Tuesday, January 27, 2009

News Clipping Archives

 

Maryland / Regional

 

Pr. George's Hospitals May Face Own Surgery (Washington Post)

County hospitals may be sold separately (Prince George’s Gazette)

Infection rate in city levels off, but some areas still up (Baltimore Sun)

Baltimore taking steps to curb MRSA infections (Baltimore Examiner)

Feds to Investigate Cancer Cases in Poolesville (WUSA-TV)

MedChi names Ransom as new leader (Baltimore Business Journal)

Federal case involves local funeral home (Hagerstown Herald-Mail)

Budget cuts postponed as federal assistance expected (Baltimore Sun)

High Lead Levels Found in D.C. Kids (Washington Post)

Correctional center nurse acquitted on sex offense charges (Montgomery Journal)

Serenity In Emergencies (Washington Post)

Medicaid aid could exceed $1 billion (Capital-Gazette)

 

National / International

 

Peanut Plant Was Cited for Violations (New York Times)

Medicare Widens Drugs It Accepts for Cancer (New York Times)

The Epidemic That Wasn’t (New York Times)

High-tech sensors help seniors live independently (Daily Record)

Spread of Malaria Feared as Drug Loses Potency (New York Times)

 

Opinion

 

Is That Device Safe? (New York Times Editorial)

 

 

 

 

 

Pr. George's Hospitals May Face Own Surgery

Panel Thinks Economy Doesn't Favor Single Buyer, Suggests Individual Sales

 

By Rosalind S. Helderman

Washington Post

Tuesday, January 27, 2009; B01

 

The panel in charge of selling Prince George's County's ailing hospital system is warning state leaders that the economic climate might make finding one buyer impossible and is asking permission to sell the health facilities piecemeal.

 

At its monthly meeting yesterday, the Prince George's Hospital Authority agreed to ask the Maryland General Assembly to allow the authority to sell the county-owned system's three hospitals and two nursing homes separately. That could mean different buyers for the more stable hospitals in Bowie and Laurel than for the system's flagship, the long-troubled Cheverly-based Prince George's Hospital Center.

 

The center, which includes the state's second-busiest trauma facility, provides otherwise unavailable health care for many poor and uninsured people and has been responsible for much of the annual losses to Dimensions Healthcare, the nonprofit group that manages the facilities.

 

Serving 180,000 patients a year, the facilities have been financially rocky for years, and state and local leaders have wrangled over how best to stabilize the system.

 

The hospital authority's request signaled that it might be having trouble finding health-care companies willing to take on the challenges of the aging system, even though state and local government have pledged to pay $174 million over five years to a winning bidder.

 

At yesterday's meeting, authority Chairman Kenneth E. Glover said seven health-care companies have expressed some level of interest in pieces of the system, a response to the bidding process he said was encouraging given the economy.

 

In an interview, he said the legislative change would give the authority more flexibility to market the system and insisted that the process would not end with the long vexing question of the Cheverly hospital's future unsettled.

 

"It can't conclude that way," he said.

 

Not all observers of the process were reassured, however. The union representing hospital workers has concerns about the request, said Stacey Mink, a spokeswoman for SEIU 1199. She said workers believe that the best solution for employees and patients would be to transfer all the facilities to an academic institution, such as the University of Maryland Medical System.

 

And a state lawmaker involved in the authority's creation said he, too, thinks that the authority's request "raises questions" about how their work is proceeding.

"We have a system here of which some parts are more competitive than others," said Del. Doyle L. Niemann (D-Prince George's). "If you sell off the competitive parts, leaving only those parts that are only not competitive and presumably serve the most uncompensated care, what do we end up with?"

 

In a Jan. 14 letter to Gov. Martin O'Malley (D), Glover requested a 60-day extension for issuing a final report on the authority's bidding process, which had been due to the General Assembly that day, the start of the legislative session. He wrote, too, that state and local agencies should develop plans for meeting the county's health-care needs that could include downplaying the central role of Prince George's Hospital Center.

 

Secretary of Health and Mental Hygiene John M. Colmers said he believed that the 60-day extension would be granted, which would give the authority until March 14 to report on the results of the process. He would not comment on the authority's request to sell the system piecemeal.

 

The state and county have each agreed to spend $12 million this year and next to keep the system afloat while it is sold. Both had hoped that the creation of the authority would finally provide an end to years of contentious debate over the system's future in the General Assembly, where tangled politics have doomed yearly efforts to restructure the system. Asking the legislature to amend the authority's mandate could renew those debates.

 

Glover said he did not think that the request would prove problematic given that elected leaders have been supportive of the authority's work.

 

A spokesman for Prince George's County Executive Jack B. Johnson (D) said Johnson supports the authority's request. "If that's what the authority deems is the solution, he's supportive of that change that would allow them to sell it in pieces," John Erzen said.

 

© 2009 The Washington Post Company

 

 

 

 

 

County hospitals may be sold separately

Hospital Authority seeks emergency legislation to sell three health centers to different companies

 

By Daniel Valentine

Prince George’s Gazette

Tuesday, January 27, 2009

 

Acknowledging that no one wants to buy all three of Prince George's County's struggling hospitals in the current economy, county Hospital Authority members said Monday they will ask the state for permission to sell each facility in Bowie, Laurel and Cheverly separately.

 

"When we started in July, we started on the premise of selling all of [the hospitals] to one entity. The financial markets did a downturn on us," said Kenneth Glover, chairman of the authority commissioned to find private buyers for the long-suffering health system.

 

At their monthly meeting in Laurel, members of the appointed group agreed to ask the General Assembly for an emergency bill that would let them split the system among multiple buyers. Members hope to have a deal to sell the facilities approved before the General Assembly ends April 14.

 

Glover said that seven unnamed companies are in negotiations for Prince George's Medical Center in Cheverly, Laurel Regional Hospital and Bowie Health Center, but no bidder wants to purchase all three.

 

"We should at least be optimistic that there's an interest," Glover said.

 

The authority was created in the latest attempt by the state and county to resolve issues with the government-owned hospital system, which has been losing money for years and has been in jeopardy of being closed down.

 

More than 180,000 people a year rely on the centers for emergency and basic medical care in a county where close to 150,000 people do not have basic insurance coverage.

 

Unpaid costs from treating uninsured patients at the centers have cost the state and county more than $12 million per year, while declining facilities and turnover have caused the hospitals to lose paying patients to other areas. More than 25 percent of the patients are uninsured, according to hospital officials.

 

Several attempts to broker a partnership between county and state officials on the hospital have failed when the two sides could not reach agreement. Last year, both governments agreed to set up the independent authority to handle selling off the centers without political interference.

 

When the authority was created, the law was drafted so that the authority could only sell the system wholesale. Officials feared that private buyers would snap up the more profitable centers and leave others to continue losing money at the expense of the state and county.

Glover said he believes no hospital would be left out if they are sold piecemeal.

 

"We are under the impression that all the [centers] are covered by the seven bidders," said Glover, who would not indicate which companies expressed interest in the centers. "We're not going to leave anything out there."

 

The group has until March 14 to present deals for the hospitals to the legislature, but splitting the sale creates new challenges.

 

The Maryland House of Delegates and Senate would need to pass an emergency bill in the next month giving permission for a site-by-site sale, noted authority member Thomas Himler.

 

"Everyone knows how long it takes to get things enacted in our delegation," Himler said.

 

Questions would also have to be resolved over how to split up $174 million the state and county have pledged to give the new owner of all three hospitals, and how to divide outstanding debts owned by the current hospital management company, Dimensions Healthcare.

 

Authority members plan to take their proposals to legislators later this week, Glover said.

 

Officials with SEIU, a labor union representing thousands of hospital workers, declined to speculate on the state of the sale after Monday's meeting.

 

Maryland Health Secretary John M. Colmers said his department will look at the legislation for the hospital deal, but acknowledged that the hospital sale is mutating form its original intent.

 

"Reality has a way of affecting the plans," Colmers said.

 

County and state officials have pledged funding for 2010 to keep the hospital open even if a deal is not reached this year, Colmers said.

 

Copyright © 2009 Post-Newsweek Media, Inc./Gazette.Net

 

 

 

 

 

Infection rate in city levels off, but some areas still up

Focus renews on antibiotic-resistant bacteria like MRSA for Baltimore health officials

 

By Kelly Brewington

Baltimore Sun

Tuesday, January 27, 2009

 

The overall rate of infections caused by antibiotic-resistant bacteria has leveled off in Baltimore, but some types of infections remain much higher than in surrounding jurisdictions and statewide, according to data released yesterday by the city Health Department.

 

While rates have declined in hospitals and among intravenous drug users, infections reported at dialysis centers and long-term care facilities have had only modest decreases. Meanwhile, rates among people with HIV are up.

 

City officials pledged to devise better strategies for combating infections caused by invasive methicillin-resistant Staphylococcus aureus, commonly known as MRSA.

 

"For the first time, we have the overall picture of how these infections are playing out in Baltimore," said Dr. Joshua M. Sharfstein, the city health commissioner. "This gives us a mechanism to understand and respond to this problem."

 

MRSA can live harmlessly in the body but can attack wounds and cause life-threatening infections, including pneumonia. Over the years, it has evolved into a superbug that resists most antibiotics; experts have blamed overuse of antibiotics.

 

For years, most MRSA infections were found among hospital patients, older adults and people with weakened immune systems. Recently, MRSA has increased among healthy people in other settings.

 

A national study in 2007 found that Baltimore's MRSA rate was the highest of nine sites studied. Alarmed, city officials pursued additional studies, released yesterday.

 

The first was an analysis of Centers for Disease Control and Prevention data from 2004 to 2007. Figures showed fluctuating MRSA rates, leveling off in 2007. The study did not discuss why infections are rising among people with HIV. The second study, done for the city by the RAND Corp., examined hospitalization rates for skin infections often caused by MRSA. From 2000 to 2006, the number of people hospitalized increased 74 percent, among all ages and regardless of insurance coverage. While the figures leveled off from 2005 to 2007, Baltimore's rates were nearly twice as high as Washington and statewide.

 

"Barely a week goes by where I don't see one or two preschool-aged children who have drainable skin infections," said Dr. Michael Barone, a pediatrician at St. Agnes and Johns Hopkins hospitals.

 

Sharfstein said the department plans to share the data with HIV clinics and dialysis centers to come up with strategies for eliminating infections.

 

He stressed that everyone should take precautions such as thorough hand washing, good skin care and not sharing personal items such as towels and razors.

 

Copyright © 2009, The Baltimore Sun

 

 

 

 

 

Baltimore taking steps to curb MRSA infections

 

By Sara Michael

Baltimore Examiner

Tuesday, January 27, 2009

 

Baltimore health officials will be encouraging dialysis centers and HIV treatment clinics to review procedures for stopping the spread of drug-resistant staph infections in the wake of two new reports shedding light on the bacteria.

 

“MRSA has typically been a hospital issue,” Baltimore Health Department Commissioner Joshua Sharfstein said of methicillin-resistant staphylococcus aureus, the bacteria that cause sometimes-fatal skin infections.

 

But MRSA is also transmitted in other settings, such as outpatient clinics, suggesting officials should find a more systematic way to reduce infections there, Sharfstein said.

 

Baltimore’s MRSA infection rates are greater than surrounding jurisdictions, and now two reports provide a picture of the bacteria in the city.

 

“This gives, for the first time, an overall picture of how these infections have been playing out in Baltimore,” Sharfstein said at a news conference Monday at the health department headquarters.

 

Overall, MRSA infections have declined in Baltimore between 2004 to 2007, mainly in cases associated with intravenous drug use and surgery, according to a health department analysis of Centers for Disease and Control and Prevention data.

 

MRSA incidence linked to hospitalizations declined 16 percent and infections linked to surgeries dipped 30 percent, the data show.

During the same time, non-hospitalized residents receiving dialysis reported a 1-percent increase, and HIV-positive residents who weren’t hospitalized saw a 12-percent increase in infections, the data show.

 

A related study from the Rand Corp. found that, from 2000 to 2006, hospitalizations for cellulitis, a skin infection frequently associated with MRSA, rose 74 percent in Baltimore. Rates of hospitalization in Baltimore in 2007 were twice as high than in Maryland and Washington.

 

“MRSA is likely a major cause of preventable hospitalization in the city,” said Mayor Sheila Dixon.

 

“It’s important we act now. Good policy eventually leads to good health.”

 

State Sen. Lisa Gladden, D-Baltimore, said she is drafting legislation requiring local health departments to provide data similar to what was outlined in these reports to the state health department.

“Quite frankly, when I hear the word ‘MRSA,’ I still get scared,” she said.

 

Multiple cases of MRSA were reported in Howard and Anne Arundel public schools in 2007.

 

baltimoreexaminer.com

 

 

 

 

 

Feds to Investigate Cancer Cases in Poolesville

State and county health departments are asking the federal  Centers for Disease Control for help in Poolesville cancer investigation.

 

By Jason Adams

WUSA-TV

Tuesday, January 27, 2009

 

POOLESVILLE, Md. (WUSA) -- State and county health officials told worried Poolesville residents Monday evening that they are asking the federal Centers for Disease Control to help them investigate cancer cases in this small northern Montgomery town. The initial focus on the investigation will be to determine whether there is an abnormally high number of cancer cases in the community, a so-called cancer cluster.

 

As the meeting was about to begin Jeri Ofarrell told 9News Now "I'm a breast cancer survivor. I'm a thyroid cancer survivor. My sister is currently being treated for melanoma. My mom passed away less than three years ago from ovarian and uterine cancer. I know a child that has leukemia. I know another gentleman who is a prostate cancer survivor."

 

All of whom live in Poolesville?," 9 News Now asked.

 

"Correct," Ofarrell answered.

 

On the town's Hempstone Avenue, Kathy Krasner lives with her two sons, her husband and a two dogs. She lost a German Shepard to liver cancer, and speaks of a neighbor with sinus cancer.

 

"I will not let my kids drink the water at all," she said. "I guess it was about six or seven years ago that we stopped drinking the town water," she told 9 News Now.

 

There is no hard evidence the town's water supply, based largely on well water is causing Poolesville residents to become ill. Some residents suspect other possible sources of pollution, including a county trash collection center, a power plant, and a manufacturing facility.

 

Diagnosis of any cause of cancer cluster is step two in the investigation. First, the federal, state, and county agencies will do that study to determine whether a cancer cluster really does exist.

 

Health Department officials told residents on Monday that results may be six months away.

 

Copyright ©2009 WUSA9.com

 

 

 

 

 

MedChi names Ransom as new leader

 

Baltimore Business Journal

By Sue Schultz

Tuesday, January 27, 2009

 

MedChi, the state’s medical society, tapped Gene Ransom III Monday to serve as its executive director, ending a nearly eight-month search.

 

Ransom, 36, an attorney, has served as head of the organization’s membership department since 2007. He also serves as president of the Queen Anne’s County Commission.

 

He will replace Stephen H. Johnson, who served an interim executive director for MedChi since June.

 

Dr. Martin P. Wasserman, MedChi’s former executive director left the organization last June. Wasserman, former secretary of the Maryland Department of Health and Mental Hygiene, was head of the doctor’s advocacy group since 2006. The group represents about 7,000 physicians across the state.

 

Wasserman told the Baltimore Business Journal last June that he was asked to step down by MedChi’s board.

 

MedChi plans to host a rally in Annapolis Feb. 18 to urge lawmakers to support legislation to create greater health care access and reimbursements for doctors throughout the state.

 

All contents of this site © American City Business Journals Inc.

 

 

 

 

 

Federal case involves local funeral home

 

By Heather Keels

Hagerstown Herald-Mail

Tuesday, January 27, 2009

 

WASHINGTON COUNTY — A federal appeals court is scheduled to hear a case today that would affect a Hagerstown cemetery owner’s right to own the associated funeral home, an attorney in the case said.

 

Charles Brown, owner of Rest Haven Cemetery, was one of four plaintiffs who sued the Maryland State Board of Morticians to overturn the state’s limitations on ownership of funeral homes.

 

Prior to their case, a state law required funeral home owners to be state-licensed morticians and limited ownership of funeral homes by corporations, according to Clark Neily, senior attorney with the Institute for Justice, which is representing Brown and the other plaintiffs.

 

Brown’s son, who is a licensed mortician, owns Rest Haven Funeral Chapel, but Brown, who is not licensed, would like the entire operation to be family-owned to ensure it will stay open and can be passed down within the family, Neily said.

 

In October 2007, a federal judge found that the law limiting funeral home ownership was unconstitutional because it excluded companies and entrepreneurs from other states, Neily said. However, the judge did not address the law’s requirement that funeral home owners be licensed morticians, Neily said.

 

The Institute for Justice appealed the case, supporting the judge’s decision that the law was unconstitutional, but requesting that the state be ordered to further open the market, Neily said.

 

The state Attorney General’s Office, which is representing the defendants, cross-appealed, challenging the ruling, Neily said.

 

The Attorney General’s Office declined to comment on the case Monday.

 

Neily said he will argue it is unreasonable to require the owner of a funeral home to be a licensed mortician when it would be sufficient to require that the home be supervised by one. The requirement is similar to saying that the owner of an airline must be a licensed pilot, he said.

Mountain Motors

 

© 1996–2008 The Herald-Mail Company

 

 

 

 

 

Budget cuts postponed as federal assistance expected

O'Malley's proposed cuts could be reversed if $3.5 billion comes through

 

By Gadi Dechter and Laura Smitherman

Baltimore Sun

Tuesday, January 27, 2009

 

Gov. Martin O'Malley has postponed tomorrow's round of planned budget cuts in light of a roughly $3.5billion windfall in federal funds his administration is cautiously estimating will flow to Maryland over the next two years.

 

If passed by Congress and signed by President Barack Obama, the much hoped-for stimulus package could allow a reversal of painful budget cuts already put in motion, O'Malley said. The money could also possibly forestall laying off workers and trimming millions of dollars from Baltimore schools next year.

 

Maryland's projected share of stimulus funds is derived from an $825 billion bill that is "all but certain to pass" the House of Representatives tomorrow, said Stephanie Lundberg, a spokeswoman for Rep. Steny H. Hoyer, the majority leader from Southern Maryland.

 

Senate committees are expected to begin working on a similar bill today.

 

O'Malley, a Democrat, said recent discussions with Maryland congressmen have produced a firmer estimate of how much the state could reap from a stimulus package.

 

Last week, O'Malley presented the General Assembly with a spending plan that assumed only $350 million in anticipated federal funds, and which included cuts to local schools, community colleges and layoffs of hundreds of state workers to close a projected $2 billion revenue gap.

 

Additionally, O'Malley had planned to bring about $54 million in cuts before the Board of Public Works tomorrow, said spokesman Rick Abbruzzese. The Baltimore Sun reported this month that the governor's budget secretary had proposed $66 million in cuts to local jurisdictions, including reductions in state aid to public schools, community colleges, health departments and local police.

 

But with Congress and the White House accelerating work on an extensive emergency spending bill, the O'Malley administration has put those plans on hold.

 

The governor said conversations yesterday with Hoyer and Sen. Barbara A. Mikulski have given him confidence that roughly $2.5 billion in operating assistance over two years and $1 billion more in infrastructure spending are possible.

 

"Governor O'Malley and I have been talking about the economic recovery package almost every day," said Mikulski, a Democrat who sits on the Appropriations Committee. "We've been BlackBerrying, we've been strategizing. ... The economic recovery package is on the move in the Senate. We are committed to working with our colleagues in the House to have it ready for the president to sign by Presidents Day weekend."

 

If that happens, Feb. 16 "would be very, very good for all of us," O'Malley said.

 

Roughly $1 billion over two years would be set aside for road, transit and sewer projects under one version of federal legislation under consideration. Another $1.6 billion would go to education and general government funding in the federal bill.

 

While legislation moving through Congress largely directs portions of the package to specific programs, it is unclear how much flexibility states will have. Sen. David R. Brinkley, a Frederick County Republican, said he favors using the federal money for infrastructure projects and not for government operations.

 

Maryland lawmakers who oversee the state's budget were cautioned yesterday by Warren Deschenaux, the General Assembly's chief fiscal analyst, that the state still faces annual budget shortfalls of at least $700 million in future years. He urged lawmakers not to use federal aid to fill budget gaps in the short term while ignoring a long-term imbalance between revenues and spending.

 

Deschenaux also said O'Malley's proposed budget for next year leaves just $46 million in unspent funds, a cushion he called "grossly insufficient" because the economy might decline further. Moreover, he warned, Congress could ultimately fail to pass an aid package. "This is a very unusual year with very unusual levels of uncertainty," Deschenaux said.

 

Hoyer estimated that the so-called American Recovery and Reinvestment Act would create or save about 100,000 Maryland jobs, offer tax cuts for 2 million families in the state and pump money into education, highway and health care programs.

 

Patrick Moran, Maryland director of the American Federation of State, County and Municipal Employees, said he was "encouraged" by the optimistic talk on the stimulus plan. But he said AFSCME, which represents about 30,000 state and higher education workers, has received no assurances from the governor that extra money would prevent the 700 layoffs in O'Malley's proposed budget for the fiscal year starting July 1.

 

"We would hope that the state would come to that decision," Moran said, "and we're going to do everything within our means to hold them to that."

 

Stimulus proposal

 

Maryland stands to receive about $3.5 billion in the House version of the proposed federal stimulus package. Among the elements:

 

Balancing state budget: $1.1 billion

 

Medicaid: $650 million

 

Needy schools (Title I) and special education: $406 million

 

School construction: $191 million

 

Tax cuts: 2 million families to receive $500 (individual) or $1,000 (family) tax cut

 

Unemployment insurance: 242,000 workers to receive additional $25 weekly; 40,200 to receive extension of benefits

 

Sources: Federal Funds Information for States; office of Rep. Steny H. Hoyer

 

Baltimore Sun reporter Julie Bykowicz contributed to this article.

 

Copyright © 2009, The Baltimore Sun

 

 

 

 

 

High Lead Levels Found in D.C. Kids

Numbers Rose During Water Crisis

 

By Carol D. Leonnig

Washington Post

Tuesday, January 27, 2009; A01

 

A new study concludes that hundreds of young children in the District experienced potentially damaging amounts of lead in their blood when lead levels were dramatically rising in the city's tap water.

 

In some high-risk neighborhoods, the number of toddlers and infants with blood-lead concentrations that can cause irreversible IQ loss and developmental delays more than doubled after harmful levels of lead began leaching into the city's drinking water in 2001, according to the findings. The peer-reviewed study, obtained by The Washington Post, is to be published soon in Environmental Science and Technology, a journal on advances in chemical and environmental research.

 

Authors of the study, at Virginia Tech and Children's National Medical Center, said their findings raise concern about the 42,000 D.C. children, now ages 4 to 9, who were in the womb or younger than 2 during the water crisis. Those children might be at risk of future health and behavioral problems linked to lead, the report said.

 

The study, based on a detailed analysis of thousands of children's blood tests from 2000 to 2003, contradicts the public assurances issued by federal and D.C. health officials starting in 2004. At the time, although officials acknowledged that the amount of lead in city water were at record-breaking levels, they said repeatedly that they found no measurable impact on the general public's health.

 

The lead concentrations in the city's water were sometimes hundreds of times higher in individual homes than the amount the federal government considers a level of concern. The lead concentrations began rising in 2001, after a new chemical was added to the water treatment, and they persisted until they were publicized in a February 2004 Post article.

 

The current researchers found the most dramatic rise in the number of children with unsafe blood-lead levels in Mount Pleasant and Columbia Heights, the southeastern portion of Capitol Hill, a large swath of Ward 4 along Georgia Avenue, and Northeast Washington's Langdon Park. According to a Post analysis of lead tests in 2003 and 2004, these were all neighborhoods where some of the highest levels of lead were measured in tap water during the crisis. Those areas also relied heavily on lead pipes.

 

Specialists say damage from lead is often permanent. Children can exhibit signs of aggressiveness and difficulty focusing in school. Numerous studies show lead-poisoned children can on average lose 3 to 7 IQ points. The harm can be mitigated, however. Doctors say parents should focus on providing children with a healthful, calcium-rich diet and an enriching educational environment that includes reading to them regularly. There is no blood test to detect years-old lead exposure, but parents are encouraged to monitor their children.

 

The D.C. Water and Sewer Authority said the most recent tests of the city's water show lead levels in the safe range, with an average reading of 8 parts per billion or lower, in a group of homes. That is far below the federal level of concern of 15 parts per billion and is the result of a chemical treatment added in 2004.

 

Public health officials said this week that their earlier statements and reports did not try to suggest that the city's lead crisis had no impact on health but that at the time they had no data to indicate a problem. Some said they would have liked to do more research on possible links but ran into obstacles. Federal agencies and WASA cited a 2004 Centers for Disease Control and Prevention report as having "confirmed that there was no identifiable public health impact from elevated lead levels in drinking water."

 

The CDC relied on a broad, wide-ranging look at citywide tests for children and adults. The new study looks more specifically at children most vulnerable to lead poisoning and focused on neighborhoods with the highest levels of lead in water.

 

Mary Jean Brown, the CDC's lead poisoning prevention director, said she welcomes the new research and said the CDC's 2004 report noted concerns about a possible health impact but found no direct link. She said this week that she cannot control how other public agencies and officials might have interpreted the 2004 report.

 

"If people are walking away from this and saying there's no problem with drinking water, I don't know how to respond to that," she said. "We were under some constraints . . . working as quickly as we could. We didn't find evidence of a public health crisis. We used the methods at our disposal at the time."

 

The 2004 report found that of 201 residents tested in homes with unusually high lead in the water, "all had blood lead levels below CDC's concern." It also found that average blood levels did not rise measurably in the city but that D.C. residents in homes with lead pipes did not follow the national trend of lower blood-lead levels.

 

WASA General Manager Jerry Johnson said he could not comment on the new study because he has not seen it but said he relied in the past on the advice of trained scientists as WASA tried to disseminate all the information it could as fast as possible.

 

"I was quoting information that was provided to us by health experts with the very best information we had at the time," he said.

 

A spokesman for Mayor Adrian M. Fenty (D) said the mayor would look at the study when it is released and consider how to use it to continue improving the District's response to public health problems.

 

D.C. Attorney General Peter J. Nickles said yesterday that "obviously we'll take a close look at the study, and if the science demonstrates we need to do more for the public, we'll do more. Mayor Fenty takes the issue of lead in water very seriously."

 

The researchers in the latest report, based on a subset of tests reviewed by the CDC, identified hundreds of specific children whose blood lead rose to harmful levels during the city's lead crisis and generally fell when the water lead levels fell.

 

The correlation of timing and geography, several experts not involved in the study said, increases the likelihood that leaded water contributed to the changes in blood readings.

 

"There is no doubt that many children in this city were profoundly impacted by the years of completely unnecessary exposure to high lead in the District's water," said co-author Marc Edwards, a Virginia Tech engineer and MacArthur scholar. "We hope this study will stop future harm and address the misrepresentations and false statements about what really happened." Edwards has been a dogged critic of the government's role in creating the lead crisis and its later response.

 

Children younger than 2 and fetuses are the most vulnerable to permanent damage from lead, experts agree, because their brains are still developing and because they tend to both ingest and absorb much more of the toxic metal than do adults or older children, based on their body weight. Federal health officials have long viewed lead paint as the most dominant source of lead poisoning for children. But because the District's tap water had the highest lead readings ever measured in the nation, many experts have become increasingly concerned.

 

"I was surprised by how high the blood-lead levels were," said study co-author Dana Best, a Children's National Medical Center pediatrician and epidemiological researcher. "And by the time there are measurable levels, the damage has been done. We cannot continue to use children as the canaries in the coal mine. We have to stop testing children to determine what danger is in the environment and start testing the environment to make sure children don't get harmed."

 

Some parents, local activists and lead experts said the new research raises questions about the sweeping statements of public officials -- and the thoroughness of preliminary reports.

 

"Residents with high lead levels in their tap water did not have elevated blood lead levels, " the U.S. Environmental Protection Agency said in one fact sheet, citing the 2004 CDC report.

 

The news of the study came the day after the new EPA administrator, Lisa P. Jackson, pledged in a letter to employees that protecting children from toxins would be one of her top priorities in office.

 

David Bellinger, a well-known neurologist at Harvard University who focuses on the effects of lead and other toxin exposure on children, said he is struck that the number of young children with unsafe blood lead levels more than doubled in some targeted neighborhoods during the lead crisis.

"That's a big increase, and even the lower increase for kids with moderate risk is reason for worry," he said. "Compared to other kids in the U.S., these kids [in D.C.] were getting exposed to a lot more lead than other preschoolers."

 

If earlier reports were so limited in their scope, researchers should have avoided sweeping conclusions, Bellinger said.

 

"If these data were available previously, I would be surprised that anyone would be assuring the public there was no problem," he said. "It's hard to say in hindsight how much they should have known, or how deeply they should have probed. But without looking at the study, it surely sounds like the earlier statements made were falsely reassuring."

 

The CDC study was limited, according to public records and some environmental researchers.

 

CDC researchers tested the blood lead of 201 people in 2004. The residents had been warned in 2003 of unusually high lead levels in their tap water. They had been advised to use alternative sources for drinking water, and all the children were using bottled and filtered water when tested, according to their parents, and were thus unlikely to have high blood-lead levels.

 

Some of the public health officials said this week they had wanted later to analyze the possible links between blood lead and leaded water. Tee Guidotti, a George Washington University environmental health professor who was under contract as WASA's health adviser, said he stands by his findings in a 2007 report that average blood-lead levels were generally falling in 2003 and 2004, when water lead levels were generally rising.

 

"Do I wish we were better understood? Do I wish certain things were said differently? Do I wish we'd had better data? Sure," Guidotti said. "But those things were out of my control. In terms of what was under my control, I have no regrets about my role."

 

Walter Smith of the nonprofit advocacy group D.C. Appleseed Center for Law and Justice said his organization is still pushing for independent testing of the water.

 

Of the report, he said, "This casts further doubt on the reliability of the agencies who told us not to worry and are still telling us not to worry. We're talking about the health of little children. It's not like this is some insignificant issue."

 

Database editors Dan Keating and Sarah Cohen and researcher Julie Tate contributed to this report.

 

© 2009 The Washington Post Company

 

 

 

 

 

Correctional center nurse acquitted on sex offense charges

Walkersville man found not guilty of assaulting inmate

 

By Andrew Ujifusa

Montgomery Journal

Tuesday, January 27, 2009

 

An employee at a Montgomery County correctional facility was acquitted earlier this month on charges that he committed a sexual offense with a male inmate last year.

 

Francisco Modesto Redona, 51, of Walkersville, was found not guilty on Jan. 18 of one charge of correctional-inmate sexual offense and one charge of second-degree assault stemming from allegations from April 2008 at the Montgomery County Pre-Release Center. The trial took place over four days before Circuit Court Judge David Boynton in Rockville.

 

Redona was employed as a nurse at the Montgomery County Pre-Release Center on Nebel Street in North Bethesda when he was accused of performing a sexual act on a 35-year-old male inmate on April 29, 2008. The inmate originally came to Redona to obtain nasal spray and a physician's referral for a medical condition. The inmate told center staff there had been an incident at least 45 minutes later, and the staff subsequently called police.

 

According to charging documents, police obtained DNA evidence from the inmate and the inmate's boxer shorts that matched Redona's DNA.

 

Redona's attorney, Andrew Jezic of Wheaton, said the inmate admitted that he was alone for a short period of time in an examination room with tissues and paper towels that had been used by Redona.

 

Two employees at the Pre-Release Center, including a counselor who had worked with the inmate in 2005, also testified that the inmate was "not a truthful person," according to Jezic.

 

Jezic said Redona was currently in the process of trying to get his job back at the Pre-Release Center, where he is on unpaid administrative leave. He said his client had gone through "eight or nine months of hell." Redona had worked for the county's correctional system since 2003 and for the Pre-Release Center since 2006.

 

"The jury got to hear that this is an exemplary person, an exemplary nurse, an exemplary father and husband, and these are false charges," Jezic said.

 

Copyright © 2009 Post-Newsweek Media, Inc./Gazette

 

 

 

 

Medicaid aid could exceed $1 billion
01/27/2009
Capital-Gazette

WASHINGTON - Maryland could receive more than $1.4 billion in Medicaid assistance under the federal economic stimulus plan wending its way through Congress, according to an analysis by the Center on Budget and Policy Priorities.

An $825 billion spending and tax cut proposal being considered by the House includes provisions to temporarily raise the federal government's share of the heath care program.

If passed as proposed, more than $87 billion in Medicaid assistance to states would bring Maryland about $371 million in 2009 and 2011, and $664 million in the 2010, according to the analysis released Thursday.

'It's very good news for the states and very good news for the economy as well,' said Jason Levitis, a policy analyst with the Washington-based center.

'It's really important to get money to states so they aren't cutting health care ... and so that they aren't laying off other workers.'

Created to extend health care to low-income adults and children, Medicaid is jointly funded by the states and the federal government, with the federal share higher for states with lower average incomes.

Under the House plan, the federal government would defer any planned increases in the share of Medicaid costs borne by each state.

The plan also reduces the percentage paid by 'high unemployment' states and increases the federal match for each state by 4.9 percent.

States earning a 'high unemployment' designation must show that their unemployment rate has increased by a specific percentage since July 1, 2006.

Maryland's eligibility for the unemployment benefit is unclear. But under the plan, the state would see its federal match increase from 50 percent to 54.9 percent.

Appearing on WTOP-FM radio Friday, Gov. Martin O'Malley said without federal assistance, the state could be forced to go further than the job and program cuts in the 2010 budget he unveiled Wednesday.

Like a majority of states, Maryland is feeling the pinch of a dismal national economy. With more than 2 million jobs lost last year and foreclosures at a record high, states are facing severe revenue declines.

O'Malley's budget includes 700 layoffs and $1.2 billion in cuts. And to close a projected $2 billion deficit caused by declining revenues, it relies on a 'conservative' estimate of $350 million in forthcoming federal assistance.

Without federal help, 'there will be probably a higher number of job layoffs and also deeper cuts to things none of us wanted to cut,' O'Malley said.

Maryland's budget problems also prevent the continued expansion of Medicaid eligibility approved by state lawmakers during the 2007 special session.

In July 2008, a lower income ceiling took effect, allowing more low-income families to enroll. This coming July, eligibility was supposed to be expanded to childless adults, provided that certain revenue targets were met.

'We're going to have to hold where we are until we hit those benchmarks that allow us to go to the next phase,' O'Malley said.

Last year's expansion has brought 28,000 new enrollees to the program, said John Folkemer, deputy secretary for health care financing for the Maryland Department of Health and Mental Hygiene.

'In the last little more than a week, (enrollment) grew by more than 1,000,' he said. 'We figured probably that first six months, you're going to see steady growth and then after that not so much.'

Over the last year, overall participation in the program grew from 707,000 to 760,000, Folkemer said. He described the increase as 'not typical.'

'If the unemployment rate keeps going up, we will likely see an increase in the number of people qualifying for Medicaid,' he said.

Money from a federal stimulus plan could meet current needs and enable Maryland to follow through with enrolling more single adults, said Vinnie DeMarco, president of the Maryland Citizens' Health Initiative.

'I think that extra money should be enough to continue our health care expansion,' he said. 'It would definitely be enough to cover this.'

Copyright 2008 University of Maryland Philip Merrill College of Journalism
 

 

 

 

 

Serenity In Emergencies

A Silver Spring ER Aims to Serve Older Patients

 

By Beth Baker

Washington Post

Tuesday, January 27, 2009; HE01

 

When Barbara Rayner, 78, came to the emergency room at Holy Cross Hospital in Silver Spring last month with severe lower back pain, she was expecting a long wait and harried staff. But within minutes she was whisked into a separate area, called the senior emergency center. It is one of the nation's first ERs designed to serve a population 65 and older.

 

"It's a really forward-thinking idea," said Rayner. "I think senior citizens will appreciate it a great deal -- and their families."

 

Staff training in geriatrics and communication as well as a comprehensive approach to care and patient follow-up set the center apart from the typical emergency room. "They're actually structuring acute emergency services around the needs of the people they're taking care of, rather than forcing older people to conform to the operations of the hospital," said geriatrician William H. Thomas, a professor of aging studies at the University of Maryland Baltimore County's Erickson School who helped the hospital design the new area.

 

While patients in the main ER typically share a room crowded with monitors and equipment, separated from one another only by a flimsy curtain, each patient in the new center has an uncluttered cubicle, with a comfortable chair for a family member or visitor. Rayner said she appreciated the extra privacy. She also was grateful for the mattress -- twice as thick as other ER beds and specially designed to prevent skin breakdown that leads to bedsores, which can develop rapidly in elderly patients. There are plenty of blankets -- kept toasty in a blanket warmer -- and pillows.

 

Holy Cross consulted with the Erickson School on all aspects of the center and drew on experts in lighting and audiology to make the experience as soothing as possible on aging eyes and ears.

 

Walls are painted a warm gold, with wooden handrails for safe walking. Rather than slick linoleum, the floor is made of faux wood. Each patient has a television with headset, a large-face clock and overhead lighting controlled by a dimmer switch. There are just eight rooms, clustered near a small nurse's station. During a recent visit, the only disturbance was the squawk of the hospital-wide intercom -- and according to Bonnie Mann, director of Holy Cross's office of seniors, the center will soon switch to wireless paging to eliminate that distraction.

 

Staff members are given training in geriatrics, including techniques for communicating with patients whose hearing may be impaired or who process information slowly but don't want to be patronized. "Senior citizens frequently feel they're invisible," said Rayner. "People walk in front of you in line or talk over your head. No one's been condescending here. They've been respectful."

She added: "My previous experience in the emergency room certainly was not bad, but I was left alone longer. This time you had the feeling someone was paying attention the whole time."

 

Dolores Bartlett of Damascus was in the senior emergency center with her mother, Margaret Fenwick, 96, a fiercely independent woman who lives alone in Wheaton and still rakes her own leaves. Fenwick had fallen and fractured two ribs. She was to be admitted to the hospital and was waiting for a private room to open up.

 

Bartlett was impressed that the staff had brought down a hospital bed so that her mother would be more comfortable.

 

"The nurses have all been so pleasant, so calm, so caring," said Bartlett. When she asked to speak to the doctor, she said, "it wasn't long before he came and gave me an in-depth explanation of what was going on, in layman's terms, that encouraged me to encourage her." The staff even looked out for Bartlett, offering her a bed to nap on and bringing her a box lunch.

 

Bartlett's only complaint was when her mother was taken to radiology. Bartlett felt the technicians positioned her mother too roughly, causing her excessive pain.

 

Judith Rogers, the hospital's vice president of patient care services, said she was disappointed but not surprised to hear this. "We started geriatrics-specific training with registered nurses in the ER, then nurses on the medical floors, and we're beginning now to train the ancillaries" such as radiology and respiratory therapy staff, she said.

 

Holy Cross chief executive Kevin Sexton said the idea for an emergency room for older people came to him after he got a call from his mother from an ER in New Jersey. "It was clear she was really stressed out," he said. "It was the combination of her being there quite some time and it being very crowded and chaotic. It came to me we really do treat seniors poorly in that setting."

 

The aging of Montgomery County contributed to the decision to open the center: 70 percent of anticipated population growth over the next decade will be people older than 65, according to Sexton. "An enormous demand for services is going to befall hospitals," he said. "Figuring out how to do it better without bankrupting us all is going to be one of the challenges."

 

The senior emergency center is a first step in the hospital's long-term plan to become known for serving older people. It's an unusual concept: An expert at the Society of Academic Emergency Medicine could think of only one similar facility, located at Nassau University Medical Center in New York.

 

Holy Cross spent $150,000 on its center, raised through an annual gala, to renovate an existing space and to train nursing staff. The hope is that the center will run more efficiently than the general ER, getting test results more quickly, for example. The staff will also monitor whether the improved assessment and follow-up lead to fewer return admissions for these patients. Mann stresses that most of the extra services are low-cost.

 

Not all older patients end up in the senior emergency room. Those arriving with traumatic injury -- from a car accident, for example -- or in acute distress such as a heart attack will still be treated in the general ER. Nearly three-quarters of people over 65, though, come to the emergency room not in life-threatening crisis but because of a fall, chest pain, shortness of breath or other problem related to chronic conditions.

 

Once the patient is stable, nurses screen for cognitive loss, depression, possible interactions from taking multiple medications, and alcohol and drug use. They also perform a risk assessment for falls, neglect or abuse. Those who test positive in any of these areas are referred to community resources and receive a follow-up call from a geriatric nurse practitioner or social worker.

 

Holy Cross hopes not only to provide first-class service to seniors at no extra cost, Sexton said, but also to deliver health care more efficiently by reducing future hospital stays. A trip to the emergency room, then, is not only about fast treatment and discharge, but it is also an opportunity to uncover chronic problems that need attention.

 

When planning the new ER, Holy Cross conducted focus groups with older people to find out what they'd like to see in an emergency room. Mann was struck by the common themes that emerged. "Over and over we heard, 'Keep me informed' and 'Keep me warm,' " she said.

 

Focus group participant Betty Ann Barnes, 73, of Silver Spring said she was impressed that the hospital would solicit the opinions of older people as part of the planning process and not just as an afterthought. She was pleased that her group's request for warm blankets was met, although another wish -- free valet parking for older people -- was not. After touring the center, Barnes declared it "magnificent."

 

Augusta Widmer, 82, a patient who arrived at the ER with pain in her hip, agreed. "Everybody's been wonderful," she said. "I couldn't ask for anything nicer. Other emergency rooms I've been to were much more hectic and noisy, and you wait a long time."

 

Asked if she would add anything, she suggested, "Soft music. And a cup of coffee. Other than that, no."

 

In fact, both these requests were already met. Using their television remote, patients can select a soft music channel or one with pastoral scenery to view. Coffee, bouillon and juice are also available. "We're on a learning curve," said Mann. "Now we have to make sure the staff let patients know what we offer."

 

© 2009 The Washington Post Company

 

 

 

 

Peanut Plant Was Cited for Violations

 

By Roni Caryn Rabin

New York Times

Tuesday, January 27, 2009

 

The plant in Georgia that produced peanut butter tainted by salmonella has a history of sanitation lapses and was cited repeatedly in 2006 and 2007 for having dirty surfaces and grease residue and dirt buildup throughout the plant, according to health inspection reports. Inspection reports from 2008 found the plant repeatedly in violation of cleanliness standards.

 

Inspections of the plant in Blakely, Ga., by the State Agriculture Department found areas of rust that could flake into food, gaps in warehouse doors large enough for rodents to get through, unmarked spray bottles and containers and numerous violations of other practices designed to prevent food contamination. The plant, owned by the Peanut Corporation of America of Lynchburg, Va., has been shut down.

 

A typical entry from an inspection report, dated Aug. 23, 2007, said: “The food-contact surfaces of re-work kettle in the butter room department were not properly cleaned and sanitized.” Additional entries noted: “The food-contact surfaces of the bulk oil roast transfer belt” in a particular room “were not properly cleaned and sanitized. The food-contact surfaces of pan without wheels in the blanching department were not properly cleaned and sanitized.”

 

A code violation in the same report observed “clean peanut butter buckets stored uncovered,” while another cited a “wiping cloth” to “cover crack on surge bin.” Tests on samples gathered on the day of that inspection were negative for salmonella.

 

The inspection reports were provided by Georgia officials in response to a request made by The New York Times under the state’s open-records act.

 

Two inspection reports from 2008 found the plant out of compliance with practices for making sure “food and non-food contact surfaces were cleanable, properly designed, constructed and used.”

 

The state performs the inspections on behalf of the Food and Drug Administration as part of a contractual agreement with the federal agency, officials said.

 

Representatives of the Peanut Corporation of America did not respond to requests for comment.

 

The salmonella outbreak has sickened almost 500 people around the country and is linked to seven deaths. More than 125 products containing peanut butter or peanut paste from the Georgia plant have been recalled.

 

Copyright 2009 The New York Times Company

 

 

 

 

 

Medicare Widens Drugs It Accepts for Cancer

 

By Reed Abelson and Andrew Pollack

New York Times

Tuesday, January 27, 2009

 

Medicare, with little public debate, has expanded its coverage of drugs for cancer treatments not approved by the Food and Drug Administration.

 

Cancer doctors had clamored for the changes, saying that some of these treatments, known as off-label uses, were essential if patients were to receive the most up-to-date care. But for many such uses there is scant clinical evidence that the drugs are effective, despite costing as much as $10,000 a month. Because the drugs may represent a patient’s last hope, though, doctors are often willing to try them.

 

The new Medicare rules are the latest twist in a protracted debate over federal spending on off-label drugs — drugs prescribed for uses other than those for which they have been specifically approved.

 

Proponents of the changes say such spending not only helps patients, but can also enhance medical understanding of which treatments work against various forms of cancer.

 

But opponents argue that the new approach may waste money and needlessly expose patients to the side effects of drugs that may not help them. They also raise the possibility of conflicts of interest, because the rules rely on reference guides that in some cases are linked to drug makers.

 

The new policy, which took effect in November, makes it much easier to get even questionable treatments paid for, critics of the changes say. Medicare is providing “carte blanche in treatment for cancers,” said Steven Findlay, a health policy analyst for Consumers Union. He said overly expansive coverage encourages doctors to use patients as guinea pigs for unproved therapies.

 

Because Medicare officials canceled a cost analysis of the changes, it is hard to predict how much spending will increase beyond the $2.4 billion Medicare paid in 2007 for cancer drugs. But cancer doctors and other experts say the new policies, adopted in the final months of the Bush administration, seem almost certain to raise the federal drug bill, while making it more difficult for the new administration to rein in spending on unproven medical treatments.

 

Although President Obama has made a goal of controlling health care costs, a spokesman for the Obama administration declined to comment on the Medicare changes.

 

One of the many drugs whose use is likely to expand is the Eli Lilly product Gemzar, which costs $2,500 to $5,000 a month. The F.D.A. has approved it to treat only four types of cancer. But the new rules will virtually guarantee that Medicare will pay for its use for about a dozen other cancers, including advanced cervical cancer — even though the evidence supporting Gemzar for that use is “inconclusive,” according to one of the reference guides Medicare will now be consulting.

 

In the case of Genentech’s Avastin, one of the world’s most expensive and widely used cancer drugs, Medicare rejected in 2007 nearly all of the estimated $16 million in requests from doctors’ offices to cover its off-label use for ovarian cancer, according to claims specialists who work with Medicare data but declined to be identified because of the controversy over the topic. Under the new rules, Avastin will be routinely covered for ovarian cancer — as will at least some other off-label uses, including for brain and kidney cancer.

 

It is unclear how much precedent Medicare’s new rules might have on private insurers, which often follow the agency’s lead on paying for drugs.

 

Medicare officials defend the new policies, saying they respond to cancer doctors’ concerns that the agency has been too slow to recognize promising new off-label treatments. Dr. Steve Phurrough, who has overseen coverage for the agency since 2003, noted that a 1993 federal law gave Medicare specific authorization to cover some unapproved uses of cancer drugs.

 

“Congress wanted a lesser level of evidence,” Dr. Phurrough said. The question of what is adequate evidence is “not a line in the sand,” he said. “It’s a broad stripe in the sand.”

 

The American Society of Clinical Oncology, which represents cancer doctors, has hailed the new rules, saying they will ensure that the appropriate off-label uses are covered.

 

But some specialists say that being able to offer off-label drugs can also let physicians avoid hard discussions with patients about a grim prognosis.

 

“It makes it easier to give drug after drug,” said Dr. Andrew Berchuck, director of gynecologic oncology at Duke University, “and keep the fantasy alive.”

 

The new rules expand the number of reference guides — or compendiums — that Medicare relies on for determining which off-label uses of cancer drugs to cover. The writers and editors of these compendiums, who work completely outside the federal government, scan the medical literature and evaluate the evidence in making their recommendations.

 

In 1993, Congress had authorized three compendiums for Medicare, all published by not-for-profit organizations. But by 2007 two had stopped publishing, leaving Medicare with a single compendium. Having selected three additional guides last year, the agency plans to review its choice of guides every year.

 

Under the old rules, Medicare representatives were supposed to consult the compendiums but also use their own discretion in interpreting the guides’ recommendations. The new rules essentially delegate the decision to guides Medicare has selected, even when there is little clinical evidence behind a particular recommendation. As long as at least one of them recommends a cancer treatment, Medicare is essentially obliged to pay for it — unless one of the other guides specifically advises against it.

And some of these new compendiums have close financial ties to the drug industry, according to the draft of a report Medicare commissioned last year after Congress raised questions about possible conflicts of interest. The draft was completed in October, with a final version to be released soon.

 

The draft criticizes the new rules for essentially taking most decisions about off-label cancer drugs out of Medicare’s hands, even when the agency is aware of potential conflicts. The guide’s recommendation, the report says, “becomes the final word.”

 

For some experts, the bigger concern about using some cancer drugs off-label without adequate evidence is that they may not only be useless — they may cause dangerous side effects.

 

“We have very little faith that those indications that make it into the compendia are safe, let alone effective,” said Dr. Allan M. Korn, the chief medical officer for the Blue Cross and Blue Shield Association, who added that Medicare should cover off-label drugs only if the results of their use are carefully tracked afterward. There is no such requirement in the new Medicare guidelines.

 

There have been three different top Medicare administrators since the off-label rule changes were set in motion a few years ago. The second of them, Leslie V. Norwalk, chose to select the compendiums through a streamlined and internal administrative process, instead of the more elaborate and public process that Medicare often uses for broad coverage decisions.

 

“I did not see it as a significant step in coverage,” said Ms. Norwalk, who left Medicare in 2007.

 

Drug makers say they welcome the Medicare changes. A spokesman for the Pharmaceutical Research and Manufacturers of America, the industry’s main trade group, said the new rules ensured “that cancer patients have access to the treatments they need.”

 

Many oncologists say they needed greater flexibility in using cancer drugs because it can take months or years for a new use to be approved by the F.D.A. They cite the example of Celgene’s drug thalidomide, now a mainstay treatment for multiple myeloma, which was prescribed only off-label for years before the F.D.A. formally approved it for that use.

 

And in the case of rare types of cancer, there may be so few potential patients that companies have little financial incentive to undergo the formal F.D.A. process for approving a drug for expanded use. Only two drugs have been approved by the F.D.A. for brain cancer, for example, and cancer doctors say they need the ability to try other drugs or other combinations of treatments.

 

“To arbitrarily stop after two drugs to me is ludicrous,” especially for younger patients, said Dr. Virginia Stark-Vance, a solo practitioner in Dallas and Fort Worth. She said one of her brain cancer patients had been kept alive for 10 years by off-label use of irinotecan, a colon cancer drug that was the ninth drug the patient tried.

 

Medicare seems to have ignored some concerns raised by a group of outside researchers whom the agency had asked to survey a half-dozen compendiums, including the four that Medicare has now adopted. That report, completed in 2007, found that the six guides “cited very little of the available evidence,” said Dr. Amy P. Abernethy, a Duke oncologist who led the study.

 

The study also found great variability among the guides, in terms of what uses were recommended — or discussed at all.

 

Despite her study’s findings, Dr. Abernethy says she does not oppose Medicare’s new rules.

 

“I think the addition of the new compendia this year is an important increase in the bandwidth,” she said.

 

Critics say the agency also seems to have played down the potential financial conflicts of interests between the drug industry and the producers of the compendiums. The draft study that was completed in October notes that one of the new guides is published by the National Comprehensive Cancer Network, a group of 21 leading cancer centers that routinely employs experts who have financial ties to the drug industry.

 

William T. McGivney, the network’s chief executive, said each committee of reviewers had 20 to 30 members, which “diminishes the opportunity for dominance of one person’s opinion,” regardless of any ties to drug makers.

 

Then there is the American Hospital Formulary compendium, the one that Medicare was using before the November changes and will continue to consult. It has long been published by the nonprofit American Society of Health-System Pharmacists. But last year the society forged a financial relationship with a foundation linked to drug companies and some cancer doctors’ private practices.

 

A drug company can apply to that foundation, the Foundation for Evidence-Based Medicine, and pay a $50,000 fee to have new uses of its drug reviewed by the compendium within 90 days. The foundation was started in 2007 by the Association of Community Cancer Centers, which represents oncology practices, and says it received about $200,000 in initial funding from drug makers.

 

Gerald K. McEvoy, the guide’s editor in chief, said the application fee was meant to raise money to pay for additional researchers, to address previous criticism that the publication was too slow to vet new evidence. The foundation insulates the guide’s staff from industry pressure, he said, and fewer than one-third of the reviews under the new arrangement have resulted in a positive recommendation in the compendium.

 

Medicare officials acknowledge that some of the potential conflicts need to be addressed. But they say they have confidence in the guides they have chosen. “We had significant conversations with all the companies,” Dr. Phurrough said.

 

Copyright 2009 The New York Times Company

 

 

 

 

The Epidemic That Wasn’t

 

By Susan Okie

New York Times

Tuesday, January 27, 2009

 

BALTIMORE — One sister is 14; the other is 9. They are a vibrant pair: the older girl is high-spirited but responsible, a solid student and a devoted helper at home; her sister loves to read and watch cooking shows, and she recently scored well above average on citywide standardized tests.

 

There would be nothing remarkable about these two happy, normal girls if it were not for their mother’s history. Yvette H., now 38, admits that she used cocaine (along with heroin and alcohol) while she was pregnant with each girl. “A drug addict,” she now says ruefully, “isn’t really concerned about the baby she’s carrying.”

 

When the use of crack cocaine became a nationwide epidemic in the 1980s and ’90s, there were widespread fears that prenatal exposure to the drug would produce a generation of severely damaged children. Newspapers carried headlines like “Cocaine: A Vicious Assault on a Child,” “Crack’s Toll Among Babies: A Joyless View” and “Studies: Future Bleak for Crack Babies.”

 

But now researchers are systematically following children who were exposed to cocaine before birth, and their findings suggest that the encouraging stories of Ms. H.’s daughters are anything but unusual. So far, these scientists say, the long-term effects of such exposure on children’s brain development and behavior appear relatively small.

 

“Are there differences? Yes,” said Barry M. Lester, a professor of psychiatry at Brown University who directs the Maternal Lifestyle Study, a large federally financed study of children exposed to cocaine in the womb. “Are they reliable and persistent? Yes. Are they big? No.”

 

Cocaine is undoubtedly bad for the fetus. But experts say its effects are less severe than those of alcohol and are comparable to those of tobacco — two legal substances that are used much more often by pregnant women, despite health warnings.

 

Surveys by the Department of Health and Human Services in 2006 and 2007 found that 5.2 percent of pregnant women reported using any illicit drug, compared with 11.6 percent for alcohol and 16.4 percent for tobacco.

 

“The argument is not that it’s O.K. to use cocaine in pregnancy, any more than it’s O.K. to smoke cigarettes in pregnancy,” said Dr. Deborah A. Frank, a pediatrician at Boston University. “Neither drug is good for anybody.”

 

But cocaine use in pregnancy has been treated as a moral issue rather than a health problem, Dr. Frank said. Pregnant women who use illegal drugs commonly lose custody of their children, and during the 1990s many were prosecuted and jailed.

Cocaine slows fetal growth, and exposed infants tend to be born smaller than unexposed ones, with smaller heads. But as these children grow, brain and body size catch up.

 

At a scientific conference in November, Dr. Lester presented an analysis of a pool of studies of 14 groups of cocaine-exposed children — 4,419 in all, ranging in age from 4 to 13. The analysis failed to show a statistically significant effect on I.Q. or language development. In the largest of the studies, I.Q. scores of exposed children averaged about 4 points lower at age 7 than those of unexposed children.

 

In tests that measure specific brain functions, there is evidence that cocaine-exposed children are more likely than others to have difficulty with tasks that require visual attention and “executive function” — the brain’s ability to set priorities and pay selective attention, enabling the child to focus on the task at hand.

 

Cocaine exposure may also increase the frequency of defiant behavior and poor conduct, according to Dr. Lester’s analysis. There is also some evidence that boys may be more vulnerable than girls to behavior problems.

 

But experts say these findings are quite subtle and hard to generalize. “Just because it is statistically significant doesn’t mean that it is a huge public health impact,” said Dr. Harolyn M. Belcher, a neurodevelopmental pediatrician who is director of research at the Kennedy Krieger Institute’s Family Center in Baltimore.

 

And Michael Lewis, a professor of pediatrics and psychiatry at the Robert Wood Johnson Medical School in New Brunswick, N.J., said that in a doctor’s office or a classroom, “you cannot tell” which children were exposed to cocaine before birth.

 

He added that factors like poor parenting, poverty and stresses like exposure to violence were far more likely to damage a child’s intellectual and emotional development — and by the same token, growing up in a stable household, with parents who do not abuse alcohol or drugs, can do much to ease any harmful effects of prenatal drug exposure.

 

Possession of crack cocaine, the form of the drug that was widely sold in inner-city, predominantly black neighborhoods, has long been punished with tougher sentences than possession of powdered cocaine, although both forms are identically metabolized by the body and have the same pharmacological effects.

 

Dr. Frank, the pediatrician in Boston, says cocaine-exposed children are often teased or stigmatized if others are aware of their exposure. If they develop physical symptoms or behavioral problems, doctors or teachers are sometimes too quick to blame the drug exposure and miss the real cause, like illness or abuse.

 

“Society’s expectations of the children,” she said, “and reaction to the mothers are completely guided not by the toxicity, but by the social meaning” of the drug.

 

Research on the health effects of illegal drugs, especially on unborn children, is politically loaded. Researchers studying children exposed to cocaine say they struggle to interpret their findings for the public without exaggerating their significance — or minimizing it, either.

 

Dr. Lester, the leader of the Maternal Lifestyle Study, noted that the evidence for behavioral problems strengthened as the children in his study and others approached adolescence. Researchers in the study are collecting data on 14-year-olds, he said, adding: “Absolutely, we need to continue to follow these kids. For the M.L.S., the main thing we’re interested in is whether or not prenatal cocaine exposure predisposes you to early-onset drug use in adolescence” or other mental health problems.

 

Researchers have long theorized that prenatal exposure to a drug may make it more likely that the child will go on to use it. But so far, such a link has been scientifically reported only in the case of tobacco exposure.

 

Teasing out the effects of cocaine exposure is complicated by the fact that like Yvette H., almost all of the women in the studies who used cocaine while pregnant were also using other substances.

 

Moreover, most of the children in the studies are poor, and many have other risk factors known to affect cognitive development and behavior — inadequate health care, substandard schools, unstable family situations and exposure to high levels of lead. Dr. Lester said his group’s study was large enough to take such factors into account.

 

Ms. H., who agreed to be interviewed only on the condition that her last name and her children’s first names not be used, said she entered a drug and alcohol treatment program about six years ago, after losing custody of her children.

 

Another daughter, born after Ms. H. recovered from drug and alcohol abuse, is thriving now at 3. Her oldest, a 17-year-old boy, is the only one with developmental problems: he is autistic. But Ms. H. said she did not use cocaine, alcohol or other substances while pregnant with him.

 

After 15 months without using drugs or alcohol, Ms. H. regained custody and moved into Dayspring House, a residential program in Baltimore for women recovering from drug abuse, and their children.

 

There she received psychological counseling, parenting classes, job training and coaching on how to manage her finances. Her youngest attended Head Start, the older children went to local schools and were assigned household chores, and the family learned how to talk about their problems.

 

Now Ms. H. works at a local grocery, has paid off her debts, has her own house and is actively involved in her children’s schooling and health care. She said regaining her children’s trust took a long time. “It’s something you have to constantly keep working on,” she said.

 

Dr. Belcher, who is president of Dayspring’s board of directors, said such programs offered evidence-based interventions for the children of drug abusers that can help minimize the chances of harm from past exposure to cocaine or other drugs.

 

“I think we can say this is an at-risk group,” Dr. Belcher said. “But they have great potential to do well if we can mobilize resources around the family.”

 

Copyright 2009 The New York Times Company

 

 

 

 

 

High-tech sensors help seniors live independently

 

Associated Press

Daily Record

Tuesday, January 27, 2009

 

COLUMBIA, Mo. — After back-to-back hospital visits for congestive heart failure, Eva Olweean figured her health was back to normal. But the nurses at her retirement home knew better: Motion sensors in the 86-year-old's bed detected too many restless nights.

 

Tiny sensors hover unobtrusively over the toilet, shower and doorways to detect Olweean's movements inside her apartment. Pneumatic tubes tucked in the mattress and beneath her easy chair measure weight shifts. Caregivers and researchers at the University of Missouri-Columbia study the data, noting changes in behavior that could signal medical problems.

 

Recognizing the coming "silver tsunami" of graying baby boomers, tech companies are racing to help aging Americans spend more time living independently instead of in nursing homes. For the first time earlier this month, the International Consumer Electronics Show in Las Vegas featured a special section devoted to high-tech senior living.

 

Among the advances at the show were motion sensors, the kind that allowed Olweean's nurses to figure out what was keeping her up at night. She was experiencing excessive bloating, a common symptom of congestive heart failure. So Olweean's cardiologist prescribed diuretics and made other adjustments to her medication that helped the woman again sleep soundly.

 

"We try to identify when those small problems occur, so we can fix them before they become big problems," said Marjorie Skubic, an electrical and computer engineering professor who works with Sinclair School of Nursing researchers on the aging-in-place project.

 

At Oatfield Estates in the Portland suburb of Milwaukie, Ore., resident movements in the private retirement home are tracked by what employees call "bed bugs." Those are embedded motion sensors that detect when someone's behavior could trigger a medical alert.

 

Sensors like those, "smart carpets" and other tracking devices will be the norm in both private homes and group settings within the next decade, said Jason Hess, chief executive officer of Elite Care, the Portland company that owns Oatfield Estates. He said that will especially be true as insurers start embracing the cost-saving devices.

 

"You will see a lot more places implementing these," he said. "It comes down to cost, and out-of-the-box thinking."

 

At the Las Vegas show, on display were talking pill boxes that remind seniors to take their medicine at regular intervals, and which can notify out-of-town caregivers if that doesn't happen. There were robotic companion pets that mimic the real thing for lonely seniors in need of a psychological boost.

"We're talking about an important paradigm shift in how we think about aging," said Majd Alwan, director of the Washington-based Center for Aging Services Technologies. Alwan led a panel discussion on smart-home technology at the Las Vegas event.

 

Delaying institutionalization by a year or more, is a significant financial savings, he added. "Let alone the benefits in quality of life for the senior and for the caregiver."

 

Alwan previously led the eldercare technology unit of the University of Virginia's Medical Automation Research Center, which developed the passive sensor technology used in Missouri.

 

Unlike medical warning badges worn by seniors, the motion sensors' success doesn't depend on the cooperation of patients. Elderly people can be prone to forget the badges when dressing, or who might resist the devices as too obtrusive, said University of Missouri nursing professor Marilyn Rantz.

 

"Our intent with this project was to incorporate (it) into their daily lives — and make it invisible to their daily lives," she said.

 

Olweean, a retired factory worker, said she barely notices the sensors.

 

"I don't even know they're here half the time," she said.

 

Fifteen of the 35 residents at her apartment complex take part in the motion sensor research project. The complex is named Tiger Place after the University of Missouri mascot and is owned by the university, though managed by a private company.

 

Researchers there are also fine-tuning a more advanced monitoring system using virtual-reality silhouette images to allow observation of posture, gait and other movements. The silhouettes are considered a preferred alternative to more invasive video cameras.

 

Rantz, Alwan and other experts acknowledge that rapid technological advances in elder care must be balanced with privacy protections. That dilemma concerns Fredda Vladeck, executive director of the United Hospital Fund's Aging in Place Initiative.

 

"Technology does have a role to play," she said. "It's a tool, not the answer."

 

- end -

 

 

 

 

 

Spread of Malaria Feared as Drug Loses Potency

 

By Thomas Fuller

New York Times

Tuesday, January 27, 2009

 

TASANH, Cambodia — The afflictions of this impoverished nation are on full display in its western corner: the girls for hire outside restaurants, the badly rutted dirt roads and the ubiquitous signs that warn “Danger Mines!”

 

But what eludes the naked eye is a potentially graver problem, especially for the outside world. The parasite that causes the deadliest form of malaria is showing the first signs of resistance to the best new drug against it.

 

Combination treatments using artemisinin, an antimalaria drug extracted from a plant used in traditional Chinese medicine, have been hailed in recent years as the biggest hope for eradicating malaria from Africa, where more than 2,000 children die from the disease each day.

 

Now a series of studies, including one recently published in The New England Journal of Medicine and one due out soon, have cemented a consensus among researchers that artemisinin is losing its potency here and that increased efforts are needed to prevent the drug-resistant malaria from leaving here and spreading across the globe.

 

“This is something we can’t just slide under the carpet,” said R. Timothy Ziemer, a retired admiral in the United States Navy who heads the President’s Malaria Initiative, the $1.2 billion program started by the Bush administration three years ago to cut malaria deaths in half in the countries affected worst.

 

Admiral Ziemer met with Thai and Cambodian officials last month to assess the resistance problem, which affects the same drugs used by the malaria initiative in Africa.

 

“We feel that we not only have to beat the drum but shake the cage: guys, this is significant,” he said.

 

Though the studies show relatively early signs of resistance to artemisinin, the drugs were judged to have failed in only two patients in the recently published study. Even they were eventually cured.

 

But malaria experts note that several times in the past, this same area around the Thai-Cambodian border appears to have been a starting point for drug-resistant strains of malaria, starting in the 1950s with the drug chloroquine.

 

Introduced immediately after World War II, chloroquine was considered a miracle cure against falciparum malaria, the deadliest type. But the parasite evolved, the resistant strains spread, and chloroquine is now considered virtually useless against falciparum malaria in many parts of the world, including sub-Saharan Africa.

 

It took decades for this resistance to spread across the world, so by the same token artemisinin-based drugs are almost sure to be useful for many years to come.

 

To protect against artemisinin resistance, the global health authorities are trying to assure that it is sold only as a combination pill with other antimalaria medicines that linger longer in the blood, mopping up any artemisinin-resistant parasites.

 

The two most recent tests showing artemisinin resistance were done with pills that had no combination drug. But if resistance spreads, there are no new drugs to take the place of artemisinin-based combinations and no immediate prospects under development.

 

“This could spread in any direction; we have to make sure it doesn’t,” said Pascal Ringwald, malaria coordinator at the World Health Organization, who three years ago led a study of drug resistance in Cambodia and is co-author of a coming study on the subject. “We know it’s not yet in Bangladesh,” he said. “It’s not yet in India.”

 

Scientists have documented how malarial parasites that were resistant to chloroquine in the 1950s spread across Thailand, Burma, India and over to Africa, where a vast majority of the nearly one million annual malaria-related deaths occur.

 

To prevent a recurrence with artemisinin therapies, the United States has put aside political considerations and approved a malaria monitoring center in military-run Myanmar, formerly Burma. The Bill and Melinda Gates Foundation, one of the largest donors to malaria research, is giving $14 million to the Thai and Cambodian governments to help pay for a containment program.

 

That program includes efforts to supply the area with mosquito nets, a screening program for everyone living in affected areas and follow-up visits by health workers to assess the effectiveness of the drugs, said Dr. Duong Socheat, director of Cambodia’s National Malaria Center. On the Thai side of the border, the government has “motorcycle microscopists” who take blood samples from villagers and migrant workers, analyze them on the spot and distribute antimalaria drugs.

 

But some experts would like to see an even more aggressive approach.

 

“Many of us think this should be treated on the same order as SARS,” said Col. Alan J. Magill, a researcher at the Walter Reed Army Institute of Research in Maryland. “This should be a global emergency that is addressed in a global fashion.” SARS, the respiratory disease that spread rapidly through Asia and beyond in 2003, killed more than 700 people.

 

The falciparum parasite is one of four types of malaria and by far the most virulent. It enters the bloodstream through a mosquito bite, and after incubating about two weeks, it multiplies and takes over red blood cells. There it causes fever, chills, headaches and nausea, among other symptoms. If untreated, the infected cells can block blood vessels and fatally cut off blood supply to vital organs.

 

The recent studies show that artemisinin-based drugs are becoming less effective in removing the parasite from the bloodstream. While a few years ago it took the drugs 48 hours to clear the bloodstream of parasites, it now can take 120 hours.

 

“What our study demonstrates is that therapy for some patients fails — the malaria goes away and comes back,” said Lt. Col. Mark M. Fukuda, a United States Army doctor whose study was published in The New England Journal of Medicine in December.

 

Different regions rely on different artemisinin combinations. The Cambodian government recommends that artemisinin be combined with mefloquine, which was developed by the American military and is known commercially as Lariam. Artemether, a derivative of artemisinin, is often combined with another antimalarial drug, lumefantrine. This was recently judged to be the most effective combination in a study of children in Papua New Guinea.

 

The same combination is also expected to be approved for sale in the United States soon, marketed by Novartis and mainly intended for people traveling overseas or for those who arrive in the United States with malaria.

 

The mosquito responsible for transmission of malaria is still endemic in the United States. But modern housing, better access to health care and the use of insecticides have virtually eradicated the disease in wealthier countries.

 

Here in Tasanh, a village 20 miles east of the Thai border, Dr. Fukuda and a team of researchers work in what is euphemistically called a more challenging environment. Tasanh is served by a dirt road and has no running water and no public supply of electricity.

 

In a small, spartan clinic, Chet Chen, an 18-year-old malaria patient, lies listlessly on an old metal-framed bed next to a sample of his urine in a used water bottle. The male nurse who examines blood samples is out helping to fix the weed whacker, which has broken.

 

In a small but newer annex to the clinic, Dr. Fukuda and his researchers work in a trilingual environment — Khmer (Cambodian), Thai and English — that sometimes sows confusion.

 

Americans in the clinic recently chuckled when a Thai researcher described a patient as having a “hot body” — a literal translation of “fever” in Thai, but one that evoked nightclub images.

 

Dr. Fukuda calls this region of Cambodia the “canary in the coal mine” for drug resistance.

 

In the past, migrant workers in plantations and gem mines are believed to have helped spread drug-resistant strains westward. A history of civil unrest, counterfeit drugs and a weak and underfinanced government has made it difficult to control malaria. In the case of chloroquine, preventive use of the drug — including putting it in table salt to protect a wide swath of the population — might have actually encouraged resistance to the drug, Dr. Fukuda and others say.

 

It was not until the 1990s that mefloquine, the American army drug, was combined with artemisinin, made from a Chinese herb.

 

Artemisinin-based combinations turned out to be fast-acting and seemed to slow transmission of the disease, said Dr. John MacArthur, an infectious disease expert with the United States Agency for International Development in Bangkok.

 

Dr. MacArthur and others say resistance to malaria drugs is a natural consequence of widespread use of the drug. “In the case of malaria, it’s the Darwinism of the parasite,” he said. “It likes to survive.”

 

Still, some researchers remain concerned about sending the wrong message to the public about the efficacy of artemisinin-based drugs.

 

“This is not the death knell of artemisinin,” said Dr. Nicholas White, a malaria expert who is chairman of a joint research program between Oxford University and Mahidol University in Thailand. “The drug still works in Cambodia, maybe not as well as before.”

 

But given the history of drug failures here, there appears to be a consensus on the solution.

 

“Get rid of all malaria from Cambodia,” Dr. White said. “Eradicate it. Eliminate it.”

 

Copyright 2009 The New York Times Company

 

 

 

 

 

Is That Device Safe?

 

New York Times Editorial

Tuesday, January 27, 2009

 

The Food and Drug Administration has been justly pilloried for grievous flaws in its regulation of foods and drugs. Now Congressional investigators, and some of the agency’s own scientists, are charging that the F.D.A. has failed to adequately regulate medical devices.

 

The Government Accountability Office recently reported that the F.D.A. has failed — for decades — to subject some of the riskiest devices to a rigorous review mandated by Congress. A group of F.D.A. scientists complained to the Obama transition team — and before that to Congress and to the agency’s commissioner — that during the Bush years, managers in charge of medical device reviews had corrupted and distorted the process in ways that put the public at risk.

 

Under a 1976 law, the F.D.A. is required to divide medical devices into three classes and to impose different levels of scrutiny. The riskiest Class III devices — such as implantable pacemakers and replacement heart valves — require the most stringent review, usually including clinical evidence that they are safe and effective.

 

Unfortunately, the law left a gaping loophole. Certain types of Class III devices already on the market, and later devices deemed substantially equivalent to them, could be approved for sale with the less stringent review — until the F.D.A. required them to pass a more rigorous test or put them into a lower class.

 

The agency made so little progress in closing the loophole that Congress in 1990 ordered it to quickly decide which classes the grandfathered devices should be in and to schedule rigorous reviews for those remaining in Class III. Although the agency has done that for most of the remaining devices, the G.A.O. found that it has still not completed the task.

 

In a recent five-year period, the F.D.A. used the less stringent procedures to clear 228 Class III devices, including certain types of metal hip joints and implanted blood access devices.

 

The Obama administration will have to send a clear signal to the bureaucracy that the days of neglect are over. Officials will also have to make clear that the Bush administration’s practice of distorting science and weakening regulation to favor industry also is over.

 

We are pleased to hear that F.D.A. scientists have been raising the alarms. As Gardiner Harris reported in The Times, internal documents show that front-line scientists believe their managers have become too lenient with industry and, in one case, improperly forced them to alter reviews of a breast imaging device after Christopher Shays, a former Republican congressman from Connecticut, intervened on behalf of the manufacturer.

 

The G.A.O. has rightly urged the F.D.A. to make final decisions on all grandfathered Class III devices. That would be a good start — provided the reviews are honest and uncoerced — but not sufficient. The next F.D.A. commissioner should ensure that past decisions on medical devices were properly made. Given its sorry performance in so many areas important to public health and safety, the agency is ready for a major overhaul.

 

Copyright 2009 The New York Times Company

 

---

BACK TO TOP