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			Tuesday, June 30, 2009 News Clipping Archives *Maryland / Regional* Rosewood Center for mentally disabled closing (Daily Record) Future uncertain for Rosewood (Baltimore Sun) Balto. Co. pharmacist charged with illegal sale of oxycodone (Baltimore Sun) Intimidation accusations surface against dental assistant charged with molesting patient (Frederick News-Post) EPA gives California emissions waiver (Baltimore Sun) Hopkins Bayview agrees to $2.75M settlement (USA Today) Novavax in multi-million Spanish deal on vaccines (Daily Record) D.C. Area Health Officials See Rise in Summertime Flu Cases (Washington Post) *National / International* Blood Samples Raise Questions of Privacy (Washington Post) Doctors warn against 'swine flu parties' (CNN) Making a swine flu vaccine (Baltimore Sun) *Opinion* Maryland Medicaid expansion a success that must be continued (Baltimore Sun Editorial) Try something different (Baltimore Sun Commentary) Pharmacists need a place at the health reform table (Baltimore Sun Commentary) *Maryland / Regional* Rosewood Center for mentally disabled closing Associated Press Daily Record Tuesday, June 30, 2009 The Rosewood Center is closing its doors. The state facility for mentally disabled adults that was founded in 1888 closes on Tuesday. Gov. Martin O'Malley ordered the center closed after the latest in a series of reports about substandard conditions. Most of the 166 residents at the time of the announcement have been placed in group homes and 13 people with criminal histories were moved to a unit at Springfield Hospital Center in Sykesville. Some of the more than 500 employees have gotten jobs at other state facilities and 97 were laid off. The Department of Health and Mental Hygiene plans to offer the property to state agencies and seek comment from Baltimore County officials before considering proposals from the public for redevelopment of the campus. Copyright 2009 Daily Record. Future uncertain for Rosewood Closed state center for disabled sought for school campus By Nick Madigan and Mary Gail Hare Baltimore Sun Tuesday, June 30, 2009 The Rosewood Center, founded in 1888 as an asylum for the "feeble-minded," closes its doors for good today and awaits an uncertain future - with an expansion-minded college expressing interest in its space. Stevenson University would like to take over most of the sprawling Owings Mills campus, now filled with dilapidated buildings contaminated with lead and asbestos, and many neighbors of the facility say they'd be pleased to see the school move in. "It is a completely neglected time bomb and an environmental cesspool," said state Sen. Bobby A. Zirkin, a Democrat who represents the area. "Most of the buildings have to be torn down, and the cost of remediating is staggering." Gov. Martin O'Malley ordered the center closed early last year after the latest in a series of reports about substandard conditions. Most of the 166 people who lived in Rosewood at the time of the announcement have been placed in group homes - a move that prompted its own controversies - while 13 people with criminal histories were moved to a newer, secure unit at Springfield Hospital Center in Sykesville. More than 500 employees have dispersed, some to jobs at other state facilities. Many retired or resigned and 97 were laid off, although state officials say they are still helping them find work. Other than security guards, only three state employees will remain on the site, a maintenance crew for its 30 buildings. Offer to other agencies Now about 200 acres but once more than three times that size, the site presents enormous environmental challenges before redevelopment can occur, and it could be months before the state decides what to do next. The Department of Health and Mental Hygiene plans to offer the Rosewood property to all state agencies and seek comment from Baltimore County officials before considering proposals from the public. For now, the campus remains vacant but for the ghosts of its troubled inhabitants. The once-stately stone-and-brick structures are overgrown with weeds and ivy and strewn with junked gurneys, file cabinets and wheelchairs. Zirkin supports the proposal from Stevenson, whose campus next door has nearly doubled in physical size and enrollment in the past five years. The university, until recently known as Villa Julie College, is considering using the land for athletic fields that could help accommodate a football program being launched, a park, an amphitheater and a school of education. No cost estimates It may renovate the newer buildings and use them for classrooms. There's no price tag yet, and the school would likely seek state and federal assistance for environmental work. "This is the only plan out there, but it is a great one," Zirkin said. "All of a sudden, Owings Mills could become a college town. The university could create a heart here for this community and take what has been a major problem and turn it into a community resource." Glenda G. LeGendre, a spokeswoman for Stevenson, said the university is "very interested" in using about 150 acres of the property, including setting aside some of the land as open space. In a letter to state officials, James J. Angelone, president of the Greater Greenspring Association, wrote that the university's proposal "is by far the best solution proposed for this site." Rosewood once housed more than 3,000 people, most of them severely retarded and completely dependent on others for their care. The long wards and echoing hallways were often their home for life, but the conditions and care were frequently judged to be substandard. 'Badly neglected' Over the course of decades, residents drowned in bathtubs when left unattended or froze to death after wandering out into the snow. "It is a great thing for Maryland that this institution is closed," said Nancy Pineles, an attorney with the Maryland Disability Law Center, a watchdog group that promotes the civil rights of people with disabilities. "It was a badly neglected facility that didn't serve any purpose any more." In 2007, the law center called for state officials to shut down what it called "this flawed, outmoded institution," and noted findings by the state Office of Health Care Quality that conditions at Rosewood posed "immediate jeopardy to the health and safety of residents." The 180-page survey noted abuses that included treating a deaf patient "with restraints to control his behavior" rather than a staff member skilled in American Sign Language, and found "sustained isolation of individuals with intellectual disabilities in rooms with no personal effects [that] shocks the conscience." In December 2000, a resident died while being restrained, face-down on a floor, by Rosewood staff members "because he didn't want to go to the gym," said Pineles. She said the care quality office conducted a "limited investigation" but found no deficiencies and required no plan of correction. Still, some family members fought to keep Rosewood open, hoping to preserve stability for patients. As it is, scores of patients are now adjusting to new environments. Michael Jarowski, 61, lived at Rosewood for 32 years until January, when he moved to a group home in Carney that he shares with three others supervised by three staff members. Jarowski has a history of seizures and profound mental retardation. He wears a protective helmet, uses a wheelchair and does not speak. "It is still a learning curve for his service provider," said his sister, Joan Druso. The transition has been rough on Harry Yost, 81, who fought hard to keep Rosewood open. His 53-year-old son Larry, who cannot see, hear or speak, had lived there since childhood. "Things starting going downhill this spring," Yost said, when the hospital lost all his son's clothes and replaced them with items that did not fit. 'They sent temps' In April, Larry Yost was moved to a group home run by Catholic Charities. Officials at Rosewood had promised to send some of its staff to the home to help him with the transition, the same promise they made to Druso. "They had laid off the people Michael was used to," she said. "They sent temps who really didn't care." Harry Yost said his son "is doing all right, but I can't say he is better off." Another former Rosewood resident, General Lee Oliver, 60, remains hospitalized after being severely beaten on June 10 by one of his caretakers at a group home in Windsor Mill, according to a Baltimore County police spokesman. The caretaker was arrested but has not been charged while the attorney general's office investigates the incident, Cpl. Michael Hill said. While reports of beatings are uncommon, the level of care in some group homes has long worried relatives of the disabled. "There is a great concern among Rosewood families that there will not be the kind of oversight and accountability a state facility provides," said Joelle Jordan, an advocate for a group of family members who were fighting last year to keep Rosewood open. But the litany of incidents left state officials with little choice, they say. 'Inappropriate' to continue "The magnitude of the problems there were such that to continue operations at Rosewood was inappropriate," said John M. Colmers, secretary of health and mental hygiene, who said the issue landed on his desk at the start of the O'Malley administration. The group homes to which most of the Rosewood residents have been sent are being adequately supervised and monitored by visiting state inspectors, he said. "Can we catch everything? No, we can't," Colmers said. "When bad things happen, the most important thing is to prevent them from happening again." Copyright © 2009, The Baltimore Sun. Balto. Co. pharmacist charged with illegal sale of oxycodone 47-year-old man accused of illegally distributing more than 23,000 pills By Tricia Bishop Baltimore Sun Tuesday, June 30, 2009 A Reisterstown pharmacist was arrested Tuesday morning on federal charges he illegally sold more than 23,000 prescription pills, making him the second largest distributor of oxycodone products in Baltimore County. A six-count indictment, unsealed today, claims Ketankumar Arvind Patel, 47, used his Medicine Shoppe pharmacy on Reisterstown Road to illegally sell the depression medication Xanax, along with thousands of Oxycontin and Percocet pills, both of which contain "oxycodone." The opioid painkiller is responsible for more overdose deaths per year than heroin and cocaine combined, according to the Baltimore Drug Enforcement Administration. Patel faces a combined maximum of 86 years in prison if convicted on all counts, and he and his business, Deepa Inc., could be subject to fines totalling more than $26 million. The government is seeking forfeiture of $310,170-worth of alleged criminal proceeds, which could include Patel's Eldersburg house, his company, two cars - including a 2006 Porsche - and funds held in numerous bank accounts. Patel is expected to make an initial appearance in Baltimore U.S. District Court this afternoon. The arrest was announced at a press conference Tuesday morning by Maryland U.S. Attorney Rod J. Rosenstein, who emphasized that prescription-drug abuse is not just a celebrity problem. Some have suggested that prescription drug abuse may have played a role in the untimely death of pop singer Michael Jackson, though nothing has yet been confirmed. "Day in and day out, juveniles and young adults are abusing [oxycodone] and similar dangerous substances," Rosenstein said, hoping today's arrest announcement might help "raise an alarm about a broader problem." Carl J. Kotowski, Assistant Special Agent in Charge of the Drug Enforcement Administration in Baltimore, said the indictment was intended to send a "clear message" to pharmacists who would illegally sell prescription drugs. "You'll be arrested and prosecuted like any other drug dealer," he said. "You will lose your license and you risk losing your business and other assets." Kotowski also announced plans Tuesday to increase funding within the Baltimore DEA to fight prescription drug abuse and form a "Tactical Diversion Squad" made up of the U.S. Department of Health and Human Services, Office of the Inspector General; Maryland State Police and detectives from the Baltimore City and Baltimore, Howard and Anne Arundel counties. The investigation into Patel's activity began in March after a confidential source admitted to buying fraudulent prescriptions from him for more than a year. The Department of Health and Human Services, along with police from Baltimore City and Baltimore and Howard counties participated in addition to the DEA and the U.S. Attorney's Office. Copyright © 2009, The Baltimore Sun. Intimidation accusations surface against dental assistant charged with molesting patient By Kate Leckie Frederick News-Post Tuesday, June 30, 2009 Maryland State Police on Monday added two new charges against a dental assistant accused of sexually molesting a 23-year-old female patient. As the result of a tip, Trooper First Class Gary Martin charged Danilo Carabio Banados, 37, of Frederick , with two counts of soliciting a person to intimidate the victim into recanting. Banados allegedly tried to have a man approach the woman at her residence late at night on two occasions, June 13 and 16, Martin said. Specifics of the intimidation were not revealed. Martin served a criminal summons on Banados at the Frederick County Adult Detention Center, where he continues to be held in lieu of $25,000 bail, authorities said. "He refused to cooperate," Martin said. "He said he was getting a lawyer." Banados now faces six charges, according to court documents. A Frederick County grand jury indicted Banados on June 12 on three counts of third-degree sex offense and one count of second-degree assault for taking sexual liberties with the woman while she was under anesthesia April 22, documents state. As she woke up from surgery, the woman found Banados kissing her mouth and fondling her under her clothes, State's Attorney Charlie Smith said. The sex offense is a felony punishable by 10 years in the Maryland Division of Correction. The assault charge is a misdemeanor, punishable by 10 years and a $2,500 fine. A pretrial conference on those charges is scheduled for July 20 in Frederick County Circuit Court. Meanwhile, a Sept. 3 court date is set for Banados on the new charges in Frederick County District Court. Attempting to intimidate the witness is a misdemeanor punishable by five years in prison and a $5,000 fine. Should Banados post bail while awaiting trial, he is to consume no alcohol or drugs and to have no contact with the victim, according to court records. Banados had been employed as a dental assistant in the Frederick area for more than two years, state police said. Copyright 2009 Frederick News-Post. EPA gives California emissions waiver The state can develop its own standards on greenhouse gas emissions from cars and trucks, though it agrees not to toughen the standards before 2017. Automakers agree to drop lawsuits. Los Angeles Times By Jim Tankersley Baltimore Sun Tuesday, June 30, 2009 Washington - The Environmental Protection Agency will announce today that it is granting California's request to impose tough restrictions on greenhouse gas emissions from cars and trucks -- reversing the Bush administration's position and opening the way for the state to take the lead on global-warming policy. Thirteen other states -- including Maryland -- are slated to adopt Calfornia's standards. California developed the standards in 2004 but was barred from implementing them. EPA officials say granting California the waiver from federal standards gives the state wide latitude to promulgate stricter rules, restoring a 40-year interpretation of the Clean Air Act. "It preserves California's role as a leader on clean air policy," particularly on motor vehicles, EPA Administrator Lisa Jackson said in an interview. "It feels good to know that we are able to move past -- address -- this issue, responding to the president's call." President Obama had criticized the Bush EPA's denial and, shortly after his inauguration, ordered the agency to revisit it. California Gov. Arnold Schwarzenegger called the decision a "huge step for our emerging green economy that will create thousands of new jobs and bring Californians the cars they want while reducing greenhouse gas emissions." Sen. Barbara Boxer (D-Calif.), a longtime advocate of the waiver, said the EPA did "what is right for the people of California, the environment and the many states in the union that intend to follow California's lead in cleaning up tailpipe emissions." But critics said the EPA should not give up federal control of climate policy. "California already has experience in adopting differential regulations for gasoline and electricity," said Scott Segal, an attorney for Bracewell and Giuliani in Washington, which represents utilities and refiners on climate change policy. "In each case, the results have been high prices for consumers, small businesses, schools, hospitals and industry. The precedent set here for cars could be just as damaging." Today's decision sets the stage for the proposed national vehicle emissions standards that President Obama announced in May: New cars and trucks sold in the U.S. will be required to improve their fuel efficiency gradually over the next seven years, reaching an average of 35.5 miles per gallon by 2016 -- a 40% improvement over the current 25 mpg level. The federal government agrees to adopt California's standards as its own, and the state agrees not to toughen the standards before 2017. Automakers agree to drop lawsuits against California's standards. Agreement on the national standards came after intensive negotiations between the administration, California, environmentalists and the auto industry. In the future, California could petition the EPA to set even stricter emissions standards, which probably would be granted on the legal grounds that the administration reaffirmed in granting this request. "Congress recognized that California could serve as a pioneer and a laboratory for the nation in setting new motor vehicle emission standards," Jackson wrote in today's decision. "Congress intentionally structured this waiver provision to restrict and limit EPA's ability to deny a waiver, and did this to ensure that California had broad discretion in selecting the means it determined best to protect the health and welfare of its citizens." The original Clean Air Act, passed in the 1960s, included a provision that allowed California to seek permission to set its own tougher standards. Other states could adopt California's rules or stick with the federal government's. Spurred by a 2002 state law, California adopted standards for tailpipe emission of greenhouse gases, which scientists blame for climate change. The state petitioned to enforce them under the Clean Air Act, and a dozen other states lined up to adopt them. But late in 2007, Bush's EPA denied the request -- the first time in more than 50 instances that the agency had rejected an entire set of proposed California standards. Stephen L. Johnson, EPA administrator at the time, said California had failed to demonstrate that the standards were necessitated by "compelling and extraordinary conditions" as required by law, because global warming was not an extraordinary threat to the state compared to the country as a whole. Obama's EPA disagreed. Jackson, the current administrator, said today's decision stemmed from a careful reading of the Clean Air Act and EPA history. "This decision was based entirely on the law," she said, "and not at all on politics." Longtime advocates of the waiver cheered Monday night. State Sen. Fran Pavley (D- Agoura Hills), who wrote California's 2004 emissions law, took a break from state budget negotiations to share a celebratory bottle of non-alcoholic Pinot Noir with colleagues. "For our state, it's quite a victory," she said, "and for the coalition we had working on this bill back when global warming wasn't the issue of the day." Copyright © 2009, The Los Angeles Times. Hopkins Bayview agrees to $2.75M settlement Associated Press By Alex Dominguez USA Today Tuesday, June 30, 2009 BALTIMORE — Johns Hopkins' Bayview Medical Center has agreed to pay $2.75 million to settle whistleblower claims that it inflated federal reimbursements by reporting patients had conditions that were not diagnosed or treated, federal prosecutors announced Tuesday. The whistleblowers will receive 20 percent of the settlement, or $550,000. Bayview denies the claims but settled to avoid protracted litigation, according to the agreement. The two women were employed as inpatient coding specialists and alleged their department reviewed charts to see if payments could be increased by adding secondary diagnoses such as malnutrition or respiratory failure. Doctors were advised to add the conditions to patient records even if they were not diagnosed or treated, prosecutors said. "We think this sort of thing goes on quite often," U.S. Attorney Rod Rosenstein said, adding he hoped the case would serve as a deterrent to prevent other health care providers and federal contractors of all types from filing false claims and encourage more employers to report fraud. Attorney Lon Engle, who represented the two women, identified in court documents as Margaret E. Mayer and Robin L. Emrick, said his clients did not want to speak to the media about the case. Johns Hopkins issued a statement Tuesday saying that "at no time were there any questions raised regarding the quality of the services provided." It added that while Bayview denies any wrongdoing it entered into the settlement "to avoid the time, effort, expense, and uncertainty of protracted litigation so that it can continue to focus on providing high quality patient care." Rosenstein said he wouldn't comment on whether the two women falsified records other than saying they had personal knowledge, but added employees did not benefit from the practice. The alleged falsification was claimed to have occurred between July 1, 2005 and Feb. 28, 2007. Bayview filed the records with the Maryland Health Services Cost Review Commission, which sets rates that are used by all insurance companies, including federal health benefit plans. "The allegation was that it was a management strategy to try to increase reimbursements. The employees gained no personal benefit by engaging in this strategy," Rosenstein said. "It was in fact alleged to be a conscious strategy by management to bring in somebody to review the records after the fact and change the diagnosis." Copyright 2009 The Associated Press. All rights reserved. Novavax in multi-million Spanish deal on vaccines Associated Press Daily Record Tuesday, June 30, 2009 Rockville-based vaccine developer Novavax Inc. has signed a deal with Spain's health ministry and a specialty drugmaker there to license its genetically engineered technology to produce pandemic and seasonal flu vaccines and build that country's first vaccine-making plant. Novavax shares shot up 81 cents, or 32 percent, to $3.31 on the news. Novavax told The Associated Press the deal, to be announced later Tuesday by the Spanish government, will bring the company development funding needed in the short term and will be worth tens of millions of dollars in future royalty and milestone payments once the vaccines are approved and marketed. Novavax, Spain's Ministry of Health and ROVI Pharmaceuticals of Madrid are aiming to have the manufacturing plant running and win approval to sell the vaccines in the European Union in 2012. The plant is to be built in Granada, at an expected cost of about 20 million euro, or $28 million. Novavax, a development-stage company with no marketed products, is in midstage testing in the U.S. of a vaccine against swine flu, or H1N1 flu, using the same technology to produce vaccines more quickly and cheaply than the traditional method of growing the key vaccine component in chicken eggs, a process that takes several months. Novavax developed what's called virus-like-particle technology to make vaccines. The technology genetically engineers a particle that looks like a flu virus, but contains contains only three of its eight genetic building blocks, enough to make the shell of the virus and key proteins on its surface, Singhvi said. "It's like a decoy of the virus, but the immune system recognizes it as if it were the flu virus" and mounts a vigorous immune response, he said. "It cannot replicate, and it cannot cause illness." The company is aiming to get approval to sell both pandemic flu vaccines and seasonal flu vaccines in the U.S., also by 2012. Spanish government agencies will provide 60 million euros, or about $84.1 million, to complete late-stage testing of the vaccines and gain marketing approval in the European Union and eventually elsewhere. In addition, ROVI will make an immediate $3 million equity investment in Novavax, at a 10 percent premium to the company's $2.50 closing price on July 29, and will provide additional development funding if needed. "This is a huge validation of our technology," Rahul Singhvi, president and chief executive of Novavax, said in an interview. "This is going to enable us to go to market," both with vaccines made by ROVI and with its own products. ROVI will use the same technology to make its vaccines. Virus-like-particle technology is behind Merck & Co.'s cervical cancer vaccine Gardasil. Other companies working on flu vaccines are using the technology in laboratory testing, but Novavax is the only company using the technology that has advanced to midstage testing in people for flu, Singhvi said. ROVI, which makes and sells a version of the blood thinner heparin in about two dozen countries in Europe, Asia and South America, will have exclusive licenses to sell the vaccines in Spain and Portugal, plus nonexclusive licenses in Europe, Latin America and Africa. The company does contract manufacturing for other drugmakers, including filling syringes with various vaccines. Novavax will retain exclusive licenses for the vaccines in North America, Asia and Australia and also would be able to sell them in other countries, except Spain and Portugal. The planned Granada plant would be able to make more than 15 million doses of seasonal flu vaccine a year, plus surge capacity to produce many more doses in the event of another pandemic flu, said Tom Johnston, vice president of strategy at Novavax. That's intended to supply the market in Spain, which has more than 43 million people and is the world's eighth-largest economy, with some remaining for other parts of Europe, Latin America and Africa. Copyright 2009 Daily Record. D.C. Area Health Officials See Rise in Summertime Flu Cases By Lori Aratani Washington Post Tuesday, June 30, 2009 Hospital emergency rooms and doctor's offices across the Washington region are reporting a higher-than-normal number of flu cases during a time of year when such infections are rare, a signal that the H1N1 virus continues to spread. Officials at Washington Adventist Hospital said they have seen 68 flu cases in June compared with 11 in May. Officials at Inova Health systems say they have treated more flu cases during a single week this month than during the peak week of flu season in February. Many of those being treated are school-age children, officials said. "It's like snow in the summer,'' said Gaurov Dayal, chief medical officer at Shady Grove Adventist Hospital, which has also reported a higher-than-normal number of flu cases, more than half of which were confirmed to be H1N1. "We typically don't see flu at all this time of year." Medical experts say the unusually high number of cases might be due in part to increased vigilance among the public and health officials because of the attention given to H1N1. The new strain has perplexed medical researchers who are studying its potential long-term effects. They theorize that younger patients may be getting infected at higher rates because they may not have developed immunity to the strain. The Centers for Disease Control and Prevention's most recent surveillance report for June 14-20 said there had been a higher than normal number of flu cases nationally for this time of year. The federal authorities said it's too early to tell whether those who contract H1N1 now will be immune in fall when the flu season kicks into high gear. "Even with the seasonal flu, people can get re-infected,'' said CDC spokeswoman Shelly Sikes Diaz. "We just don't know yet with H1N1.'' H1N1 symptoms are similar to the typical flu and include fever, cough and sore throat. Medical experts said those who are especially susceptible to the flu -- the young, elderly and those with underlying health problems -- should see a doctor if they have symptoms. Dayal said officials at Shady Grove Adventist saw 63 flu cases in June, 42 of which tested positive for H1N1. Nine of the patients had to be hospitalized, all of them children with underlying health conditions who recovered. Of the 68 flu cases at Washington Adventist in June, 54 were confirmed H1N1 infections. Officials at Washington Hospital Center said they have seen a slight uptick in the number of cases this month, but nothing dramatic. There are 567 confirmed cases of H1N1 in Maryland. Officials reported the first H1N1-related death last week. The victim was an elderly Baltimore area woman who also had underlying health issues. There has been one death believed to be connected to H1N1 in Virginia, where there were 224 confirmed cases as of last week. Health officials said the unusually high number of cases is a reminder that the public must continue to be vigilant. People should remember to wash their hands, cover their coughs and stay home from work, school or summer camps if they feel ill. Fran Phillips, Maryland's deputy secretary for public health, said state laboratories continued to screen the virus for mutations or resistance to flu treatments such as Tamiflu. Yesterday, Reuters reported that the manufacturer of Tamiflu, one of the main drugs used to fight H1N1, said it had discovered the first case in the world of a patient, a Danish man, who developed resistance to the drug. Copyright 2009 Washington Post. *National / International* Blood Samples Raise Questions of Privacy Some Samples Are Stored and Used For Research Without Parents' Consent By Rob Stein Washington Post Tuesday, June 30, 2009 Matthew Brzica and his wife hardly noticed when the hospital took a few drops of blood from each of their four newborn children for routine genetic testing. But then they discovered that the state had kept the dried blood samples ever since -- and was making them available to scientists for medical research. "They're just taking DNA from young kids right out of the womb and putting it into a warehouse," said Brzica, of Victoria, Minn. "DNA is what makes us who we are. It's just not right." The couple is among a group of parents challenging Minnesota's practice of storing babies' blood samples and allowing researchers to study them without their permission. The confrontation, and a similar one in Texas, has focused attention on the practice at a time when there is increasing interest in using millions of these collected "blood spots" to study diseases. Michigan, for example, is moving millions of samples from a state warehouse in Lansing to freezers in a new "neonatal biobank" in Detroit in the hopes of helping make the economically downtrodden city a center for biomedical research. The National Institutes of Health, meanwhile, is funding a $13.5 million, five-year project aimed at creating a "virtual repository" of blood samples from around the country. The storage and use of the blood is raising many questions, including whether states should be required to get parents' consent before keeping the samples long-term or making them available to scientists, and whether parents should be consulted about the types of studies for which they are used. The concern has prompted a federal advisory panel to begin reviewing such issues. "There has not been a good national discussion about the use of these samples," said Jeffrey Botkin, a pediatrician and bioethicist at the University of Utah who is studying policies and attitudes about the newborn blood samples as part of a federally funded project. "Genetics is an area that touches a nerve. The public is concerned about massive databases." Hospitals prick the heels of more than 4 million babies born each year in the United States to collect a few drops of blood under state programs requiring that all newborns be screened for dozens of genetic disorders. The programs enable doctors to save lives and prevent permanent neurological damage by diagnosing and treating the conditions early. Although parents are usually informed about the tests and often can opt out if they object for religious and other reasons, many give it little thought in the rush and exhaustion of a birth. And parents are generally not asked for permission to store the samples or use them for research. Each state determines what is done with the blood spots afterward. The District discards them after a year. Virginia saves them for up to 10 years but does not allow them to be used for research, officials said. Maryland has been storing blood spots since 2004 and may make its inventory of about 350,000 samples available to researchers. At least nine other states also keep the blood spots indefinitely. "We consider them a national treasure," said Sharon Terry of the Genetic Alliance, a coalition that promotes genetics research. "We think they offer us the beginnings of a national blood bank to understand disease at an early age and follow people longitudinally over time." The stored samples are mostly used to validate the accuracy of newborn screening and evaluate new tests. But scientists are also using them for other types of research, including to study specific genetic disorders, explore the frequency and causes of birth defects, decipher how genes and environmental factors interact, and probe whether exposure to chemical pollutants early in development plays a role in cancer and other diseases. Research projects are only approved, officials in Maryland and other states said, after undergoing careful scientific and ethical review. In most cases, all identifying information is stripped from the samples. "I've never heard anyone complain that their privacy was violated or their dried blood was used for something that negatively impacted them," said Michael S. Watson of the American College of Medical Genetics, which has the NIH contract to create an electronic database of newborn blood samples from across the country. But the states can still link each sample to an individual child -- and that worries some parents, patient groups, bioethicists and privacy advocates, especially with advances in genetics and electronic data banks linking medical information from different sources. "It's fine and good to say these can't be identified, but how real is that?" said Hank Greely, a Stanford University bioethicist. "Just because you don't have a name or Social Security number doesn't mean you can't identify it. Once we start using DNA for more and more things like regular medical records, somebody could do a cross-check and say whose blood it is." As scientists continue to discover new genetic markers, many wonder what such databases might reveal. "I'm not a big scaremonger about the dangers of DNA medicine," Greely said. "But you could use someone's DNA to make some inferences about their future health, about their future behavior, and if you got samples from their parents or a DNA databank, you can make inferences about family relationships." Because of those and other concerns, parents and privacy activists in Minnesota are asking that more than 800,000 blood spots that have been stored without parents' approval since 1997 be destroyed. "Once learning the genetics of one child, you could see an insurance company seeing that possibility for the next child and making it clear that this is a preexisting condition that the company would not cover. Or perhaps an employer that found out about it wouldn't want to have us as an employee," said Twila Brase of the Citizens' Council on Health Care in St. Paul. Guaranteeing Privacy The Minnesota case prompted a similar parents' lawsuit in March against Texas, which since 2002 has stored an estimated 4 million samples. The litigation spurred the Texas legislature to require the state health department to start getting parents' permission to store the samples and honor requests that samples be destroyed. But the lawsuit is still pending over what should be done with the samples already on file. "I don't want to sound paranoid, but I'm not comfortable with a governmental agency having this information, with potentially the ability to share it with sister governmental agencies, such as criminal agencies," said Maryann Overath, an Austin lawyer with two sons who sued the state. Law enforcement agencies have been cataloguing millions of DNA fingerprints in recent years, raising similar concerns. State officials argue that strict safeguards protect the privacy of information associated with the newborn blood samples and say details about a child's medical history are provided to researchers only if parents are contacted individually for approval. "Privacy is very important, and we protect it every way we can," said David Orren, the Minnesota health department's chief legal counsel. In Michigan, officials plan to start asking new parents for permission to include their children's samples in the stockpile. But officials decided it would be impractical to try to contact the parents of all 3.5 million children whose samples are already on file. Instead, they are publicizing the biobank to allow parents to object if they don't want their children's samples included. But even if the question of consent is resolved, other issues remain. "There might be some research that offends moral sensibilities of citizens, such as research into prenatal screening for some genetic condition that might lead some parents to make a decision to selectively abort affected fetuses," said Tom Tomlinson, a bioethicist at Michigan State University. Concerned that the debate might undermine the newborn screening programs, the federal Advisory Committee on Heritable Disorders in Newborns and Children will discuss the issue in September. "There are obviously legal and ethical issues that need further discussion," said R. Rodney Howell, who chairs the committee. "Unfortunately we live in a world of conspiracy theories. We want to inform people that these spots are retained in some states and that they are carefully guarded. We want to be totally transparent." Copyright 2009 Washington Post. Doctors warn against 'swine flu parties' By Mark Tutton CNN Tuesday, June 30, 2009 LONDON, England (CNN) -- Health experts are warning parents against holding "swine flu parties" in the hope of infecting their children with the H1N1 virus. Talk of swine flu parties has emerged on Internet forums. The idea is that exposing a child to the H1N1 virus while it remains relatively mild will give the child immunity if the virus returns in a more virulent form later on. The idea is an extension of chicken pox and measles parties that were once a popular way of exposing children to those diseases so that they might acquire resistance to subsequent infections. But health officials have been quick to condemn the idea. Speaking at a conference, Dr Richard Jarvis, chairman of the British Medical Association's public health committee, said "I have heard of reports of people throwing swine flu parties. I don't think it is a good idea. "I would not want it myself. It is quite a mild virus, but people still get ill and there is a risk of mortality." Last month, Richard Besser, the acting head of the U.S. Centers for Disease Control and Prevention, also warned against deliberately exposing people to the virus. While it's not clear if any swine flu parties have been held, Justine Roberts, the founder of Web site mumsnet, today told BBC Radio 4 that some people have been discussing the idea. "We have heard of people saying 'can we come round to your house when you get it?" she said. "There's definitely a prevailing view that it might be better to get it now and some people are not despairing if there is a case in their school." Flu epidemics often come in waves and there are fears that a more virulent form of H1N1 may strike in the fall. That happened with the Spanish flu pandemic in 1918. Researchers at George Washington University in Washington DC have studied the 1918 pandemic and have found that in areas where there were more cases during the first wave of Spanish flu, there were fewer deaths during its second wave, in the fall of that year. The suggestion is that exposure to the first wave of the flu conferred immunity to its second wave. But H1N1 is still very much an unknown quantity. Experts warn that little is known about the virus and that actively encouraging its spread could risk the health of those who are most vulnerable. While the symptoms associated with swine flu are not usually life threatening among people in good health, it can be deadly for elderly people or those with other medical conditions. The latest figures from the World Health Organization show there have now been 311 confirmed deaths around the world from the H1N1 virus first identified in Mexico this spring, and just over 70,000 infections in 113 countries. © 2009 Cable News Network. Making a swine flu vaccine By Stephanie Desmon Baltimore Sun Tuesday, June 30, 2009 So officials are saying an immunization campaign to protect against the swine flu pandemic could involve as many as 600 million doses of vaccine. Fortunately, the government has been counting its chickens. The traditional way of making flu vaccine involves using eggs. Lots of eggs. Tens of millions of eggs. The virus is injected into the eggs and is grown inside for three days to produce large quantities to be used in vaccine production. But these are not just any eggs and government scientists have long known that. These are eggs laid by special breeds of hens, eggs carefully guarded to be kept free of pathogens, eggs chosen to be more oval than round to fit properly in the machines at the Sanofi-Aventis production plant in Swiftwater, Penn. "The chicken eggs you find on your grocery shelf won't work," Dr. Robin Robinson, director of the Biomedical Advanced Research Development Authority at HHS, told me last month. When the avian flu outbreak started hitting Asia nearly six years ago, officials in the U.S. took notice. Sure they had enough eggs to produce seasonal flu. But would they have enough if there was an emergency and they needed to manufacture more vaccine? The answer was no. ... With a 5-year, $44 million contract with more than 30 farms less than a day's drive from Swiftwater, HHS quietly got into the egg business. Robinson told me he would try to arrange for me to visit one of the farms, but I still haven't gotten permission. I am being told officials have "security concerns" about giving me a tour. Robinson called the chickens part of the United States' "national critical infrastructure." "If we don't have the birds, we don't have the eggs," he said. "If we don't have the eggs, we don't have the vaccine. We consider them enlisted in Uncle Sam's Army, so to speak." No final decision has been made about whether a swine flu vaccine will be manufactured on a massive scale. To do that, not only will they need all of BARDA's eggs (475,000 a day) but also eggs from contingency farms under contract. If the eggs aren't needed, they can always be sold to be used in livestock feed. For pigs, actually. Says Robinson: "We're so much better prepared than we would have been before." Copyright 2009 Baltimore Sun. *Opinion* Maryland Medicaid expansion a success that must be continued Baltimore Sun Editorial Tuesday, June 30, 2009 At a time when some cash-strapped states are contemplating reducing their Medicaid coverage, Maryland has boldly moved in the opposite direction. Today marks the one-year anniversary of a program that has brought taxpayer-financed medical assistance to 40,000 previously uninsured low-income parents. That's about 15,000 more people than advocates had expected to enroll one years ago and it's one of the more significant accomplishments of Gov. Martin O'Malley term in office. Previously, Maryland was among the stingiest states in the nation in terms of providing medical care for poor adults and now it's closer to the national average. Why underwrite health care for the poor? The most obvious justification is to ensure that all Marylanders have access to decent and affordable medical care. But as compassionate and laudatory a purpose as that might be, it's far from the only reason. Another critical one is to simply save money for the rest of us. Regular check-ups at a doctor's office or clinic are a lot less expensive than trips to a hospital emergency room which is exactly what happens when medical problems are ignored and allowed to worsen into full-blown health crises. Who pays for that? Such uncompensated care is built into hospital rates charged to the insured and financed by employers and their employees. No matter how President Obama and Congress choose to reform health in this country, expanded Medicaid coverage is likely to play a crucial role. The expansion in Maryland - approved by the state legislature two years ago - is intended to continue so that all working people earning up to 116 percent of the federal poverty guideline can receive benefits and not merely those with minor children. But the recession has caused that element of the plan to be deferred. Even when the economy recovers, the program will require a source of funding to avoid further (and perhaps even permanent) delay. One possibility is to raise the state tax on alcohol which is now among the lowest in the nation. Advocates say a tax increase that amounts to about 10 cents per drink would raise $200 million annually. That, along with the savings from less uncompensated care, could foot the bill, but a tax increase of most any kind has a frozen daiquiri's chance in Hades of passing in 2010, an election year. So while health care advocates can rejoice at the success of their efforts so far, the job is far from complete. An estimated 750,000 Marylanders lacked health insurance as of last year - and now that number may be closer to 700,000. That amounts to a good start. Copyright © 2009, The Baltimore Sun. Try something different The feds should allows Baltimore to pursue alternatives to the failed drug war - including heroin maintenance By Raymond Daniel Burke Baltimore Sun Commentary Tuesday, June 30, 2009 The Abell Foundation recently commissioned a study to evaluate the possible implementation of a heroin maintenance program in Baltimore. Such programs treat addiction as a health problem by providing drugs to addicts, and then moving the users into treatment. The controlled distribution takes the profit out of the illegal drug-distribution network, and treatment aims to diminish its market. Whether such proposals offer the hope of making a dent in the city's massive drug problem remains to be seen. But one thing that should not stand in its way is federal policy - particularly a federal policy that has been a disaster by any measure. California's struggle with the federal government to implement a tough anti-pollution regime offers a potentially instructive example for Maryland. In 2002, California enacted a law regulating greenhouse gas emissions, and for the next several years it battled the federal government for the right to implement it. In an agreement earlier this year, the Obama administration essentially adopted the California standards for emissions cutbacks as national policy. This compromise has far-reaching significance with respect to the issue of the constitutional authority of states to adopt policies at odds with those of the federal government. California's action forced the issue of environmental standards to be confronted at the national level. Moreover, if it had succeeded in going it alone, it would have provided a working experiment in alternative policy. That concept may have value in the development of alternatives to federal policies that are failing at the community level. And few national policies have failed more dismally than the so-called war on drugs. Yet it continues in its unceasing appetite for the wasteful consumption of resources, while creating a thriving gangster culture that drives generation after generation further and further from any connection to the values and hopes of society as a whole. Criminal drug prohibition has so grossly inflated the value of drug products that even small percentages that avoid diligent interdiction efforts bring enormous profits to the marketers. As long as such huge profit margins are possible, it is ludicrous to think that prohibition has any hope of being effective. And that simple economic principle cuts cruelly at the heart of Baltimore neighborhoods. The byproducts of our misguided policy include the outrageous financial costs of enforcement, prosecution and incarceration. But there is also a staggering human cost - not only in those plagued by the scourge of addiction but with respect to neighborhoods that are stripped of their ability to provide a healthy forum for the growth of families and stable households. That, in turn, drags down the city as whole. It renders entire communities and the public schools that serve them unacceptable to middle-class families, thereby depriving much of the city of the core constituency for establishing and maintaining neighborhood and school stability. We have allowed the creation of a subculture that is an anathema to the values that bring us together as a people and community. It embraces violence and cold disregard for life and practices disdain for education and personal responsibility. And, for many, it holds far more promise of a rewarding lifestyle than that offered by the school system or employment opportunities. And so we have neighborhoods dominated by single-parent or no-parent households, where addiction is prevalent, medical care lacking, adult activism in education virtually non-existent and crime a major career option - all despite, and in some ways because of, the billions spent on criminal drug enforcement. Baltimore has earned enough battle ribbons in the federal war on drugs. It is entitled to the opportunity to try something new. As California sought to enact a means of relief from its polluted air, so should we exercise our right of self-determination to find a cure for a cancer that robs our communities of vitality and possibility. The implementation of a heroin maintenance problem requires debate. But it is a debate that should be based on its merits, and not the mere the fact that it represents a departure from federal law. Local policy experimentation at least offers a chance to escape from what has been an exercise in failure and hopelessness. Raymond Daniel Burke, a Baltimore native, is a principal in a downtown law firm. His e-mail is rdburke@ober.com. Copyright © 2009, The Baltimore Sun. Pharmacists need a place at the health reform table By Natalie D. Eddington Baltimore Sun Commentary Tuesday, June 30, 2009 To help guarantee health care reform that reduces costs and builds "health care teams that work" (to use President Barack Obama's words), pharmacists must play a key role in the planning process being undertaken by the federal government. The health care reform principles being considered are well grounded in developing strategies to promote the prevention and management of chronic diseases. Essential to the success of those strategies is the fully integrated role of pharmacists, the country's most accessible health care professionals. Patients' easy access to their pharmacists results in adherence to medications, a critical issue in disease management and control. In the United States, medications comprise approximately 10 percent of health care expenditures, and a staggering $117 billion of this is attributed to medication misuse and patient noncompliance. Adherence to, or the appropriate use of, medications is especially problematic for patients with chronic diseases such as diabetes and hypertension. In addition to their role in dispensing medications, pharmacists provide chronic disease management programs that promote patient wellness, reduce costs and prevent medication errors. With extensive expertise in appropriate medication therapy and an understanding of adverse effects of medications, pharmacists can identify drug interactions, administer lifesaving immunizations and alert patients if they need more urgent care. In community pharmacies in almost every state today, pharmacists customize their roles in direct patient care, coaching patients on disease, diet, health goals and the importance of properly taking their medicines. In groundbreaking programs, such as the Asheville Project in North Carolina and the P3 (Patients Pharmacists Partnerships) Program in Maryland (both diabetes management programs) pharmacists foster appropriate medication therapy management for the patients, complementing the treatment and counsel provided by a patient's physician. The American Pharmacists Association Foundation's Ten City Challenge Project, which followed the Asheville model, showed a decrease in health care costs of $1,079 per patient compared with projected costs if the program had not been implemented. It also showed an increase in the number of patients achieving health care goals established by the American Diabetes Association. In Maryland, the innovative P3 Program, launched by the University of Maryland School of Pharmacy, has also shown a reduction in health care costs and improvements in specific health care clinical endpoints while reaching populations with long histories of lack of access to health care. Pharmacists have proved that their expertise in drug therapy and their active engagement in chronic disease management programs improve health and reduce costs. Recently, thought leaders from the pharmacy profession representing academia, industry, community pharmacies and professional organizations gathered at the University of Maryland School of Pharmacy for a round-table discussion on pharmacists' potential role in the federal government's health care reform plans. The group was greatly disappointed that the White House had neglected to invite a representative of the pharmacy profession to sit at the health care reform table. There was a clear and strong consensus in the group that pharmacists must play a key role in that reform. Based in community pharmacies on nearly every street corner in the country, and in hospitals, clinics and long-term care settings, pharmacists have clearly demonstrated their impact on improving health and reducing costs. The federal government is now in the process of defining the details of health care reform, and from the pharmacy perspective, successful reform must include insurance reimbursement for pharmacist services beyond dispensing, including chronic disease management, medication therapy management programs and the administration of lifesaving immunizations. A successful health care reform package must also include community-based programs delivered by pharmacists that have proven track records, programs that have amassed evidenced-based data on pharmacy services' impact on those goals of improving health care and reducing costs. Pharmacists must be included as reimbursable providers under any health care reform, and patients sh ould have access to these services without restrictions. Natalie D. Eddington, dean of the University of Maryland School of Pharmacy, is a member of the American Pharmacists Association, the American Association of Colleges of Pharmacy, the American Society of Health-System Pharmacists and the National Community Pharmacists Association. Her e-mail is neddingt@rx.umaryland.edu. Copyright © 2009, The Baltimore Sun. BACK TO TOP


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