'It’s heartbreaking': Cancer drugs shipped to more than 100 countries fail quality tests

Vital chemotherapy drugs used around the world have failed quality tests, leaving cancer patients in more than 100 countries at risk of ineffective treatments and fatal side effects, the Bureau of Investigative Journalism (TBIJ) can reveal.

The drugs in question form the backbone of treatment plans for numerous common cancers, including breast, ovarian and leukemia. Over the past six years, they have been shipped to every populated continent on the planet, to both low- and middle-income countries like Nepal, Ethiopia and North Korea, and wealthy nations such as the US, UK and Saudi Arabia.

The test findings come from a landmark study by researchers at the University of Notre Dame, Indiana, who analysed 189 samples of various cancer drugs. About one-fifth failed.

"We were all taken aback when we saw the results,” said Marya Lieberman, the professor who led the research.

The worst-performing drug in the study is made by Indian manufacturer Venus Remedies. All eight samples of the company’s cyclophosphamide product failed, with six containing less than half the stated active ingredient.

Venus Remedies told TBIJ that our results were “not scientifically plausible” given the company’s “validated manufacturing systems and quality controls.” It said it has received no complaints or concerns about the batches in question and shared the results of its own testing that indicated they were of a good standard.

The manufacturer said storage conditions in the supply chain – which can impact drug quality – might have affected the researchers’ test results. However, the absence of similar quality issues across the entire data set suggests this is not the case.

Venus Remedies is one of three companies or regulators that queried the methodology used by the lab, saying it deviated from international standards or could give erroneous results. However, Lieberman said that her researchers’ methods follow international standards as closely as possible and employ similar standards to a regulatory lab. Both the findings and methods have been scrutinised by independent academics.

Two other manufacturers whose products failed the testing, Zuvius Lifesciences and GLS Pharma, have supplied failed brands to over 40 countries.

Of the 17 companies to have manufactured failed drugs, 16 are based in India. Five have been previously flagged by regulators for producing substandard drugs, including Zee Laboratories, which has been flagged 46 times since 2018.

Some drugs contained so little of their key ingredient that pharmacists said giving them to patients would be as good as doing nothing. Other drugs, containing too much active ingredient, put patients at risk of severe organ damage or even death. “Both scenarios are horrendous,” said Shereen Nabhani-Gebara, vice chair of the British Oncology Pharmacists Association. “It’s heartbreaking.”

Zuvius Lifesciences, GLS Pharma, and Zee Laboratories did not respond to multiple requests for comment.

Doctors from multiple countries told TBIJ of the drugs in question not working as expected, leaving patients suddenly unresponsive to treatment. Other patients suffered side effects so toxic that they could no longer tolerate the medicine. “It’s very worrying,” a pharmacist in Malawi told TBIJ.

These findings expose huge holes in the global safety nets intended to prevent profit-seeking manufacturers from cutting corners and to protect patients from bad drugs. More than two in three countries around the world are reportedly unable to ensure the quality of medicines their populations are exposed to.

One such country is Nepal, which is also one of the biggest importers of the failed chemotherapy brands in this investigation. The country’s medicines regulator does not have the capacity to test cancer drugs and although it can recall cancer drugs based on external evidence, it has never done so.

“Neither patients nor their families have any way of knowing the quality of these drugs,” said Smriti Pokharel of the Wish Nepal Foundation. “No one seems willing to take responsibility for ensuring proper treatment for cancer patients.”

Much of the global demand for cancer treatment is met by generic drugs, which can be made once the original manufacturer’s exclusivity rights have expired. The bad drugs found by TBIJ in this investigation were all generics.

In India, the world’s largest producer of generic drugs, questions have been raised over whether manufacturers are properly punished for producing drugs unfit for purpose.

“The Indian government’s interest is in trying to protect the industry,” said public health activist and former Big Pharma whistleblower Dinesh Thakur.

India’s drug regulator defended the oversight system, saying that failing drugs are recalled and manufacturers face “either administrative penalties or legal prosecution in court”.

Thakur pointed to limitations in the World Health Organization’s means of ensuring that people across the world have access to safe effective drugs. He described one WHO standards certificate scheme as “not worth the paper it’s written on”. The WHO did not respond to several requests for comment made by TBIJ.

One cancer pharmacist in Ethiopia estimated that it could take over a year for a patient to save for cancer treatment. If that medicine then turns out to be faulty, they simply might not be able to afford to pay for another.

“Most people believe cancer is incurable,” they said. “When they end up with a medicine that won’t cure them, that’s another tragedy.”