HealthLawProf Blog

Editor: Katharine Van Tassel
Akron Univ. School of Law

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Saturday, March 22, 2008

Recycling "Single Use" Medical Equipment: Common Practice?

The Wall Street Journal ran a piece this past week discussing how many medical providers apparently re-use various medical equipment to save money.  Not just any medical equipment - but medical equipment labeled "single use."  Sounds a little "iffy" to me - even though I understand the profit-motive of the medical device companies. Journalist Laura Landro reports,

In a bid to save costs and stem a rising tide of medical waste, hospitals are recycling a growing number of medical devices labeled as single-use, from scissors and scrubs to the sharp blades surgeons use to saw through bones. 

Recycling medical devices labeled for single use is legal as long as certain Food and Drug Administration guidelines are followed. But the practice, which involves shipping devices to reprocessing facilities to be cleaned, sterilized and tested for reuse, has raised concerns about safety. Medical device makers say their single-use products are just that, and pose a higher risk of failure and harm when recycled. Reprocessing companies, hospital associations and environmental groups counter that the devices they reprocess are as safe as new thanks to modern sterilization methods, cost 40% to 60% less, and can eliminate thousands of tons of waste from landfills.

In January, after reviewing eight years of FDA data, the Government Accountability Office weighed in with a report concluding there is no evidence that reprocessed single-use devices create an elevated health risk for patients. About 100 devices -- just 2% of all devices labeled for single use -- are now reprocessed.

But while the GAO report tilts the debate strongly in favor of reprocessing and opens the door to more widespread use, device makers are sticking to their guns. They are lobbying in several states for legislation that would require health-care providers to obtain "informed consent" from a patient before using a reprocessed device during a procedure. Utah already has approved liability protections for original equipment makers, and other state bills include measures that would free original manufacturers from liability if a reprocessed device fails and causes injury or death.

Device makers maintain that their products labeled for single use aren't designed to hold up to harsh sterilization chemicals and processes. Even when the devices are sterilized, blood, tissue or other bodily fluids on porous surfaces and in tiny crevices could allow transmission of viral and bacterial infections, they say. In general, "single-use devices present an increased safety risk to patients because they are designed for optimal performance and safety in a single patient," says Tara Federici, vice president of technology and regulatory affairs at AdvaMed, a trade group that represents leading device makers.

For example, heart stabilizers, the devices used to position a beating heart during surgery, have hollow tubes and other parts that device manufacturers say could harbor blood and tissue and become weakened during reprocessing in ways that might not be evident during inspection. A study by the University of Minnesota of stabilizers made by Medtronic Inc. found that while new devices showed little or no manufacturing debris, a majority of reprocessed devices had corroded parts and traces of human hair and protein, bringing into question the effectiveness of the reprocessing efforts.

Last year, the FDA began requiring that reprocessed heart stabilizers undergo more rigorous premarket clearance reviews, and a Medtronic spokesman says the company plans to repeat the tests to see if the more stringent requirements improve performance. Until then, he says, the company stands by its position that the devices can't safely be reprocessed.

The Association of Medical Device Reprocessors, a trade group whose members reprocess the majority of devices, counters that it recycles only products made from rigid, hard metals or durable polymers and plastics that can safely be reused between two and five times, depending on the device. The group has petitioned the FDA to require new heart stabilizers to undergo the same premarket review as reprocessed ones, because the device itself is high-risk. Since 2001, the group notes, there have been 73 adverse events reported to the FDA involving devices used to stabilize the heart, including incidents in which pieces have broken off and fallen into the chest cavity.

Dan Vukelich, president of the group, says reprocessed devices can be safer in some cases because each must be inspected before reuse, while original manufacturers test new devices only in batches. He also contends that device makers label many products as single-use merely to be able to sell more new devices to hospitals and thwart competition -- a contention that medical device makers dismiss.

About $31.5 billion of single-use medical devices are sold annually in U.S. hospitals and surgery centers, of which around $150 million are recycled, according to Ascent Healthcare Solutions, a leading reprocessing company. John Grotting, Ascent's chief executive, estimates that about $3.6 billion of single-use devices are safe for reprocessing, which could save the health-care industry about $1.8 billion a year. Ascent hospital customers eliminated about 1,684 tons of waste from their local landfills last year, a 31% increase over 2006, by using reprocessed devices, Ascent says. . . . .

"Single-use labeling is a real scam for a lot of devices, and by not using reprocessed devices where possible it is wasteful and not environmentally responsive, since these items have to be disposed of as biomedical waste," says Kenneth Kizer, a consultant and former undersecretary for health at the U.S. Department of Veterans Affairs. "The reuse of medical devices that are labeled for single-use only is a well-established and safe practice regulated by the FDA and utilized by most of the top-ranked hospitals in the country."

Dr. Kizer testified last year at a congressional hearing that the VA could save up to $30 million in 2008 by using reprocessed medical devices. The VA, with 153 hospitals, has had a longstanding policy against the use of reprocessed devices on the grounds that it can't determine if they are safe, noting that manufacturers didn't design them to be used more than once and don't provide instructions on cleaning and sterilizing the devices. A spokesman says the VA reviews the policy from time to time but has no plans to change it at present.

The FDA has stepped up its oversight of reprocessing, including more plant inspections, after new legislation in 2002 began requiring devices to be labeled if they are reprocessed. The FDA says it is working on a new strategy for monitoring and communicating information about reprocessed devices, and conducting research on "acceptable" single-use device-cleaning criteria. . . .

Not quite sure about this money saving technique - I fear that it could lead to the situation we see in Nevada with all kinds of medical devices being "recycled" with harmful impacts. 

 

 

March 22, 2008 | Permalink | Comments (0) | TrackBack (0)

Friday, March 21, 2008

Fellowship Opportunities for Aspiring Law Professors

Professor Paul Caron of the TaxProfBlog provides an excellent listing of the many fellowship opportunites that individuals interested in teaching law may wish to research and pursue.  I know that many law students do not immediately think of teaching but it is a good resource that they may wish to consult in the future and some Alumni of your schools may wish to learn more about these opportunties.

March 21, 2008 | Permalink | Comments (0) | TrackBack (0)

Supreme Court Receives Request to Hear Sperm Donor Case

Law.com/Associated Press reports on a case recently presented to the United States Supreme Court.  The article states,

A Topeka, Kan., man wanting parental rights to children conceived with sperm he donated is taking his case to the U.S. Supreme Court. Attorneys for Daryl Hendrix on Monday filed an appeal with the Court, seeking to overturn a Kansas Supreme Court ruling last year.

In a 4-2 opinion on Oct. 26, the Kansas court said a state law that doesn't give sperm donors any parental rights unless there's a written agreement is indeed constitutional. The court said the decision upholding the 1994 law was the first of its kind in the nation because no other state has ruled on a provision requiring a written agreement between mother and donor. . . . .

Hendrix's case is the result of a dispute he has with the mother, Samantha Harrington. Hendrix and Harrington were friends for a number of years, and he agreed to donate his sperm to help her become pregnant. Harrington gave birth to twins in May 2005. No written agreement was signed between them, although Harrington is an attorney.  People who donate sperm at a sperm bank must sign a waiver to parental rights, and Hendrix signed nothing, Leving said, adding that Hendrix planned to co-parent the children. Harrington has maintained that she always intended to be a single mother. . . .

Yikes! 

March 21, 2008 | Permalink | Comments (0) | TrackBack (0)

Thursday, March 20, 2008

Better & Cheaper Health Care without Insurance

RNCentral.com blog has a great article by Chrisin Laun entitled, "How to: Get Better, Cheaper Health Care Without Insurance (25 Tips, Tricks and Resources)."  The list provides some valuable information for obtaining access to medical care such as:

  1. Take advantage of walk-in clinics. Chances are, if you just have a head cold or need a refill on a prescription like birth control pills, you don't need to head into a full-fledged hospital or even a traditional doctor's office. These facilities tend to be cheaper and can suit the needs of most people for any minor illnesses or medical issues. Major retailer Wal-Mart has even announced plans to open their own clinic, allowing you to get a diagnosis for your cold while you're picking up some chicken soup. Many chain drugstores like Walgreens and CVS already have this kind of clinic on-site.
  2. Consider alternative therapies. Chronic back pain and stress related illnesses, no matter how annoying they may be, may not always warrant a trip to the doctor's office. Many alternative therapies like massage and acupuncture can be just as effective and might save you a few dollars in the long run. Before starting any of these therapies, however, make sure you are in the proper condition to do so.
  3. Try a nurse. Nurse practitioners can often give patients just as good of care as doctors, but at a much lower cost. When care from the two are compared, studies have shown that nurses often have more time to spend with patients and do just as good of a job diagnosing problems. . . . . 

I think that some of my students will find this helpful. The article also discusses ways to gain access to pharmaceuticals and medical equipment.  Thanks to Sally Thompson for this article and for information about rncentral.com.

March 20, 2008 | Permalink | Comments (0) | TrackBack (0)

OB/GYN Ethics Rule Upset HHS

Late last year, the American College of Obstetricians and Gynecologists (ACOG) issued new ethics guidelines. Among other things, the new guidelines provide that physicians "have the duty to refer patients in a timely manner to other providers if they do not feel they can in conscience provide the standard reproductive services that patients request."

National Public Radio's Morning Edition reported today and yesterday on the involvement of HHS and HHS's assertion that such guidelines may violate federal "conscience" laws.  In a letter to the American Board of Obstetrics and Gynecology (ABOG), Health and Human Services Secretary Michael Leavitt stated that ob/gyns who have moral objections to abortion should have no obligation to refer patients.  NPR interviewed several individuals about the controversy and Julie Rovner stated in her report yesterday the potential consequences from the failure to refer for both women and physicians,

Ob/Gyn Wendy Chavkin of Columbia University welcomes the new AGOG ethics statement. She's the immediate past chairwoman of Physicians for Reproductive Choice and Health.  "It says that if a physician has a personal belief that deviates from evidence-based standards of care they have to tell the patient that, and that they do have a duty to refer patients in a timely fashion if they do not feel comfortable providing a given service," Chavkin says.

She says it isn't just about abortion, but also about things like emergency contraception — high doses of regular birth control pills that can prevent pregnancy in most cases if taken within 72 hours. She points to a scenario in which a woman has been raped and shows up at the only health care facility in her area.  "And she comes upon some doctor who thinks that emergency contraception is the equivalent of abortion, which is incorrect, but nonetheless what this individual believes," Chavin says. "What this ACOG statement is saying is she should not be deprived of something that's needed right away to take care of her emergency situation."

But doctors who object to providing certain types of care — particularly abortion — also object to referring patients.  "I'm not going to refer someone to a hit man to put to death someone that's inconvenient in their life," says Joseph DeCook, a retired Ob/Gyn from Holland, Mich., and vice-president of the American Association of Pro-life Obstetricians and Gynecologists. "I wouldn't do that. This is the very same thing. I'm not going to refer a pregnant woman to a physician who will purposefully terminate her pregnancy — better known as purposefully kill the unborn child. I'm just not going to do it." . . . .

But it's not entirely clear that board certification would — or even could — be stripped from doctors who don't want to make abortion referrals. Officials from the certifying board weren't available for comment.  But Greg Phillips, a spokesman for ACOG, says that the November ethics opinion was just that — an opinion. He says it's not a formal part of group's code of ethics that board certified Ob/Gyns must obey.

The updated story by Ms. Rover provides a statement from Dr. Norman Gant, executive director of the certifying board, who claims that "HHS got it all wrong."

Gant, who didn't respond sooner because he was out of the office, backed up what ACOG spokesman Gregory Phillips said Tuesday, which is that the ethics committee opinion regarding referrals is not a binding portion of the college's ethics code, and therefore not a factor in the decision about board certification.

"We do not restrict access to our exams for anyone applying for initial certification, or maintenance of certification, based on whether they do or do not perform an abortion," Gant said. "We do not base this upon whether they do or do not refer patients to an abortion provider if they do not choose to do abortions."

Gant said he dictated a letter back to Leavitt to that effect Wednesday. He added that the board has long respected the fact that its members disagree on the abortion issue — more than a decade ago it removed abortion from the list of cases to be used in oral exams.  On the other hand, Gant, himself an Ob/Gyn, said he personally had no problem with the November ethics statement, particularly the idea that Ob/Gyns should be ethically bound to provide contraception.

So, all and all, this looks like a good use of HHS's time. . . . .

March 20, 2008 | Permalink | Comments (0) | TrackBack (2)

Stem Cells and Vision Treatment Updated

On Tuesday, NPR's morning edition ran the story discussing a new controversial treatment for infant blindness involving stem cells.  NPR's morning edition has followed up with an interview Dr. Mark Borchert who believes that the treatment is rather risky and possibly not producing the results that parents claim to see.   It did sound too good to be true. . . .

March 20, 2008 | Permalink | Comments (0) | TrackBack (0)

Wednesday, March 19, 2008

Defeating the SuperBugs - Screenings

LATimes reports discusses a new study on how hospitals have worked to reduce the spread of infections within their walls.  Judith Graham writes,

Adding to the debate over how to control drug-resistant bacteria, researchers reported Monday that screening all hospital patients could sharply reduce hospital-acquired infections.

The study published in the Annals of Internal Medicine comes a week after a well-publicized study in the Journal of the American Medical Assn. concluded that screening of surgical patients for methicillin-resistant staphyloccocus aureus, or MRSA, isn't particularly effective.

The take-home message is that "a very comprehensive, aggressive MRSA screening program can significantly reduce the number of infections," said Dr. Lance Peterson, founder of the MRSA screening program at Evanston Northwestern Healthcare in Illinois, which published the second report. . . .

In August 2005, Evanston Northwestern became the first hospital group in the U.S. to screen all patients for MRSA. This time, the intervention worked, and hospital-acquired MRSA infections plummeted by 70%.

But an editorial in the Annals of Internal Medicine sounded a note of caution.  Dr. Ebbing Lautenbach of the University of Pennsylvania School of Medicine questioned which part of the screening intervention worked. Was it the isolation of affected patients, the use of antibiotic ointments, or other actions?  Until further evidence comes in, "each institution may need to tailor its intervention to its unique needs and resources," he concluded.

"Testing high-risk groups isn't enough," he said. "You stop some [of the bacteria's] spread but not enough" to make a difference in hospital-acquired infections.

March 19, 2008 | Permalink | Comments (1) | TrackBack (0)

Tuskgee Still Has Health Impact . . . .

The Associated Press has a story discussing two recent studies conducted by Johns Hopkins University examining the long-term impacts of the Tuskegee Syphilis Study on health care for African Americans.  The AP reports,

The infamous Tuskegee Syphilis Study, a government experiment that charted the effects of the untreated disease on mostly poor and uneducated Black men, was conducted for 40 years before it was exposed and ended in 1972 amid widespread condemnation.  A number of participants in the study died of the disease, which the men spread to women and to children at birth. But does it still take a toll on the health of new generations of Blacks? Even the experts, apparently, can't agree.

Two separate studies by Johns Hopkins University physicians took opposing sides on whether the Tuskegee experiment remains a significant factor in turning Blacks away from clinical trials at a greater rate than Whites. And both tended to contradict an extensive 2005 National Institutes of Health computer survey that found, in fact, Blacks are no different than Whites in the rate at which they take part in clinical trials when offered the chance.

Despite the different findings, researchers involved in the studies, along with others who work on minority medical issues, said more needs to be done to make sure Blacks have proper access to clinical trials as well as medical care.

In research reported earlier this year, Johns Hopkins University doctors found that Blacks were more reluctant than Whites to take part in medical studies because they fear being improperly used as guinea pigs. Their lack of participation, the authors said, inhibits efforts to develop treatments for diseases that Blacks suffer from in disproportionately large numbers.  “So long as the legacy of Tuskegee persists, African-Americans will be left out of important findings about the latest treatments for diseases,” said senior study author Dr. Neil Powe, a professor at Johns Hopkins School of Medicine.  “There is enormous irony that without African-American subject participation in clinical trials, we are not going to have tested the best therapies we need to treat African-Americans,” Powe said.

But less than three years earlier, researchers from the Johns Hopkins Bloomberg School of Public Health reached a different conclusion about the Tuskegee experiment. Their study published in the July 2005 issue of the Journal of the National Medical Association found that few Blacks had heard of the Tuskegee experiment and fewer knew accurate facts. They agree with Powe that Blacks are significantly more likely than Whites to be mistrustful of medical care and clinical trials. But they don't view the experiment conducted by the U.S. Public Health Service in Macon County, Ala., to be a major reason. Dr. Thomas LaVeist, co-author and director of the Bloomberg School's Center for Health Disparities Solutions, said the Tuskegee study plays only a modest role in producing distrust.

Instead, LaVeist said emphasis should be placed on contemporary factors that may make Blacks less likely to want to participate: They’re more likely to go to lower quality health care facilities, they have more difficulty getting appointments and they experience longer waiting times. All supporting the notion that Blacks aren’t treated the same, he said. . . . .

The study by Powe and other Johns Hopkins physicians, released in the journal Medicine online Jan. 14, involved a random survey of 717 outpatients at 13 cardiology and general medicine clinics in Maryland from April to October 2002. Thirty-six percent of participants were Black, the rest White.

Each participant was asked to enroll in a mock trial to test a heart disease pill and were given an in-depth explanation of risks and benefits by a physician, either Black or White. Only 27 percent of Blacks were willing to participate, as opposed to 39 percent of Whites. Seventy-two percent of Blacks said doctors would use them guinea pigs without their consent, versus 49 percent of Whites.

“The thing we were surprised about was that African-Americans were two times or 200 percent more likely to perceive a chance of harm from participating in medical research,” Powe said. “That perception of harm accounted for why they were less willing to participate in a trial.”

Powe said the study provided several possible remedies, including an increase in the number of minority physicians involved in clinical research studies. Some 12 percent of the U.S. population is Black, but only 4 percent are physicians.

He said health care providers need to do a better job at building trust with patients.  “We need to take time to communicate and explain what the risk and benefits are to participating in research and dispel myths that unrealistic harms could result,” he said.

Dr. Mona Fouad, director of the University of Alabama at Birmingham’s Minority Health and Research Center, said a number of reasons have been reported for low participation by Blacks in clinical research. These include economic barriers, time off to participate, negative experiences in the medical system and the complexity of required procedures such as consent forms.  She said the latest Johns Hopkins study is important in underlining the need to reach out and develop culturally competent recruitment strategies.

March 19, 2008 | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 18, 2008

Utube: Youth Discusses Health Care Reform and Obama's Plan

The New York Times ran an interesting piece yesterday discussing a recent utube video in which a young person discusses the reason that he will vote for Barack Obama.  Much of his discussion concerns some pretty detailed thoughts about our health care system and ways to provide reform.  I was pretty impressed.  You can watch for yourself here.  The article discusses how this interview happened and how it has become a popular view for people.  The article states,

On Jan. 31, Derrick Ashong, a 32-year-old musician, dropped off his pal, Shaunelle Curry, at the Democratic primary debate taking place at the Kodak Theater in Hollywood. After shrugging off her suggestion that he join her in carrying a sign for Barack Obama outside the theater — his band was leaving on tour the next day — he reconsidered and walked back to join her.

Carrying a sign saying “¡Sí, se puede!” (Yes, we can!), he joined a throng that was milling around in the background of the live CNN shot focused on the anchor Wolf Blitzer. Then a guy named Mike carrying a video camera came walking by and began peppering Mr. Ashong with a series of skeptical and very pointed questions.

“So why are you for Obama?” he asked. It was clear from his approach that he expected a dimwitted answer, an expectation that he was about to talk to another acolyte smitten by Senator Obama’s rock star persona.

But, as it turned out, Mr. Ashong, who was raised in Ghana and elsewhere, was glad to be asked. For almost six minutes — about a century in broadcast television years — Mr. Ashong, who has an immigrant’s love of democracy and the furrowed brow of a Brookings fellow, held forth on universal health care, single-payer approaches and public-private partnerships.

“A lot of these H.M.O.’s are publicly traded companies anyway, but I don’t think we want to create a market for health care per se, like we don’t want to create a futures market in health care,” he said. And so on.

Cute stuff. Highly informative. But not the kind of political discourse that generally captures a wider audience.

But here’s the weird part. On Feb. 2, the interview of Mr. Ashong was posted on a YouTube channel called “The Latest Controversy,” where supporters of both Senator Hillary Rodham Clinton and Senator Obama are asked very aggressively to justify their choice of candidates. The video blew up, drawing more than 850,000 views. And after that huge response to his policy analysis, Mr. Ashong decided to double down and explain the emotional component of his support for Obama in a follow-up video that was posted Feb. 11 and received 300,000 views.

Taken together, that means a guy who was looking to (anonymously) show a little love for a candidate was able to look into the camera for more than 13 minutes combined and draw in more than a million clicks with an impassioned but reasoned pitch.

At a time when politics and popular culture are still in an awkward mating ritual, Mr. Ashong inadvertently tapped into the youthquake that is shaking up the campaign. While the clip could have been lost among some of the popular rubble at YouTube (“Let me see, do I watch a tutorial on health care or Tori Spelling on ‘Jimmy Kimmel’?”), Andrew Sullivan at The Atlantic blogged about it, as did Think on These Things, a political blog. Then The Economist chimed in, which led to an editor at The New York Times hearing about it and — well, you get the idea. . . .

I think I might ask my class to watch and discuss when we review different ways to organize and reform our health care system.  It is interesting to see young people discussing this topic with such enthusiasm.

March 18, 2008 | Permalink | Comments (0) | TrackBack (0)

Better Vision Through Stem Cells?

National Public Radio's Morning Edition had an interesting piece this morning on the use of stem cells in China to improve the vision of a number of blind children.   It sounds like a new frontier in medicine - unfortunately without the appropriate testing and protective standards we would hope to see - especially when dealing with children.  The background piece states,

China is gaining popularity among a new breed of travelers: patients with incurable conditions who are visiting the country to receive experimental stem-cell treatments not offered in the United States. One company is now claiming a medical breakthrough, advertising that its treatments are restoring vision to blind children. It has ignited a firestorm of controversy in both China and in the U.S.

Giving Parents a New Option

Jena Teague and her husband Terry Williams are among these new visitors. They traveled to China to seek stem-cell treatment for their blind, 7-month-old baby daughter, Laylah. She was born with optic nerve hypoplasia, or ONH — when the optic nerves fail to develop properly in the womb. Conventional medicine offers no treatment and no cure.  But Teague came across a Web site about stem-cell treatments offered by Beike Biotechnology in China and decided to try it — against advice from specialists at home in Georgia.  "None of the specialists had heard of the stem cells, of what they're doing here. They didn't believe it would work. They told me not to expect anything to happen out of it," Teague says. . . . . They are spending $23,000 for Laylah to have infusions of stem cells harvested from umbilical cords — not the more controversial embryonic stem cells. In the U.S., cord blood stem cells are used for treating blood diseases, but are not used for treating other conditions, such as Laylah's vision problem.

Treatment Seems to Yield Positive Results

After three sessions, Teague and Williams say the therapy is already working.  The doctors have told Laylah's parents that the baby now sees light through one eye, while the other eye is dilating almost to the point where she can see light.  So far, 10 patients suffering from ONH have received the same stem-cell treatment in China, and doctors there claim that the vision of all 10 improved after the therapy.  Dr. Shalesh Kaushal, an eye specialist at the University of Florida, . . . . is now evaluating other patients before and after the stem-cell treatment. But he is not recommending that patients go to China; he says much more research needs to be done.  "It's clearly a provocative result. … If this is a real, reproducible observation or effect in other patients, one may consider it as a fundamental breakthrough," says Kaushal.

Reasons for Improvements Remain a Mystery

Dr. Sean Hu, the 40-year-old chairman of Beike Biotechnology, is a medical doctor-turned-entrepreneur with a doctorate in biochemistry from a Swedish university.  Less than three years ago, he set up Beike. Since then, 3,000 patients — most of them from China — have received Beike's stem-cell treatments for a wide range of conditions. He says 70 percent have seen improvements, but he admits he can't explain why.  "In the clinical areas, we know there are improvements. We don't know the mechanism behind it," Hu says.

That raises many concerns. Any improvement could be due to the placebo effect — or other factors besides the stem-cell therapy — and may not lead to longer-term functional gains. No rigorous, controlled clinical trials were carried out before the treatment was offered to patients. No research has yet been published in established peer-review journals overseas. And no one knows for sure what the possible risks might be.  But Hu isn't worried by the ethical implications of what he's doing.  "I can say I changed the life of these patients. Now they get their vision back. They went from completely blind, now they can see stuff. You think that's ethical or nonethical?" he asks.

Therapies Criticized as 'Extreme Nonsense'

Beike claims to treat a wide range of conditions with stem-cell therapy — from spinal-cord injuries to epilepsy to cerebral palsy to neurodegenerative disorders. But critics have their doubts.

Bruce Dobkin is director of the neurologic rehabilitation and research program at the University of California, Los Angles. In response to questions from NPR, he writes in an e-mail that "it is extreme nonsense to think that cells can be incorporated into the complex nervous system and do so much, when we cannot even get cells in mice and rats to do very much."

Chinese scientists are worried, too.  Dr. Naihe Jing is the deputy director of one of China's top stem-cell research labs and a member of the prestigious Chinese Academy of Sciences. He fears Beike could ruin the reputation of China's entire biotech industry. "We think money is mainly behind this," he says, adding that he is concerned that one company's pursuit of profit will create a bad reputation for the whole country.

Providing Help, Providing Hope

Already, 600 foreigners have come to China and paid about $20,000 each for the stem-cell therapy, while even more Chinese patients are flocking for treatment.  The venture capital is flooding in, too. Hu, Beike's chairman, says he has raised about $15 million in funding, although NPR could not verify the claim. He admits making a calculated decision to go into stem-cell research: As he puts it, you have to choose the area with the best return. . . . .

The results of Beike's experimental therapy may be uneven and unproven. Yet for patients and their families, hope is, perhaps, the most important commodity on sale in China — even if it costs tens of thousands of dollars.

March 18, 2008 | Permalink | Comments (0) | TrackBack (0)

Monday, March 17, 2008

Discipline and Firings After Snooping Through Britney Spears' Records

The LA Times reports on the some recent disciplinary charges and firings that occurred at the UCLA Medical Center after the Center learned of snooping that ccurred into the medical records of Britney Spears.  You would think that people would know better.  Charles Ornstein writes,

UCLA Medical Center is taking steps to fire at least 13 employees and has suspended at least six others for snooping in the confidential medical records of pop star Britney Spears during her recent hospitalization in its psychiatric unit, a person familiar with the matter said Friday.  In addition, six physicians face discipline for peeking at her computerized records, the person said.

Questioned about the breaches, officials acknowledged that it was not the first time UCLA had disciplined workers for looking at Spears' records. Several were caught prying into records after Spears gave birth to her first son, Sean Preston, in September 2005 at Santa Monica-UCLA Medical Center and Orthopaedic Hospital, officials said. Some were fired.

"It's not only surprising, it's very frustrating and it's very disappointing," said Jeri Simpson, the Santa Monica hospital's director of human resources, who handled the discipline in the first instance.  "I feel like we do everything that we possibly can to ensure the privacy of our patients and I know we feel horrible that it happened again."  Simpson said UCLA treats celebrities "all the time and you never hear about this."  "I don't know what it is about this particular person, I don't know what it is about her," she added, referring to Spears. . . .

Such prying is also considered a violation of state and federal laws governing medical privacy. The laws allow for fines of up to $250,000, although such penalties are uncommon. Under different laws, separate fines are allowed if patients are receiving treatment for mental illness or substance abuse.

The state Department of Public Health said late Friday that it had opened an investigation of the hospital.  Klove declined to discuss specifics of the most recent incidents, citing privacy protections for patients and workers. But she did say the hospital began taking disciplinary actions immediately upon discovering each breach.  "Right from the minute she came in, audits were continually being done," she said. "We watch this all the time. We have people dedicated to looking at records to monitor access." . . . .

Medical and nonmedical employees are set to be disciplined, although no doctors were targeted for firing, the person said. There is no evidence that any employee leaked information to the media or sold it -- something that hospitals in a celebrity culture have reason to fear.

Nicole Moore, whose union represents three of the non-physician workers involved, said she is trying to determine whether the discipline was administered fairly. Workers are entitled to contest their proposed termination before it becomes final.  "We believe that the university has a responsibility to their patients but also their employees to administer fair and consistent discipline to everybody, regardless of their position, whether it's a doctor who violated it or a certified nursing assistant," said Moore, lead organizer for the American Federation of State, County and Municipal Employees, Local 3299 at UCLA.

Klove said doctors are overseen differently than other employees. By law, they report to a medical staff governing body, which has the authority to limit, suspend or revoke their practice privileges.In January, Spears was admitted to UCLA under Section 5150 of California's Welfare and Institutions Code, which allows patients to be held against their will for up to 72 hours for evaluation if they are deemed a danger to themselves or others. Her hold was extended and she was released Feb. 6. . . . .




March 17, 2008 | Permalink | Comments (0) | TrackBack (0)

Medicare Strike Force Moving After New Targets

Law.com discusses some of the new geographic targets for the Medicare Strike Force as well as providing a summary of their success in Miami.  Julie Kay writes.

After winning almost all of its cases, the U.S. Department of Justice's Medicare strike force is preparing to move out of Miami and on to the next bastions of Medicare fraud, Los Angeles and then Houston, where it is sure to be greeted with a mixture of pleasure and concern by the defense bars there.

The Medicare strike force set up shop in Miami in March 2007. The plan was to bring a batch of quick cases in seven months, then move on to the next region. Miami was chosen because law enforcement officials consider it ground zero for Medicare fraud. In Miami, an estimated $2 billion is stolen annually from Medicare. The majority of the fraud is billing for nonexistent durable medical equipment and unnecessary infusion therapy for AIDS patients.

With $2 million in funding from both DOJ and the Miami U.S. attorney's office, the strike force was initially staffed by two Miami and two DOJ prosecutors. But the group did so well that seven DOJ prosecutors came down to help.  In Miami, the strike force garnered 90 guilty pleas and 10 convictions out of 120 cases. One client was acquitted, one trial ended in a mistrial, one client died, 13 are fugitives and four are awaiting trial. In the seven-month period, 120 defendants were indicted for allegedly committing $420 million in fraud. Ninety of the defendants pleaded guilty and 10 went to trial so far. A few trials remain. More importantly, though, Medicare billing dropped off in Miami by $1.4 billion during the previous year.

The strike force's conviction rate is an impressive 99.3%. The Miami U.S. attorney's office was so pleased with the results that when the joint strike force ended its run, the office made it permanent, staffed internally. . . .

The strike force's arrival did not go unnoticed by the Miami criminal defense bar. While some attorneys appreciate the business, some take issue with the strike force's tactics.  Jose Quinon, a Miami criminal defense lawyer and solo practitioner, argues that the strike force uses "over-the-top aggressive tactics." For example, he said it files cases on easily proven charges and then throws the kitchen sink at defendants at sentencing.  "You indict someone for spitting on the sidewalk and then at the sentencing hearing, you say, 'We're going to electrocute you,' " he said. . . . .

March 17, 2008 | Permalink | Comments (0) | TrackBack (0)