By Kim Coghill

Washington Editor

WASHINGTON ¿ A government report on financial conflicts of interest that could impact the safety of clinical trial participants concluded that oversight regulations currently in place might need strengthening.

The Government Accounting Office (GAO) report, commissioned by Sen. Bill Frist (R-Tenn.), says the Department of Health and Human Resources needs to encourage better communication between federal agencies and to simplify regulations to avoid misinterpretation. Frist, the only physician in the Senate, requested the report after a series of public concerns surrounding the safety and integrity of clinical trials. The GAO is the investigational arm of Congress.

Interest in clinical trials hit a peak back in 1999 when Jesse Gelsinger, a Phase I gene therapy patient at the University of Pennsylvania, died after receiving a hepatic infusion of an altered adenoviral vector. Gelsinger, 18, was enrolled in a study of patients with ornithine transcarbamylase deficiency.

That well-publicized death opened the floodgates of criticism, concern and investigation into who conducts clinical trials, how they are paid for, and how they are monitored and regulated to avoid conflicts.

¿Recent events have shaken the public¿s faith in the quality of oversight and safety for individuals participating in clinical trials and other research,¿ Frist said in a prepared statement. ¿While this report acknowledges that some steps have been taken to address these concerns, the report clearly indicates that additional measures are needed. Chief among them is the need to develop enhanced conflict of interest guidelines and harmonize differences between competing federal regulations.¿

It is likely there will be congressional hearings next year, possibly followed by stronger legislation, Frist¿s office said.

The investigation found that federal requirements on financial disclosure and management conflicts of interest are too flexible, therefore allowing institutions to implement them on their own terms.

Furthermore, ¿the Health and Human Services financial interest regulations are not directly linked to regulations on human subject protection, which means that financial interest information may not necessarily be conveyed to IRBs (institutional review boards) for consideration when they review research proposals for risks to human subjects.¿

The potential for conflicts has increased because of the growth in government and private biomedical research funding, and in financial relationships between government-funded investigators and private industry, according to the GAO.

In fiscal year 1980, the National Institutes of Health spent $3 billion on biomedical research, compared to $20 billion in fiscal 2001. Meanwhile, drug companies spent $1.5 billion in 1980 compared to $22.4 billion in 2000.

The GAO report was based on a study of five universities: the University of California at Los Angeles; University of North Carolina at Chapel Hill; University of Washington at Seattle; Washington University, of St. Louis; and Yale University, of New Haven, Conn.

The entire report, titled ¿Financial Conflicts in Biomedical Research,¿ can be accessed by visiting the GAO¿s website at

OPPS Payment Cuts Delayed 3 Months

The Centers for Medicare and Medicaid Services (CMS) postponed for three months implementation of a rule that would cut the payments for innovative medicines used in the outpatient hospital setting.

CMS, formerly HCFA, is proposing a one-year, 68.9 percent reduction in the pro rata pass-through payment for innovative medicines in the outpatient prospective payments system (OPPS). The pro rata pass-through payment makes up a percentage of the total cost the government will pay for an innovative product. The percentage is not flat; rather, it¿s based on a government formula. (See BioWorld Today, Dec. 3, 2001.)

¿CMS discovered non-trivial errors¿ in the calculations used to arrive at the cuts, and we are pleased that they are taking the time to gather and analyze more data ¿ and share data with BIO and other interested parties ¿ before implementing changes that would dramatically affect Medicare beneficiaries¿ access to potentially lifesaving medications,¿ Sharon Cohen, vice president for government affairs of Washington-based Biotechnology Industry Organization (BIO), said in a prepared statement.