GM-free Scotland

March '08 | Lessons from the pharmaceutical industry

 

GIVING GM EVERY OPPORTUNITY

... to harm us.

COMMENT

Regular readers of GM Free Scotland will have noticed that we keep a wary eye on the pharmaceutical industry. Besides the amount of Research and Development being poured into creating GM crops to produce drugs and vaccines which could end up in our food, there is an arguably unhealthy overlap between the biotech companies which produce pharmaceuticals and the biotech companies which are a root source of our food. The progressive closing of legal loopholes which were enabling the marketing of harmful or substandard drugs, has led to a refinement of the tricks of the pharmaceutical trade which can be used with even greater ease in the patchily-regulated world of agri-biotech ...

All the signs are that GM foods will be given every opportunity to cause us harm.

We can say that with confidence because, in recent months, the pharmaceutical industry has provided us with lessons on how this will happen. And, the pharmaceutical story translates with great ease into the GM story.

One such lesson is the case of the anti-depressant drug, Seroxat, made by GlaxoSmithKline. The drug induced suicidal tendencies in those under eighteen years old, in whom it has also proved ineffective.

A second lesson comes from France where two GlaxoSmithKline managers are under investigation for the non-disclosure of side-effects from its anti-hepatitis-B vaccine. The vaccine has been found to increase the risk of multiple sclerosis and rheumatoid diseases, and has been responsible for the deaths of at least five people. A similar investigation over this vaccine, this time for manslaughter, has opened against the drug company, Sanofi Pasteur MSD.

The third lesson is avian 'flu': the pandemic which never happened.

The problems with Seroxat were known by the company as early as 1998, but it seems to have succeeded in keeping quiet about them for some six years. After the cat got out of the bag, the official investigation has taken a further four years and has only just been completed. New laws will be in place by the end of this year placing a greater obligation on companies to disclose results of their trials. The hepatitis-B vaccine was widely used in France between 1994 and 1998 but the official investigation has only just begun. If the time-scale of the Seroxat inquiry and ensuing re-drafting of regulations is anything to go by, it may well amount to a total of 15 - 19 years before any liability catches up with its manufacturers and preventative legal measures are in place.

These time-lags between the marketing of a product, the discovery that it is harmful or not fit for its purpose, the necessary official inquiry, and the final action against the manufacturer or the drafting of a new law, are very significant: the profit generated by block-buster products during the years which are likely to elapse before they must be withdrawn or restricted, is enormous. GlaxoSmithKline has been fined £1.25 million for the Seroxat problem: the company's profits are measured in billions of pounds. It is well worth industry's while covering up for a few years, and then paying the paltry price demanded.

Then, there's industry's attitude to safety.

An internal GlaxoSmithKline document, dated 1998, just after the revelation of the side-effects caused by Seroxat, said the company would have to “effectively manage the dissemination of these data in order to minimise any potential negative impact”. Thus, in the tightly-regulated world of pharmaceuticals, industry still views their safety more as a PR exercise than as a humanitarian issue. In the sparsely-regulated world of GM, the biotech industry has had free reign to conceal any negative impacts under lots of positive words and confidentiality clauses.

Safety tests are also expensive. The tight regulation of pharmaceuticals has come about because of catastrophes like thalidomide. The infant business of GM foods has yet to accept any need for safety testing.

Despite the hype, a product doesn't have to be useful or justifiable to be marketed.

Vaccines are seen as a boon to society and it is considered by many unethical to refuse them since their widespread use is designed to protect the wider community. But, how much of this perceived 'boon' is real? How much is simply clever marketing to make us accept the financial and humanitarian cost of something which will provide questionable benefits and for which we already have safe alternatives?

The hepatitis-B vaccine was part of a massive national programme in France. It was given to two-thirds of the population and to almost all new-born babies before it was withdrawn. Since the effective life of the vaccine is only a few years (60% of people vaccinated loose all protection within 12 years) and children are rarely exposed to the contagious body fluids (blood and sexual secretions) necessary to catch the disease, the French vaccination programme appears to have been an expensively pointless one, even if people hadn't been harmed.

Opinion polls indicate people are more positive towards GM drugs than towards GM foods. However, as far as usefulness or justifiability goes, the case of GM food is not proving very different from this pharmaceutical example: the benefits seem, at best, ephemeral and, a worse case scenario is that they are harmful to human health, the environment and the economy. GM foods are no more justifiable than drugs which don't work, because we have plenty of sustainable, safe, non-GM, and cheaper food production technologies at hand.

The bird flu pandemic gives us an example of an expensive pharmaceutical exercise. It also shows how a problem can be exacerbated by the high-tech solution supposed to solve it. The epidemic was forecast to be about to kill anything between 200 thousand to 150 million people, but it has fizzled out with 115 deaths in 2006 and 86 deaths in 2007. This non-event was marked by a massive vaccination programme and stockpiling of vaccines: at $100 per dose, this has probably had the flu vaccine manufacturers laughing all the way to the bank. The side effects of the unnecessary 'Tamiflu' vaccine included delirium, seizures and loss of consciousness. However, of more concern is that the widespread introduction of altered viral material into organisms already harboring the bird-flu virus could itself be responsible for stimulating the very mutations of which we were told to be scared. GM food, pressed upon us to save the world from starvation, is showing every promise of being a useless road leading to weakened, resource-hungry, overpriced crops, and famine.

How did we get into this PR-driven culture of drugs-for-health, which promises shortly to become a similar culture of GM-for-food?

One reason is that the framing of laws without loopholes seems almost impossible. Despite years spent tightening up the laws on drug safety, GlaxoSmithKline will not face criminal prosecution over Seroxat because the company followed the letter of the law: it didn't do anything it had been told not to do, and it didn't specifically market the drug to the subset of the population which has experienced problems. This translates into great big loopholes in GM regulations: even in Europe where controls over GM foods are probably the most advanced in the world, biotech companies have been given no specifications on what safety test results are actually needed to pronounce GM foods safe; nowhere is the industry required to carry out any clinical tests nor monitor the effects of GM foods on the general population, never mind any vulnerable sectors within the population. In other words it has full reign to make up the tests as it goes along, or avoid them altogether, without any possibility of prosecution.

The ability to control the definition of 'safe' food and 'safety testing' has been possible because industry has a strangle-hold on science: it has been allowed to dictate what science is carried out, and on what science is published. That this is biasing our scientific knowledge-base heavily in favour of the pro-biotech agenda is clear: 38% of independent studies of drug safety come out negative to the test product, while only 5% of industry studies come out negative. Comparative figures for GM food are not available because independent studies of GM food safety are few and far between.

Now set all this within the existing legal frameworks which enable blocks on transparency.

In the EU, it is illegal for a member state to compel disclosure of industry's safety trials. The Seroxat affair brought to light that the organisations responsible for promoting the marketing of the product (in the case of GM foods these would be the Food Standards Agency, National Farmers Union and food trade associations etc) do not have access to all the safety information: they only ever receive what the industry permits them to see.

Freedom of information legislation has been a great boon to those wanting to get at the truth about what the biotech industry knows, but it is difficult to use. Applicants have to be very specific about what they want: this makes it very easy for a company to keep quiet about information it doesn't want you to know. Deliberate delays, refusal to respond, and prohibitive costs are all tactics used to avoid giving out embarrassing information. Information on foods marketed globally also has an intrinsic complexity to hide behind: the Seroxat cover-up needed researchers in the UK, Canada and the US to obtain all the data presented to the various regulators.

OUR COMMENT

All the above indicates that GM food will be given every opportunity to cause us harm.

But, at the end of the day, there is one simple way to block all these opportunities to harm you: DON'T BUY GM.

And we suggest you don't choose to give GM the benefit of the doubt: don't wait for problems to emerge and be 'sorted out' by due legal process, life's too short.

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