JAMA. 2010;304(10):1060. doi:10.1001/jama.2010.1284
Author: Mike Mitka
“Citing a record 1742 drug recalls in 2009, a 400% increase from 2008, Sen Michael Bennet (D, Colo) introduced legislation designed to enhance the ability of the Food and Drug Administration (FDA) and the pharmaceutical industry to ensure that medications are safe and effective regardless of where they are manufactured. The bill (S 3690 [http://thomas.loc.gov]), introduced August 3, would enhance the FDA’s ability to track and monitor foreign manufacturing sites and give the agency additional recall power and enforcement options, such as assessing civil penalties. …In addition, the bill would give the FDA new oversight of over-the-counter (OTC) drugs…”
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Archive for category The Pharmaceutical Industry
Improving Drug Safety
Sep 8
Australian Doctor-03 September, 2010
“The rules surrounding the promotion of therapeutic goods are being examined by a government committee, following long-running concerns that companies that mislead health professionals and the public about the efficacy and safety of their products were escaping sanctions. “
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The American Journal of Bioethics 10(9):35-45 2010, By Laurence B. McCullough, Robert Brent, Frank A. Chervenak, Benjamin Hippen, 3 September 2010
“On February 3, 2010, a Letter of Concern from Bioethicists, organized by fetaldex.org, was sent to report suspected violations of the ethics of human subjects research in the off-label use of dexamethasone during pregnancy by Dr. Maria New. Copies of this letter were submitted to the FDA Office of Pediatric Therapeutics, the Department of Health and Human Services (DHHS) Office for Human Research Protections, and three universities where Dr. New has held or holds appointments.”
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KevinMD.com- 26 August, 2010
Author: Daniel J. Carlat
“Big Pharma was once a proud industry, a scientific crucible that created the first antibiotics, cardiac medications, and chemotherapeutics. But over the last fifteen years, the output of drug companies has gone into a steady decline. It is unclear exactly why the pipeline began to dry up, but in response, companies changed their business strategies.”
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SMH, AP, 3 September 2010
“Allergan Inc., the maker of wrinkle-smoothing Botox, has agreed to pay $US600 million ($660 million) to settle a years-long federal investigation into its marketing of the top-selling, botulin-based drug. The Justice Department and the company said in a statement it will plead guilty to one misdemeanour charge of “misbranding”, in which the company’s marketing led physicians to use Botox for unapproved uses. Those included the treatment of headache, pain, spasticity and cerebral palsy in children.”
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KevinMD.com-28 August, 2010
Author: Daniel Carlat
“… He was arguing that drug companies should be allowed to wine and dine doctors in order to sell them on their newest drugs. From his perspective, doctors, with all their training, should be smart enough to separate the hype from the truth. But unfortunately our extensive training does nothing to immunize us from the effects of marketing, as many companies have discovered.”
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Washington Post- 24 August, 2010
Author: Carolyn Butler
“…Overall, 20.8 percent of Americans 12 and older — or nearly 52 million people — have taken prescription drugs for nonmedical reasons, according to the latest National Survey on Drug Use and Health, from 2008. When it comes to illicit drug use, only marijuana is more popular.”
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KevinMD.com-18 August, 2010
Author: Michael Kirsch
“The Food and Drug Administration (FDA) wants physicians to turn in Big Pharma marketing and promotional materials that are misleading, that are poisoning us with information that reaches beyond FDA’s approved indications and regulations.”
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Slater & Gordon, media release, 20 August 2010
“In March this year, Slater & Gordon succeeded in a claim against Merck, Sharp & Dohme (Australia) the producers of the anti-inflammatory drug Vioxx. That claim was on behalf of grandfather Graeme Peterson, who suffered a heart attack after taking Vioxx. The win paves the way for similar compensation claims. Slater & Gordon litigation lawyer James Higgins said the Federal Court of Australia had issued a deadline of August 25 for people to take part in the group claim currently before the court.”
Find public notice here.