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We desperately need this search. And to spur it along, we need broad discussion on the ever more urgent question of whether we dare continue to let material progress be our only guide.

[From the Washington Post, Feb. 24, 1971]

EXPERIMENTS ON HUMANS

In your most thoughtful editorial of Feb. 4, you discuss many of the matters which I talked about recently before the House Science and Astronautics Committee. The International, Commission on Genetic Engineering that I proposed be set up, however, would not have as its purpose the outlawing of human embryo experimentation. Instead its task would be to assess the state of the art, and so be in a position to advise the world's governing bodies of the particular consequences of any given technique in genetic engineering.

Some governments, upon thoughtful consideration, might wish to ban certain manipulations (e.g. human cloning). But in other cases, there may be general agreement that certain producers (e.g. test-tube conceptions to overcome infertility due to oviduct blockage) are in the national interest and should be actively promoted. In any case, I think the matter is much too important to be left in the hands of the scientists whose careers might be made by the achieving of a given experiment. In no case should we forget that the products of these experiments will be human beings, which we must afford the same opportunities for a meaningful life that are now given to children born of "God's" will.

J. D. WATSON, Professor, Molecular Biology, Harvard University; Director, Cold Spring Harbor Laboratory, CAMBRIDGE.

[From the New York Times, July 3, 1970]

RX FOR CHILD'S LEARNING MALADY

(By Robert Reinhold)

PROVIDENCE, R.I., July 2.-A few months ago Jackie D., a 6-year-old boy with big brown eyes, was so bad that his mother was at her wits' end.

He could not sit still, he fought with all the other children on the block, was so clumsy that he could not ride a bicycle, had trouble reading and got so frustrated with his first-grade arithmetic that he would tear up his lessons.

But today, Jackie was not his usual self. He deftly climbed up and down a ladder and did somersaults under the approving eyes of Dr. Eric Denhoff, a pediatric neurologist.

In fact, Jackie has not been himself for sometime now-ever since he started getting an amphetamine-like medicine called Ritacin a few months ago. Now he is quite, coordinated and has even done well enough in his lessons to be promoted to second grade.

Jackie is one of countless thousands of American youngsters with normal or even high intelligence who get Ritacin or amphetamines. The aim is to counter a complex and little-understood learning and behavior disorder sometimes called "minimal brain dysfunction" that afflicts as many as three million children.

GROWING ACCEPTANCE

The treatment is a widely accepted and growing one-if still somewhat controversial. It has been used throughout the United States for 10 or 15 years, often yielding results that one expert called "black magic when it works."

The change it induces, often within hours, is described by doctors, parents and teachers as "remarkable" or "amazing."

But amid mounting concern wtih pill-popping, many medical and laymen have expressed worry over the potential long-term effects of amphetamines, which are widely abused. Moreover, one side effect is loss of appetite, which is particularly undesirable in disadvantaged children who may be undernourished to begin with.

The practice has sporadically generated public dispute. A number of physicians and laymen have expressed fears about long-term effects. In Omaha black

parents were recently reported to have protested that their children were being drugged into submission.

According to the best estimates, from 5 to 20 per cent of American chlidren suffer from this disorder, making it a problem of epidemic proportions.

Such children, usually boys, are all too evident in almost every classroom. They jump up and down, throw paper airplanes at the teacher, fight and shove on the lunch line, can concentrate for only a short time, frustrate easily and often do so poorly in school work that they eventually drop out despite good intelligence.

Very frequently this "hyperkinetic" behavior is linked to marked perceptual impairment; that is, visual and auditory signals are not assimilated properly. The child may read words and letters backward, a problem sometimes called dyslexia, or confuse the meaning of sounds.

This neurological disorder, possibly a result of subtle brain damage during or soon after birth, has been found in many but not all cases to respond dramatically to amphetamines, drugs that are normally used, and sometimes abused, to speed up bodily processes.

But for reasons that are not fully clear these stimulants have the paradoxical effect of calming hyperactive pre-puberty children, allowing them to concentrate for normal periods of time.

The drugs do have some side effects-largely loss of appetite and insomnia. Also, there have been reports of children swapping their pills in the school yard with unfortunate effects.

The most commonly used medications are Ritalin, made by CIBA, and Dexedrine and Benzedrine, made by Smith Kline and French.

"These drugs had been called the penicillin of children with learning disabilities," said Dr. Denhoff, director of the Meeting Street School, an Easter Seal-supported school for handicapped children here. Over the last 2 years, he has maintained 3,000 or so hyperkinetic children on drugs, often with spectacular results.

In fact, it was only a few miles from where Dr. Denhoff was examining Jackie D. that the value of amphetamines was discovered in 1937 quite accidentally by Dr. Charles Bradley, then director of the Bradley Hospital in East Providence, R.I.

Dr. Bradley noticed that drugs he had been giving to control weight problems in disturbed children also seemed to improve their behavior.

SYMPTOMS MASKED

The treatment, which may last for many years, can be likened to the use of insulin for diabetics. That is, it does not cure the underlying neurological disorder, but it masks the symptoms enough to allow the child to become organized, to cope with his environment and to respond to special therapy that is often needed in addition to the medication.

The treatment is not used for children with learning or behavior problems. It is connected with mental retardation, emotional disturbance or psychosis.

The dose varies, but is usually around 30 milligrams a day, about the same that an adult taking amphetamines to lose weight would get, but considerably less than hippies shooting "speed." A 10 milligram tablet of Ritalin esots about 10 cents, so that a week's treatment runs about $2.

Various studies have shown that young children do not become addicted or develop tolerance for the drugs and that the medication can be readily withdrawn after puberty, when minimal brain dysfunction often remits spontaneously. While physicians have been using the drugs empirically for 30 years, there have been few controlled sceintific studies. One of the first to start such studies was Dr. Leon Eisenberg, chief of psychiatric services at the Massachusetts General Hospital in Boston, and his associate, Dr. C. Keith Conners, a psychologist.

DRUGS HELD VERY SAFE

"When used properly, they are remarkably safe-even safer than penicillin," said Dr. Eisenberg, who has tested about 750 children.

Referring to fears that children were being doped up, he said:

"The basic confusion is to apply standards which were developed in adults to children without recognizing the very marked difference in response to his agent.” He and Dr. Conners have just completed an experiment in which 75 children were broken up into three groups. Twenty-five were given Ritalin, 25 Dexedrine

and 25 a placebo with no medicine. Each child was given a wide battery of intelligence and perception tests before and after medication.

SURVEY OPTIMISTIC

The experiment was "double blind", meaning that neither the children, parents nor testers knew which children were getting the drugs. The results showed “extremely strong" beneficial effects of the stimulants on a variety of cognitive, perceptual, attentional and learning tasks, including the so-called Draw-a-man test in which the child is asked to draw a human figure.

Similar results were obtained recently by Dr. Denhoff and Dr. Anthony Davids, a professor of psychology at Brown University, in a study of 42 children at the Governor Center School in Providence. However, Dr. Davids believes much more study is needed before he can say conclusively that the drugs aided learning. In a survey of studies conducted through 1967, Dr. J. Gordon Millichap and Dr. Glenn W. Fowler of Northwestern University found that 83 per cent of 337 children given Ritalin by various scientists had shown improvement while only 1 per cent got worse from the drug. Undesirable side effects were reported in 14 per cent of the cases.

As for the amphetamines (benezedrine and dexedrine), improvement was found in 69 percent of 610 cases and a worsening in 11 per cent.

In an attempt to measure the long-term effects, Dr. Eisenberg's group recently followed up on 100 children given drugs by Dr. Bradley in the nineteen thirties and nineteen forties. No indication of addiction or other drug-induced emotional or psychological damage was found.

Dr. William S. Langford, director of the pediatric language disorder clinic at Columbia's College of Physicians and Surgeons in New York, has been using the amphetamines since 1938 and Ritalin more recently.

"I don't think it's a learning pill," he said of Ritalin, "but our impression is that it is a safe drug-it keeps kids in school." Dr. Langford said that he had one child on it from age 3 to 13, the boy went on to complete college successfully.

The achievement has probably gained its greatest foothold in California. There, Dr. Sidney Adler, of Anaheim, a consultant to eight school districts in Orange County, has 2,000 children including 200 college students, on various drugs. "I have saved many many kids from going down the drain," Dr. Adler said. As elsewhere, school systems in California do not prescribe the drug. This is done by private physicians, often after a teacher or school nurse suggests that the parents seek medical help.

The chemical effects of the drugs are not clear. One theory holds that children with the disorder have immature nervous systems and that the stimulants affect certain immature parts of the brain, allowing the child to use his cortex, which controls logic and reasoning.

A number of pediatric authorities believe that some doctors have used the drugs too readily and have urged caution.

"No doctor should use any of these drugs lightly," said Dr. Robert Cook, of Johns Hopkins Medical School. "The whole drug culture of our society is a worry, but in appropriately selected patients it may be as effective as insulin in diabetes."

[From the Washington Post, Sept. 30, 1970]

FDA WARNS AGAINST USES OF "BEHAVIOR" AMPHETAMINES

(By Robert C. Maynard)

Federal Food and Drug Administration officials have warned physicians in Omaha, Neb., against the use of two drugs that had been commonly prescribed there for the "behavior modification" of schoolchildren.

The revelation was among several that emerged in a long day of testimony in Congress yesterday on the use of amphetamine-type drugs to curb the behavior of "hyperactive" children.

Minutes after the FDA warning was introduced to the Right to Privacy Inquiry of the House Government Operations Committee, a Little Rock, Ark., physician testified that once the drugs was among those used in his behavior modification program.

"That's one of the great concerns about the use of these drugs," said Rep. Cornelius Gallagher (D.-N.J.), chairman of the inquiry. "You are using drugs that FDA says are dangerous and you didn't even know the drugs were

dangerous. We should suspend the use of these drugs for this purpose until more is known."

His remarks were addressed to Dr. John E. Peters of Little Rock, who said he uses one of the drugs, Tofranil, for children with learning disabilities.

Neither Tofranil nor the other drug, Aventyl, should be used in children, and the FDA said it "now specifically warns against such use." The agency advised Dr. Byron B. Oberst of Omaha of this in a letter on Aug. 6. Dr. Oberst had been quoted in an article earlier in The Washington Post as saying that Tofranil and Aventyl were among several drugs he prescribed for modifying the behavior of children. The most common drug is Ritalin.

The FDA in its letter to Dr. Oberst emphasized that Tofranil's labeling specifically warns against its use in children. Its side effects include constipation, difficulty in focusing the eyes, precipitation of glaucoma, nausea, vomiting and mild symptoms of Parkinsonism among others.

Aventyl, the agency reminded Dr. Oberst, had been re-labeled to warn against its use in the treatment of children. Its known side effects include fall of blood pressure, tremors and bleeding into organs.

The FDA said in its letter that if Dr. Oberst wished to use these drugs in children, it would constitute an experiment and he would have to apply for a special permit.

Dr. Peters, head of the division of child and adolescent psychiatry at the University of Arkansas Medical Center, said he would suspend the use of Tofranil "until this is cleared up."

The discovery that the FDA had warned a doctor against the use of Tofranil in children came late in the day's testimony and after representatives of the agency had testified.

Dr. Dorothy Dobbs, the agency's director of the Division of Neuro-Pharmacological Drug Products, was asked whether she had investigated the use of drugs for behavior modification in Omaha. She said she had telephoned Dr. Oberst and determined that nothing irregular was taking place.

Dr. Oberst is one of several physicians in Omaha involved in a program for children with behavior and learning disabilities. Many of the children had been placed on amphetamines.

It was well after the testimony of Dr. Dobbs and several other FDA witnesses that the existence of the letter from the agency's legislative liaison, M. J. Ryan, was introduced by Theodore J. Johnson, a black chemist and Omaha resident. The letter had been addressed to Ernie Chambers, an opponent of the drug treatment approach to hyperactive children and an Omaha candidate for the Nebraska legislature.

"I am very disturbed," Gallagher said after Johnson introduced the FDA's letter. He charged that the agency had said that "everything is hunky dory" about using amphetamine-type drugs in children, only for the committee to discover later that two common drugs in such treatment are declared dangerous for children.

FDA officials could not be reached last night for comment, but Gallagher said before the hearing recessed that the agency would be recalled later.

Sally R. Williams, president of the Department of School Nurses of the National Education Association, was among those witnesses who said she felt stimulant drugs were safe if given to children under careful conditions.

But Gallagher hammered away throughout the day's testimony at the fact that amphetamines, commonly known as "speed," are a major cause of drug abuse in the United States.

The FDA witnesses had said there was no evidence of a link between drug abuse and the administration of such drugs to children.

Don Warner, retired assistant superintendent of schools in Omaha, said he was cooncerned that the national attention had made it appear that the school system was dispensing drugs. He said only private physicians prescribe the drugs.

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