Date: 3/18/2009
By LEE LOGAN
Associated Press Writer
JEFFERSON CITY, Mo. (AP) — Could a vintage, dog-eared copy of “The Cat in the Hat” or “Where the Wild Things Are” be hazardous to your children?
Probably not, according to the nation’s premier medical sleuths, the Centers for Disease Control and Prevention.
But a new federal law banning more than minute levels of lead in most products intended for children 12 or younger — and a federal agency’s interpretation of the law — prompted at least two libraries last month to pull children’s books printed before 1986 from their shelves.
Lead poisoning has been linked to irreversible learning disabilities and behavioral problems, and lead was present in printer’s ink until a growing body of regulations banned it in 1986. The federal law, which took effect Feb. 10, was passed last summer after a string of recalls of toys.
The Consumer Product Safety Commission has interpreted the law to include books but has neither concluded that older books could be hazardous to children nor made any recommendations to libraries about quarantining such tomes, agency chief of staff Joe Martyak said Tuesday.
Still, the agency’s interpretation itself has been labeled alarmist by some librarians.
“We’re talking about tens of millions of copies of children’s books that are perfectly safe. I wish a reasonable, rational person would just say, ‘This is stupid. What are we doing?'” said Emily Sheketoff, executive director of the American Library Association’s Washington office.
A CPSC spokesman told The Associated Press in a recent interview that until more testing is done, the nation’s more than 116,000 public and school libraries should take steps to ensure that children are kept away from books printed before 1986.
After the spokesman’s comments appeared Tuesday in an AP story, Martyak said the spokesman “misspoke” about the agency’s stance on older books and younger children.
“We’re not urging libraries to take them off the shelves,” Martyak said. “It’s true the CPSC is investigating whether the ink contains unsafe levels of lead in children’s books printed before 1986.”
Jay Dempsey, a health communications specialist at the CDC, said lead-based ink in children’s books poses little danger.
“If that child were to actually start mouthing the book — as some children put everything in their mouths — that’s where the concern would be,” Dempsey said. “But on a scale of one to 10, this is like a 0.5 level of concern.”
The publishing and printing industries set up a Web site for book publishers last December to post the results of studies measuring the lead in books and their components, such as ink and paper. Those results show lead levels that were often undetectable and consistently below not only the new federal threshold, but the more stringent limit that goes into effect in August 2011.
Those findings were cited in a letter from the Association of American Publishers to the CPSC.
The American Library Association said it has no estimate of how many children’s books printed before 1986 are in circulation. But typically, libraries don’t have many, because youngsters are hard on books, librarians said.
“Frankly, most of our books have been well-used and well-appreciated,” said Rhoda Goldberg, director of the Harris County Public Library system in Houston. “They don’t last 24 years.”
Also, the lead is contained only in the type, not in the illustrations, according to Allan Adler, vice president for legal and governmental affairs for the Association of American Publishers.
Sheketoff said she heard of just two libraries that started to restrict access to children’s books last month amid publicity about the new law. One roped off the children’s section; the other covered children’s books with a tarp. Both libraries, which she declined to identify, stopped after being contacted by the association, she said.
“Communities would have a stroke if public libraries started throwing out hundreds and hundreds of books just because they came out before a certain copyright date,” said Margaret Todd, librarian for the Los Angeles County system, which has 89 branches and about 3 million children’s books. Todd said she expects the commission to develop reasonable standards that protect children.
Nathan Brown, a lawyer for the library association, said libraries should not even be subject to the law. He argued that Congress never wanted to regulate books and that libraries do not sell books and thus are not subject to the consumer products law.
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Associated Press Writer David A. Lieb contributed to this report.
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On the Net:
Safety Commission: http://www.cpsc.gov/index.html
Publishers Association study: http://www.rrd.com/cpsia
Copyright 2009 The Associated Press.
Government probes chelation-heart disease study
Date: 9/25/2008 6:38 PM
By MARILYNN MARCHIONE
AP Medical Writer
The largest alternative medicine study the government has ever launched has stopped enrolling people while officials investigate whether participants were fully informed of the risks and are being adequately protected, The Associated Press has learned.
More than 1,500 heart attack survivors are involved in the research, which tests a controversial treatment called chelation. It is mainly used to treat lead poisoning.
More than two people have died, although the Miami doctor leading the study said the deaths were not a direct result of the treatments. He said he doesn’t know exactly how many deaths have occurred.
He also acknowledged that some doctors who had been involved in the study have been disciplined by state boards or have criminal records and have been asked to drop out.
“We think we have a safe and ethical trial and we’re protecting our patients,” said the leader, Dr. Gervasio Lamas of the University of Miami.
Federal officials confirmed their probe of the $30 million study on Thursday. Those directing the research, conducted at 100 sites around the United States and Canada, voluntarily stopped enrolling patients earlier this month, after the investigation was launched.
The research was designed to test very high doses of vitamin and mineral supplements and chelation, which has not been proved effective for heart disease. Chelation (pronounced kee-LAY-shun) involves intravenous doses of a drug, in this case disodium EDTA, that proponents claim will bind to calcium built up in artery walls and help flush it from the body.
Conventional treatments for heart disease include medicines, surgery and artery-clearing angioplasty.
When the study was approved in 2002, federal officials said many heart patients were exploring chelation therapy, and the research would give answers about whether the treatment was safe and effective.
A similar philosophy was behind an effort to test chelation on autistic children. However, the government recently scrapped that plan, citing safety concerns as one reason.
The heart disease study was based on misrepresentations about safety and effectiveness and “should never have been approved,” said Dr. Kimball Atwood, an anesthesiologist in suburban Boston and an assistant clinical professor at Tufts University.
He and several others sent a complaint about the heart study to the federal research protection agency, and recently published a lengthy report detailing alleged problems.
“The consent form is inadequate. It doesn’t tell people, for example, that people have died from this drug,” said a report co-author, Liz Woeckner. She is president of Citizens for Responsible Care and Research, or CIRCARE, a nonprofit group focused on research safety.
More than half of the doctors running the study make money by selling chelation treatments — a conflict of interest, critics say. Study documents misrepresent what previous, smaller chelation studies have found and “omit abundant evidence of injuries and deaths,” Atwood wrote.
Woeckner and Atwood’s article alleges problems with the licenses of several doctors who had roles in the trial, including a couple with criminal records.
“That’s frightening to me as a potential subject” in the study, Woeckner said.
The federal Office for Human Research Protections determined there was merit to the complaint and opened an investigation, spokeswoman Pat El-Hinnawy said.
Until June when he joined the University of Miami’s Miller School of Medicine, Lamas had been at Mount Sinai Medical Center and the Miami Heart Institute in Miami Beach, Fla.
After the federal agency opened the probe, the study’s leaders decided to stop enrolling subjects until it was resolved. People already enrolled are still being treated, said a spokeswoman for the National Heart, Lung and Blood Institute, which is sponsoring the study with the National Center for Complementary and Alternative Medicine.
The American College for Advancement in Medicine, a group of chelation practitioners who helped design and run the research, put a statement on its Web site addressing the matter. The group vowed to work with Lamas “to answer the unfounded allegations of impropriety” and said federal officials “will find that the allegations are of a political nature.”
“We call for a swift end to the moratorium and resumption of the trial,” says the statement by the group’s president, Dr. Jeanne Drisko.
Lamas said that any study involving older heart attack survivors was bound to have deaths. After federal officials questioned one death that study investigators had deemed unrelated to the trial, a change was made to report all deaths to the federal Food and Drug Administration, he said.
Many independent groups, including heart specialists at Duke University, are monitoring the study, Lamas said. “The last time they looked at this was at the end of April and there were no safety concerns,” he said.
As originally designed in 2002, the study was to enroll nearly 2,400 people, 50 or older, who had suffered a heart attack at least six weeks previously. Some would be randomly assigned to get either chelation or dummy infusions weekly for 30 weeks, then 10 more treatments bimonthly, over a 28-month period. The assumption was that chelation would cut heart-related problems and deaths by one-fourth.
Others in the study were randomly assigned to get high or low doses of antioxidant vitamin and mineral supplements. The study was to have been nearly completed by now, but enrollment lagged and researchers now aim to sign up fewer than 2,000.
Chelation has been highly controversial, and the American Heart Association and other groups have spoken out against it. The heart group’s Web site says a single treatment costs $50 to $100. In the first month, patients usually are given daily treatments, which insurers do not cover since it is of unproven benefit.
The form of EDTA used in the trial is supplied by AkzoNobel, a Dutch company, Lamas said.
“EDTA isn’t totally safe as a drug. There’s a real danger of kidney failure,” bone marrow problems, shock, low blood pressure, convulsions, heart rhythm problems, allergic reactions and breathing troubles, the heart association site says.
“A number of deaths in the United States have been linked with chelation therapy. Also, some people are on dialysis because of kidney failure caused, at least in part, by chelation therapy,” the site says. “Clearly, people who choose chelation therapy are risking more than money.”
The FDA, the American College of Physicians, the American Medical Association and others have noted that chelation is experimental and of unknown value or risk for heart disease patients.
“What this controversy highlights is the need to do a trial of this treatment,” Lamas said. “It goes on all the time in many physicians’ offices in the U.S. and worldwide.”
The American College of Cardiology is listed in study documents as one of the groups associated with the research. The group’s president, Dr. W. Douglas Weaver, noted the treatment is “experimental, unproven.” But he supports finding out if it might work, and the Henry Ford Health System in Detroit where he works is participating.
“It would be a real disservice to scare people” and cause any study participants to stop treatments, because then we’d never have answers, Weaver said Thursday. If there were a safety concern, the federal government would have stopped the trial, rather than study leaders just suspending enrollment in it, he said.
Copyright 2008 The Associated Press.
By MARILYNN MARCHIONE
AP Medical Writer
The largest alternative medicine study the government has ever launched has stopped enrolling people while officials investigate whether participants were fully informed of the risks and are being adequately protected, The Associated Press has learned.
More than 1,500 heart attack survivors are involved in the research, which tests a controversial treatment called chelation. It is mainly used to treat lead poisoning.
More than two people have died, although the Miami doctor leading the study said the deaths were not a direct result of the treatments. He said he doesn’t know exactly how many deaths have occurred.
He also acknowledged that some doctors who had been involved in the study have been disciplined by state boards or have criminal records and have been asked to drop out.
“We think we have a safe and ethical trial and we’re protecting our patients,” said the leader, Dr. Gervasio Lamas of the University of Miami.
Federal officials confirmed their probe of the $30 million study on Thursday. Those directing the research, conducted at 100 sites around the United States and Canada, voluntarily stopped enrolling patients earlier this month, after the investigation was launched.
The research was designed to test very high doses of vitamin and mineral supplements and chelation, which has not been proved effective for heart disease. Chelation (pronounced kee-LAY-shun) involves intravenous doses of a drug, in this case disodium EDTA, that proponents claim will bind to calcium built up in artery walls and help flush it from the body.
Conventional treatments for heart disease include medicines, surgery and artery-clearing angioplasty.
When the study was approved in 2002, federal officials said many heart patients were exploring chelation therapy, and the research would give answers about whether the treatment was safe and effective.
A similar philosophy was behind an effort to test chelation on autistic children. However, the government recently scrapped that plan, citing safety concerns as one reason.
The heart disease study was based on misrepresentations about safety and effectiveness and “should never have been approved,” said Dr. Kimball Atwood, an anesthesiologist in suburban Boston and an assistant clinical professor at Tufts University.
He and several others sent a complaint about the heart study to the federal research protection agency, and recently published a lengthy report detailing alleged problems.
“The consent form is inadequate. It doesn’t tell people, for example, that people have died from this drug,” said a report co-author, Liz Woeckner. She is president of Citizens for Responsible Care and Research, or CIRCARE, a nonprofit group focused on research safety.
More than half of the doctors running the study make money by selling chelation treatments — a conflict of interest, critics say. Study documents misrepresent what previous, smaller chelation studies have found and “omit abundant evidence of injuries and deaths,” Atwood wrote.
Woeckner and Atwood’s article alleges problems with the licenses of several doctors who had roles in the trial, including a couple with criminal records.
“That’s frightening to me as a potential subject” in the study, Woeckner said.
The federal Office for Human Research Protections determined there was merit to the complaint and opened an investigation, spokeswoman Pat El-Hinnawy said.
Until June when he joined the University of Miami’s Miller School of Medicine, Lamas had been at Mount Sinai Medical Center and the Miami Heart Institute in Miami Beach, Fla.
After the federal agency opened the probe, the study’s leaders decided to stop enrolling subjects until it was resolved. People already enrolled are still being treated, said a spokeswoman for the National Heart, Lung and Blood Institute, which is sponsoring the study with the National Center for Complementary and Alternative Medicine.
The American College for Advancement in Medicine, a group of chelation practitioners who helped design and run the research, put a statement on its Web site addressing the matter. The group vowed to work with Lamas “to answer the unfounded allegations of impropriety” and said federal officials “will find that the allegations are of a political nature.”
“We call for a swift end to the moratorium and resumption of the trial,” says the statement by the group’s president, Dr. Jeanne Drisko.
Lamas said that any study involving older heart attack survivors was bound to have deaths. After federal officials questioned one death that study investigators had deemed unrelated to the trial, a change was made to report all deaths to the federal Food and Drug Administration, he said.
Many independent groups, including heart specialists at Duke University, are monitoring the study, Lamas said. “The last time they looked at this was at the end of April and there were no safety concerns,” he said.
As originally designed in 2002, the study was to enroll nearly 2,400 people, 50 or older, who had suffered a heart attack at least six weeks previously. Some would be randomly assigned to get either chelation or dummy infusions weekly for 30 weeks, then 10 more treatments bimonthly, over a 28-month period. The assumption was that chelation would cut heart-related problems and deaths by one-fourth.
Others in the study were randomly assigned to get high or low doses of antioxidant vitamin and mineral supplements. The study was to have been nearly completed by now, but enrollment lagged and researchers now aim to sign up fewer than 2,000.
Chelation has been highly controversial, and the American Heart Association and other groups have spoken out against it. The heart group’s Web site says a single treatment costs $50 to $100. In the first month, patients usually are given daily treatments, which insurers do not cover since it is of unproven benefit.
The form of EDTA used in the trial is supplied by AkzoNobel, a Dutch company, Lamas said.
“EDTA isn’t totally safe as a drug. There’s a real danger of kidney failure,” bone marrow problems, shock, low blood pressure, convulsions, heart rhythm problems, allergic reactions and breathing troubles, the heart association site says.
“A number of deaths in the United States have been linked with chelation therapy. Also, some people are on dialysis because of kidney failure caused, at least in part, by chelation therapy,” the site says. “Clearly, people who choose chelation therapy are risking more than money.”
The FDA, the American College of Physicians, the American Medical Association and others have noted that chelation is experimental and of unknown value or risk for heart disease patients.
“What this controversy highlights is the need to do a trial of this treatment,” Lamas said. “It goes on all the time in many physicians’ offices in the U.S. and worldwide.”
The American College of Cardiology is listed in study documents as one of the groups associated with the research. The group’s president, Dr. W. Douglas Weaver, noted the treatment is “experimental, unproven.” But he supports finding out if it might work, and the Henry Ford Health System in Detroit where he works is participating.
“It would be a real disservice to scare people” and cause any study participants to stop treatments, because then we’d never have answers, Weaver said Thursday. If there were a safety concern, the federal government would have stopped the trial, rather than study leaders just suspending enrollment in it, he said.
Copyright 2008 The Associated Press.
