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Inspired By Family Illness, Philanthropist Gives $650 Million For Psychiatric Research

The Broad Institute of Harvard and MIT  summer student Lydia Emerson and aesearch associate Aldo Amaya. (Courtesy/Kelly Davidson Photography)

Researchers at the Broad Institute plan to use Ted Stanley’s money to catalog all the genetic variations that contribute to severe psychiatric disorders. (Courtesy/Kelly Davidson Photography)

In the largest-ever donation to psychiatric research, Connecticut businessman Ted Stanley is giving $650 million to the Eli and Edythe Broad Institute of MIT and Harvard. The goal — to find and treat the genetic underpinnings of mental illnesses — was inspired by a family experience.

Ted Stanley made his fortune in the collectibles business. He founded The Danbury Mint, a company (later MBI, Inc.) whose first product was a series of medals commemorating the biggest scientific achievement of its time: the moon landing in 1969. While his business grew, his son Jonathan Stanley grew up as a normal Connecticut kid. Until, at age 19, Jonathan came down with bipolar disorder with psychosis, which got worse over the next three years.

“We’ll call it the epiphany from my dad’s standpoint at least,” Jonathan Stanley remembered of the turning point in his illness. “I went three days straight running through the streets of New York, no food, no water, no money, running from secret agents. And not surprisingly, after I stripped naked in a deli, ended up in a psychiatric facility.”

Jonathan was a college junior at the time.

“My dad came to visit, and he got to see his beloved son in a straitjacket,” Jonathan Stanley said.

The Stanleys were lucky. Jonathan responded well to the lithium, then a newly-approved drug. He went on to graduate from college and law school, too. Yet along the way, his father had met other fathers whose sons did not respond to treatment. He met other families who had to keep living with uncontrolled mental illness.

Ted Stanley said that gave him a focus for his philanthropy.

There was something out there that our son could take, and it made the problem go away,” he said. “And I’d like to see that happen for a lot of other people. And that’s why I’m doing what I’m doing.”

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Judge Delays Review Of Partners HealthCare Deal

Update 6:35 p.m.: A judge has granted Attorney General Martha Coakley’s request for an extension. The comment period will now close Sept. 15, and Coakley will have until Sept. 25 to file comments from her office after seeing the full Health Policy Commission report. A new hearing has been set for Sept. 29.

Our original post continues:

BOSTON — Massachusetts Attorney General Martha Coakley is asking a judge to postpone reviewing a settlement between her office and Partners HealthCare that would allow the hospital network to acquire three new hospitals.

Massachusetts Attorney General Martha Coakley (Steven Senne/AP/File)

Massachusetts Attorney General Martha Coakley (Steven Senne/AP/File)

Coakley’s motion asks a judge to wait until September to hold a hearing on the deal, which aims to limit the market clout of the state’s largest hospital network in exchange for allowing it to acquire South Shore Hospital and Hallmark Health.

A spokesman for the attorney general says Coakley has seen findings from a preliminary review of the deal from the state’s Health Policy Commission, and she believes the court should consider the full report.

The statement reads in full:

Our office always retained the option to seek to renegotiate portions of this agreement as it relates to Hallmark following a Final Report by the Health Policy Commission.  After reviewing the preliminary findings by the HPC, we believe it is in the interest of the public and the parties involved to wait for the final report before any final consent judgment is considered by the court.

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Can Brain Science Help Lift People Out Of Poverty?

Five years ago Lauretta Brennan was a single mom on welfare with a pack-a-day smoking habit, stuck in a “bad” relationship and living in the South Boston projects where she grew up.

Now, she’s still living in the projects with her young son, but the bad boyfriend is gone and Brennan’s got a job as an administrative assistant after receiving a business management degree. And she quit smoking.

Her childhood in the projects was marked by alcoholism and violence all around, Brennan said; “having no adult role model was the norm, being with a man who’s ignorant, that was the norm.”

Lauretta Brennan graduated from Bunker Hill Community College with an Associates Degree in Business Management in June 2013 (Courtesy)

Lauretta Brennan graduated from Bunker Hill Community College with an Associates Degree in Business Management in June 2013 (Courtesy)

But now, thanks to a novel program that uses the latest neuroscience research to help women dig themselves out of poverty, Brennan says: “I don’t want to live off welfare. I want to make money and be around people who work and go to school. In five years, the program got me to think more like an executive — I have goals, I’m an organizer managing my family well. I’m not scared anymore.”

This shift in thinking — from chaotic, stressed-out, oppressed and overwhelmed to purposeful and goal-oriented — may not sound like brain science. But it fits into an emerging body of research that suggests that the stress of living in poverty can profoundly change the brain: it can undermine development and erode important mental processes including executive function, working memory, impulse-control and other cognitive skills.

To fix that damage, the new thinking goes, people must engage in activities and practices that strengthen this diminished functionality and, exploiting the brain’s ability to change (plasticity in neuroscience lingo) re-train themselves to think more critically and strategically.

“Poverty whacks executive function and executive function is precisely what’s needed to move people out of poverty,” says Elisabeth Babcock, chief executive of the nonprofit Crittenton Women’s Union, a Boston-based group that draws on the latest brain research to help families achieve economic success. “What the new brain science says is that the stresses created by living in poverty often work against us, make it harder for our brains to find the best solutions to our problems. This is a part of the reason why poverty is so ‘sticky.’”

In a recent paper, “Using Brain Science To Design New Pathways Out Of Poverty,” Babcock makes the case that living in an impoverished environment “has the capacity to negatively impact the decision-making processes involved in problem-solving, goal-setting and goal attainment.” In other words, this type of stress can “hijack” the brain.

As other researchers, including Jack Shonkoff, director of the Center on the Developing Child at Harvard, have noted, this chronic vise of pressure — to pay the bills, function at work, raise the kids, and simply survive in an atmosphere rife with social bias and harsh living conditions — “places extraordinary demands on cognitive bandwidth.” Babcock writes:

“The prefrontal cortex of the brain — the area of the brain that is associated with any of the analytic processes necessary to solve problems, set goals and optimally execute chosen strategies — works in tandem with the limbic system, which processes and triggers emotional reactions to environmental stimuli…When the limbic brain is overactive and sending out too many powerful signals of desire, stress, or fear, the prefrontal brain can get swamped and the wave of emotion can drown out clear focus and judgement…”

How does this play out in real life? Chuck Carter, senior VP of research at Crittenton Women’s Union, explains:

“One of the things the brain science brings is something of an ‘aha’ in terms of why things are sometimes harder than we expect them to be. When you’re looking at a family that is struggling and making decisions that you don’t really understand, having that research helps you reassess…it adds another perspective. A lot of nonprofit organizations look at the social determinants [of poverty] but not a lot look at the science that says, ‘What else is at play?’

“I think that, on the ground, it gives us creative ways to think about the work and how we might approach it…Often families are in a lot of crises…and they feel they need to do things ‘right now.’ So, for instance, we’ve got a family, and they’re in a hallway and they’ll have to talk to the case manager ‘right now.’ And we ask whether it’s a true emergency, and if not, can we talk about this the next morning, and not in the hallway. It’s a problem with executive function and poor impulse control, but we can help them slow down and figure out the right time to figure this out and what information do they need. It’s about not responding so impulsively in other parts of their lives. So, in thinking about what to do with money, it can be a question of, ‘Do I buy cigarettes now or save the money for some new furniture when I move?’”

So how do you begin to fix all of this?

I asked Babcock a bit about the science behind her organization’s Mobility Mentoring program, in which low-income — mostly single — mothers apply to get training, professional mentoring, financial and other support for three to five years, in hopes of attaining economic independence.

Here, edited, is our discussion:

RZ: What does the research say about how poverty changes the brain? And how does a “hijacked” brain function compared to a brain not experiencing intense, chronic stress?

EB: Poverty hits what scientists call our executive functioning skills: our ability to problem-solve, set priorities and goals, juggle and multi-task, focus and stick to things. And it does this in at least two very important ways. First, the stress of dealing with new problems every day and never having enough to make ends meet overwhelms our heads and swamps us. It overloads the circuits in our brains and compromises our decision-making in the moment. Continue reading

Pregnancy Woes: Why Did The Price Of My Progesterone Skyrocket?

(Photo: Rekha Murthy)

(Photo: Rekha Murthy)

By Rekha Murthy
Guest Contributor

Update: KV Pharmaceutical changed its name to Lumara Health, two days after this post was published.

I’m 34 weeks pregnant and working hard to keep this baby inside me for as long as possible. As with my last pregnancy, there’s a real risk that the baby could come too early. But we’re both holding on so far, thanks to a combination of luck, modified bed rest and medical science.

The science is my biggest concern right now. I will spare you much of it because, man or woman, you will instinctively cringe and close your legs. However, one critical medical intervention that has been proven to work for countless women and babies is again under threat, and I must speak up.

Every week, my husband injects me with 250 mg (1 ml) of 17 alpha-hydroxyprogesterone caproate (“progesterone” for short). Leaving aside what this does to an otherwise tender and loving marriage, these injections have been found to significantly lower the risk of preterm birth.

Two weeks ago, my insurance co-pay for progesterone went from $5.50 per dose to $70 per dose. Just like that. For those without insurance (or with a deductible), the medication went from $32.50 per dose, according to my local compounding pharmacy, to…wait for it…$833 per dose, according to the new pharmacy my insurer is now requiring me to use.

$833. Per. Dose.

Pricing varies somewhat across pharmacies and insurers, but not enough to make this price change any less breathtaking. In fact, the drug’s list price is $690 per dose.

The 12-fold leap in my co-pay sent an epic shock through my (natural and synthetic) hormone-laden system. I immediately called both pharmacies, my insurer, and my doctor, and started digging around online. I soon learned that the price increase came from a new requirement to buy expensive brand-name progesterone, instead of the affordable compounded version I had been getting. A disturbing picture came into focus. Continue reading

AG Inks Deal To Rein In Partners HealthCare, But Does It Go Far Enough?

If you check in to a hospital or see a doctor connected to the Partners HealthCare network, your care will almost certainly cost more — sometimes a lot more — than at any other hospital in the state.

Brigham and Women’s, a Partners hospital, might get $1,500 for an MRI, while the same health insurance plan would pay Beverly Hospital roughly half that amount for the same test.

A deal reached Monday between Partners and Attorney General Martha Coakley aims to address that disparity in exchange for allowing the network to acquire Shore Shore Hospital and Hallmark Health.

“[Partners is] a Goliath in a market that has used its dominance to drive up costs,” Coakley said at a press conference Monday. “Those higher prices have led to an increased burden for families, for businesses, they’ve drained taxpayers … and they have contributed to the difficulties that many of our community hospitals have had to compete and to stay in business.

“How to address the Partners problem has been an issue in our commonwealth for years,” Coakley added. “But with this agreement, I believe we move from just documenting that problem to solving it.”

Coakley and the U.S. Department of Justice have looked for several years at whether Partners’ use of market clout violates antitrust laws. When Partners’ plan to acquire South Shore Hospital landed on Coakley’s desk for review last spring, South Shore became leverage for an agreement in principle that Coakley and Partners representatives signed Monday.

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A Victory For Women And Medical Research

The New York Times reports that a pair of influential scientists are calling for an end to gender bias in medical research, starting with a warning that researchers must “begin testing their theories in female lab animals and in female tissues and cells.”

From the article:

Name a new drug or treatment, and odds are researchers know far more about its effect on men than on women. From sleeping pills to statins, women have been blindsided by side effects and dosage miscalculations that were not discovered until after the product hit the market.

Now the National Institutes of Health says that this routine gender bias in basic research must end.

In a commentary published on Wednesday in the journal Nature, Dr. Francis Collins, director of the N.I.H., and Dr. Janine A. Clayton, director of the institutes’ Office of Research on Women’s Health, warned scientists that they must begin testing their theories in female lab animals and in female tissues and cells.

The N.I.H. has already taken researchers to task for their failure to include adequate numbers of women in clinical trials. The new announcement is an acknowledgment that this gender disparity begins much earlier in the research process.

“Most scientists want to do the most powerful experiment to get the most durable, powerful answers,” Dr. Collins said in an interview. “For most, this has not been on the radar screen as an important issue. What we’re trying to do here is raise consciousness.”

Women now make up more than half the participants in clinical research funded by the institutes, but it has taken years to get to this point, and women still are often underrepresented in clinical trials carried out by drug companies and medical device manufacturers.

Dr. Paula Johnson (courtesy)

Dr. Paula Johnson (courtesy)

Score a point for Dr. Paula Johnson, executive director of the Connors Center for Women’s Health and Gender Biology
and a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital. Johnson, earlier this year, led a coalition of doctors, policymakers and others calling for an overhaul of clinical trials and medical research to address the gender gap.

I asked Johnson for her take on the new NIH stance, and she offered this update:

In March of 2014, the National Policy Summit on Women’s Health brought together policymakers, practitioners, advocates and academics who, for the first time, gathered specifically on the issue of sex and gender inequity in biomedical science. For discussion was a new report, “Sex Specific Medical Research: Why Women’s Health Can’t Wait.” Continue reading

Restraining Partners? Rampant Speculation On A Deal In The Works

What’s up with that Partners-South Shore deal?

This question has come up in every conversation about hospitals in Massachusetts for the past three to four months, at least.  It’s important because the final resolution will be a benchmark for future hospital mergers, acquisitions and partnerships in Massachusetts and beyond. And it may finally address complaints that Partners Healthcare hospitals and doctors are paid more, in some cases much more, than most of their competitors.

If you’ve (understandably) lost track, here’s a recap:

partnersPartners announced plans to acquire South Shore Hospitals in June 2012.

The state’s Health Policy Commission concluded the deal would increase costs $23-$26 million a year.

Partners countered, saying that adding South Shore to its network, currently the largest in the state, would save $27 million a year.

The commission stuck to its original findings and sent a report to Attorney General Martha Coakley.  She, along with the U.S. Department of Justice, have been looking at whether Partners exploits its size and market clout to drive up health care prices and all of our premiums.

There are lots of theories about why we haven’t heard anything since Coakley acknowledged in March that she was in talks with Partners and South Shore.  Is there an impasse?  Are federal regulators clogging up the works?  What kind of pressure is Coakley (who is also running for governor) facing? I’ve heard all kinds of theories. Feel free to add yours below.

Coakley told the South Shore Chamber of Commerce last week that she expects to complete her review of the deal in a month or two.

Working with the Department of Justice, Coakley could sue to try and block Partners from bringing South Shore into its system.

But a deal that would limit Partners clout seems more likely. So what should it include?

Here’s where my random conversations with doctors, hospital executives and patients gets really interesting. The virtual water cooler chatter includes these possible scenarios:

1. Partners can add South Shore — and that’s it.  No further expansion for, say, five years or so (the time frame varies from three to 10 years). Keep in mind, Partners has already announced plans to acquire two North Shore hospitals after the South Shore deal is done.

2. Partners can add South Shore, but it must sell off another hospital of equivalent size or scope. Continue reading

Midnight Friends: How Wired Patients Are Transforming Chronic Illness

(mic_000/Flickr)

(mic_000/Flickr)

By Nell Lake
Guest contributor

Over the years, I’ve watched my cousin Deborah Haber struggle with several chronic, painful medical conditions, including fibromyalgia and a rare incurable disorder called Ehlers-Danlos Syndrome, a connective tissue disease that causes profuse sweating, a high heart rate and insomnia, among its many symptoms.

Largely housebound, and managing the life of her 11-year-old daughter, Deborah faces social isolation and persistent pain.

But along the way, my cousin has discovered a lifeline that’s lifted her outlook and improved her health. It combines the best qualities of a mother, best friend, therapist and trusted doctor to help her cope: it’s social media.

Deborah, 39, used to lie awake at night with “agonizing, shooting nerve pain,” feeling helpless and alone. She began going online, where she found others who were also awake and in pain; they became her midnight friends. “When you cannot sleep,” she says, “and you know your kid’s going to be up in a couple of hours, and you’re going to have to get her to school on time,” even if you’re exhausted — “knowing that you are not alone is a life-saver.”

With a rare and painful chronic condition, Deborah Haber found a lifeline: social media (Courtesy)

With a rare and painful chronic condition, Deborah Haber found a lifeline: social media (Courtesy)

Early on in her social media journey, Deborah mostly used Twitter. It was through people she met there that she learned about Ehlers-Danlos syndrome. She talked with her doctor, who did her own research and sent Haber to a specialist, who diagnosed the rare congenital disease. Deborah’s online activity, then, led directly to the diagnosis, which led to “far better care.”

Clearly, Deborah’s not alone: she’s part of a large and growing group of people with chronic illness in the U.S. who are using the Internet and other online technology to take charge of and improve their own health. This goes far beyond Googling your child’s weird rash: these millions of “empowered patients” are joining social-media communities, consulting online health databases, learning and sharing knowledge about drug side effects, crowdsourcing research studies, electronically monitoring their health and becoming health care activists who share what they’ve learned with their doctors.

Online patients with chronic illness use social media to improve both mental and physical health and to better connect with an understanding community, says Jennifer Covich Bordenick, chief executive officer of eHealth Initiative, which published a study earlier this year on patients’ social media patterns.

“It’s really incredible, if you look at what social media is allowing patients…to do right now,” she says. “It’s providing tremendous access to support, information, and it’s connecting people in a way that they haven’t been able to do before. … People with chronic illness are more motivated. … There’s an urgency there.” Continue reading

Consumer Advocates: FDA’s Action On Vaginal Mesh ‘Too Little Too Late’

Public Citizen, the consumer advocacy group that years ago called for tighter restrictions on a type of surgical mesh used to treat pelvic organ prolapse, called the FDA’s latest proposal to increase oversight on the products “troubling both in its scope and timing.”

The group said in a statement that the government agency waited too long to act and that its recommendations may still put women at risk.

Here’s the full statement from Public Citizen’s Health Research Group Director Michael Carome on the FDA’s latest proposal:

Public Citizen welcomes…[the] long-overdue issuance of a proposed order by the U.S. Food and Drug Administration (FDA) that, if finalized, would reclassify surgical mesh for transvaginal pelvic repair organ prolapse (POP) from a moderate-risk device (class II) to a high-risk device (class III). This would subject these devices to a more rigorous approval process that would require manufacturers to submit to the agency premarket approval applications with evidence from clinical trials that the devices are safe and effective. Such an order would implement one of three actions requested in Public Citizen’s August 25, 2011, petition to the FDA, which also requested an immediate ban and recall of all such devices currently on the market.

(wikimedia commons)

(wikimedia commons)

However, the FDA’s action today is troubling both in its scope and timing. First, the agency acknowledged that the safety and effectiveness of surgical mesh for transvaginal repair of POP has not been established and that these devices frequently cause serious adverse events. But the agency has taken no action to immediately remove currently available products from the market, as we requested in our petition, or to warn physicians and patients to stop using these devices.

Second, it is disturbing that the agency has taken so long to begin the regulatory process to reclassify surgical mesh for transvaginal repair of POP Continue reading

FDA Proposes New Restrictions To Address ‘Health Risks’ Of Vaginal Mesh

The U.S. Food and Drug Administration today proposed strict new regulations to address the “clear risks” associated with surgical mesh used to treat vaginal prolapse in women.

Specifically, federal regulators want to reclassify surgical mesh as a “high-risk” medical device (it’s now in the “moderate-risk” category) and also impose more requirements on manufacturers in which they must demonstrate that the device is safe and effective.

The risks and health problems related to this type of surgical mesh, which we’ve detailed here, include infections and nerve damage that can occur when the material erodes through the vaginal lining, as well as excruciating pain, the inability to sit down or urinate without a catheter, multiple hospitalizations and an end to a women’s sex life.

Here’s the full FDA news release:

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.” Continue reading