The UK's National Institute for Health and Clinical Excellence reported that Roche Holding AG's Avastin (bevacizumab) should not be prescribed for bowel cancer patients under the National Health Service because it is too costly. NICE added in its preliminary ruling that Avastin in combination with oxaliplatin should not be paid for by NHS because it is not cost-effective. The recommendation follows Roche's offer to subsidize treatment following discussions with the UK Department of Health.
NICE's formula to determine the cost-effectiveness of drugs "looks at quality of life and overall cost effectiveness," but its maximum limit "has not changed in ten years despite inflation." A number of "patient groups and experts voiced their dismay" regarding the decision, and the Daily Mail adds that NICE, "which has been accused of spending more on spin than on evaluating drugs, has often been criticized for banning drugs from NHS use as too expensive."
Judge dismisses Fosamax case.
The Wall Street Journal reported that a federal judge dismissed a case over allegations that Merck & Co.'s osteoporosis drug Fosamax caused osteonecrosis in a 74-year-old woman. Bessie Flemings claimed that she developed the severe jaw condition from taking the drug and that Merck did not adequately warn of the risk of osteonecrosis.
The judge ruled that "experts for Bessie Flemings...can't establish that Fosamax caused her osteonecrosis," and as a result, "her failure-to-warn claim is insufficient as a matter of law," An attorney for Merck noted that "Flemings did not present any reliable evidence supporting her claim," adding that "Flemings had medical problems that cause people to develop jaw problems regardless of whether they were taking Fosamax." The company, "as of Sept. 30, faced about 953 Fosamax cases, including suits with multiple patients.".
Pfizer ordered to pay $103 million in punitive damages in hormone drug cases. On the front page of its Business Day section, the New York Times reported that, "Pfizer has been ordered to pay a total of $103 million in punitive damages to two women who were found to have breast cancer after they used" the hormone drugs Premarin and Prempro. Pfizer units Pharmacia and Wyeth "marketed the drugs as a standard, long-term hormone treatment for menopausal women, until medical evidence emerged indicating that such therapy raised women's risk of breast cancer." Now, a jury has "reached a $28 million judgment" in a case Monday, "while a judge unsealed a month-old $75 million judgment in the other case."
Lawyers for the plaintiff Monday noted, "This is just the tip of the iceberg as Wyeth faces lawsuits from more than 10,000 additional women who also claim that Wyeth's drugs gave them breast cancer," But, a Pfizer spokesman said that "of the 34 trial-set cases to date, there have been only four plaintiffs' verdicts that have not been set aside."
Also at http://www.qa-expert.com/2010/01/drug-regulatory-updates.html