Archive for July, 2006

Vegas Flight Passengers, Crew Quarantined

Monday, July 24th, 2006

(AP) - DENVER-A section of the Las Vegas airport was closed for several hours after a flight arrived from Denver with 11 sick people on board, officials said Sunday.

Passengers and crew members on United Airlines Flight 1491 were quarantined for several hours Saturday night at McCarran International Airport while the plane, passengers and luggage were checked by hazardous materials experts, said Elaine Sanchez, a McCarran spokeswoman.

Four of the victims were flight attendants, Sanchez said.

Sanchez said the cause was still being investigated. A passenger, Don Yarbrough, told KUSA TV of Denver that investigators believed the victims reacted to a cleaning fluid containing ammonia that had been used on the plane after it arrived in Denver from Cancun, Mexico.

A United spokeswoman in Chicago, Robin Urbanski, said victims felt weak and nauseous but she had no other details.

There were 143 passengers and crew on the plane when it landed in Las Vegas.

Cancer Drug May Pose Heart Danger

Monday, July 24th, 2006

WASHINGTON (July 23) - A successful cancer-fighting drug may also damage the heart, although a researcher says leukemia patients who need Gleevec should not abandon it.

While effectively treating cancer, Gleevec can lead to heart failure in some patients, said Dr. Thomas Force, who teaches medicine at Jefferson Medical College of Thomas Jefferson University in Philadelphia.

His study, published Sunday in the online edition of the journal Nature Medicine, was prompted by reports that 10 patients taking Gleevec for chronic myelogenous leukemia developed severe congestive heart failure.

Gleevec, sold under the Glivec in some countries, had worldwide sales of $1.2 billion in the first six months of this year, according to the manufacturer, Novartis Pharmaceuticals Corp.

“Gleevec is a wonderful drug and patients with these diseases need to be on it. It’s a lifesaving drug for sure,” Force said in a telephone interview.

“This is not a Vioxx situation,” Force added, referring to Merck & Co.’s painkiller that was pulled from the market because of heart side effects.

Force said he is trying to call attention to the fact that Gleevec and other similar drugs coming along could have significant effects on the heart and that doctors need to be aware of this and watch for symptoms. These patients can be helped with heart treatment, he said.

Novartis cited the limited data and said further research was needed to better understand the relationship between such studies and their potential impact on monitoring patients who are on the drug.

The company said in a written statement that the prescribing information with the drug includes data on heart problems. In addition, the drug maker said clinical trials and postmarketing safety data have shown that the incidence of heart failures among people taking drug is “extremely rare.”

Novartis said Force’s work does not change “the positive benefit/risk ratio of Glivec for thousands of patients being treated for cancer and other life-threatening diseases.”

Force said the 10 patients with heart failure were taking Gleevec at the University of Texas’ M.D. Anderson Cancer Center in Houston and had no heart problems before going on the drug.

He said doctors took baseline measures of the patients’ left ventricular heart function and determined that heart failure developed in these patients between two months and 14 months after they began Gleevec.

Dr. Jean-Bernard Durand of M.D. Anderson discussed these cases with Force at a meeting and suggested they try to determine the cause of this problem, Force said.

Gleevec targets three specific proteins, including one called ABL.

In chronic myelogenous leukemia, genes known as ABL and BCR become fused and produce a hybrid BCR-ABL enzyme that is always active. The overactive BCR-ABL, in turn, drives the excessive proliferation of white blood cells that is the hallmark of leukemia.

Using viruses that produced for normal ABL and a Gleevec-resistant mutant in laboratory studies and in mice, the researchers found that Gleevec inhibited the normal enzyme but not the mutant, and the mutant ABL “rescued” heart cells from the toxic effects of Gleevec.

The research was supported by the National Heart, Lung and Blood Institute, the Leukemia and Lymphoma Society, the Finnish Heart Foundation and the Paavo Nurmi Foundation.

FDA and Merck Collaborate to Mislead Public About Fatal Risks with Vioxx

Sunday, July 23rd, 2006

There have been recent allegations that a federal health official worked with the drug maker, Merck, to discredit a government whistleblower that exposed the potentially fatal risks associated with the painkiller Vioxx. The allegations came from Sen. Charles Grassley, R-Iowa, who is now overseeing an investigation into the matter.

Sen. Grassley asked the inspector general at the Health and Human Services Department to probe whether the Food and Drug Administration and Merck acted together to call into question the safety findings made by Dr. David Graham, an FDA drug safety official.

In a letter on Wednesday, Grassley cited handwritten notes made by the Merck employee documenting an October 13, 2004 conversation with the FDA official that suggests the two collaborated.

According to the notes quoted in the letter, the FDA official mentioned an “opportunity to get (the) message out” on Graham, a longtime employee of the agency, and provide journalists with a company critique on him.

According to Grassley in the letter to Inspector General Daniel Levinson, “It is no secret that Dr. Graham was and is a critic of the FDA. However, that does not mean the FDA should scheme with drug sponsors to discredit its own employees.” Grassley said, the FDA must maintain a “clear, bright line between the related and the regulator.”

The spokesperson for the FDA, Susan Bro, had no comment on the issue.

In a statement, Merck & Co, Inc. said that it has the right to express their views when they believe information others have presented is not “fair and balanced”. Merck said, “Dr. Graham’s conclusions with regard to Vioxx differed from those of the FDA and to that extent, the FDA and Merck separately expressed their scientific views to the public and scientific community.”

In September 2004, Merck announced the voluntary withdrawal of Vioxx, citing a study that revealed the pain medication could double the risk of a stroke or heart attack if taken for 18 months or longer.

Two months later, Graham testified before a Senate committee that the FDA fumbled the handling of Vioxx, and mishandled safety problems with five other commonly used drugs on the market. The FDA defended its oversight of Vioxx before the hearing; an agency official later dismissed Graham’s research as “junk science.”

The following month, 22 members of Congress signed a letter requesting the FDA to investigate the “smear campaign” against him.

Merck is now facing more than 16,000 Vioxx-related lawsuits.

The meeting mentioned by Grassley took place two weeks after the drug was withdrawn.

The Associated Press viewed FDA e-mails indicating that the agency shared in advance with Merck details about a presentation that Graham was to make in France in August 2004 about the dangers of Vioxx. The e-mails suggested that such practice was commonplace.

Merck then issued a statement indicating that it stood by the safety of Vioxx. At the time, an FDA spokesperson said removing Vioxx was “not on the table”.

The notes obtained by Grassley indicate the FDA later went even further in helping Merck rebut Graham’s work.

According to the notes which were admitted as evidence in a federal Vioxx trial, the FDA’s Dr. Brian Harvey suggested to Merck’s Dr. Ned Braunstein “an official rebuttal on Graham.”

Graham said he was “quite shocked” to learn about Braunstein’s notes.

On May 9, 2006 during a sworn deposition, Graham said, “This actually demonstrates more clearly just how widespread the organized campaign to discredit and smear me was.”

Attorneys for Merck have sought to keep portions of the deposition from jurors, saying they go beyond what Graham has previously said.

Workers’ Comp To Pay $52 Million In Lawsuit

Sunday, July 23rd, 2006
The Ohio state insurance fund for injured workers said yesterday that it will pay $52 million to workers hurt on the job who won a class-action lawsuit that accused the agency of wrongly taking back payments for their injuries. 

About 7,900 workers will receive the reimbursement for money taken under 1993 and 1995 laws that were later declared unconstitutional by the state Supreme Court.

Judge Michael Donnelly, of Cuyahoga County Common Pleas Court, approved the payment process yesterday after the Bureau of Workers’ Compensation decided to drop further appeals. The bureau lost its case against the workers in December 2004.

William Mabe, the bureau’s new administrator, decided that appealing the ruling was not appropriate, given the agency’s attempts to rebuild trust after an investment scandal that rocked the agency.

The decision “comes down to doing the right thing,” Mabe said.

“Without question, we must be responsible and fair as we build a more equitable workers’ compensation system for Ohio’s employers and injured workers,” he said. “Returning these moneys is another step in that direction.”

The bureau had argued that workers should not have been paid twice for the same injury: once by the state, once by insurance companies.

The bureau’s decision to pay is a victory for thousands of workers “who finally after a seven-year-long legal fight will see a return of their funds that had been unlawfully collected,” said lead attorney Craig Bashein.

Paying out the $52 million comes at a difficult time for the workers’ comp agency, still reeling from the scandal that erupted in April 2005 over unorthodox investments in rare coins and other collectibles and included a $215 million hedgefund loss.

Two years ago, the bureau said it didn’t expect to pay anywhere close to the $52 million it now will distribute.

However, the agency says the repayment won’t hurt its finances because it began setting aside money earlier this year.

A fact sheet about the payment obtained by the Associated Press says workers eligible for the reimbursement will receive 70 percent of what the bureau took from them. The other 30 percent — or about $15.6 million — will go to fees for the workers’ attorneys.

Bashein said the money will be shared by a dozen lawyers at five different firms. He said the fees also will help cover the cost of a court-appointed administrator hired to distribute the money.

In 2001, the Ohio Supreme Court declared a portion of the law allowing the bureau to demand the reimbursement unconstitutional.

In 2004, the court again ruled in favor of injured workers suing over the money, saying the claim belonged in a Common Pleas court, not the Columbus-based Ohio Court of Claims.

The case was named for a Cleveland man who received both state benefits and an insurance payment for a workrelated injury.

Angel Santos had received $121,941 in benefits from the Bureau of Workers’ Compensation and $500,000 more in a settlement with his employer after he lost three fingers on his left hand in 1997 when he accidentally triggered a stamping machine.

Santos sued after the bureau sought to collect the money it paid.


California Appeals Court Affirms $30 Million Award in Seat-Belt Case

Sunday, July 23rd, 2006

A California state appeals court has affirmed a $30 million verdict against Ford Motor Co. in a seat-belt-defect case, rejecting the automaker’s contention that the trial judge should not have barred certain issues and evidence.

The panel said evidence- and issue-preclusion sanctions against Ford for discovery violations were properly applied in jury instructions, evidentiary rulings and the plaintiff’s arguments.

According to the trial record, Johan Karlsson, then 5, suffered a broken spine and was rendered paraplegic in 1996 when the 1996 Ford Windstar minivan in which he was riding struck a 15-ton steel coil that fell off the back of a tractor-trailer onto an interstate highway.

Johan’s mother, uncle and four siblings were also in the van.

The Karlssons sued the truck driver and his employer, TransContinental Transport, which cross-complained against Ford, alleging the Windstar’s defective design contributed to Johan’s injuries. The Karlssons eventually added Ford as a defendant, alleging claims of design defect and failure to warn against the auto manufacturer.

The van had lap belts and shoulder harnesses for all seats but the third row center, where Johan was riding. At that position, there was only a lap belt.

Johan’s spinal injuries were consistent with having jackknifed over at the waist, the plaintiffs claimed, arguing that had he been wearing a three-point restraint, his injuries would have been far less severe.

The trucking company settled with the Karlssons for $10 million.

Before trial in the Los Angeles County Superior Court, the judge ruled that Ford could not offer evidence on warnings and the technical feasibility of a safer, alternative seat belt design, citing the automaker’s failure to timely provide answers to discovery requests.

The jury awarded Johan nearly $10.5 million in economic damages, $20 million for pain and suffering, and $15 million in punitive damages. The parties agreed to reduce the total damages to $30.3 million, factoring in the comparative fault and settlement of TCT.

Affirming, the state’s 2d District Court of Appeal said the sanctions excluding Ford’s evidence were, for the most part, properly applied and that any errors by the judge were harmless.

Boy Killed by Falling Mirror in Wal-Mart

Sunday, July 23rd, 2006

INDIANAPOLIS (July 23) A mirror at a store fell on a 3-year-old boy, killing him, officials said.

Christopher Antonio was apparently playing near the 5-foot-tall floor-mounted mirror in the children’s section of a Wal-Mart when it fell Saturday.

The toddler was likely killed by the blunt force of the crash, said Marion County Sheriff’s Lt. Michael DeHart.

“The mother was approximately 5 feet away from the child when she heard a loud crash,” DeHart said. The boy’s 5-year-old sister was also at the store, deputies said.

His mother and another shopper pulled the mirror off the boy, DeHart said.

Wal-Mart was cooperating with investigators, said Jolanda Stewart, spokeswoman for Bentonville, Ark.-based Wal-Mart Stores Inc.

“Our thoughts and prayers are with the family and the matter is under investigation,” she said.

FDA Reform Still On Hold

Friday, July 21st, 2006

It has been almost two years since Congress was asked to consider implementing stronger drug safety procedures. The proposed changes would include reforming the FDA’s handling of Vioxx and other heavily marketed pain medications that studies have linked to deaths, heart attacks and strokes.

It has been reported that Congress has refused to consider any of the proposals to reform the FDA due to the fact that congressional members are too comfortably involved with the pharmaceutical industry.

Drug giant Merck, maker of Vioxx, pulled the painkiller from the market in 2004. Shortly thereafter, the FDA ordered Pfizer to withdraw its arthritis medicine Bextra, requiring that more warnings be put on the pain pills.

Reform of the manner in which the FDA approves and distributes new drugs to the public is crucial. In 2005 a public hearing was held to create an independent drug safety center within the FDA. Under this bill, if a drug turned out to have safety problems the center could restrict distribution, require labeling changes or even withdraw its approval.

A Wall Street Journal Online/Harris Interactive poll released in May 2006 revealed that on 36 percent of the public thinks the FDA is doing a good job, down from 56 percent in 2004. The poll also found that 80 percent of the public has concerns about the FDA’s ability to make independent decisions regarding the safety of medications.

The pharmaceutical industry, in response to deteriorating levels of public confidence, has adopted voluntary guidelines for direct-to-consumers advertisements of prescription drugs. Further to this effort Bristol-Myers Squibb recently imposed a ban on advertising its drugs to consumers during their first year on the market.

The spotlight needs to remain on the weaknesses in the FDA that have already caused tens of thousands of people to die needlessly because of inadequately tested drugs that are too aggressively advertised.

1.5 Million Injured Annually by Drug Errors

Friday, July 21st, 2006

A report issued yesterday by the Institute of Medicine said that medication errors injure or kill at least 1.5 million Americans every year – a number that amounts to one mistake per hospital per day.

The most common drug errors are caused by name confusion, wrong doses, and various other problems. In 1999, the institute reported that 98,000 deaths a year are caused by medical errors, with at least 7,000 a result of medication mistakes.

“We were initially quite surprised by the number of mistakes, but the more we heard, the more convinced we were that these are actually serious underestimates,” said Dr. Kevin Johnson of Vanderbilt University.

A Treatment Tragedy

The report cited the story of Boston Globe health reporter Betsy Lehman, a 39-year-old mother of two who was being treated for breast cancer at the Dana-Farber Cancer Institute in 1994.

Farber received an overwhelming dose of cancer drugs when a nurse administered in one day the total amount she was supposed to receive over a period of four days. The staff paid no attention to Farber’s complaints about the effects of the overdose, and she ended up dying.

Recommendations for Improvement

In light of the evidence, researchers have made several recommendations for new risk-minimizing medication procedures. The recommendations specifically emphasize computerized prescribing, administration, and data acquisition procedures.

“The current process by which medications are prescribed, dispensed, administered and monitored is characterized by many serious problems that threaten both the safety and positive outcomes of patients,” said panel co-chairman J. Lyle Bootman of the University of Arizona College of Pharmacy.

Of the 1.5 million drug mistakes made annually, an estimated 400,000 are preventable. More than 4 billion prescriptions are written each year in the United States, with most errors associated with insulin, morphine, potassium chloride, and certain anticoagulants.

Allergic Reaction To Codeine Was Proximate Cause Of Death: Plaintiff

Friday, July 21st, 2006

On June 9, 2002 plaintiff’s decedent Robert Earl Long Sr., 62, disabled, was admitted to Capital Regional Medical Center in Tallahassee. On the third day of his hospitalization Long complained of pain in his back and right side. His treating physician administered to him Fioricet with codeine. About two hours later, Long Sr. complained that he could not breathe and clutched his chest. Doctors responded but Long soon died.On behalf of Long’s estate, his son sued Tallahassee Medical Center, Inc., operating as Capital Regional Medical Center, for medical malpractice, seeking wrongful death damages. The estate’s attorney contended that the doctors knew that Long was allergic to codeine. He offered the testimony of his wife who claimed that she explicitly informed Long’s physicians of this well before he was administered the drug.Plaintiff’s expert, Lori Black, a registered nurse, testified that codeine would be harmful given Long’s medical records which indicated he sometimes suffered from itching as a mild reaction to codeine. She also criticized the way the Capital maintained its medical records.

The estate’s attorney alleged that the physician administering Codeine was the proximate cause of Long’s death. Plaintiff’s pathology expert, Carl Williams, testified that Long died of a delayed reaction to Codeine.

Capital claimed that it was appropriate to administer codeine to Long. Treating nurses who monitored him an hour before he died testified that he appeared fine. Defense counsel also offered testimony from Long’s treating physician that Long did not mention any allergic reactions to codeine when he took his history. Defense nursing expert Cindy Stuart testified that Long’s treating nurses were correct in relying on his statements that he was not allergic to Codeine.

Defense counsel argued that the codeine was not the proximate cause of Long’s death, but rather it was his preexisting cardiac condition, which included a valve replacement, that was the cause of death. Defense cardiology expert Hall Whitworth testified that Long had preexisting artery disease placing him at risk for sudden death independent of any codeine usage. Defense pharmacology expert Paul Doering testified that Long did not present the signs of a codeine allergic reaction such as redness in the face, sweating and trouble breathing. He added that such a reaction would occur immediately, not two hours later.

Defense counsel also presented testimony that detailed Long’s autopsy, which revealed the Long had a 90% occlusion of the left anterior descending coronary artery, thickened heart wall muscle and an enlarged heart. And on cross-examination of the plaintiff’s pathology expert, Carl Williams, defense counsel noted Williams’ lack of experiencedealing with allergic reactions of this manner.

Long died on his third day of hospitalization. On behalf of his estate, his son, Kristopher Long, 20, sought wrongful death damages. During summation, plaintiff’s counsel suggested an award in the range of $500,000 to $1 million.

The jury found that the hospital was not liable.

The plaintiffs are appealing the verdict.

 

Firestone Tires Recall Linked To Recent Deaths

Friday, July 21st, 2006

ATLANTA (CNN) — Firestone announced a renewed recall effort Friday for its radial tires, mainly spares, still remaining on the Ford Explorer and similar SUVs from the 1990s.

The action followed talks with the federal highway safety agency after a complaint about recent deaths and injuries in rollovers involving SUVs, often bought used, that had older Firestone spare tires.

Firestone said it will send letters to owners of Ford Explorers, Mercury Mountaineers or Mazda Navajos made prior to the 2000 model year. Mazda, like Mercury, is part of the Ford Motor Co. (See details on www.Firestone.com)

Six years ago, Firestone recalled an estimated 6.5 million of its Radial ATX and Wilderness AT tires after numerous rollover deaths.

Firestone says 6.3 million tires were replaced, making it the most successful recall ever. But independent safety consultant Sean Kane said as many as 200,000 were missed for a number of reasons. For example, Kane said, substitute tires were often scarce or owners simply didn’t think about turning in the spares.

On the Explorer and some other Ford SUVs, the spare is attached to the undercarriage of the vehicle, and an owner would need to crawl under it to be able to read the brand name.

In a letter to the National Highway Traffic Safety Administration, Kane listed these accidents, among others:

– Michael Enriquez, 28, of Deltona, Fla., was permanently paralyzed when his 1993 Ford Explorer rolled over and slid upside-down into an oncoming car near Orlando in May 2005. The other driver was killed. Witnesses told police the tread came off Enriquez’ right rear tire. It was a Firestone made 12 years earlier. The Florida Highway Patrol cited the tread separation as the cause of the crash.

– An 11-year-old boy, William Moreno of Duarte, Calif., was killed this May when his family’s 1994 Ford Explorer overturned and rolled down a hill beside Interstate 15 in Riverside County. Another driver told the California Highway Patrol “he saw the tire tread come off the left rear tire.”

– In June two years ago, Anthony Scudera, 20, of Sunrise, Fla., noticed a leak in a rear tire while washing his mother’s 1993 Ford Explorer. He replaced the tire with the spare, which was an older Firestone. Just three days later, as Scudera was driving to work on Interstate 75, the Florida Highway Patrol said, he had a right rear blowout and rolled over. Scudera, who was not wearing a seat belt, was ejected and killed.

“I had no idea how dangerous that tire was,” his mother, Linda Scudera, told CNN. “The treads peeled completely off the tire, my car went out of control. My son didn’t even have a chance.”

Both Mrs. Scudera and Michael Enriquez are suing Firestone. The company denies any responsibility for those accidents and, in each case, blames the drivers.

A Firestone spokesperson told CNN it wants to get all pre-2000 tires off the SUVs. “Bring them into a company-owned store and we will replace them,” she said. “No questions asked. Free of charge. It is in everyone’s interest to get those tires off the road.”

Firestone said it is also writing all its dealers to remind them to check their customers’ spare tires and to replace any tire that is outdated.

The 2000 recall covered all Radial ATX tires in the size P235/75R15 and certain Wilderness AT tires in the same size that were made at Firestone’s since-closed plant in Decatur, Illinois. A Wilderness AT tire made in Decatur is identified by the letters VD at the beginning of the 10-digit code found on the side of the tire, Firestone said.

A second replacement program in 2001 covered other Wilderness AT tires in either size P235/75R15 or P255/70R16 made from 1994 through May 1998. If the 10-digit code ends with the number 4, 5, 6 or 7, that size Wilderness tire was made in 1994-97. If the last number is 8 and the two numbers before it are anywhere from 01 to 18, then that tire was made in those first months of 1998, according to Firestone.

In a random test, NHTSA recently checked a number of older Ford SUVs in the Washington, D.C., area and found up to 10 percent still carrying the older Firestones as spares, even though they should have been replaced long ago.

On its Web site, Ford Motor Co. recommends all tires, including the spare, be replaced after six years, regardless of which brand they may be.

Kane said that even if spares look brand new, older tires can suffer from aging. “These are bad tires that are now worse,” he said.

By CNN’s Drew Griffin and James Polk