Cover of: Adequacy of access to investigative drugs for seriously ill patients | United States. Congress. House. Committee on Commerce. Subcommittee on Oversight and Investigations.

Adequacy of access to investigative drugs for seriously ill patients

hearing before the Subcommittee on Oversight and Investigations of the Committee on Commerce, House of Representatives, One Hundred Fifth Congress, first session, September 23, 1997.
  • 78 Pages
  • 2.21 MB
  • English
U.S. G.P.O., For sale by the U.S. G.P.O., Supt. of Docs., Congressional Sales Office , Washington
Pharmacology, Experimental -- United States, Drugs -- United States -- Testing, Clinical trials -- United States, Human experimentation in medicine -- United States, Medical ethics -- United S


United States., United S

LC ClassificationsKF27 .E5546 1997d
The Physical Object
Paginationiii, 78 p. ;
ID Numbers
Open LibraryOL427275M
ISBN 100160557593, 0160557593
LC Control Number98133492

Get this from a library. Adequacy of access to investigative drugs for seriously ill patients: hearing before the Subcommittee on Oversight and Investigations of the Committee on Commerce, House of Representatives, One Hundred Fifth Congress, first session, Septem [United States.

Congress. House. Committee on Commerce. (7) Patients should explicitly acknowledge the limited data available. (8) There should be a shared, secure, technical platform to facilitate expanded access. All the authors' strategies present important prospects for improving treatment options for the most seriously ill patients.

Description Adequacy of access to investigative drugs for seriously ill patients EPUB

PMCID: PMC [Available on ] PMID: Cited by: 5. Investigational drugs may not be accessible to patients even if government authorities grant patients the freedom to access them. Most doctors are likely to be unwilling or unable to assume the responsibility of obtaining adequate informed consent from patients who are desperate for treatment and often unable to dispassionately assimilate the Cited by: 6.

The FDA authorizes “99 percent” of the treatment applications it receives each year under the so-called “expanded access” program for seriously ill patients, Gottlieb told a House Author: Elise Viebeck.

a controlled trial to improve care for seriously ill hospitalized-patients - the study to understand prognoses and preferences for outcomes and risks of treatments (support).

Pros and Cons/Easier Patient Access to Experimental Drugs Page 2 Although the agency says it often grants approval in 24 hours, the reality is that the system is too cumbersome for people with just weeks to live and little to lose. People such as Austin lawyer Andrea Sloan, who fought ovarian cancer for.

—A 2-year prospective observational study (phase I) with patients followed by a 2-year controlled clinical trial (phase II) with patients and their physicians randomized by specialty group to the intervention group (n=) or control group (n=).

Setting. —Five teaching hospitals in the United States. by: Determining Patient Access to Investigational Drugs in the US Philip Katz examines the reasons for and against treating terminally ill patients with investigational drugs, focusing on efforts to change the FDA’s regulations.

Terminally ill patients do not have a constitutional right. Letting Seriously Ill Patients Try Drugs Whose Safety, Efficacy Hasn't Been Proven Could Be Deadly [email protected] Former Contributor Opinions expressed by Forbes.

Notes. Food and Drug Administration Center for Drug Evaluation and Research. New Drug Application (NDA) Process.

Details Adequacy of access to investigative drugs for seriously ill patients PDF

Associated Press. Court: Terminally Ill Patients Can Sue FDA. May Washington Post. A Court Makes Up a Right. Emanuel, Ezekiel J. July 3, Cancer in the Courts. The New Republic (): Adler, Jonathan.

A Constitutional Right to Drugs. FDA should allow treatment of terminally ill patients with experimental drugs. The FDA says it approves almost all requests for access to investigative treatments.

Last year, that was a little Author: Matthew Bellina. Access to Experimental Drugs for Terminally Ill Patients Article in JAMA The Journal of the American Medical Association (23) January with 60 Reads How we measure 'reads'.

The agency already runs an "expanded access" program where seriously ill patients can apply to access experimental treatments. Commissioner Scott Gottlieb has said the agency has grants 99.

New Access To Experimental Drugs For Terminally Ill Patients. Colorado patients will have access to drugs that have passed "Phase 1"—known as the safety phase—of clinical trials. The Author: Katherine Harmon Courage.

When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years.

This raises an issue for drugs which could benefit terminally ill patients. These patients might set their hopes on the experimental drug but are unable to wait since they are likely to pass away before the drug is by: 9.

Not all such campaigns result in expanded access for the patients in question. Yet, as noted by Lee and co-author Alexandra Murata, a master of public health candidate at the Johns Hopkins Bloomberg School of Public Health, the publicity has helped to inspire more than 30 states to pass "Right to Try" laws that aim to override FDA limitations on expanded access and thus make it easier for.

Medication non-compliance, a pervasive problem among persons with serious, chronic mental illness, has been linked to increased inpatient resources use in public mental health systems. The objective of this analysis was to determine which factors are associated with medication compliance in this population so that more appropriate screening and intervention programs can be by:   Under current federal policy, when terminally ill patients want to use drugs and devices that are too early in their development to be approved by the FDA, their doctors typically ask for the drug.

Health Canada has a similar program, Special Access Programme – Drugs; last year there w requests of which 87 per cent were granted. (However, the.

Terminally ill patients for whom conventional medicine offers little benefit are often willing to try unproven therapies. Because these individuals are often ineligible for clinical trials and compassionate use can be procedurally difficult to secure, gaining access to experimental drugs is not a viable option for many patients.

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1 Congress and the US Food and Drug Administration (FDA) have Cited by: The paper, titled "Characterizing Expanded Access and Compassionate Use Programs for Experimental Drugs", found most drugs (76%) provided through registered expanded access and compassionate use.

The "right to try" legislation gives terminally ill patients the ability to access drugs that have cleared the initial phase of review but have not been fully cleared by the FDA.

PSAP-VII • Critical and Urgent Care Safe Drug Use in Critically Ill Patients errors from nonstudy ICU staff. A total of MEs were found involving the care of patients (i.e., errors per patient-days). Unfortunately, 15 MEs in 12 patients resulted in either permanent harm (n=7) or death (n=5).

The Abigail Alliance for Better Access to Developmental Drugs and the Washington Legal Foundation sued the FDA inseeking access for terminally ill patients to drugs that have undergone.

Lynn J, Teno JM, Phillips RS, et al. Perceptions by family members of the dying experience of older and seriously ill patients.

Ann Intern Med ; 97 - Web of ScienceCited by:   During the past few decades the numbers of ICUs and beds has increased significantly, but so too has the demand for intensive care. Currently large, and increasing, numbers of critically ill patients require transfer between critical care units.

Inter-unit transfer poses significant risks to critically ill patients, particularly those requiring multiple organ support. A Controlled Trial to Improve Care for Seriously Ill Hospitalized Patients: The Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments (SUPPORT) Creator.

Connors, Alfred F. Dawson, Neal V. Desbiens, Norman A. Fulkerson, William J. Goldman, Lee. Knaus, William A. In addition, if more people get access to drugs through right-to-try laws, they may be less likely to participate in the clinical trials that are essential to new drug development, say experts.

Situational factors have been identified as important determinants of relapse to both alcohol and drug use in general samples of substance abusers (Marlatt, ).Annis and her associates designed the Inventory of Drinking Situations (IDS; Annis, ) and the Inventory of Drug-Taking Situations (IDTS; Annis & Martin, ) to assess the degree to which individuals are at risk for alcohol or Cited by: 1 INVESTIGATIONAL DRUG AND DEVICE ACCESS FOR 2 TERMINALLY ILL PATIENTS 3 GENERAL SESSION 4 STATE OF UTAH 5 Chief Sponsor: Gage Froerer 6 Senate Sponsor: Evan J.

Vickers 7 8 LONG TITLE 9 General Description: 10 This bill amends provisions related to investigational drugs and devices. 11 Highlighted Provisions: 12 This bill.

Providing Hope: Developing a Viable Regulatory Framework for Providing Terminally Ill Patients With Adequate Access to Investigational Drugs “If I die I want my children to know I did everything I could.” This is a common feeling among terminally ill individuals facing : James P.

Sikora. States Allowing Terminal Patients Access to Experimental Drugs — Arizona is the fifth state to approve a "right-to-try" law this year. by Michelle. President Donald Trump on Wednesday signed a bill that will allow terminally ill patients to request experimental drugs that the Food and Drug Administration has not yet approved.

"Our implementation of the Right to Try Act will build on our long-standing efforts to help patients and families who are facing life-threatening diseases or conditions, in a way that seeks to protect their autonomy.