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D RU G S A N D I N T E R N E T – A DA N G E RO U S A F FA I R INTRODUCTION Every day people die after having used fake medicines. On the internet you are promised miracle pills and life-saving remedies for all kinds of aches and pains. The scientific proofs are not as promising, i.e. if you have a pill containing anything at all. There are two kinds of medicines you can get from the internet. One pretending to be a well-known medicine that in fact is a forgery, the second being a miracle medicine you have never heard of, promising a lot of advantages. Buying this kind of preparations from the internet can be a life threatening and an expensive affair. COUNTERFEIT MEDICINES Why does the problem exist? The development and production and of a new pharmaceutical product involves enormous costs and the pharmaceutical companies have to bring the money in before they loose the patent, which means expensive medicines to the customer. That is why making counterfeit medicines is a great source of income. Swindlers can manufacture well-known drugs without their expensive active ingredient. The customers might be people wanting prescription drugs without visiting a doctor. Ordering from the internet is the easiest way to get hold of the wanted medicines without having to deal with the shame about ones condition when visiting the doctor. In some cases, for example, to get a prescription for Xenical you have to be motivated to loose weight, and need to show to the doctor that you are ready to diet. If you are not, you could find it easier to get the prescription drug from the internet. Another group of customers is bodybuilders wanting different kinds of preparations for bodybuilding. The extent of the problem Between five and ten percent of the medicines sold in the world can be fake (1). The developing world suffers the worst problem, but also the industrial countries have got their share, due to an increased trade in pharmaceuticals over the internet. “Trade with pharmaceuticals over the internet means that the risk of fakes increasing even for us Europeans” says Sten Olsson at the Uppsala Monitoring Centre, which is the WHO’s agency for monitoring pharmaceutical side effects (1). In the developing world it is often more commonly used medicines that are counterfeited, such as painkillers, antiparasitic medicines and antimalarial drugs. In the industrialised world the counterfeit tends to be more lifestyle-oriented medicines, like oral contraceptives, virility drugs and drugs for loosing weight. Swedish medical products agency reported 2001 that Viagra is sold illegal and that it has been an attempt to smuggle tablets of Viagra from Estonia to Finland (2). At a routine check 150 packages of Viagra á 50 tablets were found. The colour of the tablets resembled the colour of Viagra but the shape was not identical. Laboratory analyses showed that the tablets did not contain any active substance. This was one of the first attempts to import counterfeit drugs into the Nordic. Another example is smuggled growth hormone from the former Soviet Union. Analyses showed that the hormone probably was extracted from human pituitary gland, which can increase the risk for Creutzfeldts-Jacobs disease. 2002 the Swedish medical agency reported that a batch of fake Xenical, used for loosing weight, was found in the customs in South Korea on its way from China (3). Analyses showed they Photo: CBS/AP contained another active substance that is normally found in CBS/AP Reductil (another drug for loosing weight). WHO had a project in the late 90’s in which the aim was to chart the incidence of counterfeit pharmaceuticals (1). The result in all was 751 cases recorded, and a full eleven percent of those were recorded in Europe. Some of the forgeries were so cleverly done that the manufacturer of the original product could not tell which one was the fake by studying the packaging. They even found a fake hologram. In the developed countries taking the fake medicines often leads to non-appearance of the promised effect. The fakes themselves are seldom dangerous. In the third world on the other hand they can be poisonous or even lethal. In Delhi, 1998, 33 children died after haven taken contaminated cough-medicine (5). The contaminant was dietylenglycol, which can induce renal failure. Approximately 500 people have died from dietylenglycol poisoning. Dietylenglycol is a cheap solutant and has been used to substitute more expensive ones MIRACLE PILLS There are a lot of different kinds of miracle pills on the internet, in magazines and from mail-order companies. What they all have in common is the fact that they are not registered medicines. If they would have all the effects they promise, they would be a source of great income. The medical companies, would fight to get hold of them and sell them as registered medicines. Why, in that case, are they only sold on the internet? When finding a great drug on the internet you should consider a few things before ordering: Photo: www.tiofoto.se Have you ever heard about the drug in another context. For example on the news or in the newspaper?. Newly discovered cures for diseases are getting a lot of attention. Can you get information about the drug from trustworthy suppliers of medical information, like medical products agencies, pharmacies, Netdoctor or Infomedica. Do you think the information is trustworthy, if you consider your previous knowledge about the disease and treatment. Preparations that are said to have effect against diseases are by law required to undergo controlled studies for effect and patient safety. Are there controlled studies for the miracle pill and has a comparative study been done, comparing the effect of the miracle pill versus other medicines used to treat the condition. CONSEQUENCES Health One could say, so what if I get a preparation without active substance or a herbal drug from the internet. At least it is not harmful. In fact, you should be afraid of what you can get. In the above example with Xenical the active ingredient, orlistat, had been changed to sibutramin, which is the active substance in the weightloss preparation Reductil. Reductil has other contraindications, i.e. diseases when you cannot use the preparation, for example heart disease and mental disturbances. This means that for some people this batch can be even fatal. People tend to believe that herbal medicines are safe and not dangerous at all. Sellers on the internet prey on that myth, even selling herbal remedies as antibiotics and cure for cancer. The Swedish medical products agency have recently attracted attention to extracts from grapefruit seeds sold in herbal shops (4). This extract is said to be working as an antibiotic and to strengthen the immundefense against bacteria, viruses and fungus. This means according to the definition of a medicine, that this product is, in fact, medical. The corporation has not applied for registration of such a drug. The extract can cause severe damage to mouth and throat due to irritation. You can get prescription medicines from the internet without seeing a doctor by just filling out a questionnaire on the webpage, in some cases you do not even have to do that. This can delay your true diagnosis leading to serious harm in the future. That is, if you are not harmed by the received drug itself. Economomy There are a lot of laws and regulations concerning import and mail deliveries of medicines. Drugs that are sent by mail can be held in customs. Products ordered from the internet are often expensive, and you are often required to pay in advance. If you can’t convince the medical agency to approve the import, the mail package will be returned or destroyed and your money will be lost. If one is in fact injured of drugs from the internet one is at risk of being denied economic compensation for medical attention, because the common health insurance only cover damages from registered drugs in the country you are living in. DISCUSSION There is very little documentation of pharmaceutical counterfeiting. The risk of getting cought is negligible, the risk of getting punished even less and the profits are great. The swindlers can make a greater profit producing fake medicines than producing and selling narcotics. With fake medicines getting around in the world, the risk for a fake batch ending up on the shelves of real pharmacies increases. In the ongoing situation of competitive pricing it would be a possibility for a less honest company to dilute a batch of genuine product with fakes to cut costs, make more profit or win an order. The pharmaceutical companies have to, and are, getting together to fight forgeries. The best way to fight fake medical products is to make the pharmaceutical product, and foremost the packaging, more difficult to counterfeit. Holograms are already in use, another way is to include trace elements in the medicine which makes it easier to analyse. Of course this means that the product becomes more expensive, which economically hurts poor people, leading to extensive internet shopping for cheaper drugs. The increasing problem with medicine counterfeit threatens the credibility of the original products. This leading to the worst scenario that people refuses to take any medicine out of fare for poisonous medicines. REFERENCES 1. Näsström Jan, Fight against fake medicine, Holmen business report, February 2003 2. Svart Viagra kan vara dyrbar placebo, Läkemedelsverket i Sverige, 19.02.2001. 3. Läkemedelsverket, http://www.mpa.se/observanda/obs02/020508_xenical.shtml, 08.10.2004 4. Läkemedelsverket, http://www.mpa.se/press/press98/981016.shtml, 08.10.2004 5. Hake Karl-Magnus, Förfalskade läkemedel-ett växande internationellt problem, Läkemedelsvärlden (6), June 2001