Search Results for "off-label"
Off-label use & aggressive public relations • Treating depression with botox
A magazine cover like this can raise three things: eyebrows … questions … hope. How can one drug do all this cover claims? Botox injections (usually botulinum toxin type A) are currently FDA-approved for overactive bladders, chronic migraine headaches, repetitive neck spasms (cervical dystonia), spastic arm muscles, overactive sweat glands in the armpits (axillary hyperhidrosis), and […]1
Off-label drug marketing: Who will decide what’s “truthful” when the evidence can’t be trusted?
Earlier this month, the Food and Drug Administration (FDA) held an important public hearing on “off-label” marketing of drugs and medical devices to physicians. “Off-label” refers the use of an FDA-approved medical product for a condition that it hasn’t been approved to treat — for example using a drug approved for depression to treat a […]4
Coverage of Amarin off-label promotion agreement should have acknowledged deadly history of such marketing
Alan Cassels is a drug policy researcher in Victoria, British Columbia and a regular contributor to HealthNewsReview.org. Follow his writings on Twitter @akecassels. Last August, the drug company Amarin won a court case that essentially granted them a protected “free speech” right to promote their fish oil-derived product Vascepa for off-label purposes. And this week, […]
Harvard’s Jerry Avorn warns against FDA loosening off-label marketing restrictions
Jerry Avorn wrote the book, “Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs,” one of many great books written on this general theme in the past decade or so. This week, the Harvard prof – Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital – writes a warning in […]10/17/2011
"Off-label" Drug Use and Marketing
back to “Tips for Understanding Studies” Prescription drugs are approved by the Food and Drug Administration for specific uses (or indications) to treat specific conditions or diseases. Physicians may prescribe a drug for a use that’s not described in the approved labeling if it seems reasonable or appropriate to them. This is what’s called “off-label […]4/6/2011
Off-label drug marketing study: “Insidious forms of illegal marketing”
There’s an important paper in PLoS Medicine, “Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints.” The authors provide this background on off-label marketing: “An important part of the (drug) approval process is the creation of the “drug label,” a detailed report that specifies the exact diseases and patient groups […]2/8/2010
Off-label penis-straightening promotion by ABCNews.com
Last week the website reported that the FDA approved a drug for claw hand – a painful condition that causes bent fingers. That was the news of the day. But ABCNews.com only briefly discussed claw hand before catapulting into a non-stop promotion of possible off-label use of the drug for Peyronie’s Disease – a condition […]
Reuters once again rehashes drug company news release
There was also no information about how or where these research findings were presented, nor was there any input from independent experts.
J&J's Stelara succeeds in chronic bowel disease study
Newsweek prematurely reports ‘promise’ for ketamine as a treatment for depressed teens
And potential harms weren’t spelled out — particularly important when it comes to the unknown effects of long-term use on developing brains and bodies.
KETAMINE SHOWS PROMISE AS TREATMENT FOR ADOLESCENTS WITH DEPRESSION
Let’s be clear: claim that new cancer combo ‘improves survival’ misleads
As new drug combos come on line for difficult to treat cancers like uterine serous carcinoma (USC), researchers claim success in terms of months, not years. Increasingly, months of progression-free survival — not overall survival — is reported as the clinical trial endpoint. But taking into account harms and costs, is that cause for celebration?
New drug combo improves survival of women with rare uterine cancer
Advocates push for access to secret clinical data, while FDA drags its feet
A recent analysis of once-secret clinical trial data concluded that a popular morning sickness drug, Diclegis, doesn’t actually work. That surprising finding, made possible by the release of previously undisclosed data by Canadian regulators, drew a barrage of headlines, including coverage by Reuters, Healthline, and HealthDay. But those news reports didn’t mention a much bigger […]2
Toilet Bowl Tuesday: A craptastic race to the bottom for misleading health news
Sunday’s Super Bowl supposedly represented the zenith of professional football: top players, in top form, playing at the top level. Anyone want to give me odds on any of the following news stories — which all showed up in our newsfeed before 9 AM today — winning some sort of Toilet Bowl for health news? […]
Little evidence to support assertion in U.S. News story that ADHD drugs can help smokers quit
When it comes to the ADHD drug Vyvanse helping smokers quit, this article is much ado about nothing.
ADHD Stimulants Might Help a Smoker With the Disorder Cut Back on Cigarettes
A pharma sales army aims to increase ‘fibroid awareness’; women’s health experts brace for collateral damage
Women’s health advocates have long battled for wider recognition of the problems caused by fibroids, noncancerous growths on the uterus that can cause bloating, discomfort and heavy menstrual bleeding. Getting women to talk about their fibroids has been viewed as a way to break the stigma around the condition and encourage more research and better […]5
‘A blow to [STAT’s] credibility’: MD listed as author of op-ed praising drug reps didn’t write it. Ghostwriting/PR influence
[Editor’s note: In response to our reporting, STAT has retracted the flawed op-ed that is the subject of this post and revised its policies on authorship and conflict of interest disclosure in its opinion columns. See here for details.] The physician whom STAT lists as author of a now-retracted op-ed praising the vital role of […]