- Kashish Parpiani 2 April 2020
Even as experts urge caution on the drug’s efficacy against COVID-19, production of chloroquine in India is being ramped up to cater to US demand
Source: White House
As the world continues to grapple with the novel coronavirus, diagnosed cases of the COVID-19 respiratory disease has surpassed 700,000. With little breakthrough on a prospective vaccine, preventive social containment strategies continue to remain as the primary prescription of medical professionals.
Amidst the resultant anxiety of cities under lockdown, US President Donald Trump has been touting a combination of medicines to be efficacious. Earlier this month via a tweet, the US president said, the combination of hydroxychloroquine and the common antibiotic azithromycin can be “one of the biggest game changers in the history of medicine”. Since then, Chloroquine and Hydroxychloroquine — a less potent version, has continually been touted by Trump in his daily Coronavirus Task Force briefings. The drug is commonly used to treat malaria and at times, prescribed against lupus and rheumatoid arthritis.
Absent of clinical trials however, the US Food and Drug Administration (FDA) is reported to have reached out to drug manufacturers on “ramping up production of the drugs to handle a spike in demand and to ensure that people with life-threatening conditions such as lupus can still obtain it.”
Ramping up production in India
Although the World Health Organisation (WHO) includes chloroquine on its list of “essential medicines” — meaning “it should be kept affordable and accessible at all times”, drug manufacturers are ramping up production as the American Society of Health-System Pharmacists recently listed the drug on its shortage list.
This has triggered US manufacturers to rely on subsidiaries or partner producers in India, as Indian imports “accounted for 24 percent of medicines and 31 percent of medicine ingredients” in the US (as per 2018 FDA data). Hence, after having received “five times as many orders as usual” for chloroquine this month, New Jersey-based Rising Pharmaceuticals for instance, announced that it “is ramping up production in India to meet demand, purchasing “extraordinary amounts” of more active ingredients, bottles and labels.”
On anti-malarial drugs especially, India is known to be “self-sufficient” owing to the prominence anti-malaria efforts hold in the country’s national health initiatives. As a result, Ipca Laboratories and Zydus Cadila have reportedly received orders to produce chloroquine for the American market.
Furthermore, in line with the Trump administration’s announced plan to “eliminate outdated rules and bureaucracy” on procurement and testing, the FDA lifted the “three-year-old ‘import alert’” on Ipca to seek the import of hydroxychloroquine sulphate and chloroquine phosphate. Three Ipca facilities had been under an FDA ‘import alert’ since 2015, after inspectors “discovered multiple violations of its manufacturing guidelines, including “systemic data manipulation” in tests meant to ensure the drugs’ efficacy and safety.”
Moreover, India’s ban on exporting the drug may not apply to these instances as the ban does not apply to cases where the “outbound shipment is made to fulfil export obligation under any advance authorisation license issued on or before the date of” March 25, 2020.
These measures by the US seem to have been triggered at the hands of President Trump’s relentless advocacy of those drugs in the fight against coronavirus.
Trump’s advocacy spurring US dispensations to follow through
In a recent tweet, the US president shared a New York Post report of a Florida man diagnosed with coronavirus, claiming to have been “saved” by chloroquine. Moreover, Trump recently also said, “The nice part is,” that chloroquine has been “around for a long time, so we know that if things don’t go as planned, it’s not going to kill anybody.”
With continued questions over its efficacy, Trump’s relentless advocacy eventually even triggered the FDA to announce fast-track testing of the drug. Moreover, FDA Commissioner Stephen Hahn also announced that the drug would be available for “compassionate use” i.e. using “a drug off-label when other treatment options aren’t available.”
Trump even went on to announce: “At my direction, the federal government is working to help obtain large quantities of chloroquine”. Concurrently, it was reported that multinational pharmaceutical giant Bayer has “donated 3 million doses of Resochin, its brand name for chloroquine” to the US federal government.
State-level dispensations have also begun to procure the drug, and that has spurred Trump to even commend his otherwise political critics. Recently, the US president hailed two clinical trails announced by Democratic New York Gov. Andrew Cuomo.
As New York has emerged as the American epicentre of the outbreak, the two leaders have clashed over states assuming a heightened role in face of an inadequate federal response. However, one of the announced trails, which would combine the antibiotic zithromax (azithromycin) and hydroxychloroquine, prompted Trump to acknowledge Cuomo as having “been working very hard“. Following through, the Cuomo dispensation is reported to have acquired 750,000 doses of chloroquine and 70,000 doses of hydroxychloroquine.
Absent of large-scale definitive clinical trials to support Trump’s claims, experts have cautioned against overpromising on chloroquine.
Claim triggers panic-buying and self-medication
The consequence of overstating the drug’s efficacy — without commensurate trials, has led to people scrambling to get their hands on the drug, and even self-medicate.
Dr. Anthony Fauci — Director of the National Institute of Allergy and Infectious Diseases and a central member of the Trump administration’s Coronavirus Task Force, has tempered Trump’s positive outlook on the drug by underscoring that there is no “magic drug” to treat coronavirus. He has also referred to evidence that the drug could be helpful as being merely “anecdotal.”
Further, Dr. Deborah Birx, US Vice President Mike Pence’s coronavirus response coordinator clarified that the drug has to-date only shown “promise in the test tubes.” Lastly, testing of chloroquine warrants long-term follow-ups as it is known to trigger side-effects like seizures, nausea, vomiting, deafness, vision changes and low blood pressure.
However, across the world, panic-buying has ensued. For instance, Nigeria’s government recently reported three people to have been hospitalised after overdosing on chloroquine, and its city of Lagos reported running out of stock. Similar events were also reported in Uganda, Ghana, Kenya, Morocco and Pakistan.
Even in the US, attempts to dampen panic-buying and self-medication have borne little effect. According to a recent report, American hospitals’ orders for chloroquine were “up 3,000%”.
Furthermore, a man in Arizona died and his wife was put under intensive care after the couple sought to self-medicate with chloroquine. The woman reportedly told NBC News that the couple got the idea to protect themselves from the novel coronavirus via Trump’s televised Coronavirus Task Force briefings. She added, “Don’t believe anything the president says… And his people. Because they don’t know what they’re talking about”.
In India, a death possibly linked to the use of chloroquine was recently reported. The deceased, who was a doctor in Assam was known to have self-medicated with hydroxychloroquine. That report closely followed the Indian Council of Medical Research issuing an advisory on permitting the use of Hydroxychloroquine only for “restricted use in emergency situations” only. Possibly, it is now time to also consider a campaign advising the common populace to refrain from panic-buying and self-medicating.
I have never seen someone that much stupid as Trump.
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