It will ensure that the standards issued in 2004 by NICE for the delivery of high-quality foot care can be achieved. The need for better foot care was highlighted at the 2006 Diabetes UK Annual Professional Conference in Birmingham in March, which showed that more than a quarter of people with diabetes who were thought to be at high risk of having an amputation were not offered any kind of specialist appointment.

This is the first framework for foot care services for diabetes that states how foot care should be delivered and what skills healthcare workers responsible for it should possess (see box).

There is a lack of diabetes specialist podiatrists available, which means that other healthcare professionals in primary care organisations will have a crucial role to play in providing effective loot care. According to the framework, which has been developed by leading UK diabetes charities and societies, annual foot checks should be carried out by an appropriately trained healthcare professional.

It states that the risk status of a patient should be assessed by identifying the presence of sensory neuropathy, when the arterial supply to the foot is reduced, the presence of deformities and/or the abnormal build up of callus.

It is important that Healthcare professionals discuss the patient’s individual level of risk and agree plans for future surveillance.

County Down GP, Dr Colin Kenny, chairman of the Primary Care Diabetes Society, backed the framework as clear and well expressed.

Dr Niti Pall, a GPSl in diabetes in the West Midlands, said: ‘In our practice, we train healthcare assistants to carry out the foot tests. But there are a lot of different types of skill mix, so this guidance would be very useful for our healthcare assistants.

‘The serious cases will be referred to the GPs who have sufficient expertise to successfully treat patients,’ she added.

Zoe Harrison, care advisor at Diabetes UK, one of the societies involved in the development of the framework, said: ‘We hope that this new framework will fill the gap around foot care.’

Annual foot checks could prevent ischaemic gangrene

Foot management

* Routine assessment of the foot without ulcer/lesion.

* Expert assessment and care of the foot at risk.

* Expert assessment of foot ulceration or lesion.

* Management of resolved foot ulcer.

Diabetic foot care guidance

Live links at healthcarerepublic.com

sanjay.tanday@haymarket.com

Copyright Haymarket Business Publications Ltd. Dec 1, 2006

(c) 2006 GP. Provided by ProQuest Information and Learning. All rights Reserved.

Doctors in recent years had become excited over substances in the blood that appeared to be powerful new predictors of a heart attack. These substances included C-reactive protein, or CRP; homocysteine; and BNP, or B-type natriuretic peptide.

An increasing number of family doctors have been ordering expensive tests for these substances, and some patients have started requesting them, in hopes of identifying people who do not have the standard risk factors but are still likely to suffer a heart attack or stroke.

But the new research, by scientists at the Framingham Heart Study, found that tests of CRP, BNP, homocysteine and seven other substances are only a couple of percentage points better at predicting outcomes than the standard, commonsense risk factors that doctors have known for decades.

The difference in accuracy was considered so small as to be negligible.

“It’s a little bit disappointing,” said the lead author, Dr. Thomas Wang, a Harvard Medical School assistant professor. “I think our study and some other recent studies have begun to dampen that enthusiasm.”

The study was published in today’s New England Journal of Medicine.

On the Web

http://www.nejm.org

(c) 2006 Commercial Appeal, The. Provided by ProQuest Information and Learning. All rights Reserved.

He thought there was no hope he would walk again.

But with his family’s prodding and financial backing, the former licensed boat captain from Florida traveled to China, where doctors are treating people with spinal cord injuries and other conditions with stem cells obtained from umbilical cord blood. Out-of-pocket costs are high _ $20,000 to $25,000 on average.

While some umbilical cord stem cell treatments are available in the United States with special permission from the U.S. Food and Drug Administration, Aldrich said he opted to go to China because spinal cord treatments are not yet available here. The Miami Project to Cure Paralysis is doing research on embryonic stem cells in animals, but is not ready to try the treatments in humans.

Slowed by political opposition, embryonic stem cell research is limited to a small number of cell lines that qualify for federal research dollars. Private companies have raised more than $440 million to advance their work outside the confines of federal funding, but for the most part are still in the early stages of laboratory work and animal experiments.

Several states have enacted stem cell research programs, but they are in their infancies. In Florida, the Supreme Court has been asked to sort out the language in competing proposals for constitutional amendments: One would prevent spending money on embryonic stem cell research; another that would require the state to appropriate $20 million annually for 10 years to pay for such research. Voters could decide the issue in 2008.

Congress is expected to take up the issue again next year.

Opponents of embryonic stem cell research argue that the work is unethical because they say it requires ending a human life _ that of an embryo.

“We are in favor of all types of adult stem cell research and using umbilical cord blood,” said Lynda Bell, spokeswoman for the Florida Right to Life Committee. “We support any research that does not require the destruction of a human embryo, but when you’re destroying human life to do experimentation, that is wrong.”

As the debate rages, some desperate patients are going to other countries _ China, Mexico, the Dominican Republic, Brazil, Portugal, Sweden and elsewhere _ hoping for miracle cures now.

Kayce Barnes, of Florida, has taken her 7-year-old daughter, Brianna, to the Dominican Republic twice for infusions of cells she hopes will save her child from Batten’s disease, a rare, fatal degenerative neurological condition.

“If there’s any chance to save my daughter’s life,” she said, “I’ll do it.”

Brianna’s treatment, offered by a California company called Medra, is performed at a hospital in the La Romana region of the Dominican Republic.

A stem cell trial to treat Batten’s disease is planned at Oregon Health and Science University’s children’s hospital, but only six children will be treated initially and Brianna is not a candidate. If the treatment proves safe, the trial could be expanded to include more children, but it could take several years to win FDA approval for all children with the condition.

“She was denied from that trial because they want kids who are less medically involved, kids with very few symptoms,” Barnes said.

Researchers in the United States have successfully treated conditions such as sickle cell disease, some genetic diseases and immune deficiencies using umbilical cord stem cells, but the treatments require permission from the FDA and other regulatory oversight, such as institutional review boards, safeguards that may be lacking in other countries.

Bernard Siegel, executive director of the Genetics Policy Institute, which has offices in Wellington, Fla., and Washington, D.C., said going offshore for such treatments is risky.

“We pay close attention to these so-called stem cell therapies that are taking place outside the United States, and my own personal view is that we must take a very cautionary approach to this,” said Siegel, who has organized several international meetings of stem cell researchers.

Three scientific journals, Science, Nature and The New England Journal of Medicine, have reported on China’s stem cell programs, and a British trade group that visited there two years ago reported that China might be at the forefront of international stem cell research.

Aldrich’s sister-in-law, Sally Aldrich, a retired nurse who lives in New Hampshire, found the site for Stem Cells China and began making inquiries.

She explored other options before she and her husband, Paul, offered David the China option.

“There are people who are saying it’s too early to do this, but David and Paul and I are adventurers. You don’t get anywhere without risk,” she said. “For people like David and Christopher Reeve, all it takes for them to die is an infection.”

Reeve, a prominent actor paralyzed when he was thrown from a horse, died Oct. 10, 2004, of an infection.

W. Dalton Dietrich, scientific director of the Miami Project, said there have been preliminary talks with the FDA about how best to conduct clinical trials using a combination therapy that the Miami researchers have shown can restore 70 percent of the movement in paralyzed limbs of rats.

“We’re at that phase of the research where we’re really thinking seriously about translating it into people, moving things from the bench to bedside, but it’s difficult to tell how long that will take,” Dietrich said.

When people consult him about leaving the country for stem cells, he said, he advises against it.

“We tell them this is premature and may be dangerous,” he said.

David Aldrich thinks the treatments and the physical therapy he received in China have given him more movement in his fingers and legs. His spinal injury is classified as “incomplete,” meaning the cord was not severed. His vision was impaired, and he was on a ventilator for months and in the hospital for a year.

He credits the China treatment and rehabilitation with his ability to sit up on his own, and he said his vision also has improved.

“I have more flexibility in my fingers. That’s pretty exciting. I can move both legs, and I’ve got a lot more control of all my limbs. I believe what I’m experiencing is a result of the strength training, and the rehab work while I was there. You can’t just put in stem cells one day and get up and walk the next day,” he said.

Aldrich said he hopes the climate for research in this country improves soon.

“People are looking for hope, and it’s too bad they have to go outside the U.S. to find it. That’s all any of us have to look forward to is hope, to cure our disease or improve our quality of life.”

___

BE CAREFUL

The possibility that stem cells may cure many ills has led to an explosion of clinics around the world offering cell-based therapies, but experts urge caution.

Many countries have no guidelines for use of stem cells in research or human treatment applications, so patient safeguards are lacking.

If you opt for a treatment in another country, you will likely be excluded from later clinical trials in the United States because your previous treatment might skew the results.

Costs can be high and are not covered by insurance.

For more information on stem cell research, visit www.genpol.org/ and http://stemcells.nih.gov/

___

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PHOTO (from MCT Photo Service, 202-383-6099): MED-STEMCELLS

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Not since “erectile” and “dysfunction” became household words have there been so many media messages about middle-aged men and their plumbing problems.

But here’s the thing about the prostate gland: Every guy has one. And as men get older, this body part they were only vaguely aware of can cause problems such as frequent or difficult urination.

Thus they might wonder whether they have “a going problem” or “a growing problem,” as described in a commercial for a medication treating an enlarged prostate.

Ads for medications such as Flomax and Avodart depict men who now can enjoy ballgames, go fishing and get a good night’s sleep without the worry of urination difficulties that an enlarged prostate can entail.

“I think the overall effect of the ads has been positive, because I think education is the key to health care,” said Dr. Kevin O’Kelly, of Low Country Urology in Florence, S.C.

The ads also urge patients to make sure their symptoms are not related to prostate cancer. That helps raise awareness about the cancer most frequently diagnosed in men, said O’Kelly, who recently began doing robotic assisted prostate surgery at Carolinas Hospital System.

“It’s getting the attention of a lot of females, too,” he said. “A lot of wives and sweethearts are saying, `You need to make sure you don’t have prostate cancer.’”

Here’s some information about prostate problems (and solutions).

GROWTH IS COMMON

The prostate is a round gland that’s underneath the bladder and _ usually is about walnut-sized. It manufactures the fluid in semen. It surrounds the urethra, through which urine and semen pass.

A painful, swollen prostate might mean a man has prostatitis, an inflammation usually treated with antibiotics and other drugs.

But simple prostate enlargement _ benign prostatic hyperplasia _ is “as common a part of aging as gray hair,” according to the National Institutes of Health, which says the condition sent 4.5 million men to their doctors in 2000.

That number is bound to increase as baby-boom men hit their senior years, said Joe Turner, a urology nurse practitioner at the Medical University of South Carolina.

An enlarged prostate might not cause symptoms and isn’t necessarily a crisis. But it can be, if the gland grows to the point where it blocks the flow of urine. It can lead to serious bladder and kidney ailments.

More commonly, urination may become difficult, more frequent or more urgent. As with the guy in the commercials with the “going problem,” that can interfere with a man’s normal activities and social life.

Surgery to remove some tissue from the prostate _ which can reach the size of an orange or larger _ has been the time-honored treatment.

In a procedure called transurethral resection of the prostate (TURP for short), the surgery is done through an instrument inserted through the penis.

“About 1 in 4 men would have some sort of procedure for this, before the (prostate) medicines came out,” said Dr. John Wofford of Columbia Urological Associates.

Now, Wofford said, most urologists probably perform only about 20-25 TURP procedures a year. Usually, men whose enlarged prostates are causing problems will try medication first:

_Avodart (dutasteride) works by lowering the level of the hormone dihydrotestosterone, which in turn can shrink the prostate gradually. An earlier drug, Proscar (finasteride), is similar.

_Flomax (tamsulosin) is one of several drugs that work by relaxing muscles in the prostate and the neck of the bladder, helping urine flow more easily. It doesn’t change the size of the prostate, but may relieve symptoms such as difficult urination in only a few days, Wofford said.

Side effects are possible with both types of medication, but “very few men have complaints,” Wofford said.

Turner said that for older patients especially, medications can help men avoid surgery.

“If you are 75 and this could stop you from having surgery for seven years, in all likelihood that’s the rest of your life,” Turner said.

A man who seeks treatment for problems caused by an enlarged prostate may have tests including an examination of the prostate (which a doctor can feel by checking through the rectum), tests of urine flow and volume, and possibly ultrasound imaging.

A major ailment that must be ruled out is prostate cancer. Though it usually grows very slowly, it is the No. 2 cancer killer of men (behind lung cancer).

Prostate cancer death rates are declining, but are twice as high in black men compared with white. In South Carolina, death rates of black men from prostate cancer are the highest in the nation.

Early prostate cancer usually does not cause symptoms, but when the disease is advanced it may cause symptoms similar to those of an enlarged prostate. Prostate cancer screening is recommended at age 50 for white men and at 45 for black men.

Virtually everything about prostate cancer is complicated, however.

Experts disagree on the usefulness of the PSA screening test, for a protein found in the blood. A recent study did back the notion that a rapidly rising PSA could signal more aggressive cancer.

There’s also debate on whether older men should be screened, on whether surgery is advisable in some cases since it may cause impotence and incontinence, and on when a strategy of “watchful waiting” makes sense.

Men need to read up on the options and discuss them with their doctors.

“You have to figure out what works best … for the person and his stage of life,” Turner said.

Surgical techniques and other treatments _ such as targeted radiation now offered at Lexington Medical Center _ are focusing more on removing the cancer while preserving a man’s ability to have sex and urinate normally.

The robotic assisted prostate surgery O’Kelly is doing at Carolinas lets him operate through five small incisions rather than one larger one. So far, he said, subsequent rates of impotence and incontinence are similar to those of regular surgery, but patients benefit from shorter hospital stays and lower rates of infection.

The first man to have robotic prostate surgery in South Carolina was O’Kelly’s patient Michael Best, who came to Florence all the way from Chicago. Best, who sang for 22 seasons with the New York Metropolitan Opera, has a home in Florence but was teaching in Chicago when his prostate cancer was discovered.

Best recalled that a cousin who had prostate surgery “was practically immobile for two months. I was up and walking the next day and they sent me home.”

When his prostate was removed, so was his cancer, said Best, 67.

“We caught it, fortunately, at the earliest stage,” he said.

“Fortunately” is right: Men whose prostate cancer is found early have a five-year survival rate of about 100 percent, compared with 33.5 percent when the cancer has spread significantly.

Now, along with all those TV commercials, Best’s male friends can count on him to remind them about paying attention to early detection and prostate health.

“I was surprised to learn how common prostate cancer is,” he said. “I’m preaching this to my friends.”

PROSTATE HEALTH

Information on some problems that can affect the prostate:

_Prostate enlargement is common as men age, especially after 50. In some cases it can cause problems with urination (trouble starting to urinate, or frequent or urgent urination).

_Medications such as Avodart may shrink the prostate by lowering levels of a male hormone. Side effects may include impotence and breast tenderness.

_Medications such as Flomax may help urinary symptoms by relaxing prostate and bladder muscles. Side effects may include dizziness and retrograde ejaculation (semen flows back into the bladder).

_Prostatitis involves painful inflammation and swelling of the prostate, which may be treated with antibiotics and other medications.

_Prostate cancer is the most common cancer in men and the No. 2 cancer killer in men. More than 65 percent of cases are diagnosed in men 65 and older, with black men at increased risk.

_Annual prostate screening _ including a digital rectal exam and PSA blood test _ is recommended for white men starting at age 50, black men at 45.

_There is evidence that obesity increases a man’s risk for prostate cancer.

_For more information: www.nih.gov, www.cancer.org, www.ustoo.org.

Sources: National Institutes of Health, American Cancer Society, Merck Manual of

___

(c) 2006, The State (Columbia, S.C.).

Visit the State at http://www.thestate.com/

Distributed by McClatchy-Tribune Information Services.

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ARCHIVE ILLUSTRATIONS on MCT Direct (from MCT Illustration Bank, 202-383-6064): 20030203 PROSTATE; 20030923 Prostate cancer

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NEW ORLEANS — If this is ground zero for the federal government’s war on poverty, it’s hard to find the front lines.

Since Hurricane Katrina struck on Aug. 29, 2005, only 94 homeowners — and no tenants — have received federal aid to rebuild. The poor have been treated at walk-in health clinics while a federal-state partnership struggles to finance a new medical complex.

“I thought they would do a lot for us, but so far they haven’t given us anything,” says Albert Walker, 75, who’s using insurance to rebuild a one-story home in the devastated Lower 9th Ward, which nearly disappeared under 11 feet of water. “Most of the people down here are waiting on the road to recovery.”

Fifteen months ago, President Bush stood in Jackson Square, in this city’s fashionable French Quarter, and pledged to confront poverty, racial discrimination and a “legacy of inequality.”

Now, as Democrats prepare to take charge of Congress, advocates for the poor say New Orleans symbolizes the government’s fits and starts in addressing poverty. They want lawmakers to increase the minimum wage, cut interest rates on college loans and expand health insurance to more poor children.

Lawmakers take on issues

Democrats say they intend to raise the profile of anti-poverty issues. Rep. Maxine Waters, D-Calif., who will take over a key housing subcommittee, plans hearings here next month. Rep. Charles Rangel, D-N.Y., incoming chairman of the House Ways and Means Committee, plans to examine how poverty negatively affects economic growth, sprawl, crime, health care, even national security. “We can’t afford poor folks,” he says.

Any broader war on poverty will have to wait. The annual budget deficit is nearly $300 billion. “It’s a reflection of the political realities,” says Rep. Mel Watt, D-N.C., outgoing chairman of the Congressional Black Caucus. “The public is fed up with these growing deficits.”

Politics, too, presents a problem. Conservatives led by Rep. Mike Pence, R-Ind., don’t want to spend heavily on social programs. Even liberals such as Rangel don’t want to raise taxes. Senate Republicans can block almost anything from passing. “I don’t see a concentrated war on poverty by Democrats,” says Jared Bernstein of the liberal Economic Policy Institute. “But you are going to see a couple of well-chosen battles.”

Like many, Tracie Washington remembers the Bush speech.

“I bought it,” says Washington, director of the NAACP’s Gulf Coast Advocacy Center. Today, she says, “It’s like that old Wendy’s commercial — ‘Where’s the beef?’”

“There’s been very little done for health care, very little done for mental health services, virtually nothing done to shore up and support the criminal justice system,” says Sen. Mary Landrieu, D-La. “For all the president saying ‘We’ll do whatever it takes,’ it hasn’t quite happened that way.”

The majority of New Orleans’ poorest residents remain outside the city, unable to return because of a shortage of habitable housing and soaring prices. More than 200,000 former residents are in the nationwide diaspora that Katrina created, about 80% of them black.

Tenants have yet to receive anything from a federally financed program intended to help people get back into their homes, even though more than 50,000 units of rental housing were destroyed. The federal government plans to replace many of those with private, mixed-income developments.

Making the immediate shortage worse is the Department of Housing and Urban Development’s plan to tear down more than 4,000 units of public housing. HUD says it would cost $130 million to rehabilitate the run-down projects. Low-income-housing advocates have gone to court to block the move. HUD now says it will be phased in.

It has been left to groups such as Catholic Charities USA and ACORN, which represents low-income families, to gut flooded houses. “The joke here is that we need a New Orleans Study Group,” ACORN founder Wade Rathke says.

The federal government has invested billions into housing, health care and education, but red tape and a fear of fraud have slowed the flow of funds. The administration wants to change systems that were failing before Katrina struck:

*Housing. It’s trying to turn renters into homeowners with jobs and rent-to-own programs. The state is readying $1.5 billion in rental aid to landlords and $1.7 billion in low-income tax credits.

*Health care. It wants to replace the old two-tiered system, in which the poor were relegated to Charity Hospital, by having the Department of Veterans Affairs join Louisiana State University in building a modern medical complex.

*Education. It’s investing in charter schools, where parents play a direct role, rather than rebuilding the old public school system that was one of the nation’s worst.

Donald Powell, the federal coordinator of Gulf Coast rebuilding, is frustrated with the delays. “We need to be very resourceful about finding ways to speed up the process,” he says.

Andy Kopplin, executive director of the Louisiana Recovery Authority, says aid was slow to arrive and tied up in red tape. “We asked for significantly more than we got in lots of categories,” he says.

Despite Bush’s speech on poverty Sept. 15, 2005, little has been done to address it nationally.

The need is clear: Census Bureau figures show that about 37 million Americans, or 12.6%, lived in poverty in 2005 (annual income of $19,971 or less for a family of four). The poverty rate has been rising since 2000. About 8.8 million families have severe housing-cost problems, up 33% since 2000.

New Orleans had the eighth-lowest median income in the nation among big cities in 2005 — $30,771 — before Katrina. Orleans Parish had the sixth-highest poverty rate among counties, 24.5%.

Some experts say that if disaster struck elsewhere, poor city dwellers would fare worst. “We’re underinvesting in our urban core,” says John Powell, executive director of the Kirwan Institute for the Study of Race and Ethnicity at Ohio State University.

Democratic leaders in the House and Senate have pledged to vote early next year to raise the federal minimum wage, stagnant since 1997, to $7.25 an hour over two years from $5.15. That would have an immediate impact in states such as Louisiana that have no minimum wage laws.

Program funding sought

The leaders also will try to reduce interest rates on student loans and expand the Children’s Health Insurance Program to some of the 9million children still uninsured.

Anti-poverty advocates such as Mark Greenberg of the liberal Center for American Progress say more money is needed for programs set to expire in coming years: food stamps, child care, Head Start, job training. They want changes in the tax code that would benefit the poor, such as an expansion of the earned income tax credit.

Democratic lawmakers caution against high expectations. They point to the budget deficit, the future insolvency of Medicare and Social Security and their own promises to pay for new spending.

“The body politic does not want to mention the word ‘poverty.’ All you’re going to hear about is the middle class,” Waters says. “We’ve got to talk about poverty, not only in Louisiana but in America.”

As the 2008 presidential campaign heats up, experts say, the issues of poverty and inequality will be given voice by Democratic candidates such as former North Carolina senator John Edwards, who plans to announce his quest in New Orleans next week. “This is going to be a reference point for the debates nationally about equality and poverty,” Rathke says. (c) Copyright 2005 USA TODAY, a division of Gannett Co. Inc.

Due to a technical malfunction whereby a complete measurement of oxygen levels in the brain of one treated patient was not made, nine patients were treated during this study to meet the eight-patient enrollment goal. While survival was not a trial endpoint, seven patients in the trial survived their brain trauma. Neither of the two mortality cases was related to the safety of Oxycyte. One patient suffered massive injury and was not expected to survive. Another patient was withdrawn from the trial upon the voluntary decision to remove life-support.

M. Ross Bullock, M.D., Ph.D., Department of Neurosurgery, Medical College of Virginia, Virginia Commonwealth and the study’s principal investigator, said, “We are encouraged to report that following administration of Oxycyte, we saw a survival rate in these patients that was far better than we had anticipated, as well as exceptional improvements in clinical outcomes especially given the severity of these cases that would typically constitute irreparable tissue damage. Each patient’s oxygen level increased significantly, with some increasing three- to five-fold. To date all seven surviving patients are neurologically intact and have been discharged to their homes. This is extremely impressive as historical experience suggests that patients suffering from this level of traumatic brain injury have a 30% to 40% mortality rate and a 40% to 60% neurological deficit rate, and that an estimated 10% to 15% of patients require long-term care.”

“Oxycyte continues to show great promise as a safe and effective therapeutic oxygen carrier,” said Robert Nicora, Synthetic Blood President and CEO. “We are delighted with the findings of this preliminary analysis and Oxycyte’s ability to increase brain oxygen tension more effectively than either 50% or 100% inspired oxygen, and we continue to believe that Oxycyte may be a valuable treatment for patients with traumatic brain injury.”

About Synthetic Blood International

Synthetic Blood International is dedicated to commercializing innovative pharmaceuticals and medical devices in the field of oxygen therapeutics and continuous substrate monitoring. The Company has under development a blood substitute, a liquid ventilation product and an implantable glucose sensor. These products are based upon core technologies that include biomedical applications for perfluorocarbons, and medical and industrial applications for biosensors. Each of the product candidates is designed with advantages over currently marketed products in major markets including acute respiratory distress syndrome, stroke, myocardial infarction, surgery, trauma, malignant tumors and diabetes. For further information, please visit www.sybd.com.

Safe Harbor Statement The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking information made on the Company’s behalf. All statements, other than statements of historical facts which address the Company’s expectations of sources of capital or which express the Company’s expectation for the future with respect to financial performance or operating strategies, can be identified as forward-looking statements. Such statements made by the Company are based on knowledge of the environment in which it operates, but because of the factors previously listed, as well as other factors beyond the control of the Company, actual results may differ materially from the expectations expressed in the forward-looking statements.

A proposed Food and Drug Administration plan to consolidate its network of labs could leave half of them shuttered, Public Employees for Environmental Responsibility said. The labs test food, cosmetics, drugs and other medical products for safety, purity, effectiveness and to ensure they are properly labeled. They also help investigate public health threats such as the recent outbreaks of E. coli in spinach and lettuce.

The group believes the closures could slow the response to a bioterrorism attack or outbreak of foodborne illness.

“There is no reason why these decisions have to be made in a black box,” said Jeff Ruch, the group’s executive director.

The FDA is reviewing ways to prioritize and best match its resources with its operational responsibilities, said Julie Zawisza, an FDA spokeswoman. “We are committed to our mission of protecting and advancing the public health and continually explore ways to improve our field operations,” she said.

In a Dec. 6 e-mail sent to staff of the FDA office that oversees the agency’s field work, associate commissioner for regulatory affairs Margaret Glavin said a transformation leadership team would discuss in coming weeks which of the agency’s labs would remain open. The consolidation would, in part, maximize efficiencies, Glavin wrote. She did not return messages left Thursday.

No laboratories were mentioned by name in Glavin’s e-mail. The group listed as being considered for closure the facilities in Cincinnati, Denver, Detroit, Kansas City, Philadelphia, San Francisco and Seattle.

Public Employees for Environmental Responsibility, whose members include local, state and federal government workers, said it pieced the locations together from details culled from oral presentations made to FDA employees and a 1996 list of 10 labs the agency sought to close under a previous restructuring plan.

—

On the Net:

Food and Drug Administration office of regulatory affairs: http://www.fda.gov/ora/

Public Employees for Environmental Responsibility: http://www.peer.org/

The 32nd annual Monitoring The Future study shows continuing drops in the use of marijuana, alcohol and tobacco.

This year, 13 percent of U.S. teens said they smoked pot in the past 30 days, down from 17 percent in 2001. But the decline was mostly in 10th and 12th grades, and not among eighth-graders.

Lloyd Sederer, executive deputy commissioner at the city’s Department of Health and Mental Hygiene, said the data on pot, alcohol and cigarettes coincide with local trends.

“New York City has also seen declines in the use of these substances over the past few years in public high school students,” he said.

“While declines are heartening, much remains to be done to reduce the number of teens using these substances,” Sederer added.

Elsewhere in the survey, a disconcerting rise was seen in prescription drug use.

Recreational Vicodin use remained level, but the painkiller Oxycontin showed gains in popularity in all three grade groups, with 4 percent of teens using.

Addiction Institute of New York Director Petros Levounis said he has seen the trend locally for a few years.

“The general impression here is, if it’s prescribed by a doctor for someone, it must not be all that bad for you,” said Levounis.

___

(c) 2006, New York Daily News.

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Doctors in recent years had become excited over substances in the blood that appeared to be powerful new predictors of a heart attack. These substances included C-reactive protein, or CRP; homocysteine; and BNP, or B-type natriuretic peptide.

An increasing number of family doctors have been ordering expensive tests for these substances, and some patients have started requesting them, in hopes of identifying people who do not have the standard risk factors but are still likely to suffer a heart attack or stroke.

But the new research, by scientists at the highly regarded Framingham Heart Study, found that tests of CRP, BNP, homocysteine and seven other substances are only a couple of percentage points better at predicting outcomes than the standard, commonsense risk factors that doctors have known for decades.

The difference in accuracy was considered so small as to be negligible.

“It’s a little bit disappointing,” said lead author Dr. Thomas J. Wang, a Harvard Medical School assistant professor. “I think our study and some other recent studies have begun to dampen that enthusiasm.”

The study was published in Thursday’s New England Journal of Medicine.

The Framingham researchers, who have been testing residents of the Boston suburb for several decades, used frozen blood samples taken from 3,209 healthy Framingham participants in the mid-1990s, then checked to see who had major heart complications or died over the following decade.

The best predictors were tests for BNP, CRP, homocysteine and renin in the blood and albumin in the urine. Patients with the highest levels of BNP and albumin were nearly twice as likely as those with lowest levels to suffer a heart attack, stroke or heart failure; those with the highest levels of CRP, BNP and the three other substances were four times as likely to die during the decade.

However, the standard risk factors - high blood pressure, high cholesterol, family history, advanced age, smoking, obesity, lack of exercise and diabetes - proved to be just as accurate when it came to predicting heart disease.

And the new blood tests, which are not covered by insurance companies, can run from $25 to more than $150.

“This really supports the value of focusing on risk factor reduction, not looking for a magic blood test,” said Dr. Richard Stein, director of preventive cardiology at Beth Israel Medical Center in New York. He predicted some insurance companies will soon start telling doctors to limit such tests, which are not covered by some insurers.

“At present, I don’t think we should be measuring these in routine clinical practice,” said Dr. Daniel Levy, director of the Framingham study, which is funded by the National Heart, Lung, and Blood Institute.

Levy and Wang said the 10 “biomarkers” tested in the study may still be useful for the many patients at intermediate risk of heart problems - those determined by the conventional risk factors to have a 10 percent to 20 percent chance of suffering a heart attack or stroke over the next decade.

Dr. Sidney Smith, former president of the American Heart Association and director of the Center for Cardiovascular Science and Medicine at University of North Carolina, noted the findings may not apply to minorities. The Framingham residents are almost all whites of European extraction.

He said the findings also show that doctors and patients should work harder to get known risk factors such as obesity and diabetes under control to prevent serious heart problems.

Some doctors said they expect better blood tests to be discovered eventually.

“The question is, `Where’s the next frontier?’” Levy said.

He said the answer could come from two huge federal studies. One, with results expected next year, is examining about 500,000 genetic variations in 10,000 people to spot differences linked to heart disease; the other, still being planned, will examine about 150 biomarkers to see which ones best predict future heart problems.

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On the Net: http://www.nejm.org

American Heart Association site on cardiac risk factors: http://www.americanheart.org/presenter.jhtml?identifier4726

A preliminary investigation by the Los Angeles County Department of Public Health traced the fatal outbreak at White Memorial Medical Center to contaminated laryngoscope blades, a type of medical instrument used to look inside a patient’s mouth.

White Memorial closed off its neonatal intensive care unit Dec. 4 following the outbreak of Pseudomonas aeruginosa that sickened five infants. Officials believe the subsequent deaths of two of the babies may be linked to the pathogen, which is a common but potentially deadly bacterium, particularly to people with weak immune systems.

Of the roughly two million hospital-acquired infections each year, about 10 percent are caused by P. aeruginosa. The germ can be spread by health care workers, medical instruments, disinfectant solutions and food.

Until earlier this year, cleansing of laryngoscope blades had been done by White Memorial’s in-house sterilization department, which subjected the devices to high-level disinfection as required by the manufacturer.

Then the practice was abruptly changed and cleaning was handled by the respiratory therapy staff instead. It’s unknown whether the respiratory staff followed proper cleaning procedures. White Memorial has since returned to having the blades cleaned by specialized technicians.

Disease control experts, who noticed the change in cleaning procedure, said they were still awaiting an explanation by the hospital.

“We know they had deviated from that policy, but we’re not sure how,” said Dr. Laurene Mascola, the director of the county’s acute communicable disease control unit.

While it’s not unheard of for hospital staff to clean medical instruments themselves, lapses can occur if the cleaning is not done according to the manufacturer’s instructions, say medical experts.

“If they were just wiping them down, it would be a breach of sterility,” said Dr. Gerald Berke, chief of head and neck surgery at the David Geffen School of Medicine at the University of California, Los Angeles.

The outbreak at White Memorial, which serves mostly minority patients, forced it to close its neonatal and pediatric wards two weeks ago to new patients. Both units were reopened this week after hospital officials assured the community that the outbreak was contained.

Hospital-acquired infections cause about 90,000 deaths and $4.5 billion in health care costs annually, according to the federal Centers for Disease Control and Prevention.

Reporting of Pseudomonas outbreaks varies by state and the CDC does not keep national statistics on the prevalence of the bacterium, said agency spokeswoman Jennifer Marcone.

In light of past deadly outbreaks, hospitals nationwide typically take strict precautions such as disinfecting medical equipment and tabletops to prevent the spread of the bacterium.

“At the current time, there is no way to completely prevent Pseudomonas infections because the organism is so ubiquitous,” said Dr. Joseph Bocchini, chief of pediatric infectious diseases at Louisiana State University Health Sciences Center.

Dr. Rosalio Lopez, the chief medical officer at White Memorial, has declined to comment on the hospital cleaning policy, citing the ongoing investigation. He also refused to name the maker of the laryngoscope blades used by the hospital.

Since the outbreak was made public on Dec. 15, Lopez has repeatedly apologized to the families. David Marin, whose infant son died on Monday, plans to file a wrongful death lawsuit against White Memorial.

Lopez insisted the hospital informed patients and public health officials about the outbreak in a timely manner and has since stepped up their policing by requiring nurses to wear protective coverings when caring for infants and re-educating the staff about infection control policies.

It’s not the first time a Pseudomonas outbreak has been linked to contaminated equipment. In 2002, 16 patients at Allegheny General Hospital in Pennsylvania were exposed to Pseudomonas through bronchoscopes that weren’t properly sterilized. The flexible devices are used to look into the lungs of seriously ill patients.

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On the Net:

White Memorial Medical Center: http://www.whitememorial.com

Los Angeles County Department of Public Health: http://www.lapublichealth.org