# 35. Statistical manipulation - Biased Sampling - Selective bias ## 35.5. Methodology/Refinements/Sub-species ### 35.5.5. Fox guards the chickens A very appropriate term describing how manipulative sampling bias and other statistical aberrations are possible in our heavily regulated world. It works like this: In the Western world, the development of new drugs, chemicals, food products etc. is largely controlled by just a small number of wealthy corporations. They have the resources, technology and expertise to carry out research, test and market highly complex new pharmaceuticals, agrochemicals, and new food products. In fact, these corporations are about the only organisations that have the ability to invest in such research. Government is largely excluded from the process of research. It acts as a passive rubber stamp when all the ticks are in the right boxes. Thus control takes place by means of self-regulation. #### 35.5.5.1. Trust - the regulatory black hole In a world where most governments see themselves as just supporting actors to the main corporate players, the use of self-regulation is now widespread. Government tries to keep out of the way of the corporate research efforts and the core principle in regulation is trust and "auto-control". What this means for Big Pharma, Big Food and Big Chemical is that they are effectively charged with regulating themselves. Given the fortunes involved in these industries and the history of appallingly irresponsible behaviour of some corporate entities, this is really the equivalent of asking a bunch of hungry foxes to guard the chickens. Self-regulation gives rise to a great potential for large scale statistical manipulation. Trials are not cross-checked by independent studies conducted in parallel by our governments. The quality of trials is accessed by government regulators but is based only on the final report of the corporate researchers themselves. The details of studies and trials remain largely obscured to the public or governments. Test results are often not even published because they contain so-called "corporate confidential" data. Despite some of the past, tragic consequences of this self-regulation - as in the dreadful Thalidomide disaster - the system that allowed this tragedy to happen is still in place today for all drugs, in all countries in the world. So we end up with aberrations like negative trial result data being "lost", or inconvenient or negative reports being sidetracked. Regulators and professional bodies, whom we could reasonably expect to stamp out such manipulative practices, have basically failed us and continue to do so. Compounding this felony, these problems are largely hidden from public scrutiny because they're too complex to convey in a single sound bite, so our politicians aren't competent to understand or to discuss them. This is one of the reasons why these regulatory issues have gone unfixed by our politicians. The other reason is that it takes a lot of time and detail to explain these issues correctly to the public. And so we now have a situation where drugs are tested by the people who design and manufacture them, in poorly designed trials, on hopelessly small numbers of unrepresentative patients, and analysed using techniques that are flawed by design in such a way that they exaggerate the benefits of treatments. This is now the state of the modern pharmaceutical industry. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don't like, they are perfectly likely 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 way by the over-worked and often misled general medical profession.