Health & Fit: State attorneys general: Use federal law to lower cost, increase supply of COVID-19 drug remdesivir

Firm behind coronavirus drug faces questions over pricing, potentially cheaper option

  Firm behind coronavirus drug faces questions over pricing, potentially cheaper option Executives with Gilead Sciences are now facing harsh criticism over the initial business decisions they’ve made in the midst of a pandemic. © Ulrich Perrey/Pool via Reuters, FILE In this April 8, 2020, file photo, two ampules of Remdesivir are pictured during a news conference at the University Hospital Eppendorf in Hamburg, Germany, as the spread of COVID-19 continues.

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.

The world desperately needs coronavirus treatments, even if we get a vaccine. These 9 candidates are our best hope so far.

  The world desperately needs coronavirus treatments, even if we get a vaccine. These 9 candidates are our best hope so far. Trainer Lindsey Clayton shows you a yoga-inspired core workout.

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.

Start the day smarter. Get all the news you need in your inbox each morning.

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

  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

  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

  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.

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

  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.


Video: FDA commissioner: ‘We will not cut corners’ on a coronavirus vaccine (TODAY)

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.

See also