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Can a new project stop flawed medical research before it causes harm?
Can a new project stop flawed medical research before it causes harm?

Business Standard

time03-07-2025

  • Health
  • Business Standard

Can a new project stop flawed medical research before it causes harm?

With trust in science under scrutiny, a global initiative seeks to catch manipulated or inaccurate medical studies before they influence clinical or policy decisions Sarjna Rai New Delhi Every day, clinical decisions, health policies, and patient treatments are shaped by scientific studies. But what if those studies are based on manipulated images, skewed data, or biased analysis? What if the medicine you are prescribed was approved based on flawed evidence? These are not just academic questions—they directly affect lives. Flawed medical research is a growing problem According to a report published by The Guardian last year, around 10,000 research papers were retracted by journals in 2023. Watchdog groups like Retraction Watch have tracked the surge in scientific retractions, often issued only after serious flaws or fabrications are uncovered. An analysis by Nature showed a steep rise—from just over 1,000 retractions in 2013 to more than 4,000 in 2022, with numbers crossing 10,000 in 2023 —signalling a deepening credibility crisis in research publishing. The pandemic accelerated this trend with a spike in pre-prints—scientific papers made public before peer review. While helpful in fast-tracking global knowledge sharing, this also allowed questionable research to bypass scrutiny. Between January 2020 and October 2021, 157 COVID-related papers were retracted, including some from top-tier journals, as reported by The New Indian Express. Notably, high-profile studies on hydroxychloroquine and blood pressure medication in COVID treatment were withdrawn after experts revealed serious data inconsistencies. In 2016, an inspection of Semler Research's facility in Bengaluru by the US FDA uncovered severe data falsification, including sample manipulation and substitution. The FDA declared the firm's studies unreliable, forcing sponsors to redo trials through alternate agencies. The World Health Organization and European Medicines Agency also took action, highlighting the global reach of flawed data. What is the Medical Evidence Project trying to do? The Medical Evidence Project aims to tackle the mounting crisis in research reliability. Funded by a $900,000 grant from Open Philanthropy, the project will focus on identifying manipulated or low-quality studies before they affect patient care or policy. Led by Boston-based research scientist James Heathers, the initiative will be run under the Centre for Scientific Integrity, the non-profit that also operates Retraction Watch. Heathers will collaborate with Ivan Oransky, the centre's executive director and co-founder of Retraction Watch. 'We originally set up the Centre for Scientific Integrity as a home for Retraction Watch, but we always hoped we would be able to do more in the research accountability space,' Oransky said in a statement. 'The Medical Evidence Project allows us to support critical analysis and disseminate the findings.' By combining editorial review, forensic screening, and whistleblower tips, the initiative hopes to build a stronger accountability model—preventing both misconduct and honest errors before they influence decisions. From whistleblowers to watchdogs: How the system will work The Medical Evidence Project will operate via a dual strategy—combining tip-offs from whistleblowers with systematic screening using digital tools. A core team of up to five investigators will use forensic metascience methods to analyse papers for signs of manipulation, bias, or methodological error. Their findings will be published on Retraction Watch, known for tracking research retractions. James Heathers described the process in a blog post: A flaw is identified in a published paper A detailed report is prepared If the flaw is serious, it undergoes internal peer review The findings are then made public In addition, the project will: Build software tools to automate parts of the verification process Follow up on anonymous tips through a dedicated whistleblower channel Pay external reviewers to independently verify and scrutinise findings The team aims to uncover at least 10 flawed meta-analyses per year, with the broader goal of raising the reliability of published medical literature. Why this matters to patients, policymakers, and the public A study in Misinformation Review by Harvard Kennedy School found that nearly two-thirds of sampled scientific papers on Google Scholar showed signs of being generated using AI tools like GPT. Roughly 14.5 per cent of these flagged studies were health-related—some even appearing in established journals. The problem is worsened by the fact that Google Scholar does not differentiate between peer-reviewed publications and unvetted content like preprints or student theses. Once flawed studies are cited in meta-analyses or referenced by clinicians, they can misguide patient care, misallocate public funds, and skew health policies. This is why initiatives like the Medical Evidence Project are vital—not as punitive measures, but as proactive efforts to improve transparency, raise research standards, and restore faith in evidence-based medicine. Conclusion Science thrives on credibility. The global push to catch flaws before they become crises marks a pivotal shift in how health research is verified. With ethical oversight, smarter tools, and dedicated investigators, the goal is clear and urgent: to ensure medical evidence truly serves the people who depend on it.

Meet science's new fraud fighter
Meet science's new fraud fighter

Politico

time25-06-2025

  • Health
  • Politico

Meet science's new fraud fighter

INVESTIGATION A new scientific integrity project aims to find 'bad medical evidence before it kills people.' Or at least that's how James Heathers describes his new role, as director of the Medical Evidence Project, on LinkedIn. The nascent project is predicated on the belief that uncovering flawed research is a slow and arduous process with few enforcement mechanisms. And allowing bad research to go unchecked can have high stakes. If flimsy or incorrect studies are incorporated into health or medical treatment guidelines, they can cause widespread public health harms. The Medical Evidence Project will operate on two levels: Whistleblowers can use a tip line to alert Heathers' team to problematic research and the team will build digital infrastructure to vet research more efficiently. The project is funded through a two-year $900,000 grant from Open Philanthropy. The nonprofit Center for Scientific Integrity, the parent organization of Retraction Watch, a blog that tracks retractions in scientific publications, is running the initiative. Heathers, a Boston-based research scientist leading the project, talked with Erin about the project's launch earlier this month and why correcting the record matters: This interview has been edited for length and clarity. How will you choose which research tips to pursue? I triage things in terms of: What is it supposed to prevent? What harm could be caused? What actually happens? Let's say we were talking about vitamin K or another necessary supplementation to support healthy birth. That's really important. Is everyone eating enough salmon? Significantly less important. If there are things that are inaccurate, obviously that's a problem. But if there are things that are inaccurate that are going to hurt people and the research is provably inaccurate, then I have officially become very interested, which is often a process that people who are less than honest do not enjoy. If you identify research that's inaccurate and harmful, what happens next? It depends on the nature of the inaccuracy. Let's say there were two studies in the same meta-analysis, and one was heavily plagiarized from the other, and it was fake, but it was being counted twice in a meta-analysis. Let's also say that the outcome of that was particularly harmful. I have no interest in an 18-month process where they will eventually conclude that there was a problem if people are going to get hurt in the meantime. Those things, frankly, go straight to press. The proper channels are unfit for purpose when it comes to things that hurt people. If we find a paper that's mathematically impossible, we don't need to have a conversation about whether or not they meant it, or what was in their heart when the paper was made wrong. I don't really care. What I care about is the consequences of it being wrong. Something like that we would pursue immediately — in public. If it's something more complicated, more abstract, bigger, less threatening, then I will probably have to take that to journals, universities, maybe scientific societies and try to get clarity on elements of what's happening. Does pursuing action in public mean putting out reports or press releases? Calling The New York Times? It could very well be all of those. Because we're a kind of sister organization of Retraction Watch, some of it will likely go straight to Retraction Watch. I'll look for larger or more prominent outlets based on the seriousness of what's found. This is global, so if we have a problem that's within, let's say the Canadian gastroenterology guidelines, it's much better published in Toronto than it is in Sydney or Dubai or Singapore or New York. It's an interesting time to launch a project on scientific integrity. Trust in the medical research enterprise is low right now in the U.S. People have been very critical of the regulatory system here, but it's infinitely better than it is in a lot of other places. Historically, approval here carries a collective of weight internationally. This country has an excellent, developed medical research infrastructure. It's also 4 percent of the whole world. So the other 96 percent have got what they've got, and usually it's not as good as the FDA. For all its vagaries and oversights, I promise you, the rest of the world exists, and a lot of the time it's playing catch-up to Uncle Sam. Is there anything else readers should know about the project? I'll definitely take tips. It's very straightforward. It's tips@ WELCOME TO FUTURE PULSE This is where we explore the ideas and innovators shaping health care. While President Donald Trump and Republicans seek to turn the screws on elite liberal universities with their megabill, a conservative Christian liberal arts college has managed to secure a carveout, POLITICO's Caitlin Oprysko reports. Share any thoughts, news, tips and feedback with Danny Nguyen at dnguyen@ Carmen Paun at cpaun@ Ruth Reader at rreader@ or Erin Schumaker at eschumaker@ Want to share a tip securely? Message us on Signal: Dannyn516.70, CarmenP.82, RuthReader.02 or ErinSchumaker.01. WASHINGTON WATCH HHS Secretary Robert F. Kennedy Jr. offered perhaps his most extensive statement on his department's stance on psychedelic research during a House Energy and Commerce Health Subcommittee hearing Tuesday. When Rep. Dan Crenshaw (R-Texas) — who lost an eye fighting in Afghanistan and co-authored an amendment that passed in the 2024 spending bill to fund psychedelics trials for active-duty service members with PTSD — asked how he planned to accelerate psychedelic research and clinical trial access, Kennedy didn't hesitate. He pointed to the 11 ongoing psychedelics clinical trials at the Department of Veterans Affairs and promised to launch trials at the Food and Drug Administration. 'We've brought on personnel to liaison directly with the VA. I talk with [VA Secretary] Doug Collins about it all the time. It's something that both of us are deeply interested in,' Kennedy said. 'Particularly for our retired service members, it's critically important that we make sure that the science on this is solid,' he said, adding, 'The preliminary results are very, very encouraging, and it's something that we want to pursue.' Big picture: Psychedelics advocates have been trying to predict where the Trump administration stands on psychedelic medicine. Last summer, at the end of the Biden administration, the psychedelics industry suffered a setback when the FDA rejected Lykos Therapeutics' application for MDMA, also known as ecstasy, combined with talk therapy as a PTSD treatment, on the grounds that the regimen was not proven to be safe or effective. What's next: On Tuesday, Kennedy appeared willing to revisit that decision. 'These are people who badly need some kind of therapy. Nothing else is working for them,' Kennedy told Crenshaw. '[FDA Commissioner] Marty Makary has told me that we don't want to wait two years to get this done,' he added. 'This line of therapeutics has tremendous advantage if given in a clinical setting, and we are working very hard to make sure that that happens within 12 months.'

Can we trust scientific papers?
Can we trust scientific papers?

ABC News

time02-06-2025

  • General
  • ABC News

Can we trust scientific papers?

Robyn Williams: The Science Show on Radio National. Over in America, universities are facing massive cuts, the loss of scientific staff and misinformation in the press, as well as on the dreaded social media. So what can we make of some of that? Here's Len Fisher who writes in the Blue Mountains and does research in Bristol. Len Fisher: How do you know when to trust a scientist? For that matter, how does a scientist know when to trust a scientist? These questions are stimulated by an article that Robyn has brought to my attention. James Heathers from the Linnaeus University in Sweden claims that up to one scientific paper in seven may be at least partly fake and not to be trusted. So what is going wrong? Is Heathers paper itself partly fake? If not, what can we do to protect both science and the wider community from such fakery? Let's start at the beginning. The trust of scientists in published science relies, or at least it used to rely, on peer review. Careful and critical examination of the work by one or more experienced fellow scientists who may award a pass, fail, or go back and try harder. One problem with this process is the possibility of favouritism or even delaying the publication of a paper so that the reviewer, who will sometimes be working along similar lines, can get there first. I've seen it happen, although it does seem to be rare. A more likely reason for delay is that reviewers are not paid for their work, and with many pressures on their time, reviewing tends to be put on the back burner. This gets to be real problem in a rapidly moving field, where younger workers are often involved and where priority can be important both for self-esteem and for actual promotion or the awarding of a degree. To get round the problem, authors these days tend to resort to online publication prior to peer review and conventional journal publication. In fact, Heather's paper itself was published in this way, in what is called the Open Science Framework. It has not yet been peer reviewed. Does this matter for trust? At least Heather's paper is out there in the open, subject to critical commentary. Some of that commentary has been pretty devastating. One fellow scientist, an expert in the sort of meta-analysis that Heathers uses, claims that Heathers' falsely labels studies with some problem as definitely being fake and incorrectly lumps together different studies measuring different phenomena. To his credit, Heathers accepts these criticisms in essence and even admits that his work is wildly non-systematic averaging as it does the results of 12 different studies of fakery in different fields and using different criteria. But he says that this is the best that he can do with the data available. So far, so what? This is a squabble between scientists, and let's leave them to it. But the real problems start when the work impinges on the wider world. Scientific misconduct undermines public trust in science. It is rightly a matter of public concern. So studies like those of Heathers find their way into the media, but with no mention of the essential caveats that, in Heathers' case, could well have meant that it would never have passed peer review. Even with quite careful journalistic treatment of the caveats, the majority of people who come across the story are likely to notice only the headline. 'One in seven science papers are fake'. Not even one in seven science papers could be fake. Such headlines provide a convenient reason to reject scientific findings for those whose beliefs are challenged by these findings. A prime current example is the political dismissal of even very rigorous studies on the role of fossil fuels in global warming. Let us return to the underlying problem, which is the current erosion of trust in science. What can be done to restore and maintain trust, both of scientists with each other and of the wider public the science? The first thing to note is that most published papers are essentially trivial, small studies that receive at most one or two citations and whose results are of little concern except to the authors, whose quota of publications has increased, and their small circle of specialists. When a paper does address an important issue or reveal an important new finding that is of wider interest, then other scientists are likely either to repeat or to use the results. If there is fakery or sloppy science involved in the original publication, then hopefully the truth will out. Unfortunately, this process can take some time, especially if the original work was convincing and fitted scientific preconceptions, as happened with the attribution of Alzheimer's disease to the presence of protein plaques in the spaces between brain cells. Also, replication can be difficult, or even impossible when specialist techniques sometimes possessed only by the originator are involved, or when conclusions are based on large-scale surveys that may have had inadequate controls. There is also the very human problem that scientists are likelier to accept the results of their fellows, especially the senior ones, without going to the bother of replication. This can be a problem of money or resources. Whatever the reason, it is a systemic problem in some disciplines witness the current well-publicised crisis of reproducibility in the psychology literature. In general, however, replication, or even just its possibility, remains a powerful tool for the evocation of trust among scientists. The wonderful online retraction watch reports such exposures on a routine basis. Another welcome development is that of online pre-publication facilities such as arXiv which has the very peculiar spelling of small a small r capital X small i small v, which filters papers on the basis of the established reputations of the authors or recommendation by an established scientist. In fact, as I sit writing this talk, my collaborator on another publication, the Swedish polymath Anders Sandberg, is sitting in the corner of the same room submitting a paper of ours to Archive Physics but they won't accept it until it receives the approval of another known expert in the field, and even then it will be subject to moderation. It is a pity that this same process can't be applied to books, especially those that make exaggerated claims based on little or no evidence. A recent New Scientist article has pointed out how few of such books are fact-checked. This may be just as well for the profits of the publishers, who often rely on the sales of such books. The New Scientist itself employs two levels of fact-checking. But facts are dull, and sadly they are often trumped by simplistic exaggerations, especially when these appeal to pre-established prejudices. Maybe the answer is for scientists to learn to share more fully the very real excitement that comes from the pursuit and capture of facts, and their sharing with other scientists in an established atmosphere of trust. Only then will public trust in science already high in most countries, grow to overcome misleading stories about its very human vicissitudes. Robyn Williams: Len Fisher is a Fellow of the Royal Society of New South Wales.

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