• FDA to Assess Post-Marketing Study Commitment Decisions
The FDA has awarded a contract to Booz Allen Hamilton to evaluate the post-marketing study commitment process for collecting medical information. The goal of this in-depth examination is greater internal consistency across all centers at FDA for requiring, requesting, facilitating, and reviewing post-market study commitments.
These commitments, also called Phase IV trials, are studies conducted after FDA has approved a product, because either it is required or the sponsor has agreed to it. They play a vital role in helping complete the medical community's knowledge about the best use of a product because they are intended to further define safety, efficacy, and optimal use.
“Even the largest and best designed pre-market studies cannot reasonably answer all the important questions that may arise about medicines,” said Steven Galson, MD, Director of the Center for Drug Evaluation and Research. “Continuing to evaluate drugs after they are approved is an important part of ensuring their safety and learning new things about their benefits.”
The Agency intends to work with sponsors to make sure these important commitments are properly focused and designed, and ultimately completed in an appropriate amount of time to be of value to practitioners and patients. Over the next year, Booz Allen Hamilton will examine the agency's internal processes and make recommendations about how to improve post-market commitment studies of human drugs, biologic products, and medical devices.
• FDA Outlines Blueprint to Modernize Medical Product Development
The Food and Drug Administration has released an initial list of priority research projects that could advance innovation in medical products. The Critical Path Opportunities List is aimed at modernizing product development so that new medical discoveries are brought to patients faster and at lower cost.
There are 76 initial projects to bridge the gap between the quick pace of new biomedical discoveries and the slower pace at which those discoveries are currently developed into treatment.
Release of the list marks a starting point in identifying priorities. Government, industry, and academic experts estimate that, if the initiative accomplished, the new tests and tools developed will modernize the process by 2010.
The list was developed based on feedback to the FDA's 2004 Critical Path Report, which diagnosed a slowdown in development of innovative medical therapies and proposed a long-term initiative to address the problem.
“Right now, researchers are trying to bring 21st century medical innovations to market using 20th century tools to evaluate them,” said Acting FDA Commissioner Andrew C. von Eschenbach, MD. “Under this initiative, we anticipate being able to dramatically increase the success rate in moving products from the lab to the patient.”
The report was organized into six major areas: development of biomarkers, clinical trial design, bioinformatics, manufacturing, public health needs, and pediatrics.
The first two are deemed the most important. “Most researchers agree that a new generation of predictive biomarkers would dramatically improve the efficiency of product development, help identify safety problems before a product is on the market—or even goes to clinical trials—and facilitate development of new types of clinical trials that will produce better data faster,” said Janet Woodcock, MD, FDA Deputy Commissioner for Operations.
• Physicians' Charity Care Continues to Decline
According to a report released by the Center for Studying Health System Change in Washington, DC, the proportion of American physicians who provide charity care has dropped 8% in the last decade: 68% of physicians in 2004–05 compared with 76% in 1996–97.
This decrease has occurred at the same time as the number of uninsured Americans increased to 45.5 million in 2004, signaling growing stress on the health care safety net.
“The decline in physician charity care—long a critical part of the safety net—is alarming given the increase in the number of uninsured Americans,” said Paul B. Ginsburg, PhD, President of the Center, a nonpartisan policy research organization funded principally by the Robert Wood Johnson Foundation.
Despite the decrease in the proportion of physicians providing charity care, the number has remained relatively stable, because the overall number of practicing physicians increased from about 347,000 in 1996–97 to 397,000 in 2004–05. Nevertheless, the amount of charity care provided has dropped—falling from 7.7 hours per week to 6.3 hours. Most of this decrease has occurred since 2000–2001, primarily because of the dramatic increase in the number of uninsured.
“Already there are signs that uninsured Americans are having more problems getting care, and if the decline in physician charity care continues, those problems are going to get worse,” said the Center's Senior Researcher, Peter J. Cunningham, PhD.
The report concludes that ongoing financial pressures and changes in physician practice arrangements may account, in part, for the continuing decline in the provision of charity care.
• Report Describes Cancer Burden Two Decades after Chernobyl
Twenty years after the world's worst nuclear power plant accident, the full health effects of Chernobyl are still difficult to assess.
Peter Boyle, PhD, Director of the International Agency for Research on Cancer (IARC), established an international working group in June 2005 to study the cancer consequences after the accident in the Ukraine, and the conclusions were published in the April 20, 2006 issue of International Journal of Cancer.
“Because the cancer burden from Chernobyl cannot yet be directly measured, the working group relied on risk-prediction models developed from studies of other populations exposed to radiation in other settings, particularly the atomic bomb survivors in Japan,” Dr. Boyle said.
“Based on these models, the number of cancer cases in Europe resulting from radiation exposure from the Chernobyl accident in the lifetime of exposed populations is expected to be large in absolute terms.”
Elisabeth Cardis, MD, head of the IARC Radiation Group, provided greater detail: “By 2065, predictions based on these models indicate that about 16,000 cases of thyroid cancer and 25,000 cases of other cancers may be expected due to radiation from the accident, with about 16,000 deaths.”
Most of the cancer burden rests with the most exposed populations. “About two thirds of the thyroid cancer cases and at least half of the other cancers are expected to occur in Belarus, Ukraine and the most contaminated territories of the Russian Federation,” she said. Three countries are in close proximity to the site of the accident.
“While these figures reflect human suffering and death, they nevertheless represent only a very small fraction of the total number of cancers seen since the accident and expected in the future in Europe,” Dr. Cardis continued. “Indeed, our analysis of the trends in cancer incidence and mortality does not demonstrate any increase that can be attributed to the Chernobyl accident. The exception is thyroid cancer, which 10 years ago, increased in the contaminated areas near the site of the accident.”
Dr. Boyle said that the study is unique in that it applies state-of-the-art radiation risk-projection models to updated estimates of radiation dose from Chernobyl throughout Europe, and includes a comprehensive examination of trends in cancer incidence and mortality data. The study provides the best estimate to date of the effect of the Chernobyl accident on cancer in Europe.
To put it in perspective, he said, “tobacco smoking will cause several thousand times more cancers in the same population.”