Around 25 per cent of all prescription drugs are given to patients 'off label' or for unlicensed use (see BMJ, 1998; 316: 343-5). This means that, despite the expensive safety trials that all drugs have to go through, one in four is given either to a group - usually children - who were not part of any safety trials, or for conditions for which they were not tested to treat.
Not only does this practice provide the drug company with its profit margin, it also gives it a legal loophole that allows it to conceal research feed-back, even when it suggests the drug may be dangerous.
This is the reason why GlaxoSmithKline (GSK) has escaped punishment after failing to reveal that its antidepressant Seroxat could increase the risk of suicide among the under-18s. Researchers at the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) discovered that the data related to off-label use, and so the drug company was not compelled to tell drug regulators about the dangers.
The drug has since been banned, but files within the company suggest that GSK knew about the suicide risk at least five years beforehand.
While GSK acted within the legal requirements - bizarre though they may be - it can hardly claim the moral highground, as health ministers and MHRA have been quick to point out.
But, as drug companies have been known to hide damaging data when they should have revealed it, it's hardly surprising that GSK concealed their findings.
As it is, young people took their own lives, and GSK suspected they might without alerting anyone, and they did so in order to maintain profit margins.
Perhaps one day the penny will drop that drug companies are commercial, profit-making enterprises that are there primarily for shareholders, and not for the sick and needy.
There is something about spring that gets us bright eyed, bushy tailed, and ready to shake things up. I don’t know how many of us still shake the bedding and leave it out in the sun in the garden, but cleaning out the house and wiping out the dank corners can be done in any abode.
So how do we do that with our bodies? Do they need cleaning? On the whole, our bodies are self-cleaning, if we give them enough time. We can’t actually go in there and clean up, except for the large bowel – but whatever is in the large bowel is already ready to come out, so it’s kind of after the fact. But we can encourage the body to clean itself further by some simple, time-tested practices. If you are ready to do a little spring cleansing of your own, try any or several of the following.
1. Eat less! Cut down on the quantity of food by half, and if you get hungry, drink water.
2. Do a 3-day fast on nothing but fruits and vegetables, both cooked and raw.
3. Try a 3-day juice fast, followed by 3 days of only vegetables and whole grains.
4. For good bowel function, add fermented vegetables to your meals – sauerkraut, kim chee, pickled beets – these should be brine-fermented, with salt, not vinegar
5. After the fast, it's a good time to review your eating habits, and say goodbye to those that damage you, such as sugared sweets, soda pop, pastries, and packaged snacks. Stick to nuts and seeds for crunchy snacks.
You can do this once or twice a year – say, spring and fall – and such a simple regime can be really good for your health and longevity.
The news this week that antidepressant drugs are no better than placebo underlines just how drug-dependent conventional medicine has become.
Even though researchers had to use the powers of America's freedom of information legislation in order to see antidepressant drug trials that had never been published, it's hardly been a secret that the drugs don't work too well.
It's also not a secret that the 'talking cures', such as cognitive behavioural therapy, work better than the antidepressants, especially in cases of mild to moderate depression. One study even found that patients fared better than drugs if they received a measly postcard from the hospital! It wasn't supposed to be an act of kindness from hospital administrators - it was just that there wasn't the staff available to phone the patient about the next appointment.
So if everyone has known about the poor response from the antidepressants and they've also known about the efficacy of therapy, why haven't doctors been pushing the 'talking cures' to patients?
It's certainly true that the lack of resource plays a part - but I suspect it is more down to the fact that the doctor is wedded to his prescription pad. It is, after all, a quick and easy response - even if it'll do little to help the patient.
I hope the latest antidepressant study makes the doctor stop and think. I also hope it might remind him about the reasons he took the arduous path to become a doctor in the first place - to heal, and not just to act as a drug company salesman.
Who do our health guardians and regulators care about most? Is it us - as it should be - or is it the drug companies, who invariably sponsor them, or could it be their immediate bosses, the government?
America's health guardian, the US Centers for Disease Control (CDC), has been accused by Congress of sitting on research that suggests large swathes of the population living around the Great Lakes suffer more health problems, such as cancer, than the standard population.
Although the Great Lakes had a big clean-up that started in the 1970s, health campaigners fear that toxins are still at a dangerous level, and are endangering populations that live around them.
The CDC study has found that children in these areas are especially at risk, and cancer cases are also higher than in other regions of the USA. The report was due to be released last July, but the CDC has said it has sat on it because it is unhappy with some of the methodology used.
Despite its shortcomings, members of Congress and academics want the report published because it reveals a situation that is of overwhelming public interest and concern.
The CDC has now said the report will be published in the spring, but nobody's holding their breath. Critics fear that parties within the Bush administration are putting pressure on the CDC to suppress the report - possibly until the beleagured president finally leaves the White House.
If this is true, should the CDC be allowing itself to be controlled by its political masters, especially if they know that children's lives are at risk?
The MMR-autism debate just isn't letting up, especially in the States where a TV drama has this week jettisoned it back onto the front pages.
The programme, Eli Stone, features a lawyer who wins a $1 million lawsuit for a mother whose child became autistic after having the MMR vaccine.
Doctors have been so concerned by the programme's impact on parents whose children are about to be vaccinated that they have rushed out a study that 'proves' autism is not caused by the vaccine. The study, which was due to be published in an upcoming issue of the medical journal 'Pediatrics', shows that thimerosal, a preservative made with mercury that was regularly used in vaccines until 2001, doesn't stay in the body for any great length of time.
After studying the 'before' and 'after' blood samples of 216 babies who were vaccinated, the researchers found that the mercury levels in the babies' blood lowered after a few weeks, and fell to a level that was just one-tenth of that predicted in earlier studies.
Underlining the significance of the study, leading autism expert Dr Nancy Minshew has given a "one hundred per cent assurance" to America's parents that vaccinations don't cause autism. "I think the issue is done," she told reporters.
I can only assume that Dr Minshew hasn't had the time to read another study, published in the Journal of Child Neurology, which has discovered a definitive link between mercury and autism. By re-analysing the data from another emphatic study published in 2004, Catherine DeSoto from the University of Northern Iowa has discovered a basic mistake in the calculations.
"A significant relation does exist between the blood levels of mercury and diagnosis of an autism spectrum disorder," she writes.
Not surprisingly, she found that the mercury doesn't affect all children in the same way. The most vulnerable were those children who were least efficient at removing mercury - and it could be that none of the children in the latest study had under-performing immune systems.
Perhaps Dr Minshew might like to bring down her 100 per cent guarantee a point or three.
Forgive the metaphysical tone, but what is Man? It is one of the most fundamental of questions, and its answer would determine many things, not least of which the way we treat disease.
In the West, medicine is based on the standard bio-chemical model, and, with the rise of the specialisms, an increasing focus on the body's individual parts. It has become the dominant approach almost everywhere other than a few pockets of resistance.
So it's surprising to read that another healing system, based on a completely different view of Man, seems to be working rather well. The British Medical Journal this week reports that acupuncture raises the success rate of IVF treatment by 65 per cent. The finding is based on seven solid scientific trials involving 1,366 women, and the researchers say the result is "statistically significant", which suggests that it is far above the placebo effect.
Now how can this be? Acupuncture doesn't work with the standard bio-chemical model, but instead sees Man as an energy system.
So who's right?
The final arbiter in all such things is, of course, Prof Edzard Ernst, that scourge of all things alternative. He told a journalist at The Times newspaper: "Much of the observed effect could be due to a placebo response. IVF may not seem to be 'placebo-prone' but it probably is."
Thoughts affecting the body? So, it's true - Man is an energy system after all.
While getting rid of excess weight is a good thing, it should, however, not be an obsession. Sometimes the body wants to be at the weight it wants to be, and fighting with it is counterproductive. So chew, enjoy your meals, and live your life!
Annemarie Colbin, Ph.D.
ANNEMARIE COLBIN, Ph.D., CHES, is an award-winning leader in the field of natural health She founded Natural Gourmet Institute for Health and Culinary Arts (TM) in New York City in 1977, and is adjunct professor of nutrition at the city’s Empire State College. She is the author of four books, including The Book of Whole Meals (Autumn Press, 1979; Ballantine Books, 1983), The Natural Gourmet (Ballantine Books, 1989, 1991), and Food and Healing (Ballantine Books, 1986, 1996). Her website is: www.foodandhealing.com
The WDDTY archives are full of evidence suggesting that we should be avoiding conventional cough remedies. Here are five stories providing reasons why you should be seeking out the alternatives.
If you want a safe and effective alternative, the Proof! website has a report on The Best Alternative Cough Mixture.
Most diseases have something to do with lifestyle and the environment, but the experts in our community, the doctors, know very little about such things. As they only get about one hour's teaching on nutrition in their five years of medical training, this is probably not so surprising.
So when overweight and obese people come to them for advice, the doctor is instead likely to revert to pill-pushing type and reach for the prescription pad. As a result the anti-obesity drugs orlistat (Xenical) and sibutramine (Reductil) have recently become the most prescribed drugs on the UK's National Health Service, with more than 1 million prescriptions written every year.
The drugs are supposed to be used only when dieting and exercise have failed, but, as Alan Maryon-Davis, president of the Faculty of Public Health, has said: "My fear is that these drugs of last resort are actually used quite early on. It is too easy to turn to the prescription pad."
But is this really helping the patient? Despite the enormous commercial success of orlistat, it doesn't seem to. The drug has lived off early glories for the longest time. One of the very first trials found that a third of participants lost 10 per cent of their initial weight, a result that had newspapers such as the Daily Mail claiming this was the magic bullet cure for obesity.
Since then, researchers have conducted 30 further trials on the drug, and have never been able to replicate that early result. A review of 30 trials into orlistat and other weight-loss drugs found that it achieves an average weight loss of just 2.9 kg a year.
The drugs can also increase the risk of heart disease, and orlistat is especially likely to cause gastro-intestinal problems and faecal incontinence, which the manufacturer has delicately described as "the ooops factor."
The World Health Authority says that "eating less and exercising more must remain the cornerstones of managing obesity."
Just don't go to the doctor if you want to find out how.
In the 1970s, computed axial tomography (CAT), or CT, scans revolutionized diagnosis, offering pictures ith up to 20 times the detail of ordinary x-rays, particularly of bones, blood vessels and soft tissues of the body. It has made it possible to scan for diseases of the abdomen, lungs, heart, liver and pancreas, and even for early osteoporosis.
Adapted from an image-processing system developed for the Apollo moon landings, CT scans take a 360-degree series of crosssectional x-ray images from multiple angles—up to 30 shots—by passing a pencil-thin beam through a particular portion of the body, usually with the use of a contrast agent. An X-ray tube on a moveable ring revolves around your body, taking individual slices of images; this nformation is then passed through a computer, which reconstructs the slices into a three-dimensional mage on a video screen.
The problem is, now that your doctor has such a computerized diagnostic toy at his disposal, he’s more ikely to want to play with it. Indeed, the CT scan is now the special province of the ‘worried well’—perfectly healthy people who are convinced that an annual scan will catch something dreaded like cancer before it strikes. Although Japan leads the world in per capita CT-scan use, some 62 million CT scans are now carried out every year in the US—a 20-fold increase in just 25 years. Even in the UK, the number of CT scans has doubled in the last decade, and is set for a massive increase
with the purchase of £20 million’s worth of new equipment.
While no doubt CT scanning represents the height of 20th-century technology, it also poses far more isks than most other tests, blasting you with far higher doses of radiation than ordinary x-rays.
This month’s issue of WDDTY exposes just how much more. The latest estimates are that one standard course of CT scans exposes you to more radiation than the citizens of Hiroshima or Nagasaki received when the atomic bomb was dropped on their cities.
Shockingly, the carnage from these hyper-x-rays can only be estimated, as a large-scale study into their safety has never been carried out. Nevertheless, David Brenner, a leading radiologist from Columbia University in New York, has finally gone public to admit that they are likely to account for some 29,000 new cases of cancer every year in the US. Worse, CT scans could be causing 100,000 new cases of cancer per year across the globe.
But this might be worth it if CT scans are accurate and could in any way prevent future illness. However, the latest evidence is that CT scans can be wrong up to 75 per cent of the time in trauma injuries, and almost one-third of the time in early-stage diagnoses.
The bottom line is that the diagnostic revolution promised by this state-of-the-art gadgetry has failed to materialize. Although all the early evidence showed that CT scans would reduce diagnostic time, reassure doctors of their diagnosis or treatment plans and preclude the need for other tests, very few studies have proven that this knowledge has in any way reduced illness, shortened hospital stays or prevented death. And it now appears that CT is simply killing perfectly healthy people.
There is virtually no disagreement in medical circles that ionizing radiation is damaging. “Medical irradiation is by far the largest man-made contribution to the radiation burden of the population of developed countries,” once wrote Richard Wootton, professor and director of medical physics at Hammersmith Hospital in London, in a textbook on the subject. The only thing that has changed is the degree—every CT scan magnifies that risk 500 times.
What shall we do with the drug companies? The year is only a few weeks old but already they've been caught out on two occasions suppressing vital data that revealed their drugs weren't working anywhere near as well as they have claimed.
In the first case - involving the cholesterol-lowerting drug Zetia (ezetimibe) - the truth about its inneffectiveness was revealed only when a Congressional hearing in the USA forced the manufacturer to release the data from its Enhance trial.
In the second, independent researchers discovered that selective reporting of data from trials into a range of antidepressants had made them seem at least 30 per cent more effective than in fact they were.
America's drug regulator, the Food and Drug Administration (FDA), has one answer. From next September, every drug trial must be registered with the agency, and ongoing reearch and findings must be revealed other than during the first, preliminary stages.
The worry is that the ruling has no teeth. Drug companies that fail to comply can be fined a whopping $10,000 (UK£5,100), which will certainly make them think twice before suppressing data on drugs that generate billions of dollars of sales every year.
Still, it's an attempt of sorts, we suppose, and we don't expect the UK's drug regulators - who pride themselves on being the fastest in the world - to come up with anything similar any time soon.
Running is undoubtedly hard on your lower limbs. A year-long Australian study found that distance-running injuries were the second most common sports injury seen at a sports clinic. (Clin J Sport Med, 1997; 7: 8–31).
Runners commonly suffer from overuse injuries of the lower limbs, including stress fractures, and soft-tissue injuries such as shin splints, Achilles tendonitis, knee pain and other problems, ranging from simple inflammation to structural degeneration (Scand J Med Sci Sports, 1996; 6: 222–7).
The best preventative for such injury is to slow down, cut down the duration, add stretching and/or warm-ups and cool-downs to your routine, and change or improve your running shoes (Cochrane Database Syst Rev, 2001, 3: CD001256).
But even walkers have to walk with care, so here are a few useful tips:
I certainly hope you had a grand time, and that the New Year is a good one for you. And does your New Year’s resolution include cleansing and detoxing your system? If so, here are some ideas, from the least complicated to the most committed.
1. EAT LESS! If you just overdid it but don’t want to spend too much time worrying about what you should or should not eat, try just cutting down on what you normally eat. In every meal, pay close attention to how you feel, and as soon as your hunger is assuaged, STOP. This takes some attention, but only while you’re eating, not for planning or cooking, so you’re off the hook there.
2. Go low-fat and vegan for a few days – no dairy, eggs, meats. LOTS of vegetables, soups, whole grain breads and brown rice. Chew well!
3. Start each day with a detox drink. Examples: freshly made fruit or vegetable juice, with some garlic, ginger, and ground flax seed.
4. Try a liver flush: Into the blender, while running, drop a garlic clove, stop when chopped. Add 2 tablespoons lemon juice, ¼ cup extra virgin olive oil, blend briefly, pour, drink up. Chase with a glass of water. Then for lunch have a big salad and nothing else, a light dinner. You can do this 3-4 days in a row.
5. Do a one-day vegetable juice fast – try carrot, celery and apple, or carrot, celery, beet, parsley, in the juice machine, and one snack of freshly squeezed orange juice. Then only soups (no flour or cream) and salads with lemon juice and olive oil the next day. Back to normal eating the third day.
Eating with consciousness – that is, chewing well and paying close attention to how your food makes you feel – is a good idea, as it will prevent “eater’s regret” next time you have a fine event where the food is truly tempting. If you just eat some of it, savoring it slowly and stopping when you had enough, you are less likely to overdo it.
Annemarie Colbin, Ph.D.
ANNEMARIE COLBIN, Ph.D., CHES, is an award-winning leader in the field of natural health She founded Natural Gourmet Institute for Health and Culinary Arts (TM) in New York City in 1977, and is adjunct professor of nutrition at the city’s Empire State College. She is the author of four books, including The Book of Whole Meals (Autumn Press, 1979; Ballantine Books, 1983), The Natural Gourmet (Ballantine Books, 1989, 1991), and Food and Healing (Ballantine Books, 1986, 1996). Her website is: www.foodandhealing.com