Remembering Barbara

Barbara was eulogized by Rabbi Margaret Holub, of the Mendocino Coast Jewish Community, and five speakers at her funeral on May 13, 2013. Their eulogies are published on the Afterwords page of this blog.

A number of obituaries were published in print and online. Links to these tributes are also published on the Afterwords page.

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Funeral arrangements and after

Funeral services for Barbara will be held on Monday, May 13, at 10:00 AM (sharp!) at Sinai Memorial Chapel, 1501 Divisadero, San Francisco, CA 94115.

Burial will be on Tuesday, May 14, at 1 PM at Ocean View Cemetery, Fort Bragg, CA.

To get to Ocean View Cemetery (once you get to the Mendocino area on Highway One): Take Highway One north through Fort Bragg to Pudding Creek Road. Turn right (east) and then take the first left turn into the cemetery.

Because Shavuot begins on Tuesday evening, Shiva will not be observed formally. Susie will be observing informally, and visits are welcome in the afternoons and evenings from Wednesday evening through next Monday. We will gather at 6:30 each evening to share amusing stories about Barbara. (If we have a minyan, we will also say Kaddish.)

If you’d like to bring some food for people to share, don’t worry about Susie’s (in)famous food restrictions, but please avoid pork, shellfish, and red meat.

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Barbara Brenner 1951-2013

Barbara Brenner passed away peacefully at home on Friday evening.

Funeral services will be held in San Francisco, with burial in Fort Bragg. Arrangements are pending and will be posted Sunday on Barbara’s blog, Healthy Barbs (barbarabrenner.net), our Caring Bridge site (caringbridge.org, barbarabrenner community), and Barbara’s Facebook page.

Contributions in lieu of flowers may be made to the Barbara Brenner Rapid Response fund at Breast Cancer Action, 55 New Montgomery Street, Suite 323, San Francisco, CA 94105 (bcaction.org).

Thank you for all your love and support.

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Thanks and Blessings

As my life comes to an end, I want to thank readers of this blog (and our Caring Bridge site for reading all that I have written while I deal with ALS. I’m sure some of what I wrote was difficult to read, some of what I wrote helped others, while other pieces just made you think. This blog will be up awhile — and some ambitious person might turn it into a book. If you think of others who might benefit from anything I’ve written, please send it along to them.

I have been blessed to lead a rich life, full of love and culture and travel and work that had meaning for me. I have no regrets except that I got ALS in the first place.

I have met amazing people both in person and on-line. Everyone I have come in contact with has had something unique to offer the world. The world is a better place because these people are or were in it. Some of these people I have mentored (and you know who you are), others have taught me. What I know about all of these people is that I have been blessed to know them, and that they will succeed at what they set their hearts and minds to do.

In the Jewish tradition there is a Priestly Blessing. I copy below it because it is what I wish for all readers of these words:

May the Lord bless you

and keep you;

May the Lord make his face shine on you

This is sort of what the priestly blessing looks like at my synagogue, except that the rabbi and a number of members of priestly tribe are women

This is sort of what the priestly blessing looks like at my synagogue, except that the rabbi and a number of members of priestly tribe are women

and be gracious to you;

May the Lord turn his face toward you

and give you peace.

 

 

© Barbara A. Brenner 2113

Posted in Illness | Tagged | 82 Comments

The Legislature and Breast Cancer: Not a Good Match

The Legislature and Breast Cancer: Not a Good Match

According to California law, starting on April 1, 2013 (I note that that was April Fool’s

This is where the California meets to make laws. Nice building.

This is where the California meets to make laws. Nice building.

Day), women whose mammograms revealed dense breast tissue will get the following notice:

Your mammogram shows that your breast tissue is dense. Dense breast tissue is common and is not abnormal. However, dense breast tissue can make it harder to evaluate the results of your mammogram and may also be associated with an increased risk of breast cancer.

This information about the results of your mammogram is given to you to raise your awareness and to inform your conversations with your doctor. Together, you can decide which screening options are right for you. A report of your results was sent to your physician.

I would call this silly legislation, but that is a redundant phrase for far too much that the legislature does.

What You See Is Not What You Get

Here are the problems: About 40% of women have dense breast tissue (as the notice says, it’s not abnormal). Not all dense breast tissue is associated with an increased risk of breast

A dense forest. Dense breast tissue is white, so it wouldn't show up here.

A dense forest. Dense breast tissue is white, so it wouldn’t show up here.

cancer. And, when there  is an increased risk, it’s not increased by very much. A woman who is 40 without dense breast tissue has a risk of developing breast cancer in the next 10 years of 1.47%. A 40 year old woman who has dense breast classified as grade 4, has a risk of developing breast cancer over the next 10 years of 2.38.

Dense breast tissue is categorized on a scale of 1 to 4, with 4 being the most dense. Under the current state of our knowledge about breast cancer, we “know” that 1 or 2 breast density is not associated with an increased risk of breast cancer. Women with breast density of 1 or 2 will not be notified under the law.

Women with density of 3 or 4 will be notified under the law. There’s the rub. We know that breast density of 4 is associated with a slightly increased risk of breast cancer. A woman in her 40′s with very dense breast (a grade 4) has the same risk of breast cancer as women in their 50′s. We have no evidence about whether the risk — if it is higher at all — for women with grade 3 breast density.

When Legislatures Prescribe

There are two problems with this law. One is that it requires telling women that they may be at increased risk of breast cancer when they may not be. Given that women

This is what panic looks like.

This is what panic looks like.

overestimate their risk of breast cancer to begin with, this type of notice will panic some women.

The other problem is that the law tells women to explore with their doctors which screening options are right for them to reduce the risk of a late-stage diagnosis. But the only screening option that has been shown to do this is an annual digital mammogram for women in their 40′s. Women in their 50′s with grade 4 density do not risk a late diagnosis if they have mammograms every two years. Annual mammograms for this age group which result in more false positives and unnecessary biopsies.

Medicine and Lawmakers: A Match Made Somewhere Other Than Heaven

That heading could be about abortion policy, but that is not my topic today. The legislature cannot deal with nuance. It makes broad laws that, in the best case, benefit most people on whom the law has impact. So laws that purport to mandate medical care will always miss the mark.

For a good analysis of the “dense breast” law, check the story on KQED, the San Francisco-based NPR affiliate.

Some years ago, when the first recommendations were made by scientific organizations that women in their 40′s didn’t need annual mammograms, Congressional representatives, all of were men, took it upon themselves to write laws mandating annual mammograms for women in their 40′s. They gained political points with women in their 40′s whose breast cancer had been found with mammograms. They did nothing to advance the public’s understanding of breast cancer screening issues.

The California law is no better.

© Barbara A. Brenner 2013

Posted in Breast Cancer, Health Policy, Medical Science | Tagged , , , | 4 Comments

Telling the FDA What I Think About ALS Drug Trials

As readers of this  blog know, I have taken issue with a number of things related to how ALS drug trials are run. Some people at the Food and Drug Administration (FDA) read my blog and the comments to them. In response, the Agency has set up a public hearing for February 25 in the Washington, D.C. area to consider  comments on the FDA’s “Regulation of Clinical  Trials  of Drugs for the Treatment and/or Management of ALS.”

Since traveling to hearing was out of the question for me, I submitted a written statement for the FDA’s consideration. Below is the statement I submitted, but without the pictures.

The agency wants to hear from you.

The agency wants to hear from you.

If you have things to say to the FDA on this topic, you have until March 25, 2013 to submit a written statement. Go to /www.regulations.gov, search for the name of the hearing, click on that name when you locate it, and you will see how to submit a comment.

Gentle Persons:

As someone living with ALS and a health activist, I very much appreciate the opportunity to submit my thoughts about improving ALS clinical trials. I have commented many times on this topic at my blog, Healthy Barbs, at www.barbarabrenner.net.

For a disease that is so devastating and that has seen so few advances in treatment, it is time to consider patient needs in the design of clinical trials to a degree that has not been demonstrated to date. I think this can and should be done in five areas:

– Trial eligibility

– Subset analyses to deal with new devices or drugs that become available after a trail has started

– Expanded access

– Release of data from negative trials

– Independent trial ombudsman

Trial Eligibility

It is my understanding that all ALS drug trials limit participation to patients are less than 2 years from diagnosis to. Given that most ALS patients live longer than 2 years, this eligibility requirement excludes many people from participating in trials. People with more advanced ALS also want to participate in trials, and may benefit from any drug found to work for people with less advanced disease. Drug trial sponsors should not be permitted to limit trial access to patients within 2 years of diagnosis.

Subset Analyses Should Be Required

In the EMPOWER trial of dexpramipexole, several patients, including me, wanted to get a diaphragm pacer while in the trial. The pacer was not excluded when the trial started. The exclusion was added in a later consent form — I believe it was the fourth one. The trial was near it’s end, so that there was sufficient data from participants who had joined the trial early on. The trial required at least 12 months of participation; I had been enrolled at the point for 15 month. I requested that the sponsor either abandon the pacer exclusion or commit to subset analysis that would permit me and those like me to stay in the trial without sacrificing of the possible life-extending benefits of the pacer. I was rebuffed at every turn.

I did learn later that subset analysis was done on the dex data.

Given the range of health challenges that ALS patients face, clinical trials that test only  one drug or device leave participants with terrible choices. If sponsors of large Phase III trials were required to subject their data to subset analyses that include patients on a second drug or with a device that might improve quality or length of life, the patients will have more incentives to participate in trials and sponsors would recruit trial participants faster.

Expanded Access

In light of the constraints on ALS clinical trials and the absence of treatment options, it is imperative for patients that each Phase III trial have an expanded access component whereby patients, with their doctor’s support, could have access to the drug despite their ineligibility to participate in the trial. There are many ways to structure such programs. It’s the concept that has to be a commitment required of sponsors.

Release of Data from Negative Trials

The field of ALS drug research is littered with the detritus of negative trials. Negative trials can also be informative, but  only when the data from the negative trials are publicly released. The FDA should require sponsors to release to the public the  data gathered in negative trials, with appropriate safeguards for patients privacy.

Independent Trial Ombudsman

In large trials, sponsors should be required to appoint independent ombudsman to address

Let your voice be heard.

Let your voice be heard.

the concern of trial participants. The CEO of the sponsor is hardly a position to address those concerns, having the shareholders interest as his/her primary concern.

I hope the FDA will take these concerns and suggestions seriously.

Sincerely,

Barbara A. Brenner

© Barbara A. Brenner 2013

 

Posted in ALS, ALS Treatment, Health Policy | Tagged , , | 1 Comment

Has NBCC Lost Its Way?

Has NBCC Lost Its Way?

I’m currently reading letters sent to me by community college students in Utah who watched Pink Ribbons, Inc. and have questions about become activists. Many of these students wonder how they might become activists if they are poor. I will tell them that activism doesn’t require money. But the National Breast Cancer Coalition (NBCC) seems to think differently. And that is way too bad.

I’ve written about NBCC before. I even devoted a whole blog post to the organization,

A deadline makes sense for finishing a peper, not ending breast cancer

A deadline makes sense for finishing a peper, not ending breast cancer

entitled “NBCC: The Promise, the Process, and the Problems.. I stand behind everything I said in that post, but NBCC’s most recent move has me wondering whether the organization should shut its doors.

Here’s the deal. NBCC is known in the breast cancer world for, among other things, hosting an Annual Advocate Conference in the spring. People come to network, hear speakers and panel discussions on relevant breast cancer topics, get oriented on NBCC’s legislative agenda, and lobby members of Congress on that agenda. While I have never attended this

Happy advocates at an earlier an earlier NBCC conference.

Happy advocates at an earlier an earlier NBCC conference.

conference, I’ve heard lots of good things about it over the years. There was a fee for attending (that ranged from $125 to $245 depending on how far in advance you registered and whether you were an NBCC member or not) and scholarships were available.

This year NBCC has changed the name of its conference to “Breast Cancer Deadline 2020 Advocate Leadership Summit.” To attend, leaders have to raise or give a $1000 donation to NBCC. So, for the opportunity to lobby Congress on the ridiculous  “breast cancer deadline” that NBCC has set, you have to pay big money.

Women without cash need not apply for this year's conference.

Women without cash need not apply for this year’s conference.

I’m sure NBCC has a justification for this fundraising ploy, but it turns activism on its head. You shouldn’t  have to be rich or have wealthy friends to be an activist or an “advocate leader.” What you need is heart and commitment, and others who share — or might be persuaded to share — your view of the world.

If NBCC is having money troubles, could it be an indication of doubt on the part of donors in the organization’s mission or direction? In any event, to try to solve money troubles on the backs of people who are working hard on breast cancer issues is wrong-headed. If this approach means many fewer people at the NBCC conference, maybe the organization will re-think its approach. In any case, NBCC is turning their conference into a very different event than it was. I have trouble believing this conference will be a success.

Whether it’s a success or not though, I firmly believe that to require a donation of $1000 for a breast cancer advocacy conference is simply wrong.

As 2020 approaches, I hope some people will remember that was the deadline that NBCC set to end breast cancer forever. If NBCC is still around then, ask them what happened to the deadline. Maybe it will die with this year’s conference.

© Barbara A. Brenner 2013

Posted in Breast Cancer | Tagged , , | 8 Comments

Steve Gleason: A Rare Celebrity Doing Good by Talking About His Illness

Steve Gleason: A Rare Celebrity Doing Good by Talking About His Illness

She  looks surprised.

She looks surprised.

People who know me know that I am no fan of either football or celebrity spokespeople for illnesses they have had. In that light, this blog is bound to surprise those folks.

You have probably noticed that when a famous people get sick, they often become spokespeople for the illness they have. In my memory, the first person to do this was Betty Ford, who spoke publicly about her breast cancer in 1974. (Okay, I’m old enough to remember that.) That act of courage was followed by Betty Rollin, a prominent  TV reporter, who published First You Cry about her breast cancer experience in 1976.

Since then, it’s been pretty much downhill. Some celebrities lend their names to organizations raising awareness. In breast cancer, that is so not helpful: everyone is aware

She can sing. Breast cancer advice yiour  should get elsewhere.

She can sing. Breast cancer advice your should get elsewhere.

of breast cancer already unless they live under a rock. Other celebrities give (bad) medical advice based on their experience. Sheryl Crow, for instance, told the world that her breast cancer was the result of drinking water out of plastic bottle that had  been warming in the sun on the back seat of her car. That email  travelled the world for years — coming back

like a bad penny. For all I know, it still circulates. It’s not a good thing to drink water out of plastic bottles, but neither does it give you breast cancer. Or Robin Roberts, whose breast cancer was missed by a screening mammogram, who nevertheless urged women to get mammograms.

As for football, I consider it a game of unnecessary violence, played by some people who get in trouble for

I didn't want want  a violent image in this post. Enjoy this.

I didn’t want want a violent image in this post. Enjoy this.

being violent in society, often towards women.

So when ALS folks (called PALS — People with ALS) got excited because Steve Gleason, a famous retired football player who had been safety with the New Orleans Saints, started speaking out about his ALS, I was more cautious because the breast cancer experience with famous people had been, to my mind, less than helpful.

Steve Gleason and Team Gleason — folks are

Steve Gleason, football player.

Steve Gleason, football player.

working with and supporting Steve and his family through his ALS — have persuaded me out of my caution. In fact, I’m thrilled by what they are doing.

Here’s the deal. Team Gleason (www.teamgleason.org) has put together an ALS PSA (public service announcement) that will air during the Superbowl in New Orleans, where Steve and his family live. Having seen the ad on line, I hope it airs many times after the game is over. In case you won’t or didn’t watch the Superbowl, or missed the ad, you can watch it here.

What’s important about this ad from my perspective is that there is no attempt to sugar coat anything, or make people feel good about ALS. This is not an illness that is a “gift” and don’t let anyone suggest to you that is. This is ALS awareness at its best and I hope millions of people see it.

Steve Gleason, football player with ALS.

Steve Gleason, football player with ALS.

If you are on Facebook, post the ad there. Or forward this blog and encourage people to watch the ad. People need to see this.

Thanks to you Steve and Team Gleason. Lou Gehrig can finally be retired. You are giving hope to everyone affected by ALS, by raising awareness of the existence and realities of horrible but little known disease, and by calling on people to act. That is no mean trick.

© Barbara A. Brenner 2013

 

Posted in ALS, Breast Cancer | Tagged , , , , | 14 Comments

Approaching Gun Violence as a Public Health Problem: Who Gets to Have a Say?

Disclosures

I’m a public health activist. I am also a member of the ACLU, and committed to the 1st Amendment (and all the other Constitutional Amendments, including the 2nd).

This blog argues that some organizations should be excluded from participating in the policy debate and decisions about how to reduce gun violence, so my public health

What do guns have to with protecting public health? Nothing

What do guns have to with protecting public health? Nothing

perspective and my civil liberties values come into conflict. Since I don’t think it’s possible, as a practical matter, to exclude organizations from the debate, I guess my argument is that, whatever they say, no one should listen.

I am not a gun owner. I have never fired a gun. I am not a member of the NRA or any other gun rights organization.

Gun Purchases Soar

We have recently experienced  as a nation the worst non-military gun violence imaginable. The cry to “do something” about gun violence is louder and deeper than ever. Yet gun sales are going through the roof. Why?

President Obama and Jon Stewart have both explained it. Guns sales are skyrocketing because people are concerned that gun control laws that may be enacted in response to the

People who fear their guns will be taken liken themselves to people who fought the Revolutionary War. Really, the do.

People who fear their guns will be taken liken themselves to people who fought the Revolutionary War. Really, the do.

latest outrage will mean the government takes all the guns away from private citizens. Nothing could be further from the truth, but the myth persists for two reasons that are connected.

The first reason is that there have always been people who fear government, and who see tyranny around every corner. For these folks, any talk of regulating any form weaponry confirms their concern about government run amok. As Jon Stewart said, these peoples’ fear of a dystopic future is a barrier to our addressing our dystopic present.

The second reason is that this irrational fear is fed by gun rights organizations like the National Rifle Association (NRA), who claim that the 2nd Amendment rights of gun owners will be trampled by any new law that attempts to regulate any aspect of gun or munitions sales. Can someone explain to me how a ban on military assault style weapons affects a hunter’s right to own hunting rifles or gun owner’s right to own a hand gun? Or how a restriction on sale of ammunition clips holding hundreds of rounds adversely affects any “good guy with a gun,” to use a phrase from the NRA?

The Current Gun Control Debate: A Few Words about some of the Players

The NRA claims to represent the interests of gun owners, but the organization’s true constituency is companies who make guns and rifles, and it’s objective is to make sure there are as many guns in circulation as possible.

Hence their proposed solution to the Newtown massacre is to arm teachers, school administrators and school guards. The NRA also threatened to sue the Tucson, AZ Police

Wayne LaPierre, NRA spokesperson who argues for making schools armed camps.

Wayne LaPierre, NRA spokesperson who argues for making schools armed camps.

Department over a gun buy-back program (people were given certificates to purchase food at local supermarkets in exchange for turning in their firearms) if the Department insisted in melting down the weapons instead of re-selling them to willing buyers.

Right after President Obama announced his intentions about regulating some aspects of the firearms industry, NRA spokespeople said that the organization would not participate in these discussions. And they have been true to their word. They showed up at a meeting with Vice President Biden and claimed to be “disappointed” that gun control legislation was under discussion. Since Vice President Biden is leading the White House effort to find ways of controlling gun violence, the NRA’s disappointment was disingenuous at best. They could not have seriously believed that the White House would get on board with their notion of making schools into armed camps.

The violent video game makers are interested in making money: that’s why they advertise and sell the games. They spend considerable resources to ensure that Congress doesn’t limit their market, or require studies of the impact of these games on behavior, or impose

An actual image from a video game.

An actual image from a video game.

warning labels for the games. The industry asserts that there is no evidence that their games lead to violent behavior. In this case, the absence of evidence is not evidence of absence. The industry has succeeded in blocking the studies that might establish the harm these games do. It’s clever lobbying strategy. The NRA uses it too, to block federal funding to study the impact of gun violence on communities in the U.S.

How to Make Progress Against Gun Violence

If we are to have a prayer of advancing approaches that may, over time, reduce the gun violence in the U.S., groups like the NRA and makers of violent video games should not be listened to by anyone engaged in the debate. They are not interested in reducing gun violence. They are part of the culture that has created this horror.

As a society, we are willing to take extraordinary measures (without evidence that those steps work) to protect children from sex abuse. Shouldn’t we be willing to take small steps to protect our children from the risk of dying by gunfire?

© Barbara A. Brenner 2013

 

 

Posted in Health Policy | Tagged , , | 2 Comments

Adventures with a Feeding Tube Replacement: A Not So Funny Story, a Cautionary Tale, and A Call To Action

I have had a feeding tube since January 2012 because, thanks to ALS, I can not swallow food or liquids.  I have been nourishing myself since I got the tube. The tube is called a

Your dinner may look like this

Your dinner may look like this

PEG tube. I have a hole in my stomach to accommodate it.

A Clogged Feeding Tube

On Saturday, December 8, 2012 my tube became clogged. I couldn’t get anything through it. With the help of our hospice

My dinner (& breakfast & lunch & snack) come packaged this way

My dinner (& breakfast & lunch & snack) come packaged this way

team, I ended up in the emergency room, where a knowledgeable and very kind doctor determined that he couldn’t replace the tube, but he could unclog it. He advised that I promptly contact the doctor who had put in the tube I had to find out about getting it replaced.

On Tuesday, December 11 (2 days after the ACLU awards ceremony  (the speech I gave at that event is the last blog I posted before this one), I was at the hospital to have my tube replaced by the same gastrointestinal surgeon who placed the original tube. Unlike the original tube, the replacement did not require me to be under general (or any)

What a feeding tube looks like coming out of guy's body

What a feeding tube looks like coming out of guy’s body

anesthetic. That was good: I didn’t want general anesthetic because I didn’t want to risk being permanently on a ventilator after surgery, or to expose myself to the risk that general anesthetic would hasten the progress of my ALS.

The replacement tube can easily be put in (or removed) by pushing it (or pulling it) through the hole in my stomach. It has a balloon that holds it in place in the stomach.

That’s the good news. Also, the replacement tube was not clogged. Also good news. The rest of the news about this tube is not good.

A Little Background About Nourishing with a PEG Tube

The nourishment process involves several steps. All of them involve putting the tip of a fluid-filled bolus [think of a cartoon-sized syringe] into the opening of the tube that’s called

Not recommended for heroin administration

Boluses: not recommended for heroin administration

a port. These are the steps:

 

1) Close the clamp on the tube so that stuff does not come out when the port is opened to insert the tip of the bolus.

 

2) The bolus is filled with water that will be flushed through the tube. The port is  opened, and the tip of the bolus is inserted. The  clamp is opened so the liquid  can pass through. When the bolus is empty,  the clamp is closed before the bolus  tip is removed.

 

3) The bolus is filled with liquid nourishment that will be pushed slowly through the tube. This is repeated until multiple times until the amount of nourishment for the meal is consumed. The clamp is closed and opened and closed again with each bolus.

 

4) The bolus is filled two more times with water that is flushed throughout the tube. The clamp is closed and opened and closed again with each bolus.

Medications are also dissolved in water and put through tube, with a water flush preceding and following the meds.

The Replacement Tube

The replacement tube came with no clamp!  As you can see from the description above, this lack of a clamp is a big problem. If there is no clamp, there is no way to keep liquid from coming out through the port when the bolus is removed and before the port can be closed.

There’s a second problem: the port for receiving the bolus is very shallow, so the bolus can and does slip out, spilling liquid. The first time we used the new tube, I needed a shower afterwards.

With the help of the surgeon’s nurse and our hospice nurse, we obtained a surgical clamp to solve the clamp problem, but this requires two people when the tube is in use: one to hold the bolus securely in the port, and another to open and close the clamp.

The manufacturer of this tube, called an EndoVive, is Boston Scientific. I contacted the Boston Scientific rep for this area by email. In that message, I laid out the design problems

If this is defining tomorrow today, I'll stick with today.

If this is defining tomorrow today, I’ll stick with today.

with the replacement tube.

I closed my email with the following paragraph:

“ALS patients have many problems. Boston Scientific should not add to those  problems with sloppy design. My previous tube had a clamp on it that I could  open and close easily with my thumb. It’s not rocket science. Boston Scientific should be able to quickly add such a clamp to the EndoVive product. While you are doing that, I believe it should be possible to modify the valve to accept a                    standard-sized 60 ml bolus.”

The Boston Scientific rep passed my email on to the person at the company responsible for managing this product. He agreed that the company should not be making products that make my day-to-day life (or presumably anyone’s day-to-day life) more difficult. In a telephone conversation with my partner Susie, he told her that he regretted that no one at the company thought of these issues. He also said there was not quick fix, since any changes to the design would have to approved by the FDA.

In the meantime, our contact at the California Home Medical Equipment, which supplies my nourishment and necessary accoutrements, began to pursue solutions. He found a CHMEclamp that could be added to after the tube was in place, and an extension tube with a much deeper port. The only remaining challenge at the moment that is keeping me from being able to nourish myself is that my weakened hands can not close the new clamp. So, for that, I need help.

Of course, at some point, I won’t be able to nourish myself as the ALS progresses. But the tools needed by ALS patients and others with disabilities should be designed to allow them to function independently as long as possible. This feeding tube by Boston Scientific does the opposite.

In looking on line for other replacement PEG tubes that are balloon anchored (and therefore can be inserted without general anesthetic), I found several others, none of which come with a clamp. I could not tell the depth of the ports on those tubes from the information I found on line.

I am frankly appalled that companies and the FDA seem to think that these types of replacement PEG tubes are appropriate. It seems to me that there were never tested on patients or with caregivers who might know what the practical issues are. After all, I can’t possibly be the first person with PEG tube to have this problem. Why was this design approved in the first place?

A Call to Action

If you agree, send an email to the FDA Center for Devices at dsmica@fda.hhs.gov. Demand that the FDA consider patient needs in the device approval process.

© Barbara A. Brenner 2013

Posted in ALS, Disability | Tagged , , , | 9 Comments