Tag: FDA

Blog Posts (30)

July 1, 2014

Supreme Court Rejects Contraceptives Mandate for Some Corporations

[The New York Times]  The Supreme Court ruled on Monday that requiring family-owned corporations to pay for insurance coverage for contraception under the Affordable Care Act violated a federal law protecting religious freedom. It was, a dissent said, “a decision of startling breadth.” The 5-to-4 ruling, which applied to two companies owned by Christian families, opened the door […]
June 23, 2014

Teen Suicide Attempts Rise as Warning Cuts Medicine Use

[Bloomberg] A widely publicized warning by U.S. regulators a decade ago about risks for teenagers taking antidepressants led to plummeting prescriptions and increased suicide attempts, Harvard University researchers said. As the public took the Food and Drug Administration’s 2004 warning to heart, adolescent attempted suicides increased 21.7 percent and a 31 percent decline in antidepressant […]
May 16, 2014

Advocating Pill, U.S. Signals Shift to Prevent AIDS

[The New York Times]Federal health officials recommended Wednesday that hundreds of thousands of Americans at risk for AIDS take a daily pill that has been shown to prevent infection with the virus that causes it.If broadly followed, the advice could transform AIDS prevention in the United States — from reliance on condoms, which are effective […]
May 8, 2014

Nobel laureate Yamanaka denies image manipulation in 2000 paper

Original commentary by BEI Young Professionals Olivette Burton MBe MSW Asking for forgiveness rather than permission is, unfortunately, becoming a recurring international theme in the world of biomedical research.  Questions surrounding trust and integrity in science inevitably become more difficult for honest champions of research to answer convincingly.  Some of my previous work has been dedicated […]
May 5, 2014

State Defends Ban on Powerful Painkiller Zohydro

<p>The governor of Massachusetts <a href="http://www.boston.com/news/local/massachusetts/2014/04/14/state-asks-judge-uphold-emergency-ban-powerful-painkiller-zohydro/VgOBt3e76mRZwBm5yxsDFM/story.html">placed an emergency ban</a> on Zohydro ER (Extended Release), a Schedule II controlled substance that is hydrocodone bitartrate in extended-release capsules.  The easily crushed capsules contain 50 milligrams of pure hydrocodone, which is 10 times more that a regular Vicodin. The FDA approved the drug with a few conditions attached last December although FDA’s advisors voted 11-2 against approving the drug due to concerns about addiction. Governor Patrick does not want the drug in his state until Zogenix, the pharmaceutical company that manufactures the drug, develops an abuse-deterrent version of the drug. He believes that adequate measures are not in place to safeguard against the potential for diversion, overdose and misuse. He was not alone in his concerns.  State attorneys general urged the FDA to reconsider and Congress called a hearing and a bill was introduced by West Virginia Senator Joe Manchin to force the FDA withdraw the drug. </p> <p>Zohydro supporters view it as a very important drug to treat chronic pain in fewer doses than hydrocodone therapies that are shorter acting and contain acetaminophen.  The <a href="http://www.fda.gov.newsevetns/newsroom/pressannoincements/umc372287.htmnaccess">battle began</a> when “Zohydro ER was approved by the FDA after an exhaustive 18-month review of the clinical trial data.  The product’s release requires post-marketing studies as part of a Risk Evaluation and Mitigation Strategy (REMS) to assess serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose and death associated with long term use beyond 12 weeks.”   Though Zohydro is the first drug to undergo these studies, other extended release (ER) and long acting (LA) opioid analgesics will also be studied in this manner. <a href="http://ir.zogenix.com/phoenix.zhtml?c=220862&amp;p=irol-newsArticle_print&amp;ID=1916462&amp;highlight= ">Practioners are recommended</a> to limit the use of Zohydro to patients whom alternative treatment options such as non-opioid analgesics or immediate-release opioids are ineffective, not tolerated or would be otherwise inadequate to provide sufficient management of pain.    </p> <p><strong style="color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px; line-height: 20px;">The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI's online graduate programs, please visit our <a style="color: #000099; text-decoration: underline;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
April 30, 2014

New Painkiller Rekindles Addiction Concerns

[New York Times] The abuse of prescription painkillers has reached epidemic proportions in America. Nearly half of the nation’s 38,329 drug overdose deaths in 2010 involved painkillers like hydrocodone and oxycodone, according to the Centers for Disease Control and Prevention. These narcotics now kill more adults than heroin and cocaine combined, sending 420,000 Americans to emergency rooms each year. […]
November 8, 2013

The Fat-That-Must-Not-Be-Named

by Craig Klugman, Ph.D.

As you may have heard, the FDA is considering changing its recommendations concerning partially hydrogenated oils, or what are commonly known as trans fats.…

February 8, 2011

Dirty Windows of Drug Development

Think of clinical trial data as a window on the efficacy and safety of a drug. Think of data protection and trade secrecy as soot. The above picture? This is the public view on drug safety and efficacy.According to a recent report in Nature Biotechnolo...
January 4, 2011

Coming Soon: Skull and Crossbones on Your Coke?

That purveyor of ideas all in the name of the “public’s interest”, the Center for Science in the Public Interest is calling for FDA Commissioner Margaret Hamburg to mandate warning labels on none other than your good ole’ soda pop.…

September 3, 2010

FDA and Office of Human Research Protection Respond to Fetal Dex Complaint

The September issue of The American Journal of Bioethics, presaged by such astonishing articles as “The Lesbian Drug” in Newsweek, stretched the boundaries of the Journal by engaging questions about the relationship between advocacy and scholarship, the meaning of transgressing boundaries in that regard, and the extraordinary implications of the social and medical debate concerning the administration of dexamethasone during pregnancy in females with congenital adrenal hyperplasia.…