A whistleblower lawsuit has been filed against drugmaker Roche, alleging the company made false claims and misrepresented studies, causing the U.S. government to stockpile $1.5 billion of its influenza medicine Tamiflu (oseltamivir).1 The lawsuit was filed by Dr. Thomas Jefferson, a researcher associated with the Cochrane Collaboration research network, under the False Claims Act, in which individuals may file suit on behalf of the government. Jefferson has been questioning Tamiflu’s effectiveness since 2009. The lawsuit, which was unsealed in September 2019, alleges Roche duped the U.S. government into stockpiling Tamiflu while mispresenting its effectiveness. According to the Houston-based Lanier Law Firm, which filed the suit:
‘Multisystem Failure’ Involved in Tamiflu’s SuccessAntiviral drugs like Tamiflu are still recommended by government agencies like the U.S. CDC,3 despite long-standing studies questioning their effectiveness and safety. At one point, the World Health Organization (WHO) even classified Tamiflu as an "essential" medicine,4 "selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness" — but downgraded the drug’s status in 2017. In July 2017, WHO moved Tamiflu from a “core” essential medicine to a “complementary” drug, which is used for those that are less cost effective.5 (To clarify, a correction to the article was published in November 2017, saying the drug was still on the essential list, but “downgraded.”6) In a BMJ editorial, Mark Ebell, professor of epidemiology at the University of Georgia, called the move “far too late” and described a multisystem failure that allowed Tamiflu to become a blockbuster medication.7 According to Ebell:8
Examples of system-wide failures that let Tamiflu slip through regulatory cracks included a failure to publish all available evidence and make that data available at the individual patient level, along with a failure of recognizing the limitations inherent to observational data. It wasn’t until repeated requests from The BMJ were honored that data from unpublished trials were released to researchers, revealing the true extent of Tamiflu’s effectiveness — or lack thereof.9 Tamiflu Reduced Duration of Flu by Just 16.8 HoursIn the BMJ review of Tamiflu it’s found that Tamiflu shortened the duration of flu symptoms by less than a day, specifically, by just 16.8 hours, and did not affect the number of hospitalizations.10 In exchange for this very modest benefit, Tamiflu caused nausea and vomiting and increased the risk of headaches and renal and psychiatric syndromes. “The trade-off between benefits and harms should be borne in mind when making decisions to use oseltamivir for treatment, prophylaxis or stockpiling,” the researchers added.11 What’s more, in a Cochrane Review of the data on both Tamiflu and Relenza (zanamivir), another antiviral drug, Jefferson and colleagues noted:12
Further, the review noted that the drugmakers’ proposed mechanism of action, which suggests the drugs work via a multisystem and central action, does not fit with the clinical evidence they reviewed. Any beneficial effects of the drug may have occurred due to lowering levels of pro-inflammatory cytokines or via depressing the central nervous system, not by actually inhibiting the replication of the influenza virus.13 Tamiflu Causes Psychiatric SymptomsTamiflu and Relenza are part of a group of anti-influenza drugs called neuraminidase inhibitors, which work by blocking a viral enzyme that helps the influenza virus to invade cells in your respiratory tract. The problem is that your nervous system also contains neuraminidase enzymes essential for proper brain functioning, and when blocked with these dangerous drugs, severe neurotoxicity may ensue, especially in the infants and children whose blood-brain barrier has not yet developed sufficiently. Serious side effects include convulsions, delirium or delusions and suicidal behavior. In January 2020, an Oregon woman warned that her son experienced hallucinations while taking the drug, telling a news outlet, “He was saying that everything was going fast and that everything was in fast forward. He was hearing voices. He was seeing things. He was crying and grabbing his head and it was really scary.”14 The boy’s pediatrician said the hallucinations were due to Tamiflu, and Dr. James Shames, Jackson County medical health director, likewise stated, “Psychiatric symptoms are more unusual. It wasn’t even recognized until after the drug had been released and they started doing further studies. It does look like it occurs more commonly in children.”15 In another report, a 6-year-old girl in Texas also had hallucinations while taking Tamiflu and even tried to jump out of a second story window.16 A 16-year-old boy with no prior suicidal thoughts or depression also committed suicide less than 24 hours after taking the drug, which his parents believe is what caused the suicide to occur.17 Japan banned the use of Tamiflu in children and teens in 2007, after cases of teenagers trying to dump from apartment building windows while taking the drug. In 2018, the country lifted the ban, but still said the relationship between Tamiflu and the unusual actions is unclear and patients should be warned of such side effects.18 Corruption Surrounding TamifluCorruption has surrounded Tamiflu from the start. Former U.S. Defense Secretary Donald Rumsfeld was made the chairman of a company called Gilead in 1997. While drug company Roche manufactured Tamiflu, it was developed by Gilead decades ago, and they gave Roche the exclusive rights to market and sell the drug in 1996 (an agreement they attempted to terminate in 2005).19 Rumsfeld held major portions of stock in Gilead and was reported to have made more than $5 million from selling shares of the company around the time of the bird flu hoax in 2005. Rumsfeld was on the board of Gilead between 1988 and 2001, and when he left to join the Bush administration he reportedly retained a large shareholding (worth $25 million or more). Roche also engaged in extensive lobbying to influence countries to stockpile Tamiflu, including in Denmark. In a 2018 review published in the Journal of Public Health, researchers investigated how members of Denmark’s pandemic planning committee experienced lobbying efforts by Roche, noting:20
Lawsuit Alleges Roche Knew Tamiflu Was IneffectiveThe whistleblower lawsuit alleges that Roche knew Tamiflu was ineffective at fighting influenza pandemics but went ahead and “masterfully marketed this drug to fill Roche’s coffers at taxpayer expense,” Clayton Halunen of Halunen Law said. “This is precisely the type of corporate behavior the False Claims Act is designed to stop.”21 Because the False Claims Act mandates payment of triple damages along with civil penalties, Roche could face a judgment in excess of $4.5 billion. Attorney Mark Lanier, of Lanier Law Firm, added:22
While Roche is on trial for fraud, the fact remains that Tamiflu is likely to do little to help in the event you or a loved one comes down with flu, and it could end up causing harm. Prevention is a far better option, and along these lines vitamin D testing and optimization has been shown to cut your risk of respiratory infections, including colds and flu, in half if you are vitamin D deficient.23,24 In my view, optimizing your vitamin D levels is one of the absolute best respiratory illness prevention and optimal health strategies available. Influenza has also been treated with high-dose vitamin C,25 and taking zinc lozenges at the first sign of respiratory illness can also be helpful. Following other basic tenets of health, like eating right, getting sound sleep, exercising and addressing stress are also important, as is regularly washing your hands — sound advice for staying healthy not only during flu season but also year-round. from http://articles.mercola.com/sites/articles/archive/2020/01/28/tamiflu-fraud-stole-billions.aspx
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