In recent years up to date, several governmental as well as non-governmental launched several complaints about the United States-based Food and Drug Administration for inadequate regulation and at times excessive regulation. The Food and Drug Association is the leading agency in the office of the U.S Department of Health and Human Services. It has the task of ensuring safety regulation for a variety of products namely drugs, radiation-emitting devices, dietary supplements, blood products, various types of foods, vaccines, medical devices, cosmetics, biological medical products, and veterinary products. FDA also makes sure that section 361 is accomplished; that is the Public Health Service act plus other related regulations like provisions for sanitation when traveling to other states and other rules, which govern diseases, associated with animals like pets and donation of body organs, tissue, and blood.
The inception of the Food and Drug association goes way back to June 1906 after President Theodore Roosevelt enacted the Food and Drug Act. As a result, the food and drug administration was established to look after the American consumers from the dangers arising from the agricultural community and the pharmaceutical industry. The establishment was at the forefront in fighting against any methods of growing crops that were detrimental to the health of consumers and the formulation of all prescription drugs that caused dangerous side effects. However, the FDA we know today can no longer be trusted.
FDA with Food Production
Many Americans remain without sufficient knowledge concerning Genetically Modified Organisms. These GMOs are chemicals that are used for seed production. Most companies are responsible for the manufacture of GMOs like Monsanto, the leading producer claim that they produce large yields of these chemicals, which in turn increase food production all over the world.
‘Roundup’ is the most profitable chemical from Monsanto, which is widely used throughout the globe. Formerly, the roundup was so very effective in killing the weeds growing among other crops without causing any damage or affecting the food supply. Some years ago, things took a turn with Monsanto’s profits; notably, many weeds started showing resistance to Roundup. A quick solution had to be engineered by the scientists working at Monsanto; the GMOs. Nevertheless, the scientists were well aware that a stronger formulation of round-up would end up killing not only the weeds but other crops as well and therefore, they manufactured seeds using GMOs. The resultant modified seeds had the ability to kill the weeds with no effects on any crop.
The problem was discovered when scientists from about 60 nations all over the world tested GMOs and found out about the possibility of persisting health issues for consumers in the future. The team of scientists came from countries like Australia, the European Union, and Japan and these countries, GMOs are either restricted or banned. The best method was letting consumers be aware of the presence of GMO in the food they purchased by placing the signs ‘Manufactured with GMO’ and ‘No GMO’.
Surprisingly, the FDA released a report after testing the GMOs and they claimed they were safe; to them, the scientists from other nations were mistaken and alarmed for no reason. The FDA assigned the task of conducting these tests to Monsanto as a project.
FDA and unsafe drug products
FDA has proved that it is in no hurry to withdraw any approved drugs especially after there has been sufficient evidence about the drugs being unsafe. Time and again, the FDA ignores safety concerns when it comes to approving new drugs. Prime examples of such high-profile drugs approved by the FDA were Vioxx (rofecoxib) and Rezulin (troglitazone). Later on, the two drugs were withdrawn from markets for the risks they pose to the consumers. For instance, the FDA approved Troglitazione as an effective diabetes drug but post-marketing data showed that this specific drug caused dangerous side effects - liver failure. In 1997, the UK pulled off the drug from the market but it was until 2000 that the FDA withdrew it; within those three years, thousands of Americans were reported to have been injured or killed by Troglitazone.
For Vioxx, a study was conducted before its approval and it discovered that a group of people taking this drug were exposed to the probability of getting heart attacks for times more than their counterparts who relied on naproxen, another anti-inflammatory drug. The approval board from the FDA approved the drug all the same. The outcome of another study in 2005 that was placebo-controlled came up with findings showing that consumers of Vioxx were at a higher risk of heart attacks coupled with a number of cardiovascular conditions than the patients who took no medicine. All these studies resulted in Merck removing the drug from the market after some disclosed that the company purposefully refused to give out information concerning its risks to patients and doctors for more than five years. Because of this unfortunate event, 88,000 to 140,000 serious heart disease cases were reported and half of those unfortunately died.
Scientist David Graham from the office of drug safety revealed the fact to Congress that he was under duress majorly from his supervisors to remain silent about all the dangers he knew associated to Vioxx and other similar drugs. He continued to say that there was indeed a conflict of interest since the organization responsible for approving and monitoring the safety of the drugs is under the influence of the same people who at first, accepted the same drugs saying they were effective. After testifying against Vioxx, Graham was ostracized because he was under strict instructions not to engage in any evaluation of safety issues of any discovered drug; the management of the FDA marginalized him.
Thirteen years ago in 2006, the Union of Concerned Scientists carried out a survey and discovered about a fifth of all scientists working for FDA have been asked to wrongfully omit or fabricate technical information for non-scientific intentions together with their final thoughts or comments on any FDA scientific document.