- The Washington Times - Tuesday, August 24, 2010

There is often a disconnect between the actual contents of government publications and the way they are represented by various interested parties - that is to say, the “spin.” This was evident in the various alarmist interpretations of a recent report by Department of Health and Human Services Inspector General Daniel R. Levinson on the geographical distribution of clinical trials of drugs.

The lead sentence in the New York Times story by public health reporter Gardiner Harris was as follows: “Medical ethicists have worried for years about the growing share of new drugs whose human trials took place in foreign countries where federal auditors could not make sure patients were protected, but no one knew how big the potential problem was.” In the next sentence, Mr. Harris reveals the magnitude of this potential problem: “Eighty percent of the drugs approved for sale in 2008 had trials in foreign countries, and 78 percent of all subjects who participated in clinical trials were enrolled at foreign sites.”

Sounds as though the medical ethicists were right to worry. Except that in the fifth paragraph, we learn that it’s not such a big deal: “In many cases, foreign trials provide invaluable information proving that drugs are effective in a variety of ethnic groups. Mr. Levinson’s report found that most foreign clinical trial sites and subjects were in Western Europe, where ethical controls over research generally are as robust as those in the United States.”

Some argumentative commentators seem not to have read the inspector general’s report or gotten to the fifth paragraph of Mr. Harris‘ article. The consistently clueless Rep. Rosa DeLauro, Connecticut Democrat, who is chairman of the House committee that appropriates funds for the Food and Drug Administration (FDA), worried that the report “highlights a very frightening and appalling situation” and that “[b]y pursuing clinical trials in foreign countries with lower standards and where FDA lacks oversight, the industry is seeking the path of least resistance toward lower costs and higher profits to the detriment of public health.”

Not one to waste an opportunity to blast both the developers and regulators of drugs, anti-drug, anti-industry activist Dr. Sidney Wolfe offered that “the quality of the data used by the FDA as a basis for approving the drugs being studied may well be flawed, resulting in dangerous, incorrect decisions to approve drugs.”

The carping about clinical trials performed abroad is at odds with the inspector general’s analysis, which, in fact, found no evidence of systematic malfeasance, dishonesty, unethical behavior, harm to individual patients or “detriment to public health.” Nor did it identify any “dangerous, incorrect” approvals based on data from foreign trials or determine that their results were more suspect than those from domestic ones.

Much of the media, congressional and nongovernmental-organization spin of this issue appears to be an attempt to justify even more stultifying, punitive, risk-averse regulation of the developers of pharmaceuticals - regulation that during the past 15 years has pushed development costs into the stratosphere and shrunk a once-robust stream of new drug approvals to an anemic trickle.

Several additional points relevant to the supposed “potential problem” of foreign clinical trials:

c Over the past decade, eligibility criteria for the types of patients who may be enrolled in a particular clinical trial (such as age, gender and diagnosis) and the number of procedures (tests, scans, endoscopy, etc.) that must be conducted on each patient have increased sharply. This has made it difficult both to recruit and retain enrollees, so the ability to conduct trials outside the United States offers a valuable source of additional eligible patients.

c Because the costs and time required for drug development in the United States have skyrocketed during the past 20 years, lower-cost foreign clinical trials can keep drug development costs from escalating even further. The lower the costs of development, the greater number of drugs in the pipeline and the greater number that ultimately become available to patients in the United States and abroad.

c The drug sponsor (the company) is ultimately responsible for the integrity of all the data, foreign and domestic, submitted to the FDA. Misrepresentations or submission of falsified data is subject to harsh civil and criminal penalties.

In sum, although some fine-tuning of the reporting of clinical trial data - such as the use of a standardized electronic format - from foreign trials might be indicated, there is no evidence of major problems that compromise the quality of the data or the rights of human subjects. On balance, conducting clinical studies abroad is a positive development. But you’d never know that from the spin.

Dr. Henry I. Miller, a physician and fellow at Stanford University’s Hoover Institution, was the founding director of the Office of Biotechnology at the Food and Drug Administration.