Genes Are Not Destiny

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If you’ve been following health issues for the last decade or so, you must have noticed that genes are all the rage. Hardly a day goes by that doesn’t carry news of some breakthrough about a gene that is claimed to explain one disease or personality characteristic or another.

In preparation for writing this post, I did a google search for “gene explains heavy breathing,“ and I found a story. Try it yourself: pick some condition or characteristic that strikes you as in the range of normal, and see if a gene has been found to help explain it. Tell me if you don’t find something.

And keep in mind as you read this post that, if genes are really destiny, then it’s a good thing I didn’t have kids, given my health history.

The Breast Cancer Context

In the realm of diseases, there is an enormous focus on the genetic “causes” of illness. In breast cancer, 2 genes have been identified as linked to inherited susceptibility to the disease. These genes are cleverly called BR(breast)CA(cancer)1 and 2.

The BRCA 1 Gene

If you have a strong family history of breast and/or ovarian cancer – defined as at least two first degree relatives, especially if they were pre-menopausal at diagnosis — the odds are you carry an inherited mutation on one of these two genes. And if you carry one of these mutations, your risk of getting the disease goes up, sometimes way up.

Notice I didn’t say that the odds are you carry one of the two genes. We humans all have all the same genes. It’s the mutations – the changes in the structure of the genes – that either we inherit or that occur from a lifetime of different exposures to various things – that increase the risk of disease.

Notice, too, that I didn’t say that, even if you have one these mutations you will get the disease. I said your risk increases. I did not say “will get breast cancer,” because even in cases where the risk from the mutation is very high, 15 to 25% of people who inherited the mutation do not get the disease.

So, genes alone are not causing breast cancer, or anything else. Something has to happen to the genes to make them go haywire and trigger disease. And whether your body will respond to whatever that trigger is, no one can say for sure.

Two other things about the “breast cancer genes.”

1)    BRCA 1 and 2 are patented by Myriad Genetics. They’re not the only human genes that are patented, but they are the most famous. Gene patents inhibit research and  limit the amount of the information available to patients. The breast cancer gene patents are being challenged in a ground-breaking lawsuit led by the ACLU and the Public Patent Foundation. Breast Cancer Action was the first – and, for a long time, the only – breast cancer organization to sign on as a plaintiff in this lawsuit.

2)    When BRCA1 and 2 were found, researchers were sure they would find BRCA3 and 4 very quickly thereafter. The researchers were wrong, and the hunt has pretty much been abandoned.

Genetic Testing: An Art More Than A Science

As more and more disease-related genes have been found, tests have become available to identify these genes in people. Gene tests are done from blood taken from a simple blood draw.

But reporting the results to patients is not so simple. The issues can be very complicated. What do the results mean for whether the patients will become ill? What do they tell her/him about how to lead life despite or with the results? What do the results mean for the immediate family of the patient, especially brothers and sisters who come from the same genetic background? The discussions are long and involved.

Fortunately, a professional field of trained genetics counselors has emerged. These folks are trained not only in genetics, but in how to talk to people about gene test results. At Breast Cancer Action, we always encouraged people who were considering genetic testing to consult a trained genetics counselor.

Working with trained genetics counselors is better for patients, and for the health care providers who otherwise find themselves in the uncomfortable position having to explain things they may not be equipped to explain.

The ALS Context

Because I had an older sister, Ruth, who died of ALS, neurologists think there has to be some inherited genetic component to my illness. While I always resisted being tested for the breast cancer gene mutations, I decided to be tested in the ALS context. One reason is that the results might help researchers understand more about a disease about which very little is known. The other reason is that I have nieces and nephews of child-bearing age who might want to consider the risk, if I have a mutation, that they might have it, too, and consider that risk as they think about having kids.

But ALS is not breast cancer. First of all, the disease is rare – certainly compared to breast cancer — striking 5600 Americans each year. (For comparison, approximately 260,000

The gene hunt

U.S. women are told each year that they have breast cancer.) Of that number, 5% of ALS cases are considered “familial,” with multiple members of the same family having the disease. It’s this 5%– 280 people a year — that is the focus of the genetic research in ALS.

And genetic mutations have indeed been found: SOD1 is the most common and has been the most studied. It is believed to be responsible for as little as 10% and as much as 25% of familial ALS, though how it triggers the disease is not understood. That range (10% to 25%) is a very good indication of how little is known about the genetics of familial ALS.

Other gene mutations associated with familial onset have also been identified. They are

SOD 1 gene

rarer than SOD1 and their “penetrance” (the proportion of people with the mutation who go on to get ALS) is lower than for SOD1.

All of these mutations can be tested for, but together they explain only about 30% of all cases of familial ALS. Which means that 70% of familial cases are unexplained. In other words, a negative gene test in a person whose family has more than one case of ALS is more likely than not to get a negative gene test result. Which is what happened in my case.

Learning Gene Test Results: The Good and the Bad

I learned my test results from a very nice and caring person, a trained nurse and clinical research specialist at the Forbes Norris Center where I’m being seen for ALS. I was a little surprised to learn the results when I did, because I was at the Center for a follow- up visit related to a clinical trial in which I’m participating. Gene test results were not, as far as I knew, on the agenda for that day. And there wasn’t a trained genetics counselor in sight.

The conversation started when the nurse said to me something like, “I don’t recall whether you are someone who wanted to know the gene tests results or not.” That seemed more than a little odd to me, since that information should be in my medical chart, somewhere near the consent form I signed for the genetic test.

When I indicated that I did want to know the results – in order to be helpful to the rest of my family – the nurse said that my results came back classified as “unknown,” meaning that none of the identified genes had been found.

The nurse said that none of the genes had been found. I never heard the word mutation mentioned, though the difference between genes and mutations is a very important distinction. I’m sure the genes were found – we all have them, after all – but that none of the known mutations associated with ALS was found.

What bothered me as much was the discussion about how likely it was that I had a familial form of ALS, despite the results of my gene test. The nurse pretty much insisted that, if I had a sister who had had ALS, there had to be a familial genetic component. This was especially true, from her perspective, because so much of familial ALS cannot be explained by the gene tests that can be done at this time. Of course, if your perspective is genetics, this makes sense because the thinking is “It must be genes, we just haven’t found the right ones yet.”

If your perspective isn’t genetics, the thing to say might be as simple – and as shocking in the medical field – as “We don’t know.”

Beyond Genes

The limited view held by the nurse fails to take into account how little genes can tell us about our health. My sister and I grew up in the same family, in the same house, exposed to the same things in our common environment at an early age. But it seems no one is looking to see whether those common exposures might explain either her disease or mine.

No one is helped when medical professionals insist we know what we don’t. Thinking outside the box will never happen if we can’t see that we’re in a box to begin with. If we look only for genes, that’s all we’ll find. If we open our minds to other possibilities, we just might find other explanations.

© Barbara A. Brenner 2011

Posted in Environmental Health, Medical Science | Tagged , , , , , , , , , , , , , | 11 Comments

Having a Voice, Communicating, and Somewhere In Between

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I need to start this post with a disclaimer that may surprise you: I am not Christopher Hitchens. First of all, our politics are very different. More importantly for purposes of this

This is Hitchens, not me

post, Hitchens wrote a moving and erudite piece of Vanity Fair about the impact of losing his speaking voice to cancer. It’s worth reading:

ALS is robbing me of my speaking voice. For me, the onset of this damned progressive disease was with my speech: I started to have trouble enunciating words clearly. (That’s how ALS starts in about 1/3 of people with the disease.) I’m now in a situation where it is most often very hard for me to project my voice beyond a whisper.

This is me, not Hitchens (in Oregon, at Opal Creek)

Followers of this blog know that some time ago I began using a voice amplifier (See: “There Goes That Person With . . .”). That doesn’t help so much now. But, fortunately, there are other technologies.

Meet Kate


Many people with many different kinds of disabilities have known for a long time that technology makes continuing to be — and engage — in the world a possibility. For folks who have trouble talking, one form the technology takes is programs that convert text to speech. I use a program called NeoKate, a free app for the iPad. I type in the text, tap on “done” and then Kate “says” what I typed.

Kate’s English is pretty good, but she does have problems with some words, such as proper names and words that might have multiple pronunciations, like “read.” So, occasionally, after Kate attempts to pronounce what I’ve typed, I have to retype using phonetic spellings to get the words spoken correctly.

The program allows me to adjust Kate’s speed (so I can make her sound like a native New Yorker if I want to), her pitch, and her volume. And if I want to save something I typed so I can have Kate speak it again later, there’s a library where I can save files, with names I choose so I can find the files again later.

How Kate and I Behave in Company

In two-way conversations, using Kate to communicate slows things down a bit, since it always takes longer to type than to speak. It means there are longer pauses than there would be if two humans were talking to each other directly (without text-to-voice assistance). But it also means, at least so far in my experience, that people pay close attention to what Kate is saying for me, and it makes me listen more carefully to what’s being said to me.

In conversations involving more than two people, Kate and I have a tougher time. You may have noticed that conversations often go off on tangents, rather than following a straight line. You may also have noticed that sometimes people talk over each other — one person starts to say something before someone else finishes. When you add Kate to this mix, her part of the conversation can become quite disjointed. By the time I’ve finished typing a response to something someone said, the conversation may well have taken 3 other turns. When Kate says what I’ve typed, people have to stop to remember what the topic was that prompted the comment, and get drawn back to a part of the conversation they thought was finished.

The delay has real impact on conversations. In a way, there is more continuity, in a disjointed way, than non-technologically driven chats. Makes me think about those old ads from the brokerage firm EF Hutton: When Kate, talk, people listen.

Can We Banter with Technology?

The m.o. for much conversation in my circles is banter: a statement is made, someone responds with a quip, and someone else answers the quip with another quip or statement or story. I love to banter, but my speaking ability won’t let me do that anymore, and Kate’s ability is limited by the time it takes for me to tell her what to say.

A friend of mine has suggested that we could even the conversational playing field by requiring everyone in the conversation to use Kate to communicate. That might be a little

Imagine dualing iPads

extreme, but we might all listen to each other better if we did something like this. On the other hand, we might all get so involved in typing our own stuff that we won’t listen to other peoples’.

Given how ALS progresses, at some point (hopefully in the far distant future), it will become harder for me type fast, or at all. Then, assuming (as I do) that I will continue to want to communicate, I will use technology that allows me to type by moving my eyes over characters on the computer screen. This process will inevitably be slower than the NeoKate method. The concept of “super slo-mo” will take on a whole new dimension. And the ability of other people to listen in this mode might be sorely tested.

So, how I communicate in conversation with others – both how we talk and how well we listen – will be a growing issue for me. If it’s an issue for me, it’s an issue for everyone with whom I come in contact, and everyone else who is in the place of losing their speaking voices.

You may have noticed that this blog post is less about health policy – my usual topic — and more about social behavior. How we talk to each other affects how we hear each other, no matter what our limitations are or may become.

Think about it.

Posted in ALS Treatment, Illness | Tagged , , , , | 18 Comments

Understanding Health Numbers: Not Easy, but Important

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The 21st Century seems to be, among other things, the Age of Health. Everybody’s concerned about health, everyone’s talking about health, and every cultural medium is flooded with ads about how to improve your health. The idea seems to be that, if you’re smart enough and take enough of the right drugs, you’ll live forever.

Whether you believe that myth or not, the ability to read and understand numbers in medical studies is becoming increasingly important. I’ve been talking about this for years, starting with the study of tamoxifen (a breast cancer treatment drug) for use in healthy women to reduce their risk of developing (not to be confused with “preventing”) breast cancer.

The “Tamoxifen for Prevention” Story

In 1998, when the study results were announced to great fanfare,the scientific journalsand press reports breathlessly reported that women taking tamoxifen reduced their chances of getting breast cancer by a stunning 50%. Reading this information, womennaturally concluded that, if they took tamoxifen, they could reduce their individual risk of developing breast cancer by almost 50%. From the hoopla that characterized and surrounded this news, you’d think we had finally cured cancer. Not really.

The 50% number led to the wrong conclusion. It turned out that, for individual women, the amount they would reduce their risk by taking tamoxifen was actually 2%. What’s the difference? The difference is between “relative” and “absolute” risk reduction.

A Brief Digression: Risk Reduction is Not Prevention


Before I get into the numbers and unravel the difference between relative and absolute risks or benefits, a few words about words. The tamoxifen study — like many subsequent studies of other drugs like raloxifene (Evista) and exemestane (Aromasin) — was described as a breast cancer prevention study. Its official name was BCPT-1: Breast Cancer Prevention Trial 1. And the results were described in terms of how much breast cancer was prevented. But some people in the study who took tamoxifen got breast cancer, just not as many as people who didn’t take the drug. So, for any individual woman, tamoxifen and other drugs used for the same purpose reduce the risk of getting breast cancer. They do not prevent the disease.The general understanding of the word “prevention” is that if you do step A, you will not get disease B. When scientists and health policy people use the word “prevention” to mean anything else, they mislead and confuse people. That shouldn’t be the goal, should it?

It’s Absolutely About You


The difference between “relative” and “absolute” benefit or risk is important to understand. I know that from my work as a breast cancer activist. I also know it because the New York Times, in an article published in the Science Section on May 30, 2011 reported that “Translation Matters in Choices On Data.” The article describes the different ways that the same medical data can be presented, and talks about how important it is to clearly present data so people can understand it. Since the New York Times reported it, this information must matter, right?

There are basically 3 different ways to convey information about a study of a drug to reduce the risk of a disease: relative risk reduction, absolute risk reduction, and number needed to treat.

In the simplest possible terms, here’s the difference among these 3 ways of describing the numbers, using a hypothetical example.

When someone says that taking a drug reduces your risk of disease by half, that’s a relative risk reduction number.

Another way to convey exactly the same information is to say that the risk of the disease is 2% for people who don’t take the drug, but your risk if you take the drug is reduced to 1%. Your risk has been reduced by half, but in absolute terms, that’s a reduction of only 1%. In other words, in this hypothetical, 98% of people won’t get cancer if they don’t take the drug; but if everyone takes the drug, that number changes to 99%.

A third way to convey exactly the same information is to say that 100 people would have to be treated with the drug for 1 person to get the benefit of the risk reduction from it. This number matters a lot if you’re concerned (or should be) about the other effects the drug might have, which are referred to medically as “side” effects.

For a real life example, we can look at these kinds of numbers from the tamoxifen prevention trial. In that study, as mentioned above, the relative risk reduction was 49%. The absolute risk reduction was 2.1%. The number needed to treat to prevent one case of breast cancer was 48.

So, when a medical professional recommends you start a drug, you should start by asking what your risk is if you don’t take the drug, and what your risk will become if you take the treatment. And what are the potential side effects?

“Other Effects”: The Devil’s in the Details


All drugs have side effects. Any drug powerful enough to prevent a serious disease like cancer is going to have other effects on your health besides potentially reducing your risk of getting cancer. With tamoxifen, the most serious risk is endometrial cancer. The drug also increases the risk of stroke, deep vein thrombosis (blood clots), and cataracts. Many women also experience hot flashes and vaginal discharge with tamoxifen.

The risks of the other effects, and their seriousness, will depend a lot on the individual to whom the drug is offered and that person’s current medical condition. But, in almost every case where we’re giving strong drugs to people to reduce their risk of getting sick, the “other effects” can loom very large, indeed.

Pay Attention to How Numbers are Reported


The take-home message in the New York Times article on how reporting data matters, is this: “Journalists have to be careful about press releases with ‘new’ or ‘groundbreaking’ studies presented with relative risk reductions.” I would add that scientists should be required by the journals that publish their studies to report the absolute risk reduction numbers, as well as the number needed to treat.

Tamoxifen Redux: Aromatase Inhibitors for Breast Cancer “Prevention”


In the early 2000’s, I was attending a San Antonio Breast Cancer Symposium where the first data on an aromatase inhibitor (AI) for treating breast cancer were presented. There was a great deal of excitement about the data. It was the kind of excitement that meant that medical practice was about to change, and did it ever. Almost overnight, oncologists began prescribing an AI called Arimidex (anastrozole) for post-menopausal women with hormone receptor positive breast cancer.

Up to this point, the standard treatment in this setting had been tamoxifen. But the news of the AI study was so striking that doctors came up to me at the San Antonio meeting to assure me that tamoxifen was dead.

Tamoxifen’s obituary hadn’t really been written at the time, and still hasn’t. But the other thing that I heard at that San Antonio was from advocates and activists who were concerned that this new class of drugs would be tested in healthy women for breast cancer risk reduction, just as tamoxifen had been.

Those advocates were right. At a huge cancer meeting recently in Chicago, the results of the first study of an AI in women who did not have breast cancer were released. While sources like Medscape and the National Institutes of Health heralded the news about exemestane (Aromasin) as breast cancer “prevention,” the June 4, 2011 New York Times was more cautious, with a headline that read “Drug Can Reduce Breast Cancer Risk, Study Says.”

And how were the results presented in the study? As relative risk reduction numbers, of course. All the press stories led with the news that women taking the drug in the trial reduced their risk of breast cancer by 65%.

The New York Times followed the 65% relative risk reduction numbers with the absolute risk reduction number, which is far different: about 0.9%. Imagine what the response to the story would have been different if it had led with this number instead?

According to the study, 94 women would need to be treated for 3 years with exemestane to prevent one case of breast cancer. That means that 93 women would be exposed to other effects that include bone pain, joint pain, and — noticeably missing from the list in the New York Times — osteoporosis. Most women on AI’s for breast cancer develop osteoporosis, which means they get to take another drug to reduce the risk caused by the AI.

Know Your Numbers

In the Age of Health, we need to understand health numbers and their significance. Only with this information can we make intelligent decisions about treatment options and their risks. A great deal depends on understanding health numbers– maybe even your life.

© Barbara A. Brenner 2011

Posted in Breast Cancer, Medical Science | Tagged , , , , , , , , , , , , , , , , , , , , , , , , , , , , | 21 Comments

People’s Lives as the Endpoints of Medical Research – Now There’s An Nifty Idea

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A little history, from a breast cancer perspective

During my time at Breast Cancer Action, I became something of an expert on reading clinical trial data. I learned that the success of clinical trials is based on what the scientists call “the primary endpoint.” That’s the effect of the drug under study on what the scientists are trying to study.

And, during that time, the primary endpoint of many studies shifted from “overall survival” (OS) – did the people in the study live longer?—to “progression free survival” (PFS) – did it take longer for the cancer to grow in people in the study receiving the study drug, as compared to the control group?

Why did this shift take place?

It seems logical that if it takes longer for cancer to grow, the people with the cancer will live longer. And both people with cancer and drug companies are impatient for results, though for different reasons. People with cancer want drugs today that don’t have so many side effects and that help them live longer. Drug companies want to get their drugs approved quickly so they can capture a share of the big markets, and cancer is a very big market.

With most types of cancer, you have study a lot of people for a long time to figure out if the treatment you’re giving helps them live longer. The thinking behind the shift in primary endpoints of studies, motivated by impatience, was this: We can determine whether a drug affects PFS more quickly than whether it extends OS.

And, if PFS indicates that a drug will work to extend the lives of cancer patients, then we can get to the market faster. Viewed this way, PFS is a “surrogate” – a stand in – for OS, and studying it is just as good as studying OS.

The Rub

Unfortunately, it turns out that delaying progression of cancer doesn’t predict very well whether a person with the cancer will survive longer.

In the case of Avastin, a drug made by Genentech and approved for several cancers, the attempt to keep approval for its use in breast cancer has, at least so far, been foiled by the fact that in no study has Avastin been shown to improve overall survival of breast cancer patients, though it does delay progression. (The history of this drug in breast cancer can be found at Just put “Avastin” into the search engine on the site.)

The FDA is still considering whether to withdraw Avastin from the breast cancer market. The stakes are very high for Genentech, but they are higher for people like you and me.

The Lesson

The reason the stakes of the Avastin issue are high for folks like us is that we need drugs that actually help us when we’re sick, not ones that may control some biological element related to our disease but not really make us better. And we sure don’t need any more drugs that make us feel awful (that is, degrade our quality of life) while not helping us at all. We are the ones who take these drugs, and need to them to work in a way that actually helps us. The use of surrogate endpoints puts too much emphasis on the “surrogate” and not enough on the people – us – the drugs are supposed to be helping.

Surrogate Endpoints: They’re Not Just for Cancer

There was a story you might have missed in the news in the last week – what with all the items about tornadoes and debt limits and other scary things — about using drugs to raise “good cholesterol” in the hopes that, like lowering bad cholesterol, doing so would extend the lives of people with heart disease.

In this case, the surrogate endpoint was a measurable increase in “good cholesterol,” on the theory that if that goes up, your heart is healthier.

The drug used to raise good cholesterol is niacin. It’s apparently pretty hard to tolerate – patients report flushing and headaches. And the drug did indeed raise good cholesterol, but it didn’t do a thing to improve the heart health of the people taking it. The surrogate endpoint was a failure.

When it comes to ALS, the disease with which I’m now dealing, the causes and biological drivers are not understood so there are, as yet, no real surrogates to try to control with drugs. ALS drugs that get tested will have to improve peoples’ symptoms, actually delay their decline in function (this is meaningful delayed progression, which improves quality of life), or help them live longer. I think that’s a good thing.

Can We Focus More on People?

Maybe it’s time to take a step back from the rush to approve drugs as fast as possible, and make sure they work for people who are suffering, no matter what the condition being addressed. After all, we’re not surrogate endpoints; we’re human beings.

© Barbara A. Brenner 2011

Posted in Medical Science | Tagged , , , , , , , , , , , , , , | 6 Comments

If It’s Bad for Us . . . – When Will We Learn the DDT Lesson?

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If you’ve been reading this blog for a bit, you know I read the New York Times. I do that because I live in a major city (San Francisco) that has one of the poorest excuses for a major newspaper — The San Francisco Chronicle — you can imagine. (When we used read it, we called it the SF Comical.)

So, I was reading along a week or so ago, and I find an article entitled “As an Insecticide Makes a Comeback, Uganda Must Weight Its Costs.” I had to read 5 paragraphs into the story to learn that the insecticide referred to in the headline was DDT. I was appalled, for many reasons.

The chemical structure of DDT

DDT: A Long, Bad History

One reason for my strong reaction is that I have a long memory. I remember Rachel Carson’s 1962 book “Silent Spring,” which warned so compellingly of the dangers of DDT for all living things. That book lead to banning of the use of the insecticide in the U.S. 10 years later.

Another reason is that DDT has been linked to breast cancer. First, by women with breast cancer who remember the times in summer they spent running after the trucks spreading the cool mist of DDT as it was being sprayed to kill mosquitoes when they were children. And later by the important work of Barbara Cohn, an epidemiologist whose work established the risk of early exposure to DDT for later the development of breast cancer.

One more reason – as if I need one – is that DDT has been associated with neurological disorders in those exposed to it. I now have a major neurological disorder after having had breast cancer in my early ΄40’s, so I’m sensitive to the consequences of the things to which we’re exposed that may increase the risk of all sorts of awful diseases.

The Re-emergence of DDT

It’s not unusual that when something we’re doing in the U.S. proves not to be so good for us, someone figures out how to send to some unsuspecting (or relatively powerless) country overseas so their people can have the consequences. This happened with our old, high-radiation-producing mammogram machines, and it’s happening now with rBGH, the hormone given to cows to make them produce more milk. So, we shouldn’t be surprised that it’s happened with DDT, too.

The ostensible reason for the re-introduction of DDT, mostly in Africa, is to control malaria, a disease that kills more than one million people, including, including 20% of African children under 5 years of age. It’s an awful disease, and it’s spread by mosquitoes. DDT is used to kill mosquitoes.

There are Other Options Besides DDT

There is no dispute that there is a need to control malaria, and to do so by controlling the mosquitoes that spread them. But that doesn’t mean that insecticides like DDT are the answer. Over many years, many other approaches have been tried, and all have had some success. They include: draining wetlands, improving sanitation, indoor residual spraying (with things other than DDT), and mosquito nets (impregnated with insecticide or not).

So why do we resort to a toxic like DDT? For one thing, the World Health Organization began supporting it use against malaria in 2006. After all, DDT was effective for a time in killing mosquitoes. But it also has the additional consequence of making people sick, sometimes in the short term, and sometimes in the longer run.

As is always the case with insects exposed to insecticides, mosquitoes have now become resistant to DDT. In the long run, the insects get stronger, and pouring more poisons on them won’t help.

Impact of DDT on Organic Farming

The May 23 story in the New York Times that captured my interest wasn’t about the health effects of DDT. It was about how the spraying of the insecticide had wiped out the growing organic farming movement in Uganda.

On the same day, the business section of the New York Times, ran an article about how strong sales of organic foods were attracting investors. So, as the market for organic food grows, its farming is being wiped out in Uganda.

Organic farming had been an effective economic development strategy for Uganda, encouraged and supported by the US. But the US also supported spraying DDT, which made the produce from the affected farms no longer organic.

What’s Good for the Goose . . .

In the United States, we know the dangers of DDT. That’s why we ban the stuff. But we don’t seem to mind if other places use it – we even encourage them to do so. And Uganda isn’t the only country where DDT is being used. As of 2008, there were a dozen countries – including India and countries in Southern Africa – using DDT, and the number has almost certainly risen with the support of the U.S. and the World Health Organization.

US policy is at cross-purposes, and certainly not for the first time. But if we don’t want DDT sprayed on us, why do we allow it to be sprayed on people in Africa?

Inquiring minds want to know.

© Barbara A. Brenner 2011

Posted in Breast Cancer, Environmental Health | Tagged , , , , , , , , , , , , | 7 Comments

That’s why they call them “trials”

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Given the times we seem to be in, maybe you’re thinking you’re about to read a blog about the trials and tribulations of Donald Trump, who can’t seem to tear himself away from the big bucks of an NBC contract to run for President, or the upcoming trial of Dominique Strauss-Kahn, managing director of the International Monetary Fund, on rape charges, or

He was as bad a governor as he was a husband

the struggles of Maria Shriver, who turns out to have been married to another male politician who can’t seem to keep his pants zipped.

While those topics are undoubtedly more fun to explore, they are not my subject today. I want to address the serious topic of drug clinical trials, a topic that most people who aren’t doctors – and, tragically, some who are – don’t understand.

What is a drug clinical trial?

Clinical trials are used to advance scientific research into the treatment of illnesses.

A clinical trial is a medical research process used to determine if a drug is (1) safe for humans to take and (2) effective to treat the medical condition that it is intended to address. The drug under investigation – called the treatment — is compared to what is called a “control,” which is either a placebo (a pill or infusion that looks like the drug under investigation, but that has no biological properties) or an existing treatment for the condition, so that researchers can determine whether the drug under investigation is more effective that the alternative to which it’s being compared. The treatment group of patients and the control group of patients have to be balanced in number so that the results of the trial are meaningful.

Drug trials are necessary because, without them, there is no way of knowing whether the treatment drug that is the subject of the trial will work for the patients in the trial.

There are a couple of other features of well-designed trials that are important to try to insure that the outcomes of the trial reflect how the drug being tested works, rather than any sort of bias on the part of those administering the trial. These features are randomization and blindness.

Randomization is the process by which patients in the trial are assigned to receive either the drug under investigation or the control. By assigning to patients at random, researchers avoid any bias that might creep into trial results by choosing, for example, the apparently healthier patients to receive the drug, or the less-healthy patients to receive the control.

Blindness refers to who knows what about which patients are in which group – the treatment group or the control group. Ideally, drug trials are “double blind,” meaning that neither the researchers nor the patients know which group the patient is in. Double-blind trials keep researchers from making judgments about how patients are doing based on what they are known to be taking. They may also keep patients from deciding to drop out of trials because they didn’t get into the treatment group. (Open-label trials – where both the patients and the researchers know what drug is—have become much more common in breast cancer than double blind trials.)

A drug trial is considered a success if the patients getting the treatment drug do better than patients in the control group by a statistically significant percentage. A successful trial tells nothing about whether the treatment drug actually worked in an individual patient. After all, it’s possible that the patient would have improved without the drug in question. Miracles do sometimes happen in medicine, and not necessarily because doctors make them happen.

Clinical Trials in the Abstract

I know a lot about clinical trials from my work as a breast cancer activist. From that work, I have come to believe that trials should demonstrate that the drug being tested can do at least one of three things before it is marketed to the public:

–       Improve survival

–       Improve quality of life

–       Cost less than existing, equally effective treatments


These ideas about the goals and structures of clinical trials are fine in the abstract. It’s harder when they have very personal implications, either for you or for someone you love. While no promises are ever made to patients entering clinical trials, it’s hard for the patients or the people who love them to not believe at some level that the drug under investigation will improve their lives. People often enter trials believing this, no matter what they are told about the purpose of the trial.

The personal side

That my friends share this belief was evident when I told them that I was being screened to see if I’m eligible to be in a clinical trial. Many have hoped for me that, if I was eligible for the trial, I would get the drug being investigated, not the control, which in this case is a placebo. That hope seems to convey the belief that the drug will work. Whether it will or not is, in fact, what the trial is intended to test.

I know that participating in a clinical trial means taking a chance that I won’t get the drug under investigation, as well as the chance that that drug won’t work anyway. I know that it’s impossible to know from a clinical trial whether the drug under investigation will help me, even if it shows benefit for a significant percentage of people in the trial.

At the same time, I know there is only one approved treatment for ALS, the disease I have. At best, that treatment delays progression. Better treatments are needed: ones that will extend patients lives or improve the quality of the lives they live with this devastating illness. I know that only through clinical trials can better drugs be found, and I hope that this trial – and other trials –will advance the knowledge of what does and doesn’t work to treat ALS.

And I’ll also keep in mind, as I enter the trial that placebos also work sometimes.

© Barbara A. Brenner 2011

Posted in Medical Science | Tagged , , , , , , , | 17 Comments

Mammograms — They call this a new problem???!!!

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I was going to write this post about clinical trials – since I’m trying to get into one for ALS. But breast cancer activism is in my blood and a story that I saw in the New York Times this week just screamed at me for a comment. So stay tuned for the blog post on clinical trials, while I rant briefly about yet one more mammogram study.

The headline of the story in the Times on May 10 was “Screening: New Threat Rises Between Mammograms.” The report is of a study of what are called “interval” breast cancers – the ones that show up between regularly scheduled mammograms.

Women do research. Let's be sure it matters.

This was a study of “screening” mammograms – which are done when a woman has no symptoms. It’s not a study about diagnostic mammograms, which are done when a woman has a pain or a breast lump or thickening that needs to be examined.

In Canada, where the study was done, the normal “interval” between screening mammograms for women over 50 is two years.

A brief aside in this brief post: The “every 2 years” thing is interesting. You might want to know that Canada and most European countries follow this pattern, and have outcomes in terms of breast cancer mortality that are no different from the U.S., where we usually screen women over 50 every year..

So the study in question was looking at breast cancers found in women some time between one regularly scheduled mammogram and the next one two years later. It distinguishes “true” interval cancers from those that were actually evident on the first mammogram, but not seen by the people reading it.

As they say on the NPR radio program I sometimes hear, let’s look at the numbers. This study found the following.

Total women screened 431,480
Breast cancers found on screening 450 (0.10% of women screened)
Interval breast cancers found 288 (0.07% of women screened)
Interval breast cancers missed 87 (0.02% of women screened)

From these numbers, it’s clear that the “problem” of “interval cancers” identified by the researchers and the news headline is not the real one. The real problem is that over 99% of the women screened every two years didn’t have cancer, which means a hug cost to society and a lot of radiation exposure for women could have been avoided. And – shockingly to those who have not followed the real mammogram story – of the cancers founds in this group of screened women, mammograms missed a third of them.

So we have one more study that tells us that mammograms don’t always work. It also confirms the huge cost – to society and individuals – of screening programs. How much research money is going to be spent proving what we already know, instead of looking for better ways to detect breast cancer? Or maybe doing studies of the 1/3 of breast cancers found by women themselves, despite all the mammograms they have.

The person who did this study, Anna M. Chiarelli, did have some good advice: “Better screening technology is needed. Until it arrives, women should seek immediate care for cancer symptoms even if they recently had a negative mammogram.”

Ms. Chiarelli  is absolutely right that women should seek immediate help if they have symptoms that might indicate breast cancer, no matter what their most recent mammogram says.

Aim this at a woman's breast? I hope not!

But the need for better screening technology is simply old news. We’ve been promised it for years. The National Cancer Institute had a program for a while called “Missiles to Mammograms” that promised to bring the benefits of military technology to the breast cancer detection field. We’re still waiting.

Mammograms are a limited technology. While having a mammogram every day would eliminate “interval cancers, we still wouldn’t find all the breast cancer.

So let’s advance the field. The public has been oversold on mammograms. It’s time to face reality, and push for better screening methods – methods that are more accurate, can be targeted to those a greatest risk of breast cancer, and that aren’t based on radiation – which, after all, causes cancer.

Can we finally move post the mammogram discussion. I hope so, but history tells me the answer is probably no.

© Barbara A. Brenner 2011

Posted in Breast Cancer | Tagged , , , , , , | 9 Comments

The Obligation of Privilege

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I am a person of privilege. I am well-educated, I know how to get the things I need, and I have the resources at my disposal to get them, usually. Privilege means having access and knowing you have it.

Being a person of privilege doesn’t keep people from getting sick – at least, not always – but it can sure help deal with the consequences of being ill.

For me, the obligation of privilege is to pay it forward: to do all I can to make sure that the benefits that I get are available to others in need, and to articulate my advantages in ways that make it clear that they reflect injustices that we as a society must address.

My topic this week is about privilege in health care. But I think you can see from the analysis below that privilege is a reality in all aspects of our lives, and needs to be addressed in all of them.

Privilege in the Politics of Health Care

Many Republicans are privileged. In a recent New York Times survey, people were asked whether it’s the government’s job to provide health care for the poor.  Seventy-one percent of the Republicans surveyed said no. But asked whether the government is responsible for provided health care for the elderly, 55% of Republicans said yes. Seems that Republicans can see themselves getting old – and entitled to government sponsored health care if they do. They just can’t see themselves as poor. 

I think most Republicans are, like me, people of privilege, On big difference between me and them is that they seem mostly — at least as far as this survey reveals – to think that their privilege doesn’t carry with it any obligations.

Stories of Privilege in Cancer

My story: When I was diagnosed with breast cancer, the word spread pretty fast among my community of friends. My friend Carol called to suggest I see a certain surgeon. I had already called that surgeon’s office, but he was booked for many weeks into the future. So, imagine my surprise when I got a call from my partner Susie saying that I had an appointment with that surgeon for six o’clock that very evening.

When I inquired later about how that appointment had miraculously appeared, I learned that Carol had a friend – Muffie — who was one of our city’s great movers and shakers. (Muffie tragically died of brain cancer last year at the age of 59). Muffie called the surgeon’s academic boss at the University of California San Francisco. She told UCSF emphatically that I needed to see the surgeon, and that they had better pay attention because I was the lawyer for the Speaker of the California Assembly, which had a lot to say about funding for the university.

I was, of course, deeply grateful for the effort that my friends had made on my behalf, at that same time that I was intensely aware that this is not the way the world should work. People who need to see doctors should be able to see them without the intervention of powerful friends.

I never forgot the kind of care and support I got when I had breast cancer, and used every opportunity given to me as I led Breast Cancer Action to articulate the need for everyone to have that kind of care.

Lance Armstrong’s Story: Everyone knows this story, I think. Lance Armstrong was diagnosed with late-stage testicular cancer. Through the miracle of modern medicine and the strength of his incredibly athletic body, he recovered from cancer, and went on to win the Tour de France.

But have you ever heard Lance say one word about all the access he had to the best care, thanks in no small part to who he is and the resources he had? I have always wondered why Armstrong has never used his considerable influence to advance the needs of all cancer patients to get the kind of care he got. Though I have seen lots of ads of Armstrong promoting drugs made by Bristol-Myers-Squibb, the company that made his very expensive cancer drugs.

Jerri Nielsen FitzGerald’s Story: Jerri Nielsen wasn’t as famous as Lance Armstrong, but she had her moment in the sun. She’s the doctor who, in 1999, stuck on the South Pole where she was working, did a biopsy on herself, and then had chemotherapy drugs airlifted to the South Pole. Later, she was airlifted out of the South Pole. Both the drug drop and the airlift out of the South Pole were enormously expensive. Dr. Nielsen was very grateful. She wrote a book about her experience, called “Ice Bound: A Doctor’s Incredible Battle for Survival at the South Pole.” (Later turned into a movie starring Susan Sarandon.) And, until her death from breast cancer at the early age of 57, she traveled the world as a motivational speaker.

But she never talk about the resources used to help her, or how we might allocate resources to make sure everyone has the care they needed.

A Story of Privilege in ALS

As readers of this blog know, I have ALS, an insidious, pernicious and unrelenting disease that is already making it hard for me to walk, and will one day put me in a wheelchair. In order to stay in our 3-story home of 36 years once I am unable to walk, we will have to install an elevator. One aspect of privilege is that we have the financial resources to cover the cost of this change. Another is more subtle, and that has to do with getting permission from the city planning authorities to make this addition.

Putting in an elevator means changes to the footprint of our house to accommodate the machine plus the room we will need for a caretaker. Changing the footprint of the house means we need permission to do something the zoning code says we can’t do. This is called a variance. In San Francisco, you have to apply to the city for a variance, and there is a somewhat involved process for getting your application heard and approved.

We were told by many people that this process could take months, and we don’t have months, given the progressive nature of my illness. But, as privileged people do, we have friends.  Some of our friends are people who understand the approval process and how to move it forward. So, thanks to these friends and the responsiveness of city employees to our situation, our application for a variance moved forward with what we hear is record speed.

We are, of course, deeply grateful for the help we are getting from all quarters as we work to stay in our home, but we are intensely aware that there must be others similarly situated who do not have the access we do to get what they need. We know we are no more deserving than these people, and that the system needs to pay attention to their needs when they arise.

So, once our construction is well underway, we will work with San Francisco city officials to make sure that the process for applying for a variance when disability is the cause is clear and understandable to everyone who needs it. That’s our obligation as people of privilege.

© Barbara A. Brenner 2011

Posted in ALS Treatment, Illness | Tagged , , , , , , , , , , | 14 Comments

There’s that person with . . .

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I’m “meeting” some wonderful people as I deal with ALS, including folks who have other conditions that impair their ability to function in some way. Most of these meetings are by email, but they are delightful nonetheless.

I was listening recently on my local PBS station – KQED — to a radio perspective recorded by Patty, who has Parkinson’s Disease. Fortunately, medication for now controls for Patty some of the movement challenges that that disease presents. In that commentary, she talked, among other things, about being concerned that by going public with her disease, she would become “That Person With Parkinson’s.”

We All Have Something

Most of us have – or will have at some point – some condition that will make us “that person with . . .” When I was Executive Director of Breast Cancer Action, I was concerned that people would see me and say to themselves “here comes that breast cancer person again.”

Of course, breast cancer people can identify each other by those damn pink ribbons or pink wrist bands, or the chemotherapy-induced baldness or head turbans, or the more direct “Cancer Sucks” buttons that tell the real story of a breast cancer diagnosis. (Available from Breast Cancer Action – email

Other conditions are not so easily identified as you walk down the street or sit in a coffee shop. When I see people who have trouble walking or hear people having trouble speaking, I can’t tell what the underlying problem is, but – because I now share these characteristics — I’m far more sympathetic than I used to be.

None of us wants to be identified as the illness we have. We are all human beings, with thoughts, and feelings, and emotions, things we want to do and are doing, and things to contribute to the world. Patty, for instance is dancing!

Technology: Part of the Answer

I’m being public by blogging and tweeting, but that has a limited audience. Pretty soon (no telling when), I won’t be reminding people about ALS by the way I walk or talk, because I won’t be doing either, and certainly not doing them in public.

Technology is making many things possible for people like me. I have a program called “Speak It” on my iPad that translates the words I type into audible voice. There’s another program, called NeoKate, that supposedly works the same way, but I haven’t figured out how to use it yet. And there’s a somewhat expensive program called JayBee that has prepared phrases that make it easy to make audible what you want to say, even if you can’t talk. That program doesn’t run on the iPad.

These are just a few examples. There are many more programs available for people, some for folks who can no longer type because they have lost control of the muscles in their hands.

What We Can’t See Is Still a Problem

I’m left with this question:  how important is it to be public about what we have, so that the communities in which we live will know that there is something going on that is causing their neighbors to suffer in some way? Or so that people will think about whether there are things they can do that might help others who are struggling?

ALS, unlike breast cancer, is not a public disease, because the people who have it almost inevitably end up confined to their homes or nursing homes. They don’t go out, either because they can’t physically manage to, or they are too self-conscious to be seen in such a compromised situation.

But we need to pay attention to what we can’t see, as well as to what we can.

So if you have friends with some illness or condition that makes it hard for them to be in the public eye, think about what it means to them, and to us as a society. Maybe we should find ways to help make those people visible and able to continue to be their full human selves, and maybe be less self-conscious than they otherwise would be.

© Barbara A. Brenner 2011


Posted in ALS Treatment, Breast Cancer, Illness | Tagged , , , , , , , , , | 12 Comments

Medicare Efficiency? – Not Really

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Anyone who has ever confronted a serious health issue knows that going on line for information can be a daunting process. How do you figure out what’s true and what isn’t, or even begin to sort through all the data that comes your way? And when it’s help you’re seeking, how do you get it in the easiest way possible?

I know from many years of “talking” – by phone, in person, and by email – to thousands of woman recently diagnosed with breast cancer or with a recurrence of the disease that it’s very easy to be misled into information that is not helpful.  And I know from that experience that some government websites are either not very helpful — like that of the National Cancer Institute — or downright confusing and very hard to navigate, like that of the Food and Drug Administration. 

So maybe I should not have been surprised and appalled to find that the website set up to guide people in making choices related to Medicare was worse than unhelpful. It’s pretty hostile to people trying to get information.

I’m only 59 years old, but I’m eligible for Medicare because I have ALS. ALS is one of those conditions that qualifies for almost automatic Social Security Disability coverage, and that coverage includes Medicare eligibility.

When I learned that I could get Medicare, I quickly turned to my older friends who are already taking advantage of the program, and asked them for guidance. Turns out there are lots of places that claim to be helpful. I consulted the folks who had helped me navigate the Social Security Disability application process and they quickly pointed me to

That seemed promising. A central place to get information, learn about health care plans, and sign up for the best care available, given the resources I have.

The inviting and apparently friendly Medicare website

If it sounds too good to be true, it is.

The first thing that happens when you go that website is that you have sign into the site. If you haven’t done that before, you have to register. This is to be expected, of course. So I signed up, and got myself a unique identifier and password, which would (should?) allow me to come back to the site anytime and get what I needed. I poked around on the site, did some searches, and then took a break.

Keep in mind that this is 2011. I don’t think it’s unreasonable to expect, in the 21st century, that a website that provides you with a unique identifier and password keeps track of information that you enter so you won’t have to enter again. But the government has not figured out how to do that with the Medicare site. So every time I visited the site to try to get information, I had to re-enter my date of birth and the start date of my Medicare coverage. Those are two bits of information that the government knows. Why do I have to re-enter them every time?

To make matters worse, searching the website for the plans available for someone in my situation – under 65, in the San Francisco Bay Area seem to be the relevant factors – turns up far less than the full range of options open to me. This from the go-to site for Medicare plan options.

I know that the site was showing me less than the full set of  my true options only because the person helping me with this process is experienced with Medicare and knows the plans available in the area. The government’s Medicare site said there was only one plan available to me, from a company of which I had never heard. Fortunately, the person helping me knew better.

There is a lot of talk at the federal level of making Medicare more efficient. Maybe the efficiencies that need to take precedence are the ones that will help people who need Medicare to navigate the system. Especially people who don’t have help or the resources to find the help they need to deal with this unnecessarily complicated system.

© Barbara A. Brenner 2011




Posted in Health Policy, Illness | Tagged , , , , | 15 Comments