Italian woman in right-to-die case worsens
ROME (AP) _ The condition of an Italian woman at the center of a right-to-die case worsened after she suffered a massive hemorrhage, doctors said Saturday.
Eluana Englaro has been in a vegetative state for 16 years and her father has led a protracted court battle to disconnect her feeding tube, insisting it was her wish.
This summer a Milan court granted his request, setting off a political storm in this overwhelmingly Roman Catholic country. Italy does not allow euthanasia, but patients have a right to refuse treatment.
Catholic and anti-euthanasia groups protested the ruling by leaving bottles of water in front of Milan’s Duomo cathedral. Prosecutors appealed the decision and the father pledged not to disconnect the tube before Italy’s high court weighed in.
Carlo Alberto Defanti, Englaro’s doctor, told reporters gathered Saturday at a clinic in northern Italy that over the last two days Englaro had been bleeding from her uterus.
“It was a very abundant hemorrhage, which puts her life at risk,” he said. “This afternoon it stopped. We can’t make predications; if it doesn’t restart she may recover.”
Italian news reports said doctors had agreed not to give Englaro a blood transfusion.
Englaro was 20 years old when she fell into a vegetative state following a car accident in 1992. Two years later, doctors called her condition irreversible.
Her father, Beppino Englaro, has said she had visited a friend who was in a similar condition shortly before her accident and had expressed the will to refuse treatment if in the same situation.
The case has drawn comparisons here with that of Terry Schiavo, the American woman who was at the center of a right-to-die debate until her death in 2005. Schiavo’s husband, who wanted her feeding tube removed against her parents’ wishes, prevailed in a polarizing battle in the United States that reached Congress, President George W. Bush and the Supreme Court.
Copyright 2008 The Associated Press.
Pa. widow sues US over Iraq vet-husband’s suicide
By MARYCLAIRE DALE
Associated Press Writer
PHILADELPHIA (AP) _ The widow of an Iraq war veteran who committed suicide while in outpatient care for depression at a Veterans Administration hospital has sued the federal government for negligence.
Tiera Woodward, 26, claims in her lawsuit that her late husband, Donald, sought treatment at a VA hospital in Lebanon after three failed suicide attempts but wasn’t seen by a psychiatrist for more than two months.
She says doctors were slow to diagnose her husband with major depression, and that once the diagnosis was made, a psychiatrist failed to schedule a follow-up meeting with her husband after he informed the doctor he had gone off his medication.
Donald Woodward killed himself in March 2006 at age 23.
“I intend to make them make changes,” said Donald Woodward’s mother, Lori Woodward. “I have too many friends whose kids are in Iraq. I have a nephew now in Iraq, in the same unit, and I can’t have my family go through this again.”
Alison Aikele, a VA spokeswoman in Washington, D.C., said the agency does not typically comment on pending litigation.
The lawsuit, filed in the Middle District of Pennsylvania, seeks an unspecified amount for funeral expenses, lost income and pain and suffering.
It echoes other lawsuits nationwide over VA mental-health services, despite legislation President Bush signed in November ordering improvements.
The family of Marine Jeffrey Lucey, also 23, has a federal suit pending in Massachusetts over his June 2004 suicide. And two veterans groups sued the VA in San Francisco seeking an overhaul of its health system, citing special concerns about mental health, but a judge dismissed the suit in June over venue issues.
More than 150,000 Iraq and Afghanistan war veterans have already sought mental health care from the VA, and another 200,000 have sought medical care, according to Veterans for Common Sense, one of the groups involved in the California lawsuit.
“Each tragic veteran suicide is yet another painful reminder of the human cost of the Iraq and Afghanistan wars and VA’s abject failure to provide timely and appropriate mental health care,” said Paul Sullivan, the group’s executive director. “How many wake-up calls does (the) VA need?”
Copyright 2008 The Associated Press.
Canines provide PTSD support for Iraq troops: Updated
Washington, DC October 1st – Operation Baghdad Pups is a SPCA International (www. SPCA. com) initiative created to provide medical care, clearance and transport for the animals our U.S. soldiers have come to love during deployment in the Middle East. Today, the United States military committed a crime against their own mentally wounded U.S. soldiers serving in Iraq. Commanding officers ordered the confiscation of a dog, Ratchet, befriended by a group of soldiers during a 15th month of deployment. Ratchet has been a lifeline to Sgt. Gwen Beberg. This morning, Ratchet was on his way to SPCA International rescue experts at the Baghdad Airport to be flown home to Gwen’s parents in Minneapolis, MN when Sgt. Beberg’s commanding officers ordered Ratchet confiscated and held in Iraq to face certain death.
“This year has been extremely difficult on my daughter and her family. It has been a year of disappointments, loneliness, and fear because of all the sacrifices the army has required of Gwen. Ratchet was the savior of her sanity. Now they have cruelly ripped Ratchet away from her and sentenced him to death. I don’t know how my daughter will cope. Ratchet has been her lifeline,” explains Sgt. Beberg’s mother, Patricia Beberg. Gwen Beberg, a decorated soldier, has been held by the military more than 15 months past her original commitment due to the stop-loss policy and now the military that asked extraordinary sacrifice from her has crushed her by ripping her lifeline away. Now, Sgt. Beberg is under military investigation for befriending the dog that saved her life.
It is against military regulations for active duty troops to befriend animals – Soldiers can face immediate court-marshal and some even see their animals brutally murdered by a direct gunshot to the head from commanding officers who will not bend the rules. Hundreds of U.S. soldiers in the Middle East befriend animals in the war zone to help themselves cope with the hardship and terror they face every day. These dogs and cats become their lifeline – saving them from deep depression and Post-traumatic Stress Disorder (PTSD).
The military refuses to help or formally recognize the lifeline these animals give to our mentally wounded soldiers. Veterans returned from Iraq are committing suicide at twice the rate of average Americans. The dogs and cats befriended by our troops rescued by Operation Baghdad Pups are providing proven pet therapy to soldiers who may otherwise suffer from PTSD and deep depression.
Gwen and Ratchet
LEARN MORE ABOUT OPERATION BAGHDAD PUPS
-SPCA
UPDATE: Date: 10/14/2008 4:36 PM
US mil: Iraqi puppy adopted by US soldier is alive
By KIM GAMEL
Associated Press Writer
BAGHDAD (AP) _ The Iraqi puppy adopted by an American soldier but refused a flight to the U.S., is alive, the military said Tuesday, giving hope to an animal rescue group that is trying to take it to the United States.
The case has cast a spotlight on Defense Department rules that prohibit soldiers in the U.S. Central Command, which includes Iraq, from adopting pets or transporting them home.
Army Sgt. Gwen Beberg, 28, of Minneapolis, tried to send Ratchet home with the help of Operation Baghdad Pups earlier this month as she prepared to leave Iraq. But the dog was reportedly confiscated by a U.S. officer before it could reach the Baghdad International Airport, raising concern about the animal’s fate.
U.S. military spokesman Lt. Cmdr. David Russell said in an e-mail that the dog was alive, but he could provide no other details or comment on the effort to take it to the United States.
More than 30,000 people have signed an online petition urging the Army to let the puppy go home with Beberg, nearly tripling in a day as publicity over the case spread.
Beberg, who had been based south of Baghdad, has been transferred to a staging area to prepare for her departure from Iraq.
The coordinator for Operation Baghdad Pups — a rescue program run by the Society for the Prevention of Cruelty to Animals International — planned to travel to Baghdad on Wednesday to collect six dogs rescued by U.S. troops.
Terri Crisp is hopeful Ratchet will be one of them, but she has a substitute dog ready to go in his place if necessary.
“There’s a lot of pressure being put on the military right now to allow Ratchet to leave,” she said in a telephone interview.
Baghdad Pups has taken more than 50 dogs and cats home for their warrior owners, although the group had to cease its activities over the summer because of the heat.
Crisp said the U.S. military should cooperate with the group instead of obstructing the animals’ transportation because it helps the troops deal with the stress of being in Iraq.
“These dogs and cats are incredibly therapeutic,” she said. “With all the talk of post-traumatic stress disorder, this is a way they can deal with things — not only when they’re in Iraq serving but when they’re at home.”
Last week, Beberg’s congressman, Minnesota Democrat Keith Ellison, wrote to the Army urging it to review the case.
Beberg and another soldier rescued Ratchet from a burning pile of trash in May. But Defense Department rules prohibit U.S. troops who are deployed from caring for pets in theater or taking them home.
Sgt. Brooke Murphy, a U.S. military spokeswoman, said there were several reasons for the rule, including health issues and difficulties in caring for the animals.
“The military has these policies in place for a reason and really is looking out for the best interests of the soldier and the interests of the animal and the interests of the community,” she said.
Baghdad Pups tried to collect Ratchet two weeks ago, but Crisp said a U.S. commander had intercepted a military convoy carrying the dog to Baghdad and sent it back to Beberg’s former base.
Crisp said the group relies on donations to pay for the missions — Wednesday’s will cost just under US$10,000 — but recently has had to ask the soldiers to contribute because of fundraising troubles.
In June, a dog brought back to the U.S. by Operation Baghdad Pups tested positive for rabies after it was euthanized for other health concerns. That prompted a public health investigation, and the federal Centers for Disease Control and Prevention recommended immediate vaccination and six-month quarantine for the other animals on the shipment.
SPCA International spokeswoman Stephanie Scroggs said the group meets agency requirements that specify animals that have not been vaccinated for at least 30 days prior to entering the United States be quarantined for at least 30 days.
___
Associated Press writer Frederic J. Frommer in Washington contributed to this report.
___
On the Web: Ratchet petition: http://www.thepetitionsite.com/2/clemency-for-ratchet
Baghdad Pups site: http://www.baghdadpups.com
Copyright 2008 The Associated Press.
Armor Holdings settles federal probe for $30M
By DONNA BORAK
AP Business Writer
WASHINGTON (AP) _ Armor Holdings Inc. will pay $30 million to resolve allegations that it knowingly made and then sold defective bulletproof vests to law enforcement personnel, the Justice Department said Tuesday.
Armor Holdings, now a subsidiary of British defense conglomerate BAE Systems PLC, allegedly had information that showed ballistic materials known as the Zylon Shield, “degraded quickly over time” and were unfit for use by state and local law enforcement agencies, according to the government settlement.
A representative from BAE Systems was not immediately available to comment Tuesday afternoon. Armor Holdings denied any responsibility or wrongdoing related to the government’s complaints in its agreement.
The latest settlement is part of a widespread federal investigation of several vendors who played a role in making the defective bulletproof vests. The government has previously settled with three other companies, including aerospace supplier Hexcel Corp., for a total of $16 million.
“The Justice Department will not tolerate its first responders wearing defective bulletproof vests,” said Gregory Katsas, the assistant attorney general for the civil division. “This settlement will help ensure that first responders receive the highest quality ballistic protection.”
In June, the government sued diversified manufacturer Honeywell International Inc. for selling defective material used in the bulletproof vests and for failing to notify the government or Armor Holdings of the defect.
The fabric used in Honeywell’s Zylon Shield was supplied by Japan’s Toyobo Co. Ltd. and its U.S. subsidiary Toyobo America Inc. Honeywell patented its Zylon Shield and later sold it to Armor Holdings and its subsidiaries.
Between 2000 and 2005, the U.S. paid $1.3 million for more than 1,700 vests sold by Armor Holdings that contained Honeywell’s Zylon Shield. The government has paid roughly another $20 million for more than 11,000 bulletproof vests made with the Zylon Shield.
Copyright 2008 The Associated Press.
US woman loses appeal in ‘milkshake murder’ trial
By DIKKY SINN
Associated Press Writer
HONG KONG (AP) _ An American woman lost an appeal Monday of her conviction in a Hong Kong court for the beating death of her husband in a sensational case widely known as the “milkshake murder” trial.
Dressed in black, Nancy Kissel nodded her head and appeared to be holding back tears when a judge announced the decision in the Court of Appeal. Kissel, who suffered a knee injury in prison, limped out of the courtroom aided by two policewomen.
The 44-year-old housewife from Minnesota was convicted in 2005 of giving her husband a milkshake laced with sedatives before fatally bashing the wealthy banker on the head with a metal ornament in 2003.
Kissel said she was defending herself from an abusive husband and appealed the conviction and her life sentence in prison. But prosecutors argued Kissel was a cold-blooded wife who planned the attack in the couple’s luxury apartment.
Defense attorney Simon Clarke said he was “very disappointed” but not surprised by Monday’s ruling.
“This court doesn’t uphold many appeals at all,” Clarke said. “But we are expecting a better hearing at the Court of Final Appeal.”
The three-judge panel did not give approval for the case to proceed to a higher court, and Kissel will need to apply for permission to get the Court of Final Appeal to hear the case.
The defendant’s mother, Jean McGlothlin, said her daughter was fragile physically. But she added, “Her spirit is strong. Her will is strong. Her heart and mind are strong.”
The sensational trial has made headlines worldwide because of its allegations of drug abuse, kinky sex and adultery in the wealthy world of expatriates in this Asian financial center.
Kissel said her then 40-year-old husband, Robert, an investment banker for Merrill Lynch, was an erratic whiskey-swilling workaholic who also snorted cocaine and forced her to have painful anal sex. She testified that she killed him as he was threatening her with a baseball bat in a quarrel.
During the appeal hearings, Kissel’s defense lawyer said the woman suffered an abnormality of mind that substantially impaired her self-control.
But prosecutors argued that Kissel was a cold-blooded, scheming woman who plotted to kill her husband. They said Robert Kissel of New York had been angry about his wife’s affair with a repairman who worked on the couple’s vacation home in the northeastern U.S. state of Vermont. He had planned to seek a divorce just before she killed him.
Robert Kissel’s estate was worth US$18 million in life insurance, stocks and properties before he was murdered, prosecutors said.
Copyright 2008 The Associated Press.
Brain Injury Association of America Policy Corner E-Newsletter – October 3, 2008
__________________________________________________________________
Dear Advocates:
In late breaking news from the United States Capitol, Congress has just approved a $700 billion financial bailout package, which also includes landmark mental health parity legislation (H.R. 1424/S. 558) and dozens of expiring tax breaks for businesses and individuals.
This legislation was sent in an expedited fashion this afternoon to President Bush who signed the measure into law hours after its passage.
As the previous edition of Policy Corner noted, several important legislative developments occurred last week, and this week’s edition of Policy Corner includes additional details about these developments as they pertain to brain injury policy.
It remains unclear whether Congress will return for a lame duck session in November after the elections, although at least a short session appears likely for the Senate the week of November 17. BIAA will provide an update on the remainder of this year’s congressional schedule as soon as this information available.
*Distributed by Laura Schiebelhut, BIAA Director of Government Affairs, on behalf of the Brain Injury Association of America; 703-761-0750 ext. 637; lschiebelhut@biausa.org
BIAA’s Policy Corner and Legislative Action Alerts are made possible by the Centre for Neuro Skills, James F. Humphreys & Associates, and Lakeview Healthcare Systems, Inc. The Brain Injury Association of America gratefully acknowledges their support for legislative action.
To sign up to receive future BIAA Policy Corner E-Newsletters and Legislative Action Alerts, please go to http://capwiz.com/bia/mlm/signup/
__________________________________________________________________
Congress Passes Financial Bailout Legislation, Mental Health Parity
In late breaking news from the United States Capitol, Congress has just approved a $700 billion financial bailout package, which also includes landmark mental health parity legislation (H.R. 1424/S. 558) and dozens of expiring tax breaks for businesses and individuals.
This marks a tremendous victory for mental health advocates and others who have supported efforts to enact a parity bill for years. This legislation will require private health insurers to offer mental health and addiction benefits equal in cost and scope to traditional medical benefits.
Earlier this year, BIAA strongly endorsed the House version of this legislation. In a letter officially endorsing the bill in March, BIAA noted, “An intricate and intertwined relationship exists between substance abuse, mental health, and traumatic brain injury (TBI). Substance use and abuse is often both an antecedent to and a consequence of TBI.”
Upon its passage this afternoon, one of the bill’s sponsors and leading champions, Congressman Patrick J. Kennedy (D-RI), stated:
“This legislation is one more step in the long civil rights struggle to ensure that all Americans have the opportunity to reach their potential. For far too long, health insurance companies have used the stigma of mental illness and substance abuse as an excuse to deny coverage for those biological disorders. That ends today when this critical legislation outlaws the discrimination that is embedded in our laws and our policies.”
Other bill sponsors and leading supporters include Rep. Jim Ramstad (R-MN) in the House of Representatives, as well as Sen. Pete Domenici (R-NM) and Sen. Edward Kennedy (D-MA) in the Senate. Late Senator Paul Wellstone (D-Minn.) was also a leading champion of this legislation.
Appropriations Update
Last week, the House passed an omnibus continuing appropriations bill to fund most government programs – including TBI and trauma-related programs – at Fiscal 2008 (last year’s) levels until March 6, 2009.
Over the weekend, the Senate also passed this omnibus legislative package and forwarded it to President Bush, who signed it into law just hours before the beginning of the new fiscal year on October 1.
This massive year-end spending package includes a Continuing Resolution (CR) which funds programs covered by nine unfinished appropriations bills (including the Fiscal 2009 Labor-HHS-Education Appropriations bill, which contains funding for key federal TBI programs) at Fiscal 2008 levels until enactment of the bills or March 6, 2009 – whichever comes first. This essentially leaves final funding decisions on domestic programs to the next Congress and president.
Within this CR, all civilian health programs, including TBI and trauma-related programs, are funded at Fiscal 2008 levels. These Fiscal 2008 levels, and thus continuing funding levels through the beginning of next year, are as follows:
CDC TBI Programs (HHS): $5.709 million
HRSA TBI Programs (HHS) (HRSA TBI State Grant Program and Protection and Advocacy Systems): $8.754 million
TBI Model Systems of Care (NIDRR/Department of Education): $8.155 million
In addition to the CR to provide continuing appropriations for most federal programs, the omnibus bill also includes three Fiscal 2009 appropriations bills in their entirety. These three appropriations bills are those that fund Defense, Homeland Security and Military Construction-VA for all of FY 2009.
The Defense appropriations measure included in this legislative package contains $300 million in funding for Traumatic Brain Injury and Psychological Health initiatives within the Department of Defense.
The Military Construction-VA appropriations measure includes $41 billion in funding for the Veterans Health Administration (veterans medical care), representing $1.8 billion above the President’s budget request earlier this year and $4.1 billion above 2008 levels. This funding bill also provides $510 million in funding for Medical and Prosthetic Research, including cutting edge research into areas such as Post Traumatic Stress Disorder (PTSD), Traumatic Brain Injury, suicide prevention, and polytrauma. This funding level for research represents $30 million above 2008 levels, and rejects a $38 million cut proposed by President Bush.
The Military Construction-VA appropriations bill contained in this omnibus legislative package also included important report language (strongly supported by BIAA) urging the Department of Veterans Affairs to increase returning servicemembers’ access to TBI care and expertise in the civilian sector. Specifically, the Explanatory Statement accompanying this bill states:
“The Appropriations Committees strongly urge the Department to establish and expand cooperative agreements with public and private entities with neurobehavioral rehabilitation and recovery experience in the treatment of Traumatic Brain Injury (TBI) as recommended in section 1703 of Public Law 110-181” [FY 2008 National Defense Authorization Act].”
In addition, the bill provides $200 million for fee-based services intended to allow the VA to tap expertise in the public and private sector for health care that may not be readily available within VA medical centers.
Congress Authorizes VA Epilepsy Centers of Excellence
Last week, the House passed an omnibus veterans health care package (S. 2612), including key provisions of The Epilepsy Centers of Excellence Act (H.R. 2818/S. 2004), which BIAA has strongly endorsed.
Over the weekend, the Senate also passed this legislation and it is expected to be signed into law by the President imminently.
The legislation, championed by the American Academy of Neurology and endorsed by BIAA, anticipates an expected increase in the number of TBI-related epilepsy cases among veterans returning from service in Iraq and Afghanistan. The bill will create up to six Epilepsy Centers of Excellence (ECoE) at the Depart ment of Veterans’ Affairs (VA), and is aimed at restoring the VA as a national leader in epilepsy care and research.
The bill was sponsored by Rep. Ed Perlmutter (D-CO) in the House of Representatives and Sen. Patty Murray (D-WA) in the Senate.
Congress Clears FY 2009 Defense Authorization Bill For President’s Signature
Within the past few days, Congress also passed the FY 2009 defense authorization bill (S. 3001). This legislation contains a “Sense of Congress on TBI Research.” Specifically, the bill states in Sec. 725:
“It is the sense of Congress that the requirement under section 1621(c)(7) of the National Defense Authorization Act for Fiscal Year 2008 (Public Law 110–181; 122 Stat. 453; 10 U.S.C. 1071note) to conduct basic science and translational research on traumatic brain injury includes pilot programs designed to test the efficacy of clinical approaches, including the use of pharmacological agents. Congress urges continued studies of the efficacy of pharmacological agents for treatment of traumatic brain injury and supports continued joint research with the National Institutes of Health in this area.”
BIAA Signs on To Coalition Letter Opposing Proposed Medicaid Outpatient Regulation
BIAA recently signed on to a coalition letter urging Congress to enact a moratorium on a regulation proposed by the Centers for Medicare and Medicaid Services (CMS) to restrict Medicaid reimbursement for outpatient services. This regulation is termed the “Medicaid Outpatient Clinic and Hospital Services Rule,” and it would reduce federal Medicaid funding to states for freestanding health clinics and hospital outpatient departments.
This regulation, published on September 28, 2007 – and expected to be finalized in November of this year – would cut Medicaid reimbursement to many types of outpatient services, including services utilized by individuals with brain injury. [72 Federal Regulation 55158 to 55166 (to be codified at 42 C.F.R. 440, 447 and sometimes referred to as CMS 2213-P).]
To prevent finalization of this rule, BIAA has joined the Consortium for Citizens with Disabilities in urging Congress to enact a moratorium delaying implementation of this harmful regulation through April 2009.
In a heartening development, this week Members of Congress introduced legislation aimed at enacting such a moratorium.
Yesterday, Sen. Charles Schumer (D-NY) and Sen. Hillary Rodham Clinton (D-NY) introduced the “Preserving Access to Healthcare” (PATH) Act of 2008, which would, among other provisions, delay the proposed Medicaid outpatient regulation by six months.
In addition, earlier this week, Rep. John McHugh (R-NY) introduced H.R. 7219, the Protecting Hospital Outpatient and Community Clinic Services Act of 2008, which would provide a moratorium on the regulation.
BIAA strongly supports these legislative efforts.
BIAA Representatives Attend Trauma Spectrum Disorders Conference
Multiple BIAA representatives attended this week a scientific conference titled, “Trauma Spectrum Disorders: The Role of Gender, Race & Other Socioeconomic Factors.”
This conference – jointly sponsored by the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, the Department of Veterans Affairs, and the National Institutes of Health – focused on identifying and sharing knowledge and lessons learned about gender and race as they relate to psychological health and traumatic brain injury.
Presentations made at this conference are expected to soon be made publicly available on the Defense Center of Excellence’s website: http://www.dcoe.health.mil/.
Government probes chelation-heart disease study
By MARILYNN MARCHIONE
AP Medical Writer
The largest alternative medicine study the government has ever launched has stopped enrolling people while officials investigate whether participants were fully informed of the risks and are being adequately protected, The Associated Press has learned.
More than 1,500 heart attack survivors are involved in the research, which tests a controversial treatment called chelation. It is mainly used to treat lead poisoning.
More than two people have died, although the Miami doctor leading the study said the deaths were not a direct result of the treatments. He said he doesn’t know exactly how many deaths have occurred.
He also acknowledged that some doctors who had been involved in the study have been disciplined by state boards or have criminal records and have been asked to drop out.
“We think we have a safe and ethical trial and we’re protecting our patients,” said the leader, Dr. Gervasio Lamas of the University of Miami.
Federal officials confirmed their probe of the $30 million study on Thursday. Those directing the research, conducted at 100 sites around the United States and Canada, voluntarily stopped enrolling patients earlier this month, after the investigation was launched.
The research was designed to test very high doses of vitamin and mineral supplements and chelation, which has not been proved effective for heart disease. Chelation (pronounced kee-LAY-shun) involves intravenous doses of a drug, in this case disodium EDTA, that proponents claim will bind to calcium built up in artery walls and help flush it from the body.
Conventional treatments for heart disease include medicines, surgery and artery-clearing angioplasty.
When the study was approved in 2002, federal officials said many heart patients were exploring chelation therapy, and the research would give answers about whether the treatment was safe and effective.
A similar philosophy was behind an effort to test chelation on autistic children. However, the government recently scrapped that plan, citing safety concerns as one reason.
The heart disease study was based on misrepresentations about safety and effectiveness and “should never have been approved,” said Dr. Kimball Atwood, an anesthesiologist in suburban Boston and an assistant clinical professor at Tufts University.
He and several others sent a complaint about the heart study to the federal research protection agency, and recently published a lengthy report detailing alleged problems.
“The consent form is inadequate. It doesn’t tell people, for example, that people have died from this drug,” said a report co-author, Liz Woeckner. She is president of Citizens for Responsible Care and Research, or CIRCARE, a nonprofit group focused on research safety.
More than half of the doctors running the study make money by selling chelation treatments — a conflict of interest, critics say. Study documents misrepresent what previous, smaller chelation studies have found and “omit abundant evidence of injuries and deaths,” Atwood wrote.
Woeckner and Atwood’s article alleges problems with the licenses of several doctors who had roles in the trial, including a couple with criminal records.
“That’s frightening to me as a potential subject” in the study, Woeckner said.
The federal Office for Human Research Protections determined there was merit to the complaint and opened an investigation, spokeswoman Pat El-Hinnawy said.
Until June when he joined the University of Miami’s Miller School of Medicine, Lamas had been at Mount Sinai Medical Center and the Miami Heart Institute in Miami Beach, Fla.
After the federal agency opened the probe, the study’s leaders decided to stop enrolling subjects until it was resolved. People already enrolled are still being treated, said a spokeswoman for the National Heart, Lung and Blood Institute, which is sponsoring the study with the National Center for Complementary and Alternative Medicine.
The American College for Advancement in Medicine, a group of chelation practitioners who helped design and run the research, put a statement on its Web site addressing the matter. The group vowed to work with Lamas “to answer the unfounded allegations of impropriety” and said federal officials “will find that the allegations are of a political nature.”
“We call for a swift end to the moratorium and resumption of the trial,” says the statement by the group’s president, Dr. Jeanne Drisko.
Lamas said that any study involving older heart attack survivors was bound to have deaths. After federal officials questioned one death that study investigators had deemed unrelated to the trial, a change was made to report all deaths to the federal Food and Drug Administration, he said.
Many independent groups, including heart specialists at Duke University, are monitoring the study, Lamas said. “The last time they looked at this was at the end of April and there were no safety concerns,” he said.
As originally designed in 2002, the study was to enroll nearly 2,400 people, 50 or older, who had suffered a heart attack at least six weeks previously. Some would be randomly assigned to get either chelation or dummy infusions weekly for 30 weeks, then 10 more treatments bimonthly, over a 28-month period. The assumption was that chelation would cut heart-related problems and deaths by one-fourth.
Others in the study were randomly assigned to get high or low doses of antioxidant vitamin and mineral supplements. The study was to have been nearly completed by now, but enrollment lagged and researchers now aim to sign up fewer than 2,000.
Chelation has been highly controversial, and the American Heart Association and other groups have spoken out against it. The heart group’s Web site says a single treatment costs $50 to $100. In the first month, patients usually are given daily treatments, which insurers do not cover since it is of unproven benefit.
The form of EDTA used in the trial is supplied by AkzoNobel, a Dutch company, Lamas said.
“EDTA isn’t totally safe as a drug. There’s a real danger of kidney failure,” bone marrow problems, shock, low blood pressure, convulsions, heart rhythm problems, allergic reactions and breathing troubles, the heart association site says.
“A number of deaths in the United States have been linked with chelation therapy. Also, some people are on dialysis because of kidney failure caused, at least in part, by chelation therapy,” the site says. “Clearly, people who choose chelation therapy are risking more than money.”
The FDA, the American College of Physicians, the American Medical Association and others have noted that chelation is experimental and of unknown value or risk for heart disease patients.
“What this controversy highlights is the need to do a trial of this treatment,” Lamas said. “It goes on all the time in many physicians’ offices in the U.S. and worldwide.”
The American College of Cardiology is listed in study documents as one of the groups associated with the research. The group’s president, Dr. W. Douglas Weaver, noted the treatment is “experimental, unproven.” But he supports finding out if it might work, and the Henry Ford Health System in Detroit where he works is participating.
“It would be a real disservice to scare people” and cause any study participants to stop treatments, because then we’d never have answers, Weaver said Thursday. If there were a safety concern, the federal government would have stopped the trial, rather than study leaders just suspending enrollment in it, he said.
Copyright 2008 The Associated Press.
Fortis denies solvency problem as shares drop
AMSTERDAM, Netherlands (AP) _ Shares in Fortis NV fell sharply on Thursday amid continuing worries about the solvency of the Dutch bank and insurance company.
Fortis denied having any problem “concerning solvency and liquidity,” spokeswoman Lililane Tackaert said.
She said several “unfounded rumors” were circulating. “We’ve heard one rumor that we are desperate to sell activities that we don’t even own,” she said.
Fortis shares fell 20 percent in Amsterdam to 5.61 euros ($8.21) on Thursday. This year they have lost two-thirds of their value.
The company had said in July it needed to raise 5 billion euros ($7.4 billion) in additional capital by 2010 to maintain solvency targets. It also caught investors by surprise by announcing a 1.5 billion euro ($2.2 billion) share issue, and canceling dividends to preserve capital.
That triggered a decline in shares, credit downgrades, and the abrupt departure of Chief Executive Jean-Paul Votron in July.
Some analysts are skeptical of Fortis’s ability to issue debt or sell assets at a reasonable price in the current market environment.
The spokeswoman said Fortis has a viable plan to improve capital ratios.
“We have a plan in place and we are carrying it out,” Tackaert said. “We have some flexibility about the timing of that plan.”
She denied rumors that Fortis was planning another new share issue.
Dutch and Belgian financial market watchdogs last week began investigating allegations of a malicious e-mail campaign spreading rumors against Fortis.
Copyright 2008 The Associated Press.
Footnote: Fortis Healthcare is now Assurant Health which is headquartered in Milwaukee, Wisconsin.
Judge rules in McMahon’s favor in hospital lawsuit
By ANTHONY McCARTNEY
AP Entertainment Writer
LOS ANGELES (AP) _ Ed McMahon’s lawsuit against a hospital and doctors he claims failed to properly diagnose and repair his broken neck has passed a key legal hurdle.
A Los Angeles Superior Court judge ruled last week that McMahon’s lawsuit against Cedars-Sinai Medical Center and two physicians lays out adequate legal ground to pursue claims that include negligence, elder abuse, battery, fraud and intentional infliction of emotional distress.
Attorneys for Cedars-Sinai had challenged the legal basis for six of the claims.
But Judge John P. Sook disagreed, and his ruling also allows McMahon to seek punitive damages.
McMahon, 85, filed suit in July and is seeking an unspecified amount for injuries he sustained after a fall last March at a Los Angeles socialite’s home.
According to his lawsuit, doctors at Cedars-Sinai failed to perform an X-ray and determine that he had a broken neck when he was brought into the emergency room. The suit also claims that a doctor at the hospital’s spinal-care center improperly performed two surgeries.
“The court’s ruling rejected the contention by Cedars-Sinai that it could not be responsible for the botched surgeries,” said McMahon’s attorney, William Stoner. “It was a very important day for Ed McMahon.”
A phone message for an attorney representing Cedars-Sinai left after business hours Monday was not returned.
Cedars-Sinai was given 20 days to reply further to the lawsuit.
Stoner said McMahon’s injuries contributed to his money woes, which include falling behind on mortgage payments and being sued for unpaid loans and by a New York attorney who represented his daughter in her divorce and claims he has not been paid.
“He was making a good living, and he was very active in the business,” Stoner said.
McMahon is seeking a jury trial; a date has not yet been set.
Copyright 2008 The Associated Press.
Police say officer feared insulin pump was weapon
DETROIT (AP) _ Police officers in two Detroit suburbs are accused of beating a motorist who was suffering a diabetic episode on a freeway.
Lawyer Arnold Reed says 59-year-old Ernest Griglen had brain surgery after the June 15 encounter with police and has been clinging to life with help from a ventilator.
Reed filed a lawsuit Monday in federal court seeking at least $20 million from Allen Park and Dearborn police. He says officers mistakenly believed Griglen was resisting arrest when he was having a major medical problem.
An Allen Park police report says Griglen’s car was swerving.
Allen Park police wouldn’t comment on the lawsuit. Dearborn police released a report saying an officer feared Griglen’s insulin pump was a weapon.
Copyright 2008 The Associated Press.