- The Observer,
- Sunday July 11 2004
Across Britain this summer, an infection which had dwindled into insignificance has suddenly made a painful reappearance. Teenagers, army recruits and college students have found themselves with the tell-tale swollen glands and earache which are the first signs of mumps.
Most of them will make an easy recovery, but for a few there will be unpleasant and potentially dangerous complications. For this reason, emergency clinics have been set up in libraries and student campuses around Cornwall, Derbyshire, Nottinghamshire and now Birmingham to try to immunise the 18-to 25-year-olds most at risk.
The latest figures show mumps is at its highest level since 1995, when a new surveillance system to detect the disease was set up. In England and Wales there have been 1,272 reported cases and 307 confirmed for the first quarter of this year, almost as many as the whole of 2002. In Scotland there were 515 cases in the first half of this year, far more than the same period last year.
The MMR jab was introduced in October 1988 and there was no mumps inoculation before that, so there are many teenagers who never received immunisation against the virus. They are sandwiched between younger children who received the measles, mumps and rubella vaccine and the adults who gained natural immunity as a result of being exposed to it.
But the surge has caused panic among parents who fear that giving their children the MMR jab might lead to autism. One health company has a waiting list of 18,000 people prepared to queue for up to a year for the single mumps inoculation rather than give their children the triple dose.
Measles is normally the disease which carries the greatest fear factor. Mumps is a milder viral infection that is completely harmless in most cases, but can cause complications and even fatalities. It causes flu-like symptoms and swelling of the glands, but occasionally it will cause orchitis, a condition which can lead to sterility in boys and men.
In rare cases, mumps leads to viral meningitis, and in pregnant women there is a risk of a spontaneous abortion in early pregnancy.
Today The Observer can reveal how the massive demand for the jab has created a black market, with middlemen who offer to import the vaccine from the US in breach of the normal regulations.
Ironically, attempts to bring in the vaccine by the back door are partly fuelled by the government's attempts to encourage the take-up rate for the MMR triple jab, by making it harder and harder for licensed clinics to obtain the single doses they need for their clients.
Under the current system, clinics have to be licensed by the Medicines and Healthcare Products Regulatory Agency, the MHRA, if they wish to import the vaccine from a named supplier. The limitation they face is that they can opnly import it in batches of 25 doses at a time.
Theoretically, clinics could make several applications a day for a batch, but in practice the system is intensely bureaucratic and clinics are only receiving up to 30 doses a week.
The vaccine, known as Mumpsvax, is manufactured by Merck Sharp and Dohme and uses the Jeryl Lynn strain of the virus. In the UK, the distributor is Aventis Pasteur. The demand for the single vaccine creates a real dilemma for Merck, which also makes and supplies many thousands of doses of the MMR vaccine to the NHS.
One doctor who runs a private clinic, Dr Julian Eden, told us exactly how he managed to get the vaccines. Eden founded the online company e-med and runs the clinic from the private Hospital of St John and St Elizabeth in north London, which is highly fashionable among celebrities such as Gwyneth Paltrow and Jerry Hall. The clinic charges £120 per Mumpsvax shot.
Eden told us he had 1,000 doses of the vaccine in stock. 'Between you and me, what we do is use a wholesale importer who backdoors it to us once it is in the UK. But the papers say it is destined for Delhi. Sometimes you need to bend the rules in this situation.
'Otherwise you approach the DoH (Department of Health) and say, "Can you give us approval?" and they have a huge amount on their books.'
He explained how the deal works: 'I happened to stumble upon someone who is a group wholesaler, working with 100 doctors (in the US), so they can get 100 doctors' worth of stuff coming in. The main delay is getting the paperwork sorted with customs. If you tell them you have vaccines they go spare, so you tell them it is medicines.'
He defended the action by saying: 'All you are doing is trying to get a vaccine which will stop some sterility. But it's as if you're trying to bring in cocaine. It's mad.'
He claimed he had a wholesale supplier who got it in through 'the back door' once it was in the UK, but was adamant that he used the 'cold chain' system - ensuring that the vaccines were kept at the correct temperatures in refrigerated boxes during transport.
Eden told The Observer that the importation papers would sometimes say the load was destined for India or other countries. He went on to say that he had to hand over £40,000 in cash to receive his last load of vaccine.
'My man is a bona fide wholesaler. But you have to be flexible with the truth to get it. Sometimes you call it vaccines bound for Pakistan or Afghanistan, but like any parallel import it actually goes out of the back door at Heathrow.'
The problem is that other clinics who do not go down the same route now have an enormous number of patients waiting. Sarah Dean, a nurse who set up Direct Health 2000 because she believed her son was damaged by MMR, is incandescent about what is happening.
'We have about 18,000 people on our books waiting for immunisation for mumps, either for themselves or their child. At a time when you have outbreaks occurring all around the country, this is not a good situation to be in.'
Dean's company, which runs outreach clinics around the country, has a licence to import the vaccines. It would be illegal for her to import more than the specified amount of doses, and she would have to name her source.
She said a former employee, Dr Stuart Wallace, had offered to put her in touch with a US contact for more vaccine. He wrote in an email in May: 'Has several thousand in stock ... interested. As with all things in life, there is a price to pay. Make me an offer.'
When she inquired further, Wallace told her she could not know the source until he received payment prior to release. He said that the price was '£70 per vial from me ... $16 is the cost from the dealer in USA.'
Worried that she might be breaking the rules, she turned down the chance to make a deal. 'I want to do things by the book, but I believe there are unscrupulous people who are importing this vaccine without following the rules.'
Wallace,who is registered with the General Medical Council and is based in York, now runs his own clinic offering immunisations. He said that the emails were simply a way of offering to put Dean in touch with an American broker, whom he claimed had supplied another private health clinic in Britain.
The American broker denied to us that he would export the vaccines; apart from any qualms, he has no export licence anyway.
Other clinics are managing to obtain supplies, although the MHRA would not reveal the details.
Healthchoice UK is a network of 20 private clinics, run by nurse Kathy Durnford and supervised by fully registered doctors. She strongly denied having used any underhand methods in obtaining her supplies, but declined to say where they came from, citing commercial confidentiality.
Her company charges £140 to administer a single vaccine, even though vials cost as little as $10 in the US. Durnford said: 'There are lots of running costs involved - arranging the transport, having the staff of doctors and nurses to run the clinics properly.' She has full approval from the MHRA to import the vaccines, and stressed that her work was above board.
'At the beginning of the year there was a backlog, but that has cleared up now,' she said. 'I have people who have got good sources, and they are getting them through.' She added that they were requesting around 125 doses a week.
The Department of Health said last night that, for reasons of commercial confidentiality, it could not reveal the amounts individual clinics are allowed.
However, a spokeswoman said: 'The MHRA take very seriously any breach of medicines legisation, and will investigate any report of an individual or company who is not complying with the regulations around the import of unlicensed medicines.'
The manner in which vaccines are moved between countries is important because they have to go through a 'cold chain' system, which entails them being kept in medical refrigerators at the correct temperatures throughout their journey while they are being couriered by DHL or Fedex.
At the same time, other problems can arise, as Dean explained: 'The problem you can have with vaccines coming in without the proper paperwork, through the back door, is that you may have no way of knowing whether they have been stored in the right way. If I was a parent, I wouldn't want to take that risk.'
Many think the situation highlights the role of some private health clinics who have made large profits from the MMR scare.
Mike Fitzpatrick, a London GP who recently wrote a book detailing his son's autism - which he does not blame on the jab - said: 'It's such a terrible trade, profiting out of peoples' fear and anxieties. Some of these clinics serve no purpose other than to make lots of money out of people.
'The difficulty for politicians is that, at a time when they are offering more choice in healthcare and education, they are saying you can have no choice at all over vaccines. It's the right policy to choose, but it's hard to explain that to a public which has been terrified over autism.'
