September 2012
Table of Contents
® NASPGHAN Launches
Magnet Safety Facebook Page
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.