Most people have deep reservations about the use of facial recognition technologies in healthcare settings, a survey has found.
Facial recognition technologies – often used to unlock a phone or in airport security – is becoming increasingly common in everyday life, but how do people feel about this?
To answer this, researchers surveyed more than 4000 US adults and found that a significant proportion of respondents considered the use of facial image data in healthcare across eight varying scenarios as unacceptable (15–25%). Taken with those that responded as unsure of whether the uses were acceptable, roughly 30–50% of respondents indicated some degree of concern for uses of facial recognition technologies in healthcare scenarios. In some cases, using facial image data – such as to avoid medical errors, for diagnosis and screening, or for security – was acceptable to the majority. However over half of respondents did not accept or were uncertain about healthcare providers using this data to monitor patients’ emotions or symptoms, or for health research.
In the biomedical research setting, most respondents were equally concerned over use of medical records, DNA data and facial image data in a study.
While there was a wide range of demographics among respondents, their perspectives on these issues did not differ.
“Our results show that a large segment of the public perceives a potential privacy threat when it comes to using facial image data in healthcare,” said lead author Sara Katsanis, Research Assistant Professor of Pediatrics at Northwestern University Feinberg School of Medicine. “To ensure public trust, we need to consider greater protections for personal information in healthcare settings, whether it relates to medical records, DNA data, or facial images. As facial recognition technologies become more common, we need to be prepared to explain how patient and participant data will be kept confidential and secure.”
Senior author Jennifer K Wagner, Assistant Professor in Penn State’s School of Engineering Design, Technology, and Professional Programs adds: “Our study offers an important opportunity for those pursuing possible use of facial analytics in healthcare settings and biomedical research to think about human-centeredness in a more meaningful way. The research that we are doing hopefully will help decision-makers find ways to facilitate biomedical innovation in a thoughtful, responsible way that does not undermine public trust.”
The research team hopes to conduct further research to understand the nuances where public trust is lacking. The findings were published in PLOS One.
SARS-CoV-2 virus. Source: Fusion Medical Animation on Unsplash
The global race to develop new stem cell-based COVID treatments during the pandemic was filled with violations of government regulations, inflated medical claims and distorted public communication, according to an article appearing in Stem Cell Reports.
While stem cell therapy has treatment applications for a limited range of diseases and conditions, at present no clinically tested or government-approved cell therapies are available for the treatment or prevention of COVID or long COVID.
Despite this, some clinics have started offering unproven and unsafe “stem cell” therapies that promise to prevent COVID by strengthening the immune system or improving overall health, according to lead author Laertis Ikonomou, PhD, associate professor of oral biology in the University at Buffalo School of Dental Medicine.
The article explores the negative effects that misinformation about cell therapies has on public health, as well as the roles that researchers, science communicators and regulatory agencies should play in curbing the spread of inaccurate information and in promoting responsible, accurate communication of research findings.
“Efforts to rapidly develop therapeutic interventions should never occur at the expense of the ethical and scientific standards that are at the heart of responsible clinical research and innovation,” said Prof Ikonomou.
Other investigators include Megan Munsie, PhD, professor of ethics, education and policy in stem cell science at the University of Melbourne; and
Many of the studies on possible stem cell-based COVID treatments are at an early stage of investigation and further evaluation on larger sample sizes is required, says Munsie. However, the findings from preliminary studies are frequently exaggerated through press releases, social media and uncritical news media reports.
“Given the urgency of the ongoing pandemic, even the smallest morsel of COVID science is often deemed newsworthy and rapidly enters a social media landscape where—regardless of its accuracy – it can be widely shared with a global audience,” said Aaron Levine, PhD, associate professor of public policy at Georgia Institute of Technology..
Clinics selling such treatments sometimes use these findings and news reports to exploit the fears of vulnerable patients by unethically advertising unproven stem cell treatments benefits of boosting the immune system, regenerating lung tissue and preventing transmission of COVID, said co-author Leigh Turner, PhD, professor of health, society and behaviour at the University of California, Irvine.
Reportedly some harm to patients resulted from unproven stem cell therapies, including blindness and death. Patients suffer financially as well, said Prof Ikonomou, as the products range in price from a few thousand to tens of thousands of dollars, and people are often encouraged to receive the expensive treatments every few months.
Patients who COVID may decline vaccines, stop wearing masks and stop other COVID safety measures, Prof Turner warned. They may also be less likely to participate in ethically conducted clinical trials.
“The premature commercialisation of cell-based therapeutics will inevitably harm the field of regenerative medicine, increase risks to patients and erode the public’s trust,” said Prof Ikonomou.
Despite warnings, many offending companies continue to make false claims. The authors recommend that regulatory agencies consider implementing stronger measures.
They also suggest that scientific and professional societies lobby regulatory agencies to increase enforcement of laws and regulations. The authors recommended that science communicators and journalists can combat misinformation by not engaging in hyperbolic coverage of research results and conveying study limitations.
On Wednesday, the trial of Elizabeth Holmes, founder of medical technology company Theranos, began. Prosecutors alleged she “lied and cheated” for money and fame.
Ms Holmes faces 12 fraud charges over her role at the failed company which was once worth $9bn, facing up to 20 years in prison if found guilty.
She is accused of deceiving patients and investors about the company’s testing technology, which was claimed to diagnose basic illnesses from a few drops of blood. Her defence team argues that she was naive and her company simply failed.
“Failure is not a crime. Trying your hardest and coming up short is not a crime,” said defence lawyer Lance Wade in his opening statement on Wednesday.
Former Theranos executive Ramesh “Sunny” Balwani faces the same charges next year. He was romantically involved with Ms Holmes.
Ms Holmes, who founded Theranos in 2003 aged 19, was dubbed the world’s youngest self-made female billionaire and hailed as the “next Steve Jobs”.
In 2015 and 2016, investigations by the Wall Street Journal revealed Theranos’ blood-testing devices did not work and the company was doing most of its testing on commercially available machines made by other manufacturers. She initially denied these reports.
Prosecutor Robert Leach alleges that, after running out of funds, Ms Holmes and Mr Balwani turned to fraud in 2009, lying about the tests and exaggerating the firm’s performance. Mr Leach said this included falsely claiming the tests were vetted by Pfizer and being used by the US military.
The case will probably take months and Ms Holmes will likely take the stand — a necessary gamble in the face of overwhelming evidence that the technology did not work.
Ms Holmes “dazzled” Walgreens into using the company’s services, and the company brought her fame.
“She had become, as she sought, one of the most celebrated CEOs in Silicon Valley and the world. But under the facade of Theranos’ success there were significant problems brewing.”
The defence’s Mr Wade said Ms Holmes “naively underestimated” the business challenges but did not attempt to defraud investors. Ms Holmes has also alleged years of emotional and psychological abuse by Mr Balwani, who has denied the allegations. She is likely to testify as to how this affected her.
An article by the Daily Maverick reveals that a wave of suspensions in the Department of Health are impending as a result of the investigation into the Digital Vibes contract, which prompted the resignation of Dr Zweli Mkhize.
Minister of Health Dr Joe Phaahla said that he received a letter from the Special Investigations Unit (SIU) which he would have to act on.
Dr Phaahla said that “in the next few days and weeks there will unfortunately be some action and that will have some impact also on our capacity as a department”, adding that “when wrong things have happened and investigations have led to findings, then people have to be held answerable”.
However, Dr Phaahla said it was regrettable since “it will have an impact on our capacity, because from what I have seen, a number of people will have to be on suspension, pending charges.” He said it would be difficult for the vaccination programme as management staff were already stretched thin, but “it’s a consequence which must follow”.
Drs Buthelezi and Pillay denied any knowledge of suspension, though the Daily Maverick has found out that referral for disciplinary action have been sent to the presidency.
The details of the SIU’s investigation have not been made public yet, although the Daily Maverick was able to tease out some details from an affidavit to set aside the Digital Vibes contract and to seeks to reclaim up to R150 million that was paid for the contract.
The affidavit further reveals that Dr Mkhize allegedly pressured the previous Director-General, Precious Matsoso, to employ Tahera Mather to be contracted for communication.
Precious Matsotso was replaced after an unblemished ten years by Dr Anban Pillay, who had been Deputy DG. Dr Pillay then became the active facilitator for the Digital Vibes contract, the affidavit suggests — a matter in which the DIU has also referred to the National Prosecuting Authority.
The current DG, Dr Sandile Buthelezi, who replaced Dr Pillay, is also noted as approving payments to Digital Vibes, though the DIU states it is not seeking any relief against him other than setting aside of relevant agreements.
The situation still has a way to run, with disciplinary inquiries, the Special Tribunal hearing and NPA investigations all ongoing.
However, the Daily Maverick warns that it is clear that this critical government department is in “freefall” and will not have the capacity to deal with South Africa’s health challenges in the months and years to come.
Clinical trial data helps in deciding prescriptions and is good for science, but a new study revealed that not many pharmaceutical companies are completely transparent with the development data for their products. The study also found that large companies are much more transparent than smaller ones.
The study, co-authored by Yale researchers and published in The BMJ Open, assessed the data-sharing practices of 42 pharmaceutical companies for clinical trials of 40 novel drugs and 22 biologics which received US Food and Drug Administration approval in 2016 and 2017. They were evaluated with the Good Pharma Scorecard, which consists of transparency measures and a ranking system.
The researchers found that only seven of the 42 companies (17%) entirely met the tool’s standards for transparency and sharing data, with smaller companies being particularly opaque.
“The non-large pharmaceutical companies are dragging down the sector, often failing to meet federal reporting requirements, much less voluntary standards,” said study co-author Jennifer Miller, assistant professor at Yale School of Medicine, founder of Bioethics International.
“The lack of transparency is a problem because access to robust clinical-trial data supports patient care and good science,” she added. “Full transparency allows scientists to learn from previous work and prevents people from being exposed to unnecessary experiments.”
From the late 1990s, requirements for pharmaceutical companies to register and report results from clinical trials have been increasing. However, not all companies fully comply with the rules and industry guidelines vary. In a smaller 2019 study using the transparency scorecard, 25% of companies fully met the standards, which include registering clinical trials, sharing data and study protocol publicly, and annually reporting requests for data. When given a 30-day window to improve, 33% met the standard.
For the latest study, the researchers also included biologics and smaller companies. While 17% of companies had perfect scores, 58% of the companies assessed had publicly available results for all patient trials, 42% complied with federal reporting laws, and 26% met the scorecard’s data-sharing measure.
Non-large companies were less responsive than large companies when offered the 30-day window to fix errors and improve data-sharing practices. Four companies used the window to improve data-sharing procedures
“It’s not surprising that non-large companies lag behind large as they may have fewer resources and smaller staffs with less compliance experience,” Miller said. “Our findings suggest that large companies may benefit from reviewing the transparency procedures of smaller companies before partnerships, mergers, and acquisitions so they don’t inherit any deficiencies.”
The researchers did notice improvements among large companies between the 2019 study and the latest one. For example, the median data-sharing score for large companies increased from 80% for drugs approved in 2015 to 100% for products approved in 2017.
Journal information: Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis, BMJ Open (2021). DOI: 10.5061/dryad.r2280gbdb
MedPage Today reports that a large ivermectin study has been retracted over concerns of plagiarism and serious problems with their raw data.
Michele Avissar-Whiting, PhD, editor-in-chief of the preprint server Research Square, wrote in a July 14 statement that the study was retracted “because we were presented with evidence of both plagiarism and anomalies in the dataset associated with the study, neither of which could reasonably be addressed by the author issuing a revised version of the paper.”
Dr Avissar-Whiting noted that the concerns were first raised by Jack Lawrence, a British medical student, according to The Guardian.
“Based on what Jack found, we have reason to believe the preprint’s conclusions are compromised, so the withdrawal was done to stop its propagation as sound science,” she said. “This is the strategy employed by a number of preprint servers, per best practice guidance.”
The 400-patient Egyptian trial, from Ahmed Elgazzar, MD, of Benha University, and colleagues, had been included in two recent meta-analyses (Bryant et al. and Hill et al.) which drew significant attention for their positive results — especially the much-anticipated Hill review. Two ivermectin proponent groups, the Front Line COVID-19 Critical Care Alliance (FLCCC) and the British Ivermectin Recommendation Development Group (BIRD), released a statement saying that removing the Algazzar data from the two studies did not change their overall positive result.
In an email to MedPage Today, lead author Andrew Hill, PhD, of the University of Liverpool in England, said that his team will be “re-running our analysis with the Elgazzar trial removed.”
Dr Hill added that the analysis would also be updated with a recent 500-patient randomised controlled trial from Argentina, which found no effect for ivermectin in terms of preventing hospitalisation in patients with COVID. The study also fiend that patients receiving ivermectin required invasive ventilation sooner than those on placebo.
“In our published paper, we emphasised the preliminary nature of our results and the need to continue more definitive studies,” Hill wrote in his email.
The Elgazzar study’s main findings have already been cited by other publications: Hospitalised patients with COVID who were treated with ivermectin were 90% less likely to die than those who didn’t receive the drug.
Lawrence had taken on an assignment for medical school which had prompted a deeper look at the paper, coming across plagiarism with entire paragraphs copied from other sources.
Additionally, the raw data, which can be purchased online, contradicted the study in several instances. Gideon Meyerowitz-Katz, an epidemiologist from the University of Wollongong in Australia, highlighted some of those discrepancies in a Medium post.
“For example, the study reports getting ethical approval and beginning on the 8th of June, 2020, but in the data file uploaded by the authors onto the website of the preprint fully 1/3 of the people who died from COVID were already dead when the researchers started to recruit their patients,” Meyerowitz-Katz wrote.
“Moreover, about 25% of the entire group of patients who were recruited for this supposedly prospective randomised trial appear to have been hospitalised before the study even started, which is either a mind-boggling breach of ethics or a very bad sign of potential fraud,” he continued. Other phase III randomised clinical trials continue to investigate ivermectin for COVID such as the PRINCIPLE trial which seeks 1500 participants for its ivermectin arm.
SARS-CoV-2 virus. Source: Fusion Medical Animation on Unsplash
For most of 2020, the notion that SARS-CoV-2 may have originated in a lab in Wuhan, China, was regarded as a debunked conspiracy theory, only embraced by some conservative media supportive of President Donald Trump. But in early 2021 that all changed, and today most outlets across the political spectrum agree that the ‘lab leak’ scenario deserves serious investigation.
An investigation by The BMJ uncovered a concerted campaign by researchers with funding on pandemic-potential virus research to label ‘lab leak’ scenarios as a conspiracy, effectively stifling journalism and investigation into the topic for over a year. One of the leaders of this was Peter Daszak, president of EcoHealth Alliance, a non-profit organisation which received millions in grants for pandemic preparedness research. EcoHealth Alliance subsequently subcontracted work out to the Wuhan laboratories.
Almost from the outset of the pandemic, a February 2020 statement in the Lancet coauthored by Daszak effectively ended the debate. “We stand together to strongly condemn conspiracy theories suggesting that covid-19 does not have a natural origin.”
“It’s become a label you pin on something you don’t agree with,” said Nicholas Wade, a science writer who has worked at Nature, Science, and the New York Times. “It’s ridiculous, because the lab escape scenario invokes an accident, which is the opposite of a conspiracy.”
But hostility to the scenario continued to grow. Filippa Lentzos, codirector of the Centre for Science and Security Studies at King’s College, London, told the Wall Street Journal, “Some of the scientists in this area very quickly closed ranks.” She added, “There were people that did not talk about this, because they feared for their careers. They feared for their grants.”
Daszak wrote an essay for the Guardian in June 2020 attacking the former head of MI6 for saying that the pandemic could have “started as an accident,” and continued to receive support from coauthors of the letter. But Daszak’s role in drawing up the statement in the Lancet was revealed in November 2020 in emails obtained through freedom of information requests.
“Please note that this statement will not have EcoHealth Alliance logo on it and will not be identifiable as coming from any one organization or person,” wrote Daszak in a February email, while sending around a draft of the statement for signatories. He also considered omitting his name from the statement to reduce potential negative exposure. A number of the 27 co-signatories omitted reporting their ties to EcoHealth Alliance.
Richard Ebright, professor of molecular biology at Rutgers University in New Jersey and a biosafety expert, considered scientific journal to be complicit in helping to clamp down on talk of a lab leak. “That means Nature, Science, and the Lancet,” he said. Along with dozens of other academics, he has been pushing back against the conspiracy theory labelling of the lab leak scenario.
“It’s very clear at this time that the term ‘conspiracy theory’ is a useful term for defaming an idea you disagree with,” said Ebright, referring to journalists and scientists making use of the term to attack others. “They have been successful until recently in selling that narrative to many in the media.”
Daszak enjoyed more support after then-President Trump cancelled EcoHealth Alliance’s National Institutes of Health funding, and the lab leak scenario remained buried for most of the year. It only resurfaced when a January 2021 New York magazine published an article detailing a possible lab leak scenario, in the face of stiff criticism. The tide began to turn when the World Health Organization investigation (which included Daszak) produced a report which attracted criticism for effectively ruling out the lab leak scenario in the face of almost a complete lack of evidence, such only being allowed a few hours’ worth of supervised access to the Wuhan labs. When Donald Trump lost the Presidential office, the criticism suddenly lost its greatest means for shutting down challenges — its mere association with its most widely-known and disliked proponent.
Citing an intelligence report, the Wall Street Journal, recently reported that three Wuhan Institute of Virology researchers were admitted to hospital in November 2019. When President Joe Biden ordered an investigation into the scenario, it marked a slow turn-around in media coverage. Many outlets started backtracking their previously publicised viewpoints or adding qualifying statements, justifying them as simply a matter of tracking a “scientific consensus” which, they say, has now changed. Vox posted an erratum noting, “Since this piece was originally published in March 2020, scientific consensus has shifted.”
In recent weeks, a number of high profile scientists who once denigrated the idea that the virus could have come from a lab have made small steps into demanding an open investigation of the pandemic’s origin.
In a recent interview, NIH director Francis Collins said, “The Chinese government should be on notice that we have to have answers to questions that have not been answered about those people who got sick in November who worked in the lab and about those lab notebooks that have not been examined.” He added, “If they really want to be exonerated from this claim of culpability, then they have got to be transparent.”
It is worth noting that searches with phrases like “conspiracy theory”, “lab leak” and “Wuhan” do not turn up any relevant hits on The BMJ website, other than articles published this year which discuss the lab leak scenario seriously and credibly, or an article which discusses the more outlandish viral disinformation typical of the COVID pandemic typically seen in social media. Nor are there any articles with “Daszak” as an author.
An investigation by The BMJ uncovered undisclosed financial links between certain authors and the tobacco and e-cigarette industry in a number of COVID research papers, which had suggested that smokers were less likely to develop COVID.
In April 2020, two French studies (in preprint and not yet peer reviewed) suggested that nicotine might have a protective effect against COVID, which was coined the ‘nicotine hypothesis’.
The studies were reported on widely by the media, causing fears that it could undermine decades of tobacco control. What should have been an opportunity for promoting cessation of this practice which every year kills five million people around the world.
Since then, the ‘nicotine hypothesis’ has been soundly disproved, with several studies showing that, to the contrary, smoking is associated with an increased chance of COVID related death.
Journalists Stéphane Horel and Ties Keyze investigated the circumstances of these reports. They pointed out that one of the study authors, Professor Jean-Pierre Changeux, has a history of receiving funding from the Council for Tobacco Research, whose purpose was to fund research that would cast doubt on the dangers of smoking and focus on the positive effects of nicotine.
From 1995 to 1998, documents from the tobacco industry show that Changeux’s laboratory received $220,000 (£155,000; €180,000) from the Council for Tobacco Research.
When approached by The BMJ, Changeux assured them that he has not received any funding linked “directly or indirectly with the tobacco industry” since the 1990s.
In late April 2020, Greek researcher Konstantinos Farsalinos was the first to publish the ‘nicotine hypothesis’ formally in a journal, in an editorial in Toxicology Reports.
That journal’s editor in chief, Aristidis Tsatsakis was a co-author, as was A Wallace Hayes, who in 2013 had been a member of Philip Morris International’s scientific advisory board, and had served as a paid consultant to the tobacco company.
Another co-author is Konstantinos Poulas, head of the Molecular Biology and Immunology Laboratory at the University of Patras, where Farsalinos is affiliated.
The laboratory has been receiving funding from Nobacco, the market leader in Greek e-cigarettes and the exclusive distributor of British American Tobacco’s nicotine delivery systems since 2018. However, in their published scientific articles, neither Farsalinos nor Poulas had ever declared this Nobacco funding.
Yet the journalists showed that two grants were attributed in 2018 by the Foundation for a Smoke Free World—a non-profit established by tobacco company Philip Morris International in 2017—to ‘Patras Science Park’.
The grants, which according to tax documents came close to €83 000, went to NOSMOKE, a university start-up incubator headed by Poulas, which markets an ‘organic’ vaping product.
Last month, the European Respiratory Journal retracted a paper with Poulas and Farsalinos as co-authors, after two other authors failed to disclose conflicts of interest.
The retracted article had found that “current smoking was not associated with adverse outcome” in patients admitted to hospital with COVID, and it claimed that smokers had a significantly lower risk of acquiring the virus.
The foundation has invested heavily in the COVID/nicotine hypothesis, said Horel and Keyzer.
In June 2020 it set aside €900 000 for research “to better understand the associations between smoking and/or nicotine use, and COVID-19 infection and outcome.”
Its request stated that the pandemic offered “both an opportunity and a challenge for individuals to quit smoking or transition to reduced risk nicotine products.”
They concluded that, in 2021, “amid a global lung disease pandemic, tobacco industry figures are increasingly pushing the narrative of nicotine as the solution to an addiction that they themselves created, with the aim of persuading policy makers to give them ample room to market their “smoke-free” products. This makes studies on the hypothetical virtues of nicotine most welcome indeed.”
Article information: Covid 19: How harm reduction advocates and the tobacco industry capitalised on the pandemic to promote nicotine, The BMJ, DOI: 10.1136/bmj.n1303 , www.bmj.com/content/373/bmj.n1303
For Kevin Lamb, MD, the opioid crisis became real to him in 2009.
Once, he said, he had spoken at a leadership forum on opioid abuse, about the role of hospital systems in addressing it. Thinking over what to say, he “realized there was very little I could add. The crisis is epidemic, and hospitals are ill-prepared to do anything proactive. It is that overwhelming.” But leading medical missions made him realise that the rest of the world has overwhelming needs too, which only become real once they are experienced firsthand.
Since transparency is so important, he decided to share his own story.
“This is my story of how close I came to going down that perilous path that is opioid addiction (or any addiction for that matter). I was fortunate that I stopped before I went too far down that path. Unfortunately, too many are unable to stop and continue the downward spiral toward that deep, dark pit called despair and its brother hopelessness. If this could happen to me, it could happen to anyone. If my story prevents even one of you from experiencing this, then the trepidation I feel sharing this will be worth it.”
His story began following his first back surgery in 2009 for an acutely herniated disc that occurred while leading a medical mission in Eastern Europe, which he said was the worst pain he had ever experienced, leaving him with a weak, numb right leg. Having to be carried to bed, living in very basic conditions, with no running water and power interruptions, he feared his condition would force him to be evacuated, although he was able to regain neurologic function for a short while, finishing the mission.
He went in for surgery two days after getting home. He received Oxycontin with a refill, which at the time was common practice, and it eased the pain and had a calming effect, he said. Before the trip, he had experienced a lot of stress, and now being on medical leave he enjoyed the feeling of relief that it gave.
However, as the pills started to run out, he felt embarrassed at the thought of having to request a refill, at being thought of as an addict. But after he used the last pill, withdrawal symptoms kicked in — restlessness, abdominal cramping, diarrhea. “Though relatively mild, it frightened me. I never imagined I could become physically and mentally dependent. I thought this only happened to people who were ‘weak’ or lacked ‘self-discipline’. I was wrong,” he recalled.
He said that besides “scary and humbling”, it was also “surreal… “If it could happen to me, it could happen to anyone!” he warned. The reality is that many in the medical profession are at risk, the pressures of the profession can mean that substance abuse is an easy escape with devastating consequences.
He concluded, hoping that by sharing his story he could make a difference. “My fervent desire is that it will make this crisis more personal and thus more real to you. Only then can you better know the enemy you face and how best to defeat it.”
In order to improve transparency about the opioid crisis, the University of California San Francisco and Johns Hopkins University launched a digital public archive of documents from lawsuits against drug manufacturers.
The digital repository of publicly disclosed legal documents related to the crisis allows free, public access to anyone interested in the continuing litigation and uncovered evidence.
“All too often, the public never gets the benefit of seeing and learning from litigation that generally takes place behind closed doors,” said Caleb Alexander, MD, a professor of epidemiology and medicine at Johns Hopkins and the founding co-director of the Center for Drug Safety and Effectiveness, which will assist in maintaining the archive.
“Our focus is to be sure that the millions of pages of documents arising from opioid litigation ultimately see the light of day,” Alexander told MedPage Today. “We owe it to all those who have been impacted — especially patients and their loved ones — to see to it that these materials are placed in the public domain.”
The goal of the archive is to provide transparency into the methods used by drug companies to increase opioid sales, which led to the opioid epidemic in which, according to the CDC, over the past two decades, nearly 500 000 Americans died of overdoses involving an opioid. Additionally, the economic cost of the crisis in 2015-2018 was put at $2.5 trillion by the White House Council of Economic Advisers.
Most of the archive’s documents were released thanks to efforts by the Washington Post and the Charleston Gazette. Records include company emails, memos, presentations, sales reports, audit reports, budgets, Drug Enforcement Administration briefings, expert witness reports, and depositions of drug company executives.
The archive is located on a website called Drug Industry Archives, a UCSF project that houses documents illustrating how the pharmaceutical industry, academic institutions, continuing medical education organizers and regulatory agencies impact public health. (UCSF also maintains similar archives related to tobacco, food, chemicals, and fossil fuel industries.)
The Opioid Industry Documents Archive presently holds over 3300 legal documents, much of it coming from litigation in Kentucky and Oklahoma, as well as documents from the Insys investigation, which sold an oral fentanyl spray called Subsys. This archive’s launch coincides with the university hosting over 250 000 documents produced during Insys’ bankruptcy proceedings that resulted from successful lawsuits and criminal prosecutions.
“We don’t really know what’s in these documents yet, but there is a wealth of information,” said Kate Tasker, an associate librarian at UCSF who helps manage the archive. “Our number one goal is to make this information accessible and useful.”
Alexander said the opioid crisis was “an epidemic of catastrophic public health proportions.” He said that placing legal documents in the public domain is a crucial step to ensure that lessons are learned from the crisis.
“The primary goal is to ensure that history never repeats itself,” Alexander said. “And we can’t learn from past mistakes without understanding what those mistakes have been.”
