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Monday, December 7, 2020

The Truth about Generic Drugs

It took 10 years to interview more than 240 people and expose the truth behind generic drugs!

The Truth about Generic Drugs
Image source: Royalfree Creative Commons

In 2018, with the release of "I'm Not the God of Medicine", many Chinese people were also shocked by the huge price difference between brand-name drugs and generic drugs when they were moved by the moving stories in the movie, which produced a lot of Question, what is a generic drug? Why is there such a big gap between generic drugs and brand-name drugs?

What are generic drugs?

Generic drugs mean that after the patents for certain brand-name drugs expire, other pharmaceutical companies can also produce such drugs. However, the produced drugs must have the same active ingredients, route of administration, dosage form and the same therapeutic effect as the original drugs. This is imitation.

For example, we saw in "I'm Not the God of Medicine" that Chen Yong went to India to buy VEENAT for the treatment of chronic myelogenous leukemia, which is a generic drug of the original drug Gleevec. Because of the high price of Gleevec, many people with poor financial resources choose generic drugs from India.

In fact, whether it was in movies or in real life, because of its low price, the appearance of generic drugs has indeed solved the urgent needs of many families. Its appearance was once considered to be the gospel of patients and is a "21st century public health - The greatest progress in the field".

But in the United States nearly ten years ago, a national public radio host named Joe Gladden continued to complain from many patients. These patients' complaints were all kinds of generic drugs. Many of them have not achieved the expected therapeutic effect after taking generic drugs, some even have other side effects that should not occur, and some drugs can even cause cancer. For a time, generic drugs were pushed to the forefront.

So, Joe Gladden turned to the senior American investigative journalist and writer for Fortune: Ms. Catherine Eban. Because she has been investigating drug and public health issues, after receiving Joe Gleden's request for help. Ms. Catherine Eban immediately launched her investigation of generic drugs, and finally wrote the "The Truth About Generic Drugs" which was called an epic by the New York Times.

For 10 years, Ms. Catherine Eban interviewed more than 240 people, including doctors in various hospitals, patients, employees of some pharmaceutical companies, and some staff of the US Food and Drug Administration. These people provided Catherine Eban with many investigation reports and medication reactions and other information related to generic drugs.

In 2018, a "I'm Not the God of Medicine" was born in mainland China, with a Douban score of 9.0 and a box office of more than 300 million. It caused an upsurge in viewing by the whole people and became a rare word-of-mouth phenomenon with a double harvest at the box office.

The film tells the story of Cheng Yong, the actor starring Xu Zheng, risking his life and legal sanctions to smuggle the generic drug "Glenin" for the treatment of leukemia from India and sell it to patients at an extremely low price. This saved countless families who were on the verge of breaking because they could not afford expensive brand-name drugs.

The contradiction between the high price of the original research drug for the treatment of leukemia in the movie and the struggling of the patient to go bankrupt to treat the disease hits the hearts of the people. The hero's self-sacrificing spirit touched countless people and earned enough tears from the audience.

For a time, India's generic drugs have become synonymous with "good quality and low price", and become a miraculous medicine to save the lives of patients. However, there must be shadows under the sun. Are Indian generic drugs really so magical? The answer is not yes.

(One)

Harry Liver is a 62-year-old cardiologist in the United States. His specialty is the treatment of hypertrophic cardiomyopathy. Many of his patients need diuretics to reduce edema and prevent fluid accumulation. He has prescribed brand-name drugs to patients for several years, and the effects of the drugs have achieved the expected results. However, he recently discovered that a patient had taken a diuretic called "furosemide" imitation by India's Lambeth Company, and it was still difficult to remove body fluids. He replaced the patient with a diuretic produced by another company, and a week later, the patient discharged 15 pounds of body fluids.

Another patient had a similar situation. He took a generic drug called torasemide, but he still had swollen ankles. He could only fall asleep with a pillow to keep his upper body upright. After Liver replaced them with a diuretic produced by another company, the situation improved immediately.

As a result, Liver began to pay attention to the inexplicable symptoms and suspicious drugs that occurred in patients, and more and more discoveries were made.

One of his patients had obstructive cardiomyopathy. He had been taking a brand-name drug called Pravastatin to control cholesterol. Later, he changed to a generic drug called Pravastatin sodium. During the examination, the doctor found that her cholesterol was high. Amazing. And this generic drug also comes from a pharmaceutical company called Glennmark in India.

Many people does not know the difference between generic drugs and original drugs.

The so-called generic drugs are drugs that have the same active ingredients, dosage forms, routes of administration and therapeutic effects as the original drugs. Because it saves expensive research and development costs, the price of generic drugs can also be greatly reduced.

In theory, generic drugs and original drugs should have the same therapeutic effect. But in fact, the situation is not so simple.

For their own interests, the original research drug company with patents will not easily reveal some of the secrets of its production process even after the patent expires. Strict control of the production process is an important way to ensure the quality of drugs.

Therefore, although each generic drug manufacturer knows what the molecular formula of the drug is, how do they synthesize this ingredient? How to ensure its stability and not decompose to produce toxic and harmful impurities during production and storage? How to control the slow-release technology of drugs so that the generic drugs and the original drugs have the same bio equivalence are a series of problems that are insurmountable on the road of generic drug production.

For example: GlaxoSmithKline has a very popular antidepressant Wellbutrin XL. After the patent expired, the Israeli pharmaceutical company Teva launched a generic version of "Budeprion XL". The patient complained of headache, nausea, dizziness, irritability, and sleep and anxiety problems after taking the medicine.

The pharmacologist and medical anthropologist Gladden and his wife took the drug complained by the patient to several independent laboratories for testing, and found that the "Budeprion XL" produced by Teva was suddenly released in the patient's body two hours after taking it. Four times the amount of active ingredients under normal conditions. It's like drinking a glass of wine slowly in two or three hours without feeling drunk, but if you finish drinking it in one breath, you may get drunk.

It can be seen that although various countries and pharmaceutical companies can produce generic drugs after the patent protection period of various original research drugs expires, there are still many problems to be solved, which are not as simple as imagined.

(Two)

At present, there will be more than 150 patents of original research drugs in the world that are about to expire, which means that more countries and pharmaceutical companies will seize this multi-billion dollar market.

However, medicines are different from ordinary commodities after all. It is not just an ordinary workshop that can produce qualified medicines that can treat diseases.

Companies that produce drugs must strictly abide by the requirements of "Good Manufacturing Practices" or GMP.

Any problem in any part of the production process may lead to serious consequences. For example, if the sanitary conditions are not up to standard, then the microbiological limit of the medicine may not pass. Another example is the aging of the gasket in a mixer, and black plastic particles will be mixed into the medicine produced on this assembly line, and once it enters the human body, it may cause unpredictable adverse reactions.

However, driven by huge economic benefits, many companies use forged clinical data, copy and paste the map of branded drugs, or even replace the generic drugs with the original drug to obtain a qualified inspection report when the drug quality is not up to standard., In order to pass the technical review of the US Food and Drug Administration and seize the market for generic drugs.

Indian-American Dinesh Sakur is an information engineer at Bristol-Myers Squibb. This company focuses on the development of new drugs, from Pracos, which treats high cholesterol, to Plavix, which prevents blood clotting. The company’s scientists have won the prestigious Lasker Award and were awarded the National Technology and Innovation Award in the White House in the United States.

Here, Sakur can give full play to his professional strengths and has a boundless future.

However, because of the influence of his old boss Papuhia, he decided to return to India to develop and join the generic drug industry. There is a different culture here, which is also the best medicine, and it should make all patients look up and see the disease.

In India, Lambeth is a legendary enterprise, and its founder, the Singh family, is also known as the royal family in the corporate world.

Sakur came to Lambeth with confidence, ready to use his expertise to bring better development to the company. But soon after, he felt obstructed by all kinds of things.

His first job was to digitize the company's clinical trials records, including informed consent forms, patient cases, and laboratory results.

However, his work was opposed by older employees. The other party even said: "If we do this, how can we back-sign the document?" This is an obvious fraud.

Soon after, his old boss Papuhia suddenly decided to leave Lambeth. He mentioned the "ghost tricks" the company played, many of which were enough to make the company shut down, such as the annual budget.

Sakur clearly remembers that the company has developed about 150 products. Based on the cost of each generic drug of 1.5 million U.S. dollars, Lambeth’s total development budget should also be around 225 million. However, it actually only has About 100 million U.S. dollars, the company made a big discount.

Later, Sakur discovered more evidence of the company's fraud.

Because many Lambeth's production companies are in India. When inspectors from the U.S. Food and Drug Administration come to check on the spot, they must apply for a visa to the customs several months in advance.

This also gives overseas companies more time to prepare, destroy evidence, and falsify data.

As the investigation deepens, Sakur is even more shuddering that this is not just a question of a pharmaceutical factory under the name of the Lambeth Group. It is a practice of the Lambeth Group in global production companies.

Sakur, who had a lot of evidence, resigned from Lambeth.

In order to prevent more patients from becoming victims of this appalling scam, he decided to anonymously report Lambeth’s criminal activities to the U.S. Food and Drug Administration.

However, what he didn't expect was that this eventually turned into a protracted tug of war.

Lambeth is a large multinational company. For Sakur, it is undoubtedly a contest between elephants and ants. The generic drugs exported by Lambeth to the United States not only involve huge economic interests, but also political relations between the United States and India.

What's more frightening is that in India, where the legal consciousness is indifferent, whistle blowers often end up tragically, and may even end up with corpses in the wilderness.

In order to prevent the news from leaking, Sakur had to hide it from his family and daughter. This also caused his marriage to gradually break up.

Sakur is like a weak ant. Can he shake the elephant of Lambeth?

(Three)

The above story comes from the book "The Truth About Generic Drugs". This is the author Catherine Eban's combing and investigation of the global generic drug industry chain over a period of ten years, interviewing whistleblowers, investigators and medical staff. He consulted countless confidential documents in the U.S. Food and Drug Administration, and wrote a documentary that exposed a terrifying scam in the Indian generic drug industry that seriously endangered public health safety.

This book also won the Cornelius Ryan Award for best international non-fiction work.

The New York Times commented on it as "exciting. In addition to the compact rhythm, Eban's narrative structure makes this extremely complex story easy to understand, which gives the book a rough and natural elegance. The significance of this exposure is priceless and it can be called a wonderful epic." This book was also included in the list of 100 notable books in 2019 recommended by the New York Times.

The author of "The Price of America" ​​and Pulitzer Prize winner James Reyson also praised it, "This book will save lives. Catherine Eban asks whether the drugs we take every day will threaten our health. Like Rachel Carson's persistence when he explored environmental crises, "The Truth About Generic Drugs" is a masterpiece of global investigative reporting."

Now, the world's generic drugs account for 90% of the total drugs, but the quality of generic drugs is also uneven. Most medicines of poor quality are sold to backward regions, such as Africa.

The biggest harm of these ineffective generic drugs is that the viruses in those places have developed resistance.

It's like Xiao Yu'er has been soaking in the medicinal wine of the genius doctor of the Evilman Valley since he was a child, thus developing a body that is not invading. In the end, no amount of powerful drugs can kill this virus.

This is also one of the reasons why super viruses are always produced in poor and backward places in Africa and South America.

The emergence of generic drugs is undoubtedly a milestone of great significance in the history of human medicine. However, it is also a double-edged sword. The book "The Truth about Generic Drugs" undoubtedly exposes the shadows behind the sun, allowing more people to look at the same thing from different angles.

It is not only a professional documentary novel, but also a detective novel with ups and downs in plot.

Generic drugs are cheap versions that are legally copied after the patents of brand-name drugs expire. It is said that its ingredients and effects are almost the same as those of brand-name drugs. The widespread application of generic drugs is hailed as "the greatest advancement in the field of public health in the 21st century."

Today, generic drugs account for nearly 90% of the pharmaceutical market. But what is the real state of this industry? Is it flooded with dishonest counterfeiters, or is there no shortage of discounters who ensure quality?

Catherine Eban conducted a decade-long investigation on the global industrial chain of generic drugs, revealing the hidden safety hazards behind it and the terrible risks it brings to global public health. Through interviews with whistleblowers, investigators, and medical staff, and combing through the massive amounts of information contained in thousands of pages of confidential documents from the U.S. Food and Drug Administration, Eban exposed an industry that is rampant in fraud and falsified data. In order to reduce costs and maximize profits, business managers do not hesitate to evade almost every principle of safe production. And patients who take these drugs without knowing it will have unpredictable consequences and sometimes even life-threatening.

All this is not happening in isolation, and the generic drug industry can be described as the ultimate touchstone of globalization. Catherine Eban’s thrilling documentary literature will lead readers to witness how a pioneering work in the field of public health has gradually developed into a terrifying hoax.

Patients often think that the generic drugs they are taking are exactly the same as the brand-name drugs, partly because they imagine a simple and friendly process: after a drug’s patent expires, the brand-name drug company will hand over the formula, and then the generic drug company. The same drug will be produced, but at a fraction of the cost, because it does not have to spend money on research or marketing. But in fact, from the moment they start to develop generic drugs, generic drug companies have begun a battle involving law, science, and regulation, and they often have to fight in the dark. Most of the time, when their products enter the market, they are not helped by brand-name drug companies, but obstructed. Generic drug manufacturers need samples of brand-name drugs in order to conduct research and decomposition, but brand-name drug companies often hold samples and do not sell them. Once a generic drug company locks in a molecule and the company’s scientists have figured out how it works in the human body, the company’s lawyers will begin to investigate the extent to which it is protected by law. The next thing is going on in the laboratory: synthesizing and developing the effective ingredients of the drug. This process alone may take several years of trial and error. Then there is testing. Brand-name drug companies must test new drugs on thousands of patients to prove their safety and efficacy. Generic drug companies only need to prove that their drugs can have similar effects to brand-name drugs in the human body. To this end, they must also test on dozens of healthy volunteers and draw a map of the concentration distribution of the drug in their bodies. After making the active ingredients, selecting additional ingredients, and conducting major laboratory and clinical trials, the formula must be transferred to the production workshop to see if it can be produced on a commercial scale. With the expansion of production scale, the production process has become more difficult to control. As long as any step can go wrong, it will go wrong. Responsible manufacturers will try to prevent old disasters and prevent new ones. But because the production workshop is operated by people, the system will always fail, no matter how well they are designed. To eliminate such variables, the only way is to make the factory strictly abide by good manufacturing practices and record every pharmaceutical step in real time. The data generated from this can be used as a blueprint to find and correct inevitable errors, which is also a process that US Food and Drug Administration investigators will carefully check.

It is not easy to tell an intricate story clearly. Generic drugs have prices in the third world, and there are hidden dangers in the third world, quality control and internal company management issues. Brand-name pharmaceutical companies will not give out formulas even if the patents expire, and the main ingredients are disclosed, but the steps and processes are still confidential, so generic pharmaceutical companies need certain R&D funds and strength. When generic drugs are packaged as charity, it is necessary to expose their fraudulent activities.

The plot is ups and downs, the truth is shocking, the reality is thought-provoking, and the future needs to be changed! This book deserves a more gimmick title "There is no Medicine God in India" for more people to read, because it deeply exposes an important issue that "I am not a medicine god" avoids-driven by profit and lack of effectiveness Regulated generic drugs, because of their cutting corners and low quality, are largely the same as ineffective or even harmful counterfeit drugs. The root cause of this problem is still the "poor disease." Even the U.S. Drug Administration, the world's highest standard (in exchange for the lessons of blood), is forced by the financial pressure of the American people's medical insurance to turn a blind eye to inferior or even killing generic drugs. Close one eye. Of course, the culprit is still India's lustful drug dealers and the national government umbrella behind them. Although the protagonist of this book is India, it is difficult not to think of my country during the reading process. Sure enough, compared with the English version, it was found that the Chinese version had almost deleted every sentence involving my country (I sorted it out and posted it in the discussion area. Is negative information). From this to the present, there can be no falsehoods in every aspect of vaccine development.

About the author ... 

Katherine Eban

Senior investigative journalist, Andrew Carnegie researcher, and Fortune magazine writer, graduated from Brown University and Oxford University. Author of "Dangerous Dose: The True Story of Police, Counterfeiters, and Contamination of the U.S. Drug Supply." Eban's in-depth reports on counterfeit and substandard drugs, CIA torture, and gun trafficking have won numerous awards in the press.


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