Latest news with #MaryaLieberman
Business Insider
a day ago
- Health
- Business Insider
Nearly 1 in 6 cancer drugs found in Africa are defective, study finds
A new study has found that almost 17% of cancer drugs sampled in Ethiopia, Kenya, Malawi, and Cameroon were substandard or counterfeit, raising concerns over patient safety and gaps in pharmaceutical regulation across Africa. A study published in The Lancet Global Health revealed nearly 17% of cancer medications sampled in Ethiopia, Kenya, Malawi, and Cameroon were substandard or counterfeit. Approximately one in six tested medications had incorrect levels of active ingredients, highlighting risks to patient safety and treatment efficacy. The study attributes issues to factors like poor manufacturing practices and storage conditions, as well as counterfeiting. Published in The Lancet Global Health, the study tested nearly 200 unique cancer drug products collected from hospitals and pharmacies in the four African countries. It found that around one in six contained incorrect levels of active ingredients, putting patients at risk of ineffective treatment and disease progression. Researchers said causes ranged from poor manufacturing and inadequate storage to deliberate counterfeiting. The problem is difficult to detect visually: only about 25% of the defective products could be flagged by inspecting packaging or color, while the majority required laboratory testing to uncover quality failures. 'If you can't test it, you can't regulate it,' said Marya Lieberman of the University of Notre Dame, who led the investigation. 'The cancer medications are difficult to handle and analyze because they're very toxic, and so many labs don't want to do that.' The study points to big challenges for many African countries in making sure cancer drugs are safe. Many places don't have the right labs or trained staff to properly test these medicines. Even where labs do exist, they often can't handle these very strong and dangerous drugs. WHO Addresses Cancer Drug Quality Concerns The World Health Organization (WHO) said it is in contact with authorities in the four affected countries to review the findings and develop a response plan. 'We are concerned with the findings the article has highlighted,' the WHO said in a statement. 'We expect to assess full information to evaluate the situation... But we're committed to address these issues working with the relevant countries and partners.' Defective or falsified medicines are not new challenges in Africa. Previous studies have found similar rates of poor-quality antibiotics, antimalarials, and tuberculosis treatments. The WHO has estimated that roughly 10% of all medicines in low- and middle-income countries are substandard or falsified, leading to treatment failures, adverse reactions, and wasted healthcare spending. Despite the worrying results, researchers noted that most of the cancer drugs tested did meet quality standards, with around two-thirds of suppliers consistently delivering safe products. Experts called for improved manufacturing oversight, stronger regulatory frameworks, and investment in local testing capacity. They also pointed to new screening technologies under development, such as portable 'paper lab' tests designed to help detect poor-quality medicines before they reach patients.
Eyewitness News
5 days ago
- Health
- Eyewitness News
'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.'
