Did a Flu Drug Manufacturer Withhold Evidence From Drug Trials?

Did a Flu Drug Manufacturer Withhold Evidence From Drug Trials?
Posted by: Dr. Mercola
December 24 2009 | 4,194 views


Doctors have alleged that Roche, the manufacturer of Tamiflu, has made it impossible for scientists to assess how well the anti-flu drug stockpiled around the globe works by withholding the evidence the company has gained from trials.

A major review of what data there is in the public domain has found no evidence Tamiflu can prevent healthy people with flu from suffering complications such as pneumonia.

Tamiflu may shorten the bout of illness by a day or so, the investigators say, but it is impossible to know whether it prevents severe disease, because the published data is insufficient. Roche has failed to make some of the studies carried out on the drug publicly available.


Sources:

The Guardian December 8, 2009


Channel 4 News December 8, 2009






Dr. Mercola's Comments:



This is not the first time that conscientious scientists have questioned the work of researchers and drug manufacturers who, for a variety of reasons, fail to provide solid clinical evidence that a drug or medical device they are promoting really works.

History is full of examples where “science” was fudged – that’s the nice word for manipulated, if not outright falsified – to facilitate a desired outcome. It’s called bias, something that can happen either subconsciously or intentionally, when a scientist sets out to prove a point (hypothesis).

Bias was the topic of a report in 2007 that analyzed in depth how and why bias happens, and what can be done to curb it. The main concern is that bias can distort results of clinical trials, making a drug or medical device appear to be more effective than it is.

“Unless (bias) is carefully controlled, treatments that actually have little or no therapeutic potential often seem to produce fairly substantial benefits,” the author of this study wrote.

A year ago, in August, Donald Light, a professor and sociologist at the University of Medicine and Dentistry in New Jersey, voiced similar concerns at the annual meeting of the American Sociological Association. Asserting that drugmakers cherry pick clinical trial subjects to assure positive outcomes, Light quoted a Cochrane Center analysis that shows company sponsorship not only can create a conflict of interest when it comes to outcomes, but in itself is a major predictor of positive effects.

Why Did it Take So Long for Someone to Call Roche Out?

Tamiflu has been around for over ten years, and the claims about the drug's effectiveness in reducing hospitalizations have been a key factor in decisions by governments around the world to stockpile Tamiflu.

The drug, however, has a rocky reputation trailing it, including reports of Japanese children who suffered bizarre psychological side effects from it, in some instances leading to their deaths. Subsequently, Tokyo’s Ministry of Health instructed officials not to give Tamiflu to children ages 10 to 18, after receiving reports of 18 pediatric deaths connected with the drug.

When symptoms such as convulsions, delirium or delusions – but no reported deaths – happened to U.S. children, major media began reporting that the FDA was investigating the possible association between Tamiflu and neuropsychiatric effects.

Roche mentions the Japanese Tamiflu side effects on its website and in its package insert. But it also discounts the reports by saying, ”The contribution of TAMIFLU to these events has not been established.”

It’s no surprise that a drugmaker would try to contradict any findings that would negate or cast doubt on its products. But it’s outrageous that Roche and the FDA – as well as the World Health Organization – would continue to push Tamiflu, now that at least one major medical journal as well as a major magazine are questioning possible conflicts of interest between endorsers of Tamiflu, as well as its true effectiveness in combating flu symptoms.

In an article on December 10, 2009, The Atlantic repeats its earlier allegations that Tamiflu just isn’t what it’s been made out to be. The scientific evidence just isn’t there, The Atlantic tells its readers. Citing an investigation by the Cochrane Collaboration, The Atlantic reports that Cochrane researchers were repeatedly rebuffed by Roche scientists and officials when they tried to duplicate Tamiflu’s clinical data.

Ultimately, after multiple requests over several months, Cochrane determined that “ the evidence that Tamiflu reduces complications, hospitalizations, or deaths is weak at best, and if the drug does offer any benefit, it is slight indeed.”

When you consider that the U.S. FDA also told the British Medical Journal that its findings show that there is no difference between Tamiflu and a placebo, it makes me wonder why somebody hasn’t called Roche on the carpet about this sooner. Add in the fact that some whistleblowers admitted to ghost-writing some of Tamiflu’s published studies, and "outrageous" isn’t a sufficient adjective for what Roche has done.

The Ultimate in Recycling: Remake It for Kids

It’s an understatement to say that I am shocked at the façade that Roche has managed to keep up on Tamiflu all these years. But even more shocking is the latest news about this dangerous and questionable drug: The FDA has approved using expired Tamiflu capsules to make an oral liquid version of the drug for children!

The reason, according to media reports, is because liquid Tamiflu, ordinarily mixed in the factory just for children, has run short while Roche concentrated on making the adult version in pill form. To make up for the shortage – and possibly to help take care of Tamiflu pill leftovers from the bird flu hoax – the FDA implemented its shelf-life extension program.

The “new” children’s version will be concocted from old Tamiflu lots left over from the government’s own national stockpile.

How convenient! If you can’t get rid of it on a pandemic, just recycle it. Expiration dates be damned.

Public Health Emergency for Expired Antivirals

The government isn’t the only agency that will be using expired antivirals, however. On October 31,2009, on its News and Events website, the FDA outlined how companies, U.S. states and localities, and other organizations with Tamiflu and Relenza (GlaxoSmithKline’s version of Tamiflu) can recyle their flu antiviral leftovers. The recycling is possible for up to a year under an emergency declaration by the Secretary of the Department of Health and Human Services.

The site explains that during this public health emergency (which I would assume refers to the swine flu) the FDA has issued emergency use authorizations for these expired, or soon-to-be expired, drugs.

Eighteen lots of Tamiflu Capsules and three lots of Relenza Inhalation Powder have been authorized by FDA for use beyond their expiration dates under this directive, the site says.

But that’s not all. The emergency declaration not only allows the use of expired antivirals, but also waives the storage requirements for Tamiflu!

What are they thinking? Why would they do this? Why would expiration dates even be suggested on a drug, if they were not important? And storage? If the way you store a drug isn’t vitally important, why would they have storage requirements in the first place?

It is interesting how the drug companies conveniently manipulate expiration dates. Nearly ten years ago the Wall Street Journal (long before it was purchased by Murdoch) ran an excellent expose on drug expirations which is still valid today.

Seems when it is to their benefit they make the expirations nice and short so people will purchase them more frequently, but when they get stuck with the “expired” drugs they claim they are safe to use. How can they possibly have it both ways?

Why Doesn’t the FDA Follow Its Own Guidelines?

Unfortunately, it’s shenanigans like this that cast doubt on true science and researchers who work hard to show that their data is substantive. When the very agency that is supposed to protect you changes its rules to fit whatever game it’s playing at the moment, it’s hard to believe anything that the agency puts out.

And that can be alarming, because one day the FDA may come up with some important rulings, possibly during a real pandemic of epidemic proportions, that people won’t pay attention to, after fiascos like this.

The FDA has policies and procedures aimed at reducing conflicts of interest in drug trials and reviews. But it also provides a slew of waivers that can allow scientists – or ghostwriters – to get away with creating studies that contain significant bias.

Many arguments could be posed for why researchers would want the FDA to overlook bias in their work. The obvious one is greed. Less obvious is a subconscious “placebo-type” effect that simply leads the researchers into coming to conclusions they don’t really see.

This effect could be due to what’s known in the scientific world as “target-based discovery”. That’s when a researcher sets out with a target in mind – say, you want to find a drug component that can reduce flu symptoms – and then comes up with trials that point straight to the target.

It doesn’t necessarily have to be an intended consequence, meaning a dishonest attempt to deceive, but, like a placebo effect, what happens is that human nature tends to find what the brain is looking for.

The need for speed could be another factor in how bias comes into play. Sometimes public pressure for a cure can hurry up drug research and production – and increase the possibility of tainted trials.

But no matter what the reason, there’s no excuse for it.

There are Cost-Effective Ways to Control Bias

Perhaps Roche and the FDA should read that 2007 article on how bias can adversely affect clinical trials. In it, the author, Mark Lindner, shows how controlling bias actually can increase productivity and, ultimately produce more revenue than having to recall a failed drug.

Making sure that bias doesn’t happen from the start, in the preclinical trials, is one of the best ways to assure that an ineffective drug doesn’t expend time and money in the actual trials, Lindner says.

This is vitally important, because in clinical trials, the hopes, beliefs, and expectations (together referred to as the biases of the patients and investigators) can affect the results, usually to exaggerate the therapeutic effects of the treatment being evaluated, according to Lindner.

As far as Tamiflu goes, we don’t know what happened with the clinical trials of this drug. We can only guess if bias or conflicts of interest played a part in its creation. Was it pressure to quickly come up with a drug to combat flu? Or money? Or was it wanton placebo-effect expectations that brought this drug to market? We don’t know.

What we do know, however, is that there’s more evidence of Tamiflu being harmful, than evidence backing up its reputed effectiveness. In fact, proof of its benefits is nearly nonexistent.

The truth is, Tamiflu just isn’t as safe or effective as you’ve been led to believe. I’ve been telling my readers to avoid this dangerous drug for years, and finally the word is getting out.




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