Children were the raw material of medical research /Newborn Screening for 29 conditions

Children were the raw material of medical research – CBS 60 Minutes /Newborn Screening for 29 conditions – NYT

Mon, 28 Feb 2005

Children have historically been the voiceless victims of medical research abuse – and the doctors and staff who abused them have almost never been held accountable – they are shielded by a whitewashed wall of silence. On Feb. 9, CBS 60 Minutes reported about the buried secrets at Sonoma State Hospital (now Sonoma Developmental Center), where 3,500 children with disabilities lived in the 1950s and 1960s. The children were used in medical experiments without parental informed consent – they were subjected to government-sponsored radiation experiments, among others. Susan Lederer, who teaches medical history at Yale University, and was a member of President Clinton’s Advisory Commission on Human Radiation Experiments, told 60 Minutes that the researchers and staff regarded the children as “the raw material of medical research.” When they died researchers acquired their brains, also without consent.

Despite the institution’s continued denial that such experiments took place, the facts were uncovered by Karen Alves who spent 12 years on a hunt to find out what happened to her little brother, Mark, who had cerebral palsy and was sent to Sonoma in 1958, at age 3. He died in 1961, when he was 6 years old – no death certificate had been issued. Mark was one of 1,100 Sonoma State cerebral palsy patients who were experimented on from 1955-1960. Karen Alves wasn’t able to find out what tests Mark was subjected to. But she found a document that showed that her brother had been part of the study, assigned Specimen #8732. Karen discovered that patients in the study were put through painful procedures like the pneumoencelphalogram, in which air is injected into the brain before a series of X-rays. “Imagine puncturing someone’s spinal cord, drawing fluid out and putting a foreign substance in there. Gas,” says Karen. “When they trap air in your body, you’re in pain, excruciating pain, for days.”

After a two year battle to obtain her brother’s medical records, a court order finally forced Sonoma to release them. Although incomplete, Karen found that her brother had suffered horribly before he died– most likely as a result of the radiation experiment:

The record indicated he had suffered from unusually high fevers the last six months of his life before dying of a seizure. Karen notes that “Swollen eyes, seizures, those things can fit in with radiation poisoning.” She also discovered that “They took my brother’s brain without consent, and the doctor, in his obituary it said that he had one of the largest brain collections,” says Karen.

Lederer told 60 Minutes that she wasn’t shocked by the findings because "researchers have been using disabled children in experiments for over a century." She acknowledges that the experiments were not intended, nor were they, of any benefit to the children who served as mere guinea pigs. Lederer said that using captive populations meant big money for medical researchers: “It would even be an advantage in applying for grant money, because you don’t have to go to the problem of recruiting subjects.” In the case of Sonoma State, records show that when the study began, cerebral palsy admissions there jumped by 300 percent.

Even today, the medical research establishment and those who set government health care policy appear to have learned little from the lessons of the radiation experiments. A report in The New York Times (Feb 21) reveals that "An influential federal advisory group plans to recommend in the next few weeks that all newborns be screened for 29 rare medical conditions." Some of the conditions are well known, like sickle cell anemia, some obscure, affecting less than 100 infants a year. Those who want to screen the infants offer no known treatment for all but 5 of the conditions to be screened, and no medically justifiable rationale for screening.

Responsible medical experts oppose such screening – the challenge is to ensure that the commercial interests of screening proponents do not prevail. Dr. Norman Fost, a professor of pediatrics and director of the program in medical ethics at the University of Wisconsin, points out: “The majority of newborn screening tests have failed. Over the years, thousands of normal kids have been killed or gotten brain damage by screening tests and treatments that turned out to be ineffective and very dangerous.” He recounts the harmful consequences from premature screening for PKU, an enzyme deficiency which, in affected infants, can cause brain damage. But screening for PKU in the 1960s did not distinguish between true PKU and benign versions for whom treatment caused harm. Screening resulted in healthy babies being harmed from a prescribed low phenylalanine diet, causing them a deficiency of this essential amino acid. The American Academy of Pediatrics wrote to the secretary of health, education and welfare stating: “There is a big problem here. We don’t know what a true positive test means. We can’t distinguish a true positive from a false positive, and we don’t know what the right dose of the diet is. Mandatory screening programs should be stopped.’ ”

Given the lack of knowledge about these conditions, the inaccuracy of most screening tests, and the lack of proven treatments for most of these conditions, the risk / benefit ratio is negative, putting babies at unjustifiable risk. Dr. Lainie Friedman Ross, a pediatrician and medical ethicist at the University of Chicago, said: “We don’t know if they are medical conditions. We don’t know what to do with the information." Most conditions for which a baby may carry a genetic marker will never actually develop. Both sides agree that the tests "unintentionally pick up about 25 other conditions, in addition to the 29 that the screening is intended to find. These additional conditions show up as abnormalities, but no one knows what they mean. It is not known whether they are associated with a disease or, if so, what the effects will be."

Yet, despite the absence of a medical justification for mass screening, "It’s going like a house on fire.” Indiscriminate screening is an ill-advised irresponsible policy. Acceding to researchers’ demand for access to the DNA of newborns exposes infants to unnecessary, even harmful treatments – babies who would otherwise have led normal lives may become prisoners of medical providers. The Times reports that "in most states today, parents are not asked if they want their babies tested, though they have the right to decline it; it is simply done, with the cost, about $70 to $120, built into their hospital bills."

Another ill-advised, government sponsored screening initiative was recommended by the President’s New Freedom Commission on Mental Health– the entire population is to be screened for undetected mental health disorders – even though no valid, objectively verifiable screening tools exist. Check the AHRP website for information. We will provide updates on efforts to stop the madness of unproven medical tests and interventions

Contact: Vera Hassner Sharav
212-595-8974

60 Minutes: A Dark Chapter In Medical History
“They were the raw material of medical research.”
Feb. 9, 2005

Karen Alves was just 10 when she lost her baby brother, Mark, in 1961. Mark, who suffered from cerebral palsy, was sent to Sonoma State Hospital. (Photo: CBS) As the oldest of four, she says her fondest childhood memories are of doting on her little brother. “One of the things we looked forward to, when we came home from school, was to play with Mark,” she says. But life would be a struggle for the Dal Molins because Mark was born with cerebral palsy, a condition that cripples the body, but not necessarily the mind. “In the ’50s, cerebral palsied children were considered to be developmentally disabled, mentally retarded,” says Alves to correspondent Vicki Mabrey.

“I never believed he was mentally retarded. When you looked into his eyes, he communicated through his eyes. Š He’d laugh and giggle and kick, and just screech when he saw us.” But by 3, Mark could neither walk nor talk, which meant his mother, Rosemarie, had to care for him. “We know he recognized everybody,” says Rosemarie. “He would laugh or he would cry if he was unhappy.”

The children’s father, Bill Dal Molin, felt that Rosemarie was neglecting their three daughters, because of Mark. “His mother was very, very much attentive to him, and the girls, I felt, were like troops to her,” says Bill. “She was very hard on them, the girls.”

Doctors advised the Dal Molins to commit their son, so Bill told Rosemarie they had to send Mark to an institution. It was November 1958. “I just remember one day coming home from school and the house was very quiet,” says Karen, who never got to say goodbye to her brother. “I don’t remember much after that. It profoundly affected me.”

Rosemarie had committed 3-year-old Mark to Sonoma State Hospital, the largest institution for children in California. At the time, the hospital housed 3,500 children with diverse needs, from babies born with minor defects, like a cleft palate or a club foot, to children with epilepsy and Down syndrome. While the severely disabled languished in overcrowded rooms, the able-bodied were put to work in the institution’s dairies and orchards. Rosemarie did something more that other parents who had committed their children to Sonoma State did not; she visited her son every Wednesday. “It was just a small thing that I can still do is to go see him,” says Rosemarie. “Because most of these children, they never see parents again.”

But those visits came to an abrupt end on Memorial Day, 1961, when Mark was 6. “I picked up the phone and I heard a voice say, ‘Is Mrs. Dal Molin in?’ and I just knew,” says Karen. “They didn’t even say where they were calling from. But I just, this dread came into my heart, and I got my mom and I left. I ran. I hid. Nobody told me. I knew he was dead.” From that day on, Karen and her sisters, Chris and Gail, say they never spoke Mark’s name again. They buried their grief, grew up and had families of their own. But after 40 years, they still struggle with the decision to institutionalize their brother. “It pretty much blew the family apart,” says Gail. “I believe that Dad did what he felt was best for the family. In my heart, I know that is true. But the impact of it on each one of us and the family was devastating.”

In 1994, haunted by thoughts of her baby brother, Karen decided to devote all her spare time to answering the question that had burdened her for decades: how exactly did Mark die? “I just needed to know and, no matter what it was, I needed to know. So I went to the recorder’s office,” says Karen. “There was no death certificate. One of the clerks came over to the front desk, leaned over and said ‘When did he die?’ And I said, ‘1961.’ ‘Well, when did he go into Sonoma State?’ And I said, ‘1958,’ and she said, ‘You better look into it, because strange things happened there.'”

Things got stranger still when Karen noticed an article in the local paper saying 16,000 people, including children, had been used in radiation experiments. “Out of curiosity, I started to read it, and they mentioned patients that were in state-run hospitals being used,” says Karen. “And I just go, ‘Oh my God.’ This could be it.”

Then, President Clinton had just ordered thousands of secret documents on government-sponsored human radiation experiments declassified and made available on the Internet. Karen found a study funded by the federal government involving 1,100 Sonoma State cerebral palsy patients from 1955-1960. One document she also found showed that her brother had been part of the study, assigned Specimen #8732.

Karen wasn’t able to find out what tests, if any, Mark was subjected to. But some of the patients in the Sonoma State study were put through painful procedures like the pneumoencelphalogram, in which air is injected into the brain before a series of X-rays. “Imagine puncturing someone’s spinal cord, drawing fluid out and putting a foreign substance in there. Gas,” says Karen. “When they trap air in your body, you’re in pain, excruciating pain, for days.”

“They were the raw material of medical research,” says Susan Lederer, who teaches medical history at Yale University. She was a member of the presidential committee that investigated the radiation experiments, and she says she wasn’t shocked by the findings because researchers have been using disabled children in experiments for over a century. “Children in orphanages, children in homes of the mentally retarded, these are all good populations from the sense of medical research, because you have an easily accessible group of people living in controlled circumstances, and you can monitor them,” says Lederer.

Lederer read the study that was conducted at Sonoma State Hospital, and says the children underwent painful experimentation “for which they received no direct benefit.” “It seems clear that these were intended to enlarge knowledge about cerebral palsy,” adds Lederer. It did not produce a breakthrough, although Lederer says studies using mentally retarded children were critical in creating vaccines for polio and hepatitis.

Lederer says using captive populations meant big money for medical researchers: “It would even be an advantage in applying for grant money, because you don’t have to go to the problem of recruiting subjects.” In the case of Sonoma State, records show that when the study began, cerebral palsy admissions there jumped by 300 percent. “One of the ways that medical directors of such institutions sort of connected themselves to the world of medical research was simply to provide their patients as commodities,” says Lederer. “I mean, we can provide this many guinea pigs for you.”

Sonoma State is now known as Sonoma Developmental Center. During her 12-year search, Karen repeatedly wrote to the current administrator, looking for information about Mark. She was told that there were “no records on radiation studies at Sonoma,” and that there was “no record that your brother was involved in radiation research.” “And I’d say, ‘Just go to the human radiation Web site and put in Sonoma State Hospital in your search and documents come up,” says Karen. “You’ve gotta have something there. No. They deny it. Deny it. If I called her right now, she’d deny it.”

Administrator Theresa Murphy has worked at Sonoma State for 30 years. She said she didn’t have any information about the medical experimentation that was taking place at the institution. When asked if patients at state hospitals were used in medical research, Murphy says, “I’ve read that there has been things like using rattlesnake venom of epilepsy. But you know, there’s just nothing in our archives about the research you are talking about.” “If these studies were being done, if there are patients from here being sent for radiation studies, is that a stain on the hospital record,” asks Mabrey. “I think in the history of people with developmental disabilities, and there have been some dark times. I truly believe that,” says Murphy. “And it wouldn’t surprise me that there were things we would find – consider questionable today.”

It took two years and a court order for Karen to get Sonoma State to turn over Mark’s medical records. Though not complete, records did show that Mark Dal Molin suffered unusually high fevers the last six months of his life before dying of a seizure. “He ran extremely high fevers that none of us here right now would live through,” says Karen. “Swollen eyes, seizures, those things can fit in with radiation poisoning.” Mark’s records contained another shock. Karen found not one, but two autopsy reports, one for his body and another for his brain. Karen says that Mark’s brain was removed after he died. “They took my brother’s brain without consent, and the doctor, in his obituary it said that he had one of the largest brain collections,” says Karen. “And if there’s any way for me to find that, I would like to put him back together.”

60 Minutes Wednesday learned that between 1955 and 1960, the brain of every cerebral palsy child who died at Sonoma State was removed and studied.

Rosemarie says she never gave them permission to take Mark’s brain for research purposes. “I came from Europe after the war, where all these horrendous things happened,” says Rosemarie. “I never dreamed that in this country, they would do experimenting children. Handicapped children.” Unless their families claimed them, the children ended up in a community grave with the ashes of 500 other people, or buried in a empty field without a headstone to mark their passing.

Theresa Murphy showed 60 Minutes Wednesday the final resting place of 1,400 Sonoma State patients. “The folks that remain here are undisturbed and available for family visitation,” says Murphy. But Mark Dal Molin’s family was able, at least, to spare him that fate. They had him cremated and placed his ashes in a private mausoleum.

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THE NEW YORK TIMES
February 21, 2005
Panel to Advise Testing Babies for 29 Diseases
By GINA KOLATA

EXCERPT

An influential federal advisory group plans to recommend in the next few weeks that all newborns be screened for 29 rare medical conditions, from the well known, like sickle cell anemia, to diseases so obscure that they are known to just a handful of medical specialists and a few dozen devastated families.

But while no one argues with the idea of saving babies, the proposed screening is generating fierce debate. The dispute centers on how useful the test findings would be. Would going ahead with the full list of tests result in more good than harm, physically and emotionally? Or would it be better to forgo most of them?

Proponents say that the diseases are terrible and that an early diagnosis can be lifesaving. When testing is not done, parents often end up in a medical odyssey to find out what is wrong with their child. By the time the answer is in, it may be too late for treatment to do much good. But opponents say that for all but about five or six of the conditions, it is not known whether the treatments help or how often a baby will test positive but never show signs of serious disease. There is a danger, they say, of children with mild versions of illnesses being treated needlessly and aggressively for more serious forms and suffering dire health consequences. And both sides agree that the tests unintentionally pick up about 25 other conditions, in addition to the 29 that the screening is intended to find. These additional conditions show up as abnormalities, but no one knows what they mean. It is not known whether they are associated with a disease or, if so, what the effects will be.

The federal advisory group recommended informing the parents of such results. But that advice, too, is controversial. “Giving parents the result, saying, ‘Here’s the mutation; we are not sure what the outcome will be,’ is better than not telling,” said Sharon Terry, president and chief executive of the Genetic Alliance, an advocacy group for people with genetic disorders. Ms. Terry said it was paternalistic for doctors to presume that it was better for parents not to know.

Dr. R. Rodney Howell, a professor of pediatrics at the Leonard M. Miller School of Medicine at the University of Miami and the chairman of both the committee that wrote the report and the federal advisory group, agreed. “Do I feel it will be difficult for physicians and caretakers to deal with this?” Dr. Howell said. “The answer is yes. But I just don’t think it is proper for us to have information about an abnormality without conveying it.” But Dr. Lainie Friedman Ross, a pediatrician and medical ethicist at the University of Chicago, said: “We don’t know if they are medical conditions. We don’t know what to do with the information. Reporting test data for which there are no systems in place for follow-up testing and treatment is not rejecting paternalism, but it is patient abandonment.” In any event, Dr. Howell said, noting that states were plunging into testing programs: “It’s not really a question of, ‘Should we expand newborn screening?’ It’s happening. It’s going like a house on fire.”

In most states today, parents are not asked if they want their babies tested, though they have the right to decline it; it is simply done, with the cost, about $70 to $120, built into their hospital bills. Dr. Howell said the idea of the new recommendations was “to try to organize the programs and to try to be consistent from state to state.” “Some states screen for four conditions; others screen for 35,” said Dr. Michael S. Watson, the federal project’s director and the executive director of the American College of Medical Genetics. “A family can have their first child in one state where 25 conditions are screened and then move to another where only four are screened.”

Yet, critics say, the fact that testing is happening does not mean that it should be expanded. The history of newborn screening, they say, is filled with cautionary tales.”The majority of newborn screening tests have failed,” said Dr. Norman Fost, a professor of pediatrics and director of the program in medical ethics at the University of Wisconsin. Over the years, Dr. Fost said, “thousands of normal kids have been killed or gotten brain damage by screening tests and treatments that turned out to be ineffective and very dangerous.” To those who ask what is wrong with simply doing every available screening test, Dr. Fost tells what happened with PKU, the first genetic screening test for newborns. Today every state tests for PKU, or phenylketonuria, and it is widely acknowledged as the perfect example of screening that saves lives and prevents disability. But Dr. Fost says that a few decades ago, the situation was not nearly so rosy.

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