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Wednesday, April 8, 2020

FDA OKs generic version of Merck bronchospasm med

The FDA approves Mumbai-based Cipla Limited’s generic version of Merck’s (MRK +2.6%) Proventil HFA (albuterol sulfate) Metered Dose Inhaler, 90 mcg/Inhalation for the treatment or prevention of bronchospasm in patients at least four years old who have reversible obstructive airway disease and the prevention of exercise-induced bronchospasm.
This is the first generic Proventil HFA approved in the U.S.
https://seekingalpha.com/news/3559435-fda-oks-generic-version-of-merck-bronchospasm-med

Warning: Autoimmunity on the Rise in the U.S.

The prevalence of autoimmunity, as suggested by the presence of antinuclear antibodies (ANA), has been rising in the United States, a large cross-sectional study found.
Data from the National Health and Nutrition Examination Survey (NHANES) showed an overall ANA prevalence of 11% (95% CI 9.7-12.6) for 1988-1991; 11.5% (95% CI 10.3-12.8) for 1999-2004; and 15.9% (95% CI 14.3-17.6) for 2011-2012 (P<0.0001 for trend), according to Frederick W. Miller, MD, PhD, of the National Institute of Environmental Health Sciences in Research Triangle Park, North Carolina, and colleagues.

As they reported online in Arthritis & Rheumatology, those numbers corresponded with totals of 22 million, 27 million, and 41 million affected individuals across the 25-year time frame.
The presence of ANA is the most common biomarker for autoimmunity, occurring in patients with many conditions such as systemic lupus erythematosus and rheumatoid arthritis. The antibodies also are sometimes seen in the general population, particularly among women and the elderly and after exposures to chemicals and infections, Miller and co-authors noted.
“Growing evidence suggests that autoantibodies precede the onset of symptomatic autoimmune disease by many years; thus, ANA may be an intermediate marker on the pathway to disease or may signal increased susceptibility to autoimmune diseases through related causal pathways,” the researchers explained.
Earlier studies had suggested that the rates of autoimmune disease were increasing, but it’s been unclear whether this represented better detection or a true increase, so Miller and colleagues analyzed the prevalence of ANA positivity in the nationally representative NHANES database for 1988-2012.

The analysis included 14,211 individuals ages 12 and older from the three time periods who completed questionnaires on demographics and health factors and also provided blood samples. Indirect immunofluorescence was used to detect ANA.
Of the included individuals, 13.9% were positive for ANA. At all three time intervals, the likelihood of ANA positivity was two to three times higher for women than men, with odds ratios of 2.53 (95% CI 1.90-3.36) for 1988-1991, 2.97 (95% CI 2.30-3.84) for 1999-2004, and 1.94 (95% CI 1.57-2.40) for 2011-2012.
Antibody positivity also was more common among individuals age 50 and older compared with adolescents, with odds ratios of 3.63 (95% CI 2.02-6.55), 1.80 (95% CI 1.23-2.63), and 1.71 (95% CI 1.21-2.42) for the three time periods, respectively.
The odds of ANA positivity also were higher for blacks and Mexican-Americans in the earliest time period, but ethnic/racial differences declined in the two later time periods.
In a time-trend analysis, the researchers reported “strong evidence” for an increasing prevalence of ANA positivity in the two later time periods compared with the first (reference) period, with overall prevalence odds ratios of 1.02 (95% CI 0.85-1.24) for 1999-2004 and 1.47 (95% CI 1.22-1.78, P<0.0001 vs reference) by 2011-2012.

The greatest rise in prevalence was between the second and third time periods, and by 2011-2012 the prevalence odds ratios were significantly increased in these subgroups (vs the baseline period):
  • Men, OR 1.73 (95% CI 1.31-2.30, P<0.0001)
  • Women, OR 1.35 (95% CI 1.08-1.69, P=0.008)
  • Adolescents, OR 2.88 (95% CI 1.64-5.04, P<0.0001)
  • Older adults, OR 1.51 (95% CI 1.17-1.95, P=0.001)
  • Non-Hispanic whites, OR 1.66 (95% CI 1.30-2.12, P<0.0001)
  • Overweight individuals, OR 1.88 (95% CI 1.33-2.65, P=0.0001)
  • Second-hand smoke exposure, OR 1.65 (95% CI 1.29-2.12, P=0.0002)
  • Moderate/heavy alcohol consumption, OR 2.41 (95% CI 1.55-3.75, P<0.0001)
“Our novel and robust findings suggest that ANA prevalence increased substantially in the U.S. over the 25-year time frame examined,” the investigators wrote.
They described the “dramatic” increase in ANA positivity in adolescence as “particularly concerning if ANA are harbingers of increased susceptibility to future autoimmune diseases.”
A study limitation, the team said, was the cross-sectional design.
The researchers added: “Additional studies to complement our exploratory investigation, particularly of the aforementioned sociodemographic groups, should be the focus of future research to determine the driving forces underlying these ANA increases and to inform the development of possible preventative measures.”
Last Updated April 08, 2020

Generic drugmakers win EU okay to cooperate in coronavirus fight

Generic drugmakers will be allowed to cooperate to supply hospital medicines for COVID-19 patients without fear of breaching the bloc’s competition rules, EU antitrust regulators said on Wednesday.
The step is the latest loosening of the bloc’s strict antitrust rules to help tackle the novel coronavirus pandemic.
The European Commission, the EU executive, has allowed EU governments to hand out subsidised loans, grants and defer tax payments to thousands of companies.
Regulators said waiving antitrust rules for generic drugmakers, which produce the largest part of critical hospital medicines, will help to avoid shortages.
“In the current circumstances, this temporary cooperation appears indeed justifiable under EU antitrust law, in view of its objective and the safeguards put in place to avoid anticompetitive concerns,” the EU executive said in a statement.
It will provide a business document, known as a comfort letter, to industry body Medicines for Europe, giving guidance on what will be allowed.

Specifically, it will address a voluntary cooperation project among pharmaceutical producers, both members and non-members of the generic drugmakers’ association.
Enforcers will monitor the market to ensure that companies do not fix prices or abuse their market power, the Commission said.
https://www.reuters.com/article/us-health-coronavirus-antitrust/generic-drugmakers-win-eu-okay-to-cooperate-in-coronavirus-fight-idUSKBN21Q1FR

Britain says aiming to roll-out millions of coronavirus tests in months

Britain said on Wednesday it aimed to roll-out millions of coronavirus tests in months after criticism that it had moved too slowly on the issue, adding that a partnership with private firms would help it hit 100,000 tests a day by the end of April.
England’s Chief Medical Officer conceded on Tuesday that there were lessons to learn from Germany on testing.
Foreign Secretary Dominic Raab, who is deputising for Prime Minister Boris Johnson while he is in hospital with COVID-19, has said Britain is making progress to its daily testing target but there was “more work to do.”
The Department of Health said that a new testing laboratory set-up by AstraZeneca, GSK and Cambridge University would aim to carry out 30,000 tests a day by May, and Thermo Fisher would continue to supply the UK with testing kits and aim to scale up manufacturing.
Government testing adviser John Newton said the 100,000 daily test target was feasible, and that 20,000 National Health Service workers had already been tested.
“Testing capacity now is not what we would like, but it is by no means inconsiderable in terms of what we need,” Newton told lawmakers on Wednesday.

“We do anticipate that the need will increase dramatically, and therefore we want to get as much testing in place as possible.”
The government also said a business consortium had launched plans to develop an antibody test, in order to detect those who have been infected with COVID-19 and therefore had immunity.
Newton said he did not expect such tests to be widely available by the end of April and would not rely on them to contribute to the target, even though some laboratory-based antibody tests were beginning to come on stream.
https://www.reuters.com/article/us-health-coronavirus-britain-testing/britain-says-aiming-to-roll-out-millions-of-coronavirus-tests-in-months-idUSKCN21Q290

GM to supply 30,000 ventilators in $500 million U.S. contract

The United States on Wednesday awarded automaker General Motors Co (GM.N) a contract worth $489.4 million to make ventilators needed to treat severely sick coronavirus patients.
The Department of Health and Human Services contract is the first for ventilator production under the Defense Production Act, invoked by President Donald Trump to get companies to produce essential gear needed to fight the pandemic.
GM will work with ventilator firm Ventec Life Systems to deliver 30,000 ventilators under the contract to the U.S. government by the end of August, with deliveries of the first 6,132 ventilators taking place by June 1.
The company “will fulfill the government contract and (has) the capacity to supply more if needed,” GM spokesman Jim Cain said, adding that the contract also includes “consumables and accessories (hoses, stands, etc.) to support each unit.”

GM Vice President Gerald Johnson told Reuters last month the automaker is spending tens of millions on retooling costs as it produces the ventilators, and that if supplier retooling costs are factored in, total retooling costs were in the hundreds of millions of dollars.
Last week, smaller rival Ford Motor Co (F.N) also said it will produce 50,000 ventilators over the next 100 days at a plant in Michigan in cooperation with General Electric Co’s (GE.N) healthcare unit.
https://www.reuters.com/article/us-health-coronavirus-gm/gm-to-supply-30000-ventilators-in-500-million-u-s-contract-idUSKBN21Q1YA

U.S. coronavirus death projection cut, but official warns of ‘second wave’

An influential university model on the U.S. coronavirus pandemic on Wednesday scaled back its projected death toll by 26% to 60,000 but a federal health official warned of a second wave of infections if Americans relax “social distancing” practices.
The downward revision in the death toll in the University of Washington model – often cited by U.S. and state policymakers – coincides with comments by some political leaders that caseloads may have reached a plateau in certain areas.
Those assessments in recent days, including an apparent leveling out in hospitalizations in New York state – the U.S. epicenter of the pandemic – are tempered by a persistent climb in the U.S. death toll, which rose by more than 1,900 on Tuesday as some 30,000 new infections were reported.
New York Mayor Bill De Blasio told a briefing on Wednesday that coronavirus-related hospitalizations in the most populous U.S. city had stabilized and that the need for ventilators was lower than projected.
“In the last few days we’ve actually seen fewer ventilators needed that were projected,” the mayor said.
Even that revised forecast suggested months of pain ahead for the United States. All told, about 400,000 U.S. infections have been reported, along with roughly 13,000 deaths.
“What’s really important is that people don’t turn these early signs of hope into releasing from the 30 days to stop the spread – it’s really critical,” said Deborah Birx, the coordinator of the White House coronavirus task force, referring to guidelines aimed at reducing the spread of the virus.
“If people start going out again and socially interacting, we could see a really acute second wave,” Birx added.
The pandemic has upended American life, with 94% of the population ordered to stay at home and nearly 10 million people losing their jobs in the past two weeks.
Hospitals have been inundated with cases of COVID-19, the respiratory disease caused by the virus, resulting in shortages of medical equipment and protective garments.
The University of Washington’s Institute for Health Metrics and Evaluation model is one of several that the White House task force has cited. It now projects U.S. deaths at more than 60,000 by Aug. 4, down from the nearly 82,000 fatalities it had forecast on Tuesday.
The White House coronavirus task force has previously projected 100,000 to 240,000 Americans could die.
The institute also moved up its projected peak in the number to U.S. deaths to this Sunday, when it predicted 2,212 people will succumb to the disease. The revision moves forward the projected peak by four days, suggesting the strain on the country’s healthcare system will begin to abate a little sooner than previously expected.

AT-HOME DEATHS UNTRACKED
New York’s de Blasio estimated an undercount in the death toll of 100 to 200 people per day who are dying at home but excluded from the city’s rapidly growing coronavirus count. So far the city’s announced death toll has reflected only COVID-19 diagnoses confirmed in a laboratory.
But after a spike in the number of people dying at home, the city will now try to quantify how many of those died from coronavirus-related causes and add that to the its official death toll, New York’s health department said.
“Every single measure of this pandemic is an undercount. Every. Single. One,” Mark Levine, chairman of the City Council’s health committee, wrote on Twitter. “Confirmed cases? Skewed by lack of testing. Hospitalizations? Skewed by huge # of sick people we are sending home because there’s no room in ERs. Deaths? Massive undercount because of dying at home.”
The state of New York accounts for more than a third of U.S. confirmed coronavirus cases, and nearly half the cumulative death toll.
Authorities in various states in recent days have disclosed data showing that the pandemic was having a disproportionate impact on African Americans, reflecting longstanding racial inequities in health outcomes in the United States.
De Blasio said there were “clear inequalities” in how the coronavirus is affecting his city’s population.
In New York, long weeks of fighting the pandemic were taking a toll on hospital staff, some of whom are coming down with the disease they have been fighting.
One resident doctor at New York-Presbyterian Hospital said he had been surprised by the number of hospital workers infected.
“There are people around the hospital who are sick and now they’re showing up on our patient list. … It’s hard not to see yourself in them,” the resident said. “A lot of us feel like we are being put in harm’s way.”
https://www.reuters.com/article/us-health-coronavirus-usa/u-s-coronavirus-death-projection-lowered-new-york-fears-undercount-idUSKBN21Q204

U.S. planning ways to ‘ease’ back to normal if virus efforts work: Fauci

U.S. health officials are planning ways for the country to return to normal activities if distancing and other steps to mitigate COVID-19 this month prove successful in curbing the outbreak, the top U.S. infectious disease official said on Wednesday.
The Trump administration has called for 30 days of measures, including staying at least six feet away from other people, that have upended American life as most people stay isolated at home, shuttering schools and closing businesses through at least the end of April, with some states continuing certain closures through May and June.
Dr. Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, said such steps must continue but that there are hopeful signs they are working.
“If in fact we are successful, it makes sense to at least plan what a re-entry into normality would look like. That doesn’t mean we’re going to do it right now, but it means we need to be prepared to ease into that,” Fauci, a member of the White House coronavirus task force, told Fox News in an interview.
Fauci and other public health experts have said the strict measures are needed to control the fast-spreading and potentially fatal disease that has already led to about 400,000 confirmed COVID-19 U.S. cases and nearly 13,000 deaths, even as the shutdowns have roiled the U.S. economy.
Dr. Deborah Birx, another task force member, said isolation measures must continue for now or else the country could risk a repeated spike despite the allure of warmer spring weather.

“What’s really important is that people don’t turn these early signs of hope into releasing from the 30 days to stop the spread. It’s really critical,” she told NBC News’ “Today” program. “If people start going out again and socially interacting, we could see a really acute second wave.”
Asked if 30-day distancing practices would be enough or that steps might have to continue longer, she said officials were looking at each area of the country differently as they weigh the data.
“Clearly, there are metro areas that are struggling,” Birx said.
https://www.reuters.com/article/us-health-coronavirus-usa-activity/u-s-planning-ways-to-ease-back-to-normal-if-virus-efforts-work-fauci-idUSKBN21Q1ZM