Wednesday, March 4, 2009

News Clipping Archives

 

Maryland / Regional

Board of Public Works cuts about 892 vacant, 2 filled jobs (Daily Record)

Bills aim to provide universal health care for uninsured residents (Daily Record)

Lawmakers Weigh Bills To Promote Healthy Food (Washington Post)

Health-Care Bill Is Boon To Children In Region (Washington Post)

Trans-fat bill draws an unlikely ally (Baltimore Sun)

Teen suicides on rise in county (Annapolis Capital)

State must make farm pollution reports public (Annapolis Capital)

Delegate wants medical marijuana law review (Montgomery County Gazette)

National / International

Md. men charged in Ga. suicide case (Baltimore Sun)

Supreme Court backs patients' right to sue drug makers (Baltimore Sun)

High court upholds $6.7 million award to amputee, rejects limits on suits against drug makers (Baltimore Sun)

Study Urges More Oversight of Dietary Items (New York Times)

It’s Organic, but Does That Mean It’s Safer? (Annapolis Capital)

Opinion

Unseen victims (Baltimore Sun)

Liability limits save access to care (Baltimore Sun)

Nurse practitioners part of the solution (Baltimore Sun)

 

Maryland / Regional

 

Board of Public Works cuts about 892 vacant, 2 filled jobs

 

Associated Press

Daily Record

Wednesday, March 4, 2009

 

Members of Maryland's Board of Public Works officially slashed $82 million from the state's current budget Wednesday, including about 892 vacant positions and two filled jobs.

 

The filled positions that will be eliminated are in the governor's office and the Historic St. Mary's City Commission.

 

The Department of Public Safety and Correctional Services will lose nearly 250 vacant positions, more than any other department.

 

Gov. Martin O'Malley, Comptroller Peter Franchot and State Treasurer Nancy Kopp hold the only positions on the three-member-board.

 

State Budget Secretary T. Eloise Foster says the cuts stemmed from a December recommendation to eliminate 1,000 vacant positions to help balance the current year's budget.

 

Copyright 2009 Daily Record.

 

Bills aim to provide universal health care for uninsured residents

 

By Richard Simon

Daily Record

Wednesday, March 4, 2009

 

ANNAPOLIS — Legislators and representatives from CareFirst BlueCross BlueShield unveiled jointly sponsored bills today aimed at providing universal health care for an estimated 760,000 Maryland residents who are uninsured.

 

Senate Bill 515 and House Bill 860, sponsored by Sen. Thomas M. Middleton, D-Charles, and Del. Peter A. Hammen, D-Baltimore City, respectively, would require Maryland residents to obtain insurance and employers to offer coverage for their workers.

 

Organizers said they hope that the “Healthy Maryland” plan will offer health coverage to every Maryland resident regardless of health status or pre-existing conditions.

 

Massachusetts is the only state that has successfully passed universal health care legislation.

 

Organizers said 75 percent of the money that would fund the program would come from premiums.

 

Chet Burrell, CareFirst President and CEO, said that the Healthy Maryland program could be self-sustaining for as many as 10 years from premiums, which could range from as little as $25 per month to a little more than $250 per month for the average member, depending on the subscriber’s income.

 

The Senate bill, which has a hearing in the Finance Committee this afternoon, isn’t expected to pass this year, but is being seen as a starting point, according to experts familiar with the situation.

 

“We’re just at the beginning of this, and we look forward to working through the spring, the summer and into the fall on really examining what the issues are and what the best approaches might be with the idea that when we reach the fall perhaps clarifying language in the legislation an entire bill can be put together that best fits what Maryland’s needs are,” said Burrell, who added that it’s an issue that will not go away.

 

Experts foresee the bill to be an election issue in 2010.

 

Another universal health care plan, called Maryland Citizens’ Health Initiative, was introduced by Vincent DeMarco of Maryland Health Care for All in November.

 

DeMarco is expected to testify at the hearing today.

 

Copyright 2009 Daily Record.

 

Lawmakers Weigh Bills To Promote Healthy Food

Trans Fat Ban, Detailed Labeling Sought

 

MARYLAND LEGISLATURE

 

By Rosalind S. Helderman

Washington Post

Wednesday, March 4, 2009; Page B08

 

Your mother is not the only one who'd like to make your food healthier.

 

Members of the Maryland General Assembly are considering measures aimed at improving food safety and reducing obesity rates.

 

One proposal heard by a House committee yesterday would follow Montgomery County's lead and ban cholesterol-raising trans fatty acids at restaurants throughout the state. Another measure would require fast-food restaurants and other chain restaurants to conspicuously post calorie counts on their menus, as is now required in New York City.

 

Other bills would require that labels indicate whether food contains any product from a cloned animal and, to help people with food allergies, whether olive oil contains any other kind of oil.

 

Not all the measures are likely to be successful. The General Assembly took no action in 2007 on a similar trans fat proposal and rejected a bill last year to require labeling products from cloned animals.

 

The proposals are part of a national trend related to obesity and food safety. This summer, California became the first state to ban trans fats. Seattle requires menu labeling comparable to what has been proposed in Maryland, and similar legislation goes into effect next week in Portland, Ore.

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Del. Doyle L. Niemann (D-Prince George's) said he thinks there is a "national tsunami" of interest in such measures, noting similar bills are pending in 12 states. He said a food industry survey in New York City found that menu labeling has been broadly popular and that consumers feel better informed when they learn the calorie count of popular foods. Niemann is sponsoring the menu measure with Sen. David C. Harrington (D-Prince George's).

 

Customers are often surprised by the calorie counts: A pumpkin scone at Starbucks has more calories than a pumpkin cream cheese muffin. Gooey grilled cheese for children at Cosi has more calories than a peanut butter sandwich. Niemann noted that the Cosi chain reduced calories in both sandwiches after New York laws required posting the information prominently.

 

"This bill doesn't limit what anyone can sell, what anyone can eat," he said. "It says you have to tell people the cost of what they are eating."

 

Del. James W. Hubbard (D-Prince George's) is encouraging the General Assembly to take action against trans fats. Trans fats are found in oils that some bakeries and restaurants like to use, in part, because they have a long shelf life. Studies have shown that trans fats can contribute to heart disease and other health problems.

 

The state bill follows similar measures in Montgomery and Baltimore. A representative with the Maryland Restaurant Association told the committee that restaurants in those jurisdictions have found it less difficult and costly to make the transition than they had feared. He said the association could support the bill, provided it was amended to apply to packaged foods sold at retails stores.

 

The olive oil bill is sponsored by Del. Jon S. Cardin (D-Baltimore County) and is intended to protect consumers from being fooled by impure oil. Tests of olive oils have shown that producers sometimes add soybean, hazelnut and peanut oils.

 

Members of an online cake community appeared before the Health and Government Operations Committee, which was hearing the food-related bills yesterday, to ask that Maryland make it legal for them to sell "non-potentially hazardous" items baked in their homes. Unlike in neighboring states, it is illegal in Maryland for unlicensed and unregulated home bakers to sell their wares.

 

The bakers said they wanted the ability to start home businesses to supplement their incomes in difficult economic times. But Alan L. Taylor, director of the Office of Food Protection and Consumer Health Services, told the committee that he opposed the idea because customers would have no way of knowing whether the items had been baked in safe conditions.

 

"Let's consider some popular pies: Apple, lemon meringue, pumpkin, sweet potato," he said. "Many bakers can produce an excellent pie. But three of those pies are potentially hazardous."

 

The safer pie? Apple, in part because the filling in the others might contain bad eggs, he said.

 

Copyright 2009 Washington Post.

 

Health-Care Bill Is Boon To Children In Region

Lack of Providers Remains a Concern

 

By Megan Greenwell

Washington Post

Sunday, February 15, 2009; SM01

 

The newly expanded State Children's Health Insurance Program will pave the way for more than 2,000 uninsured children in Charles County to receive comprehensive medical care, local officials said last week.

 

But questions remain about whether Southern Maryland can attract enough doctors, nurses and dentists to serve the additional children, especially in the rural corners of the region, where even private doctors can be scarce.

 

At an event Monday at the Charles health department, U.S. House Majority Leader Steny H. Hoyer and U.S. Sen. Benjamin L. Cardin, both Maryland Democrats, joined state and local elected officials in celebrating passage of the insurance bill, which President Obama signed Feb. 4. They said that children who have been underserved by private insurance and Medicare will soon have the health-care options available to more affluent families.

 

But for the most part, the question of who will treat those children has not been answered.

 

"The disparity in medical and dental care in rural areas of the state is pronounced, and that's a major issue," Cardin said in an interview after Monday's event. "Doctors do not always go where they are most needed."

 

A physician shortage in rural areas of Maryland is expected to worsen over the next several years, as a large number of doctors prepare to retire in 2015. A report last year from the Maryland Hospital Association and MedChi, the state medical society, found that Calvert, Charles and St. Mary's counties have "critical shortages" in 25 of 30 physician categories. The region has 44.4 primary care physicians for every 100,000 people, well below the state average of 57, the report said.

 

Maryland is not considered a particularly "physician-friendly" state, in large part because Medicaid reimbursement rates for doctors are in the lowest quadrant nationwide. About half of Maryland medical school graduates accept jobs in the state, the report said.

 

The federal bill increases Medicare and Medicaid reimbursements for all doctors, Cardin said, which should help remove a major obstacle in attracting physicians.

 

But Southern Maryland also faces challenges that do not affect more urban and suburban areas of the state, such as a relative lack of amenities, which can deter young doctors beginning their careers. And although most areas of the region offer easy access to Washington, the most rural parts are more difficult to get to. The most acute physician shortages are in Southern Maryland, western Maryland and the Eastern Shore, the three most rural areas of the state.

 

In St. Mary's County, which is smaller and more rural than Charles, a single family is responsible for caring for most residents. Vinod K. and Ila Shah built the region's largest private specialty practice beginning in 1995, filling a vital need because of a lack of doctors in the area.

 

Without them, Hoyer said in an interview, "we would have a very tough time providing medical services to our community."

 

Dental care has been a particular area of concern in Southern Maryland, especially since a 12-year-old Prince George's County boy died from a treatable tooth infection that spread to his brain. Deamonte Driver's death in February 2007 sparked reforms statewide, but some areas still lack dentists, especially those who accept Medicaid.

 

At Monday's event, several people mentioned the Charles health department's eight-month-old dental clinic, which targets children who are uninsured or covered by Medicaid. A mobile dental clinic is expected to begin serving western Charles, the most rural and impoverished part of the county, this year.

 

"We know there is more work to do, and we are committed to it," said John M. Colmers, secretary of the state Department of Health and Mental Hygiene. Referring to Driver's death, he said, "Never again will Maryland be in the news for such a tragedy. We will lead the nation in making health care affordable and accessible."

 

View all comments that have been posted about this article.

 

Copyright 2009 Washington Post.

 

Trans-fat bill draws an unlikely ally

 

Baltimore Sun

Wednesday, March 4, 2009

 

Legislation to ban trans fat in restaurant cooking statewide has drawn backing from an unlikely ally - the Restaurant Association of Maryland.

 

The group has lobbied hard against the proposal in recent years. But this year, it said it is squarely behind the ban and pointed out that most restaurants have eliminated trans fat from frying oil and are buying trans fat-free alternatives for baked goods.

 

The group said the bill should be expanded to cover food products sold at stores. The group is bowing to a trend; the Baltimore City Council passed such a ban last year. But the Maryland Department of Health and Mental Hygiene, while not taking a position on the bill, cautioned that the proposal could have the unintended consequence of diverting consumer attention from other unhealthy ingredients such as sugar or sodium.

 

After all, one official put it, Krispy Kreme doughnuts no longer contain trans fat.

 

Copyright 2009 Baltimore Sun.

 

Teen suicides on rise in county

Four middle schoolers caught discussing suicide

 

By Elisabeth Hulette

Annapolis Capital

Wednesday, March 4, 2009

 

Police discovered four truant eighth-graders discussing suicide last week, a disturbing discovery after the deaths of five young people from self-inflicted causes in the county since July.

 

The incidents have unnerved local officials, who yesterday announced that they would step up their efforts to prevent teenage suicide, starting by getting the word out to parents and peers.

 

"There's always a close group (teens) share with," Frank Sullivan, director of the county's Mental Health Agency, said during a presentation by county officials at the Arundel Center in Annapolis. "We want to instill resilience in our youth to get them help."

 

About 15 officials - including County Executive John R. Leopold, schools Superintendent Kevin M. Maxwell and Police Chief James Teare Sr. - said they're extremely concerned about the rise in teen suicides and suicide attempts. The incident on Feb. 25, in which four middle-school students apparently skipped classes and went into the woods to discuss suicide, is just one sign of a larger problem, they said.

 

"There have been a lot of incidents in recent months that make this a matter of some urgency," Leopold said.

 

The four students have been "referred for assistance," Maxwell said.

 

He and other officials refused to release details, such as which middle school the students attend, citing fears of copycat suicides and having the school targeted by the media. They argued that if the school is identified, the public might think teen suicide is confined to that school, when the problem is countywide.

 

The five suicides since July were spread across several communities and schools, Maxwell said. All of the victims were between the ages of 15 and 22.

 

General calls for help are up as well: The county's crisis "warmline" has received about 12,000 calls since July, already nearing the 16,800 that county officials budgeted for the year.

 

"We don't have data on the attempts, but we think that's there," Sullivan said.

 

Reasons for the surge range from bullying to relationship issues to family problems, he said. Substance abuse also often plays a role.

 

"When you are altered, that is when you're most likely to find a permanent solution to a temporary problem," said Katherine Rovendro, director of the Mental Health Agency's Crisis Response System.

 

Peter D'Souza, executive director of Hope House, a drug and alcohol treatment facility in Crownsville, said he also has seen a correlation between suicide and substance abuse.

 

"Usually, when people are really depressed, they self-medicate," he said. "They start self-medicating with alcohol and drugs. Instead of helping reduce the depression, that just exacerbates depression to the point that it drives them to commit suicide."

 

The ongoing recession also may be a contributing factor, as parents who lose their jobs pass that stress on to their children, officials said.

 

But Dr. Karin Anstendig Mosk, a psychologist who works with teens at a private practice in Severna Park, said the economy is less of an issue than other factors, like feelings of depression, anger and hopelessness.

 

Teens considering suicide often believe their peers will miss them and regret not treating them better while they were alive. Memorial sites set up on social networking Web sites like Facebook - in which students post poems, photos and messages to peers who have died - may fuel that belief, she said.

 

Teens who are depressed often don't see a way out of their problems, but parents and peers can help by showing them a reason to choose life, Mosk said. However, sometimes parents may not realize their children need help, because the teens closest to suicide are usually the ones who don't speak up.

 

"The kids who are resigned to doing it are not talking, because they know if they bring it up, there'll be an intervention," she said.

 

Still, county officials are hoping an awareness campaign will make a difference. They sent a letter home with students yesterday, asking parents to watch for warning signs, and gathered teachers to review protocol for children in crisis.

 

This year officials have started sending the county's mobile crisis unit out to schools, and recently they formed a suicide-prevention work group, in which agencies - including the police, the schools and the health department - will collaborate.

 

"Parents can be assured that we have taken pretty significant steps to address this issue," Maxwell said.

 

Lisa Hurka Covington, of the Baltimore-based Suicide Prevention Education Awareness for Kids, said that discussion is important. It will help that Anne Arundel County is not keeping the problem of teen suicide a secret, she said.

 

"We need to educate more and speak about this more," she said.

 

 

 

 

 

Staff Writers Shantee Woodards and Erin Cox contributed to this story.

 

Copyright 2009 Annapolis Capital.

 

State must make farm pollution reports public

 

By Pamela Wood

Annapolis Capital

Wednesday, March 4, 2009

 

Reports detailing pollution flowing off of farms are public government records that can be released for public scrutiny, a county court has ruled.

 

Environmentalists, farmers and state agriculture officials have been tussling for a year now over whether the reports, called nutrient-management plans, should be open for public review. The region's riverkeepers first sued agriculture officials in 2008 and the two parties struck a deal over when and how to release the plans.

 

But farmers who didn't want to make the plans public struck back with a lawsuit of their own.

 

A ruling on Feb. 10 from county Circuit Court Judge William Mulford II said the state must treat the farmers' plans as public documents. The state is allowed to block out identifying information for plans less than 3 years old, but plans more than 3 years old generally must be released in full, according to the judge's order.

 

Environmentalists said the ruling will help them identify pollution sources that harm the Chesapeake Bay.

 

"Maryland is finally catching up with other states across the country that have for years given citizens the tools they need to help enforce our country's environmental laws through citizen actions," Michele Merkel, Chesapeake regional coordinator for the Waterkeeper Alliance, said in a statement.

 

Nutrient-management plans detail how farmers deal with fertilizer, manure and other sources of harmful nutrients that can flow into the Chesapeake Bay. Nutrients such as nitrogen and phosphorus run off of farmland, causing the algae blooms that suck life-sustaining oxygen from the water.

 

Farms cause 19.3 million pounds of nitrogen and 1.5 million pounds of phosphorus to flow into the bay each year, according to Maryland's BayStat program. That's about 36 percent of all nitrogen and 39 percent of all phosphorus that flows into the bay in Maryland.

 

In 2008, 98 percent of the state's 6,000 farmers filed their plan, according to the Maryland Department of Agriculture. And 99 percent of farmers filed their annual updates that are supposed to show how well they are carrying out the nutrient plans.

 

Sue DuPont, a spokeswoman for the Maryland Department of Agriculture, said her agency is reviewing the ruling to see how to best carry it out.

 

Officials with the Maryland Farm Bureau, who filed the lawsuit, couldn't be reached for comment.

 

All of Anne Arundel's riverkeeper programs were part of the lawsuit. State lawmakers are considering a bill that would allow the state to destroy the nutrient plans after three years. The bill will be discussed in public hearings in over the next two weeks.

 

Copyright 2009 Annapolis Capital.

 

Bills aim to provide universal health care for uninsured residents

 

By Richard Simon

Daily Record

Wednesday, March 4, 2009

 

ANNAPOLIS — Legislators and representatives from CareFirst BlueCross BlueShield unveiled jointly sponsored bills today aimed at providing universal health care for an estimated 760,000 Maryland residents who are uninsured.

 

Senate Bill 515 and House Bill 860, sponsored by Sen. Thomas M. Middleton, D-Charles, and Del. Peter A. Hammen, D-Baltimore City, respectively, would require Maryland residents to obtain insurance and employers to offer coverage for their workers.

 

Organizers said they hope that the “Healthy Maryland” plan will offer health coverage to every Maryland resident regardless of health status or pre-existing conditions.

 

Massachusetts is the only state that has successfully passed universal health care legislation.

 

Organizers said 75 percent of the money that would fund the program would come from premiums.

 

Chet Burrell, CareFirst President and CEO, said that the Healthy Maryland program could be self-sustaining for as many as 10 years from premiums, which could range from as little as $25 per month to a little more than $250 per month for the average member, depending on the subscriber’s income.

 

The Senate bill, which has a hearing in the Finance Committee this afternoon, isn’t expected to pass this year, but is being seen as a starting point, according to experts familiar with the situation.

 

“We’re just at the beginning of this, and we look forward to working through the spring, the summer and into the fall on really examining what the issues are and what the best approaches might be with the idea that when we reach the fall perhaps clarifying language in the legislation an entire bill can be put together that best fits what Maryland’s needs are,” said Burrell, who added that it’s an issue that will not go away.

 

Experts foresee the bill to be an election issue in 2010.

 

Another universal health care plan, called Maryland Citizens’ Health Initiative, was introduced by Vincent DeMarco of Maryland Health Care for All in November.

 

DeMarco is expected to testify at the hearing today.

 

Copyright 2009 Annapolis Capital.

 

Delegate wants medical marijuana law review

Heller calls for state to look at health ramifications

 

By Alan Brody

Montgomery County Gazette

Wednesday, March 4, 2009

 

ANNAPOLIS — A Montgomery County delegate wants the state to examine whether to make marijuana more accessible for medicinal purposes.

 

Del. Henry B. Heller says concern for the safety of the elderly or impaired patients who might need to obtain marijuana is driving the issue. He wants a state task force to study a law on the books that allows anyone charged with possession or use of marijuana to introduce evidence in court related to medical necessity; that law limits any penalty to $100.

 

The General Assembly in 2003 adopted the law, which is dedicated to Darrell Putman, a former Army Green Beret and conservative activist from Howard County who used marijuana to treat his cancer in the final months before his death in 1999.

 

Now, Heller (D-Dist. 19) of Leisure World says the state should consider making it easier for people in need to obtain marijuana, which has been shown to reduce nausea in cancer patients and relieve pressure for those with glaucoma.

 

"The task force would look at it from a medical point of view, not a criminal point of view," he said.

 

One of the shortcomings of the 2003 law, Heller said, is that it only allows physicians to recommend, not prescribe, marijuana for medicinal purposes. That leaves ailing or older patients to acquire the drug on their own, potentially endangering their own well-being.

 

"Drug dealers aren't the most ethical of people," he said. "They kill each other and rob each other all the time. What are they going to do to an impaired senior or an impaired 25-year-old?"

 

Former Republican delegate Donald E. Murphy, who championed the medical marijuana campaign during his time in the legislature, believes a closer look at the law is warranted "to see how it works in the real world."

 

More than a dozen states have similar laws allowing the medicinal use of marijuana to be entered as court evidence. Some states prevent marijuana users from being arrested if they can furnish proof that the drug is used as medical treatment.

 

"What it does is take away the fear of arrest and incarceration on the patient end," said Murphy, now a lobbyist who travels to other states to advocate for compassionate medical marijuana laws. "From that point, the law is good in all those states, but it could be better."

 

The task force also would explore whether the medical schools at Johns Hopkins University and the University of Maryland should establish research programs to study the medical and social issues relating to medical marijuana.

 

Copyright 2009 The Gazette.

 

National / International

 

Md. men charged in Ga. suicide case

 

Associated Press

Baltimore Sun

Sunday, March 3, 2009

 

ATLANTA - Two Baltimore men who are members of an alleged assisted suicide ring were booked yesterday on assisted suicide charges in Georgia and released on $66,000 bond.

 

Dr. Lawrence D. Egbert and Nicholas Alex Sheridan are two of four Final Exit Network members charged with assisted suicide in the death of a Georgia man in June. Egbert is the organization's medical director and Sheridan is a regional coordinator.

 

Along with assisted suicide charges, which carry a five-year prison sentence, they were also charged with tampering with evidence and racketeering.

 

Copyright 2009 Baltimore Sun.

 

Supreme Court backs patients' right to sue drug makers

6-3 decision rejects Bush move to shield FDA-approved products

 

Tribune Washington Bureau

By David G. Savage

Baltimore Sun

Wednesday, March 4, 2009

 

WASHINGTON - The Supreme Court today upheld the right of patients who are hurt by a prescription or over-the-counter drug to sue the drug maker for damages.

 

The 6-3 decision rejected a strong move by the Bush administration and the pharmaceutical industry to shield drug makers from lawsuits if their products were approved by the Food and Drug Administration.

 

At issue were suits involving the more than 11,000 drugs on the market in the United States. The outgoing Bush administration told the court last fall that federal approval of a drug "preempts," or bars, juries from deciding whether it is unduly dangerous.

 

But the high court, led by Justice John Paul Stevens, disagreed and said Congress had not taken away the consumer's right to sue. He said the view of the Bush administration "does not merit deference," particularly considering that the FDA prior to the Bush era had favored lawsuits as a means of protecting consumers from dangerous drugs.

 

Today's ruling upholds a nearly $7 million jury verdict in favor of a Vermont musician whose right arm was amputated after she was injected with an anti-nausea drug made by Wyeth.

 

The injection struck an artery and caused gangrene, a rare but occasional complication from directly administering Phenergan, the anti-nausea drug.

 

Diana Levine, the Vermont woman, settled a suit against the clinic that gave her the injection and then sued Wyeth. She contended that the drug maker had not properly warned her and other consumers of the danger.

 

In its defense, Wyeth said the federally approved warning label told doctors and nurses to use extreme caution when injecting the drug. Levine and her lawyers said that was not sufficient. Who would take an injection to relieve nausea, she asked, if a patient knew she could lose her arm as a result?

 

The jury agreed with her and awarded her $6.7 million in damages.

 

In its appeal in Wyeth v. Levine, the drug company argued that since the FDA had approved its warning label as adequate, a jury should not have the power to second-guess this conclusion.

 

"Congress has repeatedly declined to preempt state law," Stevens said today. "Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling."

 

Justices Anthony M. Kennedy, David H. Souter, Ruth Bader Ginsburg and Steven G. Breyer agreed with him.

 

Justice Clarence Thomas concurred in the result. Thomas has been reluctant to go along with decisions that say federal regulations trumps state law.

 

The dissenters were Chief Justice John G. Roberts Jr. and Justices Antonin Scalia and Samuel A. Alito Jr.

 

"This case illustrates that tragic facts make bad law," Alito wrote. He called the result "a frontal assault on the FDA's regulatory regime for drug labeling."

 

Copyright 2009 Baltimore Sun.

 

High court upholds $6.7 million award to amputee, rejects limits on suits against drug makers

 

Associated Press

By Mark Sherman

Baltimore Sun

Wednesday, March 4, 2009

 

WASHINGTON (AP) — The Supreme Court on Wednesday upheld a $6.7 million jury award to a musician who lost her arm because of a botched injection of an anti-nausea medication. The court brushed away a plea for limiting lawsuits against drug makers.

 

In a 6-3 decision, the court rejected Wyeth Pharmaceuticals' claim that federal approval of its Phenergan anti-nausea drug should have shielded the company from lawsuits like the one filed by Diana Levine of Vermont.

 

Levine, 63, struggled with her emotions when told of the ruling in a phone call from an Associated Press reporter Wednesday: "Oh, my God. I'm so, so happy. I can't believe this phone call," she said.

 

"I've been waiting for so long, and I had no idea of what the chances were," Levine said. "I'm just ecstatic. I'm going to have to sit down."

 

Wyeth had no immediate comment on the ruling. The company is in the process of being bought by rival Pfizer, Inc., in a $68 billion deal that is expected to close later this year.

 

The decision is the second this term to reject business groups' arguments that federal regulation effectively pre-empts consumer complaints under state law.

 

A Vermont jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks of quickly injecting the drug into a vein, a method called IV push. Gangrene is likely if the injection accidentally hits an artery — precisely what happened to Levine.

 

The company appealed and, backed by the Bush administration, argued that once a drug's warning label gets approval from the Food and Drug Administration, the label can't be changed without further FDA approval and consumers cannot pursue state law claims that they were harmed.

 

Justice John Paul Stevens, writing the majority opinion, said Wyeth could "unilaterally strengthen its warning."

 

Stevens said he was persuaded that until a recent change by the FDA, the agency "traditionally regarded state law as a complementary form of drug regulation" because it monitors 11,000 drugs.

 

Justice Clarence Thomas agreed with the outcome of the case, but did not join Stevens' opinion.

 

Justice Samuel Alito wrote a dissent that was joined by Chief Justice John Roberts and Justice Antonin Scalia.

 

"This case illustrates that tragic facts make bad law," Alito said. "The court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs."

 

The FDA has approved the use of Phenergan by injection, including the method at issue in Levine's case. The drug has been available for decades to treat nausea and when used properly, both sides agree it is safe and effective.

 

The Bush administration and business groups aggressively pushed limits on lawsuits through the doctrine of pre-emption — asserting the primacy of federal regulation over rules that might differ from state to state.

 

The Supreme Court had largely agreed, ruling last term that FDA approval shields medical devices from most lawsuits. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices.

 

The Levine case drew a lot of attention because the administration and Wyeth contended that, although the federal Food, Drug and Cosmetic Act lacks a similar provision, drug manufacturers also are protected from most suits over federally approved drugs.

 

Stevens said there could be circumstances where consumer lawsuits would not be allowed, including if the FDA had considered and rejected a stronger warning label.

 

But that was not the case with Phenergan, he said. "As we have discussed, the FDA did not consider and reject a stronger warning against IV-push injection of Phenergan," Stevens said.

 

Justice Stephen Breyer agreed in a brief, separate opinion. "It is also possible that state tort law will sometimes interfere with the FDA's desire to create a drug label containing a specific set of cautions and instructions," Breyer said.

 

The case is Wyeth v. Levine, 06-1249.

 

Associated Press writer John Curran contributed reporting from Montpelier, Vt.

 

Copyright 2009 Associated Press. All rights reserved.

 

Study Urges More Oversight of Dietary Items

 

By Natasha Singer

New York Times

Wednesday, March 4, 2009

 

More than half of all American adults, or at least 114 million people, use dietary supplements like vitamin pills, diet pills, herbs and energy drinks. But the Food and Drug Administration does not have enough authority to ensure that the products are safe, and it should seek more oversight power, according to a government audit released Tuesday.

 

The new report from the federal Government Accountability Office acknowledged that the F.D.A. had taken some steps in the last few years to supervise the supplement industry more closely — but the report said those steps did not go far enough.

 

In the first 10 months of last year, for example, the audit said the F.D.A. received 948 reports of health problems associated with dietary supplements, but not necessarily directly caused by them. Those included 9 deaths, 64 life-threatening illnesses and 234 hospitalizations.

 

Even so, the number of problems is underreported. The F.D.A. recently estimated that there are more than 50,000 minor and serious health problems a year related to dietary supplements. “Consumers,” the G.A.O. report said, “remain vulnerable to risks posed by potentially unsafe products.”

 

Besides advising that the agency ask for more power from Congress to regulate supplements, the report recommended that the agency make sure consumers know that such products, unlike drugs, do not need agency approval and that their makers do not have to prove their safety and efficacy before they go on sale.

 

Although the G.A.O. cannot compel the drug regulators to act, an F.D.A. spokeswoman said her agency welcomed the report as a way of “calling attention to the challenges that the agency faces with respect to regulating dietary supplements.”

 

The audit of dietary supplements was commissioned by several members of Congress, including Representative Henry A. Waxman, a Democrat of California who has been investigating the safety of certain prescription drugs as chairman of the House Committee on Energy and Commerce.

 

The market for dietary supplements is growing. Americans spent an estimated $25 billion on such products last year — up from about $23.7 billion in 2007 — according to Nutrition Business Journal, which covers the industry.

 

The F.D.A. currently regulates dietary supplements as ingestible nonfood substances, but it does not have the same authority over the products as it does with drugs. The agency, for example, lacks basic information about the supplement industry: although dietary supplement makers are required to register with the F.D.A. as food manufacturers, they do not have to identify themselves as makers of specific supplements or supply the agency with product information, the report said.

 

Moreover, the F.D.A. cannot require manufacturers to remove tainted supplements from shelves. The F.D.A. recently published a report citing 69 brands of weight-loss supplements that illegally contained active drug ingredients that could be harmful to consumers. So far, only three of the brands have been voluntarily recalled. Such limited authority over supplements, along with inadequate allocation of F.D.A. resources, leaves consumers vulnerable, the report said.

 

To improve oversight, the report recommended that the F.D.A. seek authority to require supplement makers to register as such, provide lists of products and copies of product labels, and to disclose all reports of health problems — not just hospitalizations and deaths, as they have been required to do since the end of 2007.

 

In a written response, which the G.A.O. published with the report, the F.D.A. generally agreed that it could better ensure the safety of dietary supplements if it received more comprehensive information about supplement companies, products and health problems. But the agency also said that additional requirements could lead to information overload.

 

“We are uncertain whether, in practice, such information would advance the agency’s ability to identify unsafe dietary supplements or to do so quickly,” the F.D.A. said.

 

Copyright 2009 The New York Times Company.

 

It’s Organic, but Does That Mean It’s Safer?

 

By Kim Severson and Andrew Martin

Annapolis Capital

Wednesday, March 4, 2009

 

MOST of the chicken, fruit and vegetables in Ellen Devlin-Sample’s kitchen are organic. She thinks those foods taste better than their conventional counterparts. And she hopes they are healthier for her children.

 

Lately, though, she is not so sure.

 

The national outbreak of salmonella in products with peanuts has been particularly unsettling for shoppers like her who think organic food is safer.

 

The plants in Texas and Georgia that were sending out contaminated peanut butter and ground peanut products had something else besides rodent infestation, mold and bird droppings. They also had federal organic certification.

 

“Why is organic peanut butter better than Jif?” said Ms. Devlin-Sample, a nurse practitioner from Pelham, N.Y. “I have no idea. If we’re getting salmonella from peanut butter, all bets are off.”

 

Although the rules governing organic food require health inspections and pest-management plans, organic certification technically has nothing to do with food safety.

 

“Because there are some increased health benefits with organics, people extrapolate that it’s safer in terms of pathogens,” said Urvashi Rangan, a senior scientist and policy analyst with Consumers Union, the nonprofit publisher of Consumer Reports. “I wouldn’t necessarily assume it is safer.”

 

But many people who pay as much as 50 percent more for organic food think it ought to be. The modern organic movement in the United States was started by a handful of counterculture farmers looking to grow food using methods that they believed were better for the land and produced healthier food. It was a culture built on purity and trust that emphasized the relationship between the farmer and the customer.

 

By 2002, those ideals had been arduously translated into a set of federal organic regulations limiting pesticide use, restricting kinds of animal feed and forbidding dozens of other common agricultural practices.

 

To determine who would be allowed to use the green and white “certified organic” seal, the Department of Agriculture deputized as official certifiers dozens of organizations, companies and, in some cases, state workers.

 

These certifiers, then, are paid by the farmers and manufacturers they are inspecting to certify that the standards have been met. Depending on several factors, the fee can be hundreds or thousands of dollars. Manufacturers who buy six or seven organic ingredients to make one product are especially dependent on the web of agents.

 

If agents do a thorough job, the system can be effective. But sometimes it falls apart.

 

Texas officials last month fired a state worker who served as a certifier because a plant owned by the Peanut Corporation of America — the company at the center of the salmonella outbreak — was allowed to keep its organic certification although it did not have a state health certificate.

 

A private certifier took nearly seven months to recommend that the U.S.D.A. revoke the organic certification of the peanut company’s Georgia plant, and then did so only after the company was in the thick of a massive food recall. So far, nearly 3,000 products have been recalled, including popular organic items from companies like Clif Bar and Cascadian Farm. Nine people have died and almost 700 have become ill.

 

The private certifier, the Organic Crop Improvement Association, sent a notice in July to the peanut company saying it was no longer complying with organic standards, said Jeff See, the association’s executive director. He would not say why his company wanted to pull the certification.

 

A second notice was sent in September, but it wasn’t until Feb. 4 that the certifier finally told the agriculture department that the company should lose its ability to use the organic label.

 

Mr. See said the peanut company initially appeared willing to clear up the problems. But he said the company was slow to produce information and then changed the person in charge of the organic certification, further delaying the process.

 

He said his organization finally decided to recommend suspending the organic certification after salmonella problems at the plant were exposed.

 

Although certifiers have some discretion in giving organic companies time to fix compliance problems, Barbara C. Robinson, acting director of the agriculture department’s National Organic Program, said her agency is investigating the gap between the first notice of noncompliance and the recommendation that the peanut plant surrender its organic certification.

 

To emphasize that reporting basic health violations is part of an organic inspector’s job, Ms. Robinson last week issued a directive to the 96 organizations that perform foreign and domestic organic inspections that they are obligated to look beyond pesticide levels and crop management techniques.

 

Potential health violations like rats — which were reported by federal inspectors and former workers at the Texas and Georgia plants — must be reported to the proper health and safety agency, the directive said.

 

“For example, while we do not expect organic inspectors to be able to detect salmonella or other pathogens,” Ms. Robinson wrote, “their potential sources should be obvious from such evidence as bird, rodent and other animal feces or other pest infestations.”

 

Even some certifiers say that while their job is not to assure that food is safe, taking account of health inspections will help consumers.

 

“It’s a reassurance that they have another set of eyes, and more eyes is always a good thing,” said Jane Baker, director for sales and marketing of California Certified Organic Farmers, a nonprofit certifying organization in Santa Cruz, Calif., and one of the largest and oldest in the country. “But let’s not confuse food safety controls with the organic side of things.”

 

Organics has grown from an $11 billion business in the United States in 2001 to one that now generates more than $20 billion in sales, so the stakes for farmers, processors and certifiers can be high. But the agency overseeing the certifying process has long been considered underfunded and understaffed. Critics have called the system dysfunctional.

 

Arthur Harvey, a Maine blueberry farmer who does organic inspections, said agents have an incentive to approve companies that are paying them.

 

“Certifiers have a considerable financial interest in keeping their clients going,” he said.

 

Meanwhile, consumers are becoming more skeptical about certification, said Laurie Demeritt, president of the Hartman Group, a market research firm.

 

Some shoppers want food that was grown locally, harvested from animals that were treated humanely or produced by workers who were paid a fair wage. The organic label doesn’t mean any of that.

 

“They’re questioning the social values around organics,” Ms. Demeritt said.

 

The Organic Trade Association, which represents 1,700 organic companies, wants to shore up organic food’s image. This week it’s beginning a $500,000 Web-based campaign on the benefits of organic food with the slogan: “Organic. It’s worth it.”

 

Supporters of the National Organic Program think additional money in the recent farm bill will help improve its reach.

 

And great hope is being placed in Kathleen A. Merrigan, director of the agriculture, food and environment program at Tufts University, who was appointed the deputy agriculture secretary last week. Dr. Merrigan helped design the national organic standards, and is seen as a champion of organic farmers and someone who can help clarify and strengthen federal food laws.

 

Meanwhile, consumers remain perplexed about which food to buy and which labels assure safer and better-tasting food.

 

Emily Wyckoff, who lives in Buffalo, buys local food and cooks from scratch as much as possible. Although she still buys organic milk and organic peanut butter for her three children, the organic label means less to her these days — especially when it comes to processed food in packages like crackers and cookies.

 

“I want to care, but you have to draw the line,” she said.

 

But the line stops when it comes to basic food safety.

 

Recently, a sign near the Peter Pan and Skippy at her local grocery store declared that those brands were safe from peanut contamination. There was no similar sign near her regular organic brand.

 

“I bought the national brand,” she said. “Isn’t that funny?”

 

Copyright 2009 New York Times.

 

Opinion

 

Unseen victims

Our view: The budget crisis is real, but what gets lost in abstract talk about spending and revenues is that the poor are hit hardest by cuts in state agencies

 

Baltimore Sun Editorial

Wednesday, March 4, 2009

 

In tough economic times, lawmakers must make difficult choices about how to allocate resources and rein in spending. But too often, the brunt of the pain falls on the most vulnerable members of society as cuts in social services and the agencies that administer them not only can't keep up with rising needs but find themselves falling further and further behind. In an economy where unemployment is still climbing, businesses are shutting their doors and the foreclosure crisis keeps unfolding, the people hit hardest by Maryland's budget crunch are the state's poorest residents.

 

At the state Department of Human Resources, for example, waiting lines are longer, caseworkers are stretched to the limit and many people end up being denied benefits because there simply aren't enough staff members to process all the claims coming in. The agency is responsible for the food stamp program; cash assistance to the elderly, indigent and disabled; and child protective services. But under a statewide hiring freeze that began eight years ago, DHR has lost hundreds of staff positions, leaving the remaining workers unable to carry out all the duties assigned to them.

 

So what happens? Routine tasks that used to take hours or days - such as recertifying clients for benefits they've already qualified for - now take weeks or even months to complete. Crucial documents get misplaced or disappear. Legal Aid attorneys who advocate on behalf of the poor say offices in Towson and the city that once had 20 clerical workers distributing food stamps now have 10 or less, and instead of 50 clients per caseworker, staffers have to deal with 200 or more. DHR officials aren't disputing that reality. To give priority to abused or neglected children, the agency has stopped accepting new poor, elderly and disabled adults who would receive mental health treatment, vocational rehabilitation and in-home assistance through the agency. Most people would agree that services for vulnerable children should be a priority in times of great economic uncertainty. But the price for that is doing even less for needy adults, and when you cut off people who already have so little, they can fall into dire straits.

 

Like the current economic downturn, this problem has been a long time in the making. The attrition at DHR started under Gov. Parris N. Glendening and has continued ever since. From 2001 to 2008, DHR lost 1,333 full-time positions, according to figures provided by the Maryland Budget and Tax Policy Institute. Meanwhile, the Transportation Department lost just 347 and the Maryland State Police 133, while juvenile services and public safety each gained 174, the judiciary rose by 635 and higher education ballooned by 3,363.

 

The point isn't that these departments shouldn't grow. It's that their growth has been at the expense of agencies that serve Maryland's neediest residents, leaving them unable to fulfill their basic mission.

 

The burden of tough times should be shared equally, not thrust upon the state's most vulnerable merely because they are invisible to almost everyone except the harried social workers trying to help them.

 

Copyright 2009 Baltimore Sun.

 

Liability limits save access to care

 

Baltimore Sun Letter to the Editor

Wednesday, March 4, 2009

 

Proven medical liability reforms, including a cap on noneconomic damages, are working to keep Maryland physicians caring for patients while still allowing injured patients access to the court system. In fact, as the column from the president of the Maryland trial lawyers association suggests, about the only people complaining are trial lawyers ("Time to treat malpractice victims fairly," Feb. 27).

 

In states without such reforms, many cases result in runaway jury awards for noneconomic damages. Yet a recent Harvard University study shows that 40 percent of malpractice cases involve no medical error.

 

Since the 2004 action by the Maryland legislature, premiums have stabilized and high-risk specialty physicians have decided to stay in Maryland, giving patients greater access to care.

 

The American Medical Association urges that this progress not be reversed.

 

Dr. Nancy H. Nielsen

Chicago

 

The writer is president of the American Medical Association.

 

Copyright 2009 Baltimore Sun.

 

Nurse practitioners part of the solution

 

Baltimore Sun Letter to the Editor

Wednesday, March 4, 2009

 

The article "Goodbye, country doctors" (March 1) brings to our attention the physician shortage that is expected to deepen in Maryland as up to 32 percent of our physicians retire by 2015.

 

Today, Maryland has 16 percent fewer practicing physicians per capita than the national average, and the shortage is particularly acute in primary care and emergency medicine and in several other specialties.

 

I attended the MedChi rally in Annapolis on Feb.18 and heard speaker after speaker explain how high malpractice insurance rates and low reimbursement rates were driving them out of practice. I was with a small group of nurse practitioners who were there to support the physicians and to call for action to keep care providers in Maryland.

 

Our message was that nurse practitioners can be part of the solution.

 

With state and federal governments working to provide health coverage for the uninsured, all turf battles must be put aside as care professionals work together to provide access to care.

 

Sandra Nettina

West Friendship

 

The writer is president-elect of the Nurse Practitioner Association of Maryland.

 

Copyright 2009 Baltimore Sun.

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