The Phase 3 ACTIV-1 Immune Modulators study was sponsored by the National Institutes of Health as part of the ACTIV initiative
Orencia was one of two immune modulators that improved survival for people hospitalized with COVID-19
Safety profile of Orencia remained consistent, with no new safety signals reported
The political distortion of medical research has a sordid history, but it’s unfortunately not just a thing of the past. Today, a popular narrative has taken hold that a racist medical establishment is the reason that blacks have shorter life expectancies, worse clinical outcomes for many diseases, and even excess maternal and infant mortality. The claim is unsupported by evidence, however, and believing it won’t do anything to improve black patients’ health.
Search for the terms “racism” and “medicine” in the National Library of Medicine database, and thousands of scientific publications appear. Journalists and a growing number of doctors regard this as proof of medical discrimination. But most of these studies do not prove any causality; they merely document disparities in clinical outcomes and medical services for black Americans. Nonetheless, they increasingly serve to justify such discriminatory practices as preferentially reserving scarce Covid-19 therapies for blacks.
A rush to find racism typifies most of the many thousands of opinion pieces, original investigations, and review articles on the topic of clinical outcomes for black patients. That literature supports a media that has eagerly adopted the narrative of racism embedded in American health care. The result undermines the trust in medical care needed for successful patient- physician relationships and diverts scarce resources in combating a nonexistent factor in poor health outcomes.
The rules for conducting robust scientific research require scientists to try to disprove their own theories. One can never absolutely prove a hypothesis correct; one can only show that experiments fail to disprove it. The investigator should begin by doubting the hypothesis and do his best to disprove it with carefully designed experiments. Unfortunately, too many studies on medical racism are carried out by investigators who, following the prevailing political trend, set out to confirm their ideas of a racist health-care system. A biased experiment can easily lead to a desired outcome, and emphasizing some results while ignoring others can lead to a faulty conclusion.
Consider a 2022 research article in the highly regarded journal Health Affairs. Titled “Negative Patient Descriptors: Documenting Racial Bias in the Electronic Health Record,” the study uses automated systems to review more than 18,000 electronic medical records. It finds that “bad descriptors” are used in the medical records 2.54 times as frequently in the records of black patients compared with white patients. The headline: “Our findings raise concern about racial bias and possible transmission of stigma in the medical record.”
One might expect that the investigators found that physicians and nurses demeaned or disparaged patients based on their race. So what were the negative words that allegedly show bias? The most common was “refused.” If a patient refused treatment, refused recommendation for a procedure, refused allowing a blood draw, or refused a medication, the authors consider a physician’s or nurse’s writing about the refusal in the medical record an indicator of racism. But that word describes the patient’s actions—it is a fact, not an opinion. Other words that the AI robot found to indicate biases were “not adherent” and “agitated.” Health Affairs highlights this paper in its advertising, but its spuriousness can be discerned only with a close look into its methods and results sections.
Medical research is rife with similar studies. Another study, cited hundreds of times in the medical literature and published in the New England Journal of Medicine, used simulated patient cases to determine whether physicians would assess black patients with chest pain differently from the way they would white patients with similar complaints. The physicians treated black men exactly the same as white men but referred black women less often for cardiac procedures than white women (it is not clear why). Journalists and academics cite this study to support the idea of racism in cardiac care, but they rarely point out that men received equivalent care.
The widespread availability of large databases like the one used by the Health Affairs investigators allows studies of the difference between black and white patients’ utilization of procedures and health outcomes. A notorious example, published in the Proceedings of the National Academy of Sciences, used a database from Florida to show that black newborn babies had a greater chance of survival if they were treated by a black pediatrician. A dangerous conclusion might be that patients should seek out physicians matching their own race. If this study is correct, we could be on the path to medical apartheid.
But the study suffers from fatal mistakes. Any study using a large database to assess the cause of death should undertake a chart-level assessment of the circumstances of the patient’s death. A large database is often riddled with errors, as the various entries are made by administrative personnel who are rarely, if ever, trained in health care. It’s a game of telephone: the truth can become hopelessly muddled after multiple rounds. In this paper, the infant mortality data were never checked at the level of the patient’s chart, so it’s impossible to know which doctors actually cared for the patient during any acute event. Moreover, the authors had no way of determining the race of the physician of record besides scanning available photos, and almost 2,000 of the nearly 10,000 doctors in the sample had no photos (they were excluded from the analysis). Finally, it was not clear whether the infants who died had been referred from outlying hospitals to large medical centers because they were already critically ill. If so, the treating physician under whose care the patient died may have received a desperately ill baby with little chance of survival.
These flaws notwithstanding, the study was widely cited in the press as proof of the need for more black physicians. USA Today headlined its story: “Black babies are more likely to survive when cared for by Black doctors, study finds.” The coverage only fed the narrative that racism permeates American medicine.
One could go on dismantling studies like these. But the key finding lacking in any of the studies of racism in medicine is evidence that the countless diversity, equity, and inclusion trainings to which doctors are now subjected would alter patient outcomes. A vast gulf remains between methods of traditional medical research and these alleged remedies. In medical research, cures are proposed and then tested in two populations; if an improvement in outcomes results between the two groups, the therapy may work, and the “null hypothesis” is rejected. But with an antiracist approach to improving medical outcomes for black patients, a cure is proposed, consisting of expensive and time-consuming antiracist training, but the testing step is ignored. One simply must adopt the antiracist cure and implement it widely.
To the extent that medical research exaggerates racism in clinical outcomes, it does a disservice to identifying the real basis for discrepant results. Disparities aren’t always due to discrimination. If a genetic trait is the culprit—for example, increasing susceptibility to chronic kidney disease—then encouraging physicians to become activists will do nothing to improve patients’ outcomes. The failure of antiracist programs to do anything to improve clinical outcomes for black patients will only deepen the frustration of clinicians and the dismay of patients.
Doctors should conduct research and find treatments that work. They shouldn’t treat patients differently based on skin color. Doing so would undermine everything that physicians pledge when they first are called “doctor.”
Squeezing back into a pair of jeans bought before March 2020 is a challenge for lots of Americans — and a new study found that injury may be to blame.
The study of 2,000 adults, by OnePoll in partnership with CURAD, found that seven out of 10 respondents said they stopped working out during the thick of the COVID-19 pandemic.
Eighty-eight percent said they had every intention of getting back to their pre-pandemic bod, but 56 percent have since sustained an injury.
Of them, 64 percent of people admitted they jumped back into their normal routine too quickly after sitting on the couch for a year and some change. Others — 56 percent, to be exact — said they got back into their competitive sports too soon, and 45 percent either pulled a muscle or “moved too quickly.”
“It’s important to ease back into your old workout routine, especially if you’ve been away for a while,” NCAA Team Physician and Orthopedic Surgeon Dr. Gloria Beim said. “Jumping back in too quickly can put you at risk of pulling muscles or even more serious injuries.”
Overall, 85 percent of respondents said their injuries have stopped them from getting back into shape, with 90 percent saying they had to switch up their routines because of their ouchie.
Beim suggested easing back into a routine.
Still, 46 percent of respondents fear that their injury will impact their future fitness plans. That would be a great setback to the 83 percent of participants who would love to get back to their “peak performance days.”
Those days, by the way, averaged out to be when they were just 28 years old.
Participants also cited having to wear a mask at the gym (60%), catching COVID (58%) and changing up their normal workout routine (57%) as reasons they didn’t stay active during the coronavirus pandemic.
The other 41 percent still blame the pandemic itself for the weight gain.
Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the Company's Phase 2 clinical trial of ATH434 for the treatment of patients with Multiple System Atrophy (MSA) is now open for enrolment in New Zealand.
MSA is a rare neurodegenerative disease. While it is similar to Parkinson's disease, MSA progresses more rapidly and causes profound disability. In addition to the motor symptoms characteristic of Parkinson's disease, MSA manifests with more severe autonomic nervous system impairment resulting in bladder dysfunction and the inability to maintain normal blood pressure, as well as uncoordinated or clumsy movements that contribute to falling. Currently available treatments only address certain symptoms of MSA. There are no therapies that slow disease progression and there is no cure.
ATH434 is designed to reduce the toxic accumulation of α-synuclein, a pathological hallmark of MSA, and preserve nerve cells by restoring normal iron balance in the brain. Therefore, ATH434 has the potential to address the underlying pathology of the disease and preserve function in individuals with MSA.
Cassava Sciences is reeling after another journal retracted an article co-authored by a key collaborator on its experimental Alzheimer's disease therapeutic, simufilam.
On Wednesday, the science publication Springer pulled the article "Increased Aβ42-α7-like nicotinic acetylcholine receptor complex level in lymphocytes is associated with apolipoprotein E4-driven Alzheimer's disease pathogenesis," co-authored by Hoau-Yan Wang, a key collaborator with Texas-based Cassava Sciences. Springer said following the 2017 publication of the article, concerns have been raised regarding some of the western blot images used in the article. Western blotting is a technique used in a lab to detect a specific protein in a blood or tissue sample.
"The authors have provided the raw data, which have been assessed by independent experts and deemed insufficient to address the concerns. Therefore, the Editors-in-Chief no longer have confidence in the integrity of the data in this article," Springer wrote on its website.
This is not the first time that papers authored by Wang have been called into question regarding data cited in the articles. Earlier this year, PLoS One retracted five papers that Wang co-authored. The papers were pulled following an in-depth investigation that revealed "serious concerns about the integrity and reliability of the results."
The retraction of the papers in PLoS One led other publications to examine articles that Wang co-authored. Following the pulling of the five papers, in April, the New York Times reported that other journals, including Neurobiology of Aging, took a close look at papers authored by Wang. Those journals did not find evidence of data manipulation but listed methodological errors.
The Times article also included criticisms of Cassava Sciences' research on simufilam, an oral small molecule drug candidate that is designed to restore the normal shape and function of altered filamin A (FLNA) protein in the brain. Some sources, including Nobel Laurette Thomas Sudhoff, questioned the FLNA approach. Sudhoff told the Times that Cassava's conclusions regarding FLNA are "not in the mainstream" and seem "implausible and contrived." Cassava is currently assessing Simufilam in two Phase III studies.
The expose in the Times caused Cassava Sciences President and Chief Executive Officer Remi Barbier to rebut the claims in the report, calling the article "one-sided" and saying the venerable newspaper misrepresented his company's research by only using sources who were critical of the Texas-based company. Barbier also claimed that those who spoke with the Times maintain a negative bias about Cassava. Two, in particular, the Times relied on for its article are known to be shorting the company stock, he added at the time.
Both neuroscientists were behind a Citizen's Petition filed with the U.S. Food and Drug Administration that aimed to suspend the company's clinical research into simufilam. The neuroscientists suggested that Cassava's research included published images that appeared to have been manipulated using Photoshop or similar software. That petition was denied earlier this year after the journal Neuroscience announced that it could find no evidence to support claims of data manipulation in a 2005 paper authored by the company and its scientific collaborators.
Shares of Cassava are down slightly in premarket trading. The stock closed at $26.82 per share on Wednesday.
Regeneron Pharmaceuticals announced intentions to acquire Sanofi’s stake in a drug they developed together, Libtayo (cemiplimab). The drug is a fully human monoclonal antibody that targets the PD-1 checkpoint receptor.
To date, the drug has been approved in more than two dozen countries, including the U.S., as a monotherapy for advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC). It is generally viewed as the standard of care for the treatment of approved non-melanoma skin cancers.
Regulators are reviewing the drug in the U.S. and Europe as a combination treatment with chemotherapy for first-line therapy in advanced NSCLC. Libtayo is also being evaluated in 22 clinical trials with 18 investigational compounds for various difficult-to-treat cancers.
“This strategic acquisition is a major step towards Regeneron’s goal of becoming a global oncology leader, centered on Libtayo as an important choice in settings where PD-1 inhibitors can be used as monotherapy and, excitingly, in potential new combinations with our differentiated and diverse pipeline of oncology assets,” Dr. Leonard S. Schleifer, M.D., Ph.D., president and CEO of Regeneron said.
Schleifer added, “In 2021, Libtayo was approved for two new monotherapy indications in the U.S. and EU and global net product sales increased 32% year-over-year, providing a strong foundation for our multi-faceted oncology strategy and helping to maximize the potential value of our pipeline.”
The two companies inked the original immuno-oncology deal in 2015. Up to this deal, they split the drug’s global operating profits equally and co-commercialized the drug in the U.S., while Sanofi handled sales and marketing outside the U.S.
Under this acquisition deal, Regeneron is paying Sanofi $900 million upfront. Sanofi will be eligible for an 11% royalty on global net sales. Sanofi will also be up for a $100 million regulatory milestone, once the drug is approved by either the U.S. Food and Drug Administration or the European Commission for the chemotherapy-combo for first-line treatment of NSCLC. Sanofi will also be eligible for sales-related milestones of up to $100 million over the next two years.
For 2021, Regeneron reported $306 million in Libtayo sales for the year, up 13% from $271 million in 2020. That pales to another of the two companies’ collaboration drugs, Dupixent, which recorded $1.77 billion in the fourth quarter of 2021 alone, and about $5.6 billion for the year.
In 2020, Regeneron bought back about $5 million of its shares directly from Sanofi. At the time, Sanofi owned about 23.2 million shares of Regeneron common stock, an approximately 20.6% stake. The two companies have collaborated since 2003. Regeneron was viewed as Sanofi’s “innovation engine” for quite some time.
On May 31, the FDA accepted the two companies’ Dupixent (dupilumab)’s supplemental Biologics License Application (sBLA) for priority review. The indication is for prurigo nodularis, a chronic inflammatory skin disease. A decision is expected by September 30, 2022. The drug is a fully human monoclonal antibody that inhibits interleukin-4 and interleukin-13 pathways. The drug is approved for various indications in more than 60 countries, including the U.S., Europe and Japan. It is approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis and eosinophilic esophagitis.
As part of the acquisition of Libtayo rights, Regeneron plans to speed the reimbursement of the development balance associated with the two companies’ separate Antibody Collaboration. Regeneron will jump from 10% to 20% of the share of its profits paid to Sanofi to reimburse Sanofi’s part of the development expenses until Regeneron’s share of the total costs has been reached.
Former Homeland Security Secretary Jeh Johnson in an op-ed published Wednesday argued that “something graphic is required to awaken the public to the real horror” on mass shootings after a deadly shooting at an elementary school in Uvalde, Texas, left 21 dead.
“I lack the moral standing to tell a parent to accept and approve, for the greater good, the public display of photos of his or her dead child. Only they can judge the additional weight that doing so would place on them, at a time when they are already struggling with unimaginable grief,” the Obama-era official wrote in his op-ed, which was published in The Washington Post.
“Nor do I suggest the release of any images in particular. But something graphic is required to awaken the public to the real horror of these repeated tragedies,” he added,
Johnson argued that certain images have had a major impact on Americans’ understanding of historical events, including photos of Black protesters in Birmingham, Ala., attacked with firehoses and dogs and footage of a white police officer kneeling on the neck of George Floyd, a Black man, which reignited protests across the country around police brutality and criminal justice.
“Conversely, imagine if there had been no video of Floyd’s killing, leaving us with the initial Minneapolis police report, which was headed simply, ‘Man dies after medical incident during police interaction,’” Johnson wrote.
Johnson described the Uvalde elementary school, where a gunman killed 19 children and two teachers last week, as a “crime scene” and argued that legislators should see the evidence of the horror of the mass shooting.
“Robb Elementary School in Uvalde is a crime scene. If there were a case to go to trial, the prosecution would have to present publicly the shocking evidence of guilt. Put another way: Why must innocent schoolchildren, for the rest of their lives, carry the vivid memories of the executions of their teachers and classmates, while federal and state lawmakers (and the adult constituents who elect them) are spared?” he wrote.
