Medical Research Archives - Page 21 Of 24

What is ethical animal research? A scientist and veterinarian explain

A proposed measure in Switzerland would have made that country the first to ban medical and scientific experimentation on animals. It failed to pass in February 2022, with only 21{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of voters in favor. Yet globally, including in the United States, there is concern about whether animal research is ethical.

We are scientists who support ethical animal research that reduces suffering of humans and animals alike by helping researchers discover the causes of disease and how to treat it. One of us is a neuroscientist who studies behavioral treatments and medications for people with post-traumatic stress disorder – treatments made possible by research with dogs and rodents. The other is a veterinarian who cares for laboratory animals in research studies and trains researchers on how to interact with their subjects.

We both place high importance on ensuring that animal research is conducted ethically and humanely. But what counts as “ethical” animal research in the first place?

The 4 R’s of animal research

There is no single standard definition of ethical animal research. However, it broadly means the humane care of research animals – from their acquisition and housing to the study experience itself.

Federal research agencies follow guiding principles in evaluating the use and care of animals in research. One is that the research must increase knowledge and, either directly or indirectly, have the potential to benefit the health and welfare of humans and other animals. Another is that only the minimum number of animals required to obtain valid results should be included. Researchers must use procedures that minimize pain and distress and maximize the animals’ welfare. They are also asked to consider whether they could use nonanimal alternatives instead, such as mathematical models or computer simulations.

These principles are summarized by the “3 R’s” of animal research: reduction, refinement and replacement. The 3 R’s encourage scientists to develop new techniques that allow them to replace animals with appropriate alternatives.

What is ethical animal research? A scientist and veterinarian explain — L’Oreal Brazil CEO Marcelo Zimet looks at microscope samples at the Episkin laboratory, which has developed alternative methods to animal testing.
Mauro Pimentel/AFP via Getty Images

Since these guidelines were first disseminated in the early 1960s, new tools have helped to significantly decrease animal research. In fact, since 1985, the number of animals in research has been reduced by half.

A fourth “R” was formalized in the late 1990s: rehabilitation, referring to care for animals after their role in research is complete.

These guidelines are designed to ensure that researchers and regulators consider the costs and benefits of using animals in research, focused on the good it could provide for many more animals and humans. These guidelines also ensure protection of a group – animals – that cannot consent to its own participation in research. There are a number of human groups that cannot consent to research, either, such as infants and young children, but for whom regulated research is still permitted, so that they can gain the potential benefits from discoveries.

Enforcing ethics

Specific guidelines for ethical animal research are typically established by national governments. Independent organizations also provide research standards.

In the U.S., the Animal Welfare Act protects all warmblooded animals except rats, mice and birds bred for research. Rats, mice and birds are protected – along with fish, reptiles and all other vertebrates – by the Public Health Service Policy.

Each institution that conducts animal research has an entity called the Institutional Animal Care and Use Committee, or IACUC. The IACUC is composed of veterinarians, scientists, nonscientists and members of the public. Before researchers are allowed to start their studies, the IACUC reviews their research protocols to ensure they follow national standards. The IACUC also oversees studies after approval to continually enforce ethical research practices and animal care. It, along with the U.S. Department of Agriculture, accreditation agencies and funding entities, may conduct unannounced inspections.

Laboratories that violate standards may be fined, forced to stop their studies, excluded from research funding, ordered to cease and desist, and have their licenses suspended or revoked. Allegations of misconduct are also investigated by the National Institutes of Health’s Office of Laboratory Animal Welfare.

Above and beyond the basic national standards for humane treatment, research institutions across 47 countries, including the U.S., may seek voluntary accreditation by a nonprofit called the Association for Assessment and Accreditation of Laboratory Animal Care, or AAALAC International. AAALAC accreditation recognizes the maintenance of high standards of animal care and use. It can also help recruit scientists to accredited institutes, promote scientific validity and demonstrate accountability.

Principles in practice

So what impact do these guidelines actually have on research and animals?

First, they have made sure that scientists create protocols that describe the purpose of their research and why animals are necessary to answer a meaningful question that could benefit health or medical care. While computer models and cell cultures can play an important role in some research, others studies, like those on Alzheimer’s disease, need animal models to better capture the complexities of living organisms. The protocol must outline how animals will be housed and cared for, and who will care for and work with the animals, to ensure that they are trained to treat animals humanely.

During continual study oversight, inspectors look for whether animals are provided with housing specifically designed for their species’ behavioral and social needs. For example, mice are given nesting materials to create a comfortable environment for living and raising pups. When animals don’t have environmental stimulation, it can alter their brain function – harming not only the animal, but also the science.

Monitoring agencies also consider animals’ distress. If something is known to be painful in humans, it is assumed to be painful in animals as well. Sedation, painkillers or anesthesia must be provided when animals experience more than momentary or slight pain.

For some research that requires assessing organs and tissues, such as the study of heart disease, animals must be euthanized. Veterinary professionals perform or oversee the euthanasia process. Methods must be in compliance with guidelines from the American Veterinary Medical Association, which requires rapid and painless techniques in distress-free conditions.

Fortunately, following their time in research, some animals can be adopted into loving homes, and others may be retired to havens and sanctuaries equipped with veterinary care, nutrition and enrichment.

Continuing the conversation

Animal research benefits both humans and animals. Numerous medical advances exist because they were initially studied in animals – from treatments for cancer and neurodegenerative disease to new techniques for surgery, organ transplants and noninvasive imaging and diagnostics.

These advances also benefit zoo animals, wildlife and endangered species. Animal research has allowed for the eradication of certain diseases in cattle, for example, leading not only to reduced farm cattle deaths and human famine, but also to improved health for wild cattle. Health care advances for pets – including cancer treatments, effective vaccines, nutritional prescription diets and flea and tick treatments – are also available thanks to animal research.

People who work with animals in research have attempted to increase public awareness of research standards and the positive effects animal research has had on daily life. However, some have faced harassment and violence from anti-animal research activists. Some of our own colleagues have received death threats.

Those who work in animal research share a deep appreciation for the creatures who make this work possible. For future strides in biomedical care to be possible, we believe that research using animals must be protected, and that animal health and safety must always remain the top priority.

Editor’s note: One photo depicting a species that is highly restricted for use in biomedical research has been removed from the article.

Tom Meade obituary | Medical research

Tom Meade, who has died aged 86, pioneered the field of cardiovascular epidemiology. His research, spanning five decades, gave medical science a vastly improved understanding of the biology of blood and the circulatory system, opening the door for targeted new heart disease treatments.

By the early 1960s, heart disease was the leading cause of death in many countries, with the culprit widely believed to be atheroma (fatty deposits inside the arteries), brought on by high cholesterol and a fatty diet. But in 1965, Meade, a researcher at the Medical Research Council (MRC), read something he described as “a real eye-opener”. His boss, the pre-eminent epidemiologist Jerry Morris, wrote that while the numbers of men dying aged 50-69 had surged since 1908, analysis of autopsy reports showed that the numbers dying with coronary atheroma had decreased. Meade wondered if other factors were in play, and what role blood might have in heart disease. He wanted to investigate.

In 1970, he became director of the newly created MRC Epidemiology and Medical Care Unit at Northwick Park in Harrow, north-west London. He set up the Northwick Park heart trial in 1972 with 3,900 volunteers, who were mostly workers at the nearby Heinz factory. Among other things, Meade and his team wanted to study fibrinogen and Factor VII (proteins in the blood essential for clot formation, but too much of which can make blood “sticky” and liable to clot inappropriately).

The trial found fibrinogen levels are linked to heart disease, and one of the reasons smoking is a risk factor for heart disease is that it raises fibrinogen levels. The findings pointed to the need for fibrinogen-lowering drugs. They also found high levels of Factor VII increased heart disease risk, which posed the question – what might lower it? In 1983 Meade’s thrombosis prevention trial began, which took 5,500 high-risk individuals and gave them aspirin, warfarin, a combination of the two, or a placebo. Of the four groups, those on the combination fared best, with heart attacks reduced by more than a third.

Recruits for the thrombosis prevention trial came through the MRC GP Research Framework, a network of GP practices around Britain. Meade directed many trials through this network, not just on blood circulation, but also on blood pressure, incontinence, back pain, stroke rehabilitation and other topics. Chiropractic was considered a quack science, but Meade’s trial in 1990 comparing it with standard treatment for low back pain found it to be more effective.

It was compulsory to retire from the MRC at 65, so in 2001 Meade stepped down as director. He was glad, as the administrative demands had become steadily more onerous, but was keen to retain an academic foothold somewhere to continue his research. After a five-week campervan holiday in Australia, he became an emeritus professor of epidemiology at the London School of Hygiene and Tropical Medicine, with, to his wry amusement, pay of £10 a month to formalise the agreement.

As well as his own work, he also chaired the LSHTM research ethics committee and was the co-author of an overview of trials into aspirin to prevent heart disease, which also found it valuable in preventing bowel and other cancers.

Meade stayed at the LSHTM for more than 15 years and was able to do a 30-year follow-up of his Northwick Park heart trial. One finding was that having a respiratory infection made people more susceptible to having a heart attack. Knowing there is this link has prompted officials to encourage uptake of flu vaccinations in vulnerable groups.

Born in Oxford, Tom was the son of Margaret (nee Wilson), a committed Quaker, and James Meade, a distinguished economist and Nobel laureate. Tom was the eldest of four children, with three sisters, Charlotte, Bridget and Carol. In 1940 the second world war was still in its “phoney” stage, so the family went on holiday in France (from Geneva, where James was serving with the League of Nations), but rapidly turned for Britain with the Germans advancing behind them. After days waiting on the French coast they were rescued by a tramp steamer and taken to Barry in Wales.

His mother then took the children to the US for safety, and his father pressed a copy of Rudyard Kipling’s Jungle Book into Tom’s hands, with an inscription. It was a memento should they never meet again. Meade’s mother did not like being away from the UK, however, and they returned in 1942, a perilous crossing, with masts of sunken ships just visible as they sailed into home waters.

In 1949, Meade won a scholarship to Westminster school in London, where in 1953 he took part in an ancient rite at Queen Elizabeth’s coronation. (The scholars were the first to greet the new monarch with Vivat Regina.) In 1950 he had his appendix out and, although he excelled at classics, seeing a hospital at close quarters inspired him to read medicine. He studied at Christ Church, Oxford, and Bart’s hospital in London, where he qualified in 1962.

Meade originally wanted to join the prison medical service and to that end worked for 18 months as a junior doctor at Littlemore hospital, a mental health facility in Oxford. However, he had become increasingly interested in public health, and decided to work for Morris at the Medical Research Council.

In 1962 Meade married Liz Perks, a social worker, and the couple went on to have three children: Richard, Helen and Rebecca. They went to India in 1969 for a year (with their London house let to the king of Tonga) so that Meade could study the epidemiology of leprosy at the Schieffelin research laboratory in Karigiri.

The family lived in Highgate, north London, and when in 1979 Haringey council shut the borough’s schools for several weeks in response to a caretakers’ strike, Meade sued the council in a case that reached the court of appeal, by which time the schools were open again. Modest yet principled, Meade was happy to accept appropriate accolades: in 1996 he was elected a fellow of the Royal Society and in 1997 received the Balzan prize for epidemiology. In 1994 he was appointed CBE, although he was always uneasy about the honours system. When he heard that the head of the MRC, Colin Blakemore, was not getting a knighthood, as was customary with that position, he handed back his CBE in protest; Blakemore’s knighthood came in 2014. When several of the congregation stayed away from his granddaughter’s confirmation in disapproval of female priests, Meade was so incensed that he left the Church of England and became a Quaker.

In middle age, Meade took up running, completing a marathon, and for decades had an allotment in Highgate. He and Liz moved into a flat in Highgate in 2016 and his health gradually began to falter.

He is survived by Liz and their children and eight grandchildren, and by his sisters.

‘Game-changing’ gender quotas introduced by Australian research agency

In an attempt to achieve gender equity, Australia’s leading health and medical research funding organization plans to award half of its research grants for its largest funding programme to women and non-binary applicants, starting next year.

The National Health and Medical Research Council (NHMRC) announced the move last week. It will apply to researchers at the mid-career and senior level applying for the agency’s investigator grants, which fund research and salaries. Grants will also be fixed at Aus$400,000 (US$252,000) each a year for five years. Many countries struggle to achieve gender equity in research funding, and the NHRMC will be one of the first agencies to introduce gender quotas at this scale, say researchers.

“It’s game-changing,” says Anna-Maria Arabia, chief executive of the Australian Academy of Science in Canberra. The plan “directly removes a barrier that’s historically led to attrition in the research workforce and has led to the significant under-representation of women at senior levels”, she says.

“It’s a really significant step in the right direction,” says Kylie Walker, chief executive of the Australian Academy of Technological Sciences and Engineering, a Canberra-based organization representing applied scientists and engineers. From 2015 to 2020, the number of women enrolling in undergraduate science, technology, engineering and mathematics (STEM) courses in Australia increased by 24{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}, compared with a 9{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} increase in the number of men enrolling. “We need to obviously work out how to keep them,” says Walker.

Biggest gap

In 2021, 254 investigator grants were awarded, worth Aus$400 million in total. But when two researchers in Melbourne reviewed the data, they found that men had received 23{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} more of the grants, worth an extra Aus$95 million, than had women. There was an outcry from researchers. This year, the agency conducted its own review of investigator-grant outcomes from the past three years and found that the biggest gap was among the most senior researchers. A subsequent discussion paper and consultations with researchers informed the latest decision.

The NHMRC has been working for a decade to address gender inequity in its grant funding. For example, in 2017, it introduced ‘structural priority funding’, which reserves additional money — around 8{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the overall grant budget — for high-quality ‘near-miss’ research applications led by women. This approach is also used to support Aboriginal and Torres Strait Islander researchers

But this did not address the gender imbalance among the most established researchers. In 2021, only 20{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the applicants in this group were women. Modelling suggested that even raising the priority-funding allocation to 20{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the grant budget for senior researchers did not achieve parity, says Anne Kelso, chief executive of the NHMRC. “The skewing of application numbers from men versus women is so great at the upper end of the scheme that the structural priority funding doesn’t get you there,” she says.

The council will be looking to see whether awarding equal numbers of grants by gender leads to an increase in the number of senior women applying for leadership grants, says Kelso.

Skewed workforce

The gender disparities in grant applicants and recipients among senior researchers reflect disparities in the STEM workforce, says Isabelle Kingsley, a research associate at the office of the Australian government’s Women in STEM Ambassador in Sydney. She hopes the NHMRC’s policy will help women to stay in research and progress in their careers.

For early-career researchers, the NHMRC will continue with existing gender-parity measures, such as structural priority funding. Kelso says there is significantly less gender imbalance among early-career researchers. From 2019 to 2021, more applications for investigator grants at the earliest career stage came from women — who were awarded 137 grants, compared to 123 for men. “We found that we hardly needed to use any structural priority funding for the more junior levels,” she says.

Tony Kenna, president of the Australian Society for Medical Research in Brisbane, welcomes the changes, but hope this won’t be the final step. Other NHMRC grant schemes could benefit from similar reforms, he says, as could funding schemes offered by other agencies, such as the Australian Research Council.

Cornelia Schroeder obituary | Medical research

My mom, Cornelia Schroeder, who has died aged 73, was a virologist specialising in influenza and also the editor of her mother’s memoir.

Cornelia used the early several years of her occupation in her indigenous East Germany, but immediately after its collapse, she went to do the job at the National Institute for Health-related Study in Mill Hill, London. From 1990 to 1993, she was Wellcome analysis fellow at the institute’s division of virology, working on isolation of the influenza virus protein. There, she fulfilled an global crowd of like-minded individuals with whom she remained pals and went mountaineering in west Wales every single yr – extensive right after she went back again to Berlin in 1993, returning to the Charité Institute for Virology to take up a write-up as associate professor.

From 2002, she was dependent at the Max-Planck-Institute in Dresden, as senior virologist, and right after her official retirement in 2016 she stayed on there to complete her experiments and oversee PhD learners until eventually 2018.

Cornelia, acknowledged as “Corky”, was born in occupied Berlin to the American author Edith Anderson (nee Handelsman) and her husband, Max Schroeder, a still left-wing mental and publisher who had only returned to Germany two years earlier from his exile in New York. She grew up in the somewhat leafy suburb of Grünau, between other families of communist, typically Jewish, emigrants, and went to the Heinrich-Hertz Schule in Berlin-Friedrichshain, a selective secondary faculty and sixth kind for pupils excelling at maths and science.

At the Humboldt university in East Berlin, where by she finished her scientific tests – in chemistry in 1970 and biochemistry in 1972 – she fulfilled Rainer Wetzel, a PhD college student. I was born in 1974 and they divided in 1976.

Cornelia stayed on at the Humboldt university and accomplished her PhD on bacteriophage-virus host mobile interactions, in 1980, at the affiliated Institute for Biochemistry and the Charité Institute for Virology. At the exact time, she worked as a junior research scientist, 1st concentrating on bacteriophages and afterwards on the herpes simplex virus. From 1984, she more and more grew to become concerned in influenza analysis.

However it was her spouse and children historical past that determined (what she thought of) her finest achievement. Her mom experienced died in 1999, acquiring just published her memoir, Love in Exile, in the US. The guide was an angry, unembellished account of how a operating-course, nonconformist Jewish female from the Bronx expert the postwar interval among the the overwhelmingly male East German cultural elite.

Corky manufactured it her mission to have her mother’s perform launched in Germany and translated the e-book with the author Christa Tragelehn. An endorsement from Doris Lessing aided and following the hardback launch (Liebe im Exil) in 2007, Bertelsmann picked up the paperback rights.

Corky is survived by me and by two grandchildren, Benjamin and Isla.

Agata Everest Aids in Medical Research With Her Foundation

LOS ANGELES, CA, November 19, 2022 /24-7PressRelease/ — The Everest Foundation was started in honor of the late Dr. Everest, a distinguished doctor, and educator. It operates under the leadership of Dr. Michael Everest and Agata Everest, who are committed to ensuring that the organization achieves its vision.

It funds innovative medical research initiatives critical to medical innovation and affordable healthcare. It invests in global initiatives such as higher learning and research grants.

The foundation also runs medical residency training programs. The foundation is committed to Graduate Medical Education. It partners with various medical schools to provide training opportunities to medical graduates.

It supports poor populations where people cannot access primary healthcare. In these countries, it is estimated that 2 million children succumb to an array of treatable diseases such as diarrhea and pneumonia.

The Everest Foundation is keen on alleviating suffering in vulnerable communities worldwide. More importantly, the foundation engages in venture philanthropy funding various charity initiatives in their areas and contributing to medical research.

It also places medical residents in underserved communities so that the population can get direct medical care.

Some medical specialties they study and support include internal medicine, Cardiology, Oncology, in-vitro fertilization, Gastrointestinal, Obstetrics, Pathology, Reproductive research, Gynecology, Opiates Addiction, Neurology, Psychiatry, and Infectious Diseases, among others.

It places a lot of emphasis on IDDM and Cardiac research. The Everest Foundation supports US medical research scholars, and some notable people have contributed significantly to medical research through the foundation’s help.

Agata Everest Supporting The Everest Foundation Scholars
Dr. Patel, a medical scholar and a research fellow, has done outstanding research on Opioid use. Dr. Patel notes that it is essential to ensure proper stewardship when prescribing opioids.

She notes that a medical professional needs to prescribe the right opioids, the right dose of opioids, and for correct length. Incorrect prescriptions can negatively interfere with recovery and cause severe side effects.

The Everest Foundation funded Dr. Patel’s research initiative and provided her with the necessary medical equipment to carry out the research.

Dr. Ramalingam has also researched “clinicians-based paracentesis VS interventional radiology paracentesis.” Paracentesis is the perforation of a cyst or body part to diagnose an infection.

Medical scholars have divergent views on the more effective procedure for paracentesis between interventional and clinical-based radiology. Dr. Ramalingam took the trouble to research more about these two types of paracentesis.

It is ongoing research that uses an evidence-based approach and clinical tests. It will help the medical fraternity know the more effective type of paracentesis based on the clinical outcomes.

Agata Everest and the Everest Foundation are offering immense support to help her go about the research.

Another scholar that has been a beneficiary of the foundation is Dr. Obamiro. Dr. Obamiro has researched changing trends in orthopedic services due to the Covid 19 pandemic.

According to Dr. Obamiro, Covid 19 has changed how orthopedic care is given because of massive changes in the frequency of admissions and changing lifestyles. The research examines how the pandemic has affected planning, care, and preventive education.

Circumstances have compelled doctors and patients to change how they operate to keep human contact at a minimum.

To reduce the spread of Covid 19, some health facilities have introduced telehealth whereby patients can receive treatment from home using telemedicine technologies.

This is just one example of how orthopedic services have changed. Agata Everest and the Everest Foundation are glad to help Dr. Obamiro with her research, publication, and ultimately achieving a medical residency placement.

—
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Investigation raises concerns about poor FDA oversight of clinical trials

COVID-19 vaccines and drugs were developed at “warp speed” and now experts are concerned about the US Food and Drug Administration’s (FDA) inadequate surveillance of clinical trial sites, reports an investigation published by The BMJ today.

Regulatory documents show that only nine out of 153 Pfizer trial sites were subject to FDA inspection prior to licensing its COVID-19 mRNA vaccine. Similarly, 10 out of 99 Moderna trial sites and five of 73 remdesivir trial sites were inspected, writes investigative journalist Maryanne Demasi.

Notably, the FDA received a complaint from whistle-blower Brook Jackson, about misconduct at three clinical trial sites that were testing Pfizer’s COVID-19 vaccine, while she was employed as a regional director. Jackson observed a range of problems including falsified data, unblinded patients, and inadequately trained vaccinators who were slow to follow up on adverse events. “I thought that the FDA was going to swoop in and take care of everything,” said Jackson. The FDA did not, however, inspect the trial sites in question.

Experts have criticized the FDA’s oversight of clinical trials, describing it as “grossly inadequate.” They say the problem, which predated COVID-19, is not limited to a lack of inspections, but also includes failing to proactively notify the public or scientific journals when violations are identified, effectively keeping scientific misconduct from the medical establishment.

The FDA is “endangering public health” by not being candid about violations that are uncovered during clinical trial site inspections, says David Gortler, a pharmacist and pharmacologist who worked as an FDA medical reviewer between 2007 and 2011 and then as a senior advisor to the FDA commissioner in 2019-2021.

The FDA oversees clinical research of FDA-regulated drugs and devices in the US and abroad, if the product is intended for the US market. It conducts routine visits for trials, reviews records of those sites or the institutional review boards (IRBs) that oversee trials locally and follows up on complaints of violations. The FDA does not have a target for the proportion of trial sites it inspects.

Despite the estimated hundreds of thousands of clinical trial sites in operation across the US and abroad, the FDA told The BMJ that it only has 89 inspectors for its bioresearch monitoring program, which assures the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications, but that it is recruiting more inspectors to reach its yearly average of 100.

“I don’t think that it is a sufficient number of staff to do that kind of level of oversight,” says Jill Fisher, professor of social medicine at the University of North Carolina. “The FDA must have enough of a presence to dissuade investigative sites from committing fraud,” she continues.

Between March and July 2020, at the peak of pandemic restrictions, the FDA paused its site inspections and only “mission critical” inspections were carried out. However, Gortler says this was the precise time that the FDA should have ramped up its oversight, not scaled back, especially since COVID-19 products were being developed at warp speed and intended for millions of people.

The FDA told The BMJ it takes oversight of clinical trials seriously and had adapted to travel restrictions, publishing draft guidance for remote regulatory assessments, which describes virtual inspections using live streaming and video conferencing and requests to view records remotely.

The FDA has a long history of failing to adequately oversee clinical trial sites, notes Demasi. For example, a 2007 report by the Department of Health and Human Services’ Office of the Inspector General found the FDA audited less than 1{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f} of the nation’s clinical trial sites between 2000 and 2005 and was highly critical of the agency because it did not have a database of operational clinical trial sites.

In response, the FDA said it created a dedicated task force and “developed new regulations and guidance further to improve the conduct of clinical trials and enhance the protection of people participating in clinical trials,” but denied The BMJ an interview with a member of the task force.

Further, a 2020 investigation by the journal Science into the FDA’s enforcement of clinical research regulations between 2008 and 2019 concluded that the agency was often light handed, slow moving, and secretive. It said that the FDA rarely leveled sanctions and when it did formally warn researchers about breaking the law, it often neglected to ensure that the problems were remedied.

Although the FDA publishes its inspection reports, they are not proactively disclosed. Nor does it typically notify journals when a site participating in a published clinical trial receives a serious warning or alert the public about the research misconduct it finds.

Demasi points to reports of insufficient staff and low morale at the FDA. Fisher says the FDA “needs to be better funded and staffed to conduct inspections. At a minimum, the agency needs to inspect sites when complaints or concerns have been filed.”

Gortler doesn’t agree, however, that the FDA is under-resourced. With a total budget of $6.1bn in 2021, he suggests the agency needs to be leaner and more efficient, with employees interested in improving public health. “Half of its budget, about $3bn, is discretionary, which means it could have hired contractors, retirees, or repurpose existing workers. It chose not to. The FDA was just yawning its way through the pandemic. The entire agency is broken.”

More information:
Maryanne Demasi et al, Investigation: FDA oversight of clinical trials is “grossly inadequate,” say experts, The BMJ (2022). DOI: 10.1136/bmj.o2628

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