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When studies are not needed

By Siegfried Othmer, PhD

studiesRecently a study showed that some people react badly to statins. Statins have been in use for twenty years, and if some people respond badly to them, then that has also been a fact for about the same number of years. So why was a study needed? And if a study was needed, why did that same reasoning not prevail many years ago? It’s surely not that the facts have been changing. Rather, it was becoming increasingly difficult to ignore the facts that we have already known all along.

Most likely the study was done in order to be able to claim that before these formal results became known, “we did not know, and could not have known, that such hazards existed.” The study was likely done to exonerate and inoculate prior inaction. But of course we did know because the customers have been complaining. And it was only because we did already know that the study was done at all.

How do we know this? Because in other, similar contexts the case is still being made that safety studies are not needed in spite of numerous ongoing complaints from customers. Vaccine safety is a case in point. In the face of contrary evidence, it has been argued all along that such testing is not needed. Reliance is instead placed on adverse event reporting. The reasons for this are actually quite sound in principle. Such reliance would even be appropriate–and sufficient–if indeed adverse event reporting were being done more faithfully and more systematically. But that is not the case when it comes to the issue of vaccine-related injury.

The real target of all the propaganda about vaccine safety is not so much the public but rather the MD community itself. Lay people whose children responded badly are unlikely to be swayed by the propaganda, but MDs are very likely to take official pronouncements quite seriously. If vaccine safety is a settled issue, then going through with adverse event reporting might just reflect badly on the MD himself. Time and again, MDs will deny vaccine risk to their alarmed parents reporting post-vaccine trauma and/or functional loss. With such a mindset, they will not be inclined to execute an adverse event report on behalf of their patients. The chain of evidence is therefore broken, and vaccines officially remain safe.

A similar situation prevails in the case of Ritalin and other stimulants. Around the mid-nineties ominous reports started surfacing of sudden cardiac death among children on Ritalin, or perhaps combinations of Ritalin and clonidine. Even more ominous, these sudden deaths were not preceded by obvious warning signs. A child might just suddenly drop dead. In one case, the autopsy of an eight-year-old who had not been on Ritalin more than a few months revealed what the pathologist called a ‘cocaine heart,’ something he would expect to see in a long-term user.

These cases were sufficiently concerning that Professor Dennis Cantwell, noted authority on ADHD at the UCLA Department of Child Psychiatry, saw the need for an alternative to stimulant medication. He came to visit us at our office to look into the viability of neurofeedback. “ADHD can be a terrible thing to have,” he said, “but it doesn’t kill you, and neither should the remedy.” This is a categorical judgment. A risk of death is morally acceptable only if it serves the reduction of a yet larger risk of death. “If there is anything to neurofeedback, we really need to know,” said Cantwell.

A formal study proposal was prepared, but unfortunately Professor Cantwell died before it could be executed, and the study died with him. Somehow over the succeeding years these ominous data on stimulant risk never had a policy impact on the prescribing of stimulant medication to young children. The risk is small, to be sure, but nevertheless one would think it would be cause for raising the bar on the casual administration of stimulant medication—or perhaps even for considering neurofeedback as an alternative remedy.

Another ten years passed before the FDA finally recognized the cardiac risk of stimulants to be worthy of a formal study. As in the case of statins, it served to exonerate past inaction. When I last looked at the medical risks of Ritalin, the risk of death was right at the top.

At the same time, we already know that more than 85% of children with ADHD no longer benefit from stimulants after neurofeedback training of their brains. The remainder also depend upon other measures (dietary adjustments, toxic load reduction, managing Irlen Syndrome, improved sleep hygiene, etc.) to allow the children to derive full benefit from the neurofeedback training.

The largest study ever done on ADHD, the Multi-Modal Study, also showed that the benefit of stimulant medication can no longer be identified after three years. So we know that even under the best of circumstances the benefit of stimulant administration appears to be largely transient.

Yet this most thorough and comprehensive of studies has had no impact on liberal prescribing policies, and provoked no search for an alternative. Meanwhile, all of the studies over the last forty years in support of neurofeedback for ADHD are simply ignored.

And yet they call it science.

Siegfried Othmer, PhD
drothmer.com

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