UK regulator investigating bad cancer drugs revealed by TBIJ

“I’m very proud of her,” said Neil Ranasinghe of his daughter Anne. “She’s well aware she’s a cancer survivor but it’s not really shaped her negatively.”

He is telling me about the time 22 years ago when Anne, aged just three, was diagnosed with leukaemia. “It’s pretty tough to see a small child suffering,” he said. “It’s very tough to see when it's your own daughter.”

What followed was a gruelling two years on a variety of chemotherapy drugs. But from the get-go, Neil and his wife took the attitude that Anne would get through it. “We just had certain faith in the 100% quality of the drugs when she was on treatment,” he said.

Neil’s faith was well founded: the UK’s medicines regulator, the MHRA, is regarded as one of the best in the world.

Yet this year we found that various poor-quality cancer drugs – including methotrexate, which Anne was treated with – had found their way to more than 100 countries, one of which was the UK. And last week the regulator said it will investigate how they got here.

On the thought of patients receiving these medicines, Shereen Nabhani-Gebara, an oncology professor and chair of the British Oncology Pharmacy Association (BOPA) said: “It just makes my blood boil.”

Speaking to me last week, Nabhani-Gebara said she’d always been reassured by the rigorous checks applied to medicines before they’re used in the UK. “In my head, nothing gets past the MHRA,” she said. “They protect us.”

But our findings had alarmed her. On Thursday, she formally wrote to the MHRA on behalf of BOPA requesting that they investigate what happened with these drugs. The MHRA said it would look into the matter and promised a full response at a later date.

We don’t have all the key details. All we were able to find out is that four brands of drugs that had failed quality tests in other countries have been exported to the UK since 2018. Some of the shipments were very small, while others carried tens of thousands of doses. But we don’t know whether they were then sent to hospitals, or even if they remained in the country.

We contacted the MHRA for the original story and it told us that one of the products holds a licence for use in the UK. This is the brand for which our records showed the largest number of imports: more than 50,000 units over an 18-month period. For the other three brands, they had no record of intention to import – meaning these medicines could not lawfully be distributed in the UK.

It also provided possible explanations for why the medicines may not have remained in the UK, or entered the country at all.

“I would just like the MHRA to have a closer look, go through that documentation with a magnifying glass [to] make sure that everything that is being marketed is of good quality,” said Nabhani-Gebara. She suggested that the MHRA may need to re-check some of the studies provided by the manufacturers or even conduct them again in approved UK laboratories.

We’ve done a lot of reporting to reveal how bad drugs make their way around the world. Often our stories focus on countries with weak protections, like Nepal, where the regulator doesn’t have the means to test any cancer drugs on the market. Or India, where this week we revealed that huge numbers of drugs made by one company, Zee Labs, have failed quality tests – and drug inspectors are overworked and underresourced.

The MHRA, though, is far better equipped. It is named on the World Health Organization’s list of top-tier regulators.

For Nabhani-Gebara, being able to provide safe medicines to people like Neil’s daughter Anne speaks to the very essence of her role as a healthcare professional – and the oath she took when she became one.

“I think it’s a fundamental right,” she said. “It’s a fundamental human right to be provided the care that you need to give you the best chance at recovering and living a healthy life.”

Two decades on from her leukaemia, Anne is a shining example of what a difference the right medicines can make. She has graduated with a master’s, landed a job at a non-profit and goes climbing regularly. “She’s very conscious about the world and about life,” Neil said. “She absolutely loves helping people, she gets a lot of joy from that.”

With medicines like those that saved Anne’s life being given to thousands of patients every day, it is vital that regulators in the UK and around the world hold them to the highest standards. As her father put it: “You just trust the drugs you’re getting.”