Beta blockers and their impact on heart attack sufferers

 

Recent research suggests that the prescription of beta blockers for heart attack patients may not have the benefit ascribed to them.

In the UK, the prescription of beta blockers is routine for patients who have had a heart attack. There are two categories of patients – those who have had a heart attack, and those who have had a heart attack with heart failure, the latter of which is the more severe case. A heart attack involving heart failure is a complication in which the heart muscle has experienced damage and where proper function is compromised.

Beta blockers work by reducing the activity of the heart and lower blood pressure. In essence, the pressure on the heart is lessened by a reduced demand on it.

Current guidelines recommend that the first group of patients are prescribed beta blockers, while for those in the second group, who have experienced heart failure, beta blockers are mandatory.

The research investigated the effect of beta blockers on the first group, for whom beta blockers are recommended but not compulsory. The findings suggested that 95% of patients in the first group did not experience a significantly longer life span and beta blockers did not have any significant impact. There was no statistical difference in death rates within a year large enough to attribute to any positive impact of the beta blockers.

As the data involved tracking a very large sample size of 179,810 people, the results could be deemed to be fairly accurate.

So what the ramifications of this research?

The first is that the vast majority of the first group of heart attack patients are being over-prescribed beta blockers. Beta blockers, while reducing the workload of the heart, can induce side effects such as drowsiness and fatigue as a result of lower blood pressure. Patients may be experiencing these burdens on their health unnecessarily.

The second issue is that over-prescription causes an unnecessary burden on the NHS if it is prescribing drugs unnecessarily. Imagine a patient who has just had a heart operation. While he or she is recuperating in hospital, beta blockers are prescribed as part of the medication. Multiply that by over 100,000, and the result is an unnecessary annual cost to the NHS if the drugs that are needless and have no impact.

Furthermore, the use of drugs with no apparent benefit can, in the long run, only weaken the body’s immunity.

The findings of the survey, however, do not reflect on the impact of beta blockers on the second group of patients – those who have had a heart attack involving heart failure. Another outcome of the findings was the suggestion that treatment be more personalised in order to locate and target patients in the first group who would benefit from the prescription of beta blockers for heart attacks which did not involve heart failure.

Beta-blockers are prescription-only medicines, commonly referred to as POMS, which means they cannot be obtained over the counter. They must be prescribed by a GP or pharmacist. They work by blocking the action of hormones like adrenaline in order to reduce the activity of the heart.

Examples of commonly used beta-blockers include:

  • atenolol (Tenormin)
  • bisoprolol (Cardicor, Emcor)
  • carvedilol metoprolol (Betaloc, Lopresor)
  • nebivolol (Nebilet)
  • propranolol (Inderal)

The generic name which contains the active ingredient is named first, the brand name is in parentheses.

There are many types of beta-blockers and they may be used to treat symptoms such as angina, heart failure, atrial fibrillation (irregular heartbeat), heart attack or high blood pressure. Those are the more common uses of beta-blockers, also they can also be used for migraine or to treat an overactive thyroid (hyperthyroidism), anxiety, tremor, anxiety conditions or even glaucoma.

Beta-blockers, including beta-blocker eye drops, can interact with other medicines, and in doing so alter the effects of one of the medicines. Some of the more common medicines that can cause interference through interaction with beta-blockers include medicines such as anti-arrhythmics (used to control irregular heartbeats), antihypertensives (medicines for lowering blood pressure), antipsychotics, and clonidine, which is commonly used to treat high blood pressure and migraine.

While the most common side-effects of beta-blockers are dizziness and tiredness, other arising side-effects can include blurred vision, cold hands and feet, and slow heartbeat.

Less common symptoms may include sleep disturbance (insomnia), depression, impotence or libido.

The majority of beta-blockers are to be taken once a day, with the exception of certain beta-blockers that are used during pregnancy and the beta-blocker Sotalol, which is administered two or three times a day. The NHS estimates the annual cost of Sotalol per patient to be 77.09 a year.

On the face of it, the results of the research are pretty straightforward. But are they as almost too straightfoward, to warrant the question of why such research needed to be conducted in the first place?
One cannot blame the cynics for questioning what outcomes the research is meant to arrive at.

Let’s consider the matter in a different light. It is estimated that heart attack survivors have a higher risk of recurrent heart attacks or cardiac death, and 10% of heart attack sufferers die within two years. Only 50% of initial survivors are alive at 10 years.

It is not unreasonable to surmise that those who suffer initial heart attacks either experience mortality between the first and second year or develop recurrent attacks which push them to a compulsory prescription of beta-blockers.

Critics to the research point out that a fairer assessment on the effects of beta-blockers should have examined an extended time period of two years rather than one year. They also point out that the research should have focussed on how many heart attack sufferers, who did not have heart failure, and who then did not use beta-blockers, went on to develop recurrent heart attacks, or heart attacks that included heart failure, as it would be more indicative of the effectiveness of beta blockers.

So why did the findings choose to use the timeframe of a year?

The NHS makes baseline assessments on the cost effectiveness of medicines and treatments according to a scale of quality-adjusted life years, or QALYs. It weighs the cost of treatment against the number of years of significant benefit to the patient gained from the treatment. According to the NHS, a figure of twenty thousand pounds per QALY represents treatment that is value for money. In other words, if a treatment can extend and improve a patient’s life for a year, and costs under 20,000, it is worth it.

The NHS’s Regional Drug and Therapeutic Centre, based in Newcastle, gives the cost of beta blockers as between 10 and 512 pounds annually, depending on the type of beta-blocker required. While this falls well within the QALY threshold of 20,000 pounds, using the research findings that beta blockers have no significant impact on health within the first year allows it to scrap the cost of funding this treatment because beta-blockers supposedly offer no significant benefit. The research has focussed on a time period that cannot significantly examine the effectiveness of beta blockers.

Cynics suggest that the research is merely an attempt to reframe the data regarding beta-blockers in order to minimise the cost of healthcare in an NHS which is lacking in resources.

Medical research, is unfortunately often subservient to economics and often the research appears to be carried out to arrive at a pre-planned conclusion. Wasn’t it long ago, when the economic crisis was looming and the government was looking to raise tax on alcohol, that we were told a glass of red wine a day had health benefits? Yet when the NHS struggled years later and was overburdened by drunken citizens dialling emergency services the evidence peddled about red wine was to the contrary.

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.

The need for cautious antibiotic usage

Antibiotics are medicines which are used to treat forms of bacterial infection or prevent their spread. As the name “antibiotics” suggest, they are anti-bodies and work by killing bacteria or preventing them from reproducing and spreading.

That all sounds impressive. But unfortunately antibodies don’t work for everything. For example, antibiotics don’t work for viral infections such as colds and flu, and most coughs and sore throats. Someone suffering from these infections usually get better without the use of antibiotics. The use of antibiotics to treat these is actually counter-productive, as taking antibiotics when you don’t need them encourages dangerous bacteria that live inside you to become resistant. Over time, this will mean that when you require the help of antibiotics most, they may not work for you as you may have actually been encouraging the tolerance of bacteria by suppressing your body’s ability to fight bacteria.

So don’t use antibiotics for common ailments that can get better on their own. In these situations, what you need is pain relief, and there are many options to choose from. However, antibiotics may be used to treat bacterial infections in cases such as when bacteria could infect others unless treated or infections are not likely to clear up without antibiotics. In other words, if there is further risk of infection to others, or complications which may arise from a lack of treatment, then a course of antibiotics is best followed.

The doses of antibiotics vary but if you are prescribed a course, then take the antibiotics as directed on the packet or the patient information leaflet that comes with the medication. If in doubt then seek advice from the pharmacist.

Antibiotics can be administered in various ways. The most common antibiotics are oral ones, in the form of capsules, tablets or liquid. These are commonly used to treat moderate infections or infections which are milder. There are also topical antibiotics, which are basically creams, lotions, sprays or drops, which are often administered for skin infections.

Topical and oral antibiotics are for less-serious infections. More serious infections, where the medicine has to be absorbed more quickly into the bloodstream, have to be treated by antibiotics administered through injection or drip infusion.

It is essential to finish taking a prescribed course of antibiotics, even if you feel better before the course has ended The prescribed doseage is the estimated time it will take to completely kill off the bacteria. Midway through a course, you may have killed off enough bacteria to not be under the effect of the infection, but stopping the course of antibiotics then can leave the remaining bacteria become resistant to the antibiotic.

But what if you missing a dose of antibiotics? If that is the case, then it is advisable to take that dose as soon as you remember and then continue to take your course of antibiotics as normal. However, if you have missed a dose and only remembered it when it is nearly time for the next dose, it is preferable to simply skip it and merely to continue your regular dosing schedule. Taking two doses only encourages the body to anticipate needing the double doseage in order to fight the infection, and messes up the body’s resistance levels.

Furthermore, there is a higher risk of side effects if you take two doses closer together than recommended. You may experience effects such as pain in your stomach, diarrhoea, and feeling or being sick. Most side effects are gastro-intestinal, and overdosing on anti-biotics may cause bloating, indigestion and diarrhoea.

Some people may have an allergic reaction to antibiotics, especially penicillin and a type called cephalosporins. In very rare cases, this can lead to a serious allergic reaction (anaphylaxis), which is a medical emergency. Sufferers carry an epi-pen and the drug is administered in the bloodstream through injection.

Antibiotics are not over the counter medicines and you should never use any remaining tablets arising from someonbe else’s incomplete course, as you may experience different reactions to the drug. Some antibiotics are also not suitable for people with certain medical conditions, or women who are pregnant or breastfeeding, as they may, for example, adversely affect the lining of the stomach. You should only ever take antibiotics prescribed for you and also never pass them on to someone else.

Antibiotics are only still chemicals and depending on the constituents, some can also react unpredictably with other medications, such as the oral contraceptive pill and alcohol. It’s important to read the information leaflet that comes with your medication carefully and discuss any concerns with your pharmacist or GP.

There are hundreds of different types of antibiotics, but most of them can be broadly classified into six groups. These are outlined below.

Penicillins (such as penicillin and amoxicillin) – widely used to treat a variety of infections, including skin infections, chest infections and urinary tract infections

Cephalosporins (such as cephalexin) – used to treat a wide range of infections, but some are also effective for treating more serious infections, such as septicaemia and meningitis

Aminoglycosides (such as gentamicin and tobramycin) – tend to only be used in hospital to treat very serious illnesses such as septicaemia, as they can cause serious side effects, including hearing loss and kidney damage; they’re usually given by injection, but may be given as drops for some ear or eye infections

Tetracyclines (such as tetracycline and doxycycline)– can be used to treat a wide range of infections, but are commonly used to treat moderate to severe acne and rosacea

Macrolides (such as erythromycin and clarithromycin) – can be particularly useful for treating lung and chest infections, or an alternative for people with a penicillin allergy, or to treat penicillin-resistant strains of bacteria

Fluoroquinolones (such as ciprofloxacin and levofloxacin) – broad-spectrum antibiotics that can be used to treat a wide range of infections

The use of antibiotics especially for conditions that aren’t serious has led to a rise in the number of high-tolerant infections, or superbugs. These superbugs and have a high tolerance to many anti-bodies and include:

methicillin-resistant Staphylococcus aureus (MRSA)
Clostridium difficile (C. diff)
the bacteria that cause multi-drug-resistant tuberculosis (MDR-TB)
carbapenemase-producing Enterobacteriaceae (CPE)

Ridding the world of these types of infections can be challenging, and these superbugs are becoming an increasing cause of disability and death across the world. The biggest worry is that new strains of bacteria may emerge with higher levels of resistance and that can’t be effectively treated by any existing antibiotics, so we have to be wary in how we use them, and when we suffer from minor infections, let the body try to fight off the infection instead of relying on antibiotics which may weaken the body’s immunity in the long run.

Medicines: Brand Names and Generics

William Shakespeare once wrote that “A rose by any other name is still a rose.” And in the pharmaceutical world it is a common occurrence to see that the same medicine can be called by different names. This can prove to be confusing.

Many medicines have two names. The first is the scientific name to the medicine itself – an expert committee decides the generic or common name for it, named for the active ingredient itself. For example, erectile dysfunction is treated by a medicine containing sildenafil, which is a generic name.

The same medicine also has a second name, the brand name. For example, sildenafil is more commonly known by its brand name, Viagra. Pfizer, the company that produces it, has chosen to market it under this name because brand names are more memorable than scientific names, especially at the onset when new products have just been launched. Can you imagine someone going to the pharmacist and asking for the “Silder .. silver … cyber … you know, the thing that gives more bounce and keeps going for longer?”

“Red Bull? Duracell?”

You get the idea.

The company that produces a new medical product is usually granted a patent. This patent grants the company exclusive rights to the product for a standard period usually of twenty years, and allows the company to recoup the investment spent on the development on the drug as well as to financially benefit from sales during the patent period.

While twenty years may seem like an extraordinary amount of time, it is actually not so. Most companies apply for the patent at the initial stages at development, to avoid the situation of being trumped by another company after they have done a few years of research. Imagine you have done five years of research and when you are about to proceed further, someone has applied for a patent for a product that effectively nullifies the work you have done. Or what is worse, they may even draw on your research from various medical publications to further the development of their own product. The time you have spent has been wasted and your intellectual property has been stolen.

The first ten to fifteen years of a patent are hence a covering period for the research into it and to cover the licensing process while the remaining period is the time the company has to solely market the product using as brand name, so that it becomes memorable and commandeers a huge market share after the patent period has expired.

Once the patent protection expires, other companies can produce their own version of the medicine. Hence, pharmaceutical companies are always engaged in a race against time. They have a twenty-year period to research, license, market and profit from their product before the other sharks enter the fray, so to speak.

Take for example, ibuprofen, the medicine commonly used to treat pain and inflammation. There are many branded versions of ibuprofen, such as Nurofen and Hedex. Various supermaket chains distribute their own versions as well, but under the common scientific name. You have Tesco’s ibuprofen or Superdrug’s ibuprofen. We can assume that once a product (such as Neurofen) reaches the mass market, and has been quoted enough times as to “contain ibuprofen”, the scientific name itself becomes somewhat of a brand in its own right.

Having various versions of the same medicine is confusing, but depending on our loyalty we may opt for Neurofen because it is the established brand we know. This of course depends on how it has been marketed; if the pharmaceutical company has done enough advertising to convince us that “Neurofen”, and not “Ibuprofen” is the key to pain-relief, then by association we may go for Neurofen whenever we have a headache. If cost is a more significant factor than loyalty, then we might go for the generic medicines because they are usually cheaper – they have had fewer research and development costs, but they contain the same active ingredient as the branded products.

In some cases latter companies may have simply waited for the patent to lapse, before moving in to reverse-engineer their own version of the product and market it. This is especially true for products that people will always have a need for, such as products offering relief from pain, flu, or colds; or balms of various descriptions.

Generic medicines go through the same detailed safety and quality requirements as the original branded product, but because the significant outlay of research costs have been avoided (the initial company has done the hard work) the latter products are cheaper.

Supermarket chains are already flooded with many versions of the same product. Look at your supermarket chain – how many brands of ibuprofen do they stock? This begs the question of whether chains will eventually simply stick with the products with a big market share (and hence likelihood of sale), stock more cheaper options, or even offer cheaper, newer brands. It is likely that they will do a combination of the first two. New and cheaper brands will find it hard to penetrate the market based on cost alone, as the cost of advertising is too huge. The only way they can hold on to a significant market share is if one of the bigger brands declines, perhaps through negative publicity, and one of the new brands promotes itself by aligning itself with a social cause.

Imagine, for example, there is a medicine called Increasil (scientific name) produced under the brand name Livealongerlife by parent company Healthpharm. Liveralongerlife claims to prolong the life of the terminally-ill and extend their high-functioning years by delaying the onset of infections. After it has been doing well for a few years, towards the end of its patent, it is discovered that Healthpharm conducted unethical drug trials – they tested liquid versions of Increasil by injecting them into corpses to see if it would slow the rate of decay.

Amidst the media storm, the company Fitness21 prepares to produce its own version of Increasil under the brand name Newtrition. They reverse-engineer batches of Increasil, and benefit from the research Healthpharm had previously done. As part of its submission evidence into the safety of Increasil, Fitness21 conducts trials on aging volunteers to see if they experience any increased life expectancy. The evidence gathered by Fitness 21, and also the perceived benefit of Increasil (while it was sold by Healthpharm), contributes to Fitness21 gaining a license to market Increasil in the form of Newtrition.

Fitness21 builds its factories in the impoverished third-world town of Valhalla, promising to regenerate the area. The people of the town benefit from employment, and Fitness21 sells Newtrition to its own employees at a vastly discounted rate, announcing that it hopes to raise the life expectancy of Valhalla from 50 to 75 within two decades, and in doing so, allowing the citizens to have a longer working life and more wealth, with the aim of lifting the town out of its doldrums. Future generations will benefit and the children and grandchildren of those now of working age will have very different futures from their forefathers. Fitness21 announces that its employees are like family, and it has an interest both in elevating their working and life conditions, and the fact that it is distributing Newtrition to its own employees means it has an obligation in ensuring the product itself is of the highest quality. Fitness21 is strongly interwoven and ingrained in the social fabric from which Newtrition is produced.

Whose version of Increasil would you buy? Probably the latter’s. And that is probably the only way for unestablished brands to forge through a packed market, by leveraging on social and ethical links. We have seen various products – not just medicines – marketed using that angle. Do the words Fairtrade and Co-Op sound familiar?

Prescribers (people who prescribe medicines, such as GPs) are encouraged to prescribe medicines by their generic name, not only because it is ethically right to prescribe the medicine costing less if the results are similar – and generic brands can cost significantly less – but also because it gives the pharmacist the widest choice of products to dispense, which can be important, particularly if there is a shortage of a particular product.

If you are switched from a particular brand to a generic, it is standard practice for your pharmacist to explain the changes to you, in terms of side effects, and to address any concerns you may have. In fact, this is not just if you switch brands – whenever you have changes in medication you should always speak to your pharmacist.

Only in rare cases it is important for a patient to stay on the branded medicine previously prescribed for them, rather than changing to a generic medicine. This is usually because of the way the medicine acts on the body.

Some examples of when you should keep taking your brand of prescribed medicine include:

Epilepsy medicines – these should be treated with care because different versions may have slight differences in the way they are absorbed, which can cause big differences in their effect. For example, prescribers may decide the branded version of lamotrigine (Lamictal) is more suitable than the generic version.

Modified-release preparations of medicines – such as modified-release versions of theophylline, nifedipine, diltiazem and verapamil. A branded version may sometimes be a better option than the generic equivalent, as they can be absorbed differently, and suited differently to various individuals.

Biological medicines – these complex medicines are derived from proteins and other substances produced by the body. Copies of biological medicines, called biosimilars, can never be exactly the same so shouldn’t be automatically used as substitutes. Doctors should always reference the brand name so the manufacturer and batch could be identified if there were any problems with the medicine.

Ciclosporin – a medicine that suppresses the immune system (the body’s natural defence system). Different branded versions may cause different levels of ciclosporin in your blood.

Mesalazine – which is used to treat ulcerative colitis (a long-term condition that affects the colon). The way that mesalazine is absorbed varies between different brands.

Lithium – this treats a number of mental health conditions. Different brands vary widely in terms of how much of the medicine is absorbed and becomes active.

Beclometasone dipropionate CFC-free inhalers to treat asthma – there are two inhalers that contain the same active substance (beclometasone dipropionate), but one is much stronger.

Drugs and Side Effects

All drugs come with side effects, whether they be common off-the-counter medicines or ones that require specialist prescription. Most of these effects can be minor, and some can just be an inconvenience – like having to go to the toilet more often than usual. But a few are serious, and some can just have unforeseen effects that address other ailments.

The most common set of side effects for drugs taken internally involves the gastrointestinal system. Because all prescription drugs invariably end up broken down in the stomach, nearly any drug can cause nausea or an upset stomach. The chances of these happening are quite rare, though for the handful of users this happens too the results can be quite upsetting. For drugs used externally, skin irritation is a common complaint. Which leads me to wonder – if you are merely replacing one symptom with another, is medicine merely an elimination of an ill-effect by replacement through increasingly minor symptoms, until they are bearable?

Side effects fall into several categories. The most common allergic reactions can happen with any drug and can range from itching and rash, which cause flaring on the skin and trigger even more itching and rash. They can be serious all the way up to a life-threatening anaphylactic reaction.

So if drugs have side effects, why not just get rid of these effects in the course of construction? Surely the likes of Glaxo Smith Kline, with their huge companies and research budget, can afford to genetically alter the drugs and lower the side effects? Some drugs can’t help but trigger side effects because of their chemical structure. One example is the common allergy drug diphenhydramine (more commonly known by the brand name Benadryl). It eases allergy symptoms but in the course of doing so, it also suppresses the activity of the body chemical acetylcholine. The side effect it causes is drowsiness and a host of other side effects, including dry mouth. It seems like to minimise allergies, it makes you fall asleep. Surely any fool could do that? Want to stop scratching? Go to bed!

Some drugs typically have barely noticeable side effects when dosed properly. The side effects can be minimal externally but internally they can be quite serious. For example, Warfarin (also known as Coumadin or marketed as Jantoven), is used to prevent blood clots, and while it is usually well tolerated, it can cause serious internal bleeding. I suppose it is like cancer, or heavy consumption of alcohol.

And while side effects may exist within the drug itself, further complications may also occur when certain drugs are mixed with certain other things. If you are mixing different types of drugs together, the combined chemical properties might cause complications. I suppose this is why my mother used to say never take Neurofen and Paracetamol within hours of each other. These might also be considered drug interactions. Drinking alcohol with narcotic painkillers has also caused an alarming increase in accidental overdose deaths. What??? Again, part of me wonders whether it isthe interactions of these chemicals that induced these, or whether it was because drinkers thought they had taken drugs to counter the effects like headaches, and then proceeded to consume more than they would normally have. Drinking grapefruit juice can affect the blood levels of several drugs, including some blood pressure and cholesterol medicines. Citrus fruits tend not to mix well with other foods, although vodka and orange seem a common mix?

Information about drugs legally has to be made available on the label of over-the-counter drug products and on package inserts or printed materials included with the packaging. Usually on the outer box you will find the concise version of all the drug does, and the inserts include the longer version. Because this could be potentially be a long list of possible bad effects, and written in a technical style, it is very helpful to also talk to pharmacists or doctors if you have any queries regarding a drug’s side effects.

Drugs are sometimes prescribed to young children – the more common examples are for hyperactivity, although depression prescriptions are becoming increasingly common, even for children under the age of ten. In the case of hyperactivity, for example, we should always be mindful of simply prescribing medication because it may be that the behaviour is a response to the demands of the task. In the case of depression, it may be that the individual is overwhelmed by demands, and coping strategies, rather than medication, may provide better help. Drugs should be carefully considered because one of the long term side effects is addiction and resistance to medication.

In America, before a drug is released on the market it must be approved by the FDA. Pharmaceutical companies typically submitted New Drug Applications (NDAs) which contain the pre-requisite clinical evidence demonstrating that the drug has the therapeutic effect it is supposed to have. The NDA must also contain proof that the drug is safe for human use. Unfortunately this proof comes from testing of the drug, first in animals and then in humans. Is it fair that rabbits and rats should suffer for the human race, in cages, doused with experimental acids to see if they develop irritations or severe symptoms? I guess you have to decide for yourself where you stand on that.

Homeopathic remedies may still be a long way away before they can be relied wholly on as a cure, but the day where herbal or plant-based remedies replace animal-treated alternatives is one we can look forward to. Once the basic questions of safety are settled, the FDA will approve the drug if it deems that the benefits outweigh its risks.

Sometimes not everything is known about a drug’s side effects until after it enters the marketplace and more people start using it. The pool of human testers is fairly small, so until a large data sample of users is obtained the side effects are not wholly known. MedWatch, the FDA’s post-marketing surveillance program seeks voluntary input, mainly from health care professionals, on adverse effects they may be seeing in ”the real world”. Sometimes these reports are numerous and serious enough for the FDA to take regulatory action, either through the addition of warnings to a drug’s label. One example of that involves the psoriasis drug Raptiva. The FDA required that the drug carry the agency’s strongest warning, known as a black box warning, after reports of brain infections and meningitis in patients taking the drug were received. The side effects were deemed so dangerous that the drug was later withdrawn from the market. Did the testers not recognise this when the lab mice died?

In soliciting feedback, the FDA also wants input from consumers using the various prescription drugs. All prescription drugs must be labelled with a toll-free number maintained by the agency for the purpose of reporting side effects with drugs. The FDA labels these “adverse events.” Severe side-effects can be reported through calling MedWatch at 1-800-FDA-1088 or through the FDA web site: www.­fda.­gov/­Safety/­MedWatch/­HowToReport/­default.­htm.

As we have seen earlier, the post-marketing information coming in to the FDA is so disturbing that it results in a drug coming off the market. Another case can be seen with the drug Baycol, which lowers cholesterol, after it was strongly linked to a potentially fatal breakdown of muscle tissue. While it had been initially approved in 1997, it was voluntarily withdrawn just four years later when evidence of its side effects was published. The anti-inflammatory drug Duract spent just one year on the market. It had been approved as a product strictly for short-term use, but the FDA found serious liver problems with people taking the drug for longer than what was recommended. Which begs the question: “Who is responsible for regulating patients’ consumption of medicines?” While they are safety guards in place, such as some drugs available only on prescription, what is to stop patients obtaining multiple prescriptions?

That aside, drug companies are also required to report adverse events to the FDA, and failure to do so can lead to prosecution. In 1985, two drug companies were fined and sentenced to community service for not reporting adverse events involving the blood pressure drug Selacryn and arthritis drug Oraflex. Both products were pulled from the market.

In the UK, licenses can only be granted by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA).

The stages through which potential medicines are first thoroughly researched start first with the use of tissue culture, followed by computer analysis techniques and finally animal testing.

Likewise, if strict standards of safety and effectiveness are met, clinical trials involving humans can then be used. The license for wider use is approved only if a medicine passes all the phases of clinical trials.

The whole process from discovery to licensing can take a long time, around 10 to 15 years, which means pharmaceutical labs work under a cloak of secrecy and also explains why they may not be willing to withdraw a drug for its side effects if they have invested that much time and money in it.

Not every side effect is a bad one. Some are downright welcome. Take finasteride. Introduced in 1992 to treat noncancerous enlargement of the prostate gland, it was found to regrow hair (and is marketed for that purpose under the name Propecia). Patient: “Doctor, how’s my prostrate?” Doctor: “Under control, but a bit hairy.”

Today, millions of men use a low dose of finasteride to treat male pattern baldness. Minoxidil, originally marketed as an oral tablet for high blood pressure, was found to grow hair in those using it. Today, as a topical lotion or foam, it is a popular over-the-counter remedy for baldness. But can you imagine the doctor going “Your blood pressure is normal, Chewbacca”?

Money for education? Why not the NHS, or mental health?

Grammar schools have been invited to apply for a money from a government pot for expansion. This is for “good” or “outstanding” schools in areas where there is a shortfall in secondary places. The expansion proposals will be divided into either on-site expansion, or expansion to another site, with land to be acquired. This announcement of funding for grammar schools, provoked criticism from many campaigners, with many saying that it was a shady way to get around a ban on opening new grammar schools.

The deadline for submissions is tight, and given that plans include drawing up building plans for an annexe, even existing grammars are keen on applying. The logistics of working around split sides adds costs and means teachers moving between sites, which mean more co-ordination.

And what if this money was transferred to the NHS instead? The sum of the government’s fund adds up to fifty million pounds, which may be a small drop in the ocean, but it is money that could open a new ward, more beds, and relieve the pressure on existing wards.

The money could also been used to fund more trips, and prevent brain drain of existing students for whom the classroom only disseminates information to be memorised, and not internalised. According to a Piano Teacher in Crouch End, information that is presented as a to-do list is less effective than what it is made relevant through experience and meaning. Playing a piece of music has internal satisfaction, but when learning music involves going beyond the information to understand composer motivation, there is more relevance.

Existing grammar schools have not been keen to take it up, with only one or two keen to apply. Perhaps the fund could be diverted to other health means instead, such as improving mental health services, or the acquistion of buildings or rooms where volunteers could provide some form of care for the community. Certainly the fifty million would go a longer way!