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”?