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  • Since 2009, Roche, the maker of Tamiflu, has refused to release data from eight of 10 clinical trials on the drug. To address the dangers inherent with withholding of clinical trial data, the Cochrane Collaboration group in collaboration with the British Medical Journal has created the BMJ Open Data Campaign
  • There is currently no scientific basis for the worldwide recommendation to use Tamiflu for the prevention or treatment of influenza. It is believed, however, that the missing trial data may reveal potential harms, and/or verify the drug’s ineffectiveness
  • Researchers are calling for an end to the “culture of haphazard publication and incomplete data disclosure,” the implementation of more robust regulation, and full access to the raw trial data to ensure transparency
 

Science Behind Tamiflu Recommendations “Missing in Action”

November 28, 2012 | 228,581 views
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By Dr. Mercola

What should you reach for when you come down with the flu? The antiviral drug Tamiflu is the second recommendation on the US Centers for Disease Control and Prevention's (CDC) list of recommended treatments, right behind the flu vaccine.

Both the US Food and Drug Administration (FDA) and the European Medicines Agency have approved Tamiflu for both the treatment and prevention of flu, and governments around the world have stockpiled the drug at the recommendation of the World Health Organization (WHO), in preparation for potential flu pandemics.

Use of the drug dramatically increased after the worldwide 2009 swine flu pandemic. But does Tamiflu actually work?

Researchers with the prestigious Cochrane Collaboration group are now raising serious questions about the drug's effectiveness and the scientific basis for the global recommendation of the drug. In a similar vein, despite the fact that the science behind flu vaccines is flimsy at best, with numerous studies showing flu vaccines simply do not work, 150 Cincinatti health care workers now face being fired unless they get a flu shot, as reported by CNBC above. This trend of widely recommending, or worse, mandating, certain drugs and vaccines without a sturdy scientific base for doing so is truly troubling, and must be addressed.

Researchers Demand Transparency of Science

The Cochrane Collaboration conducts and publishes analyses of the scientific evidence supporting the use of various drugs and vaccines. They are considered the "gold standard" of independent scientific reviews, so when they issue a report, you're well advised to pay heed because it's free of conflict of interests and therefore very objective.

I've previously discussed a number of their reviews on flu vaccines that have shed light on the sheer lack of scientific data supporting the claim that flu vaccines are a safe and effective means of preventing seasonal influenza.

Most recently, Cochrane decided to update previous reviews that might have a bearing on influenza management, which includes Tamiflu. The previous assessment of Tamiflu was done in 2009. At the time, the group was unable to get Roche, the manufacturer of Tamiflu, to release eight of the 10 clinical trials involving the drug. The review therefore concluded that:

"Paucity of good data has undermined previous findings for oseltamivir's prevention of complications from influenza. Independent randomized trials to resolve these uncertainties are needed."

Three years later and now faced with continued stonewalling, Cochrane in collaboration with the British Medical Journal decided to take the issue to the public. The BMJ Open Data Campaign1 was recently created in an effort to force transparency as Roche continues to refuse to release the data from eight out of 10 clinical trials on Tamiflu. The campaign site contains links to Cochrane's correspondence with not just Roche, but also with the CDC and WHO — all of whom appear to be complicit in this scheme to massively promote a drug without scientific support for doing so.

"This open correspondence of letters offers readers the chance to witness attempts to compel greater accountability and responsibility in public health decision making and policy. The BMJ plans to launch other campaigns linked to its investigations in the future," the campaign page reads.

This is indeed an unsuspected and exciting turn of events. Such a campaign for transparency in science is fairly unprecedented. According to Peter Doshi,2 a postdoctoral fellow at Johns Hopkins University:

"I'm not aware of anything that does more than just a simple open letter," he tells David Payne, editor of BMJ.3 "The reader can see the correspondence almost as a stage play. One can see how the actors are actually acting, especially when one is pushing for accountability but the other party refuses to engage. If you make that kind of behavior visible, perhaps you can actually achieve progress."

"For decades industry and regulators have worked largely under agreement — sometimes forced by law and other times just tacit agreements — that the data that would be shared between them would be confidential and treated as a trade secret. Now we're realizing there is a number of enormously harmful consequences from those policies in which arguably drug disasters like Vioxx [rofecoxib] or Celebrex [celecoxib] or Avandia [rosiglitazone] could have been detected much earlier had the data been available."

Government Recommendations for Tamiflu are Based on "Nothing"

In 2009, conflicts of interest within WHO were unearthed, showing links between Roche, the manufacturer of Tamiflu, and those responsible for creating pandemic flu planning guidelines. Tamiflu is currently on the organization's list of "essential medicines." Meanwhile, the Cochrane team could find "no evidence" to suggest that Tamiflu actually reduces complications in cases of influenza...

BMJ editor David Payne reports:

"Influenza drug oseltamivir has made billions of pounds for Roche, but why won't the company give patients and doctors access to the full clinical data? ... [Cochrane researcher Tom] Jefferson told the BMJ... the US Food and Drug Administration had described Tamiflu's effects as modest. 'Despite this, WHO and CDC have been extensively promoting the drug. WHO has made Tamiflu one of the essential drugs, so it sits next door to aspirin and penicillin, cortisone,' he said.

"The CDC has extensively recommended the use of Tamiflu, and, as you know, governments worldwide have stockpiled it on the advice, essentially, of WHO. 'We were trying to find out exactly what evidence these decisions were made on. So we asked questions, and we also asked WHO and CDC whether they'd seen our review and what their thoughts were.'

"Readers will see the kind of stonewalling that we got. Indeed, my correspondence with WHO shows that they didn't answer a single one of my questions. Politicians have ignored the problem and have not demanded accountability from their own decision makers, from regulators, and from industry."

One in 10 Scientists Have Witnessed Scientific Fraud

I for one am thrilled to see that people with functional moral compasses still exist, who are willing to fight for true science-based medicine. Hiding unfavorable research and/or "cherry picking" data has become a monstrous problem in medical science, along with outright fraud.

Earlier this year, a BMJ poll4 revealed that more than 1 in 10 scientists and doctors have witnessed colleagues deliberately fabricating data in order to get their research published! At the time, Dr. Richard Lehman from Oxford University and BMJ editor of clinical epidemiology Dr. Elizabeth Loder wrote:5

"Clinical medicine involves making decisions under uncertainty. Clinical research aims to reduce this uncertainty, usually by performing experiments on groups of people who consent to run the risks of such trials in the belief that the resulting knowledge will benefit others. Most clinicians assume that the complex regulatory systems that govern human research ensure that this knowledge is relevant, reliable, and properly disseminated.

It generally comes as a shock to clinicians, and certainly to the public, to learn that this is far from the case. The linked cluster of papers on unpublished evidence should reinforce this sense of shock.

These articles confirm the fact that a large proportion of evidence from human trials is unreported, and much of what is reported is done so inadequately. We are not dealing here with trial design, hidden bias, or problems of data analysis — we are talking simply about the absence of the data. And this is no academic matter, because missing data about harm in trials can harm patients, and incomplete data about benefit can lead to futile costs to health systems. Moreover, researchers or others who deliberately conceal trial results have breached their ethical duty to trial participants."

The pair called for an end to the "culture of haphazard publication and incomplete data disclosure," through the implementation of more robust regulation and full access to the raw trial data to ensure transparency. The BMJ Open Data Campaign demanding the release of trial information about Tamiflu is part and parcel of this new effort to put the house of medical science back in order.

What You Need to Know About Tamiflu

Tamiflu (oseltamivir phosphate) is approved for treatment of uncomplicated influenza A and B in children one year of age or older. It is also approved for prevention of influenza in people 13 years or older. It is 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.

If taken within 48 hours of onset of illness, it may reduce the duration of flu symptoms by about a day to a day and a half. That's the extent of what this $100-plus treatment will get you.

However, some patients with influenza are at increased risk for secondary bacterial infections when on Tamiflu, which of course would defeat the plan of being able to jump out of bed a day sooner. Furthermore, adverse events reported include pediatric deaths, serious skin reactions, and neuropsychiatric events, including suicide committed while delirious.

According to BMJ editor-in-chief Fiona Godlee,6 Tamiflu's effectiveness has likely been overstated and serious adverse effects have been under-reported, and with eight out of 10 clinical trials "missing in action," there's every reason to suspect this to be true.

As for the claims that Tamiflu can prevent flu if you've come in contact with someone who's ill, Cochrane's review of the available data shows that any preventive effect is modest at best. Pediatric studies showed that 13 children would need to be treated to prevent just one case of flu. So if 13 children were treated, 12 would receive no benefit. A Cochrane review published in April of this year7 concluded that:

"There is currently no high-quality evidence to support targeted treatment of 'at risk' children (with underlying chronic medical conditions) with neuraminidase inhibitors."

Tamiflu — Another Massive Drug Scam?

So, let's face it. You've been scammed. Health care providers around the world have been scammed. Patients have been hurt, and children have died because of this drug, just like 60,000 people died from Vioxx, and tens of thousands were injured by the diabetes drug Avandia — all because those in charge of the science behind these "science-based" medicines decide to withhold critical data in order to protect their bottom lines.

"[T]axpayers in the United Kingdom and around the world have spent billions of dollars stockpiling a drug for which no one except the manufacturer has seen the complete evidence base," Fiona Godlee, BMJ editor-in-chief, writes.8

In response to the Open Data Campaign, Sarah Wollaston, a general practitioner and Conservative Member of Parliament in the UK, recently brought the issue of missing clinical trial data before the Parliament, asking ministers from the Department of Health to make sure all historical and future data is released in the public domain.9 British health minister Norman Lamb subsequently agreed to meet experts to discuss what he referred to as "the really important issue" of access to data from clinical trials.10

"In an email telling [Cochrane researcher] Jefferson about the planned meeting, Wollaston said: "It will surely be a turning point in the campaign for open data if we can show that £1 in every £200 of the total NHS budget for 2009 was spent stockpiling a drug for which a drug company had knowingly concealed data either showing it had no real benefits . . . or worse . . . caused real harm," Payne writes.11

The Two Most Potent Flu Prevention Strategies I Know of

So, what is the best way to avoid contracting the flu each and every year? And what can you do to speed up your recovery should you get ill? In a recent WebMD article,12 Chris Del Mar, MD, dean of medicine at Bond University in Australia, echoes my own sentiments when he says:

"Don't take [the antivirals] to prevent complications because we don't have enough good data for that. It reduces the [duration of the] illness by one day. So you have to make a decision about whether it's worth it or not."

But while Dr. Del Mar limits his recommendations to taking acetaminophen or a hot lemon drink, I believe there are far more effective alternatives. The answer lies in maintaining a robust immune system, and the first thing you want to do when you feel yourself coming down with a cold or flu is to avoid ALL sugars (fructose in particular), artificial sweeteners, and processed foods. This also includes fructose from fruit juice, and all types of grains (as they break down as sugar in your body).

It's important to remember that excessive sugar consumption effectively suppresses your immune system and impairs your defenses against all infectious disease.

I also strongly recommend taking one specific action that can help reduce your chances of ever developing symptoms in the first place, and that is to make sure your vitamin D levels are optimized year-round. There's a hypothesis that the widespread prevalence of colds and flu's may actually be due to vitamin D deficiency, which is incredibly common in the United States, especially during the winter months when cold and flu viruses are at their peak. And, while studies keep confirming the ineffectiveness of flu vaccines and flu drugs like Tamiflu, several studies now support that vitamin D can help keep you healthy during flu season:

  • In the largest and most nationally representative study13 of its kind, people with the lowest vitamin D levels reported having significantly more recent colds or cases of the flu.
  • In another study,14 published two years ago, schoolchildren were given either vitamin D or a placebo for a year. Influenza A occurred in just 10.8 percent of the children in the vitamin D group, compared with 18.6 percent children in the placebo group.
  • At least five additional studies also show an inverse association between lower respiratory tract infections and vitamin D levels.

This is not surprising once you realize that vitamin D produces 200 to 300 different antimicrobial peptides in your body that kill bacteria, viruses and fungi. Essentially, it works as a very broad antibacterial and antiviral agent.

Other All-Natural Immune-Boosting Strategies

Aside from boosting your vitamin D levels and abstaining from sugary foods, additional long-term prevention strategies include getting plenty of quality sleep, exercising regularly,15 and effectively addressing the daily stresses of your life. Taken together, these strategies lay the groundwork for a robust immune system that can stand up to all kinds of viral and bacterial assaults. However, there are also a number of all-natural therapies that can help you combat colds and flu's on a more short-term basis. Here's a listing of some of the most effective ones:

  • Zinc: According to a Cochrane Database Review of the medical research on zinc, when taken within one day of the first symptoms, zinc can cut down the duration of a cold by about 24 hours. It was also found to greatly reduce the severity of symptoms.
  • Chicken soup: Chicken contains a natural amino acid called cysteine, which can thin the mucus in your lungs and make it less sticky so you can expel it more easily. For best results, make up a fresh batch yourself (or ask a friend or family member to do so) and make the soup hot and spicy with plenty of pepper. The spices will trigger a sudden release of watery fluids in your mouth, throat, and lungs, which will help thin down the respiratory mucus so it's easier to cough up and expel. I would also strongly recommend using local pastured chicken and simmering the bones (and the feet if available) for 24 hours to get the most you can out of the chicken. It makes an absolutely heavenly soup.
  • Mushrooms: While most people think only of eating the fleshy fruiting body of the mushroom (the part that grows above ground), most of the benefits are actually located in their complex root structure, called the mycelium. Beta glucans and proteoglycans are the primary biologically active compounds in the mushroom fruit body and mycelia that support your immune system. The beta glucans are special proteins with unique side-branching patterns that "fit" perfectly with cellular receptor sites that support your immune system, just like a key in a lock.
  • Mushrooms also contain trace minerals, polysaccharides, amino acids and fiber that support your health by protecting against environmental stressors; supporting your detoxification process; and promoting healthy gut flora and optimal digestion, just to name a few of the known health benefits.

  • Vitamin C: A very potent antioxidant; use a natural form such as acerola, which contains associated micronutrients. You can take several grams every hour till you are better unless you start developing loose stools
  • Oregano Oil: The higher the carvacrol concentration, the more effective it is. Carvacrol is the most active antimicrobial agent in oregano oil.
  • Propolis: A bee resin and one of the most broad-spectrum antimicrobial compounds in the world; propolis is also the richest source of caffeic acid and apigenin, two very important compounds that aid in immune response.
  • A tea made from a combination of elderflower, yarrow, boneset, linden, peppermint and ginger: drink it hot and often for combating a cold or flu. It causes you to sweat, which is helpful for eradicating a virus from your system.
  • Olive leaf extract: Ancient Egyptians and Mediterranean cultures used it for a variety of health-promoting uses and it is widely known as a natural, non-toxic immune system builder.

Protect Your Right to Informed Consent and Defend Vaccine Exemptions

With all the uncertainty surrounding the safety and efficacy of vaccines, it's critical to protect your right to make independent health choices and exercise voluntary informed consent to vaccination. It is urgent that everyone in America stand up and fight to protect and expand vaccine informed consent protections in state public health and employment laws. The best way to do this is to get personally involved with your state legislators and educating the leaders in your community.

THINK GLOBALLY, ACT LOCALLY.

National vaccine policy recommendations are made at the federal level but vaccine laws are made at the state level. It is at the state level where your action to protect your vaccine choice rights can have the greatest impact. It is critical for EVERYONE to get involved now in standing up for the legal right to make voluntary vaccine choices in America because those choices are being threatened by lobbyists representing drug companies, medical trade associations, and public health officials, who are trying to persuade legislators to strip all vaccine exemptions from public health laws.

Signing up for NVIC's free Advocacy Portal at www.NVICAdvocacy.org gives you immediate, easy access to your own state legislators on your Smart Phone or computer so you can make your voice heard. You will be kept up-to-date on the latest state bills threatening your vaccine choice rights and get practical, useful information to help you become an effective vaccine choice advocate in your own community. Also, when national vaccine issues come up, you will have the up-to-date information and call to action items you need at your fingertips.

So please, as your first step, sign up for the NVIC Advocacy Portal.

Share Your Story with the Media and People You Know

If you or a family member has suffered a serious vaccine reaction, injury, or death, please talk about it. If we don't share information and experiences with one another, everybody feels alone and afraid to speak up. Write a letter to the editor if you have a different perspective on a vaccine story that appears in your local newspaper. Make a call in to a radio talk show that is only presenting one side of the vaccine story.

I must be frank with you; you have to be brave because you might be strongly criticized for daring to talk about the "other side" of the vaccine story. Be prepared for it and have the courage to not back down. Only by sharing our perspective and what we know to be true about vaccination will the public conversation about vaccination open up so people are not afraid to talk about it.

We cannot allow the drug companies and medical trade associations funded by drug companies or public health officials promoting forced use of a growing list of vaccines to dominate the conversation about vaccination. The vaccine injured cannot be swept under the carpet and treated like nothing more than "statistically acceptable collateral damage" of national one-size-fits-all mandatory vaccination policies that put way too many people at risk for injury and death. We shouldn't be treating people like guinea pigs instead of human beings.

Internet Resources Where You Can Learn More

I encourage you to visit the website of the non-profit charity, the National Vaccine Information Center (NVIC), at www.NVIC.org:

  • NVIC Memorial for Vaccine Victims: View descriptions and photos of children and adults, who have suffered vaccine reactions, injuries, and deaths. If you or your child experiences an adverse vaccine event, please consider posting and sharing your story here.
  • If You Vaccinate, Ask 8 Questions: Learn how to recognize vaccine reaction symptoms and prevent vaccine injuries.
  • Vaccine Freedom Wall: View or post descriptions of harassment and sanctions by doctors, employers, and school and health officials for making independent vaccine choices.

Connect with Your Doctor or Find a New One That Will Listen and Care

If your pediatrician or doctor refuses to provide medical care to you or your child unless you agree to get vaccines you don't want, I strongly encourage you to have the courage to find another doctor. Harassment, intimidation, and refusal of medical care is becoming the modus operandi of the medical establishment in an effort to stop the change in attitude of many parents about vaccinations after they become truly educated about health and vaccination.

However, there is hope.

At least 15 percent of young doctors recently polled admit that they're starting to adopt a more individualized approach to vaccinations in direct response to the vaccine safety concerns of parents. It is good news that there is a growing number of smart young doctors, who prefer to work as partners with parents in making personalized vaccine decisions for children, including delaying vaccinations or giving children fewer vaccines on the same day or continuing to provide medical care for those families, who decline use of one or more vaccines.

So take the time to locate a doctor, who treats you with compassion and respect and is willing to work with you to do what is right for your child.

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