Meconium Drug Testing: method of testing infants for exposure to drugs during pregnancy - discovered and developed by a Filipino

Meconium

Meconium is the earliest stools of a mammalian infant. Unlike later feces, meconium is composed of materials ingested during the time the infant spends in the uterus: intestinal epithelial cells, lanugo,mucus, amniotic fluid, bile, and water. Meconium begins to form between the 12th and 16th week of gestation. Meconium is normally stored in the infant's bowel until after birth, but sometimes it is expelled into the amniotic fluid (also called "amniotic liquor") prior to birth or during labor and delivery. The stained amniotic fluid (called "meconium liquor" or "meconium stained liquor") is recognised by medical staff as a sign of fetal distress, and puts the neonate at risk of meconium aspiration. Medical staff may aspirate the meconium from the nose and mouth of a newborn immediately after delivery in the event the baby shows signs of respiratory distress to decrease the risk of meconium aspiration syndrome.

Dr. Enrique “Buddy” Ostrea pre-discovery

The use of meconium in the testing the mother’s abuse of drugs during the course of pregnancy is pioneered by Dr. Enrique “Buddy” Ostrea, a Filipino medical doctor known for his researches in pediatrics. He studied medicine in the University if the Philippines specializing Pathology and Pediatrics where he graduated cum laude in 1965.

He had chosen pediatrics because he wants to study not just the illnesses of infants and children but also their development.  After he graduated, he spent his first years of being a doctor in the Philippine General Hospital and cured mostly adult patients. Due to this, he thought of studying in the United States and landed in Boston Children's Hospital Medical Center in Harvard University in 1969. Dr. Ostrea learned various approaches in the field of medicine. Here, he learned how to do autopsy in deceased person to know the exact cause of his death. He also found out that knowing ten types and cases of illnesses in not enough, a doctor must do further readings and does research about the nature of the particular type of disease.

One event that opened another opportunity of his life of being a doctor was having met a child diagnosed with diabetes insipidus that come-and-go to the hospital for the treatment of the disease. He found out that the patient has a low serum potassium level which is not a common condition of the disease. He did extensive readings and research on the illness until he discovered that the condition of the child is the same with the symptom of the Bartter’s syndrome. He told his discovery to the child’s attending physician and he recommended the patient to undergo serum rennin test (serum rennin is a kind of hormone from the kidney). Coincidentally, the expert in rennin was located in a nearby hospital (Peter Bent Brigham Hospital), Dr. John Merrill. He proved that the claim of Dr. Buddy is correct. The level of the child’s rennin is high and the child’s disease is Bartter’s Syndrome contrary to the early diagnosis. This event paved the way in earning a fellowship in Neonatology (a subspecialty of pediatrics that consists of the medical care of newborn infants, especially the ill or premature newborn infants) in 1972 in John Hopkins Hospital in Baltimore, Maryland where he was under the supervision of Dr. Gerald B. Odell, an expert in bilirubin (commonly related to jaundice). He learned more in being detailed in the laboratory, investigating for facts and doing extensive scientific data evaluation.

In the following years, he was able to work in Children's Hospital of Michigan. He was granted with a high salary, free fare, and access to advanced laboratory equipment, apparatus and facilities.

The Research

Dr. Buddy continued to serve in different hospitals in the US until he became colleague with Dr. Stryker who studied the effect of opium in pregnant monkeys. After the mother monkeys gave birth to their youngs, Dr. Stryker gave Dr. Buddy the newborn monkeys to study the effect of opium accumulation in infant monkeys. Dr. Buddy’s hypothesis was that the opium accumulated and has an effect in the newborn’s brain, liver and kidney. He was not able to include the possibility of the accumulation in intestines and stomach. He nearly forgot to include these parts in his experiment yet he accidentally found the opium in the intestine. Better he was able to remember the statement: If the data does not agree with the hypothesis, then the hypothesis is false.

These findings served as the basis of his recommendation that the first stool (meconium) of newborn infants is the best sample to test the effect of drug taken by the pregnant mother. It was in the year 1992 that he was given funding worth $100,000 by the Michigan Department of Public Health to do further research and prove his claim that drug accumulation can be effectively found in meconium compared to saliva, urine,or in the blood of the infant. After a successful research, he called a press conference that made his discovery known to the Americas, Asia, and Europe.

He invented the Mec test kit or Meconium Test Kit to test if the mother is taking drugs like cocaine, opium, marijuana or being exposed with nicotine through smoking in the course of pregnancy.

Patents

Dr. Enrique Ostrea received US patents #5015589 and patent #5185267 for methods of testing infants for exposure to drugs or alcohol during pregnancy. The abstracts are as follows:

• US 5015589 A: Method for detecting maternally transferred drug metabolites in newborn infants

Abstract: A method for detecting the presence of drug metabolites in the meconium of newborn infants is described. The method involves separation of the drug metabolites from meconium in solution and then assaying the solution for the presence of the drug metabolites. The method is particularly useful for detection of cocaine, morphine and cannabinoids; however, any drug metabolite in the infant meconium can be tested. Conventional assay methods are used for the drug metabolites in the solutions derived from the meconium. The method provides for early detection of drug presence in infants which contribute to infant illness.

• US 5185267 A: Method for detecting maternally transferred drug metabolites in newborn infants

Abstract: An improved method for detecting the presence of durg metabolites in the meconium of newborn infants is described. The method involves a single step extraction of the drug metabolites from meconium using a buffered aqueous solution containing methanol in an amount between about 10 and 30% by volume and buffered to a pH between 6 and 7 and then assaying the extract individually for the presence of the drug metabolites. The method is particularly useful for detection of cocaine, morphine, cannabinoid and amphetamine metabolites; however, any drug metabolite in the infant meconium can be tested if it is extracted by the solution from the meconium. Various assay methods are used for the drug metabolites in the solutions derived from the meconium, including immunoassays, fluorescent assays and mass spectroscopy. The method provides for early detection of drug presence in newborn infants which contribute to infant illness.

The Meconium Drug Testing

Meconium drug testing can detect maternal drug use during the last 4 to 5 months of pregnancy. A negative result does not exclude the possibility that a mother used drugs during pregnancy. Detection of drug use depends on the quantity and quality of the specimen tested as well as the pattern and frequency of drug(s) used by the mother. Although not likely, drugs administered during labor and delivery may be detected in meconium. Interpretive questions should be directed to the laboratory.  The concentration at which the screening test can detect a drug or metabolite varies within a drug class. The concentration value must be greater than or equal to the cutoff to be reported as positive.

Dr. Ostrea’s meconium drug-testing formula is now widely used by hospitals and pharmaceutical companies. The formula detects the presence of prohibited drugs – such as narcotics like morphine, shabu, marijuana and opium – in the baby’s first poops (meconium), which is a green matter. High concentration of any of these drugs or a combination of these drugs in the meconium shows that the mother had been taking the drugs while she was pregnant. There are several adverse effects of the fetus’s exposure to these drugs which include abnormal development, caesarian delivery and cerebral palsy.

The first of its kind to be used by the Federal Drug Administration (FDA), Ostrea’s formula can also be applied in other medical fields. His continuing clinical-chemistry research found that his formula can detect the presence of toxins, nicotine, non-narcotics drugs and other substances in the meconium. High concentration of toxins in the tot’s first stool indicates that the mother had been exposed to environmental toxic elements from insecticides and/or herbicides. Doctor Ostrea said that the exposure of a pregnant mother to the excessive use of home insecticides, like Baygon, may cause the abnormal development of the fetus’s motor system.

This particular finding seems to give credence to reports from the Philippines that some babies in localities in Mindanao, where there are large banana and pineapple plantations, were born with physical defects. These plantations have been extensively using insecticides, including DDT, to control pests. Doctor Ostrea said that a series of field tests he had conducted at the Bulacan Provincial Hospital in the Philippines validated earlier findings of the lethal effects of pesticides on children.

Likewise, the formula can determine the presence of nicotine in the meconium. A pregnant mother who is a heavy smoker is exposing her fetus to nicotine, which contains, among others, carcinogenic elements. Second-hand and third-hand cigarette smoke has the same adverse effects on babies, although in lesser degree. Doctor Ostrea, who is a professor of pediatrics at Wayne State University, advised parents that when they come home from work or parties where smoking is tolerated, they should change their clothes before they hug their baby. The cigarette smoke sticks to clothes, he said.

Dr. Ostrea became rich for his discovery and invention?

Today, the meconium drug testing formula that Dr. Ostrea discovered and developed is widely used in hospitals and pharmaceutical industries, but did he receive large amount of money for it? It is sad to say that he is not profiting at all from his invention, which is the product of his 10-year-long research on meconium (infant’s first stool) and mothers who take drugs during pregnancy.

“Many people may think that I am now a rich man because of my patented drug testing,” he told a motley crowd who attended his recent lecture at the Philippine American Community Center of Michigan (PACCM) in Southfield. “The truth is that I am not rich because I’m not making any money from it.”

He had secured a patent for his very useful invention, but the infringement on his patent was widespread and rampant. If he goes after the violators, he would be caught up in a gargantuan legal tangle that would require much of his time and resources. Thus, he cancelled his plan to fight for his rights in court.

Did he try to find out how much money the people illegally using his invention are raking in? He said, “No, I did not because I do not want to know how much I’m missing.” This indicates that for Doctor Ostrea, whose father hails from Balaoan, La Union, money is not everything. But he is happy in the thought that the product of his painstaking research for 10 long years at Wayne State University has become a big boost to the efforts to improve healthcare of people all over the world.

Source: http://www.filipinostarnews.net/opinion/plain-rice/why-doctor-ostrea-is-not-a-rich-man.html

            http://www.healthcare.uiowa.edu/path_handbook/handbook/test2732.html
                http://inventors.about.com/od/astartinventors/a/Asian_Inventors.htm
            http://www.google.com/patents/US5015589 
            http://www.google.com/patents/US5185267
            http://www.childrensdmc.org/enriqueostrea
            http://tl.wikipedia.org/wiki/Enrique_Ostrea
            http://en.wikipedia.org/wiki/Neonatology
            http://en.wikipedia.org/wiki/Meconium