Ten years is a long time to wait to find out if what you believe is true. Of course, if I had had the weight and huge finances of a Pharmaceutical company behind me the wait may have been shorter – they could have brought to bear a large regulatory department and a scientific team to smooth the way.
When I first took the idea of our live, activated probiotic supplement to the human medical fraternity over a decade ago, I think it would be polite to say that in general they were disinterested. One man however was prepared to give me the time of the day and fortunately for me, he was a very eminent scientist indeed, Professor Ingvar Bjarnason.
The Professor’s terms of engagement were strict from the outset, “I will not work with you unless these studies are conducted at full clinical standards, investigator led, placebo controlled and ethics and R&D approved. There is no way that I am damaging my reputation by being involved in studies that are not set at a level that a clinician could understand and find acceptable”. He also said – even back then – that he was no longer prepared to prescribe drugs that target individual symptoms of IBS because the downsides outweighed any benefit and in his view these drugs were not addressing the problem per se. And so it was that I determined that we would focus our efforts entirely on establishing efficacy for our product.
We opted out of “have a happy summer day or your money back” preferring instead to conduct trials and build data that would be acceptable to the medical fraternity. This by default – I realise in hindsight – has led us away from the mass market of general well-being and towards a target market – specifically targeting people that are often very unwell indeed.
The amount of work it took to get all of this scientific work underway will be a story for another day, but essentially we had to focus for ten years on one study. Over that period of time, I watched with interest, as many other probiotic companies made various product claims, rarely with anything close to the level of evidence that would be required to convince the medical fraternity. And with each claim, and with each poorly designed study, the credibility of probiotics seemed to be ebbing away.
I have been to large meetings where speaker after speaker, has argued for a different set of rules and a different set of standards for probiotics, essentially shying away from the inevitable. At one of these meetings, a Doctor, stated the “inconvenient truth” that “you have to do your studies at Full Clinical Standards”. It is this view that has prevailed within EFSA and is the reason why there is now very little acceptance of claims based on anything less.
Probiotic companies continue to post studies with very low patient numbers, often conducted in far corners of the earth and somehow squeeze out of these trials some sort of pseudo significance. This is further compounded by a huge proportion of the declared studies being on individual strains of bacterial and not on the actual product being marketed and sold to the public. I am proud that we persevered and that our product has achieved the necessary research to warrant a full peer reviewed medical publication in the AP&T Journal, but even with this publication I (still a layman) didn’t really understand the full significance of publication in a journal of this significance. I was already aware of the trial results, so what difference would the publication make?
The AP&T article was published in Volume 40, 1st July, and within a few months this real scientific evidence has made a huge difference, not only to Symprove’s credibility but also to engage properly with the medical fraternity.
I read last week about a $3.5 million (US) out of court settlement made by a major pharmaceutical player recently for making claims without sufficient evidence on a probiotic and I couldn’t help wonder how much research and development we could manage with that sort of money. But irrespective of funding I hope that our story illustrates that it’s sometimes better to be patient and face up to the standards that the medical fraternity requires rather than to try and change the rules to suit your purposes.