on top of the 4,200 already filed against the drug's maker, Merck & Co., and push liability estimates that reach $18 billion even higher, analysts said. (...)

The loss is especially damaging because Merck initially had been expected to win what was considered a weak case because no studies have linked Vioxx to arrhythmia.

Some of the other cases are presumably stronger than Ernst's case. Now lawyers and analysts expect a flood of new suits. Merck has set aside $675 million to fight them, but analysts think it may have also need to reserve funds to pay verdicts.

CBS News Legal Analyst Andrew Cohen says Merck now has to figure out how it will defend itself in all these other lawsuits. (...)

U.S. Food and Drug Administration researcher David Graham published an article last year in the British medical journal, The Lancet, that said between 88,000 and 140,000 people suffered serious cardiovascular events related to Vioxx. Plaintiff lawyer Mark Lanier said the verdict has emboldened more of those people or their families to file suits.

CBS News Correspondent Anthony Mason reports that Lanier admitted the fight is far from over.

"But we got justice and we got the verdict we wanted whether we see a penny or not. The truth is out there," said Lanier. (...)

Widow Triumphs Over Drug Maker
CBS 19.8.2005
ANGLETON, Texas, Aug. 19, 2005
A Texas jury found pharmaceutical giant Merck & Co. liable Friday for the death of a man who took the once-popular painkiller Vioxx, awarding his widow $253.4 million in damages in the first of thousands of lawsuits pending across the country.

A seven-man, five-woman jury deliberated for 10½ hours over two days before returning the verdict in a 10-2 vote. But the damage award is likely to be drastically cut to no more than $26.1 million because Texas law caps the punitive damages that made up the bulk of the total. (...)

CBS News Legal Analyst Andrew Cohen said the jury found Merck to have acted with malice, which is a cut below negligence on the sliding scale of responsibility.

"That tells me that these jurors were convinced that Merck didn't just drop the ball but that it purposely reacted inappropriately," Cohen said.

Jurors in the semi-rural county rejected Merck's argument that Robert Ernst, 59, died of clogged arteries rather than a Vioxx-induced heart attack that led to his fatal arrhythmia. Ernst, a produce manager at a Wal-Mart store, ran marathons and taught aerobics classes on the side.

Merck insisted no studies ever showed a link to irregular heart beat although CBS News Correspondent Cami McCormick reported that it wasn't an issue in this case. (...)

Ernst called the verdict a "wake-up call" for pharmaceutical companies. "This has been a long road for me," she told reporters later. "But I felt strongly that this was the road I needed to take so other families wouldn't suffer the same pain I felt at the time."

After news of the late-afternoon decision, Merck shares fell 7.7 percent to close at $28.06, wiping away almost $5.2 billion in market capitalization.

Merck lawyer Jonathan Skidmore said the appeal would center on what he termed "unreliable scientific evidence."

"It'll be based on the fact that we believe unqualified expert testimony was allowed in the case; there were expert opinions that weren't grounded in science, the type that are required in the state of Texas," he said. "We don't believe they (plaintiffs) met their burden of proof." (...)

Jury Awards $253 Million to Plaintiff in First Vioxx Case
MedPage Today 19.8.2005
ANGLETON, Tex.-The jury in the first Vioxx (rofecoxib) personal-injury case ruled today that the once popular arthritis agent caused the death of a 59-year-old man. It ordered Merck, the maker of the drug, to pay his widow $253.4 million in compensation.

An estimated 4,200 Vioxx personal-injury suits are pending in state and federal courts, and this case involving the death of Robert Ernst was closely watched. Merck said it plans to appeal. (...)

In Texas, punitive damages are capped at twice the amount of economic damages and up to $750,000 can be awarded for mental anguish and loss of companionship. There is no limit on unspecified non-economic damages in product liability cases. (...)

Merck win would be only mildly positive
Boston Globe 18.8.2005
LAKE JACKSON, Texas --If the jury decides against Merck & Co. in the first wrongful death case related to the painkiller Vioxx, it may open the legal floodgates and drive up the company's potential liability, already estimated at as much as $18 billion, analysts say.

But a win for Merck won't be considered a major victory, because the case against the New Jersey-based pharmaceutical company was widely considered weak. Analysts note that Merck still faces another 4,200 lawsuits, some presumably stronger than the first one.

"The negative if Merck loses is more important than the positive if they win," said Catherine Arnold, an analyst at Credit Suisse First Boston LLC. "This case was always a long shot in terms of the facts."

Bob Ernst had been taking Vioxx for about eight months when he died of a heart arrhythmia, or irregular heart beat, in 2001. His widow, Carol, is suing Merck in a trial that began last month in Angleton, Texas.

No studies have linked Vioxx to arrhythmias, which is why many thought the case couldn't be won. Merck removed the drug from the market last year after a study did find it doubled patients' risk of heart attack and strokes after 18 months.

Now some analysts believe Merck may lose, because plaintiff lawyer Mark Lanier was skillful in presenting evidence suggesting that Ernst had a heart attack. Testimony from Dr. Maria Araneta, who performed Ernst's autopsy, said the former Wal-Mart produce manager could have died of a heart attack, damaging Merck's defense.

Evidence pointing to efforts by Merck to mute the risks associated with Vioxx is also problematic for the company. Marketing materials that taught sales representatives to dodge doctors questions about the drug's cardiovascular danger and a letter from a top Stanford University doctor admonishing Merck's former chief executive for the company's attempts to quash Vioxx critics were among the documents that resonated with analysts.

"It certainly looks like Merck tried to minimize negative information," said David Moskowitz, an analyst at Friedman, Billings, Ramsey Group Inc.

Moskowitz estimates Merck's eventual liability in the face of the lawsuits to be $11 billion, an amount likely to increase if the company loses this case. (...)

Vioxx jury to start deliberating Thursday
USA TODAY 17.2005
ANGLETON, Texas (AP) - The nation's first civil trial involving the once-popular painkiller Vioxx has been given to a jury after more than a month of testimony.
The seven-man, five-woman panel received the case Wednesday and was to begin deliberating Thursday morning. The case is the first to go to trial among more than 4,200 state and federal lawsuits.

During closing arguments, the lawyer who represents the widow of a Texas man who died in 2001 accused Merck (MRK), the New Jersey pharmaceutical company, of practicing denial and deception for the last decade. He said Merck minimized safety concerns about Vioxx to reap billions in annual profits.

"We have a right to know," Mark Lanier said of any potentially lethal side effects. "They ought to tell us the good, the bad and the ugly."

Merck lawyer Gerry Lowry urged jurors to consider what would happen to the 100-year-old company if it knowingly created deadly drugs.

"Would that be good business? Would that make sense?" she asked. (...)

Vioxx Research Defended in Trial
New York Times 11.8.2005
Vioxx Research Defended in Trial
By THE ASSOCIATED PRESS
ANGLETON, Tex., Aug. 10 (AP) - Merck & Company's head of clinical trials denied Wednesday that the company skewed studies to make the multibillion-dollar drug Vioxx appear safer than it was.

In testimony in the nation's first Vioxx-related trial, the official, Dr. Alise Reicin, countered assertions that Merck minimized safety concerns. (...)

Ex-CEO: Merck was conservative with Vioxx 9.8.2005
The Mercury News
ANGLETON, Texas - Vioxx was important to Merck & Co.'s future growth when the painkiller went on the market a year before patents began expiring on several other lucrative medicines, former Merck CEO Raymond Gilmartin told jurors in the nation's first Vioxx-related civil trial.

But Gilmartin, testifying via videotaped deposition, insisted Merck did not put profits over safety to rush Vioxx to market in 1999, as alleged by plaintiffs. Gilmartin also said a study that last year prompted the New Jersey pharmaceutical giant to pull the drug from the market because of increased heart attack risk was "totally unexpected."

"Our reputation, our credibility is very important to our success and we're not going to do anything and have not done anything to compromise that credibility," Gilmartin said in the deposition conducted several weeks after he retired in May. Gilmartin remains as a special adviser to a committee of Merck directors. (...)

Merck scientist: No rush to market Vioxx
USA TODAY 7.8.2005
ANGLETON, Texas - Merck's former top scientist in charge of Vioxx studies bristled repeatedly Friday when pressed about whether the pharmaceutical giant's eye was on its bottom line in rushing the once-lucrative drug to market.
Alan Nies, testifying as Merck continued its defense in the nation's first Vioxx-related civil trial, insisted the drugmaker wasn't in a race with Pfizer's Celebrex.

He grew angry when questioned about his own written 1996 Vioxx product development plan that said Merck was concerned about a "significant negative impact" on financial projections if Celebrex made it into medicine cabinets first.

In a bruising cross-examination, plaintiff's lawyer Mark Lanier showed jurors where the document said Merck could lose up to $611 million in potential revenue if Vioxx lagged behind Pfizer's goal of selling Celebrex by late 1998, allowing the competitor to snag critical market share. (...)

At Midpoint of Vioxx Trial, Merck Looks Battered
nytimes.com 6.8.2005 (New York Times)
ANGLETON, Tex., Aug. 5 - Ernst v. Merck, the first Vioxx-related lawsuit to come to trial, is not over yet. But as the company begins to present its case after 14 days of testimony from plaintiffs, Merck appears to be in a deep hole.

It is always risky to handicap the outcome of a trial, of course. But Merck's expert witnesses may face a challenge in trying to turn the case - especially since W. Mark Lanier, the lead lawyer for the plaintiffs, is known for his skill at cross-examination. (...)

U.S. Vioxx Trial Set for November
nytimes.com 5.8.2005 (New York Times)
By THE ASSOCIATED PRESS
NEW ORLEANS, Aug. 4 (AP) - The first federal trial over Vioxx, the painkiller made by Merck & Company, is scheduled to begin here on Nov. 28 and concerns whether the drug caused the fatal heart attack of a 53-year-old Florida man.

Judge Eldon E. Fallon in United States District Court for the Eastern District of Louisiana decided on Wednesday to make the case involving Richard Irvin Jr. the first to go to trial. Judge Fallon is handling all pretrial proceedings for federal cases. Thousands of lawsuits have been filed against the company.

Mr. Irvin's wife, Evelyn Irvin Plunkett, filed the suit against Merck after her husband died of a heart attack in May 2001, one month after he started taking Vioxx for back pain. (...)

Widow of Vioxx Patient Is Pressed by Merck Lawyers
nytimes.com 5.8.2005 (New York Times)
ANGLETON, Tex., Aug. 4 - The plaintiffs rested their case Thursday in the first Vioxx lawsuit to reach trial after the widow of Robert Ernst told jurors that she believed her husband would be alive if he had not taken Vioxx.

"For me to listen to the evidence that's been presented just makes the pain that much more intense, because I can see so clearly that this didn't have to happen to Bob, that this didn't have to happen to the other people who it happened to," the widow, Carol Ernst, said near the end of about four hours of testimony and cross-examination. "There was no reason for this to happen. They had information available."

Mr. Ernst, who was 59, died in his sleep in May 2001 after taking Vioxx, a painkiller and arthritis drug, for eight months. His family is suing Merck, Vioxx's manufacturer, in state court in Brazoria County, Tex., claiming that Vioxx was responsible for his death. (...)

Tears flow as widow takes stand in Vioxx trial
chron.com 4.8.2005 (Houston Chronicle)
ANGLETON - There were tears on the witness stand, tears in the gallery and tears in the jury box today as Carol Ernst described the night in 2001 when her husband, Robert, died.

"You might think you know what it's like," she said in a soft voice. "I don't think God ever lets us know the depth of that pain, because I don't think we would survive if we knew," she said.

Her testimony came in the trial of her lawsuit in which she claims her husband's death was caused by the once-popular painkiller Vioxx. Hers is the first of almost 4,200 lawsuits filed against drugmaker Merck & Co. over the drug, which was withdrawn from the market in September. (...)

In Vioxx Trial, Merck's Case Suffers Setback
nytimes.com 2.8.2005 (New York Times)
By THE ASSOCIATED PRESS
ANGLETON, Tex., Aug. 1 (AP) - Jurors heard testimony Monday from a pathologist who said the death of a man taking the painkiller Vioxx was more than likely caused by a heart attack, potentially damaging Merck's defense in the first liability case involving the drug to reach trial.

Judge Allows Vioxx Class Action
CBS 29.7.2005
In the latest blow for beleaguered drug maker Merck & Co., a New Jersey judge has ruled health plans that paid for members' Vioxx prescriptions can sue as a class to recover billions of dollars they spent on the recalled painkiller.

Superior Court Judge Carol E. Higbee in Atlantic City late Friday granted a motion filed by a labor union health plan to allow a nationwide class-action lawsuit to proceed under the New Jersey Consumer Fraud Act. Merck, based in Whitehouse Station, N.J., had opposed the motion, which was filed by the International Union of Operating Engineers Local 68 Welfare Fund. (...)

Judge Denies Merck Request at Vioxx Trial
nytimes.com 29.7.2005
ANGLETON, Tex., July 28 - A state court judge ruled Thursday night that the coroner who conducted the autopsy of Robert Ernst, who died after taking the painkiller Vioxx, can testify in the lawsuit that Mr. Ernst's widow has brought against Merck, the maker of the drug. (...)

Lawyer: Vioxx Danger Was Minimized
CBS 27.7.2005
ANGLETON, Texas, July 27, 2005
The plaintiff's lawyer in the country's first Vioxx-related civil trial grilled Merck & Co.'s top epidemiologist Wednesday about whether Merck deliberately minimized safety issues of the drug while promoting it to doctors in 2000. (...)

Cardiologist Testifies Vioxx Contributed to Man's Death
New York Times 26.7.2005
ANGLETON, Tex., July 25 - The painkiller Vioxx probably led to the death of Robert Ernst, a cardiologist told jurors on Monday in the first Vioxx lawsuit to reach trial. (...)

Autopsy central in Vioxx trial
The Miami Herald 26.7.2005
ANGLETON, Texas - Lawyers on both sides of the nation's first Vioxx-related civil trial on Tuesday will depose the coroner who autopsied a man who died of an irregular heartbeat eight months after beginning a regimen of Vioxx to ease pain in his hands.

Dr. Maria Araneta is a crucial witness to the question of whether the once-popular painkiller caused Robert Ernst's death. (...)

In Training Video, Merck Said Vioxx Did Not Increase Risk of Heart Attack
New York Times 21.7.2005
Merck told its sales representatives that its painkiller Vioxx did not increase the risk of heart attacks, according to a Merck training video played on Wednesday for jurors in the first Vioxx lawsuit to reach trial.

The video, which had never before been publicly shown, also depicts actors playing Merck representatives avoiding a question about Vioxx's potential to increase blood pressure - a documented side effect.

While the training tape was never shown to doctors or consumers, its existence may further undercut Merck's claim that the company properly disclosed Vioxx's risks during the five years the drug was on the market. (...)

At Vioxx Trial, a Discrepancy Appears to Undercut Merck's Defense
New York Times 20.7.2005
In a 2001 letter to doctors, Merck seriously understated the heart risks faced by patients taking its painkiller Vioxx, according to evidence presented Tuesday in the first Vioxx lawsuit to reach trial.

In the letter, Merck reported that patients taking Vioxx in the largest clinical trial of the drug ever, only 0.5 percent had incurred "cardiovascular events," or heart and circulation problems. That would mean only about 20 patients among the more than 4,000 who took Vioxx during the study. (...)

But in fact, 14.6 percent of the Vioxx patients - or 590 people - had cardiovascular troubles while taking the drug, according to Merck's own report on the study to federal regulators. And 2.5 percent, or 101 people, had serious problems, like heart attacks. (...)

Some Pointed Questioning at the Vioxx Trial in Texas
New York Times 19.7.2005
ANGLETON, Tex., July 18 - The plaintiff's lawyer in the first Vioxx lawsuit to reach trial confronted his first witness on Monday, challenging a senior scientist from the drug maker Merck over the company's marketing practices. (...)

First Vioxx Suit: Entryway Into a Legal Labyrinth?
New York Times 11.7.2005
In a small town in South Texas, a long legal journey will begin this week for Merck, the giant drug maker, and thousands of people who suffered heart attacks and strokes after taking its painkiller Vioxx.

On Thursday, opening arguments are expected to start in a state court in Angleton, Tex., in Ernst v. Merck, the first civil case to reach trial among thousands of suits that people who took Vioxx or their families have filed against Merck. In the suit, the wife and children of Robert Ernst contend that Vioxx caused Mr. Ernst to die in bed on May 6, 2001.

Assuming that the case is not settled before trial - a possibility both sides discount - a Texas state district judge, Ben Hardin, and a 12-member jury can be expected to hear two starkly differing views of Merck and the way it researched and marketed Vioxx. (...)

Texas sues Merck over Vioxx safety
Houston Chronicle 1.7.2005
State claims the painkiller's maker misrepresented its danger to heart. (...)

Vioxx Lawsuits Could Reach Trial in Fall
ABC 23.6.2005
The first federal lawsuits against drug maker Merck & Co. over its withdrawn painkiller Vioxx could reach trial in the late fall, according to lawyers who gathered Thursday for a monthly status conference on the massive litigation. (...)

Vioxx Lawsuits Could Reach Trial in Fall
ABC 23.6.2005
First Federal Lawsuits Against Merck Over Vioxx Could Reach Trial in Late Fall, Lawyers Say (...)

Merck's New Boss Inherits a Mess
New York Times 21.5.2005
WHITEHOUSE STATION, N.J. - Among the perks that come with running Merck is a corner office overlooking an idyllic 1,000-acre company-owned preserve, where deer and foxes roam freely.

But as Richard T. Clark leaned over a balcony outside his new office to pose for a photograph on a recent morning, he seemed oblivious to the view. "I'm not going to jump," he said.

He was joking, of course, but the comment revealed a lot about him - and the company he has been chosen to run.

Under Raymond V. Gilmartin, who was Merck's chairman and chief executive from 1994 until earlier this month, Merck stumbled badly. (...)

As the company's crisis deepened, Mr. Gilmartin appeared to freeze. He could hardly bring himself to speak publicly of Merck's problems, much less address them. (...)

Merck under investigation over Vioxx
Guardian 22.4.2005
British health regulators are investigating the American drugs company Merck to find out whether it correctly reported side-effects from the arthritis painkilling drug Vioxx to the authorities. (...)

Läkemedelsregister hade avslöjat riskerna med Vioxx
Läkemedelsvärlden 29.4.2005
Riskerna med Vioxx hade kunnat upptäckas med det läkemedelsregister som nu inrättas. Även om det tar tid innan registret kan användas för långtidsuppföljningar kan man snabbt göra till exempel interaktionsstudier.

LÄKEMEDELSREGISTER I onsdags tog riksdagen beslut om att inrätta ett nationellt läkemedelsregister som ska ligga hos Socialstyrelsen. Ansvariga för detta liksom de övriga hälsodataregistren blir Epidemiologiskt centrum, EpC, en självständig verksamhetsgren inom myndigheten.
- Det här är väldigt roligt och jättestort för oss, säger Måns Rosén, chef för EpC.
Möjligheterna med registret är hur många som helst, säger han entusiastiskt. Problemet är snarare hur man ska hinna med att analysera alla data som man kommer att få tillgång till.

- En av de viktigaste möjligheterna är förstås att vi kan följa de långsiktiga effekterna av läkemedelsanvändning. Och det kommer att bli allt intressantare ju längre tiden går, eftersom vi får möjlighet till allt längre uppföljningar.

Till exempel hade man kunnat upptäcka risken med Vioxx om man haft ett läkemedelsregister.

- Vi hade kunnat samköra Vioxx-användarna med Patient- och Dödsorsaksregistret. Då hade vi kunnat se att det fanns en överrisk för hjärtsjukdomar hos dem som tagit Vioxx, säger Måns Rosén. (...)

Bitter Pill
cjr.org (2005)
(...) Aricept, is a case in point. In April, The New England Journal of Medicine published a study about how Vitamin E and donepezil affected patients with mild cognitive impairment from Alzheimer’s disease. The study had three conclusions: first, Vitamin E did not work; second, donepezil did not slow the progression to Alzheimer’s after three years of treatment; and third, the drug was “associated” with a lower rate of progression after one year of treatment. Dr. Jeffrey Drazen, who edits the Journal, says the study showed that donepezil “had a little bit of an effect,” but adds that “the major conclusion had to do with Vitamin E.” ABC News, though, didn’t see the study that way. On both World News Tonight and Good Morning America, the network focused on the shred of positive data about donepezil, making it sound like a major breakthrough. ABC’s Dr. Tim Johnson, the network’s physician-reporter, recommended that people who have pre-Alzheimer’s disease take donepezil even though the Journal study on which the ABC segment was based did not support such a clear-cut recommendation. (...)

Aseptic Meningitis Cases Linked to Rofecoxib (Aseptisk meningitt linket til Rofecoxib)
medscape.com 26.3.2006
Forskere hos Food and Drug Administration (FDA) beskriver 5 tilfeller av aseptisk meningitt forårsaket av rofecoxib i 25. mars utgaven av Archives of Internal Medicine. (US Food and Drug Administration (FDA) investigators describe 5 cases of aseptic meningitis caused by rofecoxib in the March 25 issue of the Archives of Internal Medicine.)

Som med andre [ikke-steroide betennelsesdempende legemidler (NSAID-er)], skal rofecoxib vurderes i atskillende diagnoser av aseptisk meningitt med eller uten reumatisk sykdom," skriver Renan A. Bonnel, PharmD, MPH, og kollegaer i FDA. (As with other [nonsteroidal anti-inflammatory drugs (NSAIDs)], rofecoxib should be considered in the differential diagnosis of aseptic meningitis with or without rheumatological disease," write Renan A. Bonnel, PharmD, MPH, and colleagues from the FDA.)

Selv om aseptisk meningitt er kjent for å være en sjelden uheldig effekt av NSAID-er, er dette den første publiserte serie som impliserer de nye cyclooxygenase (COX)-2 hemmerne. (Although aseptic meningitis is known to be a rare adverse effect of NSAIDs, this is the first published series implicating the new cyclooxygenase (COX)-2 inhibitors.)

Hver av de 5 tilfeller startet innen 12 dager etter terapistart og gikk over etter seponering. Innleggelse var nødvendig for fire kvinner og en mann hadde klinisk indikasjon og typiske funn i ryggmargsvæske for aseptisk meningitt. En pasient hadde reumatoid artritt. Etter bedring, straks legemidlet ble seponert (avsluttet), førte 2 påfølgende forsøk med legemidlet hos en pasient til tilbakefall. (Each of the 5 cases started within 12 days of initiation of therapy and resolved with discontinuation. The 4 women and 1 man all required hospitalization and had a clinical presentation and cerebrospinal fluid findings typical for aseptic meningitis. One patient had rheumatoid arthritis. After recovery once the drug was discontinued, 2 consecutive rechallenges in 1 patient led to relapse.)

Mekanismen for aseptisk meningitt i disse rapporter er uklar, og kan beskrives som en idiosynkratisk reaksjon i det sentrale nervesystemet på rofecoxib terapi," skriver forfatterne. (The mechanism of aseptic meningitis in these reports is unclear, and may be described as an idiosyncratic central nervous system reaction to rofecoxib therapy," the authors write.)

(Anm: Aseptic meningitis associated with rofecoxib. Arch Intern Med 2002;162:713-5.)

(Anm: meningitt; hjernehinnebetennelse; akutt meningitt er ein alvorleg sjukdom som gjerne ytrar seg med feber, hovudverk, stiv nakke, kvalme og oppkast, forvildring (uklart sensorium), stundom krampar m v, spinalpunksjon viser oftast blakka spinalvæske med auka innhald av celler, protein m v; jf pakymeningitt, leptomeningitt, virusmeningitt, akutt bakteriell meningitt, Mollarets meningitt og oppslag på meningitis. EN meningitis ET [gr meninx hinne + -itis betennelse] Kilde: Norsk medisinsk ordbok.)

Report Links Vioxx to Meningitis (Rapport kobler Vioxx til meningitt)
New York Times 26.2.2002
Food and Drug Administration rapporterer at det populære smertestillende midlet Vioxx er linket til fem tilfeller av ikke bakteriell type meningitis, som selv om den er sjelden, er alvorlig. (The popular painkiller Vioxx has been linked to five cases of a nonbacterial type of meningitis, a possible side effect that, although rare, is serious, the U.S. Food and Drug Administration reports.)

Tilfellene er blant de syv innrapportert til FDA fra mai 1999 - da de godkjente Vioxx for artritt og annen akutt smerte – ved utgangen av februar 2001, ifølge rapporten i mandagsutgaven av Archives of Internal Medicine. (The cases are among seven reported to the FDA from May 1999 -- when it approved Vioxx for arthritis and other acute pain -- through February 2001, according to the report in Monday's Archives of Internal Medicine.)

Det er foretatt 52 millioner Vioxx forskrivninger i USA siden juni 1999, sa en talsmann for Merck & Co. (Some 52 million Vioxx prescriptions have been written in the United States since June 1999, a spokeswoman for Merck & Co. said.)

Alle syv pasienter tok Vioxx da de utviklet hjernehinnebetennelse, men to tilfeller manglet nok informasjon til å bestemme mulig årsak, sa rapporten. (All seven patients were taking Vioxx when they developed meningitis, but two cases lacked enough information to determine possible causes, the report said.)

Siden february 2001, er hjernehinnebetennelse også rapportert hos fem andre Vioxx-pasienter, men disse tilfeller er ikke blitt vurdert i detalj, sa Renan Bonnel hos FDAs Center for Drug Evaluation and Research, en av forfatterne av rapporten. (Since February 2001, meningitis also has been reported in five other Vioxx patients, but those cases have not been evaluated in detail, said Renan Bonnel of the FDA's Center for Drug Evaluation and Research, an author of the report.)

Ingen er i disse tilfellene døde, sa Bonnel. (No one has died in any of the cases, Bonnel said.)

Rapporten bemerker at andre ikke-steroide betennelsesdempende legemidler, blant annet ibuprofen og naproxen, også i sjeldne tilfeller er linket til meningitt. Celebrex, et legemiddel som likner Vioxx, er blitt linket til seks tilfeller av meningitt men rapportene ”inneholder lite eller ingen informasjon for å kunne vurdere årsakssammenheng,'' sa Bonnel. (The report notes that other nonsteroidal anti-inflammatory drugs, including ibuprofen and naproxen, also have been linked in rare cases to meningitis. Celebrex, a drug similar to Vioxx, has been linked to six cases of meningitis but the reports ``contain very little or no information to assess causality,'' Bonnel said.)

Vioxx pasientene beskrevet i Archives var i alderen 16 til 67, og utviklet symptomer opp til 12 dager etter oppstart med legemidlet. Symptomer inkluderer hodepine, stiv nakke, øyesmerter, feber og forkjølelse. (The Vioxx patients described in Archives were ages 16 to 67 and developed symptoms up to 12 days after starting the drug. Symptoms included headache, stiff neck, eye pain, fever and chills.)

”Alle tilfeller var alvorlige og krevde innleggelse,'' ifølge rapporten. (“All cases were serious, requiring hospitalization,'' the report said.)

Diagnosen var bakteriefri hjernehinnebetennelse, betennelse i hjernen og ryggmarg, som ikke er forårsaket av bakterier, og som vanligvis ikke så alvorlig som bakteriell meningitt. Den er iblant forårsaket av et virus eller et legemiddel og FDA rapporten sier ikke at den definitivt ble forårsaket av Vioxx. (The diagnosis was aseptic meningitis, inflammation of the brain and spinal cord that is not caused by bacteria and is generally less severe than bacterial meningitis. It is sometimes caused by a virus or a medication and the FDA report doesn't say it was definitely caused by Vioxx.)

Men FDA har krevet at Merck tilføyer meningitt til listen over mulige sideeffekter i Vioxxs preparatomtale og innleggsseddel. (However, the FDA has required Merck to add meningitis to the list of potential side effects included on the Vioxx product label and package insert.) (Anm: Ifølge en korreksjon i New York Times var dette allerede medtatt.)

Mercks talsmann Chris Fanelle sa at bare fordi en uheldig hendelse opptrer hos pasienter “beviser det ikke at legemidlet forårsaket det,'' og de rapporterte tilfeller representerer en ørliten brøkel av 52 millioner Vioxx forskrivninger. (Merck spokeswoman Chris Fanelle said that just because an adverse event occurs in patients “does not prove that the drug causes it,'' and the reported cases represent a tiny fraction of the 52 million Vioxx prescriptions.)

"Dette er en sjelden hendelse og vi tror ikke det er grunn til bekymring,'' sa Fanelle. (“This is a rare event and we don't think this is cause for worry,'' Fanelle said.)

Vioxx er blitt gransket for data som noen sier tyder på en mulig link til hjerteanfall, selv om Merck bestrider denne kjonklusjonen. (Vioxx also has been scrutinized for data that some say suggests a possible link to heart attacks, though Merck disputes that conclusion.)

Are selective COX 2 inhibitors superior to traditional non steroidal anti-inflammatory drugs? (Er selektive COX 2 hemmere bedre en tradisjonelle ikke-steroide betennelsesdempnde legemidler)

Editorials. Are selective COX 2 inhibitors superior to traditional non steroidal anti-inflammatory drugs?
BMJ 2002;324:1287-1288 (1 June)
Adekvate analyser i CLASS-forsøket indikerer at dette kanskje ikke er tilfellet. (Adequate analysis of the CLASS trial indicates that this may not be the case.)

Selektive cyclo-oxygenase 2 (COX 2)-hemmere, blant annet celecoxib (Celebrex) og rofecoxib (Vioxx), er antatt å ha en lavere risiko for gastrointestinale komplikasjoner enn tradisjonelle ikke-steroide betennelsesdempende legemidler.1 I september 2000 ble langtidsstudien av artritt for celecoxib, bedre kjent som CLASS, publisert i JAMA.2 Dette forsøket, som fikk bred omtale, konkluderte at en COX 2 hemmer var assosiert med en lavere forekomst av komplikasjoner enn tradisjonelle ikke steroide betennelsesdemepende legemidler. Det som ble mye mindre omtalt var kritikken som dementerte denne konklusjon. (Selective cyclo-oxygenase 2 (COX 2) inhibitors, including celecoxib (Celebrex) and rofecoxib (Vioxx), are hypothesised to have a lower risk of gastrointestinal complications than traditional non-steroidal anti-inflammatory drugs.1 In September 2000 the celecoxib long term arthritis safety study, better known as CLASS, was published in JAMA.2 This trial, widely cited and distributed, concluded that a COX 2 inhibitor was associated with a lower incidence of complications than traditional non-steroidal anti-inflammatory drugs. What was much less widely publicised were criticisms that contradicted this conclusion.)

Patient Information about VIOXX® (rofecoxib tablets and oral suspension) VIOXX® (pronounced "VI-ox") for Osteoarthritis, Rheumatoid Arthritis and Pain Generic name: rofecoxib ("ro-fa-COX-ib") fda.gov (April 2002)
I tillegg, er følgende sideeffekter innrapportert: angst, forvirring, reduserte nivåer av natrium i blod, depresjon, væske lunger, hårtap, hallusinasjoner, økte nivåer av kalium i blod, lavt antall blodceller, hjertebank, pankreatitt, kriblende fornemmelser, uvanlig hodepine med stiv nakke (aseptic meningitis), svimmelhet. (In addition, the following side effects have been reported: anxiety, confusion, decreased levels of sodium in the blood, depression, fluid in the lungs, hair loss, hallucinations, increased levels of potassium, in the blood, low blood cell counts, palpitations, pancreatitis, tingling sensation, unusual headache with stiff neck (aseptic meningitis), vertigo.)