Text ::   Skip Nav ::

circare logo

Brochure Contact Home Privacy Site Map Terms of Use Tools Prev Next

print Print page ::   Link to CIRCARE Link To ::

Troubling Ephedra Research

The problem: between 1995 and 2003, FDA held a number of hearings to consider whether ephedra posed an unreasonable risk to public health when used as directed. In 1997 the agency proposed to regulate ephedra as a drug, only to be thwarted by DSHEA and industry stakeholders. More recently, following the sudden death of Steve Belcher and the discovery of over 13,000 previously undisclosed adverse event reports from persons taking this product, FDA renewed these efforts and subsequently announced its intention to ban the sale of ephedra as a dietary supplement. During this same period, industry stakeholders sponsored clinical trials of ephedra and ephedra compounds, the results of which were heavily advertised as the gold standard proof of safety and efficacy. These claims came under sharp scrutiny within the last year and a half as evidence from civil litigation became public and a striking collection of documents were released to the public in July 2003 by the House Committee on Energy and Commerce in the course of its investigation of ephedra. These documents, including sponsor and investigator correspondence, internal FDA memoranda, depositions, institutional correspondence, and data from clinical trials, appear to paint a dismal picture of scientific misconduct, IRB lassitude, and regulatory impotence coupled with a complete and utter disregard for the rights and welfare of the human beings enrolled in these studies. Perhaps the most remarkable document we've come across is the 300-plus page deposition of the principal investigator for the two most respected clinical trials, which Senators Kennedy and Durbin and Representative Waxman submitted into the public record through the FDA Dockets. The deposition points up an alarming number of gaps in our feeble system of research protections, and taken as a whole, forms some of the strongest evidence supporting the need for statutory protection of human research subjects.

Some of the more alarming allegations to surface were:

What's the answer? Accountability.

We believe the way to create a mechanism of accountability is through federal legislation, in the form of a National Human Research Protections Act that would empower the federal government to impose civil and criminal penalties on researchers and institutions that violate established guidelines for the ethical conduct of research on human subjects.

Index of Ephedra Material

Ephedra Research I – FDA and HHS Documents, including:

Ephedra Research II – Clinical Trials Testing Ephedra, including:

Ephedra Research III – Government Hearings and Investigations, including:

Ephedra Research IV – Dubious Research, including:


Last Updated: 2007-06-01

If you find the information on this page helpful, please support CIRCARE with a tax-deductible contribution today. Help us advocate for meaningful protection of human subjects in research. Donating on-line with PayPal is quick and easy. Find out more on our Support page

All material on this site © CIRCARE Incorporated (2002- ) or as indicated. Single copies can be downloaded for personal education.   Adobe® Reader ::   ::

Valid HTML 4.01! Valid CSS!