As supporting research grows, the regulatory environment tightens

While the evidential base for medicines based on foods and herbs has literally exploded in volume in recent years, in spite of this, some would say because of this, regulators cheered on by drug company lobbyists are working to make things very difficult for the natural medicines business.

Pharmaceutical companies have long been trying to shackle the natural medicines business in Europe and indeed worldwide but of course must persuade the regulatory authorities to do the actual shackling. It has taken time. Perhaps straining credibility a little, the drug companies have variously cited two logically conflicting arguments against the herb and food supplement trade, namely on the one hand, dubbing such remedies “inert placebos peddled by con men” and on the other hand, using an argument that deems natural medicines to be “potent and potentially dangerous medicines peddled by the reckless”. And now, to the delight of some and the deep dismay of many, this approach seems to be paying off as Europe may be well be about to administer another serious blow to the natural medicines business.

This Thursday a vote takes place in Europe that may be the last opportunity to halt the passing into law of a blanket prohibition across Europe on any business or healthcare professional stating either in writing or even in speech, that certain foods offer certain health benefits (unless such claims are on a very short pre-approved shortlist).

So let's take a step back and look at the broader political and commercial context in which this is taking place. It seems clear to this author and I believe to anybody with even a passing curiousity in the future of Public Healthcare, that the whole area of food as medicine is the next big global, cultural sea change coming. Indeed it is really already well underway. The only thing that is not at all clear at this juncture is who will be supplying what to whom in the years ahead.

Let us say that traditionally we had 3 more or less distinct “industries” in Pharmaceuticals, Food Production and Natural / CAM Medicines. Until recently, there was no overlap between the products of these industries : drugs, foods and supplements were different things used by different people for distinct purposes.

Already, all involved with any kind of nose for the future can now see that these 3 once separate areas are beginning inexorably to become one. All around us we see countless examples: functional foods to lower cholesterol; probiotic drinks for immunity; bone building yoghurts; green tea extracts to treat the prostate; cherry juice for inflammation; salvestrols form tangerine peel products used to treat cancers etc.

For decades there was little quality research of the standards insisted upon by the Pharmaceutical orthodoxy into food based medicines. Why? Probably principally because our entire system is based on one enormous wrong and dangerous foundation: Pharma companies only want to make patentable medicines and what exists in nature is not patentable! Only a “new to nature” molecule can be patented and thus support “super-normal” shareholder profits.

In recent times, in spite of the dearth of research cash available for same, an ever growing and now very substantial body of evidence is now at last available to support innumerable health claims relating to foods and herbs, some of which are of newer origin but many of which are nothing more than recently scientifically verified examples of the “folk research” of our ancestry, here in Europe, in the Americas, around the world generally but perhaps most of all in Asia.

Readers may be familiar with the US based Institute for Functional Medicine, an organisation created by leading doctors in the United States for implementation by forward thinking doctors Worldwide. Today IFM is championing a radical new way of practicing medicine, safe and effective, where patients health truly is paramount and where the ethos is about “all of the research but none of the drugs”.

It seems clear that the pharmaceutical companies have been more than acutely aware of the sea change here referred to. Indeed, evidence would suggest they are in fact preoccupied with little else. Given the way things are trending, the world's multinational pharmaceutical companies can really only be expected to accept either of 2 main outcomes to this emerging future:

Possibility # 1: If medicines in coming years are going to be increasingly all about functional or medical foods and food derived medicines, then they, “Big Pharma” themselves will need to own a majority of this market. This will require them to push the absolute primacy of a requirement for vast and expensive research, and where possible, the need for a prescription. (We have seen this already: as one example: as soon as the herb St. John's Wort had proven itself beyond all doubt as a quality treatment for mild to moderate depression, becoming the number 1 medicine used for same in Germany establishing both its safety and efficacy, the Pharmaceutical lobby went into action and managed to persuade Europe that this medicine needed to be under regulatory control). Historically, the public healthcare orthodoxy, all too often dancing to the drug company tune, has continued to heap scorn on any and all natural medicines as being totally ineffective, their suppliers being labeled as scam artists etc. as referred to above. In spite of this, whenever a number of these natural medicines, due to their unequivocal and enormous success, begin to attract something of a mass appeal then suddenly they become potentially dangerous and Big Pharma need to step in to ensure the safety of the public. The thinking is as follows: “if it's a natural medicine, it doesn't work. If eventually overwhelming evidence shows that indeed it does work, and works well, then it's now dangerous and needs pharmaceutical regulation and controlled supply."

Possibility # 2: If nature based medicines are not something that the Pharmaceutical companies believe that they can profit from, at least not on the scale of heretofore, they will endeavour at all costs to halt or at least greatly restrict any general move towards nature based medicines in favour of their own patented lab-created medicines.

As alluded to above, historically, the drug industry lobby has tried a number of arguments to secure its own interests. Initially, the lobby tried to stifle the natural medicines, herbs and supplements business by the “inert argument”, claiming that these medicines were just plain bogus, expensive placebos that do nothing at all in the human body and thus that their promoters and suppliers were snake oil salesmen etc. When this tack ultimately failed to fully convince Europe to begin to dismantle the natural medicines business as it (Big Pharma) wished, then the lobby tactics were changed. In more recent years, rather than accusing natural medicines of being inert placebos, they began to argue on the contrary that many of these medicines were not only quite potent indeed but so potent as to be potentially very dangerous. In very recent times, incredibly, the Pharma lobby has managed somehow to variously label the “competition's” products as being both “inert” and “dangerous” at the same time! The truth is of course that drug company executives have woken up to the fact that most of the wonderful medicines that are emerging into the market now are precisely those naturally based ones that they have derided for years but which they now wish to own, and own exclusively.

Some readers may be familiar with the global non-profit Alliance for Natural Health, ANH , a lobby group effectively, led by Dr. Robert Verkerk and which, in spite of minimal funding, continues to exist to try to stop the Pharmaceutical companies having things all their own way as they work to dismantle the natural medicines business. They, the ANH, refer to the tactic being used as one of “boiling the frog slowly”: rather than risk a major public backlash by destroying the natural medicines business in one fell swoop, regulators doing the bidding of the Pharma lobby are moving new legislative measures against natural health piece by piece.

The last battle was comprehensively won by the drug companies when a ban was put in place effective from May 2011 outlawing the vast majority of plant based medicines. The Pharma lobby did a great job of playing the “public safety / potentially dangerous” card in this instance and regrettably the bill was passed into law support from many of our own MEPs. In the end, the disingenuous nature of the operation was rather clearly highlighted in the fact that none of the medicinal herbs were banned in themselves, only standardized extracts prepared from same. Readers will realise that while the potency of raw herbs may naturally vary a great deal (stain, climate, storage etc.), standardized extracts are tablets or capsules which have been manufactured to Pharma style standards offering a totally controlled and defined dose of the active ingredients. In short, the “dangerous” herbs are all still for sale in the form of raw herbs, but the undeniably safer extract pills are now (for the most part) illegal. Who is being protected from what here exactly?

As we write, tomorrow, Thursday 9 February, a last chance exists for MEPs to lodge an objection to the passing of another bill which will greatly impair the functioning of the natural medicines industry not to mention our collective health by outlawing the making of “unapproved” health claims relating to food. Were this bill to pass, for companies and healthcare providers, it will not only be then illegal to suggest in writing that a given food may have whatever beneficial effect is understood, but to even say so verbally will be an offense. This is simply a ban on free speech, no more, no less and is without precedent in the history of the European project.

And so last year's curtailment on herbal medicines was about “saftey from dangerous agents” and this year the planned proscribing of free speech relating to functional foods will be about, once again, “inert, placebo cures”.

It is difficult not to see a similar pattern at work here as has been seen recently in another realm, namely behind the whole, ever-unfolding tragedy concerning top level banking, public debt and the related crisis afflicting the whole of Europe. Whilst Europe is clearly beavering away to try to plug the leaks in the system, it seems that the obvious lesson on offer, namely having allowed the unchecked greed of a tiny minority to cripple the masses, has bizarrely not yet sunk in generally at the European policy making level. The current topic here concerning free speech and natural medicines shares many of the same characteristics of the high finance fiasco: once again, a small number of super-powerful beneficiaries of a proposed piece of legislation are poised, incredibly, to “sell Christmas to us turkeys” all over again. Were this bill to pass into law, the likely positive outcomes would be minimal to zero: possibly a tiny handful of small-time peddlers of innocuous powders with brave claims may get their wings clipped. What a result! On the other hand, the vast populace of Europe will be prevented from being able to have unfettered access to information on their own health and that of their loved ones that has not being sanctioned by the authorities. Given that an enormously unequal playing field exists between the typical small operator making and supplying natural medicines and the large Pharmaceutical companies, some of the richest corporations on the planet, the small guys will simply not be able to finance the proving of any food based claim to the “necessary” standards. They will lose simply due to not being able to play at the million dollar research table.

This brings us to perhaps the most serious negative outcome of this proposed legislation. The undoubted effect, if not the intent of the original promoters of this legislation will be to, quickly and steadily, instigate a massive decline in research and innovation around nature based medicines. In a market where it will not be possible even to refer to any possible positive health implications for a given agent, why would any quality research continue to take place or who would carry out such? This impact alone would represent a very grave affront to natural science and to humanity's common search for ever greater knowledge of the workings of our universe.

As a citizen, parent and healthcare practitioner, my hope is that this latest battle about free speech will go “our” way, the way of freedom of expression and choice in personal healthcare support. Either way, be sure of one thing: this war will drag on.

Conor Saunders, 9 Feb 2012

Editor’s note: the vote by MEP’s mentioned in the article took place on Thursday 9 February, and went against the Commission’s proposals. For more details see, for example, . http://www.foodmanufacture.co.uk/Regulation/MEPs-slam-Commission-s-health-clai ms- plans.