Oncologists don’t disclose nearly half of the funding they receive for clinical trials of cancer drugs, new research reveals.
Drug companies with deep pockets often provide funding for trials of their medicines and the practice is legal.
Doctors are not required by law to disclose these payments but are expected to hold themselves accountable.
Previous research has shown that doctors’ and scientists’ findings are influenced by where the money for their work comes from – and that can undermine their objectivity.
New research from Oregon Health and Science University (OHSU) and Oklahoma State University (OSU) found that oncologists may be green-lighting expensive cancer drugs without fully disclosing millions of dollars of collective funding.
About a third of oncologists don’t disclose all of the funding they receive for working on clinical trials of expensive – and sometimes marginally effective – cancer drugs, a study finds
Drug development is an extraordinarily expensive process.
A Tufts Center study estimated in 2017 that every cancer drug costs $2.7 billion to make.
More recently, a JAMA report gave a more measured figure of $757 million per drug – still a high cost, but one well-worth the lives these drugs save.
Thanks to surgical and pharmacological treatments for cancer, there were more than 15.5 million survivors living in the US at the end of 2016, and that number has likely grown.
Cancer treatments cost patients an average of $10,000 a month – twice what they did a decade prior.
These treatments are only worth their bank-breaking price tags if they are safe and effective.
Drug companies are allowed to help fund the clinical trials that serve as evidence for or against the safety and efficacy of a drug when it is assessed by the US Food and Drug Administration (FDA).
But when it reviews these findings, the FDA is putting its trust in the word and work of clinicians and financial disclosures help them to identify whether or not these doctors have any reason to present their findings in a biased light.
These disclosures amount to ‘the honor system,’ according to study co-author Dr Erick Turner, a medical ethics assistant professor at the OHSU School of Medicine.
‘The journals ask the authors to make these disclosures, but there’s no legal force behind it.’
Ethicists, the FDA, drug companies and much of the public sector are all aware of research showing that payments do inevitably sway clinicians – and so are many clinicians.
But, of course, doctors running drug trials have good reason to maintain the appearance of objectivity.
So Dr Turner and his team wanted to investigate how much funding these physicians and scientists kept to themselves and failed to document in their studies.
They compared data from the accountability and financial transparency site OpenData.gov to the funding disclosures that 344 oncologists included in their studies of cancer drugs between January 2016 and August 2017.
These doctors were paid out a total of $216 million in fees for four categories of work: Speaking fees and other general payments; research for study coordination; research grants, and ownership through stock payments, according to OpenData.gov.
But 110 of the 344 doctors omitted at least some of these payments from their written studies published in six of the most prestigious medical journals in the US, including JAMA Oncology, the Lancet and the New England Journal of Medicine.
‘We know that pharmaceutical companies sponsor trials of their own drugs. That’s not a surprise,’ said lead author Dr Cole Wayant of OSU.
‘But what is a surprise, and what warrants concern, is that this funding is often not disclosed in the publication of clinical trials that form the basis of FDA approvals and clinical practice guidelines.’
The authors concluded: ‘In clinical trials of FDA-approved oncology drugs, bias, either real or potential, is more concerning because these oncology drugs are often associated with marginal improvement in survival but exorbitant costs.’