JFActivist

FDA Review of Medical Devices: Will People with Disabilities Benefit?

From AAPD Policy Intern Zoe Levenson  (6.9.2010):

Will People with Disabilities Benefit?

On June 2, 2010, AAPD attended a briefing by trade association AdvaMed on the implications of the Food and Drug Administration (FDA)’s market review process.  The briefing focused specifically on the 510(k) process for devices of moderate risk and included some life-sustaining technologies.  Speakers included Janet Trunzo, AdvaMed’s Executive Vice President of Technology and Regulatory Affairs, who gave an overview of the review process, and Dr. Roshan Shah from the American Academy of Orthopaedic Surgeons, who discussed the implications of the process for patients and physicians.

The FDA’s 510(k) process was established under the Medical Device Amendments of 1976 to achieve two goals: make safe and effective devices available to consumers; and to promote innovation in the medical device industry.  Medical devices are divided into three classes, from low-risk (products like bandages, scales, and mechanical wheelchairs), to moderate risk (such as contact lenses, power wheelchairs, and sutures), to the highest-risk, life-sustaining technologies (such as permanent implants and pacemakers).   The moderate-risk technology is the group that undergoes 510(k) review, that is, things like contact lenses, power wheelchairs, and sutures.  Thousands of such products are cleared through this process every year.

 Dr. Shah talked about the benefits of the 510(k) process for patients, stating, “Incremental improvements can advance technology while having substantially equivalent safety and efficacy profiles.”  For example, devices can be adapted to exclude allergens or to fit patients with a variety of body types.  Another result of the process has been more durable and longer-lasting technology.  This allows us, as consumers of medical devices, to obtain the best technology in a safe way. It also allows physicians to provide patients with technology tailored to their specific needs.  As a whole, the process seems to support high standards and consistency while allowing for adaptability in the medical technology market.

FDA has been publicly revising the 510(k) process since February 2010 and is looking to complete their review by September 2010.  Between February and March, the FDA received open written consumer feedback, and the Institute of Medicine (IOM), which is also participating in the review process, is currently holding public hearings regarding changes to the process.  Following these hearings, they will make their own recommendations to the FDA.  According to Trunzo, “The basic structure of the 510(k) process is sound, but every process can be improved.”  AdvaMed expressed hope that the process would improve its clarity and consistency, making it easier for the FDA and medical device manufacturers to work together for premarket clearance.

What do you think of the FDA’s premarket review of items like bandages, wheelchairs, and pacemakers?  Is it helpful to the medical device market?  Do you think it slows down the introduction of new technology? Should there be more consumer involvement? Do you think the usability and accessibility concerns of people with disabilities are considered enough in development of medical devices?

More about the 510(k) process at: http://www.fda.gov/medicaldevices/deviceregulationandguidance

More on AdvaMed’s position on technology and regulatory issues at: http://www.advamed.org/MemberPortal/Issues/FDA/

More on the Institute of Medicine (IOM) and the 510K process at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm183497.htm

What does Oil Spill Mean for Those with Disabilities?

From AAPD Policy/Legal Intern Charla Wright (6.9.2010):

Deepwater Oil Spill: White House Briefing

On April 20, 2010, Deepwater Horizon, a British Petroleum (BP) oil rig, exploded killing eleven people. This explosion was due to a pipe break almost a mile down under water and 42 miles away from land. As of April 28th, an estimated 5,000 barrels of oil per day was escaping from the underwater pipe. Oil first reached land on May 6th, when it touched the shore an island off Louisiana, then reached mainland Louisiana on May 19. Throughout the entire five week period, the U.S. government, BP, other oil companies and volunteers have been working around the clock to contain and clean-up the oil. In President Obama’s latest remarks, he stated, “. . .  we are relying on every resource and every idea, every expert and every bit of technology, to work to stop it. We will take ideas from anywhere, but we are going to stop it.” 

Last Friday, May 28, 2010, AAPD participated in an off-the-record phone briefing from the White House concerning this Deepwater oil spill in the Gulf of Mexico. Also on the call were representatives from other non-profit organizations eager to be updated on the containment and clean-up progress. The intent of the briefing was to help reassure our communities that the U.S.  government, oil companies, and volunteers were continuously working to repair pipe damage, clean up the spilled oil and save the ecosystems which are in considerable jeopardy.

The briefing specified that work efforts in the gulf included 20,000 people in the region working on clean-up and containment, including 1,400 members of the National Guard from four states - Alabama, Illinois, Louisiana and Missouri. Moreover, 1,300 vessels are assisting in the containment and clean-up and three million feet of boom – floating plastic pipe and shoreline barriers -- is being used to stop the oil from coming ashore.

Many people with disabilities may be affected by this catastrophe. The states most likely to be affected by the oil spill are Florida with 2.3 million people with disabilities, Alabama with about 741,000 people with disabilities, Louisiana with over 645,000 people with disabilities, and Mississippi with over 482, 000 people with disabilities. Advocates expect state emergency response developers to include people with disabilities in any emergency evacuation planning, and any response and recovery efforts connected to the oil spill’s containment and clean-up. Involvement in these plans are crucial to the health and safety of people with disabilities and their families.

People with disabilities should also be included in the volunteer containment and clean-up efforts. The federal and state governments are requiring people to register and train before volunteering, as oil has toxic effects. Once trained, volunteers can participate in a range of activities including shoreline monitoring, wildlife marking, transportation assistance, pre-impact beach cleanup and light construction. People are also encouraged to donate their vessels for clean-up, report oiled or injured wildlife and to report sightings of oil on land. 

Although the briefing’s purpose was helpful in providing recent information on the spill, many questions still linger. For example, how will the oil spill impact persons with disabilities in these states? Are local governments developing emergency evacuation plans for people in assisted living centers and group homes, or any other institutional settings, in the event this becomes necessary? Hurricanes are also expected: do hurricanes pick up oil and how will a hurricane carrying oil affect people with disabilities?  Is there any research on how oil in the environment causes any disability?

How to help:

•    Register to volunteer: (866)-448-5816

•    Offer your boat as a vessel of opportunity skimming system or submit alternative response: 

       (281) 366-5511

Technology, services or products: 

•    Report oiled or injured wildlife: 1-866-557-1401

•    Report oil on land: 1-866-448-5816

For more information:

•    Environmental Hotline/Community Information - 866-448-5816

•    Assistance Hotline/Boom Reports - 281-366-5511

•    Vessels of Opportunity (boats) - 281-366-5511

•    Wildlife Distress Hotline - 866-557-1401

•    Hotline --Specialty Volunteer Training)- 866-647-2338

•    Claims Hotline - 800-440-0858

Latest news on the Deepwater Oil Spill at: http://www.cnn.com/2010/US/06/01/oil.spill.hurricane.season/?hpt=C1

Deepwater Horizon Response at: http://www.deepwaterhorizonresponse.com/go/site/2931

To volunteer in Louisiana: http://www.volunteerlouisiana.gov/help-in-disaster/response-recovery-efforts/

To volunteer in Mississippi: http://www.volunteermississippi.org/1800Vol/OpenIndexAction.do

To volunteer in Florida: http://www.volunteerfloridadisaster.org/

To volunteer in Alabama:  http://www.servealabama.gov/2010/default.aspx

Tips on Preparedness at: http://www.fema.gov/pdf/media/factsheets/2009/cdp.pdf

General information on emergency preparation and response at: http://www.fema.gov/

President Obama’s latest remarks on the Deepwater Oil Spill at: http://www.whitehouse.gov/the-press-office/remarks-president-gulf-oil-spill

White house Blog on the Deepwater Oil Spill at: http://www.whitehouse.gov/blog/2010/05/27/ongoing-administration-wide-response-deepwater-bp-oil-spill-may-27-2

Blind Doctor and Researcher: "Remarkable" or "Routine"

From the Capital Times (6.2.10):

Tim Cordes one of few sightless doctors in U.S.

by TODD FINKELMEYER  

...[Tim] Cordes has been reticent to share his story, not wanting to become a poster boy for overcoming visual disabilities. But he’s slowly becoming more at ease telling his inspirational tale...

...Cordes was valedictorian of his class at the University of Notre Dame in 1998, posting a 3.99 GPA while earning an undergraduate degree in biochemistry and conducting research on antibiotics. He then was accepted into the UW School of Medicine and Public Health’s medical scientist training program, completing the notoriously challenging sequence that requires a student to finish both medical school and a Ph.D.-level research program.

Over the years, Cordes also earned black belts in jujitsu and tae kwon do, carried the Olympic torch during its cross-country journey to the Salt Lake City Games in 2002, and developed computer software that uses a number of musical instruments, varying tones and left-right speakers to allow those with vision problems to conceptualize and study protein structures...

...Dr. Brad Schwartz still remembers the paperwork Cordes forwarded to the UW Medical School when applying to the medical scientist training program.

While most attempting to head down this path are high achievers, Schwartz says Cordes stood out from the pack due to his Medical College Admission Test scores, 3.99 GPA in a demanding major and his interesting research on antibiotics. It was a reference letter from a Notre Dame researcher, however, that floored Schwartz, who was director of the program in the spring of 1998.

“It’s just this incredible, glowing letter,” says Schwartz, now the dean of the University of Illinois-Urbana’s College of Medicine. “And then you get to the last line, and it says, ‘This is all the more remarkable because Tim is blind.’ We’re all thinking, 'Oh my God!'"...

...Despite these made-for-the-big-screen qualities to his life, Cordes remains leery of being put on a pedestal: “I look forward to a world where people with disabilities do what they can and what they want, and it’s not exciting or it’s not different.”...

...He wishes others would view it as ordinary. “Just like you, I have a job to do and I figured out how to do it,” he explains. “To me, it’s gratifying how profoundly routine this all seems at times.”

>>>Read Full Article

"Cure" with Caution: Why We Shouldn't Jump to "Fixing" Disabilities

From ChristianityToday.com (2.12.10):

Considering 'Curing' Down Syndrome with Caution

Why we shouldn't be too quick to think disabilities need correcting.
By: Amy Julia Becker

"Should Down syndrome be cured?" read the title of a Motherlode (the parenting blog at The New York Times) post a few weeks ago. "Would you cure your kid's Down syndrome?" was Rod Dreher's version of the question. Both posts and the hundreds of comments they provoked originated with a study published in Science Translational Medicine last November. The study detailed research conducted on mice that had been genetically engineered to mimic Down syndrome. The researchers provided a drug to alter the brain chemistry of these mice, and the mice who received the drug demonstrated improved cognitive function...

...the study itself raises ethical and philosophical questions, but even more problematic is the writers' suggestion that this treatment offers a way to "cure" Down syndrome. The language implies that Down syndrome is a disease, a sickness...This language demonstrates more than ignorance of biology. It reduces Down syndrome to a medical condition rather than understanding people with Down syndrome as whole—emotional, physical, social, spiritual—persons...

...Readers who commented on the posts reflected this perspective with comments like, "DS is a disease that limits a child's potential. You'll never meet a Doctor or a Lawyer with DS," or, "The reason it is called a disability is because it is a lack of something (mental ability in the case of Downs) that makes a complete human being. That is a tragedy; it is not another equally good form of personhood." Again, the language is telling. Limitations are bad. Being a doctor or lawyer is good. People with Down syndrome are incomplete human beings.

...[One] theological lens I use to think about Down syndrome, and about human life in general, comes from John 10:10, where Jesus says, "I have come that they might have life, and have it to the full." When our daughter was a few months old, I wrote in my journal, "It is hard to believe that she won't be able to solve problems or read literature. And yet it is easy to believe that she will rush to a friend, or even a stranger, in need. Easy to believe she will bring joy and light and life. Can she live a full life without ever solving a quadratic equation? Without reading Dostoyevsky? I'm pretty sure she can. Can I live a full life without learning to cherish and welcome those in this world who are different from me? I'm pretty sure I can't."

This recent research demonstrates a theoretical possibility that drug therapy can increase the cognitive potential of people with Down syndrome and also potentially protect against Alzheimer's disease, which is prevalent among people with Down syndrome. This research is probably good news for those with Down syndrome. But the language used to discuss this potential therapy demonstrates that we have a long way to go before we understand these individuals for who they are: members of the human family who, like the rest of us, are limited and vulnerable and have much to offer. We should all watch how our language and assumptions can unintentionally exclude and devalue human beings created in the image of God.

People with Down syndrome don't need to be cured. They do need to be treated as the complete human beings they are.

>>>For More Information

Comment Below:  How does your faith affect your perception of disability?  Where do you draw the line between acceptance of the person and seeking a cure for the condition?

Physician Assisted Suicide: A Disability Perspective

From the American Association of Health and Disability (1/13/10):

A Disability Perspective on the Issue of Physician Assisted Suicide

The entire January, 2010 issue of the Disability and Health Journal is available at no cost on line at www.disabilityandhealthjnl.com. Usually, only the abstracts are available to non-members of AAHD, however, this special issue is available to the general public.  This special issue is focused on Physician-Assisted Suicide: A Perspective from Advocates for People with Disabilities.  Although public opinion in the United States on physician-assisted suicide is evenly divided, about half of states have either defeated bills to legalize assisted suicide or have passed laws explicit ly banning it and only two states, (Oregon and Washington) have legalized it.  In this environment, A Disability Perspective on the Issue of Physician-Assisted Suicide, a special issue of Disability and Health Journal: The Official Journal of the American Association on Health and Disability, published by Elsevier, examines the issues related to assisted suicide and disability, the legal considerations and the Oregon and Washington experiences.

Articles include:

Assisted suicide: Why this is an important issue for the Disability and Health Journal
Suzanne McDermott

Killing us softly: the dangers of legalizing assisted suicide, 05 November 2009
Marilyn Golden, Tyler Zoanni

Assisted suicide laws create discriminatory double standard for who gets suicide prevention and who gets suicide assistance: Not Dead Yet Responds to Autonomy, Inc.
Diane Coleman

Public health, populations, and lethal ingestion
Kirk C. Allison

No, we don't think our doctors are out to get us: Responding to the straw man distortions of disability rights arguments against assisted suicide

Carol J. Gill

Comment Below: Where do you stand on this issue?  Do you think that the right to death is just as important as the right to life, a cornerstone of self-determination?  Do you think that assisted suicide is morally repugnant and socially dangerous, a treacherous scam that takes advantage of the most vulnerable?  Or do you see this issue with more subtle shades of right and wrong?

Down Syndrome Births Rise Unexpectedly

From NPR (12/1/09):

Heidi Moore holds her son, Jacob, 8, at their home in Alpharetta, Georgia in 2008. Jacob has Down Syndrome but takes music therapy class, reads at an age-appropriate level and plays piano. (Jenni Girtman/AP)

Down Syndrome Births Rise Unexpectedly
By Joseph Shapiro

You might be surprised to learn there's been an increase in the number of children born with Down syndrome in recent years. The conventional wisdom holds that with more prenatal screening, the rate at which children would be born with Down syndrome would have fallen.

But as researchers write in the latest issue of the medical journal Pediatrics, there was an increase in Down syndrome births between 1979 and 2003. "It went up by 31 percent--from 9 per 10,000 births to 12 per 10,000 births," says Dr. Adolfo Correa, an epidemiologist at the federal Centers for Disease Control and Prevention and co-author of the study...

>>> For the Whole Article

>>> For the Scientific Report published in Pediatrics

Comment Below: What is your reaction to this article?  After years of depressing statistics, is it a welcome ray of hope?  or is it too good to be true?  Do you think it reveals a shift in the mindset of American mothers or the triumph of our ever-improving medical care? How would you explain this new data? 

Study: One in 91 are Autistic

From Reuters (10/6/09):

New Government Report Shows Autism Now Affects One in 91
National Autism Association Calls Upon Obama to Declare Autism a National
Health Crisis

A new report out yesterday places autism rates among U.S. children at one in 91, with autism now affecting one in 58 boys. These new numbers, from Health Resources and Services Administration (HRSA), U.S. Department of Health and Human Services, are prompting outrage from parents and autism advocates over inaction from government health agencies in addressing the crisis affecting hundreds of thousands of American families.

...The new study also reports that 38.2% of children surveyed had at one time been diagnosed with autism but later lost the diagnosis.  Increasing numbers of parents and researchers believe that autism is preventable and treatable, yet health officials routinely ignore reports of children who have recovered from autism, and to date have not funded clinical studies on promising treatments. According to Ms. Vanicek, "We need our government health agencies to recognize the biomedical treatments that are helping these children recover from autism.  Effective treatments should be available to anyone with the diagnosis, and also carry implications for probable causation." ...

>>> For the full release

>>> For Additional News on this Study

>>> For the CDC Statement

Comment Below: Which is more troubling to you-the increase in the incidence of autism or the reaction of NAA?

Just In: AAPD Joins Facebook Causes

From the JFA Moderator:

AAPD recently joined Facebook Causes as a way to get the word out about the disability rights movement and to make it easier for YOU, our dedicated activists, to contribute your support.

Take Action TODAY: Join or Donate to AAPD's Cause on Facebook and share these links with your friends.

>>> To Join the Movement

>>> To Support our Work

Handicap is NOT a Death Sentence

From U.S.News and World Report (August 10, 2009):

Handicap Is Not a Death Sentence and Should Not Be Treated as One
"Futile" healthcare is in the eye of the beholder, and should be in the hands of the patient
By Laura Hershey

Laura Hershey of Englewood, Colo., is a national advocate for the rights of the handicapped.

When people discuss "end-of-life care," they often invoke scenarios meant to sound ominous: tubes, breathing machines, physical dependency. I'm not scared by those images, having lived for 46 years with increasing reliance on technological and human support. A ventilator aids my breathing. Personal care assistants bathe, dress, and feed me. I operate my wheelchair by blowing into a tube. And my life is far from over. Of course, none of us can know for sure, but I plan on being around for a while.

That plan has not always gone unquestioned. Tactless acquaintances have told me they would kill themselves if they became as disabled as me. More chillingly, the last time I was hospitalized for pneumonia, I had two different nurses ask if I had a DNR—a "do not resuscitate" order. I replied that I had come to the hospital to get better, not to die.

Unfortunately, that expectation of medical treatment can run up against physicians' opposing views and hospitals' rules. In dozens of states, laws allow doctors to unilaterally deny lifesaving treatments that they deem "futile," even if the patient or a surrogate decision maker wants care continued. Some people actually advocate this, as a way to ration healthcare—limiting the resources available to sicker patients, to extend basic care to more healthy people...

Who should make medical decisions? The individual in the hospital bed, with everything at stake? The family, with their complex and sometimes contradictory concerns about love, obligation, and money? The doctor, with a vested interest in achieving rigidly defined "successful" outcomes? Or hospital administrators, with one eye on the bottom line?

The situations that worry me most are those involving different definitions of "futile" and "effective..."

Some prominent bioethicists, seeking easy scapegoats for escalating healthcare costs, increasingly question the value of providing care to people with disabilities, whose lives they (mistakenly) consider undesirable.

>>> For the Full Article

>>> For the Counter-Argument read the case for healthcare rationing from Michael Tanner of the Cato Institute.

NYT: To Fix Health Care Simply Stop Treating People with Disabilities

Excerpts From the New York Times Magazine Section (July 15, 2009):

Why We Must Ration Health Care
By Peter Singer

...The debate over health care reform in the United States should start from the premise that some form of health care rationing is both inescapable and desirable. Then we can ask, What is the best way to do it?...

...If the U.S. system spent less on expensive treatments for those who, with or without the drugs, have at most a few months to live, it would be better able to save the lives of more people who, if they get the treatment they need, might live for several decades...

...When a Washington Post journalist asked Daniel Zemel, a Washington rabbi, what he thought about federal agencies putting a dollar value on human life, the rabbi cited a Jewish teaching explaining that if you put one human life on one side of a scale, and you put the rest of the world on the other side, the scale is balanced equally. Perhaps that is how those who resist health care rationing think. But we already put a dollar value on human life. If the Department of Transportation, for example, followed rabbinical teachings it would exhaust its entire budget on road safety. Fortunately the department sets a limit on how much it is willing to pay to save one human life. In 2008 that limit was $5.8 million. Other government agencies do the same...

...multiplying what we would pay to reduce the risk of death by the reduction in risk lends an apparent mathematical precision to the outcome of the calculation — the supposed value of a human life — that our intuitive responses to the questions cannot support. Nevertheless this approach to setting a value on a human life is at least closer to what we really believe — and to what we should believe — than dramatic pronouncements about the infinite value of every human life, or the suggestion that we cannot distinguish between the value of a single human life and the value of a million human lives, or even of the rest of the world. Though such feel-good claims may have some symbolic value in particular circumstances, to take them seriously and apply them — for instance, by leaving it to chance whether we save one life or a billion — would be deeply unethical...

...the benefits may vary in ways that defy straightforward comparison. We need a common unit for measuring the goods achieved by health care. Since we are talking about comparing different goods, the choice of unit is not merely a scientific or economic question but an ethical one.

As a first take, we might say that the good achieved by health care is the number of lives saved. But that is too crude. The death of a teenager is a greater tragedy than the death of an 85-year-old, and this should be reflected in our priorities. We can accommodate that difference by calculating the number of life-years saved... It’s easy to say, “What if the teenager is a violent criminal and the 85-year-old is still working productively?” But just as emergency rooms should leave criminal justice to the courts and treat assailants and victims alike, so decisions about the allocation of health care resources should be kept separate from judgments about the moral character or social value of individuals.

...How can we compare saving a person’s life with, say, making it possible for someone who was confined to bed to return to an active life? ...One common method is to describe medical conditions to people — let’s say being a quadriplegic — and tell them that they can choose between 10 years in that condition or some smaller number of years without it. If most would prefer, say, 10 years as a quadriplegic to 4 years of nondisabled life, but would choose 6 years of nondisabled life over 10 with quadriplegia, but have difficulty deciding between 5 years of nondisabled life or 10 years with quadriplegia, then they are, in effect, assessing life with quadriplegia as half as good as nondisabled life...restoring to nondisabled life two people who would otherwise be quadriplegics is equivalent in value to saving the life of one person, provided the life expectancies of all involved are similar.

This is the basis of the quality-adjusted life-year, or QALY...

Some will object that this discriminates against people with disabilities. If we return to the hypothetical assumption that a year with quadriplegia is valued at only half as much as a year without it, then a treatment that extends the lives of people without disabilities will be seen as providing twice the value of one that extends, for a similar period, the lives of quadriplegics. That clashes with the idea that all human lives are of equal value. The problem, however, does not lie with the concept of the quality-adjusted life-year, but with the judgment that, if faced with 10 years as a quadriplegic, one would prefer a shorter lifespan without a disability. Disability advocates might argue that such judgments, made by people without disabilities, merely reflect the ignorance and prejudice of people without disabilities when they think about people with disabilities. We should, they will very reasonably say, ask quadriplegics themselves to evaluate life with quadriplegia. If we do that, and we find that quadriplegics would not give up even one year of life as a quadriplegic in order to have their disability cured, then the QALY method does not justify giving preference to procedures that extend the lives of people without disabilities over procedures that extend the lives of people with disabilities.

This method of preserving our belief that everyone has an equal right to life is, however, a double-edged sword. If life with quadriplegia is as good as life without it, there is no health benefit to be gained by curing it. That implication, no doubt, would have been vigorously rejected by someone like Christopher Reeve, who, after being paralyzed in an accident, campaigned for more research into ways of overcoming spinal-cord injuries. Disability advocates, it seems, are forced to choose between insisting that extending their lives is just as important as extending the lives of people without disabilities, and seeking public support for research into a cure for their condition...

...The QALY approach does not even try to measure the benefits that health care brings in addition to the improvement in health itself. Emotionally, we feel that the fact that Jack Rosser is the father of a young child makes a difference to the importance of extending his life, but his parental status is irrelevant to a QALY assessment of the health care gains that Sutent would bring him. Whether decisions about allocating health care resources should take such personal circumstances into account isn’t easy to decide. Not to do so makes the standard inflexible, but taking personal factors into account increases the scope for subjective — and prejudiced — judgments...

>>> For the Full Article

Comment Below: I think this one speaks for itself, but I look forward to the inevitable comments.