11/05/2012

'Fringe' treatment stuns cardiologists

Chelation therapy is an alternative treatment for heart disease.
Chelation therapy is an alternative treatment for heart disease.
  • Chelation therapy for heart patients involves a series of IV drug infusions
  • A new study shows the therapy was effective at preventing heart problems
  • But some experts are challenging the validity of the study and its results
  • The study "raises more questions that must be answered," says one expert

(CNN) -- In results that are stunning cardiologists, a new study shows a "fringe" alternative treatment for heart disease was found to be very effective at preventing heart problems -- but the report is so controversial even its lead author is questioning the results.

The patients in the study had had heart attacks, and were assigned to receive either a placebo or a series of intravenous drug infusions called chelation therapy, an unorthodox treatment that has long been looked down upon by cardiologists.

In the report -- the first large, long-term trial of chelation for heart patients -- the therapy reduced the risk of heart attacks, deaths, strokes and other cardiovascular problems by 18%.

"If this were true, it would be significant. It would put this therapy in the same ballpark as high blood pressure drugs, or drugs used to lower cholesterol," said Dr. Steven Nissen, chair of the department of cardiovascular medicine at the Cleveland Clinic, who doubts the results of the study.

A doctor with the American Heart Association warned that the results "should not be interpreted as an indication to adopt chelation therapy into clinical practice."

"(The study) raises more questions that must be answered before we're ready to act on the observations reported today," said Dr. Elliott Antman, professor of medicine at Harvard Medical School.

Even the lead author of the study tempered his enthusiasm about the results by warning that they might not be valid.

"The most exciting part of this study is that there may be an unexpected signal of benefit," Dr. Gervasio Lamas, chief of Columbia University Division of Cardiology at Mount Sinai Medical Center in Miami Beach, Florida, said in a press release put out by the American Heart Association. "We need to understand whether the signal is true, or whether it occurred by chance."

Safety concerns

Doctors who practice chelation welcomed the new study results, which were announced at the American Heart Association's annual meeting in Los Angeles.

Helping in a cardiac emergency

These doctors believe chelation can help remove heavy metals from the body. Chelation is approved by the Food and Drug Administration for the treatment of lead poisoning, but doctors are free to use it for other purposes.

"I'll be pushing this data to my patients, and I'll be reaching out to local cardiologists, because chelation should be a part of the regular regimen for heart patients, like taking an aspirin or a statin," said Dr. Kirti Kalidas, who charges his heart patients in Orlando, Florida, around $3,000 for a full round of chelation treatments.

This enthusiasm is exactly what frightens many doctors. Chelation is already popular -- more than 100,000 people said they'd used it in the past 12 months, according to a 2007 report from the Centers for Disease Control and Prevention -- and they fear the new study results will encourage more people to use it.

In 2006, the CDC reported that two children and one adult had died after receiving chelation. They all developed dangerously low calcium levels, which can cause the heart to stop beating.

In this new study, one patient receiving the therapy died and another had a "severe adverse event." Both events were "possibly or definitely related to study therapy," according to the study author's slide presentation. A patient who received a placebo solution also died, and another had an adverse event.

It wasn't clear from the presentation exactly how the patients were harmed, and Lamas, the lead study author, declined to answer questions about the study until the research is published in a medical journal.

Some doctors worry patients will hear only the positive results of the study and not the possible dangers, and would opt for it over proven treatments such as bypass surgery.

"I'm fearful that patients will hear the sales pitch for this treatment and, not being well-versed in medicine, will succumb to the seduction of this therapy," said Nissen, adding that chelation might sound more appealing than an invasive procedure like bypass surgery.

Dr. Kimball Atwood agrees. In an article about the chelation trial, Atwood and his colleagues labeled the $30 million study funded at taxpayer expense by the federal National Institutes of Health "unethical, dangerous, pointless, and wasteful" and called for it to be abandoned.

"These new study results will encourage chelationists, and state medical boards will be loathe to step in because the chelationists have this study on their side," said Atwood, a clinical assistant professor of anesthesiology at Tufts Medical Center.

"Every now and then somebody will get killed," he added.

Kalidas, the doctor who practices chelation, disagreed, saying this study would help -- not hurt -- patients.

"Chelation has been lifesaving for hundreds of my patients," he said.

Dangerously low calcium levels

According to the Mayo Clinic, some doctors think chelation helps heart patients because the medication being infused into patients binds to calcium in their clogged arteries, sweeping it away.

But "sweeping" calcium away is a double-edged sword. While it might help unclog coronary arteries, it might also lead to deadly low calcium levels in the blood, as happened to the three people whose deaths were described in the CDC report.

That's one reason why the National Institutes of Health required that the infusions be done at a slow rate -- over a period of three hours or more -- so problems like low calcium levels could be caught easily.

In a series of letters to the study's authors, the Department of Health and Human Service's Office for Human Research Protection cited several concerns about the study, including that the researchers hadn't followed the rules about doing the infusions at a slow rate.

In one letter, the government overseers expressed concern that infusions were performed in "shorter than recommended" times in 440 instances, involving 251 subjects.

The study was stopped from September 2008 until June 2009 to respond to the government's concerns.

A question of significance

In addition to possible safety problems, there are concerns that the study was poorly done and doesn't actually show that chelation works.

In the study, researchers divided the patients into two groups. One group of 839 patients received 40 infusions of a chemical drug solution called disodium EDTA.

Another group of 869 patients received infusions with a placebo solution of salt and sugar water. Neither the patients nor the doctors knew who was receiving which treatment.

Among the patients receiving chelation, 26% went on to have a cardiovascular event, such as death, heart attack or stroke. Among the placebo group, 30% went on to have a cardiovascular event.

According to the authors' analysis, this four-percentage-point difference was barely statistically significant, leading Lamas to note that the difference may have been by chance, not because chelation actually worked.

Further watering down the report is the fact that a relatively large number of patients -- 17% -- dropped out of the study.

Experts say patients usually drop out of studies when things aren't going well -- when they're having bad side effects, for example, or when the therapy isn't working. But since they dropped out, their results can't be included in the study.

"This study was so badly done and the results are so marginal from a statistical perspective that this therapy can't be recommended," said Nissen, the Cleveland Clinic cardiologist.

"Making a treatment decision about a life-threatening disease based on poor-quality scientific data can be dangerous," he added. "History has taught us that when this happens, considerable harm can come to patients."

The future of chelation

Kalidas, the chelation practitioner in Florida, said he hopes these new study results will help persuade insurance companies to start paying for chelation.

But insurance companies usually only pay for treatments that are FDA approved -- and there's little chance the FDA would approve chelation for heart disease based on this study, experts say.

"This would never pass muster at the FDA," said Nissen, the former chairman of the FDA advisory panel that examines applications to put new heart drugs on the market.

Substitute teacher: 14-year-old got me pregnant

By Sevil Omer, NBC News

A 35-year-old Texas woman accused of having sex with a 14-year-old boy and then claiming to be pregnant from the relationship may have worked as a substitute teacher at least once in the boy's classroom, a school official said.

Bexar County Sheriff's Office

Amanda Sotelo, a resident of Von Ormy, was booked into a Bexar County jail on Nov. 1 on a charge of indecency with a child, according to KSAT-TV in San Antonio. Bond was set at $75,000.

Attempts by NBC News to reach officials at Bexar County Sheriff's Office were not successful Monday.


School district officials learned of the allegations Oct. 31 after the boy's mother alerted them of the relationship, Anne Marie Espinoza, spokeswoman for the Southwest Independent School District in San Antonio, told KSAT-TV.

KSAT-TV account of the arrest warrant:

Sotelo told them she and the teen would meet in her home, at first, to discuss their problems. The relationship, she said, turned sexual in July, with them having sex about once a week.

Sotelo said she learned she was pregnant during a visit to a hospital emergency room in early September.

"She's in jail but that's about the only thing we've heard. We've got a lot of family problems going on right now," Johnny Lopez, Sotelo's son-in-law, told KSAT.com.

Lopez said Sotelo is married, and her husband was out of town. They have other children.

Watch US News crime videos on NBCNews.com 

Espinoza confirmed that Sotelo had worked as a substitute in several of the district's schools, and possibly, substituted at least once in the boy's classroom, KSAT.com reported.

Esponiza told NBC News district officials refused to further comment.

"The district learned of an allegation of inappropriate behavior of a substitute with a high school student," said the district in a emailed statement. "The district immediately took appropriate actions to ensure the substitute was not on any campus pending an investigation. The district made contact with appropriate agencies including law enforcement. The substitute is no longer employed by the district."

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N.J. lets Sandy victims vote via e-mail

Critics argue that Internet-based voting systems are vulnerable to hacking and other security risks.
Critics argue that Internet-based voting systems are vulnerable to hacking and other security risks.
  • New Jersey residents displaced by Superstorm Sandy will be allowed to vote via e-mail
  • Residents must first submit a ballot application by e-mail or fax to their county clerk
  • Critics argue that Internet-based voting systems pose security risks

(CNN) -- New Jersey residents displaced by Superstorm Sandy will be allowed to vote in Tuesday's elections via e-mail or fax, the first time civilians in the state have been allowed to vote remotely.

Despite some security concerns, the state announced the change to make it easier for voters who may have been forced by flooding, power outages or other storm damage to temporarily leave their communities. The directive also is intended to help emergency workers who are busy with disaster-relief efforts away from home.

Find your polling place

Under the New Jersey directive, displaced storm victims qualify as "overseas voters," meaning they are eligible to vote remotely. To vote electronically, residents first must submit a ballot application by e-mail or fax to their county clerk. Once the application is approved, the clerk will e-mail or fax a ballot to the voter, who must send it back no later than Tuesday at 8 p.m. ET.

In many states, remote electronic voting is already available to members of the military and U.S. citizens living overseas, but this marks the first time that civilian residents in New Jersey have been permitted to vote via e-mail.

Sandy's effect on the election
Sandy's impact on Election Day

"This has been an extraordinary storm that has created unthinkable destruction across our state, and we know many people have questions about how and where to cast their vote in Tuesday's election," said Lt. Gov. Kim Guadagno in a statement. "To help alleviate pressure on polling places, we encourage voters to either use electronic voting or the extended hours at county offices to cast their vote."

How secure is your electronic vote?

In recent years, as Americans have grown used to banking, shopping and socializing online, many have wondered why they can't vote online as well. Canada, Sweden, Latvia and Switzerland all have experimented with Internet voting, and Estonia has allowed online voting for all of its citizens since 2007.

But many critics argue that Internet-based voting systems are vulnerable to hacking. Critics also worry that electronic voting leaves no paper trail, making it more difficult to determine whether there has been tampering, or some other irregularity, in a close election.

That may not be an issue in the presidential race in New Jersey, where President Barack Obama has maintained a comfortable lead over GOP challenger Gov. Mitt Romney in most polls.

"Does e-mail voting make sense for New Jersey during this emergency? It's hard to say one way or the other without a lot more information than has been released so far about how the system will work and how it will be secured," wrote computer-security expert Matt Blaze in a blog post.

"The security implications of voting by e-mail are, under normal conditions, more than sufficient to make any computer security specialist recoil in horror," he added. "E-mail, of course, is not at all authenticated, reliable, or confidential, and that by itself opens the door to new forms of election mischief that would be far more difficult in a traditional in-person polling station or with paper absentee ballots."

In their announcement of the new directive, New Jersey officials did not explain how they will authenticate e-mails or faxes from voters. A call to Guadagno's office seeking more details was not immediately returned.

New Jersey residents can find contact information for their county clerk at the New Jersey Division of Elections website.

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How astronauts cast ballots from space

Call it the ultimate absentee ballot. NASA astronauts aboard the International Space Station have the option of voting in Tuesday's presidential election from orbit, hundreds of miles above their nearest polling location.

Astronauts residing on the orbiting lab receive a digital version of their ballot, which is beamed up by Mission Control at the agency's Johnson Space Center (JSC) in Houston. Filled-out ballots find their way back down to Earth along the same path.

"They send it back to Mission Control," said NASA spokesman Jay Bolden of JSC. "It's a secure ballot that is then sent directly to the voting authorities."

This system was made possible by a 1997 bill passed by Texas legislators (nearly all NASA astronauts live in or around Houston). It was first used that same year by David Wolf, who happened to be aboard Russia's Mir space station at the time.

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"You think about being in a foreign country and voting — he was actually on a foreign space station," Bolden told Space.com.

Wolf participated in a local election in 1997. The first American to vote in a presidential election from space was Leroy Chiao, who did it while commanding the International Space Station 's Expedition 10 mission in 2004. (The first crew arrived at the $100 billion orbiting lab in November 2000.)

The station's current Expedition 33 counts two Americans among its six-person crew — commander Sunita Williams and flight engineer Kevin Ford. But both of them have already had their say in Tuesday's presidential election, voting from Earth just like the rest of us.

"They actually both did it while they were stationed in Russia, before they launched," Bolden said.

Williams and Ford both rode to orbit aboard Russian Soyuz spacecraft, which launch from Baikonur Cosmodrome in Kazakhstan. Williams blasted off in mid-July, while Ford launched Oct. 23.

Williams is slated to return to Earth on Nov. 12. When she departs, Ford will become commander of the new Expedition 34 mission, which runs through March 2013. 

Follow Space.com senior writer Mike Wall on Twitter @michaeldwall or Space.com @Spacedotcom. We're also on Facebook and Google+.

© 2012 Space.com. All rights reserved. More from Space.com.

Report: 'Whitey' Bulger hospitalized for chest pains

AP Photo/WBUR 90.

This booking photograph shows Boston mob boss James "Whitey" Bulger.

By NBC News staff and wire services

Mobster James "Whitey" Bulger was taken to a Boston hospital Sunday after complaining of chest pains at the prison where he is awaiting trial for his alleged role in 19 murders, local media reported.

Bulger, 83, the former leader of the Winter Hill Gang, was hospitalized Sunday for chest pains at Boston Medical Center, according to The Boston Globe.

Plymouth Fire Department battalion chief Kevin Murphy told The Globe that firefighters responded to the Plymouth County Correctional Facility at 1:48 a.m. Sunday and took Bulger to the hospital.

WBUR-FM in Boston first reported that Bulger was hospitalized for chest pains, citing unnamed law enforcement sources.

According to NBC affiliate WHDH in Boston, security has been heightened at the medical center, and Massachusetts State Corrections officers are working in shifts during Bulger's stay. U.S. marshals are also at the site guarding Bulger, WHDH reported.

"Maybe he's trying to get a rest, get out of the jail cell for a while," a local resident told WHDH.

A Boston Medical Center representative refused to comment on the hospital's public safety plans, WHDH said.

The U.S. attorney's office, the U.S. Marshals Service, and Bulger attorney Hank Brennan declined to comment.


Bulger's trial is scheduled to begin in March, but his lawyers have said they cannot be ready by then because they are reviewing more than 300,000 documents turned over by prosecutors. Last week, they asked that the trial be moved to November 2013.

Whitey Bulger was often seen around Santa Monica, Calif. and took frequent trips to Mexico while evading the FBI. But after 16 years on the run, he's adjusting to life behind bars. NBC's Miguel Almaguer reports.

Bulger's lawyers said in court papers filed Friday that the current trial date infringes on Bulger's constitutional rights to effective counsel and due process.

Bulger's lead attorney, J.W. Carney Jr., has repeatedly complained that prosecutors have turned over documents in a disorganized fashion. Prosecutors have accused Carney of using stall tactics.

Whitey Bulger's lover gets 8 years in prison

Bulger fled Boston in 1994 and was captured last year in Santa Monica, Calif.

The defense says Bulger was an FBI informant who had immunity to commit crimes while he was providing information about the Mafia, his gang's main rival. In court papers filed this week, Carney identified former U.S. Attorney Jeremiah O'Sullivan as the federal official Bulger claims gave him immunity. O'Sullivan died in 2009.

Prosecutors say Bulger never received immunity from anyone.

The Associated Press contributed to this report.

Boston Police Department via EPA

A Boston Police booking image dated March 16,1953, of James 'Whitey' Bulger.

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Small earthquake rattles storm-stricken New Jersey

By NBC News staff and wire reports

A small earthquake hit northern New Jersey early Monday morning, the U.S. Geological Survey reported. 

The magnitude 2.0 temblor struck at 1:19 a.m. and was centered in Ringwood, N.J., a community that's still reeling from downed trees and power outages caused by Superstorm Sandy.

Geophysicist Jessica Turner at the National Earthquake Information Center said some people reported hearing a loud boom in their homes, according to The Associated Press. Turner said those on upper floors of a home may have felt shaking or saw objects on walls vibrate. 

The quake was 3 miles below ground and could also be felt in Wanaque, Oakland, Franklin Lakes, West Milford and Peterson.

Ringwood police said there are no reports of damage in the area, the Associated Press reported.

The last recorded earthquake in New Jersey struck in February 2010 and measured 2.2 magnitude, Turner said. 

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'Duck!' Home video shows plane hitting top of SUV

View more videos at: http://nbcdfw.com.

By Amanda Guerra, NBCDFW.com

A pilot involved in a crash where his plane landed on top of an SUV has released home video of the crash.

William Davis was trying to land a 2005 Cessna Skyhawk plane at the Northwest Regional Airport in Roanoke, Texas, on Saturday when he clipped an SUV on the runway.

Meanwhile, his wife was filming the landing.

In the video, you can see the plane coming in, when just seconds before it crosses a road, a black SUV drives underneath it, causing the plane to nearly peel off the SUV's roof.

The crash sent debris flying, including the plane's landing gear. The plane took a sharp nose-dive into the ground.

The couple in the car, identified by DPS as Frank and Heather Laudo of Flower Mound, were taken to the hospital with non-life threatening injuries.

On Saturday, the couple talked to NBC 5 about the incident.

"I saw it about a second before it hit us. I was opening my mouth to go 'duck!'," Frank Laudo said. "The next thing you know there's shattering."

"It it was kind of like a hawk with it's talons coming up and scooping the car," Heather Laudo said. "And the talons breaking off."

Right now it is unclear why the car was on the runway.

The Federal Aviation Administration is investigating.