A Workout Booster, and a Lawsuit

By NATASHA SINGER and PETER LATTMAN 

For the last few weeks, GNC, the dietary supplements retailer, has run a special on its Web site for a workout booster called Jack3d. “Hot Buy, Hot Buy, Hot Buy,” reads a red banner splashed across the product’s page.

Federal health regulators issued a warning in April that the stimulant in Jack3d, a workout booster, frequently raises blood pressure and heart rate, and could lead to heart attacks.

Related

• Army Studies Workout Supplements After Deaths (February 3, 2012)

Enlarge This Image

Leanne Sparling

Michael L. Sparling, who used Jack3d, died in 2011.

Pronounced Jacked, the powder contains a stimulant that marketers say increases strength, speed and endurance. At VitaminShoppe.com, where Jack3d is also sold, a reviewer boasts, “My muscles have gained mass like never before.”

Yet, last April, federal health regulators issued a warning that the stimulant — called dimethylamylamine, or DMAA — frequently raises blood pressure and heart rate, and could lead to heart attacks. In December 2011, after the deaths of two soldiers who had used Jack3d, the Defense Department removed all products containing DMAA from stores on military bases, including more than 100 GNC shops.

Now the parents of Michael L. Sparling, one of the soldiers who died, have filed a wrongful-death lawsuit against USPlabs, the developer and marketer of Jack3d, and GNC, the store where he bought it. The suit, filed on Wednesday in state court in San Diego, claims that the companies deceptively marketed Jack3d as safe and effective while not warning consumers about its potential health risks. It seeks unspecified punitive damages.

The Sparling case highlights gaps in product safety and regulatory oversight of the $30 billion dietary supplement industry in the United States, some supplement researchers say.

Under federal law, supplements are defined as natural products that contain only dietary ingredients. Yet the pharmaceutical company Eli Lilly originally developed the stimulant now used in Jack3d and other workout boosters as an inhaled drug for nasal congestion in the 1940s.

With prevalent chains like GNC lending their reputations and reach to such products, the researchers fault the retailers as much as manufacturers for promoting what they see as questionable supplements.

“It’s a pharmaceutical-grade product which is being directly introduced into the supplement marketplace with absolutely no regulatory oversight,” said Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School who has studied dietary supplements.

In the medical literature, DMAA has often been described as a synthetic stimulant similar to amphetamines that can constrict blood vessels, raise blood pressure and heart rate, potentially increasing the risk of heart attacks and strokes. In 2005, supplement makers began to market the substance in workout and weight-loss products, often combining it with caffeine, which may enhance the stimulant’s effects. Products like Jack3d and OxyElite Pro, which USPlabs also markets, became popular among fitness buffs as part of their pre-workout routine.

GNC.com said that Jack3d “produces an intense sensation of drive, focus, energy, motivation and awareness.” Last week, a reporter bought the original version of Jack3d at a GNC outlet in Midtown Manhattan.

 But a study commissioned by the United States military after the two soldiers died raised red flags about the safety of DMAA products.

 “DMAA in combination with other ingredients may be associated with significant consequences,” a team of military, sports and supplement researchers wrote in case reports about the deaths of the two soldiers that was published last December in Military Medicine, the journal of the Society of Federal Health Professionals. The researchers added, “DMAA continues to be available in dietary supplements despite the lack of evidence that it qualifies as a dietary ingredient.”

The Food and Drug Administration also issued warning letters to 10 marketers of the workout boosters, but critics charge that the agency has been slow to take definitive action against the products. Health regulators in at least seven other countries, including Britain, Sweden, Denmark, Finland, Canada, New Zealand and Australia, have effectively banned supplements containing DMAA.

Last month, a coroner in Britain cited the stimulant in the death of Claire Squires, 30, who took Jack3d before running the London Marathon last year, collapsed late in the race and died. DMAA “on the balance of probabilities, and in combination with extreme physical exertion, caused cardiac failure which resulted in her death,” the coroner wrote in his report.

The F.D.A. warnings sent to companies last spring said that the agency had no evidence that DMAA qualified as a dietary ingredient or that it was safe. Health professionals asked why, nearly a year after the warnings, retailers continued to sell products containing the stimulant.

“The F.D.A.’s warning process may do little to nothing to stem the significant public health risk posed by this potentially dangerous ingredient,” Philip J. Gregory, an associate professor at the School of Pharmacy and Health Professions at Creighton University in Omaha, Neb., wrote in a research letter last December in Archives of Internal Medicine.

The F.D.A. has received 60 reports of health problems in people who had ingested products containing DMAA, including reports of at least two deaths. Federal regulators cautioned that the reports did not prove the products themselves caused the health problems. Even so, they said they had safety concerns.

 “It was a drug. That certainly calls into question whether it even fits in the supplement space,” Daniel Fabricant, the director of the F.D.A.’s division of dietary supplement programs, said in a telephone interview last week. “We continue to send warning letters.”

Steve Mister, the chief executive of the Council for Responsible Nutrition, a trade group, said the agency had been too slow to issue a final decision about DMAA.

“It is incumbent upon the F.D.A. to make a decision as to whether it is a legitimate and safe dietary ingredient,” he said.

The wrongful-death lawsuit filed Wednesday adds to the legal battles being waged by USPlabs. In December, the company paid $2 million to settle a false-advertising lawsuit filed against it in California state court by consumers who bought Jack3d and OxyElite Pro. As part of the settlement, USPlabs did not admit wrongdoing, but agreed to change the labeling to make warning statements on the products larger and easier to understand.

 The company has also gone on the legal offensive, using the courts in an attempt to defend Jack3d’s reputation. Last October, USPlabs filed a defamation lawsuit against the owner of a supplements store in Reno, Nev., who gave a television interview about Jack3d as part of a consumer safety report on a local news broadcast. Philip Tracy, the owner of Max Muscle of Reno, described Jack3d as an “amphetaminelike compound” that “speeds up your heart rate” and could “possibly” cause death. A judge dismissed the lawsuit, which was filed in federal court in Dallas, for lack of jurisdiction.

 The lawsuit filed by Mr. Sparling’s parents said that on the morning of June 1, 2011, Mr. Sparling took the recommended dose of Jack3d after buying it at a GNC store at Fort Bliss in El Paso. During a moderate workout with his unit — a short run interspersed with lunges up a small hill — Mr. Sparling, 22, collapsed. He died at a hospital several hours later of respiratory failure and cardiac arrest. Anne Andrews, a lawyer for Mr. Sparling’s parents, said it was appalling that GNC continued to sell Jack3d.

 “Jack3d is a product with well-established dangers, and the F.D.A. and medical community have made that abundantly clear,” Ms. Andrews said. “GNC has chosen financial gain over the safety of the consumer.”

Students, doctors are at fault for growing Adderall misuse

Monday, February, 11, 2013; 9:54 PM | 1 | ShareThis | Print

by Kelsey Edelmann, regular columnist

SHARE

It’s all too easy to obtain that magic pill that gives you a boost during finals. You probably know someone willing to sell you an Adderall, and if not, you can easily find a Concerta, Ritalin, Methylin, Dextrostat, or a Decedrine on campus. It’s so tempting to take a pill to obtain tunnel-like focus that in turn will give you that bright, shining “A” you desperately need.
After the first time, it’s too tempting to pass up again—the thought of being locked in the library without your six-hour ancillary capsule is just horrifying.  So when students get hooked on recreational test helpers, they move to the major leagues and get their own prescription. It’s simple enough to get a recommendation from a doctor; Wikipedia can tell you all the answers you need to pass the test proving you are positive for attention deficit hyperactivity disorder. Yes, you have trouble sitting still, yes, you have trouble concentrating… it’s the one test you don’t need an Adderall to pass. The results of tests of students with A.D.H.D. and those merely faking symptoms are absolutely indistinguishable. The test doctors hand out is a short cut, a cop-out diagnosis.
Physicians and psychiatrists will make the process even easier for perspective clients. They make hasty diagnoses to lying patients and up dosages even with evidence of growing addiction and psychiatric instability to make a quick buck off of a desperate college student. The mutual understanding of faking tests and writing prescriptions is a travesty. Obliging doctors give out hundreds of pills each day even if more medication might be detrimental to a patient’s health. According to the New York Times, as many as 35% of college students use stimulant drugs to enhance their academic performance. The pills are a kind of steroid for your study skills.  For most who use the drugs more than once and a while, they find daily activities difficult without popping a pill. It’s at this point when they become an addict. It is projected that ten percent of Adderall users become addicted.
While a pill might give you six hours of pure concentration and studying bliss, the side effects take over the remaining eighteen hours of your day. Mood darkening, scattered sleep pattern, tics, and decreased appetite might consume your non-stimulated part of the day. As the dosage goes up, the negative symptoms do, as well. In extreme cases of addiction suicide is a threat.
The pills aren’t the problem with overwhelming addiction and abuse of the drug, but, rather, the doctors that prescribe the medication. Too lenient and too easy with their prescription pad, doctors fail to take the time to inspect the real severity of a patient. More often than not, doctors take the clients’ word for granted and trust their articulated symptoms without seeing any real evidence toward A.D.H.D. Doctors and students, both, should stop relying so much on pills as problem solvers. The cycle of abusing Adderall and similar drugs is one that should be stopped immediately, before dangerous outcomes become more prevalent around the country.

A version of this article appeared in the Feb 12 issue of the Collegiate Times.

The 11 Scariest Things in Your Food

I always tell my daughters they can make a difference in the world, even at their tender ages of 10 and 7. To them, I probably sound like the teacher from Peanuts—they're more interested in soccer and American Girl right now—but I hope the lesson eventually sinks in.

My latest example of a kid heroics for them: 15-year-old Sarah Kavanagh from Hattiesburg, Mississippi, who gathered more than 200,000 signatures in her online petition asking Gatorade to remove a controversial flame-retardant chemical. Last week, Gatorade announced that they would be removing the ingredient, brominated vegetable oil (BVO), within the next couple of months. That's great news—especially for me personally, because I love the stuff! Actually, so do my daughters.

While Gatorade spokeswoman Molly Carter said the decision wasn’t in response to Sarah’s petition, the teen is claiming victory. Either way, we all win.

Truth is, chemicals that are used as weed killer, flame retardant, and sunscreen are startlingly common in your supermarket. But you won’t find “carcinogens,” “paint chemicals,” or “beaver anal gland juice” on the back panel. They’ll be hidden under names like “Butylated HydroxyAnisole” or “natural flavoring.” Break through the science experiment to find out what you’re really eating.

Here are the 11 scariest ingredients in your food:

Acesulfame Potassium (Acesulfame-K)

WHAT IT IS: A calorie-free artificial sweetener 200 times sweeter than sugar. It is often used with other artificial sweeteners to mask a bitter aftertaste.
FOUND IN: More than 5,000 food products worldwide, including diet soft drinks and no-sugar-added ice cream. Click here to discover The Strange Reason Diet Soda Makes You Fat.
WHAT YOU NEED TO KNOW: Although the FDA has approved it for use in most foods, many health and industry insiders claim that the decision was based on flawed tests. Animal studies have linked the chemical to lung and breast tumors and thyroid problems.

Aspartame

WHAT IT IS: A near-zero-calorie artificial sweetener made by combining two amino acids with methanol. Most commonly used in diet soda, aspartame is 180 times sweeter than sugar.
FOUND IN: More than 6,000 grocery items including diet sodas, yogurts, and the table-top sweeteners NutraSweet and Equal. (Did you know that most flavored yogurt is a step above ice cream? Find out the 25 New Healthy Foods That Aren’t.)
WHAT YOU NEED TO KNOW: Over the past 30 years, the FDA has received thousands of consumer complaints due mostly to neurological symptoms such as headaches, dizziness, memory loss, and, in rare cases, epileptic seizures. Many studies have shown aspartame to be completely harmless, while others indicate that the additive might be responsible for a range of cancers.

STRANGE BUT TRUE: If beating asthma with sweet potatoes sounds too good to be true, wait till you read these 14 crazy-sounding (but completely true) health tips!

Titanium Dioxide

WHAT IT IS: A component of the metallic element titanium commonly used in paints and sunscreens. The food industry adds it to hundreds of products to make overly processed items appear whiter.
FOUND IN: Processed salad dressing, coffee creamers, and icing.
WHAT YOU NEED TO KNOW: Titanium is a mined substance that's sometimes contaminated with toxic lead. Plus, most white dressings (like creamy ranch) aren’t great for you anyway. Both your health and your waistline will fare better if you go with an olive oil- or vinegar-based salad topper instead.  

Glyphosphate

WHAT IT IS: The active ingredient in the popular week killer Roundup. It’s used on corn and soy crops genetically engineered to withstand a heavy dousing of the chemical.
FOUND IN: Most nonorganic packaged foods containing corn- and soy-derived ingredients. Because it’s a systemic herbicide, it’s taken up by the plant—meaning you eat it.
WHAT YOU NEED TO KNOW: Glyphosphate exposure is linked to obesity, learning disabilities, and infertility.

BONUS TIP: For simple steps to live a longer and healthier life, check out Dr. Oz's 25 Greatest Health Tips Ever.

Butylated HydroxyAnisole (BHA)

WHAT IT IS: A petroleum-derived antioxidant used to preserve fats and oils.
FOUND IN: Beer, crackers, cereals, butter, and foods with added fats.
WHAT YOU NEED TO KNOW: Studies have shown BHA to cause cancer in the forestomachs of rats, mice, and hamsters. The Department of Health and Human Services classifies the preservative as "reasonably anticipated to be a human carcinogen."

Interesterified Fat

WHAT IT IS: A semi-soft fat created by chemically blending fully hydrogenated and non-hydrogenated oils. It was developed in response to the public demand for an alternative to trans fats.
FOUND IN: Pastries, pies, margarine, frozen dinners, and canned soups.
WHAT YOU NEED TO KNOW: Testing on these fats has not been extensive, but the early evidence doesn't look promising. A study by Malaysian researchers showed a 4-week diet of 12 percent interesterified fats increased the ratio of LDL to HDL cholesterol. Furthermore, this study showed an increase in blood glucose levels and a decrease in insulin response. 

Red #3 (Erythrosine) and Red #40 (Allura Red)

WHAT THEY ARE: Food dyes that are orange-red and cherry red, respectively. Red #40 is the most widely used food dye in America.
FOUND IN: Fruit cocktail, candy, chocolate cake, cereal, beverages, pastries, maraschino cherries, and fruit snacks. (Confused by now about what you can eat? We scoured the supermarket for the125 Best Packaged Foods in America.)
WHAT YOU NEED TO KNOW: The FDA has proposed a ban on Red #3 in the past, but so far the agency has been unsuccessful in implementing it. After the dye was inextricably linked to thyroid tumors in rat studies, the FDA managed to have the liquid form of the dye removed from external drugs and cosmetics.

Yellow #5 (Tartrazine) and Yellow #6 (Sunset Yellow)

WHAT THEY ARE: The second and third most common food colorings, respectively.
FOUND IN: Cereal, pudding, bread mix, beverages, chips, cookies, and condiments.
WHAT YOU NEED TO KNOW: Several studies have linked both dyes to learning and concentration disorders in children, and there are piles of animal studies demonstrating potential risks such as kidney and intestinal tumors. One study found that mice fed high doses of sunset yellow had trouble swimming straight and righting themselves in water. The FDA does not view these as serious risks to humans.

Castoreum

WHAT IT IS: Beaver anal gland juice. Really. Beavers combine it with their urine to mark their territory.
FOUND IN: Vanilla or raspberry flavoring in processed foods, labeled only as “natural flavoring.”
WHAT YOU NEED TO KNOW: It’s beaver anal gland juice.

You won't believe what else you've been putting in your body. Click here to find out the 14 Foods You Should Never Eat. 

Excess Protein Linked to Development of Parkinson's Disease

Accumulation appears to progressively disrupt neuronal function and viability

Researchers at the University of California, San Diego School of Medicine say overexpression of a protein called alpha-synuclein appears to disrupt vital recycling processes in neurons, starting with the terminal extensions of neurons and working its way back to the cells’ center, with the potential consequence of progressive degeneration and eventual cell death.

The findings, published in the February 6, 2013 issue of The Journal of Neuroscience, have major implications for more fully understanding the causes and mechanisms of Parkinson’s disease (PD), a neurodegenerative movement disorder that affects an estimated one million Americans.

“This is an important new insight. I don’t think anybody realized just how big a role alpha-synuclein played in managing the retrieval of worn-out proteins from synapses and the role of alterations in this process in development of PD,” said principal investigator Mark H. Ellisman, PhD, professor of neurosciences and bioengineering and director of the National Center for Microscopy and Imaging Research (NCMIR), based at UC San Diego.

Using serial block face scanning electron microscopy and other technologies, researchers created three-dimensional images of the neocortex of transgenic mice engineered to over-express the human protein, alpha-synuclein, and noted massively enlarged nerve terminals. In this image, an over-sized terminal (green) forms a synapse (red) with a dendritic spine (golden). A normal and smaller terminal (blue) forms a synapse with an adjacent spine on the same dendrite. 

Parkinson’s disease is characterized by the gradual destruction of select brain cells that produce dopamine, a neurotransmitter involved in regulating movement and emotion. Symptoms include increasing loss of muscle and movement control. While most cases are sporadic – that is, their causes are unknown – there are also inherited forms of PD linked to specific gene mutations and modifications.

The UC San Diego researchers, with colleagues at the University of Illinois, Urbana, focused upon one of those gene products: alpha-synuclein. Using a variety of leading-edge imaging technologies, including a new fluorescent tagging technique developed for electron microscopy by UC San Diego Nobel laureate Roger Tsien’s lab and colleagues at NCMIR, the scientists created three-dimensional maps of alpha-synuclein distribution both in cultured neurons and in the neurons of mice engineered to over-express the human protein.

They found that excess levels of alpha-synuclein accumulated in the presynaptic terminal – part of the junction where axons and dendrites of brain cells meet to exchange chemical signals.

“The over-expression of alpha-synuclein caused hypertrophy in these terminals,” said Daniela Boassa, PhD, a research scientist at NCMIR and the study’s first author. “The terminals were enlarged, filled with structures we normally don’t see.”

Boassa said that as alpha-synuclein accumulates in the terminals, it appears to hinder normal degradation and recycling processes in neurons. This would progressively impair the release of neurotransmitters. In time, the neurons might simply stop functioning and die.

“Other studies have noted that PD is characterized by progressive loss of vesicle traffic, and neurotransmitter release,” Boassa said. “Our study provides a structural and mechanistic explanation for why that happens.”

Boassa said the findings shed greater light upon how PD is caused, at least in some heritable forms. Researchers plan to now probe more deeply into how the disease is propagated and how dysfunctional alpha-synuclein proteins spread from one neuron to another, hastening the advance of the disorder.

“The better we understand the mechanisms of PD, the easier it will be to develop clinical interventions,” she said.

Co-authors are Monica L. Berlanga, Masako Terada, Junru Hu, Eric A. Bushong and Minju Hwang, National Center for Microscopy and Imaging Research and Center for Research on Biological Systems; Mary Ann Yang and Julia M. George, Department of Cell and Developmental Biology, University of Illinois, Urbana; and Eliezer Masliah, Department of Neurosciences, UCSD.

Teen narrowly escapes death after smoking synthetic marijuana

STORY HIGHLIGHTS

• Emily Bauer wound up in ICU after her family says she smoked synthetic marijuana
• Synthetic marijuana is an herbal mixture sprayed with chemicals
• The drug was a form of synthetic weed packaged as "potpourri" at a gas station
• The Bauer family is starting a nonprofit organization called Synthetic Awareness For Emily

(CNN) -- Hospital staff removed Emily Bauer's breathing tube and stopped all medication and nourishment at 1:15 p.m. December 16. Only morphine flowed into her body, as the family waited by her side in her final moments.

But the next morning, she was still alive.

"Good morning, I love you," her mother told Emily as she approached the bed.

A hoarse voice whispered back, "I love you too."

Emily was back.

Her family said the drug that landed the Cypress, Texas, teenager, then 16, in the ICU two weeks earlier wasn't bought from a dealer or offered to her at a party. It was a form of synthetic weed packaged as "potpourri" that she and friends bought at a gas station.

At first, her stepfather, Tommy Bryant, said he was "fixing to whip somebody's ass," as he thought someone older than 18 bought it for her.

Bryant already knew she used real marijuana occasionally. "It's not that I condoned it," he said, adding that he couldn't follow her around all day. Bryant enforces a strict no-smoking rule in the house, and said that if he ever caught Emily smoking, she'd be grounded.

"Had I thought that there was any chance that she could have been hurt by this stuff, I would have been a lot more vigilant. I had no idea it was so bad," Bryant said.

"I'd never have thought we'd be in this situation. If she had bought it off the street or from a corner, that's one thing, but she bought it from convenience store."

Best known by the street names "Spice" or "K2," fake weed is an herbal mixture sprayed with chemicals that's meant to create a high similar to smoking marijuana, according to the National Institute on Drug Abuse. Advertised as a "legal" alternative to weed, it's often sold as incense or potpourri and in most states, it's anything but legal.

Synthetic marijuana was linked to 11,406 drug-related emergency department visits in 2010, according to a first-of-its-kind report by the Substance Abuse and Mental Health Services Administration. This is when it first started showing up on health providers' radar, as the Drug Abuse Warning Nework detected a measurable number of emergency visits.

Who wound up in the emergency room the most? Children ages 12 to 17.

The first state laws banning synthetic drugs popped up in 2010. Now at least 41 states -- including Texas, where Emily lives -- and Puerto Rico have banned them, according to the National Conference of State Legislatures.

Older legislation targeted specific versions of the drug, but the makers of Spice were a step ahead.

"These drug manufacturers slightly change the chemical compound, and it becomes a different substance that's not covered by the law," said NCSL policy specialist Alison Lawrence. "That's why in 2011 and 2012, we saw the states enacting these broader language bans."

Synthetic marijuana just as dangerous

Migraines came first

CNN first learned about Emily's story when her sister, Blake Harrison, wrote an impassioned narrative to CNN iReport. The story was viewed more than 130,000 times, shared more than 25,000 times on Facebook, and dozens of people shared comments, some supportive and others critical.

Harrison said she was surprised by how many people cared, especially on Facebook.

"You think a lot of people are going to say, 'Oh, it's just another person hurt by drugs.' But so many people were sharing it. It was a common ground for people against this stuff because it's a terrible substance."

Emily, a straight-A and B sophomore, developed persistent migraines about two weeks before she wound up in the ICU early on December 8, said Bryant. One bad migraine even sent her to the ER, and doctors scheduled an MRI.

But anxiety and claustrophobia prevented Emily from getting the test.

Bryant said doctors at Memorial Hermann-Texas Medical Center said the migraines were possibly related to using the drug.

"We correlated the time she got migraines with the time she started smoking this stuff," he said. "In their professional opinion, they think it's related. But medically speaking, they don't have a picture of her brain from before and after, so they can't say."

While her family doesn't know how long she'd been using the drug, her stepfather suspected she started around two weeks before the night that sent her to the hospital.

Common side effects to smoking synthetic marijuana include bloodshot eyes, disturbed perceptions and a change in mood, said Dr. Melinda Campopiano, a medical officer with the Substance Abuse and Mental Health Services Administration.

"People can become very agitated or can be come unresponsive -- conscious but not reacting normal to situations," she said. They may also appear paranoid or describe hallucinations. Some of the more potentially serious effects include an elevated heart rate and elevated blood pressure.

Campopiano said she had never heard of a patient having a stroke in these circumstances, but she described how high blood pressure could lead to one.

"Generally, strokes are caused by restricted circulation, or a blood clot that blocks circulation. What we would be looking at with Spice, or K2, is the restrictive circulation model," she said.

Bryant told CNN that doctors diagnosed his daughter with vasculitis, which is an inflammation of the blood vessels. The vessels going into Emily's brain were constricting, limiting blood and oxygen flow. Campopiano confirmed that vasculitis is one of the causes of strokes of this type.

"One of the difficulties is that there's no existing toxicology screen that can reliably detect these substances," said the physician. "There could very well be harms out there that we don't know about yet."

Online tools aimed at educating parents about synthetic drugs

'She was literally just a shell'

Emily complained of a migraine and took a nap at her house after allegedly smoking Spice with friends on December 7, said Bryant. She woke up a different person.

Stumbling and slurring her words, she morphed into a psychotic state of hallucinations and violent outbursts, her family said.

They called 911 after they realized she had "done something," some drug, said her stepfather. The Harris County Sheriff's Office confirmed they visited the house but declined to provide details.

When paramedics arrived, they restrained her and rushed her to a Houston-area hospital, where she was admitted to the ICU.

She bit guardrails and attempted to bite those trying to help her. Hospital staff strapped Emily down in the bed, said her sister.

"We thought once she comes down off the drug, we'd take her home and show her the dangers of this drug," said the 22-year-old. "We didn't think it was as big of a deal until 24 hours later she was still violent and hurting herself. We realized you're not supposed to stay high this long."

To keep Emily safe, doctors put her in an induced coma.

After days in the sedated state, an MRI revealed she had suffered several severe strokes, said Bryant.

"In four days' time, we went from thinking everything is going to be OK and we'll put her in drug rehabilitation to now you don't know if she's going to make it," he said.

The doctors at North Cypress Medical Center told the family there was nothing more they could do. She was sent to Children's Memorial Hermann Hospital. Citing patient privacy, doctors at Children's Memorial declined to be interviewed.

No consistency, no way of knowing

Knowing how different people will react to fake weed is impossible. There are a few reasons that explain why.

"You're hearing some pretty bad things with the synthetic cannabinoids -- part of that has to do with the potency. It can be 100 times more potent than marijuana," said U.S. Drug Enforcement Administration spokeswoman Barbara Carreno.

"Anything that was truly a fake pot wouldn't be making your heart race. I've heard of palpitations with marijuana, but not tachycardia."

In four days' time, we went from thinking everything is going to be OK ... to now you don't know if she's going to make it.
Tommy Bryant, Emily's stepdad

Carreno explained there's no consistency or quality control from one time to the next. The people making these products can be anyone from a college kid wanting to make extra cash to an operation blending large quantities in a cement mixer, she said. Two batches made by the same person could have different doses.

CNN showed Carreno a picture of the packets of potpourri Emily reportedly used -- the teen's friends gave her family the pouches after the incident. One black wrapper adorned with marijuana leaves reads "KLIMAX potpourri" and both labels read "KUSH TM."

"It's definitely a synthetic cannabinoid," Carreno said after seeing the photo.

The potpourri displays at stores also include a label that reads "not for human consumption."

Carreno called these labels a "cynical attempt" for the distributor to dodge the Controlled Substances Analogue Act, which covers any chemical similar to controlled substances such as cocaine or marijuana. It states that substances mimicking an existing illegal substance, such as marijuana, are also illegal.

"Everything about this is a lie," she said. "They're not potpourri. They're called that as a smoke screen for people naive to drugs and not to admit that it's drugs. But you can see it that they are."

Opinion: Regulate fake pot, it's not going away

From joy to nightmare

Up until December 13, Emily had been in an induced coma the whole time, said her stepdad. Her only movements were involuntary reflexes.

"Seeing her in the hospital, she was literally just a shell. There was nothing in her eyes. She was just lying there alive minimally," said Harrison.

ICU doctors said some of Emily's blood vessels were starting to open up. Harrison said it was a glimmer of good news that was quickly snatched away: "We all grew overjoyed, little did we know this would become our next nightmare," she wrote on CNN iReport.

The pressure on Emily's brain skyrocketed, she said. Doctors asked to drill a hole in Emily's skull and insert a tube to relieve pressure and drain excess fluid. The family signed off on an emergency surgery.

"The family waited and cried, we had no idea if we would ever see Emily again, but we knew that even if we did, we will never have our old Emily back," Harrison wrote on December 14.

It was a tense hour, but Emily pulled through.

What would Emily want?

A day after the emergency surgery, the Bauer family saw the extent of the damage to Emily's brain.

"We met with Neurology team who showed us Emily's brain images," wrote her mother, Tonya Bauer, in a daily journal on Facebook. "They told us that all white areas on images were dead. It looked to us at least 70% of the images were white."

Without the breathing tube, Emily's throat would not be able to stay open, as that part of the brain was dead, her family said.

Doctors painted a bleak picture of Emily's future. She would likely not recognize her family. She would be completely unaware of her surroundings. She would never be able to eat on her own and never regain function of her arms and legs, her family said.

"We were asked to think of what Emily would want. What quality of life would Emily want?" Tonya wrote.

The family decided they would take Emily off life support, just four days before her 17th birthday.

Hurdles to enforcement

One in every nine high school seniors admits to having used fake weed in 2011, according to a national survey by the University of Michigan. Synthetic marijuana is the second-most popular illicit drug they use, behind marijuana.

In July 2012, President Barack Obama signed legislation banning five common chemicals used to make synthetic marijuana and bath salts. And that same month, the DEA seized almost 5 million packets of fake weed in its first national sweep of the drug.

States handle the penalties for drug offenses in lots of different ways and possession has varying definitions, according to NCSL's Lawrence.

Some states, such as Texas, classify synthetic marijuana asSchedule I drugs, which are unsafe, have no medical use and a high potential for abuse.

"They're in line with other states. It's hard to say if there's a middle, but they're similar to other states," Lawrence said.

Each day is a fight

Three days after pulling life support, the Bauer family marked a day they didn't think they would: Emily's 17th birthday.

"Even though she couldn't move, is blind, and could hardly be aware of what was going on around her, she laughed with us as we made jokes and listened to her soft whisper replies," wrote Harrison.

"It is my little sister shining through, in every way she can manage, with every ounce of strength."

Each day since has been a fight -- a fight to move a finger, a fight to whisper something to her family, a fight for life, according to her big sister.

"She is in so much pain and confusion, but the family is thankful every single day to still have her alive," she said.

Her stepfather, who has been in Emily's life since he saw her in the delivery room, hopes he can spare other people his family's pain.

"I don't wish this upon anybody at all. When she cries for help and not being able to help her, to have her just lay there. ... She gets depressed because she can't move," he said.

"She wants daddy to fix it. It's very hard for me. If we could save one more parent this emotional roller coaster, then what we do and what we sacrifice will all be worth it."

Emily knows she's in the hospital and recognizes her family's voices, but Bryant says she's often confused. They're taking things slow, trying to get an idea of her capabilities. It's too early to tell the effects of the brain damage, but she's moving her arms and legs a little bit these days.

More than one month after the life-changing night, Emily was transferred to TIRR Memorial Hermann rehab hospital on January 14. The family says they haven't heard Emily's prognosis yet, but they remain hopeful as the teenager tackles physical, occupational and speech therapy, as well as living a new life.

Two weeks ago, Emily started eating solid food again. She even asked her sister for Ramen Noodles as they talked on the phone. "Even though they're such small steps for her, they're such giant steps of positivity," Harrison said.

Saving other kids from this

Bryant and his family are starting a nonprofit organization calledSynthetic Awareness For Emily. Their goal with SAFE is to educate families, as well as teachers and doctors, about the dangers and warning signs of synthetic marijuana use. Bryant said he has filed the paper work and is waiting to hear from the federal government on reviewing their nonprofit application.

"That's why we want to let kids and parents know about the warnings signs: migraines and withdrawal," he said. "We all know the warning signs of alcohol and cocaine, but with this synthetic weed stuff, it's so new that nobody knows about this stuff. We want to let other parents know about this so they don't have to go what we've been going through."

F.D.A. Approves Genetic Drug to Treat Rare Disease 

The Food and Drug Administration approved a new drug Tuesday that not only treats a rare inherited disorder that causes extremely high cholesterol levels and heart attacks by age 30, but does so using a long-sought technology that can shut off specific genes that cause disease.

The drug, Kynamro, which was invented by Isis Pharmaceuticals and will be marketed by Sanofi’s Genzyme division, is unlikely to be a blockbuster. It has some worrisome side effects and there might be no more than a few hundred people in the United States with the disease, known as homozygousfamilial hypercholesterolemia, or HoFH.

Still, Kynamro could become the first commercial success for the gene silencing technique, which is known as antisense, and which some experts say is finally poised to fulfill its promise after over two decades of research and numerous disappointments.

“What many people have been waiting for is validation where someone actually makes a profit and where patients actually benefit,” said Arthur M. Krieg, chief executive of RaNA Therapeutics, an antisense drug developer in Cambridge, Mass.

Isis, which is based in Carlsbad, Calif., has been pursuing antisense technology since the company’s founding in 1989, spending about $2 billion. It had one drug approved in 1998 for an infection associated with AIDS, but the drug did not sell well and some experts said it did not really use the gene-silencing mechanism.

Isis’s experience contrasts with that of Gilead Sciences, which was also founded in the late 1980s to pursue antisense technology. It gave up after several years — selling the patents it no longer needed to Isis — and went on to develop antiviral drugs using other techniques. It is now a biotech superstar with a market value of $59.8 billion, compared with $1.4 billion for Isis.

Stanley T. Crooke, the founder and chief executive of Isis since its inception, said the long period of development was not unusual for a new technology.

“I told people it would be at least 20 years and $2 billion before we knew if the technology would work,” he said in an interview Tuesday. “We think it’s a seminal day for the technology and the company.”

Isis or its partners are developing drugs to lower triglycerides, treat spinal muscular atrophy and reduce scarring from operations, among other things. The partners include Biogen Idec, Pfizer and AstraZeneca.

Two rival antisense companies, Sarepta Therapeutics and Prosensa are developing drugs for muscular dystrophy that have shown promise in early clinical trials.

Still, Dr. Cy Stein, a longtime antisense researcher, said it was too early to say that antisense had arrived. There have been false dawns in the field before.

Antisense drugs work essentially by shooting the messenger. The recipe to make a protein is carried from a gene in the nucleus into the body of a cell by a single strand of RNA, called messenger RNA.

Antisense drugs are small snippets of synthetic DNA or RNA that bind to that messenger RNA in a way that inactivates or destroys it.

In theory, an antisense drug can be made to shut down any gene, providing a means to develop a virtually unlimited number of drugs. But in practice, it has been difficult to deliver the drugs into cells with sufficient potency and lack of toxicity. Companies have developed ways to chemically modify the drugs to help in that regard.

Kynamro, known generically as mipomersen, inhibits action of a gene, apolipoprotein B, that is involved in the formation of particles that carry cholesterol in the blood.

If untreated, people with HoFH can have levels of LDL cholesterol, the so-called bad cholesterol, as high as 1,000 milligrams per deciliter. A level of 130 or less for LDL is generally considered desirable.

Statins work for these patients and have helped increase the typical life span to 33 years, from 18, but further cholesterol reduction is needed. Patients can also have their blood cleansed of cholesterol by being connected to a machine for a few hours once a week.

Patients in the main clinical trial of Kynamro started with LDL levels of around 400. After 26 weeks of treatment, those getting Kynamro had a mean decline in LDL cholesterol of 24.7 percent compared with a decline of 3.3 percent for those getting a placebo.

The label for Kynamro will carry a boxed warning about potential liver damage. Other side effects include injection-site reactions and flulike symptoms.

Kynamro will share the market with Juxtapid, a drug developed by Aegerion Pharmaceuticals that won approval last month.

In October, an F.D.A. advisory committee voted 13-to-2 in favor of approval of Juxtapid but only 9-to-6 in favor of Kynamro, largely because of concern about side effects. Juxtapid is a once-a-day pill, while Kynamro is injected once a week.

Genzyme has not announced the price for Kynamro but it might be similar to that of Juxtapid, which costs $235,000 to $295,000 a year, similar to some other drugs for extremely rare conditions
.