Introduction: Since 2001, compounded drugs have caused more than 1,000 illnesses, and 87 deaths in the United States (cite 1). All of these unfortunate incidents were caused by errors during the manufacturing of compounded drugs, and in most cases, because of contamination. On the 25th of September 2013, the Drug Quality and Security Act, also known as H.R. 3204, was introduced, and three days later, was passed by the House of Representatives. On the 18th of November, this Act cleared the Senate. On the 27th of September, 2013, President Barack Obama signed the Drug Quality and Security Act into law (cite 2).
During the 1970s, a drug U-47700 was created by researchers as an anesthetic, less addictive than a morphine substitute. U-47700 was eventually tossed out and discontinued. The Food and Drug Administration did not approve it for human use. Unfortunately, the patent, which included instructions on how to produce the drug, became public information (Mato, 2016). This resulted in foreign drug manufactures gaining access to the formula through academic journals and patent filings (Blau, 2016). Currently, dealers from out of the country are using the chemical recipe and selling the drug in the United States, (Mato, 2016).
Economic: Globalization of the pharmaceutical industry is an exciting opportunity to have research and development done at cheaper prices in other countries. However, this could be a double edged sword for companies because it is easy for other countries, such as India, to produce generic versions of the drug in bulk.
The rise in global demand for Tamiflu has contributed to the production and sale of illegal, fake Tamiflu. Pills purporting to be Tamiflu, which contain only trace elements of Tamiflu’s active ingredient shikimic acid, have been shipped from parts of Asia to the United States after unsuspecting customers had ordered the counterfeit pills via the Internet.
The industry of the pharmaceutical companies has become involved in a heretic and manipulative manner which affects the credibility of the medications. The health care providers (medical practitioners) community are entitled to make an informed judgment when it comes to the plausibility and safety of the drugs.
In 1996, Pfizer tested a new antibiotic called Trovan. Trovan was an antibiotic intended to treat meningococcal meningitis. Pfizer tested it 's new antibiotic on 100 children in Kano, Nigeria, while another 100 children (the control group) were treated with fully vetted antibiotics such as cephalosporin. Trovan had never been tested on children before, and the United States refused to license Trovan due to side effects such as joint pain and liver damage. As a result, five children died. One such child, a three year-old known only as “Patient #69,” became so alarmingly sick, that her father begged the doctors to help her. She continued to be given Trovan, rather than the tried and tested cephalosporin. She died. Many consent forms were found to be falsified, and some families were not informed that they were taking part in a drug trial, a clear violation of the Nuremberg Code and The Declaration of Helsinki. Alarmingly, when the American drug company Pfizer was bought before a New York judge to answer for their ethical and moral violations, the judge decided that the case should be heard in a Nigerian court (Woods & Simkin). Nigeria happens to be one of the most corrupt countries in the world, and its government has little to no international transparency or accountability (Transparency International), and it 's criminal justice system is “blighted by corruption and generally distrusted” (“Amnesty International” 285). There are many more instances of drug companies taking
Pharmaceutical companies had been reluctant to provide drugs to developing countries at reduced prices because of concerns around distributing drugs in unregulated and unreliable environments. They argued that this could create new drug-resistant
Pharmaceutical companies spend millions to billions of dollars designing, developing and protecting their properties. They deserve to reap the benefits of their work, but at what cost? Certain circumstances should circumvent the patents protecting these life-altering drugs. There are millions of opinions on the subject, seen by the shear girth of the literature on the subject, but it is imperative that lives do not continue to be measured in dollar signs. The balance must be designed as to protect all parties in difficult situations like the HIV/AIDS epidemic. The battle is not always the disease versus humans, but sometimes humans versus humans.
The market for counterfeit pharmaceuticals has grown exponentially in the last five years. According to an estimate published by the Center for Medicine in the Public Interest in the USA, “Worldwide sales of counterfeit medicines could top US$ 75 billion this year, a 90% rise in five years” (WHO, 2010). This massive rise has greatly affected pharmaceutical companies and law enforcement agencies.
Counterfeit drugs contain contaminants that can dangerously harm, and in a lot of cases, kill patients. In 2008 the United States had an incident where the blood-thinner, heparin, used to prevent blood clotting in patients, was found to be contaminated. 81 patients died as a result (Blackstone, Fuhr and Pociask, 2014). The contaminant found was an oversulfated version of another drug called chondroitin sulphate, which
While recent advancements in modern medicine have turned it into a field of competition between generic and name-brand drugs, these drugs show very slight differences in ability while they have a large difference in price. The FDA is in charge of overseeing the creation of these generic and name brand drugs. Too much diversity in their results is unacceptable to FDA so they keep a close watch on the makeup and effectiveness of the drugs and how they impact the human body. Along with the differences in their chemical makeups shown by the results of each drug there are the social issues that accompany the name-brand and marketed drugs vs. the generic drugs which are never advertised and only sold. The idea that and almost identical product
1. Pricing: Many Asian and African countries are poor and cannot afford the costly medicines. The Pharmaceutical firms spend vast amounts on R&D in creating and marketing drugs, thus charging high prices enables for cost of capital recovery and profit generation.
Every year 14 million people die due to infectious diseases that to mostly in developing countries. Factors such as poverty and lack of access to health services worsen the situation. The high prices of medicines has made it inaccessible to various developing countries The high prices are a result of patents, which give their holders the right to restrict competition and therefore sell a certain innovation and information flows. The 20 year protection for pharmaceutical products and processes made the production of genetic drugs equivalent to expensive branded drugs. Also implementation of TRIP’s put an end to the practise of reverse engineering (practise where developing countries did not use to grant product patents but process patents for pharmaceuticals, enabling domestic researchers to develop similar products through a process of reverse engineering ) practised in various developing countries.
Remember that time you really wanted to buy a Louis Viton bag? Then the thought of spending thousands on it held you back? So instead you bought a knock off, and saved yourself a boat load of money. No harm done right? Well not exactly, of course your wearing your new bag out with your friends didn’t make a difference verse the real one. You felt a little spoiled and your friends loved it too. However, what if it wasn’t just a purse that you bought as a counterfeit, let’s say for example, it was a knockoff Tylenol or birth control. Think it would be harmful then? You may be surprised to know that this actually happens all the time, and the production and sales of counterfeit drugs is more common than you think. This essay will explain why the production and sale of counterfeit pharmaceutical drugs is wrong.
At first, India’s trade industry was one that was known for being an international outcast in the pharmaceutical industry. The counterfeit drugs that they were producing and selling eventually was revealed by the Western and Japanese pharmaceutical companies. Therefore, they were not allowed to sell their products in any developed markets considering that they dishonored intellectual property rights. Intellectual property rights include any patents, copyrights, or trademarks associated with a typical good or invention. The copies of untested products that India caused any other foreign drug company caused any other foreign company to turn the other way. Those companies refused to participate in or partner with any of the Indian’s productions, which really limited business prospects of Indian companies.