Science Behind the Miracle
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The Science Behind The Miracle

FOR CENTURIES, HEMOLYTIC DISEASE OF THE NEWBORN WAS AN UNKNOWN KILLER OF BABIES, THEN 20TH-CENTURY SCIENCE GAVE IT A NAME AND TOOK AWAY ITS POWER

For hundreds of years, women with Rh-negative blood experienced the heartbreak of mysteriously losing baby after baby for no apparent reason. Many of these women gave birth to a healthy first child, only to experience subsequent pregnancies that ended in miscarriage, stillbirth, or birth to babies with anemia, jaundice, or other serious health problems.

Desperate for an effective treatment to overcome the disease, physicians resorted to administering blood transfusions to babies still in the womb or conducting complete exchange transfusions after birth. Then in the early 1940s, two scientists discovered the presence of the Rh factor in the blood. During the next quarter of a century, scientists from around the world joined the search to find a treatment that would prevent the expectant mother’s blood from being sensitized by the Rh factor. In the 1960s, researchers at the Ortho Research Foundation, a division of Johnson & Johnson, closed in on an answer to this devastating disease.


THE COMPANY THAT BUILT ITS REPUTATION CARING FOR BABIES DELIVERS A LIFE-SAVING BREAKTHROUGH THERAPY

The first human trials of a new anti-sensitization agent began with one woman at New York’s Columbia Presbyterian Hospital. In 1966, researchers at Ortho reported the first successful prevention of maternal sensitization to the Rh factor following the administration of an anti-Rho(D) preparation following delivery.

By 1968, this new therapy had a name, and on May 29th—only hours after the initial batch of RhoGAM® Brand Rho(D) Immune Globulin (Human) was approved by the U.S. Food and Drug Administration—the first dose of RhoGAM® Brand was administered to a new mother at Holy Name Hospital in Teaneck, New Jersey. That mom, Marianne Cummins, would safely give birth to two more healthy children a few years later, all thanks to the protective properties of RhoGAM® Brand. To read more about the first “RhoGAM® Brand mom,” and other women touched by this miracle of science, click on Mothers’ Stories.

Prior to the development of RhoGAM® Brand, it is estimated that 10,000 babies in the U.S. were lost annually to HDN every year—more than two dozen babies each day. Since then, HDN has been virtually eliminated in the developed world. This remarkable achievement is due not only to the efficacy of the product, but also to the reliability of its manufacturer, Ortho Clinical Diagnostics. In 40 years of manufacturing RhoGAM® Brand, there has never been an interruption in product supply.

"One of the greatest accomplishments in obstetrics and gynecology in the past 50 years.”
Dr. Charles Lockwood
Chair, Committee on Obstetric Practice
American College of Obstetricians and Gynecologists

Today, the use of Rh immune globulin to protect babies of Rh-negative mothers is the standard of practice around the world. In fact, RhoGAM® Brand has been recognized as one of the greatest accomplishments in obstetrics and gynecology in the past 50 years by Dr. Charles Lockwood, chair of the American College of Obstetricians and Gynecologists' Committee on Obstetric Practice. The timeline below highlights the significant scientific research that led to the development of RhoGAM® Brand.


Timeline to a miracle

  • 1939: Dr. Philip Levine and Dr. Rufus Stetson publish a paper showing that baby-mother incompatibility is the cause of hemolytic disease of the newborn (HDN).
  • 1944: Dr. Levine joins Ortho to continue his breakthrough research into the mechanics of the Rh system.
  • 1950: Ortho introduces The Coombs Test to identify sensitized Rh-negative patients.
  • 1960: Drs. John Gorman, Vincent Freda (Columbia University), and Dr. William Pollack (Ortho Research Foundation) embark on a program to prevent Rh sensitization by immunizing patients with an Rh antibody.
  • 1964: The three doctors begin the first female clinical trials at Columbia Presbyterian Hospital in New York City.
  • 1966: Gorman, Freda, and Pollack report the first successful prevention of maternal sensitization to the Rh factor by the administration of anti-Rho(D) preparation following delivery.
  • 1968: RhoGAM® Brand Rho(D) Immune Globulin (Human), the first drug proven to prevent HDN, is introduced. The first shipment is loaded onto a delivery truck 10 minutes after the U.S. Food and Drug Administration grants approval. A short time later, an Rh-negative woman in nearby Teaneck, New Jersey becomes the first RhoGAM® Brand recipient. She went on to have two more healthy children
  • 1977: The first mini-dose, MICRhoGAM® Brand Rho(D) Immune Globulin (Human) is introduced in the marketplace.
  • 1984: Antepartum protocols are recommended by the American College of Obstetricians and Gynecologists as a result of ongoing studies
  • 1985: Pre-filled syringes of RhoGAM® and MICRhoGAM® Brand Rho(D) Immune Globulin (Human) are introduced in the marketplace.
  • 1997: RhoGAM® and MICRhoGAM® Ultra-Filtered Rho(D) Immune Globulin (Human) are introduced in the marketplace.
  • 2001: Ortho Clinical Diagnostics enhances the safety of RhoGAM® Brand by removing the latex components and preservatives from its formulation and adding safety shields to its syringes — the first U.S. company to do so.
  • 2006: Ortho Clinical Diagnostics added barcodes to the labels on RhoGAM® Brand and MICRhoGAM® Brand syringes
  • 2007: Ortho Clinical Diagnostics introduces RhoGAM® and MICRhoGAM® Ultra-Filtered PLUS Rho(D) Immune Globulin (Human).
Rhogam Ultra-filtered PLUS