A new study has confirmed that bisphenol A leaches from those popular, colored plastic drinking bottles into people’s bodies.

A research team led by Karin Michels of the Harvard School of Public Health asked 77 students to consume beverages from stainless steel bottles for a week to rid themselves of BPA, which is normally cleared through the urine hours after consumption.

The students provided urine samples throughout the washout period and during the second week, when they consumed all liquids from polycarbonate bottles manufactured using BPA.

Week 2 specimens contained 69% more BPA than those from Week 1, and were equivalent to levels routinely observed in the general population. All other dietary habits were unchanged over the course of the study, leaving no doubt the BPA came from the bottles.

The study appears in Environmental Health Perspectives.

BPA makes those reusable plastic bottles more durable. It also prevents corrosion in the cans used for commercial soup and baby formula products.

Animal studies suggest that BPA causes developmental and endocrine problems. Recent human studies have linked urinary BPA concentrations to behavioral problems in children, reproductive problems, immune deficiency and an increased risk of diabetes and heart and liver problems.

Last year, amid growing concerns about its health effects, Canada proscribed the use of BPA in baby bottles.

The FDA says that BPA-laced products are safe, even for infants and children. In reaching that conclusion, it overruled its own advisory board which had chastised the agency for relying on industry-sponsored research in its analysis.

Steven Hentges, an American Chemistry Council official representing manufacturers, actually found the Harvard study results to be heartening.  To him, the study indicates “that even exclusive use of polycarbonate bottles does not lead to unusually high levels of bisphenol A in the urine.”

In 2006, Massachusetts enacted a law requiring that all residents obtain health insurance.

Ever since, developments there have been watched closely since what happens in the state might play out nationally should the Great American Health Care Do-Over include an individual mandate.

Unfortunately, the Bay State’s program has been plagued by unsustainable cost escalations since Day 1, and the situation has been exacerbated recently by recession-related budget shortfalls and rising unemployment.

It was a matter of time before cuts had to be made, and that happened yesterday when state policymakers announced they’re cutting $115 million, or 12% from the budget of Commonwealth Care, a centerpiece of the state’s initiative which subsidizes premiums for poor residents.

The cuts amount to a forced slowdown in Commonwealth Care enrollment. According to the Boston Globe, about 18,000 residents who qualify for subsidies but who have not designated a health plan will no longer be automatically enrolled in program.

Tentative cuts in dental coverage for 92,000 Commonwealth Care enrollees and health insurance for 28,000 legal immigrants have also been proposed, although these proposals  must be approved by governor Deval Patrick.

He has until Monday to decide.

Commonwealth Care currently has 177,000 members. It’s projected to have 212,000 by year end, 2010.

“No decision has been made’’ on the immigrant coverage issue, Leslie Kirwan, Patrick’s secretary of administration and finance told the Globe. “It’s certainly going to be at the top of the list’’ of items Patrick might restore to the budget, she added.

Leaders of Health Care for All, a Bay State consumer group, said the proposal would be tough on non-English-speaking residents who find it hard to navigate the complex enrollment process for Commonwealth Care.

“My concern is people will not get the care they need,’’ lamented the group’s representative, Lindsey Tucker to the Globe.

Biotech giant Genzyme has shuttered a drug production complex after discovering a virus in a bioreactor used to produce its best selling drugs, Cerezyme and Fabrazyme.

The virus, Vesivirus 2117, is not thought to harm humans, according to company officials. It does affect growth of the cells used to produce the drugs, however. The tainted plant will stay closed for at least 6 weeks while decontamination takes place.

For about 8,000 people worldwide, the drugs are life-savers, although the temporary interruption in production should not pose significant risks to them.

Cerezyme is used for Gaucher disease, a hereditary condition in which an inactive enzyme causes fats to accumulate in multiple organs. 

Fabrazyme is used to treat Fabry disease, another inherited enzyme deficiency that leads to fat build-ups in various organ systems as well.

As a result of the shutdown, Cerezyme patients could miss one or 2 treatments. Those taking Fabrazyme could miss up to 4 doses.

Patients usually receive IV infusions of the drugs every 2 weeks. Any missed doses will not result in significant health sequellae, since it takes more than a few missed treatments to result in significant reaccumulation of the fatty substances.

“It is not a life-and-death situation we’re dealing with here,’’ Henri Termeer, the company’s chief executive told the Boston Globe.

The production glitch will cost the company $200-$300 million in lost revenue, however. Last year, Cerezyme garnered $1.2 billion in revenue, about  a quarter of the company’s total. Fabrazyme generated $500 million.

“This is an unusual event, but they’ll solve it and go on,” Leerink Swann’s John Sullivan told the Globe. “Traditionally, in cases like these, you worry about a market share shift. With these products, that is not a consideration.’’

Massachusetts’ universal health care plan has increased the number of insured Bay State residents and caused the states’ already highest-in-the-nation health care costs to balloon 42% in just 3 years.

Now it’s time to pay the piper, and the Bay State’s Special Commission on the Health Care Payment System believes the way to do that is to implement a capitation model similar to the one that was ridiculed, then buried 15 years ago.

In proposing a system that establishes prospectively a single, comprehensive payment that covers all care for an entire year, Commissioners hope to discourage providers from offering unneeded tests and treatments, and encourage provider network development.

The networks would, they hope, more effectively manage care across the continuum of care and reduce errors in information handoffs.

The old fee-for-service system “has all the wrong incentives,” Dolores Mitchell, a Commission member told the Boston Globe. “People know the system has been dysfunctional for years.”

The Commission must still decide how quickly to implement the new payment mechanism, which necessitates a massive reorganization on the provider side, and how to split fees among PCPs, specialists and hospitals. That’s the La Brea of tar pits.

Capitation was popular during the heyday of managed care in the 1980s and early 1990s.

It caused many small practices to lose millions on very sick patients, and raised concern that physicians were denying patients necessary care in order to stay within budget.

Commissioners believe the state can overcome the former problem by setting aside a separate pool of funds for the very sick, or by insuring providers against large losses.

The denial of service issue, they hope, could be handled through close monitoring of the quality of care.

Data are filtering in on Massachusetts’ grand plan to extend health insurance coverage to virtually all Bay Staters. The good news is just about everyone’s covered. The bad news is just about everything else.

When it comes to controlling health care costs, the state’s performance has been abysmal. Experts recently predicted that the state will spend $600 million more in 2009 on health care than in 2006, a 42% bump.

Now comes troubling data on a measure of access to care, emergency room visit volume.

In theory, the state’s new law should cut the costly visits because more people have access to PCPs that can either treat health situations before they reach crisis proportions or prevent them altogether.

In fact, ER visits went up 7% and the cost per ER visit jumped 17% in Massachusetts between 2005 and 2007, according to data shared with the Boston Globe.

The fraction of ER visits for non-urgent matters that could have been handled by a PCP remained unchanged at an astonishingly high 47%.

Massachusetts officials said several more years were required before accurate assessments could be made regarding the impact of their law on access to care.

The law actually went into effect half-way through the data collection period used to make the conclusions above, so they may have a point there.

Still, many worry that simply extending health insurance coverage isn’t going to control costs or improve access. They say the state needs to beef up its PCP corps before the program can work.

“Just because you have insurance doesn’t mean there’s a [PCP] who can see you,” said Sandra Schneider, VP of the American College of Emergency Physicians. “I am not surprised that visits went up.”

In an effort to buffer or perhaps counteract private sector influence on the treatment decisions of its physicians, Partners HealthCare will soon enact new rules of engagement for its panels.

Partners, which includes Brigham and Women’s Hospital and Massachusetts General Hospital, has decided for example to prohibit its physicians from accepting gifts and meals from Big Pharma and medical device firms.

Also banned will be cross-country junkets as paid members of “speakers bureaus” and ghostwriting, a practice in which scientists allow themselves to be included as authors on scholarly manuscripts penned by folks on drug company payrolls.

The plan will also tighten rules on how and when drug reps can visit physicians in the hospital, and include disclosing to the public more information about the nature of the relationships its physicians have with Big Pharma. Details of this latter change have yet to be worked out.

“We don’t want our faculty being on the road” as “hired guns,” Mass. General president Peter Slavin told the Boston Globe. And those free meals are history as well because they don’t “promote a positive image of physicians and increase healthcare costs,” he added.

The new policies were announced months after congressional klieg lights found Harvard-affiliated psychiatrists that might have engaged in improper relationships with Big Pharma. 

Republican Senator Charles Grassley has for example, accused Joseph Biederman of failing to reveal he’d pocketed $1.5 million in fees from Big Pharma between 2000 and 2007.

The moves did not completely satisfy HMS professor and former New England Journal of Medicine editor Arnold Relman.  He told the Globe “there should be no, zero, industry funding for any particular educational program,” involving Harvard-affiliated physicians.

Massachusetts General Hospital can’t seem to get out of its own way lately.

Already in the doghouse with Bay state public health officials for high mortality rates in its cardiac cath program, the prestigious Harvard Medical School affiliate has suspended its pediatric cardiac surgery program after errors during 2 open-heart surgery procedures caused serious complications.

The public health officials, who have to be considering monthly parking permits in the lot on Fruit Street as a way to control costs, began looking into the incidents shortly after the General notified them last week.

Both babies survived the mishaps, although one sustained neurological damage and required transfer to Children’s Hospital across town.

Just 2 years ago, the General beefed up what had been a tiny pediatric cardiac surgery program by recruiting Jeff Myers, a specialist in the field.

The unfortunate development has reignited debate concerning the extent to which patient outcomes are compromised by policies, or the absence of same, that foster proliferation of multiple low-volume providers for complex, risky procedures like this one.

Children’s Hospital is located just 4 miles west of the General. It does 1,100 pediatric open-heart cases per year, making it the highest-volume program in the country.

The General has managed to log 90 cases in the last 20 months. Meanwhile, about 3 miles south of the General, Tufts Medical Center has a program that did 24 last year.

The General’s “numbers are pretty small” Peter Manning told the Boston Globe. The director of CT surgery at Cincinnati Children’s Hospital added, “when you get below 100 cases you really worry… whether the [surgeon] is doing enough to keep their skills up.”

The chairmen of 13 clinical departments at Boston’s Beth Israel Deaconess Medical Center agreed last week to donate $350,000 to help reduce the need for staff layoffs.
 
“This was a really easy decision,” Mary Ann Stevenson told the Boston Globe.

The Radiation Oncology chair added, “most of us have been longtime campaigners for the hospital. Most of us feel really strongly about where we work.”

And they’ve appealed to their physician colleagues and reports who are affiliated with the hospital to follow suit.

“We invite you to consider making as generous a contribution as possible,” the chiefs penned in a letter to 1,100 staff physicians that was obtained by the Globe. Donated funds “will support job preservation among the hospital staff (so) they can continue to provide great service to our patients.”

Beth Israel Deaconess is affiliated with Harvard Medical School. It announced last month that it faced a $20 million operating loss for the fiscal year, and planned to enact cost-reducing moves including RIFs as a consequence.

After that announcement, hospital CEO cum blogger extraordinaire Paul Levy began working with employees on money saving, job preserving ideas.

That let BIDMC reduce the number of layoffs from 600 to 150.

The ideas included a temporary halt in funding employees’ 401(k) and 403(b) retirement plans, suspending a planned 3% salary increase for certain employees, eliminating the annual employee barbecue and ending hospital reimbursement for staff cell phones.

In addition, Levy has cut his own pay by 10%, and that of his executive staff by 5%.

Hospitals across the country have seen patient volumes drop as the Great Economic Crisis prompts people to defer elective procedures. Inpatient volume at BIDMC is off 1% this year.

When Massachusetts treasurer Tim Cahill floated the idea of licensing a trio of slot parlors in the state, mental health and gambling experts said he was asking for trouble.

For fun-seekers susceptible to gambling addiction, those new video slot games might as well be crack cocaine, they claim. 

The computer-driven sound-and-light extravaganzas create an allure so strong it has prompted some to wear adult diapers so they don’t have to worry about bladder control when they get on a roll.

Video slots let players gamble rapidly. There’s no more waiting for wheels to stop, cards to flip or horses to run. That’s been replaced by a mash-up of colors, bells, crowds cheering “Wheel of Fortune!” and just the right amount of payouts.

The slots also generate a disproportionate share of near-wins designed to convince players their luck is about to change.

“Slot machines (are) more problematic than other types of gambling in terms of addiction,” Mark Griffiths told the Boston Globe.

The professor of gambling studies at England’s Nottingham Trent University noted that nearly 90% of calls to gambling help-lines in Europe involve slots.

But Holly Thomsen, spokeswoman for the American Gaming Association says that despite recent growth in gambling outlets across the nation, gambling addiction rates remain flat at 1%.

And the pragmatic Cahill argues that people are going to gamble anyway, in Rhode Island and Connecticut for example.

“All we’re saying is, let Massachusetts people do what they want with their money in their state,” he told the Globe.

Adding a skosh of reason to the endless cacophony emanating from Atkins advocates, Ornish impresarios  and South Beach braggadocios, scientists at the Harvard School of Public Health have shown they all work equally well and what really matters is total caloric intake…pure, plain and simple.

Frank Sacks and colleagues randomly assigned 811 overweight or obese men and women to one of 4 heart-healthy, reduced-calorie diets that differed in the proportions of carbohydrates, fats and protein.

They followed participants for 2 years, asking that they exercise for 90 minutes per week and inviting them to attend group support sessions along the way. There was some periodic individual counseling as well.

The dieters recorded details of their food intake and tracked progress on a Web site.

Eighty percent of the subjects hung in there for the duration. By 6 months they had lost an average of 13 pounds, and they weighed-in at a minus 9 soaking wet when the study ended.

But the key was that subjects in all 4 groups had lost the same amount of weight and reduced waist girth by the same 2 inches. And all 4 groups experienced similar, modest beneficial effects on serum cholesterol and triglyceride levels and blood pressure.

The most successful dieters were those who regularly attended counseling sessions. They were good for a drop of 22 pounds on average.

“It’s just the calories that count,” Sacks underlined for the Boston Globe.

“The most important thing…to lose weight is to choose a heart-healthy diet and to keep the amounts down.”

Scientists at Dana-Farber Cancer Institute and the CDC have produced monoclonal antibodies that can destroy most strains of flu virus, a new line of attack that promises to overcome the virus’ maddening ability to mutate and thus fool today’s vaccines.

Such antibodies “could provide broad protection against all seasonal and pandemic influenza A viruses,” according to Wayne Marasco of Harvard Medical School and colleagues.

The potion targets the flu virus near its base, a region that turns out to be genetically stable.

The base mediates viral entry into cells, Marasco’s team wrote in Nature Structural & Molecular Biology.

Today’s vaccines stimulate antibody production against the viral head, a region that demonstrates extraordinary genetic polymorphism. That’s why flu vaccines are useless after one year at best and queueing-up for a jab has become an annual ritual for millions.

Coauthor Ruben Donis of the CDC is confident his group has flu by the short hairs, pointing out to MedpageToday that “By mutating (at the base, the flu virus) commits suicide.” 

The monoclonal antibodies appear to work against multiple strains of flu, including H5N1 avian flu and the H1N1 Spanish flu strain that killed 50 million people in 1918.

They also were shown to prevent flu symptoms in animals even when given 24 hours after exposure to flu virus, so long as they’re given in higher but “achievable” doses, according to the scientists.

The next step is to see whether the antibodies work in ferrets, which strangely enough have immunologic responses to flu virus more like humans than any other species.

Clinical trials could begin in 2 years.
 
The Dana-Farber holds patents on the discovery of the static region and the monoclonal antibodies against it.

Bay State public health officials have discovered that the cardiac catheterization programs at Boston’s vaunted Massachusetts General Hospital and Worcester’s St. Vincent Hospital had unexpectedly high death rates in 2007.

In fact 43 of 1,543 patients undergoing the procedure at the General died and a ridiculous 16 of 112 patients died at St. Vincent.

That was significantly higher than state norms after accounting for severity of illness.

Hospital officials at both facilities attributed the high mortality rates to aggressive treatment strategies involving seriously ill patients, often at the request of family or referring physicians.

Which is better than leaving the old meat cleaver inside the body but it sure sounds like a quality problem in any case.

“Some of these patients are very difficult and quite ill,” St. Vincent’s CMO Octavio Diaz told the Boston Globe.  “Sometimes it’s very difficult to say no to those patients and their families.”

But he and Michael Fifer, director of the General’s cath lab promised to give it the old college try. They’re mandating a second opinion from a cardiologist before green-lighting caths on critically ill patients.

Conveniently, at the time of the announcement Paul Dreyer, the state’s director of healthcare safety and quality already had data in hand for 2008 and the death rates had settled down at both facilities so he saw no need to suspend the programs.

Which is good for everyone because that’s a story that would have gone national in a heartbeat.

So there’ll be a few extra inspections, an outside expert will fly in for a look before catching a Sox game and the shuttle home, maybe some extra documentation here and there and that’ll be the extent of it.

If Massachusetts Governor Deval Patrick has his way, the state’s major restaurant chains will soon be required to post calorie counts for all offerings, either on the menu or at the counter.

And public schools will have to measure the height and weight of all children in grades 1, 4, 7 and 10, determine which students are overweight using a BMI calculation, and report the results to parents or guardians.

Patrick’s anti-obesity proposals must first be approved by the Public Health Council and that is expected to happen shortly.

“Our approach here is comprehensive – like with smoking cessation and HIV-prevention, a single message is not enough,” state public health commissioner John Auerbach told the Boston Globe.

Massachusetts is one of the nation’s most health conscious states but even here the percentage of overweight or obese adults increased from 43% to 59% between 1990 and 2007. Meanwhile, a third of the state’s middle school and high school students are overweight, 3 times more than 20 years ago.

Massachusetts officials estimate that about 2,000 restaurants would be subject to the new rules, which apply only to chains having 15 or more stores in the state.

Massachusetts-based Dunkin’ Donuts said it embraced a “responsibility to provide health-related public information,” but whined that “for multistate operators…the complex, localized regulatory approach to menu labeling is costly and disruptive.”

New York City has required that fast-food chains post calorie counts on menu boards since April and the information surprised even Gotham’s health commissioner. 

“It was sticker shock,” Thomas Frieden told the Globe. “Who knew a bran muffin could have 450 calories?”

Omaha resident Pam Ford has participated in several clinical trials in the last 2 years. She likes participating in efforts to get low cost generic drugs on the market and doesn’t mind the free health care she gets along the way.

But these aren’t her primary motivations. “It’s absolutely to make extra money,” she told the Boston Globe, and if that’s the case, she’s not alone.

The US economy shed 2.5 million jobs last year, the most since 1945. No region or sector was spared and the unemployment rate stands at 7.2%.

Meanwhile Ford has pocketed $10,000 for her efforts, a nice supplement to what she makes from her cleaning business.

During the Great Economic Crisis of ’08-’09, record numbers of people are applying for positions in clinical research trials that pay participants up to several thousand dollars in return for a commitment of between a few and several weekends to various clinical protocols.

At Omaha-based Qualia Clinical Services for example, the participant database has risen from 9,000 to 16,000 in the last year. Qualia handles Phase 1 testing of generic drugs on healthy volunteers.

And the pool has grown more diverse than the usual college crowd, according to Steve Peck, director of operations. The trend is large enough to possibly convince some clinical research organizations to cease outsourcing early phase trials to developing nations like India.

The weakening economy has probably also helped increase plasma donation rates by 50% in the last 2 years, according to Josh Penrod, VP of the Plasma Protein Therapeutics Association.

Penrod added that payment is essential to assuring an adequate supply of blood products. Plasma collection centers develop their own payment rules, although overall compensation and time commitment remains a small fraction of that associated with clinical trials.

More than 11% of US children and teens take herbal supplements or another type alternative medicine, according to a study by the Centers for Disease Control and Prevention.

The study is the first to assess utilization of oral supplements, acupuncture, meditation and chiropractic care among children. The same study concluded that adult utilization of these treatments remained stable since 2002 at about 37%.

Herbal supplements were the most frequently used alternative therapy in all age groups. Children were particularly common users of Echinacea, fish oil, combination herb pills, flaxseed oil, and prebiotics or probiotics.

The most common symptoms triggering use of herbal supplements were head or chest colds, anxiety/stress and back or neck pain. Insomnia, attention deficit hyperactivity disorder and body aches made the top 10.

Kids were 5 times more likely to use alternative therapies if a parent or relative used them. Those with higher incomes and education, and those covered by private health insurance were more likely to use them than children who were uninsured or covered by public programs.

It’s hard to say whether this degree of utilization is useful or harmful since few of the therapies have been tested rigorously according to Richard Nahin, a study author head of the National Center for Complementary and Alternative Medicine.

The study relied on a 2007 survey of 23,000 adults representing themselves and 9,000 other adults who spoke for a child in their home.

The study did not examine use of vitamin and mineral supplements, folk medicine practices or religious healing.

Use of alternative therapies is likely much higher in immigrant communities, particularly those from China, Africa and the Caribbean.

Congratulations to Somerville, Massachusetts, Washington DC and 7 other cities!

The Robert Wood Johnson Foundation identified them as national innovators in the fight against childhood obesity. The honor comes with a cash payout from RWJF’s $44 million Healthy Kids, Healthy Communities program which hopes to spread fat-busting social innovations to 70 more communities.

Somerville attacked the scourge on many fronts. The city repainted crosswalks and added bike lanes. Public schools shelved deep fryers and replaced canned fruits with fresh produce. Elementary school kids maintained vegetable gardens on school grounds, and the Rec. Department offered low-cost dance classes.

As a result, Somerville 8-year olds gained one pound less than children in a control group over the course of a school year, according to Tufts nutritionist Christina Economos.

That’s not bad in a community where 44% of the kids are overweight or at risk to become so, and public health officials believe the gains will increase over time.

Since 66% of Somerville students hail from low-income families and half do not speak English in the home, there is hope the innovations can be reproduced in other locations that have been hit hard by the epidemic.

In the nation’s capital, the Summit Health Institute for Research and Education, along with 6 local agencies and community groups will receive $400,000 from RWJF to focus their battle against childhood obesity in Wards 7 and 8.

According to the RWJF Web site, Healthy Kids, Healthy Communities is a national program whose goal is to “implement healthy eating and active living policy- and environmental-change initiatives that can support healthier communities” across the US.

The program emphasizes reaching “children who are at highest risk for obesity on the basis of race/ethnicity, income and/or geographic location.”