Myth Versus Reality: Promoting A Pricey Gout Pill
Nearly three years ago, the FDA approved a version of colchicine – a cheap, decades-old treatment for gout – and a controversy quickly ensued. The new med won approval under the Orphan Drug Act, which means the manufacturer received seven years of marketing exclusivity. And the FDA later forced other manufacturers to halt marketing on […]
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Americans Cut Back on Health Care During Recession
In 2009 and 2010 total health care spending grew at just under 4 percent, at the slowest rate since the government began keeping records over fifty years ago, one big reason is that Americans dramatically curtailed their use of physician and hospital services. “This certainly was a very deep and significant recession,†said Stephen Heffler, […]
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Nicotine patches, gums won’t help smokers quit long-term
Nicotine patches and nicotine gum — the popular mainstays of so-called “nicotine replacement therapy” — don’t help many smokers kick the habit and remain cigarette-free over the long haul, new research suggests. The study authors concluded that the findings raise “serious questions” about the effectiveness of nicotine replacement therapy as experienced by most smokers. This […]
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Boehringer’s Pradaxa Increases Risk of Heart Attack, Study Shows
Boehringer Ingelheim GmbH’s anti- coagulant Pradaxa increases a patient’s risk of heart attack or severe chest pain, according to a review of studies conducted on the drug. An analysis of seven clinical trials found that it was “significantly associated with a higher risk†of heart attacks and acute coronary syndrome, or ACS, a designation that […]
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CROs Blast New Clinical Trial Rules In India
Overseas clinical trials are a perennially controversial issue, but especially in India, where the population is regularly tapped by overseas drugmakers. At the same time, the Indian government is increasingly concerned about patients. Notably, India’s health ministry last year found that drugmakers running clinical trials had not compensated survivors of most volunteers who died during […]
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Senator warns FDA on danger of newest super painkillers now under review after NY shooting
Following fatal shootings in two New York pharmacy robberies, a U.S. senator is warning that a new batch of “super painkillers†now under review could force repeats of recent violent robberies that left six people dead. “It’s tremendously concerning that at the same time policymakers and law enforcement professionals are waging a war on the […]
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What Novartis Did Wrong At Its Consumer Plant
Last month, Novartis quietly suspended production at a plant in Lincoln, Nebraska, where various over-the-counter and animal health meds are made. The drugmaker called the move a voluntary step to improve compliance and strengthen standards (back story). However, when we asked about any regulatory actions that may have prompted its decision, the drugmaker would only […]
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Docs To Hospira: Restrict Med Used For Executions
The ongoing shortage of drugs used for prison executions has prompted more than two dozen prominent physicians from different countries to write to Hospira ceo Michael Ball, urging him to restrict the use of Pancuronium, which is one of three drugs that are used in a lethal injection cocktail administered by many states in the […]
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AstraZeneca leaks confidential information
There have been red faces at AstraZeneca after the company sent confidential information to analysts by mistake. It was forced into issuing a clarification about its financial prospects, saying that the information it inadvertently let out “does not represent the company’s view of expected financial performance for the full year 2011 or for future periodsâ€. […]
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Novartis Recalls OTC Meds Made At Troubled Plant
Less than a month after quietly shutting a plant that makes over-the-counter and animal health meds, Novartis has now recalled an unspecified number of OTC drugs – including Excedrin, No-Doz and Bufferin – due to complaints about incorrect or chipped tablets and broken gelcaps, as well as an FDA review that found inconsistent bottle packaging […]
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