lundi 29 février 2016

‘Female Viagra’: Is This The Moral Of The Story Of The Little Pink Pill?

‘Female Viagra’: Is This The Moral Of The Story Of The Little Pink Pill?

 (AP Photo/Allen G. Breed)

(AP Photo/Allen G. Breed)

Remember “the little pink pill”? The great brouhaha last year about the FDA’s approval of “the female Viagra?”

Let us recap: The drug — flibanserin, brand name “addyi” — is aimed at boosting the libido in pre-menopausal women who have “Hypoactive Sexual Desire Disorder.” (In fact, it’s radically different from Viagra, aimed at desire rather than performance and taken daily, not as needed.)

The Food and Drug Administration declined to approve it twice, citing potential harms and marginal benefits. But then, in August — amid head-spinning debate about whether it’s sexist to approve a drug for female desire or sexist not to — the FDA said yes. Addyi went onto the market in October.

Now, a new meta-analysis, just out in JAMA Internal Medicine, sums up the handful of existing studies on the drug’s benefits — a resounding “eh” — and potential harms.

It finds that women who take the daily pill average just one additional “Satisfying Sexual Event” every two months. Compared to placebo, just 10 percent more women who take it report significant improvement in their sex lives.

As for harms, 21 percent of women on the drug reported severe drowsiness, compared to 8 percent on placebo. Of greater concern: When combined with alcohol, the drug can apparently lead to dangerously low blood pressure and even fainting.

The analysis confirms findings from before the FDA approval, and it’s not a very sexy picture. That could be why initial sales of Addyi seem to have been lackluster: Bloomberg reports that only a couple of hundred women got prescriptions for Addyi in the weeks after it was released, compared to the half million men who got Viagra in the month after it came onto the market in 1998.

So what’s the moral of this story? Drs. Steven Woloshin and Lisa M. Schwartz of the Dartmouth Institute of Health Policy and Clinical Practice wrote a biting editorial to accompany the meta-analysis, sub-headlined “Even The Score Does Not Add Up.”

“Even The Score” is the advocacy group that reportedly packed the FDA hearing room with women telling powerful stories of how desperately a treatment for loss of libido is needed. Woloshin and Schwartz write that it “conducted an intense promotional campaign directed at journalists, women’s groups, Congress and the FDA.”

The campaign, Schwartz says, “ignored the idea about the science and made it all about these charges of sexism, as opposed to the idea that there were real concerns about science here.”

“To me, as a woman, I think that what feminism means is getting good drugs that help more than they hurt — or non-drugs. I think it’s important to meet the needs of women, but we want to do that based on good science that tells us that we’re helping more than we’re hurting women. Even the Score started to become about something else.”

The moral, Woloshin says, is that while under such political pressure, “FDA approved a marginally effective drug for a non-life-threatening condition in the face of substantial and largely unnecessary uncertainty about its dangers.”

Unnecessary, that is, because the FDA had told the drug makers what to do to determine the risks — but they didn’t do it. For example, Schwartz says, it told the company to test the drug in women who take other medications, but it didn’t.

Most strikingly, “The FDA told the company to do a study looking, in pre-menopausal women, how the drug interacted with alcohol and the study was — amazingly — done in men,” Schwartz says, “and not just men but men who were moderate drinkers.”

That alcohol interaction is the greatest concern about Addyi, and the drug includes a black box warning not to drink while on it. But “I think everyone knows people will drink on this drug,” Schwartz says. And if your blood pressure drops to the point that you pass out “and you’re driving, you could hurt somebody else. So it has [the potential for] both personal harm plus you could harm somebody else.”

The FDA often offers helpful guidance on how to design studies, Woloshin says: “It’s really unfortunate that the companies know they don’t have to listen.”

After years of advocating for clearer public information on the risks and benefits of drugs, Woloshin and Schwartz have started a company to do that: Informulary. Here, with their permission, is their information box on Addyi:

(Courtesy: Informulary.)

(Courtesy: Informulary.)

vendredi 26 février 2016

The Office Corner Workout: A Dozen Quickie Exercises For Cubicle Plebes

The Office Corner Workout: A Dozen Quickie Exercises For Cubicle Plebes

No, you didn’t read the headline wrong. This is not the “corner office workout,” for the elite who occupy spacious private offices. This is the “office corner workout” for cubicle-dwelling plebes who occupy space only as wide as our arm-spans, and pop up like prairie dogs to confer with each other.

In our class, there’s often not enough floor space to do a push-up or a crunch without risk of being run over by an oblivious colleague’s office chair. But here, Rick DiScipio, assistant manager of Boston University’s FitRec Center, demonstrates the minimalist glory of the simple but powerful moves we can do at or near our desks. (If, that is, we can also establish a workplace culture that accepts our colleagues’ quiet exertions.)

Why bother? Sitting is the new smoking (sort of). Even dribs and drabs of activity can improve your health. (A study last year suggested even two minutes an hour of light activity can have an effect.) And if you have to be a worker bee, at least you can be a fitter worker bee. More rationales later. First, the work-out.

1) The Wall Slide

Fitness expert Rick DiScipio talk WBUR's Clint Cavanaugh through a wall slide. (Robin Lubbock/WBUR)

Fitness expert Rick DiScipio talks WBUR’s Clint Cavanaugh through a wall slide. (Robin Lubbock/WBUR)

Stand against the wall and slide downward until your knees are at a 90-degree angle. Then slide back up again. Two sets of 12.

2) Sit and Stand

Fitness expert Rick DiScipio shows WBUR staff a sit and stand routine. (Robin Lubbock/WBUR)

DiScipio shows WBUR staff a sit and stand routine. (Robin Lubbock/WBUR)

Stand just in front of a chair with feet about shoulder-width apart. Slowly squat until you sit in the chair for a second, then stand back up again. For more challenge, put one foot in front of the other or — if very fit — try it one-legged. Two sets of 12.

3) Leg Extension

Fitness expert Rick DiScipio shows WBUR staff a leg extension. (Robin Lubbock/WBUR)

DiScipio shows WBUR staff a leg extension. (Robin Lubbock/WBUR)

Sit in a chair and fully extend one leg, then the other. Two sets of 12.

[Time at this point: About five minutes.]

4. Wall Push-up

Fitness expert Rick DiScipio watches as WBUR staff do wall push-ups. (Robin Lubbock/WBUR)

DiScipio watches as WBUR staff do wall push-ups. (Robin Lubbock/WBUR)

Stand at arm’s length from the wall with your arms at shoulder height and your hands flat on the wall. Do a standing push-up, keeping your elbows close to your sides and concentrating on squeezing your shoulders. Two sets of 12. More challenge? Desk push-ups.

5) Reverse Shoulder Flies With Band

Fitness expert Rick DiScipio uses a resistance band to work his shoulders. (Robin Lubbock/WBUR)

DiScipio uses a resistance band to work his shoulders. (Robin Lubbock/WBUR)

Grasp elastic in hands, elbows straight. Move arms away from each other, out to sides. Focus on squeezing the shoulders together. Slowly return to start position. Two sets of 10.

6) Lateral Band Walking

Fitness expert Rick DiScipio demonstrates using a resistance band to work his legs. (Robin Lubbock/WBUR)

DiScipio demonstrates using a resistance band to work his legs. (Robin Lubbock/WBUR)

Keeping the band flat, not bunched, place it just above each ankle and wrapped around both legs. With your feet shoulder-width apart, the band should be taut, but not stretched. Bend your knees slightly and move into a half-squat position while keeping your feet in line with your shoulders, and face forward with your body weight evenly distributed over both feet. Walk laterally eight to 10 steps on each side.

7) Tubing For Biceps

Fitness expert Rick DiScipio uses resistance tubing to work is biceps. (Robin Lubbock/WBUR)

DiScipio uses resistance tubing to work is biceps. (Robin Lubbock/WBUR)

Assume a stand-up position, palms facing forward. Stand firmly on tube with the arch of your foot. Keep elbows stabilized at your sides as you lift hands up toward your shoulders. Return to start position. Two sets of 12.

[Time for this section: three to four minutes.]

8) Wrist stretch

Fitness expert Rick DiScipio demonstrates a wrist stretch for WBUR staff. (Robin Lubbock/WBUR)

DiScipio demonstrates a wrist stretch for WBUR staff. (Robin Lubbock/WBUR)

Hold your arm out in front, palm up, and grab your fingers with your other hand. Gently pull them towards you, holding for 20 seconds on each side.

9) Hip Flexor Stretch

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DiScipio demonstrates a hip flexor stretch. (Robin Lubbock/WBUR)

Sit on the front edge of your chair, with thighs parallel to the floor and feet below knees. Place foot (between ankle and heel) on your knee and work towards shin being parallel with the ground.
More challenge? bend at the hips and tilt your torso forward. Hold for 20 seconds on each side.

10) Quad stretch

Fitness expert Rick DiScipio demonstrates a quad stretch. (Robin Lubbock/WBUR)

DiScipio demonstrates a quad stretch. (Robin Lubbock/WBUR)

Stand on one leg and hold on to the back of a chair for balance. Bend your knee and bring your heel towards your buttocks, grabbing your ankle or foot with your hand. Stand up straight and feel a slight pull in the front of your thigh and hip. Hold for 20 seconds on each side.

11) Hamstring stretch

Fitness expert Rick DiScipio demonstrates a hamstring stretch. (Robin Lubbock/WBUR)

DiScipio demonstrates a hamstring stretch. (Robin Lubbock/WBUR)

Place your heel on your chair, with hips square to the chair, and standing leg straight. Keeping your back straight, lean forward from your hips toward the leg on the chair. Hold for 20 seconds and switch legs.

12) Lower back stretch

Fitness expert Rick DiScipio demonstrates a standing back stretch. (Robin Lubbock/WBUR)

DiScipio demonstrates a standing back stretch. (Robin Lubbock/WBUR)

In an upright position, place hands on lower back and slowly lean back. Hold for 10 seconds. Repeat.

[Time used stretching: about four minutes.]

And a reminder from Rick: Nothing beats deep breathing for stress relief.

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Questions? Skeptical? Professor Carol Ewing Garber, of Teachers College at Columbia University and formerly the president of the American College of Sports Medicine, says the research is clear that breaking up our sitting time throughout the day can have a powerful effect on wellness.

Those breaks don’t negate the standing consensus recommendation to get at least 30 minutes a day of at least moderate exercise, but to make it easier to fit into your day, you can rack up that half hour in blocks as short as 10 minutes, Garber notes.

Have less than 10 minutes? One thing is clear: taking a break from sitting, in and of itself, reduces your risk of disease, Garber says. “And we always know that something is better than nothing — in most cases.”

So, I asked, does it make sense to aim for a workday in which you work for an hour, then stretch for five minutes, then work for an hour, then do a few push-ups, and on throughout the day?

It does make sense, Garber said, not just for health but for concentration and productivity, and to reduce stress.

She warns that of course it’s not a good idea to do a heavy workout without warming up and cooling down, and if you’re stretching, remember that you’re not as flexible when you’re not warmed up.

The goal is mild or moderate-intensity moves, “so they aren’t really going to pose a great risk to anyone, and in fact, the risk is still considerably greater by remaining seated in your chair. So we’re not talking about doing all-out sprinting down your hallway, which I wouldn’t recommend for various reasons — it might be very disruptive, too! But a moderate walk is quite safe for pretty much everybody, even people who have chronic diseases.”

So how might eager employees pitch workplace workouts to a boss? Perhaps a little “fitspot” area to replace a smoking spot?

Garber would emphasize the health benefits, including perhaps fewer sick days, she says, and the cognitive boost.

“It also helps people clear their minds. I would argue that you might meet your deadline more readily because you had a couple of minutes to do some exercise, clear your head, re-focus. And honestly, some of your best ideas come while you’re exercising. (Or in the shower — but your boss may not want you to have a shower in the corner. Though that would be nice, too.)”

Readers, have you figured out how to squeeze a bit of fitness into a tight workplace? Please share.

(If you have questions for Boston University’s FitRec Center‘s Rick DiScipio you can reach him at discipio@bu.edu).

jeudi 25 février 2016

Teen At Center Of Custody Battle Over Diagnosis Sues Boston Children’s Hospital

Teen At Center Of Custody Battle Over Diagnosis Sues Boston Children’s Hospital

Justina Pelletier, seated, speaks to media alongside the Rev. Patrick Mahoney, left, and her mother Linda Pelletier on Thursday outside the State House in Boston. The Pelletiers filed a lawsuit against Children's Hospital in Boston over a medically-related custody dispute. (Bob Salsberg/AP)

Justina Pelletier, seated, speaks to media alongside the Rev. Patrick Mahoney, left, and her mother Linda Pelletier on Thursday outside the State House in Boston. (Bob Salsberg/AP)

The family of a Connecticut girl who was the focus of a high-profile medical dispute is suing Boston Children’s Hospital.

Justina Pelletier’s family accuses the hospital and four doctors of negligence and violation of civil rights.

“They were really treating me badly. They really didn’t care, and, it was awful,” Justina said from her wheelchair. The now-17-year-old clutched a stress ball with her blue painted fingernails as she spoke to reporters outside the Massachusetts State House Thursday.

“Just imagine being in a psych ward without needing to be in a psych ward, and just not being treated like everyone else was,” she added.

Justina’s family contends she was taken away from them and placed in state custody, after they disagreed with Children’s Hospital doctors about her diagnosis. Justina had been treated by doctors in Connecticut and at Tufts Medical Center in Boston for a rare mitochondrial disease before being sent to Children’s for a stomach ailment. The family says doctors at Children’s concluded Justina’s condition was psychological, and not physical, and ultimately put the girl in state custody.

Justina is home now, but is still upset by being placed in state custody for 16 months.

“Justina and her family have been, as you can imagine, both the emotional and financial devastation that this has caused,” said attorney Kathy Jo Cook, who represents the Pelletiers. “Additionally, this is a civil rights lawsuit. We are very, very concerned of the rights that were violated here, and want to ensure that this doesn’t happen again.”

Children’s Hospital issued a written statement saying they welcome the opportunity to vigorously defend the medical care it provided to Justina Pelletier, but due to patient’s privacy and the lawsuit, it cannot comment further on the case.

Earlier:

'I Don't Feel Trapped On Earth': Ketamine Lifts Many From Depths Of Major Depression

'I Don't Feel Trapped On Earth': Ketamine Lifts Many From Depths Of Major Depression

Sarah Kramer, 37, has been profoundly depressed most of her life. But "right now, thanks to ketamine," she says, “I don’t feel despair. I don’t feel hopeless. I don’t feel trapped on earth.” (Jesse Costa/WBUR)

Sarah Kramer, 37, has been profoundly depressed most of her life. But “right now, thanks to ketamine,” she says, “I don’t feel despair. I don’t feel hopeless. I don’t feel trapped on earth.” (Jesse Costa/WBUR)

Thirty-seven-year-old Sarah Kramer has been profoundly depressed most of her life. She remembers feeling different from the time she was 4.

“I never wanted to be anything when I grew up, because I didn’t want to grow up, because I didn’t want to keep living,” Kramer, of Medford, recalls.

Kramer grew up a diplomat’s daughter. The family moved around Africa, the United States and Canada. She started out a straight-A student, then her grades slipped and she gained weight. She never attempted suicide, but it was always in her thoughts. She had a breakdown in high school and over time ended up on a slew of psychiatric medications.

But she remained depressed and suicidal. In more recent years, she barely left the house.

Now for the first time since Kramer was a child, she has hope. The veil of depression is lifting.

“I feel very much like a stranger in a strange land,” she says.

Within A Few Minutes, The Ketamine Kicks In

Kramer is taking a medicine doctors call the biggest discovery in the treatment of mood disorders in decades. It’s a drug that was never intended to treat depression. It’s used as anesthesia — and used illegally as a club drug called “Special K.”

The drug is ketamine. Kramer takes it as a nasal spray.

We meet Kramer at a Massachusetts General Hospital outpatient clinic where doctors are prescribing ketamine to the most severely depressed patients. Psychiatrist and lead researcher Christina Cusin says many of the patients are on the verge of suicide. They’re people who get little or no relief from traditional antidepressants. But they do get relief from ketamine.

MGH first studied ketamine for major depression in a clinical trial using intravenous infusions of the drug. It’s one of several research hospitals doing so, and it’s currently recruiting patients for more trials. Janssen Research & Development, a division of Johnson & Johnson, is in late-stage clinical trials of a nasal version of ketamine called esketamine. It plans to apply to the FDA for approval of the medicine for treatment-resistant depression in 2019, according to a company spokesman.

Lots of small, private ketamine clinics are popping up around the country, as well; some are administering intravenous ketamine as treatment for obsessive compulsive disorder, anxiety and bipolar disorder, in addition to major depression. There’s a clinic in Newburyport and another in Lexington. All ketamine treatment for mental illness is, at this point, experimental.

“During the first administration [of intranasal ketamine] we take vitals every 10 minutes," says Dr. Christina Cusin, a psychiatrist and lead researcher at the Massachusetts General Hospital outpatient clinic. (Jesse Costa/WBUR)

“During the first administration [of intranasal ketamine] we take vitals every 10 minutes,” says Dr. Christina Cusin, a psychiatrist and lead researcher at the Massachusetts General Hospital outpatient clinic. (Jesse Costa/WBUR)

Kramer was part of the first MGH trial with ketamine infusions. Now she takes the nasal ketamine at home. But on this day, she’s taking it at the clinic to show us how it works and that it does, indeed, work. Kramer leans back on the exam table and tilts her head so the ketamine trickles into her nasal passages. She puts on headphones and turns on some music that helps her relax.

Within about three minutes, the ketamine kicks in. It makes Kramer feel kind of loopy. The drug has psychoactive effects that leave patients high or out-of-sorts for about an hour.

“OK, I’m starting to get a little woozy,” Kramer says. “A lot of people report out-of-body experiences with ketamine. And I have not experienced that. But I have experienced elation. There are definitely aural effects. I hear almost reverb a little bit.”

She does a little mental exercise, counting forward and backward out loud, to try to meditate.

Drastic Results, But Unknown Long-Term Side Effects

Kramer and the 30 other patients at the MGH ketamine clinic had to sign consent forms acknowledging the risk of long-term side effects.

“Nobody knows the repeated use of [a] very small dose of ketamine, what that will do to the brain. We don’t know yet,” researcher Cusin says. “[The patients] all say to us, ‘I don’t care if it’s going to cause some side effect down the line. I don’t feel like killing myself tomorrow, and this is what matters for me.’ ”

In MGH’s clinical trial, intravenous ketamine alleviated depression in about half of participants. Some other studies with different patient criteria have had success rates as high as 75 percent.

Cusin says patients in the MGH trial saw their moods change quickly and drastically. They came in with deep emotional pain that was unrelenting, and they saw it melt away.

“They just say, ‘I don’t feel like I felt two hours ago. I don’t know why.’ They just wanted to go out and enjoy the spring or to look at the sky, and the colors were brighter and just life had meaning again,” Cusin recalls. “I was very surprised!” she says of her reaction. “I’ve never seen this.”

She’s never seen such a dramatic and fast improvement in someone with such severe depression. Traditional antidepressants can take four to six weeks to work — if they work. The effect of the ketamine taken intravenously lasts several days, and for some patients several weeks. The nasal spray is less effective but more practical for outpatients.

Research has found ketamine acts on the neurotransmitter glutamate — and sparks growth of new connections among brain cells.

Planning For An Unexpected Future

Sarah Kramer’s depression doesn’t disappear with the ketamine. It does relent.

But now, she’s having to wrestle with a whole new set of emotions because she never imagined a future without depression — or planned for it.

“It’s almost overwhelming, like, ‘Oh God, what do I do now that that thing that was, you know, the defining factor in my life — it’s not gone, it’s still there. It’s my history. It’s my identity in a lot of ways. But it’s not holding me back today,” she says, beginning to choke up. “I’m so thankful, and that’s all. It’s complicated in a few ways, because now I feel like I have this burden, like I have to figure out the rest of my life if I’m going to have one!”

Ketamine is not a cure for depression. Doctors emphasize that.

And one drawback is that the longer Kramer takes it, the larger the dose she needs to get the same relief. That’s known as “habituation.”

Kramer’s husband Dave, who has a different last name but doesn’t want to use it because of medical privacy reasons, has concerns about ketamine. He worries that people with depression may abuse the drug because of its mind-altering effects. But, he says, it’s better than the mega-doses of psychiatric drugs his wife has been taking for years.

“It’s helped keep her on slightly more of an upward level, out of the depression,” he says. “And we’ve been able to do more things, and I’ve been able to get her to go outside and be social with people, and do all the normal human things I’ve been trying to get her to do.”

Even going out to brunch together was a victory for them.

Kramer shops at her favorite shop for art supplies, the store Tokai in Cambridge. (Jesse Costa/WBUR)

Kramer shops at her favorite shop for art supplies, the store Tokai in Cambridge. (Jesse Costa/WBUR)

A few weeks after we met Kramer at the clinic, we catch up with her doing something else that before ketamine was overwhelming. She’s shopping at a mall in Cambridge, in her favorite shop for art supplies, the Japanese store Tokai.

Kramer has brought along a small gift box she covered in turquoise paper. It holds eight ornate glass fridge magnets lined with pretty bits of mulberry paper. She made them, and she’s going to ask the store manager if he’d like to sell them at the shop. That’s another huge step for her. He’s not in, and she says she’ll come back later.

When we ask her how she’s feeling today with the help of the ketamine, she says it’s tough to answer.

“Right now, thanks to ketamine, I can really tell you better what I don’t feel,” she reflects. “I don’t feel despair. I don’t feel hopeless. I don’t feel trapped on earth.”

Related:

Unequal Cancer: Leukemia Study Finds Children In Poverty Face Earlier Relapse

Unequal Cancer: Leukemia Study Finds Children In Poverty Face Earlier Relapse

How might poverty impact childhood cancer?

That’s the question pediatric oncologist Dr. Kira Bona, a researcher at Dana-Farber/Boston Children’s Cancer and Blood Disorders Center, set out to answer.

Her findings: Even with the same medical treatment, children with leukemia living in high-poverty areas were more likely to suffer an early relapse compared to their wealthier counterparts. The research, published this week in the journal Pediatric Blood & Cancer, is important, Bona says, because earlier relapses of this particular cancer — the most common pediatric cancer, called acute lymphoblastic leukemia — are harder to treat successfully.

We already know poverty is bad for your overall health. Among children, Bona says, poor kids tend to have worse underlying health, and higher rates of hospitalization, infectious disease and risk of death compared to more affluent children.

(DebMomOf3/Flickr)

(DebMomOf3/Flickr)

When it comes to cancer treatment though, for the 15,000 American children diagnosed with cancer every year, most are enrolled in clinical trials and treated using similar protocols, Bona said. Still, she said: “Historically, in pediatric oncology, we haven’t included social determinants of health, like poverty and education, as part of the data we collect in clinical trials; we’ve had an almost exclusive focus on biology.”

But since about 20 percent of kids in the U.S. live in poverty, Bona says, that non-biological data is also critical.

I spoke with Bona more about the latest research. Here, edited, is some of our discussion:

What’s the bottom-line finding here?

We looked at 10 years of data; 575 kids ages 1-18 who were treated at major academic medical centers around the U.S, with uniform therapy as part of the same two consecutive clinical trials. We went back and analyzed disease outcome data — overall survival and relapse data — with the question: Does poverty impact these disease outcomes? We used a proxy for poverty, zip codes linked to U.S. census data, to determine high-poverty or low-poverty areas.

We did not see a significant difference in overall survival between high-poverty and low-poverty groups. Additionally, we did not find a significant difference in relapse rates. But we did see a significant difference in the timing of relapse. And the timing of relapse is important, because if you experience an early relapse it’s harder for us to ultimately cure you.

In our study, among kids who relapsed, 92 percent of relapses from high poverty areas were early relapse (defined as relapsing less than 36 months after achieving remission) compared to 48 percent in low poverty areas.

[Overall survival for kids with acute lymphoblastic leukemia is around 90 percent. In the new study among children from high-poverty areas, 85 percent survived five years or longer, compared with 92 percent of other children but this difference was not statistically significant after controlling for other risk factors.]

What does this difference in relapse timing mean?

Prior studies have demonstrated that poor children with leukemia have lower overall survival but those studies have been done at a population level….and didn’t have data from a uniform care setting.

Our data demonstrate that there is in fact a disease outcome disparity due to poverty even when we treat children with the best available care. The reason that’s important is it suggests an opportunity to improve current outcomes if we include poverty and the social determinants of health when we treat and study cancer.

What do you think is going on here? Why are poor children faring worse?

We have two hypotheses:

One is that poor children in the U.S. have worse underlying health. if you present with leukemia and have worse underlying health, you might experience more complications of the chemotherapy we give you, and we know complications of therapy that land you in the hospital or ICU can cause delayed chemotherapy administration or reduced doses of chemotherapy. It’s possible that could explain the earlier relapse. it’s something we have to study further.

There’s also a body of literature that has shown poor families across many diseases have a harder time with adherence to oral medications, and the reasons for that are many, whether it’s because you can’t afford the co-pay for a prescription, or your mom is working three jobs and can’t give you medication at night. If poor children with leukemia had poor adherence to their chemotherapy that could worsen outcomes. (Acute lymphoblastic leukemia therapy lasts for two years — the first month and a half is in the hospital, the rest is outpatient chemotherapy, including a combination of clinic visits and oral chemotherapy administered at home by parents.)

So what’s the next step in research?

This is something we are going to be looking at on our next ALL trial, a prospective trial, opening in the fall.

We will be measuring income at the time of diagnosis; and also what’s called ‘material hardship,’ that is food, housing, energy insecurity. In an earlier study we found that one-third of families of children with cancer suffered from material hardship six months after treatment began…

But these are remediable domains of poverty; these are concrete resource needs that can be fixed with interventions.

I just want to emphasize that from my standpoint the take-away of this is that poverty-related outcome disparities exist in pediatric ALL despite highly standardized care, and this suggests a significant opportunity for us as a field to systematically incorporate poverty (and other social determinants of health) into every subsequent trial we run for kids with cancer. If poverty, in addition to biology, is impacting outcomes we have an opportunity to improve outcomes by designing targeted adaptations in care to address it.

mercredi 24 février 2016

Gov. Baker Appears To Be Growing Frustrated With Lack Of Movement On Opioid Bill

Gov. Baker Appears To Be Growing Frustrated With Lack Of Movement On Opioid Bill

Gov. Charlie Baker listens as President Obama speaks during a meeting with fellow governors at the White House on Monday. The governors spoke about the opioid addiction crisis. (Jacquelyn Martin/AP)

Gov. Charlie Baker listens as President Obama speaks during a meeting with fellow governors at the White House on Monday. The governors spoke about the opioid addiction crisis. (Jacquelyn Martin/AP)

As the second month of the year draws to a close, Gov. Charlie Baker appears to be growing more frustrated with the Legislature’s pace in passing his comprehensive opioid bill.

The legislation remains bottled up in a conference committee that’s working out the differences between the House and Senate.

“I’m hopeful that we’ll get something passed through the Legislature that we can sign and we can begin implementing … when [legislators] come back in January,” the governor said last November, after testifying in favor of his opioid bill. “If the clock’s still ticking and nothing’s happening in February or March, I’m going to start to get pretty impatient.”

And there has been progress. Last month, the House passed its version of the legislation, which is slightly different than the one passed by the Senate last fall. The major difference is the number of opiate-based pills a doctor could prescribe to a first-time patient.

A major provision of the package, the part banning the involuntary commitment of female opiate users to the state women’s prison in Framingham, was busted out of the overall bill, approved in its own right, and signed into law by the governor. But with March just a few days away, the governor says he’s worried that other initiatives will be vying for attention on Beacon Hill.

“We have four people a day dying in the commonwealth,” an increasingly frustrated Baker said Wednesday, after taking part in a State House event urging proper disposal of old medications. “We have legislation pending in a conference committee that everybody says they support, that everybody agrees would be a terrific set of tools to put in the toolbox to help us deal with the epidemic here in Massachusetts, and I’d like to see some action on that, yes. And I’d especially like to see it before, as I said, it gets lost in the sort of cacophony of the rest of the work that’s going to be going on up here between now and July.”

As for that conference committee, House Speaker Robert DeLeo says it met last Friday and made some headway, but couldn’t say when work might be finished.

“My feeling is, I don’t think there are any large, major [sticking] points,” DeLeo said after emerging from a House caucus Wednesday. “I think there are a number of small points that I think they’re just trying to address. But I can’t say there’s one major issue that’s really holding up the bill. I think there’s just a number of things we’re trying to factor how we address them.”

The opioid legislation is just one major piece of legislation still in conference.

Other bills being worked out include one that would revamp the state’s public records law, a solar energy bill and a bill eliminating the automatic suspension of drivers’ licenses of some offenders convicted of certain drug crimes.

Of course the major piece of legislation looming on the horizon is the state budget, which needs to be completed by July 1. The Legislature ends its session just 30 days later.

mardi 23 février 2016

Dana-Farber Cancer Institute Taps Leading Cancer Researcher As First Woman President

Dana-Farber Cancer Institute Taps Leading Cancer Researcher As First Woman President

Dr. Laurie Glimcher, who has long-standing ties to Harvard Medical School, will become the next president and CEO of the Dana-Farber Cancer Institute, it announced on Tuesday morning. Glimcher is currently dean of the Weill Cornell Medical College.

She’ll transition to Dana-Farber next January. Last April, Dr. Edward Benz had said he would retire in June 2016, but he will continue to lead Dana-Farber until Glimcher arrives.

“The opportunity to advance Dana-Farber’s groundbreaking research and improve the care available to patients with cancer is truly special to me,” Glimcher said in a statement.

Dr. Laurie Glimcher (Courtesy of the Dana-Farber Cancer Institute)

Dr. Laurie Glimcher (Courtesy of the Dana-Farber Cancer Institute)

Dana-Farber says Glimcher is widely considered a world leader in cancer research, highlighting her recent discovery of a critical signal pathway in tumor cells and immune responses that will translate into a new approach to cancer immunotherapy.

The hospitals’s board chair calls Glimcher an ideal choice for Dana-Farber.

“She is a distinguished immunologist, widely renowned for her work in one of the most promising areas of cancer research,” said Josh Bekenstein, chairman of the Dana-Farber Board of Trustees. “She has a deep understanding of the latest developments in cancer research and care, and a clear vision of how Dana-Farber can most powerfully affect the fight against cancer.”

Glimcher has led Cornell’s Medical College for just over three years. She moved to the job in New York City from Boston, where she was a professor of immunology at the Harvard T.H. Chan School of Public Health and Harvard Medical School.

Glimcher’s father, who she once described as a “larger-than-life figure,” was a biochemist at Harvard Medical School. She graduated from Radcliffe in 1972 and from Harvard Medical School in 1976. She has practiced at Brigham and Women’s Hospital in Boston and served in board or advisory roles at Mass General, MIT and the Broad Institute. Glimcher is board-certified in internal medicine and rheumatology.

She comes to Dana-Farber in a period of renewed optimism and excitement about cancer research. In January, President Obama launched his “moonshot” program, pledging to eliminate cancer as we know it. Glimcher said in an interview shortly after the announcement that it may be more realistic to think of cancer as a chronic disease. She says she’s inspired by the promise precision medicine offers for cancer, diabetes and depression. “We are at a moment in science with unprecedented potential,” she wrote last month for The Huffington Post.

Glimcher says a passion for immunology has kept her going for many years, especially while building a career and raising two children. She sits on the board of directors for Bristol-Myers Squibb and the Waters Corporations, experience she has said builds essential links between researchers and the private sector.

Glimcher’s Twitter profile describes “[a] scientist, a physician, an educator, a New Yorker, but also a mom & grandmom dedicated to extending & improving the lives of patients.”

Last spring, she urged the graduating class of Cornell Medical College to think of life as a story that is unfolding, and to remember that patients see their lives as stories too.

“Listening to the stories our patients tell helps us to become better doctors and leaders,” Glimcher said, according to a transcript of her speech. “It can give us clues into the kinds of treatment that someone may want or is willing to accept. It can help us understand what health and illness mean to different people. And it forces us to acknowledge that despite our professional competence, uncertainty and complexity lie at the heart of everyone’s life.”

Earlier:

Health Leaders Want Warnings Highlighting Deadly Risks Of Opioid, Benzo Combos

Health Leaders Want Warnings Highlighting Deadly Risks Of Opioid, Benzo Combos

Many patients who take an opioid to relieve pain also have anxiety, headaches or trouble sleeping and take a benzodiazepine like Valium or Xanax or Klonopin. But together, these two classes of drugs slow breathing and can be deadly, especially if the patient is using one or both of them to get high.

In 2013, traces of both drugs were found in one third of men and women across the U.S. who died from an unintentional overdose. In Massachusetts, 13 percent of overdose deaths in 2014 involved heroin in combination with a benzo.

Public health leaders are calling on the FDA to make sure doctors and patients understand the risks.

Officials from 17 states and 13 cities have signed a petition asking the FDA to place a black box warning on prescription packaging for opioids and benzos. They also want medication guidelines that tell patients that taking these two drugs at the same time can increase the risk of overdose.

“Black box warnings work, we know they do,” said Rhode Island Health Director Nicole Alexander-Scott. “Doctors pay attention to them and they change their clinical practice.”

Massachusetts Commissioner of Public Health Monica Bharel signed the petition, as did Boston Public Health Commission Director Monica Valdes Lupi.

“Strong and accurate prescription drug labeling is critical to our efforts to inform residents about the dangers inherent in prescription drugs,” Jennifer Tracey, director of the city of Boston’s Office of Recovery Services, said in a statement. “We need to work at all levels of government on policy and systems changes like these to prevent potentially deadly drug misuse and abuse.”

The FDA responded to the petition with a statement.

“The FDA is committed to working with the health care community and our federal, state and local partners to help reduce opioid and benzodiazepine misuse and abuse. We will continue to monitor the combined use of these products and take necessary actions to ensure prescribers and the public are informed of the risks involved with the use of these medications.”

Parents’ Depression May Impact Children’s Classroom Performance, Study Finds

Parents’ Depression May Impact Children’s Classroom Performance, Study Finds

A study found that depression in parents may negatively affect their children’s school performance. (Hadley Green for WBUR)

A study found that depression in parents may negatively affect their children’s school performance. (Hadley Green for WBUR)

Joshua Eibelman
CommonHealth Intern

Are your mood swings and depression hurting your children in the classroom?

A new study that followed more than a million Swedish children and their parents suggests the answer may be “yes.”

The Drexel University study, published in the journal JAMA Psychiatry, found that depression in parents may negatively affect their children’s school performance.

Researchers used Sweden’s computerized health and population records, allowing them to analyze parents’ inpatient medical records from 1969 onward and outpatient records from 2001 onward, as well as education records for all children born in Sweden between 1984 to 1994.

Led by Hanyang Shen, a Drexel alumna, the study looked at how depression in parents at various stages of their children’s lives — before birth, after birth, at ages 1-5, 6-10 and 11-16 years, and anytime before the final year of school at age 16 — was connected to school performance.

The study’s conclusion? Both “maternal depression and paternal depression at any time before the final compulsory school year were associated with worse school performance,” researchers wrote.

Specifically, depression in mothers was found to be linked to a 4.5 percent decrease in grades [grades or test scores? just checking], while paternal depression resulted in a 4 percent decrease, compared with children without depressed parents.

But even worse, low education [what does low education mean, and why is this here? you mean depression among those with less education?] in mothers may be a more profound factor in kids’ classroom performance: It’s associated with a 16.2 percent decrease in school grades.

Worryingly, maternal depression was more strongly associated with worse school performance for children than lower family income, which was linked to a grade decrease of 3.6 percent, researchers wrote.

Maternal depression seemed to have affected children’s grades the most at ages 11-16, with 5.1 percent lower grades in kids, while depression in fathers was most strongly associated with worse performance at ages 1-5, with a 4.1 percent decrease.

Conversely, depression in mothers had the smallest effect on kids’ academic achievements at ages 1-5, with only a 3.5 percent decrease in grades, while paternal depression was least associated with poor school performance right after birth, with a 2.3 percent decrease.

While the effects of maternal and paternal depression were similar overall, effects of maternal depression differed for girls and boys, while paternal depression had a similar effect on both girls and boys.

“Maternal depression episodes before birth and during child ages 6 to 10 and 11 to 16 years were more associated with school performance in girls than in boys,” researchers wrote in the study.

Interestingly, one of the study authors, Brian Lee, associate professor of epidemiology and biostatistics at Drexel, said in a phone interview that “to do an equivalent study like this in the entirety of the U.S. would be impossible due to how decentralized everything is.” [this seems like a last graf, an add on]

Asked what he thought was the most surprising part of the findings, Lee said in an interview he did not expect to find such long-term effects of parental depression on kids’ academic performance.

“Looking at the associations with the child’s school grades at age 16, even if there’s a decade’s worth of difference between depression and when school grades were assessed, there’s still an association, which I think is pretty interesting,” Lee said.

Though Lee emphasizes that the study did not investigate the mechanisms through which parental depression might negatively affects child school performance, he says that the fact that even prenatal depression was linked to worse academic achievement in kids indicates that there may be a genetic aspect to the problem.

Genes causing depression in parents may be passed on to kids, and Lee says that depression in kids has long been associated with lower grades in school.

Another, potential reason, researchers suggest: A child’s awareness of a mental health problem in a parent could also cause the child to worry and possibly do worse in school.

Still, Lee wouldn’t comment on whether genetics or environment — nature or nurture — or both, might be the root cause for the children’s worse school performance because the study did not pursue this question.

It is important to note that the study did not find a causal relationship between depression and school performance, so there is no evidence yet that poor grades are a direct result of depression in parents.

Another limitation of the study is that depression is often underdiagnosed, so the true number of cases of depression in parents is likely much higher than what was found by the study, according to the paper.

Additionally, although researchers wrote that they were unable to ascertain whether children lived with both parents for the entire duration of the study, depression in a parent living apart from a child could still affect him/her because of genetic factors.

Lee said parents should “realize that the negative effects of mental health problems can extend to immediate family members and others close to them, especially children who are young and vulnerable.”

Lee said he would urge parents concerned about their mental health (and the well-being of their kids) to seek treatment.

lundi 22 février 2016

Behind The Times: Pregnant Patient Asked About Travel To Ebola Region, But Not Zika

Behind The Times: Pregnant Patient Asked About Travel To Ebola Region, But Not Zika

Jaqueline Vieira, left, watches as her 3-month-old son Daniel, who was born with microcephaly, undergoes physical therapy at the Altino Ventura foundation in Recife, Brazil. (AP Photo/Felipe Dana)

A baby born with microcephaly undergoes physical therapy at the Altino Ventura foundation in Recife, Brazil. (Felipe Dana/AP)

Dr. Shira Fischer is a RAND Corporation researcher whose interests include using electronic health records to improve care. She also happens to be pregnant, and she went in recently to the obstetrical urgent care unit at Brigham and Women’s Hospital.

She got “swift and appropriate” care, she writes on The Health Care Blog in a post headlined: Electronic Health Records: From Ebola To Zika, Fighting The Last War. Just one little problem: She was asked if she’d recently visited a country with Ebola, but not Zika.

Let me not get too snarky about health systems that don’t keep up with huge international health news. But something is clearly wrong here, in this latest example of how electronic medical records often lag. Fischer writes:

The existing system is too slow to respond and when it does, it finds itself chasing the past. Like security protocols at airports, where travelers are required to remove shoes because someone in 2001 hid explosives in his sneaker soles, instead of anticipating the next creative attack, the U.S. public health system finds itself asking about yesterday’s Ebola and not today’s Zika, because the gears of change move too slowly.

But the limitation is not the technology. Technology systems should be the first to respond, even more quickly than official government responses. They should be deployed more nimbly to support faster, more informed decisionmaking. Just as my iPhone automatically receives Amber Alerts as soon as they are issued by authorities, EHR could easily reflect the most relevant public health issues. It is shocking that health care providers are still asking about Ebola when Zika is already all over the news. The tools and the technology exist, but smarter ways to use them must be implemented.

Read her full post on The Health Care Blog here. And just a note of self-congratulation: She writes on Facebook that WBUR’s Narrating Medicine — a platform for first-person writing by people in health care, from doctors and nurses to patients and caregivers — motivated her to write up this experience. Want to get in on the narrative action? Just request to join here.

vendredi 19 février 2016

Researchers Use Big Data To Seek ‘Unique Fingerprint’ Of Long-Term Lyme Disease Symptoms

Researchers Use Big Data To Seek ‘Unique Fingerprint’ Of Long-Term Lyme Disease Symptoms

In this 2014 file photo, an informational card about ticks distributed by the Maine Medical Center Research Institute is seen in the woods in Freeport, Maine. (Robert F. Bukaty/AP)

In this 2014 file photo, an informational card about ticks distributed by the Maine Medical Center Research Institute is seen in the woods in Freeport, Maine. (Robert F. Bukaty/AP)

By Richard Knox

One of the hottest fashions in science these days is Big Data: the idea that revelations can be teased out from great masses of information. Now, some researchers are using the strategy to pry open the black box of Lyme disease.

Four decades after the tick-borne infection first came to light in the vicinity of Lyme, Connecticut, the small world of Lyme-focused researchers isn’t even close to understanding why the disease often seems to plague its victims with disabling immunologic and neurologic problems that can persist for years.

Dr. John Aucott thinks Big Data can change that. “We’re really embarking on a new stage — a new era,” says Aucott, director of the year-old Lyme Disease Clinical Research Center at Johns Hopkins University School of Medicine.

The first step is to show that chronic Lyme disease “is a real illness,” Aucott says. “Many people don’t believe it exists because there’s no objective underpinning.”

That is, there’s no diagnostic test — a biological marker that’s present in people who suffer from chronic Lyme disease symptoms and absent in others. Consequently, the disorder widely called “chronic Lyme disease” is a grab bag of a diagnosis — and probably not one singular disorder.

“Chronic Lyme usually refers to a very heterogeneous population with nonspecific ailments,” Aucott says. “Some may be related to Lyme, others to other tick-borne infections or illnesses we can’t define accurately.”

Aucott and his colleagues have just published some of the first Big Data-derived evidence in the journal mBio. They’ve found a set of activated genes in immune cells of patients newly infected with the Lyme disease bacterium, compared to similar people without Lyme.

Intriguingly, some of these genes were still activated six months later, even among patients with verified Lyme disease who were successfully treated with antibiotics. Some of these genes overlapped with those activated in autoimmune diseases such as lupus and arthritis — a hint that the Lyme disease bacterium can have a lasting effect on the immune system, a leading hypothesis that has lacked concrete evidence until now.

Dr. Harriet Kotsoris, chief science officer of the Global Lyme Alliance, says the results are provocative. “It may finally start cracking the mystery of why people fail therapy and give us an insight of the genetic makeup of post-treatment Lyme disease syndrome,” she says. “And importantly, it may offer a diagnostic profile.”

One big problem is that patients who believe they have chronic Lyme disease can test negative for antibodies for the infection. That doesn’t mean they weren’t infected, but it does leave them in diagnostic limbo.

To uncover the gene-expression pattern, Aucott and his colleagues had to do 73 million gene sequence “reads” for each of the study subjects — 29 with Lyme disease and 13 controls. That’s the Big Data. They’ve since sampled the immune cells of 175 patients.

Next they’ll determine what proteins the turned-on genes make, which immune cells have the activated genes, and “the whole business” of what’s unique about Lyme disease patients, Aucott says.

“Maybe there’s a unique fingerprint,” Aucott says — a molecular signature that distinguishes patients who have symptoms such as fatigue, joint and muscle pain, and cognitive and sensory problems following initial antibiotic treatment of acute Lyme infection.

That would be a big deal. Perhaps one in five Lyme disease patients goes on to develop long-term symptoms. Since federal officials estimate around 300,000 Americans get Lyme every year — nearly all of them in the Northeast and upper Midwest — that could mean 60,000 of them may develop chronic symptoms. And those numbers accumulate year-upon-year.

Desperation And Despair

This situation frustrates doctors confronted with patients suffering post-Lyme symptoms. And it drives patients to desperation and despair. Heated controversies over what chronic Lyme is and how to treat it has attracted fringe-y practitioners and made many mainstream physicians wary.

“My family doctor said, ‘I can’t help you,’ ” says Sherrill Franklin, a 63-year-old Pennsylvania woman who says she’s suffered from Lyme-related symptoms on and off for 30 years. “Doctors are scared to touch it. They’re afraid they’re going to lose their licenses.”

There’s no doubt what caused Franklin’s initial illness back in 1986. The bite of a deer tick infected her with Borrelia burgdorferi, a bacterium which causes Lyme disease. (Mayo Clinic researchers recently identified a new tick-borne bacterial species that can also cause Lyme, though it produces slightly different initial symptoms.)

Soon after her tick bite, Franklin developed a sore throat and big bull’s eye rash followed by painful joints — typical hallmarks of Lyme, although they don’t appear in every case.

Two courses of antibiotics over the following two years made Franklin’s symptoms go away. Then in 2008 she got another tick bite. No one can say what caused the subsequent dizziness, vision problems, ringing in the ears, weight loss, muscle pain and extreme fatigue she suffered after that. She’s still not fully recovered.

It could have been reinfection with the Lyme bacterium. Or perhaps not; a blood test suggested it could have been anaplasmosis, another disease carried by ticks. Or maybe some of the Lyme bacteria evaded her long-ago antibiotic treatment and persist in her body somewhere — a current hypothesis that so far lacks evidence. Or possibly it’s just the way Franklin’s immune system reacted to the tick-borne infection(s).

Repeated courses of antibiotics, by mouth and IV, appear to have helped Franklin. “I’m better — like 85 percent of normal,” she says. “I usually can’t stay awake past 8:30 and I used to stay up ‘til midnight. I used to ice skate three times a week. Now I can’t do it at all. My ears still ring sometimes and I still have muscle aches. So something is still there. It could be permanent.”

Franklin’s story is typical of tens if not hundreds of thousands of Americans who have troublesome ailments following apparent Lyme disease infections.

‘We Don’t Have To Wait’

She also represents a different Big Data approach to the problem of just what ails these people.

Franklin is among 3,000 or so people who have agreed to submit detailed data on their illness — their illness history, treatments, symptoms, daily functioning, test results and other relevant data every three months going forward. The project also aims to upload patients’ test results, genetic profiles, if available, and input from their physicians.

The newly launched project is called MyLymeData, sponsored by a Web-based group called LymeDisease.org, which is headed by Lorraine Johnson, a Lyme disease patient herself.

“It’s time for us to turn to the tools of Big Data to try to solve the problems that have existed in Lyme for a long time,” Johnson says. “We have tools available we didn’t have 15 years ago. There hasn’t been an NIH study on the treatment of Lyme in 15 years. But we don’t have to wait.”

Johnson hopes to enroll thousands more patients. The aim is to identify patterns — such as what distinguishes patients who get well from those who don’t, which treatments work and which don’t, and whether having other infections or disorders affects their symptoms.

Johnson talked about the project at a Feb. 13 session of the American Association for the Advancement of Science in Washington, D.C., in which Aucott also participated.

Those in the field welcome the patient-generated Big Data project, says Kotsoris of the Global Lyme Alliance. But some point out the pitfalls in deriving self-reported data from self-selected patients — a method that can’t hope to match carefully vetted information from well-done conventional clinical studies.

Kotsoris agrees that “there will be a lot of data that will not be valid.” But she says if enough patients participate and the data are properly analyzed, large numbers of data points can wash out spurious leads.

“We can only hope that data analysts will find certain trends or patterns that give researchers clues,” Kotsoris says. “If you have significant numbers reporting the same thing, then you may say, ‘Aha! Let’s look at this, there may be something interesting here.’ ”

In general, she says, research in Lyme disease is “woefully under-funded” by the federal government. And more research is better than less.

Related:

jeudi 18 février 2016

The Upside of Alzheimers?

The Upside of Alzheimers?

(Timothy Kolczak/Unsplash)

(Timothy Kolczak/Unsplash)

Can Alzheimer’s ever heal relationships?

This week Modern Love: The Podcast (a collaboration between WBUR and the New York Times) explores the story of one family whose lives were changed–for the better–by the disease.

According to the National Institutes of Health (NIH), it is estimated that more than five million Americans suffer from the disease.  Known for it’s devastating symptoms–memory loss, mood and personality changes–Alzheimer’s ranks third nationwide in the leading cause of death just behind heart disease and cancer.

Narrated by the actor Michael Shannon, Robert Leleux’s Modern Love essay, “A Memory Magically Interrupted,” retells the story of his grandmother’s struggle with the disease.  While her memory was erased, her sense of humor remained.

“The wonderful thing about Alzheimer’s,” she would say, unfurling her arm like Bette Davis, “is that you always live in the moment.”

In an interview with WBUR’s Meghna Chakrabarti and New York Times Modern Love editor, Daniel Jones, Leleux remembers the “hundreds of letters” he received after the essay was published.

One man wrote of his long estrangement from his father–a difficult man who had survived Auschwitz.  Alzheimer’s changed his personality completely, erasing all memories of the trauma he had faced.  The man wrote that he was finally able to have a relationship with his father at the end of his father’s life.

To listen to this episode, click HERE.

Trial Opening For Medical Marijuana On Boston’s Border

Trial Opening For Medical Marijuana On Boston’s Border

Patient Service Associate Ashley Cabana dispenses 14 grams (1/2 oz) of Facewreck marijuana flower for patient Sam Brown. (Jesse Costa/WBUR)

Patient Service Associate Ashley Cabana dispenses 14 grams (1/2 oz) of Facewreck marijuana flower for patient Sam Brown. (Jesse Costa/WBUR)

Under the teal dome of a former bank lobby, Ashley Cabana pulls the top off a plastic storage box labeled “Facewreck.” Cabana rests the box on a glass counter and flaps the lid sending the aroma of marijuana toward Sam Brown.

“Yeah,” says Brown, breathing deeply. “Smells good.”

Brown, 32, will inhale more than than just the smell through a vaporizer, to relieve insomnia and anxiety.

“I’m using it to treat lifelong issues that I’ve treated through psycho-therapy and medication at various points,” Brown says. “This is another avenue like that.”

New England Treatment Access in Brookline, in a former branch of Brookline Bank. (Jesse Costa/WBUR)

New England Treatment Access in Brookline, in a former branch of Brookline Bank. (Jesse Costa/WBUR)

Brown is among the first wave of patients to shop at the New England Treatment Access (NETA) dispensary in Brookline. It’s open by appointment only for two weeks, a condition set in agreement with the town, where the main concern is crowds. This dispensary, just 300 paces from Boston, is the first within easy reach of the city and could be overwhelmed by patients. Brookline Public Health Director Dr. Alan Balsam says he and the chief of police are monitoring the situation.

“If we do do away with appointments and the volume does become an issue, we reserve the right to ask them to reinstate appointments,” Balsam said. “But I think once other dispensaries open in the Greater Boston area, the problem goes away.”

NETA staff say they’re confident they can manage an increased volume of patients while keeping up with demand. Some dispensaries that opened last year ran out of marijuana and had to close occasionally.

A sample of Facewreck marijuana flower in a display cabinet in the retail area of New England Treatment Access. (Jesse Costa/WBUR)

A sample of Facewreck marijuana flower in a display cabinet in the retail area of New England Treatment Access. (Jesse Costa/WBUR)

Brown chose Facewreck from a menu of eight varieties or strains of marijuana flower. The description for Facewreck says it “may be ideal for pain issues, energy and mood elevation.” The menu lists the concentration of each cannabinoid or compound in Facewreck and in all of the strains.

NETA plans to change the menu regularly, rotating between about 50 varieties it’s growing or plans to grow at a warehouse in Franklin. If patients don’t want the raw plant, there are pre-rolled joints, candy, tinctures or capsules.

There are no firm guidelines about which strain works for which ailments or how much to take. Many patients, like Brown, figure out what variety and dose works for them based on trial and error.

“I was self-medicating long before the medical option was legalized in Massachusetts,” Brown says, “so I’ve come to realize what works for me over the course of time.”

Before purchasing the Facewreck marijuana flower, Gene Wackrow checks out the product. (Jesse Costa/WBUR)

Before purchasing the Facewreck marijuana flower, Gene Wackrow checks out the product. (Jesse Costa/WBUR)

Other patients coming to the Brookline dispensary have used marijuana before, but maybe not for a specific medical purpose. The median age of patients is 47.

“We get a lot of people, the last time they tried this was in college many years ago,” says Norton Arbelaez, a consultant for standards and practices at the dispensary. “So we really need to understand the baseline knowledge of the product and from there we go to method of delivery.”

Salves, for example, might be effective for joint pain but not nausea.

At the counter, Brown watches Cabana drop handfuls of Facewreck onto a scale then pour the half ounce of glittering bright green buds into a tamper-proof black plastic container.

“Can I get you any more flower today?” Cabana asks.

Brown is ready to pay and hands Cabana a credit card.

His total, $145, will be processed as a debit.

New England Treatment Access has a somewhat unusual pricing model. All varieties of marijuana flower are the same price every day. But Arbelaez says he can not talk about the dollar figures, except directly with patients.

“We can’t publicize prices, that’s part of the DPH rule,” Arbelaez said.

Department of Public Health rules say dispensaries can not advertise prices. There was concern, when the regulations were written, about the effect of publicizing dispensary prices. If dispensary prices were low, might patients be encouraged to sell the marijuana they bought legally, for a profit on the street?

A few dispensaries are pressing DPH to lift this restriction and some consumer groups may join the call.

“From a consumer’s perspective, what’s important is to know what the cost is ahead of time, to be able to budget the therapy, and not to be surprised once they’re already present at a clinic to fill a prescription,” said Health Care For All Director Amy Whitcomb Slemmer.

That pricing rule and some of standards for testing marijuana are in discussion as dozens more dispensaries move through the state application process. The state issued new testing protocols last week, but some dispensaries say they are still overly restrictive without improving safety for patients.

With NETA in Brookline and Patriot Care in Lowell, as of Feb. 16, there are now six medical marijuana dispensaries open in Massachusetts. And patient demand continues to climb.

The state's tally of medical marijuana patient numbers as of Jan. 31. (Courtesy Massachusetts Department of Public Health)

The state’s tally of medical marijuana patient numbers as of Jan. 31. (Courtesy Massachusetts Department of Public Health)

mercredi 17 février 2016

Testosterone For Older Men: Major Study Finds Modest Benefits, Mainly Sexual

Testosterone For Older Men: Major Study Finds Modest Benefits, Mainly Sexual

(Anokarina/Flickr Creative Commons)

(Anokarina/Flickr Creative Commons)

It’s controversial territory, the whole “Low T” arena, and will likely long remain so. But at least some serious data points are beginning to emerge in the form of the Testosterone Trials: a major set of government-funded, double-blind, placebo-controlled studies just published in the New England Journal of Medicine.

The seven linked trials examined the benefits of a year of testosterone gel (vs. placebo gel) in more than 700 men over age 65. It found those benefits to be “moderate,” and mainly for sexual function. Not vitality. Not much for physical functions like walking. A bit for mood. Overall, the Mighty T of the infomercial world is looking more like the modest T.

I spoke with Harvard Medical School’s Prof. Shalender Bhasin, director of the Research Program in Men’s Health: Aging and Metabolism at Brigham and Women’s Hospital and one of the lead researchers on the Testosterone Trials. Our conversation, lightly edited:

How would you sum up these findings?

The main finding of the Testosterone Trials was that testosterone treatment of older men with low testosterone levels has certain benefits, but the size of the benefits was modest. Testosterone improved all aspects of sexual function: It improved sexual activity, sexual desire, erections. Again, the magnitude of the effect was small, much smaller than the effect from previously approved medications for erectile dysfunction such as Viagra and Cialis.

The benefits on physical function and vitality were unclear. There was no improvement in vitality and there was a small improvement in walking ability whose clinical meaningfulness is not clear at the present time. And there was some improvement in mood. The trial was mostly an efficacy trial, so the long-term safety of testosterone still remains unclear. We need larger studies to address the issue of long-term safety, so that the risk-benefit ratio can be appropriately evaluated.

I must say that given all the buzz around testosterone, and the advertisements, the efficacy seems to be kind of underwhelming, doesn’t it?

Yes, the conversation around testosterone’s benefits and risks has been very schizophrenic. A lot of the discussion is conflated because people confuse hypogonadism — due to known diseases of the testis, pituitary and the hypothalamus — with age-related decline in testosterone concentrations.

Testosterone is currently approved by the FDA for treatment of hypogonadism in men due to known diseases of the testis, pituitary and hypothalamus, but neither the long-term risks nor benefits of testosterone were known prior to the Testosterone Trials. There have been many small studies but none adequately powered to determine the effects in older men who had low testosterone levels for no discernible reason other than age, and who also had symptoms. So this is a landmark set of trials in that these trials were adequately powered for efficacy, they recruited men who had clearly low testosterone concentrations and who had symptoms.

What do those symptoms tend to be?

To enroll in one of the three major testosterone trials, the participants had to have either sexual symptoms — low libido; physical symptoms — difficulty in walking and low gait speed; and low vitality or fatigue.

How do you imagine these new data playing out in the doctor’s office?

I think there are a couple of things that are clear, which doctors can use in their conversations with patients who are seeking testosterone therapy.

From this trial, and from a previous trial which we published last June, in which we included men with no symptoms and normal testosterone concentration, it’s clear that testosterone does not improve sexual function in men who have normal testosterone concentrations.

The second point is that in men who have low libido and low testosterone levels, testosterone improves sexual function modestly.

The third point is that there are two aspects of the clinical decision to consider in choosing a treatment: The potential benefits of the treatment, and then the potential benefits of the treatment in relation to the potential risks. This set of testosterone trials were designed to determine efficacy; they were not statistically powered to determine long-term risks, particularly cardiovascular and prostate risks. So I think the risk-benefit ration still remains unclear, in need of much larger and longer trials.

And though the results are mixed, there is a real suggestion of possible cardiovascular and prostate risks — even though they’re unclear, right?

Those are potential risks, but we don’t know whether they are real risks, whether testosterone increases the risk of prostate cancer or of cardiovascular events. And so that’s an important part of the clinical decision-making for which we do not have definitive data from this trial or any other trial.

So with these trials, patients are hearing about the benefits before they’re hearing about the risks. It seems a little fraught with peril, doesn’t it?

You’re exactly right: The results need to be viewed in the context of the fact that these were efficacy trials, they were not designed to establish long-term safety. And, in addition, the treatment effects were modest.

So the doctor says to the patient, we see some moderate benefits, and the risks are unknown, so therefore, caution?

I think it’s appropriate for doctors to consider these results in weighing the decision to treat or not treat. In older individuals who are experiencing distressing sexual symptoms and have consistently low testosterone concentrations, these results provide the basis for a conversation for prescribing testosterone with the admonition that the potential improvements in sexual function may be modest and that the long term risks remain unknown.

Some people draw potential parallels with Hormone Replacement Therapy in women. How do you see that?

That parallel has some historical resonance, in that the estrogen use peaked just before the major randomized trials were being published. And then, after the Women’s Health Initiative trial was published, estrogen sales plummeted. And now, estrogen sales have recovered quite a bit. We have come to an understanding that estrogen therapy is useful in a subset of women, but that it should be used in a time-limited manner, in a specific subset of women who are having vasomotor or other symptoms. We have a better understanding of the risks and benefits.

For testosterone, this is the first adequately powered set of efficacy trials, which now provide a context for the potential benefits, so this will be part of the conversation between doctors and men who seek treatment for age-related symptoms. But these trials were not designed to address the long term safety issue. So we still need larger trials, but the landmark Testosterone Trials have certainly advanced the field very substantially.

And there will be more trials soon to assess the risks better?

Those are needed. Of course, getting funding for such large trials is not easy. So it’s unlikely we’ll have data in the next year or two, but I think, given the need for such large-scale safety trials in light of the widespread and growing off-label use of testosterone in middle-aged and older men, such trials will be conducted. But it will be many years — at least six, seven, eight years — before we see data from these new large safety trials.

How Community Health Workers Act As A ‘Bridge’ For Patients Needing Extra Help

How Community Health Workers Act As A ‘Bridge’ For Patients Needing Extra Help

Guissela Mariluz, left, a community health worker at Rosie's Place in Boston, translates and negotiates a new plan for diabetes treatment for patient Luciana Joaquin with endocrinologist Dr. Devin Steenkamp. (Martha Bebinger/WBUR)

Guissela Mariluz, left, a community health worker at Rosie’s Place in Boston, translates and negotiates a new plan for diabetes treatment for patient Luciana Joaquin with Dr. Devin Steenkamp. (Martha Bebinger/WBUR)

When Guissela Mariluz calls every day, Luciana Joaquin remembers to take her pills for diabetes, anxiety and paranoia. When Mariluz doesn’t call and Jaoquin forgets to take her medication, she hears voices inside her head, reacts, and gets in trouble.

Like the time last year when Joaquin heard a threat: People were coming to invade the building, owned by the Boston Housing Authority, where Joaquin rents a one-bedroom apartment. Joaquin rushed into the hall to alert her neighbors.

“She started knocking on everyone’s doors, at 3 or 4 in the morning, so everyone could get out,” Mariluz recounted. “She was throwing things from her building down the stairs, things you can’t do in housing, but in her head she was doing it because she wanted to help.”

Joaquin’s misguided warnings almost got the generally demure, middle-aged native of the Dominican Republic evicted.

But Mariluz intervened, in her role as a community health worker. She’s one of at least 3,600 men and women in Massachusetts who help patients pay bills, arrange pet or child care so the patient can have surgery, or sit with them at an AA meeting. It’s a job that’s been taking shape for decades but is just now becoming a more formal profession. Massachusetts is finalizing rules that are expected to establish the first voluntary community health certification.

Mariluz is in a newly created position at Rosie’s Place, where the focus for decades has been on helping women find stable jobs and housing. The idea for her job took shape a few years ago when Rosie’s Place director Sue Marsh realized that about 20 percent of her clients were losing their housing, even though they could pay rent and utility bills.

“Their housing was relatively under control; what wasn’t under control was their health problems,” Marsh said.

A woman with diabetes who passed out when her blood sugar got too high might be sent to a nursing home and then be back on the streets. Women like Joaquin, with untreated mental health, bothered other tenants. So Marsh hired Mariluz and asked her to figure out what it would take to help about 20 women get control of their health.

Her first step: “to build trust,” said Mariluz. Then she established a routine with each woman: daily calls, restocking refrigerators, pills sorted into boxes marked “morning” and “night” each day, ad hoc exercise and addiction counseling, trips to the pharmacy or clinic or hospital.

Mariluz became the mom or grown son or sister that Joaquin and many women at Rosie’s Place do not have.

“They don’t have the daughter who goes with them to the doctor’s appointment and then hounds the home health agency to do what they’re supposed to do, or who reminds the doctor that the guest has an allergy to something,” Marsh said. “It’s running interference for somebody who has health problems and lacks that person in their lives to serve that need.”

Community health workers are running interference for all kinds of patients in all kinds of social service and health care settings. The job title covers more than 50 positions, including health care coaches, patient navigators and peer counselors.

Caitlin Allen, a research assistant at Emory University in Atlanta, surveyed community health workers across the country in 2014, four years after the Affordable Care Act “created a watershed moment” for the profession. She found that many doctors and nurses see the need for someone who can monitor or track patients between appointments.

“Community health workers can really become that bridge between the community and clinic that I think a lot of providers have been looking for for a long time,” Allen said.

But beyond the bridge, Allen said it often isn’t clear who the community health worker reports to, how much authority they have, or even just what they’re supposed to do.

Mara Laderman, a senior research associate at the Institute for Healthcare Improvement in Cambridge, said clinics and agencies that want to hire a community health worker must be prepared to define that role and train the new employee for a specific set of tasks.

“Organizations, both health care and community-based, that are thinking about bringing in a community health worker should not rely on them to serve as a one-size-fits-all solution to a heterogeneous set of problems,” Laderman said.

There are no national standards for community health workers and no required training or certification. The Massachusetts Department of Public Health is finalizing regulations for voluntary certification that would include 80 hours of training in 10 core areas.

Lissette Blondet, director of the Massachusetts Association of Community Health Workers, started crafting requirements for this field 25 years ago. In that quarter century, Blondet says one thing has not changed: Her members are in the job to give back.

“Many of them have walked the shoes of their clients, because of poverty or because they share the health issue, they understand the barriers, obstacles and issues that their clients are facing,” Blondet said, “so they can coach them in very pragmatic ways.”

Blondet says these workers, who often start at $12 an hour, save the health care system much more than they are paid. Preliminary results from a demonstration project, using community health workers to help children manage asthma in New England, show fewer hospital admissions and emergency room visits with savings of $1,104 per patient in one year.

Most community health workers are paid through short-term grants and change jobs frequently.

That’s not the plan for Mariluz, who is full time at Rosie’s Place. Joaquin and other women have become so dependent on Mariluz that when she takes time off, they fall apart.

“This is the product of me being out,” Mariluz said while walking down a hallway inside Boston Medical Center, flipping through Joaquin’s medical chart. Her blood sugar had been dangerously high recent mornings. Joaquin had stopped taking her pills at night.

When Joaquin’s sugar is high, she gets massive headaches and a racing heart. “The other day something happened in my heart, it was beating a lot,” Joaquin said in Spanish, patting her chest and sitting on an exam table in the officer of her endocrinologist, Dr. Devin Steenkamp.

The racing heart could also be a symptom of dehydration, Dr. Steenkamp told Joaquin. He was concerned and went over a new plan to get Joaquin’s blood sugar back into a stable, safe range.

“You can do it,” Steenkamp said to Joaquin, as Mariluz translated. “You have before.”

Joaquin nodded, a shy smile lights her face.

As long as she can keep her family, Joaquin said. All she has is Mariluz and Rosie’s Place.

“They’ve given me a lot of help and that’s been my saving grace because I don’t have any other help,” she said.