Patients beating the regulators

Lots of people die while regulators take years to evaluate new treatments so it is good that there is a loophole for those who are prepared to take a risk

Australians with type 2 diabetes are signing up for a costly, unproven stem cell "cure" at a South American clinic. The San Nicolas Clinic says 89per cent of its patients are insulin and medication-free 90 days after being injected with their own stem cells. The treatment costs $US16,000. Some patients who have undergone the same stem-cell therapy for heart disease - which is illegal in all Western countries - say it has given them "a new lease on life". But the world's leading stem-cell scientists warn that patients desperate for a miracle cure are putting themselves at grave risk by undergoing a treatment yet to be fully tested in humans.

The San Nicolas Clinic is bank-rolled by a US energy corporation and is part of the International Clinics of Regenerative Medicine. ICORM director Mike Bartlett said more than 300 patients had been successfully treated for heart disease, diabetes, emphysema and Parkinson's disease at its hospitals in South America and Asia. Mr Bartlett spent last week in Sydney meeting diabetes specialists and cardiologists to encourage them to refer their end-stage patients. To date, 31 Australians with type2 diabetes and seven with heart disease had indicated a wish to travel to Argentina as soon as possible, and a further 208 had made inquiries, he said.

Dr Ross Walker, a Sydney Adventist Hospital cardiologist and author of the bestselling book The Cell Factor, said he would travel to the San Nicolas Clinic early next year to assess the claims for himself. "I believe it is the next big thing in medicine but I want to see solid scientific evidence that it doesn't do any harm before recommending it for the wider population," he said.

Under the patented process, 250millilitres of a patient's blood is manipulated to yield millions of therapeutic stem cells. The cells are then injected into the diseased organ or tissue. Patients are usually sent home within two days. Numerous patients have testified to the "miraculous" effects of the treatment, which uses adult stem cells, not the more ethically-questionable embryonic stem cells. Keith Fanning said the $70,000 he spent flying his dying father, Mick, 75, to Bangkok for stem-cell therapy was "the best $70,000 I ever spent". Oxygen-dependent and barely able to walk before the procedure in July, Mr Fanning's ejection fraction (EF) - the measurement of the capacity at which the heart is pumping - increased so much that he can now breathe, talk and eat on his own. His insulin dependency is also down and his violent shaking from Parkinson's has virtually disappeared. "I'm the ultimate sceptic and it's the closest thing I've seen to a miracle," he said from his Queensland home.

In October, Lynley White, from Melbourne, spent $45,000 to have 30 stem-cell injections in her heart after traditional drug therapy failed to improve her cardiomyopathy. "My doctors laughed at me and said I had rocks in my head but so far so good. I'm feeling more and more energetic," she said. At 62, she was unlikely to receive the heart transplant she needed to keep going. Of the 120 people who have tried the treatment at Bangkok Heart Hospital, four have died. But Mrs White said her only fear was she would not survive the anaesthetic. "My ejection fraction was getting lower and lower - it got down to 12 when it should be 55 plus - and I thought 'I've got to help myself'," she said. Immediately after treatment her EF rating was up by 64 per cent.

Dr Teija Peura, director of human embryonic stem cell laboratories at the Australian Stem Cell Centre, said: "It's understandable that patients who are desperate can't wait for treatment to go through the approval process but it's dangerous because these countries are giving treatment which they don't know how or why [it] works." The International Society for Stem Cell Research said the only stem cell-based therapy with clearly proven efficacy was bone marrow transplantation for blood disorders and leukaemia.

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The British scene: Don't drink if you want to be merry

With undercover cops spying on pub staff, and everyone else conforming to official wisdom on 'binge-drinking', Xmas boozing might be a rather flat affair.

When you're sipping a festive pint in your cosy local this Christmas, beware the figure lurking behind you, strangely interested in your trips to the bar. In Blackpool, England, recently, police piloted a scheme where undercover officers spied on patrons and bar staff. The underwhelming result of this dragnet was that two bar staff were fined for serving drunk customers. Now it looks like this scheme could be heading to a boozer near you (1). But it's not just the forces of law and order watching our behaviour that we should be concerned about - it's the little puritan voice inside our heads, as scripted by health campaigners and moral guardians.

The plainclothes surveillance scheme in Blackpool is one of a recent barrage of initiatives and commentary aimed at Britain's apparently frenzied and deadly alcohol consumption. The campaign on drink driving isn't just for Christmas anymore, it's for life. Other government-funded adverts remind us that while we may feel superhuman after a drink or two, that's precisely when we're more likely to have an accident. Then there's the constant advice to count the number of units you consume (as if you could count after a session).

The media draw daily on Dantesque visions of our streets as `the playgrounds of puking post-adolescents' (2) where `weekend droves pile into chain pubs and the police have been known to set up mobile holding rooms' (3). While `confessions of a middle-class binge drinker' columns sniggered at recent panics about `respectable' home drinking, the drive for behaviour modification has continued apace. Even the homely Campaign for Real Ale (Camra) now defines pubs as `the proper place to enjoy a drink in a responsible and regulated atmosphere' (4).

The attack on our drinking habits is part of a wider process in which the political class and lifestyle authoritarians, lacking any grander vision of the world, turn the banal facts of existence - like the things we consume for sustenance and pleasure - into morally charged issues because they have little to offer us in any other sphere. And whether they are haranguing us about public behaviour or private habits, the space they really want to colonise is inside our heads: our guilty consciences.

This potent cocktail of conformity is two parts misanthropy to one part health neurosis. When we swallow this mix - apologising for that next glass, fretting about another cigarette or worrying about the letch at the Christmas party - we are doing the puritans' work for them. As Dolan Cummings argued in a recent essay, when smokers say they welcome the ban on public smoking because it will help them quit, they `express a peculiar sort of resolution: one which they claim to be incapable of exercising without external compulsion. By banning smoking in pubs, we collectively save ourselves from temptation.' (5)

An Australian business venture provides a startling illustration of this increasing rejection of personal responsibility. In 2004, Virgin Mobile responded to an apparent Aussie epidemic of embarrassing drunken calls to exes and colleagues. Their service allowed customers, before drinking, to dial `333' followed by the number they wanted to avoid `drunk dialling'. For 25 cents, attempts to phone blacklisted numbers initiate a message: `This call cannot be connected; this is for your own good.' Psychologist John McIlroy believed `it could come in handy for Americans who know themselves well enough to not have self-control over their impulses' (6).

This version of the human subject as incapable of personal restraint leads to obsessive use of the term `binge' in alcohol coverage. The hysterical portrayal of bingeing also exposes the root of anti-alcohol culture: a fear of human agency and by implication humanity itself.

Alcohol becomes the locus for behaviour politics because it removes inhibitions, acting as social glue. Drink can make us feel fearless, free or profound. At the right pitch of tipsiness, alcohol exaggerates our great qualities; we're perhaps more animated, articulate or communicative. Whether that's about anything of substance is another matter. Alcohol can also magnify morbidity or aggression, it is true, but current policy is founded on the assumption that these murkier qualities will emerge in the first sip of a pint. The assumption is that everyone needs some kind of rules and regulation because we can all suddenly `get out of hand' (7).

The heightened sense of freedom alcohol provides is precisely why it's troubling - and the pleasure it provides so baffling - to increasing numbers of official killjoys. Current `drink responsibly' public information films betray fears that the demon drink will unleash the violent, vile core lurking beneath the thin veneer of polite social intercourse. The evolution of attitudes to smoking from a private matter to a public scourge reveals how potent the desire to control our conduct has become. Below I have listed what I consider to be key rhetorical stages in the journey from liberty to prohibition - best illustrated by the bans on public smoking but increasingly defining the discussion of alcohol, too:

Availability phase: availability is problematic, with the suggestion that we're bombarded with advertising seducing us to rabidly consume cut-price crates. Youth, it is said, are hit hardest.

Health/crime phase: consumption, we are told, leads to ill-health or criminality. The proper priorities are to extend your life and to relieve your financial burden on the state, showing you're a morally worthy individual by demonstrating health preoccupations. Because disease/crime can result from consumption, such behaviour is therefore inherently bad. Redefining previously acceptable consumption as `abuse' or `addiction' is key.

Anti-social phase: consumption is discussed as anti-social, displaying offensive disregard for sacred environmental and psychological concerns; it pollutes air and relationships. This phase overlaps with the health/crime phase because `the government is redefining "the social" to mean an area where people cause a costly amount of damage (either fiscal or environmental) that the government has to mop up' (8).

Misanthropic momentum phase: warnings are issued that control-measures only go part of the way to addressing much deeper problems that require further bans/legislation/education, particularly surrounding people's ability to parent.

Common sense phase: in the run-up to a ban, and in the period after, the defining outlook is silent compliance. To argue that the ban is an infringement on freedom is to challenge the health position, and is therefore an affront to common sense and `The Science'.

For those who don't believe that restrictions on public intoxication are likely, it should be noted that drunkenness in public is already illegal in many US states. Serving an intoxicated patron has been illegal in Australia since 1998. The increasingly aggressive implementation of intoxication law in these countries serves as sobering examples of how the campaign against drunkenness could play out in Britain.

In Virginia, during Christmas 2003, local police launched a sting on 20 neighbourhood bars and restaurants to `apprehend "drunk" patrons before they try to drive'. Officials said evidence could have been based on `unflicked cigarette ashes, an excessive number of restroom visits, noisy cursing, or a wobbly walk'. Police in Dallas have performed similar sting operations on the publicly legless. In 2006, agents entered 36 bars and arrested 30 people for public intoxication (9). In August 2007, San Diego City Council banned alcohol on all city beaches and parks for a year trial period.

An essay by American sociologist William Sumner, written in 1883, throws light on the deadening logic of behaviour manipulation policy. In the essay, entitled `On the Case of a Certain Man Who Is Never Thought Of', Sumner notes: `The fallacy of all prohibitory, sumptuary, and moral legislation is the same. A and B determine to be teetotallers, which is often a wise determination, and sometimes a necessary one. If A and B are moved by considerations which seem to them good, that is enough. But A and B put their heads together to get a law passed which shall force C to be a teetotaller for the sake of D, who is in danger of drinking too much. There is no pressure on A and B. They are having their own way, and they like it. There is rarely any pressure on D. He does not like it, and evades it. The pressure all comes on C. The question then arises: who is C? He is the man who wants alcoholic liquors for any honest purpose whatsoever, who would use his liberty without abusing it. He is the Forgotten Man again. what each one of us ought to be.' (10)

The public tap on the back from bar-room spies is overtly Orwellian, yet it's the internal spying we really have to watch: measuring yourself against `concerning' statistics; suddenly reassessing intake; seeing others as vulnerable. So, for example, daft drunken antics are now reframed as potentially psychologically damaging. This is why staff Christmas parties were vetoed by nine out of 10 employers last year over fears they could lead to tribunal claims. A survey of 4,915 companies showed most managers fear that employees may behave inappropriately and drink too much alcohol at the office party. The striking majority of respondents (86 per cent) said they'd received complaints from staff due to a Christmas party incident (11).

The new prohibition project - whether it relates to smoking, drinking, or interpersonal office relationships - relies on making us internalise ever-restricted norms of what is `healthy' and `dangerous' activity. We could ignore the momentum of behaviour politics and adopt the state's dim view of us: as forever in need of protection from ourselves and each other. It would be better, however, to forget what our indiscretions might cost the National Health Service and remember the social cost of perceiving everyday freedoms and interactions as little more than potential occasions for harm.

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Just some problems with the "Obesity" war:

1). It tries to impose behavior change on everybody -- when most of those targeted are not obese and hence have no reason to change their behaviour. It is a form of punishing the innocent and the guilty alike. (It is also typical of Leftist thinking: Scorning the individual and capable of dealing with large groups only).

2). The longevity research all leads to the conclusion that it is people of MIDDLING weight who live longest -- not slim people. So the "epidemic" of obesity is in fact largely an "epidemic" of living longer.

3). It is total calorie intake that makes you fat -- not where you get your calories. Policies that attack only the source of the calories (e.g. "junk food") without addressing total calorie intake are hence pissing into the wind. People involuntarily deprived of their preferred calorie intake from one source are highly likely to seek and find their calories elsewhere.

4). So-called junk food is perfectly nutritious. A big Mac meal comprises meat, bread, salad and potatoes -- which is a mainstream Western diet. If that is bad then we are all in big trouble.

5). Food warriors demonize salt and fat. But we need a daily salt intake to counter salt-loss through perspiration and the research shows that people on salt-restricted diets die SOONER. And Eskimos eat huge amounts of fat with no apparent ill-effects. And the average home-cooked roast dinner has LOTS of fat. Will we ban roast dinners?

6). The foods restricted are often no more calorific than those permitted -- such as milk and fruit-juice drinks.

7). Tendency to weight is mostly genetic and is therefore not readily susceptible to voluntary behaviour change.

8). And when are we going to ban cheese? Cheese is a concentrated calorie bomb and has lots of that wicked animal fat in it too. Wouldn't we all be better off without it? And what about butter and margarine? They are just about pure fat. Surely they should be treated as contraband in kids' lunchboxes! [/sarcasm].

9). And how odd it is that we never hear of the huge American study which showed that women who eat lots of veggies have an INCREASED risk of stomach cancer? So the official recommendation to eat five lots of veggies every day might just be creating lots of cancer for the future! It's as plausible (i.e. not very) as all the other dietary "wisdom" we read about fat etc.

10). And will "this generation of Western children be the first in history to lead shorter lives than their parents did"? This is another anti-fat scare that emanates from a much-cited editorial in a prominent medical journal that said so. Yet this editorial offered no statistical basis for its opinion -- an opinion that flies directly in the face of the available evidence.

Even statistical correlations far stronger than anything found in medical research may disappear if more data is used. A remarkable example from Sociology:

"The modern literature on hate crimes began with a remarkable 1933 book by Arthur Raper titled The Tragedy of Lynching. Raper assembled data on the number of lynchings each year in the South and on the price of an acre's yield of cotton. He calculated the correlation coefficient between the two series at -0.532. In other words, when the economy was doing well, the number of lynchings was lower.... In 2001, Donald Green, Laurence McFalls, and Jennifer Smith published a paper that demolished the alleged connection between economic conditions and lynchings in Raper's data. Raper had the misfortune of stopping his analysis in 1929. After the Great Depression hit, the price of cotton plummeted and economic conditions deteriorated, yet lynchings continued to fall. The correlation disappeared altogether when more years of data were added."

So we must be sure to base our conclusions on ALL the data. But in medical research, data selectivity and the "overlooking" of discordant research findings is epidemic.

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