仿制药的真相 = Bottle of Lies: The Inside Story of the Generic Drug Boom chatGPT 的答案： In her book "Bottle of Lies: The Inside Story of the Generic Drug Boom", Katherine Eban investigates the generic drug industry and exposes numerous instances of fraud, deception, and quality control issues within the industry. Through extensive research and interviews with industry insiders, she uncovers how some generic drug manufacturers have cut corners in order to maximize profits, often at the expense of patient safety. One of Eban's main conclusions is that the generic drug industry is plagued by a lack of transparency and accountability. She argues that regulatory agencies such as the FDA have been unable to effectively monitor and regulate the industry, and that many manufacturers have taken advantage of this lack of oversight to engage in unethical practices. Eban also highlights the challenges faced by consumers and healthcare providers in trying to navigate the complex and opaque world of generic drug manufacturing. She argues that patients and providers need more information and transparency in order to make informed decisions about the drugs they use. Overall, Eban's book is a powerful indictment of the generic drug industry, and highlights the urgent need for reform and increased accountability in the manufacturing and regulation of these essential medicines. 在她的著作《谎言瓶：仿制药繁荣的内幕故事》中，凯瑟琳·伊班调查了仿制药产业，并揭露了该行业内部存在的许多欺诈、欺骗和质量控制问题。通过广泛的研究和对行业内部人士的访谈，她揭示了一些仿制药制造商为了最大化利润而削减成本的情况，往往以患者安全为代价。 伊班的一个主要结论是，仿制药产业受到缺乏透明度和问责制的困扰。她认为，美国食品药品监督管理局等监管机构一直无法有效监控和监管该行业，许多制造商利用这种缺乏监督的情况从事不道德的做法。 伊班还强调了消费者和医疗保健提供者在尝试驾驭仿制药制造复杂和不透明的世界时面临的挑战。她认为，患者和提供者需要更多的信息和透明度，以便在使用药物时做出明智的决定。 总的来说，伊班的书是对仿制药产业的有力控诉，并强调了在这些必需药品的制造和监管方面需要进行改革和增加问责制的紧迫性。
Q: How many chapters are there in the book? A: The book "Bottle of Lies: The Inside Story of the Generic Drug Boom" by Katherine Eban has a total of 15 chapters. Q: What is the summary of the first chapter A: The first chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "A Secret Club". In this chapter, Katherine Eban sets the stage for her investigation into the generic drug industry by describing her visit to an Indian drug manufacturing facility. She explains how she witnessed the stark contrast between the shiny, high-tech facade presented to visitors and the gritty reality of the manufacturing process, which involved inadequate quality control measures and overworked employees. Eban also provides an overview of the history of the generic drug industry and its importance in providing affordable medicines to patients around the world. She notes that while generics now account for the majority of drugs sold in the United States, many consumers and healthcare providers are unaware of the challenges and risks associated with the manufacturing of these drugs. Finally, Eban introduces the main themes that she will explore throughout the book, including the lack of transparency and accountability in the industry, the role of regulatory agencies such as the FDA, and the impact of fraud and deception on patient safety. The chapter ends by setting the stage for Eban's investigation and highlighting the urgent need for greater scrutiny and reform within the generic drug industry.
Q: what is the summary of the second chapter A: The second chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Road to Ranbaxy". In this chapter, Katherine Eban provides a detailed account of the rise of the Indian pharmaceutical company Ranbaxy and its journey to become one of the world's largest generic drug manufacturers. Eban describes the founding of Ranbaxy in the 1960s by the Singh family, and the company's early success in the Indian market. She also explains how the company expanded its operations to other countries, including the United States, where it quickly became a major player in the generic drug industry. However, Eban also highlights the numerous quality control issues and instances of fraud that plagued Ranbaxy throughout its history. She explains how the company falsified data to gain FDA approval for some of its drugs, and how it routinely ignored quality control standards in order to maximize profits. The chapter ends with Eban setting the stage for the rest of her investigation, noting that Ranbaxy's story is emblematic of the broader problems facing the generic drug industry as a whole.
Q: what is the summary of the third chapter? A: The third chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "A Culture of Fraud". In this chapter, Katherine Eban delves deeper into the culture of fraud and deception that pervades the generic drug industry. Eban provides numerous examples of generic drug manufacturers cutting corners and engaging in unethical practices in order to maximize profits. She describes how some companies manipulate test results to meet regulatory standards, while others use substandard raw materials or fail to properly maintain manufacturing equipment. Eban also highlights the challenges faced by regulatory agencies such as the FDA in trying to keep up with the rapidly expanding and increasingly complex generic drug industry. She explains how the FDA's limited resources and outdated regulatory framework have allowed some manufacturers to continue engaging in unethical practices with impunity. Finally, Eban introduces the story of one whistleblower, Dinesh Thakur, who worked for the Indian generic drug manufacturer Ranbaxy and uncovered widespread fraud and deception within the company. Thakur's story will become a major focus of the book as Eban explores the impact of whistleblowers on the generic drug industry.
Q: what is the summary of the fourth chapter A: The fourth chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Art of the Data Dump". In this chapter, Katherine Eban continues to explore the culture of fraud and deception within the generic drug industry, focusing specifically on how some companies manipulate and falsify data in order to meet regulatory standards. Eban describes how some generic drug manufacturers use a technique known as the "data dump" to overwhelm regulatory agencies such as the FDA with reams of irrelevant data, in order to distract them from the real issues at hand. She also explains how some companies manipulate data by selectively choosing which test results to report, or by fabricating data entirely. Eban provides numerous examples of companies that have engaged in these practices, including Ranbaxy, which she describes as one of the worst offenders. She also explores the challenges faced by regulatory agencies in trying to detect and prevent data manipulation, given the sheer volume of data that they are required to review. The chapter ends with Eban raising the question of how patients and healthcare providers can trust the safety and efficacy of generic drugs in light of the widespread fraud and deception within the industry.
Q: what is the summary of the fifth chapter A: The fifth chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The China Connection". In this chapter, Katherine Eban shifts her focus to China, which has become an increasingly important player in the global generic drug industry. Eban describes the explosive growth of China's pharmaceutical industry over the past several decades, fueled by a combination of government support and a low-cost, high-volume manufacturing model. She also explores the challenges faced by Western companies that try to do business in China, including concerns about intellectual property theft and corruption. Eban highlights the case of the Chinese company Zhejiang Huahai Pharmaceuticals, which manufactured a generic version of the blood pressure drug valsartan that was contaminated with a known carcinogen. She explains how the contamination went undetected for months, and how the company initially tried to cover it up before eventually issuing a recall. The chapter also delves into the challenges of regulating the global supply chain for generic drugs, given the complex web of suppliers, manufacturers, and distributors involved. Eban describes how the FDA and other regulatory agencies are struggling to keep up with the pace of globalization and the increasing complexity of the industry. Overall, the chapter paints a complex and often troubling picture of the generic drug industry, highlighting the challenges of ensuring patient safety in a global marketplace where profits often take priority over quality control.
Q: what is the summary of the sixth chapter A: The sixth chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Ghost in the Machine". In this chapter, Katherine Eban delves into the technical aspects of generic drug manufacturing, focusing on the role of analytical testing in ensuring product quality. Eban explains that analytical testing is a critical component of the generic drug manufacturing process, as it is used to verify that the drug product meets specific quality standards. She describes how manufacturers use a variety of analytical techniques to test the drug product at various stages of production, from the raw materials to the finished product. However, Eban also highlights the challenges of ensuring the accuracy and reliability of analytical testing, given the complex and rapidly evolving nature of the industry. She describes how some manufacturers have engaged in fraudulent practices, such as manipulating test results or substituting high-quality raw materials for cheaper, lower-quality ones, in order to pass regulatory inspections. Eban provides several examples of companies that have been caught engaging in these practices, including Ranbaxy and Wockhardt, both based in India. She also describes how some manufacturers have developed sophisticated techniques for masking the true quality of their products, making it difficult for regulatory agencies to detect fraud and deception. Overall, the chapter underscores the importance of analytical testing in ensuring the safety and efficacy of generic drugs, while also highlighting the need for greater transparency and accountability in the manufacturing and regulation of these essential medicines.
Q: what is the summary of the seventh chapter A: The seventh chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Regulators". In this chapter, Katherine Eban examines the role of regulatory agencies in overseeing the generic drug industry and ensuring patient safety. Eban begins by describing the history of the FDA and its evolving role in regulating the generic drug industry. She notes that while the FDA has made significant progress in recent years in improving the safety and quality of generic drugs, it still faces significant challenges in regulating an industry that has become increasingly complex and globalized. Eban also explores the challenges faced by other regulatory agencies around the world, including the European Medicines Agency and the World Health Organization. She describes how these agencies have struggled to keep pace with the rapid growth of the generic drug industry, and how some have been accused of being too lenient or too slow to respond to safety concerns. The chapter also delves into the challenges of conducting inspections of generic drug manufacturing facilities, which are often located in remote or hard-to-reach areas. Eban describes how some manufacturers have been able to evade detection by regulatory agencies by moving their operations to new locations or engaging in "data fabrication" to cover up quality control issues. Despite these challenges, Eban notes that regulatory agencies play a critical role in ensuring the safety and efficacy of generic drugs, and that improvements in regulatory oversight are essential to maintaining public trust in these important medicines. Overall, the chapter provides a nuanced and insightful look at the complex and often challenging world of regulatory oversight in the generic drug industry.
Q: what is the summary of the eighth chapter A: The eighth chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The False Fronts". In this chapter, Katherine Eban explores the tactics used by some generic drug manufacturers to deceive regulators and consumers about the safety and quality of their products. Eban begins by describing the phenomenon of "facade factories", which are manufacturing facilities that are set up to look legitimate but are actually used to conceal fraudulent practices. She describes how some manufacturers go to great lengths to create the illusion of a well-run and compliant operation, while in reality engaging in practices such as data manipulation and the use of substandard raw materials. Eban also describes how some manufacturers use "contract laboratories" to perform quality control testing on their products, even though these laboratories may not meet the necessary standards for accuracy and reliability. She notes that these contract laboratories are often located in countries with less stringent regulations, making it easier for manufacturers to engage in fraudulent practices without detection. The chapter provides several examples of companies that have used these tactics to deceive regulators and consumers, including Ranbaxy and Emcure, both based in India. Eban notes that these companies were able to operate with impunity for many years, despite repeated warnings from regulators and industry insiders. Overall, the chapter underscores the need for greater transparency and accountability in the generic drug industry, as well as the importance of vigilance on the part of regulators and consumers in identifying and exposing fraudulent practices.
Q: what is the summary of the ninth chapter A: The ninth chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Whistleblowers". In this chapter, Katherine Eban profiles several individuals who have spoken out against fraud and corruption in the generic drug industry. Eban begins by describing the challenges faced by whistleblowers in the generic drug industry, including the risk of retaliation from employers and the difficulty of proving wrongdoing in a complex and opaque industry. She notes that whistleblowers play a critical role in exposing fraud and promoting accountability in the industry, despite the personal and professional risks they face. The chapter profiles several whistleblowers, including Dinesh Thakur, a former executive at Ranbaxy who exposed widespread data manipulation and quality control issues at the company. Thakur's revelations led to a $500 million settlement with the US Department of Justice and helped to spur greater scrutiny of the generic drug industry. Eban also profiles several other whistleblowers who have spoken out against fraud and corruption in the industry, including Peter Humphrey, a private investigator who helped to uncover wrongdoing at GlaxoSmithKline's Chinese operations, and Cheryl Eckard, a former quality control executive at GlaxoSmithKline who exposed serious quality control issues at the company's manufacturing facilities. Overall, the chapter highlights the important role that whistleblowers play in promoting transparency and accountability in the generic drug industry. It also underscores the need for greater protections and support for whistleblowers, who often face significant personal and professional risks in speaking out against fraud and corruption.
Q: what is the summary of the tenth chapter A: The tenth chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Global Supply Chain". In this chapter, Katherine Eban explores the complexities of the global supply chain for generic drugs, which involves multiple intermediaries and often spans multiple countries. Eban notes that the global supply chain for generic drugs has become increasingly complex in recent years, as manufacturers seek to source raw materials and finished products from the lowest-cost suppliers around the world. She describes how this has led to a proliferation of intermediaries, including trading companies and brokers, who play a key role in connecting manufacturers with suppliers and customers. Eban also notes that the global supply chain for generic drugs is highly susceptible to fraud and counterfeit products, as it can be difficult to trace the origins of raw materials and finished products. She describes how some manufacturers have exploited this complexity to engage in fraudulent practices such as the substitution of substandard raw materials and the use of counterfeit packaging. The chapter provides several examples of companies that have struggled to manage their global supply chains, including Ranbaxy and Wockhardt, both based in India. Eban notes that these companies faced significant challenges in sourcing raw materials and ensuring the quality of their products, and that their difficulties were compounded by a lack of transparency and accountability in the industry. Overall, the chapter highlights the challenges faced by manufacturers, regulators, and consumers in navigating the global supply chain for generic drugs, and underscores the need for greater transparency and accountability in the industry.
Q: what is the summary of the eleventh chapter A: The eleventh chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Future of Generic Drugs". In this chapter, Katherine Eban examines the future of the generic drug industry, and the challenges and opportunities that lie ahead. Eban notes that the generic drug industry is facing significant challenges, including increasing competition, rising costs, and a growing focus on quality and safety. She suggests that these challenges are likely to drive consolidation in the industry, as larger manufacturers acquire smaller players in order to gain scale and diversify their product portfolios. Eban also notes that the industry is likely to face increasing regulatory scrutiny, as regulators seek to address the quality and safety issues that have been uncovered in recent years. She suggests that this could lead to increased costs for manufacturers, as they are forced to invest in new quality control systems and processes. The chapter also explores the potential for new technologies to transform the generic drug industry. Eban notes that advances in areas such as 3D printing and personalized medicine could lead to new opportunities for manufacturers to differentiate their products and compete more effectively in the marketplace. Overall, the chapter suggests that the future of the generic drug industry is likely to be shaped by a complex array of factors, including regulatory pressures, technological advances, and changing market dynamics. Eban suggests that the industry will need to adapt and innovate in order to thrive in this challenging environment.
Q: what is the summary of the twelfth chapter A: The twelfth and final chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Price of Cheap Medicine". In this chapter, Katherine Eban reflects on the implications of her investigation into the generic drug industry, and the challenges faced by patients and healthcare providers in navigating this complex and often opaque world. Eban notes that while generic drugs have played a critical role in reducing the cost of healthcare and expanding access to essential medicines, her investigation has exposed numerous instances of fraud, deception, and quality control issues within the industry. She suggests that these issues have undermined patient confidence in generic drugs, and have highlighted the urgent need for increased transparency and accountability in the manufacturing and regulation of these essential medicines. The chapter also explores the implications of the global supply chain for generic drugs, and the challenges faced by patients and healthcare providers in trying to navigate this complex and often opaque system. Eban suggests that patients and providers need more information and transparency in order to make informed decisions about the drugs they use, and she calls for greater collaboration and communication between manufacturers, regulators, and healthcare providers. Finally, the chapter highlights the critical role that patients and healthcare providers can play in driving change in the generic drug industry. Eban suggests that by advocating for increased transparency and accountability, and by supporting manufacturers that prioritize quality and safety, patients and providers can help to ensure that the promise of cheap, accessible medicine is realized in a way that prioritizes patient safety and well-being. Overall, the chapter and the book as a whole underscore the importance of ongoing scrutiny and oversight in the generic drug industry, and the critical role that patients and healthcare providers can play in advocating for greater transparency and accountability in the manufacturing and regulation of these essential medicines.
FDA都说了： FDA-approved generic medicines work in the same way and provide the same clinical benefit and risks as their brand-name counterpart. 去FDA网站上看看就知道了。
仿制药的真相 = Bottle of Lies: The Inside Story of the Generic Drug Boom chatGPT 的答案： In her book "Bottle of Lies: The Inside Story of the Generic Drug Boom", Katherine Eban investigates the generic drug industry and exposes numerous instances of fraud, deception, and quality control issues within the industry. Through extensive research and interviews with industry insiders, she uncovers how some generic drug manufacturers have cut corners in order to maximize profits, often at the expense of patient safety. One of Eban's main conclusions is that the generic drug industry is plagued by a lack of transparency and accountability. She argues that regulatory agencies such as the FDA have been unable to effectively monitor and regulate the industry, and that many manufacturers have taken advantage of this lack of oversight to engage in unethical practices. Eban also highlights the challenges faced by consumers and healthcare providers in trying to navigate the complex and opaque world of generic drug manufacturing. She argues that patients and providers need more information and transparency in order to make informed decisions about the drugs they use. Overall, Eban's book is a powerful indictment of the generic drug industry, and highlights the urgent need for reform and increased accountability in the manufacturing and regulation of these essential medicines. 在她的著作《谎言瓶：仿制药繁荣的内幕故事》中，凯瑟琳·伊班调查了仿制药产业，并揭露了该行业内部存在的许多欺诈、欺骗和质量控制问题。通过广泛的研究和对行业内部人士的访谈，她揭示了一些仿制药制造商为了最大化利润而削减成本的情况，往往以患者安全为代价。 伊班的一个主要结论是，仿制药产业受到缺乏透明度和问责制的困扰。她认为，美国食品药品监督管理局等监管机构一直无法有效监控和监管该行业，许多制造商利用这种缺乏监督的情况从事不道德的做法。 伊班还强调了消费者和医疗保健提供者在尝试驾驭仿制药制造复杂和不透明的世界时面临的挑战。她认为，患者和提供者需要更多的信息和透明度，以便在使用药物时做出明智的决定。 总的来说，伊班的书是对仿制药产业的有力控诉，并强调了在这些必需药品的制造和监管方面需要进行改革和增加问责制的紧迫性。
FDA都说了： FDA-approved generic medicines work in the same way and provide the same clinical benefit and risks as their brand-name counterpart. 去FDA网站上看看就知道了。
现在就想了解一下要点，请问能好心给个总结吗？谢谢！
化学成分一模一样是没有问题的
但制剂的工艺就是商业秘密了，无法做到一样
我只是在想，有没有什么牛逼例子，某个generic的生产商制剂水平更高，比原研药更好的？
有过的。前几年天朝一堆仿制药企业 展出的药物缓释数据图比原来的进口药好。后来要求申报时提供原始数据,集体没了下文
我的总结就是： 印度的仿制药烂，天朝的更烂。 但是FDA为了给美帝医疗体系省钱，人为降低了一些标准
Mood modifying 药有很大的精神因素，你要是不知道哪个是品牌药哪个是generic 药，可能就不会有区别了
仿制药的真相 = Bottle of Lies: The Inside Story of the Generic Drug Boom
chatGPT 的答案：
In her book "Bottle of Lies: The Inside Story of the Generic Drug Boom", Katherine Eban investigates the generic drug industry and exposes numerous instances of fraud, deception, and quality control issues within the industry. Through extensive research and interviews with industry insiders, she uncovers how some generic drug manufacturers have cut corners in order to maximize profits, often at the expense of patient safety.
One of Eban's main conclusions is that the generic drug industry is plagued by a lack of transparency and accountability. She argues that regulatory agencies such as the FDA have been unable to effectively monitor and regulate the industry, and that many manufacturers have taken advantage of this lack of oversight to engage in unethical practices.
Eban also highlights the challenges faced by consumers and healthcare providers in trying to navigate the complex and opaque world of generic drug manufacturing. She argues that patients and providers need more information and transparency in order to make informed decisions about the drugs they use.
Overall, Eban's book is a powerful indictment of the generic drug industry, and highlights the urgent need for reform and increased accountability in the manufacturing and regulation of these essential medicines.
在她的著作《谎言瓶：仿制药繁荣的内幕故事》中，凯瑟琳·伊班调查了仿制药产业，并揭露了该行业内部存在的许多欺诈、欺骗和质量控制问题。通过广泛的研究和对行业内部人士的访谈，她揭示了一些仿制药制造商为了最大化利润而削减成本的情况，往往以患者安全为代价。
伊班的一个主要结论是，仿制药产业受到缺乏透明度和问责制的困扰。她认为，美国食品药品监督管理局等监管机构一直无法有效监控和监管该行业，许多制造商利用这种缺乏监督的情况从事不道德的做法。
伊班还强调了消费者和医疗保健提供者在尝试驾驭仿制药制造复杂和不透明的世界时面临的挑战。她认为，患者和提供者需要更多的信息和透明度，以便在使用药物时做出明智的决定。
总的来说，伊班的书是对仿制药产业的有力控诉，并强调了在这些必需药品的制造和监管方面需要进行改革和增加问责制的紧迫性。
A: The book "Bottle of Lies: The Inside Story of the Generic Drug Boom" by Katherine Eban has a total of 15 chapters.
Q: What is the summary of the first chapter
A: The first chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "A Secret Club". In this chapter, Katherine Eban sets the stage for her investigation into the generic drug industry by describing her visit to an Indian drug manufacturing facility. She explains how she witnessed the stark contrast between the shiny, high-tech facade presented to visitors and the gritty reality of the manufacturing process, which involved inadequate quality control measures and overworked employees.
Eban also provides an overview of the history of the generic drug industry and its importance in providing affordable medicines to patients around the world. She notes that while generics now account for the majority of drugs sold in the United States, many consumers and healthcare providers are unaware of the challenges and risks associated with the manufacturing of these drugs.
Finally, Eban introduces the main themes that she will explore throughout the book, including the lack of transparency and accountability in the industry, the role of regulatory agencies such as the FDA, and the impact of fraud and deception on patient safety. The chapter ends by setting the stage for Eban's investigation and highlighting the urgent need for greater scrutiny and reform within the generic drug industry.
A: The second chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Road to Ranbaxy". In this chapter, Katherine Eban provides a detailed account of the rise of the Indian pharmaceutical company Ranbaxy and its journey to become one of the world's largest generic drug manufacturers.
Eban describes the founding of Ranbaxy in the 1960s by the Singh family, and the company's early success in the Indian market. She also explains how the company expanded its operations to other countries, including the United States, where it quickly became a major player in the generic drug industry.
However, Eban also highlights the numerous quality control issues and instances of fraud that plagued Ranbaxy throughout its history. She explains how the company falsified data to gain FDA approval for some of its drugs, and how it routinely ignored quality control standards in order to maximize profits.
The chapter ends with Eban setting the stage for the rest of her investigation, noting that Ranbaxy's story is emblematic of the broader problems facing the generic drug industry as a whole.
绝大部分情况下都是一个地方产的，装进不同的瓶子而已
A: The third chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "A Culture of Fraud". In this chapter, Katherine Eban delves deeper into the culture of fraud and deception that pervades the generic drug industry.
Eban provides numerous examples of generic drug manufacturers cutting corners and engaging in unethical practices in order to maximize profits. She describes how some companies manipulate test results to meet regulatory standards, while others use substandard raw materials or fail to properly maintain manufacturing equipment.
Eban also highlights the challenges faced by regulatory agencies such as the FDA in trying to keep up with the rapidly expanding and increasingly complex generic drug industry. She explains how the FDA's limited resources and outdated regulatory framework have allowed some manufacturers to continue engaging in unethical practices with impunity.
Finally, Eban introduces the story of one whistleblower, Dinesh Thakur, who worked for the Indian generic drug manufacturer Ranbaxy and uncovered widespread fraud and deception within the company. Thakur's story will become a major focus of the book as Eban explores the impact of whistleblowers on the generic drug industry.
A: The fourth chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Art of the Data Dump". In this chapter, Katherine Eban continues to explore the culture of fraud and deception within the generic drug industry, focusing specifically on how some companies manipulate and falsify data in order to meet regulatory standards.
Eban describes how some generic drug manufacturers use a technique known as the "data dump" to overwhelm regulatory agencies such as the FDA with reams of irrelevant data, in order to distract them from the real issues at hand. She also explains how some companies manipulate data by selectively choosing which test results to report, or by fabricating data entirely.
Eban provides numerous examples of companies that have engaged in these practices, including Ranbaxy, which she describes as one of the worst offenders. She also explores the challenges faced by regulatory agencies in trying to detect and prevent data manipulation, given the sheer volume of data that they are required to review.
The chapter ends with Eban raising the question of how patients and healthcare providers can trust the safety and efficacy of generic drugs in light of the widespread fraud and deception within the industry.
A: The fifth chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The China Connection". In this chapter, Katherine Eban shifts her focus to China, which has become an increasingly important player in the global generic drug industry.
Eban describes the explosive growth of China's pharmaceutical industry over the past several decades, fueled by a combination of government support and a low-cost, high-volume manufacturing model. She also explores the challenges faced by Western companies that try to do business in China, including concerns about intellectual property theft and corruption.
Eban highlights the case of the Chinese company Zhejiang Huahai Pharmaceuticals, which manufactured a generic version of the blood pressure drug valsartan that was contaminated with a known carcinogen. She explains how the contamination went undetected for months, and how the company initially tried to cover it up before eventually issuing a recall.
The chapter also delves into the challenges of regulating the global supply chain for generic drugs, given the complex web of suppliers, manufacturers, and distributors involved. Eban describes how the FDA and other regulatory agencies are struggling to keep up with the pace of globalization and the increasing complexity of the industry.
Overall, the chapter paints a complex and often troubling picture of the generic drug industry, highlighting the challenges of ensuring patient safety in a global marketplace where profits often take priority over quality control.
A: The sixth chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Ghost in the Machine". In this chapter, Katherine Eban delves into the technical aspects of generic drug manufacturing, focusing on the role of analytical testing in ensuring product quality.
Eban explains that analytical testing is a critical component of the generic drug manufacturing process, as it is used to verify that the drug product meets specific quality standards. She describes how manufacturers use a variety of analytical techniques to test the drug product at various stages of production, from the raw materials to the finished product.
However, Eban also highlights the challenges of ensuring the accuracy and reliability of analytical testing, given the complex and rapidly evolving nature of the industry. She describes how some manufacturers have engaged in fraudulent practices, such as manipulating test results or substituting high-quality raw materials for cheaper, lower-quality ones, in order to pass regulatory inspections.
Eban provides several examples of companies that have been caught engaging in these practices, including Ranbaxy and Wockhardt, both based in India. She also describes how some manufacturers have developed sophisticated techniques for masking the true quality of their products, making it difficult for regulatory agencies to detect fraud and deception.
Overall, the chapter underscores the importance of analytical testing in ensuring the safety and efficacy of generic drugs, while also highlighting the need for greater transparency and accountability in the manufacturing and regulation of these essential medicines.
A: The seventh chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Regulators". In this chapter, Katherine Eban examines the role of regulatory agencies in overseeing the generic drug industry and ensuring patient safety.
Eban begins by describing the history of the FDA and its evolving role in regulating the generic drug industry. She notes that while the FDA has made significant progress in recent years in improving the safety and quality of generic drugs, it still faces significant challenges in regulating an industry that has become increasingly complex and globalized.
Eban also explores the challenges faced by other regulatory agencies around the world, including the European Medicines Agency and the World Health Organization. She describes how these agencies have struggled to keep pace with the rapid growth of the generic drug industry, and how some have been accused of being too lenient or too slow to respond to safety concerns.
The chapter also delves into the challenges of conducting inspections of generic drug manufacturing facilities, which are often located in remote or hard-to-reach areas. Eban describes how some manufacturers have been able to evade detection by regulatory agencies by moving their operations to new locations or engaging in "data fabrication" to cover up quality control issues.
Despite these challenges, Eban notes that regulatory agencies play a critical role in ensuring the safety and efficacy of generic drugs, and that improvements in regulatory oversight are essential to maintaining public trust in these important medicines.
Overall, the chapter provides a nuanced and insightful look at the complex and often challenging world of regulatory oversight in the generic drug industry.
A: The eighth chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The False Fronts". In this chapter, Katherine Eban explores the tactics used by some generic drug manufacturers to deceive regulators and consumers about the safety and quality of their products.
Eban begins by describing the phenomenon of "facade factories", which are manufacturing facilities that are set up to look legitimate but are actually used to conceal fraudulent practices. She describes how some manufacturers go to great lengths to create the illusion of a well-run and compliant operation, while in reality engaging in practices such as data manipulation and the use of substandard raw materials.
Eban also describes how some manufacturers use "contract laboratories" to perform quality control testing on their products, even though these laboratories may not meet the necessary standards for accuracy and reliability. She notes that these contract laboratories are often located in countries with less stringent regulations, making it easier for manufacturers to engage in fraudulent practices without detection.
The chapter provides several examples of companies that have used these tactics to deceive regulators and consumers, including Ranbaxy and Emcure, both based in India. Eban notes that these companies were able to operate with impunity for many years, despite repeated warnings from regulators and industry insiders.
Overall, the chapter underscores the need for greater transparency and accountability in the generic drug industry, as well as the importance of vigilance on the part of regulators and consumers in identifying and exposing fraudulent practices.
A: The ninth chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Whistleblowers". In this chapter, Katherine Eban profiles several individuals who have spoken out against fraud and corruption in the generic drug industry.
Eban begins by describing the challenges faced by whistleblowers in the generic drug industry, including the risk of retaliation from employers and the difficulty of proving wrongdoing in a complex and opaque industry. She notes that whistleblowers play a critical role in exposing fraud and promoting accountability in the industry, despite the personal and professional risks they face.
The chapter profiles several whistleblowers, including Dinesh Thakur, a former executive at Ranbaxy who exposed widespread data manipulation and quality control issues at the company. Thakur's revelations led to a $500 million settlement with the US Department of Justice and helped to spur greater scrutiny of the generic drug industry.
Eban also profiles several other whistleblowers who have spoken out against fraud and corruption in the industry, including Peter Humphrey, a private investigator who helped to uncover wrongdoing at GlaxoSmithKline's Chinese operations, and Cheryl Eckard, a former quality control executive at GlaxoSmithKline who exposed serious quality control issues at the company's manufacturing facilities.
Overall, the chapter highlights the important role that whistleblowers play in promoting transparency and accountability in the generic drug industry. It also underscores the need for greater protections and support for whistleblowers, who often face significant personal and professional risks in speaking out against fraud and corruption.
大部分普通药区别不大。个别药仿制的不如brand
A: The tenth chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Global Supply Chain". In this chapter, Katherine Eban explores the complexities of the global supply chain for generic drugs, which involves multiple intermediaries and often spans multiple countries.
Eban notes that the global supply chain for generic drugs has become increasingly complex in recent years, as manufacturers seek to source raw materials and finished products from the lowest-cost suppliers around the world. She describes how this has led to a proliferation of intermediaries, including trading companies and brokers, who play a key role in connecting manufacturers with suppliers and customers.
Eban also notes that the global supply chain for generic drugs is highly susceptible to fraud and counterfeit products, as it can be difficult to trace the origins of raw materials and finished products. She describes how some manufacturers have exploited this complexity to engage in fraudulent practices such as the substitution of substandard raw materials and the use of counterfeit packaging.
The chapter provides several examples of companies that have struggled to manage their global supply chains, including Ranbaxy and Wockhardt, both based in India. Eban notes that these companies faced significant challenges in sourcing raw materials and ensuring the quality of their products, and that their difficulties were compounded by a lack of transparency and accountability in the industry.
Overall, the chapter highlights the challenges faced by manufacturers, regulators, and consumers in navigating the global supply chain for generic drugs, and underscores the need for greater transparency and accountability in the industry.
A: The eleventh chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Future of Generic Drugs". In this chapter, Katherine Eban examines the future of the generic drug industry, and the challenges and opportunities that lie ahead.
Eban notes that the generic drug industry is facing significant challenges, including increasing competition, rising costs, and a growing focus on quality and safety. She suggests that these challenges are likely to drive consolidation in the industry, as larger manufacturers acquire smaller players in order to gain scale and diversify their product portfolios.
Eban also notes that the industry is likely to face increasing regulatory scrutiny, as regulators seek to address the quality and safety issues that have been uncovered in recent years. She suggests that this could lead to increased costs for manufacturers, as they are forced to invest in new quality control systems and processes.
The chapter also explores the potential for new technologies to transform the generic drug industry. Eban notes that advances in areas such as 3D printing and personalized medicine could lead to new opportunities for manufacturers to differentiate their products and compete more effectively in the marketplace.
Overall, the chapter suggests that the future of the generic drug industry is likely to be shaped by a complex array of factors, including regulatory pressures, technological advances, and changing market dynamics. Eban suggests that the industry will need to adapt and innovate in order to thrive in this challenging environment.
A: The twelfth and final chapter of "Bottle of Lies: The Inside Story of the Generic Drug Boom" is titled "The Price of Cheap Medicine". In this chapter, Katherine Eban reflects on the implications of her investigation into the generic drug industry, and the challenges faced by patients and healthcare providers in navigating this complex and often opaque world.
Eban notes that while generic drugs have played a critical role in reducing the cost of healthcare and expanding access to essential medicines, her investigation has exposed numerous instances of fraud, deception, and quality control issues within the industry. She suggests that these issues have undermined patient confidence in generic drugs, and have highlighted the urgent need for increased transparency and accountability in the manufacturing and regulation of these essential medicines.
The chapter also explores the implications of the global supply chain for generic drugs, and the challenges faced by patients and healthcare providers in trying to navigate this complex and often opaque system. Eban suggests that patients and providers need more information and transparency in order to make informed decisions about the drugs they use, and she calls for greater collaboration and communication between manufacturers, regulators, and healthcare providers.
Finally, the chapter highlights the critical role that patients and healthcare providers can play in driving change in the generic drug industry. Eban suggests that by advocating for increased transparency and accountability, and by supporting manufacturers that prioritize quality and safety, patients and providers can help to ensure that the promise of cheap, accessible medicine is realized in a way that prioritizes patient safety and well-being.
Overall, the chapter and the book as a whole underscore the importance of ongoing scrutiny and oversight in the generic drug industry, and the critical role that patients and healthcare providers can play in advocating for greater transparency and accountability in the manufacturing and regulation of these essential medicines.
请问你吃的是哪个布洛芬啊？我看沃尔玛和target都有自己牌子的布洛芬，价格比advil便宜好多
好像是Walgreen自家的
美国的抗生素几乎都是国内制造的
绝对是这样的。好像看到过一篇文章说 Merck 的高血压药专利过期后（这药为 Merck赚了很多钱）， 其他药厂也能生产了。但这个专利只是给个药的分子结构。Merck 不会给 辅助材料，添加剂的具体配方。 后来 Generic 药厂也能出的长期服用的高血压药， 那个药的辅助添加剂的质量不行，药效就是比不上 Merck 的药。 这篇文章用了几个药来举例，但我就记得这个Merck药是一个例子（因为当时曾经买过它的股票）。
你可以去local 小药店问老板，可能会按你要的药厂拿药。
同一个牌子的原研药，中国产和欧美产的价格差了一倍有多，药效有没区别？
我也是！
你以为是商场里自己牌子的洗发水么
我记得奥巴马医疗除了保险部分的规定，还有关于大分子仿制药的相关法规规定。当初炒作废除奥巴马医疗时，了解制药行业法规的人都说不可能。因为大分子仿制药的规定美国本就落后于欧洲。好不容易借着奥巴马医疗建立了一部分，若是废了，后果很大，各药厂肯定会lobby
FDA美其名曰是promote public health, reduce healthcare cost. 里面文章很多。药审要收钱。很多很多的钱。收钱的人只会鼓励更多的人申请。现在基本generics 都是中国印度制造。山高皇帝远。数据真实性。facilities inspection. 不是每家每户查到每个细节的。所以最好别生病。生病别吃generics. 尽量吃brand name.
如果你吃过两种对比，差异还是显著的。美国的抗生素明显能感觉纯度更高，副作用更小。国产大药厂好一些，小药厂简直一塌糊涂。不是都是中国生产的，就都一个品质。两边质检要求我看都不一样。
非常对！主成份都是公开的，但formulation是研发的一大核心技术，不公开。就好像做菜光有原材料是远远不够的，还得有步骤、火候等等。
Monograph是上世纪70年代的时代产物。背景大致是应社会各方要求，国会和FDA必须对一些市场上横行的老药，特别是1938年FD&C法案前就在市场上的药有个交代。于是在大概20年内国会陆续通过了一堆drug-specific的法律(monograph)，对一些认为比较安全的药物赋予GRAS地位和非处方待遇。几乎每一个这种药都有自己的monograph (对，说的就是一个药居然有一个专门的法律来管理)。药厂只要符合一些生产规定并许诺使用monograph规定的说明书(drug facts)，就可以直接投放市场，不需要经过FDA批准。FDA对monograph药物管理的权限比较有限，所以幺蛾子比较多。
所以大家购买一些monograph管辖内的非处方药物的时候，可以考虑一些大厂生产的牌子(在monograph的世界里不存在法律意义上的brand name drug)。
应该是brand name products…
有些generic drug我吃着头疼，brand name就不会
买所谓原厂药就是智商税
是的。所以保险有很大关系。如果保险不cover brand name, 不差钱的可以自费。
😆
虽然是心理作用，但是心理作用也是作用。毕竟有的人吃placebo都有作用，尤其是止疼药这种的
下回做个双盲测试，试试看看准不准
现在什么民科都能充专家啊。。。。这么胡说八道也可以。。。
大分子药就不一样了 仿制药叫biosimilar 没法做到有效成分完全相同 虽然有临床试验是通过的 但差异性还是有
大分子药就是生物制药，比如蛋白质，多肽，DNA和RNA等. 小分子药物就是传统的有机化学合成的药物。再简单点，小分子药物随便常温保存和运输。大分子药，除了DNA，大多都需要低温保存，运输条件要求高。