Saturday, February 4, 2023

Tag: FDA

Regulators Are Approving Drugs Without Clear Evidence That They Work

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Drug regulators frequently approve drugs despite contradictory clinical trial results and without evidence of clinical benefits.

FDA Approves Failed Alzheimer’s Drug

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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

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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

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More than 200 people signed an open letter to the FDA requesting electroconvulsive therapy’s safety studies and electrical dosing protocols.

New FDA Study Shows Benzodiazepines Can Cause Long-Term Injury

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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?

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The UK’s 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

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From Science: "Brilinta fits a pattern of what might be called pay-later conflicts of interest, which have gone largely unnoticed—and entirely unpoliced. In examining...

The Truth About “Breakthrough” Drugs

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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

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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

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From Forbes: "A new Netflix documentary — The Bleeding Edge — highlights a wide range of systemic flaws in the FDA’s regulation of medical devices. As always,...

FDA Repays Industry by Rushing Risky Drugs to Market

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From ProPublica: "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

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Members of the U.S. Food and Drug Administration’s Psychiatry Products division go on the defensive in a new article, responding to concerns about the agency’s approval of digital aripiprazole.

FDA Shakes Up Guidance on Antidepressant Trial Design

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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

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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...

It’s Time to Levy Penalties for Failing to Report Clinical Trial...

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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.

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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?

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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

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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?

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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

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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

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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 can’t conclude that our drug did it.

Jim Gottstein: Patient Rights in Mental Healthcare

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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.

Scott Gottlieb Confirmed as Head of the FDA

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From Pacific Standard: This past Tuesday, the Senate confirmed Scott Gottlieb as head of the Food and Drug Administration. "Although some Senate Democrats had worried about...

Change in Chicago: Playing Go

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The jury was out for days. And when they came back it became clear they were wrestling with the issue of who to blame. This was like playing Go, where it can look like the black counters on the board have white encircled until white puts down one more piece and all of a sudden it wins.

Dear Scott Gottlieb: Add New Warnings to Paxil Labels

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From STAT: Scott Gottlieb, Trump's pick to lead the FDA, should consider pursuing a stronger warning label for the antidepressant Paxil. Paxil's label currently does...