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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The 'fiscal cliff' con game

Whatever the ultimate shape of the "fiscal cliff" solution that has preoccupied all Washington, and a fair swath of the rest of country, in the final days of 2012 and into the new year, Americans of all walks of life should be asking themselves this question: How do we like being conned?

The deal, passed by the Senate on New Year's morning, was made final late Tuesday when the House of Representatives signed on. Its essential elements include expiration of the President George W. Bush-era income and capital gains tax cuts on couples' incomes over $450,000, and a modest increase in the estate tax.

Unemployment benefits and tax credits for lower-income families will be extended. The payroll tax holiday that replaced a low- and middle-income tax credit in 2009 will end, but the tax credit won't return. Many other items, including the fate of automatic spending cuts mandated by the 2011 debt-ceiling deal, are being put off for weeks or months. Another debt-ceiling fight looms on the near horizon.

Almost everything mentioned above involves a con game of one sort or another, because almost none of it is what it seems on the surface. Since such fakery is certain to continue well into the new year, here's a quick guide to its basic features.

The deficit con: The big daddy. Despite the lawmakers' claims that the debate has been about closing the federal deficit and reducing the federal debt, none of the negotiating over the past weeks has dealt with those issues. Indeed, the tax and spending package will widen the deficit by some $4 trillion over 10 years, compared with what would happen if the tax increases and spending cuts mandated by existing law were implemented.

The House Republican caucus has consistently looked for ways to protect high-income taxpayers from a tax increase, at the expense of beneficiaries of government programs such as enrollees in Social Security and Medicare. If there's a dominant preoccupation with cutting the deficit lurking somewhere in that mind-set, good luck finding it.

The shared sacrifice con: If the goal has been for an approach to deficit cutting balanced among economic strata — and Democrats and Republicans both pay lip service to this notion — then the final deal is a fraud. Every working person earning up to $113,700 in wages this year will shoulder an instant tax increase of 2%. That's because the payroll tax holiday enacted in 2010 is expiring.

The tax holiday, which cut the employee's share of the Social Security tax to 4.2% from 6.2% of income up to the annual wage cap, was always designed as a temporary stimulus measure. But few people expected that it would expire at a single stroke — and without a countervailing working-class tax credit to soften the blow.

Monkeying with the payroll tax was never a great idea, because it undermined Social Security's essential funding mechanism. But what's often forgotten is that the holiday was implemented to replace an existing tax break for the middle class — the Making Work Pay credit—opposed by the GOP. But the credit isn't coming back, so the end of the holiday means a pure tax increase on the 98% of working Americans earning $113,700 or less in wages. For a couple touching, say, $80,000, the increase will come to $1,600.

Quiz: How much do you know about the "fiscal cliff?"

Compare that with the break reaped by taxpayers declaring income in the $250,000 to $450,000 range. That's the difference between the threshold at which President Obama proposed restoring pre-Bush tax rates and the level enacted by Congress. Exempting that slice of income from higher taxes saves up to $9,200 in taxes for families earning $450,000 or more (depending on the cost of phaseouts of exemptions and deductions for those taxpayers).

The estate tax con: There's no purer giveaway to the wealthy than this. The final deal raises the tax to 40% from 35% on estates over $10 million. (That figure is for couples, whose estates are each entitled to a $5-million exemption upon their deaths.) The alternative was to return to 2009 law, which set the tax at 45% on couples' estates more than $7 million.

Who pays the estate tax? In 2011, about 1,800 taxpayers died leaving estates of more than $10 million. Their average estate was somewhere from $30 million to $40 million. Their heirs cashed in on some of the most nimble tax planning on Earth: Although the statutory top rate was 35%, the average rate on estates of even $20 million-plus (the average gross value of which was $65 million) came to only 16.2%.

Estate tax bonus babies long have been protected by the myth that the tax falls heavily, and unjustly, on small family farms and businesses. The Washington-based Tax Policy Center found, however, that fewer than 50 small farms and businesses paid any estate tax in 2011. Their liability came to less than one-tenth of 1% of the total collected. On the other hand, more than 50% of the estate tax was paid by people whose income placed them in the top tenth of 1% of all taxpayers. These are the people protected by estate tax opponents.

The debt ceiling con: The original of this con is what put us at the fiscal cliff in the first place, for the automated spending cuts being dealt with now were put in place as the GOP's price to raise the federal debt ceiling and stave off a government default in 2011. The debt ceiling was not designed as a constraint when it was created in 1917 — it was convenient blanket authority for the Treasury to issue debt so that Congress wouldn't have to vote permission each time a new bond had to be floated.

Approval was always routine — the limit was raised 91 times between 1960 and the showdown in 2011. Now it's a hostage-taking situation, destined to return in the next month or two when Republicans who didn't get what they wanted in this week's cliffhanger menace the creditworthiness of the U.S. again.

For a brief shining moment, President Obama dreamed of folding an end to the debt limit into a fiscal cliff deal, but that didn't happen. The idea that the debt limit discourages fiscal irresponsibility is a scream. It doesn't now, and never has, stopped Congress from enacting any spending plan or tax break it pleases, creating a budget demand that has to be paid for with, yes, debt. If Congress wants less debt, it can cut spending or raise taxes. The debt limit is a dangerous weapon in the hands of irresponsible legislators, and it's time to take it out of their hands.

The bond vigilante con: This is the bedrock con that fuels deficit hawkishness. The idea is that if America doesn't get its debt under control, it will be punished by unhappy bond investors worldwide. U.S. interest rates will soar and the standard of living will plunge.

This con depends on voters overlooking that it hasn't happened. U.S. government bonds remain the most sought-after in the world. Remember August 2011, when Standard & Poor's cut America's credit rating because of poor fiscal policy and dysfunctional government? Neither condition has improved, but the yield on the 30-year Treasury bond has fallen from 3.75% to 2.82%, and on the 10-year note from 2.14% to 1.68%.

The bogeymen of higher interest rates and inflation that are supposed to follow inevitably from our current level of deficit spending have simply not materialized, and aren't visible on the horizon. Moreover, history suggests that more typically they're responses to vigorous economic growth, not to policies aimed at reviving recovery.

That's a clue that the whole fiscal cliff affair is a major con. There is no reason for the country to suffer now the austerity embodied in the spending cuts and tax hikes that were to come due Jan. 1; what's needed is continued stimulus to complete the economic recovery. Indeed, the starkness of the Jan. 1 deadline is itself a con — nothing except its own inaction prevents Congress from temporarily moderating the effects of the cliff by voting to defer tax increases and spending cuts, as it did this week.

In the golden age of individualistic rural America so beloved of today's conservative dreamers, people who perpetrated cons such as these would be tarred, feathered and ridden into the sunset on a rail. Today we allow them to set the agenda in Washington. Is that supposed to be progress?

Michael Hiltzik's column appears Sundays and Wednesdays. Reach him at mhiltzik@latimes.com, read past columns at latimes.com/hiltzik, check out facebook.com/hiltzik and follow @latimeshiltzik on Twitter.

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Ruling over bumper-car injury supports amusement park

SAN FRANCISCO — The California Supreme Court, protecting providers of risky recreational activities from lawsuits, decided Monday that bumper car riders may not sue amusement parks over injuries stemming from the inherent nature of the attraction.

The 6-1 decision may be cited to curb liability for a wide variety of activities — such as jet skiing, ice skating and even participating in a fitness class, lawyers in the case said.

"This is a victory for anyone who likes fun and risk activities," said Jeffrey M. Lenkov, an attorney for Great America, which won the case.

But Mark D. Rosenberg, who represented a woman injured in a bumper car at the Bay Area amusement park, said the decision was bad for consumers.

"Patrons are less safe today than they were yesterday," Rosenberg said.

The ruling came in a lawsuit by Smriti Nalwa, who fractured her wrist in 2005 while riding in a bumper car with her 9-year-old son and being involved in a head-on collision. Rosenberg said Great America had told ride operators not to allow head-on collisions, but failed to ask patrons to avoid them.

The court said Nalwa's injury was caused by a collision with another bumper car, a normal part of the ride. To reduce all risk of injury, the ride would have to be scrapped or completely reconfigured, the court said.

"A small degree of risk inevitably accompanies the thrill of speeding through curves and loops, defying gravity or, in bumper cars, engaging in the mock violence of low-speed collisions," Justice Kathryn Mickle Werdegar wrote for the majority. "Those who voluntarily join in these activities also voluntarily take on their minor inherent risks."

Monday's decision extended a legal doctrine that has limited liability for risky sports, such as football, to now include recreational activities.

"Where the doctrine applies to a recreational activity," Werdegar wrote, "operators, instructors and participants …owe other participants only the duty not to act so as to increase the risk of injury over that inherent in the activity."

Amusement parks will continue to be required to use the utmost care on thrill rides such as roller coasters, where riders surrender control to the operator. But on attractions where riders have some control, the parks can be held liable only if their conduct unreasonably raised the dangers.

"Low-speed collisions between the padded, independently operated cars are inherent in — are the whole point of — a bumper car ride," Werdegar wrote.

Parks that fail to provide routine safety measures such as seat belts, adequate bumpers and speed controls might be held liable for an injury, but operators should not be expected to restrict where a bumper car is bumped, the court said.

The justices noted that the state inspected the Great America rides annually, and the maintenance and safety staff checked on the bumper cars the day Nalwa broke her wrist. The ride was functioning normally.

Reports showed that bumper car riders at the park suffered 55 injuries — including bruises, cuts, scrapes and strains — in 2004 and 2005, but Nalwa's injury was the only fracture. Nalwa said her wrist snapped when she tried to brace herself by putting her hand on the dashboard.

Rosenberg said the injury stemmed from the head-on collision. He said the company had configured bumper rides in other parks to avoid such collisions and made the Santa Clara ride uni-directional after the lawsuit was filed.

Justice Joyce L. Kennard dissented, complaining that the decision would saddle trial judges "with the unenviable task of determining the risks of harm that are inherent in a particular recreational activity."

"Whether the plaintiff knowingly assumed the risk of injury no longer matters," Kennard said.

maura.dolan@latimes.com

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DiDonato a luminous Mary Stuart at Met

NEW YORK (AP) — The Metropolitan Opera may have pretty much turned opening night over to the glamorous Anna Netrebko, but New Year's Eve belongs to a very different diva — Joyce DiDonato.

Last year the Kansas-born mezzo-soprano headlined a starry lineup in the baroque pastiche "The Enchanted Island." On Monday night she brought a gala audience to its feet with a luminous performance in the title role of Donizetti's "Maria Stuarda."

Never before performed at the Met, this second opera in the composer's so-called "Three Queens" trilogy portrays the lethal conflict between Mary, deposed queen of Scotland, and Queen Elizabeth I of England.

From the moment she makes her entrance in the second scene, singing of her joy in strolling outside her prison in Fotheringay Castle, DiDonato rivets attention. She imbues every syllable with a concentrated eloquence that makes her compact voice seem larger than it is. She displays seemingly effortless command of coloratura embellishments throughout a wide vocal range. And she is equally impressive in fiery outbursts and in hushed, long-held phrases — like the ones she spun out as she sang through the chorus in the final scene.

The opera's dramatic heart is a confrontation between the two queens that never took place in history but that figures in the Friedrich Schiller play on which the libretto is based. Mary at first abases herself in hope of winning a pardon; then, as Elizabeth hurls insults, her pride reasserts itself and she seals her doom by denouncing her rival as "figlia impura di Bolena" ("impure daughter of Anne Boleyn") and "vil bastarda" ("vile bastard").

DiDonato was impressive in this scene when she sang the role for the first time last spring in Houston, but her performance Monday night was even better — more confident and more filled with vocal and dramatic shadings. There was a wonderful touch when, after she had spent her fury, she allowed herself a beatific smile, as if to convey: "There! I said it and I'm glad!"

Of course, it takes two to stage a confrontation, and DiDonato's partner at the Met is Elza van den Heever, a South African soprano making her debut. She has a voice that's impressive in many respects, with a large and vibrant upper register. But she tended to fade out in the lower part of her range, where much of Elizabeth's music lies.

More damagingly, she was victimized by a quirk of David McVicar's production that has Elizabeth lurching awkwardly about the stage for much of the evening, as if thrown off balance by John Macfarlane's elaborate period costumes. Perhaps this bizarre gait is intended to contrast with Mary's immaculate poise, but it mainly proves distracting.

The opening scene in Elizabeth's palace is garishly staged, with what look like red rafters hanging down from the ceiling and gratuitous acrobats in devil costumes, but once past this, matters improve. For the scene outside Fotheringay, Macfarlane fills the stage with spindly trees barren of leaves and provides a painted backdrop that evokes a cloudy landscape. The final tableau is also striking: Mary, shorn of her long hair and wearing a simple red dress, climbs a staircase with her back to the audience to meet her executioner and the chopping block.

Though the two queens dominate the opera, there are some other characters, and they are all in extremely good hands. Having the elegant tenor Matthew Polenzani take on the thankless role of the ineffectual Leicester is luxury casting indeed. Bass Matthew Rose is warmly sympathetic as Mary's confessor, Talbot; baritone Joshua Hopkins sings with robust tone as her nemesis, Cecil; and mezzo Maria Zifchak lends her customary strong support as Mary's attendant, Anna.

Maurizio Benini conducts a lithe and lively performance of the score, even if he can't quite disguise the fact that the second half of the opera is decidedly anti-climactic.

There are seven more performances, including a matinee on Saturday, Jan. 19, that will be broadcast live in HD to movie theaters around the world.

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In Theory: Pill Could Join Arsenal Against Bedbugs

THE HYPOTHESIS

A common deworming drug can be used to kill bedbugs.

THE INVESTIGATOR

Dr. Johnathan M. Sheele, Eastern Virginia Medical School

It was a visit to a cousin in New York City two years ago that inspired Thang D. Tran, a medical student at Eastern Virginia Medical School, to volunteer to become a human booby trap in the war on bedbugs.

“She told me everyone in New York was scared of bedbugs,” he said of his cousin. So when Dr. Johnathan M. Sheele, an emergency medicine specialist at his school, asked for volunteers to test a new way of killing the pests, Mr. Tran raised his arm. Soon, it was covered with itchy welts.

Dr. Sheele’s study, released at a tropical medicine convention in November, unveiled a possible new superweapon against Cimex lectularius: a deworming pill.

You take the pill and go to bed — perchance even to sleep, if you can sleep knowing how patiently bedbugs wait in your walls or mattress, sniffing for the sweet stream of your exhaled carbon dioxide and for your warm skin to grow still. You let them bite you. And then — in a few days — they die.

The technique is known as xenointoxication, which sounds like intergalactic beer pong but in medical pathology is Greek for “poisoning the guest.” In Dr. Sheele’s study, over 60 percent of the bedbugs died after volunteers like Mr. Tran took a single pill. Bigger or more regular doses might improve the lethality.

And it’s not as if the drug is rare and dangerous. It’s already in thousands of American households: ivermectin, the active ingredient in the beef-flavored Heartgard Chewables that kill heartworm in dogs.

(For humans, the brand name is Stromectol, and it is available by prescription only, usually for travelers who pick up worms overseas, or toddlers who get them from playing in sandboxes used by dogs.)

Ivermectin is also very safe. Millions of doses have been given to African children to kill the worms that cause river blindness. Many Papua New Guineans get double doses to kill scabies. One early study of the drug found that up to 10 times the normal dose was safe.

Ivermectin attacks a type of “gated chloride channel” in the nerves of insects that does not exist in mammals.

Dr. Sheele is not advising bedbug-tormented Americans to start eating Fido’s worm tablets. With only four volunteers, his study was tiny and preliminary, he emphasized. Neither the Food and Drug Administration nor any medical society has approved using ivermectin this way, and no one yet knows what the ideal antibedbug dose is.

But ivermectin experts say his idea isn’t crazy.

“Maybe partially crazy,” said Dr. Peter J. Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. “But not entirely crazy.”

Dr. Hotez’s hesitation is mostly that bedbugs, unlike body lice and worms, do not cause disease, so xenointoxication seems heavy-handed.

But many Americans, including many New Yorkers, are so terrified of the bugs that they have spent thousands of dollars fighting them, so ivermectin could be cost-effective.

Brian D. Foy, a virologist at Colorado State University’s veterinary school, has shown that it also kills mosquitoes, and so could be used against malaria. His initial reaction to using it against bedbugs was that he thought it would be easier to clean one’s house and throw out one’s mattress.

“But maybe that’s just my ignorance about bedbugs,” he admitted. “We don’t have them out here in Colorado.”

(Local news reports do not back him up on that.)

“Needless to say,” he correctly pointed out, “this isn’t going to solve the problem of bedbugs in hotel rooms.”

Dr. Sheele speculated that ivermectin might be best used in combination with current measures like pesticides, desiccant powders, mattress covers, heat treatment, steaming and vacuuming. While it might not work alone, it could give exterminators a head start.

Dr. Frank O. Richards Jr., a parasitologist at the Carter Center in Atlanta who has spent years running programs in Africa and Asia that give out ivermectin donated by Merck to fight river blindness, said he was “excited to see how this plays out.” Americans might be initially squeamish about deworming pills, he said, but the country does have “a lot of worried rich people who don’t like bug bites.”

He has tracked women in his river-blindness programs who took ivermectin before realizing they were pregnant, he said, “and all their babies were cool.”Nonetheless, he said, even though one 2002 study found a huge dose to be safe, which theoretically means that multiple small ones also would be, “as a physician, I’d be very concerned about an off-label use like that.”

“If I gave that out, and something happened,” he continued, “I would not have a leg to stand on in court.”

Because each bug feeds only occasionally, he said, “I don’t buy that a week would do the trick. I think you’re going to need two, three, four weeks. And that’s concerning. We don’t have any toxicity data like that.”

Like Dr. Sheele, he favors more testing of multiple doses.

Ivermectin is not cheap. In the United States, a typical adult dose of Stromectol is about $40, and no generic version is sold legally. A year’s supply of Heartgard for a big dog can cost more than $100.

But, Dr. Sheele said, that pales beside the price of multiple visits by a team of exterminators.

He got interested in bedbugs, he said, because they plagued so many of his Norfolk, Va., emergency room patients.

“I even had one patient come in with a baggie full of them,” he said. “As a physician, there’s nothing you can do for them except give them Benadryl and steroids for the itching.”

He knew about ivermectin’s power to kill skin parasites because he had done a fellowship in international emergency medicine, he said.

His school provided financing but was nervous about letting him officially import bedbugs to campus, so he had to borrow the lab of a tick researcher at Old Dominion University. (Mr. Tran remembers it as humid and redolent of lab rats.)

Eastern Virginia Medical School also wanted animal studies before he recruited medical students, so he dosed mice first; in that case, 86 percent of the bedbugs died.

Now he hopes to find support for a full-fledged clinical trial.

And he is working on a new project: If xenointoxication kills bedbugs, he surmised, how about ticks?

The parasite-host relationship isn’t as predictable as it is between bedbugs and their dinner. But the stakes are higher, since ticks carry serious diseases like Lyme and babesiosis.

“It could be interesting for people who have to spend a lot of time in the woods — like soldiers,” he said.

Meanwhile, Mr. Tran and An Teng, another medical student and study participant, are enjoying their new notoriety.

“My friends were completely grossed out that I let myself be bitten,” said Mr. Tran, whose rash from the bites lasted for a month. “But working on something so relevant to society caught my attention.”

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In this video from Eastern Virginia Medical School, one of the bedbug study participants demonstrates how he became human bait for bedbugs.

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California regulators seek to police out-of-state pharmacies

SACRAMENTO — State regulators are responding to a deadly nationwide meningitis outbreak linked to contaminated drugs by seeking new power to inspect out-of-state pharmacies that sell special-order prescription drugs in California.

In September, the New England Compounding Center in Framingham, Mass., sent three shipments of contaminated injectable steroid solutions to 76 healthcare facilities and pain-control clinics in 23 states, including four in California.

These customized drugs, which were injected into patients' spines and joints, caused 39 deaths among 620 reported cases of fungal meningitis and other infections, according to a Dec. 17 report from the federal Centers for Disease Control and Prevention in Atlanta.

The steroids were recalled by the now-bankrupt firm before they caused any deaths or illnesses in California. But that fortunate outcome hasn't kept the California Board of Pharmacy from being more aggressive about policing sometimes poorly regulated pharmacies that produce and ship large volumes of these medications, known as compounded drugs.

At issue is whether these outfits ought to be regulated by the U.S. Food and Drug Administration. The FDA regulates large drug manufacturers, but its legal authority to oversee the compounding pharmacies has been disputed in the courts. As a result, states are moving to play a bigger role in ensuring the safety of their products.

In one such case in 2012, the now-defunct Franck's Compounding Pharmacy in Ocala, Fla., shipped supposedly sterile products for injecting into the eye that caused infections in 17 California surgery patients.

The state pharmacy board, which oversees and licenses nearly 7,000 drugstores in California, plans to sponsor a bill in the Legislature this year that would give state agents the authority to make unannounced on-site inspections of out-of-state pharmacies that the board licenses to ship sterile medicines, such as injectable steroids, eyedrops and inhaled aerosol drugs, to healthcare providers here.

The California initiative is getting preliminary support from two industry trade groups, the Pharmacy Compounding Accreditation Board and the International Academy of Compounding Pharmacies. The FDA also is supportive of the thrust of the proposed legislation, said Virginia Herold, the state pharmacy board's executive director.

"We're being proactive for the public health because we don't want another incident," she said. "We want to make sure that if the product is coming into California, it meets the requirements of California law."

Increasing amounts of these compounded drugs are flowing into the state. The Board of Pharmacy told a congressional committee in December that it licensed 86 out-of-state compounding pharmacies to make sterile medications for use in California in fiscal year 2011-12, compared with just 17 in 2003-04 and none in 2002-03.

But keeping track of out-of-state, large-volume pharmacies isn't easy, Herold conceded, because both state and federal laws are ambiguous about who is responsible for regulating different types of compounded drugs.

The advantage of traditional compounding, federal and state health officials agree, is that it enables pharmacies to offer prescriptions in individualized formats. That includes producing such drugs as creams, powders or solutions to direct relief to specific parts of the body or supplying drugs as a liquid to make it easier for people who can't swallow pills, for example.

Any state-licensed pharmacist can make these drugs with a doctor's prescription, if the pharmacy also has a state license. In most cases, regulation and inspections are the legal province of state pharmacy boards, not the FDA.

But over the last decade, the definition of what is a compounding pharmacy has been blurred. Some pharmacies have begun manufacturing large volumes of drugs — such as sterile, injectable steroids used to temporarily ease back pain — that are shipped in bulk to hospitals and outpatient surgical centers.

"FDA's ability to take action against compounding … that exceeds the bounds of traditional pharmacy compounding and poses risks to patients has been hampered by gaps and ambiguities in the law, which have led to legal challenges to FDA's authority to inspect pharmacies and take appropriate enforcement actions," FDA Commissioner Margaret Hamburg said in congressional testimony Nov. 14.

The House Energy and Commerce subcommittee on oversight and investigations was probing the New England Compounding Center-related deaths.

As part of Hamburg's effort to boost enforcement and protect patients, she met in December with representatives from the boards of pharmacies in all 50 states.

California supports federal and state efforts to figure out a way to avoid more contamination-related illnesses from these drugs, said Amy Gutierrez, a California Board of Pharmacy member and chief pharmacy officer for the Los Angeles County Department of Health Services.

"The problem is really the other states" that might have different or weaker standards or less enforcement resources than California, she said.

"What we're looking for is holding the out-of-state pharmacies that compound sterile products to the same standards as our own state-licensed pharmacies."

marc.lifsher@latimes.com

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This Rose Parade marks a major step for a young float designer

Charles Meier pulled his first all nighter when he was 11 years old. His mother found him asleep in a flower box.

It was the night before final judging for the 1990 Rose Parade. Meier, a volunteer, had been running around for hours helping float decorators fill vials of water, scrape seeds and glue last-minute details. Exhausted, he finally crawled into a box that still smelled of orchids.

His parents snapped a picture, not knowing that their son would go on to win South Pasadena's float design contest just two years later, making him the youngest designer in Rose Parade history.

Nor did they imagine he would one day break through a tight-knit institution and start his own float company. When the 124th Rose Parade rolls out Tuesday, Meier's company will be the event's first new professional builder in almost two decades.

"I basically traded in stuffed animals for Rose Parade floats," said Meier, 34. "Other kids were at home reading comic books, and I'm here organizing my float pictures into photo albums. It was what captured my imagination."

::

Meier still remembers the moment he fell in love.

He was 9 years old, sitting in grandstand seats his parents had won in a raffle. It was sensory overload: Booming marching bands. Floats adorned with tractors and dancers on a giant piano. And color. So much color.

He started drawing floats that day. He studied flowers, memorized parade brochures and, accompanied by his parents, joined float decorating committees. He couldn't stop talking about his ideas.

"I don't want to hear you describe another float," his mother, Carol, told him. "Just draw one and send it in and see if they will build it."

Every year, he submitted designs to his hometown float committee. On his 13th birthday, South Pasadena selected his drawing. Instead of letting the experts take over, he insisted on working with the graphic designer on his vision of two aliens playing tug-of-war with a spaceship.

"It was really kind of funny. He was so young. I mean, he was 13, just a kid," said Dex Regatz, 82, the graphic designer who took Meier under his wing.

"Before they knew it, I had insisted I do the complete floral plan," Meier said. "And they actually took most of those ideas and ran with them."

He quickly became a live encyclopedia of flowers and colors.

He once exercised his mental floral database by designing a Valentine-themed float with 94 types of roses, an unmatched feat in Rose Parade annals. He juggled hot pink Hot Ladys, bicolored Panamas and King Kongs with hints of green.

He experiences his life through the prism of floats. Walking across moss inspired the furry texture for an animal. Coconut flakes, so white he thought they sparkled, looked perfect for celestial stars and eyeballs.

::

To pay his bills, Meier worked as a senior caretaker and freelance floral designer.

But on the side, he continued to volunteer for South Pasadena and Sierra Madre. He won fans with his enthusiasm, many said, and he treated each float as an intricate work of art.

"I'm always so impressed with his floats. You can stand anywhere, from any angle, and it looks good," said Gwen Robertson, a longtime Sierra Madre volunteer.

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Top 5 Kids Apps: Best Games

1. Bugs and Bubbles

Ages 3-up Overall rating: 5 out of 5 stars Why we like it: Fun, fast and good for building emerging math skills, Bugs and Bubbles contains 18 leveled sorting, classification games set in Uncle Bob’s Bubble Factory. The goal is to collect stickers by harvesting bubbles, requiring kids to apply skills of counting, sorting and remembering patterns in an elegant fashion. Need to know: The better you do, the greater the challenge, and progress can be saved over time on different devices. Watch a video review of this app here. Ease of use: 10/10 Educational: 10/10 Entertaining: 10/10 $ 2.99

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[More from Mashable: 7 Bad Moves That Hurt Facebook in 2012]

Chris Crowell is a veteran kindergarten teacher and contributing editor to Children’s Technology Review, a web-based archive of articles and reviews on apps, technology toys and video games. Download a free issue of CTR here.

While you’re at the grownup table this holiday season, the kids could be eating their vegetables and sitting quietly — what’s more likely is they’ll be playing on their smart devices.

[More from Mashable: 40 Digital Media Resources You May Have Missed]

So we’ve rounded up the best 5 games that were included in this year’s Top 5 Kids Apps. All these games are not only a lot of fun, they’re also educational for your kids. The top game, Bugs and Bubbles, got 5 stars out of 5 for its perfect mix of entertainment and math teaching. There’s also room for pure fun with games like Build and Play and Rush Hour.

SEE ALSO: Mobile Apps Under Scrutiny: Is Your Kid’s Privacy at Risk?

Our friends at Children’s Technology Review shared with us these 5 top apps from their comprehensive monthly database of kid-tested reviews. The site covers everything from math and counting to reading and phonics.

Check back next week for more Top Kids Apps from Children’s Technology Review

Photo via Christopher Furlong/Getty Images

This story originally published on Mashable here.

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Kanye West, Kim Kardashian expecting 1st child

ATLANTIC CITY, N.J. (AP) — A kid for Kimye: Kanye West and Kim Kardashian are expecting their first child.

The rapper announced at a concert Sunday night that his girlfriend is pregnant. He told the crowd of more than 5,000 at Revel Resort's Ovation Hall in song form: "Now you having my baby."

The crowd roared. And so did people on the Internet.

The news instantly went viral on Twitter and Facebook, with thousands posting and commenting on the expecting couple.

Most of the Kardashian clan also tweeted about the news, including Kim's sisters and mother. Kourtney Kardashian wrote: "Another angel to welcome to our family. Overwhelmed with excitement!"

West, 35, also told concertgoers to congratulate his "baby mom" and that this was the "most amazing thing."

Representatives for West and Kardashian, 32, didn't immediately respond to emails about the pregnancy.

The rapper and reality TV star went public in March.

Kardashian married NBA player Kris Humphries in August 2011 and their divorce is not finalized.

West's Sunday night show was his third consecutive performance at Revel. He took the stage for nearly two hours, performing hits like "Good Life," ''Jesus Walks" and "Clique" in an all-white ensemble with two band mates.

___

AP Writer Bianca Roach contributed to this report.

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Chinese Firm Is Cleared to Buy American DNA Sequencing Company

Ramin Rahimian for The New York Times

DNA sequencing machines at Complete Genomics in California. The firm dismissed concerns about its acquisition.

The federal government has given national security clearance to the controversial purchase of an American DNA sequencing company by a Chinese firm.

The Chinese firm, BGI-Shenzhen, said in a statement this weekend that its acquisition of Complete Genomics, based in Mountain View, Calif., had been cleared by the federal Committee on Foreign Investment in the United States, which reviews the national security implications of foreign takeovers of American companies. The deal still requires antitrust clearance by the Federal Trade Commission.

Some scientists, politicians and industry executives had said the takeover represented a threat to American competitiveness in DNA sequencing, a technology that is becoming crucial for the development of drugs, diagnostics and improved crops.

The fact that the $117.6 million deal was controversial at all reflects a change in the genomics community.

A decade ago, the Human Genome Project, in which scientists from many nations helped unravel the genetic blueprint of mankind, was celebrated for its spirit of international cooperation. One of the participants in the project was BGI, which was then known as the Beijing Genomics Institute.

But with DNA sequencing now becoming a big business and linchpin of the biotechnology industry, international rivalries and nationalism are starting to move front and center in any acquisition.

Much of the alarm about the deal has been raised by Illumina, a San Diego company that is the market leader in sequencing machines. It has potentially the most to lose from the deal because BGI might buy fewer Illumina products and even become a competitor. Weeks after the BGI deal was announced, Illumina made its own belated bid for Complete Genomics, offering 15 cents a share more than BGI’s bid of $3.15. But Complete Genomics rebuffed Illumina, saying such a merger would never clear antitrust review.

Illumina also hired a Washington lobbyist, the Glover Park Group, to stir up opposition to the deal in Congress. Representative Frank R. Wolf, Republican of Virginia, was the only member of Congress known to have publicly expressed concern.

BGI and Complete Genomics point out that Illumina has long sold its sequencing machines — including a record-setting order of 128 high-end machines — to BGI without raising any security concerns. Sequencing machines have not been subject to export controls like aerospace equipment, lasers, sensors and other gear that can have clear military uses.

“Illumina has never previously considered its business with BGI as ‘sensitive’ in the least,” Ye Yin, the chief operating officer of BGI, said in a November letter to Complete Genomics that was made public in a regulatory filing. In the letter, Illumina was accused of “obvious hypocrisy.”

BGI and Complete said that Illumina was trying to derail the agreement and acquire Complete Genomics itself in order to “eliminate its closest competitor, Complete.”

BGI is already one of the most prolific DNA sequencers in the world, but it buys the sequencing machines it uses from others, mainly Illumina.

Illumina, joined by some American scientists, said it worried that if BGI gained access to Complete’s sequencing technology, the Chinese company might use low prices to undercut the American sequencing companies that now dominate the industry.

Some also said that with Complete Genomics providing an American base, BGI would have access to more DNA samples from Americans, helping it compile a huge database of genetic information that could be used to develop drugs and diagnostic tests. Some also worried about protection of the privacy of genetic information.

“What’s to stop them from mining genomic data of American samples to some unknown nefarious end?” Elaine R. Mardis, co-director of the genome sequencing center at Washington University in St. Louis, said in an e-mail.

Dr. Mardis could not specify what kind of nefarious end she imagined. But opponents of the deal cited a November article in The Atlantic saying that in the future, pathogens could be genetically engineered to attack particular individuals, including the president, based on their DNA sequences.

BGI and Complete Genomics dismissed such concerns as preposterous.

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