The Ethical Health Lawyer

2005 ◽  
Vol 33 (1) ◽  
pp. 160-162 ◽  
Author(s):  
Leslie Griffin
Keyword(s):  
Patient Safety ◽  
Side Effects ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
National Institutes Of Health ◽  
Public Attention ◽  
Institutional Misconduct ◽  
Heart Attacks ◽  
The Public

“There's a new whistleblower in Washington,” according to CNN News. He is Food and Drug Administration scientist David Graham, who claims that the FDA failed to warn the public about certain drugs' dangerous side effects and pressured him to change his research's conclusion that the arthritis drug Vioxx caused heart attacks. Another Washington whistleblower, Dr. Jonathan Fishbein of the National Institutes of Health, alleged that he was fired because “he had raised concerns about sloppy practices that might endanger patient safety” in a study of the AIDS drug nevirapine.Graham and Fishbein thus joined the ranks of whistleblowers who have gained some prominence in recent years for their reporting of corporate or institutional misconduct. The best-known whistleblowers—the FBI's Coleen Rowley, Enron's Sherron Watkins, and WorldCom's Cynthia Cooper, who together received Time magazine's Whistleblower Person of the Year Award in 20024 - focused public attention on the reform of corporate accounting and legal practices.

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.

scholarly journals Infections Deaths in the PLATO Trial

TH Open ◽  
2021 ◽  
Vol 05 (04) ◽  
pp. e503-e506
Author(s):  
Victor Serebruany ◽  
Jean-Francois Tanguay
Keyword(s):  
Antiplatelet Therapy ◽  
Drug Administration ◽  
Dual Antiplatelet Therapy ◽  
Food And Drug Administration ◽  
Platelet Inhibition ◽  
Public Domain ◽  
The Public ◽  
Local Evidence ◽  
Local Site ◽  
Therapeutic Outcomes

Abstract Background Cardiovascular benefits of aggressive dual antiplatelet therapy may be associated with extra risks including bleeding, cancer, and infections discovered first for prasugrel in the TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet InhibitioN with prasugrel (TRITON) trial. Ticagrelor in PLATO also caused slightly more infections but surprisingly less sepsis-related deaths (SRD) than clopidogrel. However, verified infection fatalities in PLATO were lacking from the public domain. We obtained the complete Food and Drug Administration (FDA)-issued primary causes death list, matched it with the few local site records dataset and analyzed the patterns of infections and deaths reported in PLATO. Methods Among infections, the FDA spreadsheet contains only two primary death codes for pneumonia (12–2) and SRD (12–8). We obtained local evidence for two pneumonia and two SRD and matched those with the FDA records. We assessed how SRD patterns were reported among nonvascular death's dataset. Results The FDA PLATO records indicate that clopidogrel caused numerically less (n = 8) primary pneumonia deaths than ticagrelor (n = 10) but over three times more SRD (n = 23/7). Among matched verifiable outcomes, both pneumonia deaths were correct, but two clopidogrel SRD were incorrect. Of the remaining 21 clopidogrel SRD, 6 were reported as two separate closed paired entries in Brazil (lines 76 and 78 and 86 and 88) and India (lines 436 and 440), suggesting last minute addition of potentially incorrect SRD reports. Four ticagrelor SRD (lines 24,193,467 and 650) were “compensated” with close or next in line clopidogrel SRD entries (lines 22,195,468 and 651). Conclusion The FDA-issued evidence suggests no benefit of ticagrelor in preventing deaths from infections with slightly more pneumonia deaths, with possible misreporting of SRD in PLATO. These findings require an in-depth precise review of sepsis deaths in this trial.

Aspirin and myocardial infarction

1987 ◽  
Vol 25 (5) ◽  
pp. 17-19
Keyword(s):  
Myocardial Infarction ◽  
Drug Administration ◽  
Coronary Thrombosis ◽  
Food And Drug Administration ◽  
Preventive Effect ◽  
Vascular Disorders ◽  
Heart Attacks ◽  
The Us

When we last reviewed the use of aspirin in vascular disorders we concluded that a preventive effect in coronary thrombosis was uncertain.1 In 1985 the US Food and Drug Administration accepted, after reviewing the evidence, that aspirin can reduce the likelihood of heart attacks for some patients.2 How strong is this evidence?

scholarly journals KEWENANGAN BADAN PENGAWAS OBAT DAN MAKANAN TERHADAP PERDA PROVINSI BALI NO 5 TAHUN 2012 TENTANG PENGENDALIAN PEREDARAN MINUMAN BERALKOHOL

2013 ◽  
Vol 2 (3) ◽  
Author(s):  
I Putu Mahentoro
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Alcoholic Beverage ◽  
Provincial Government ◽  
Alcoholic Beverages ◽  
Ministry Of Health ◽  
The Public ◽  
The Republic ◽  
The Government ◽  
Imported Foods

ABSTRACTThe research was conducted based on the same authority which is ownedby the two institutions, namely Food and Drug Administration of the Republic ofIndonesia and Bali Provicial Government in monitoring and controlling ofalcoholic beverages in Bali.The results of this study demonstrate the Food and Drug Administrationand the Provincial Government of Bali have the same authority to supervise andcontrol alcoholic beverages in Bali. Bali Local Government Regulation Number 5of 2012 on the Circulation of Alcoholic Beverage Control only requires each hasa label on alcoholic beverages issued by the Government of Bali has to bedistributed to the public, while the authority of the Food and Drug Administrationis regulated in the Regulation of Minister of Health of the Republic of IndonesiaNumber 382/MENKES/PER/VI/1989 on Registration of Food that requires allfood produced both by local producers and imported foods are required to beregistered to the Ministry of Health through the Food and Drug Administration.In the Regulation Number 5 Year 2012 did not include the authority of theFood and Drug Administration (the Empty Norms) so that the Food and DrugAdministration can not perform optimally the law enforcement againstmanufacturers, distributors and sellers of alcoholic beverages in violation. Tocope with the condition it should be a amendment in the Bali ProvincialRegulation Number 5 of 2012 by stating firmly and clearly the authority of theFood and Drug Administration related to the registration of food, which requiresthat for all foods and beverages that will be distributed to the public must beregistered to the Ministry of Health through the Food and Drug Administration.

scholarly journals Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

2017 ◽  
Vol 14 (3) ◽  
pp. 225-233 ◽  
Author(s):  
Raymond Perez ◽  
Patrick Archdeacon ◽  
Nancy Roach ◽  
Robert Goodwin ◽  
Jonathan Jarow ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Patient Safety ◽  
Drug Administration ◽  
Drug Safety ◽  
Food And Drug Administration ◽  
Educational Materials ◽  
Research Staff ◽  
Safety Reporting ◽  
New Drug ◽  
Final Rule

Background/aims: The Food and Drug Administration’s final rule on investigational new drug application safety reporting, effective from 28 March 2011, clarified the reporting requirements for serious and unexpected suspected adverse reactions occurring in clinical trials. The Clinical Trials Transformation Initiative released recommendations in 2013 to assist implementation of the final rule; however, anecdotal reports and data from a Food and Drug Administration audit indicated that a majority of reports being submitted were still uninformative and did not result in actionable changes. Clinical Trials Transformation Initiative investigated remaining barriers and potential solutions to full implementation of the final rule by polling and interviewing investigators, clinical research staff, and sponsors. Methods: In an opinion-gathering effort, two discrete online surveys designed to assess challenges and motivations related to management of expedited (7- to 15-day) investigational new drug safety reporting processes in oncology trials were developed and distributed to two populations: investigators/clinical research staff and sponsors. Data were collected for approximately 1 year. Twenty-hour-long interviews were also conducted with Clinical Trials Transformation Initiative–nominated interview participants who were considered as having extensive knowledge of and experience with the topic. Interviewees included 13 principal investigators/study managers/research team members and 7 directors/vice presidents of pharmacovigilance operations from 5 large global pharmaceutical companies. Results: The investigative site’s responses indicate that too many individual reports are still being submitted, which are time-consuming to process and provide little value for patient safety assessments or for informing actionable changes. Fewer but higher quality reports would be more useful, and the investigator and staff would benefit from sponsors’“filtering” of reports and increased sponsor communication. Sponsors replied that their greatest challenges include (1) lack of global harmonization in reporting rules, (2) determining causality, and (3) fear of regulatory repercussions. Interaction with the Food and Drug Administration has helped improve sponsors’ adherence to the final rule, and sponsors would benefit from increased communication with the Food and Drug Administration and educational materials. Conclusion: The goal of the final rule is to minimize uninformative safety reports so that important safety signals can be captured and communicated early enough in a clinical program to make changes that help ensure patient safety. Investigative staff and sponsors acknowledge that the rule has not been fully implemented although they agree with the intention. Clinical Trials Transformation Initiative will use the results from the surveys and interviews to develop new recommendations and educational materials that will be available to sponsors to increase compliance with the final rule and facilitate discussion between sponsors, investigators, and Food and Drug Administration representatives.

scholarly journals Drug-Associated Delirium Identified in The Food and Drug Administration Adverse Events Reporting System

2019 ◽  
pp. 1-7
Author(s):  
Adrian Wong ◽  
Angela Li ◽  
Kane Gill ◽  
Matthew P. Gray ◽  
Pamela L. Smithburger ◽  
...  
Keyword(s):  
Adverse Events ◽  
Drug Administration ◽  
Reporting System ◽  
Case Reports ◽  
Food And Drug Administration ◽  
Public Knowledge ◽  
Future Studies ◽  
The Public ◽  
Post Marketing Surveillance ◽  
Post Marketing

Introduction: Drug toxicity and polypharmacy are major risk factors for delirium, especially in older adult patients with underlying comorbidities. However, numerous case reports have described drugs with a lower suspicion of being deliriogenic. The objective of this study was to identify deliriogenic drugs in the Food and Drug Administration Adverse Events Reporting System (FAERS) to broaden the public knowledge and understanding. Study Design: Retrospective pharmacovigilance evaluation. Methods: FAERS reports from 2004 through 2015 were reviewed for delirium-associated terms, which were utilized to identify drugs most frequently reported to cause delirium. Drugs were categorized as: 1) known to be deliriogenic; 2) potentially deliriogenic; or 3) new potential to be deliriogenic. The 100 most frequently reported drugs were analyzed in reporting odds ratios (ROR). Results: Of the known deliriogenic drugs (n=32), paroxetine (ROR 4.1, CI 4.0-4.3), olanzapine (ROR 3.3, CI 3.2-3.4), and clozapine (ROR 2.9, CI 2.8-3.0) were most reported. Of the potentially deliriogenic drugs (n=54), duloxetine (ROR 3.2, CI 3.1-3.3), varenicline (ROR 3.1, CI 3.0-3.2), and gabapentin (ROR 2.9, CI 2.7-3.0) were most reported. Three drugs were considered to have new potential to be deliriogenic: heparin (ROR 1.5, CI 1.4-1.6), metformin (ROR 1.3, CI 1.3-1.4), and dalfampridine (ROR 1.1, CI 1.1-1.2). Conclusion: The majority of drugs were considered potentially deliriogenic. FAERS can provide post-marketing surveillance data to guide future studies on potentially deliriogenic drugs to guide management of causal agents.

Sulfites—A Food and Drug Administration Review of Recalls and Reported Adverse Events

2004 ◽  
Vol 67 (8) ◽  
pp. 1806-1811 ◽  
Author(s):  
BABGALEH TIMBO ◽  
KATHLEEN M. KOEHLER ◽  
CECILIA WOLYNIAK ◽  
KARL C. KLONTZ
Keyword(s):  
Drug Administration ◽  
Fruits And Vegetables ◽  
Adverse Reactions ◽  
Food And Drug Administration ◽  
Study Data ◽  
Current Status ◽  
Food Labels ◽  
Passive Surveillance ◽  
The Public ◽  
Passive Surveillance System

Sulfite-sensitive individuals can experience adverse reactions after consuming foods containing sulfiting agents (sulfites), and some of these reactions may be severe. In the 1980s and 1990s, the U.S. Food and Drug Administration (FDA) acted to reduce the likelihood that sulfite-sensitive individuals would unknowingly consume foods containing sulfites. The FDA prohibited the use of sulfites on fruits and vegetables (except potatoes) to be served or presented fresh to the public and required that the presence of detectable levels of sulfites be declared on food labels, even when these sulfites are used as a processing aid or are a component of another ingredient in the food. In the present study, data from FDA recall records and adverse event reports were used to examine the current status of problems of sensitivity to sulfites in foods. From 1996 through 1999, the FDA processed a total of 59 recalls of foods containing undeclared sulfites; these 59 recalls involved 93 different food products. Fifty (55%) of the recalled products were classified as class I, a designation indicating that a consumer reasonably could have ingested ≥10 mg of undeclared sulfites on a single occasion, a level that could potentially cause a serious adverse reaction in a susceptible person. From 1996 through mid-1999, the FDA received a total of 34 reports of adverse reactions allegedly due to eating foods containing undeclared sulfites. The average of 10 reports per year, although derived from a passive surveillance system, was lower than the average of 111 reports per year that the FDA received from 1980 to 1987, a decrease that may have resulted in part from FDA regulatory action.

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