AUGUST 2005
Gurgaon, India
The heat and humidity of monsoon season rolled in, pelting the house with rain. On increasingly fitful nights, as the diesel generator rumbled, Dinesh Thakur lay awake with a map of the world in his head. It was divided into Ranbaxy’s five major markets: the United States and Canada, Europe, Latin America, India, and ROW (rest of the world). Night after night, he visualized the reams of data he had prepared about the drugs in each market, every data set spelling out a hazard to patients that was almost certainly continuing.
The HIV drugs bound for Africa troubled Thakur the most. He knew they were bad. They had high impurities, degraded easily, and would be useless at best in the hot, humid Zone IV conditions of sub-Saharan Africa. They would be taken by the world’s poorest patients, who had almost no medical infrastructure and no recourse for complaints. The injustice made Thakur livid.
Before he’d arrived at Ranbaxy, he assumed that a pill was a pill, manufactured identically for all the regions of the world. Publicly, the company made this claim. It stated that it keyed all its standards across world markets to the most rigorous—those of the United States. But Thakur now knew that the company reserved its worst drugs for countries with little to no regulation, where the chances of getting caught were minuscule.
The FDA, which was now monitoring the quality of all PEPFAR drugs, obviously had no idea this was going on. A month after Thakur resigned, the agency approved Ranbaxy’s Paonta Sahib plant to make AIDS drugs for the PEPFAR program. And in early August, the World Health Organization had restored the company’s AIDS drugs—the ones tested at Vimta—to its prequalified list, to the great relief of AIDS activists who wanted to ensure a low-cost supply of lifesaving drugs.
After leaving Ranbaxy in late April 2005, Thakur tried to convince himself that the company’s medicine was no longer his problem. But his immediate relief had given way to anxiety. He was jobless and piecing together haphazard consulting work as the family’s savings dwindled. Sonal was pregnant with their second child. He mentioned nothing to her about his larger concerns. But night after night he found himself wondering what, if anything, he could do about Ranbaxy’s deceptions. Did he have an obligation to expose them?
The incessant questions took him back to the nighttime stories—and daytime riots—of his childhood. Thakur grew up one hundred miles north of Hyderabad in the lush agricultural town of Nizamabad, where sugarcane, turmeric, and maize grew in abundance. Three generations of Thakurs lived in the family’s ancestral home. His mother was a homemaker. His father, a lawyer, was a civil litigator who did more pro-bono than paid work.
They lived comfortable if modest lives. “Money was not a driver in any sense,” said Thakur. But education was. Thakur and his younger brother and sister were taught by nuns at a strict Catholic school that emphasized discipline and memorization. Each day they took a rickshaw to school along one of the town’s two major roads.
His grandmother, Amba Bai—a bespectacled slip of a woman who wore simple saris—made the biggest impression on Thakur. At home, the principal entertainment for the children were the stories she told every night, drawn from India’s two most famous epic poems, the Ramayana and the Mahabharata. The stories were teeming with characters facing long odds: righteous kings, scheming relatives, fantastical gods, monkey armies.
Each night the characters confronted essential questions of right and wrong and how to live their lives. Would they grab power or choose justice? Would they descend on a road to the underworld or ascend into the light? And while demons and goddesses clashed in his nighttime stories, the real world outside his door was also replete with conflict. In that postcolonial powder keg, perceived slights led to frequent strife between Hindus and Muslims that sometimes led to full-scale riots just outside his door.
His father frequently waded into these skirmishes, racing out to the street to mediate. “I would always ask him, ‘Why are you going out there? It’s not our problem,’” Thakur recalled. “His answer was always, ‘When you see something that’s wrong you have to make sure that you do whatever you can.’” Often, his father would return with cuts and bruises from his peacemaking trips, to the dismay of Thakur’s mother. “She used to absolutely hate him going out there,” Thakur recalled, and inevitably the same discussions ensued: “This is not your problem. They don’t listen to you anyway!” But there was no stopping his father.
For young Thakur, the moral dilemmas his father faced were subtler than those playing out in his grandmother’s stories. If a bad situation is “not your fight,” then what is your obligation? His father’s answer was clear. As a senior lawyer in town, he believed that he had a duty to intervene and serve as a liaison between the people and the justice system, however flawed.
Thakur absorbed this lesson but found it difficult to implement. In eighth grade, one of his friends got suspended from a soccer game for an infraction that wasn’t his fault. Thakur appealed to the physical education teacher on his friend’s behalf but made no headway. So he took his appeal directly to the headmaster. In front of the entire team, Thakur told him that the physical education teacher was being punitive and his friend did not deserve the suspension. The headmaster slapped Thakur across the face and told him never to complain about any of his teachers. “The headmaster did not want to see a teacher challenged by an eighth-grader,” Thakur realized afterward.
The school’s value system, and that of the culture at large, prioritized deference to authority above simple fairness. Thakur rejected this doctrine. He maintained his own value system as he grew into adulthood. His father had gone into the streets to reason with hostile neighbors, with little thought of the dangers to himself. But for a problem that sprawled all over the world, where were Thakur’s streets? With whom could he reason? Thakur knew that others had detected fraud at Ranbaxy, but he believed he was one of the few insiders who understood its full extent. And among that small circle, none had expressed any inclination to address the crime.
Some had even profited from it. His old boss, Barbhaiya, had been given a hefty compensation package on his departure, which Thakur and Kumar believed was to ensure his silence. “The systems in India are so corrupting that even if you are not corrupt, you get corrupted,” Thakur would later say. The middle course for the honest man was to do nothing, which seemed to Thakur to be a version of complicity. There was the option to speak up, but honesty came with peril.
Whistleblowers in India faced mortal risks. Just eighteen months earlier, a project director at the National Highways Authority of India had exposed massive corruption in a highway building project. He was found shot to death by the side of a road. While his death provoked national outrage, it was not all that unusual—especially since whistleblowers in India had no legal protection. As for Ranbaxy, the powerful Singh family had a reputation for being bullies. Their internecine family feuds had even involved gangs of paid thugs, according to published news accounts.
It would have made the most sense for Thakur to do nothing. Being a good Samaritan could backfire in ways that were hard to predict, as it had when he’d rescued the drunk pedestrian from the Mehrauli-Gurgaon Road. That had led to a police officer attempting to frame him as part of a shakedown. The lesson was to keep moving and mind his own business, as his driver Vijay had urged him to do. But Thakur rarely considered the societal norms when deciding whether to act in a way he considered just. He had an absolute set of ethical coordinates that dictated his actions.
On the morning of August 15, 2005, four months after submitting his resignation, he woke up determined to do something. It was India’s Independence Day, a national holiday celebrating the day fifty-eight years earlier when the country had gained its freedom from British rule. Thakur wanted his own liberation from the concerns that had dogged him for months.
He descended to his basement office and opened a Yahoo email account that he had created while weighing his options. Posing as a low-level company scientist and using intentionally broken English, he wrote to officials at the U.S. Agency for International Development (USAID) and the World Health Organization. He stated, “Ranbaxy Laboratories in India is fooling you to get their product on the market with fake data.” He claimed that Ranbaxy was forcing him to falsify data: “I cannot sleep at night knowing that these drugs will be used to cure sick patients in Africa. At best, this drug are ineffective and at worst, they cause adverse reaction and kill people.” He had sent his email using a pseudonym. In choosing one, he reached for a name that invoked power and prestige, in the hope of drawing attention to his cause. He had created an email account using the name of Ranbaxy’s heir apparent, Malvinder Singh.
Each night after that, he went down to his basement computer to check his email, expecting some response. The wait was excruciating. And each day that passed without a response brought a fresh round of pain and self-doubt. He suspected that his email had not been authoritative or detailed enough to penetrate the bureaucracy. So he wrote again, this time more pointedly, to half a dozen FDA officials: “I fear for the poor people in Africa who buy these fake medication from WHO and PEPFAR in the hope of getting better, but no, they do not get better, they get died.” Silence.
He continued to write, adding details and even attaching documents. The silence persisted. A week later, he wrote back to FDA officials, still in the voice of a lowly bench scientist, but this time with more detail. “Ranbaxy management, including the CEO, Head of business and Head of QA systematically ask people in the lab and plant to fabricate data to support stability. There is no data to support shelf life and the formulation you now approve will be degrade in Zone IV conditions in Southern Africa before it gets to the patients. The formulation is worthless. It produce no results.”
Thakur was relentless—and disappointed. He’d thought that if he could only overcome his fear of speaking up, the world would respond and regulators would descend on the company. But no one seemed to care. Over the course of several days, polite but vague responses trickled back. A secretary from the World Health Organization wrote that the officials he’d contacted were out of the office, but his message had been received “and will be dealt with in due course.”
After two weeks of waiting, he put aside the ruse of writing in broken English and sent a message directly to FDA commissioner Lester Crawford. In a forceful and urgent email, he alleged that Ranbaxy was selling “untested, spurious, ineffective medication.” He noted that he’d written repeatedly to Crawford’s subordinates and had included “documents, e-mail messages exchanged between the senior management of this company, including the CEO.” He finally used the word that had come to him months earlier, as he unearthed the company’s misdeeds. “I plead with you,” he wrote, “to put a stop to this crime.”
This time his message broke through. Two days later, Thakur got a detailed email back from Edwin Rivera-Martinez, then chief of investigations and preapproval compliance in the FDA’s Center for Drug Evaluation and Research. Rivera-Martinez stated that he had Thakur’s “e-mail communications of August 15th, 17th, 27th and 31st” and asked Thakur if he would consent to a conference call. Thakur had planned to stay hidden. He had initially expected to set regulators on the trail but limit his own involvement. It had not actually occurred to him that he would have to do more than that.
The two went back and forth. Thakur declined the call, citing a risk to his family, but attached more documents. Rivera-Martinez responded, reassuring him that he could remain anonymous. “From your emails, we got the impression that you believe that people are being killed by fake medications and you want to stop this from happening,” Rivera-Martinez wrote. “. . . without opening a telephone dialogue with you, our investigation may be significantly hampered.”
Thakur was wary. He wrote back: “Will this conversation be recorded? Who will be with you when we talk? Is there any personal liability for me if I talk to you? What protection do I have from prosecution? What we are discussing here is a crime that was committed by the company.” Rivera-Martinez wrote back that it was far more effective to gather relevant officials for a conference call than to go back and forth on email. He also assured Thakur that his identity would be held in strictest confidence, unless the matter went to court and the FDA was required to divulge his identity.
Hesitantly, Thakur consented to the call. But still wanting to maintain control of the interaction, he tried to school Rivera-Martinez on the best and most secure way to set up the conference call. “Do you have access to publicly available VOIP applications?” he asked in one email. “I mean apps like GoogleTalk or SKYPE? In order to use either of these apps, you only need a microphone and speakers on your computer.” He then sent links for the FDA official to download. But the FDA had its own technology—and its own way of operating.
Thakur ended up phoning in to the agency, as instructed. The conference call lasted about ninety minutes. Rivera-Martinez, who was formal and persuasive, gently asked the questions while staffers from different divisions of the agency listened in. There was a special agent, Douglas Loveland, from the FDA’s Office of Criminal Investigations. Dr. Mike Gavini sat in, as did a compliance officer, Karen Takahashi. They wanted to know where Thakur had gotten his information, how confident he was about it, and what some of the documents he’d shared meant.
In an email afterward, Thakur wrote to Rivera-Martinez, sounding almost disappointed in advance: “If I am successful in proving to you that the medicines that this company sells worldwide are not of the quality the US FDA mandates, I will be satisfied. Whether you choose to take this up further is completely your prerogative. I personally hope you would.”
But in the coming months, Thakur was not satisfied at all. To him, the wrongdoing was black-and-white. He had given proof and expected action. And yet ten days after the conference call, the FDA announced that it had approved Ranbaxy’s application for the first generic pediatric AIDS drug for the U.S. market, zidovudine. “Given all the data you have in your possession today about the criminal activities of this company in registering ARVs with fabricated data, I am confused how the USFDA could give such an approval,” Thakur wrote to Rivera-Martinez. “Does this mean that you have concluded your investigation and decided that Ranbaxy is not guilty of these crimes?”
The bureaucrat wrote back that because the drug had been approved before Thakur made contact, only actual proof of fraud could reverse the decision. Thakur was staggered. He’d emailed the agency reams of internal data and communications that clearly showed top-level executives conspiring to alter test results. If that didn’t count for proof of fraud, what did? It was a question with no easy answer, as he would come to learn.
Over the weeks that followed, the communications between Thakur and Rivera-Martinez unfolded as a cordial, slow-motion, arm-twisting duel, fought almost entirely over email. Rivera-Martinez coaxed a reluctant Thakur to give up more information and be more patient; Thakur goaded and needled Rivera-Martinez to make the FDA take action more quickly and aggressively.
On October 6, Rivera-Martinez sent an email asking Thakur “urgently to call regarding several Agency press releases in the works.” Thakur did not get the message in time. The agency announced two more approvals for Ranbaxy: a diabetes drug, glimepiride, and an antiseizure drug, gabapentin. Despondent, Thakur emailed Rivera-Martinez back, noting that he’d provided as much information as he could, “at great risk to me and my family.” He went on: “The actions of the agency really worry me, since it appears to me that you have chosen to largely ignore the evidence I have given you. . . . If you have already concluded that this company has done nothing wrong, please tell me and at least I would have the satisfaction that I have done my duty.”
He wanted to give up and several times declared as much to Rivera-Martinez. In the wake of the October approvals, he sent the resignation letter written by his old boss Raj Kumar, and his last communications with the CEO, Brian Tempest. Thakur called it “a final gesture. . . . The ball is in your court now Mr. Rivera-Martinez, I cannot do anything more for you or the Agency. I will wait and watch your actions . . . before initiating any further dialogue with you.”
But the dialogue continued. Thakur had remained anonymous. Those in the agency referred to him simply as “M,” or “Mr. M,” short for the name he’d used to first make contact with them, Malvinder Singh. And though Thakur had shared many documents, he had withheld the one that mattered most: the Self-Assessment Report (SAR) that Kumar had presented to board directors. That document was radioactive inside the company and would lead directly back to Thakur. On November 2, Rivera-Martinez wrote back, “During our teleconference . . . you mentioned a risk assessment document that you were asked to prepare while you were at Ranbaxy. . . . A copy of this document may be what we need to focus our investigation.”
The request sparked another concern. Though Thakur had done nothing wrong, he had no lawyer and no immunity. “As you have seen from our two-month long association, my only interest in this is to protect the people who pay for the medicines this company makes,” he wrote to Rivera-Martinez. Before he could share more documents, “I need to have immunity from prosecution,” Thakur warned.
Rivera-Martinez tried to explain that the FDA had no power to confer immunity. But he arranged a teleconference with an FDA criminal investigator who was able to reassure Thakur. With that remaining obstacle removed, Thakur sent Rivera-Martinez the document that Ranbaxy’s CEO had been so intent on destroying: the PowerPoint Kumar showed to a subcommittee of the board of directors. The agency now had its fullest picture of a company that was fraudulent to its core.
Though Thakur didn’t know it at the time, the FDA had found his information credible and had been moving to confirm it. In October 2005, less than two months after he first contacted the agency, Rivera-Martinez’s division had sent a request to the Division of Field Investigations to perform high-priority inspections at two of Ranbaxy’s main manufacturing plants, Dewas and Paonta Sahib.
The five-page assignment memo set out a host of alleged frauds for which the inspectors needed to look. Rivera-Martinez requested a face-to-face meeting with the chosen investigators before they left on their trip. The memorandum also recommended that the investigators collect any documents on the day they requested them, noting that the “informant said that the firm has fabricated documents overnight during inspections.”
The agency needed an unvarnished view of the company. In January 2006, however, Thakur urgently relayed to Rivera-Martinez what he had learned from former colleagues: the senior leadership of the company was “camped out in the plant locations, both at Paonta Sahib and at Dewas,” he wrote, warning of “a massive cover-up effort underway to ‘produce’” any documentation that agency investigators might request. Given what Ranbaxy seemed to know about the upcoming inspection, Thakur demanded to know whether the investigation had been compromised in some way. The answer stunned him: Ranbaxy had been notified months in advance that the regulators were coming, because overseas companies always were. It’s the way things were done.