Public Citizen Health Research

Sasich, L., Lurie, P, and Wolfe, S.M., The drug industry s performance in finishing postmarketing research (phase IV) studies, letter and report from Public Citizen, Health Research Group Publication 1520, Washington, DC, April 13,2000. 

Petition to the Occupational Safety and Health Administration Requesting That Limits Be Placed on Hours Worked by Medical Residents (HRG publication 1570). Washington DC Public Citizen Health Research Group, 2002. (Accessed September 24, 2002, at http //www.citizen.org/publications/release.cfm7nit6771.). 

Many," Health Letter, vol. 2, no. 3. Public Citizen Health Research Group, Dr. Sidney M. Wolfe, Editor (July/August, 1986). 

One year later, in June 1990, Health Letter (Public Citizen Health Research Group, 1990) estimated that akathisia affects a whopping 15% to 25% of Prozac patients. 

Public Citizen Health Research Group. (1990). Prozac Benefits and risks of a new antidepressant. Health Letter 6(6), 1-3. 

Public Citizen, Health Research Group. Clioquinol (Letter to FDA). Public Citizen, 1985. 

PCHRG (1986). Public Citizen Health Research Group v. Tyson, 796 F2d 1479 (CA.D.C.)-... 

Public Citizen Health Research Group, Comments to the Office of Federal Patent Licensing, National Technical Information Service, unpublished memorandum, Washington, DC, April 29, 1988. 

Public Citizen s Health Research Group. (1993). Worst pills best pills II. Washington, DC Public Citizens Health Research Group. 

Public Citizen Health Research Group, Worst PiUs, Best PUls http //www.citizen.org/hrg, USA, January 2000. 

Occupational Safety and Health Administration, Occupational Exposure to Hexava-lent Chromium Final Rule, 71 Fed. Reg. 10,099,10,224 (2006) Public Citizen Health Research Group v. Chao, 314 F.3d 143 (3d Cir. 2002) David Michaels, Doubt is Their Product 98, 99-101, 108-09 (2008). 

The FDA Modernization Act of 1997 contains a requirement for public disclosure and congressional reporting by October 2001 of Phase IV studies. FDA intends to meet the public disclosure requirement by posting Phase IV study commitments, the projected end of the study, and the current status of the study on their web site [102]. Sponsors whose new drug was approved with a Phase IV study requirement must submit an initial status report to FDA within one year of approval. According to data compiled by Public Citizen s Health Research Group [103], not one of the Phase IV study commitments for 107 new molecular entities approved between January 1995 and December 1999 had been completed as of December 1999. 

LD Sasich, P Lurie, SM Wolfe. The drug industry s performance in finishing postmarketing research (Phase IV) studies, a Public Citizen s Health Research Group report, [Internet]. URL http // www.citizen.org/hrg/PUBLICATIONS/1520.htm, accessed 4-14-2000. 

Health Research Group (HRG). 2001. Pediatric Exclusivity Changes Needed to Assure Safety and Effectiveness of Medications for Children and More Affordable Drugs for Seniors. Washington, DC Public Citizen. 

Initiatives by medical researchers, by DES Action, and by the Public Citizen s Health Research Group secured funding in the USA for medical research on the prevalence of cancer and other effects in the young women who had been exposed in utero, and eventually also the men. The US National Institute for Environmental Health Sciences (NIEHS) has been one of the centers for toxicological studies of the effects of diethylstilbestrol. A substantial amount of research on the effects of diethylstilbestrol— animal experiments as well as epidemiological studies— has produced a valuable body of knowledge about how hormones affect the development of the fetus and prime the individual for disease later in life. 

Beyond these risks, bitter orange also may carry unique dangers because of its effects on metabolism. A 2004 article in OB/GYN News warns that taking the herb can interfere with the body s ability to effectively make use of medications. "This introduces a whole new set of problems aside from the stimulant effects," Dr. Sidney Wolfe, director of Public Citizen s Health Research Group, told OB/GYN News. "We certainly would not recommend that anyone use this."... 

Public Citizen s Health Research Group. (2006, February 28). Petition to FDA to ban all propoxyphene (Darvon) products prescription painkiller causes many fatalities Letter to Andrew Von Eschenbach, Acting Commissioner, Food and Drug Administration. Washington, DC Author. 

As research chemists, you may be interested in how your data are sometimes used and how they are presented to the concerned public. Conclusions or simplified research data may be presented by public agencies—such as state or federal departments of agriculture, forestry, public health, or occasionally the EPA or a Department of Environmental Quality, and by citizens or public interest groups (especially by those groups which are opposed to the use of pesticides in general), and also by university research, teaching, or extension faculty. 

This has stimulated increased scientific study on plants and increased the interest in the validation of traditional medicines and the role that they could play in modem health care systems. The increased public sector pressures to address poverty, illness and disease may give rise to governments recognition that pubhc health care policies and research need to be more inclusive of plants and natural products as vehicles to provide affordable health and nutrition to their citizens in ways that still assure safety and efficacy. 

Public opposition to incineration has come from several citizens groups, states, and environmental organizations. They have raised concerns about incineration because of questions about adverse health effects, such as birth defects, respiratory diseases, neurological damage, and cancer. The linkage between these health problems and incineration is still being researched and debated. For example, dioxins and furans have been linked to cancer and other long-term health problems. 

The committee recognizes that the first of the following recommendations is a recommendation, not for research itself, but for the prerequisites for productive R D. The committee strongly believes that no research effort, no matter how important or sophisticated, will be productive until the nation rebuilds the public health infrastructure to a level at which the results of appropriate research can be properly applied. This infrastructure improvement would have enormous value to the average citizen on a day-to-day basis and would generate significant health benefits beyond readiness for terrorist events. 

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