Morales mum on Cuba trip after Chavez surgery

 Bolivian President Evo Morales made a lightning trip this weekend to Havana where ally Hugo Chavez is convalescing after cancer surgery, but was mostly silent Monday on the details of his trip or even whether he met with the ailing Venezuelan leader.
The secrecy surrounding his visit was sure to add to the uncertainty surrounding Chavez's condition, despite reassurances Monday from Venezuelan officials that the president was slowly improving.
The Venezuelan leader has not been seen or heard from since his Dec. 11 surgery. Venezuelan officials have given few specifics about his condition and have offered no information about his long-term prognosis.
Luis Vicente Leon, a pollster who heads the Venezuelan firm Datanalisis, said the government's daily but vague updates on the president's health seem designed to calm anxious Chavez supporters rather than keep the country fully informed. For government opponents, however, he said the updates likely raise more questions than they answer.
"It's more for the Chavez movement than the country in general," Leon said. "There's nothing that one can verify, and the credibility is almost nil."
Morales did not speak to the foreign media while in Havana. Journalists had been summoned to cover his arrival and departure, but hours later that invitation was canceled. No explanation was given, though it could have been due to confusion over Morales' itinerary as he apparently arrived later than initially scheduled.
Cuban state media published photos of President Raul Castro receiving Morales at the airport and said he came "to express his support" for Chavez, his close ally, but did not give further details.
At an event in southern Bolivia on Monday, Morales made no mention of his trip to Cuba, even though aides had told reporters that he might say something about Chavez's recovery. Later, Morales' communications minister did not respond directly to a question about whether the two South American presidents had met face-to-face, saying only that he "was with the people he wanted to be with" and had no plans to return to Cuba.
"The report that President Morales has given us is that Chavez is in a process of recovery after the terrible operation he underwent," Amanda Davila told The Associated Press.
Morales is the second Latin American leader to visit since Chavez announced two weeks ago that he would have the operation. Rafael Correa of Ecuador came calling the day of the surgery. Uruguay's Jose Mujica has expressed interest in making the trek.
The visits underscore Chavez's importance to regional allies as a prominent voice of the Latin American left, as well as how seriously they are taking his latest bout with cancer.
Chavez underwent his fourth cancer-related operation of the last year-and-a-half on Dec. 11, two months after winning reelection to a six-year term. Venezuelan officials say Chavez is stable and his recovery is progressing, though he was treated for a respiratory infection apparently due to the surgery.
If Chavez is unable to continue in office, the Venezuelan constitution calls for new elections to be held. Chavez has asked his followers to back his vice president and hand-picked successor, Nicolas Maduro, in that event.
In Caracas, Venezuelan Information Minister Ernesto Villegas read a statement Monday saying that Chavez is showing "a slight improvement with a progressive trend," is keeping up with events back home and sends Christmas greetings to Venezuelans.
Maduro and several Cabinet ministers attended a Christmas Eve Mass in Caracas to pray for the president. Maduro again assured Venezuelans that the president was recovering, though he and other officials continued to strongly suggest that Chavez would not return in time for his Jan. 10 inauguration.
Opposition leaders have argued that the constitution does not allow the president's swearing-in to be postponed, and say new elections should be called if Chavez is unable to take the oath on time.
But Attorney General Cilia Flores insisted the constitution lets the Supreme Court administer the oath of office at any time if the National Assembly is unable to do it Jan. 10 as scheduled.
"Those who are counting on that date, hoping to thwart the Revolution and the will of the people, will end up frustrated once again," Flores said. "What we have is a president who has been re-elected, he will take over, will be sworn in on that day, another day, that is a formality."
Jaqueline Farias, the head of government for the Caracas area, told the AP outside the church that "we are very happy because each hour the 'commandante' is showing signs that he is overcoming this phase of the operation, his fourth operation."
When asked if the president was breathing on his own, she said she didn't know and walked off, refusing to answer more questions.
Dozens of Chavez supporters gathered outside the church, some carrying posters of the president or wearing red T-shirts decorated with a photograph of just Chavez's eyes. Some women rushed to the church after seeing footage of the Mass on state television and yelled at security guards to let them inside.
"Chavez is going to be mad, if he sees this," said Andres Sanchez, an unemployed Chavez supporter watching a woman shouting at a guard that she wanted to pray for Chavez, too. "He told the ministers to talk to the people."
"Venezuela without Chavez is like a ship without a rudder," Sanchez said, his voice wobbling. "I pray to God that he recovers because he is a man who loves the people, the children, the elderly and everyone a little bit."

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Oregon Teen Loses Legs to Mystery Illness

An Oregon teen has lost both her legs to a mysterious infection, leaving doctors searching for answers.

Tabitha Schulke, an 18-year-old woman who wanted to devote her future to helping others as a missionary, is now fighting for her life in the critical care unit of a Portland Hospital.

The teen first started feeling ill on Thanksgiving morning, when she came down with flu-like symptoms, but in a strange turn of events, she quickly developed gangrene on her feet.

"They looked like she'd been out in the snow, like they turned black," Katie Zimmerman, the teen's aunt, told ABC News affiliate KATU.

The teen was taken to a nearby hospital, but her condition quickly worsened to the point that doctors felt there was little else to be done to save her.

"They told the family that she was going to die, that you need to come say goodbye," said Amber Shoebridge, public relations officer at Legacy Emanuel Medical Center, where the teen would later be transferred.

In a last-ditch effort, the hospital contacted Legacy Emanuel, requesting that they send an emergency team to set up "extracorporeal membrane oxygenation," technology that provides support to patients whose heart and lungs are so severely damaged that they no longer function properly.
PHOTO: Tabitha Schulke, 18, lost her legs to a mystery infection.
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PHOTO: Tabitha Schulke, 18, lost her legs to a mystery infection.
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Tabitha Schulke, 18, lost her legs to a mystery infection.
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But the gangrene continued to spread, forcing surgeons to amputate her legs near each knee.

Doctors still do not know what exactly has transformed Schulke from a healthy-appearing young teen into a critically ill patient fighting for her life.

Photographs of her, bruised and swollen, breathing from a ventilator appear nothing like the beautiful young teen taken prior to that Thanksgiving morning.

Signs point to toxic shock syndrome, a disease with a 50 percent chance of survival caused by certain types of Staphylococcus bacteria. The syndrome can often initially look like a flu infection, but can quickly worsen with high fevers, dangerously low blood pressure and organ failure.

The rare condition is sometimes seen after superficial skin wounds become infected or when cloth is packed in the nose to stop a common nosebleed. And about half of all cases occur in menstruating women or women using barrier contraceptive devices, according to the New York City Bureau of Communicable Disease.

"I recommend that women use pads," said Dr. Philip Tierno, an expert on toxic shock syndrome and director of clinical microbiology and immunology at New York University's Langone Medical Center. "Or use tampons from the health food stores that are 100 percent pure cotton."

Lab studies will confirm whether Schulke's infection was caused by toxic shock.

Although Schulke is still in critical condition, hospital staff are hopeful that she'll recover.

"She's improving very much so. She's a little more responsive than she had been," said Shoebridge.

But family members are still devastated by what has happened to this young vibrant woman.

"She's beautiful on the outside, but she's even more beautiful on the inside," Schulke's aunt, Katie Zimmerman, told ABC affiliate KATU.

For the family, "just her surviving, that's all that matters," said Zimmerman.

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Relationship Ranch: Horses Help Couples Heal Broken Hearts

It's fascinating to watch a man trying to win back the love of his life by talking to a horse.

Horse therapy has been used for decades to help treat people with physical disabilities or learning disorders, but now they are also being used in an unconventional form of couples counseling.

Nancy Hamilton and Lottie Grimes are marriage therapists who run Relationship Ranch in Louisville, Colo. They are convinced that horses can help feuding couples make peace.

"You wouldn't think they would have any role in marriage therapy," Hamilton said. "But because horses are so exquisitely sensitive, they can help us determine what a couple is actually, really feeling."

For three weekends, "Nightline" followed one couple's last-ditch effort to save their crumbling relationship and attended their equine therapy sessions.

Justin and Lyz, both 30 and never married, have been together for nine years and have two sons. But lately, they said, the bickering and fighting at home got so bad that Justin reluctantly agreed to move out.

"We have piled problem on top of problem on top of problem for years," Lyz said. "Who knows what's at the bottom of that?"

Although he was skeptical about the healing powers of horses, he said he was willing to try just about anything to make his family whole again.
PHOTO: Horses are being used in an unconventional form of couples counseling at a Colorado ranch.
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PHOTO: Horses are being used in an unconventional form of couples counseling at a Colorado ranch.
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Horses are being used in an unconventional form of couples counseling at a Colorado ranch.
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On their first day of therapy, the couple was introduced to the ranch's herd of horses. Justin was magnetically drawn to the newest and most aggressive horse, Danny, who came to the ranch after surviving a grizzly bear attack. Danny wasn't fitting in with the other horses, which hit home for Justin, who felt exiled from his own herd. Hamilton said horses can sense and read people's emotions.

"They're almost like a Rorschach projective test with a mane and a tail, where people can project onto them their feelings, their thoughts and their fears," she said.

Hamilton said she believes those fears can stem from what she called unresolved childhood wounds, which plague adult relationships. That was the case with Justin. When he was 9 years old, his sister was brutally murdered by an ex-boyfriend and young Justin saw the murder scene.

"He chased her down and cut her throat," he said. "We went back several days later and they hadn't cleaned anything up."

After working with Justin and Lyz, Hamilton said Lyz saw Justin as controlling, but those tendencies are rooted in his childhood trauma.

"Trauma survivors are very concerned with being able to control their present environment because they were not able to control their environment when they were traumatized," she said.

Hamilton had Justin go through a blind trust exercise with Danny to force Justin to surrender control to his partner. The goal was to expose Justin's old wounds. Hamilton instructed him to talk to Danny about what had happened when his sister was killed. Danny, the trauma-surviving horse, set the stage for a major breakthrough.

"It seemed so stupid at first, and then it was actually helpful," Justin said. "Therapeutic."

Watching Justin talk to the horse, Lyz said she never saw him so vulnerable. After the session, the two apologized for hurting each other.

Two weeks later, Justin went through a final exercise to fully cope with his past. In a pen, surrounded by the herd, Justin became 9 years old again. He was instructed to confront his absent father through a role-playing exercise, while Lyz acted as a stand-in for his dad.

"You abandoned all of us," he said aloud. "I had to be the man of the family and I think that you're a coward."

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NJ residents go home after toxic chemicals cleared

PAULSBORO, New Jersey (Reuters) - Residents of New Jersey evacuated after a freight train derailment last week spewed toxic vinyl chloride began returning home on Friday as tests of the air came back clean, a Coast Guard official said.

Exactly one week after a bridge collapsed, derailing seven of the 82 Conrail freight-train cars crossing the Mantua Creek in southern New Jersey, residents who were ordered out of more than 200 homes nearest the wreck were allowed back into their homes on Friday afternoon.

Coast Guard Captain Kathy Moore said air tests in Paulsboro showed no further evidence of vinyl chloride, which had leaked from a gash in one tanker that tumbled into the waterway that feeds into the Delaware River near Philadelphia.

At the time of the wreck, authorities said 12,000 gallons (45,425 liters) of vinyl chloride had escaped.

Groups of residents were being led to their homes by law enforcement and air quality officials. The Coast Guard also offered in-home air quality checks to any resident seeking further assurance that their home is safe.

One of those set to return home Friday was Yasmen Stafford, 19, the mother of 6-month-old twin boys who has been living in a motel for the last week.

"I just want to get settled back in and get back to my regular routine," said Stafford as she waited at the Paulsboro volunteer fire department for an escort by a police officer and air quality specialist.

Koren Warrington, 39, who has also been living in a nearby hotel, confessed she was a "little nervous" about returning home, fearing her home would smell of toxic chemicals.

Paulsboro Mayor Jeff Hamilton said 680 people from some 204 houses had been evacuated after the train crash. He said he knew of nobody that has reported an air quality problem upon returning home.

Vinyl chloride is a highly toxic and flammable industrial chemical. Exposure to it can cause respiratory problems, coughing and light-headedness, said Lawrence Ragonese, spokesman for the state Department of Environmental Protection.

The failed rail-bridge is near both residential and commercial sections of the town of 6,100 people, which is also home to two oil refineries as well as chemical plants.

Conrail is jointly owned by rail operators CSX Corp and Norfolk Southern Corp.

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Supreme Court to hear "pay-for-delay" drug case

(Reuters) - The Supreme Court agreed on Friday to decide whether brand-name drug companies may pay money to generic drug  rivals to keep their lower-priced products off the market, a practice estimated to cost consumers and the government billions of dollars each year.

The arrangements, known as "pay-for-delay" or "reverse payments," have for more than a decade vexed antitrust enforcers, including the Federal Trade Commission (FTC), which have been stung until recently by a series of court decisions allowing such practices.

In a typical case, a generic rival challenges the patent of a brand-name competitor, which then pays the rival a sum of money to drop its challenge. Defenders of the practice call it a legitimate means to resolve patent litigation.

The court accepted an appeal by the FTC, which had challenged annual payments of $31 million to $42 million by Solvay Pharmaceuticals Inc, now owned by Abbott Laboratories, to stop generic versions of AndroGel, a treatment for the underproduction of testosterone, until 2015.

These payments went to rivals such as Watson Pharmaceuticals Inc, Paddock Laboratories Inc and Par Pharmaceutical Cos, and were intended to help Solvay preserve annual profits estimated at $125 million.

The 11th U.S. Circuit Court of Appeals in Atlanta ruled against the FTC and upheld the arrangement in April. Two other circuit courts have also upheld such arrangements.

But the federal appeals court struck down a similar arrangement in July involving Merck & Co Inc. The Supreme Court often steps in to resolve such splits.

"This will be one of the most important business decisions that the court will have issued in quite some time," said Michael Carrier, a professor at Rutgers Law School in Camden, New Jersey. "These agreements cost consumers billions of dollars a year."

'WIN-WIN' FOR DRUGMAKERS

According to the FTC, 127 reverse payment arrangements were struck between 2005 and 2011, at an annual cost to consumers of $3.5 billion.

The agency calls the arrangements a "win-win" for drug companies that can share the benefits of high prices, while consumers, pharmacies and insurers miss out on generic drug prices that could be as much as 90 percent lower.

And in November 2011, the nonpartisan Congressional Budget Office said a U.S. Senate bill to ban reverse payments would save the government $4.79 billion and lower U.S. spending on prescription drugs by $11 billion over a decade. (http://aging.senate.gov/publications/s27.pdf)

That bill has not become law.

Under the Hatch-Waxman Act, the first company to win U.S. Food and Drug Administration approval to sell a generic drug before the underlying patent expires has a 180-day exclusive right to market that product.

This typically results in litigation by the brand-name rival, which can lead to reverse payment settlements.

MERCK CASE

In the Merck case, the 3rd U.S. Circuit Court of Appeals had struck down payments by Schering-Plough Corp, later bought by Merck, to rivals to delay generic versions of its potassium supplement K-Dur 20. Upsher-Smith Laboratories Inc was paid more than $60 million, court records show.

The U.S. Department of Justice, acting on the FTC's behalf, urged that the Supreme Court accept the FTC case for review and reverse the 11th Circuit decision.

It said the 3rd Circuit was correct to conclude that reverse payment agreements are presumptively anticompetitive and unlawful. Thirty-one states led by New York also urged the Supreme Court to hear the FTC appeal.

"The court has an opportunity to clarify the law," said Keith Hylton, a professor at Boston University School of Law. "It's very important to the drug industry because companies have many investments tied up in these drugs and that would be put at risk if pay-for-delay agreements were overturned."

The FTC case will be decided by an eight-member court. Justice Samuel Alito recused himself, without giving a reason.

A decision is expected by the end of June.

The case is Federal Trade Commission v. Watson Pharmaceuticals Inc et al, U.S. Supreme Court, No. 12-416.

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FDA panel opposes recommending painkiller, cites safety

WASHINGTON (Reuters) - A U.S. Food and Drug Administration panel of outside experts voted against recommending Zogenix Inc's Zohydro painkiller for FDA approval on Friday, citing concerns about the danger of addiction posed by the drug class known as opioids.

But FDA officials said the regulatory agency could still approve the drug for sale in the United States by imposing restrictions to protect public safety.

In an 11-2 vote, advisory committee members said the San Diego-based pharmaceutical company had met narrow FDA targets for safety and efficacy but worried that the drug known generically as hydrocodone bitartrate could become a drug of choice for people addicted to other opioid painkillers including those based on the drug oxycodone.

"The primary thing has to be the public health," said Dr Judith Kramer of Duke University. "And I don't see how we can't see this as a promised repeat performance."

FDA officials will consider the committee's recommendation in deciding by March 1 whether to approve Zohydro for sale in the United States for people who require a round-the-clock painkiller for an extended period of time.

Dr Bob Rappaport, director of the FDA's division of anesthesia, analgesia and addiction products, said regulators must decide whether the panel's decision was based on a tangible difference between Zohydro and opioid-based medications already available in the marketplace.

Otherwise, he told the panel, "you're punishing this company and this drug because of the sins of the previous developers and their products. And from a regulatory standpoint, that's not really something we can do."

POSSIBLE SALES BOOST

Wall Street analysts say FDA approval could bring Zogenix up to $500 million in annual sales from Zohydro by 2019, or more than ten times the pharmaceutical company's expected 2012 annual revenue of $45.5 million.

Trading of Zogenix shares was suspended on Friday because of the FDA hearing. The stock closed at $2.36 on Thursday.

Zohydro is a single-entity, extended-release product containing the narcotic painkiller hydrocodone with no other pharmaceutical ingredient such as acetaminophen, which can lead to liver damage if used too often.

"Zogenix recognizes and appreciates that prescription opioid misuse and abuse is a critical issue. However, it is also important to remember that there is a documented patient need for an extended-release hydrocodone medicine without acetaminophen," the company said in a statement.

"We remain confident in the measures we have proposed to support safe use of Zohydro and are committed to continuing to work with the FDA through the review process to bring this treatment option to this specific patient population," it added.

Health officials say hydrocodone, the active ingredient in Zohydro, is already the most widely abused drug in an opioid class linked to a prescription drug abuse epidemic that has ballooned over the past 20 years.

Law enforcement officials say prescription drugs now pose a bigger public safety hazard than more traditional narcotics, including heroin and cocaine.

An estimated 7 million Americans abuse pharmaceutical drugs. Prescription drugs account for about 75 percent of all drug-related U.S. overdose deaths, according to the U.S. Centers for Disease Control and Prevention. Three of every four deaths from pills involve opioid pain relievers including oxycodone.

SHARPLY CONTRASTING TESTIMONY

Before voting, the panel heard testimony from more than a dozen public witnesses, including chronic pain sufferers who see drugs like Zohyrdo as needed treatments to control their chronic discomfort and allow them to lead normal lives without endangering their health.

But some speakers before the panel implored the experts not to recommend another potentially addictive opioid.

"Today we have a chance to save people," said Avi Israel, father of an 18-year-old boy who suffered from Crohn's disease and committed suicide after becoming addicted to hydrocodone that was prescribed to slow his bowels.

"Ask yourself this question," he added, "do we really need another narcotic pill to help anybody with pain? We can't handle what we have."

Earlier on Friday, the panel conducted separate and sharply divided votes on safety and efficacy.

Committee members voted 9-5 to find that the drug was not safe for treating patients with moderate to severe chronic pain, after voting 7-6 to find the treatment effective against pain. A panel member later changed her vote on efficacy from "no" to "yes," saying she had made a technical error.

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Judge rejects bid to block Washington state "stoned driving" rules

OLYMPIA, Washington (Reuters) - A judge on Friday rejected a request by a medical marijuana  user to block Washington state from enforcing tougher "stoned driving" rules after it became one of the first U.S. states to legalize the recreational use of marijuana.

Washington state voters last month approved marijuana legalization by a margin of 56 percent to 44 percent, making the state, along with Colorado, the first in the country to legalize recreational pot use.

The new rules, which for most marijuana smokers would put them over the legal driving limit for a couple hours after taking two or three hits from a joint, took effect on Thursday.

The legal challenge came from Arthur West, an Olympia-based lawyer and medical marijuana patient who said the ballot initiative's title wrongly left out any mention of the DUI provisions.

He also argued that those provisions will enable police to target medical marijuana users, who typically have higher residual blood levels of THC--the active ingredient in marijuana--for car stops.

"I don't think it's fair that the tens of thousands of patients in the state of Washington have to choose between whether they take their medicine or be subject to arrest for driving under the influence every time they get in their cars," he said.

In rejecting West's request for a preliminary injunction, Judge Lisa Sutton noted that police have long been empowered to pull over drivers they suspect of impaired driving.

"That is the same case today, after the passage of this initiative, as it was before," Sutton said.

Though the hearing Friday dealt primarily with the DUI provisions, West's lawsuit also asserts that the initiative wrongly earmarks tax money raised by regulating marijuana for unrelated services such as primary health and dental care, and that state legislators improperly advocated its passage.

West said he will push ahead with his case, taking it all the way to the state's supreme court if necessary.

Assistant Attorney General Bruce Turcott, who defended the new marijuana law in court, said he was satisfied with the ruling.

"I would have been very surprised" if the judge had ruled differently, Turcott added.

Alison Holcomb, an attorney with the Washington state ACLU who led the legalization campaign, declined to comment on the case.

Previously, Holcomb told Reuters that she included the DUI provisions in the initiative after an internal poll in May showed that 62 percent of 602 likely voters said a pot-impaired driving standard would make them more likely to vote for legalization

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