Tips Of All Sorts

Lead is such a well-known health hazard -- perhaps even contributing to the fall of the Roman Empire -- that it came as a shock to discover that toys handled by children could contain this toxin. Physicians are now dealing with the aftershocks.

Just how dangerous is this exposure? That's the question physicians are being asked by parents who find a lead-tainted Elmo, Dora or other toy among their child's possessions. Millions of toys, lunch boxes and pieces of jewelry manufactured in China have been recalled because they contain lead either in the paint that coats them or as a component of the plastic used to make the item more flexible. The lead content in some of the toys recalled this summer was 180 times the amount allowed by law. Some pieces of jewelry were almost 100% lead.

Experts advise that the items do pose a risk and that physicians should urge parents to check the comprehensive lists of recalled products on the Consumer Product Safety Commission's Web site and return any appearing on those lists to the manufacturers.

If exposure is suspected, a blood test is in order. "Err on the side of caution" is the mantra.

Since there is no safe level of this ubiquitous element, the risk faced by children for lead poisoning and its accompanying threat of learning disabilities and behavior problems is substantial.

Physicians who have toys in their waiting rooms also are advised to see if any of them have been recalled and to check for chipped, flaking paint -- even on those that haven't yet been recalled -- since new announcements of toy risks continue.

Symptoms of high lead levels in children can be vague and easily confused with a viral illness or crankiness.

"What we have been advising parents to do is if their child is under 72 months of age and has been playing with one of these painted toys for a period of a month or more, that it is better to be extremely cautious and have the child tested for lead," said John Rosen, MD, professor of pediatrics at Children's Hospital at Montefiore in New York City. Montefiore has long operated a Lead Poisoning Prevention Program.

Since 1969, Dr. Rosen has been treating children exposed to lead . He isn't giving up the fight in the face of this new challenge, either. In October he went to a conference in China to present information on childhood lead poisoning.

"The disappointing aspect of all of this from the U.S. standpoint is that the Consumer Product Safety Commission has not been proactive in preventing hazardous toys from ever getting into the marketplace. They have only taken action after the hazard and the risk was identified," he said.

Actions to take

One thing doctors and parents don't want to do is wait and see if a child exhibits symptoms of lead poisoning before acting, cautions Allison Muller, PharmD, clinical managing director of the poison control center at Philadelphia Children's Hospital.

The symptoms of high lead levels can be vague and easily confused with a viral illness or even the terrible twos -- and 2-year-olds represent the peak in lead poisoning cases, Dr. Muller said.

Long-term exposure to lead can result in IQ loss, behavioral and cognitive problems.

Picture the 2-year-old who doesn't want to eat dinner, may have some constipation and seems a little irritable or under the weather. "That could be a lot of things, but it could be lead poisoning, too," she said. "But we don't want to get a lead test on every child who is cranky and doesn't want to eat their dinner that night."

The risk of poisoning increases depending on whether the child chews on a toy or simply handles it, Dr. Muller noted. "Regardless, I would feel more comfortable screening a child if there had been oral contact with a toy or there was hand-to-mouth contact with flaking paint."

Urging parents to consult lists of recalled toys and pay attention to the condition of the paint on toys not on the recall list would be a good step for any physician to take, said several lead experts. But remember that not all toys pose a threat. For example, none of the toys used by Dr. Muller's 3-year-old daughter showed up on any recall lists, she noted.

Adam Spanier, MD, MPH, medical director of Cincinnati Children's Hospital Lead Clinic, said he is encountering parents who say, "I've gotten rid of all the toys that are from China." Since almost all toys are made in China, Dr. Spanier wonders if those children have any toys left.

Plus, it's hard to make such blanket statements, since lead items may come from any of several countries, noted Rebecca Morley, executive director of the National Center for Healthy Housing, a nonprofit group in Columbia, Md., that develops and promotes measures to protect children from residential environmental hazards.

A bigger problem

Toys aside, many stress that the largest risk to children continues to be the lead paint found in old homes. "So while lead-based paint in toys does pose a risk, I think there is a lot more exposure still from older housing," Dr. Spanier said.

Until 1978, lead paint was commonly used in homes. The U.S. Dept. of Housing and Urban Development estimates that about 38 million homes in the nation still contain some lead paint. Although paint that is intact does not pose an immediate threat, paint that is allowed to deteriorate creates a hazard.

38 million U.S. homes contain some lead paint.

But flaking paint isn't even the only problem, Dr. Muller said. "If it's on a window sill, the constant motion of the window grinding up against the paint can produce lead dust." The lead has a sweet taste to it, and the frequent hand-to-mouth action of the very young can result in lead poisoning."

Testing products or painted surfaces for lead using kits, sometimes called swab tests and sold in hardware stores and large home improvement emporiums, can be somewhat useful. "I don't discourage people from using them as a screen," Morley said. However, on Oct. 22 the Consumer Product Safety Commission questioned the reliability of such test kits.

X-ray fluorescence is another method that has been used for measuring lead in soil and paint, and portable machines can be used in homes, Morely said.

Dr. Spanier hopes that the latest news about lead in toys signals physicians to watch their young patients more carefully. "Many physicians out there believe that the lead poisoning issue has gone away, but I can tell you from working in the lead clinic that we actually have seen more patients in the last few years than we have in previous years. I think it's because the awareness here is a little greater."

Dr. Muller also would encourage doctors to stay alert to the dangers of lead. "We are in West Philadelphia, and we have a population that always struggles with lead poisoning, so that has always been on our radar," she said. But it isn't always so obvious.

Only in rare cases does a child come into a clinic with acute lead poisoning from a one-time exposure, perhaps swallowing a lead toy, which is considered a health emergency requiring rapid action. Most cases involve chronic, low-level exposures.

The dangers

The results of such long-term exposure are many and serious. Dr. Rosen reels them off: IQ loss; being unable to sit, listen and learn in school; problems with memory, attention span, language and communication capabilities; and planning, organization and cognitive flexibility. All impact success in school and, ultimately, workplace productivity, he noted.

"If a child mouths a toy or the toys are deteriorating, the only way you can determine if a child has an elevated lead level is to check with a blood test," said Helen Binns, MD, MPH, chair of the American Academy of Pediatrics' Committee on Environmental Health and director of the lead evaluation clinic at Children's Memorial Hospital in Chicago. Testing for elevated blood lead levels is relatively innocuous and low cost, she added. A small blood sample is sent to a lab, and a report is available in a couple of days.

Several cities and states require that young children be tested for lead. Medicaid has similar requirements. AMA policy recommends that all physicians screen for possible lead exposure and test when appropriate.

Chicago is one of the localities requiring tests. Children with a blood lead level of 10 micrograms of lead per deciliter of blood or higher are referred to Dr. Binns. Some experts suggest that lower amounts of lead also are harmful.

The actions Dr. Binns takes include counseling parents on ways to counter lead's harms. "You encourage good parenting skills," she said. "Parents make a big difference in cognitive development, particularly of the very young."

She also checks to make sure a child is not iron deficient, which could lead to an enhanced absorption of lead. Only occasionally does she use drugs to treat the problem, since they are rarely effective.

The Chicago health department also inspects the home to eliminate sources of exposure. In addition to lead paint in homes, parents who work at jobs or have hobbies involving lead can bring it home on their shoes and clothes.

Other sources of lead have included pottery from other countries and even candy. Folk medicines also may be high in lead. Azarcon or greta, a Mexican remedy for indigestion, was found to contain almost 90% lead.

Despite ongoing challenges, public health efforts are paying off, and lead levels in children have fallen steadily since 1997, according to CDC surveillance data. But some segments of the population, including non-Hispanic black children and the children of recent immigrants, continue to be threatened, and the CDC estimates that 310,000 children ages 1 to 5 continue to be at high risk.

Meanwhile, congressional hearings have begun on ways to ensure the safety of imported products, including toys from China, as well as the effectiveness of the Consumer Product Safety Commission, which is charged with overseeing the safety of such goods. If nothing else, the toy recall brought attention to the need for adequate regulation and oversight of consumer products.

Washington -- Two physician organizations have produced what are considered by many to be the first comprehensive national guidelines since 1994 on the diagnosis and treatment of acute low back pain, when a federal directive on the same topic caused a furor that resulted in congressional hearings and the government's stepping out of the guidelines business.

So far, the blueprint published in the Oct. 2 Annals of Internal Medicine has not generated the same controversy as the earlier venture, which came under fire by those who favored a surgical approach to alleviate back pain. The new document, available online (www.annals.org/cgi/content/full/147/7/478/), was spearheaded by the American College of Physicians and the American Pain Society and is intended to aid primary care physicians in handling this common condition.

The two organizations enlisted the help of numerous specialty physician groups, including spine surgeons, and weighed evidence offered in hundreds of published studies. The process took more than two years.

This time around, the guidelines -- which ironically make many of the same recommendations as did those put forward 13 years ago -- are enjoying the support of groups that condemned the earlier effort made by the Agency for Health Care Policy and Research, the predecessor of the Agency for Healthcare Research and Quality.

What changed in the intervening years is the mounting evidence in support of the recommendations.

What has not changed is the prevalence of back pain. The condition is second only to headaches as the most common neurological ailment in the United States. It is also the most common cause of job-related disability and is a leading cause of missed work, according to the National Center for Health Statistics, which asks about back pain in its National Health Interview Survey.

The guidelines include an algorithm to guide doctors in obtaining and interpreting data during the first patient visit to place those with back pain in groups ranging from nonspecific low back pain -- 85% fall into this group -- to pain associated with conditions such as spinal stenosis and sciatica or to pain thought to be caused by cancer or infections.

Why new guidelines?

"We wanted to review all the evidence and develop guidance for clinicians and give our patients a realistic sense of what they can expect when they visit a clinician for low back pain," said Amir Qaseem, MD, PhD, senior medical associate in the ACP Dept. of Clinical Programs and Quality of Care and an author of the guidelines.

The groups were not dissuaded from their task by the 1994 ruckus, said Roger Chou, MD, the director of the pain society's clinical guidelines program. He was also an author of the latest document. "We really felt it was time to update the guidelines, because there has been a ton of new evidence since 1994."

27% of Americans report chronic back pain.

Plus, the lead groups worked hard to assemble the many stakeholders who diagnose and treat acute low back pain, he noted. "They range from surgeons to anesthesiologists to primary care physicians to chiropractors to physical therapists and psychologists," he said. "We had 14 or 15 disciplines represented."

Consensus was achieved for all seven recommendations, Dr. Chou said. "We tried to ground things as much as we could in the evidence. So it is pretty bulletproof from that perspective."

The guidelines probably include the most comprehensive review of the evidence on diagnosing and treating low back pain since the 1994 effort, said Jeffrey Susman, MD, a professor and chair of family medicine at the University of Cincinnati College of Medicine. He served on the panel that developed the earlier guidelines.

Both documents arrived at the same basic take-home message, he noted: "Treating low back pain is a case of more is less, and we should be parsimonious in our diagnosis and management."

The new set is "first rate" and valuable for primary care physicians, said Richard Deyo, MD, MPH, professor of family medicine at the Oregon Health and Science University in Portland. Dr. Deyo also served on the 1994 guidelines panel. "Primary care doctors can't do the kind of extensive literature searching and appraisal of those articles that this group has done," he said.

Surgeons also found the new directive of value. "This is a very good attempt at gathering the plethora of information we have out there guiding us on what we should do with a patient with acute back pain," said Arya Nick Shamie, MD, assistant professor of orthopedic surgery and neurosurgery at the University of California, Los Angeles and a spokesman for the American Academy of Orthopaedic Surgeons.

Good for primary care

This set of principles is "extraordinarily educational to primary care physicians," agreed William Watters, MD, chair of the evidence-based guidelines committee at the North American Spine Society. The spine society was one group that had campaigned hard against the earlier guidelines and the agency that developed them.

Today's situation is entirely different from that of 1994, Dr. Watters said. "Guidelines are being created now in a very different fashion than they were even that short time ago," he said. "Any reasonable guidelines today will be evidence-based in order to even get published."

The next ACP/APS back pain guidelines, due to be published next year, will cover surgical procedures, a more challenging area because the evidence isn't as strong, Dr. Chou said.

Dr. Deyo wondered whether the release of this next set could cause an uproar and said, "I think the controversy has to do with the parts that haven't been published yet."

As of Jan. 1, 2008, the North Dakota Dept. of Health will stop struggling to pay for many of the vaccinations for all the state's children and adolescents. The recommended list has gotten too long and too expensive, so officials are now asking insurance companies to pay to immunize the children on their rolls. If it is a covered service, they will be billed.

"When we gathered information on who was receiving vaccines, we discovered that nearly all '317 funds' (a Centers for Disease Control and Prevention immunization grant) were subsidizing insurance companies. That didn't seem to be right," said State Health Officer Terry Dwelle, MD, MPH.

Public health officials appreciate the opportunity to prevent more disease, but paying the tab for an ever-expanding childhood and adolescent vaccination schedule has become a significant challenge. It was also a focus of the first National Immunization Congress organized by the American Medical Association and the American Academy of Pediatrics earlier this year.

AMA policies support increased federal funding for vaccine purchase, the establishment of a national immunization strategy and encouraging health insurers to pay for this preventive service.

Uninsured children can get their shots through the federal Vaccines for Children Program, but more than half of states use other federal funds to attempt to do more. They use this money to broaden access to immunizations to those who do not fully qualify for this program, such as those whose insurance doesn't cover vaccines. A handful of states also attempt to give vaccines to all children to simplify administration, but this bill has become extremely hefty for many of these jurisdictions.

Consider North Dakota. Until 2002, it provided all recommended vaccines to all children. In the past few years, though, its policies have been shifting toward supplying the full schedule to uninsured and underinsured kids and only an abbreviated list to those with insurance. The most recent, soon-to-take-effect change has advanced with the support of BlueCross BlueShield of North Dakota, the state's largest insurer, because the number of vaccines recommended for children has nearly doubled in the past five years, while federal funding has not kept up.

The number of vaccinations recommended for children has nearly doubled in the past five years.

"There's any number of states looking at alternative ways to pay for vaccine, and there's a number of ideas floating around," said Claire Hannan, MPH, executive director of the Assn. of Immunization Managers.

And some of these examinations may evolve into official recommendations. The vaccine finance working group of the National Vaccine Advisory Committee will publish a draft white paper on this topic by the end of the year. Their suggestions are expected to call for increases in the maximum allowable payment for this service from Medicaid and the collection of data on the expenses associated with vaccination in private physician practices beyond just the cost of the shot itself to ensure that reimbursement reflects the true expense. Manufacturers and distributors most likely will be asked to reduce financial liability for the initial stocks of newly approved vaccines.

"It's great that we have new vaccines on the market. We have a tremendous opportunity, but the challenge is to get all children access to all recommended vaccines without any financial barriers," said Guthrie Birkhead, MD, MPH, chair of the working group and director of the Center for Community Health at the New York State Dept. of Health.

Cautious and optimistic

While both North Dakota's efforts and the ongoing, broad consideration of vaccine-financing issues have garnered much praise and attention, a great deal of concern haunts any such discourse for fear that resulting steps might negatively affect vaccination rates.

For example, it's unknown what kind of impact, if any, having an insurance co-pay will have on a parent's decision to have a child vaccinated. Physicians also are hesitant to support anything that may make vaccine administration more complicated. Already, physicians working in states that provide shots only to those eligible for the Vaccines for Children Program have to keep those supplies separate from those for kids who don't qualify for the program.

But evidence is demonstrating that increased private-sector involvement can work. A paper presented at the 2006 National Immunization Conference documented the experience of the Oregon Dept. of Human Services. Several years ago, the department started billing insurance companies covering children who received immunizations in public clinics. The approximately $1 million so far resulting from this initiative has allowed the state to increase the number of hepatitis vaccinations it provides.

"Some people still think we're crazy, but billing worked really well for us," said Lorraine Duncan, lead author on that paper and the immunization program manager for the department.

And many in the public health system strongly support greater private-sector involvement.

"These are very creative and very important responses to the vaccine-financing issue," said Lance Rodewald, MD, director of the CDC's Immunization Services Division. "The best way to provide vaccinations is a private-public collaboration."

The goal of these efforts is not just to increase childhood vaccinations. North Dakota officials are expecting to generate enough money from insurance payments to be able to start providing publicly funded vaccines for adults, and some states already have expanded their programs to serve this age group.

In September, the Vermont Dept. of Health announced that it would start providing pneumococcal and the combined tetanus, diphtheria, pertussis vaccines at no charge for administration to those older than 18. A select list of clinics in Bennington, Vt., has started receiving supplies, and the intention is to eventually expand this program to the entire state.

Washington -- Long-awaited resources to help the Food and Drug Administration more closely monitor the safety and effectiveness of the nation's pharmaceuticals and medical devices will begin to flow as a result of a comprehensive new law signed Sept. 27 by President Bush.

The Food and Drug Administration Amendments Act of 2007 reauthorizes the Prescription Drug User Fee Act, the Medical Device User Fee Act and laws that govern the safety of children's drugs and devices.

It also includes new measures that require the monitoring of massive databases to detect safety problems early, expand clinical trial registries and add a new public-private foundation dedicated to drug development.

The law was given "must-pass" status by Congress because without it, an important FDA funding source -- PDUFA -- was set to dry up at the end of September.

Congress also stepped in to help the beleaguered agency shore up its sagging reputation as the nation's pharmaceutical watchdog. Recent high-profile drug withdrawals had shaken public confidence in the FDA's abilities.

Sen. Mike Enzi (R, Wyo.), a bill sponsor and ranking member of the Senate Health, Education, Labor and Pensions Committee, praised the way the House and Senate worked together to gain the measure's final approval. But yet, "Is it a perfect bill?" he asked. "That never happens around here. Is it a big victory for patients and children? Yes it is."

Some specifics

The legislation ensures funding continuity by extending until 2012 user fee programs that allow the agency to collect millions of dollars from pharmaceutical and medical device manufacturers to speed review of their products. Both programs were to have expired Sept. 30.

In addition, the law increases by about $87 million a year the agency's user fees from pharmaceutical companies. This increase brings total PDUFA funding to about $392 million annually, said Randall Lutter, PhD, the FDA's Deputy Commissioner for Policy. He spoke at a briefing held after the president signed the law.

Starting in 2008, the FDA will collect about $392 million a year in pharmaceutical user fees.

User fees from manufacturers of medical devices will also increase. The law authorizes fee increases of about 30% for 2008 and 8.5%in each fiscal year through 2012.

For the first time, some of the user fees will help pay for agency work in policing drugs and devices already on the market. The law also provides the FDA with new authority to address postmarketing surveillance, a responsibility that had previously been unclear. Now the agency will be able to require pharmaceutical companies to make label changes that reflect new safety information and to order companies to conduct additional studies or clinical trials for products on the market. The law provides for civil monetary penalties for violations.

AMA Board of Trustees Chair Edward Langston, MD, praised the law's safety provisions, noting that the measure "will help the FDA to better serve America's patients and physicians by providing the best methods to identify drug risks and communicate them to the public."

The law also encourages more accurate drug advertising. The FDA can now require companies to submit their direct-to-consumer television ads for review before they are aired, if there are safety concerns. The law includes heavier fines for running misleading ads. Some user fee funds will be dedicated to this review process.

"The reauthorization of PDUFA and MDUFA programs and their expansion will make sure the [agency's] centers have the additional resources they need for complex reviews of new drugs and devices," said FDA Commissioner Andrew von Eschenbach, MD.

It was also welcomed by Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, a Washington, D.C.-based group that represents many large pharmaceutical and biotechnology companies. "Since its original enactment in 1992, PDUFA has been a resounding success for FDA, pharmaceutical research companies, taxpayers and, most importantly, patients," he said.

The measure is also notable for what it doesn't contain. The AMA opposed a provision in an earlier version of the bill that would have restricted physicians' ability to prescribe certain medications.

Sen. Tom Coburn, MD, (R, Okla.) took action to ensure that the law preserves physician discretion in prescribing. "The AMA greatly appreciates Sen. Coburn's determination to ensure that physicians, rather than the FDA, are empowered to make appropriate risk/benefit decisions with their patients," said Dr. Langston.

Large amounts of caffeine may increase the risk of liver dysfunction caused by ingesting higher-than-recommended doses of acetaminophen, according to a study published in the Oct. 15 Chemical Research in Toxicology. The authors are urging patients to be more judicious with these substances, especially if they also imbibe alcohol.

"You don't have to stop taking acetaminophen or stop taking caffeine products, but you do need to monitor your intake more carefully when taking them together, especially if you drink alcohol," said Sid Nelson, PhD, the paper's senior author and dean and professor of medicinal chemistry at the University of Washington.

Dr. Nelson and his team subjected Escherichia coli bacteria to large amounts of caffeine and acetaminophen. The bug was engineered genetically to produce a human liver enzyme, and caffeine tripled the production of the toxic byproduct created during the breakdown of acetaminophen responsible for problems in this organ. Previous studies conducted in Dr. Nelson's lab also suggested that large amounts of caffeine worsened acetaminophen-induced liver damage in rats.

The link between excessive doses of this drug and liver damage is well-established and on the label. Concern has been increasing over the past few years about the risk of overdosing inadvertently, and several over-the-counter products on the market combine this medication with caffeine. But drug safety experts said this paper was too preliminary to warrant changing how this drug is used in humans.

"While results from in vitro studies, such as this, may be interesting and raise concern for some individuals, acetaminophen users should understand that this drug is among the safest pain relievers available, and that switching to another class of drugs may ultimately raise their risk of a drug-related adverse event," said A. Mark Fendrick, MD, professor of internal medicine at the University of Michigan.

McNeil Consumer Healthcare, the maker of Tylenol, reiterated that its product is safe when taken as directed.