A bipartisan coalition of attorneys general asked the U.S. Department of Health and Human Services on Tuesday to invoke a federal patent law to increase supply and lower prices of the COVID-19 drug remdesivir.
The group, led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry, said HHS, the Food and Drug Administration and National Institutes of Health should license Gilead Sciences’ antiviral to other manufacturers to ease potential shortages and lower the drug's price.
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Gilead charges $3,120 for a five-day course for patients with private insurance, Medicare or Medicaid. Remdesivir supplies are "dangerously limited," and the price will "impede access to treatment" and strain state budgets, the attorneys general wrote in a letter to the federal agencies.
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The 1980 Bayh-Dole Act allows federal agencies to retain patent rights if a drug company charges too much or fails to reasonably “alleviate health or safety needs” of consumers, the letter says. If federal agencies refuse the request, the group wants "march-in" rights to be assigned to states.
Trump is being treated for COVID-19 with drug developed for Ebola
President Donald Trump's physician confirmed Friday night he is being treated for COVID-19 with remdesivir at Walter Reed Military Medical Center.For patients hospitalized with COVID-19, the FDA has given emergency-use of the intravenous antiviral drug sold by Gilead Sciences Inc, which has been shown to shorten hospital stays.
"We cannot afford to leave the supply of this critical medication to chance and the whims of the marketplace when it was funded in part by taxpayer dollars," said Becerra, a Democrat.
Landry, a Republican, said Gilead's pricing is not reasonable and the drug company has not met the public's health and safety needs.
"Our bipartisan coalition is calling on the federal government to exercise its rights to help increase the supply of remdesivir and lower its price," he said.
The letter is signed by attorneys general of 31 states: California, Louisiana, Alaska, Connecticut, Delaware, Hawaii, Idaho, Illinois, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Utah, Vermont, Virginia and Washington. Attorneys general for the District of Columbia, American Samoa and Guam also signed.
Doctors say giving Trump the antiviral drug remdesivir is a sign his infection may be serious — even though the timeline is still unclear
Trump received an IV infusion of the antiviral drug remdesivir on Friday. The therapy is typically reserved for severe cases."At this time, the team and I are extremely happy with the progress the president has made," White House physician Sean Conley said on Saturday.
The nonprofit Institute for Clinical and Economic Review suggested remdesivir should be priced from $2,520 to $2,800 per course. The price takes into account the benefit of the inexpensive steroid dexamethasone, which showed in an early study to be a lifesaving treatment for seriously ill COVID-19 patients.
Remedsivir, an antiviral developed to treat Ebola, benefited from public funding, including a $30 million NIH-funded clinical trial this year, the letter says.
Gilead plans to make 2 million treatment courses available by the end of this year, which the attorneys general said isn't enough to meet the needs of the nation's coronavirus patients. As of Tuesday, more than 4.7 million Americans have been diagnosed with COVID-19, and almost 156,000 have died, according to Johns Hopkins University.
A study in JAMA Internal Medicine estimated COVID-19 cases ranged from six to 24 times higher than official counts. The large federal study relied on antibody testing data in 10 cities to gauge whether individuals previously were infected with SARS-CoV-2, the virus that causes COVID-19. Antibody tests are different from diagnostic tests, which detect whether someone is currently infected.
Remdesivir, the only antiviral authorized for COVID-19 in US, does not improve chances of survival, a massive WHO study found
Gilead's antiviral drug remdesivir, taken by US President Donald Trump, doesn't stop COVID-19 patients dying or shorten hospital stays, the WHO found.The WHO's Solidarity trial, one of the largest ongoing studies of COVID-19 drugs, examined the effects of remdesivir and three other potential coronavirus treatments in more than 11,000 patients in 30 countries.
In July, Gilead said a late-stage clinical trial of nearly 400 patients showed 74% of patients given remdesivir recovered by their 14th day of hospitalization compared with 59% of those who did not get the drug. Patients who received remdesivir had lower mortality rates than patients who did not get the drug.
Hundreds of Muslim pilgrims circle the Kaaba, the cubic building at the Grand Mosque, as they observe social distancing to protect themselves against the coronavirus, in the Muslim holy city of Mecca, Saudi Arabia, Wednesday, July 29, 2020 During the first rites of hajj, Muslims circle the Kaaba counter-clockwise seven times while reciting supplications to God, then walk between two hills where Ibrahim's wife, Hagar, is believed to have run as she searched for water for her dying son before God brought forth a well that runs to this day.
A handout picture released by the Saudi ministry of media shows a small number of pilgrims circumambulating around the Kaaba, Islam's holiest shrine, at the center of the Grand Mosque in the holy city of Mecca in Saudi Arabia at the start of the annual Muslim Hajj pilgrimage on July 29, 2020.
Muslim worshippers, distanced safely from each other and clad in face masks due to the COVID-19 coronavirus pandemic, attend a sermon during the Friday prayers at a mosque in Kuwait City on July 17, 2020.
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Ultra-Orthodox Jewish men pray in divided sections which allow a maximum of twenty worshipers in line with government measures to help stop the spread of the coronavirus, at the Western Wall, the holiest site where Jews can pray, in Jerusalem's Old City, Thursday, July 16, 2020.
Attendees are sat socially distanced as Bishop of Manchester David Walker (C) leads a memorial service for the victims of the novel coronavirus at Manchester Cathedral in Manchester, northwest England, on July 16, 2020.
Faithful attend a drive-in mass at the Silvio Pettirossi International Airport parking in Luque, near the Paraguayan capital, on June 28, 2020, amid the COVID-19 novel coronavirus pandemic. The pandemic has killed at least 498,779 people worldwide since it surfaced in China late last year, according to an AFP tally at 0930 GMT on Sunday based on official sources.
Faithful sit on their two-wheelers and pray as they attend a drive-in mass in an open area of Bethel AG Church as part of maintaining social distancing to prevent the spread of coronavirus in Bengaluru, India, Sunday, June 21, 2020. India is the fourth hardest-hit country by the COVID-19 pandemic in the world after the U.S., Russia and Brazil.
Congregation members wear face masks as they receive communion from the Rev. Jan Schmidt during a morning Mass at the Cathedral of St. Peter in Chains Catholic Church in downtown Cincinnati on May 25. The Memorial Day Mass was the first inside the church since the state-mandated stay-home order in March.
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Pastor Billy Jones speaks to his congregation from a repurposed potato truck during a drive-in Sunday church service at Dunseverick Baptist Church on May 24, 2020 in Bushmills, Northern Ireland. The Northern Ireland power sharing government has relaxed some of the Covid-19 lockdown restrictions which now permits drive-in church and cinema services.
Margaret Cruz, Sophia Perez and Edwin Perez pray together after returning to Potential Church as it opened on May 24, 2020 in Cooper City, Fla. The church reopened it's doors to a select group of people with safety measures in place after hearing President Donald Trump announcing on Friday that governors around the country should allow houses of worship to reopen.
Pastor Bobby Contreras, center, leads his church in music churchgoers, using social distancing practices, return to in-person services at Alamo Heights Baptist Church, Sunday, May 10, 2020, in San Antonio. Texas' stay-at-home orders due to the COVID-19 pandemic have expired and Texas Gov. Greg Abbott has eased restrictions on many businesses, state parks, churches and places of worship.
Father Bryan Timby of Our Lady of Sorrows Catholic Church in Memphis, Tenn. on Good Friday April 10, 2020 as the church holds confessionals with marked, spaced flooring for social distancing and plans for a virtual Sunday Easter service. "The foundation of any faith is hope, and a brighter tomorrow. We don't know what it is going to look like, we just know it is going to be better than we have today," said Timby.
An altar boy stands in the central aisle of the Basilica of Neuchatel which pews display the portraits of 400 parishioners unable to attend the mass due to the COVID-19 outbreak, caused by the novel coronavirus, on May 3, 2020. Switzerland started to ease the restrictions imposed to control the COVID-19 pandemic but masses are still forbidden.
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The Ariff family prays at their Phoenix home on the first day of Ramadan. Due to COVID-19, the family is praying at their home instead of going to their mosque.
Deacon Larry Smith leads a procession, including the Very Rev. Christopher A. House, Deacon Scott Keen, Springfield Bishop Thomas Paprocki and Fr. Dominic Rankin, into the Cathedral of the Immaculate Conception in Springfield, Ill., that is closed to and empty of parishoners due to COVID-19 pandemic precautions during a livestreamed Easter service Sunday April 12, 2020.
Congregants celebrate Easter during a "drive-up" church service at the Family Worship Center on April 12, 2020 in Beloit, Wisconsin. Wisconsin Gov. Tony Evers authorized churches to hold drive-up services, despite the shelter-in-place order issued to curtail the spread of the coronavirus (COVID-19), as long as congregants avoided person-to-person contact.
Pastor Brian Hill in the parking lot of the First Baptist Church Corpus Christi leads a drive-in Easter service on Sunday, April 12, 2020. First Baptist Church Corpus Christi had not held an in-person serves since Nueces County issued a stay at home order do to the COVID-19 outbreak.
A parishioner of the First Baptist Church Corpus Christi holds a bible as she prays during a drive-in Easter service lead by Pastor Brian Hill on Sunday, April 12, 2020. First Baptist Church Corpus Christi had not held an in-person serves since Nueces County issued a stay at home order do to the COVID-19 outbreak.
Bishop Richard Umbers is seen live-streaming during 'The Celebration of the Passion of The Lord' service at St Paul of the Cross Church on April 10, 2020 in Dulwich Hill, Australia. With religious services and congregations banned due to COVID-19 restrictions, churches are adapting their services to connect with parishioners online through email, website, live streamings and service pre-recordings.\
Holy water is out while hand sanitiszer is installed as part of an effort to prevent the spread of COVID-19 coronavirus at The Holy Redeemer Church during the Good Friday service in Bangkok on April 10, 2020.
Rabbi Dean Shapiro, left, of Temple Emanuel in Tempe, angles his laptop so others online can see their Seder plate as Shapiro's partner, Haim Ainsworth and their son, Jacob Shapiro-Ainsworth, 11, look on, as they participate in an online Seder during the first night of the Jewish holiday of Passover at their home in Tempe Ariz. on April 8, 2020. The Seder which included members from Temple Emanuel was being held online because of the coronavirus pandemic.
The Rev. David Clark prays Wednesday, April 8, 2020, at Boston Baptist Church in Memphis. Religious leaders prayed in unison from their houses of worship, and invited all people of faith to join them in prayer from wherever they were. Clark is a member of Boston Baptist Church, and serves as the pastor at True Light Baptist Church in Blytheville, Ark. The Rev. Ydell Ishmon, pastor of Boston Baptist Church, said religious leaders in the tri-state area will continue praying in unison on Wednesdays at noon until the threat of COVID-19 subsides and a more traditional normalcy resumes.
A Catholic priest sits on an empty bench due to social distancing guidelines during the coronavirus outbreak inside the Jesus de Medinaceli church on Palm Sunday in Madrid, Spain, Sunday, April 5, 2020.
At the end of worship service, members wave goodbye to each other rather than hug or shake hands while as they practice social distancing in the pews at the Union Springs Baptist Church on Sunday, March 29, 2020, in Rutledge, Ga. Pastor Robert L. Terrell spoke to the congregation on how to worship while keeping social distance and two nurses met worshipers as they entered the church taking temperatures to keep the congregation healthy.
A small staff streams an online service without church goers present at Alamo Height Baptist Church in San Antonio, Texas, Sunday, March 29, 2020. Due to the coronavirus outbreak churches in the area are closed and many are televising services or holding services online.
The Rev. Lou Ann Jones, right, leads prayer as eight people spread out around the flagpole at St. John's Blymire's United Church Of Christ near Dallastown, Pa. on Wednesday March 16, 2020 and prayed for the community, nurses and doctors, government leaders and many others during the turmoil from the coronavirus pandemic.
Fran DiBiasio sits alone in Our Lady of Grace Catholic Church as Rev. Peter Gower celebrates Mass from the front door as worshippers listen over the radio from their cars in the parking lot, Sunday, March 29, 2020, in Johnston, R.I.
Reverend Peter Gower walks out to the parking lot to spread incense to worshippers sitting in their cars during a Mass he holds from the front door of Our Lady of Grace Catholic Church, Sunday, March 29, 2020, in Johnston, R.I.
In response to the coronavirus outbreak, pastor Rex Simmons, of Living Grace Baptist Church in Piedmont, S. C. decided to have a drive-in style service so congregants could sit in their vehicles. Sunday, March 22, 2020.
Brian Harris prays Sunday, March 22, 2020, while live streaming the Mississippi Boulevard Christian Church service at his home in Collierville, Tenn. Harris, who has been a congregant of the church for more than 35 years, said the COVID-19 outbreak is the only time he can remember not being able to worship in his church. "I know we're a community of faith. We're a community of believers," Harris said. "Here in the south, we're huggers. We love on people. Although we physically can't hug and we're encouraged not to do that, still love and check on people."
Cars line the entrance to St. Joseph Church. Parishioners drove to the covered entrance of St. Joseph's Church, walked to the windows with Deacon Bill Shea on the left and and Father Bob Grattaroti on the right, for blessings, on Sunday, March 22, 2020.
The Humphries family and their dog, are blessed by Deacon Bill Shea. Parishioners drove to the covered entrance to St. Joseph Church for a blessing on Sunday, March 22, 2020. The parishioners parked their cars and walked up to the windows to receive their blessings.
Reverend Allan Boyer of First Bethel AME Church in Paterson, N.J. conducts a service in the church's parking lot, keeping chairs six feet apart in accordance with social distancing practice recommendations from the CDC to help prevent the spread of the coronavirus on March 22, 2020.
First Bethel AME Church in Paterson conducts a worship service in the church's parking lot, keeping chairs six feet apart in accordance with social distancing practice recommendations from the CDC on March 22, 2020.
Hunter Hilburn of Anderson watches from a balcony couch at Capstone Church, a live online broadcast of his pastor Rev. David Barfield's sermon in Anderson, S.C. Sunday, March 22, 2020. The church usually has 200 in attendance but with many practicing social distancing, the online broadcast helps deliver the service. Hilburn, who usually runs the lighting at the church, didn't have to while his mother helped with the online production.
Andrew Cronic stands by the video camera for a live online broadcast of Capstone Church praise band with Lynneth Renberg (keyboard), Adam Renberg (guitar), and Jacob Barfield (bass) during worship in the nearly empty church sanctuary in Anderson, S.C. Sunday, March 22, 2020.
Isabelle Rector, 14, daughter of lead pastor Kevin Rector, welcomes congregants before a parking lot service at Gallatin First Church of the Nazarene in Gallatin, Tenn., Sunday, March 22, 2020. The church hosted the drive-in service in light of the COVID-19 pandemic, allowing congregants to safely watch from their parked cars, listening to the service via radio.
Isabelle Rector, right, 14, daughter of lead pastor Kevin Rector, collects offerings with a butterfly net after a parking lot service at Gallatin First Church of the Nazarene in Gallatin, Tenn., Sunday, March 22, 2020.
This article originally appeared on USA TODAY: State attorneys general: Use federal law to lower cost, increase supply of COVID-19 drug remdesivir
Remdesivir has 'no meaningful impact' on COVID-19 survival, huge study finds
Patients given the drug did not show a significant decrease in mortality, risk of ventilation or time in the hospital.The Food and Drug Administration, in May, authorized remdesivir to be used in an emergency to treat COVID-19, after a large clinical trial suggested that the drug reduces the time it takes for COVID-19 patients to be discharged from the hospital, as compared with a placebo treatment, Live Science previously reported. As of August, the drug has been authorized for use in all patients hospitalized with COVID-19, not only those on supplemental oxygen, The New York Times reported. Thousands of U.S. patients have received the treatment, including the president.
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The FDA approved remdesivir to treat Covid-19. Scientists are questioning the evidence. .
Researchers are concerned the FDA’s first full approval of a Covid-19 drug doesn’t have enough research behind it.Developed by Gilead Sciences and marketed under the brand name Veklury, remdesivir previously received emergency use authorization from the FDA in May, which allowed it to be used to treat patients with severe Covid-19. In August, the FDA relaxed its guidelines to allow the drug to be used in less serious cases. President Donald Trump also took the drug as part of his treatment when he was diagnosed with Covid-19 earlier in October.