Monday, April 12, 2021

“Public Wary of Faster Approvals of New Drugs, STAT-Harvard Poll Finds”

According to a new STAT-Harvard poll, the majority of Americans oppose new legislation that would speed up the approval of new drugs and medical...

FDA: New Depression Drug “Not Approvable”

Gepirone, a new depression drug by Fabre-Kramer Pharmaceuticals, did not meet the FDAs efficacy standards. The new drug application for gepirone has now received...

Despite Risks, Antidepressant Use among Reproductive Age Women Increases

Accumulating evidence points to serious risks associated with antidepressant use during pregnancy, yet data suggests that prescriptions continue to rise in the US. "Given...

Off-Label Prescribing Increases Risk of Adverse Effects

The first systematic investigation of the adverse effects associated with prescribing drugs “off-label” found that the common practice of using drugs for conditions for which they are not approved increases the risk of adverse effects.

“Mental Health Care Bill Hits House Amid Concerns”

The Boston Herald reports on mental health care reform bills moving through both houses of Congress. Lawmakers warn, however, “that some aspects of the legislation could create greater barriers to access mental health care for some.”

“Martyrs to Science? When Research Participants Die”

Neuroskeptic covers a short article by Susan Lederer that appeared in the American Medical Association Journal of Ethics discussing what happens when research participants die.

“Bernie Sanders Blocks Obama’s FDA Nominee for Big Pharma Ties”

Yesterday, senator and presidential candidate Bernie Sanders announced that he will formally oppose Robert Califf’s nomination as FDA commissioner. “Dr. Califf’s extensive ties to...

“Punish People, Not Just Corporations”

Drug makers have faced large fines for unethical and harmful practices but have simply treated these as a cost of doing business. Ed Silverman reports...

University of Minnesota Ends Recruiting of Research Subjects on Involuntarily Holds

The University of Minnesota announced a change to its research ethics policies this month after coming under criticism “following the recruitment of a schizophrenia...

“Woman Can Sue Study Sponsor for Suicide Try”

A woman in Texas attempted suicide while in the active group of a clinical trial for smoking-cassation drugs Chantix and Zyban, both known to...

Hospital Website Health Care Information May Not Be Reliable

An investigation found that many US hospital websites were more like advertising outlets than educational portals.

“How Open Data Can Improve Medicine”

“Those who possess the data control the story.” In the wake of the reanalysis of the infamous Study 329, where scientific data claiming the antidepressant Paxil was safe and effective for teens was egregiously manipulated, researchers are pushing for open access to raw data. “The issue here, scientists argue, is that without independent confirmation, it becomes too easy to manipulate data.”

“Opioids and Benzos Not a Good Combination, Health Directors Say”

“Health Commissioner Leana Wen will join other health directors across the country today in asking the federal government to require a ‘black box warning’...

Canadian Institute of Health Identifies Provinces Overprescribing Antipsychotics

“A new study is giving insight into how long-term care patients in the province are progressing — or, in some cases, worsening — over time. It found those living in central Newfoundland are more likely to be given antipsychotic drugs they don't need.”

“Why Does Psychiatry So Often Get a Free Pass on Standards of Evidence?”

Rob Wipond takes HealthNewsReview.org to task for its coverage of a Philadelphia Inquirer article about a medical device designed for people experiencing panic. He writes that “hyperbolic psychiatric and psychological claims frequently get free passes from otherwise thoughtful medical critics.”

“New Pill for Boosting Female Libidos Off to a Slow Start”

Ed Silverman reports that only 80 prescriptions for Addyi, or Flibanserin, were filled in the drugs’ first two weeks on the market. Article →

“Saving Congressman Murphy from Fraudulent Information”

Dennis Embry, a clinical psychologist and government consultant on mental health, shares a letter he sent to congressman Murphy warning him about how he may have been misled concerning his mental health bill. “I am specifically writing you about erroneous, false information you’ve been given about the National Registry of Evidence Base Programs and Practices. That erroneous information is likely to cause serious problems, which have been withheld from you.”

“Why Ted Cruz’s Plan to Overhaul the FDA Would Jeopardize Public Health”

"To be sure, the FDA review process is not perfect. What is? But the agency is still considered the gold standard by which other...

Failure to Report, Patients at Risk”

"A STAT investigation finds that “Most research institutions — including leading universities and hospitals in addition to drug companies — routinely break a law that requires...

“Drug Trials Not Reported in Line with Ethical and Legal Demands”

“Decisions about the effectiveness of drugs are being made with incomplete information because results of almost three-quarters of clinical trials are still not published...

“Hospitals Want to Test Drug with No Consent”

“A group of Boston doctors is proposing to join a study that would provide emergency treatment for brain-injured patients without obtaining the trauma victims’...

“Second Patient Dies in Zafgen Obesity Drug Trial”

Two patients have now died while taking the drug beloranib in an obesity drug trial. Both patients were in the active arm of the study and had received the drug rather than a placebo. Zafgen did not say whether it believed the drug had caused the blood clotting in the lungs that led to the patient’s death.

GSK to Face Lawsuits Over Antidepressant Paxil and Birth Defects

The antidepressant Paxil has been linked to birth defects. "An Ohio federal judge on Wednesday ruled that GlaxoSmithKline must face a product liability suit brought by a woman whose child was born with heart defects after she took the antidepressant Paxil during her pregnancy, ruling that she had successfully pled fraud."

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