By Lisa Belkin, February 21, 2008, The New York Times – ONE of the first decisions you make in the emotional hours after a scary diagnosis is whether to tell others. Most of us share the news with our loved ones, but what of the circles beyond, particularly those at work? Your boss?
At first, Richard M. Cohen, whose multiple sclerosis was diagnosed at 25, did not tell. Mr. Cohen — whose latest book, “Strong at the Broken Places,” recounts the stories of five patients with chronic illnesses — was starting what would become a hard-charging career as a television news producer when he learned of his condition. He feared he would be considered unfit. He kept his secret for years despite failing vision and shaky balance.
Marlene Kahan, in turn, disclosed her condition right away. Four years ago, when she learned she had Parkinson’s disease, she had been the executive director of the American Society of Magazine Editors for more than a decade. With that longevity came security, she hoped.
Ms. Kahan was also afraid that the mix of symptoms and side effects from the treatments would leave her at “less than 100 percent,” she said, making it seem as if she was either slacking or even sicker than she was. “I didn’t want people to wonder and jump to other conclusions,” she said.
Gayle Backstrom, whose fibromyalgia, a chronic pain condition, was diagnosed decades ago, understands both paths. Still she advises to keep your condition to yourself for as long as possible, because that is safer.
The Americans with Disabilities Act prohibits an employer from dismissing or failing to hire a chronically-ill employee on the basis of that disability “if they are able to do the job with reasonable accommodation,” she said. But in many cases, “reasonable” and “able” and even “job” all become open to interpretation, said Ms. Backstrom, the author of “I’d Rather Be Working” (Amacom, 2002).
An excellent resource for workers facing this choice, she said, is the Job Accommodation Network, a service of the federal Department of Labor. Most questions on its site, she said, come from workers, not management, and “they are looking for suggestions on how to do adjust their work without bringing it to the attention of their bosses,” she said. They buy themselves custom footstools and wrist-rests, and sneak off to restrooms to take medications. To hide their condition on the worst days, they call in sick, giving a reason other than their chronic illness.
Mr. Cohen did that for nearly 10 years. In “Blindsided: Lifting a Life Above Illness,” he recalled an interview for a job as a producer on the “CBS Evening News with Walter Cronkite.” He asked a friend, Robert MacNeil, whether he should mention his multiple sclerosis. Recalling Mr. MacNeil’s answer, he wrote: “Say nothing. Your silence is an honorable dishonesty.”
Mr. Cohen got the job and was able to keep his secret with scrupulous attention to logistics, quietly using public transportation to conceal that he could not see well enough to drive. Years later, the executive who first hired him agreed that he had been wise to stay mum. “I am not proud to say this,” Mr. Cohen quoted the man as saying, “but I don’t think I would have hired you if I had known.”
Celeste Lee also chose to keep the details of her life from her employers for years. An autoimmune disease she developed in high school, 25 years ago, led to kidney failure. A transplant was initially successful, but eventually her body rejected the organ. That left her dependent on regular dialysis.
At first, she managed it on her own with a saline bag and an IV needle. She then worked as an administrator at a Boston law firm, and because the process took 15 minutes behind her closed office door, “it was something they didn’t really need to know,” she said of her employers and co-workers.
The timing was sometimes tricky, but life went on. She got her master’s degree, was promoted, married and had a son.
But after she moved to take a job at Duke University, the simpler form of treatment began to prove insufficient. She had to switch to hemodialysis, which required that she be hooked to a machine that cleaned her blood for three hours, three days a week.
Shortly after, she was offered her “dream job” as chief of staff to the chief executive of the Duke University Health System. The high-paced work would require 12- to 15-hour days. For the first time, she wondered whether her illness would hold her back.
She raised the issue in her interview. “At first they were uncomfortable because they thought that if they didn’t hire me I would accuse them of discrimination,” she said. “But I said: ‘No, we have to talk about this. It needs to be on the table.’ ”
She got the job. Now she is on the dialysis machine at the outpatient dialysis clinic at Duke by 7 a.m. on Tuesdays, Thursdays and Saturdays. On workdays she is at her desk by 10 a.m., respectable by most standards, but hours later than her arrival on nondialysis days. She also arrives feeling “hung over” from the six-pound weight loss post-treatment, she said, another reason why she felt she had to be upfront. “On Tuesdays and Thursdays, everyone knows that I can’t always be accountable for my personality,” she said.
Mr. Cohen eventually also revealed all once he had proved himself. He then went on to squint his way through the Solidarity protests in Poland and the violence in Beirut, once staring down Palestine Liberation Organization guards because he could not see the guns pointed at his head. Eventually he left breaking news for the slower pace of documentary television.
Now even writing books is increasingly difficult because of his worsening condition. He wrote most of “Strong at the Broken Places” with his left hand, because his right side doesn’t function well. The patients profiled in his book live nationwide, so he spent a lot of time in airports. “Picture it,” he said. “I am legally blind, I have trouble with mobility, I was constantly lost and under pressure to get from point A to point B. More than once I dropped everything I was carrying, because I do that, and I had tears in my eyes. I thought, ‘I can’t do this.’ ”
Yet he commutes daily to his office on the Upper West Side from Westchester, where he lives with his wife, Meredith Vieira, a host of “Today,” and their three children.
“Barbara Walters is always asking me, ‘Why do you do that?’ ” he said of his wife’s former colleague on “The View.” “Because I can. You do it until you can’t do it anymore.”
That is Ms. Lee’s mantra, too. In recent weeks her doctors have confirmed that she faces a new challenge: nephrogenic systemic fibrosing. It is essentially a thickening of the tissue or subcutaneous skin that can affect muscle and organ functions.
“At some point I have to consider whether I will have to bow out of this position,” she said. “But I want that to be my decision, and I won’t make it until I have to.”
By Nate Chinen, February 21, 2008, The New York Times – Not quite a month ago the alto saxophonist Andrew D’Angelo had a major seizure while driving his elderly landlady to a store in Brooklyn. “I was convulsing all over the place,” he later wrote on his blog, “grabbing onto the steering wheel violently, biting my tongue and basically acting crazy.”
Fortunately, the driver behind him recognized what was happening, and after quite a bit more drama — in the ambulance, Mr. D’Angelo apparently tore through the straps of his gurney and tried to strangle an emergency medical technician — he underwent testing that revealed a large tumor on his brain.
Within days he was scheduled for surgery and had started writing about the experience at andrewdangelo.com. He was clear about the fact that he had no health insurance.
The health of jazz, as a topic of conversation, has long inspired a lot of hand wringing among sympathetic parties. When the focus turns toward the health of jazz musicians, the discussion assumes a different, less abstract character: solicitous and supportive. Most people who play jazz for a living are accustomed to self-reliance. When that system fails, they lean on one another.
“Since I’ve been on the scene, there have been benefits for musicians that were in need, unfortunately, because so many of us are,” the guitarist John Scofield said in the rear stairwell of the Village Vanguard on Monday night. Along with the tenor saxophonist Joe Lovano and the Vanguard Jazz Orchestra, he was playing a benefit for the bassist Dennis Irwin, who has recently been struggling with a spinal tumor.
“I’m lucky enough that I can afford health insurance,” Mr. Scofield continued, “but a lot of people can’t. On a jazz musician income they’re getting by from gig to gig, keeping the roof over their heads and feeding a family, and insurance doesn’t happen for them.”
Mr. Irwin, the regular bassist with the Vanguard Jazz Orchestra and a seasoned sideman who has logged extensive time with Mr. Scofield and Mr. Lovano, is another uninsured musician.
The sudden struggles of Mr. Irwin, 56, and Mr. D’Angelo, 41 — musicians equally beloved in different sectors of the New York jazz grid — have abruptly brought the issue of health care to the foreground within jazz circles. Their stories have resonated with musicians, who tend to absorb news of this sort with a tribal concern: jazz is a collaborative art, after all, even if its artists are the ultimate individualists. It may seem negligent that so many jazz musicians lack basic health-care coverage, but monthly fees through an organization like the Freelancers Union easily run to several hundred dollars, and these days many gigs in New York literally involve a tip jar.
The Vanguard sets were a great success, financially as well as musically (it was Mr. Scofield’s first time performing with the orchestra, and he nailed it). There will be another, bigger chance to support Mr. Irwin on March 10, when Mr. Scofield and Mr. Lovano spearhead an A-list benefit concert in partnership with Wynton Marsalis and Jazz at Lincoln Center. Proceeds will go to the Jazz Foundation of America, a nonprofit organization that provides aid to jazz and blues musicians.
Mr. Irwin, speaking this week from his Manhattan home, said he had just completed radiation treatments. His ordeal began in December with a mysterious back pain. The Jazz Foundation referred him to the Dizzy Gillespie Cancer Institute and Memorial Fund at Englewood Hospital and Medical Center in New Jersey, which regularly provides free treatment to jazz musicians. (Dr. Frank Forte, the institute’s director and a jazz guitarist, treated Gillespie there during the final months of his battle with pancreatic cancer in 1993.)
The Jazz Foundation does considerably more than steer musicians toward services. Its mission also involves protecting musicians from eviction, malnutrition and other misfortunes.
“We get 60 cases a week like this, each having its own urgency and desperation,” Wendy Oxenhorn, the executive director, said. Referring to Mr. Irwin, she added, “I’ve never seen an outpouring of so much for one musician.”
If that’s true, Mr. D’Angelo runs a close second. “I knew that I was loved,” he said this week, “and I knew that this musical community was close. But I had no idea the compassion ran this deep, and I mean that from the bottom of my heart.”
Mr. D’Angelo is a key figure in Brooklyn’s underground jazz scene, and part of a peer group that includes the guitarist Kurt Rosenwinkel, the drummer Jim Black and the saxophonist and clarinetist Chris Speed. He has a strong new album, “Skadra Degis,” on Mr. Speed’s label, Skirl, with Mr. Black and the bassist Trevor Dunn. Its release party had long been scheduled to take place Friday at the Tea Lounge in Park Slope.
The gig is still on, but now it will be one of more than a dozen benefits for Mr. D’Angelo, spread across the United States and Europe. Mr. Black, Mr. Speed and Mr. Dunn will perform, as will the multireedist Oscar Noriega and the drummer Matt Wilson, two more of Mr. D’Angelo’s close compatriots. A separate benefit is scheduled for next Thursday at Barbès, also in Park Slope.
Mr. D’Angelo has received financial support from both the Jazz Foundation and the MusiCares Foundation, a program of the National Academy of Recording Arts and Sciences. His operation was a success in the sense that most of the tumor was removed, with no adverse effects. But further analysis revealed that he has an especially serious form of brain cancer.
“The doctor said that without treatment, I will live for five years,” he wrote last Friday, after receiving the news. “Seems dismal and I’m unwilling to accept it.” He is likely to begin radiation treatment shortly, having ruled out further surgery.
Apart from the dramatic nature of their stories, Mr. Irwin and Mr. D’Angelo are sadly not exceptions. A few years ago, for instance, the tenor saxophonist Michael Blake had two operations for a ruptured appendix. Having no insurance, he chose Bellevue Hospital Center for its sliding-scale fee; he also received assistance from MusiCares. He still has no insurance, though he is obviously aware of the risks. (He just spent the weekend at Bellevue watching over Scott Harding, a prolific record producer and engineer who was critically injured in a car accident last week. Mr. Harding does not have insurance either.)
The situation is the same for Mr. Speed, who has spent a lot of time visiting Mr. D’Angelo in hospitals lately. “A lot of my friends, myself included, don’t have insurance, which seems really idiotic, especially now,” he said. “But it’s also very expensive to get coverage.”
It should be noted, too, that even musicians with health coverage encounter serious financial needs; this is one of the major areas of concern for the Jazz Foundation. The costs associated with an illness can go well beyond the literal costs of treatment, because a musician who is not working usually translates to a musician without an income.
Last October the pianist George Cables, who does have private health insurance, had simultaneous transplant operations, receiving a new liver and kidney. While the procedures were covered, he has not been able to earn a living during his recovery. So he was fortunate to have two all-star tributes presented in his honor recently, in San Francisco and New York. He received about $12,000 from each, he said.
But the money wasn’t the only benefit, so to speak. “One of the best things for me was how people came together, and expressed their concern, and expressed their support by coming and playing,” he said. “That was better than anything.”
Benefits for Andrew D’Angelo: Friday at the Tea Lounge, 837 Union Street, near Sixth Avenue, Park Slope, Brooklyn, (718) 789-2762, tealoungeny.com; Feb. 28 at Barbès, 376 Ninth Street, at Sixth Avenue, Park Slope, Brooklyn, (718) 965-9177, barbesbrooklyn.com. Benefit for Dennis Irwin: March 10 at the Allen Room, Frederick P. Rose Hall, Jazz at Lincoln Center, 60th Street and Broadway, (212) 721-6500, jalc.org.
By Sarah Lyall, February 21, 2008, The New York Times, LONDON — Created 60 years ago as a cornerstone of the British welfare state, the National Health Service is devoted to the principle of free medical care for everyone. But recently it has been wrestling with a problem its founders never anticipated: how to handle patients with complex illnesses who want to pay for parts of their treatment while receiving the rest free from the health service.
Although the government is reluctant to discuss the issue, hopscotching back and forth between private and public care has long been standard here for those who can afford it. But a few recent cases have exposed fundamental contradictions between policy and practice in the system, and tested its founding philosophy to its very limits.
One such case was Debbie Hirst’s. Her breast cancer had metastasized, and the health service would not provide her with Avastin, a drug that is widely used in the United States and Europe to keep such cancers at bay. So, with her oncologist’s support, she decided last year to try to pay the $120,000 cost herself, while continuing with the rest of her publicly financed treatment.
By December, she had raised $20,000 and was preparing to sell her house to raise more. But then the government, which had tacitly allowed such arrangements before, put its foot down. Mrs. Hirst heard the news from her doctor.
“He looked at me and said: ‘I’m so sorry, Debbie. I’ve had my wrists slapped from the people upstairs, and I can no longer offer you that service,’ ” Mrs. Hirst said in an interview.
“I said, ‘Where does that leave me?’ He said, ‘If you pay for Avastin, you’ll have to pay for everything’ ” — in other words, for all her cancer treatment, far more than she could afford.
Officials said that allowing Mrs. Hirst and others like her to pay for extra drugs to supplement government care would violate the philosophy of the health service by giving richer patients an unfair advantage over poorer ones.
Patients “cannot, in one episode of treatment, be treated on the N.H.S. and then allowed, as part of the same episode and the same treatment, to pay money for more drugs,” the health secretary, Alan Johnson, told Parliament.
“That way lies the end of the founding principles of the N.H.S.,” Mr. Johnson said.
But Mrs. Hirst, 57, whose cancer was diagnosed in 1999, went to the news media, and so did other patients in similar situations. And it became clear that theirs were not isolated cases.
In fact, patients, doctors and officials across the health care system widely acknowledge that patients suffering from every imaginable complaint regularly pay for some parts of their treatment while receiving the rest free.
“Of course it’s going on in the N.H.S. all the time, but a lot of it is hidden — it’s not explicit,” said Dr. Paul Charlson, a general practitioner in Yorkshire and a member of Doctors for Reform, a group that is highly critical of the health service. Last year, he was a co-author of a paper laying out examples of how patients with the initiative and the money dip in and out of the system, in effect buying upgrades to their basic free medical care.
“People swap from public to private sector all the time, and they’re topping up for virtually everything,” Dr. Charlson said in an interview. For instance, he said, a patient put on a five-month waiting list to see an orthopedic surgeon may pay $250 for a private consultation, and then switch back to the health service for the actual operation from the same doctor.
“Or they’ll buy an M.R.I. scan because the wait is so long, and then take the results back to the N.H.S.,” Dr. Charlson said.
In his paper, he also wrote about a 46-year-old woman with breast cancer who paid $250 for a second opinion when the health service refused to provide her with one; an elderly man who spent thousands of dollars on a new hearing aid instead of enduring a yearlong wait on the health service; and a 29-year-old woman who, with her doctor’s blessing, bought a three-month supply of Tarceva, a drug to treat pancreatic cancer, for more than $6,000 on the Internet because she could not get it through the N.H.S.
Asked why these were different from cases like Mrs. Hirst’s, a spokeswoman for the health service said no officials were available to comment.
In any case, the rules about private co-payments, as they are called, in cancer care are contradictory and hard to understand, said Nigel Edwards, the director of policy for the N.H.S. Confederation, which represents hospitals and other health care providers. “I’ve had conflicting advice from different lawyers,” he said, “but it does seem like a violation of natural justice to say that either you don’t get the drug you want, or you have to pay for all your treatment.”
Karol Sikora, a professor of cancer medicine at the Imperial College School of Medicine and one of Dr. Charlson’s co-authors, said that co-payments were particularly prevalent in cancer care. Armed with information from the Internet and patients’ networks, cancer patients are increasingly likely to demand, and pay for, cutting-edge drugs that the health service considers too expensive to be cost-effective.
“You have a population that is informed and consumerist about how it behaves about health care information, and an N.H.S. that can no longer afford to pay for everything for everybody,” he said.
Professor Sikora said oncologists were adept at circumventing the system by, for example, referring patients to other doctors who can provide the private medication separately. As wrenching as it can be to administer more sophisticated drugs to some patients than to others, he said, “if you’re a doctor working in the system, you should let your patients have the treatment they want, if they can afford to pay for it.”
In any case, he said, the health service is riddled with inequities. Some drugs are available in some parts of the country but not in others. Waiting lists for treatment vary wildly from place to place. Some regions spend $280 per capita on cancer care, Professor Sikora said, while others spend just $90.
In Mrs. Hirst’s case, the confusion was compounded by the fact that three other patients at her hospital were already doing what she had been forbidden to do — buying extra drugs to supplement their cancer care. The arrangements had “evolved without anyone questioning whether it was right or wrong,” said Laura Mason, a hospital spokeswoman. Because their treatment began before the Health Department explicitly condemned the practice, they have been allowed to continue.
The rules are confusing. “It’s quite a fine line,” Ms. Mason said. “You can’t have a course of N.H.S. and private treatment at the same time on the same appointment — for instance, if a particular drug has to be administered alongside another drug which is N.H.S.-funded.” But, she said, the health service rules seem to allow patients to receive the drugs during separate hospital visits — the N.H.S. drugs during an N.H.S. appointment, the extra drugs during a private appointment.
One of Mrs. Hirst’s troubles came, it seems, because the Avastin she proposed to pay for would have had to be administered at the same time as the drug Taxol, which she was receiving free on the health service. Because of that, she could not schedule separate appointments.
But in a final irony, Mrs. Hirst was told early this month that her cancer had spread and that her condition had deteriorated so much that she could have the Avastin after all — paid for by the health service. In other words, a system that forbade her to buy the medicine earlier was now saying that she was so sick she could have it at public expense.
Mrs. Hirst is pleased, but up to a point. Avastin is not a cure, but a way to extend her life, perhaps only by several months, and she has missed valuable time. “It may be too bloody late,” she said.
“I’m a person who left school at 15 and I’ve worked all my life and I’ve paid into the system, and I’m not going to live long enough to get my old-age pension from this government,” she added.
She also knows that the drug can have grave side effects. “I have campaigned for this drug, and if it goes wrong and kills me, c’est la vie,” she said. But, she said, speaking of the government, “If the drug doesn’t have a fair chance because the cancer has advanced so much, then they should be raked over the coals for it.”
By LINDA GREENHOUSE
Published: February 21, 2008
The New York Times – WASHINGTON — Makers of medical devices like implantable defibrillators or breast implants are immune from liability for personal injuries as long as the Food and Drug Administration approved the device before it was marketed and it meets the agency’s specifications, the Supreme Court ruled on Wednesday.
The 8-to-1 decision was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation.
In 2004, the administration reversed longstanding federal policy and began arguing that “premarket approval” of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.
The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws.
The case before the court concerned only medical devices that had gone through the premarket approval process specified by the Medical Device Amendments of 1976. Most devices now available reached the market through a different process, under which the F.D.A. found them to be “substantially equivalent” to those marketed before the 1976 law took effect.
The Supreme Court ruled in 1996 that this less rigorous approval process does not pre-empt state damage suits against the manufacturers of “grandfathered” devices.
Devices subject to the premarket approval process, and thus affected by the court’s opinion, tend to be more technologically advanced, expensive and, in some instances, risky.
Examples of devices that have been the subjects of recent lawsuits include an implantable defibrillator, a heart pump, a spinal cord stimulator, a drug-coated stent, an artificial heart valve, and prosthetic hips and knees.
It was not immediately clear how many of the thousands of lawsuits against medical device manufacturers would be affected, though some pending cases will almost certainly be nullified.
The decision, for example, does not foreclose lawsuits claiming that a device was made improperly, in violation of F.D.A. specifications. Cases may also be brought under state laws that mirror federal rules, as opposed to supplementing them.
Next Monday, the court will hear another F.D.A. pre-emption case, on whether a state case can be based on the claim that a drug maker committed fraud by misrepresenting or withholding information from the agency during the approval process. The administration is supporting the manufacturer in that case, Warner-Lambert Co. v. Kent, No. 06-1498, which concerns the diabetes drug Rezulin.
Writing for the majority in Wednesday’s case, Riegel v. Medtronic Inc., No. 06-179, Justice Antonin Scalia said that permitting state juries to impose liability on the maker of an approved device “disrupts the federal scheme,” under which the F.D.A. has the responsibility for evaluating the risks and benefits of a new device and assuring that it is safe and effective for its intended use.
A jury, looking only at the injured plaintiff, will tend to weigh only the dangers of a device and “is not concerned with its benefits,” Justice Scalia said, adding, “the patients who reaped those benefits are not represented in court.”
The decision affirmed the dismissal of a lawsuit by a patient who was injured during an angioplasty when a balloon catheter burst while being inserted to dilate a coronary artery. The device won F.D.A. premarket approval in 1994, two years before the incident. The patient, Charles R. Riegel, died after the lawsuit was filed, and the case was carried on by his widow, Donna.
The medical device statute contains a pre-emption clause that bars states from imposing “any requirement” related to a medical device that is “different from, or in addition to” a federal requirement. The question of statutory interpretation at the heart of the case turned on what Congress meant by “any requirement.”
Justice Scalia said that state tort law, by imposing duties of care on product makers, amounted to such an additional requirement. He said the 1976 law “speaks clearly to the point at issue,” regardless of the federal government’s previous or current positions.
Justice Ruth Bader Ginsburg, the solitary dissenter, said the court had misconstrued Congress’s intent in adding the pre-emption clause to the 1976 law. The purpose, she said, was to prevent individual states from imposing their own premarket approval process on new medical devices. Devices were not regulated under federal law at the time, and California and other states had stepped in to fill the vacuum by setting up their own regulatory systems.
That was all that Congress had in mind, Justice Ginsburg said, not “a radical curtailment of state common-law suits seeking compensation for injuries caused by defectively designed or labeled medical devices.” She said that Congress had passed the 1976 law “to protect consumer safety,” not to oust the states from “a domain historically occupied by state law.” The decision was at odds with the “central purpose” of the 1976 law, Justice Ginsburg added.
Crucial Democratic lawmakers appear to agree with Justice Ginsburg, including Senator Edward M. Kennedy, Democrat of Massachusetts, who heads the Health, Education, Labor and Pensions Committee and was the sole Senate sponsor of the 1976 legislation in question.
“In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices,” Mr. Kennedy said in a statement. He added: “Congress obviously needs to correct the court’s decision.”
Representative Henry Waxman, the California Democrat who is chairman of the House Committee on Oversight and Government Reform and was on the House panel that approved the 1976 bill, expressed a similar view.
“The Supreme Court’s decision strips consumers of the rights they’ve had for decades,” Mr. Waxman said. “This isn’t what Congress intended, and we’ll pass legislation as quickly as possible to fix this nonsensical situation.”
The Food, Drug and Cosmetic Act of 1938, under which the F.D.A. regulates pharmaceuticals, does not contain a pre-emption clause. Nonetheless, the administration is arguing in the case the court has accepted for its next term, Wyeth v. Levine, No. 06-1249, that pre-emption is implicit in the structure of the statute.
The Supreme Court’s interest in pre-emption is not limited to the medical arena. In a similar case decided on Wednesday, this one unanimously, the court ruled that the federal law that deregulated the trucking industry in 1980 pre-empted two recent laws adopted by the State of Maine to regulate the shipment of tobacco products into the state.
The state laws were intended to prevent children who were not of legal age to buy cigarettes from ordering them over the Internet. The laws placed responsibility on shippers and delivery companies to verify the recipient’s identity and age.
Justice Stephen G. Breyer, writing for the court in this case, Rowe v. New Hampshire Motor Transport Association, No. 06-457, said the state law “produces the very effect that the federal law sought to avoid, namely, a state’s direct substitution of its own governmental commands for competitive market forces” in a deregulated environment.
The active UHF RFID system, marketed by RFID ProSolutions, is designed to protect newborn babies, Alzheimer’s patients and other individuals staying in health-care facilities.
By Beth Bacheldor
Copyright RFID Journal LLC 2008, Used With Permission
RFID Journal – Feb. 13, 2008—RFID ProSolutions, a Canadian startup company specializing in RFID systems and integration, is now reselling an RFID-enabled system designed to protect newborn babies, Alzheimer’s patients and other individuals staying in health-care facilities. The BlueTag system, from Paris-based BlueLinea, leverages active ultrahigh-frequency (UHF) RFID tags embedded in bracelets and is currently used in 50 maternity wards in 10 countries around the world.
According to Jebb Nucci, RFID ProSolutions’ VP of RFID, the BlueTag system incorporates interrogators with integrated antennas, a computer and Blue Tag software, which contains a repository of each tag’s unique ID number and associated patient information. The RFID-enabled bracelet is hypoallergenic and waterproof, and can be worn on the wrist or ankle. Removing the device without authorization—if, for instance, someone were to cut the bracelet off—triggers an audible alarm. An alarm also sounds if anyone wearing the bracelet passes through a doorway equipped with the readers.
Four hospitals in France are presently using the BlueTag system, Nucci says, including the American Hospital of Paris and Montfermeil Hospital. “Montfermeil Hospital had some issues with babies being taken from their maternity ward over the past five years,” Nucci notes. “It is now considered one of the safest and most secure maternity wards in the greater Paris area. This new system has put their patients and staff more at ease, and has helped rebuild the hospital’s positive brand.”
Nucci says one key feature of the BlueTag system is that it helps prevent mothers and babies from prematurely leaving maternity wards. “Both [of the French] hospitals had experienced a high level of mothers and babies who would leave the ward before being properly discharged,” Nucci explains. “This was a major problem for nurses, because they would spend so much time looking for mothers and babies that were already gone. With the system in place, a mother and her baby must go see the nurses before leaving so they can deactivate and remove the baby’s tag to avoid sounding the alert on their way out.”
Since announcing the availability of the BlueTag system in the North American market in January, Nucci says, RFID ProSolutions has had several hospitals and retirement homes in the Montreal area express interest. “We are forecasting our first installation of the system in the spring of 2008,” he states.
The 747-bed Boston hospital has installed an RFID-based real-time location system throughout its 17 floors, enabling it to track thousands of medical devices.
By Beth Bacheldor
Copyright RFID Journal LLC 2008, Used With Permission
RFID Journal – Feb. 20, 2008—With a months-long successful pilot now complete, Brigham and Women’s Hospital (BWH) in Boston is taking its active RFID tracking system to new heights. The 747-bed nonprofit teaching hospital, affiliated with Harvard Medical School, has wired each of its 17 floors with a real-time location system (RTLS) and plans to expand the system to an adjoining facility opening this spring.
Altogether, about 8,000 medical devices will be tagged and tracked using the RTLS. Those devices include infusion pumps, continuous veno-venous hemofiltration (CVVH) machines for removing waste products from blood, and pulse oximeters that measure the oxygen saturation of a patient’s blood.
Radianse’s active RFID tags operate at 433 MHz and communicate with Radianse receivers via a proprietary air-interface protocol. The receivers—small box-shaped devices typically mounted on walls—communicate with BWH’s wireless local area network and relay the collected RFID data to a Radianse server. The receivers can interrogate a tag from up to 50 or 60 feet away, and can pinpoint its location within an accuracy of up to 3 feet. When three or more receivers pick up a tag’s ID number, Radianse software determines its location based on signal strength.
The system is in use within the hospital’s emergency department, surgery units, cardiac care, perioperative units and common areas. It will also operate throughout the new facility, the Carl J. and Ruth Shapiro Cardiovascular Center, which will connect to the main building via a bridge and tunnel.
The hospital’s initial deployment of the Radianse system took place in 2005. During that nine-month pilot, says Steve Schiefen, Radianse’s chief operating officer, BWH tagged five types of equipment, covering about 350 devices. To date, says Michael Fraai, the hospital’s director of biomedical engineering, BWH has tagged approximately 4,000 items.
Printed on each tag is a label printed with a bar-coded number identical to the unique ID number encoded onto the tag’s RFID chip. When staffers affix an RFID tag to a device, they use a handheld bar-code scanner to record the tag’s bar code. By using a bar-code reader, employees know with 100 percent certainty that the device is correctly matched to the ID of its own tag, and not to the ID number of another nearby tag.
“Bar-code readers have become very inexpensive and easy to use,” Schiefen says, making them an ideal solution to affix and associate RFID tags on devices that will be tracked by an RFID-enabled RTLS. Once a tag’s bar code is scanned, details about the tagged device, such as its make, model and assigned location—much of which the staff accesses from the hospital’s inventory management system—are then input and stored in the Radianse system.
According to Fraai, the system is already helping improve patient care, streamline patient flow and save the hospital money. “For tagging,” he says, “we identified the critical devices that can compromise patient flow—those are the devices that, if you can’t find them, patients can’t be treated.” Staff can use a nearby computer to access the Radianse application and select the device being sought. The software then locates the item and indicates its location, down to the room level.
The hospital is now starting to collect usage data that will help it determine just how many of each device it needs to maintain in inventory, as well as whether some items could just be leased. “Let’s say you need 10 IV pumps, but you can only get your hands on eight,” Fraai says. “So you keep 12 in inventory because with that many, you think you will be able to get your hands on at least 10.” But with real-time location data, the hospital will be able to keep close tabs on where each of the 10 IV pumps is at any given time.
And with the historical data, the hospital will be able to track how often each device is in use, and decide whether it would be more cost-effective to lease rather than buy. “Take the CVVH machines, for example,” Fraai explains. “According to the clinicians, they are always in use, but this system will provide us with data that is non-biased. “We might discover that 75 percent of the time, three of the CVVH machines were just sitting in the holding area. So maybe we’d decide to lease, rather than buy, additional machines.”
Additionally, Fraai adds, the hospital hopes to eliminate incidents in which devices simply go missing. For a while, staffers suspected some items were ending up in the laundry room after inadvertently being wrapped up in dirty linens as rooms were cleaned. To prevent this from occurring, the hospital has installed receivers in the laundry rooms. “We haven’t found any devices yet that I’m aware of,” he notes, “but that is why we put the antennas there.”
BWH expects its RTLS will save it $300,000 annually. Fraai says the equipment deployed for the 2005 pilot paid for itself within 15 months, and he expects the hospital to recoup the costs of implementing the RTLS throughout its facility (excluding the adjoining cardiovascular center) in about three years. “This system is relatively easy to use,” he says. “The staff that is using it, love it now.”
The light microscope launched modern biology in the seventeenth century, letting scientists view the components of life that exist far beyond the range of unaided human vision. But light travels in waves, and its wavelength prevents researchers from focusing on details below a certain size limit without creating interference. As a result, light microscopes cannot show details that are less than about 200 to 300 nanometers apart. This is fine for viewing a single cell, but look inside it and things blur. Even a cluster of proteins, each a mere three to 10 nanometers in size, appears as an indistinct blob. (A nanometer is a billionth of a meter; a human hair is 80,000 nanometers in width.)
Creative new techniques developed in the past few years, however, have extended the boundaries of what these microscopes can reveal. The latest approach, from the lab of Xiaowei Zhuang, professor of chemistry and chemical biology at Harvard and a Howard Hughes Medical Institute investigator, uses fluorescent molecules that can be switched on and off to create images with more than 10 times the resolution of traditional light microscopes.
Zhuang says that light, despite its limitations, has important advantages for viewing cells. Electron microscopy, though more powerful in resolution, requires that cells be killed and chemically fixed. With electron microscopy, she says, “You’re looking at a still image,” rather than capturing activity in a cell. Light, on the other hand, is noninvasive, so it can be used to image live cells; scientists can use a variety of stains and fluorescent tags that let them view specific proteins or structures of a cell in different colors. Ideally, Zhuang says, “one would want to have a method that combines the merits of both”: the high resolution of electron microscopes paired with the flexibility of optical microscopes.
Image courtesy of Xiaowei Zhuang
Using conventional imaging techniques, a circular piece of DNA (bottom left) appears as an indistinct blob when magnified (center). A new technique permits three-dimensional resolution 10 times better, revealing the crisp ring structure of the object (upper right).
The new technique, which Zhuang developed with graduate students Michael Rust and Mark Bates, makes use of fluorophores—molecules that absorb light and then fluoresce, emitting light at a different wavelength. Fluorophores have been used in microscopy for many years because they can be attached to specific molecules in cells, allowing scientists to track their location.
Normally, when a sample of fluorophores is exposed to light, they fluoresce in unison. Under an optical microscope, this sea of individual spots cannot be resolved if they are densely packed. Even so, Zhuang says, scientists have known how to determine mathematically the position of a single, isolated fluorophore by calculating the center of the fuzzy spot of light detected by the microscope. The trick was to find a way to turn the lights out on a group of fluorophores, allowing only a few at a time to light up so that the microscope could pick out individual spots.
Several years ago, Zhuang’s group discovered a fluorophore that has an on-off switch—when exposed to red light, it is inactive, but when exposed to green, it has the ability to fluoresce. “This was the additional step that allowed us to control how many molecules are active,” she says. Using this molecule, they can first turn off all the fluorophores with a red light, and then expose the sample to a small amount of green light—so small that only a few of the fluorophores will activate at a time. An image of those scattered fluorophores can then be made and their positions determined to within nanometer accuracy. By repeating this process many times to locate the position of all fluorophores, the scientists can create a whole image.
Zhuang’s team calls the method stochastic optical reconstruction microscopy, or STORM, and published a demonstration in a recent edition of Nature Methods. With this technique, “You’re going to get many of the advantages of optical imaging, but sharper and crisper by more than an order of magnitude [10 times],” she says. As an example, her team attached 20 to 40 fluorophores to a circular string of DNA and proteins and was able to resolve its ring-like structure, where conventional microscopy would have shown only a blob. Zhuang’s team is now hunting for other fluorophores that have the same ability to switch on and off, but in different colors.
The main drawback of the technique is the time it takes to gather multiple views and stitch them together. Creating an image can take a few minutes, making it best for viewing fixed structures. But Zhuang’s team hopes to improve it further, to be able to capture the movements of molecules in cells, which happen on the order of seconds to milliseconds. She says STORM is one of a few promising approaches that have the potential to turn high-resolution still images of the cell into live action. “We’d like to look at events in live cells with nanometer resolution, in real time,” she says. “That’s the hope.”
The five secrets of elderly men living to age 90 include regular exercise, not smoking, avoiding diabetes, blood pressure control and maintaining normal weight, a study of aging men said. This new study shows that these five behaviors are associated not only with living into extreme old age, but also with good health and independent functioning. All of these health habits are significantly correlated with healthy survival after age 90.
It’s not surprising that choices like not smoking are associated with longer life; however, it is significant that these behaviors in the early elderly years — all of them modifiable — so strongly predict survival into extreme old age.
“The take-home message,” said Dr. Laurel B. Yates, a geriatric specialist at Brigham and Women’s Hospital in Boston who was the lead author of the study, “is that an individual does have some control over his destiny in terms of what he can do to improve the probability that not only might he live a long time, but also have good health and good function in those older years.”
The study followed more than 2,300 healthy men for as long as a quarter-century. When it began, in 1981, the subjects’ average age was 72. The men responded to yearly questionnaires about changes in health and lifestyle, and researchers tested their mental and physical functioning. At the end of the study, which was published Feb. 11 in The Archives of Internal Medicine, 970 men had survived into their 90s.
There was no less chronic illness among survivors than among those who died before 90. But after controlling for other variables, smokers had double the risk of death before 90 compared with nonsmokers, those with diabetes increased their risk of death by 86 percent, obese men by 44 percent, and those with high blood pressure by 28 percent. Compared with men who never exercised, those who did reduced their risk of death by 20 percent to 30 percent, depending on how often and how vigorously they worked out.
Even though each of these five behaviors was independently significant after controlling for age and other variables, studies have shown that many other factors may affect longevity, including level of education and degree of social isolation. They were not measured in this study.
Although some previous studies have found that high cholesterol is associated with earlier death, and moderate alcohol consumption with longer survival, this study confirmed neither of those findings.
A second study in the same issue of the journal suggests that some of the oldest of the old survive to 100 years or more, not because they avoid illness, but because they live well despite disease.
The study of 523 women and 216 men ranging in age from 97 to 119 showed that a large proportion of people who lived that long and lived with minimal or no assistance did so despite long-term chronic illness. In other words, instead of delaying disease, they delay disability.
Dr. Dellara F. Terry, the lead author and an assistant professor of medicine at Boston University, said the study showed that old age and chronic illness were no reason to stop providing thorough treatment. “We should look at the individual in making treatment decisions,” Dr. Terry said, “and not base our decisions solely on chronological age.You don’t necessarily have to be in good health for all of your life to attain age 100,” she said “People can attain very old age even in the face of age-related diseases, while in some cases maintaining good physical function.”
New York Times – Now there is another reason to eat your vegetables. A new study suggests that certain vegetables may help older women keep their brains sharper.
The researchers found that over time women in their 60’s who ate more cruciferous and green leafy vegetables than other women did went on to show less overall decline on tests that measured memory, verbal ability and attention.
The vegetables include broccoli, cauliflower, romaine lettuce and spinach.
The federally financed study did not include men. But men would probably also show the effect, said Dr. Jae Hee Kang, an instructor at Brigham and Women’s Hospital in Boston. She spoke in a telephone interview before presenting the study yesterday at the International Conference on Alzheimer’s Disease and Related Disorders in Philadelphia.
Researchers also presented evidence at the conference that obesity, high cholesterol and high blood pressure could raise the risk of developing Alzheimer’s or other forms of dementia and that leisure activities with mental, physical and social aspects might reduce the risk of later dementia.
Dr. Kang’s study and the other two ”add to the growing understanding that we may be able to reduce our risk of Alzheimer’s by changing our lifestyles — losing weight, changing our diets and staying mentally and socially active,” said Marilyn Albert, who is chairwoman of the Alzheimer Association’s Medical and Scientific Advisory Council.
Dr. Kang emphasized that her findings needed to be confirmed by more studies.
She and her colleagues looked at 13,388 nurses participating in a long-running health study. They compared the participants’ answers to questionnaires about long-term eating habits over 10 years, when they were in their 60’s, to their performance in two test sessions when they were in their 70’s. Researchers noted how the scores declined in the two years between sessions.
The tests included tasks like remembering word lists after 15 minutes, naming as many animals as possible in one minute and reciting a list of numbers backward. A pronounced drop in performance on such tests may foreshadow Alzheimer’s disease.
Although most women in the study showed some decline, those who had habitually eaten the most green leafy vegetables showed less decline than those who ate the least, Dr. Kang said.
”It was almost like they were younger by one or two years in terms of their cognitive declining,” Dr. Kang said.
The differences were seen between participants who ate about eight servings rather than three servings of green leafy vegetables a week, and between participants who ate about five servings instead of just two servings of cruciferous vegetables a week.
Another new study found that obesity, high cholesterol and high blood pressure in middle age each added substantially to the risk of developing Alzheimer’s or other types of dementia. Each risk factor roughly doubled the risk, and participants with all three problems had six times the chance of developing dementia as those without any of the risk factors, said Dr. Miia Kivipelto of the Karolinska Institute in Stockholm, who conducted the study of 1,449 Finnish men and women.
The effects appeared in both sexes, although the obesity factor was slightly stronger in women, Dr. Kivipelto said.
Harvard Medical School Family Health Guide – Bacteria have a reputation for causing disease, so the idea of tossing down a few billion a day for your health might seem — literally and figuratively — hard to swallow. But a growing body of scientific evidence suggests that you can treat and even prevent some illnesses with foods and supplements containing certain kinds of live bacteria. Northern Europeans consume a lot of these beneficial microorganisms, called probiotics (from pro and biota, meaning “for life”), because of their tradition of eating foods fermented with bacteria, such as yogurt. Probiotic-laced beverages are also big business in Japan.
Enthusiasm for such foods has lagged in the United States, but interest in probiotic supplements is on the rise. Some digestive disease specialists are recommending them for disorders that frustrate conventional medicine, such as irritable bowel syndrome. Since the mid-1990s, clinical studies have established that probiotic therapy can help treat several gastrointestinal ills, delay the development of allergies in children, and treat and prevent vaginal and urinary infections in women.
Self-dosing with bacteria isn’t as outlandish as it might seem. An estimated 100 trillion microorganisms representing more than 500 different species inhabit every normal, healthy bowel. These microorganisms (or microflora) generally don’t make us sick; most are helpful. Gut-dwelling bacteria keep pathogens (harmful microorganisms) in check, aid digestion and nutrient absorption, and contribute to immune function.
The best case for probiotic therapy has been in the treatment of diarrhea. Controlled trials have shown that Lactobacillus GG can shorten the course of infectious diarrhea in infants and children (but not adults). Although studies are limited and data are inconsistent, two large reviews, taken together, suggest that probiotics reduce antibiotic-associated diarrhea by 60%, when compared with a placebo.
Probiotic therapy may also help people with Crohn’s disease and irritable bowel syndrome. Clinical trial results are mixed, but several small studies suggest that certain probiotics may help maintain remission of ulcerative colitis and prevent relapse of Crohn’s disease and the recurrence of pouchitis (a complication of surgery to treat ulcerative colitis). Because these disorders are so frustrating to treat, many people are giving probiotics a try before all the evidence is in for the particular strains they’re using. More research is needed to find out which strains work best for what conditions.
Probiotics may also be of use in maintaining urogenital health. Like the intestinal tract, the vagina is a finely balanced ecosystem. The dominant Lactobacilli strains normally make it too acidic for harmful microorganisms to survive. But the system can be thrown out of balance by a number of factors, including antibiotics, spermicides, and birth control pills. Probiotic treatment that restores the balance of microflora may be helpful for such common female urogenital problems as bacterial vaginosis, yeast infection, and urinary tract infection.
Many women eat yogurt or insert it into the vagina to treat recurring yeast infections, a “folk” remedy for which medical science offers limited support. Oral and vaginal administration of Lactobacilli may help in the treatment of bacterial vaginosis, although there isn’t enough evidence yet to recommend it over conventional approaches. (Vaginosis must be treated because it creates a risk for pregnancy-related complications and pelvic inflammatory disease.) Probiotic treatment of urinary tract infections is under study.
Probiotics are generally considered safe — they’re already present in a normal digestive system — although there’s a theoretical risk for people with impaired immune function. Be sure the ingredients are clearly marked on the label and familiar to you or your health provider. There’s no way to judge the safety of unidentified mixtures.
In the United States, most probiotics are sold as dietary supplements, which do not undergo the testing and approval process that drugs do. Manufacturers are responsible for making sure they’re safe before they’re marketed and that any claims made on the label are true. But there’s no guarantee that the types of bacteria listed on a label are effective for the condition you’re taking them for. Health benefits are strain-specific, and not all strains are necessarily useful, so you may want to consult a practitioner familiar with probiotics to discuss your options. As always, let your primary care provider know what you’re doing.