Declaration of Helsinki revised to modernize research ethics standards; American Medical Association (AMA), November 6, 2024

American Medical Association (AMA); Declaration of Helsinki revised to modernize research ethics standards

"The World Medical Association (WMA) has updated its cornerstone ethical principles for medical research to modernize protections and reinforce respect for the rights and interests of human participants, while including new language on global justice, public health, vulnerability and consent for personal data collection and reuse.

For 60 years, these principles—dubbed the Declaration of Helsinki for the city in Finland where WMA members assembled to formally adopt them—have guided ethical conduct for medical research involving human participants on a global scale. 

The WMA General Assembly, whose constituent members represent more than 10 million physicians, recently met to adopt additional revisions crafted by an AMA-led work group from 19 countries. Through eight regional and topical meetings on many continents and two global public-comment periods, the work group gathered feedback from other experts and stakeholders including researchers, patients, bioethicists, regulators, medical leaders and others.

The AMA delegation to the World Medical Association plays a major role in proposing and authoring global policy issues including medical ethics, access to high-quality medical care, the physician workforce, public health, medical education, and advocacy for physicians’ and patients’ rights. As the predominant U.S. medical association, the AMA is the only national medical association eligible for membership in the World Medical Association, which was founded in 1947 in the wake [sic, of] involvement by physicians in medical atrocities during World War II.

The landmark amendments to the Declaration of Helsinki highlight the commitment “to reinforcing the ethical principles that guide medical research involving human participants, to safeguard patient rights and to ensure the integrity of scientific studies,” said WMA President Ashok Philip, MD, in a statement."

Peter Buxtun, whistleblower who exposed Tuskegee syphilis study, dies aged 86; Associated Press via The Guardian, July 15, 2024

 Associated Press via The Guardian; Peter Buxtun, whistleblower who exposed Tuskegee syphilis study, dies aged 86

"Peter Buxtun, the whistleblower who revealed that the US government allowed hundreds of Black men in rural Alabama to go untreated for syphilis in what became known as the Tuskegee study, has died. He was 86...

Buxtun is revered as a hero to public health scholars and ethicists for his role in bringing to light the most notorious medical research scandal in US history. Documents that Buxtun provided to the Associated Press, and its subsequent investigation and reporting, led to a public outcry that ended the study in 1972.

Forty years earlier, in 1932, federal scientists began studying 400 Black men in Tuskegee, Alabama, who were infected with syphilis. When antibiotics became available in the 1940s that could treat the disease, federal health officials ordered that the drugs be withheld. The study became an observation of how the disease ravaged the body over time...

In his complaints to federal health officials, he drew comparisons between the Tuskegee study and medical experiments Nazi doctors had conducted on Jews and other prisoners. Federal scientists did not believe they were guilty of the same kind of moral and ethical sins, but after the Tuskegee study was exposed, the government put in place new rules about how it conducts medical research. Today, the study is often blamed for the unwillingness of some African Americans to participate in medical research.

“Peter’s life experiences led him to immediately identify the study as morally indefensible and to seek justice in the form of treatment for the men. Ultimately, he could not relent,” said the CDC’s Pestorius."

A Columbia Surgeon’s Study Was Pulled. He Kept Publishing Flawed Data.; The New York Times, February 16, 2024

 Benjamin Mueller, The New York Times; A Columbia Surgeon’s Study Was Pulled. He Kept Publishing Flawed Data.

"Problems with the study were severe enough that its publisher, after finding that the paper violated ethics guidelines, formally withdrew it within a few months of its publication in 2021. The study was then wiped from the internet, leaving behind a barren web page that said nothing about the reasons for its removal.

As it turned out, the flawed study was part of a pattern. Since 2008, two of its authors — Dr. Sam S. Yoon, chief of a cancer surgery division at Columbia University’s medical center, and a more junior cancer biologist — have collaborated with a rotating cast of researchers on a combined 26 articles that a British scientific sleuth has publicly flagged for containing suspect data. A medical journal retracted one of them this month after inquiries from The New York Times."

‘The situation has become appalling’: fake scientific papers push research credibility to crisis point; The Guardian, February 3, 2024

 Robin McKie, The Guardian; ‘The situation has become appalling’: fake scientific papers push research credibility to crisis point

"Tens of thousands of bogus research papers are being published in journals in an international scandal that is worsening every year, scientists have warned. Medical research is being compromised, drug development hindered and promising academic research jeopardised thanks to a global wave of sham science that is sweeping laboratories and universities.

Last year the annual number of papers retracted by research journals topped 10,000 for the first time. Most analysts believe the figure is only the tip of an iceberg of scientific fraud."

A Little-Known Statute Compels Medical Research Transparency. Compliance Is Pretty Shabby.; On The Media, April 21, 2021

On The Media; A Little-Known Statute Compels Medical Research Transparency. Compliance Is Pretty Shabby.

"Evidence-based medicine requires just that: evidence. Access to the collective pool of knowledge produced by clinical trials is what allows researchers to safely and effectively design future studies. It's what allows doctors to make the most informed decisions for their patients.

Since 2007, researchers have been required by law to publish the findings of any clinical trial with human subjects within a year of the trial's conclusion. Over a decade later, even the country's most well-renown research institutions sport poor reporting records. This week, Bob spoke with Charles Piller, an investigative journalist at Science Magazine who's been documenting this dismal state of affairs since 2015. He recently published an op-ed in the New York Times urging President Biden to make good on his 2016 "promise" to start withholding funds to force compliance."

Scientific Publishing Is a Joke; The Atlantic, May 6, 2021

 BENJAMIN MAZER, The Atlantic; Scientific Publishing Is a Joke

An XKCD comic—and its many remixes—perfectly captures the absurdity of academic research.

"“The meme hits the right nerve,” says Vinay Prasad, an associate epidemiology professor and a prominent critic of medical research. “Many papers serve no purpose, advance no agenda, may not be correct, make no sense, and are poorly read. But they are required for promotion.” The scholarly literature in many fields is riddled with extraneous work; indeed, I’ve always been intrigued by the idea that this sorry outcome was more or less inevitable, given the incentives at play. Take a bunch of clever, ambitious people and tell them to get as many papers published as possible while still technically passing muster through peer review … and what do you think is going to happen? Of course the system gets gamed: The results from one experiment get sliced up into a dozen papers, statistics are massaged to produce more interesting results, and conclusions become exaggerated. The most prolific authors have found a way to publish more than one scientific paper a week. Those who can’t keep up might hire a paper mill to do (or fake) the work on their behalf...

A staggering 200,000 COVID-19 papers have already been published, of which just a tiny proportion will ever be read or put into practice. To be fair, it’s hard to know in advance which data will prove most useful during an unprecedented health crisis. But pandemic publishing has only served to exacerbate some well-established bad habits, Michael Johansen, a family-medicine physician and researcher who has criticized many studies as being of minimal value, told me. “COVID publications appear to be representative of the literature at large: a few really important papers and a whole bunch of stuff that isn’t or shouldn’t be read,” he said."

U.S. lab chimps were dumped on Liberia’s Monkey Island and left to starve. He saved them.; The Washington Post, December 12, 2019

Danielle Paquette, The Washington Post; U.S. lab chimps were dumped on Liberia’s Monkey Island and left to starve. He saved them.

 

"Animal testing has existed since doctors in ancient Greece studied the anatomy of rodents — an estimated 115 million creatures are still used each year in research worldwide — but rarely is the aftermath so visible. Rarely is it so hungry.

 

This colony of 66 chimpanzees, which never learned to survive in the wild, eats roughly 500 pounds of produce each day, plus a weekly batch of hard-boiled eggs for protein. They rely on money from a charity abroad and the devotion of men who’ve known them since they lived in steel cages."

Ethical questions raised in search for Sardinian centenarians' secrets; Guardian, 8/12/16

Stephanie Kirchgaessner, Guardian; Ethical questions raised in search for Sardinian centenarians' secrets:

"Some say thousands of Sardinian research subjects never agreed that their samples could be sold or used by a for-profit company when they signed a medical consent agreement at the time the database was accumulating samples...

The conflict has raised the kind of thorny ethical questions that are likely to become more pervasive as scientists tap into the promise of massive DNA databases to learn more about disease. Should a private company be able to profit from the study of a population’s DNA, when the DNA was voluntarily donated? The deal also raises uncomfortable questions for local critics: why did Shardna go bust to begin with?...

The question now is whether participants like Maria Tegas or her children will ever gain from the research that has put her corner of Sardinia on the map. When Cerrone was asked whether he believed Sardinians ought to benefit in the future from any potentially lucrative medical advancements that might emerge, the executive demurs. Tiziana has already “given back” to the community when it bought the database for €258,000, including all the outstanding debts."

Oxford professor calls for European ethical codes on patient data; Guardian, 4/12/16

Paul Hill, Guardian; Oxford professor calls for European ethical codes on patient data:

"Prof Luciano Floridi, director of research at Oxford University’s Internet Institute believes the time has come for new European ethical codes to govern “data donation” and its use for medical research.

He says debate in Europe over individual privacy versus societal benefits of shared data has been “swinging like a pendulum between two extremes”. Medical research with big data should be part of the future of Europe, according to Floridi, “not something we need to export to other countries because it is not do-able here”.

“The patient has to be informed and willing to share the information that researchers are collecting – for the benefit of the patient and anyone else affected by the same problems,” said Floridi, who is also chair of the Ethics Advisory Board of the European Medical Information Framework, the largest EU project on the unification of biomedical databases...

Floridi, who has advised Google on the ethics of information and the right to be forgotten, proposes the creation of two new ethical codes.

The first would govern the use and re-use of biomedical data in Europe – an ethical code from the practitioners’ perspective.

The second would relate to “data donation” and the informed choice of an individual to share personal information for research."

The University of Minnesota’s Medical Research Mess; New York Times, 5/26/15

Carl Elliott, New York Times; The University of Minnesota’s Medical Research Mess:

"These days, of course, medical research is not just a scholarly affair. It is also a global, multibillion-dollar business enterprise, powered by the pharmaceutical and medical-device industries. The ethical problem today is not merely that these corporations have plenty of money to grease the wheels of university research. It’s also that researchers themselves are often given powerful financial incentives to do unethical things: pressure vulnerable subjects to enroll in studies, fudge diagnoses to recruit otherwise ineligible subjects and keep subjects in studies even when they are doing poorly.

In what other potentially dangerous industry do we rely on an honor code to keep people safe? Imagine if inspectors never actually set foot in meatpacking plants or coal mines, but gave approvals based entirely on paperwork filled out by the owners.

With so much money at stake in drug research, research subjects need a full-blown regulatory system. I.R.B.s should be replaced with oversight bodies that are fully independent — both financially and institutionally — of the research they are overseeing. These bodies must have the staffing and the authority to monitor research on the ground. And they must have the power to punish researchers who break the rules and institutions that cover up wrongdoing."