The drugs don't work: a modern medical

The drugs don't work: a modern medical scandal | Ben Goldacre | Business | The Guardian

But we had both been misled. In October 2010, a group of researchers was finally able to bring together all the data that had ever been collected on reboxetine, both from trials that were published and from those that had never appeared in academic papers. When all this trial data was put together, it produced a shocking picture. Seven trials had been conducted comparing reboxetine against a placebo. Only one, conducted in 254 patients, had a neat, positive result, and that one was published in an academic journal, for doctorsand researchers to read. But six more trials were conducted, in almost 10 times as many patients. All of them showed that reboxetine was no better than a dummy sugar pill. None of these trials was published. I had no idea they existed.

An exponentially growing industry between Iv pharmaceutical companies and their patients, also doctors can act as Iv agents. Also sometimes the companies can be a V cartel like structure that use salesmen and doctors to deceive on theri behalf.

The system exploits flaws in statistics where small random differences in trials can become signficant enough to bolster sales by fiddling the parameters.  By witholding negative data it is like tossing a coin that appears random, witholding results of when it comes up tails will make it appear to favor heads more often. 

It got worse. The trials comparing reboxetine against other drugs showed exactly the same picture: three small studies, 507 patients in total, showed that reboxetine was just as good as any other drug. They were all published. But 1,657 patients' worth of data was left unpublished, and this unpublished data showed that patients on reboxetine did worse than those on other drugs. If all this wasn't bad enough, there was also the side-effects data. The drug looked fine in the trials that appeared in the academic literature; but when we saw the unpublished studies, it turned out that patients were more likely to have side-effects, more likely to drop out of taking the drug and more likely to withdraw from the trial because of side-effects, if they were taking reboxetine rather than one of its competitors.

These chaotic reactions which random statistical methods are not designed to measure. People get reactions from the drugs at below the signficance level but still want to withdraw, this withdrawal then doesn't count as a bad side effect. 

I did everything a doctor is supposed to do. I read all the papers, I critically appraised them, I understood them, I discussed them with the patient and we made a decision together, based on the evidence. In the published data, reboxetine was a safe and effective drug. In reality, it was no better than a sugar pill and, worse, it does more harm than good. As a doctor, I did something that, on the balance of all the evidence, harmed my patient, simply because unflattering data was left unpublished.

Iv-B becomes like a game of Chinese Whispers where no one might even be deceptive, it is an artefact of statistics itself as a Type One error where the null hypothesis is wrongly rejected. Also these antidepressants can be altering people's consciousness like alcohol does without treating a disease, people then report feeling different or distracted from their depression as a positive result.  

Nobody broke any law in that situation, reboxetine is still on the market and the system that allowed all this to happen is still in play, for all drugs, in all countries in the world. Negative data goes missing, for all treatments, in all areas of science. The regulators and professional bodies we would reasonably expect to stamp out such practices have failed us. These problems have been protected from public scrutiny because they're too complex to capture in a soundbite. This is why they've gone unfixed by politicians, at least to some extent; but it's also why it takes detail to explain. The people you should have been able to trust to fix these problems have failed you, and because you have to understand a problem properly in order to fix it, there are some things you need to know.

This is a disconnect, Iv-B drigs sell exponentially until they hit a ceiling where the bad side effects reach the V-Bi transparent scientific community and the poor results are exposed by statistics as significant. They might then collapse to a floor of a drug is dangerous or grow and collapse along this ceiling like a contagion such as the flu that no one can eradicate.

Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion.

In their 40 years of practice after leaving medical school, doctors hear about what works ad hoc, from sales reps, colleagues and journals. But those colleagues can be in the pay of drug companies – often undisclosed – and the journals are, too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it's not in anyone's financial interest to conduct any trials at all.

People are competing with each other so have incentives to deceive, also they start to believe the misinformation coming from each other like Chinese Whispers until exposed. An insudtry might then be patched up as zombie drugs that don't really work but are used in the hope that people spending money on them will lead to investments to find drugs that do work. This is like propping up zombie banks after the GFC in the hope they will revive with reinvestment. Allowing the fraud to be fully exposed might cause the antidepressant industry to collapse, seeing this as bad is the same as covering up fraud in the banks to avoid panic. So after reaching the chaotic ceiling a crash to the floor is prevented creating zombie drugs.