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Who will be policing the quality of a covid-19 vaccine?

In an exclusive essay for Lounge, Katherine Eban, author of 'Bottle Of Lies', shortlisted for the NIF Book Prize 2020, weighs in on the future of Big Pharma in a world racing to find a cure for covid-19

The University of Oxford and its pharmaceutical partner AstraZeneca, said they were seeking regulatory approval for the vaccine after it showed an average 70-percent effectiveness. (Photo by John Cairns / University of Oxford / AFP)
The University of Oxford and its pharmaceutical partner AstraZeneca, said they were seeking regulatory approval for the vaccine after it showed an average 70-percent effectiveness. (Photo by John Cairns / University of Oxford / AFP) (AFP)

In 2005, Dinesh Thakur, a former executive from Ranbaxy Laboratories Ltd., who’d been booted out of the company under a false claim of misconduct, lay awake at home in Gurgaon, India, as the monsoon rains pelted the roof and his diesel generator rumbled, thinking about patients he’d never met.

A map of the world was stuck in his head, as he dwelled on countries where he’d never been to, in sub-Saharan Africa and elsewhere. He knew that the world’s poorest patients, who would have little recourse, were getting substandard medicine for HIV/AIDS and other conditions, made by his former employer. Ranbaxy had made the worst drugs, with the lowest-quality ingredients, and the most manufacturing shortcuts, for patients in some of the least regulated countries, including India. That fact, which Thakur had uncovered during an internal probe of the company’s worldwide regulatory filings, had left him unable to sleep.

How many people would upend their own lives, and put their families at risk, to save the lives of patients they’d never met? But that is exactly what Dinesh Thakur decided to do, when he began sending anonymous emails to drug regulators around the world, eventually capturing the attention of the US Food and Drug Administration. The US drug regulator opened a criminal investigation into Ranbaxy’s falsification of quality data for its pharmaceuticals, a probe that lasted for eight gruelling years.

As Thakur fought to put a stop to an international pharmaceutical crime, I was working to piece together a global jigsaw puzzle. My reporting for Bottle Of Lies began in 2008, when a US pharmacologist and radio-show host contacted me to say that his listeners were complaining about side effects from their generic drugs. He believed them, and because he knew of my investigative work, he asked me, “What is wrong with the drugs?” Though unimaginable at the time, that phone call would lead me to India, and into a decade-long investigation of the manufacturing plants that make some of America’s lowest cost-drugs. Ultimately, my reporting took me into the C-suites of some of India’s largest corporations to expose corruption and malfeasance.

Dinesh Thakur’s heroic actions, which I chronicle in Bottle Of Lies, predate the current SARS-CoV-2 pandemic by over a decade. But the choices he faced back then are fully relevant today. In many ways, the global response to the outbreak of covid-19, which I report on now for Vanity Fair magazine in the US, has been shaped by some of the forces I explore in Bottle Of Lies.

Bottle of Lies, published by Juggernaut Books.
Bottle of Lies, published by Juggernaut Books.

In a globalized world, we are medically and pharmaceutically interdependent. The “China virus,” as the outgoing US President [Donald Trump] calls it, is no such thing. Sadly, the fearsome and mutating virus belongs to the entire world. But it is clear that the virus thrives in an environment like the one I describe in Bottle Of Lies: where truth and science and concern for patients take a back seat to corrupt self-interest and the belief that the ends justify the means. Today, the US and India are in close competition for the highest number of covid-19 cases worldwide—with the US currently the hands-down winner, a tragic title for a country that once led the world in public health.

As we stand at the brink of what will surely be the largest mass vaccination campaign in human history, it’s tempting to imagine a return to normalcy. But with towering profits to be made, and vaccine nationalism already trumping global cooperation for an equitable rollout, we may be looking at vaccine disenfranchisement on a grand scale. There will also be major questions about the quality of any vaccine distributed in less regulated or “rest of world” (ROW) markets, as some generic drug companies refer to them.

One of my darkest findings in reporting Bottle Of Lies is that some generic drug companies routinely make drugs of differing quality, depending on the markets for which they’re bound. This is so commonplace that the practice has a name: dual-track production. Dinesh Thakur was shocked to learn that for the drugs Ranbaxy sold in India, the company simply invented all of its quality data, with the belief that regulators wouldn’t even bother to scrutinise it. The practice amounts to a manufacturing standard of whatever you can get away with.

Given these connivances, the public needs good answers to basic questions. Who will be policing the quality of a covid-19 vaccine? Who will be vouching for its efficacy and purity? Who will be guaranteeing its proper storage? As we see moonshot numbers of 90%+ efficacy roll out from Moderna and Pfizer, journalists have an essential obligation to get behind these miraculous press releases. I am sure that Indian journalists—many of whom are bravely working under threat as press freedoms shrink—will be scrutinising the web of contractors and subcontractors who will likely be churning out covid vaccines for ROW markets.

In reporting Bottle Of Lies, I was struck by the inter-connectedness of our medical and pharmaceutical destinies. Unlike Dinesh Thakur, most of us give little more than passing thought to the citizens of a distant country who get substandard medicine. But, it turns out, if you give subpotent or impure antibiotics to enough people somewhere, that can affect people everywhere. Public-health researchers now link the prevalence of substandard generic drugs to the growing problem of anti-microbial resistance, as underdosed pathogens evolve to resist effective drugs. This is a crisis that affects us all.

So, in the upcoming vaccine race, it may appear that there will be winners and losers. But one thing is for sure. If groups, countries, or continents of citizens are denied high-quality covid-19 vaccines, that will make us all losers.

Bottle Of Lies is shortlisted for the NIF Book Prize 2020.

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