WONDER DRUGS
Coincidentally, as I write this small chapter, yet another ‘weight loss pill’ has come onto the market and only yesterday I was on the radio talking about it. I say coincidentally, but as they are coming out faster than the rate of stealth taxes, it’s not really that much of a coincidence. What’s fascinating about this particular one is the fact that for some reason it has been approved in England, but rejected by the FDA (Food and Drug Administration) in the US because the safety of the drug was not demonstrated. The first question I have is an obvious one. How can a drug be okay for humans in the UK but not for those in the US? How can it be cleared on a scientific level here and yet not on a scientific level over there? I was always taught that science is ‘fact’, when of course I now know it’s ‘opinion’. In the opinion of the FDA it is, at time of this writing, not demonstrated as being safe and in the opinion of those in England it is fine. When I say fine, it doesn’t seem to matter that this drug – Rimonabant – has noted possible side effects which may include suicidal thoughts. However, as always, the counter drug argument of ‘it does more good than harm’ soon starts after any negative drug press.
Dr Ian Campbell, medical director of the charity Weight Concern said, ‘You have to balance the risks with the advantages of quality of life improvement. Rimonabant has a role, it should be used with care but directed towards the right patient it can be effective and safe.’ However, he also goes on to say that the drug should not be used in people being treated for depression or with a recent history of depression. However, unless once again I have lost leave of my senses, the people for whom the pill is directed are more than likely going to be depressed aren’t they? If you are obese and so desperate that you are willing to take a drug which has the potential for suicidal thoughts (even if the chance is extremely small), wouldn’t it be fair to assume there’s a huge chance that person is already depressed? The medical profession will no doubt look to see before prescribing that the individual has no history of depression. But again that would be based purely on their medical records. If so, we need to ask, how many people go to their GP with depression for being overweight? And surely the ones who do are the very people who the drugs are designed for, aren’t they? Yet, it is recommended that this drug should not be taken if you are depressed, which begs the question, who exactly are these pills meant for? Deliriously happy obese people perhaps? But if they were over the moon with their weight, why would they seek medical assistance to lose weight? Can you see how mental the whole thing is when you start to look at it? It’s even more insane when you think the US committee of experts who reviewed studies of Rimonabant from all over the world, told an FDA hearing that the drug is associated with an increased risk of suicidal thoughts – even in those with no history of depression. Studies also highlighted significant increases in anxiety, insomnia, and panic attacks in patients given 20 mg of the drug compared with placebo.
This is far from the first time weight loss drugs have been put under the adverse drug reaction (ADR) spotlight. Over the years many of these ‘medically approved’ weight loss drugs have had reports of all sorts of side effects ranging from random anal leakage to even death. But at least up until now you had to see your GP first before you could get hold of them. At least it was down to a professional to make a qualified judgement as to whether you should be given such pills and whether the chance of any adverse drug reaction, in their opinion, would be outweighed by what they hope will be a reduction in the patient’s weight. However, as from the spring of 2009, the way with which people get hold of some weight loss drugs will all change. For the first time in history in the UK you will be able to buy the first ever ‘over the counter’ weight loss drug – Alli. No prescription – no doctor’s appointment – no assessment, just walk into your local chemist and get your drug. Given that we are in a world where thin is the new black, I feel the decision to license this drug as an OTC (Over The Counter), will prove to be one of the most reckless in the history of medicine. The potential for ‘drug’ abuse here is on a scale as yet unknown. After Alli was launched in the US in 2007 it sold 75 million in the first six months alone, which gives us some kind of idea of what’s in store here. I would also bet this will not be the only OTC weight loss drug either; once this comes along the floodgates will open and getting hold of your weight loss drug will become as normal as buying an aspirin (by the time you read this book it may already have happened). The dangers to anyone with a shred of common sense are painfully obvious, especially as you can also buy these pills on the Net too. Teenagers for one will no doubt get hold of these and chances are, with no one checking to see how many people are buying and taking, will take much more than the recommended dose in the delusion they will lose more by taking more (no doubt many adults will also do the same!). Losing weight is one of the biggest obsessions teenagers and many adults have and to produce a drug that anyone can easily buy without any checks with a promise of weight loss is unwise to say the least.
What’s crazy is both the FDA in the US and now the FSA (Food Standards Agency) in the UK, gave the drug the all clear to be sold over the counter, expressing the benefits far outweigh any possible risk to health. But in order for this drug to be cleared the FDA and FSA would have had to come to the conclusion that the drug is both safe and effective – the criteria all approved drugs have to pass. But, ignoring the moral issue of having a weight loss drug as an OTC and God knows how many people who may well abuse it, I question it on both the other fronts. Firstly it stops the absorption of some fat soluble vitamins like A, D, E, and K. The body is such a finely tuned machine that you simply cannot brush aside the effects this will have on the overall health of the body; effects which may not become apparent for many years. On top of this, the drug works by stopping the body from absorbing some of the fat you eat in food. This sounds like good news, but a) it’s not necessarily fat that makes you fat (as I will illustrate a little later) and b) it is essential the body does absorb fat. (They aren’t called ‘essential fatty acids’ for nothing after all). Also the actual weight loss effectiveness of the drug has been brought into question too. There was even one report that showed an average of just one pound of weight loss in an entire month. A loss hardly worth risking a bit of random anal leakage for, which, just so you know, is one of the potential side effects of this particular weight loss drug. In fact, GlaxoSmithKline recommends that Alli users wear dark pants and keep spare clothes available at work until they ‘have a sense of any treatment effects’. Yes, such are the chances of ‘steatorrhea’ – oily, loose stools – and fecal incontinence, frequent or urgent bowel movements and flatulence, that the makers suggest you wear some dark pants just in case something happens unexpectedly. Seriously, is it me or has the world gone completely bonkers? Clearly there have also been many studies with Alli that have shown significantly more weight loss than the 1 lb (0.45 kg) in a month I quoted a second ago, but is having to wear dark pants just in case something foul unexpectedly comes out of your bum really worth it?
I could write an entire book on just weight loss drugs alone, but