Monday, February 6, 2023

Tag: FDA Approval

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.

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.

Statisticians: Current Policies Approve Ineffective Treatments

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Current standards for clinical trials rely on statistical methods that allow for ineffective treatments to gain approval.

Monarch eTNS Inspires “Stop the Psychiatric Abuse of Children!” (SPAC!)

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The FDA approval of the Monarch eTNS device is the latest form of psychiatric-inspired child abuse. If not stopped, it will afflict millions of children in unimaginably damaging ways. It has inspired us to form Stop the Psychiatric Abuse of Children (SPAC!) a new international advocacy organization.

Nasal Spray for Depression? Not So Fast

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Several members of the FDA Advisory Committee perceived this new drug as a potential “game changer” in the way depression is treated. I, however, am NOT one of them. I take my role as the Consumer Representative very seriously and want to make sure that any pharmaceutical drug that the FDA approves shows greater benefit than potential harm.

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...

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...

Pfizer Gets FDA Approval For Chewable Ritalin

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Yesterday, the FDA approved Pfizer's “QuilliChew ER” chewable methylphenidate for ADHD in children as young as six. “CNS stimulants, including Quillivant XR, QuilliChew ER, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence.”

“New ‘Smart’ Drugs Tell Doctor You’re Not Taking Them”

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The Washington Examiner reports that the manufacturer of the antipsychotic Abilify is seeking FDA approval for new digitized pills that would alert doctors if patients fail to take their drugs on schedule.

Members of FDA Advisory Committee Offer Perspectives on Flibanserin Approval in...

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In the September issue of The Journal of the American Medical Association (JAMA) three FDA advisory committee members describe the convergence of factors that made the committee’s recommendation to approve flibanserin especially challenging and politically charged.

“The FDA Is Basically Approving Everything. Here’s The Data To Prove...

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Writing for Forbes, Matthew Herper documents the FDA’s increasing drug approval rates. “In 2008, BioMedTracker says the FDA approved 20 new molecular entities (NMEs) and rejected 20, for an approval rate of 50%.” So far this year, he writes, “the FDA approval rate is more like 96%.”

“Flibanserin, ‘Female Viagra,’ Distracts From Real Causes of Low Libido”

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CBC News Canada voices sex therapists and psychiatrists concerns over the FDAs decision to approve Flibanserin last week. Critics contend, “it's an ineffectual pharmacological solution for a problem better treated with relationship counselling, sex therapy and behavioural changes.” Walid Gellad, the co-director of the Center for Pharmaceutical Policy and Prescribing adds, “"[I] believe that it should be used by almost no one.”