Violent Medicine is set in the American pharmaceutical industry and begins with flashbacks. This paper mainly describes the heroine Celia Jordan's bumpy experience from a new drug salesman and deputy director of business training department to a middle-level management position such as sales manager of over-the-counter drugs and prescription drugs, who was forced to resign halfway and finally stepped onto the CEO of Fielding-Ross, a multinational pharmaceutical company. Arthur haley described the complexity of the pharmaceutical industry incisively and vividly, revealed the inside story of the entire pharmaceutical industry in the United States at that time, and deeply analyzed the inherent disadvantages in the whole process of drug research and development, clinical research, approval and marketing, showing a profound understanding of the industry, which is worth learning by our pharmaceutical industry researchers.
The book is mainly divided into four parts, with time as the axis and narrative from point to surface. Judging from the rise and fall of several key figures, the development of a pharmaceutical company is connected in series, which reflects the changes of the entire American pharmaceutical industry and social environment.
Part I (1957- 1963): After World War II, the pharmaceutical industry in the United States entered a period of rapid expansion, and new compounds were quickly discovered and listed, especially the broad-spectrum antibiotics represented by streptomycin. This is an era in which miracle drugs appear and the pharmaceutical industry is praised. It corresponds to the infinite glory that Lotring brought to Celia and Andrew and Fielding-Ross Pharmaceutical Company.
The second part (1963- 1975): After experiencing the barbaric growth stage brought by rapid development, the FDA of the United States began to strengthen supervision. Compared with the United States, the European government's management of drug clinical trials was relatively loose, and American pharmaceutical companies also adjusted accordingly, becoming cautious in the introduction and sales of new drugs, and began to set up research centers in Europe.
The third part (1975- 1977): Faced with the huge interest temptation, enterprises took risks and selectively avoided adverse events, which laid the foundation for the subsequent major setbacks.
The fourth part (1977- 1985): innovation development stage. In 1970s, American pharmaceutical industry ushered in a new era. There are two catalysts to promote this era: one is the great development of DNA recombination and genetic engineering; The other is a major breakthrough in biochemistry, enzymology and microbiology. In the early 1980s, the U.S. Congress promulgated a series of bills to promote the basic research funded by financial funds to be transformed into useful new products more quickly and improve the competitiveness of American high-tech enterprises in the world market. During this period, thousands of biotechnology enterprises have obtained financing, including listing and venture capital, and biotechnology has been greatly developed. ?
On the other hand, there will be unexpected problems in the R&D process. Although the experimental and clinical data of propranolol drugs led by Dr. Lord in the book are very good, and the sales in Europe and patient feedback are very good, there are still great difficulties in the approval of FDA in the United States, resulting in the phenomenon of "drug lag" (referring to some drugs that have been widely used in other countries, but are not allowed to be listed in the United States). This is due to the lagging process of FDA regulations in the United States. For example, at that time, although the FDA had made many improvements, it still reminded investors that when evaluating the expected benefits of pharmaceutical companies' research products, they should also consider the time when the products were approved by the FDA.
Back to the specific characters, Celia, the protagonist of Strong Medicine, has been working in Fielding-Ross Pharmaceutical Company from her early years to her fate. At first, she was a new drug salesman, and in the process of promoting new drugs, she met the upright Dr. Andrew Jordan. They were congenial, fell in love at first sight and got married. Within the company, Celia's strong sense of social responsibility and integrity hindered her promotion. For example, Dr. Lord, the director of the R&D Center with a bad temper and sharp words, has always disliked Celia's innovative spirit and repeatedly opposed Celia's views at company meetings. However, Celia was promoted from a salesman to the general manager of the company with her courage to break away from convention and challenge authority and the support of her boss Sam. The whole promotion process of the protagonist also reflects the disadvantages of the American pharmaceutical industry from the side, which is thought-provoking.
Celia is a strong career, a winner of life and a defender of morality. As early as in her twenties, she set a great ambition: "I want to do something, and I want to rise to the highest position." In fact, she is not only ambitious, but also has the spirit of adhering to principles and abiding by professional ethics. The company is going to market a new drug "thalidomide", which can treat vomiting reaction in early pregnancy. Celia pushed her way through the crowd and prevented thalidomide from going public in the United States. Soon after, there was an outbreak in European countries where a mother who took thalidomide gave birth to a fetus with seal limbs, and Celia was promoted because the company avoided risks.
? In fact, this drug was not simply invented by the author, but there was such a background event in the history of medicine, which was called "thalidomide" in history. Indirectly, the European drug regulatory authorities' market trials of new drugs before listing are not perfect, and pharmaceutical companies will shorten the trial time in order to obtain high returns, resulting in insufficient research on the effects and adverse reactions of drugs. However, the drug failed to pass the FDA review in the United States because it had a deformed fetus with seal limbs in Europe. The thalidomide incident also promoted the reform of the drug listing system in the United States. 1962, the United States promulgated a new law, requiring that a reasonable drug trial plan should be made before the drug goes on the market, and strict scientific principles should be followed during the trial.
The book has a compact plot, ups and downs and exciting content. In addition to the protagonist, the image portrayal of other characters is also in place. For example, Dr. Merry, a mean FDA examiner, Dr. Lord, director of the R&D center of pedantic company, and Dr. Martin, director of the R&D center in Britain, who is immersed in scientific research, and so on. This book deeply reveals several pairs of main lines of contradictions and conflicts between American pharmaceutical companies and all parties by using complex character relationships and fierce incident conflicts, which has great enlightenment to investors:
The contradiction between American pharmaceutical companies and doctors: information asymmetry. American pharmaceutical companies sell new drugs to doctors through drug salesmen. In the novel, Dr. Andrew mentioned that in previous cases, patients would get worse or even die after using new drugs promoted by salesmen. Secondly, the advertising problem of pharmaceutical companies, the proliferation of drug advertisements, but many advertisements do not mention what doctors should and must know, such as the side effects of drugs. At the same time, doctors' information about new drugs is mostly dictated by drug salesmen. The consequences of this information asymmetry may lead to the situation that "pharmaceutical companies sell thalidomide under 53 different names" in the book, which makes the fundamental purpose of new drugs change from treating diseases to making profits, which requires employees of pharmaceutical companies to improve their professional ethics and strengthen the ethics of new drug promotion and the supervision of FDA.
The contradiction between American pharmaceutical companies and FDA: regulatory loopholes still exist and reforms are still going on. The FDA has three identities in the pharmaceutical industry: regulator, authorizer and scapegoat. In the book, the new drug thalidomide triggered by Merrill Lynch's "thalidomide" incident is still under FDA approval, and the company distributed it to 1000 doctors through enthusiastic salesmen. The book describes the FDA as follows: "Because law and practice require it to have multiple functions at the same time. It is the defender of public health, and in turn, the bureau is a diligent and thoughtful angel. " The basic duty of FDA is to protect innocent people from some pharmaceutical companies. Because their basic goal is profit, these companies sometimes make mistakes of excessive greed or incompetence or indifference. Another task of FDA is to take certain risks for pharmaceutical companies that successfully approve new drugs. Once the approval is successful, the FDA will have a legal protection status and will accept direct criticism from the public when there is a problem with the drug. As mentioned above, the "reaction stop" incident directly led to the reform of the FDA. As consumers and investors, they prefer to see the FDA's supervision more perfect, rather than becoming a "scapegoat" for pharmaceutical companies.
What is more enlightening to investors is that the successful approval of ANDA (referred to as new drug application) in history often directly leads to the rise of the company's share price. In the book "Violent Medicine", Dr. Mace, an internal member of FDA, took advantage of his position to obtain the news that many companies were approved by ANDA, and made a fortune by buying and selling the stocks of these companies. In the United States, once the patent of an important drug expires, pharmaceutical manufacturers will apply to FDA for ANDA. As long as the drug is approved, it can be produced as a generic drug and then sold at a relatively cheap price to make huge profits. For investors, first of all, it is necessary to ensure the compliance and legality of information sources, and secondly, it is necessary to pay attention to information such as ANDA approval from pharmaceutical companies, so as to obtain reasonable income.
The contradiction between prescription drugs and OTC in American pharmaceutical companies: risks and benefits may not be equal. OTC refers to over-the-counter drugs, that is, drugs that consumers can buy directly at pharmacies or pharmacies without a doctor's prescription. The book reveals a phenomenon: the basic difference between over-the-counter drugs and prescription drugs is that prescription drugs need a lot of money to study, and then it will take at least five or six years to go on the market, while over-the-counter drugs can get the formula in less than six months, with low cost, and most of the money is spent on packaging advertising and promotion. Because the OTC market is clear, the demand is large, and the most important thing is that the side effects are small, that is to say, the risk is low and the income is high, as described in the book: "Fortunately, many people who take cold medicine are hoping in droves to spend $500 million a year to treat their incurable cold." In reality, if over-the-counter drugs account for a large proportion of the company's revenue, then the company's profit quality and revenue sustainability are insufficient, and pharmaceutical companies must firmly grasp the "innovation premium".
Contradiction between American pharmaceutical enterprises and trade associations: mutual game. American pharmaceutical industry associations, such as the "Citizens' Association for Safe Drug Use" in the book, have a game relationship with American pharmaceutical companies. The association hopes to get donations from enterprises, so as to strengthen itself and serve citizens, while enterprises hope to get industry support and social credibility from the association. For example, the "Montagny" vicious incident in the book shows that once a company has serious problems, American trade associations often condemn the company from the public's point of view, rather than helping it solve the problem.
On the whole, Fierce Medicine truly reflected the background of the entire American pharmaceutical industry at that time. The background of the whole story is that after World War II, there was a huge demand in the American market, and some enterprises began to focus on developing new products and gradually changed from production-oriented enterprises to R&D enterprises. At the same time, the medical coverage has been expanding, and the proportion of medical expenditure in GDP has been rising, which has promoted the development of the pharmaceutical industry.
For China today, biotechnology and pharmaceutical companies have increased their financing or listing, which corresponds to the times described in the book. The risks or problems faced by American pharmaceutical companies described in the book may also happen to pharmaceutical companies in China. In a comprehensive book, investors should not only pay attention to the company's profit and income, innovation ability and other positive indicators, but also pay attention to the possible risks of the products under research and the possible moral hazard within the company. Drug research and development is uncertain and accidental, and the process of drug research and development is always a long process, in which there are always good and bad accidents. In the book, Martin of the London Research Center, while developing the drug peptide 7 to improve the memory of the elderly, accidentally found that these drugs can reduce the weight of mice, thus developing a new type of diet drug.
The book "Violent Medicine" not only brings us an analysis of the pharmaceutical industry, but also tells us to keep a clear head and stick to principles when facing huge benefits. In the face of huge interests, social responsibility and integrity are paramount, and compliance is not forgotten. This deserves our vigilance.
A person discovers new things by "persistently focusing on a specific direction".
John Locke