Effective, affordable antimicrobial drugs aren’t moneymakers, despite being desperately needed. Can non-profit organizations pick up the slack?
Research fraud - a growing niche market in science
Research misconduct appears to be rising. According to a Nature analysis cited by the Lancet, more than 14 000 scientific papers were retracted after publication in 2023—the highest number ever. Mechanisms that promote research misconduct include ‘paper mills’, ‘review mills’, and fraudulent special issues.
Paper mills are profit-oriented and potentially illegal organisations which produce and sell fabricated or manipulated manuscripts which resemble genuine legitimate research. Paper mills can take the shape of special issues as well as individual papers. It can difficult to spot paper mill submissions until the paper is published. This is because many systems rely on large quantities of submissions before a trend can be seen and then used to recall falsified submissions. Review mills are booming as factories for making and selling citations. One researcher investigating review mills concludes that ‘It is not a proper review if you repeat exactly the same review, for every type of paper, in every type of journal, 85 times.’
Can the spread of dubious, even fraudulent, publication be checked or reversed? The outlook does not look good. That may be because the drivers behind paper fabrication, review construction and special issue publication are the demands of research institutions themselves. Paper mills are the, possibly inevitable, offspring of outsourced journal writing and laissez-faire capitalism. According to the Lancet “most research institutions still use the numbers of papers published and journal impact factors as proxies for quality in making decisions on hiring, promotion, or giving tenure. Allegations of misconduct are all too often not adequately investigated by institutions for fear of loss of reputation. Meanwhile, publishers are increasingly using growth in the number of publications, with insufficient attention to quality control, as the basis for their overarching business models”.
Sources: Julia Robinson Review Mills Identified As A New Form Of Peer-Review Fraud Chemistry World 5 February 2024
Jack Nash Paper Mills—The Dark Side of the Academic Publishing Industry https://blog.mdpi.com/2022/05/09/paper-mills/
Safeguarding research integrity The Lancet DOI: https://doi.org/10.1016/S0140-6736(24)00349-0
Associate rolls
The BMA urges the public to be aware of new staff roles in the NHS – Physician Associates, Nursing Associates and Anaesthetic Associates – and is joined by ex-Labour MP Claudia Webbe MP. As usual there is confusion about privatisation. News from Nowhere will try to clarify the situation.
Physician associates have been working in hospitals and general practices, under defined levels of supervision, for nearly two decades. To become a Physicians Associate an applicant must most hold an undergraduate degree in a health or life science subject, and spend two years working to postgraduate diploma level. Physician Associates must also complete 50 hours of Continuing Professional Development (CPD) annually to maintain their status. This level of supervision and regulation is needed to maintain patient safety, but it is not grounds for closing down a role that enhances continuity of care, an attribute of NHS performance that is getting very frayed. Clinical mistakes need investigation but they do not invalidate the new roles – doctors make plenty of mistakes too.
Physician Associates help to close gaps in hospital services, especially in deprived areas - another expression of the profound inequity of the NHS. They can increase team working by working in one place, unlike junior doctors who move round training posts. However, Physician Associates may be paid more than junior doctors in their first training years, which for the BMA adds injury to insult. The BMA emphasises the risks of creating a blurred ‘mini-medic’ role. Junior doctors worry that resources will be drawn away from the training of ‘real doctors’. The mood in the medical profession is getting angrier, and is likely to worsen when the Royal College of Physicians hosts a debate open to its whole membership, on March 13th.
Source: Claudia Webbe MP Morning Star, Feb 13 2024, ‘Backdoor changes in ‘medical associates’ roles are intended to confuse and increase profits’
Non-profit drug re-purposing
Last November, a clinical trial of Zoliflodacin showed it was effective against ‘super gonorrhoea’, which is resistant to most standard treatments. In the same month a new antifungal drug, Fosravuconazole, was found to be safe and effective against a devastating infection, fungal mycetoma. Antifungal drugs are difficult to develop and are scarce.
Both trials were conducted by non-profit organizations that were founded specifically to bring new drugs to the market: Zoliflodacin by the Global Antibiotic Research and Development Partnership (GARDP) based in Geneva, Switzerland, and Fosravuconazole by the Drugs for Neglected Diseases Initiative (DNDi), also based in Geneva.
Both drugs followed a complicated path to the market. They were originally developed by conventional pharmaceutical companies: Fosravuconazole by Eisai (Tokyo), and Zoliflodacin by Entasis Therapeutics (Waltham, Massachusetts), which is now part of Innoviva (Burlingame, California). The original firms retain some rights to the drugs but the aim has been to provide these drugs to low-income countries at affordable prices.
Since 2003, when the organization was founded by members of Médecins Sans Frontières, DNDi has worked on re-purposing drugs that have been abandoned or underused. Zoliflodacin’s route to market encapsulates the decline of antibiotics research. The compound was first identified at Pharmacia (Kalamazoo, Michigan). Pharmacia was acquired by Pfizer, (New York City) in 2003. When Pfizer exited antibiotics research in 2011, Zoliflodacin went to AstraZeneca (Cambridge, UK). Then, when AstraZeneca began to withdraw from antibiotic research, the drug ended up at the newly founded Entasis in 2015.
These non-profit organizations try to fill a gap in the development and testing of drugs at a time when most legacy pharmaceutical firms have withdrawn from antimicrobial drug discovery, and many of the small biotechnology companies that have contributed to past drug development have gone bankrupt. Can non-profits beat antibiotic resistance and soaring drug costs? We shall see.
Source: Maryn McKenna Can non-profits beat antibiotic resistance and soaring drug costs? Nature 28 February 2024
Read more News from Nowhere and articles on the NHS in ERA 3 at http://www.healthmatters.org.uk/