How safe are your medicines?: Channel 4 Dispatches

17 June 2019

Monday 17th June, 8pm, Channel 4

The medical authorities have been forced to launch an urgent inquiry after Channel 4 Dispatches reveals how thousands of unsafe medicines were given to NHS patients being treated for illnesses like prostate cancer, schizophrenia and epilepsy.

In a major investigation, Dispatches exposes how criminal gangs linked to the mafia infiltrated the NHS supply chain in 2014 resulting in stolen prescription medicines for several critical diseases being imported into the UK by British drug firms and supplied to pharmacies.

• Stolen drugs are classed as “falsified medicines” posing a serious health risk to patients because they could have been tampered with or stored improperly and become ineffective.
• Dispatches discovers one of the pharmaceutical companies caught up in this illegal trade is the owner of Lloyd’s Pharmacy, one of Britain’s best-known high street pharmacy chains.
• The government agency responsible for ensuring our medicines are safe is the Medicines and Healthcare Products Agency. After changing its story several times, the MHRA finally announced an urgent investigation into the scandal.

In a statement to Dispatches, the MHRA Chief Executive, Ian Hudson said: “I take our responsibility very seriously and that is why I have ordered an internal review… to make sure that if there are any areas that need strengthening we address these as a priority.”

The Mafia and NHS:

Dr Domenico Di Giorgio, part of the Italian medicines regulator AIFA, investigated a spate of major thefts between 2011 and 2014, that saw thousands of critical medicines for serious illnesses go missing.  Di Giorgio uncovered a massive criminal network that saw stolen prescription drugs infiltrate official medical supply chains across Europe including the UK.

In March 2014, a German wholesaler in pharmaceuticals had just bought a suspicious batch of the breast cancer drug, Herceptin. Tests showed that the Herceptin had been tampered with and was ineffective.

• The German firm said they had bought the drug from a wholesaler in the UK. This was the first indication of the UK medical supply chain’s infiltration by the stolen Italian medicines.

We’ve obtained the full list of those stolen medicines that were bought by UK drug firms licensed to supply the NHS.  

• It totals 25 different treatments including the epilepsy drug, Lyrica, as well as other critical medicines for diseases such as prostate cancer, Multiple Sclerosis, arthritis and asthma.  
• More than 10 thousand units of stolen drugs had arrived in Britain by 2014.

Were any of those drugs sold to UK pharmacies and dispensed to patients?

Dispatches sent a Freedom of Information request to the Medicines and Healthcare Products Regulatory Agency (MHRA) - the body that oversees the safety of our drugs.

• At least 4 types of unsafe medicine had been sold to UK pharmacies.  
• This included Lyrica, the epilepsy drug, but also drugs for prostate cancer and schizophrenia.

The MHRA also admitted they had no idea what happened to numerous other falsified medicines that were imported into the UK. They simply said they had ‘no trace’ of them.  This means they could have been exported back out of the UK but could also have been given to NHS patients.

MHRA changing story

In a statement, initially, the MHRA said they had ‘no evidence of falsified medicines reaching patients…’ But we challenged this and 48 hours later they changed their stance.  

They said: “…we have no information on what happened to affected medicines after they reached UK pharmacies”.

Then four days later a further admission, not only did they know some of these stolen medicines had gone to patients, in some cases they had sanctioned it but only “after careful consideration of the risk to patients”.

As the truth was finally squeezed out of the Agency, a day later they were forced to act, telling us they were launching an urgent investigation.

In a statement to Dispatches, the MHRA Chief Executive, Ian Hudson said: “I take our responsibility very seriously and that is why I have ordered an internal review… to make sure that if there are any areas that need strengthening we address these as a priority.”

UK Drugs Companies involvement:

The MHRA, refused to give us the names of UK drug companies involved in importing the drugs, saying it was commercially confidential.  

A Dispatches source provided names of those licensed wholesalers here in the UK that had imported these unsafe medicines.   And by far the largest purchaser of these falsified drugs is a company called Trident Pharmaceuticals.  And Trident is owned by the US firm that runs one of Britain’s best-known high street chemists, Lloyd’s Pharmacy.

More than 4000 units of epilepsy drug, Lyrica, were sold by a Spanish company to Trident in 2014.    

AAH Trident Pharmaceuticals declined to be interviewed but, in a statement, said they ‘…audited suppliers, checked licenses and reviewed batch numbers and were victims of fraud in the supply chain’ Whilst we have very tight controls there will always be a risk of human fraud which is beyond our control.  New measures introduced in the industry this year have reduced that risk significantly…Product integrity and patient safety is of the highest importance to us’

Trident said they’d quarantined some of the affected drugs but the MHRA said they could release them because they did not believe there was a “risk to public health”.

Frequency of falsified drugs in the UK system:

In a response to a further Freedom of Information request, the MHRA revealed that at least 9 times in the last 10 years falsified drugs have penetrated the UK system.

In four of the cases these were for drugs used to treat patients with HIV. Most recently, in December 2017, a life-saving drug used to treat patients with rare blood and liver conditions known as Soliris was found to have been tampered with and ineffective.  The MHRA said there was no evidence it had reached patients.

The MHRA referred to the new industry safety measures and said, “Instances where falsified medicines have penetrated the system are very rare and should be considered against the backdrop of more than 1 billion prescription items dispensed annually”

Falsified medicines:

Because these critical medicines had been removed from the official health supply system, it’s impossible for regulators to know they are safe.  They could have been tampered with, switched with fake drugs or stolen and stored improperly.

These are described as ‘falsified’ medicines, considered unsafe and should not be given to patients.

Professor Atholl Johnston is a leading expert in clinical pharmacology at Queen Mary University of London, “If falsified medicines are getting onto the market in the United Kingdom yes we should be worried because they’ll be ineffective or may give us side effect that we weren’t expecting to have. The conditions medicines are stored in is absolutely critical.  And pharmacies go to great lengths to make sure they’re stored in the right way.  If they’re not stored like that some drugs will actually degrade and breakdown into other compounds, and those may actually cause problems in themselves.  They may be carcinogenic, or they may give rise to other side effects.”

Former Lib Dem health minister, Norman Lamb MP, has called for a review. “People first of all need to be told that they may have received medicines that came through an illegal route. And what I find extraordinary is that there hasn’t been openness about this having happened. That’s why there has to be an urgent review as a result of your investigation and reform to ensure we can trace these medicines and we can be open about how many patients have been affected when something does go wrong.”

HOW SAFE ARE YOUR MEDICINES?: DISPATCHES. MONDAY 17th JUNE, 8pm, CHANNEL 4

Executive Producer: Miki Mistrati

Prod/Dir: Joanna Burge

Presenter: Antony Barnett

Production Company: TI Productions