Release Date: August 26, 2010
Pain
is a serious and costly public health issue — together, acute and
chronic pain significantly and negatively affects the lives of an
estimated one out of every four Americans, costing more than $100
billion each year in medical claims, disability payments, lost wages and
lost productivity.i This figure does not begin to cover the physical,
emotional and economic strain of pain on the individual and his or her
family members and friends.
Unfortunately, many barriers exist in
our society and culture that place access to pain management out of
reach for many Americans. Barriers are multifaceted and entrenched,
ranging from a lack of pain providers who are knowledgeable and willing
to provide appropriate pain care, to financial affordability,
disparities and discrimination, and unnecessarily restrictive
regulation. Furthermore, unintended consequences exist in policy,
third-party payer rulings and professional conduct based on fear and
stigma that continue to erode access to effective pain management among
those who are suffering.
The effects of pain on the individual
and society can be alleviated or managed with proper medical attention.
Early intervention can reduce health care costs, limit disability and
dramatically improve the lives of people living with pain and their
loved ones.
Position
The American Pain Foundation (APF)
advocates for improved access to effective pain care as a guiding
principle and integral part of its mission. People experiencing pain
have a basic human right to timely, appropriate and effective treatment
of pain.
Access to care is a difficult and burdensome barrier for
people with pain in receiving appropriate pain care and for our society
at large, and requires an elevated collaborative effort to overcome.
APF views the goal of access to care as:
* Timely and appropriate pain care that includes access to the full
range of legal, safe and effective treatment options for all
individuals, regardless of race, ethnicity, gender, age, socioeconomic
or insurance status, to lessen pain, promote recovery, restore function
and improve quality of life.
* Individual comprehensive
multimodal pain management plans devised by the person with pain and
his/her health care team. Such plans will address complex factors, such
as the patient’s health status, clinical and social circumstances, pain
condition, severity and functional impact of pain, patient preference,
provider experience and availability.
* Use of multimodal
treatment approaches tailored to the individual living with pain,
including reasonable access to medically appropriate options such as
pharmacotherapy, psychosocial intervention, physical rehabilitation,
integration of complementary and alternative medicine (CAM), injection
and infusion therapies, implantable devices and surgical intervention.
Treatment options must include access to medications, including
controlled substances, as necessary for an individual’s pain treatment.
Such medications should be used according to FDA-approved indications or
other uses justified by research and clinical experience.
It is a
moral imperative to help people living with pain achieve a standard of
life deemed worthy of living — one that permits individuals to enjoy
their family members and friends, as well as contribute to our society
and economy. To this end, all people in pain have a right to timely,
appropriate and effective pain care.
APF believes access to care can be improved by:
* Educating the medical community and the public that chronic
persistent pain is a disease state that requires medical attention and
expertise.
* Adapting disease management principles to guide primary care and appropriate specialty referral.
* Implementing standards and monitoring practices within all health
care systems and ensuring that transparency of pain care is an indicator
in satisfaction surveys and other institutional quality ratings (e.g.,
National Committee for Quality Assurance, Joint Commission on
Accreditation of Healthcare Organizations).
* Developing and implementing state specific report cards on practice and access using the Pain & Policy Studies Group (www.painpolicy.wisc.edu) model for state policy report cards.
* Identifying and eliminating regulatory and third-party payer
policies and medical practices that usurp the “doctor-patient”
relationship or deny pain care access to vulnerable groups or those
policies that are primarily developed for cost savings that may
supersede the best interest of patient care and serve as an
inappropriate and unacceptable form of health care rationing.
*
Ensuring that reimbursement is compatible with the time required for
effective pain assessment and treatment and that it includes
multi-disciplinary/multimodal practice of care.
APF calls on the
professional medical community, regulators and all concerned
stakeholders to partner with people living with pain in taking action.
Organizational leaders and members alike must reaffirm the ethical
commitment to the care of people living with pain and re-energize
collaborative efforts to strategically address the problems related to
accessing pain care and the barriers preventing care. Medical,
governmental, non-profit and private sector parties must work together
to improve clinical and economic outcomes associated with acute and
chronic pain. The overwhelming evidence of harm resulting from inaction
serves as an irrefutable call to action.
i. National Centers for Health Statistics, Chartbook on Trends in the Health of Americans 2006, Special Feature: Pain. Page 70. www.cdc.gov/nchs/data/hus/hus06.pdf.
Accessed August 24, 2010. National Institutes of Health. NIH Guide: New
Directions in Pain Research I. September 4, 1998. Available from http://grants.nih.gov/grants/guide/pa-files/PA-98-102.html. Accessed August 24, 2010.
You will find here information about specific actions you can take—by phone, e-mail, fax—to help people with EDS and their families or information important to your health.
To find the addresses of national elected officials, you can use these links:
For state, city and county information, try this directory:
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There are several upcoming changes that are going to be implemented as part of the Affordable Health Care Act beginning September 23, 2010. These include:
1Extending dependent coverage: Young adults who were usually removed from their parents’ insurance are now permitted to receive coverage under their parents’ insurance until the age of 26, even if the young adult no longer lives with his or her parents, is no longer a student, or is not a dependent on a parent’s tax return.
2Eliminating lifetime limits and restricting use of annual limits: All health insurance companies will be prohibited from imposing lifetime limits on essential benefits, such as hospital stays, and restricting annual limits.
3Eliminating pre-existing conditions exclusions for children: Job-based and new individual health insurance plans won’t be allowed to deny or exclude coverage to any child under age 19 based on a pre-existing condition, including a disability. Starting in 2014, these same plans won’t be able to exclude anyone (children and adults) from coverage or charge a higher premium for a pre-existing condition including a disability.
For more information about the implementation of the Affordable Health Care Act, please visit www.healthcare.gov.
Position Statement on Access to Pain Care
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ACTION ALERT
Newsweek Article Reinforces Negative Pain Stigmas
Newsweek.com recently ran an article titled, “Prescription Nation: Why we should worry about prescription drug abuse,” that was not only one-sided and focused on deaths from pain medication abuse and misuse, but ultimately reinforced the stigmas and stereotypes associated with pain and pain management. With a readership of more than four million, this alarmist article only contributes to barriers for people in pain.
While abuse and misuse of prescription medicines are a serious safety concern, with often devastating consequences, writer Raina Kelley failed to explore and share personal accounts from some people with pain whose needless suffering is ended and quality of life is significantly improved by taking prescription pain medication as directed and prescribed appropriately by knowledgeable health care providers.
APF was particularly concerned with several biased and unfounded comments in the article, including a quote from a doctor who works at an addiction treatment center who stated: “Opioids are really dangerous…Boomers, of course are entering their 60s, and with age comes all kinds of pain problems. If boomers aren’t treated properly, they, too, go overboard.” This comment is insulting and insinuates that this generation will become a group of addicts if they are prescribed opioid medications. Unfortunately, the article did not contain any quotes from an expert qualified to speak about addiction and pain.
Lastly, Kelley focused on celebrity deaths linked to prescription pain medication and questions how many more celebrity deaths are “needed” before people pay attention. She failed to mention how many people have died from untreated or undertreated pain and the cost of pain to our society. Every sensationalized celebrity overdose death only makes it more difficult for the more than 76.5 million Americans who have or have had a problem with pain to be believed and treated in a fair, unbiased way.
WE NEED YOUR HELP IN STOPPING THIS ONE-SIDED MEDIA COVERAGE
TAKE ACTION NOW!
We encourage anyone affected by pain, including people with pain, loved ones, caregivers, and health care providers to join us by submitting a letter to the editor and posting an online comment, insisting that Newsweek act responsibly and demanding balanced reporting with accurate information about prescription pain medication.
- Tell Newsweek that you are outraged by Kelley’s one-sided article.
- Include personal examples about how the stigmas associated with pain have affected you, a family member or one of your patients.
- Give examples of how — when untreated — pain has negatively impacted all aspects of life while living with pain (e.g., difficulties getting out of bed or performing self care, interfering with your work, inability to hold or play with your children or grandchildren).
- State how, when properly treated, your life or a patient’s life can return to some sense of normalcy.
- Encourage Newsweek to do a follow-up interview with an expert who is qualified to speak about pain and addiction.
- Reiterate that the lives and livelihoods of people lost to pain are worth no less than the celebrities and others who have died after abusing or misusing prescription pain medication. Untreated pain has been shown to shorten the lives of those who suffer — some who no longer consider their lives worth living see suicide as their only option.
- Reinforce that regardless of people who abuse or misuse pain medication, people in pain have a right to timely and effective pain management.
Next Steps:
- Read the full Newsweek article.
- Send your letters and comments directly to Newsweek at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it . Letters should be under 200 words. Include “Raina Kelley article” in your subject line.
- Post a comment in the comment section immediately following the online article. Follow posting directions on the web page.
- Share this article with your family members, friends, colleagues, health care providers and encourage them to respond to Newsweek. Don’t forget your Facebook and Twitter contacts.
- Please let us know when you have taken action by simply cutting and pasting your message to Newsweek into an email message and send to APF at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .
To assist you further in your letter, click here to view our Reporter’s Guide that includes information about pain, prescription pain medication and how untreated pain impacts society.
Thank you in advance for your response to Newsweek. We cannot do this alone — by combining our voices we can Conquer Pain Together!
Opportunity to Assist FDA on Medical Device Issues
July 30, 2010
FROM: Suki Bagal, MD
NORD has been invited to provide referrals of adult patients or patient advocates who are interested in working with FDA’s Center for Devices and Radiologic Health (CDRH) on issues related to medical devices. This could include participation in CDRH work groups or listening sessions, or participation as a Special Government Employee (SGE) at advisory panel meetings.
Names and contact information for anyone interested in working with FDA for this purpose should be submitted by email or fax to:
Helene D. Clayton-Jeter, OD
Office of Special Health Issues
U.S. Food and Drug Administration
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
Phone: 301 796-8460
Fax: 301 847-8623
Please feel free to let her know you heard about this opportunity through
NORD.
July 30, 2010
Register Online Now for Rare Disease Investigator Training Course
Online registration was launched today for the three-day training course on conducting research on rare diseases and orphan products to be offered Oct. 18-20 in Rockville, MD, by FDA and NIH in collaboration with NORD and Duke University. Anyone interested in participating in this course should register soon.
The course will focus on FDA’s regulatory requirements and clinical trial issues that are especially relevant to rare disease research. It is designed for academic clinician-researchers, medical professionals participating in rare disease clinical trials, and medical professionals from small biotechnology and pharmaceutical companies conducting research on rare diseases.
Read the flyer. Register online.
June 3, 2010
New Educational Resources on Law
Against Genetic Discrimination Now Available
WASHINGTON, DC – June 3, 2010 – With genetic testing becoming increasingly pervasive in medical care and our daily lives, three of the most prominent organizations in genetics—the Genetics and Public Policy Center at Johns Hopkins University, the National Coalition for Health Professional Education in Genetics, and Genetic Alliance—have teamed up to produce educational materials about the Genetic Information Nondiscrimination Act (GINA), a landmark federal law that protects individuals from the misuse of genetic information in health insurance and employment.
Enacted
in
2008 after 13 years of debate in Congress, GINA limits health insurers
from
using a person’s genetic information to set eligibility requirements, or
establish premium or contribution amounts. The law also prohibits
employers
from using genetic information in decisions about hiring, firing, job
assignments or promotions.
“Almost every day, our center is asked for more detailed information
about what
GINA means,” said Joan Scott, director of the Genetics and Public Policy
Center. “These targeted materials will go a long way towards answering
the
questions that still exist, paving the way for successful, long-term
implementation of this important law.”
The user-friendly materials will help health-care providers and members of the public understand their rights and responsibilities under the law and provide essential information about its details. The documents are also clear about what GINA doesn’t cover.
The
public-oriented
materials—including an interactive website, “GINA & You”
information sheet, and slide set for advocacy organizations—are
available, at http://www.GINAHelp.org,
in the
Genetic Alliance Resource
Repository, and on Genetic Alliance’s website, http://www.geneticalliance.org
“The public has waited a long time for these protections, and by providing this information as a resource we are helping individuals become informed consumers of genetic services,” said Sharon Terry, president and CEO of Genetic Alliance.
The
materials
for health-care providers include background documents, a discussion
guide suggesting how and when to talk about GINA with patients, a
teaching
slide set, and case studies that describe how the law works in a variety
of
real-world, clinical settings. These materials are available on the
website for
the National Coalition for Health Professional Education in Genetics
(NCHPEG),
at http://www.nchpeg.org.
“We’ve heard many questions already from health-care providers about the
specifics of GINA,” said Joseph McInerney, NCHPEG’s executive director.
“Especially as genetic testing becomes more common and the value of
family
history more apparent, there’s a real need for these materials to
reassure
providers and patients alike that GINA supports excellent clinical
care.”
The Genetics and Public Policy Center (GPPC), part of the Johns Hopkins Berman Institute of Bioethics, will have all of the materials on its website, at http://www.dnapolicy.org. The GPPC’s site also includes FAQs and other fact sheets about GINA aimed at a general audience.
Development of the materials was supported by a grant from The Pew Charitable Trusts.
Additional information:
Genetic
Alliance: http://www.geneticalliance.org
Genetic Alliance is a national, nonprofit health advocacy organization
based in
Washington, DC committed to transforming health through genetics and
promoting
an environment of openness centered on the health of individuals,
families, and
communities. When GINA was signed into law, the Alliance chaired the
Coalition
for Genetic Fairness, a multi-stakeholder coalition of over 500
organizations
committed to passing federal genetic nondiscrimination legislation.
National
Coalition
for Health Professional Education in Genetics: http://www.nchpeg.org
NCHPEG is a Maryland-based nonprofit organization whose mission is to
promote
genetics education for all health professionals. NCHPEG’s membership
represents
a broad range of professional societies, advocacy groups, corporate
entities,
and government agencies dedicated to the integration of genetically
based
health care into mainstream practice.
Genetics
and
Public Policy Center: http://www.dnapolicy.org
The Genetics and Public Policy Center in the Berman Institute of
Bioethics at
Johns Hopkins University was created to help policymakers, the press,
and the
public understand and respond to the challenges and opportunities of
genetic
medicine and it potential to transform global public health.
###
About Genetic Alliance
Genetic Alliance transforms health
through
genetics, promoting an environment of openness centered on the health of
individuals, families, and communities. Genetic Alliance brings together
diverse stakeholders that create novel partnerships in advocacy;
integrates
individual, family, and community perspectives to improve health
systems; and
revolutionizes access to information to enable translation of research
into
services and individualized decision making. For more information about
Genetic
Alliance, visit http://www.geneticalliance.org
FDA
Schedules Public
Hearing on Review and Regulation of Products for Rare Diseases
The Food and Drug Administration (FDA) has announced that it will hold a public hearing on June 29 and 30 on the agency’s regulation of drugs, biologics and devices for the diagnosis and treatment of rare diseases. The intent is to gain input from patients, industry, healthcare providers, academic researchers and others to help shape the future work of FDA’s committee for rare diseases.
A NORD representative will speak at the meeting. We encourage our Member Organizations also to submit requests to speak or, if unable to attend the hearing, to submit written comments. Those wishing to speak must register beforehand.
Any representative of a patient organization who would like to connect with NORD regarding speaking at the hearing or submitting comments afterward may contact Diane Dorman at NORD’s Washington Office ( This e-mail address is being protected from spam bots, you need JavaScript enabled to view it ).
The public hearing will be held from 9 a.m. to 5 p.m. on June 29 and 30 at 10903 New Hampshire Avenue, Building 31, Room 1503, Silver Spring, Maryland.
The FDA committee for rare diseases was established in March 2010 to consider how the agency reviews data from non-clinical studies and clinical trials, and makes decisions about marketing authorization and postmarketing surveillance for products being developed for the rare disease patient population.
The hearing is intended to provide advocates for patients with rare diseases, healthcare providers, the pharmaceutical industry and other interested parties an opportunity to relate their experience with, concerns about, and suggestions for the way FDA regulates the scientific evaluation of, marketing authorization for, and postmarketing surveillance of products for rare diseases.
Specific questions to be considered include whether orphan drug marketing applications should continue to be reviewed under the same process, and with the same standards, as non-orphan products; whether the current processes regarding HUDs (Humanitarian Use Devices) adequately address the needs of rare disease patients; whether current standards for approval of devices for rare diseases under the HDE (Humanitarian Device Exemption) mechanism remain appropriate; and whether current processes for rare disease stakeholders to communicate with FDA have been useful.
The public hearing is free and seating will be on a first-come, first-served basis. Attendees who do not wish to make an oral presentation do not need to register. Anyone wishing to make an oral presentation during the hearing must register by submitting a written or electronic request to Paras M. Patel by May 31, 2010. For those unable to attend the hearing, written or electronic comments will be accepted afterward until August 31.
For information about how to submit comments or requests for oral presentations, and for additional information about the hearing, read the Federal Register notice.
Questions
may
be directed to: Paras M. Patel, Food and Drug Administration, 10903 New
Hampshire Avenue, Building 32, Room 5271, Silver Spring, MD 20993-0002;
telephone: 301 796-8660; fax: 301 847 8621;
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
.
Life Caps Letter to Secretary Sebelius
EDNF is proud of its advocacy actions and we want our members to know that we are signers of an important Life Caps Letter being sent to Secretary Sebelius. To read the letter, click here.
A full-page ad by NORD in today’s edition of The Politico, a newspaper distributed widely on Capitol Hill and throughout Washington DC, urges the immediate end of annual and lifetime insurance caps. As you know, private insurers may set lifetime and/or annual caps on the amount of health care coverage an individual may have.
Many Americans with chronic diseases, rare disorders, or major medical crises exhaust their insurance benefits under this system, forcing families into financial crisis or even bankruptcy. NORD feels very strongly that annual and lifetime caps on health insurance must be ended immediately.
NORD’s reason for running the ad is as follows: The Senate health reform bill currently under consideration is believed by many to include provisions for ending lifetime and annual caps. However, certain provisions currently within that bill would allow continuation of the caps for a period of years or in many cases indefinitely. NORD is calling for changes in the language of the bill to do away with these loopholes.
To view
NORD’s ad, click
here. We will keep our members and friends informed of any new
developments on this important issue. In the meantime, if you have
stories to share with NORD about how annual or lifetime caps have affected you
or your members, please feel free to send them to
This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
.
NORD Urges Senate to Pass Patient Protection and Affordable Health Care Act
On behalf of the nearly 30 million Americans with rare diseases, the National Organization for Rare Disorders (NORD) today delivered the following letter to U.S. Senate Majority Leader Harry Reid, and faxed copies to all members of the Senate:
November 19, 2009
The Honorable Harry Reid
Majority Leader
United States Senate
Washington, DC 20510
Dear Majority Leader Reid:
On behalf of the 150 member organizations of the National Organization for Rare Disorders (NORD) representing nearly 30 million patients and families afflicted with one of the 7,000 known rare diseases, we are writing to convey our strong support for passage of the Patient Protection and Affordable Care Act. While this legislation has shortcomings and we will work to improve it before the President signs it into law, it is critically imperative the Senate votes to allow debate, to close debate, and to pass the Patient Protection and Affordable Care Act before the end of the year.
NORD members can no longer tolerate further delay in the passage and enactment of comprehensive health reform legislation. Our members are disproportionately burdened by the countless shortcomings of our health care system. They face untenable insurance access barriers through:
- Ongoing and unacceptable pre-existing condition exclusions and medical underwriting practices;
- Costly annual and lifetime caps;
- The absence of a federal guarantee issue requirement, and;
- Little to no direct financial assistance for those Americans who cannot afford insurance.
The Patient Protection and Affordable Care Act directly and helpfully addresses each one of these harmful shortcomings plaguing our nation’s health care system. With this in mind, we strongly believe that failure to act represents an explicit policy choice with severely negative consequences for our members and for all Americans. In short, health care reform delayed is health care access denied. As such, on behalf of all of our members, we urge you and all Members to promptly pass the Patient Protection and Affordable Care Act.
Thank you for the leadership that you, Chairmen Max Baucus, Christopher Dodd and Tom Harkin, as well as countless other Senators, have shown throughout this historical debate. We look forward to continuing our work with you and all Members on both sides of the aisle to finally achieve the long overdue business of ensuring affordable, quality coverage for all Americans.
Sincerely,
Peter L. Saltonstall
President and CEO
Senator Max Baucus, Chairman, Senate Finance Committee
Senator Tom Harkin, Chairman, Senate Health, Educator, Labor and Pensions Committee
Senator Christopher Dodd, Chairman, Senate Banking, Housing and Urban Affairs
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LEGISLATIVE UPDATE
October 27, 2009
HOUSE OF REPRESENTATIVES
To date, 82 members of the House of Representatives have co-sponsored the bill, including eleven members of the Ways & Means Committee, which has jurisdiction over the legislation (see current list of co-sponsors below).
We have learned that House leadership plans to include I-ACT as part of the health care reform bill now under debate.
However, as the fate of this legislation is uncertain, we continue to gather additional co-sponsors in the House in order to also allow I-ACT to be considered as a “suspension” bill, preserving another avenue for its passage this year. In order to be considered for suspension, legislation must be non-controversial, bi-partisan and, for bills referred to the Ways & Means Committee as I-ACT is, it must have 100 co-sponsors.
The bill was introduced last month with seven co-sponsors. Senate rules do not require a threshold number for consideration as the House does. This leaves two options for I-ACT in the Senate; it could either be incorporated into the Senate’s version of health reform, or passed on its own by “unanimous consent.”
ACTION
1. Help I-ACT get 100 co-sponsors by writing or calling your U.S. Representative to ask that he/she cosponsor this legislation that is so important to the rare disease community. Offices may contact Amit Mistry or Binta Beard (202-225-2836) with Representative Markey or Nicole Alexander (202-225-5744) with Representative Stearns to co-sponsor.
2. Thank Sen. Wyden for his support of I-ACT and urge him to pass it in 2009.
Read the final sign-on letter of endorsement for the “Improve Access to Clinical Trials Act”
NORD Advocacy Alert (October, 2009)
Help NORD Abolish Lifetime Insurance Caps!
As you read this, key Congressional leaders are behind closed doors determining what YOUR healthcare options will look like next year.
The time to act is now, by joining NORD and its Member Organizations in the following:
· Call the switchboard of the U.S. Congress at (202) 224-3121 and ask for your Representative’s office.
· Ask your Member of Congress to call Rep. Patrick Kennedy’s (D-RI) office to sign on to his letter to abolish lifetime caps.
· If you live in North Dakota and have been affected by lifetime insurance caps, please share your story with Senator Byron Dorgan (D-ND).
You can use the following phone script in your call to your legislator.
And…remember…the ultimate authority of the U.S. Congress to act resides in YOU! Together, we can make a difference!
PHONE SCRIPT:
Good morning/afternoon. My name is _____________________ and I am a constituent living in (city, state). I have a rare disease.
I am calling to bring to your attention a letter that Rep. Patrick Kennedy is circulating in Congress. This letter calls for the immediate abolition of lifetime insurance caps in the House health care reform bill, HR 3200.
As this bill is currently written, patients may have to wait up to nine years after reform is enacted to see those lifetime caps eliminated. People like me who have rare diseases face possible financial ruin if lifetime insurance caps are not immediately abolished. This issue is very important to me.
Will Representative (insert name of your Representative) sign on to Patrick Kennedy’s letter?
Please Help Us Educate Members of Congress About Lifetime Insurance Caps!
October 12, 2009
While NORD has been excited to see the elimination of lifetime caps included in each health reform proposal currently being considered by Congress, the old adage "the devil is in the details" still rings true. Although all of the bills eliminate lifetime caps, in some proposals the provision will be delayed and in others there is no requirement for existing plans. We need you to write your members of Congress to ask for lifetime caps to be prohibited immediately.
The way the bills are currently drafted would result in many people potentially facing lifetime caps, even after health reform is enacted. Individuals with employer-sponsored insurance could face caps until 2018 or possibly indefinitely if their insurance coverage does not change. This is unacceptable. NORD has been advocating for the immediate elimination of lifetime caps in both new and existing plans in all insurance markets.
Congressional leaders are currently working to combine the various health reform bills into House and Senate versions before they can be voted on by each chamber. Now is the time for everyone who wants lifetime caps to be eliminated to contact Congress.
Please e-mail your members of Congress TODAY to ask that lifetime caps be eliminated immediately. Sample letters have been provided (see below) that you can personalize with information about how your family or your members are affected by insurance problems, the annual cost of care and, especially, lifetime caps. If you have hit a lifetime cap, please be sure to include that as well.
To find the e-mail addresses of your Senators and Representative go to:
- U.S. House of Representatives: http://www.house.gov/
- U.S. Senate: http://www.senate.gov/
- Sample Senate Letter
- Sample House of Representatives Letter
Thank you for your continued support. In this climate of change, it's VERY important for all of us in the rare disease community to make our voices heard on issues related to health reform.
Please copy Diane Dorman, Vice President for Public Policy, on your e-mails — This e-mail address is being protected from spam bots, you need JavaScript enabled to view it .
Safety Alert: Voluntary Recall of Children's Tylenol®
September 28, 2009
McNeil Consumer Healthcare, the Maker of Children's Tylenol®,
Announces a Voluntary Recall
After discovering the possible contamination with Gram-negative bacteria, Burkholderia cepacia, McNeil Consumer Healthcare, a division of Johnson & Johnson, informed physicians and other providers of the recall in a September 18, 2009 letter. The company reported that no bacteria had been found in finished products, but bacteria were detected in an examination of the bulk materials used to make the medicine.
McNeil cautioned that infection with the bacteria can be serious in high-risk persons, including those with pulmonary disease, cystic fibrosis, or immune systems that are otherwise compromised. Young children and elders using these preparations for pain control should be warned.
The
recall covers 21 flavors of its pediatric acetaminophen product, and
several cold and cough medications that include acetaminophen,
manufactured from April 2008 through June 2008, which includes:
• Children's Tylenol® Suspension 4 oz. strawberry,
• Children's Tylenol® Pediatric Suspension 1 oz. cherry
• Infants' Tylenol® Suspension Drops 1/2 oz. grape
• For the complete list and associated lot numbers, see: http://www.tylenol.com/generic.jhtml?id=tylenol/news/subpchildinfantnews.inc.
Individuals who may have these medicines in their possession should:
• Stop taking this preparation if listed above.
• Contact your health care professional (HCP) if you or your child taking this medication has become suddenly ill
• Symptoms
of exposure can range from no symptoms to severe breathing difficulties
especially in those with chronic lung disorders. For more information,
visit the CDC website: http://www.cdc.gov/ncidod/dhqp/id_BcepaciaFS.html
• Share this information with your HCP, pharmacist and insurance provider should there be additional questions.
The recall does NOT apply to children’s Tylenol® Meltaways or Junior Strength Tylenol® Meltaways. McNeil has established a consumer call center at 800-962-5357 for parents or caregivers with questions.
2010 Genetic Alliance Annual Conference
Advancing Novel
Partnerships
July 16-18, 2010 | Washington, DC
Metropolitan Area
Call for Award Nominations
Do you know a healthcare professional who deserves recognition for all he/she has done?
Have you been interviewed by, or read a wonderful piece by a creative journalist who furthers public understanding of genetics and/or disease?
Have you worked with a company that embodies meaningful collaboration?
Then, nominate them for a Genetic Alliance Award Today!
Deadline for Nominations: November 2, 2009
About the Awards
Art of Listening honors a health professional who is a caring, receptive professional in the lives of individuals and families living with genetic conditions.
Art of Reporting acknowledges a media professional whose reporting contributes to public awareness and understanding about genetic advancements or advocacy organizations and their impact on real people’s lives.
Art of Industry Partnership honors a for-profit Biotechnology, Pharmaceutical, or genetics company whose track record models the benefits of creative partnerships between consumer advocates and industry to advance understanding and treatment of genetic conditions, disorders, and diseases.
Nomination Information
For more information and to complete a nomination form, please visit http://geneticalliance.org/ws_display.asp?filter=conference2010.awards.
If you have any questions, please contact Tetyana Murza at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it or 202-966-5557 ext. 205. To view videos of 2009 Award recipients visit our YouTube channel at http://www.youtube.com/geneticalliance.
We look forward to reading about your exceptional nominees!
Genetic Alliance
Support Expanded Access to Clinical Trials: Eliminate Barriers to Clinical Trial Participation
Current rules regarding eligibility for Supplemental Security Income (SSI) prevent many people with rare diseases who receive SSI from participating in clinical trials. The inability of SSI beneficiaries to accept research compensation for participation in a clinical trial has been shown to be a significant deterrence to research participation.
Congressmen Edward Markey (D-MA) and Cliff Stearns (R-FL) will introduce legislation to change current Social Security Supplemental Security Income (SSI) eligibility requirements so that research compensation for participation in a clinical drug study is no longer considered income for determining SSI eligibility. (See proposed legislation)
ACTION
Write your U.S. Representative asking that he/she cosponsor this legislation that is so important to the rare disease community. They can contact Amit Mistry (202-225-2836) with Representative Markey or Nicole Alexander (202-225-5744) with Representative Stearns to co-sponsor. (See the sample letter below.)
SAMPLE LETTER
As a constituent and one of the nearly 30 million Americans affected by one of the nearly 7,000 known rare diseases, I urge you to co-sponsor legislation to be introduced later this month by Congressmen Edward Markey (D-MA) and Cliff Stearns (R-FL) to change current Social Security Supplemental Security Income (SSI) eligibility requirements so that research compensation for participation in a clinical drug study is no longer considered as income for determining SSI eligibility.
To help promising drugs move swiftly from the research and testing phase to the people who need them, more people with rare diseases are needed to participate in clinical trials. Yet, current rules regarding eligibility for SSI prevent a significant number of people with rare diseases from participating in clinical trials that provide compensation for participation. As a result, many are forced to choose between taking part in important clinical trials and keeping their benefits, including Medicaid, which provides essential medical care.
This significantly reduces the number of patients able to help test promising new therapies. The bill to be offered by Congressmen Markey and Stearns will help potential new therapies for rare diseases to move swiftly from the research stage into the hands of patients who need them.
Twenty-five years ago, there were only 10 drugs to treat rare diseases. Today, thanks to the Orphan Drug Act, there are 339 orphan drugs, biologics and humanitarian devices that treat about 12 million men, women and children.
Help expand participation in clinical trials to provide treatments for the millions of people with rare diseases who continue to hold out hope that a life-saving therapy will one day be developed for their condition. Contact Amit Mistry (202-225-2836) with Representative Markey or Nicole Alexander (202-225-5744) with Representative Stearns to co-sponsor this bill.
Thank you for your help to ensure longer and healthier lives for all people with rare diseases.
GOOD NEWS!
The National Pain Care Policy Act 2009, S.660, has been introduced in the Senate!
URGENT ACTION REQUESTED:
CONTACT YOUR SENATORS TO REQUEST THEIR CO-SPONSORSHIP OF THE NATIONAL PAIN CARE POLICY ACT of 2009, S.660
The National Pain Care Policy Act of 2009, H.R. 756 has been in the House of Representatives since January of this year. It is currently pending the full vote of the House.
This bill has now been introduced in the Senate thanks to the efforts of Senator Orrin Hatch (R-UT) and Senator Christopher Dodd (D-CT). With this important bill now in both houses of Congress it is imperative that your Senators hear from you. Let your voice be heard! Take Action Now, inform your Senators that you are concerned about the hidden pain epidemic in our country and as a resident of their state you are requesting their support as a co-sponsor.
To view the National Pain Care Policy Act of 2009, S.660, please click here.
Please TAKE ACTION by sending a letter to your Senator urging their immediate support for this important legislation! American Pain Foundation Online Advocacy Center will send your message for you. It is quick and easy, just click here to TAKE ACTION!
Thank you for being part of this united effort to eliminate the under-treatment of pain in America.
Health Insurance Coverage Protection Act
On February 13th, 2009, Anna G. Eshoo (D-CA) and Jim Langevin (D-RI), along with Senators Byron Dorgan (D-ND) and Olympia Snow (R-ME), introduced the Health Insurance Coverage Protection Act (H.R. 1085, S 442). The legislation, introduced in both Houses of Congress in 2008, would set a $10 million minimum lifetime cap on health insurance, with future increases based on inflation.
A brief summary of this proposed legislation can be found here. EDNF is a member of NORD and therefore, NORD’s Washington Office will keep EDNF updated on any developments of interest related to this and other pending legislation. Rumor has it that the legislation may be folded into the larger healthcare reform legislation slated to be introduced this year. What impact this will have is yet unknown. We will know more in the next few weeks.
End the Two-Year Wait for Medicare
EDNF is a signer of this new legislation and supports this new bill to End the Two-Year Wait for Medicare. The bill will be reintroduced this week.
The major actions of this bill are:
- A 10 year phase out of the waiting period for everyone who is receiving SSDI
- An immediate elimination for individuals with life-threatening conditions – as determined by the secretary of HHS
- An immediate elimination for individuals who have no other access to insurance
The following letter will be released as soon as the bill is introduced.
To view the letter, click here.
Action Alert Update - Senate Passes NIH Amendment
Senate Passes NIH Amendment
On Tuesday night 02/03/2009, the U.S. Senate passed an amendment to include $6.5 billion in funding for the National Institutes of Health. This is an addition to the bill’s $3.5 billion for NIH, which would bring the total to $10 billion.
The amendment’s passage does not guarantee that the NIH funding will be in the final American Recovery and Reinvestment Act of 2009.
No further action is needed at this time on this request. We’ll notify you again when action is require
WE ASKED THAT YOU WRITE YOUR SENATORS AND YOU DID! THANKS FOR ALL YOUR HELP!
ADVOCACY MAKES A DIFFERENCE.
ABLE: Achieving a Better Life Experience Act of 2009
To amend the Internal Revenue Code of 1986 to provide for the establishment of "ABLE" accounts for the care of family members with disabilities, and for other purposes. Click here to learn more.
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘Achieving a Better Life Experience Act of 2009’ or the ‘ABLE Act of 2009’.
SEC. 2. PURPOSES.
The purposes of this Act are as follows:
(1) To encourage and assist individuals and families in saving private funds for the purpose of supporting individuals with disabilities to maintain health, independence, and quality of life.
(2) To provide secure funding for disability-related expenses on behalf of designated beneficiaries with disabilities that will supplement, but not supplant, benefits provided through private insurance, the Medicaid program under title XIX of the Social Security Act, the supplemental security income program under title XVI of such Act, the beneficiary’s employment, and other sources.
In simple terms, this legislation is designed to encourage individuals with disabilities such as EDS, and their families, to save money for disability-related expenses. This would supplement, NOT replace, benefits already being provided by Medicaid and private health insurance coverage, through accounts which are similar to Individual Retirement Accounts (IRA's)
Sponsors:
Rep. Ander Crenshaw [R, FL-4], Rep. Patrick Kennedy [D, RI-1], Rep. Cathy McMorris Rodgers [R, WA-5] and Rep. Kendrick Meek [D, FL-17]
This appears to be a way to help us help ourselves - urge your members of Congress to co-sponsor and support the Achieving a Better Life Experience Act of 2009.
Voluntary Recall of Morphine Sulfate 60mg Issued by Ethex Corp.
Ethex Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate. The lot was distributed by Ethex Corporation under an 'Ethex" label between April 16th and April 27th of 2008.
An over dosage or over strength of opioids such as morphine have life-threatening consequences, including respiratory depression (difficulty or lack of breathing) and low blood pressure. Due to their illness, many patients for whom this product is prescribed are more likely to be highly debilitated with reduced strength or energy. Their impairment may make it more difficult to determine that a tablet is oversized than an unimpaired individual. For questions about the recall, consumers are encouraged to call their physician, pharmacist or other healthcare provider.
For any questions related to this action, please contact Ethex Customer Service (representatives are available Monday through Friday, 8 am to 5 pm CST):
Telephone 1-800-321-1705
Fax 1- 314-646-3751
Email This e-mail address is being protected from spam bots, you need JavaScript enabled to view it
For more information see http://www.fda.gov/oc/po/firmrecalls/ethex06_08.html.