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Authors retract journal studies on hydroxychloroquine use for COVID-19



June 4 (UPI) — The Lancet and New England Journal of Medicine announced Thursday that the authors of published studies on use of the anti-malaria drug hydroxychloroquine to treat COVID-19 have retracted their findings.

The retractions come after reports questioned the validity of data used in the studies, and researchers and third-party reviewers could not verify data supplied to them for the study.

Published May 1, the New England study found COVID-19 patients with cardiovascular disease were at greater risk of death if treated with the drug.

On May 22, the Lancet study found the drug offered no clinical benefit in treating patients infected with the new coronavirus, SARS-CoV-2, and may also cause significant heart-related side effects.

“We always aspire to perform our research in accordance with the highest ethical and professional guidelines,” three of the co-authors — Drs. Mandeep R. Mehra, Frank Ruschitzka and Amit N. Patel — said in a statement issued by the Lancet on the retraction.

“We can no longer vouch for the veracity of the primary data sources,” they said.

Based partially on the results of those studies, the World Health Organization in late May discontinued research on the use of hydroxychloroquine in patients with COVID-19 because of safety concerns.

The agency announced Wednesday that trials of the drug would resume.

On Tuesday, the New England journal published an “expression of concern” about its study and requested the authors provide evidence that the data they used were reliable.

The Lancet announced plans to audit the findings on Wednesday after The Guardian reported that Surgisphere — an analytics company that provided patient information from more than 1,000 hospitals worldwide for the research — had failed to adequately explain its data or methodology after errors were discovered.

Surgisphere chief executive Dr. Sapan Desai was listed as a co-author on both published studies. A week after The Lancet publication, more than 120 researchers published an open letter calling its findings into question.

In their retraction statement, the study authors said they had launched an “independent, third-party review” of the data in response to the concerns raised. However, the third-party reviewer withdrew from the process after Surgisphere refused to transfer the full dataset for analysis as doing so “would violate client agreements and confidentiality requirements,” the authors said.

“We all entered this collaboration to contribute in good faith and at a time of great need during the COVID-19 pandemic,” they said. “We deeply apologize to you, the editors and the journal readership for any embarrassment or inconvenience that this may have caused.”

Hydroxychloroquine is an antiviral and has been shown to inhibit the new coronavirus in lab experiments but has not been proven effective in humans. The drug has also been linked by other studies with serious heart-related side effects in people with severe COVID-19.

The drug has been touted by President Donald Trump and others, including billionaire Elon Musk, as a potential treatment for COVID-19, despite a lack of scientific evidence.

Trump told reporters last month that he had started to take hydroxychloroquine, apparently going against advice from health officials at the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration.

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AI tool screens for heart disease using gut bacteria, study shows



Sept. 10 (UPI) — Artificial intelligence can help screen adults for heart disease by detecting specific bacteria in the gut, according to a study published Thursday by the journal Hypertension.

The researchers analyzed stool samples collected from nearly 1,000 patients — half of whom had known heart disease — with their state-of-the-art machine learning modeling tool that runs on artificial intelligence, or AI.

The approach correctly identified clusters of gut bacteria present in those with heart disease, researchers said.

Based on the presence of this bacteria, the AI-based tool correctly identified people with heart disease more than 70% of the time.

“Gut microbiota are associated with the development of hypertension, or high blood pressure, ‘the silent killer’ that often leads to heart disease,” study co-author Bina Joe told UPI.

“Our study shows that there are real changes in the population of these bacteria in our gut that can pinpoint people at risk for heart disease, before hypertension develops,” said Joe, professor and chair of the department of physiology and pharmacology at the University of Toledo.

Nearly half of all U.S. adults have some form of heart disease, and many of them go undiagnosed until they suffer a major event like a heart attack or stroke, according to the American Heart Association.

The new AI-based screening tool could help enhance screening for heart diseases by pinpointing the presence of specific bacteria in the gut, Joe said.

The tool uses historical data on the presence of certain bacteria in patients with high blood pressure or heart disease to identify those at risk for the conditions — based on whether they too have the same bacteria — she said.

The gut microbiome is made up of microorganisms, including bacteria, that live in the digestive tracts of humans and are involved in the digestion of food and processing of nutrients.

In recent years, bacteria in the gut has been linked with overall health beyond the digestive tract, Joe said. Recent studies have also suggested that the presence of certain bacteria can increase risk for heart disease.

Because the composition of the bacteria in the gut varies from person to person, it has been challenging to develop a test that accurately identifies the bacteria that increases heart disease risk.

The AI-based tool, however, still is in the early stages of development, and it may be several years before doctors can use it to identify at-risk patients, Joe said.

“The gut microbiome is highly variable among individuals, so we were surprised by the promising level of accuracy obtained from these preliminary results,” she said.

“It is conceivable that clinicians could analyze the gut microbiome of patients’ stool samples with our machine learning method to screen patients for heart and vascular diseases.”

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Cost puts HIV-preventing PrEP out of reach for many



The daily drug regimen known as PrEP is a nearly foolproof way to prevent HIV infection. But a new study suggests that many high-risk Americans may be giving the medication a pass because of cost.

The warning stems from a pricing analysis that tracked about 2.6 million PrEP prescriptions filled between 2014 and 2018.

The researchers found that during that time frame, PrEP prices — which were already high — shot up an average of 5% per year.

“Pre-exposure prophylaxis, or PrEP, is when people at risk for HIV take a medication to prevent HIV,” explained study author Dr. Nathan Furukawa. He is a medical officer in the division of HIV/AIDS prevention at the U.S. Centers for Disease Control and Prevention.

First introduced back in 2012, the regimen entails taking a single pill once a day (brand name Truvada), though the pill actually combines two antiretroviral drugs. According to the CDC, a second option — Descovy — is also approved for PrEP, though it is not yet clear whether it specifically protects women during vaginal intercourse.

But the bottom line is that “PrEP is highly effective at preventing HIV from sex or injection drug use when taken consistently,” stressed Furukawa. “If enough people at risk of HIV take PrEP, we can stop new HIV infections and end the HIV epidemic.”

Furukawa and his colleagues describe the widespread adoption of PrEP as “a foundational pillar” of the effort to rein in HIV among those most vulnerable, including gay and bisexual men, and drug users.

But only about 18% of Americans deemed at high-risk for HIV had embraced PrEP as of 2018. And the latest findings, said Furukawa, suggest that its prohibitive cost may be to blame.

The conclusion follows an examination of PrEP orders and prices compiled by the IQVIA prescription database. The database tracks more than nine in 10 medications dispensed by retail pharmacies in the United States, and between 60% and 86% of medications obtained online.

The investigators found that between 2014 and 2018, the number of Americans who began taking PrEP increased significantly, rising from about 20,000 to nearly 205,000.

Yet, at the same time, the cost of a month’s supply of 30 tablets rose from $1,350 to $1,638, the study authors noted.

But isn’t PrEP covered by insurance? Yes and no, Furukawa said.

“PrEP is covered by nearly all insurance plans, most state Medicaid plans and Medicare,” he noted. “However, out-of-pocket costs for patients who have not met their deductible may still be prohibitive.”

Out-of-pocket costs shot up by nearly 15% a year during the study period. That translates to an average out-of-pocket rise from $54 a month in 2014 to $94 a month by 2018, the findings showed.

“Even though insurers cover about 94% of PrEP medication costs, patients may still have difficulties paying the remaining out-of-pocket costs, since the cost of the medication is large,” Furukawa explained.

As for those who are underinsured or lack insurance altogether, state medication assistance programs and the manufacturer of Truvada (Gilead) may offer subsidies. (Furukawa directed those interested to the nonprofit website.)

Furukawa also acknowledged that there are other impediments to PrEP acceptance beyond cost, including lack of awareness and insufficient access to health care.

Still, he suggested that lowering the cost of the medication could be an important factor in getting more people on board.

That thought was seconded by Dr. Michael Horberg, associate medical director and director of HIV/AIDS and STD at the Kaiser Permanente Care Management Institute in Rockville, Md.

While drug assistance programs are available, “pharmacy costs are always a big concern in preventive medicine,” said Horberg.

But PrEP cost is likely to fall in the coming years, he said, as a cheaper generic version of Truvada comes to market. And PrEP is also now classified as a level “A” recommended drug by the U.S. Preventive Services Task Force. That designation should drive out-of-pocket costs down to as low as zero, Horberg added.

“Nonetheless, the pharmaceutical industry should aim to lower costs, and make this readily available to all U.S. citizens who would benefit from PrEP,” Horberg said.

The findings were published Sept. 8 in the Annals of Internal Medicine.

More information

There’s more on PrEP at the U.S. Centers for Disease Control and Prevention.

Copyright 2020 HealthDay. All rights reserved.

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Bars, restaurants are COVID-19 infection hotspots, study confirms



Relaxation of face mask requirements in restaurants, coffee shops and bars could make those venues prime areas for transmission of the new coronavirus, research shows.

The new study compared the behaviors of people diagnosed with COVID-19 and those without such diagnoses.

It uncovered one clear difference: Newly ill people without any known contact with a person with COVID-19 were almost three times as likely to have patronized a restaurant over the prior two weeks, and almost four times as likely to have visited a bar or coffee shop, compared to uninfected people.

The study suggests that situations “where mask use and social distancing are difficult to maintain, including going to places that offer on-site eating or drinking, might be important risk factors for acquiring COVID-19,” the research team said.

The findings come at a moment when more locales are allowing eating establishments and bars to reopen. Just this week, officials announced that restaurants in New York City could serve customers again starting Sept. 30, albeit with a 25% occupancy limit.

“As we learn more about transmission, it is not surprising that activities that cannot maintain social distancing and are not amenable to mask wearing — such as eating and drinking in close proximity to others — would result in a higher transmission rate,” said Dr. Teresa Murray Amato, who heads emergency medicine at Long Island Jewish Forest Hills, a hospital in New York City.

She wasn’t involved in the new study, which was led by Kiva Fisher of the U.S. Centers for Disease Control and Prevention’s COVID-19 Response Team. Fisher and her colleagues conducted detailed interviews with 314 U.S. adults during the month of July, about half of whom were diagnosed with COVID-19.

Comparing the activities of people who did and did not have COVID-19, the investigators found no significant differences in their patronage of venues where the use of face masks at all times was required — activities such as taking public transportation, shopping or attending church.

Mask use was common among most of the study participants. A similar number of people with or without COVID-19 said they always wore some kind of mask or face covering when out in public — 71% and 74%, respectively.

The only big difference in terms of behavior between the infected and uninfected groups was a visit over the prior two weeks to a bar, restaurant or coffee shop, Fisher’s group found.

More than half — 58% — of study participants diagnosed with COVID-19 said that they’d had no close contact with a person known to have been infected with the new coronavirus. But these individuals did have 2.8 times the odds of having patronized a restaurant over the prior two weeks, and 3.9 times the odds of having been at a bar or coffee shop, compared to uninfected people.

The study wasn’t able to ascertain whether participants had consumed food or drinks in an indoor or outdoor space.

“The bottom line is that many people don’t put their mask back on when they aren’t eating and drinking, and may be engaged in conversation,” said Dr. Robert Glatter, an emergency medicine physician at Lenox Hill Hospital in New York City. “This very fact increases the risk of transmission, and is compounded by lack of enforcement by management at eating and drinking establishments.”

Glatter also noted that ventilation within restaurants or bars is often less than adequate, and research has shown that “aerosolized droplets containing virus in normal conversation may be transmitted to others in close proximity, but may also remain suspended in air for up to 3 hours and travel as far as 13 feet during normal conversation. Such aerosolized droplets may also travel as far as 26 feet during sneezes and 15 feet during coughs.”

Finally, he said, alcohol is often a factor. Drinking “makes people move closer together, speak louder,” Glatter said, “thereby generating more aerosolized droplets that may contain infectious viral particles.”

The study is published in the Sept. 11 issue of the CDC’s Morbidity and Mortality Weekly Report.

More information

The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.

Copyright 2020 HealthDay. All rights reserved.

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