The Trial Lawyer Winter 2022 | Page 44

As Flu Fears Rose , Governments Stockpiled Tamiflu
Evan Morris , a Genentech lobbyist , reportedly hired consultants to build the frenzy over flu fears and sell Tamiflu in 2005 .
“ Dozens of U . S . senators wrote to President George W . Bush about their concerns , and the president authorized an emergency stockpile that bought $ 1 billion worth of Roche ’ s med ,” FiercePharma reported .
A whistleblower lawsuit unsealed in 2020 charged that Roche “ bilked U . S . federal and state governments out of $ 1.5 billion by misrepresenting clinical studies and falsely claiming that its well-known influenza medicine Tamiflu was effective at containing potential pandemics ,” according to Halunen Law . The UK government reportedly spent $ 710 million on stockpiling Tamiflu . Morris took his own life in July 2015 while under investigation for embezzlement .
Tamiflu ’ s Effectiveness And Safety Challenged
Claims of Tamiflu ’ s effectiveness were challenged early in the scientific literature , according to a review study titled “ Effectiveness of Oseltamivir in Adults : A Meta-Analysis of Published and Unpublished Clinical Trials ,” published in the journal Family Practice in 2012 .
“ Two large unpublished studies in the elderly and in adults with chronic disease did not find a significant reduction in the symptom duration ,” the researchers wrote .
“ There is no evidence that oseltamivir reduces the likelihood of hospitalization , pneumonia , or the combined outcome of pneumonia , otitis media [ inflammation of the inner ear ], and sinusitis in the ITT [ intention-to-treat ] population .”
Soon afterward , in a scathing report , the Cochrane Collaboration , a nonprofit group that reviews medical treatments , reported that renal disorders , high blood sugar , psychiatric disorders , and heart rhythm disturbances may be related to Tamiflu use . The BMJ and Cochrane then issued a statement charging that Tamiflu and Relenza ( an inhaled form of the
42 x The Trial Lawyer same drug ) had had their “ effectiveness overplayed , and harms underplayed .”
The BMJ and Cochrane were unable to obtain the clinical trial data on which Roche ’ s Tamiflu claims were based for a five-year period , Nature reported . In 2017 , the WHO downgraded the status of Tamiflu to “ complementary .”
More Side Effects Surfaced
In addition to the Cochrane review , post-marketing studies documented additional side effects such as allergic and anaphylactic reactions , rashes including the deadly toxic epidermal necrolysis , and aggravation of diabetes .
By 2006 , Tamiflu was also linked to neurological and psychiatric side effects and suicide .
“ The European Medicines Agency has described two deaths , both attributed to suicide , in adolescents aged 14 and 17 who were taking oseltamivir ,” the European journal Prescrire International reported .
“ According to the U . S . Food and Drug Administration , neuropsychiatric disorders were reported in 32 children ( mainly in Japan ), and include delirium , behavioral disorders , hallucinations , convulsions , and confusion .”
The IndyStar reported that the family of an Indiana teen who took his own life in 2018 blamed Tamiflu , and , also in 2018 , a 6-year-old Texan girl tried to jump out a window while on the drug .
The Prescrire authors also cited “ disturbing neurological toxicity ” in young rats exposed to Tamiflu and noted that American and European agencies “ warn against the use of oseltamivir in infants less than one year old .”
Since Tamiflu is only modestly effective in preventing or treating flu , “ the possibility of serious adverse effects should be weighed against the limited benefit of oseltamivir ,” the authors concluded .
Researchers writing in the journal Acta Neurologica Scandinavica in 2017 added more doubts about the drug ’ s safety .
“ It is known that oseltamivir inhibits nicotinic acetylcholine receptors , which are closely related to hypothermia ,” they wrote . Other receptors may be “ related to respiratory suppression followed by sudden death and psychotic reactions ,” which have been seen with Tamiflu .
Flu-Like Symptoms Caused By Drug
Tamiflu also was seen to cause the very flu symptoms it was supposed to prevent or mitigate . In 2009 , of 273 students and 53 staff given Tamiflu at a primary school in Sheffield , United Kingdom , 41 percent of the students and 47 percent of the staff reported adverse effects such as cough , fever , headache , sore throat , and nausea , according to the journal Eurosurveillance . Fourteen percent of the students and 20 percent of the staff discontinued the drug because of the effects .
Parallels Between COVID-19 Pandemic And Tamiflu Marketing
Like COVID-19 , influenza viruses continue to mutate , making vaccines less effective and raising the anxiety of patients , caregivers , and public health officials .
There ’ s also a worry in some circles that the vaccines themselves could influence virus mutations . The same is true of Tamiflu .
Notably , the CDC reported that Tamiflu created mutations as H1N1 flu became resistant to the widely used drug .
As the 2022 – 2023 flu season begins , Tamiflu is still in the news . A September study in the Journal of the American Medical Association , widely circulated by medical news sites , found early administration of Tamiflu to children hospitalized with influenza resulted in better outcomes .
Healthline , a major health site , notes , however , that the drug can cost $ 100 without insurance , may be ineffective for some flu strains , and may cause “ hallucinations , confusion , convulsions , [ and ] other neurologic or psychiatric issues .”
Yes , Tamiflu is still in the news and in use , but its safety and effectiveness questions are far from resolved .