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Thousands of patients taking a life-saving cancer medicine have been warned that counterfeits have entered the supply chain.
Drug regulators issued the alert yesterday after the discovery of fake batches of Casodex, a prostate cancer drug, after an alarming surge in counterfeit medications for critical conditions. The alert is the third in a week involving blockbuster drugs, which have also included a schizophrenia drug and a blood-thinning agent.
Police have launched a big investigation after the discoveries, which have all been traced to the same UK-based wholesaler. They are thought likely to have originated from an international criminal syndicate – possibly based in China, Pakistan or India – taking advantage of the huge profits to be made from fake drugs. The wholesaler linked to the counterfeit batch, 65520, of Casodex, a hormone treatment for men with advanced prostate cancer, has had his licence removed.
The Medicines and Healthcare products Regulatory Agency (MHRA), confirmed that a man had been arrested and released on bail last week after previous drug recalls of counterfeit Zyprexa, a schizophrenia drug, and Plavix, a blood thinner and the world’s second-biggest-sell-ing drug. Investigators believe that the dealer, who has not been charged, may have been working with other wholesalers to import the fakes from Asia via other European countries.
The latest alert comes amid fears of a huge increase in the number of counterfeit drugs entering the UK supply chain, which distributes two billion medicines a year.
The World Health Organisation estimates that up to 10 per cent of medicines available globally are counterfeits, potentially posing a serious health hazard to patients. Counterfeits – which have been found to be cut with substances including brick dust, chalk, paint and furniture polish – are notoriously difficult to detect with the untrained eye and even experts sometimes require full forensic science laboratory tests to determine whether a suspect product has been tampered with.
Patients were urged last night to contact their pharmacist if they are taking Casodex with the batch number 65520 printed on the packaging.
A spokeswoman for the MHRA said last night: “We take this very seriously and a criminal investigation is being carried out.”
The agency said it was contacted by a wholesaler who had been offered a suspicious batch of tablets. Initial tests on the seized samples showed that they contained about 75 per cent of the quantity of active ingredient stated on the label.
The recall was issued to minimise risk to patients, but any adverse effects may not be noticed by anyone taking the corrupted drugs.
“At present there is no evidence of patients having any adverse reactions specifically related to the counterfeits,” the MHRA said. “Patients should consult their GP if they have any concerns.”
About 12,000 Britons currently take Casodex, made by the pharmaceutical company AstraZeneca.
Three counterfeit batches of Zyprexa, a schizophrenia drug manufactured by Eli Lilly, were found last week. The drug is taken by 168,000 British patients. Two batches of Plavix were also recalled.
Recalled drugs
Please contact your pharmacist if you have the following medicines:
Casodex 50mg tablets, batch no 65520
Zyprexa 10mg tablets, batch nos A229505, A200127 or A216454
Plavix 75mg tablets, batch no 3098 and 6Y098 (or any variants such as
6Y098/1)
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Unfortunately, counterfeit medicine is on the increase in Europe but many governments and health authorities deny the fact. It is seen as a problem that blights "less significant" countries in the developing world. Drug companies have to go to great lengths to ensure that what they produce meets a range of strict requirements, but once it leaves their gates, many wholesalers can unpack and repack the goods, making the history of the product in the pharmacy very unclear. This is never the case for food, which comes in tamper evident packaging, so why is it for drugs? Some of the larger pharma companies are tackling this (I know, I work for one) but, as with many of these things, the first step towards cure is admission that there is a problem.
Tom, Sutton,
This is nothing new. About twenty years ago I assisted in the investigation into the counterfeiting of a drug being sold in a West African country. It was a cure for what could be called a 'regrettable social disease'. The market penetration of the fake was 100% so you can imagine the problems this caused,
Ken Luck, London,
I think it's disgusting that people have tried to make a quick buck out of selling extremely ill patients fake drugs. Is there no low some people will not sink to for money?
Charlotte, Nr. Taunton, Somerset
!8 months ago I had a concern about the effectiveness of a batch of Propanalol which I take for tremor. I have been taking this drug for about 4 years. I started a new batch and almost immediately had symptoms similar to those that I experienced before taking the drug. 10 days later I started another batch and returned to my habitual state. I went to Boots (who supplied the drug) and spoke to the pharmacist. She was totally disinterested and said counterfeit drugs were a hoax, thought up by the media! I was not happy with that response and she reluctantly gave me the telephone number of the pharmaceutical company in the UK. I contacted them and sent the tablets to be analysed. I was assured that there was nothing wrong but I would have been happier if an independant authority had done the testing. What should people do who are in a similar situation? Propanalol is normally taken as a blood pressure reducing drug. They would not have recognised any lack of effect until it was too late.
Susan Hambleton, Solihull, UK
The problem with any product with huge margins is that criminals are attracted; just look at the music business... Perhaps we have come to the point where we should look at a different model for pharmaceuticals. Sell developed products at 'normal' margins based on production and distribution costs plus associated overheads. Then introduce a development levy payable directly by the NHS based on the usage of patented drugs. That would keep the huge sums away from the criminals and at the same time, make drugs cheaper for the developing nations. Of course it would not be an open-ended cash cow as at present but maybe that would be a good thing for all concerned.
colin, Shrewsbury,
What a horrible dog eat dog world we live in.
J Hurst, Preston, England
More 'white collar' crime - not taken very seriously by the authorities, if only the same level of enforcement went into the drug supply chain that goes into policing our recycling bins
John, London, UK