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A recent study suggests that people believe that expensive drugs work better than cheaper versions and that this assumption influences how they respond to therapy.
The study involved 82 healthy volunteers who were given electrical shocks to the wrist (calibrated to each volunteer's pain tolerance) before and after taking a pill. Half the people were told they were taking an expensive opioid analgesic costing $2.50 a pill; the other half were told they were taking an opioid analgesic that had been discounted to 10 cents a pill. In fact, all study subjects received the same placebo. Eighty-five percent of people who thought they'd taken an expensive pill reported pain relief, compared with 61% of those who believed they'd taken a 10-cent pill.
Do these price perceptions diminish the therapeutic effect of generic drugs? Care providers may need to emphasize the value of discounted drugs and track patient responses to them.
Source: Waber RL, et al., Commercial features of placebo and therapeutic efficacy, JAMA, March 5, 2008.
Spurred by the poor performance of this year's flu vaccine, an FDA advisory panel has targeted three new flu strains for the 2008-;2009 vaccine: two type A strains-Brisbane/10 (H3N2) and Brisbane/59-and a new type B/Florida strain. The influenza A H3N2 strain was widespread in the 2007-;2008 flu season.
Flu vaccines are reformulated every year, based on experts' best estimate of which flu strains will predominate. Typically, only one or two strains are changed each year. Vaccine manufacturers say producing enough doses by the start of the next flu season will be difficult, given the increased vaccine complexity and relatively short lead time available. For more information, visit http://www.fda.gov and search for "2009 flu vaccine."
Asmanex Twisthaler is the first once-a-day inhaled corticosteroid to receive FDA approval for children age 4 and older. A study involving 296 children ages 4 to 11 indicated that the drug reduces daytime and nighttime symptoms and emergency medical visits. The dose for children ages 4 to 11 is 110 mcg, which is half the adult dose.
Unlike many inhalers, the Twisthaler doesn't have a propellant. A dose counter shows how many doses remain.
As with other inhaled corticosteroids, the Twisthaler can slow growth in children, cause oral fungal infections, and increase the risk of glaucoma and cataracts. The most common adverse reactions include headaches, sore throat, upper respiratory infection, stomach upset, and muscle, bone, or back pain.
The FDA has received 37 reports of suicide and more than 400 reports of suicidal behavior linked to varenicline (Chantix), marketed by Pfizer to help people stop smoking. Pfizer has added stronger warnings to the drug's label and is working with the FDA to create a medication guide for patients.
In a public advisory, the FDA urges patients who are taking the drug to inform care providers of any history of mental illness and to watch for changes in mood and behavior and strange or vivid dreams. In some cases, patients developed signs and symptoms after they stopped taking Chantix.
For more information, visit the FDA's Web site at http://www.fda.gov.
A monoclonal antibody indicated to treat lymphoma, rituximab may also help patients with a common form of multiple sclerosis (MS). A recent study included 104 patients with relapsing-remitting MS, which involves disease flare-ups and periods of remission. Patients received either 1,000 mg of I.V. rituximab or a placebo. Magnetic resonance imaging was conducted at 12, 16, 20, and 24 weeks to assess the number of inflammatory lesions in the patients' brains.
One course of rituximab significantly reduced inflammatory brain lesions and clinical relapses for 48 weeks. Compared with people who took a placebo, those who took the drug had fewer new lesions during the study and 6 months later. After 48 weeks, only 20% of those taking rituximab had experienced a relapse, compared with 40% of those taking a placebo.
Rituximab targets and depletes B lymphocytes, which researchers believe are involved in the pathogenesis of MS.
Source: Hauser SL, et al., B-cell depletion with rituximab in relapsing-remitting multiple sclerosis, The New England Journal of Medicine, February 14, 2008.
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