Accessibility is In The Eye of the Beholder

Posted on September 25, 2011 by bbzinger

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As many people who are in the disability community say, we are all, at best, only temporarily able-bodied. In the past year, I have left the world of the temporarily abled. I now walk sometimes with a cane and other times with a wheeled-walker. I need something to grab onto in the shower so I won’t fall down, and I need to sit in the shower, too. I get tired walking long distances. To be heard, I have to speak with the help of technology.

As I walk (slowly) around in the world these days, I notice how many people are hampered in someway by physical problems. I realize that what accessibility means to me is not necessarily what it means to others, even those who believe they are being responsive to people with limited mobility.

I thought a few examples of what I expected versus what I found might be illuminating.

On the Road: Thinking About Hotel Accommodations

When I traveled recently, I asked on two different occasions for hotel rooms that were accessible for people with disabilities. I told the reservations people that I didn’t need wheelchair accessibility, but I did need grab bars and a seat in the shower. The hotels were able to provide rooms with these facilities, but that was about as far as the accommodations for accessibility went.

I naively assumed, for example, that rooms with these accommodations might be located relatively close to the elevator core. In one case, the room I was given was about as far from the elevator core as one could possibly be. My pedometer showed a lot of steps, but I would have been happier accruing them by walking along the shore of Lake Louise, where I was visiting.

More generally, I also expected that thought would have been given to making doors to public spaces – not only the doors to the guest rooms, but also those used to enter and exit the hotel and the lobby restrooms – usable by people using walkers or wheelchairs. You know, those automated doors that either open when someone approaches or open when a disability access button near the door is touched.

In both hotels, there were few if any automated doors; in one, there were no disability access buttons. It would have taken me quite a while to enter or exit the building through most of their doors if I hadn’t been accompanied by my partner who could open the doors and hold them open for me.

In the second hotel, the room I was close to the elevator core, but to get into the room I had to lift my rolling walker over a floor barrier that didn’t need to be there. The bathroom was tiny: my walker wouldn’t fit through the door. And all the bath towels were placed on shelf that would have been out of reach to anyone in wheelchair. That hotel had some automatic entry doors, but the main floor women’s bathroom had a non-automated door that is so heavy (or sticky) that it was hard for able-bodied women to open it. A man staffing the concierge desk right outside that bathroom commented to me on the need to fix the door, so the hotel knows about that problem. It’s not clear whether the management knows that where there is a button to make doors open automatically, the button didn’t work.

A Cabin in the Park

Hotels aren’t the only visitor facilities that present challenges to those of us who need some accessibility accommodations. On an earlier trip to a beautiful park in Oregon called Opal Creek, we were with a group that, in light of my limitations, had reserved the accessible cabin. There was a completely accessible bathroom on the main floor, but there were challenges in the kitchen. The dishes were all placed on high shelves that people of normal height had trouble reaching, and that would have been impossible for someone in a wheelchair to reach. The refrigerator had no handle, requiring finger dexterity and strength to open.

When these issues were brought to the attention of the Opal Creek management, the response was concern and a commitment to addressing the issues as soon as possible.

If only the corporate world that owns most everything would respond so positively.

Climbing Stairs for Accessibility?

Given our experience in Phoenix where we went for a weekend to watch the (wait ’til next year) San Francisco Giants at spring training, I think that kind of response from corporate interests may be a long time in coming. Here’s a “what were they thinking?” story. At a motel where we spent one night, our friend was placed in the accessible room (not that she needed it). It had a wheel-in shower alright, but you had to climb a flight of stairs to get to the room (the elevator didn’t go that high), and the room was not large enough to allow a wheelchair to circle the bed.

Is Separate the Same as Equal?

Possibly less offensive, but thought provoking, is our experience at a showroom warehouse in San Francisco recently. They had a concrete ramp to a side entry door, but the door was locked. When we pointed this issue out to the owner, he was quite apologetic and told us that all we had to do was call first. I didn’t tell him (because I have trouble speaking) that I don’t even have a cell phone anymore, and don’t talk on the phone. Oh, and there was no phone number to call was posted on the exterior of the building.

The fact that I need assistance to walk and to talk makes me very sensitive to the fact that there all kinds of physical limitations that might pose challenges for people. I have focused here on the ones that have affected me so far. What am I missing? And what can we do about it?

© Barbara A. Brenner 2011

Posted in Disability, Health Policy | 12 Comments

Pink Ribbons and Lou Gehrig: Time to Bury Useless Symbols

Posted on September 18, 2011 by bbzinger

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People who have known me a while know that I’m no fan of pink ribbons as a symbol for breast cancer. I have the same feeling about baseball slugger Lou Gehrig as a symbol for ALS. It’s time to let go of symbols that have become useless, or, worse, misleading.

A Brief History of Breast Cancer’s Pink Ribbon

The first breast cancer ribbon was not pink.

Charlotte Haley's Ribbon

It was salmon colored. It was created by a woman named Charlotte Haley, who had seen a lot of her family struggle with breast cancer. Charlotte wanted to see more done to address the breast cancer epidemic. Inspired by the AIDS ribbon, she created salmon colored ribbons out of cloth, put 5 of them on a postcard encouraging people to contact their elected representatives, and sold the postcards for 5 bucks each so she could make more.

Estée Lauder, the cosmetics company, and Self Magazine, a woman’s publication, quickly recognized the profit-making possibilities of the ribbon. They approached Charlotte, claiming that they cared deeply about women and wanted to make her ribbon the international symbol of breast cancer. Charlotte thought that was more about the companies’ bottom lines than about women’s lives, and refused to partner with them.

The companies were advised by their lawyers that they could use a ribbon; they should just find another color. So the companies asked focus groups of women to identify the color or colors that were most reassuring, non-threatening, and comforting – everything a breast cancer diagnosis is not. The color they came up with was pink.

The Komen Foundation (now called the Susan G. Komen for the Cure Foundation) tried to trademark the pink ribbon. When that failed, everyone and their grandmother starting using it to symbolize breast cancer. Briefly put, because anyone can use the pink ribbon, everyone does, from marketers of products to huge organizations. The pink ribbon has made it possible for breast cancer to become the poster child of cause marketing by companies trying to improve their sales by linking their products to the breast cancer cause. Some people and companies merely sell ribbons (made of everything from cloth to platinum and diamonds) and keep all the revenues; others use it promote sales of other products (everything from toilet paper, to cars, to

I cannot make this stuff up

guns) by promising to donate a “portion” of the proceeds to breast cancer research.

This is not your imagination

Sometimes the ribbons are placed on products that are bad for our health. For more information on the exploitation of the pink ribbon, see www.thinkbeforeyoupink.org.

 

How Many Things Can a Pink Ribbon Cover Up?

Billions of dollars have been raised in the name of breast cancer research. We don’t know how much of that money actually goes to research. We don’t know what kinds of research are funded with that money. And the research funders often tout how much they have spent without every reporting whether the research has benefited women’s lives. What we do know is that the epidemic rages on, the incidence of breast cancer continues to increase, and the death rate does not decline.

When you ask most people what they know about breast cancer, if they can say anything, they will say something about the importance of mammograms. But there is so much more to breast cancer. To name just a few things that the pink ribbon doesn’t represent: the limits of early detection, the ineffectiveness of current treatments to keep women with metastatic breast cancer from dying, the environmental triggers of the disease (only at most 10% of breast cancer is caused by an inherited genetic mutation), and the racial inequities in both the incidence and mortality rate from breast cancer.

Many of these issues are illuminated in the new documentary from the National Film Board of Canada, Pink Ribbons, Inc., by director Léa Pool and producer Ravida Din. The film was inspired by a book by of the same title by Samantha King. The film is now being shown at film festivals outside the United States. It should be in theaters here by February, 2012.

If we’re going to focus on what needs to happen to end the scourge of breast cancer, we need to find a new symbol, one that actually conveys the impact of the disease on people’s lives and that doesn’t lend itself so readily to corporate exploitation or to covering up the realities of the breast cancer.

Maybe if we put our heads together we can come up with a new symbol. Ideas?

Lou Gehrig: May He Rest in Peace?

Lou Gehrig died of ALS in 1941at the age of 37. Many people who think they have never heard of ALS have heard of Lou Gehrig’s Disease, the “popular” name for this devastating illness. By now, more people probably know Gehrig for his illness than his baseball prowess

Gehrig died more than 70 years ago. Since he died, many more people, some of them quite well known, have died of ALS. Yet, in nearly every story about ALS, Gehrig’s name appears, often with a picture of the baseball player standing hale and hearty with a

The famous Lou Gehrig

baseball bat in his hand. He doesn’t look sick, let alone devastated by the physical ravages of ALS.

Is it any wonder that the public doesn’t understand what ALS is when the symbol they see is so unrelated to the realities of the disease? Wouldn’t a better symbol convey the real life circumstances of 21st century people with ALS? Just because “Lou Gehrig” is easier to say than amyotrophic lateral sclerosis, that doesn’t mean Lou Gehrig is a good symbol for the disease today.

Good Symbols for a Change

For people to be motivated to care about and work to change either breast cancer or ALS, the need to understand what these illnesses are and how they affect people today. Appropriate symbols can help convey that understanding.  Let’s find and use symbols that at least hint at the realities so that people might — just might — be motivated to change them.

© Barbara A. Brenner 2011

Posted in ALS, Breast Cancer | Tagged , | 21 Comments

Health Activism: Not for the Faint of Heart

Posted on September 8, 2011 by bbzinger

I have been a health activist since 1994. Having spent a long time in the cancer field, it seems that now I am destined to become an ALS activist. I just can’t seem to help myself.

Wearing One Hat

I think a lot about what it means to be a health activist, and how that differs from being an advocate. When I was a member of the California Breast Cancer Research Council, I would show up at meetings and claim my name card for the conference table. On it would be printed my name, my organization, and the word “advocate.” That title was there because the legislation that created the program required that a certain number of council representatives be “advocates.”

My experience in breast cancer taught me that many, if not most people, who called themselves advocates had no clear sense of what they were advocating for. Many of them represented two — and often more — different organizations with different missions and objectives, and they would tout the position of whichever organization suited their purposes at the moment. Others went from one organization to another until they found a place where they could claim their views as those of the group.

In my lexicon, an activist is someone who is clear about her/his goals and strategic about achieving them. S/he cannot be bought – no amount of money or privileges will change her commitment to her goals.

Clear Goals

In breast cancer, there are many goalsthat require activism, for example, better detection devices, better treatments, better access to detection and treatment for everyone, uniting and refocusing the research agenda, fighting breast cancer “fatigue” brought on by pink ribbon marketing. While some activists take on more than one of these issues at a time, all will require a lot of effort by a lot of people.

In ALS, the issues seem, by contrast, much easier to list. They are, however, no easier to achieve. In fact, I can think of only two at the moment (though I’m relatively speaking new to ALS, so the list may grow): better treatments and access for everyone affected to the kind of care that will improve the quality of their lives.

Challenges for ALS Activists

One of the differences between breast cancer activism and ALS activism is that many people survive breast cancer for a long time, so many people have time and energy to get involved. With ALS, while some people live a long time, the disease is always fatal and always robs people of some physical abilities. It’s harder to be an engaged activist. So, we do what we can.

Beyond Self-Interest

Regardless of the disease at issue, a health activist is also someone for whom her goals, while they might benefit her personally once they are achieved, are aimed at affecting people she doesn’t even know. The goals are about more than self-interest: they are about changing systems so many people who now suffer will benefit. More often than not, those goals and objectives are bigger than can be achieved in one lifetime, and activists know that their efforts are possible because of previous work done by others. They also know that, if they do their job right, others will come after them to advance the work.

Taking the Heat and Keeping An Open Mind

Health activists have to be tough. Because they publicly take principled positions, there are always people who disagree with them and say so, sometimes in not-so-nice terms. If an activist caves because her positions have been criticized, she’s not really an activist.

I learned this lesson many times in my breast cancer work. When I criticized raising money by putting pink ribbons on products to promote sales, many people got angry, wondering how anyone could criticize money being raised for breast cancer. When I argued that the drug Avastin should not be sold for treatment of breast cancer, I was accused of sentencing women to an early death. And when I endorsed the mammography screening guidelines that would end routine screening of women between ages 40 and 49, I was told I would have blood on my hands.

ALS is not as prominent as breast cancer. But when I recently posted my blog entitled “Science By Press Release – Not Good for Patients” to a site for ALS patients, there were a lot of people who disagreed with me, saying I was depriving them of hope. I’m used to this. If you’re an activist who can’t get used to it, you might want to find another line of work.

This doesn’t mean that activists never change their positions, but it does mean that those changes are the result of changed conditions or developments that compel a shift in position because the old positions don’t make sense anymore.

Doing the Work, Getting the Rewards

Activists want to make the world better for people. They are committed, tough, and they are not afraid to speak their minds. Many are willing to learn the nitty-gritty of the issues with which they are dealing so that they can engage in intelligent conversations with people who have power on those issues.

Being an activist is not for the faint of heart. But the rewards are often great. You meet great people, you learn a great deal, and sometimes, just sometimes, you make a difference in the world.

© Barbara A. Brenner 2011

Posted in ALS Treatment, Breast Cancer, Health Policy | Tagged , , | 16 Comments

Science by Press Release – Not Good News for Patients

Posted on August 26, 2011 by bbzinger

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It May Look Like News

If you have ALS, or know someone who does, you were probably inundated with emails from well-meaning and loving friends earlier this week with the news of a “breakthrough” in ALS research. I first saw the news in the press release issued by Northwestern University, the institution that sponsored the research. The headlines of many of the stories that resulted from that press release read “Major ALS Breakthrough: Researchers discover common cause of all forms of ALS.” Don’t go running to the pharmacy for the new treatment for ALS. It’s not here yet. It’s not even close.

As a long time health activist, I am more than a little bit familiar with what I have come to call “science by press release.” A research institution finds something interesting, they widely distribute a press release putting the best possible spin on it, and the media outlets run with the story. Try a google search of the phrase “ALS breakthrough” and see how many hits you get.

What Does it Mean for Patients?

The first question to ask when you see a story about a medical breakthrough is “what does this mean for patients today?” In the case of this ALS story, nada. What has been found is

Ubiquilin2, the new focus

a protein called Ubiquilin 2 that occurs in spinal and brain system cells. It’s supposed to repair or dispose of other proteins as they become damaged. The researchers discovered a breakdown of this function in ALS patients.

This may prove to be good news, especially if it is confirmed by other research and drugs can be developed to address the damaged protein. But we’re a long way from that day, and many

There's still a very long way to go

things could happen that keep researchers from getting to it. For example, it may turn out that some other protein or proteins have to be controlled to make sure that Ubiquilin 2 functions properly. The unknown territory is vast.

Key Words to Look For

There are key words to watch for in the “science by press release” world. Among them are “breakthrough”, “advance”, and “may,” “might,” or “could lead to.” When you see these words in a story about a medical breakthrough, listen carefully for what’s being reported. Far more often than not, the story is about something that worked in the lab but hasn’t been tried yet in patients, or about a study of a very small number of patients.

Those of us living with illness, and the people who love and care about them, need hope. But we don’t need research masquerading as news that will affect our chances of surviving. As one scientist interviewed on the ALS story said, “You need to understand at the cellular level what is going wrong. Then you can begin to design drugs.” Call me when you get there.

Dreaming

When I was the Executive Director of Breast Cancer Action, I often wished that a PhD candidate would review all the news stories in the last decade about medical breakthroughs in breast cancer and figure out which ones in fact resulted in improving outcomes for patients. I would love to read that dissertation.

What You Can Do

Next time you see a medical “breakthrough” story, think about contacting the media outletand telling (or just asking) them what their story means topatients today, especially if it may be, might be, or probably is nothing.

© Barbara A. Brenner 2011

 

 

 

Posted in ALS Treatment, Medical Science | Tagged , , , | 9 Comments

Drug Development and Access: Time to Act Like Lives Depend on It

Posted on August 18, 2011 by bbzinger

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The Problem and the Incremental Solution

An Op-Ed in the Sunday New York Times in the past few weeks pointed out that important cancer drugs are being rationed by companies that have simply interrupted production. (See Ezekiel Emanuel, “Short Changing Cancer Patients” NYT August 6, 2011). As a result, many cancer patients can’t get the drugs they need.

Ezekiel Emanuel: Doesn't He Look Like a Policy Wonk?

Dr. Emanuel is an oncologist and a health policy wonk who was most recently an adviser in the Obama White House. In his article the good doctor details the current shortage of commonly-used cancer drugs and what he sees as possible solutions to the problem. He clearly understands deeply the issues of cost reimbursement and the cost interaction between generics and patented drugs. He believes that the best way to get the missing drugs back on the market is to make generics of the drugs that are in short supply more profitable.

Capitalism and Health Care: Not a Good Mix

The article got me thinking once more about whether capitalism and health care are concepts that make any sense together, and about how cancer and ALS are different, yet the same.

In his op-ed, Dr. Emanuel says, “You don’t have to be a cynical capitalist to see that the long-term solution is to make the production of generic cancer drugs more profitable.”

I see the situation differently: you don’t have to be a raging socialist to see that the solution to the drug access and cost problem is to nationalize the pharmaceutical industry. We can pass laws until the cows come home to try to get pharmaceutical companies to behave in ways that will not harm patients while keeping their profits intact. But the goal of companies that make drugs is to make money, and that goal will always trump the needs of patients when the two conflict. Sadly, you can bet your life on it.

As long as we insist that health care must provide a profit for the drug companies and that this profit must not be subject to regulation our health will be short-changed.

Meanwhile, the shortage of cancer drugs is dire and getting worse as patients await the arrival of prescribed medicines so they can start or continue the treatment that may extend or improve their lives.

Cancer and ALS: Different Diseases, Similar Issues

That cancer treatment situation is terrible. Equally, but differently, bad is the situation in ALS, where there is only one drug approved to treat the disease. That drug is Rilutek. If it works – and it doesn’t work for everyone – it delays progression of the disease for up to 9 months. It does nothing to make you feel or function better and nothing to extend your life.

The absence of ALS drugs is in part the result of the fact that the market is so small: because, relative to cancer and some many other diseases, so few people have ALS. That means there is not as much profit to be made from ALS drugs. But that doesn’t mean that the research resources are so limited that we can address only the diseases for which drugs can be profitably made. It simply means that there’s not enough potential profit in ALS drugs or drugs to treat other relatively untreatable diseases (like pancreatic or head and neck cancers, to name just a few) to make the research attractive to private companies.

Potential profit will continue to be an incentive to develop drugs for diseases that are relatively wide spread. What we need are incentives to push the research also in the direction of, if you will “less profitable” diseases that need treatments. What would happen if national policy required drug development for diseases that are always or nearly always fatal, and for which there are very few if any good treatment options? I’m sure there are many people who would take issue with this standard, but maybe we should have the conversation and think about whether and how it might work.

In my opinion, it’s time to get away from niggling around the edges of how to make capitalism and drug development (or health care in general) work together. Maybe it’s time to put patients’ needs first. Isn’t that a nifty idea?

© Barbara A. Brenner 2011

Posted in ALS Treatment, Health Policy | Tagged , , , , , | 7 Comments

My Life as A Guinea Pig, aka ALS Patient

Posted on August 9, 2011 by bbzinger

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Drug Trial Travails

I’m a participant in a clinical trial for an ALS drug. The trial goes by the catchy name “Biogen 223AS302 Dexpramipexole.” Let’s just call it the trial. It’s a randomized double-blind trial, which means that neither I nor the medical team knows whether the little white pill I take twice a day is the drug being evaluated or the placebo.

To keep track of what impact the drug is having on patients of a degenerative disease like ALS, a lot of follow-up tests are done to measure things like lung capacity, muscle strength, heart and liver function.

And, since it is not known whether a given patient in the trial is getting the drug or the placebo, these follow-up tests are done on everyone. To do them all takes about half a day, and a lot of energy. Since ALS patients like me tire quite easily, it’s particularly ironic – if not downright annoying – that these follow-up tests are so exhausting.

Lots of blood draws are taken for follow up

The muscle strength test involves having a hand-held device applied to various muscles. My job is to resist the pressure applied through the device as much as possible. The lung capacity test involves having a mask pressed hard to my face while the very nice nurse holding it there also holds the back of my head and encourages me to breathe as deeply as I can, and then exhale as much as you can. This exercise is repeated at least 3 times.

Some of the follow-up tests are done every month, though not as extensively in each instance as in this half-day marathon.

These tests are not only exhausting, but for the most part they measure things about my function in ways that are meaningful to the drug company (Biogen) but not so much to me or my care providers. So, this half day of tests does not substitute for the half day in the ALS clinic where care providers focus on me instead of the things being measured in the trial.

To Trial or Not to Trial?

As I contemplated these tests on the day before I had them recently for the second time, I seriously considered dropping out of the trial. I wasn’t sure then (and am still not sure now) why I should spend so many precious hours being put through this drill. I know I’m participating in the trial because we desperately need better drugs for ALS. And I know that clinical trials are the only way to get them. But I also know that I want to spend the time and energy I have doing things I love. As you might imagine, breathing into a mask held to my face is not on that list. It’s not that I wasn’t told about the follow-up tests as

Informed consent process

part of the informed consent process for the trial, but living through them is a very different experience from reading about them.

Now that I have the experience, I wonder whether it might be possible to find other less exhausting means of collecting information needed to ascertain whether the drug in this trial or any trial meets the FDA requirements for safety and efficacy.

Botox Adventures

On a different front,  there are the things I consciously choose to do to try to improve the quality of my life with ALS. Take, for example, my efforts to improve my speech temporarily with injections of Botox into my larynx. The theory is that some ALS-related speech problems are caused by spasticity in the vocal cords and that Botox can control that problem by “freezing” the action part of the cords. This is a temporary fix that, if it works, can help people enunciate words more clearly. It requires a good deal of evaluation up front to see if it might work. Injections are repeated every 3 months or so as long as it’s working (because the effectiveness wears off over time). Botox ultimately stops working altogether when, as ALS progresses, the muscles that control the vocal cords stop working.

The up-front evaluation tests for Botox include visual examination of the muscles affecting my voice, injection of lidocaine into my larynx to mimic the effect of Botox, and a barium swallowing test (to make sure my swallowing, which is also affected by ALS, will not be adversely affect by Botox). The barium test requires standing in profile before an xray machine and swallowing barium-based substances of differing consistencies. While my swallowing is not perfect, it was evidently good enough on the day of the test not to raise serious concerns about the possible impact of botox on my swallowing.

EMG: Torture Masquerading as Medical Care

There’s one more up-front evaluation for the Botox thing, and this is a humdinger. It’s called called an EMG (electromyography) of the muscles of my larynx. I had an EMG months ago of my leg and arm muscles, and I hated it. It involved putting needles in my muscles, and running small electrical currents through them to determine how well my

Laryngeal EMG: It feels as bad as this looks

nerves communicate with my muscles. Though no electrical currents are run through the needles for the laryngeal EMG, having needles placed in my throat and moved around to measure nerve conduction was more than little bit uncomfortable. By the time the doctors (there were 5 of them in the room – 2 of whom were in training) placed the needle in my throat for the 4th time, I was done, and told them to stop. I also told them that I wanted just 5 minutes in the same room with whoever invented this damned test.

Before I would even consider the Botox injection that was to follow, I needed to know whether I would need to have another EMG for subsequent injections. The answer was, thankfully, no. By comparison to the EMG, the injection of the Botox seemed almost a non-event. It was briefly painful, but it was over in 5 seconds.

Almost two weeks later, I think I have had some help from Botox with articulating words, but my voice projection is worse, and so is my swallowing. Whether the swallowing problem is from the Botox or the disease, I can’t say. I’m not sure the benefits of Botox are worth the trade off for me. Another choice to make when I see the doctor for follow up.

Can We Do Better?

In the clinical trial setting, tests are imposed to advance the purposes of the trial. In the treatment setting, tests are imposed to assure that the treatment will, at a minimum, not be harmful. Whatever the setting, there has to be a better way to help people who are sick than to torture them with exhausting and painful tests.

© Barbara A. Brenner 2011

Posted in ALS Treatment, Medical Science | Tagged , , , , , , | 12 Comments

How Do You Spell Chutzpah: Komen

Posted on July 28, 2011 by bbzinger

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Yiddish is a very expressive language, a blend of Hebrew and German used by Jews in

Jews in a shtel

Europe when they lived in shtetls. One of my favorite Yiddish words is chutzpah. The word has taken on some positive connotations, but I’m using it here in the sense of the Hebrew source word, where it means someone who has overstepped the boundaries of accepted behavior with no shame.

Chutzpah has the benefit of being both expressive, and relatively easy to pronounce, (unless you’re Michelle Bachmann). It is also a very apt description of the Susan G. Komen for the Cure Foundation’s recent move to sponsor October as Breast Cancer Action Month.

The Longish Back Story

A little background might help illuminate why this move is so outrageous.

Back in the early 1980’s, with the help of the pharmaceutical giant now called Astra-Zeneca, Komen (then called the Susan G. Komen Foundation — “for the cure” came later) became the dominant voice in Breast Cancer Awareness Month, formerly known as October. The idea was to encourage women to get mammograms by promising, at least initially, that early detection was a woman’s best “prevention.” When it was pointed out that once you had detected something it was too late to prevent it, the message changed to guaranteeing that early detection was a woman’s best “protection,” though protection from what was never made clear.

“Breast Cancer Awareness Month” (BCAM) was largely sponsored by the pharmaceutical

The official logo of BCAM

and mammography industries. Komen was — and is — closely tied to both. Thanks to the forces behind the BCAM effort, there was never any mention in the official BCAM materials of the possible environmental links to breast cancer. As a result October came to be known in more progressive health circles as Breast Cancer Industry Month.

Breast Cancer Action (BCA), a national grassroots education and advocacy organization based in San Francisco, became a prominent voice working to re-cast October as Breast Cancer Industry Month. BCA was started in 1990 by women with metastatic breast cancer who knew they were going to die and that the public knew little or less about breast cancer. They had questions and they wanted answers.

The messages offered by BCA for October moved far beyond mammography screening and the over-simplified messages associated with BCAM. They exposed the financial interests behind BCAM and urged an understanding of the complexity of “early detection” as well as acknowledgment of the environmental drivers of breast cancer, including radiation and pesticides (which Astra Zeneca marketed at the time).

As the drum beat of breast cancer awareness reached deafening proportions, Breast Cancer Action encouraged people to look beyond awareness to what actions they could take by working together to stem the tide of breast cancer for everyone.

The Breast Cancer Trademark Business

The trademark symbol

Around the time that Breast Cancer Awareness Month came to the fore, Komen attempted unsuccessfully to trademark the pink ribbon, which was fast becoming the symbol of breast cancer.

More recently, Komen changed it’s name to Susan G. Komen for the Cure Foundation and trademarked the phrase “for the cure.” Komen then began suing other organizations that used “for the cure” in their name or fundraising efforts, even those that had nothing to do with breast cancer. As of August, 2010, Komen had more trademark applications pending with the US Patent and Trade office (291) than Google (161).

Breast Cancer Action holds two trademarks: on its name and on the name of its Think Before  You Pink Campaign.

Think Before You Pink and Komen

One more bit of background information. When the marketing of breast cancer through the sale of products with pink ribbons on them began to grow, Breast Cancer Action initiated in 2002 its award-winning Think Before You Pink Campaign. The purpose of the campaign is to get people to think critically about how the money is raised and where the money goes.

The year Think Before You Pink was launched, a reporter from PR Week called asking why Breast Cancer Action had a campaign targeting Komen. The campaign targets cause marketing for breast cancer, not Komen. But the Komen Foundation has an interesting  way of presenting — and apparently thinking of — itself as the only organization doing anything in the breast cancer world. It was clear then and as the campaign moved forward in succeeding years that Komen saw Think Before You Pink as undermining their mission.

Now Komen Wants Action — Breast Cancer Action ?!?!

It seems that Komen now agrees with BCA that there is enough awareness of breast cancer. After all, if you stop the first 10 adults you see in the street and ask if they are aware there is a breast cancer problem in this country and elsewhere, anyone who says  “no” must be living under a rock.

Komen wisely wants to move beyond awareness, but to what? The claim they want to move to “breast cancer action month.” Has a familiar ring, right? It’s often said that imitation is he sincerest form of flattery, but sometimes it’s just a rip off. Why would Komen, one of the biggest charities in the world, want to usurp the name of an organization that’s been a thorn in their side for years? Let me think . . .

While it’s conceivable that Komen just chose the words that they thought best suited their efforts, an organization that holds many trademarks and aggressively pursues them also has tons of lawyers at its disposal, and it should have crossed someone’s mind to consider the possibility that an organization named Breast Cancer Action held a trademark that would affect their effort.

For Komen, action means getting a mammogram, buying product the sale of which supports Komen, or participating in a Race for the Cure or a 3-day walk. If walking — or shopping — cured breast cancer, it would surely be cured by now.

Komen is entitled to its view of things, but not under the name of another — and very different — organization. If they want an even bigger empire, they should build it without stepping all over others in the field.

P.S. The American Cancer Society gets an honorary award for chutzpah, for it’s “official sponsor of birthdays” campaign. With mortality rates from many cancers increasing, and with the focus on 5-year survival as a “cure,” the cancer society is making a bold and unsubstantiated claim. Alcoholics Anonymous has far more basis for claiming to be the official sponsor of birthdays.

Copyright Barbara A. Brenner 2011

Posted in Breast Cancer | Tagged , , , , , , | 34 Comments

Thoughts on Dying and Living

Posted on July 20, 2011 by bbzinger

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Last week, I had an email from a friend wondering what I would say about Dudley Clendenin’s op-ed in the July 10 Sunday New York Times entitled “The Good Short Life.”

Dudley Clendenin with his bow tie

Seems that Mr. Clendenin have a few things in common: we’re both from Baltimore (I moved away many years ago); more to the point, we both have ALS, the onset of which for both of us was with slurred speech, and we both think consciously about how we live our lives. In his op-ed, Mr. C wisely observes that we don’t we don’t talk much in this country about how we die, and that we all should be making conscious choices about that when the time comes.

For those of us with ALS and the people who love and care for us, it’s impossible to imagine an outcome different from death. This reality diverges widely from my experience with breast cancer 18 years ago. At that time, and for some time thereafter, I was intensely aware that there was no guarantee of tomorrow. I, along with my beloved partner Susie, lived that reality for a while. Then the breast cancer diagnosis receded in time, and I got back to living for future things — like retirement, or that far-off trip to India.

Now, because of ALS, I am again faced with the stark reality that tomorrow is promised to no one. I’m also realizing both how hard it is to make sure my day-to-day life reflects this reality, and, at the same time, how hard it is to be constantly reminded that this is where I am.

Because of ALS, there is almost no way I will ever get to live again as if I have a lot time in front of me. And, however much I want to take advantage of today, my ability to do that will become more and more limited as my illnesses progresses.

I don’t want to die. But I will sooner than I would have thought less than a year ago. Mr. C., confronting the same reality, has decided to take control of his future by ending his life before his ALS becomes so advanced that his daughter will remember him horribly debilitated, or that he can’t tie his bow tie or walk his dog.

In the meantime, he enjoyed a couple of wakes for himself that he got to attend. There’s a celebration of me being planned for this September by folks here who know my work, and the one thing I’m insisting on is that it is not a funeral. There will be plenty of time for that — and for me to help plan it, for that matter, but I won’t be there.

I’m pretty sure I will not want to end my life because I can’t tie my shoes. There are always slip-ons, after all. But I also know that, as my ALS progresses, I want to be able to make conscious choices about what I am willing to tolerate in terms of interventions and daily life. To do that, I need to keep focusing on what I value in life (love, music, words, time with people I care about, activities of the mind, pursuit of spiritual connection), and how much of what I value can be achieved or obtained when there is so much my body will not be able to do.

I want to cherish this time when I can do so much – and do as much as I can — even as I recognize how much more limited my abilities already are. And I want keep my eyes wide open to what the future holds, realizing that I am essentially an optimist in how I approach life. This means that, even as my physical capabilities wane, I will look for and try to embrace the positive aspects in what remains available to me.

I think we respond to devastating health news from our essential beings. A fatal illness does not change who we are. Mr. C appears, from his column, to have an essential need to control the length of his ALS-compromised fate. By contrast, I think that I have an essential need to take the greatest advantage of the opportunities left in mine, though I recognize, as Mr. C does, that my need has implications for the lives of the people who care for me. Given who I essentially am, and who Mr. Clendenin appears to be from his column, I suspect he will die before I do, if that turns out to be in the control of either of us. I hope he dies as happily as he can, given that he has to go before he would want to if things were different. I hope the same for me when my time comes.

On a happier note, it seems another thing that Mr. C. and I share is a love of Leonard Cohen. Like Mr., C, I hope for what Leonard Cohen writes about in his poem/song “Dance Me to the End of Love:”

Dance me to your beauty

with a burning violin

Dance me through the panic

till I’m safely gathered in

Lift me like an olive branch

and be my homeward dove

Dance me to the end of love

For more about me and my life these days, see the profile of me published recently in USA Today, and listen to the podcast of my perspective on KQED about voice and communication.

 

© Barbara A. Brenner  2011

Posted in Illness | Tagged , , , , | 19 Comments

Fast-Tracking Cancer Drugs: The Back Story and The Future

Posted on July 11, 2011 by bbzinger

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In a previous blog post, I tried to explain the importance of understanding what was being measured in clinical trials for cancer drugs, and why it mattered. If you want to refresh your memory on this, it’s entitled “People’s Lives as the Endpoints of Medical Research – Now There’s An Nifty Idea.”

The example I used in that blog post was Avastin (generic name bevacizumab). This drug has been the subject of many hearings at the FDA — the most recent in late June, 2011 — and more news stories than can be counted of outcry from breast cancer patients. Behind all this noise, we seem to have lost sight of the purpose of putting cancer drugs on a “fast track” to FDA approval. If that purpose is lost, the end result will be a lot of drugs on the market that don’t work, and a lot of very sick people for whom hope will have been met with an empty promise and, possibly, a lot of side effects that will make their last days more miserable than they need to be.

Fast Track Approval for Cancer Drugs: The Idea

In 1992, almost twenty years ago, Congress passed PDUFA (The Prescription Drug User Fee Act). Among other things, that law provides that drug companies pay fees to the FDA to increase the agency’s drug review capacity. With that increased capacity in hand, a law called the Food and Drug Administration Modernization Act of 1997 established a process for rapid approval of treatments for life-threatening conditions and unmet medical needs. The purpose of this approach, as the FDA puts it, “is to get important new drugs to the patient earlier.”

Addressing an “unmet medical need” is defined by the FDA as “providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.” According to the agency, if there are existing therapies, a drug for which fast track approval is sought must show some advantage over available treatment, such as superior effectiveness or avoiding serious side effects that occur with an already-available treatment.

When a drug is considered for fast track approval, the FDA allows surrogate endpoints to be used to demonstrate the drug’s effectiveness. As defined by the FDA, “effectiveness” in this context means that the end point used represents a clinically meaningful outcome, such as longer survival or mitigated symptoms. By relying on these surrogate endpoints, drug companies can reduce the amount of time needed to get through the FDA approval process and get their drugs to market.

But there is a kicker, which is where Avastin got into trouble. Fast track, or accelerated, approval of a drug based on surrogate endpoints is given on the condition that post- marketing clinical trials (done after the drug is approved) verify the clinical benefit anticipated with the surrogate endpoints. In other words, the studies done after the drug is given fast-track approval for marketing must show that the benefit for which a surrogate was measured actually occurred in patients.

So, fast-track FDA approval is always conditional: conditioned on a showing by the manufacturing company that the drug actually improves patient outcomes in meaningful ways. The company is required to show that the surrogate endpoint that merited early approval for its drug is borne out by measurable and positive clinical outcomes for patients in later trials. Getting fast-track approval is not a guarantee that a drug will get full approval from the FDA. It is meant to be a guarantee that drugs that actually help patients will get to those who need them sooner.

Does the Drug Meet Its Promise?: Where The Rubber Meets the Road

So fast track approval for a drug is not the final step in the drug approval process.

In the single trial that led to the accelerated approval of Avastin for breast cancer, the surrogate endpoint was time to progression: a delay in median time before tumors started to grow in patients on the drug. There was no evidence at that time that the drug improved patient outcomes. It was believed that further trials would show this benefit, either by lengthening patients’ lives, or improving the quality of their lives by improving how they felt while on the drug as compared to other treatments.

Unfortunately, several subsequent trials performed by the manufacturer, Genentech, showed less benefit in time-to-progression terms than the trial on which approval was based. And none of these trials demonstrated the meaningful clinical outcome for patients on which accelerated approval was premised. Based on these trial results, the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended revoking marketing approval for Avastin for breast cancer in July, 2010.

Genentech Knew the Rules

None of what is described above was unknown to Genentech. The company has been involved in the FDA drug approval process for years, and has had many conversations with the FDA during the drug development process.

Now that's a tag line!

Genentech knew that, for full approval of Avastin for breast cancer, it had to show more benefit than it had in the study that led to accelerated approval.

Despite what the company knew, they requested an appeal hearing on the ODAC’s 2010 recommendation. Though other fast-tracked drugs have been removed from the market, never had there been an appeal hearing like this.

In the extraordinary two-day hearing before the ODAC in late June, 2011, Genentech made an interesting and troubling argument in its appeal. Essentially, the company argued that the drug should stay on the market while the company conducts one more trial to try to show the drug’s actual benefit.

This might seem like a reasonable request. But consider this. Avastin went on the breast cancer market in early 2008 on an accelerated basis. Genentech thereafter conducted several trials that were required as a condition of its fast-track approval. Those trials not only did not show the improvement in time-to-progression that the first trial showed, they also showed no clinically meaningful benefit for patients. Removal from the market is a step the company knew was likely. But the breast cancer market for Avastin was huge: estimated to be as large as $1billion annually for Genentech. It doesn’t take much imagination to see that the magnitude of this potential financial reward prompted the company’s appeal of the ODAC decision, and the argument they made during the appeal hearing to change the rules.

Bring in the Patients

Of course, when Avastin received accelerated approval, a lot of women with breast cancer got the drug. (In fact, a lot of women got the drug before that, because Avastin was already approved for lung and colorectal cancer, and therefore could be prescribed by doctors “off label” for other conditions, including breast cancer.)

And, predictably, when the FDA held its recent hearing, many women who were still alive and on the drug showed up to make it clear that the wanted the drug to stay on the market.

The appearance of these women at the FDA hearing got a lot of press attention. One of those women, Crystal Hanna, submitted a statement to the FDA and circulated it on the internet, where many people copied and resubmitted it. She wrote, “It’s so depressing to think that a federal agency can make a decision that can potentially cause me to die.”

Represented on the ODAC are medical experts as well as patient and consumer representatives. At the hearing itself, someone who wanted Avastin kept on the market yelled, “What a patient representative! You better hope your breast cancer doesn’t come back. You’re an embarrassment to all cancer survivors.”

Among the women who weren’t at the hearing were those who, despite or even because of Avastin, had died of breast cancer. The dead have no voice. But, fortunately, there was extensive evidence prepared both by FDA staff and Genentech for the ODAC to consider. That evidence provided a broader context for evaluating the passionate statements of those who showed up to argue for the drug.

Unfortunately, none of this evidence was heard by the angry women who showed up to defend Avastin at the hearing, because  none of them stayed to hear the ODAC presentations by Genentech and FDA staff or the discussion by the committee. They did, however, return for the vote and the protest they had organized to follow.

While the Controversy Continues

The ODAC voted unanimously at its June hearing to recommend (for the second time) revoking the approval of Avastin for breast cancer. The ultimate decision will be made by the Commissioner of the FDA, Margaret Hamburg.

Whatever that decision is, there will be controversy leading to and following it, and probably further action. Congress may get involved, as it is wont to do when constituents with breast cancer raise their voices. Genentech may bring legal action, or an individual patient might. The Obama administration may not want anything right now to smack of rationing care, which would bring pressure on the Commissioner to leave the drug on the market.

If Avastin stays on the market for breast cancer, the result will be to so undermine the fast track drug approval process as to make that process meaningless. And that is not in the interest of patients, especially the ones who think they need these drugs.

© Barbara A. Brenner 2011

November 18, 2011: Today the FDA Commissioner did the right thing. Avastin is no longer approved for breast cancer treatment. Http://nyti.ms/td1Fql Let’s hear it for following the rules and protecting lives.

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

Walk for Your Health, But It Won’t Help Anyone Else’s, Much

Posted on July 1, 2011 by bbzinger

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A Little History on the “Walk for [Disease]” Thing

Back in 2000, I wrote a column for what was called then simply The Breast Cancer Action Newsletter entitled “Exercise Your Mind.” It was a critical look at what was then the Avon 3-Day Walk for Breast Cancer:  how the money is raised, who gets to participate and who doesn’t, the administrative costs of making the walks happen, and the lack of transparency about where the money raised for the cause actually ends up.

It is now more than a decade later and the criticism has been taken up by others: Samantha King wrote a book about it called Pink Ribbons, Inc: Breast Cancer and the Politics of Philanthropy, and a June 18, 2011 op-ed in the New York Times by Ted Gup was entitled “The Weirdness of Walking to Raise Money.” Yet the phenomenon of walking to raise money to cure diseases persists and grows.

Breast cancer is by far the biggest beneficiary of fundraising walks: big ones are sponsored in multiple cities by the Susan G. Komen for the Cure Foundation (which took over the 3-day walk from Avon), The Avon Foundation (philanthropic arm of the cosmetics company, which now hosts a 2-day walk), The Revlon Foundation, and the American Cancer Society, to name a few. With all the walks going on, and all the money being raised with the promise of curing breast cancer, shouldn’t breast cancer be cured by now? (If you think it has been, check with the folks at Metastatic Breast Cancer Network for more realistic view.)

How Fundraising Walks Work

All these walks have things in common:

–your family and friends asking you for money so they will be allowed to participate (there’s always a minimum donation required)

–high administrative overhead, which means that of every dollar you give to support a walker, considerably less than a dollar goes to the cause you think you’re supporting

–decisions made by the walk organizers, not the walkers, about where the money raised will be donated, which is often to places far from the community where the funds are raised

–an opportunity for people concerned about a particular disease to be together to share stories and support each other

From Overdone to Ridiculous

The walk thing has now gone far beyond breast cancer. You can walk “for” (who is “for” diseases? Can we have a show of hands?) diabetes, birth defects, Alzheimer’s Disease, mental illness, epilepsy, hunger, and farm animals. The list goes on and on. You can even walk against abortion.

In what I think is the ultimate sad irony, there is a walk for ALS. You know, that disease that robs people like me who have it of the ability to walk.

Walk to Make a Real Difference

I still believe – and more so – what I thought in 2000 when I wrote that column for the BCA newsletter. Walk if you want to – it’s good for your health. If you want to be sure your walking truly benefits people who are ill, walk to the nearest organization doing work you admire on the issue and lend a hand. You can even hand them a check if you’re so inspired.

© Barbara A. Brenner

Posted in Breast Cancer | Tagged , , , , , , | 20 Comments