Some of the ads for hepatitis C drugs included the Centers for Disease Control and Prevention ( CDC ) logo which instantly increased credibility but also raised questions about Gilead donations to the CDC foundation and quid pro quos . Few realize that the CDC foundation boasts many drugmaker donors like Abbott , AbbVie , Bayer , AstraZeneca , Merck , Pfizer , GlaxoSmithKline Biologicals , Eli Lilly , Amgen , Genentech … and Gilead which raises questions about monetary conflicts of interest as did the Prescription Drug User Fee Act ( PDUFA ) enacted in 1992 . PDUFA allowed drugmakers to pay significant fees to the notoriously underfunded Food and Drug Administration ( FDA ), streamlining product reviews but possibly incentivizing approvals in the process , charged critics .
Do Faster Approval Foster Greater Safety Signals ?
Price was only one problem with the new , higher-priced drugs that debuted with incentivized approvals . The lucrative hepatitis C drugs , for example , had been rushed to market so quickly , a serious side effect had been missed : the drugs ’ penchant for reactivating pre-existing hepatitis B ! When the overlooked safety signal surfaced , the FDA had to add to the label a post hoc warning about the dangerous side effect but the drugs were already widely in use , causing critics to wonder if patients had served as “ guinea pigs .” The missed safety signal was reminiscent of the “ osteonecrosis of the jaw ” side effect attributed to bone drugs that was discussed in the “ Protecting Bones From Products That Protect Bones ” chapter of the first edition of this book . It was dentists , not drug makers or the FDA , who caught the serious side effect with patients again serving as de facto lab animals .
In 2017 , the New York Times reported additional , undisclosed risks with the hepatitis C drugs . Of 250,000 patients treated with them , 524 experienced liver failure and 165 died wrote the newspaper . “ An additional 1,058 had severe liver injury , and in 761 the drugs appeared not to work .”
Thomas J . Moore , a senior scientist at the Institute for Safe Medication Practices , echoed what many were thinking as the hepatitis drug risks unfolded : does the rush to bring a new drug treatment to market come at an unforeseen cost to patient safety ? Were they approved too quickly ?
Selective Serotonin Reuptake Inhibitors ( SSRI ) Antidepressants Discredited
In 2022 , a group of University College London [ UCL ] scientists wrote in the journal Molecular Psychiatry that after reviewing decades of research , there is no evidence that serotonin levels or serotonin activity are responsible for depression — the theory on which selective serotonin reuptake inhibitors ( SSRI ) antidepressants were based and marketed .
“ The popularity of the ‘ chemical imbalance ’ [ serotonin ] theory of depression has coincided with a huge increase in the use of antidepressants . Prescriptions for antidepressants have risen dramatically since the 1990s ,” said the article ’ s lead author , Professor Joanna Moncrieff , a Professor of Psychiatry at UCL . “ Thousands of people suffer from side effects of antidepressants , including the severe withdrawal effects that can occur when people try to stop them , yet prescription rates continue to rise . We believe this situation has been driven partly by the false belief that depression is due to a chemical imbalance . It is high time to inform the public that this belief is not grounded in science .”
Dr . Mark Horowitz , a training psychiatrist and clinical research fellow in Psychiatry at UCL and co-author of the article added , “ One interesting aspect in the studies we examined was how strong an effect adverse life events played in depression , suggesting low mood is a response to people ’ s lives and cannot be boiled down to a simple chemical equation .” People experiencing depression should pursue better management of stress and trauma as well as exercise , mindfulness and psychotherapy wrote the authors . Moreover , the role of poverty , stress , and loneliness in depression has been overlooked because of fidelity to the now discredited serotonin theory they suggest . The authors also note that SSRIs could actually produce “ the opposite effect in the long term ” — causing greater depression .
Antidepressants Addictive And Not Always Effective
The findings of the UCL scientists help to explain the enigma that has baffled many : even as antidepressant use has never been higher suicides are also up , zooming and accounted for 14.5 deaths per 100,000 people in the US in 2019 . Are they even working ? In the military , where antidepressants are heavily prescribed , suicides have never been higher . While the over-prescription of antidepressants , “ selling ” of depression and speciousness of the serotonin theory have been exposed for decades , other risks have emerged since the drugs were first marketed . For example , SSRIs are now correlated with bone loss and fracture risk as well as the dreaded intestinal condition of Clostridium difficile .
In 2018 , the New York Times exposed another danger of SSRI antidepressants : they can be very difficult to quit and truly addictive ( though drug makers prefer to call the addiction effects a “ discontinuation syndrome .”) Some patients say they were not warmed by their doctors that they may be indefinitely parked on the drugs because of side effects like dizziness , nausea , headache and brain zaps
The Trial Lawyer x 37