January 27, 2020
According to estimates from the Centers for Disease Control and Prevention, as of mid-January, between 15 million and 21 million Americans already had contracted the flu—leading to as many as 250,000 hospital visits.
Many of these patients are asking their doctors for a prescription for the medication, Tamiflu, an antiviral made by Hoffman La-Roche, in hopes that it will shorten the length of their suffering by about one day—if it they take it within 48 to 72 hours of experiencing the first symptoms.
But aside from some nasty side effects from the supposed wonder drug—among them, nausea, vomiting, headaches, dizziness, eye redness, and even hallucinations in children—there’s another, more serious problem with the prescription: Tamiflu’s “cred” is dropping because, patients claim, it doesn’t perform as promised.
In fact, Oseltamivir, which goes by the brand name Tamiflu, has long claimed to shorten the duration of flu severity, to skepticism and sometimes even derision from the evidence-based science community, Science2.0 reports.
What’s more, a recently unsealed whistleblower lawsuit (United States of America, ex rel Thomas Jefferson, et al. v Roche Holding AG, Hoffman-La Roche Inc., and Genentech Inc. in the U.S. District Court for the District of Maryland— Case No. 14-CV-03665) claims the company bilked U.S. taxpayers out of $1.5 billion by misrepresenting clinical studies and publishing misleading articles falsely stating that Tamiflu reduces complications, severity, hospitalizations, mortality, and transmission of influenza .
And that $1.5 billion loss represents just the stockpiling of the drug by federal and state government agencies for availability in a pandemic. It does not include people who bought it with their own money, based on aggressive marketing campaigns which used the articles as evidence, the lawsuit alleges.
“As alleged in the complaint – Tamiflu does not do what Roche promised,” said attorney Mark Lanier of the Houston-based Lanier Law Firm. “Roche hid this fact for many years by selectively citing its studies and suppressing the data about Tamiflu. The company utilized lobbyists, key opinion leaders, and ghostwriters to promote Tamiflu with a deceptive promise to governments fearful of an influenza pandemic.”
The lawsuit brings claims under the False Claims Act, which allows individuals to bring claims on behalf of the government. It seeks reimbursement of taxpayer funds spent to purchase tens of millions of courses of Tamiflu for the Strategic National Stockpile. Roche is vulnerable to a judgment in excess of $4.5 billion—because the False Claims Act mandates payment of triple damages, plus civil penalties.
Whistleblower Dr. Thomas Jefferson, a physician and public health researcher affiliated with the respected global Cochrane Collaboration research network, has researched neuraminidase inhibitors like Tamiflu for more than two decades. He began questioning Tamiflu’s efficacy in 2009 and spearheaded efforts to have the company release the underlying clinical study data. When he finally received the data in 2013, Dr. Jefferson analyzed it and concluded that the clinical data does not support Roche’s claims about Tamiflu’s effectiveness for use in an influenza pandemic, the lawsuit states.
According to the data as analyzed by the Food and Drug Administration, Tamiflu’s effectiveness is limited to a small benefit of reducing the duration of flu symptoms and preventing onset of symptoms but not transmission or infection. In addition, as early as 2000, the FDA had warned Roche that data did not support its broader efficacy claims and that such statements were misleading.
Finally, has been no evidence of a reduction in hospitalizations or serious influenza complications; confirmed pneumonia, bronchitis, sinusitis or ear infection in either adults or children who take the drug.. There was a reported increased risk of psychiatric events of around 1% when Tamiflu was used to prevent influenza
Evidence also suggests that Tamiflu prevented some people from producing sufficient numbers of their own antibodies to fight infection.
Research contact: @Science20Radio