Topic; Human Participating in drug trials
Research Question: Ill patients should have the fundamental right to access unproven experimental drugs, even if it may compromise the scientific integrity of the clinicla trial process
Affirmative Article;
1.
- The terminally ill, access to investigational drugs, and FDA Rules | Journal of Ethics | American Medical Association. (n.d.).
A. Human participating in drug trials
B. Is it ethical to provide terminally ill patients access to experimental drugs?
This research question is really controversial it can be debateable as well. The issue of giving experimental drugs to terminally ill patients raises many ethical questions. it may help patients gain more time or improve their quality of life. Experimental drugs may cause serious side effects or worsen the patients condition
C. The AFFIRMATIVE position in this debate or controversial would argue in favor of providing terminally ill patients to access drugs emphasizing the patients rights to potentially life saving treatment.
4: Article Summary
- In Paragraph 1: Fully describe what the main points of the article include.
Abigail Burroughs was diagnosed with head and neck cancer in her late teens. After a year of treatment, standard therapies failed, and her doctors suggested an experimental cancer drug meant for colon cancer patients. However, she was unable to participate in a clinical trial due to her declining health and died at 21. To honor her, her father created the Abigail Alliance to advocate for terminally ill patients’ access to experimental drugs. He sued the FDA for expanded access, raising legal questions about the right to experimental therapies and the risks terminally ill patients might take. The case U. S. v Rutherford (1979) involved patients seeking to use Laetrile, a drug blocked by the FDA, believing it was their last hope.
- In Paragraph 2: You MUST also provide information to describe how this article takes the AFFIRMATIVE position of the Debatable Research Question on this topic.
The U. S. Court of Appeals for the District of Columbia considered the case Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach nearly 30 years after a similar issue arose. The alliance challenged the FDA’s procedures for accessing developing drugs for terminally ill patients, claiming they were ineffective and demanded greater rights. A three-judge panel ruled in favor of the alliance, asserting that terminally ill patients have a fundamental right to access experimental therapies after phase I testing. They based this on the due process clause of the Fifth Amendment, highlighting a tradition of individual control over ones body. The court noted that while drug regulation is relatively new, the right to make personal medical decisions has deep historical roots.
Dissenting Article
1. Article Link
2. APA Reference
Zettler, M. E., Jeune-Smith, Y., Feinberg, B. A., Phillips, E. G., & Gajra, A. (2021, November). Expanded access and right to try requests: The Community Oncologists Experience. JCO oncology practice.
3. Research Question Information
A. Exact Approved Debatable Research Question:
Should terminally ill patients access unproven experimental drugs?
B. Explanation of the Dissenting Position:
The dissenting position argues that terminally ill patients should not have broad access to unproven experimental drugs outside of controlled clinical trials. This perspective maintains that such access may expose vulnerable patients to serious safety risks, false hope, financial exploitation, and treatments that have not been proven effective or safe through proper scientific testing.
Paragraph 1:
The article examines how the U. S. obtain investigational drugs for cancer patients who have run out of approved treatments using the Expanded Access (EA) program and the Right To Try law. A survey of 238 physicians found that 46% attempted EA and only 14% attempted Right To Try, with higher success rates for EA. Many physicians also had gaps in understanding, such as underestimating the FDA approval rate for EA requests.
Paragraph 2:
This article challenges the belief that Right To Try laws significantly improve access to investigational treatments for cancer patients. It argues that while supporters say these laws reduce regulatory barriers, data reveals that Right To Try is used less frequently and is less successful than the existing Expanded Access (EA) pathway. Many physicians lack understanding of the differences between these pathways.
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