Nearly a dozen approved drugs could be effective against COVID-19: study

(Reuters) – At least 10 different drug compounds ranging from cancer therapies to antipsychotics and antihistamines may be effective at preventing the new coronavirus from multiplying in the body, according to a multidisciplinary study conducted by a team of scientists in the United States and France.

FILE PHOTO: A computer image created by Nexu Science Communication together with Trinity College in Dublin, shows a model structurally representative of a betacoronavirus which is the type of virus linked to COVID-19, better known as the coronavirus linked to the Wuhan outbreak, shared with Reuters on February 18, 2020. NEXU Science Communication/via REUTERS

The researchers mapped the human proteins the virus interacts with inside the body when it infects cells and makes copies of itself, then looked for compounds that could block the virus from using those proteins.

The result showed that 47 compounds in cell cultures had the desired effect, at least 10 of which are already in approved drugs or being studied for diverse conditions, but could be repurposed against COVID-19, the illness caused by the new coronavirus.

Researchers have been rushing to develop experimental therapies as well as to repurpose existing drugs to treat patients with COVID-19 and communities are pinning high hopes on Gilead Sciences Inc’s experimental antiviral drug, remdesivir.

In the new study, published in the journal Nature here on Thursday, candidates for repurposing included allergy medicine ingredients including clemastine, the antipsychotic haloperidol, and malaria drug hydroxychloroquine.

The study also revealed why hydroxychloroquine is often found to have toxic effects on the heart.

The malaria drug, which has been repeatedly touted by U.S. President Donald Trump, binds to a receptor on human cells, which the virus needs to infect the cell.

But hydroxychloroquine also hits a particular protein in the heart tissue, which could explain the drug’s effect on heart rhythms – a side effect recently flagged by U.S. and EU health regulators.

The team also found that an experimental chemical, PB28, was 20-times more potent than hydroxychloroquine in targeting the receptor, but had far less affinity for the heart protein.

The hormone progesterone was also found to act against the virus, which might shed some light on the reasons that men appear to be more susceptible to COVID-19 and more often suffer severe complications.

Another compound found to have antiviral activity was plitidepsin, used in Madrid-based PharmaMar’s experimental cancer therapy Aplidin that is currently being tested in COVID-19 trials in Spain.

“Some of our drugs and compounds are many times more potent than remdesivir, at least in a laboratory setting,” study author Nevan Krogan of the University of California San Francisco, said in a media briefing.

Gilead’s remdesivir could be the closest to regulatory approval after initial trial results on Wednesday found that the drug helped patients recover more quickly.

The team said it would continue testing the candidates they have identified and use the same methods to further study the biology of the disease for more insights.

Reporting by Saumya Sibi Joseph in Bengaluru; editing by Christine Soares and Vinay Dwivedi

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CDC reports 1,031,659 coronavirus cases, 60,057 deaths

People wear masks as they walk past a closed beach during the outbreak of the coronavirus disease (COVID-19) in Del Mar, California, U.S., April 30, 2020. REUTERS/Mike Blake

(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) on Thursday reported 1,031,659 cases of new coronavirus, an increase of 26,512 cases from its previous count, and said the number of deaths had risen by 2,552 to 60,057.

The CDC reported its tally of cases of the respiratory illness known as COVID-19, caused by a new coronavirus, as of 4 p.m. ET on April 29, compared with its count a day earlier. (bit.ly/2IVY1JT)

The CDC figures do not necessarily reflect cases reported by individual states.

Reporting By Mrinalika Roy in Bengaluru; Editing by Shounak Dasgupta

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Temple University Hospital is offering COVID-19 clinical trials, investigational treatments options

Temple University Hospital is now participating in a variety of clinical trials that are testing investigational treatment options for patients diagnosed with the novel coronavirus, or COVID-19.

COVID-19 is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). While many COVID-19 patients will experience mild to moderate respiratory illness and recover, others will face lung injury, acute respiratory distress syndrome (ARDS), and even death.

At the Temple Lung Center, we have always been committed to research and to providing our patients with access to the latest treatment options that are available for their particular condition. That remains true for those diagnosed with COVID-19, a devastating virus that we continue to learn more about with each passing day.”

Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery, Lewis Katz School of Medicine, Temple University

Criner is also the Director of the Temple Lung Center.

The COVID-19 clinical trials and investigational treatments currently offered at Temple University Hospital include:

Convalescent plasma: This Phase 2 randomized study will utilize plasma from patients who have recovered from a SARS-CoV-2 infection.

The study will evaluate the safety and efficacy of treatment with SARS-CoV-2 immune plasma relative to a control arm of SARS-CoV-2 non-immune plasma in patients exposed to COVID-19.

This multi-site, interventional clinical trial will enroll up to 150 patients. >Mohamed S. Alsammak, MD, Assistant Professor of Clinical Pathology and Laboratory Medicine at LKSOM and Director of the Blood Bank/Transfusion Medicine at Temple University Hospital, is the principal investigator at TUH.

Gimsilumab: The BREATHE clinical trial is a Phase 2 randomized study that will evaluate the safety and efficacy of gimsilumab in patients with COVID-19 and ARDS.

The trial, for which Temple University Hospital treated the first patient in the United States, will evaluate the impact of gimsilumab on mortality in these patients. Gimsilumab is a fully human monoclonal antibody targeting granulocyte macrophage-colony stimulating factor (GM-CSF), which is believed to be a key driver of lung hyper-inflammation.

The primary endpoint is mortality by Day 43. Key secondary endpoints include the incidence and duration of mechanical ventilation use during the study, number of days in the intensive care unit, and number of days of inpatient hospitalization.

This multi-site, interventional clinical trial will enroll up to 270 patients. Dr. Criner is the principal investigator at TUH.

Hydroxychloroquine: The HERO-HCQ clinical trial is a Phase 3 randomized study that will evaluate whether hydroxychloroquine is better than placebo in preventing COVID-19 infection in health care workers.

Hydroxychloroquine is a U.S. Food and Drug Administration (FDA)-approved medication for malaria, lupus, and rheumatoid arthritis. This multi-site, interventional clinical trial will enroll up to 15,000 health care workers at risk of being exposed to SARS-CoV-2.

The principal investigators at Temple University Hospital are Anuradha Paranjape, MD, MPH, FACP, Professor of Medicine, Professor of Clinical Sciences, and Vice Chair of Clinical Affairs in the Department of Medicine at LKSOM; Nina Gentile, MD, Professor of Emergency Medicine at LKSOM; and Gustavo Adolfo Fernandez Romero, MD, Assistant Professor of Clinical Thoracic Medicine and Surgery at LKSOM.

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Hydroxychloroquine: The ORCHID clinical trial is a Phase 3 randomized study to evaluate whether hydroxychloroquine is better than placebo in the treatment of adults hospitalized with COVID-19.

Clinical outcomes will be evaluated on a seven-point scale on Day 15. This multi-site, interventional clinical trial will enroll up to 510 patients. Dr. Gentile is the principal investigator at TUH.

Remdesivir: This Phase 3 randomized study will evaluate the safety and efficacy of two remdesivir regimens with respect to clinical status of patients with severe COVID-19 on a seven-point scale on Day 14. Remdesivir is an antiviral medication.

This multi-site, interventional clinical trial will enroll up to 6,000 patients. Dr. Criner is the principal investigator at TUH.

Remdesivir: This Phase 3 randomized study will evaluate the safety and efficacy of two remdesivir regimens compared to standard of care with respect to clinical status of patients with moderate COVID-19 on a seven-point scale on Day 11.

This multi-site, interventional clinical trial will enroll up to 1,600 patients. Dr. Criner is the principal investigator at TUH.

Sarilumab: This is an adaptive Phase 2/Phase 3 randomized study to evaluate the safety and efficacy of sarilumab. Sarilumab is an FDA-approved medication for adults with moderate to severe rheumatoid arthritis.

It is a monoclonal antibody that binds to the interleukin-6 receptor, a cytokine associated with inflammation, and is being investigated for its ability to reduce the overactive inflammatory immune response associated with COVID-19.

The preliminary Phase 2 results show great outcomes for patients who received a higher dose (400 milligrams) and fall within the “critical” respiratory illness category, which, for this trial, means they required mechanical ventilation or high-flow oxygenation or required treatment in an intensive care unit.

While the results were not matched with a lower dosage (200 milligrams) or for patients categorized as “severe” or those with multi-system organ dysfunction, the Phase 3 trial will continue in the more advanced “critical” group with the higher dose (400 mg) compared to placebo. Temple has enrolled more than 150 patients in this multi-site, interventional clinical trial. Dr. Criner is the principal investigator at TUH.

Inhaled nitric oxide: Temple University Hospital is utilizing the INOpulse system to provide precise, constant dosing of inhaled nitric oxide to patients who are highly suspected or confirmed to have COVID-19 and require supplemental oxygen.

Patients will be evaluated on an eight-point scale on Day 15. This is an investigational product that is available via the FDA’s emergency expanded access program. Nitric oxide is a vasodilator, which means it opens up blood vessels, thereby lowering blood pressure and increasing blood flow.

Jeffrey I. Stewart, MD, Associate Professor of Clinical Thoracic Medicine and Surgery at LKSOM, is the principal investigator at TUH.

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Online searches for unproven therapies for COVID-19

A new observational study by a group of scientists explores the rise in the public’s fear-driven interest in unproven therapies for COVID-19, particularly chloroquine and hydroxychloroquine, by tracking the internet searches relating to the purchase of drugs in news reports or publicized by public figures. They conclude: “Stay grounded in evidence and fight misinformation.” The research letter and accompanying editorial comment are published in the journal JAMA Internal Medicine.

Observational Study: Internet Searches for Unproven COVID-19 Therapies in the United States. Image Credit: Olya Gan / Shutterstock

The Rise of Miracle Cures

Since the onset of the COVID-19 pandemic, several therapies have been in the news, one after the other, some claiming to be “miracle cures” for the disease. Several drugs that seemed to show promise in vitro or preclinical trials have been touted by high-profile figures, triggering a wave of warnings from the scientific and pharmaceutical communities. However, no drug has yet been proven to be highly effective in treating the virus.

One such incident occurred recently when the high-profile entrepreneur Elon Musk and US President Donald Trump publicly promoted the use of chloroquine and hydroxychloroquine in mid-March. In Trump’s tweet, he said: “Hydroxychloroquine and azithromycin have “a real chance to be one of the biggest game-changers in the history of medicine.”

The endorsement came soon after a very preliminary letter to a scientific body describing promising outcome changes after the administration of these drugs to people with COVID-19.

A chloroquine-related fatality was reported soon after the public endorsements, which was attributed to unsupervised ingestion of chloroquine phosphate, a common aquarium cleaner.

Why Is This Trend Concerning?

Chloroquine is used in malaria prophylaxis, while hydroxychloroquine, a derivative of chloroquine with lower toxicity, is used to treat certain autoimmune diseases, like lupus and rheumatoid arthritis.

The researchers stated that the public endorsement of chloroquine and hydroxychloroquine were highly unsetting for three reasons – one, that they were only known to inhibit severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus responsible for COVID-19 disease, in vitro; two, both drugs had been known to cause toxic effects to the cardiovascular system, and lastly, that the name “chloroquine” could lead the public to confuse the drug with several commercial products, including aquarium cleaner.

Hydroxychloroquine causes a prolongation of the QT interval, a measurement made on an electrocardiogram used to assess some of the electrical properties of the heart, which can cause sudden cardiac death in a high-risk population. Shortages of these drugs could hit people with autoimmune arthritis. The poor could be the first to suffer from the unavailability of these drugs.

How Was the Study Done?

The study examined the percentage of Google searches targeting the sale of these items from the three biggest e-commerce companies in the US. Researchers monitored how often specific key terms, including buy, order, Amazon, eBay, or Walmart in combination with chloroquine or hydroxychloroquine, were searched for on Google. The proportion of such searches per 10 million total searches were examined using Google Trends and comscore.com.

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The study evaluated the daily searches from February 1, 2020, to March 29, 2020, and compared observed search volumes with expected search volumes. The time-period was split into two post-periods – one, all the days after March 16, the day when Musk endorsed the drugs, and two, all days after March 22, when news reports on chloroquine-related poisoning started airing.

Queries related to purchasing chloroquine showed only 542 estimated searches (per 10 million searches) on February 1, which rose to 3,052 estimated searches on March 16, when Musk first endorsed the drug, 7,506 estimated searches on March 22, after the first chloroquine-attributed fatality was reported, and a dip to 2,177 searches on March 29. Overall, the rise was on the order of 442%.

Similar trends were observed for hydroxychloroquine, with 494 estimated searches on February 1, 871 searches on March 16, 9,006 searches on March 22, and a drop to 3,625 searches at the end of the study on March 29. The overall increase in searches to buy hydroxychloroquine was an astonishing 1390%.

The first surge in searches came with Musk’s tweet endorsing the drugs, and the biggest came with Trump’s televised endorsements. The spike in interest led to nearly 100,000 more searches than expected for purchase of chloroquine and hydroxychloroquine, under normal circumstances. In total, 216,000 total searches were linked to the purchase of the drugs in a 14-day period.

This corresponds to almost 95,000 more searches than expected for either drug. Even after the media reported the first fatality, searches to buy the drugs remained high, at over 200%, and 1,170% above the expected demand.

The Adverse Health Effects of Such Promotions

The team stated that the findings showed that the unrestricted endorsement of unproven drug therapies by public figures – leading to high news coverage – could have severe consequences for the public.

“Endorsements can lead to unsupervised use of the products with dangerous consequences to the people who take them, and hoarding of these medications can result in shortages for those who require them for legitimate health reasons,” the paper warned.

It added that this problem was even more concerning because chloroquine-containing commercial products are available to the public through e-commerce sites, among other sources.

The Way Forward

Modern medicine is above all an evidence-based approach. The researchers stress that even when faced with a lack of options to treat the pandemic, clinicians should not “jettison the tenets of evidence-based medicine and the admonition to do no harm.”

Instead, they should speak about the evidence, enroll patients in randomized clinical trials, and take into account the impact of large-scale buying of these drugs on non-COVID-19 patients who desperately need them.

The paper recommended that measures be taken by “regulatory agencies and public-facing companies” to reduce the impact of such endorsements. For instance, the US Food and Drug Administration (FDA) should issue timely warnings against procuring “unapproved therapies unless prescribed.”

Another impactful avenue could be incorporating information about the unproven nature and potential hazards of these drugs into the educational website that online giant Google has already integrated into search results related to the COVID-19 epidemic.

The researchers also advised that retailers publish warnings or withhold products that have the potential for misuse in the face of the pandemic, citing eBay’s recent move to remove chloroquine sales from its website.

The researchers look forward to continued monitoring to further unveil the real impact of the public promotion of such untried avenues. For instance, there could be an estimate of the numbers of chloroquine-containing products sold.

The study concludes: “In times of public health crises, demand for unproven and potentially hazardous COVID-19 treatments is massively increased by endorsements. Public health leaders, regulatory agencies, media, and retailers must amplify accurate information.”

Journal references:

Liu, M. et al. (2020). Internet Searches for Unproven COVID-19 Therapies in the United States. JAMA Internal Medicine. Doi:10.1001/jamainternmed.2020.1764

DeJong, C., and Wachter, R. M. (2020). The Risks of Prescribing Hydroxychloroquine for Treatment of COVID-19—First, Do No Harm. JAMA Internal Medicine. Doi:10.1001/jamainternmed.2020.1853

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Data on Gilead drug raises hopes in pandemic fight, Fauci calls it ‘highly significant’

(Reuters) – The top U.S. infectious disease official said Gilead Sciences Inc’s experimental antiviral drug remdesivir will become the standard of care for COVID-19 after early results from a key clinical trial on Wednesday showed it helped patients recover more quickly from the illness caused by the coronavirus.

Preliminary results from a U.S. government trial showing that patients given remdesivir recovered 31% faster than those given a placebo, were hailed by Dr. Anthony Fauci as “highly significant.”

“This is really quite important,” Fauci told reporters at the White House, likening it to a moment in 1986 “when we were struggling for drugs for HIV and we had nothing.”

“This will be the standard of care,” he said, adding “the FDA … is working with Gilead to figure out mechanisms to make this easily available to those who need it.”

Gilead earlier on Wednesday said the trial was positive, and provided additional data suggesting remdesivir worked better when given earlier in the course of illness, sending its shares up more than 7%.

The closely watched drug, which is given by intravenous infusion to hospitalized patients, has moved markets in the past few weeks following the release of data from several studies that painted a mixed picture of its effectiveness, and Fauci cautioned that the latest data still needs to be analyzed.

Interest in Gilead’s drug has been high as there are currently no approved treatments or vaccines for COVID-19, and doctors are desperate for anything that might alter the course of the disease that attacks the lungs and can shut down other organs in severe cases, until a preventive vaccine emerges.

The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, said early results from its 1,063-patient trial show that hospitalized COVID-19 patients given remdesivir recovered in 11 days, compared to 15 days for patients given a placebo.

The study showed a trend toward better survival for remdesivir – 8% of patients given the drug died, compared with 11.6% in the placebo group – but the difference was not statistically significant so may not be due to Gilead’s drug.

“It is the first truly high-powered randomized placebo-controlled trial,” Fauci said.

Testing the drug against a placebo can give researchers a definitive answer on whether remdesivir is having an effect.

The trial’s lead researcher told Reuters on Friday that full results could come by mid-May.

‘GLIMMER OF HOPE’

Despite the excitement, Dr. Lawrence K. Altman, global fellow at The Wilson Center in Washington, DC, was not ready to celebrate the preliminary findings.

Gilead Sciences Inc pharmaceutical company is seen after they announced a Phase 3 Trial of the investigational antiviral drug Remdesivir in patients with severe coronavirus disease (COVID-19), during the outbreak of the coronavirus disease (COVID-19), in Oceanside, California, U.S., April 29, 2020. REUTERS/Mike Blake

The new data “offers a glimmer of hope” that remdesivir has an effect against COVID-19, but more scientific analysis is needed “comparing them to other studies of the drug that have shown mixed results,” he said in a statement.

Also on Wednesday, results were published by the Lancet medical journal of a trial conducted in China that concluded remdesivir failed to improve patients’ condition or reduce the pathogen’s presence in the bloodstream. Gilead said previously that those findings were inconclusive because the study was terminated early.

“The drug seems to have antiviral activity – how much is as yet unclear,” Dr. Daniel McQuillen, an infectious disease specialist at Lahey Hospital & Medical Center in Burlington, Massachusetts, told Reuters. “Seems likely that it might need use with another antiviral agent.”

Combination antiviral treatments have proven highly effective against other diseases.

Gilead also provided data on a study in severe COVID-19 patients it has conducted in dozens of medical centers, which does not have a placebo comparison but tested the drug under five-day and 10-day regimens.

In that 397-patient trial, Gilead said 62% of patients treated early with remdesivir were discharged from the hospital, compared with 49% of patients who were treated later in the course of the infection.

Gilead Chief Medical Officer Merdad Parsey in a statement said a five-day regimen, “could significantly expand the number of patients who could be treated with our current supply of remdesivir.”

Gilead Chief Executive Daniel O’Day earlier this month said the company was prepared to donate 1.5 million doses of remdesivir to hospitals dealing with severely ill patients. Regulatory approval of the drug would also clear the way for commercial sales.

FILE PHOTO: A Gilead Sciences, Inc. office is shown in Foster City, California, U.S. May 1, 2018. REUTERS/Stephen Lam/

Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses make copies of themselves and potentially overwhelm their host’s immune system.

The company is also studying the drug in patients with less severe COVID-19, but those results are not expected until later next month.

Additional reporting by Timothy Ahmann and Steve Holland in Washington, D.C. and Carl O’Donnell in New York; Editing by Bernadette Baum and Bill Berkrot

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Trump, Fauci see hope with Gilead’s drug in coronavirus fight

WASHINGTON (Reuters) – U.S. President Donald Trump on Wednesday greeted as good news reports that a Gilead Sciences Inc experimental antiviral drug might help fight the coronavirus, and infectious disease official Anthony Fauci said data shows it appears to help patients hospitalized with COVID-19.

Fauci, though, told reporters during a White House meeting with Trump that the data on the drug, remdesivir, needs to be further analyzed.

Some trial data for the drug will likely be announced later on Wednesday at a White House task force briefing, according to the National Institute of Allergy and Infectious Diseases.

Gilead on Wednesday said remdesivir helped improve outcomes for patients with COVID-19 in a clinical trial, and provided data suggesting it worked better when given earlier in the course of illness caused by the virus. The closely watched drug has moved markets in the past few weeks following release of partial information on several studies that painted a mixed picture of its effectiveness.

Former U.S. Food and Drug Administration chief Scott Gottlieb said on Twitter there was now enough data to support authorizing the drug for emergency use.

Fauci told reporters the data shows the drug had benefit in reducing the time to recover from the virus. While the data still must be peer-reviewed, he said it is opening the door to the possibility of a treatment.

There are currently no approved treatments or vaccines for the highly contagious novel coronavirus, but many approaches are being tried while awaiting an effective vaccine to prevent infection by the virus.

FILE PHOTO: President Donald Trump stands with Dr Anthony Fauci during an announcement of the Trump administration’s guidelines for “Opening Up America Again” during the daily coronavirus task force briefing at the White House in Washington, U.S., April 16, 2020. REUTERS/Leah Millis

Trump said it is a beginning that can be built upon.

Asked by Fox Business Network earlier if the results announced by Gilead were a positive for the economy, White House economic adviser Larry Kudlow said: “Has to be a tremendous positive.”

“These are confidence-inspiring things that will help open the economy and get folks back to work,” he said of any drug trials that show promise.

Reporting by Steve Holland and Susan Heavey; Additional reporting by Tim Ahmann; Writing by Lisa Lambert; Editing by Chizu Nomiyama and Bill Berkrot

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5 things to know about the Medicare appeals process

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If you disagree with a coverage or payment decision made by your Medicare health or prescription drug plan, you can file an appeal. Here are 5 key things to know about the Medicare appeals process:

  1. You can file an appeal if Medicare or your plan denies one of these:
    • Your request to get a health care service, item, or drug you think should be covered, provided, or continued.
    • Your request for payment for a health care service, item, or drug you already got.
    • Your request to change the amount you pay for a health care service, item or drug.
  2. If you decide to file an appeal:
    • Ask your doctor, health care provider, or supplier for any information that may help your case.
    • Contact your plan for information on your appeal rights.
  3. The Medicare appeals process has 5 levels. If you disagree with the decision made at any level, you can generally go to the next one. You’ll get instructions in each decision letter on how to move to the next level.
  4. You have the right to a fast appeals process if you think your Medicare-covered services are ending too soon. Ask your provider for more information on how to file a fast appeal.
  5. You might need to send us some documents. If you do:
    • Make sure your Medicare Number is on all of them.
    • Keep a copy of everything you send for your records.

Get help and more information on filing an appeal.

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The challenges of keeping young adults safe during the pandemic

Last month, after California Gov. Gavin Newsom ordered most of the state’s residents to stay home, I found myself under virtual house arrest with an uncomfortably large number of Gen Zers.

Somehow I had accumulated four of my children’s friends over the preceding months. I suppose some parents more hard-nosed than I would have sent them packing, but I didn’t have the heart — especially in the case of my daughter’s college roommate, who couldn’t get back to her family in Vietnam.

So, I had to convince six bored and frustrated 18- to 21-year-olds that, yes, they too could catch the coronavirus – that they needed to stop meeting their friends, wipe down everything they brought into the house and wash their hands more frequently than they had ever imagined.

The first two weeks were nerve-wracking. I cringed every time I heard the front door open or close, and when any of the kids returned home, I grilled them remorselessly.

The day after a house meeting in which I laid down the law, I found my son, Oliver, 21, inside his cramped music studio in the back of the house with a kid I’d never seen before. And that night, I saw one of our extra-familial housemates in a car parked out front, sharing a mind-altering substance with a young man who used to visit in the pre-pandemic era.

If I’ve been neurotically vigilant, it’s because the stakes are high: I’ve got asthma and Oliver has rheumatoid arthritis, making us potentially more vulnerable to the ravages of the virus.

But even as I play the role of enforcer, I recognize that these kids are as anxious and worried as I am.

My daughter, Caroline, 18, is filled with sadness and despair, feelings she had largely overcome after going away to college last fall. She recently started doing telephone sessions with her old therapist. Oliver has begun therapy — remotely, for now – after dismissing it as pointless for the past several years.

A study released this month by Mental Health America, an advocacy and direct service organization in Alexandria, Virginia, shows that people under age 25 are the most severely affected by a rise in anxiety and depression linked to social isolation and the fear of contracting COVID-19.

That is not surprising, even though the virus has proved far deadlier for seniors. Mental health problems were already rising sharply among teens and young adults before the pandemic. Now their futures are on hold, they can’t be with their friends, their college campuses are shuttered, their jobs are evaporating — and a scary virus makes some wonder if they even want those jobs.

Paul Gionfriddo, Mental Health America’s CEO, says parents should be attentive even to subtle changes in their kids’ behavior or routine. “Understand that the first symptoms are not usually external ones,” Gionfriddo says. “Maybe their sleep patterns change, or they’re eating less, or maybe they are distracted.”

If your teens or young adults are in distress, they can screen themselves for anxiety or depression by visiting www.mhascreening.org. They will get a customized result along with resources that include reading material, videos and referrals to treatment or online communities.

The Child Mind Institute (www.childmind.org or 212-308-3118) offers a range of resources, including counseling sessions by phone. If your young person needs emotional support, or just to vent to an empathetic peer, they can call a “warmline.” For a list of numbers by state, check www.warmline.org.

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Caroline’s case is probably typical of college kids. She moved back home from San Francisco last month after her university urged students to leave the dorms. Her stuff is stranded up there, and we have no idea when we’ll be able to reclaim it. Meanwhile, she has been planning to share an off-campus apartment starting in August with four of her friends from the dorm. We can get attractive terms if we sign the lease by April 30 – but what if school doesn’t reopen in the fall?

For Oliver, who’s been living with me all along, the big challenges are a lack of autonomy, a need for money and cabin fever. Those stressors got the best of him recently, and he started doing sorties for a food delivery service. Of course, it makes me crazy with worry every time he goes out, and when he returns home I’m in his face: “Did you wear a mask and gloves? Did you keep your distance? Wash your hands!”

But what can I do, short of chaining him to the water heater? And if going out — and getting some cash in his pocket – makes him feel better, that can’t be all bad (unless he catches the virus).

If your kid dares to work outside the house, and you dare let him, several industries are hiring — particularly grocery stores, pharmacies and home delivery and food services. Child care for parents who have to work is also in demand, so your fearless teen might want to ask around the neighborhood.

Volunteering – again, if they dare — is another good way for young people to feel independent and useful. In every community, there are vulnerable seniors who need somebody to shop for them or deliver meals to their homes. You can use www.nextdoor.com, a local networking app, to find out if any neighbors need help.

Food banks are in great need of volunteers right now. To find a food bank near you, go to www.feedingamerica.org. Blood donations are also needed. Older teens and young adults can arrange to donate by contacting the American Red Cross (www.redcross.org). For a list of creative ways to help, check out Youth Service America (www.ysa.org).

While the kids are inside the house, which in my case is still most of the time, put them to work. “Anxiety loves idle time, and when we don’t have a lot to do, our brain starts thinking the worst thoughts,” says Yesenia Marroquin, a psychologist at Children’s Hospital of Philadelphia.

I’ve harnessed the able bodies of my young charges for household chores. A few weekends ago, I decreed a spring cleaning. They organized themselves with surprising alacrity to weed the backyard, sweep and mop the floors, clean the stove and haul out volumes of trash.

Considering the circumstances, the house is looking pretty darn good these days.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Kaiser Health NewsThis article was reprinted from khn.org with permission from the Henry J. Kaiser Family Foundation. Kaiser Health News, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health care policy research organization unaffiliated with Kaiser Permanente.

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C-Path receives EMA’s letter of support to facilitate the diagnoses of type 1 diabetes

The Critical Path Institute (C-Path) today announced that its Type 1 Diabetes (T1D) Consortium has received a letter of support from the European Medicines Agency (EMA) to facilitate the development and validation of the proposed regulatory qualification of pancreatic islet autoantibodies commonly used in clinical practice to diagnose T1D: insulin autoantibodies, glutamic acid decarboxylase 65, and insulinoma antigen-2 autoantibodies as enrichment biomarkers for T1D clinical trials.

In their response to the T1D Consortium Letter of Intent (LOI) and Briefing Package, the EMA stated, “[Therapies that preserve endogenous β-cell function and can prevent, halt or slow T1D disease progression in a clinically meaningful way would constitute a significant advancement in T1D care.

If successful, the quantitative tools proposed by this Consortium have the potential to facilitate the streamlined design, execution, and review of clinical trials targeting this goal.].”

By the year 2050, the number of people diagnosed with T1D in the U.S. is projected to quadruple from an estimated 1.6 million in 2020 to 5 million in 2050.

The ability to screen for subjects with early stages of T1D prior to the appearance of clinical symptoms is a valuable opportunity to potentially delay, and ultimately prevent, symptomatic T1D.

The islet autoantibodies provide a means to identify patients at risk of progressing to a clinical diagnosis of T1D.

C-Path’s T1D Consortium will achieve the regulatory qualification of the islet autoantibodies currently used in clinical practice to diagnose T1D by employing the resources of all its members and engaging with regulatory agencies at each step of the process with funding and input from he Leona M. and Harry B. Helmsley Charitable Trust, Janssen Research & Development, LLC, JDRF International, Novo Nordisk A/S, and Provention Bio.

The Leona M. and Harry B. Helmsley Charitable Trust, Janssen Research & Development, LLC, JDRF International, Novo Nordisk A/S, and Provention Bio.

JDRF is pleased the T1DC received a letter of support from EMA. This is an example of collaboration between regulators and researchers, in the public and private sectors, working together to accelerate delivery of therapies into the hands of patients.”

Jessica Dunne, Ph.D., Senior Director, JDRF, and Co-Director, T1DC

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This model-based qualification, will provide a tool endorsed by both the EMA and U.S. Food and Drug Administration (FDA) that utilizes islet autoantibody status, along with other relevant patient features, to identify and select patients with a likelihood of progressing to a T1D clinical diagnosis.

This regulatory endorsement will provide sponsors with the confidence to use islet autoantibodies in the optimization of clinical trials evaluating novel therapies focused on the delay and/or prevent T1D.

“We are delighted that the EMA is strongly supporting the development of quantitative tools that can accelerate drug development in T1D,” said C-Path’s Executive Director of the T1D Consortium Inish O’Doherty, PhD. “

This work has been enabled through the collaboration of the T1D community and the sharing of patient level data. We’re excited to move forward with this important project which will help pave the way for forthcoming therapies with the ability to treat early stages of T1D and delay or prevent the clinical, currently irreversible, stage of the disease.”

The consortium is currently working on the next regulatory milestones: the execution of the modeling analysis plan to inform the full Briefing Package for submission to the EMA and development of a Qualification Plan for submission to the FDA.

Source:

Critical Path Institute

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Lawmaker Pushing Mental Health Reform: It’s ‘More Needed Than Ever’

SACRAMENTO — During the first week of school closures in San Jose, state Sen. Jim Beall’s office received more than a dozen phone calls from distressed parents and caregivers.

The problem: They couldn’t get free lunches because school district rules required children be present to receive a meal. A grandmother caring for at least seven children couldn’t fit them all in her car. One parent had a sick child who needed to stay at home, and another was unable to bring her child, who has disabilities, to wait in the drive-thru lunch line.

Beall’s staff helped resolve their predicaments by calling the school districts and the schools to mediate. And while lunch line challenges alone might seem minor, Californians are contending with unexpected unemployment, social isolation and anxiety about the virus. All of those added stressors could lead to — or exacerbate — mental health problems as Californians cope with COVID-19, said the Democrat from San Jose.

As the chair of the Senate Select Committee on Mental Health, Beall is one of the most outspoken advocates for mental health in the state legislature. He believes Californians’ mental health needs are more acute than ever and ought to be addressed — even in the face of deep state budget cuts.

“He’s been a unique voice and champion who is not afraid to take an unpopular stand because it’s the right thing to do,” said Michelle Cabrera, executive director of the County Behavioral Health Directors Association of California. “We are in a precarious moment right now.”

But whether state lawmakers will have the appetite — or funding — to enact mental health reform this year is unclear. The focus is unquestionably on responding to the novel coronavirus.

Gov. Gavin Newsom is scaling back his own plans to expand health care. His budget advisers told lawmakers on April 16 the state will spend at least $7 billion to respond to the pandemic. And state Senate President Pro Tem Toni Atkins has asked lawmakers to focus on bills related to the outbreak.

Beall talked to California Healthline’s Samantha Young about why he believes mental health care must remain a priority. He and state Sen. Scott Wiener (D-San Francisco) have said they intend to pursue companion bills creating state parity laws, which would require health plans in California to provide mental health care benefits on par with medical benefits. Their previous attempts have failed, in part because of opposition from the health insurance industry.

Beall also wants the state to certify mental health peer-support specialists, people who rely on their own experiences to help others in treatment.

This interview has been edited for length and clarity.

Q: The state’s response to the coronavirus has taken center stage. Are the mental health reforms you and others have advocated on hold for the year?

I think they are more needed than ever. People are very vulnerable under this kind of stress. Senior isolation is a big problem, and it’s going to get worse and worse. The economy is distressed, people losing jobs causes a huge amount of stress, not being able to pay the rent, PTSD kicks in with veterans.

Q: How do you pay for mental health programs when there is so much competition in the budget to respond to the coronavirus?

Counties have Mental Health Services Act reserves to support existing services during a crisis like this pandemic. They are also receiving state and federal emergency funds. But it’s never enough. We have to find a way to shift our priorities.

The homeless mentally ill population is highly susceptible to the virus. Prioritizing mental health spending is key to the success of a whole community.

Q: What are your priorities on mental health care?

Mental health has always been a segregated element of health care. It should be treated just like any other part of your body in terms of the health care system. It isn’t. We’ve been trained in our minds to think of mental health as a social failing, not a real, legitimate health care issue. In fact, mental health is just like any other disease. If you don’t treat it, it gets worse and worse.

So I believe mental health parity is very important because of that. And I have a philosophical belief that unless we require parity, it won’t happen.

Q: The governor said the state can enforce the existing federal mental health parity law. Can you explain why you believe a state law is needed?

Right now with the staff the state has, they check health plans every three years. We want them to check every year and to do more vigorous checks. Real parity is how long it takes to get an appointment. How many months do I have to wait when they give me a referral to a doctor? Is the doctor able to take patients or is it just a doctor on a list?

Q: Your parity bill focuses on the treatment of substance abuse. Why is that an area that needs focus?

That’s one of the main lagging things with parity. Substance abuse, just a decade ago, was thought of by most people as a human failing, not a medical issue. A lot of people still think that way.

Now, if a doctor sees a patient and the patient has addiction, the doctor says, “You know you’re addicted to opioids and I’ve got to give you this prescription because we have to deal with your addiction. But I can’t really do it right now because I have to submit the request to the insurance company and have them review and approve your medication.” That can take a couple weeks, and in some cases they overrule it. What this bill says is if a doctor says that you’re in need of care for a medical addiction and the doctor prescribes medication, the health plan cannot stop the doctor from prescribing the medication for you.

Q: Why is it in the state’s interest to require insurance companies to cover mental health services equally?

When the insurance companies don’t provide mental health services, people get sick. You know what happens when they get sick? They lose their jobs. When they lose their jobs, guess what happens. When they’re unemployed, they go on Medi-Cal.

Not having good health insurance programs with mental health care costs the state a lot of money when people end up on the Medi-Cal system.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

Related Topics

California Health Care Costs Insurance Mental Health Public Health States

California Legislature COVID-19 Homeless Substance Abuse

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