Compassionate Use Programs And The Ethical Obligations Of The Biotech Industry

1035 words - 5 pages

The Biotechnology Industry Organization, a trade group which represents the biopharmaceutical sector, has directed its members to consider granting compassionate use access to experimental medications calling it a part of a company's larger ethical obligation to society. Under current FDA regulations, biotech companies must obtain approval from the FDA for their experimental drug before beginning a clinical trial. Biotech companies are then supposed to tightly limit who comes into contact with the drug. But over the last two decades, the FDA has allowed biotech companies to expand access to its experimental drugs through “compassionate use” exemptions. The intent of these programs is to ...view middle of the document...

Regulators, too, are wary of the program. "There's this sense from patients that these are miracle drugs," said Richard Klein, director of the FDA's Office of Special Health Issues (Dooren, 2012). Many times this isn’t the case. For drugs that are in early-stage clinical trials, the benefit might not amount to much. And worse, the drug may actually hasten a patient's death. Almost by definition, patients eligible for compassionate use programs are in danger of dying.
In March 2014, Chimerix, a biotech company headquartered in Durham, NC, was the subject of an intense lobbying campaign by the family and friends of Josh Hardy. Josh, age 7, has beaten cancer four times and even underwent a bone marrow transplant, but the latest round of treatment resulted in Josh developing a drug-resistant bacterial infection that has left him fighting for his life. Josh’s physicians at St. Jude’s Children’s Research Hospital reached out to Chimerix seeking access to the company's experimental drug, brincidofovir. The company denied the doctors request explaining that “spending time to help Josh and others like him will slow down their efforts to get this drug to market” (Cohen, 2014). While the company’s CEO said he would feel awful if Josh died, the company was not willing to jeopardize the results of the clinical trial, which could potentially benefit thousands, to save Josh’s life. In response, Josh’s family and friends took to social media even creating its own hashtag #savejosh. One tweeter warned the company, “Everyone is watching” (Cohen, 2014). Chimerix executives say they’ve even received physical threats. One month after refusing access to its experimental drug, Chimerix yielded to mounting pressure and agreed to provide brincidofovir to Josh Hardy as the first patient in a new open-label study in patients with adenovirus infections. In a press release published on its company website, Chimerix thanked the FDA for helping to expedite the approval process and thanked the Hardy family for bringing “public attention to the often-devastating impacts of adenovirus infections” (Chimerix, 2014).
"These cases are always difficult and painful for everyone involved –the patients, their families, and the companies working to find cures and gain FDA approval of their...

Find Another Essay On Compassionate Use Programs and the Ethical Obligations of the Biotech Industry

Ethical And Legal Obligations Essay

1694 words - 7 pages Ethical and Legal Obligations Ethical and legal obligations apply to all members of society. As one in society, the obligation to act in an ethical, law abiding manner on a daily basis is vital to the integrity of daily life. Many professions have their own code of ethics. Financial reporting is not exempt from such ethical and legal standards. One’s lively hood depends on decisions made in the business world. Business transactions are

Accounting and Ethical Obligations Essay

1553 words - 6 pages and care of the ordinarily prudent accountant" in the same circumstances. Two elements compose the general duty of performance: skill and care. Another element and responsibility is owed to clients and other persons, which is that accountants should observe a standard of ethical or social responsibility. One set of difficulties concerns ethics education's ability to instill chosen values, and then to try to ensure that these values stay with the

Ethical and Legal Obligations

998 words - 4 pages is the basis of the balance sheet. It is important to remember that the balance sheet is a reflection of a specific point in time. The cash flow statement shows the actual flow of cash within a company, investors use this to determine the health of a company, to make sure it has enough funds to meet payroll and pay its bills, its main equation is beginning cash balance- ending cash balance equals the change in balance. The income statement is also

The Moral and Legal Obligations of Battlefield Neutrality

1968 words - 8 pages The Moral and Legal Obligations of Battlefield Neutrality “If a body of enemy troops is repulsed, give to the wounded the same care as you would give your own men; treat them all the forbearance due to the one who is stricken…After the battle, restrain the fury of your troops; spare the vanquished…People should say of you: they fought courageously when they had to, but remained generous and humane throughout.” –General Guillaume Henri Dufour

Ethical And Legal Obligations In Accounting

2104 words - 8 pages accounting principles as issued by the Federal Accounting Standards Board (FASB). The provider will also ensure that the company, if publicly traded, complies with requirements of the Securities and Exchange Commission (SEC) and the regulations of the Public Company Accounting Oversight Board (PCOAB). This paper briefly explains the principles of financial accounting and how the deviation from ethical and legal obligations led to greater government

Moral and Ethical Obligations to Animals

2304 words - 9 pages performed on animals, for example Australia’s National Health and Medical Research Council (NHMRC) released the Australian code for the care and use of animals for scientific purposes, 8th edition in 2013. This is regarded as Australia’s code of practice, standards which absolutely must by all means, some of which must be adhered to before research can even begin. One of these initial requirements researchers must meet is an ethical

Ethical and Legal Obligations in Accounting

982 words - 4 pages executives were charged by the Securities and Exchange Commission with misleading shareholders with false disclosures leading to Kmart filing bankruptcy in 2002. This resulted in the closure of 600 stores and the loss of 57,000 jobs Parvaz, 2005). These were people at the top who were not leading by example which casued poor ethical behavior throughout the company.References:Financial Accounting Standards Board (FASB). (2005). Retrieved September 11, 2005

Obligations to the Poor

2637 words - 11 pages Rambam’s “Obligations to the Poor” from the Mishneh Torah help us understand how we should interact with the people who are less fortunate than us. As Professor Isador Twersky has said, “Maimonides’ [treatment of tzedakah] illustrates the need for sensitivity, tact, and graciousness in the act of charity. The formal, objective act of giving charity is deficient and defective if it is not characterized by kindness and sympathy.” This directly

Business Strategy for the Biotech Field

1433 words - 6 pages biotechnology are developed the potential benefits are evaluated. Biotechnology has been shown to have applications in industry, medical care, and agriculture. However, in developing countries, human, and financial resources are limited in all three areas. Because of this limitation, priorities must be set if biotechnology is to contribute to development. This means that within research programs, economic returns, and social implications should be

The Ethical Use of the Life Attitude Schedule

1928 words - 8 pages and is in paper and pencil format. Reviews of the Life Attitude Schedule In his review, Hogan recognized the two formats of the Life Attitude Schedule in both the long and short format(Hogan,). The manual was very detailed and helpful in the use of the test and data explanations. The Life Attitude Schedule was described as a good concept towards indentifying lfe threathening behaviors by addressing both positive and negative actions

Critically assess the European Union's role as the world's largest donor of development assistance, are there any ethical obligations attached to this role?

4202 words - 17 pages could say that this shows a clear change in attitude of the EU toward its development policy: the EU was resolved that recipients of its development aid (in whatever form) would stand for and promote the fundamental principles upon which the EU and its member states were founded. Further consideration is given to ethical issues and responsibilities associated with this attitude in the discussion of the ethical obligations later in this study.The

Similar Essays

The Ethical And Legal Obligations Of Accounting Reporting

1089 words - 4 pages also adhere to the standers and legal obligations set forth by governmental and state agencies.The Financial Accounting Standards Board (FASB) is an independent, private, non-Governmental authority that will be utilized to support the establishment of accounting principles in the United States. The mission of the Financial Accounting Standards Board is to establish and improve standards of financial accounting and reporting for the guidance and

Policy Analysis: The Compassionate Use Of Medical Cannabis Act

2387 words - 10 pages I chose a very controversial Pennsylvania Senate Bill, No. 1182, the Compassionate Use of Medical Cannabis Act, which proposes to legalize the medical use of cannabis in the Commonwealth of Pennsylvania. The bill will allow medical physicians in Pennsylvania to prescribe medicinal cannabis to patients who would benefit from the positive attributes (Memorandum, 2014). The bill was introduced by Folmer, Leach, Teplitz, Ferlo, Fontana, Farnese

Biotech Industry And Monsanto Essay

1135 words - 5 pages Monsanto is the leader in the biotech industry with locations spanning around the globe. Monsanto came from small beginnings in 1901 as a chemical company when it first was founded, to rapidly expanding and producing chemicals and chemical based products that have become a household name. Monsanto has managed to grab the market share of genetically modified seeds and their most profitable weed killer RoundUp in the past 30 years. This paper

Ethical And Legal Obligations Of Financial Reporting

1214 words - 5 pages The FASB, SEC, and PCAOB Ethical financial reporting is critical to ensure consumer confidence within an economy. Accounting entries record cash transactions in the form of financial reports. Financial reporting is used to interpret and analyze business activities for the purpose of investing and efficient management. Misrepresentations, whether intentional or accidental, can send the wrong signal to interested parties resulting in wrong