Recent Second Opinion:
Post-Election Predictions for Obamacare
Improving the FDA's REMS Program
Are Foreign Clinical Drug Trials Safe?
FDA's Bad Ad Program
Obesity and Public Health
The Route to Reconciliation
Conflict of Interest
Analyzing the Healthcare Bills
President Obama's Plan for Reform
The Healthcare Reform Debate
Priorities for the New FDA Commissioner
PhRMA's New Marketing Code
Personal Genetics Testing
Where health care policy experts have their say
Sources of Medical Research Funding
July 8, 2010:
Lately, news articles are highlighting a recent report by the department of Health and Human Services questioning the FDA's ability to oversee foreign drug clinical
trials. For this edition of our Second Opinion forum, we've asked policy experts if they think the existing foreign clinical trial system puts patients in the US at
risk, or if they think Americans are better off because of these trials.. Additionally, are there any global health concerns or benefits resulting from foreign
This edition of our expert panel includes:
Over the last few years, the FDA has become more and more extreme in its demand for drug testing. Now, it requires that drugs be tested, before approval, on many thousands of patients. As economists and other analysts have shown, this lengthens the time before we potential patients get drugs. Does this added testing make us safer? No. It makes us less safe because it makes the drug-testing process more expensive. Drugs aimed at less-common diseases often don’t make the hurdle.
How have drug companies responded? Many of them cut the cost of the added testing by testing in other countries as well as the United States in order to get the requisite number of test subjects. Finding subjects takes time and time is valuable. Broaden the population of people from whom you choose and you can find them more quickly.
Multimillionaire Congresswoman Rosa DeLauro of Connecticut, according to the New York Times, finds it “very frightening and appalling” that the drug industry “is seeking the path of least resistance toward lower costs and higher profits.” She thinks this is detrimental to public health but doesn’t say why. She’s wrong. Precisely because testing abroad reduces costs, it makes more drugs feasible to bring to market. That helps public health.
David R. Henderson is an associate professor of economics at the Naval Postgraduate School in Monterey,
California and a research fellow with the Hoover Institution. From 1982 to 1984, he was the senior economist for health policy with President Reagan's Council
of Economic Advisers. He blogs regularly at http://econlog.econlib.org/
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The media, congressional and NGO spin of this issue appears to be an example of a search for justification for still more stultifying, punitive regulation of the developers of pharmaceuticals.
The analysis by the HHS inspector general did not find evidence of malfeasance, dishonesty, unethical behavior or harm to patients. It did not identify any flawed drug approval decisions based on data from foreign trials, or that the results of foreign trials were more suspect than those from domestic ones.
Other points relevant to this (non-)issue:
– Because over the past decade, the mean number of procedures (tests, scans, endoscopy, etc.) and the eligibility criteria of clinical trials have increased sharply, making it difficult both to recruit and retain subjects, foreign sites offer much-needed additional sources of patients.
– Because the costs of and time required for drug development in the U.S. have skyrocketed during the past 20 years, lower-cost foreign clinical trials are useful to keep drug development costs from escalating even further. (The lower the cost, the greater number of drugs in the development pipeline, and the greater number that ultimately become available to patients in the U.S. and abroad.)
– The drug sponsor is ultimately responsible for the integrity of the data submitted to the FDA. Misrepresentations or the submission of falsified data are subject to severe 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) might be indicated, there is no evidence of major problems that compromise clinical testing or the rights of human subjects.
Henry I. Miller, M.S., M.D., is a research fellow at the Hoover Institution. Miller joined the Food and Drug Administration in 1979 and from 1989 to 1993 was the founding director of the FDA's Office of Biotechnology.
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Recently, the Department of Health and Human Services released a report suggesting that the FDA lacks the resources to adequately monitor foreign clinical trials. Some medical ethicists used the report to insinuate that pharmaceutical companies were deliberately conducting foreign trials in order to avoid U.S. ethical constraints and to experiment on unsuspecting foreign patients.
These concerns are exaggerated and ignore the complexities of modern clinical research. If the FDA and Congress push companies to conduct more domestic clinical trials, foreign patients will lose the often valuable health benefits gained from participation in clinical trials, and domestic consumers will suffer from slower access to new, life-saving therapies. Critics also forget that about half of all foreign trials are conducted in Europe. There, European regulators impose ethical rules on clinical research similar to the FDA’s.
However, we should take steps to address legitimate concerns with the rising length and costs of U.S. drug development—like the fact that many new treatments languish for years because there aren’t enough patients available to test them. Currently, less than 5 percent of eligible patients participate in U.S. trials. Researchers have great difficulty finding the few Americans who are willing to enroll in clinical trials.
We should also keep some perspective on the trend toward foreign clinical trials. While the U.S. represents just 5 percent of the world’s population, it provides over 20 percent of patients for clinical research. The reason for the disparity is that the U.S. is responsible for almost one-half of global research and development funding for new medicines. Since the benefits of drug development are shared by the whole world, a proper balance of burdens would inevitably entail more, not fewer, clinical trials conducted outside our borders.
Tomas J. Philipson, Ph.D., is the Daniel Levin Professor of Public Policy at The University of Chicago and the chairman of the Manhattan Institute's Project FDA . In 2003-04, he served as the Senior Economic Advisor to the Commissioner of the FDA.
Anup Malani is a professor at the University of Chicago Law School and a university fellow at Resources for the Future.
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The findings of the recent HHS study showing large numbers of clinical trials conducted outside the U.S. should come as no surprise to followers of the drug development process. It is extremely expensive to create new products—averaging 10 years and a billion dollars—and companies understandably are on the lookout for cost savings.
Conducting trials abroad is often cheaper since the FDA requires fairly large trial sizes and it is expensive and difficult to find sufficient numbers of Americans to participate. But running trials outside the U.S. does not necessarily make the products less safe or mean that companies are cutting corners when it comes to safety.
FDA’s standards remain just as rigorous regarding data and trial size, regardless of where the trials take place. And from the company standpoint, playing fast and loose with the data risks upending a billion dollar process.
The HHS recommendations—especially the suggestion that FDA standardize its data collection process and create an internal database—are generally sound. But a sudden discovery of the well-known fact that many trials take place abroad should be no reason for panic.
Tevi Troy is a visiting senior fellow at the Hudson Institute. From 2007-2009 he served as Deputy Secretary of the U.S. Department of Health and Human Services.
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