Unreasonable Delay Research Articles

BiDil for heart failure in black patients: The U.S. Food and Drug Administration perspective.

Critics of the U.S. Food and Drug Administration (FDA) approval of the fixed combination of hydralazine hydrochloride, 37.5 mg, and isosorbide dinitrate, 20 mg, for treating heart failure in black patients have suggested that data were insufficient to distinguish treatment effects in black and white people; that distinctions based on race, rather than pathophysiology, were scientifically unreasonable; and that a "race-based" approval could be a commercial ploy to avoid a more expensive and prolonged full evaluation of a drug. The criticisms acknowledge that data supporting the approval came from a well-designed clinical trial in which self-identified black patients with heart failure who took hydralazine hydrochloride-isosorbide dinitrate with standard therapy experienced a statistically significant 43% (95% CI, 11% to 63%) reduction in mortality compared with those who took only the standard therapy. The criticisms do not always recognize that the decision to conduct the trial in only black patients reflected careful analyses of 2 previous trials in racially mixed patient populations that compared hydralazine hydrochloride-isosorbide dinitrate with placebo or with enalapril. Both trials showed little or no overall effect of hydralazine hydrochloride-isosorbide dinitrate in the mostly white patient population but hinted at a substantial effect in subsets of black patients. Perhaps most critically, the criticisms do not appreciate the urgency of strong scientific evidence of a substantial survival benefit in black patients. A serious attempt to avoid race-based approval by mandating study of a mixed population to identify a possible white patient-responder subset, particularly without a plausible hypothesis as to what that subset might be, would have required years of work, many thousands of patients, and wholly unreasonable delay in approval of a treatment whose effectiveness had been well-documented in the group for which it was intended.

Sound Plans Help Thwart Identity Theft

Sound Plans Help Thwart Identity Theft

Rapid fixation of brains: a viable alternative?

Aim: Recent events surrounding postmortem practices have necessitated several changes in the way necropsies are conducted both within the medicolegal and hospital settings. These changes have resulted in a striking...

The DC Court of Appeals resurrects Redskins dispute

Seven American Indians petitioned to cancel trade mark registrations for various REDSKINS trade marks; the district court's grant of summary judgment against them for laches (unreasonable delay) was remanded by the Court of Appeals for the DC Circuit for a rehearing in respect of one of the petitioners on the basis that the district court ‘started the laches clock’ in 1967, when he was only 1 year old, thus contravening the equitable principle that laches runs only from the time a party has reached the age of majority.

Insurers, Claims and the Boundaries of Good Faith

This article examines the refusal of the English courts to award damages for consequential losses following unreasonable delay on the part of insurers in settling a claim. This has the potential to give rise to dire consequences for insureds. These difficulties have been addressed in North American jurisdictions where the concept of good faith has been developed and applied as a means of both compensating insureds and regulating the conduct of insurers. However, a hallmark of English law is that it fails to draw a bright line between the law of contract and the law of contracts. As a result, the policy issues that should inform insurance contracts are excluded by virtue of the notion, imported from the law of contract, that the contractual relationship is a matter of private law and is not, therefore, a means for public regulation of insurers.

Unreasonable Delay, Unreasonable Intervention: The Battle to Force Regulation of Ethylene Oxide

This chapter tells the story of the seven-year battle to force the Occupational Safety and Health Administration to regulate ethylene oxide, a widely used industrial chemical that, at levels common in the workplace, causes cancer, spontaneous abortion and genetic damage. The chapter focuses on two recurrent and controversial legal questions that formed the core of the dispute - (a) may courts force agencies to take action they would not undertake on their own, or to accelerate agency action that would otherwise proceed at a much slower pace, and (b) may the President, through the Office of Management and Budget, direct the work of agencies in promulgating regulations. The chapter contends that the Supreme Court's recent ruling in Norton v. Southern Utah Wilderness Alliance does not cast doubt on the power of courts to compel a recalcitrant agency to take action where the agency's failure to act or delay contravenes the agency's statutory mandate. The chapter also challenges the legitimacy of the OMB regulatory review process, particularly OMB's interference in the development of health and safety rules. OMB was responsible for much of the delay in promulgating an ethylene oxide regulation. OMB's participation is, by design, a one-way ratchet, pressing agencies to do less, not more, to protect the public health and to focus on lower cost options, not more protective ones. OMB's cost-benefit focus is often anti-regulatory. Substantial evidence links ethylene oxide to genetic damage and spontaneous abortion, as well as cancer. But OMB refused to place a value on avoiding these reproductive harms but nonetheless argued that regulatory measures to guard against them were not economically justified. The chapter ends by emphasizing that, although these issues were novel at the time that ethylene oxide battle was joined, they remain hotly contested today.

Developing products for personalized medicine: NIH Research Tools Policy applications.

For innovators at academic or industrial institutions to develop personalized medicine products at the accelerated pace required, rapid access to state-of-the-art research tools and reagents are needed. Unreasonable restrictions or delays in the use of such tools may undermine the development of these customized diagnostics and therapeutic products designed to provide significant treatment benefits to patients who frequently do not benefit from traditional therapeutic approaches. In its funding agreements and its own internal research programs, the National Institutes of Health is implementing policies to facilitate the exchanges of these research tools and related resources.

Misconduct ruling leads to caution for Elaine Chase

Nursing and Midwifery Council professional conduct committee goes ahead in spite of plea that there has been 'unreasonable delay' in bringing the case to a hearing

Nonmelanoma Skin Cancer Mortality (1988-2000)

To estimate (1) the magnitude of and the components and factors associated with nonmelanoma skin cancer (NMSC) mortality and (2) the proportion of deaths misclassified as NMSC. Population-based follow-back study. All Rhode Island residents whose deaths between 1988 and 2000 were attributed to NMSC. Distribution of diagnoses, verification of the causes of death, and characterization of associated factors. The proportion of misclassified deaths was significantly higher for nongenital NMSC (57%) than for genital NMSC (18%; P<.001). Most of the deaths misclassified as nongenital NMSC were caused by squamous cell carcinoma of mucosal surfaces. The age-adjusted NMSC mortality rate was 0.91 (per 100 000 persons per year), of which almost half (0.45) were due to genital carcinoma. Nonmelanoma skin cancer mortality increased sharply with age. The mortality rate from nongenital NMSC in men was more than twice that in women, but for genital NMSC this ratio was reversed. Skin cancers originating on the ear were responsible for more than a quarter of all deaths caused by nongenital NMSC. No cases of NMSC mortality occurred in organ transplant recipients. Many individuals had comorbid psychiatric conditions or evidence of unreasonable delay in seeking medical care for their lesions. Misclassifying the cause of death as nongenital NMSC accounts for a large source of error on death certificates in Rhode Island. Overall, nongenital squamous cell carcinoma and basal cell carcinoma death rates have declined, and mortality due to genital carcinoma was about half of total NMSC deaths. The dermatology community should emphasize prevention of mortality from genital skin cancer, while continuing to stress the importance of reducing excessive exposure to UV light and prompt treatment of NMSC.

Legal regulation mechanisms in the control of medicines.

In 2002, a case was brought against the Secretary of State--sued on behalf of the Committee for the Safety of Medicine (CSM)--by a mother who in May 1986 gave aspirin to her 6-year-old daughter who was suffering from chickenpox (Smith vs. Secretary of State for Health, [2002]). The child deteriorated and following admission to hospital she was diagnosed as suffering from Reye's syndrome. As a consequence, the girl was left with a serious neurological handicap and was totally dependent on others for her care. In June 1986, the government issued a general public warning advising parents not to give aspirin in any form to children under 12 years old and told chemists to take all junior aspirin preparations off their shelves. This followed advice from the CSM that in this age group aspirin could trigger the fatal disease Reye's syndrome. The CSM had been aware of this danger in September 1982 following evidence in the USA. Further evidence was produced in 1985 and the CSM continued to monitor the situation. In April 1986, a meeting was held between the Department of Health (DoH) and members of the aspirin industry. It was subsequently agreed that the producers would withdraw stocks and there would be cooperation between the industry and the DoH rather than a public warning. In May 1986, the CSM recommended that the DoH should give a general public warning, which was made on 10 June 1986. The mother's case was that there was an unreasonable delay in publishing a warning following the CSM meeting on 26 March 1986. It was accepted that the administration of aspirin was a contributory factor in the development of the girl's neurological condition and that had her mother been aware of the warnings before May 1986 she would not have given her aspirin. Were the Secretary of State and CSM liable?

Delay estimation for cortico-peripheral relations

In neurophysiology, time delays between concurrently measured time series are usually estimated from the slope of a straight line fitted to the phase spectrum. We point out that this estimate is valid only in the case in which, one signal is a mere time-delayed copy of the other one. We present a procedure for delay estimation that applies to a much wider class of systems with nontrivial phase spectrum like for example lowpass filters. The procedure is based on the Hilbert transform relation between the phase of a linear system and its log gain. The Hilbert transform relation is nonlocal in frequency space, a fact that limits its applicability to experimental data. We explore these limits, and demonstrate that the method is applicable to neurophysiological time series. We present the successful application of the Hilbert transform behavior method to concurrently recorded epicortical brain activity and peripheral tremor. We point out and explain physiologically unreasonable delay estimates given by the traditional method. Finally, we discuss the assumptions underlying the applicability of the Hilbert transform method in the neuroscience context.

Perioperative Stroke Prevention

The definitions of commonly used terms are given in Table 1 (1–8). Stroke has been simply defined as any form of cerebral infarction (2), which includes those attributable to hemorrhage. The latter group is more likely to occur as a complication of specific surgical procedures (e.g., carotid endarterectomy) or the use of anticoagulants and is otherwise rare in the perioperative period (3). Hence, much of the information in this review pertains to ischemic cerebral events.

Global Climate Change and the Precautionary Principle

The precautionary principle is promoted as a common sense approach that avoids unreasonable delays in taking action. A weak form of the precautionary principle, that action should not wait until all uncertainties are resolved, is indeed common sense and consistent with even the most elementary application of the methods of decision making under uncertainty to the climate change problem. The standard tools of decision analysis imply conclusions consistent with a weak precau tionary principle of taking some action before all the evidence is in. Decision theory also reveals what the basis is for stronger recommendations from the precautionary principle, to the effect that action should be based on the most pessimistic possible interpretation of the future. This conclusion is only possible if prior beliefs are so pessimistic and so strong that they would outweigh any possible new scientific evidence.

Disabled and disadvantaged: The plight of special patients unfit to stand trial

This article describes the legal, clinical and procedural mechanisms by which a person can be found unfit to stand trial and consequently classified as a special patient in New Zealand. It also examines the procedural effects of this status. The outcomes for twenty‐one such special patients in the Auckland region are examined, with emphasis placed on their pathway to re‐classification. These patients' rights were compromised by: lack of recognition of time served as a special patient (when sentenced) the lack of any examination of the sufficiency of the evidence against the patient; the absence of a right of appeal against disposition as a special patient; and the unreasonable time delay that it takes to be re‐classified (resulting in infringement of liberty rights). Comment is made on the extent to which proposed legislation, the Criminal Justice Amendment Bill (No 7) 1999 (NZ), addresses these concerns. Further reform is suggested to address time delay issues.

Crohn’s disease: does race matter?

OBJECTIVE: The severity of Crohn’s disease (CD) has been reported to be greater in blacks than in whites. This possible disparity may be due, in part, to differences between these groups in health care utilization and accessibility. To explore these issues, we conducted a multicenter survey of patients with CD. METHODS: One-hundred and forty-five blacks with CD, recruited from four teaching hospitals and five private practices, and identified by medical record review or ICD-9 code, were enrolled and matched to 407 whites with CD (by age, gender, and practice type [teaching vs private practice setting]). Participants were interviewed regarding medical history, health status, personal health care practices during the preceding 5 yr, and beliefs regarding health care in the general population. RESULTS: Blacks and whites were similar with respect to age of CD onset, lag in time to diagnosis, and number of gastrointestinal (GI)-related hospitalizations and surgeries. Medication usage patterns were also similar in the two groups. Quality of life, measured by SF-36, was lower in all categories for blacks, compared with whites. Blacks were more likely to have had to stop work ( p < 0.01) and have lost more work days ( p < 0.01) than were whites. Whites were more likely to have health insurance and be able to identify a regular provider than were blacks. Blacks were more likely to report the following: receiving Medicaid; difficulty affording health care; delaying appointments due to financial concerns; difficulty traveling to their provider’s office; and experiencing unreasonable delays at their provider’s office. After adjusting for potential confounding variables, we found no differences between the groups, except for the number of days of work lost because of CD. CONCLUSIONS: These data suggest that black and white patients have similar reported disease presentations and course, and contrast with prior reports suggesting a more severe disease course among black patients. Although the disease itself appears similar, there were numerous reported differences between the races in health care utilization practices and in disease impact upon daily activities. We suggest that apparent disparities in CD according to race are actually due to social and economic factors, and not to the disease itself.

Symptom duration and delay in referral for palliative radiotherapy in cancer patients: a pilot study.

To estimate the frequency of delay in referral for palliative radiotherapy (PRT), and to identify factors associated with delay. Prospective survey over three months in 1997. Radiotherapy department of a cancer centre in Melbourne, Victoria. 158 consecutive patients prescribed PRT in the lung, breast, urology and haematology units. Duration of symptoms; incidence of "unreasonable" delay in referral; and incidence of negative clinical outcome associated with referral delay. The median duration of symptoms before prescription of radiotherapy was four weeks. Thirty-eight patients (24%) were considered to have had an unreasonable delay in referral, with median symptom duration of 15 weeks, and median delay in referral of 12 weeks. Causes of delay were classified as "diagnostic uncertainty" (29%), "other treatment given" (18%), "patient related" (18%), "language difficulty" (3%), and "unexplained" (32%). Twenty-seven of these 38 patients (71%) had negative outcomes, including persistent pain, neurological deterioration and persistent respiratory symptoms. These data suggest that delay in referral for PRT is not uncommon, has a variety of causes and can result in negative clinical outcomes. There appears to be a need for greater awareness of patients' symptoms and of the role of PRT among clinicians caring for patients with cancer.

From probability to proof: The respective roles of scientific reviews and the non‐scientific press in the publicizing of medical research and its clinical applications

Can and should clearly denned distinctions between probability and proof be offered to the public by the mass media in response to popular demand for the latest medical information? Isn't the need to know both legitimate and ever‐more pronounced? The pressure for prompt public disclosure of clinical trial or medical research results emanates from a variety of highly vocal sources (the patients themselves, the investigators, the business world, the new academic commentators, the mass media, the healthy population and its requirement for “healthful”; life styles). And yet in spite of all this pressure, clinical research but rarely moves forward with a giant leap. Reasonable solutions in view of balanced and equitable release of information both to and by mass media have been proposed in editorials highlighted by the best‐known medical journals. On the one hand, the critical importance of the mass media in transmission of medical knowledge to the scientific community has been stressed. On the other hand, the highly decisive role of the best‐known medical journals in the furthering of objective release of clinical research or trial results has been corroborated by several recent initiatives of best‐known medical journal editors. A great step forward in dealings between medical journals and the mass media was approved in London in 1993 by the International Committee of Medical Journal Editors, by dint of four main recommendations. These balanced and equitable recommendations may at one and the same time: stimulate legitimate public demand for access to important medical information without unreasonable delay; and prevent that media reports on scientific research lead to wide‐spread dissemination of premature and inaccurate conclusions.

Lechner and Hess Case

430Human rights — Access to court — Right to a hearing within a reasonable time in determination of civil rights — Proceedings lasting more than eight years — Cause of delay — Factual complexity of case and conduct of applicants contributing to delay — Principal delays attributable to conduct of domestic courts — Whether violation of right to determination of civil rights and obligations within reasonable time — European Convention on Human Rights, 1950, Article 6(1)Damages — Human rights violations — Unreasonable delay in civil proceedings — Loss of opportunity — Increased costs due to delay — European Convention on Human Rights, 1950, Article 50

Unión Alimentaria Sanders Sa Case

Human rights — Access to court — Right to a hearing within a reasonable time — Proceedings lasting more than five years at first stage — Principal delays attributable to conduct of domestic courts — Whether justified in view of disruption to Spanish judicial system as a result of restoration of democracy — Whether temporary back-log of cases justifiable — European Convention on Human Rights, 1950, Article 6(1)Damages — Human rights violations — Unreasonable delay in civil proceedings — Depreciation of judgment amount due to inflation — European Convention on Human Rights, 1950, Article 50State responsibility — For acts of the judiciary — Temporary back-log of cases — Whether engaging responsibility of State

Manera Lluberas v. Uruguay

Human rights — Arrest and detention — Conditions of detention — Failure to respect human dignity of prisoner — Small cell without furniture — Lack of medical attention — Torture, inhuman and degrading treatment — Proof — Fair trial — Right to consult counsel — Defendant denied access to his own lawyer — Defendant subsequently permitted access to court-appointed lawyer — Right to prompt trial — Unreasonable delay between arrest and trial — International Covenant on Civil and Political Rights, 1966International tribunals — Procedure — United Nations Human Rights Committee — Optional Protocol to the International Covenant on Civil and Political Rights — Whether allegations to be treated as substantiated in the absence of evidence to the contrary from the State Party