Ibuprofen and the fertile imagination

There is an astounding variety of painkillers available for purchase both in supermarkets, chemists, and corner shops. Just take a look at the shelf of your nearest Tesco or Sainsbury. You have various types of paracetamol, both made by pharmaceutical companies as well as in house versions of the supermarkets.

What is the difference between them and why are there so many varieties?

When pharmaceutical companies take on the decision to manufacture a new drug, they are given a twenty-year patent which covers the research into the product, testing and manufacturing, and sales. The period of twenty years, a monopoly as such, is to reward them for the time invested into the research. In the course of the research into the product, pharmaceutical companies must publish various forms of medical evidence and put it into public domain, so that if there is any medical evidence that points to the contrary, these can be debated both by the medical community and the pharmaceutical world.

The problem, if we can call it that, is that business is a very competitive world, and if research is put out in the open without any form of intellectual protection, any manufacturer can pounce on the research undertaken by someone else who has taken the effort and trouble to do it, and produce their product off the back of it. They would have saved the time and cost investment.

Imagine if a writer has taken the time to research a topic, organise his thoughts succinctly, and find a publisher. And when his book is published, someone else photocopies it, binds the copied pages and subsequently peddles it as their own.

Within the period of twenty years, a pharmaceutical company has to research, market and sell enough of the product to recoup the investment costs and profit. It is after the twenty period has expired that the other sharks enter the fray. This is where you get the supermarket brands of the product, which are cheaper because they don’t need to pay for research.

What is the difference between brand names and generics? They essentially do the same thing. But if the original company has done a good job in making the product synonymous with its own brand, then you might think they are better. If you take Neurofen for headaches, then you might think it better than Tesco ibuprofen, even though they both contain the same active ingredient.

But pharmaceutical companies have to reinvent themselves, to make varieties of the same product, otherwise they will lose their market share and eventually die out. If you realise that Neurofen is matched in ability by the cheaper Tesco ibuprofen, you would buy the latter, unless you are persuaded that Neurofen for Flus and Colds, or Neurofen Muscle Pain has something clinically formulated for that specific purpose.

So the shelves of supermarkets are stacked with different priced products with the same active ingredient, as well as different varieties of the same product.

Painkillers are a common medicine because there will always be a demand for pain management.

The availability of pain relief medicine means it is easy for the average individual to obtain them. There is the possibility of overdose, and while this may be a rarity, there is a higher likelihood that the greater availability may mean individuals are taking more doses than they should.

What are the long term health impacts of taking ibuprofen for prolonged periods?

One problem is that the body adapts and so the long-term resistance is affected. In certain groups such as the elderly, aspirin also increased the risks of stomach bleeding.

A clinical trial seemed to suggest it may impact on testosterone production and hence affect fertility.

Test subjects were administered 2 x 600mg doses of ibuprofen daily for six weeks, much higher than the average dose. The sample size was only a small group of 30, and half received ibuprofen, while the others received a placebo. It would have been better if the subject group had been greater, so that there could be more confidence in the test results, but because a test of such nature is to examine human resistance to what is essentially toxicity, it would have been unethical to involve a large group of participants. The research findings found that there was no impact on testosterone already in the body, but the pain relieving nature of ibuprofen, as a relaxant of sorts, had impact on the production of testosterone and appeared to slow down production.

How did these reports end up in the media? The tabloids had a field day, and you would undoubtedly have found one with the usual wisecracks about balls and other man-related genitalia, along the lines of “Ibuprofen shrinks your balls” or “Ibuprofen smalls your balls”.

Maybe instead of Ibuprofen for colds or fast relief, we need Ibuprofen for Dummies.

Risks of stomach bleeding increased by aspirin in over-75s

A recent study by researchers in Oxford in June this year suggested that taking aspirin daily may have led to higher incidences of bleeding in the over-75 age group.

BBC News reported that those in the over-75 age group taking daily aspirin as a precautionary measure after a stroke or heart attack were at a higher risk of stomach bleeds than had been previously conceived.

The Oxford Vascular Study was carried out by researchers from the University of Oxford and funded by the Wellcome Trust, Wolfson Foundation, British Heart Foundation, Dunhill Medical Trust, National Institute of Health Research (NIHR), and the NIHR Oxford Biomedical Research Centre.

The study aimed to assess the bleeding risk for people taking aspirin for the secondary prevention of cardiovascular events. In other words, the people in the research had already had a stroke or heart attack and were taking aspirin to try and prevent them having another. The follow-up period was for up to 10 years with the intention of seeing how many of them were admitted to hospital with bleeds.

Aspirin performs the function of a blood thinner and hence it is often given to people thought to be at risk from blood clots, which, if left unchecked, could trigger a heart attack or stroke. Unfortunately, a potential downside is that it can trigger bleeding in the digestive system or brain.

The researchers found that for under-75s taking aspirin, the annual risk of bleeding is around 1%. However, this risk factor is tripled for those over the age of 75. What was more disturbing was the bleeds were particularly associated with those of the stomach and upper digestive tract. 405 bleeding events required medical attention during the follow-up period, and of these, 187 of which were major bleeds. 40% of bleeds were in the upper digestive tract. The risk of disabling or fatal bleeding of the upper digestive tract was 10 times higher for over-75s compared with younger adults.

The findings of the research suggested that prescribing proton pump inhibitor (PPIs) could significantly reduce these risks in older adults. PPIs are drugs which help defend the lining of the stomach and the risk of a bleed is minimised.

Currently, the prescription of PPIs together with aspirin is not routine for over-75s. While PPIs can considerably reduce the risk of digestive bleeding for regular aspirin users, there are concerns over their side effects, which can include nausea and constipation.

The findings, however, only apply to people taking regular aspirin for secondary prevention of cardiovascular events, and cannot be directly applied to people for primary prevention (that is, people with risk factors for cardiovascular disease but who have not yet had an event such as a stroke or heart attack), or to people using aspirin for brief periods for example to treat pain or fever.

But it must be stressed that no-one should come off the pills quickly, or without consulting their doctor, as doing so would create an immediate risk of heart attacks.

Around 40 per cent of pensioners in the UK take aspirin daily. This estimate is also evenly split between those who have already suffered a heart attack or stroke, and those taking it as a precaution.

Prof Peter Rothwell, the lead author from the University of Oxford said aspirin was causing around 20,000 bleeds annually – and causing at least 3,000 deaths.

Prof Rothwell said: “We know clearly from trials and other research that aspirin is effective at preventing recurrent heart attacks and strokes. Twenty per cent of potential recurrent heart attacks and strokes are prevented by aspirin.

“Nevertheless, there are also about 3,000 excess bleeding deaths attributable to blood-thinners like aspirin across all age-groups,” he said, warning that the risk of serious bleeding is much higher among the over 75s.

“You would probably be advised to stop it in your late 60s or around 70 because at that point the risk of bleeding does start to take off – the risks may well outweigh the benefits,” he said.

Dr Tim Chico, consultant cardiologist, University of Sheffield, said the risks of aspirin were often understimated. “Although bleeding is a well-recognised side effect of aspirin, this drug is still seen by many people as harmless, perhaps because of how easily it can be bought over the counter, “ he said. “Prescription of any drug is a balance between the benefits of the medication against its risks, and aspirin is no different,” he said.