Adverse Reactions

Profits before people

2008-05-09T09:25:00Z

Those who cling to the belief that medicine is more a science than a commercial enterprise might consider the story of a group of drugs known as erythropoiesis-stimulating agents (ESAs) and their approval process.

ESAs are routinely given to cancer patients with anaemia. As they are genetically-engineered forms of erythropoietin (EPO), a protein that stimulates production of blood cells, they are the only alternative therapy to blood transfusion.

They’ve been in active use since their approval in 1993 – but it’s only been in the last few months that researchers have started to realize that ESAs are killing the cancer patient, and are quickening tumour growth.

America’s drug regulator, the Food and Drug Administration (FDA), toughened warnings about the drugs last November after studying the results of six trials that demonstrated that cancer patients given ESAs died sooner and demonstrated more rapid tumour growth than patients not on the drugs.

Coincidentally, a week or so after the FDA ruling, Amgen, a drug company that manufactures the ESA Epogen, revealed the findings of its own trial, which painted a similarly disturbing picture. Five days later, Amgen suddenly found some more data, which again confirmed the FDA’s findings.

Now it’s open season on ESAs. A study published last February, led by Charles Bennett of Northwestern University’s Feinberg School of Medicine in Chicago, found the drugs increase the likelihood of death and venous thromboembolism.

Armed with this new data – partly provided by the manufacturer of one of the ESAs – the FDA is now considering a complete ban, or at least to dramatically reduce their usage.

None of this should come as a great surprise. Scientists were warning that ESAs would likely increase tumour growth 15 years ago, when the drugs were approved. As Bennett says: “We want to move to a more prospective approach on drug approval that is based on science and not on waiting 10 or 15 years to see bad outcomes emerge.

“In 1993, there was a science question suggesting that EPO would spur tumour growth. That needed to be evaluated from the start.”

Instead, a drug was approved that scientists feared would be a killer. The drug manufacturers then adopted their customary drip-drip approach to data release on a drug that they probably also knew was a killer.

This would suggest a model that is closer to commerce than science; worse, it is one that puts its profits before people.

(Sources: Journal of the American Medical Association, 2008; 299: 2016; Journal of the American Medical Association, 2008; 299: 914-24).

The metaphysics of stress

2008-05-02T12:24:00Z

Somebody dies suddenly from a heart attack. “Ah, well,” says a close friend, “I’m not surprised, really. He was always stressed.” Stress, it seems, is the great killer of our times, and medical researchers are confirming our worst fears with studies that establish a link between stress and heart disease, hypothyroidism, breast and prostate cancers, and others besides.

And when we think about stress, we conjure up images from our day of rushing for the train, getting shouted at by the boss, missing the train home, eating a fast-food meal on our laps, and collapsing into bed for a restless sleep.

But stress is our reaction to events like these, it’s the effect and not the cause. Some people don’t get stressed by any of life’s little inconveniences, others get totally stressed because they put a little too much feed in the goldfish bowl. This is supported by one study that concluded that stress is the result of a multitude of minor daily events that are each irritating little stressors.

While that’s true, I also believe that stress is something metaphysical. It’s all about your view of the world. Is it a hostile, or friendly, place? Are people in the main helpful, or are they trying to cheat you at every turn? I’ve researched the subject for the latest issue of ‘What Doctors Don't Tell You’, and I’ve concluded that – fundamentally – our levels of stress equate to our level of ‘feeling at home’ in the world. Stress is a disease of our sense of isolation and distance, not the result of the daily hurly-burly.

• The full study on stress and isolation is contained in the May 2008 issue of ‘What Doctors Don't Tell You’. To start your subscription, and so receive the report, please click here.

A fate worse than death

2008-04-25T13:50:00Z

My father was fond of the expression 'A fate worse than death'. I think it was something to do with the way we Brits would have been treated had the Nazi hordes invaded in the Second World War.

I was wondering if similar thoughts have been going through the minds of devout parents in the UK who have refused to have their teenage daughters vaccinated against cervical cancer. Like their counterparts in the States, these parents apparently see the new HPV vaccine as a licence for licentious behaviour, although it presumably doesn't also protect against an unwanted pregnancy.

A new study reveals that 20 per cent of Christian families have refused to have their daughers vaccinated against HPV, a sexually-transmitted infection that may lead to cervical cancer. At the moment in the UK, the vaccine - marketed as Gardasil - is still in the trial phase, but it's planned to introduce it nationwide in September.

It is already part of the vaccination programme in the States - and early reports suggest that the religious families may have been wise to avoid the vaccine, even if it's for the wrong reasons.

As of March, more than 7000 incidents relating to the vaccine have been reported to the US's Vaccine Adverse Event Reporting System, including 13 deaths, 204 hospitalizations, and, out of which, 124 young girls have been left disabled. Commentators agree that this is merely the tip of the iceberg as it's reckoned just 10 per cent of adverse reactions ever get reported, especially if they are transitory.

Worse, there isn't even a shred of evidence to demonstrate the vaccine can prevent cancer. One study published last year concluded that the vaccine couldn't protect against the lesions that are more likely to lead to cancer. The latest studies also suggest that protecting women against HPV strains 16 and 18 can increase the likelihood of other forms that are more closely related to cancer.

A fate worse than death. That would be the Gardasil vaccine, then.

* A FULL REPORT on the Gardasil vaccine is contained in the May, 2008 issue of 'What Doctors Don't Tell You', which is being despatched to subscribers this week. If you would like to subscribe, and so read the full report, please go to: http://www.wddtyhealthshop.com/products.asp?recnumber=246

Not even wrong

2008-04-18T12:04:00Z

You can prove the darnedest things with science. You can demonstrate that dangerous drugs are safe; you can even establish that vitamins and nutritional supplements can shorten your life, a sleight of hand that was performed this week. And the great thing is that, because it’s done in the name of science, everyone believes you!

As you may have read (and because every newspaper in the western spiral arm of the Milky Way had it on their front page, you probably did), the highly-regarded Cochrane Collaboration concluded that not only would the antioxidants A, C and E do next to nothing to improve your health, they might also shorten it.

This had everyone scratching their head. It was a startling conclusion that went against everything we thought we knew, and was contrary to the conclusions reached by almost every other significant research paper written over the past 40 years.

So how did they do it? The Cochrane paper was a meta-analysis, which means it re-analysed all existing papers that passed certain criteria for inclusion. Usually the main criterion is ‘good science’ – the studies are well-controlled and reputable.

But things weren’t quite so straight-forward with the Cochrane meta-study. The research team started out with 16,111 scientific papers, and they immediately discarded 14,910 of them. Why? Well, said the researchers, they included cancer studies, or they were duplicates, or because they were ‘not relevant’, although nobody defined what to the study was relevant. However, the researchers did include studies of precancerous lesions and skin cancer which were. . .cancer studies.

So, the researchers were left with 1,201 papers that covered 815 separate clinical trials. Of these, a further 747 were rejected because nobody died during the course of the study. After throwing out all the positive papers that demonstrated health-giving benefits of vitamins, the researchers were left with a small handful of just 68 that suggested vitamins didn’t extend life, but might even shorten it.

Of course, the discarded 16,043 papers discovered the very reverse.

Some science is so bad that scientists have a disparaging phrase for it. They say it's not even wrong. Sadly, even 'not even wrong' papers get good coverage in the media, and at a time when the EU and others around the globe are deciding on safe upper limits of vitamins, and those we shouldn't be allowed to take at all.

It would be a tragedy if this paper becomes a major influence in their decision-making.

Mumps: The second sequel

2008-04-11T12:13:00Z

Is anybody noticing a pattern here?

In 1977, children started receiving a one-dose mumps vaccine. Initially, rates of mumps fell dramatically, and health officials were congratulating themselves that they were on the road to eradicating another disease.

Then, in the late 1980s, there were unexpected outbreaks of mumps among adolescents and young adults who had been vaccinated. And so, in 1990, our health officals introduced the two-dose vaccine. Almost immediately, mumps cases fell so dramatically that everyone was predicting that mumps would be wiped out by 2010.

Then, in 2006, there was an unexpected outbreak of mumps among adolescents and young adults who had been vaccinated twice. A total of 6,584 cases among college-age kids was reported, which suggests there were many more that were never reported.

And so officials from America's Centers for Disease Control and Prevention (CDC) are suggesting the introduction of a triple vaccine "to avert outbreaks and achieve the elimination of mumps".

I think you can guess the rest.

Take a plane, not a drug

2008-04-04T12:26:00Z

Do you think that the science that determines the safety of the drugs we take is the same as the science that determines the safety of aircraft technology?

It's a question that lies at the heart of a fascinating paper from Herman Jeggels, a medically-qualified doctor who now practises in his native South Africa. In it, he compares the science employed by NASA, the American Department of Defense and the UK's Ministry of Defence, with that of medicine.

Since the 1980s, NASA has used technology readiness levels (TRLs) to eliminate risk and determine the maturity and safety of their technologies, and which has been taken up by the two ministries of defence. NASA seeks a zero risk on all its technologies, and would consider as unacceptable even a 3% risk of an aircraft or satellite crashing in a residential area.

To achieve this level of safety, the technology must pass through nine stages, which embrace the science (TRL 1-2), experimentation (TRL 2-3), verification (TRL 4-7), and demonstration (TRL 8-9).

By comparison, medicine never gets beyond TRL 3 - the level of high-risk experimental technology - in asessing the safety of its drugs. At level 3, the technology - or pharmaceutical - would still have an immature, uncertain and high-risk status. A randomised controlled trial on a drug is an experiment, producing experimental evidence only.

"Therefore," writes Jeggels, "therapies marketed on the basis of randomised, controlled trials represent unverified, untested, immature, high-risk therapies, resulting either in the suffering or death of patients, and certainly do not reverse most disorders."

So now you have an intelligent answer ready the next time somebody tells you that medicine is 'scientific'.

MMR: Don't treat parents like children

2008-03-28T12:10:00Z

It’s all unravelling badly for our health guardians who have been trying their upmost to convince us that the MMR (measles-mumps-rubella) vaccine is perfectly safe.

In the past few weeks we’ve heard from the US that a court has awarded substantial damages to a family whose child developed autism after being vaccinated, and this week Dr Andrew Wakefield – the man who started the controversy about the autism link – began his defence against charges of professional misconduct.

Dr Wakefield’s case is an own-goal by health regulators who clearly wanted revenge for a study that they considered was damaging to their aim of achieving mass immunity from vaccination. Either way they can’t win. If they succeed in getting Dr Wakefield struck off, they’ll be accused of staging a witch hunt against a doctor who was trying to help parents. If Wakefield successfully defends the charge, his research will be vindicated. And all the time the MMR debate – and Wakefield’s claims – continues to get a public airing.

Meantime, health regulators have been throwing science at worried parents. They have said that study after study has conclusively established that the MMR is safe. Unfortunately, those who’ve taken a closer look at these studies have found a number of inadequacies or inconsistencies.

In one, a junior researcher who looked over the analysis discovered a basic mathematical error that hadn’t been picked up by the eminent peers who considered the paper worthy of publication. Other papers studied the children for a very short span, and some even admitted they had left out vital evidence because it as ‘unsubstantiated’. The whole sorry catalogue is revealed in the April issue of ‘What Doctors Don't Tell You’.

Parents are rightly concerned that our health authorities – in whom we place our trust – are not playing straight. Science looks too much like propaganda, and their arguments are becoming more hectoring in tone.

If they want children to be vaccinated, the health authorities must start treating the parents as the adults they are. Yes, there is a risk with the vaccines – it might be slight, but it’s there – and, yes, your child could be affected. Part of the message should also tell parents that there are also plenty of ways you can reduce the severity of these childhood diseases through good nutrition.

Unless medicine becomes the science it always claims to be, and stops being a propaganda machine for the drugs industry, parents will rightly remain reticent.

The poisoned brain

2008-03-14T11:46:00Z

Are we poisoning our children to the extent that they can't function in the classroom?

A new study into the abilities of children in the UK who are failing basic exams known as SATS has discovered that 55 per cent have an undetected learning problem such as dyslexia.

If this were extrapolated across the nation, the numbers of British children with learning difficulties would be around 2 million, 20 times the 76,000 who are currently officially recognised as having dyslexia and the like.

Whenever studies like this are published - and always they seem to suggest a problem that's more more prevalent than government figures ever admit - experts explain that dyslexia is related to genetic factors. If this were always the case, we shouldn't be seeing an explosion in the numbers of children who are struggling at school.

A more interesting possibility comes from developmental psychologist Maryanne Wolf who, in her excellent book 'Proust and the Squid', explains that reading is a facility we learn and, as we do, so we 'educate' our neural networks that create new pathways that enable us to read and write. In a fascinating aside, she says the Chinese have completely different neural pathways in their brain that have been created by their own language and character set.

If this is so, something other than genetics may also be playing a part in slowing - or stopping - the creation of the neural pathways required for reading.

In a separate study published this week, researchers have discovered that diesel fumes affect the way our brain functions, although they don't yet know if our abilities are also impaired by these pollutants (see our News section). This suggests that our brains may be affected by a range of environmental and chemical assaults - not just diesel fumes, but also pesticides, electro-pollution, and pharmaceuticals - and the affect may be far worse in young and developing brains.

Over the past 50 years or so, we've been cavalier in our use of petro-chemicals and electro-magnetic technology. We've sprayed our crops with pesticides, we've given our children mobile phones, and we've vaccinated them with more than 20 different chemicals - all in the name of progress, and a safer and healthier world.

The legacy may be a generation that has more children with cognitive difficulties than ever before. Perhaps it's time to reconsider the level of poisons to which we expose our children. The alternative would be catastrophic.

Off label, out of sight

2008-03-07T12:54:00Z

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.

Healing, and not just prescribing

2008-02-29T13:13:00Z

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 guard?

2008-02-22T13:17:00Z

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?

MMR: Mercury, the bringer of autism

2008-02-15T16:08:00Z

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.

Thought for food

2008-02-08T15:25:00Z

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.

The slimmer's first resort

2008-02-01T15:49:00Z

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.

Suppress to impress

2008-01-25T15:06:00Z

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.