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Flu Drug Tamiflu

Story at-a-glance -

  • Drug makers hid a significant amount of negative data on flu drug Tamiflu from the public
  • The Cochrane Collaboration put in a four-year effort, including a Freedom of Information suit, to uncover the hidden documents (all 160,000+ pages of them)
  • The uncovered evidence does not support claims that Tamiflu lowers the risk of flu complications
  • The benefits of Tamiflu do not appear to outweigh the risks or justify governments stockpiling the drug

Hidden Science Reveals Major Tamiflu Scam

October 21, 2015 | 54,133 views

By Dr. Mercola

Anti-viral flu drugs like Tamiflu (oseltamivir) are stockpiled in many countries, including the US, for treating and preventing seasonal and pandemic influenza.

Influenza can be deadly, but if you're otherwise healthy, it typically is a self-limiting illness that runs its course in a few days and requires no treatment. 

Historically speaking, there have been flu outbreaks, such as the Hong Kong flu of 1968 to 1969, that were estimated to have killed over 1 million people.

If a particularly lethal flu strain were to emerge, the idea behind stockpiling is that governments would already have anti-viral flu drugs at the ready so they could potentially save thousands, or hundreds of thousands, of lives.

It sounds good in theory, but the reality is much less convincing. The most glaring issue stems from the fact that the available anti-viral drugs do not appear to be very effective at fighting the flu and instead are associated with serious side effects.

The US government has spent an estimated $1.3 billion to stockpile Tamiflu, despite a review from the Cochrane Collaboration that questioned the drug's effectiveness, and called the billions of dollars spent to stockpile the drug a waste of money.1

Cochrane Review: Benefits of Anti-Viral Flu Drugs Do Not Outweigh the Risks

The Cochrane Collaboration is considered to be the gold standard in evidence-based reviews. Previous versions of their review on anti-viral flu drugs revealed unresolved discrepancies in the published trials, including "substantial publication bias."

While there were numerous studies on the topic, only a limited number had been published.

As a result, the Cochrane Collaboration turned to a more reputable source of data: complete clinical study reports. Clinical study reports are "unpublished, extensive documents with great detail on the trials that formed the basis for market approval."

Until recently, these documents were only available to manufacturers and regulators, but, after a four-year effort, including a Freedom of Information suit, the researchers were able to assess these regulatory documents (all 160,000+ pages of them).

What they found was that the evidence does not support claims that these drugs (Tamiflu and another anti-viral drug Relenza [zanamivir]) lower the risk of complications from the flu (such as pneumonia) or that the benefits outweigh the risks.2 Dr. Tom Jefferson, who led the study, noted, "I wouldn't give it [Tamiflu] for symptom relief… I'd give paracetamol [Tylenol]."3

No Evidence to Support Claims That Tamiflu Reduces Viral Transmission

The review also found no evidence to support claims that the drugs help to reduce viral transmission, which undoubtedly is a key reason why they would be stockpiled by the government.

The World Health Organization (WHO) even classifies Tamiflu as an "essential" medicine, which they say are "selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness."4

But the review calls this into question and suggested WHO consider dropping Tamiflu from its list of essential medicines, noting "there is no credible way these drugs could prevent a pandemic."5 The review revealed:6

  • Both drugs shorten the duration of flu symptoms by less than a day (specifically, by just 16.8 hours)
  • Tamiflu did not affect the number of hospitalizations; Relenza trials did not record this data
  • The effects of the drugs on pneumonia and other flu complications were unreliably reported and included limitations in diagnostic criteria and problems with missing follow-up on participants
  • Tamiflu was associated with nausea, vomiting, headaches, kidney problems, and psychiatric events, and may induce serious heart rhythm problems

According to the researchers:7

"Based on our assessments of the regulatory documents (in excess of 160,000 pages), we came to the conclusion that there were substantial problems with the design, conduct, reporting, and availability of information from many of the trials… We identified problems in the design of many of the studies that we included, which affects our confidence in their results."

A 2015 report compiled by the UK's Academy of Medical Sciences also reviewed all available evidence on Tamiflu and concluded it's not known whether Tamiflu would be useful during a pandemic flu outbreak.

The team noted Tamiflu was handed out "indiscriminately" during the last swine flu outbreak and may have done no good at all. They added, "We really missed a trick… by not doing clinical trials early on and just making assumptions."8

Drug Makers Hide Negative Data from the Public

The Cochrane review not only highlighted Tamiflu's lack of effectiveness and side effects, and governments' wasted billions to stockpile it. It also highlighted the fact that drug makers hid a significant amount of negative data from the public. As Newsweek reported:9

"The Food and Drug Administration (FDA) knew about it, but the medical community did not; the U.S. Centers for Disease Control and Prevention (CDC), which doesn't have the same access to unpublished data as regulators, had recommended the drug without being able to see the full picture.

When results from those unpublished trials finally did emerge, they cast doubt over whether Tamiflu is as effective as the manufacturer says.

The revelation of hidden data bolstered a growing movement against what's referred to within the research community as 'publication bias,' in which scientists squirrel away mostly negative or inconclusive findings and broadcast only their positive ones.

Concealing trial data — for which patients accept the risks of untested treatments for the greater good — is routine. As many as half of all clinical trials are never published, PLOS Medicine reported…"10

In fact, while there are more than 182,000 trials registered on ClinicalTrials.gov, fewer than 16,000 posted results in 2014. Positive trials are twice as likely to be published as others.11

Further, even though the 2007 Food and Drug Administration Amendments Act (FDAAA 801) requires most trials to report a summary of their results, 80 percent of trials do not comply with this requirement (even though many are funded with taxpayer money). And why should they? There have been no fines enforced for those that fail to comply.12

Earlier this year the Institute of Medicine (IOM) released a report, "Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk."13 IOM noted they had assembled a committee to "develop guiding principles and a practical framework for the responsible sharing of clinical trial data."

The report suggests data should be shared by funders and sponsors, journals as a condition of publication, institutional review boards, and universities. They also recommended data be shared:14

  • By posting on ClinicalTrials.gov (the protocol, research questions, and plans for analysis)
  • Within 12 months of completion and posted on a public website
  • At publication (or not later than six months after)
  • By 18 months post-study, the full data set should be shared along with the protocol
  • Within 30 days for products that win regulatory approval

As it stands, however, there is no easy way for the public, researchers, or medical professionals to review data from all scientific studies done on any given topic, even those that are publically funded.

Adding to the complexity of the issue (and the degradation of scientific research), research shows when scientists are hired by a drug's manufacturer they're more likely to report on it favorably than those who are independent. Ironically, this study was also involving Tamiflu, and found 88 percent of assessments associated with a financial conflict of interest were classified as favorable compared with 17 percent among those without a financial conflict of interest.15

Did You Know Tamiflu Has Caused Bizarre Psychiatric Effects?

Tamiflu 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, and at least 14 deaths in children and teens16 have been reported as a result of neuropsychiatric problems and brain infections. Japan actually banned Tamiflu for children in 2007 because of the steep risks. It was also around this time that the US Food and Drug Administration (FDA) began reviewing reports of abnormal behavior and other brain effects in more than 1,800 children who had taken Tamiflu. 17 You can decide for yourself whether these risks are worth a measly 16.8-hour reduction in your flu symptoms:

Nausea Vomiting
Diarrhea Headache
Dizziness Fatigue
Cough Neuropsychiatric disorders, including suicidal behavior, hallucinations, seizures, delirium, and other behavioral side effects (such as reports of children jumping off roofs shortly after taking the drug)

Here's How to Stay Well During Flu Season

A healthy immune system is the key to avoiding illnesses like the flu; as long as your immune system can stay one step ahead of the virus, you'll feel better again quickly… and in some cases may not even know you were "sick." Toward that end, if your diet contains a lot of refined sugars, grains, and processed foods, you're not doing your body any favors.

Instead of giving your body the fuel it needs to function optimally, which means being healthy enough to fight off infectious viruses, you're giving it more toxic elements that it must overcome.

For instance, too many carbohydrates in the form of sugar and grains are very unbalancing for your gut flora. Sugar is "fertilizer" for pathogenic bacteria, yeast, and fungi that can set your immune system up for an easy assault by a respiratory virus. Most people don't realize that 80 percent of your immune system actually lies in your gastrointestinal tract. That's why controlling your sugar intake is crucial for optimizing your immune system.

Additionally, making sure you're ingesting plenty of beneficial bacteria in the foods you eat (specifically fermented foods) is also crucial, as is optimizing and having your vitamin D level monitored to confirm your levels are at a therapeutic 50 to 70 ng/ml year-round. I believe optimizing your vitamin D levels is one of the most potent preventive strategies available, followed by diet (including fermented foods to optimize your gut flora), stress relief, exercise, and sleep.

There are other factors that can come into play too, of course. The following guidelines will also act in concert to support your immune system and help you avoid getting sick. You can also read my complete guide to fight the flu naturally here.

  • Take a High-Quality Source of Animal-Based Omega-3 Fats. Increase your intake of healthy and essential fats like the omega-3 found in krill oil, which is crucial for maintaining health. It is also vitally important to avoid damaged omega-6 oils (think vegetable oils), as it will seriously damage your immune response.
  • Wash Your Hands. Washing your hands will decrease your likelihood of spreading a virus to your nose, mouth, or other people. Be sure you don't use antibacterial soap using synthetic chemicals for this – conventional antibacterial soaps are completely unnecessary, and they cause far more harm than good. Instead, identify a simple toxin-free soap that you can switch your family to. Avoid overwashing your hands, however, as this can lead to tiny cuts that allow an entryway for pathogens.
  • Tried-and-True Hygiene Measures. In addition to washing your hands regularly, cover your mouth and nose when you cough or sneeze, ideally with the crook of your elbow (to avoid contaminating your hands). If possible, avoid close contact with those who are sick and, if you are sick, avoid close contact with those who are well.
  • Use Natural Immune Boosters. Examples include oil of oregano and garlic, both of which offer effective protection against a broad spectrum of bacteria, viruses, and protozoa in your body. And unlike pharmaceutical antibiotics, they do not appear to lead to resistance and the development of "super germs."
  • Avoid Hospitals. I'd recommend you stay away from hospitals unless you're having an emergency and need expert medical care, as hospitals are prime breeding grounds for infections of all kinds. The best place to recover from illness that is not life threatening is usually in the comfort of your own home.

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