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In a rather unprecedented move, the U.S. Product Safety Commission (CPSC) in July sued Maxfield and Oberton, the manufacturer of Buckyballs® and Buckycube™ desk toys after the company refused to voluntarily cease distribution of these high-powered, manipulative magnet products. Less than two weeks later, the CPSC also filed suit against Zen Magnets™, another retailer of high-powered magnet sets. Eleven other manufacturers of similar magnet sets have voluntarily agreed to cease sales, and a number of retailers have pulled the products from market. By a vote of 3-1 the Commission voted to file the lawsuits because the products contain a defect in the design, packaging, warnings and instructions, which pose substantial risk of injury to children. The type legal action taken by the CPSC is rare and has only been used one other time in the past 11 years. CPSC filed the lawsuit less than two months after NASPGHAN leaders met with the CPSC to discuss, using case examples, the growing number and medical severity of high-powered magnet ingestions by children.
On September 4, the CPSC issued a proposed rule that would ban certain high-powered magnets after it reached a preliminary conclusion that these magnet sets pose an unreasonable risk of injury to children. The CPSC proposal defines these magnet sets as any aggregation of separable, permanent magnetic objects that are marketed primarily as a manipulative or construction desk toy for general entertainment, such as sculpture or stress relief. Under the proposal, if a magnet set contains a magnet that fits within the small parts cylinder that CPSC uses for testing toys, magnets from that set would be required to have a flux index of 50 or less. A flux index is a reliable way to gauge a magnet’s relative attraction force.
In the proposed rule, CPSC presents alternatives to the proposed ban to reduce the risk of magnet ingestion injuries. However, CPSC states in the proposed rule that it does not believe that any of the alternatives would adequately reduce risk or injury, including warnings on packages.
Based on its analysis of data from the National Electronic Surveillance System (NEISS), the CPSC has determined that 72 magnet ingestion cases, involving magnets from these magnet sets, occurred between Jan. 1, 2009 and Dec. 31, 2011. Based on these cases, the CPSC estimates there were 1,716 magnet injuries treated in U.S. hospital emergency rooms during this period, of which more than half appear to have involved ingestion of more than one magnet. The CPSC states in the proposed rule that because NASPGHAN is collecting additional data, incident numbers may change. Since publication of the proposed rule, NASPGHAN has completed a survey of its members and findings will be released to the public in October. The survey findings will also be incorporated into a formal comment letter in response to the proposed rule that will be submitted to the CPSC by NASPGHAN. The proposed rule is open for public comment until November 19. NASPGHAN members are strongly encouraged to submit comments and state their support for the proposed ban.
In September, NASPGHAN issued an all-member grassroots action alert asking pediatric gastroenterologists to contact their members of Congress and voice support of the CPSC’s proposed ban of high-powered magnet sets. On August 2, the House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade held an oversight hearing of the CPSC. That same day, Maxfield and Oberton, the manufacturer of Buckeyballs®, purchased full-page ads in the Washington Post, as well as in three popular Capitol Hill publications, asking Congress and President Obama to save the company from “destruction.” During the hearing, Maxfield and Oberton was successful in getting Rep. Marsha Blackburn (R-TN) to ask a convoluted question about the CPSC’s lawsuit against the company, during which she tried to compare high-powered magnets to games with marbles, fireworks, and alcohol. Check out a video clip of Rep. Blackburn at the hearing. NASPGHAN members need to make sure that members of Congress are getting all the facts and understand why these magnets are so dangerous when ingested. Take a moment to email a letter to your lawmakers through NASPGHAN’s Legislative Action Center. Additionally, contact Rep. Blackburn and tell her that she has it all wrong. Explain to her why high-powered magnets are unlike other foreign body ingestions and that you support the CPSC’s proposed ban.
The manufacturer of the popular Buckyballs®, Maxfield and Oberton, has vowed to fight a ban of it’s product. Rather than take responsibility for the known use of the product by children, Maxfield and Oberton and has launched an aggressive and well-financed “Save our Balls” campaign against the CPSC’s actions. To help physicians and parents share their voices in support of the CPSC’s proposed ban and to spread the word about the dangers of these magnet toys, NASPGHAN has launched a Facebook page. NASPGHAN members are encouraged to “Like” the page, as well as post stories, educational information, and express support for a ban on high-powered magnet sets.
Before lawmakers departed Washington in September to hit the campaign trails, Congress passed a fiscal year (FY) 2013 spending extension, or continuing resolution. The extension keeps the federal government operating after the start of the new fiscal year, which begins October 1, because Congress has yet to pass any of its 11 annual spending measures. The extension, which expires on March 27, 2013, funds the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration, among other agencies, at FY 2012 spending levels. While lawmakers could complete action on some or all of the spending bills during the post-election, lame-duck session of Congress, the presumption is that Congress will wait to finalize the spending measures until after it reaches a deal on sequestration and the looming fiscal cliff. In June, members of NASPGHAN’s Public Affairs and Advocacy Committee met with lawmakers on Capitol Hill to request $32 billion for the NIH and $50 million for the Department of Defense’s Peer Reviewed Medical Research Program in FY 2013.
In about three months, non-defense discretionary (NDD) federal programs will receive an approximate 8 percent cut in funding as a result of a budget deal struck last year by Congress, unless Congress and President Obama reach agreement on how to stop the across-the-board cut, or sequestration.
Sequestration is required under the Budget Control Act. This law established caps on discretionary spending over 10 years, resulting in $1 trillion in cuts spread across defense and non-defense programs. The law also directed a congressional Joint Select Committee on Deficit Reduction to identify an additional $1.2 trillion in budget savings. Because the Joint Select Committee failed to reach agreement on a deficit reduction plan, an automatic sequestration of both defense and non-defense programs will take effect on Jan. 2, 2013. Medicaid and the State Children’s Health Insurance Program (SCHIP) are exempt from the automatic cuts.
Sequestration would mean roughly $2.4 billion less for the NIH in 2013. It is estimated sequestration would force the NIH to fund 2,300 fewer research grants next year, which represents about a quarter of the NIH’s new and competing grants. Testifying before the House Energy and Commerce Committee in June, NIH Director Francis Collins, MD, PhD, said that sequestration could really disrupt and do “serious damage” to the progress that has been made in medical research. Dr. Collins noted that NIH grant success rates are already at their lowest in history and would drop further as a result of sequestration, dealing an unsustainable blow to researchers.
Lawmakers will have an opportunity to negotiate a budget deal when Congress reconvenes in November. However, it is possible that Congress will fail to reach a long-term deal and will instead temporarily suspend the cuts and attempt to reach agreement on a broad deficit reduction package early next year.
On September 12, the House Energy and Commerce Committee approved legislation that would authorize the NIH to establish up to 20 pediatric research consortia across the United States. The bill requires that a subset of the consortia would be required to focus primarily on pediatric rare diseases and conditions. The bill also establishes a data coordination center to facilitate the sharing of research findings in a timely manner and to provide the CDC assistance with the establishment of patient data registries. The bill is awaiting consideration in the Senate.