Scant Proof Is Found to Back Up Claims by Energy Drinks





Energy drinks are the fastest-growing part of the beverage industry, with sales in the United States reaching more than $10 billion in 2012 — more than Americans spent on iced tea or sports beverages like Gatorade.




Their rising popularity represents a generational shift in what people drink, and reflects a successful campaign to convince consumers, particularly teenagers, that the drinks provide a mental and physical edge.


The drinks are now under scrutiny by the Food and Drug Administration after reports of deaths and serious injuries that may be linked to their high caffeine levels. But however that review ends, one thing is clear, interviews with researchers and a review of scientific studies show: the energy drink industry is based on a brew of ingredients that, apart from caffeine, have little, if any benefit for consumers.


“If you had a cup of coffee you are going to affect metabolism in the same way,” said Dr. Robert W. Pettitt, an associate professor at Minnesota State University in Mankato, who has studied the drinks.


Energy drink companies have promoted their products not as caffeine-fueled concoctions but as specially engineered blends that provide something more. For example, producers claim that “Red Bull gives you wings,” that Rockstar Energy is “scientifically formulated” and Monster Energy is a “killer energy brew.” Representative Edward J. Markey of Massachusetts, a Democrat, has asked the government to investigate the industry’s marketing claims.


Promoting a message beyond caffeine has enabled the beverage makers to charge premium prices. A 16-ounce energy drink that sells for $2.99 a can contains about the same amount of caffeine as a tablet of NoDoz that costs 30 cents. Even Starbucks coffee is cheap by comparison; a 12-ounce cup that costs $1.85 has even more caffeine.


As with earlier elixirs, a dearth of evidence underlies such claims. Only a few human studies of energy drinks or the ingredients in them have been performed and they point to a similar conclusion, researchers say — that the beverages are mainly about caffeine.


Caffeine is called the world’s most widely used drug. A stimulant, it increases alertness, awareness and, if taken at the right time, improves athletic performance, studies show. Energy drink users feel its kick faster because the beverages are typically swallowed quickly or are sold as concentrates.


“These are caffeine delivery systems,” said Dr. Roland Griffiths, a researcher at Johns Hopkins University who has studied energy drinks. “They don’t want to say this is equivalent to a NoDoz because that is not a very sexy sales message.”


A scientist at the University of Wisconsin became puzzled as he researched an ingredient used in energy drinks like Red Bull, 5-Hour Energy and Monster Energy. The researcher, Dr. Craig A. Goodman, could not find any trials in humans of the additive, a substance with the tongue-twisting name of glucuronolactone that is related to glucose, a sugar. But Dr. Goodman, who had studied other energy drink ingredients, eventually found two 40-year-old studies from Japan that had examined it.


In the experiments, scientists injected large doses of the substance into laboratory rats. Afterward, the rats swam better. “I have no idea what it does in energy drinks,” Dr. Goodman said.


Energy drink manufacturers say it is their proprietary formulas, rather than specific ingredients, that provide users with physical and mental benefits. But that has not prevented them from implying otherwise.


Consider the case of taurine, an additive used in most energy products.


On its Web site, the producer of Red Bull, for example, states that “more than 2,500 reports have been published about taurine and its physiological effects,” including acting as a “detoxifying agent.” In addition, that company, Red Bull of Austria, points to a 2009 safety study by a European regulatory group that gave it a clean bill of health.


But Red Bull’s Web site does not mention reports by that same group, the European Food Safety Authority, which concluded that claims about the benefits in energy drinks lacked scientific support. Based on those findings, the European Commission has refused to approve claims that taurine helps maintain mental function and heart health and reduces muscle fatigue.


Taurine, an amino acidlike substance that got its name because it was first found in the bile of bulls, does play a role in bodily functions, and recent research suggests it might help prevent heart attacks in women with high cholesterol. However, most people get more than adequate amounts from foods like meat, experts said. And researchers added that those with heart problems who may need supplements would find far better sources than energy drinks.


Hiroko Tabuchi contributed reporting from Tokyo and Poypiti Amatatham from Bangkok.



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Brunswick to sell Hatteras, Cabo, lays off 105













Brunswick yachts


The GT63 is the latest model of motor yacht from Hatteras, a unit of Brunswick Corp.
(Hatteras Yachts / January 3, 2013)



























































Recreational boat maker Brunswick Corp. said Thursday that it is seeking buyers for its sportfishing convertible yacht brands Hatteras and Cabo, and that it laid off about 105 workers at its New Bern facility in North Carolina.

The facility had about 545 employees as of November.

Brunswick bought Hatteras for $80 million in 2001 and Cabo for $60 million in 2006.

"The current plan assumes that the eventual purchaser will retain both the physical plant and the workforce of Hatteras/Cabo," Chief Executive Dustan McCoy said.

Hatteras builds luxury motoryachts and sportfishing convertible yachts.

The boat maker suffered a slide in earnings as consumers turned away from splashing money on luxurious items like boats after the recession, and was forced to restructure its operations.

The lay off will affect 75 full-time and about 30 temporary workers, and help Brunswick "better adjust to market conditions," spokesperson Dan Kuberan told Reuters.

The New Bern plant makes Hatteras and Cabo Yachts.

The company said it expects to record charges of between $70 million and $80 million in relation to the changes announced today, a major part of which will be recorded in the fourth quarter ended December.

Brunswick shares were marginally down at $31.37 in trading after the bell. They closed at $31.51 on the New York Stock Exchange on Thursday.


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Obama immigration shift cheered by Chicago-area advocates









Chicago-area immigration reform advocates greeted the Obama administration policy shift that will allow many here illegally to remain with their families while seeking legal status as a welcome step toward an eventual overhaul of federal immigration laws.


"We're hopeful that all of this portends a bigger improvement to the immigration system," said Lisa Koop, a managing attorney with the Chicago-based National Immigrant Justice Center.


Several thousand people in the Chicago area stand to benefit from the new rule, which makes it easier for immediate relatives of U.S. citizens to apply for permanent residency by allowing them to sign up for a "provisional unlawful presence waiver" while still in this country.





Such waivers can be granted to people who have overstayed their visas or entered the U.S. illegally if they can prove that their families would suffer extreme hardship if they weren't allowed to stay in the country.


The waivers do not guarantee permanent residency status, but without one, illegal immigrants can be banned from the U.S. for 10 years or more.


The policy shift, which takes effect March 4, does away with a requirement that applicants return to their homeland to apply for the waiver. The process can take as long as a year, forcing even those who eventually get a waiver to endure long separations from their families, Obama administration officials said Wednesday.


With no guarantees that their waiver applications would be approved, many immigrants here illegally chose to remain in the shadows rather than be forced to leave their family during the application process, said Fred Tsao, policy director for the Illinois Coalition for Immigrant and Refugee Rights.


At the National Immigrant Justice Center, attorneys are preparing for an influx of cases after the policy goes into effect, Koop said.


Many clients who appear to be eligible for a waiver delayed their application after the new rule was proposed in April, she said.


The new rule still will require applicants to return to their native countries for an interview at a U.S. Consulate after a waiver is approved, Obama administration officials said.


Because an approved waiver application often means a successful immigration application, Koop said, the new rule allows applicants to hedge the risks they take in formally declaring their illegal status.


"If you have this waiver approved and then go down and have your visa interview, unless something else arises at that visa interview, there is a pretty high likelihood that your case will go through pretty smoothly at that point," she said.


aolivo@tribune.com





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U.S. soul singer Bobby Womack says he has signs of dementia






(Reuters) – U.S. singer-songwriter Bobby Womack said he is beginning to show early symptoms of Alzheimer’s disease, including trouble remembering names and song lyrics.


“The doctor said, ‘You have signs of Alzheimer’s,’” Womack, 68, told Britain’s BBC Radio 6 music station over the weekend. “He said it’s not bad yet but it’s going to get worse.”






He added: “How can I not remember songs that I wrote? That’s frustrating.”


The 2009 Rock and Roll Hall of Fame inductee, whose hits include “Woman’s Gotta Have It” and “If You Think You’re Lonely Now,” suffered a number of health problems in the past year.


In March it was disclosed that he was diagnosed with colon cancer, which was later successfully treated, and he also underwent what was termed a “minor heart procedure.”


Other recent health issues included prostate cancer, pneumonia and collapsed lungs.


The soul veteran in October won the best album award from the British magazine Q for his 2012 release, “The Bravest Man in the Universe,” beating out much younger competition.


Womack got his start in the music business as the lead singer in the soul group The Valentinos, which he formed with his brothers, and played guitar for Sam Cooke.


He also wrote The Rolling Stones’ first chart topper in the UK, 1964′s “It’s All Over Now.”


(Reporting by Eric Kelsey, editing by Jill Serjeant and Cynthia Osterman)


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5-Hour Energy’s ‘No Crash Later’ Claim Is Disputed





The distributor of the top-selling energy “shot,” 5-Hour Energy, has long claimed on product labels, in promotions and in television advertisements that the concentrated caffeine drink produced “no crash later” — the type of letdown that consumers of energy drinks often feel when the beverages’ effects wear off.




But an advertising watchdog group said on Wednesday that it had told the company five years ago that the claim was unfounded and had urged it then to stop making it.


An executive of the group, the National Advertising Division, also said that 5-Hour Energy’s distributor, Living Essentials, had publicly misrepresented the organization’s position about the claim and that it planned to start a review that could lead to action against the company by the Federal Trade Commission.


“We recommended that the ‘no crash’ claim be discontinued because their own evidence showed there was a crash from the product,” said Andrea C. Levine, director the National Advertising Division. The organization, which is affiliated with the Council of Better Business Bureaus, reviews ad claims for accuracy.


The emerging dispute between Living Essentials and the National Advertising Division is unusual because the $10 billion energy drink industry is rife with questionable marketing. And Living Essentials, which recently cited the advertising group’s support in seeking to defend the “no crash” claim, may have opened the door to greater scrutiny.


Major producers like 5-Hour Energy, Red Bull, Monster Energy and Rockstar Energy all say their products contain proprietary blends of ingredients that provide a range of mental and physical benefits. But the companies have conducted few studies to show that the costly products provide anything more than a blast of caffeine, a stimulant found in beverages like coffee, tea or cola-flavored sodas.


The dispute over 5-Hour Energy’s claim also comes as regulatory review of the high-caffeine drinks is increasing. The Food and Drug Administration recently disclosed that it had received reports over the last four years citing the possible role of 5-Hour Energy in 13 deaths. The mention of a product in an F.D.A. report does not mean it caused a death or injury. Living Essentials says it knows of no problems related to its products.


The issue surrounding the company’s “no crash” claim dates to 2007, when National Advertising Division began reviewing all of 5-Hour Energy’s marketing claims. That same year, the company conducted a clinical trial of the energy shot that compared it to Red Bull and Monster Energy.


At the time, Living Essentials was already using the “No crash later” claim. An article on Wednesday in The New York Times reported that the study had shown that 24 percent of those who used 5-Hour Energy suffered a “moderately severe” crash hours after consuming it. The study reported higher crash rates for Red Bull and Monster Energy.


When asked how those findings squared with the company’s “no crash” claim, Elaine Lutz, a spokeswoman for Living Essentials, said the company had amended the claim after the 2007 review by the National Advertising Division. In doing so, it added an asterisklike mark after the claim on product labels and in promotions. The mark referred to additional labeling language stating that “no crash means no sugar crash.” Unlike Red Bull and Monster Energy, 5-Hour Energy does not contain sugar.


Ms. Lutz said that based on the modification, the advertising accuracy group “found all of our claims to be substantiated.”


However, Ms. Levine, the advertising group’s director, took sharp exception to that assertion, saying it mischaracterized the group’s decision. And a review of the reports suggested that Living Essentials had simply added language of its choosing to its label rather than doing what the group had recommended — drop the “no crash” claim altogether.


That review concluded that the company’s 2007 study had shown there was evidence to support a “qualified claim that 5-Hour Energy results in less of a crash than Red Bull and Monster” Energy. But it added the study, which showed that 5-Hour Energy users experienced caffeine-related crashes, was inadequate to support a “no crash” claim.


Ms. Levine said Living Essentials had apparently decided to use the parts of the group’s report that it liked and ignore others.


Companies “are not permitted to mischaracterize our decisions or misuse them for commercial purposes,” she said.


She said the group planned to notify Living Essentials that it was reopening its review of the “no crash later” claim. If the company fails to respond or provides an inadequate response, the National Advertising Division will probably refer the matter to the F.T.C., she said.


A Democratic lawmaker, Representative Edward Markey of Massachusetts, has asked that the agency review energy drink marketing claims.


Asked about the position of the National Advertising Division, Ms. Lutz, the 5-Hour Energy spokeswoman, stated in an e-mail that the “no sugar crash” language had been added to address the group’s concern.


This article has been revised to reflect the following correction:

Correction: January 2, 2013

An earlier version of this article misstated the number of deaths in which the Food and Drug Administration said 5-Hour Energy possibly played a role. The number was 13, not 15.



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Dow soars 2% after deal to avoid 'cliff'










NEW YORK (Reuters) - Stocks kicked off the new year with their best day in over a year on Wednesday, sparked by relief over a last-minute deal in Washington to avert the "fiscal cliff" of tax hikes and spending cuts that threatened to derail the economy's growth.

In 2013's first trading session, the S&P 500 achieved its biggest one-day gain since December 20, 2011, pushing the benchmark index to its highest close since September 14.

Concerns over Washington's ability to sidestep the cliff had driven the S&P 500 down for five straight sessions, before signs that a resolution was near sent the benchmark index higher on the final trading session of 2012.

The CBOE Volatility Index or the VIX , Wall Street's favorite gauge of investor anxiety, dropped 18.5 percent to 14.68 at the close. The VIX has fallen 35.4 percent over the past two sessions, the biggest 2-day percentage drop in the history of the index.

The Dow Jones industrial average jumped 308.41 points, or 2.35 percent, to 13,412.55 at the close. The Standard & Poor's 500 Index gained 36.23 points, or 2.54 percent, to finish at 1,462.42. The Nasdaq Composite Index climbed 92.75 points, or 3.07 percent, to end at 3,112.26.

U.S. markets were closed on Tuesday for New Year's Day.

Market breadth reflected the strong rally, with 10 stocks rising for every one that fell on the New York Stock Exchange. All 10 of the S&P 500 industry sector indexes gained at least 1 percent. The S&P financial index shot up 2.9 percent.

The S&P Information Technology index gained 3.2 percent, including Hewlett-Packard , which climbed 5.4 percent to $15.02. HP's gain followed a miserable 2012 when the stock fell nearly 45 percent as one of the S&P 500's worst performers for 2012.

On Tuesday, Congress passed a bill to prevent huge tax hikes and delay spending cuts that would have pushed the world's largest economy off a "fiscal cliff" and possibly into recession.

The vote avoided steep income-tax increases for a majority of Americans, but failed to resolve a major showdown over cutting the budget deficit, leaving investors and businesses with only limited clarity about the outlook for the economy. Spending cuts of $109 billion in military and domestic programs were temporarily delayed, and another fight over raising the U.S. debt limit also looms.

"We got through the fiscal cliff. The next big thing, and probably more contentious thing, is negotiating the debt ceiling and possibly entitlement reform in early 2013," said Jim Russell, senior equity strategist for U.S. Bank Wealth Management in Cincinnati.

Hard choices about budget cuts and the critical need to raise the debt ceiling will confront Congress about the same time in two months "so the fur will be flying," Russell said.

U.S. stocks ended 2012 with the S&P 500 up 13.4 percent for the year, as investors largely shrugged off worries about the fiscal cliff. For the year, the Dow gained 7.3 percent and the Nasdaq jumped 15.9 percent.

Bank shares rose following news that U.S. regulators are close to securing another multibillion-dollar settlement with the largest banks to resolve allegations that they unlawfully cut corners when foreclosing on delinquent borrowers.

Bank of America Corp rose 3.7 percent to $12.03 and Citigroup Inc gained 4.3 percent to $41.25. The KBW bank index rose 3.2 percent.

Shares of Zipcar Inc surged 47.8 percent to $12.18 after Avis Budget Group Inc said it would buy Zipcar for about $500 million in cash to compete with larger rivals Hertz and Enterprise Holdings Inc. Avis advanced 4.8 percent to $20.77.

Shares of Apple rose 3.2 percent to $549.03, helping to lift the S&P information technology index up 3.2 percent following a report that the most valuable tech company has started testing a new iPhone and a new version of its iOS software.

Economic data from the Institute for Supply Management showed U.S. manufacturing ended 2012 on an upswing despite fears about the fiscal cliff, but the Commerce Department reported that construction spending fell in November for the first time in eight months.

Volume was heavy, with about 7.8 billion shares traded on the New York Stock Exchange, the NYSE MKT and the Nasdaq, well above the 2012 daily average of 6.42 billion.

(Reporting by Chuck Mikolajczak; Editing by Jan Paschal)

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House Republicans balk at fiscal cliff deal









WASHINGTON (Reuters) - The bill to avert U.S. fiscal cliff wins passage in the House of Representatives. Pres. Obama is expected to sign into law promptly.

A months-long battle over the U.S. "fiscal cliff" headed to a close on Tuesday as the House of Representatives moved toward final approval of a bipartisan deal meant to prevent Washington from pushing the world's biggest economy into recession.






The Republican-controlled House was expected to back a tax hike on the top U.S. earners shortly before midnight on Tuesday, ending weeks of high-stakes budget brinkmanship that threatened to spook consumers and throw financial markets into turmoil.

Approval of the bill would be a victory for President Barack Obama, who campaigned for re-election last November on a promise to raise taxes on the wealthiest but faced stiff opposition from congressional Republicans.

Republicans had earlier considered adding hundreds of billions of dollars in spending cuts after the bill had already passed the Senate with strong bipartisan support. That would have triggered further partisan warfare and pushed the crisis well past a self-imposed January 1 deadline.

But party leaders abandoned the effort after determining they lacked the votes.

"We've gone as far as we can go and I think people are ready to bring it to a conclusion," Republican Representative Jack Kingston of Georgia said. "We fought the fight."

Rules Committee Chairman David Dreier, a Republican, predicted the House would back the Senate bill, which also postpones for two months $109 billion in spending cuts on military and domestic programs set for 2013.

The bill easily cleared a procedural hurdle by a bipartisan vote of 408 to 10.

Lawmakers have struggled to find a way to head off across-the-board tax hikes and spending cuts that began to take effect at midnight, a legacy of earlier failed budget deals that is known as the fiscal cliff.

Strictly speaking, the United States went over the cliff in the first minutes of the New Year because Congress failed to produce legislation to halt $600 billion of tax hikes and spending cuts scheduled for this year.

TAX HIKES FOR WEALTHIEST

While many Republicans were uneasy with the tax hikes and wanted more spending cuts in the bill, they seemed to realize that the fiscal cliff would begin to damage the economy once financial markets and federal government offices returned to work on Wednesday. Opinion polls show the public would blame Republicans if a deal were to fall apart.

House Republicans had earlier considered adding $330 billion in spending cuts over 10 years to the Senate bill, which raises taxes on the wealthiest U.S. households by $620 billion over the same period.

But Senate Democrats refused to consider any changes to their bill, which passed 89 to 8 in a rare display of unity early Tuesday.

That measure, which passed the Senate at around 2 a.m., would raise income taxes on families earning more than $450,000 per year and limit the amount of deductions they can take to lower their tax bill.

Low temporary rates that have been in place for the past decade would be made permanent for less-affluent taxpayers, along with a range of targeted tax breaks put in place to fight the 2009 economic downturn.

However, workers would see up to $2,000 more taken out of their paychecks annually with the expiration of a temporary payroll tax cut.

The non-partisan Congressional Budget Office said the Senate bill would increase budget deficits by nearly $4 trillion over the coming 10 years, compared to the budget savings that would occur if the extreme measures of the cliff were to kick in.

But the bill would actually save $650 billion during that time period when measured against the tax and spending policies that were in effect on Monday, according to the Committee for a Responsible Federal Budget, an independent group that has pushed for more aggressive deficit savings.

(Additional reporting by Rachelle Younglai, Thomas Ferraro and David Lawder; Writing by Andy Sullivan; Editing by Alistair Bell and Eric Beech)

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Armed robbers hit Paris Apple store






PARIS (Reuters) – Armed robbers targeted an Apple Inc store in central Paris on New Year’s Eve, taking thousands of euros (dollars) worth of goods, a police official said on Tuesday.


The robbery took place at about 9 p.m. (1900 GMT) on Monday, three hours after closing time at one of Apple‘s flagship stores behind the Paris Opera which sells products ranging from iPhones and iPads to Mac computers.






The police official declined to comment on reports the thieves walked away with about 1 million euros ($ 1.32 million) of loot, saying the company was still evaluating the loss.


Christophe Crepin from the police union UNSA told reporters four masked and armed individuals forced their way into the shop and afterwards escaped in a van.


“They were well prepared. As the majority of police were busy watching the Champs Elysees (for New Year’s Eve celebrations), the robbers took advantage of this opportunity,” he said.


($ 1 = 0.7585 euros)


(Reporting By Thierry Leveque and John Irish; Editing by Michael Roddy)


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Heartwarming moments defy chill at Rose Parade






PASADENA, Calif. (AP) — A couple who became husband and wife on the “Love Float,” a surprise reunion between a returning soldier and his little boy, and a grand marshal famed globally for her chimpanzee research were among the highlights of the 124th Rose Parade on Tuesday.


The parade’s spectacular 42 floral floats brightened an otherwise cloudy New Year’s morning and boosted the spirits of a chilled crowd estimated at some 700,000 spectators lining the 5-mile route.






“The only way that you’re going to experience the Rose Parade is to be here in person,” said Los Angeles resident Gineen Alcantara-Nakama, who camped out Monday night to save front row sidewalk spots.


“Growing up, I watched it on television, but it’s not the same — the smell, the atmosphere, smelling the flowers as they come down the street. And the energy. It’s like being with family all night long.”


Spectators rose to a standing ovation when Army Sgt. First Class Eric Pazz, who was riding on the Natural Balance Pet Foods float along with other service members, got off the float and walked over to his surprised wife Miriam and 4-year-old son Eric Jr., who came running out of the stands into the arms of his 32-year-old father.


Miriam Pazz had been told she had won a contest to attend the parade and did not know her husband, who is deployed in Afghanistan, would be there. A native of Clio, Mich., Pazz is a highly decorated soldier who has also served in Iraq. The family, who currently lives in Germany, climbed aboard the float for the rest of the route.


Cheers also went up for a Chesapeake, Va., couple who tied the knot aboard Farmers Insurance “Love Float.”


Gerald Sapienza and Nicole Angelillo were high school classmates who reconnected 10 years later and won the parade wedding over three other couples in a nationwide contest. They received a trip to Pasadena, a wedding gown, tuxedo, rings, marriage license fees, Rose Bowl game tickets and hair and makeup for the bride.


The parade’s theme this year was “Oh the Places You’ll Go!” named in honor of the Dr. Seuss book. It served as a fitting slogan for grand marshal British primatologist Jane Goodall, who has spent much of her life in Tanzania studying chimpanzees.


Goodall chose conservation as her message for the parade


“My dream for this New Year’s Day is for everyone to think of the places we can all go if we work together to make our world a better place,” said Goodall, 78.


“Every journey starts with a step and I am pleased to see the Tournament of Roses continue to take steps toward not only celebrating beauty and imagination, but also a cleaner environment.”


This year’s parade also saw the first-ever float entered by the Defense Department.


The $ 247,000 military float was a replica of the Korean War Veterans Memorial in Washington to commemorate the veterans from that conflict.


The float that scooped up the parade’s grand “Sweepstakes” prize for the most beautiful floral presentation and design was “Dreaming in Paradise” by fruit and vegetable producer Dole.


According to parade rules, every inch of the floats must be covered with flowers or plant material, most of it applied by volunteers in the last weeks of December.


Besides floats, the parade also featured 23 marching bands and 21 equestrian units from around the world.


Banda El Salvador, a 200-plus member marching band and folkloric dance troupe, played sassy Latin rhythms and paid homage to their Central American country by dressing in the national colors of blue and white and shouting “Arriba El Salvador!”


The Aguiluchos band from Puebla, Mexico, earned cheers for their fancy footwork and vaquero rope tricks. Colorful dancers from Costa Rica and South Korea were other crowd pleasers.


Die-hard parade fans staked out their spots overnight or in pre-dawn hours with folding chairs, hammocks and portable barbeque grills despite frosty temperatures.


Emergency personnel received a number of cold-weather exposure calls, police department spokeswoman Lisa Derderian told City News Service.


As of 8 a.m. Tuesday, police had made a total of 22 arrests along the parade route since 6 p.m. Monday, said police Lt. Rick Aversan. All but one arrest were for suspected public intoxication. The other was for suspected possession of burglary tools that could have been used to break into cars, police said.


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Drug Makers Losing a Bid to Foil Generic Painkillers





Public officials have long urged makers of powerful painkillers to do more to make the medications harder to crush and abuse. But now that some companies have done so, they want something in return — a ban on generic versions of the drugs they make that do not have such tamper-resistant designs. 







Stuart Isett for The New York Times

Purdue Pharma’s OxyContin







Purdue Pharma LP

Tablets of OxyContin have been made more resistant to abuse. At left, a tablet crushed into powder. Right, a reformulated tablet does not easily turn into powder when it is crushed.






In coming months, generic drug producers are expected to introduce cheaper versions of OxyContin and Opana, two long-acting narcotic painkillers, or opioids, that are widely abused.


But in hopes of delaying the move to generics, the makers of the brand name drugs, Purdue Pharma and Endo Pharmaceuticals, have introduced versions that are more resistant to crushing or melting, techniques abusers use to release the pills’ narcotic payloads.


The two drug makers, which say they are motivated not by profit but by public safety, have also been waging a multifront political and legal war to block sales of generics that are not tamper-resistant.


The companies argue that the older designs will feed street demand for strong painkillers, drugs that are involved in more than 15,000 overdose-related deaths a year. While some experts say the new tamper-resistant products are not a cure-all for the abuse problem, others say they represent an important step forward.


“I think it would be a shame if the government would allow generics to come in without any tamper-resistant properties,” said Dr. Lynn R. Webster, a specialist in Salt Lake City who has consulted with companies developing such safeguards. Over the last year, Purdue Pharma and Endo have backed legislation in Congress that would require many opioids to be tamper-resistant, and lobbied in favor of similar state laws.


They have also urged the Food and Drug Administration to give their tamper-resistant designs a stamp of safety approval that other manufacturers would have to match. The agency does not currently differentiate between drugs that have abuse-resistant qualities and those that do not.


Thus far, the companies’ efforts have failed. In mid-December, a federal judge threw out a lawsuit by Endo that would have blocked the F.D.A. from allowing generic versions of its drug, Opana, to go on sale in January. A recent effort by some doctors and local officials in Canada to deter sales of generic versions of OxyContin there fell flat. While companies like Purdue Pharma insist the public’s health is their main concern, others note that producers introduced tamper-resistant versions of their products just as the drugs were about to lose patent protection. In court papers filed in response to Endo’s lawsuit, the F.D.A. described the company’s action as a “thinly veiled attempt to maintain its market share and block generic competition.”


An F.D.A. official, Dr. Douglas C. Throckmorton, said the agency expected to issue guidance this month that would lay out the types of scientific data that drug producers would have to submit to support a claim that an opioid’s design or formulation helped to deter its abuse.


Companies are developing a variety of methods to do that. The new OxyContin pill turns into a gummy mass when an abuser crushes it, and the Opana pill is designed to break into large pieces when manipulated. Other methods include pills that contain a second drug reversing the opioid’s narcotic effects if taken inappropriately.


“We understand the value in developing appropriate abuse-resistant technology and we want to find a way of incentivizing that,” said Dr. Throckmorton, the F.D.A.’s deputy director for regulatory programs. “But we also understand the value of generics for patients.”


A study published in 2012 in a medical journal, The Journal of Pain, found that the percentage of people treated at drug-abuse clinics who reported abusing OxyContin fell significantly since the introduction of the tamper-resistant version.


Some of those abusers said they had switched to other long-acting opioids that were easier to abuse like Opana — before its reformulation — or to illicit drugs like heroin, according to the study, which was financed by Purdue Pharma.


But the generic versions of OxyContin and Opana are expected to be significantly cheaper than the tamper-resistant versions of those drugs. At time of introduction in late 2010, the price of the new version of OxyContin was about $6 per 40 milligram tablet, the same then as the price that was not tamper-resistant. Since then, the price of the new version has risen to about $6.80 for that strength tablet. Opana costs about the same amount for a pill of the same pain-killing strength.


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