On 24 July 2014, Chevy Chase, Maryland, USA, A deaf and incompetent old man passed her 100th birthday peacefully. The outside world has little attraction for her. In addition to the FDA, The world has long forgotten her. On the list of American heroes of the 20th century, The old man had her unshakable seat, But it has long been forgotten by the world. Her name is Frances Oldham Kelsey. Life’s fame depends not so much on opportunity, Better luck. Kelsey’s luck is that her name is easily misunderstood as a man. She was born in Canada. When I was a child, Her parents wanted her to have the same education as her brother, Send her to a private boys’ school, He then received a bachelor’s degree and a master’s degree in pharmacy from McGill University. At the suggestion of the professor, Write to Eugene Geiling, an authority on pharmacy and head of the Department of Pharmacy at the University of Chicago, Apply to be his assistant. Galin wrote back immediately, Yes. Kelsey was delighted, Because men and women were not equal in those days, Women are generally discriminated against in seeking employment, It is believed that it deprives a man of the ability to raise his wife and children. I thought Galin was an alternative. A closer look at the reply, [Dear Mr. Oldham, ,,, ,,], She knew that Galin, like many people, read her name Frances as Francis. She thought she was a man. She was going to write back to Galin and tell him, I am a woman, But the professor said: Don’t be silly, Take the job, Sign your name and put MISS in brackets after it. She did so, Galin will be wrong, She came to the University of Chicago, Just in time for the sulfanilamide incident in the United States, The FDA asked Galin for help, To study the toxicology of sulfanilamide. Kelsey took part in the investigation of sulfanilamide incident. He received his doctorate in 1938, After that, he taught at the University of Chicago. He also received a doctor’s degree in medicine, Married to colleague Fremond Kelsey in 1943, Guan Fu changed her surname to Frances Oldham Kelsey. She has two daughters. She left the University of Chicago in 1954 to teach at the University of South Dakota. Three years later, she left to practice medicine there. In 1960, 46-year-old Kelsey became an FDA employee. The U.S. Government’s position is stable and her retirement benefits are good. Kelsey left for old age.
At the time, only seven full-time and four part-time doctors were in charge of reviewing drugs. A month after arriving at the FDA, she took over Richardson Merrill’s application, a regular application for the trade name Kevadon to enter the market.
This is a new drug developed by German pharmaceutical industry. Thalidomide, It was developed by Chemie Grunenthal in West Germany. The inventor who won 20 times the annual salary for developing this drug was former Nazi military doctor Muktel. Thalidomide also has a very famous name: Thalidomide. Grantai Pharmaceutical Company hopes to find another synthetic antibiotic based on thalidomide. But it was found to have sedative and analgesic effects. It went public in 1957, It claims to be a magical drug for insomnia, cough, cold and headache. It was soon discovered that it can treat morning vomiting and nausea of pregnant women. It was also promoted as an ideal choice for pregnant women, As a result, thalidomide became popular in Europe, Canada, Japan, Australia and other countries. Becomes another magic drug developed by German pharmaceutical industry. Meryl Company Obtains License, It plans to fully launch thalidomide in the U.S. Market. Although FDA has the real power of drug supervision, But it still doesn’t have much power, The number of new drug applications is still too high, From 1938 to 1962, The FDA has accepted applications for more than 13,000 new drugs, There are only a few FDA officials responsible for examining drugs. With such a heavy workload, It is difficult to strictly control. In 1951, Congress pas that Durham-Humphrey amendment, A classification of prescription and over-the-counter drugs has been developed, The safety principles of drugs have been further determined. At the same time, FDA cracked down on false drug effects, Withdraw ineffective drugs from the market. In 1959, Senator Estes Kefauver hopes to further amend the law, Increasing the authority of the FDA, Strict control of drug efficacy, But there was great resistance. Kelsey looked at Meryl’s application once. It was found that they applied for listing under the name of treating morning vomiting and nausea of pregnant women. It suddenly occurred to me nearly 20 years ago. When she and her husband collaborated on anti-malaria drugs, It was found in experimental rabbits that the drug could pass through the placenta. For this reason, she has been paying close attention to the safety of medication for pregnant This application was extremely cautious. At the end of 1957, Cases of deformed babies born to alcoholic mothers have been reported, However, the medical profession still does not believe that drugs can pass through the placenta. Therefore, pregnant women are no different from adults in medication. After thalidomide was put on the market, It was soon discovered that the baby was born with defects, Tracking found that the mother had taken thalidomide. At the end of 1959, It was found that peripheral neuritis was caused by taking the medicine. Thalidomide was no longer an over-the-counter drug. In February 1961, Kelsey read in a British medical journal a letter from a doctor about taking thalidomide and peripheral neuritis. The safety of thalidomide is more doubtful, Merrill was asked to provide more animal test data and all clinical test data. The drug cannot be approved until it is proved to be truly safe. Merrill has long hated this stubborn bureaucrat newly hired by FDA. This kind of routine application is originally a formality, A drug that has been used abroad for several years is on the market in the United States. The FDA has always been happy to approve, I didn’t expect to meet this truer person this time. I can only think of myself as unlucky, On the one hand, he sent the data of animal tests and clinical tests he had done in Europe, On the other hand, it has been widely tested in the United States. This is legal. Merrill has found 1,200 doctors in the United States. 2.5 million tablets of thalidomide were distributed, More than 20,000 people took it, Creating a lot of momentum. Kelsey is still not satisfied with their data. And believed that thalidomide might affect the fetus. As a result, she was under great pressure. From pharmaceutical companies, from lobbying groups, from women’s circles, from those who hate federal bureaucrats, But Kelsey insisted, She only needs one word: Safe. In December 1961, Australian obstetrician William McBride published an article in the British Lancet magazine. It is pointed out that thalidomide can cause infant malformation. This is a birth defect with hypoplasia of limbs. It is called seal limb disease because it is as short as a seal’s fin foot. Seal limb disease was originally rare, In recent years, there has been a sudden increase. Mothers have taken thalidomide during pregnancy, McBride thinks thalidomide is the cause of seal limb disease. German pediatrician Vidukinde Lenz came to the same conclusion. A big storm came, Countries have forced thalidomide off the shelves. About 10,000 to 20,000 seal limb babies were born. Meryl quickly withdrew the drugs it sent out. There are still 17 infants with seal limb disease in the United States. On July 15, 1962, An article in the Washington Post reported on Kelsey’s performance in the Thalidomide application, arguing that if it weren’t for her persistence and courage, thousands of American babies would have been born with birth defects. Kelsey rose from obscurity to become an American hero overnight and was awarded the Presidential Award for Outstanding Federal Citizen Service, the highest honor given to federal employees.
The Thalidomide incident has won wide support for Kiefford’s proposal. In October 1962, President Kennedy signed the Kiefford-Harrison Amendment, stipulating that the effectiveness and safety data must be submitted to FDA for the listing of new drugs. Once there is a problem with the listed drugs, they must be recovered as soon as possible.
In 1963, Kelsey became director of FDA’s Drug Investigation Department. In 1968, he was promoted to director of the Scientific Investigation Office. After 45 years of service with FDA, he retired at the age of 90 in 2005.
As when proces that application for listing of the reaction stop, The discretion, Let FDA really become a gold-lettered signboard. From then on, Safety has become the basic principle of drug supervision, Particularly for children and pregnant women, There is no room for discussion on safety. Medical modernization includes not only medical education, medical equipment and technology, health and epidemic prevention, But also drug surveillance, Without a safe drug market, It is not modern medicine. The emphasis of drug supervision lies in the medication of pregnant women and children. You can’t just reduce it, Not to mention that we can’t make loose remarks and reduce them. There must be perfect assurance, Prove that drugs do not harm children, do not cause birth defects, For those drugs that are harmful to fetuses and children, Even if there are only a few cases, Nor should it be used with caution, It must be recalled as soon as possible. The thalidomide incident shows that Serious adverse drug reactions, Particularly those leading to birth defects, Children are the future of a nation and a nation, Without providing a safe environment for children to use drugs from gestation, This country, this nation has no future. China’s drug review, Especially traditional Chinese medicine, Most of them are listed when the side effects and adverse reactions are not clear. Including medication for pregnant women and children, There is no safe dose, In this regard, China’s drug supervision is not up to standard. Drugs are used to cure diseases. It is good to be able to cure or control diseases, But the bottom line is that you can’t take medicine to treat one disease and eat another. There is a trade-off between safety and efficacy. But unless it comes to life and death, Efficacy cannot override safety, Particularly for pregnant women and children, Drugs with unclear curative effects such as Chinese herbal medicines should put safety first. There is no fait accompli in the drug market. Without the burden of history, No matter how many years it takes, In the event of serious adverse reactions, It must be recalled. At this point, China’s drug supervision is also substandard. The United States has learned a lesson. Safety is the first priority in drug supervision, and China has not learned the lessons of the past. That is why there are too many [toxic] drugs in the drug market, and too many patients, including children whose lives have just begun, are sick or even dead because of taking drugs. The distance between China’s drug supervision and the golden signboard is far from far away! Many Chinese doctors are also unqualified in this respect, When you succumb to the profits of drugs and the demands of patients’ families without putting drug safety, especially for children, in an unshakable position, Think of the dying centenarian in the distant United States. Frances Oldham Kelsey’s tenacious life is like a mirror, shaming drug supervision departments and medical workers around the world who ignore drug safety, especially for pregnant women and children. This time, God is fair! Frances Oldham Kelsey, who gave the public access to safe drugs, lived a long life. Benevolent people live a long life.