Tag: FDA

Blog Posts (33)

June 22, 2015

At Long Last: FDA Changes the Law for Hemochromatosis

by Arthur Caplan, Ph.D.

Summer in the U.S. is known for many things—time at the beach, picnics, baseball, thunderstorms, vacations and ice cream.…

October 6, 2014

Misdirected Anger With the FDA Commissioner’s Rather Perfunctory Role?

<p><span style="line-height: 22.3999996185303px;">The September 24, 2014, issue of </span><em style="line-height: 22.3999996185303px;">USA Today</em><span style="line-height: 22.3999996185303px;"> carried a story titled, “<a href="http://www.usatoday.com/story/news/nation/2014/09/24/addiction-painkillers-fda-margaret-hamburg/16150421/">Anti-Addiction Groups Want FDA Chief to Resign: Activists Say Agencies Policies Have Led to Epidemic of Painkiller Abuse.</a>” </span><span style="line-height: 22.3999996185303px;">The first sentence of the news report says: “Anti-addiction activists are calling for the Food and Drug Administration’s top official to step down, saying the agency's policies have contributed to a national epidemic of prescription painkiller abuse.” ABC News reported the story that same day with the lead, “<a href="http://abcnews.go.com/Health/print?id=25717411">Anti-Addiction Groups Call for New FDA Chief.</a>” </span><span style="line-height: 22.3999996185303px;">In the written ABC News commentary, the hype may be characterized in one inflammatory sentence: “In a letter released Wednesday, more than a dozen groups ask the Obama administration’s top health official to replace FDA Commissioner Dr. Margaret Hamburg, who has led the agency since 2009. The FDA has been under fire from public health advocates, politicians and law enforcement officials since last October, when it approved a powerful new painkiller called <a href="http://www.zogenix.com/content/products/zohydro.htm">Zohydro</a> [ZOHYDRO™ ER (hydrocodone bitartrate) extended release capsules, Zogenics, Inc.)], </span><span style="line-height: 22.3999996185303px;">against the recommendation of its own medical advisers.” Both the print and newscast reports came from an <a href="http://bigstory.ap.org/article/fda-chief-defends-approval-hydrocodone-drug">Associated Press report</a> written by Matthew Perrone about a controversy that has been brewing for sometime. </span><span style="line-height: 22.3999996185303px;">The activists’’ letter to Secretary of Health and Human Services Sylvia Burwell is <a href="http://feduprally.org/wp-content/uploads/2014/09/Burwell-Letter-completed-with-signature-Final.pdf">available online</a> and states their position clearly. </span></p> <p><strong style="line-height: 19.0400009155273px; color: #34405b; font-family: Arial, Helvetica, sans-serif; font-size: 12px;">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="text-decoration: underline; color: #000099;" href="/Academic/bioethics/index.cfm">website</a>.</strong></p>
September 2, 2014

Big Data Peeps At Your Medical Records To Find Drug Problems

[NPR] No one likes it when a new drug in people’s medicine cabinets turns out to have problems — just remember the Vioxx debacle a decade ago, when the painkiller was removed from the market over concerns that it increased the risk of heart attack and stroke. To do a better job of spotting unforeseen risks […]
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.…