Drug Recalls One thing we have to worry about in the United States is the slow process of drug recalls. Sometimes they have been going on for a long time in other countries and yet we haven’t participated in the recalls till much later, thus allowing our citizens to be subject to the bad drugs for a longer period of time. Is the problem we don’t have enough inspectors in the food and drug administration? We don’t, but that might not be the only problem. The recalls could be delayed here because the drug companies have such large lobbies. They have many if not all of the politicians in their pockets. You never hear if any of those shootings were done by people on drugs and yet if one listens to the commercials for certain drugs, they express the fact the drugs could cause homicidal and suicidal tendencies. Could we eliminate many of the shootings just by monitoring the people who take these drugs, or by not allowing those particular drugs? Not all recalled drugs are recalled for that and as a matter of fact I don’t remember any drug being recalled for making one feel homicidal, but I don’t know about every recall. There have been some drugs on the U.S. market which have affected humans in some very bad ways. Lately we seem to have more recalls on drugs which have become tainted. Could this be because many of our drugs come from China and they are not keeping a close enough eye on the production process? On July 13, 2018 the FDA announced a recall on the drug valsartan. Many other countries had already done this. The drug had been contaminated with a chemical when it was manufactured in China. The chemical is known as N-nitrosodimethylamine or NDMA. The drug is used to control high blood pressure and heart failure. Previously the drug was fine but it is said the manufacturing process had been changed and this led to the contamination. People were told to continue taking the drug until their doctors could replace it with some other drug. It is a very uncomfortable feeling knowing something is contaminated and yet you are still told to take it. Knowing about how easy it is for contamination of a drug to occur in production raises other concerns. For example, supplements and vitamins are not checked by the FDA and there was a movement to ban them years ago, but public outrage thwarted that. One of the worst drugs which were allowed to get on the U.S. market was Thalidomide. It came to market in 1961 and there was no mechanism until 1962 to approve drugs before they were put into the market place. No one knows the exact number of people who were affected by this drug, but the estimate is between 10,000 and 20,000 people. The drug was a horror show because it produced some really terrible and horrifying birth defects. This drug was considered to have produced the worst medical disasters in American history. Children were being born without arms and legs, and some other really terrifying effects. It prompted the Kefauver-Harris Drug Amendments which were passed in 1962 which gave oversight of drugs to the FDA and now drug manufacturers had to prove drugs were safe before being sold. One drug was on the market for over 24 years before it was recalled and was so popular 6.5 million people had and were taken it. It was a diet drug named Fenfluramine/phentermine known as Fen-Phen. It began to become noticeable some people on the drug had started to experience heart and pulmonary problems. After the drug was recalled over 50,000 people filed law suits against the company. The settlements were estimated to be more than 21 billion dollars. Another drug was on the market for 37 years before being recalled. The drug was Diethylstibestrol or DES. It was recalled in 1975. The drug was said to prevent problems during pregnancy. It was noticed female babies were developing tumors. It was not banned in use for men however and was used to combat estrogen deficiency. I think when we see how long a drug can be on the market before being recalled presents a lesson to all of us. Just because a drug is out there doesn’t actually mean it is safe to take. The less drugs we take the better off we are. Of course, there are times some drugs are a must for some medical condition we might have. Some of the biggest names in drugs have had drug recalls. If we are talking about a drug which had the largest recall in American history it has to be Rofecoxib known as Vioxx. This drug was on the American market for about five years before it was recalled, giving time for many people to get heart attacks and strokes. The recall affected over 20 million people. It was said at the time the FDA and the manufacturer both ignored the signs of what was happening to those who were taking it. Was this the drug lobby in action? On the other hand, when a drug is only on the market for a short time before a recall, doesn’t that indicate there is something wrong with the system? This drug should have been caught before coming to market. The manufacture according to the law had to prove the drug was safe. Anyway, in the one year Valdecoxib known as Bextra was on the market it was removed due to risk of heart attack and stroke. It was an anti-inflammatory drug for diseases like arthritis. The settlements amount to almost 2 billion dollars. Another drug was outed by the Los Angeles Times. It was Rezulin and it was recalled after the Times article. It was said an FDA doctor was fired for complaining about the drug and the FDA was criticized for delaying the recall. It turned out there was some kind of a connection with the drug and hepatitis. It is amazing to me how lax the FDA can sometimes be. I know they are understaffed and have often said there were not enough inspectors and this is proved by the amount of food recalls. We shouldn’t be afraid to eat vegetables and fruit, but how many times lately have we heard they were contaminated? It isn’t always food that comes from foreign countries either. I remember a large recall on lettuce which was grown somewhere in the Midwest. Was there safer food and drugs in the old days or do we just find it easier to spot bad drugs and food today?
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