Merck & Co agrees $1bn Vioxx settlement in US
US drugs firm Merck & Co has agreed to pay almost $1bn (£640m) to settle criminal and civil charges arising from the marketing of one of its drugs, the US Department of Justice has said.
The company will pay a $322m criminal fine and $628m to settle civil charges regarding the promotion of the painkiller Vioxx.
The department said Merck & Co promoted the drug for rheumatoid arthritis before it was officially approved.
The drug was withdrawn in 2004.
Merck & Co said the civil settlement did not constitute an admission of liability or wrongdoing.
"We believe that Merck acted responsibly and in good faith in connection with the conduct at issue in these civil settlement agreements, including activities concerning the safety profile of Vioxx," said the company's Bruce Kuhlik.
In October last year, Merck & Co said it would be setting aside $950m to cover the cost of the settlement.
In 2007, the company paid $4.85bn to settle thousands of Vioxx-related lawsuits.
A study found the drug could increase the risk of heart attacks and strokes.
New Jersey-based Merck & Co should not be confused with its German chemicals and pharmaceuticals namesake, Merck KGaA.
Although the two firms share the same historic roots, they are separate companies.
Source : BBC News
Link to Source
Doc Goes to Jail In Pfizer Research Fraud Case
Scott Reuben, who was accused of faking research for a dozen years in published studies that suggested after-surgery benefits from Vioxx and Celebrex, was sentenced to six months in jail plus three years supervised release after he pleaded guilty earlier this year to health care fraud, MassLive reports. The 51-year-old must also repay $361,932 in research grants, forfeit assets worth at least $50,000 and pay a $5,000 fine. The former chief of acute pain at Baystate Medical Center received grants from various drugmakers but never performed the studies, fabricated patient data and submitted info to anesthesiology journals that was unwittingly published. Later, an investigation found 21 papers published in journals between 1996 and 2008 in which Reuben made up some or all of the data (background here and here).
The hospital asked the journals to retract the studies, some of which reported favorable results from painkillers including Pfizer’s Bextra, Celebrex and Lyrica, and Merck’s Vioxx. His studies also claimed Wyeth’s Effexor antidepressant could be used as a painkiller. Pfizer gave Reuben five research grants between 2002 and 2007, and he was a member of the company’s speakers bureau, giving talks about Pfizer drugs to colleagues. Separately, the journal Anesthesia & Analgesia retracted 10 of Reuben’s studies last year while the journal Anesthesiology retracted three studies.
LINK TO SOURCE
Australian Court: Vioxx Doubled Heart Attack Risk
Kristen GelineauThe Associated Press
March 08, 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.
LINK TO FULL ARTICLE
Pensioner wins £28,000 payout after being left ill by drugs trial
A pensioner has won an £28,000 payout from a pharmaceutical company after being left seriously ill during a drugs trial.
Leslie Thomas, 75, claimed he suffered a string of severe side effects including blood poisoning, fits and a collapsed colon after testing anti-inflammatory drug Vioxx .
Previously fit and healthy, he was left a "virtual invalid" by the drug, which left him anorexic, dangerously dehydrated and with an irregular heart beat, he alleged.
He was later diagnosed with an incurable and life-long intestinal disease.
Mr Thomas, a former college lecturer, has now been awarded £28,000 compensation after Merck Sharp and Dohme Ltd dropped their appeal against a County Count judgement in favour of the pensioner.
It has also agreed to pay his legal fees, including £50,000 he took out from his home insurance to pursue the case.
The ruling potentially leaves the door open for a further 450 UK claimants who wish to seek compensation on grounds of ill-health caused by taking Vioxx, although Merck insists that the payout sets no precedent.
Gerard Dervan, a partner at Liverpool-based law firm MSB, who is representing more than 100 people who have been affected, said: "This is a huge development. It removes a big barrier and I hope it will herald the start of more cases.
"Now we have seen that this massive firm roll over and drop the fight."
A study published in 2004 suggested that Vioxx doubles the risk of non-fatal heart attack or stroke and increases the risk of premature death by 31 per cent when taken for 18 months or more.
Merck withdrew the drug from the market and paid out billions of pounds in compensation to Americans who suffered heart attacks and strokes after taking the drug.
It had denied that Vioxx was capable of causing Mr Thomas' intestinal condition.
More than 80 million people were prescribed Vioxx - also known as Rofecoxib - for arthritis in 80 countries between 1999 and 2004.
Mr Thomas, from Ely, Cambs, took part in the trial in 2003. It was meant to establish whether the drug could decrease the risk of prostate cancer.
Last month he became the first British citizen to win a legal ruling to bring a compensation claim against the American firm, and has agreed the out of court settlement.
He said: "I'm not happy with the sum of money but I'm thrilled at the principal. Now I'm hoping that my victory will enable others to take their case to court."
A Merck spokeswoman said the payout was in line with guidelines set out by the Association of the British Pharmaceutical Industry (ABPI).
"This case is unique and has no significance for any other claim in the UK or elsewhere. Mr Thomas’s claim - an exacerbation of ulcerative colitis - is a gastrointestinal condition that is unrelated to the cardiovascular conditions that were the subject of the US resolution.
"In addition, Mr Thomas’s condition occurred during a clinical trial and was resolved pursuant to the ABPI guidelines, which are not applicable outside of the clinical trial context.
"The company’s position with respect to claims in the UK has not changed: the appropriate way to address them is individually and in the UK courts. The company has won the overwhelming majority of product liability lawsuits regarding Vioxx that have been decided around the world."
Source: Telegraph Jan 2009
LINK TO SOURCE