Generic drugs are equivalent drugs produced by other manufacturers in the market after the expiration of the patent of the original drug. The so-called equivalence means that the active ingredients of the two are the same, and the medical properties and therapeutic effects are equal. For humanitarian and economic reasons, the world undoubtedly needs generic drugs. But once generics are available, the regulatory bodies that ensure the generics are "equivalent" determine the health and safety of the users of the generic drugs.
In India, the world's largest producer of generic drugs, the former generic drug giant Lambersy once sold all over the world, but after the boom, it finally dreamed of United States and finally closed down. Today's article is about how an internal investigation launched by Dr. Larkin ·Kumar, Director of R&D at Lambersy Pharmaceuticals, changed the company's fortunes.
This article is excerpted with permission from "The Truth About Generic Drugs" (Democracy and Construction Press, September 2020 edition), with deletion and correction, and the title is intended by the editor.
撰文 | Katherine Eban
Translation | Gao Tianyu
Gurgaon, India, 18 August 2004
By 8:30 a.m., the heat outside was already suffocating. Dinesh · Sakur looked around the six project managers at the conference table and saw six tired faces. They knew the meeting was important, but they didn't know what the agenda was. Sakur will give his team one of the strangest tasks in the history of corporate due diligence, but he decides to keep the real reason a secret for now.
"Dr. Kumar has given us a new assignment." "He wanted to know if we could prove that all the data that the company had provided to the countries was true." It would be a retrospective survey of the company's entire pharmaceutical portfolio, and he wondered how confident we had been in the information we had provided to regulators in various countries over the past 20 years. ”
His team members looked surprised, but the task really didn't go beyond their responsibilities. Their job is to chart all of Lambercy's data, so it's only natural to make sure it's accurate in the first place.
Sakur motioned for them to look at a white writing board, on which he had drawn a diagram. The vertical axis of the graph is all the regions of the world where Lambersey sells drugs, and the horizontal axis is a variety of questions: What products are on the market? When were they registered? Where is the real profile used for registration? And where is the supported data? How many lots were sold in that market? In which factory are they manufactured?
Sakur assigned each of his subordinates a zone and instructed them to compare the company's raw production data in those markets with the statements submitted to the regulators: Do the two figures match? Or is there a difference? Do those statements comply with local regulations?
Until then, no one had ever put together a complete picture of a company's operations. Until then, Lambercy's interior had been siloed. Different teams are responsible for developing products in different regions, and they almost never meet each other to compare records. No one has a complete picture of how and even where a company's drugs are approved. Now, Zakur is asking his team to do a multi-faceted assessment that covers the whole world and goes back years.
As for Sakur himself, he first visited · Kumar, the deputy director in charge of regulatory affairs, who had been instructed by Lakin · Kumar (the two were not relatives) to cooperate with Sakur in his work.
Aaron's office was upstairs from Sakur, and he waited for Sakur with a confused expression. "Actually, everybody knows that." He said as he greeted Zakur.
"Know what?" Sakur asked.
"Know what's really going on." Aaron said. He goes on to describe how Lambersy has acted arbitrarily in areas where regulation is weakest and the risk of detection is the lowest.
"You're saying that the products in those regional markets don't have enough data to back them up?"
"Well, not all of them." Aaron rummaged through a report on his desk and said casually, "We know where the vulnerabilities are. ”
Zakur was stunned by his carelessness. "Have you reported this to management?"
"What is there to report?" Aaron replied, "They all know. In fact, they probably know better than I do. ”
Sakur thought to himself that he must have been mistaken. He asked Aaron how he, as the person who reviewed the accuracy of the data, could let it go if the application contained such a loophole.
"That's to the roots." Aaron replied. Although he prepared the application documents, the leaders in charge of the regulations in each region, such as Abha · Pant in the United States, can modify any application to their liking. They report directly to the top management and do not need to inform Arun or ask for his consent to issue the application.
Sakur thought it was incredible. In companies like BMS (editor's note: Bristol-Myers Squibb, a multinational pharmaceutical company from the United States), the director of regulatory affairs has full control over the documents submitted to the United States Food and Drug Administration, and there are good reasons for such an arrangement. Once the executive in charge of regulatory affairs issues the application, they confirm that the application data is accurate. It is a crime to make false statements in the records of government agencies.
"You tell me, that's not what you said!" Sakur asked.
"The United States and European markets are too high-end, and if they are caught, the losses are too great, so you can't openly risk drugs in those regions." "But like Latin America, India [and Africa], it's a different story entirely. ”
Sakur was dumbfounded: "Who else knows these things?" ”
"Everybody knows that." Aaron replied, then added, "Everyone knows where the order comes from. ”
"Aren't you afraid of a backlash?"
"It's all under control." "Everything is under control. ”
Sakur was so shocked that he had to declare the meeting over so that he could leave to calm himself down.
When he walked through the door of his office, his administrative assistant asked him, "What's wrong with you?" You're like you've seen a ghost. ”
Sakur slumped in his chair.
He knows that there are also non-compliance and misconduct within the branded drug industry. After he left BMS, the company's chief financial officer and the head of the global pharmaceutical team became defendants on charges of criminal conspiracy, securities fraud, and inflating sales and profits by concealing unsalable inventory. The charges were later dropped.
Manipulating the stock market or harming shareholder interests is one thing, and defendants can reach an agreement with the United States Securities and Exchange Commission without having to plead guilty. But what Aaron just described is something else entirely. New drugs must be tested to confirm that they are formula-formulated, stable, and effective. The resulting data is the only evidence that the drug saves people rather than kills. But in the eyes of Lambercy's employees, data is a completely replaceable marketing tool, and they don't seem to have to think about the impact it will have on patients.
This is a blatant fraud, and the result can be life-threatening.
Sakur felt that the matter was too serious for him to accept for a while. But duty still drove him back to Arun ·'s office later in the day.
"There's no point in digging up all these things." Aaron told him, "Keep investigating, you'll just get fired from the company." You told Larkin that he had checked it all and that there was nothing more to check. ”
"I can't lie to my superiors." Zakur said.
"What happened to you United States coming back? How many years have you been thinking of yourself as the world's morality police? Allen questioned him, "Do you think the big pharmaceutical companies in United States don't do these things?" ”
In his 10 years at a big pharmaceutical company, Zakur had never seen or imagined such behavior. He's very young and a little naïve, but he's also stubborn and won't give in easily. "Work still has to be done. Where do we start? He asked impatiently.
Reluctantly, Allen walked over to a white writing board and drew a chart listing Lambosi's quality problems in different regions: United States and Canada were the lowest, Europe was second, Latin America was a little higher, India was higher, and at the top was the "rest of the world," which included several of the poorest African countries.
"I'll start here." Aaron said, pointing to the highest point on the chart.
Sakur still felt black in front of him. What he needs is numbers. Aaron called in the administrative assistant to help. Sakur asked the lad what percentage of the documents submitted to regulators contained data that did not match the company's file. The assistant flickered: "This...... It is different from region to region. ”
"You give me an estimate of the numbers for each region." Sakur said, "How much is United States? ”
The assistant pondered for a moment and estimated a number: "50 to 60 percent?" Sakur was simply out of breath: more than half of the documents submitted by Lambersey to the United States Food and Drug Administration were faked? Is it still the best quality area?
"And what about Europe?"
"Not too much." The assistant replied.
"What about India?"
After some discussion, the assistant replied, "100%." He explained that testing new drugs in India is a waste of time because regulators don't look at the data at all. Therefore, sales representatives in India simply compile their own documentation and submit it to the Directorate General for Drug Control of India (DCGI, hereinafter referred to as the Drug Control Agency of India). To get approved by the India Medicines Control Authority, what is needed is not real data, but good connections. They have connections, the assistant said.
The scale of the fraud frightened Sarkur. The thought of the patients who took the medicine made him feel sick. Sakur told the two that he needed to know the details: each product was listed from year to year, and there was fraud in each application.
When Sakur's project managers set out to analyze, including collecting data, conducting interviews, and visiting laboratories and factories, the company's rigid hierarchy became a major obstacle. Not only is Sakur's team too new, but according to the unwritten rules of India's corporate culture, team members are too junior to be qualified to ask department heads. One member of the team, who tracked data for the Asian and Brazil markets, recalled: "We were persona non grata. "So they had to rely on surprise visits and stalking to get their work done. They came to the factory without saying hello. They waited hours to be able to talk to the head of the department. They drove a few hours to a production plant far away. Bit by bit, the team members put the information together and struggled to piece together Lambercy's secret: the company manipulated nearly every step of the production process to quickly produce beautiful data that would ensure the company's bottom line.
Every member of Sakur's team reported a similar case: at the behest of the manager, the company's scientists replaced high-purity ingredients with low-purity ingredients to save costs. They modify the detection parameters so that formulations with too many impurities can pass through. They falsify dissolution studies. To produce the best results, they ground the branded drug into capsules and tested it instead of the company's own drug. They overlay the test results of their branded drugs on top of the test results of their own drugs and then use them in their applications. In some markets, companies also surreptitiously mix and match data streams, disguising the best production inspection data from one market as data unique to another market, and then handing it over to local regulators. In other markets, companies simply make up the data. Document fraud is ubiquitous. The company even fabricated its own standard manufacturing process for United States FDA investigators to check against whether the company was complying with the regulations. At one point, several employees fooled the overseers during inspections by writing down an earlier date on a document, and then placing it in a damp room overnight to accelerate its aging.
The company is also too lazy to hide this kind of business method. It's a well-known thing, from senior managers and R&D directors to those responsible for formulation and clinical trials. Basically, Lambercy's production standards can be boiled down to nothing happening.
Zakur has learned from years of training that a good medicine is not the one that passes the final test. Its quality must be evaluated at every stage of production, and quality is reflected in the data generated with each link. During the production process, a series of test results are noted down, each of which is a key signpost to quality. But because Lambercy was only results-oriented, regulations and requirements were disregarded. Good Manufacturing Practices are like stop signs and inconvenient detours. And in order to achieve a favorable result, Lambersy drove as much as he wanted, bypassing road signs along the way, resetting traffic lights, and adjusting the mileage afterwards. As the company's director of analytical research later told an auditor: "Documenting data while conducting experiments is not in line with India culture." ”
A member of Sakur's team, who had just joined Lambersy a few months ago, was caught between a dilemma: he had no data to prove that the drugs were unsafe, but no reliable data to prove that they were. He could only go home from work and persuade his relatives and friends not to buy Lambercy's products.
Sakur works 14 hours a day. He tries to create a spreadsheet of what's going on in each market, including data that was submitted with the drug at the time of application, data that the company submitted to regulators for product approval, and existing data to support those claims. He stays in the office until 9 o'clock in the evening, preparing his work plan for the next day. Back at home, he walked into his basement office and worked until midnight to compile the data reported by the team, despite the objections of his wife, Sunal. As usual, he was vague about the project, and Sunar didn't ask him. He also failed to ask himself the bigger question: What consequences would investigating his company have on his career? If he could take a step back, he might be able to see what kind of danger lurked in this mission.
He only knew the scale of the crisis: how could fraud be so serious? What words should be used to describe this kind of behavior, which was far beyond his imagination? Finally, after a few days of work, a word came to his mind, and only it could clearly describe the phenomenon he had learned: crime. Yes, that's it. What he is exposing is a crime that is spreading around the world.
After weeks of exhaustive research, Sakur presented the team's initial findings on Latin America, India and other markets to his superior, Larkin · Kumar.
It was 7:30 a.m., Kumar's usual work time, and the two met in his office. The corridor outside was also quiet. Sakur presented Kumar with several preliminary investigation forms. They show that multiple drugs have not been properly tested at all, or even at all, and there is no data to support the company's claims. Kumar read it carefully without saying a word. "It's certainly not right." He concluded. It really doesn't seem possible: Lambersey didn't test the drug before submitting the file? Kumar had never heard such a ridiculous thing. "You must have missed the data."
"We checked carefully, and there is no such data." Sakur insisted.
"You'll have to go back and recheck." Kumar didn't budge either, "This must be wrong." ”
In Kumar's view, the only plausible explanation is that Sakur either missed the existing test results or misanalyzed the findings. Otherwise, it would be Sakur who has exposed a practice that has no precedent for now. In the weeks that followed, Kumar repeatedly asked him to come back for a review, and Sakur finally called the team for a meeting so that Kumar could hear them firsthand.
The team members were also stunned by the results of this investigation, and they were overwhelmed by their findings. Dinesh later recalled · Kashuriel: "For me, corruption was what Enron did, and they were more likely to be vague about the figures on profits. Venkat · Swaminathan initially only expected the company to have problems with "nepotism and inefficiency." He had no idea that what the company was doing was endangering people's lives.
After listening to every member of Sakur's team, Kumar finally woke up to the fact that the company was defrauding and endangering patients on a global scale. He condensed the information into a four-page report that he presented to the company's CEO, Brian · Tempister. Although the title of the report is unremarkable, "Inadequate Application Documents Submitted in Different Countries for Different Products", and uses the gray area language of the company's quality assurance, the content is explosive. It exposes systematic fraud in documents submitted by Lambersey to regulators around the world. "For most of the products submitted to Brazil, Mexico, the Middle East, Russia, Romania, Myanmar, Thailand, Viet Nam, Malaysia and African countries for review, they either fabricated data that did not exist or appropriated data from other countries for other products."
Kumar's report notes that companies cut costs and use the cheapest ingredients on the market while reporting data from other, more regulated markets, using this dangerous trick to disguise the poor quality of their products. The report also states that the company blends active pharmaceutical ingredients that fail purity testing with ingredients that test well until they meet the requirements.
The report also noted that validation methods, stability results and bioequivalence reports for the company's products were "not available" in India and Latin America. To put it simply, Lambersy is unable to identify the pharmaceutical ingredients in these markets. For example, data collected by Sakur's team shows that almost every one of the 163 drugs approved in Brazil since 2000 has application documents containing false batch records and non-existent stability data.
In most of the application documents, Lambsey "deliberately exaggerated" small R&D batches (about 2,000 doses) into 100-fold demonstration batches, and then deceptively performed key bioequivalence and stability tests on smaller batches that were easier to control, the report said. The result is commercial-scale batches being sold untested, putting the lives of millions of patients at risk.
Kumar also wrote an email marked "confidential" and presented it to Tempist along with the report. In an email, he said that non-compliance was only part of the problem. "It seems that some of the problems came to light more than a year ago, but I can't find any documents that are meant to state or address them." At the end of the email, he made it clear that his ultimate loyalty was not to the company, but to the truth. "I cannot allow any information to be used in any application document without sufficient data to support it," he wrote. It was added, "With your permission, I will seek advice from the London Legal Counsel in relation to my current responsibilities and safeguards in relation to the above issues." ”
In his reply, Tempist assured Kumar that the company would do justice to him.
Although the situation is dire, Kumar reveals to Zakur that he should be able to solve the problem if he is given permission.
Other employees became suspicious. In May 2004, just three months before Sakur began his investigation, Dr. ·Kathy Spreen joined Lambercy's United States office as Executive Director for Clinical Pharmacy and Drug Oversight. She previously worked at Wyeth and AstraZeneca for 15 years to set up Lambsie's branded drug division to create new dosages and formulations for existing drugs. In Spreen's view, her job is to provide regulatory guidance to Lambersey through the United States Food and Drug Administration's intricate regulatory system.
At first, the company's production technology seemed to exceed her expectations. Once, just a few months into her job, she was preparing slides for the launch of the company's Riomet, when she noticed something unusual. The concentration of this drug in the blood seems to be exactly the same as that of the brand-name drug. She remembers thinking to herself: look at how capable this company is, how bioequivalence data from generic drugs can be directly superimposed on the original drugs it mimics.
About a month later, Mr. Spreen compared the data from Accutane, an anti-acne drug, with Sotret, a generic drug that the company had worked on in the shadows, and found that the figures were almost identical. That's when she started to worry. If the data is too good to be true, then it is most likely fake.
She knew there was a ghost in the data: even two batches of the same drug, produced in the same factory of the same company and under the same conditions, would be slightly different. A similar or imitation drug produced by another company with another formulation should have different test results.
With inner doubts, Spreen asked her colleagues in India to send her data to support the test results. The other party promised to send it immediately, and broke the appointment again and again. All she got was an excuse: the data was "too messy" and they were "embarrassed" to send it to her. She pleaded with her colleagues in India: "It doesn't matter if it's written on the back of toilet paper, you have to send it to me." "But they never sent it.
Splen had always thought that if she could explain United States regulations more clearly, Lambersie's executives would understand. But no matter how she explains it, it doesn't seem to change the way the company operates. In the eyes of India's executives, the regulatory system is an obstacle that needs to be bypassed. They often boast that someone has deceived the regulator in the most ingenious way. When a diabetes drug was unsold, an executive asked Mr. Spron if she could use her medical license to prescribe it to everyone in the company so that it could record hundreds of more sales. Splon refused.
She once asked Lambercy's global director of production to send her a document proving that an antibacterial acne gel was produced in accordance with good manufacturing practices, but the other party offered to send her a certificate that it "looked good". To Spreen, it seemed that he was trying to send a forged certificate. She struggled to explain: "I don't care what the certificate looks like, I just want the United States Food and Drug Administration to say it's in line with Good Manufacturing Practices." ”
In October 2004, in New Jersey, Sakur's superior, Larkin · Kumar, quietly admitted to Spreen that her suspicions were true: For many of the company's drugs, critical test data did not exist, and documents submitted to regulators were falsified. Once, Splon approached Malvind · Singh, the company's drug director at the time, and directly raised his suspicions. Singh asked her to be patient and promised her that everything would work out. But if this is to happen, companies must follow the rules in good faith and have a sense of urgency to protect patients.
But this consciousness seems to be lacking, and the lack is staggering. During a company call, Ms. Splen told 12 executives in attendance that she was concerned about the quality of Ms. Lambersey's anti-AIDS drugs for Africa. One of the company's top medical executives replied, "Who cares? It's about the death of a few black people. ”
Like Kathy · Splen, Kumar was confused about what to do next. On a business trip back to United States, he went to meet with the company's lawyer, Jay · Deshimuk. "I want to talk to you like a lawyer and a client," he said. "Deshimuk said he was representing a company and could not speak to him as his lawyer." But you don't understand what's going on. Kumar said, detailing the terrible problems within the company, "I was afraid of losing my personal freedom." ”
"I can't give you advice either." "I'm not an expert on this. However, after receiving Kumar, Deshimuk quietly inquired and learned about the investigation initiated by Kumar. The lawyer felt that this kind of corporate self-examination without proper safeguards was extremely dangerous. Once such an investigation has begun, it cannot be cancelled, and no one can say for sure what the consequences of the information found. He later said: "It's terrible to have people who don't know the world do it. "It's as if Kumar left a couple of children to play with fire unsupervised.
By this time, Sarkur's analysis had been quietly circulating within the company. At a senior management meeting in Bangkok, Kumar handed out a form produced by Sakur listing the various markets in Lambersey by region and alphabetically, starting in Algeria and ending in Viet Nam. One column is for the various drugs, another is titled "Risk" (Sakur refers to the risk to the patient), and another is "Action Plan". Sakur filled in the "high", "medium" and "low" categories in the patient risk column, based on how much data was missing from the company's records and what kind of data.
But at the meeting, company executives who read the form misinterpreted the column as a risk to the company. In the "Action Plan" column, two executives in charge of global marketing and regulatory affairs scribble notes in the margins. The note indicates that the company will consider two options: one is to directly suspend the supply of these drugs; The second is to temporarily recall them from the market and re-test, and the content of the test is to weigh which is more harmful than the loss of market share. The risks to patients are not taken into account at all.
At the end of the meeting, Kumar retrieved the form, along with the handwritten notes of the two men on it. Whether intentionally or unintentionally, he began to collect evidence.
On October 14, 2004, a few months after Sakur was appointed to dig up the truth, Kumar stood in the boardroom of his headquarters in Lambeth, New Delhi, facing the members of the Board's Scientific Committee. His audience included Brian · Tempist, Malvender ·Singh, who was then the director of drugs, Tejendra Khanna, chairman ·of the board of directors and former deputy mayor of New Delhi, Dr. P.S. Joshi, a renowned cardiologist, and several others. The company secretary was instructed to leave the conference room.
Kumar showed the audience a presentation prepared by Sakur with 24 slides entitled "Simplifying Risk Management for New Drug Application Portfolios". To some extent, this document is not yet complete, and it does not yet contain data on the United States market. But what is available has made it clear that in the pursuit of profit, Lamberthy lied to regulators, falsified data, and jeopardized patient safety in nearly every country where drugs are sold. "The data on the more than 200 products we sell in more than 40 countries has ingredients that are fabricated to meet business needs," the slide states. The report also shows that the so-called "business needs" are just a rhetoric to whitewash Lambersey's practice of minimizing costs, maximizing benefits, and cajoling regulators into approving substandard drugs.
No market or drug is an exception, including antiretroviral drugs procured by United States and WHO to fight AIDS in Africa. In Europe, companies use ingredients that are sourced from unapproved sources; fabricated shelf life data, sold one drug, but used other formulas of drugs for testing; Changes to the production process are not documented. The slide also noted that the results of the Wimta audit, which initially prompted Kumar to go to South Africa, had been noticed by regulators and could further damage the company's reputation.
In market after market, companies simply fabricated all the data, all in Brazil, Kenya, Ethiopia, Uganda, Egypt, Myanmar, Thailand, Viet Nam, Peru and the Dominican Republic. Referring to corporate agreements for the production of certain drugs for branded drug companies, one slide states: "We also pose a risk to our partners (Bayer and Merck in Mexico and South America because of the dubious data used in the application documents." ”
Kumar proposed a radical plan: recall all problematic drugs from the market; Redo all suspicious detections; Inform the supervisor of each case of the transfer data; Develop a process for correlating the data to the drug. One slide titled "Guiding Principles" lays out Kumar's vision of the company's obligations: "Patient safety is our primary responsibility. Our products must be proven to be safe and effective. Short-term losses are better than long-term losses for the entire business. ”
Kumar finished his report in a silent conference room. Only one of the directors, who is also a scientist, expressed a little surprise at his discovery. Others were even more surprised by Kumar's declaration: if he was not given carte blanche to solve the problem, he would resign and leave.
"Can't you hide all the data?" One of the directors turned to Tempist. No one answered. The silence made Kumar understand everything he needed to know. Tempist ordered the destruction of every copy of the presentation and the dismantling of the laptop computer on which it was made. No records were left at this meeting.
Kumar had been convinced that after seeing irrefutable evidence and realizing that he had done something wrong for so long, Lambersy would have to set things right. But it didn't turn out as he hoped, and he submitted his resignation less than two days after the board meeting. This is less than four months after he arrived at Lambercy. He wrote to Tempist that "given the serious nature of the issues we are discussing," his only option was to leave "gracefully and quickly."
As a document created by a company executive, Kumar's presentation was unrelenting. Its specter will continue to divide executives in the years to come. Within the company, it will be referred to as the "Self-Assessment Report" (abbreviated SAR, hereinafter referred to as the "Report"). The document charging the crime was like a slow-burning fuse that burned directly at the company's top executives.
Sakur remained in the company. But as soon as Kumar left, he lost his protection. Three months after that board presentation, the company's internal auditor came to his department to do what was known as a "routine inspection." They stayed for 10 weeks, during which time they looked through the department's books and interviewed department employees. According to Venkat · Swaminathan, a member of Sakur's team, the auditors are "secret police sent by the company." We eventually found out that this was part of the company's overall plan, and that Dinesch ·Zakur were their targets".
In late April, the company abruptly accused Sakaur of browsing pornographic websites on his office computer. Sakur vehemently denied it. Enraged, he asked the network administrator to look at the computer records, only to find that someone from the company's IT department had logged into his department's servers and planted his IP address in several searches.
Back home, Sakur tells his wife, Sunal, that he will leave the company. He didn't go into details, she didn't ask questions, he just said that it was impossible to continue working.
"What do we do next?" Sunar asked him.
Zakur didn't know how to answer. But thinking about what had happened, he knew that his days at Lambersey were over.
One Thursday morning, Mr. Sakur drafted a letter of resignation and printed evidence that the pornographic website had planted his IP address. The next afternoon, he arrived at Dr. Tempest's office, and it took him some effort to make an appointment to meet with Tempist for 30 minutes.
Zakur showed him evidence that computers had manipulated their hands. "I can't stay in such an environment because I was retaliated against for doing my job," he said. Then he handed in his resignation.
However, Tempist was kind, and he said, "I understand why you are leaving. He told Sakur not to go to the office this afternoon and to pick up his stuff directly next week.
By Monday, Sakur went. Under the watchful eye of the human resources minister on the side, he took a few photos of his son from his desk. They didn't even allow him to open the drawer or say goodbye to his teammates. He left the company building under the escort of someone else, and the driver, Vijay, was waiting for him in the car outside. He spent a tumultuous 22 months at Lambersey, leaving with less than 10 minutes. His business was over—at least that's what he thought.
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