Is The FDA Reliable?

The FDA was created in 1906 to prohibit the sale of contaminated food, and drugs. At this time the FDA needed to regulate food safety because there was a lot of food born illness do to poor practices. Companies would add chemicals, or preservatives to food, so you don’t know that it had gone bad. The FDA did a lot of good things in the beginning. In 1938, the Food, Drug and Cosmetic Act established new drug regulations, including pre-market approval of all new drugs, meaning that drug companies had to prove that their drug was safe before it could be brought to market. In 1960, drug manufacture’s created a sedative drug called Thalidomide. This drug was approved in other countries, but the FDA wanted to do further testing to make sure it was safe. It turned out that this drug caused thousands of birth defects. The FDA saved many lives with this decision.

Drugs

Today, however, we have a much different situation with the FDA. The FDA is now largely funded by pharmaceutical companies. In this article: https://jamanetwork.com/journals/jama/fullarticle/2625319, they show one third of all drugs that reach the market are pulled in about 4 years. They have been proven to only have about a 69% effect rate at proving drugs safe. Keep in mind that the FDA actually doesn’t actually test any of the drugs. They leave that up to the pharmaceutical companies. Leaving the same companies who made the drugs to test them, and report them being safe can lead to a direct conflict of interest. In this report: https://journals.sagepub.com/doi/10.1177/0020731416654662?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub++0pubmed&, they show that unsafe drugs were prescribed over 100 million times before being recalled. This means many people have ingested it and had severe problems. How did the FDA start receiving most of it’s funds from pharmaceutical companies? Something called user fees were passed so the FDA can approve drugs faster, and get an approval date. In this review: https://pubmed.ncbi.nlm.nih.gov/24088149/, researchers quote “Industry has demanded shorter average review times and, with less time to thoroughly review evidence, increased hospitalizations and deaths have resulted. Meeting the needs of the drug companies has taken priority over meeting the needs of patients.” What have the user fees resulted in? In 2017, the FDA rejected 19.7% of drugs, compared to 59.2% in 2010. The FDA, and pharmaceutical companies share their employees. 30% of the employees at the FDA leave their job to work at pharmaceutical companies, and the reverse also happens. According to this report: https://www.science.org/news/2018/07/hidden-conflicts-pharma-payments-fda-advisers-after-drug-approvals-spark-caethical, about 40% of the FDAs board members to approve drugs get paid by pharmaceutical companies after drug approval.

Food

The FDA is also responsible for food regulation. In 1958 something called GRAS was invented. It stands for generally recognized as safe. It was originally designed for faster approval for common ingredients like salt. Eventually companies thought it would be much more efficient to do the same thing with chemicals to get their product approved. The problem is that the companies do the testing themselves, not the FDA. Then the companies report it’s safe to the FDA, then it’s approved. Sense this process had happened, chemicals in food went from 800, to 10,000. Ultimately, we have to take the power in our own hands because these so called regulatory agencies are not doing their job. We have to decide what our health looks like.

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