Tag Archive: Stockpile


What the Tamiflu saga tells us about drug trials and big pharma

We now know the government’s Tamiflu stockpile wouldn’t have done us much good in the event of a flu epidemic. But the secrecy surrounding clinical trials means there’s a lot we don’t know about other medicines we take

Tamiflu capsules

Tamiflu capsules. Photograph: Per Lindgren/REX

Today we found out that Tamiflu doesn’t work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.

That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story.

And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment.

In 2009, there was widespread concern about a new flu pandemic, and billions were being spent stockpiling Tamiflu around the world. Because of this, the UK and Australian governments specifically asked the Cochrane Collaboration to update its earlier reviews on the drug. Cochrane reviews are the gold-standard in medicine: they summarise all the data on a given treatment, and they are in a constant review cycle, because evidence changes over time as new trials are published. This should have been a pretty everyday piece of work: the previous review, in 2008, had found some evidence that Tamiflu does, indeed, reduce the rate of complications such as pneumonia. But then a Japanese paediatrician called Keiji Hayashi left a comment that would trigger a revolution in our understanding of how evidence-based medicine should work. This wasn’t in a publication, or even a letter: it was a simple online comment, posted informally underneath the Tamiflu review on the Cochrane website, almost like a blog comment.

Tamiflu being made by Roche The UK government spent £0.5bn stockpiling Tamiflu. Photograph: Hanodut/EPA

Cochrane had summarised the data from all the trials, explained Hayashi, but its positive conclusion was driven by data from just one of the papers it cited: an industry-funded summary of 10 previous trials, led by an author called Kaiser. From these 10 trials, only two had ever been published in the scientific literature. For the remaining eight, the only available information on the methods used came from the brief summary in this secondary source, created by industry. That’s not reliable enough.

This is science at its best. The Cochrane review is readily accessible online; it explains transparently the methods by which it looked for trials, and then analysed them, so any informed reader can pull the review apart, and understand where the conclusions came from. Cochrane provides an easy way for readers to raise criticisms. And, crucially, these criticisms did not fall on deaf ears. Dr Tom Jefferson is the head of the Cochrane respiratory group, and the lead author on the 2008 review. He realised immediately that he had made a mistake in blindly trusting the Kaiser data. He said so, without defensiveness, and then set about getting the information needed.

First, the Cochrane researchers wrote to the authors of the Kaiser paper. By reply, they were told that this team no longer had the files: they should contact Roche. Here the problems began. Roche said it would hand over some information, but the Cochrane reviewers would need to sign a confidentiality agreement. This was tricky: Cochrane reviews are built around showing their working, but Roche’s proposed contract would require them to keep the information behind their reasoning secret from readers. More than this, the contract said they were not allowed to discuss the terms of their secrecy agreement, or publicly acknowledge that it even existed. Roche was demanding a secret contract, with secret terms, requiring secrecy about the methods and results of trials, in a discussion about the safety and efficacy of a drug that has been taken by hundreds of thousands of people around the world, and on which governments had spent billions. Roche’s demand, worryingly, is not unusual. At this point, many in medicine would either acquiesce, or give up. Jefferson asked Roche for clarification about why the contract was necessary. He never received a reply.

Then, in October 2009, the company changed tack. It would like to hand over the data, it explained, but another academic review on Tamiflu was being conducted elsewhere. Roche had given this other group the study reports, so Cochrane couldn’t have them. This was a non-sequitur: there is no reason why many groups should not all work on the same question. In fact, since replication is the cornerstone of good science, this would be actively desirable.

Then, one week later, unannounced, Roche sent seven documents, each around a dozen pages long. These contained excerpts of internal company documents on each of the clinical trials in the Kaiser meta-analysis. It was a start, but nothing like the information Cochrane needed to assess the benefits, or the rate of adverse events, or fully to understand the design of the trials.

Packets of Tamiflu Packets of Tamiflu in a drawer at a German pharmacy. Photograph: Wolfgang Rattay/Reuters At the same time, it was rapidly becoming clear that there were odd inconsistencies in the information on this drug. Crucially, different organisations around the world had drawn vastly different conclusions about its effectiveness. The US Food and Drug Administration (FDA) said it gave no benefits on complications such as pneumonia, while the US Centers for Disease Control and Prevention said it did. The Japanese regulator made no claim for complications, but the European Medicines Agency (EMA) said there was a benefit. There are only two explanations for this, and both can only be resolved by full transparency. Either these organisations saw different data, in which case we need to build a collective list, add up all the trials, and work out the effects of the drug overall. Or this is a close call, and there is reasonable disagreement on how to interpret the trials, in which case we need full access to their methods and results, for an informed public debate in the medical academic community.

This is particularly important, since there can often be shortcomings in the design of a clinical trial, which mean it is no longer a fair test of which treatment is best. We now know this was the case in many of the Tamiflu trials, where, for example, participants were sometimes very unrepresentative of real-world patients. Similarly, in trials described as “double blinded” – where neither doctor nor patient should be able to tell whether they’re getting a placebo or the real drug – the active and placebo pills were different colours. Even more oddly, in almost all Tamiflu trials, it seems a diagnosis of pneumonia was measured by patients’ self-reporting: many researchers would have expected a clear diagnostic algorithm, perhaps a chest x-ray, at least.

Since the Cochrane team were still being denied the information needed to spot these flaws, they decided to exclude all this data from their analysis, leaving the review in limbo. It was published in December 2009, with a note explaining their reasoning, and a small flurry of activity followed. Roche posted their brief excerpts online, and committed to make full study reports available. For four years, they then failed to do so.

 

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Row erupts over influenza drug Tamiflu

Tamiflu is on the World Health Organisation's 'essential medicines' list (Flickr: kanonn)

Tamiflu is on the World Health Organisation’s ‘essential medicines’ list (Flickr: kanonn)

Governments who stockpile the anti-flu medicine Tamiflu are wasting billions of dollars on a drug whose effectiveness is in doubt, according to a new study.

The row has drawn in the drugmaker Roche, as well as industry regulators and independent scientists. Supporters of Tamiflu says the review’s conclusions are flawed and insiste the drug is both safe and effective.

The dispute over the benefits of Tamiflu, and to a lesser extent of GlaxoSmithKline’s flu drug Relenza, blew up with the joint publication by the respected Cochrane Review research network and the British Medical Journal of an analysis of trial data, which found no good evidence behind claims the drugs cut hospital admissions or reduce flu complications.

The review’s main findings were that the medicines had few if any beneficial effects, but did have adverse side effects that were previously dismissed or overlooked.

“Remember, the idea of a drug is that the benefits should exceed the harms,” says Carl Heneghan, one of the lead investigators of the Cochrane review and a professor of evidence-based medicine at Britain’s Oxford University. “So if you can’t find any benefits, that accentuates the harms.”

But Roche, which has been under fire for several years over its refusal to allow the Cochrane team unrestricted access to Tamiflu data, rejected the findings, saying it “fundamentally disagrees with the overall conclusions” of their study.

“We firmly stand by the quality and integrity of our data, reflected in decisions reached by 100 regulators across the world and subsequent real-world evidence demonstrating that Tamiflu is an effective medicine in the treatment and prevention of influenza,” it says in a statement.

Tamiflu sales hit almost $3 billion in 2009 — mostly due to its use in the H1N1 flu pandemic — but they have since declined.

The drug, one of a class of medicines known as neuraminidase inhibitors, is approved by regulators worldwide and is stockpiled in preparation for a potential global flu outbreak. It is also on the World Health Organisation’s “essential medicines” list.

 

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Disaster Preparation and Survival

Liberal media, White House owes preppers and survivalists a massive apology in the aftermath of superstorm Sandy

 

by Mike Adams, the Health Ranger
Editor of NaturalNews.com

preppers

(NaturalNews) In the wake of superstorm Sandy, preppers are the new prophets. Those who failed to prepare are the new homeless.

For as long as we can all remember, preppers and survivalists have been derided by the mainstream media, labeled “kooks” and “wing nuts” for stockpiling food, water, ammunition, medical supplies and emergency gear. Only paranoid conspiracy theorists engage in evil preparedness activities, we were told by the sellout mainstream media, and they’ve convinced many that preppers may even be terrorists.

The very word “stockpiling” has been used in a derogatory manner, as if it’s somehow bad for private citizens to stockpile food, medicine and emergency supplies that might save lives in a crisis. Never mind that the government stockpiles all these things for its own survival; citizens are routinely taught that stockpiling is bad!

Suddenly all that has changed. In the aftermath of superstorm Sandy, preppers are the ones who aren’t starving, freezing or begging the government to come save them with emergency supplies. Those who failed to prepare are now subjected to the chaotic, incompetent actions of the federal government which is, predictably, operating in a never-ending state of logistical failure.

An one example, in response to the ongoing scarcity of gasoline, New York announced that the Defense Department would be opening up free gas stations near areas hardest-hit, but that residents should stay away and let first responders fuel up ahead of them.

This, of course, set off a wave of confusion. It was then announced that those “civilians” (a derogatory term against citizens, used only in a police state) who were already in line could stay in line, but no “civilians” could join the line. Many people waited up to six hours for gasoline. Tempers flared, fist fights were commonplace, and state troopers had to be sent to gas stations to keep the peace.

Preppers, of course, already stored away spare fuel at home and therefore didn’t need to wait in line and subject themselves to the chaos and desperation.

FEMA runs out of water

This one was easy to see coming: FEMA has run out of water to distribute to Sandy victims and is now desperately trying to find a private contractor that will deliver millions of bottles of water to the region.

That this could happen in the aftermath of a storm that everybody saw coming at least a week ahead of time is nothing short of bewildering. How could FEMA, whose only job is to plan for crisis, not have stockpiled some supplies in advance of the storm?

The answer is that FEMA is just flat-out incompetent. As described in an article by Michael Patrick Leahy:

…the agency appears to have been completely unprepared to distribute bottled water to Hurricane Sandy victims when the storm hit this Monday. In contrast to its stated policy, FEMA failed to have any meaningful supplies of bottled water — or any other supplies, for that matter — stored in nearby facilities as it had proclaimed it would on its website. This was the case despite several days advance warning of the impending storm.

Once again, preppers who had stockpiled water in advance of all this were sitting pretty, living on stored water supplies. Those who invested in water filters were even able to use water that would not have been drinkable otherwise.

No electricity = no heat for cooking

Even today, the power grid is down in many areas, and for all those residents using electric stoves and toasters, that means no ability cook anything… not even to boil water!

Most people simply have no backup plan for when the power grid goes down. So they become yet another victim who needs to be rescued by a government that has a terrible track record on rescues.

Preppers, on the other hand, own non-electric cookstoves such as this Zoom Dura cookstove which can burn paper, wood, small branches and almost anything flammable. It boils water, cooks meals, and kills bacteria. No batteries required.

In the aftermath of superstorm Sandy, people who own emergency campstoves or cookstoves have been able to cook meals if they also stored some food. Something as simple as a few cans of chili can be priceless in the middle of a grid down scenario. Or some quinoa, oatmeal, rice or whatever.

I know for a fact that we shipped a large number of 40-day organic survival food pails to the Northeast in the days before the storm hit. Those people have no doubt been sitting pretty with plenty of food to eat, compared to their neighbors who didn’t prepare and are therefore starving or dumpster diving for food scraps.

Arming up with bows, machetes, firearms and baseball bats

Looting has been widespread in some areas, thanks mostly to the fact that police are spread too thin and can’t cover all the territory. At first, the looting targeted commercial buildings, where looters made off with TV projectors, flat panel displays and valuable electronics, but it soon shifted to the looting of private homes by criminals dressed as Con Edison workers.

Citizens quickly realized they would need to fend for themselves. As the NY Daily News reports:

Ever since Sandy strafed the Queens peninsula and tore up the boardwalk, it’s become an often lawless place where cops are even scarcer than electrical power and food. Locals say they are arming themselves with guns, baseball bats, booby traps — even a bow and arrow — to defend against looters.

“We booby-trapped our door and keep a baseball bat beside our bed,” said Danielle Harris, 34, rummaging through donated supplies as children rode scooters along half-block chunk of the boardwalk that had marooned into the middle of Beach 91st St.

“We heard gunshots for three nights in a row,” said Harris, who believed they came from the nearby housing projects.

Preppers, of course, already have firearms and ammo. In fact, many preppers today are investing in firearms proficiency training in order to gain combat skills. I know several firearms instructors, and they tell me their classes are jam packed, with waiting lists increasingly common.

A typical prepper owns not only a handgun, but also a combat rifle (typically an AR or AK) and a shotgun for close quarters defense. In addition, preppers stockpile at least 1,000 rounds of ammo for each. It’s not uncommon to talk to preppers who have stored 10,000 rounds of ammo for each firearm they own.

These firearms, far from causing violence, are used in the defense of life and property in communities struck by disaster. People who legally own firearms are law-abiding citizens who typically work with local law enforcement to restore peace and security to local communities and help stop criminals and looters.

That states like New York restrict private citizens from owning firearms is, in a very real sense, denying them the ability to protect themselves during a crisis when the police can’t protect them, either. Using machetes and bows is no match for a Glock 17 or an AR-15. While anti-gun people like Bloomberg or Obama like to say that guns “have no place on the streets of America,” they are wrong. Firearms in the hands of law-abiding citizens are an essential part of restoring peace and order following any crisis. In a disaster scenario, more guns in the hands of responsible citizens really does equal less crime.

It’s just common sense: When the cops are nowhere to be found, and the National Guard isn’t helping out, and FEMA’s lack of preparedness has made the local population desperate for supplies, a privately-owned firearm is the only remaining defense against criminal-minded looters and violent opportunities who try to prey on the weak. That’s why I even published a tactical home defense guide designed to stop looters and criminals from targeting innocent victims of superstorm Sandy.

The media owes preppers a massive apology

One of the realizations emerging from all this is that the media’s portrayal of preppers has been not just malicious and highly inaccurate. Preppers are not the “kooks” you see on TV shows (which the media admits are laced with pay-for-placement messages provided by the White House); they are intelligent, forward-thinking members of society who are truly a national treasure capable of saving lives in any disaster.

Preppers pick up where the police and the government drop the ball. Preppers provide food, water, emergency medicine and even local neighborhood security. They do it without being paid and without even being thanked for their contributions to society.

In the wake of superstorm Sandy, the national media — and especially the liberal media which expresses intense hatred for preppers — owes preppers a massive apology. Preppers create stability, safety and security in any crisis, and they deserve to be portrayed as the upstanding members of society they truly are.

The White House owes preppers a huge apology as well. Preppers and survivalists have, in the last few years, been characterized as “terrorists” by the Obama administration. The message is that anyone with a gun, some ammo and a stockpile of food is somehow “dangerous” or a threat to society. In reality, that person is the guy sharing food with neighbors and helping protect the neighborhood from violent criminal looters.

Famously, a prepper was recently put on a “no-fly list” and stranded in Hawaii because he was classified by the government as a “prepper.” So hold on: Stockpiling emergency supplies makes you synonymous with a terrorist now?

Preppers are actually on the target list of the U.S. government. As an active duty National Guard member named “Soldier X” has recently revealed, the Guard is being trained to “treat preppers as terrorists.”

According to Soldier X, the government is compiling lists of preppers and intends to confiscate their guns and treat them as enemy combatants in any crisis situation. So the very group the government should be thanking for providing local community stability and order is the group being targeted for arrest, detainment and possibly being sent to Obama’s secret military prisons under the provisions of the NDAA.

The federal government WANTS chaos and panic, get it?

The reality of all this is that the federal government is trying to eliminate preppers and survivalists precisely as a way to create more panic, fear and chaos. Why? Because it is from that scenario that the government can justify yet more funding for itself, more police state crackdowns and more dependency among the citizen slaves.

Remember: Every government wants to become like North Korea, where it dominates everything in society, controls all the resources and commands citizens as if they were slaves. The U.S. government is no different: Like every government, it thirsts for unlimited power.

Preppers and survivalists interfere with the growth of government power because they demonstrate the far greater power of individual preparedness. When preppers take care of themselves and don’t need to be rescued by the government, they send a “dangerous” message to the rest of society: Emergency preparedness is YOUR responsibility, not the government’s.

The White House doesn’t like people sending that message. Neither does the liberal media which persistently pushes citizen victimization and government dependence. The very idea of thinking for yourself, taking care of yourself and being self-reliant is alien to the liberal media. And that’s one reason why the liberal media is ultimately so dangerous: Many people who followed the advice of, say, the New York Times, are now DEAD in Jersey.

The bottom line: Preppers are the future of human civilization; deniers are dead

Hurricane Sandy was a walk in the park compared to what we’ll see in a national grid-down scenario. As I’ve explained many times here on Natural News, a single solar flare (or a high-altitude EMP burst weapon) could knock out most of the national power grid.

That would thrust virtually the entire nation into the scenario we’ve recently watched unfold on Staten Island and certain parts of NY. Imagine fuel scarcity, starvation, water scarcity and looting unleashed on a national scale. That’s what we will sooner or later face in America (and everywhere else, too).

When that scenario unfolds, it’s a simple matter of fact that we’re going to see the mass death of liberal media worshippers and Big Government worshippers who refused to prepare. The survivors will, by and large, be the preppers who planned ahead.

It’s Darwinism at work, backfiring on people who call themselves “Darwinists” (who almost universally do not believe in preparedness). It’s natural selection doing its thing. People who cannot adapt to survive do not tend to reproduce, while those who can adapt and survive are the ones left remaining to repopulate the planet.

In fact, the domination of the planet by the “prepping gene” is one of the most scientific ideas of our time. That’s because crisis strikes our planet on a regular basis: Solar flares, asteroids, the spread of infectious disease and even the threat of widespread nuclear war or nuclear facility failures.

Each “wave” of crisis weeds out the ignorant unprepared masses through mass death. While those people may be in a majority right now, they and their lineage have no real future.

Interestingly, modern humanity hasn’t faced a real crisis yet. By “modern,” I mean the version of civilization that has bet everything on complex electronics, food supply logistics and the continued restocking of the artificial living zones known as “cities.” This modern civilization has only existed for about seventy-five years — a blink of an eye in terms of the big picture. So it hasn’t been tested yet with a true global survival scenario. We are one solar flare away from being thrust back to the early 1900’s.

Another mass extinction event is inevitable

Sixty-five million years ago, a single rock from space wiped out the dinosaurs. It was the most violent mass-extinction event planet Earth had ever experienced. So far, there have been five mass extinction events in the known history of our planet.

Human beings are likely going to be the sixth, through the careless proliferation of nuclear power plants, the toying with GMOs and the genetic pollution of the planet, or even through the accidental release of a military bioweapon with a 98% fatality rate.

The next mass extinction event will quickly eliminate from the planet all organisms poorly adapted to survive, which includes most New York Times subscribers. It will leave behind only those humans, plants and animals with remarkable survival adaptation skills.

The most likely survivors, it turns out, are going to be well-stocked preppers who have practiced the skills of self-reliance and sustainable living.

Survival resources

If you’re serious about survival, here are some resources I recommend:

James Wesley Rawles’ Survival Blog:
www.SurvivalBlog.com

I also recommend books by Rawles on Amazon.com.

Joe Nobody:
www.HoldingYourGround.com
Author page on Amazon.com

Lehman’s Non-Electric Store:
www.Lehmans.com

Article: How to “Bug In” for survival.

Health Ranger course on self defense and preparedness.