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Detecting the forgery.

Recently a customer in a restaurant returned a bottle of wine--a magnum of 1961 Chateau Petrus costing [pounds sterling] 18,000--on the grounds that it might be a fake. The cork did not carry the stamp of authenticity from the chateau that the customer was looking for. In the field of pharmacy, it is believed that at least 10% of the drugs sold globally, and probably a higher proportion in developing countries, is likely to be counterfeit [1]. However, according to the WHO, the true extent of the problem is not really known. Counterfeiting is hard to detect and investigate and those companies and countries that detect the problem often do not report it. Virtually all medicines are counterfeited, not just 'lifestyle' drugs such as Viagra but also life-saving medicines such as antibiotics and antiviral drugs for the treatment of HIV, antihypertensives, cholesterol-lowering agents and even simple painkillers. They can be purchased over the internet, from unsupervised sites to reduce cost and circumvent doctors' supervision, but they can also enter the legitimate supply chain.

Fake drugs can at the least contain no active ingredients and at the worst cause harm, or even death. They may contain toxic materials and impurities as a result of cheap ingredients and unhygienic manufacturing processes. In many cases active ingredients are present, however, they may be similar but cheaper generic compounds. Counterfeit medicines may also contain the correct ingredients but in the wrong proportions. It is easy to list all the things that a counterfeiter can do intentionally or otherwise to render the fake ineffective or actually harmful. The problem seems to be much more severe in those countries without strong regulatory systems, with weak law enforcement and a lack of awareness of the problem by the general population.

In developing countries, counterfeit drugs already have significant effects on public health. It is thought that the rise in resistance to antimalarial drugs is partly a result of the use of fake medicines that contain too low a dose to be efficacious against the parasite, yet high enough to contribute to resistance. WHO has many examples of deaths caused by fake medicines prescribed to patients in healthcare settings [2]. Over time it is likely to also become an increasing challenge to public health in the developed world. The parallel pharmaceutical trade in Europe has been cited as a potential risk to patients. In 2007, the Medicines and Healthcare Products Regulatory Agency (MHRA) 'issued four separate Class 1 Recalls of medicines that had entered the legitimate supply chain via parallel trade route' [3].

The manufacture and sale of counterfeit drugs is a very lucrative trade. The US-based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will reach US$75 billion globally by 2010 [2]. At the present time the chances of getting caught are small and penalties are not severe in comparison to those incurred for the sale of 'illegal' drugs such as heroin and cocaine.

More effort is now being put into policing but it remains a major problem to track a given batch of drugs from the factory to the final supplier. In the UK, the MHRA (www.mhra.gov.uk) is the government agency responsible for ensuring that medicines are safe. WHO has also created the first global partnership, International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT) that aims to improve coordination among countries so that eventually the production, trading and selling of fake medicines will cease. Drug companies themselves also put resources into fighting counterfeiting not only because of the loss of profits but also because of the damage to the reputations of their products.

With respect to the current issue of Clinical Dermatology: Retinoids and other Treatments we are reminded that the pharmacokinetics of a given drug depend on a number of factors. Orally administered drugs, for example, usually need to survive the stomach acidity and gut enzymes as well as the cytochrome P450 enzymes of the liver before they can reach their sites of action. One way of prolonging their action (if this is desired, and it may mean that potentially smaller doses can be used with fewer side-effects) is to co-administer a second compound to inhibit their metabolism. For example, RAMBAs (retinoic acid metabolism blocking agents) may be used to inhibit the action of the cytochrome P450 enzymes on retinoids, thus increasing efficacy of retinoid treatment and reducing unwanted side-effects. In this issue we present an article by Goodman and McCaffery on our present state of knowledge of RAMBAs. While the existence of such compounds has been known for quite a long time, so far they have not seen much clinical use.

All general practitioners and dermatologists have an almost daily problem of psoriasis patients who have 'tried almost everything' to reduce their symptoms. Very many different types of treatment are of course available, which is perhaps a sign that none of them, including retinoids, is completely successful. At the present time there is no cure for psoriasis and the majority of patients will have to be prepared for lifelong treatment of their symptoms. Even the most successful and recent treatments tend only to produce 70-90% clear-up rates. Furthermore, practically all the treatments seem to become less effective with continued use and most practitioners recommend changing the regimen from time to time. This may be because of inducible cytochrome P450 enzymes mentioned above. Although coal tar derivatives are traditionally used, patients find them messy to apply, they tend to stain clothing, and have limited efficacy. We really have no idea how they work and a typical coal tar product may contain thousands of different compounds.

For the typical general practitioner the first line of treatment is often to prescribe topical steroids such as betamethasone, which are much 'gentler' than coal tar and are certainly non-staining. In this issue we offer two articles by Thawornchaisit Prasutr reviewing the use and efficacy of coal tar and betamethasone, which we hope readers will find useful and interesting.

Also worthy of mention in this issue is a review of a very useful and major new book on retinoids by Vahlquist and Duvic. In fact, this book updates us not only on the retinoids as such but also on [beta]-carotene, or 'pro-vitamin A'. (Somewhat confusingly, some cosmetic companies now use the term 'pro-retinol' for an ingredient, which usually means retinyl palmitate not [beta]-carotene, and which gives rise to retinol when hydrolysed in the deeper layers of epidermal cells.)

In addition, there is also the usual selection of reviews of papers appearing in the current literature. One of these is about stress (in mice) another is about that perennial problem for the general practitioner, namely acne, and its relation to glycaemic load.

References

[1.] Jack A. Counterfeit medicines: bitter pills. BMJ, 2007, 335, 1120-1121.

[2.] WHO. Counterfeit medicines. Fact sheet No. 275. Online at www.who.int/mediacentre/factsheets/fs275 last accessed 9th April 2008.

[3.] Thompson J. BMJ Rapid Response. Hurrah--an anticounterfeiting strategy. Online at www.bmj.com/cgi/eletters/335/ 7630/1120 last accessed 9th April 2008.
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Title Annotation:Editorial
Author:Wood, E.J.
Publication:Clinical Dermatology
Date:Mar 1, 2008
Words:1177
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