The Use of Oraflex Drug - Essay Example

Oraflex Drug Death Background: Oraflex (Benoxaprofen) was an anti-arthritic drug from the stables of the large pharmaceutical company Eli Lilly & Company. The ill-fame of the drug and the company in the United States of America centers on the twenty-six deaths and more than two hundred side effect cases reported from the use of Oraflex and the subsequent actions of Eli Lilly & Company (1). Oraflex was marketed in the United States of America for about ten weeks, even though it was available in other markets for nearly two years, before it had to be withdrawn from the market on the basis of safety concerns. A team of Lilly chemists in e valuating new ant-arthritic compounds in their British laboratory discovered Oraflex in 1966. In 1973 along with filing for patents for Oraflex in its original name Benoxaprofen, it also filed for sanction for testing the drug on humans with the Food and Drug Administration (FDA) of U.S.A, thus initiating the clinical testing procedure in the country. (2). In 1980, after spending an estimated cost of $70 million resulting in a more than 100,000 pages test report and patient records Eli Lilly & Company approached FDA for sanction to market Oraflex in U.S.A. Eli Lilly on the basis of test reports claimed minimal side effects for Oraflex, essentially pertaining to enhanced sunlight sensitivity and other skin problems. No severe side effects were reported with Oraflex. Sanction was received to market Oraflex, and on May 1982 Oraflex was introduced into the American market. (2). In the same month signs of severe problems with Oraflex emerged with a report in the British Medical Journal that British physicians believed that Oraflex had caused the death of twelve individuals through its side effects associated with kidney and liver failure in the country. Nearly three months ahead, on August 4, 1982, the Oraflex issue came to head, when the British Government on the basis of calls for removal of Oraflex from the market, suspended temporarily the marketing of Oraflex on the grounds of safety. The British Committee on safety of Medicines sent a telegram to the FDA informing them that it had received reports of more than 3,500 adverse side effects with Oraflex that included sixty-one deaths mainly among elderly patients. In the meantime the FDA had received unsubstantiated reports of eleven deaths as a result of liver and kidney damage from the use of Oraflex. This caused Eli Lilly & Company to withdraw sales of Oraflex in U.S.A. in the afternoon of August 4, 1982 within ten weeks of its launch. (2). On August 3, 1982, FDA officials while testifying before a Congressional panel admitted to confusion in handling the Oraflex issue, but also accused Eli Lilly & Company of submission of incomplete test reports and filing of several adverse drug reaction reports without identifying Oraflex as the drug that caused it. Thus the Oraflex problem resulted from a faulty product being made available in the market through a faulty process. (2). Cause of the Problem: The FDA officials’ testimony to the Congressional hearing provides direction to identifying the underlying causes to the Oraflex problem. On the one hand were poor business ethics motivated by corporate greed of Eli Lilly and Company and on the other hand laxity in the processing of marketing sanction for Oraflex by FDA. Corporate greed that led to poor business ethics stemmed from the immense opportunity that Oraflex presented to Eli Lilly & Company to forge ahead in the pharmaceutical industry sector with particular emphasis on the market segment of the ever-increasing number elderly arthritic patients. Pharmaceutical industry watcher for Paine Webber, David, H. MacCallum, put this in a nutshell, when he said “Lilly, in the presence of Oraflex had a superb opportunity to grow faster than the industry” (2). This opportunity presented itself through the expectation that Oraflex sales would reach $250 million, by 1985, giving Eli Lilly and Company a formidable position in the anti-arthritic segment of the pharmaceutical market. This was an opportunity too hard to be given a go by, especially from the perspective of corporate greed and poor business ethics. So, Eli Lilly and Company did not report the severe adverse drug effects that were associated with Oraflex to the FDA. (3). The primary drug responsibility is in the supervision of the development of new drugs. Monitoring of the tests and experiments conducted by a pharmaceutical company to ensure the safety of the drug before it is made available in the markets for human consumption falls under this primary responsibility. (4). Laxity on the part of FDA in executing its primary drug responsibility is seen in the admission of “confusion” by FDA in the sanctioning marketing of Oraflex, and the lack of proper monitoring of tests and experiments to ensure safety of the product for human consumption, when Oraflex was withdrawn from the market due to safety concerns. (2). Resolution/Prevention: In spite of the loss of human life and the injury caused to others by Oraflex, the senior management at Eli Lilly and Company got away lightly from the hands of the Justice department. According to the Justice Department, Eli Lilly and Company had enough detailed information of the possibility if death and ailments from Oraflex use, but did not provide this information to the FDA. (5). In the light of this perspective of the Justice Department it is natural to expect Eli Lilly to pay a heavy price for its wrongdoings, but this did not happen. The Deputy Attorney General of the United States prevented any criminal action against the officials at Eli Lily and Company, which paved the way for plea bargaining. (6). With no intentional wrongdoing or felony charges against the officials at Eli Lilly and Company, the final result of the official action against these officials through plea bargaining, was that Eli Lilly and Company pleaded guilty to twenty-five misdemeanor charges and was fined $25,000, and the Medical Officer Dr. William I. Shedden also entered a no contest plea to similar charges and was fined $15,000.Thus the result of the official action was minimal on the reputation of the company officials and on the purse strings of the company. (5). The heavier price was paid by Eli Lily and Co in the settlement of nearly law suits brought against the company. In the first of these many cases a federal Jury in Georgia found Eli Lily and Company responsible for the death of Lola T. Jones in July 1982, and ordered the company to pay a compensation of $ 6 million as compensation. This was a reflection of the company being less than candid in their knowledge about the side effects of Oraflex and paying the price for it. (7). The only way the mortality and morbidity that resulted from the use of Oraflex could have been prevented was for Eli Lily and Company to have been more candid with their knowledge of the side effects of Oraflex, and for the FDA officials to have been more diligent in their supervision of the development of Oraflex as an anti-arthritic drug and in sanctioning it for human consumption. Research: Animal studies have been the mainstay in the development of new drugs. Drugs found to have efficacy without side effects in animals are considered viable for testing in humans. Yet, there are biological differences between animals and humans and these calls for caution in translating drug effects seen in animals to human beings. It is when sufficient caution is not paid in this translation that surprises with grave results are seen as was the case of Oraflex. (8). Oraflex was just one occurrence of the failure to employ more human-specific drug safety tests with proper monitoring. There are many such occurrences that have plagued the pharmaceutical industry due to this negligence. The examples of these occurrences are Thalidomide, Flenac (Fenclofenac), Butazolidin (Phenyl butazone), Cylert (Pemoline), Rezulin (Troglitazone), Propulsid (Cisapride), Inocor (Amrinone), and Baycol (Cerivastinin). (8). It may be well argued that the FDA has been charged with the responsibility in preventing these occurrences, but the frequency of such errors suggests the need for improved functioning of FDA. In the new millennium not less than ten FDA approved drugs introduced into the markets have had to be withdrawn due to deaths and injuries. This has raised calls for changes in the manner in which drugs are tested before approval for human use. (9). The solution to this recurring problem is provide more funding for the development of better, human-based drug safety tests with efficient monitoring by FDA. (8). Works Cited 1. “ARTHRITIS AT THE JUSTICE DEPARTMENT”. 1985. The New York Times. 15 Oct. 2007. . 2. Lueck, J. Thomas. “AT LILLY, THE SIDE-EFFECTS OF ORAFLEX”. 1982. The New York Times. 15 Oct. 2007. . 3. Spell, J. Christopher. “Adverse Drug Reactions: A Perspective”. 15 Oct. 2007. . 4. “What is the Role of the FDA/USP in Pharmaceutical Sciences?” 15 Oct. 2007. http://www.aapspharmaceutica.com/features/10Questions/skelly.asp#q1 5. Shenon, Philip. “REPORT SAYS ELI LILLY FAILED TO TELL OF 28 DEATHS’. 1985. The New York Times. 15 Oct. 2007. . 6. Shenon, Philip. “OFFICIAL SAYS HE BARRED MORE PROSECUTIONS AT LILLY”. 1985. The New York Times. 15 Oct. 2007. . 7. “Lilly’s Lament”. 1983. Time. 15 Oct. 2007. . 8. Pippin, J. John & Stoick, Kristie. “Dangerous Medicine: Examples of Animal-Based Safety Tests Gone Wrong”. 2005. 15 Oct. 2007. . 9. Pringle, Evelyn. “Big Pharma’s Big Graveyard”. 2006. counterpunch. 15 Oct. 2007. . Read More