Sample English Essays on FDA/Big Pharma

The big pharmaceuticals and the Food and Drug Administration have had strange and strained relations. They seem to be at loggerheads, with the FDA making it difficult for drugs developed by the pharmaceutical companies to get to the market. The reason for this is to ensure that the products put on the market by the pharmaceutical companies are safe for the consumer (Blackstone et al. 220). The drug companies have been known in the past to release drugs in the market that took care of one ailment and then caused other complications. Some of the drugs developed by these companies also have the capacity of becoming addictive and destroying the lives of the consumers in the process. FDA has the mandate to ensure that the drugs in the market are safe for the consumers and also to push the pharmaceuticals in their advertising processes to include the benefits and side effects of their products.

Despite the role played by the FDA, pharmaceutical companies still manage to have potentially harmful drugs in the market. The reason for that is the apparent conflict of interest that takes place in the activities of the drug companies and the role of the FDA. Some of the committee members of the FDA happen to be former employees of the big pharmaceutical companies, making it harder for them to air their disapproval of the drugs developed by their former employers (Blackstone 221). The physicians and scientists tasked with researching on the safety of the drugs are often funded by the very companies that develop the drugs. This puts them in a tricky position, and it makes it harder for the testers of the drug to give negative feedback in expectation of future funding from the companies.

This spells trouble for the consumers, as they are the end users of the drugs and are the ones that will have to contend with the negative effects of the drugs. For example, Yaz and Yasmin birth control drugs were approved for use by the FDA but were then found to have negative effects on the women that consumed them to the extent of causing death. The drugs had compounds that were clotting the blood resulting in heart failure, stroke and possible death.  As a result, thousands of women filed a lawsuit against Bayer, the pharmaceutical company that was producing and marketing the drug (USA-ANH par  5). When the approval process of the drug was investigated, it was discovered that four of the members that were in the FDA advisory committee were either former employees of the pharmaceutical companies or had received funding from these companies. Apparently, these members had disclosed their ties to the industry beforehand, but FDA still considered them as qualified to play a role in the approval process of the drug. Interestingly, all of the four committee members voted for the approval of the drug in the market (USA-ANH par 5). One of the members of the committee was barred from participating in the vote on the grounds of having an intellectual conflict of interest while the members that had a financial conflict of interest were deemed qualified.

The big pharmaceuticals are supposed by law to release all data on the research and testing of their drugs for public scrutiny. This release should contain both the negative and positive aspects of the drug that has been developed. However, most of these firms release only the supporting positive data and hide data on the possible side effects of their products intentionally (Mantus 100). This is because the big drug companies are often interested in making profits and recovering the fortunes spent in the research and development for new drugs. Some pharmaceutical companies are also known to have given kickbacks to state officials to speed up the approval of the safety of their drugs and to prevent the release of data on the negative side effects of their products. All of this is driven by greed and commercial interests instead of the health and safety of the population.

The compromise of the FDA in approving potentially harmful drugs in the market is a blow to the general population, and the legal structure in place is to blame for that. The funding of researchers, physicians, and state health officials by the big pharmaceutical companies is allowed by law. Further, persons that have industry and commercial interests in pharmaceutical companies are allowed to play roles in the FDA to decide whether a drug meets the safety threshold to be released in the market (Witten 1496). This has led to the FDA being used to pit pharmaceutical companies against each other, with the one having better monetary resources prevailing over the agency and having its drugs approved while the competition is barred from marketing its drugs. Additionally, this has the effect of denying the public access to drugs that are safe and effective and at the same time expose them to unsafe and potentially ineffective drugs. The outcome of this is injured livelihoods and litigations against the drug companies, which have strong legal teams to combat the complaints of the consumers.

The prevalence of counterfeit drugs is another problem facing the health and pharmaceutical sector in the United States. These counterfeit drugs are supplied from various parts of the world and are a public health hazard for the Americans. They are also a source of waste of the consumer’s income, as the consumer purchases them with the intention of getting better and is denied the benefit of better health (Blackstone et al. 221). The counterfeit drugs are an assault on the intellectual property and rights of the pharmaceutical companies that have invested large sums of capital in the research and development of drugs. Protection of the patents of the pharmaceutical companies contributes to making them more productive and promotes the generation of better ideas and drugs.

Medicines that are counterfeits tend to have severe consequences for the patients. The fake drugs are a public health disaster globally, especially in the United States.  The supply of the counterfeit drugs in the United States comes from all over the world. There is a lot of money in the pharmaceutical industry, and this is why there are many counterfeiters of these drugs (Blackstone et al. 221). The effect of counterfeit drugs compounded by the fact that not only does it take money from the pockets of the consumers, but also leaves them with unresolved health issues. In extreme cases, their use can lead to death. The use of counterfeit drugs can lead to the consumers having concerns regarding the safety of using various drugs. In the process, it can reduce patient adherence.

A case in which counterfeit drugs have affected the health of a patient was when a patient who had a liver transplant was injected with an anemia injection for eight weeks. No improvement was observed, and it was then discovered that the injection used was a counterfeit drug. In 2012, another case was documented when Avastin, a cancer-fighting drug, was counterfeited (Blackstone et al. 221). The fake version of the drug only contained salt and starch and was lacking the active ingredient. In addition, fake drug manufacturers had replaced the active ingredient in a blood thinner with a less costly one causing the patients to have complications. The prevention of the inflow of counterfeit drugs is very difficult in the United States. This is informed by the fact that over 40% of the drugs used in the United States are manufactured overseas (Blackstone et al. 221). Further, more than 80% of the active ingredients used in the locally manufactured drugs are imported from overseas (Blackstone et al. 221).

Many of the drugs in the United States are expensive for the ordinary consumers. The counterfeit medicines are usually cheaper, and this attracts the consumers. Internet pharmacies have made it easier and cheaper to access the drugs. It also makes it harder for the government agencies to regulate the distribution of the drugs (Belbey par 3). This difficulty in the regulation of the drugs is caused by the network of the distribution of these drugs being very complicated. This creates an opportunity for the counterfeit medicines to enter the legitimate supply chain.

In conclusion, there is less confidence in the FDA, given that it can be compromised and influenced by the big pharmaceutical companies that have significant financial power. This is caused by the legal framework in place that guides the activities of the agency and its inadequacy. Counterfeit drugs are another source of frustration for the pharmaceutical companies and the consumers. They cause loss of money for the consumers and pharmaceuticals and leave diseases unresolved.

 

 

Works Cited

Belbey, Joanna. “Big Pharma and Social Media: How to Avoid Trouble with the FDA.” Forbes, May 25, 2017, www.forbes.com/sites/joannabelbey/2017/05/25/big-pharma-and-social-media-how-to-avoid-trouble-with-the-fda/#14502826330b. Accessed 20 Feb. 2018.

Blackstone, Erwin, Joseph P. Fuhr Jr, and Steve Pociask. “The Health and Economic Effects of Counterfeit Drugs.” American Health & Drug Benefits, vol. 7 no.4, 2014,pp. 216-224, www.ncbi.nlm.nih.gov/pmc/articles/PMC4105729/, Accessed 9 Feb 2018.

Mantus, D. (2016). FDA regulatory affairs (2nd ed., pp. 98-101). Boca Raton: CRC Press.

USA, ANH, “FDA’s Huge Conflicts of Interest with Big Pharma.” Alliance for natural health USA, n.p, 13 March 2012, http://www.anh-usa.org/fda-huge-conflicts-of-interest-with-big-pharma/

Witten, Celia M., Richard D. McFarland, and Stephanie L. Simek. “Concise review: The US Food and Drug Administration and Regenerative Medicine.” Stem Cells Translational Medicine 4.12 (2015): 1495-1499.