Health

The billion-dollar battle over premenstrual disorder

Long-suffering women and big pharma make uneasy allies as the American Psychiatric Association nears a call on PMDD

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The billion-dollar battle over premenstrual disorder (Credit: Afrociaal via Shutterstock)

For about five to seven days of every month, a woman may as feel as though she were a different person. A person she doesn’t like. Things come out of her mouth that she normally wouldn’t say, cruel things, directed at the people she loves. A soundtrack of self-loathing thoughts loop in her head. Any rejection during this period has the ability to wreak fearsome terror on her psyche. She may have sudden outbursts of sobbing, overwhelming sadness or an oceanic feeling of anxiety. One woman described the several-day sensation as though she were “being forcibly held underwater” — and every time she came up for air, a “boot was pushing” her back down. Then, suddenly, the melancholic fog lifts, the fatigue evaporates and she is herself again. All because she got her period.

Doctors and psychiatrists at work on the newest version of the Diagnostic Manual of Mental Disorders — the American Psychiatric Association’s bible for mental-health professionals — describe this confluence of symptoms as Premenstrual Dysphoric Disorder (PMDD). The revised version of the DSM, just the fourth new edition in 52 years, will be published next year.

Since 1987, PMDD has lingered in the ghetto of the DSM: the appendix pages where proposed diagnoses are deemed in need of “further study.” But right now, it appears as though PMDD will ascend in the ranks from a hypothetical ailment to illness to become a full-blown depressive disorder; taking a place alongside Major Depression and Bi-Polar Depression. The upgrade in status — which will be determined in the next several months — has become the latest flash point in an ongoing controversy between psychiatrists, academics, activists, pharmaceutical giants and women who insist they suffer from the disease, as well as doctors and women who refute the existence of PMDD all together.

PMDD is not just PMS, says Dr. Kimberly Yonkers, a professor at the Yale School of Medicine and Psychiatry. “It’s more complicated than that,” she says. “It involves emotional symptoms … Women with PMDD have significant impairment,” she adds, that can interfere with going to work, school or being able to participate in a household.

Yonkers is a champion of PMDD research, and she also sits on the committee that will either greenlight or ax PMDD’s placement in the DSM.

It’s important because the DSM remains the medical doctrine that separates the sad from clinically depressed, the neurotics from the normals and, potentially, the bloated from those with a mood disorder. Besides practitioners and patients, another huge stakeholder in the debate is pharmaceutical companies. When a new diagnosis makes its way into the book, drug companies such as Pfizer and Eli Lilly set off to manufacture a drug to alleviate the symptoms. Or in the case of PMDD, they can just rebrand an old drug to do new tricks.

So what is PMDD? The current criteria being proposed for PMDD includes mood swings, marked irritability or anger or increased interpersonal conflicts, feelings of hopelessness, marked anxiety and decreased interest in usual activities. Also: a subjective sense of difficulty in concentration, lethargy, a marked change in appetite, insomnia, a subjective sense of being overwhelmed and other physical symptoms such as breast tenderness or swelling, joint or muscle pain, a sensation of “bloating,” weight gain.

Those physical ailments are the most controversial of the new proposed criteria. Some argue this would shove physiological or gynecological issues into the psychiatric realm, scrambling a mind and body separation that keeps mental health issues discreet  from physiological ones. If the newest proposal makes it into the DSM a woman will need to have had five of the symptoms during the past year, including the physical ones.

The debate has created unlikely allies. Pharmaceutical companies are eager to provide new drugs to treat PMDD. In 1999, the year Prozac was set to expire, Eli Lilly, the manufacturer of Prozac, went to the Food and Drug Administration to seek approval for Prozac as a treatment for PMDD.

The FDA approved the patent extension (in contrast, the European counterpart to the FDA found there was not enough research to establish PMDD as a medical diagnosis because of fuzzy criteria and shoddy self-reporting on behalf of women who had to track their daily moods for two months straight). It is the only time the FDA has approved treatment for a diagnosis that has not been recognized by the American Psychiatric Association. Eli Lilly then repackaged Prozac as pink and purple gel capsules and rechristened it Sarafem.

This matters because once a patent expires, a doctor can write a prescription for Prozac and the patient can get a cheaper generic brand. However, in the case of a patent extension to treat a new specific illness, there is no generic option. So when a woman gets a prescription for Sarafem, she can only get Sarafem.

Sarafem ran advertisements directly to consumers on TV and in women’s magazines. One ad featured an ordinary-looking woman in plain clothes angrily trying to pull a grocery cart from a row. The tag line read: “Think it’s PMS? Think again … It could be PMDD.”  In the first six months Lilly reported $19 million in Sarafem prescriptions. By 2001, it had raked in $85 million, then sold the patent to Galen pharmaceutical company for $259 million.

PMDD skeptics argue that this debate is about selling drugs, not science.

“PMDD is an invented ‘mental illness,’” argues Dr. Paula J. Caplan, a research associate at the Du Bois Institute at Harvard University, and author of “They Say You’re Crazy: How the World’s Most Powerful Psychiatrists Decide Who’s Normal.”

Caplan, who chaired a DSM work committee during its fourth revision, said she was appalled not only by the aggressive lobbying done by Eli Lilly to push PMDD through the committee, but also how much hard cash the company put into the research and trial groups. Caplan and others contend that PMDD has too much overlap with other mood disorders, such as depression. Creating a new diagnosis, they fear, would mostly benefit big pharma and not suffering women. Caplan argues that women “learn to pathologize themselves, often ignoring the real causes of their upset,” such as a failing relationship, a history of abuse or depression.

Additionally, critics of PMDD believe that the diagnosis is just another way to medicalize the female experience. PMDD, it’s argued, plays into ancient notions of women as overly emotional and unpredictable and needing to be contained by forces other than themselves. From puberty to PMS to PMDD to pregnancy to postpartum depression to menopause, opponents argue that throughout history there has been a one-sided conversation between doctors and women about the female body.

Indeed, public medical authority on women’s health does not have a sterling track record. In the 1800s, when issues surrounding the luteal phase (the week before menses begin) of a woman’s menstrual cycle began to be documented, there’s been a ridiculous parade of treatments. Dr. William DeWees of University of Pennsylvania coined the expression “melancholies of menstruation” in 1843 and promoted the idea “that the uterus exerts a power over every body system.”

Through the 1900s, psychoanalysis became the main treatment for women who felt not only emotional distress but physical symptoms, such as breast tenderness, bloating, food cravings and headaches during their luteal phase. In 1931, Dr. Robert Frank championed medicinal treatments for women who suffered from what he called premenstrual tension and for the next 50 years women who sought treatment for pain and distress during their luteal phase were given diuretics, saline cathartics, caffeine, calcium, Vitamin B, antispasmodics, laxatives, enemas, alcohol tonics, and in severe cases hysterectomies.  Now the cure being proposed is antidepressants. Other psychotropic drugs such as Zoloft and Paxil have also gained approval by the FDA to treat the symptoms of PMDD.

In a 1997 study of 200-plus women who were diagnosed with PMDD, conducted by Yonkers, 60 percent of women said their symptoms improved when they were given the antidepressant Zoloft. This raises an obvious question: What if these women were just depressed already?

Caplan argues that women who self-diagnosis themselves as having bad PMS or PMDD are suffering from depression for internal or external reasons, not because their menstrual cycle is wonky. In an article from the Journal of Women and Therapy, Caplan cited the experiences of an obstetrician who treated women who complained of severe PMS :

Ian Tummon an obstetrician-gynecologist who has suggested  (Tummon & Kramer, 1994) that even the term “PMS” no longer be used, reported that when his women patients begin an office visit by saying, “Doctor, I have terrible PMS,” they never again mention PMS during the rest of the session. Instead, he wrote, they spend the whole time talking about the way their husbands abuse them or about their 14-year-old children who won’t come home at night. To label these women mentally disordered – and send the message that their problems are individual, psychological ones – hides the real, external sources of their trouble.

Then what to do with a problem like Elise? Elise is a graduate student, petite, blond, with a Brigitte Bardot pout. She has never been abused. Has thrived in a healthy relationship with a female partner. Doesn’t have kids or a household to manage. Yet for years, she was incapacitated for at least seven days out of the month.

“Right before my period I would get incredible fatigue and cramps that would cripple me,” she says. “I guess I wasn’t myself, because ‘myself’ isn’t usually in such terrible discomfort. So yeah, of course, I’m more irritable and easily overwhelmed.”

Elise was diagnosed with a mood disorder before she sought treatment for her menstrual distress. She takes Zoloft for her moods and birth control for her periods. She skips the row of sugar pills every month on her birth control packet, meaning she doesn’t get her period at all now. “Breast cancer runs in my family, and taking the birth control I’m on ups my rate for breast cancer but it’s a risk I have to take. Otherwise I’m essentially an invalid for seven to 10 days. For Elise, all the solutions have seemed imperfect.

Those in favor of PMDD being absorbed into the mood-disorder section of the DSM argue that the mood swings and irritability and depressive symptoms amount to a separate diagnosis from regular depression because it is linked to the menstrual cycle and only appears days before the uterine lining is shed and disappears days afterward. “The timing is exquisite,” says Dr. Jean Endicott, professor of clinical psychology at Columbia University’s College of Physicians and Surgeons. Endicott also worked with Yonkers on the 1997 study.

If PMDD were to make it into the DSM, it’s possible that women could have a bona fide medical excuse for missing work or school during those days. Women need to report distress, not just discomfort, to their doctors to be diagnosed under the proposed criteria. The treatment regime as it exists now is antidepressants, not pain killers, anti-psychotics or tranquilizers.

Historically, differences in the sexes have been used as a tool of oppression, there is no doubt of that. However, what if there is a difference between men and women when it comes to the way hormones affect their moods and bodies? Even if women are the only ones who can get diagnosed with PMDD, even if people call it sexist, does that make it less real?

“One of the things I find frustrating about modern feminist critique,” Elise says, “is that I’m expected to be tough no matter what my body deals me, otherwise I’m giving in to patriarchy. What if sometimes, I’m in pain and I can’t do it on my own. What has to happen to make that acceptable?”

The scientific argument for being emotional

New research shows that our feelings are more important to our health than we ever thought. An expert explains

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The scientific argument for being emotional (Credit: Salon/DG Strong)

At the end of his second year of Harvard graduate school, neuroscientist and bestselling author Richard Davidson did something his colleagues suspected would mark the end of his academic career: He skipped town and went to India and Sri Lanka for three months to “study meditation.” In the ’70s, just as today, people tended to lump meditation into the new-age category, along with things like astrology, crystals, tantra and herbal “remedies.” But contrary to what his skeptics presumed, not only did Davidson return to resume his studies at Harvard, his trip also marked the beginning of Davidson’s most spectacular body of work: neuroscientific research indicating that meditation (and other strictly mental activity) changes the neuroplasticity of the brain.

Thirty years later, Davidson is still researching and writing about the intersection of neuroscience and emotion — he currently teaches psychology and psychiatry at the University of Wisconsin-Madison. In his new book, written with Sharon Begley, “The Emotional Life of Your Brain: How Its Unique Patterns Affect the Way You Think, Feel, and Live, and How You Can Change Them,” Davidson lays out a fascinating theory that parses out emotional style into six dimensions, giving readers a better understanding of where they stand on this emotional plane and how emotional styles affect the qualities of their everyday lives.

Last week Salon spoke over the phone with Davidson about how Botox injections disrupt our ability to emote, the connection between happiness and health, and why emotion has been unfairly and historically underappreciated.

There’s been stigma around the study of emotion in the past. Some people still frame emotion as pointless metaphysical leftovers that result from physiological processes. I think that your work has really come to show that that’s not true. In your view, what are the evolutionary and practical purposes of emotion and does it have intrinsic value?

I think that emotions are such an important part of our experience and behavior.. They came about over the course of evolution for a reason; to promote survival — to facilitate the adaptation of organisms to their environment. Emotions evolved to solve specific kinds of problems that arose over the course of our history. They wouldn’t be such a robust part of our experience if they didn’t have this deep evolutionary origin. Having said that, it’s also the case that we now live in an environment that is vastly different from our evolutionary origins. So some of the emotions that played a very important role in our past can be maladaptive when they are triggered in response to stimuli in our current environment. This is why developing strategies to better regulate our emotions may be particularly important for us now.

In the book you talk about some really fascinating research suggesting that emotional outlook, happiness or depression, can have a direct influence on our health.

There is an intuition in the popular culture that our emotions have something to do with our physical health, but we are just beginning to explore this connection. In our own research, we examined both the brain activity and peripheral biology of a group of individuals by giving them flu shots. It turns out that people who have a more resilient brain profile are the ones who actually have a bigger boost in their immune response when they get a flu vaccine. What it suggests is that more resilient individuals, when exposed to the flu virus, are conferred much greater immunity than a person with a vulnerable emotional style. It suggests that these brain circuits directly communicate with peripheral biological processes, in this case certain features of the immune system, and directly regulate them in ways that are consequential for our health.

In the beginning of the book, you talk about a discovery that set the course of your career in motion — this distinction between people with more right prefrontal cortical activity and those with more activity in their left prefrontal cortex.

We had been doing research looking at the neural correlates of particular short-lived emotions. We were specifically looking at neural changes during different fleeting facial expressions. The idea that we could actually identify brain mechanisms that underlie different emotional styles was not in the lexicon of science in the past. At that time the neuroscientific study of emotion was conducted mostly in rats and focused on subcortical brain regions, regions below the cortex.

What we noticed was that this right versus left activation patterns of the prefrontal cortex varied more across people than it did within one person during different emotions. So we did further studies to demonstrate that these individual variations were actually consistent for a person over time and directly related to important features of their mood and emotional styles. That’s what really launched us into thinking about emotional style and its brain bases.

Was it surprising that the prefrontal cortex was involved in emotion?

Well many psychologists and neuroscientists at that time regarded the prefrontal cortex as exclusively involved in higher cognitive function because the prefrontal cortex is among the most recent to develop over the course of evolution. In many ways it was regarded as the seat of the highest form of reason in humans. This assumption that the prefrontal cortex could not possibly be involved in emotion is, I think, part of a historical anachronism that regarded thought and feeling as two completely separate realms.

In the beginning of the book you lay out a theory that each of us has a certain unique Emotional Style, split up into six components. What are these six emotional dimensions?

One is Resilience, which refers to how quickly or slowly you recover from adversity. The second is Outlook; the duration that a person’s positive emotion persists. Then there is Context, and that is the extent to which we modulate our emotional responses in a context-appropriate way. So for example, when we are with our boss we know that it’s not permissible to discuss the same topics we might discuss with our spouse. That’s called context modulation. The fourth is Social Intuition, the sensitivity to social cues, the extent to which a person is sensitive to facial expressions or vocal expressions. The fifth is Self Awareness, the extent to which a person is aware of signals within their own body, which are important to emotion. Finally, Attention, how focused or scattered you are. Attention isn’t often thought of as part of emotional style, yet our work indicates that it significantly contributes to a person’s emotional makeup. Is your attention easily pulled by stimuli in the environment or are you able to more skillfully focus your attention on what it is you wish to attend to.

You did a really interesting study looking at how the genes that code for our temperament can actually be modified by life events and environment. What did you find?

We have learned over the last decade, and more specifically really the last five years, that the genome itself is not changed over the course of a life, but the extent to which genes are expressed can be influenced by our environment or the behavior in which we engage. This is referred to as epigenetics, the regulation of gene expression. We know that there are sites on genes that code the extent to which another gene is actually turned on or turned off. And it can be turned on and turned off in a graded fashion.

And the study looked at how kids reacted to a toy robot that approached them …

It was a longitudinal study that followed kids from age 3 to their early teens. It tracked their brain development in conjunction with the development of certain temperamental features, one in particular called behavioral inhibition, which refers to shyness. What we found is that kids can significantly change in their expression of this temperamental characteristic over time. What we also showed is that to the extent to which temperament changes, the brain also changes. So brain activity during these early years in life is not fixed and can be changed by environmental factors and activities. This is really just an example of what we refer to as neuroplasticity; that the brain can change in response to experience and training.

Another study that I found really interesting and amusing involved women who had recently had cosmetic Botox injections. How did the results speak to this mind-body connection?

That’s a great example. Beginning with Darwin’s book in 1892, “The Expression of Emotions in Man and Animals” we have known that facial expressions are very important for emotion, and recent theories suggest that facial expressions provide feedback to the brain and influence the emotional state of a person through that feedback. It suggests that if we eliminate feedback, as Botox does, we deprive the brain of certain signals that it uses to determine one’s own emotional state. The women in our study were getting Botox in the muscle just above the eyebrow, temporarily paralyzing it. That particular muscle is used in frowning and several different negative emotions. What we found is that Botox injections actually impaired their capacity to perceive negative emotion when they read negative sentences, and this suggests that we use our bodies to help decode the emotions of others by subtly simulating their emotions and mirroring their emotional state with mini-facial expressions of our own. If we can’t make those facial expressions because our face is paralyzed, then our ability to understand their emotional state is impaired.

Neuroscience has shown certain kinds of activities can influence changes in the brain, but one of the major points you make in the book is that purely mental exercises can too. How did meditation become part of your research?

I’ve had a longstanding interest in meditation personally, but it wasn’t until 1992 when I first met the Dalai Lama that that interest was catalyzed into a major component of my own scientific research. The Dalai Lama pointed out that if I could use the tools of modern neuroscience to investigate emotions like fear, anxiety and depression, then I should also be investigating kindness and compassion. So I made a commitment to put these positive qualities like kindness and compassion on the scientific map. Meditation practices are said to enhance and nourish these qualities, so we began to investigate the extent to which these kinds of meditation can lead to changes in the brain and can promote behavior associated with positive qualities of mind.

You give examples of exercises at the end of the book to help people take advantage of their own neuroplasticity. For example you say that by delaying gratification, which is associated with planning, you can strengthen the connection between your prefrontal cortex and a brain region called the ventral striatum, which increases one’s sense of well-being.

I think that we’ve learned a lot about what can induce these plastic changes in the brain. It’s quite similar to engaging in physical exercise or learning to play a musical instrument or chess. All of these require regular practice in order to become more fluent in them, and it’s the same for happiness. Well-being can be thought of as a skill; you learn it better when you practice it over time. Many of my suggestions in that last chapter of the book come from different strands of research, but they all point to the idea that we can take responsibility for our own brain. Often, we leave our emotional patterns to happenstance and we don’t intentionally cultivate them. But we shouldn’t think of emotional style as any different than cognitive skills, or activities with a tradition of intentional training. Eastern contemplative tradition, and particularly meditation, is exactly this technology of mental exercise. It fosters better habits of mind, and our neuroscientific research has shown this.

You are also sensitive to the fact that some people might not be able to change their emotional styles, especially if they are on an extreme. What are some coping mechanisms for those of us who might have a harder time changing our emotional styles?

We are all different, and for some people, certain styles may be easier to change than other styles. One of the things that I suggest at the end of the book is that instead of changing your style, you can alter your environment to make it more compatible with that style. If you are the kind of person who is terrible at picking up on social cues and who doesn’t really get a lot of enjoyment from social interaction, you can try to arrange your work life so that you don’t interact with a lot with other people and picking up on social cues is not something that you need to rely on for success. I think that the hope with this book is that people learn more about their own emotional style so they can figure out what makes the best sense for them.

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Santorum’s policies would have killed my daughter

Without amniocentesis, her rare disease would have gone untreated and she would have likely died at birth

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Santorum's policies would have killed my daughter (Credit: AP/Eric Gay)
This article originally appeared on Sarah Fister Gale's Open Salon blog.

Next month, my daughter Ella will turn 11. She’s a beautiful girl, with blond hair and green eyes. She’s an amazing artist, a brilliant writer, and she can do the splits without even warming up.

And if I hadn’t had an amniocentesis, she would have died the day she was born.

Just over 11 years ago, I received a call from my obstetrician’s assistant to let me know that there was an anomaly in my recent blood test. “It’s probably just a testing error,” she assured me.

But when I returned the following week to have the blood test redone, the anomaly showed up again. There was a foreign antibody in my blood stream that shouldn’t have been there. I was six months pregnant, and up to that point my pregnancy had been completely normal.

Rather than turning to my local politician for prenatal advice, I followed the guidance of my obstetrician, who sent me to a perinatologist, who recommended I have an amniocentesis. Because he had a medical degree and years of experience treating pregnant women, I followed his recommendation.

That day, he stuck an alarmingly long needle directly into my growing belly to sample the amniotic fluid around my baby. The results weren’t good. She had Rh negative disease.

Rh negative disease occurs when a mother has a negative blood type and a baby has a positive blood type. My negative blood perceived Ella’s positive blood as a foreign body that it needed to destroy. And that’s what it was doing. Every day, little by little, my body was wiping out every one of her red blood cells.

Before the 1960s, Rh negative disease was responsible for the deaths of thousands of babies whose mothers, like me, had negative blood. They usually carried their babies to term and gave birth to them, only to have them die or suffer extreme brain damage as a result of the anemia and jaundice that occurs with this illness.

In 1968, a drug called RhoGAM was approved by the FDA to prevent this disease, and it has since saved hundreds of thousands of lives. In almost every case when it is administered in time it is effective. But in my case, it wasn’t.

Amniocentesis is the recommended test to diagnose this disease, and it enables doctors to define a course of action to treat and monitor these babies for the best possible medical outcome. Had I not had that amniocentesis I likely would not have discovered that she had this illness. I would have carried her to term, given birth to her, and watched her die in my arms.

Instead, thanks to the amniocentesis, my doctor tracked her progress relentlessly. Every week after that I had another (expensive) prenatal screening test, called a serial ultrasound, through which he was able to monitor the anemia that grew steadily worse as more of her blood cells were destroyed — and track the development of her lungs so that she could be delivered at the best possible moment for her safety. The day he saw that her lungs could function on their own, he delivered her.

Ella was born four weeks premature, a tiny 5-pound bag of bones, with bright yellow hair and eerily orange skin from the jaundice. Within hours of her birth she was given a full blood transfusion – they replaced every single drop of her damaged blood with new blood that would save her life. Then she spent the next five days in the NICU with cotton blinders taped over her eyes and five bilirubin lights shining on her to reduce the jaundice, while my husband and I took turns sitting at her side round the clock, watching her struggle to survive.

For months after she came home, she had to have weekly blood tests to make sure the anemia was in control. They had to draw the blood from her heel because her fingers were too tiny to prick. Finally, at three months her own defenses kicked in and she started producing her own red blood cells.

Happily, she made a full recovery and has no lingering effects from the disease. And it’s all thanks to that one medical test.

If Rick Santorum had his way, I wouldn’t have been able to get that test, and she most likely would have died. Because according to him, tests that give parents vital information about the health of their unborn children are morally wrong. Though he has no medical training, and no business commenting on the medical decisions that women and their doctors make, he argues that such tests shouldn’t be provided, or that employers at least should be allowed to opt out of paying for them on “moral grounds.”

Eleven years ago, my husband and I had two kids and a mortgage, and like most young families we didn’t have $2,000 to pay for a test that my husband’s employer might object to on moral grounds.

So, while Mr. Santorum may think that his blowhard opinions about when and where women should be allowed to have medical tests is righteous, I say it’s ignorance.

In the Catholic church where I was raised, pride, arrogance and an overinflated sense of oneself were considered sins. But in Rick Santorum’s world they are virtues, and they make up the foundation from which he proclaims how other people should live their lives.

When I read stories in the news about countries where women are prevented access to birth control, or the freedom to work, or the right to make choices about their bodies and their lives, I wonder how a leadership with such crazy ideals could ever gain power. But as I look at what’s happening in the debates leading up to this presidential election in our own country, it has become chillingly evident.

As a nation, we are at the precipice of a slippery slope where men in power are arguing about how to take basic rights away from women.  I shudder to think what lies at the bottom of that slope, but if Rick Santorum has his way we will all soon find out.

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The coming medical revolution

Technology has the potential to transform our concept of sickness. An expert explains what the future holds

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The coming medical revolution

The information at our everyday disposal is growing at a breathtaking rate. From the beginning of civilization to 2003, the world accumulated 1 billion gigabytes of data. Today, we create 1 trillion gigabytes every year. These advances have transformed the way we think about knowledge, communication and countless aspects of our everyday life — and they have the potential to revolutionize the way we think about our own health.

In his new book, “The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care,” Eric Topol, a former professor and researcher at the University of Michigan and Case Western University, and chief academic officer for Scripps Health, a nonprofit healthcare system based in San Diego, argues that the digital revolution can democratize our medical system. Topol demonstrates how the digital revolution can be used to change individual care and  prevention, and even the economics of American healthcare. From cellphones that automatically collect medical data, to biosensors, advanced imaging, individualized prescriptions and gene-specific drugs, Topol’s book leads readers through science-fiction-sounding scenarios that may soon be a reality.

Salon spoke with Topol over the phone about the empowered consumer, rebooting the life science industry, and the doctors of the future. 

“Digitizing the human” is a provocative phrase you use throughout the book; what does this mean, and how can it lead to what you call the “democratization of medicine”?

We’re so used to digitizing everything — books and movies and periodicals — everything except for our bodies. My idea is to digitize the essence of what makes us tick — our genome and our physiology — thanks to different biosensors which are largely wearable, put right on a band-aid or a wrist or on the sole of a shoe. This would be combined with imaging, the ability to image any part of the body with a high-resolution pocket ultrasound device. When you take all these things together, along with personalized electronic health records and health information systems, this gives us a really panoramic, deep view of each individual.

How do cellphones fit into this?

Well, the cellphone has been the basis of a lot of democratization. You look at the Arab Spring and the Occupy movement and it’s the mobile phones that are bringing people together, through Facebook and Twitter and sharing pictures and videos and emotions. Now the digital infrastructure supports the whole medical side of this; you could have your own data for blood pressure or glucose or mood or anything quantified, right on your phone. And then that information can be shared with your social network, or your doctor, or whoever.

So the ability to have this mini computer in your pocket, that you’re essentially surgically attached to, is such a powerful force for the use of that data.

What role will the consumers play in this revolutionary shift?

I envision the consumer being the primary driver. That’s why I actually wrote the book. I’ve written a lot of medical textbooks, and I’ve lived in the medical microcosm until recent years, but then I started realizing that this digital world is really changing everything. The medical community itself is so resistant to change. The government and the life science industry are not going to be active in promoting a radical change. But consumers can do it and they’re more truly empowered, more resourceful and bound together and powerful than ever before.

And there’s one other lesson that’s really valuable: Back in 1997, the United States approved Direct to Consumer Advertising on TV for drugs, which I think was a dreadful mistake, by the way. But what’s interesting about it was it basically fueled this “Ask your Doctor” movement: a patient-centered, consumer-centered model. It was very powerful because of course these drugs [being advertised] became extraordinarily widely used. I don’t want to promote that, but on the other hand, if consumers are partnering with doctors, like, “Here’s my genome, Doctor, what do you think of it? Here’s my blood pressure and vital signs for the last three months,” it’s not just “ask your doctor” anymore it’s tell your doctor, share with your doctor.

Why is the medical field so resistant to digitization/digital records? Other industries have done this almost a decade ago.

Well, this is the history of medicine. If you go back to 1816 when the stethoscope was invented, it took 20 years before doctors would use them. The average time it takes for a medical innovation to come into daily practice is 17 years, which is just horrible. And they had all kinds of excuses, similar to the excuses that they have today. Basically, one of the main reasons doctors wouldn’t use a stethoscope was because they said it would interfere with their interactions with patients. And they didn’t want to learn all these new heart sounds and breath sounds and that sort of thing.

There’s an unwillingness to change. For example, a lot of physicians I work with are bothered by the fact that they have to be typing at a computer, looking at a screen, rather than interacting with a patient. And I understand that; both the physician and the patient take a hit in terms of optimal communication. How do we deal with that? A lot of physicians now have scribes that do the computing of data while they never lose eye contact with the patient. The patient obviously knows very well whether they’re not being listened to or looked at. So part of it is resistance to change and part of it is losing touch with a visit with a patient.

You mention this in your book, but isn’t it dangerous to have our medical files out there, in terms of security issues?

Like everything else that’s digitized, when you digitize a human being you have the potential for hacking, privacy and security issues. And already there have been breaches of electronic medical records in major medical centers around the country. So this has to be attended to with the maximal assurance that we’ll do everything we can to preserve that security. It’s a tradeoff: Do the benefits of having the essence of each individual captured digitally override the hopefully small, negligible risk of a breach of that data?

How do American doctors compare to doctors in other countries in terms of their attitudes toward technology?

Medicine on a planetary basis, on a global basis, is very conservative and resistant to change. But there are some specific examples where there’s a real gradient or heterogeneity, a real marked difference in cultures. In the U.S. the adoption of technology can be stymied because of reimbursement issues. In other countries where there’s no fee-for-service private practice, there’s been remarkable adoption of certain technologies. A great example of that is the portable ultrasound; I haven’t used a stethoscope now in two years. I use this pocket ultrasound device so I can see everything in the heart rather than listen to the heart’s sound. In the U.S., hardly any doctors are using that because they can’t get reimbursed; they much prefer to send the patient to get a cardiogram, which is an ultrasound of the heart, or an ultrasound of the abdomen or whatever the ultrasound is. Whereas in India, Brazil, China, this is one of the hottest new technologies because it saves costs dramatically and there are no issues with respect to reimbursement.

In what ways can recent breakthroughs in our understanding of the genome – from the Human Genome Project of 2000 to today – contribute to the shift to individual-based medicine?

There are three biggies right now. The longest chapter in the whole book is on genomics. The first is pharmacogenomics. Now, in the U.S. alone, we spend $350 billion a year for prescription medicines, and so many of these drugs have known serious side effects, that can be predicted by knowing a particular genotype. And in addition, some medicines don’t work for a lot of people, and we could predict that with a very simple genotype — like Plavix, which a third of people don’t respond to but they keep taking every day, or Metformin for diabetes, which 25 percent of patients don’t respond to. Tegretol has a horrendous side-effect profile. We don’t screen for it in the U.S., but you can’t get a Tegretol prescription in Taiwan without having a genotype. So in that sense we’re way behind. I could go on, a lot more examples are in the book, but that’s No. 1 – the use of genomics today. We’re not leveraging that great new knowledge.

Second is in the field of cancer therapeutics. If you have a new diagnosis of a significant cancer today, the best way to potentially get the right therapy is to get a whole genome sequence of the tumor, and also of your native so-called germline DNA, and compare the two. By comparing the mutation in the tumor to what you’re born with in your DNA, you can see what went off the tracks (because cancer is by definition a genomic disease) and then you can fashion a therapy specifically for that individual.

The third area is the elimination of the idiopathic, which is a very fancy medical term used for “we don’t know.” There’s a lot of people walking around with debilitating serious disease, and trying to get a diagnosis for what is wrong with them and they haven’t been able to do it. The issue is, until now we didn’t have a way to sort this thing out but with whole genome sequencing, we can in many of these individuals determine the root cause, the biologic basis for their illness.

Competing manufacturers of these new technologies will be required to agree upon uniform standards; is this a feasible hope?

This is a really interesting trend to watch. Now in the networking electronic world we live in, you see some unprecedented collaboration among even competing life science industry companies. So, for example, in the case of Alzheimer’s disease, where they haven’t come up with anything to prevent or change the course of Alzheimer’s, it’s been very frustrating. Many companies have invested billions of dollars in this whole objective. But now, they are working together. So most of the large pharma companies are pooling their data to basically do an autopsy of the failed drugs to find out what went wrong. And you never would have seen that in the past – I mean that’s actually remarkable.

If everyone working on cancer that did a genome sequence of an affected individual put that data in a common place and all the companies were also involved, we could really get so far ahead in this cancer problem, which is quickly emerging as the No. 1 cause of death, overriding heart disease. But we don’t have that type of collaboration yet. We need it to cross national boundaries, and to get the academic and life science industries to converge. That would be creative destruction in high gear!

What technological innovations in medicine are you most excited about? 

I think the one I’m most excited about is the embedded nano-sensor. You have to put it in the bloodstream and get it to localize, either in the finger or the wrist, someplace that’s hyper handy that will communicate with your cellphone. And that embedded nano-sensor can be used to pick up, for example, the first cancer cell that shows up in the bloodstream, which would promote the earliest possible detection of cancer.

It also could help with the autoimmune form of diabetes, called Type 1, which usually affects kids. If we have that embedded nano-sensor constantly monitoring, and a medicine used to block the immune system when needed, this, hopefully, could lead to the end of autoimmune diabetes, which is really exciting.

And the other really far out thing is the area of heart attack prevention, again through an embedded nano-sensor. It can be used to pick up cells in an artery that’s starting to crack a week or two before a heart attack. We have some really good data to suggest that this will ultimately be possible.

How does Obamacare fit into this? How much will this cost? Where will the money come from?

Obamacare is in a different orbit. There’s nothing in the 2,000-plus page bill that gets into this kind of hyper innovative individual medicine, biosensor leveraging, genome and all these sorts of things – it doesn’t really show up. But it is a great opportunity to make medicine and healthcare more affordable. For example, it’s estimated that about a third of the $350 billion spent a year on prescriptions is a total waste. So there’s a great opportunity there, with gene-specific drugs. If we do the 20 million echocardiograms, and almost as many abdominal and fetal ultrasounds, for free with ultrasound pocket devices, there are billions of dollar we could save there. With sensors, if we could get tens of millions of people in this country to manage or prevent their diabetes that could have enormous financial implications. And it’s the same for high blood pressure: 50 percent of people with high blood pressure do not have it adequately managed, so they’re vulnerable for strokes and heart attacks. If we can manage it with a simple cellphone sensor, that would be an enormous potential to lower costs for stroke disabilities, heart attack, heart failure, all those sorts of things.

In what ways can social networking be useful for physicians?

Patients share on online health communities and each of these social networks have amassed an enormous following. Let’s say you have a particular condition like multiple sclerosis, or a form of cancer or diabetes. You go on these social networks and find peers whom you’ve never met with, but they become your guidance and connections. And they are now more trusted than doctors by a substantial proportion of participants in these online health communities. Now, on the doctor side, almost 90 percent don’t even know these online communities exist, which is in itself surprising. But, if we work together, this is another opportunity to get information out there.

On the other hand, you don’t exactly want to have your patient as your Facebook friend. But one thing that’s striking me is, just a couple weeks ago in the Wall Street Journal there was this big debate: Should doctors email with their patients? And I thought, “How could that even be a question?” It seemed like a crazy throwback to a different era. Then there was an article in the Journal of American Medical Association asking, should patients be able to access their laboratory data? You’ve gotta be kidding. How could this be a question in 2012? This is the paternalistic, Doctor Knows Best mind-set that is still carrying over to today. We’re too far away from democratization, and I’m hoping we can change that.

What does all this mean for the individual consumer? How will our actual experience of going to the doctor of the future change?

The doctor of the future, who has plasticity and has moved into the digital era, will be up on all these things. There may not be in-office visits, there may be virtual visits on Skype or Facetime, and patients could send all their data real time through their phone. I think each physician has to say [to patients], We want you to have all your data. We want you to be participatory. We need you to be fully engaged. And if you’re fully engaged, you’re the one with the most vested interest in your condition. We want you to have all the data, whether it’s your lab test, your notes, your metrics on your phone, your genomic data, your scans, whatever it is, we want you to have it because we want you to help drive this process.

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Lucy McKeon is an editorial fellow at Salon.

Illuminating the history of medicine

A lush new chronicle of health-related art tracks centuries of scientific gains SLIDE SHOW

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Illuminating the history of medicineSpike Walker, "Quinidine Crystals," 2006. Polarised light micrograph. (Credit: Spike Walker, Wellcome Images, London)

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Sir Henry Solomon Wellcome died in 1936, but his curiosity about human understandings of “the preservation of health and life” — carried forward in the 21st century by the Wellcome Trust — is supremely infectious.

Open “The Art of Medicine: Over 2,000 Years of Images and Imagination” (University of Chicago Press, out now), which spotlights works from London’s Wellcome Collection, and you’ll find illuminations from late medieval medical manuals; 18th-century anatomical waxworks with removable organs; leaves from hand-colored plant and herb guides; early-20th-century lithographs advertising gout remedies; astonishing close-ups of implanting human embryos; and much, much more. The collection is so wide-ranging and diverse as to defy a pithy explanation — but taken as a whole, it’s transfixing.

Emma Shackleton, one of the book’s co-authors, answered a few of my questions over email; the accompanying slide show offers a whirlwind tour of the past few hundred years of medical imagery.

Roughly how many of the images featured in the book do you think were originally conceived by their creators as “art”? How much of the material was intended simply to be instructional?

For the historic works, we often do not know what the creators’ original intentions were. In making the images, they each would have been working within their own stylistic and cultural traditions. So, for example, anatomical representations made in Persia and Asia would have been created in line with particular traditions, in contrast to those of, say, 15th-century Europe, where the artists of “The Apocalypse” would have drawn on existing images in order to create the Organ Man [slide 1], and his accompanying anatomical figures.

There are many images in this gallery that do instruct and inform, yet, even where this is their primary role, they were often made by highly skilled artists and were valued for their artistic qualities too. In the 16th century, for example, Charles Estienne wrote of the aesthetic pleasure to be gained from studying the human anatomy, while Andreas Vesalius commissioned the engravings of his revolutionary book, “On the Fabric of the Human Body,” to be made in the great artistic center of Venice. Their work was appreciated not only by practitioners, but by lay people, too.

However, art relating to medicine has been made for many audiences, and it is the breadth of these perspectives that we were keen to explore and bring together to offer a compelling journey into the landscape of medicine. Some objects and images played a role within spiritual ritual or religious practice; others were made as artifacts intended to protect health or cure disease, as caricatures, as narrative paintings or as contemplative pieces that reflect on personal experiences or medical developments.

Do scientists and doctors today go to the same efforts as their forebears to make graphics, charts, tools and records aesthetically pleasing? How have values changed in this regard?

There is a strong tradition of the sciences and art being intertwined, and this continues. The artist Annie Cavanagh has said of the work she creates with microscopist David McCarthy [slide 9]: “It makes an idea concrete or solid, whereas interpretation of literature can go many ways.” Perhaps their extraordinary micrographs highlight one of the major changes in the visual images that are created today.

In the hands of scientists and practitioners like Annie Cavanagh and David McCarthy, we now have remarkable insights at a microscopic level into the body (so we can gain, say, a view of a blood vessel rupturing or neurons in the brain), of the appearance and actions of viruses and diseases, and the structure of medication. Such images can instruct and inform, yet they also give an aesthetic pleasure and reward the curiosity of a lay viewer.

What do you think is the single most powerful thing the collection says about the progress of medicine over the course of the periods it covers? What’s the most powerful thing it says about the progress of art?

It is interesting that you ask about progress. For me, the most powerful message the collection came to say was one about continuity. This eclectic collection does span major developments in medicine, diverse art practices and many perspectives from different cultures. Yet at the heart of it is the human body, and while we are each individuals across time and location, personally and within our cultures we have had to find ways to understand our bodies and ourselves in sickness and health. So, for me, at the core is a message about the human condition — and that is a thread connecting the past, present and future.

Do you have a single favorite image (or a favorite section) from the book? Is there something in particular you think readers might be surprised by?

I hope you don’t mind if I choose a favorite quality. It is that the images allow us to go on fascinating journeys to explore many strands of medicine across time and place, be they anatomy, medical or surgical practice, disease or medication. Follow the trail of herbal medicine, for example, and the images take us from 15th-century Europe to Japan and 19th-century Tibet, or explore astrology in medicine, and we can see visions of its practice across Europe, in Persia, Asia and Mexico.

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Emma Mustich is a Salon contributor. Follow her on Twitter: @emustich.

Komen for the Cure sells out women, again

The pink-ribbon charity, with a Sarah Palin ally as senior policy director, turns its back on Planned Parenthood

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Komen for the Cure sells out women, again Karen Handel and Sarah Palin in August, 2010. (Credit: AP/John Bazemore)

First, the good: Since its founding 30 years ago, Susan G. Komen for the Cure has put over a billion dollars toward research, screening and awareness in the name of eradicating breast cancer. It’s certainly no coincidence that in that same span of time, breast cancer rates have declined sharply, and what was once a devastating diagnosis is now, for many, a treatable condition.

Yet when the news broke Tuesday that Komen was ending its funding for Planned Parenthood breast cancer screenings and services, the organization’s eagerness to throw Planned Parenthood – and the women who depend upon it – under the bus wasn’t surprising. It’s actually thoroughly unshocking for this venerated organization to pull such a crass, insensitive move.

The very name Susan Komen — with its direct association with a real woman, and founder Nancy G. Brinker’s promise to fight the disease that claimed her sister — is heart-tugging. Today, everyone who knows a woman likely has a breast cancer story – and with it, a Komen-flavored story about donning a pink T-shirt and running in a Race for the Cure, or shopping in October for pink-themed “Girls Just Want to Have Fun” notepads to help raise “awareness.” Along the way, Komen has become the McDonald’s of cancer — an easy-to-remember brand with a logo that demands little thought or effort from the consumer. Write a check, buy a ribbon, voila! You get to feel like you’re curing cancer.

It’s not that Komen is some questionable, Wyclef Jean-esque mess. It gets high marks from both the Better Business Bureau and Charity Navigator. Yet this is an organization that has repeatedly come under fire for its extravagant promotion of itself as an organization dedicated to a “cure,” when only a small portion of its expenses go to, you know, curing cancer. Komen itself cops to portioning just 24 percent of its funds to research – and 20 percent to fundraising and administration. For an organization with reported revenues of nearly $350 million, that’s still a lot of money for research. It’s an awful lot for itself, too.

Yet Komen remains pretty damn territorial around that whole “cure” thing. In a 2010 story for the Huffington Post, writer Laura Bassett pointed out that, according to Komen’s own financial records, it spends almost “a million dollars a year in donor funds” aggressively going after other organizations that dare to use the phrase “for the cure” – including small charities like Kites for a Cure, Par for the Cure, Surfing for a Cure, Cupcakes for a Cure, and even a dog-sledding event called Mush for the Cure. Let me just give you that number again. A million bucks a year. Robert Smith, better watch your back.

Komen has also, in its relentless pursuit of ubiquity and corporate sponsorship, aligned itself with more dubious product placement than a “Jersey Shore” marathon. It has a whole online store encouraging visitors to “purchase with purpose to end breast cancer forever,” where you can buy “silicone bling watches” and “Passionately Pink” ribbon-shaped cake pans. And because you’ll have to root around for the numbers, you can spend extravagantly on candles and “spirit gloves” without knowing that merely “at least 25 percent of the retail sales price … will go to Komen to help support … research and community programs.” Twenty-five percent of that $4.95 dog leash? Why, that’s more than a whole dollar!

Komen also famously outsources its merchandising. It’s teamed up with the likes of KFC for “Buckets for the Cure” – because nothing says you care about women’s health like a big vat of fried chicken. Komen has additionally sold a pink-hued “Promise Me” perfume that contains several toxins –  including galaxolide, a synthetic musk that critics claim is a hormone disruptor. Komen has promised to reformulate the scent this year, but as Uneasy Pink calculated last spring, that’s still a lot of questionable chemicals to buy when roughly only 3 percent of the purchase price will go to Komen’s oft-invoked “cure” anyway.

And what of Komen’s latest, most potentially damaging stunt with Planned Parenthood? Komen says the move is just about “newly adopted criteria barring grants to organizations that are under investigation by local, state or federal authorities.” You know what else is pretty “new” around Komen? Its senior vice president of public policy, Karen Handel. During the Sarah Palin-endorsed, Tea Party favorite’s 2010 campaign for governor of Georgia, Handel declared, “I do not support the mission of Planned Parenthood,” making clear that she “strongly supports” laws prohibiting “the use of taxpayer funds for abortions or abortion-related services.” She did, however, emphasize that she “strongly support(s) the noble work of crisis-pregnancy centers.” If you were one of the world’s biggest charities and were looking to hire someone who had women’s welfare as her greatest imperative, would you go for someone who’d send them to a place that offers breast cancer screenings – as well as ovarian cancer screenings and HPV tests? Or someone who prefers a bunch of right-to-life fanatics pretending to be a medical facility? If you picked the former, you’re smarter than Komen for the Cure.

That Komen has raised staggering amounts of money is undeniable. There’s also pretty compelling evidence that it has done so in some pretty boneheaded ways. So given its track record, it’s fair to ask what happens now to the 11 percent of the Komen budget that goes to screening. Does it get funneled toward more glitter bracelets and “Promise Bears”? And what happens to the women who depend upon Planned Parenthood to tell them whether or not they have breast cancer? What becomes of mothers and daughters and wives and friends who believed that Komen’s commitment to “the cure” meant something more than protecting its catchphrase? It’s worth noting that while breast cancer rates are dipping, an October report from the American Cancer Society warned that they are declining more slowly among low-income women, and that “Poor women are now at greater risk for breast cancer death because of less access to screening and better treatments. This continued disparity is impeding real progress against breast cancer.” You know who loses when Komen backs away from Planned Parenthood? Probably not those nice, pink-clad ladies who attend Susan Komen wine-tasting events.

Women’s healthcare is not about lace-trimmed scarves and bottles of perfume. It’s sure as hell not about some feel-good, lip-service version of what my colleague Rebecca Traister calls “infantilizing Pepto-ed advocacy.” It’s not even — for anyone still stupid enough to think Planned Parenthood is some giant fetus-killing complex — about abortion. It’s about screening. It’s about treatment. It’s just that simple. The further away an organization gets from that mission, the more women suffer. It’s just that simple too. And you don’t make good on a “promise” to your dead sister by selling out women who need you most.

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Mary Elizabeth Williams

Mary Elizabeth Williams is a staff writer for Salon and the author of "Gimme Shelter: My Three Years Searching for the American Dream." Follow her on Twitter: @embeedub.

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