Tamiflu: A High Cost of Ineffectiveness?

by Catherine J. Frompovich

Recently, information began surfacing again about the antiviral drug Tamiflu® that has to get healthcare consumers questioning its effectiveness, if not the advertising spin used to promote its intended sales market and branding.

As a result of the Cochrane Collaboration and British Medical Journal (BMJ) review published early in April 2014, there is “…no good evidence that the drugs prevented the spread of the virus between people, or any of its serious consequences, such as infections. It found Tamiflu increased the risk of psychiatric disturbances, renal problems, nausea, vomiting and headaches.” [1]

Two antiviral drugs were reviewed after four years of trying to get the full records of more than 24,000 research participants from 20 trials of Tamiflu® made by Roche and 26 Relenza® (made by GlaxoSmithKline) trials.

According to The Boston Globe,

They found that compared with a placebo, Tamiflu shortened the duration of flu symptoms by a little less than a day on average – from 7 to 6.3 days – but led to more side effects. These included nausea and vomiting and, in those who took the drugs for weeks to prevent the flu, headaches, kidney problems, and psychiatric conditions such as depression or confusion, according to the findings published Wednesday in the British Medical Journal. Relenza, which is inhaled, had a similar effect on shortening symptoms, with no increased risk of side effects. [2]

Dr. Fiona Godlee, editor-in-chief of the BMJ who worked with the Cochrane group to procure full release of the manufacturers’ trial data, had this to say:

This is a situation where the effectiveness of the drugs have been overplayed and the harms underplayed. [2] [CJF emphasis added]

However, Dr. Godlee, if we want to be objective about Big Pharma products, these two antiviral drugs’ effectiveness overplayed and harms underplayed is not an anomaly. It happens all the time, and especially with vaccine trials, I contend. What went on with approving the HPV (human papillomavirus) vaccines needs not only a review but an investigation, I contend. Will you and the Cochrane Collaboration please obtain the research and trial data for both Gardasil® and Cervarix® and see what you come up with? The results, I predict, could be shocking.

The unfortunate part about those two antiviral drugs reviewed is that governments worldwide bought Big Pharma propaganda, ‘science’, advertising, and branding information “hook, line, and sinker”—that is, they went all out to stockpile them to the tune of billions of dollars. For example: “The US spent $1.3 billion on its stockpile of antivirals, while Britain spent £424 million on Tamiflu alone.” [1] “…Australia had spent on Tamiflu and Relenza, but the current value of the stockpile, which includes those drugs as well as other products, was $192 million.” [1]

USA Today, April 10th edition online, has this to say:

“Peter Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy and a co-author of the Cochrane review, says the team focused on the 20 trials because it was more interested in the more rigorous randomized, placebo-controlled research. “Many of these 77 trials did not meet that criteria,” he says. 

“I’m not interested in health scares,” Doshi adds. “What we’ve found here are statistically significant increases. Do I know absolutely for certain, without a shadow of a doubt, that Tamiflu is responsible for these (negative effects), based on the trial methodology? No. But what I’m seeing here are clear reasons to be concerned and to look into it further.” [3]

Readers may want to make certain to view the embedded video and interview with Dr. Thomas Jefferson of the Cochrane Collaboration on the USA Today webpage. http://www.usatoday.com/story/news/nation/2014/04/09/tamiflu-relenza-study/7478287/

Another of the reviewers, Chris Del Mar, Professor of Public Health at Bond University, Australia, had this to say:

What we did that’s unusual in this review is we didn’t just rely on published data, we realised that this could be biased… that the less good data were being withheld in some way. [1]

Furthermore, in his paper “The Tamiflu Saga Shows Why All Research Data Should Be Public,” Professor Del Mar makes some important remarks regarding pharmaceuticals, the review process, and that often it’s “a war of words with lots of public relations.” Below are some of Del Mar’s sentiments.

• Roche performed trials and the results were used to get approval from different regulatory authorities for it to be used routinely. The agencies include the US FDA (Federal Drug Administration), Europe’s EMA (European Medicines Authority), and Australia’s TGA (Therapeutic Drug Administration). 
• The FDA approved Tamiflu for shortening the illness, but not for preventing complications. “Complications” means secondary (bacterial) infections, such as pneumonia. The EMA and TGA approved it for both indications.
• The approval process is secret, ostensibly for “commercial interests”, although what these are at this stage of the drug’s development (testing how effective the drug is) remains unclear. Still, we often don’t know outside the closed doors what issues are raised in the clinical study reports. 

Probably the most remarkable statement Professor Del Mar made in his paper is this:

The whole rigmarole has two implications. 

First, we still remain in some doubt about the effectiveness of Tamiflu for preventing influenza complications. This matters because it was the prime reason the world armed itself with warehouses of Tamiflu under the threat of pandemic influenza in 2009. 

Roche sold literally billions of dollars worth of Tamiflu for this singular reason. But has the world been sold a pup? Until the trials are openly released for scrutiny, it’s impossible for us, the world, the purchasers of this drug, to know. 

Second, the implications are far beyond just Tamiflu. Until recently, the world had adopted the randomised controlled trial as the benchmark test for treatments. But there are clearly some problems with this. 

One of these problems is the partial release of trial data (effected [sic] by selective publishing) that will help the sales of a commercial drug or device. 

We are concerned that this might have happened in this instance, even though the drug company in question had declared (several times, including originally in 2009) that it will provide all the data we need. [4]

Professor Del Mar contends the above scientific sinfulness can be corrected by mandating that all clinical trials be registered. There’s a campaign to do just that; it’s called Alltrials http://www.alltrials.net/.

What this writer would like to point out in view of the above information, is that selective publishing and other ‘tricks’ are employed to get pharmaceuticals approved, especially vaccines which are ‘sacred cows’ no one seems to want to investigate.

Additionally, there is another ‘sacred cow’; it’s in the chemical industry – specifically GMOs, genetically modified organisms, which have become food crops. Monsanto, Dow, Pioneer, Aventis, Mycogen, and Syngenta produce Bt-crops, in particular, that have been designated by the U.S. EPA as PESTICIDES! Humans and animals eat those crops and their byproducts as supposedly ‘healthful’ food and/or food processing ingredients. Don’t believe that? See this EPA listing PIP [Plant Incorporated Protectants / Pesticides] Registrations http://www.epa.gov/opp00001/biopesticides/pips/pip_list.htm Furthermore, there’s an unanswered question regarding Bt-GMOs. Can – or do – humans grow Bacillus thuringiensis in their intestinal tracts after eating fresh Bt-corn-on-the-cob!

Moreover, Professor Del Mar went on to say, “Cochrane reviews are helpful to clinicians, especially when different trials on the same topic provide different answers.” However, that does not hold true for the U.S. FDA, which, in this writer’s opinion, disregards most of what Cochrane reviews find and point out.

FDA carelessly sticks with U.S. Big Pharma’s fudged science, I contend. Tamiflu should be another wakeup call that, apparently, everyone in federal health agencies has tendencies to ignore. That has to be stopped by the U.S. Congress who has oversight over the FDA.

Tamiflu and Neuropsychatric Disturbances in Adolescents

The British Medical Journal published a paper with that title in June of 2007 wherein a report was made that Japanese health authorities had advised against prescribing oseltamivir (Tamiflu®) to adolescents ages 10 to 19 years due to two 14-year-olds who jumped to their deaths with taking the antiviral drug. Furthermore, 52 other deaths, including 14 children or adolescents, also were associated with that same drug.

I should note that Japan recently has gone on record as not recommending the HPV vaccines and that further investigation is needed before it can. Japan has invoked and used the Precautionary Principle [5] in both cases, something USA health agencies dismiss totally, in my opinion, as they consider vaccines as dogmatically safe.

Other adverse effects from oseltamivir include: raised liver enzymes, hepatitis, serious skin reactions, including Stevens-Johnson syndrome [6], and erythema multiforme [7].

Oseltamivir Side Effects

According to the maker of Tamiflu, Genetech/Roche [8], here’s important information to know about the antiviral drug, which readers ought to save.

Note that changes in behavior, especially children, such as confusion, speech problems, shaky movements, seizures, hearing voices or seeing things that are not there (hallucinations) after taking Tamiflu need to be reported to your doctor immediately and stop taking the antiviral drug.

Here is other important information for healthcare consumers to know about Tamiflu that indicate you may not be a candidate for taking Tamiflu:

• Have kidney problems.
• Have a history of fructose (fruit sugar) intolerance. Tamiflu contains sorbitol and may cause stomach upset and diarrhea in people who are fructose intolerant.
• Are pregnant or plan to become pregnant. It is not known if Tamiflu will harm your unborn baby. 
• Are breastfeeding or plan to breastfeed. It is not known if Tamiflu passes into your breast milk. You and your healthcare provider should decide if you will take Tamiflu while you are breastfeeding. [8] [Shouldn’t that be studied and known before releasing the drug onto the market?]

Pandemic Pandemonium 

Readers undoubtedly will recall that the 2009 Swine flu (H1N1) pandemic did not pan out; it was a dud, despite all the fear-mongering about it. According to Gretchen Michael of the U.S. Health and Human Services, here’s the official HHS word in response to The Boston Globe’s inquiry:

In future pandemic responses, HHS purchases of antiviral drugs and vaccines will be based on risk-benefit analyses using all product safety and efficacy and disease severity and transmission data available at that time. [2]

Sounds like nothing new or an anticipated change as a result of the latest information from the Cochrane Collaborative and the BMJ. Just like I said earlier, FDA tends to disregard the Cochrane reviews.

What’s a Person to Do?

There are other resources for dealing with the flu bug.

First and foremost, eat healthfully and get rid of all junk foods, sweets, candy, sodas, and starchy edibles from your dietary. Disease organisms latch on to and thrive in an acidic inner-body environment. The edibles just mentioned turn to an acidic ash when eaten/digested so that’s a big clue about how to keep from catching colds and the flu.

Second, know that there are homeopathic remedies that deal effectively with flu. Become acquainted with them and get in a fresh supply. Check out this resource and become acquainted.

Third, consider Nature’s equivalent to Tamiflu: Elderberry extract. For starters, check out “Elderberry Trumps Tamiflu for Flu Remedy.”

Another natural remedy is star anise that can be made into tea. According to National Geographic, star anise is used to make Tamiflu! Who knew?

The eight-pointed seedpods are harvested and dried before Roche’s extraction process yields shikimic acid for Tamiflu. Just 2.2 pounds (1 kilogram) of acid is produced from every 66 pounds (30 kilograms) of pods, according to Roche’s Web site. [9]

The antiviral drugs that were reviewed should be a wakeup call for every healthcare consumer, healthcare safety advocate, Big Pharma, its scientists and researchers, the U.S. HHS/CDC/FDA, and Congress.

Vaccine safety advocates have been trying to warn everyone, but no one wants to listen and face the music that Big Pharma produces pseudoscience, which CDC and FDA gobble up like ice cream on a stick. The really sad part is that Congress goes along with it.

The take-away lesson from all this is that healthcare consumers truly need to stop believing advertising and public relations campaigns in the media, including “paid Pharma shills,” and investigate the real science about anything you put into your body as food, water, medicine, vaccines, and recreational drugs. There are consequences.

Notes:

[1] http://www.smh.com.au/federal-politics/political-news/antiviral-drug-stockpile-a-waste-of-money-says-study-20140410-zqt3i.html#ixzz2yTdatXah
[2] http://www.bostonglobe.com/lifestyle/health-wellness/2014/04/09/evidence-that-anti-viral-drugs-for-flu-prevent-serious-complications-deaths/sSpMLDjRhGwSexWYk2kzWO/story.html
[3] http://www.usatoday.com/story/news/nation/2014/04/09/tamiflu-relenza-study/7478287/
[4] http://www.australasianscience.com.au/article/issue-june-2013/tamiflu-saga-shows-why-all-research-data-should-be-public.html
[5] http://en.wikipedia.org/wiki/Precautionary_principle
[6] http://www.dermis.net/dermisroot/en/30254/diagnose.htm
[7] http://emedicine.medscape.com/article/1122915-overview
[8] http://www.tamiflu.com/side-effects
[9] http://news.nationalgeographic.com/news/2005/11/1128_051128_star_anise_2.html

Resources:

BMJ Group Blogs

What does Tamiflu do, and how will we know?
http://blogs.bmj.com/bmj/2013/06/26/trish-groves-what-does-tamiflu-do-and-how-will-we-know/

Japan issues Tamiflu warning after child deaths. Times 21 March 2007
www.timesonline.co.uk/tol/news/world/asia/article1549260.ece

Food and Drug Administration, Center for Drug Evaluation and Research. Pediatric safety update for Tamiflu. Pediatric Advisory Committee meeting, 18 November 2005.
www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4180b_06_06_summary.pdf

Is Swine Flu a Marketing Exercise for Tamiflu?
http://www.emed.com.au/2477

image source: AP via The Sydney Morning Herald