EDITORIAL

Prematurity:
A riddle wrapped in a mystery inside an enigma (Part 2)

As I described last month, prematurity looms as one of our greatest public health challenges, yet the average American is almost oblivious to the magnitude of the problem. Equally distressing is the enormous gap between our knowledge of the major pathways to premature birth and their causes and treatments. Why haven't we closed this gap and implemented strategies to make a real impact on prematurity rates? The short answer is that not nearly enough research has been conducted in the right areas. The long answer is that this lack of research reflects a general decline in reproductive scientific research at academic departments of obstetrics and gynecology throughout the United States.

Currently, almost half of all university-based departments of obstetrics and gynecology have no funding from the National Institutes of Health (NIH). In the past 10 years, the relative number of R01 grants submitted by obstetrician/gynecologists has plummeted. There are very few multiple-NIH-grant awardees even among the elite recipients of research fellowships from the Research Scientist Development Program and the American Association of Obstetricians and Gynecologists Foundation. The reasons for this decline in reproductive science research are many.

First, grants are not being submitted because there is a low likelihood that they will be funded. The National Institute of Child Health and Human Development (NICHD), the NIH branch with jurisdiction over prematurity research, received only 4.7% of the total NIH budget in 2002, yet its mandate is to support almost all research into maternal, child, and fetal health. In addition, the majority of grants issued by the NICHD go to fund much needed pediatric research. The remainder are used to support a myriad of women's health issues from contraception to infertility, leaving very little for prematurity research.

Secondly, industry has not filled the void in reproductive science research and has been particularly reluctant to support prematurity research. Battered by the impact of the Women's Health Initiative, pressured by pro-life advocacy groups, and concerned about mounting liability, the pharmaceutical industry is far more reluctant to invest in drugs affecting reproductive functions. Research in prematurity prevention has been virtually eliminated because of profound concerns about liability, adverse publicity, and the enormous expense involved in obtaining FDA approval for drugs used in pregnancy.

The third reason for the dearth of reproductive science research in general and prematurity research in particular is the desperate financial shape of academic departments of obstetrics and gynecology. Steady reductions in Medicaid and managed care revenues and soaring malpractice insurance premiums over the past 10 years have left many university-based ob/gyn departments so broke they cannot afford to sponsor research. If a promising young academic obstetrician wants to devote 80% of her effort to laboratory-based research on the genetics of prematurity, that leaves only 20% of her time for clinical practice. Since academic medical centers often provide a disproportionate share of their care to indigent populations, reimbursements are less robust. However, malpractice premiums are generally no different than in a private practice setting and virtually never pro-rated based on the percent of actual clinical effort. Thus, if the academic medical center in this example is located in a state with high premiums, the cost of the obstetrician's malpractice insurance alone will likely far exceed her annual clinical revenue. When you factor in the costs of high university fringe benefits, the excessively high rents charged by medical schools to their clinical departments to subsidize basic science departments, utilities, supplies, equipment, service contracts, support staff, billing, Dean's taxes, etc., the cost of supporting a young scholar very quickly becomes prohibitive.

Sounds pretty grim! But at least the March of Dimes is coming to the rescue with a 5-year $75 million prematurity campaign (see the February issue, p. 92). It is designed to raise public awareness of the magnitude of the problem posed by premature birth, educate women about the signs and symptoms of preterm labor, heighten clinicians' awareness, and increase public and privately-funded research into the problem. The campaign will feature hard-hitting public service announcements and active lobbying of Congress for greater funding. The March of Dimes will also greatly increase its own funding of prematurity research projects. As a recipient of such funding for the past 6 years, I am eternally grateful to this wonderful organization.

Despite the March of Dimes' help, far more needs to be done. From my perspective, increased funding for prematurity research must be tied to restoration of the health of academic departments of ob/gyn. I recommend the following steps:

1. Doubling of the NICHD budget to $2.5 billion per year, with at least $50 million per year dedicated to basic, translational, and clinical research into prematurity.

2. Providing NIH support for rebuilding the research infrastructure of academic ob/gyn departments including:

• A tripling of the number of women's reproductive health research career development centers, which provide faculty support to sustain early research careers.

• Development of a Prematurity Research Network to facilitate the collection and storage of biological samples and DNA, coupled to sociodemographic, psychiatric, anthropometric, and environmental data. These materials can be used to drive genomic, proteomic, and genetic studies seeking to define at-risk populations for a given specific pathogenic pathway. Such studies will facilitate targeted clinical intervention trials.

• Funds and interest-free loans to outfit laboratories and purchase state-of-the-art equipment.

3. Access to and adequate funding for prenatal care for all pregnant mothers in the US.

4. Immediate professional liability reform for obstetric practitioners.

Prematurity kills far more Americans than any terrorist and cripples children at a rate rivaling polio, yet until now, no public outcry has been heard and no war on this dread disease demanded. But with the March of Dimes' bold initiative there is now the promise of progress. However, if increased prematurity research funding is forthcoming, it is critical that academic departments of ob/gyn be economically healthy enough to take up the challenge. The plan I have just outlined is expensive and ambitious and its political timing couldn't be worse, but we can't afford to wait any longer.

Charles J. Lockwood, MD

Charles J. Lockwood, MD, Editor in Chief, is Anita O'Keefe Young Professor and Chair, Department of Obstetrics and Gynecology, Yale University School of Medicine, New Haven, Conn.

Charles Lockwood. Editorial: Prematurity: A riddle wrapped in a mystery inside an enigma (Part 2).

Contemporary Ob/Gyn

Apr. 1, 2003;48:8-11.