Drug maker Amneal Pharmaceuticals is donating 400,00 tablets of the unproven malaria drug that President Donald Trump has dubbed a ‘gift from God’ to Louisiana to help fight the state’s coronavirus crisis, the state attorney general said Tuesday.
The drug, hydroxychloroquine, was given emergency FDA approval Monday, and the Trump administration plans to distribute millions of doses of for experimental use in coronavirus patients.
It has shown promise in countries like China, South Korea and France to treat COVID-19, but US coronavirus task force member and infectious disease expert Dr Anthony Fauci has warned the evidence it works is only ‘anecdotal.’
US trials of hydroxychloroquine are underway in New York and Minnesota and will now begin at Louisiana’s Tulane University, a move that state Attorney General Jeff Landry called ‘one step toward trying to find treatments and cures for this epidemic.’
Amneal is donating 400,000 doses hydroxychloroquine, sold in under the brand name Plaquenil by Sanofi, to Louisiana in the hopes that the drug will help combat coronavirus there
Louisiana Attorney General Jeff Landry announced the donation to Louisiana and called it ‘one step’ toward fighting coronavirus’s impact on his state
‘Right now there are no silver bullets. We must remain vigilant against this virus.’
Louisiana has been particularly hard-hit by coronavirus.
More than 4,000 people there are infected and 185 have died.
At least 28 nursing homes across the state have reported clusters of the disease and some 1,480 people in New Orleans are sick.
Louisiana has a large population with multiple chronic conditions and is considered part of both the ‘stroke belt’ and the ‘diabetes belt’ by the Centers for Disease Control and Prevention (CDC).
Both heart conditions – like those that lead to stroke – and diabetes are underlying health conditions that put people at greater risk for contracting coronavirus and becoming life-threateningly ill from the virus, as does obesity.
And Louisiana is the third most obese state in the nation (falling behind only Iowa and Alabama), with more than a third of its population weighing in with BMIs of 30 or higher.
Hundreds of people in Louisiana are already hospitalized with coronavirus.
Currently, there are no proven treatments for the virus, and the most severely ill patients have to be put on ventilators to keep them breathing as the infection attacks their lungs.
The state has shut down its drive through testing and more than 4,000 in the state have coronavirus
US coronavirus deaths have climbed past 3,000. Doctors hope hydroxychloroquine can help save the sickest COVID-19 patients
Nearly 200 people in Louisiana have died of coronavirus and clusters have emerged at nursing homes
The hope for the Trump administration and doctors is that hydroxychloroquine can combat the dangerous lung inflammation from pneumonia triggered by coronavirus and help alleviate some of the pressure on health systems amid a shortage of ventilators.
At the request of New York Governor Andrew Cuomo, the state was the first to receive doses of hydroxychloroquine from the federal government and clinical trials of the drug began there last week.
Amneal doesn’t make Market Watch’s list of the top 10 producers of the drug, but the company has nonetheless donated a significant load of the medication to Louisiana, where hospital bed shortages are expected in the coming weeks, particularly in New Orleans.
Some companies that make hydroxychloroquine were already reporting shortages of it last week, after Trump praised it as a possible ‘game changer’ in the coronavirus pandemic.
It is also a treatment for inflammatory autoimmune diseases like lupus and rheumatoid arthritis, and patients have complained they were struggling to get their medications.
Still, Amneal has dedicated part of its stock of the drugs to the state of Louisiana.
‘On behalf of Louisiana, I want to thank Amneal for this generous donation,’ said Landry.
‘It is important we all work together to help solve the COVID-19 Coronavirus crisis. We must come together as Louisianans and as Americans.
‘This donation from Amneal demonstrates their strong effort to be a good corporate citizen in our Nation.’
He added that social distancing still needs to be practiced to keep the disease’s spread at bay.
Louisiana has emerged as a hotspot for coronavirus, although cases have now been diagnosed in every state in the nation
Cases of COVID-19 have risen sharply in the US with a steep upturn this month to bring the national total to 164,671 cases nationwide
HOW THE ANTI-MALARIA DRUG IS USED ABROAD TO TREAT CORONAVIRUS
A version of the drug the US is now testing, chloronoquine, is already part of the recommended course of treatment in China.
It is one of five antivirals included in the 7th edition of the countries guidance on caring for coronavirus patients.
Scientists there have reported that it alleviated symptoms, shorten the duration of the illness, and patients who take it seem to break their fevers earlier.
Chloroquine is also being used widely in South Korea, where officials have gone so far as to say it has ‘a certain curative effect’ and ‘fairly good efficacy’ in coronavirus patients.
The World Health Organization has also launched a large-scale trial of a number of potential coronavirus treatments, including chloroquine.
It will be tested in patients in Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland and Thailand and perhaps others. The US is not slated for inclusion.
Already in France, the drug has been tested in 36 patients.
Hydroxychloroquine, the form of the drug that will now be used ‘compassionately’ in the US, was given to 24 out of 36 trial participants. Half of them cleared the infection entirely, according to an early announcement of the results on Wednesday.
Amneal’s co-CEOs, Chirag and Chintu Patel, said: ‘We are working with urgency to assist the hardest hit states and hospitals around the country to benefit as many patients as possible during this critical time.’
South Korea’s COVID-19 task force went so far as to say that studies on the drug demonstrated it had ‘certain curative effect’ and ‘fairly good efficacy.’
Patients treated with hydroxychloroquine improved more quickly and broke their fevers earlier than those who did not receive the drug.
The drug is also included in China’s treatment guidelines for COVID-19 – described there as ‘chloroquine phosphate – for use in patients between 18 and 65.
It is one of five antivirals suggested in the 7th edition of China’s treatment plan, which also cautions the drug should not be given to patients with heart disease, as it has potential cardiac side effects.
After promising test results in petri dish studies, some Chinese scientists came to believe that hydroxychloroquine was powerful against viruses in general, and for COVID-19 in particular.
‘Previous studies have shown that chloroquine phosphate (chloroquine) had a wide range of antiviral effects, including anti-coronavirus,’ wrote scientists from China’s Guangdong province.
‘Here we found that treating the patients diagnosed as novel coronavirus pneumonia with chloroquine might improve the success rate of treatment, shorten hospital stay and improve patient outcome.’
Developed during World War II and approved by the the Food and Drug Administration (FDA) in 1955, hydroxychloroquine cured about half of the 24 patients who received the drug (there were 36 included) in a French clinical trial published yesterday.
Landry warned that social distancing is still necessary. Mega churches in Louisiana have continued to hold in-person services. Pictured: A protester stands outside in protective gear as congregants arrive at Life Tabernacle Church in Central, Louisiana (file)
It was the first clinical trial of the drug for treating COVID-19 after Chinese scientists found that it killed the virus in lab experiments, according to a study published in the Clinical Infectious Diseases Journal on March 9.
US patients with ‘mild’ coronavirus disease are currently being recruited for a trial of hydroxychloroquine (sold under the brand name Plaquenil), to be tested against the effects of another pair of antivirals, posted to clincaltrials.gov last week.
Hydroxychloroquine is also used to treat some forms of arthritis in some instances.
When it was released half-a-century ago, the malaria drug was hailed for having milder side effects than its predecessor.
But its side effects are still not to be dismissed.
If it’s used long-term, the treatment can irreversibly damage the retina, as signalled by trouble focusing, streaks of flashes of light in patients’ vision and eye swelling or color changes.
Its side effects can even be deadly.
The drug can cause strange, bad and vivid dreams and difficulty sleeping.
Taking hydrochloronoquine can also cause your heart to race, trigger headache, fainting, severe dizziness, nausea, a slow heart rate or weak pulse, muscle weakness, numbness and tingly, anxiety and irritability and low blood counts.
Still, with the death toll of coronavirus nearing 200 in the US, even a drug with significant side effects would be cause for hope in the battle against coronavirus, for which there are currently no proven treatments.
Because it is already on the market and FDA approved for other uses, hydroxychloroquine can be more easily used off-label.