Tag: FDA
A Win for Science, with Profound Implications for Industry: FDA Rejects...
Concerns, from functional unblinding to sexual assault in the clinical trials, led this week to a full repudiation of Lykos' MDMA-assisted therapy.
Only One of Five Key Xanax Trials Deemed Positive by F.D.A.
The published literature is misleading, as the negative Xanax trials either went unpublished or were spun to appear positive.
Lexapro for Children: Drug With No Meaningful Benefit and Increased Suicidality...
Response and remission rates were the same in the drug versus placebo groups, and Lexapro increased suicidality sixfold.
Regulators Are Approving Drugs Without Clear Evidence That They Work
Drug regulators frequently approve drugs despite contradictory clinical trial results and without evidence of clinical benefits.
FDA Approves Failed Alzheimerâs Drug
The FDA approved Biogen's failed drug aducanumab, overriding the 10-0 recommendation of its own advisory committee. Three panel members resigned in protest.
Ethical Issues Raised Over FDA Collaboration with Biogen on Failed Drug
The FDA collaborated with Biogen to conduct repeated re-analyses of aducanumab for Alzheimer's and FDA committee members are raising concerns.
Appealing the FDA’s Denial of ECT’s Harms
More than 200 people signed an open letter to the FDA requesting electroconvulsive therapyâs safety studies and electrical dosing protocols.
New FDA Study Shows Benzodiazepines Can Cause Long-Term Injury
The FDA has finally acknowledged the adverse effects of benzodiazepines, the dangers of withdrawal, and that the current packaging does not sufficiently warn of these harms.
Are Regulatory Bodies Prioritising Drug Company Interests Over Public Safety?
The UKâs Medicines & Healthcare Products Regulatory Agency is refusing to respond to the concerns of psychiatrists, parliamentarians, patients and other experts about the impending licensing of the street drug ketamine as a treatment for depression.
After-the-fact Pharma Payments to FDA Advisers Spark Ethical Concerns
From Science: "Brilinta fits a pattern of what might be called pay-later conflicts of interest, which have gone largely unnoticedâand entirely unpoliced. In examining...
The Truth About “Breakthrough” Drugs
From The Washington Post: "When federal regulators started giving certain drugs 'breakthrough' status in 2012, pharmaceutical company interest exploded.
The goal was to speed up...
Addyi, the First “Female Viagra,” Rises Again
From The Hastings Center Report: "Addyi, a drug that made a splash when it was approved in the summer of 2015 as the first...
New Documentary Indicts FDA’s Regulation of Medical Devices
From Forbes: "A new Netflix documentary â The Bleeding Edge â highlights a wide range of systemic flaws in the FDAâs regulation of medical devices. As always,...
FDA Repays Industry by Rushing Risky Drugs to Market
From ProPublica:Â "The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease. Once...
FDA Defends Decision to Approve Digital Aripiprazole
Members of the U.S. Food and Drug Administrationâs Psychiatry Products division go on the defensive in a new article, responding to concerns about the agencyâs approval of digital aripiprazole.
FDA Shakes Up Guidance on Antidepressant Trial Design
From MedPage Today: "The FDA released new draft guidance for development and testing new pharmacologic agents indicated to treat major depressive disorder (MDD).
For example, the new guidance...
We Pay a High Price for Unregulated Medical Devices
From The Lown Institute: New investigations and research are beginning to show the dangerous consequences resulting from the FDA's lack of oversight of medical devices.
"It sounds crazy...
Itâs Time to Levy Penalties for Failing to Report Clinical Trial...
From STAT: A decade after the Food and Drug Administration Amendments Act went into effect, requiring the results of clinical trials to be reported on the government website ClinicalTrials.gov, the government has never levied a single monetary penalty or withheld research funding under the law.
Think You’re Seeing More Drug Ads on TV? You Are.
From The New York Times: TV drug ads have dramatically increased in the past few years. According to Kantar Media, a firm that tracks multimedia advertising,...
Is the FDA Withholding Data to Protect a Drug Manufacturer?
From Scientific American: The FDA seems determined to prevent the public from accessing valuable data about the safety, efficacy, and potential adverse effects of the...
More Follow Up Needed for Drugs Granted Accelerated FDA Approval
Drugs to treat serious or life-threatening conditions can receive accelerated FDA approval, but may expose patients to increased safety risks and reduced efficacy.
Has the Era of Gene Therapy Finally Arrived?
From Scientific American: The FDA has announced its approval of Kymriah, the first gene therapy in the U.S. However, gene therapy remains far from fulfilling...
FDA Seeks Input on Drug Risk Information in Broadcast Ads
From FDA in Brief: The FDA seeks input from consumers and medical professionals on making sure the drug risk information in statements included in direct-to-consumer...
Prescription for Murder ABCD
The Anything But the Company Drug playbook involved digging deep into the medical records of the person reporting a problem in order to find the ingrown toenail at the age of two that was possibly the cause. And of course if something else was possibly the cause, then we canât conclude that our drug did it.
Jim Gottstein: Patient Rights in Mental Healthcare
Jim Gottstein, president and founder of the organisation Law Project for Psychiatric Rights, talks about his own experiences with the psychiatric system, patient rights in mental healthcare and the recent trial between Wendy Dolin and the UK Pharmaceutical manufacturer GlaxoSmithKline.