Almond milk may be the biggest thing to fly-off grocery store shelves since, well, sliced bread.

The toasty-tasting non-dairy product is produced by crushing roasted almonds into a buttery compound, and then adding water, stabilizers, vitamins, and a sweetener. A cup of almond milk contains about 60 calories, which is considerably lower than soymilk (90 calories) and less than half that contained in 2% milk (130 calories).

Enamored consumers have so far been willing to pay premium prices for almond milk. A 32 oz. container of almond milk costs approximately $1.80. That’s a few cents less than soy milk (still the leading dairy alternative), but far more than the cost of cow’s milk, which is roughly $1.25 per 32 oz. container.

Sales of almond milk and other milk substitutes topped $100 million last year. That’s trivial compared with the roughly $13 billion spent on cow’s milk. Still, its sales were up 15% year-over-year. Sales of cow’s milk are mired in a decades-old decline.

The increase in almond milk sales is driven by several factors aside from good taste and trendiness.  Increasing awareness of dairy allergies and a steady, though modest increase in vegan lifestyles play a role, for example. In addition, there has been some cannibalization of sales from soymilk after some studies suggested that estrogen-like compounds in the latter might predispose consumers to breast cancer.

The biggest factor however, has been the decision by grocery stores to sell almond milk in the refrigerator case, right next to cow’s milk. When that happened in 2009, consumer demand began to skyrocket.

“The beauty of the almond milk category is that almonds are so familiar to consumers, and there’s an expectation of great taste there,” Brooke Hansen a marketing expert at Silk, the second-leading brand of almond milk, said in an interview.

Almond Breeze, produced by Blue Diamond Growers of Sacramento, is the market leader. Blue Diamond rolled-out Almond Breeze in 2009 shortly after market testing showed huge uptake in Hispanic populations, which have high rates of lactose intolerance. Silk, which already had a soymilk product on the market, released its version of almond milk in January, 2010. Since then, the two entrants have been duking-it out in a marketing war reminiscent of the longstanding battle between Coke and Pepsi. 

Almond Breeze remains the market leader, with 2010 sales of $57.8 million. Sales of Silk were $47.1 million in 2010. (more…)

The Great Recession may have done something that countless public health campaigns and the billions of dollars spent to fund them could not: reduce our nation’s appallingly high teen birth rate.

According to CDC data released last month, the birth rate among girls between the ages of 15 and 19 dropped to an all-time low of 39.1 per 1,000 in 2009, the first full year of the worldwide economic recession. That was 6% lower than the previous year and the lowest rate since the government started tracking the statistic 70 years ago.

The trend among teens was consistent with drops in virtually all age groups, with the overall birth rates reaching a historic low of 13.5 per 1,000 females in 2009, down 4% from 2008. The drop was seen in teens in all races and ethnic groups. Among Hispanic teens, the birth rate in 2009 fell a full 10% to a still ridiculously high rate of 70.1 per 1,000 females. In African-American teens, the rate fell to 59.0.

Many scientists said it was too soon to conclude that the recession was responsible for the precipitous drop. Relevant data, like that referable to contraceptive use is still being collected for 2009. But even if there were a spike in such responsible behavior, the question remains why would that have happened? After all, the educational programs designed to promote contraceptive use have been around for years.

At a minimum, the recession is likely to be an epiphenomenon, a large contextual issue that drives more obvious relations between cause and effect. Would-be teenage moms “see parents who have lost jobs or houses. They’re very aware of how tough it is now, and I think that causes teens to be more cautious,” Sarah Brown, chief executive of the National Campaign to Prevent Teen and Unplanned Pregnancy told the Wall Street Journal. (more…)

Two years ago, Congress passed a law which tasked the FDA to regulate tobacco products. The legislation required the agency to ban cigarettes flavored with candy, fruit or spices because they might prompt younger people to start smoking. But the law punted a decision on the thornier issue of whether to ban menthol flavored cigarettes–which account for 30% of domestic cigarette sales–to the FDA.

To help the FDA decide this matter, Congress established Tobacco Products Scientific Advisory Committee. The committee’s final report on menthol cigarettes is due by the end of March. It could recommend an outright ban on the sale of menthol cigarettes, or that certain restrictions be placed on advertising these brands. Or it could recommend that the FDA take no action whatsoever.

Sometime after that, FDA will make a final call on the matter. Its decision will have a huge impact on Lorillard, the nation’s third largest cigarette manufacturer, since nearly 90% of its revenues are derived from the sale of Newport, a menthol-flavored cigarette.

Menthol is a naturally-occurring chemical that comes from mint plants. Manufacturers have added it to cigarettes for nearly a century, presumably because its local anesthetic effects and cooling sensations mask the harsh taste of cigarette smoke. The effect seems to attract young smokers in particular. A 2009 government study has shown for example, that nearly half of all smokers between the ages of 12 and 17 use menthol-flavored cigarettes.

Menthol cigarettes are also the overwhelming choice of African-American smokers. Government studies have shown that as many as 80% of African-American smokers prefer these brands, particularly Salem, Kool and Newport. Cigarette manufacturers have directed marketing campaigns for menthol cigarettes toward African-Americans for decades (see above picture). (more…)

Last year was another lackluster one for the drug and biotech industries, as the FDA seemed to ratchet-up its scrutiny of trial data and set the bar higher on requirements for drug efficacy. Overall, the regulatory agency approved 24 new drugs in 2010, which was slightly down from the 26 it approved in 2009 and dead-even with the 24 it approved in 2008. Only 17 were approved by the FDA in 2007

Two of the newly approved drugs appear to have a shot at becoming blockbusters: these are Gilenya, which is Novartis’ pill for multiple sclerosis, and Provenge, Dendreon’s injectable treatment for advanced prostate cancer. A pair of much-anticipated obesity drugs, Arena Pharmaceuticals’ lorcaserin and Vivus’ Qnexa were rejected by the FDA, as were many others. Perhaps the biggest news however, focused on the FDA’s handling of safety issues surrounding drugs it had approved in previous years. Here’s a summary of some winners and losers:

Newly Approved Drugs
Multiple Sclerosis-Patients with multiple sclerosis did have a good deal to cheer about last year. In addition to Gilenya, the FDA approved Ampyra (Acorda Therapeutics) to improve gait disturbances in MS patients.

Advanced Prostate Cancer-Dendreon finally won FDA approval for its cancer-fighting vaccine, Provenge. The regulatory agency had previously rejected the drug and required that additional trials be performed, despite early clinical trials which were generally positive.

Stroke Prevention-Drug makers have been vying for years to replace warfarin, the widely used anticoagulant that has been available for more than half a century. After receiving approval for its drug, Pradaxa to prevent stroke in patients with cardiac arrhythmias, Boehringer Ingelheim now has a head start in this highly lucrative field.

Emergency Contraception-HRA Pharma’s drug ella, was approved by the FDA last summer. It blocks pregnancy up to five days after sexual intercourse, a full-day longer than other drugs on the market. The drug is now marketed in the US by Watson Pharmaceuticals.

In Limbo
Stroke Prevention-The FDA asked AstraZeneca for more information from a generally positive study of the anticoagulant, Brilinta assuring a longer glide path to market for Boehringer’s entry into this space (see above). (more…)

Last week, Nintendo became the latest consumer electronics maker to warn that kids shouldn’t use their three-dimensional image-based gaming devices, because they may have a negative impact on development of the human visual system.

The warning came just a month before the company’s much anticipated release of the 3DS, which is just such a device that features a 3.5 inch screen which can create 3-D images without the need for special glasses. The 3DS is Nintendo’s most anticipated new product since it released the iconic Wii gaming device in 2006.

Sony’s PlayStation3, a similar product that requires glasses to create the 3-D effect, already carries a similar warning, as do 3-D TV sets made by Sony, Samsung and Panasonic.

Nintendo’s warning applies to kids that are 6 years old or younger. The Japanese company advised parents to block access to the game machine’s 3-D mode for these kids, while adding that it was OK for them to use the 3DS in 2-D mode.

The Nintendo 3DS is one of the first devices of any sort to project a 3-D image without the need for specialized glasses, which can be quite expensive in their own right. Many analysts believe this breakthrough will accelerate the adoption of home-based 3-D entertainment, a process that has been disappointingly slow to date. (more…)

Millions of parents sign-up their kids to play in organized sports leagues, happy in the belief that their little ones will, among other things, get their recommended daily amount of exercise. Remarkably, a new study suggests these parents are mistaken.

Federal guidelines call for kids to get a minimum of one hour per day’s worth of moderate-to-vigorous exercise. But scientists at San Diego State and the UCSD found that on average, only 24% of youth participants on organized soccer, softball and baseball teams met this minimum standard.

To reach these conclusions, Desiree Leek and colleagues recruited 200 kids between the ages of 7 and 14 that belonged to 29 teams from community sports leagues in San Diego County. The scientists asked the kids to wear accelerometers during practices and games.

Most kids practiced twice per week and participated in 1-2 games per week. Team practice times ranged from 40-130 minutes for soccer and 35-217 minutes for softball and baseball. Despite these lengthy practice times, the kids averaged 45.1 minutes of moderate to vigorous physical activity (MVPA) per work-out.

Participants on soccer teams (+13.7 minutes), boys (+10.7 minutes), and those aged 7 to 10 years (+7.0 minutes) got significantly more MVPA than their counterparts. Incredibly, less than 10% of kids in the 11-to 14-age bracket, and only 2% of girl softball players met the 60-minute guideline.

“Though participation in organized sports contributes to overall physical activity…sports participation is not sufficient to ensure youth meet recommendations on practice days,” the authors concluded.

In part, this turns out to be because kids are inactive for long stretches of these “organized” practices while they receive instructions from coaches or wait in line to take batting practice or run a drill.

“The health effects of youth sports could be improved by adopting policies and practices that ensure youth obtain sufficient physical activity during practices,” wrote the authors, who suggested among other things, “emphasizing participation over competition, sponsoring teams for all skill levels across all ages…increasing practice frequency, extending short seasons, using pedometers or accelerometers to monitor physical activity periodically during practices, providing coaches strategies to increase physical activity, and supporting youth and parents in obtaining adequate physical activity on nonpractice days.”

And remember, these practices and games occur only 3-4 days per week. Parents need to assure their kids get enough exercise every day.

The write-up appears in the Archives of Pediatrics & Adolescent Medicine.

No one would be surprised if, in a quiet moment, Ian Read confided that he doesn’t know what hit him.

Reid became CEO of Pfizer a few weeks back, following Jeffrey Kindler’s unexpected retirement. He took the lofty position knowing that his biggest task in the short-term would be to replace nearly 20% of the company’s annual revenues, more than $11 billion, beginning later this year when Lipitor loses patent protection.  He knew as well that Pfizer could make a good start in this regard if it could rapidly expand sales in emerging markets like China.

But he probably didn’t know that 2 people who were set to lead Pfizer’s international expansion would bolt the company soon after Kindler departed, or that a monumental regulatory shift in China was about to be announced, a move that could potentially cripple the company’s expansion plans in that country. And he almost certainly didn’t know his company would be ensnared by the WikiLeaks data dump as well.

Here’s a quick brief on the unexpected developments facing Read and Pfizer:

China-Last week, China’s National Development and Reform Commission cut prices on a host of drugs by an average of nearly 20%. Drugs on the list included Pfizer’s oral diabetes agent, glipizide (Glucotrol), and azithromycin (Zithromycin), an antibiotic.

“All the excitement about emerging markets is fine and good, but these countries are learning very fast how to contain the cost of medicines,” William Looney, the editor of Pharmaceutical Executive and a former Pfizer staffer in emerging markets told the Wall Street Journal. That may “tamp down the growth.”

Pfizer’s emerging market sales account for roughly 18% of the company’s top line, and these revenues have grown by 40% this year. Read has gone on the record stressing the need to leverage this opportunity.

Exodus-The 2 executives that followed Kindler out the door were Steve Yang and Jean-Michel Halfon. Yang had spearheaded Pfizer’s program to develop drugs in Asia. He was apparently poached by AstraZeneca. Yang is reportedly well-connected with physicians and scientists in China and knows the ropes when it comes to clinical research and trial implementation in that country. Halfon was the head of the company’s emerging markets division since its inception 2 years ago.

WikiLeaks-A leaked diplomatic cable from the US Embassy in Nigeria suggests that Pfizer hired investigators to “uncover corruption links” and other scandalous information about the country’s attorney general in an effort to persuade the Nigerian government to drop lawsuits it had filed concerning a Pfizer-funded clinical study.

The trial in question took place in 1996, and involved Pfizer’s antibiotic, Trovan. During that trial, 11 children died in a local outbreak of bacterial meningitis.

The cable was sent during settlement talks between the drug giant and Nigerian federal and state governments. The latter had claimed that Pfizer tested the antibiotic without obtaining consent from parents of children involved in the study. Pfizer responded that the deaths were caused by the infection, not the drug, and that it had obtained proper consent.

Pfizer reached a $75 million settlement with a state government in Nigeria soon after the cable was sent, and shortly after that, it settled with the Nigerian federal government. Pfizer has ridiculed the claims made in the cable as being “simply preposterous.”

A company the size of Pfizer can move-on rather easily from a fiasco like WikiLeaks-Nigeria, but as for the other matters mentioned above, let’s just say that Ian Read knows quite well the exact date his company’s Lipitor patent expires, and that the clock is ticking.

Lost amid coverage of the repeal of Don’t Ask Don’t Tell and passage of a new START treaty, the lame-duck Congress passed the America Competes Act last week. Although the move didn’t receive much coverage by the press, it is quite significant in its own right.

In what could turn out to be a decisive move in the effort to leverage American ingenuity and innovation, America Competes empowers all federal agencies to sponsor prize competitions to spur innovation, solve their most difficult problems, and advance their missions.

Prize competitions have been shown to be effective as a strategy to energize our nation’s innovators. The private sector and philanthropists use them quite often. According to a study by McKinsey  in fact, more than 60 prizes valued at $100,000 or more were introduced by such organizations between 2000-2007. Total prize money associated with these competitions approached $250 million.

Perhaps the best known among these are the competitions sponsored by the X Prize Foundation, a nonprofit organization that works with philanthropists and the private sector to foster innovation by offering enormous cash prizes to those who solve key technological challenges. In September, for example, it awarded a $10 million prize to 3 teams who created a production-ready car that got 100 miles per gallon (or an energy equivalent).

The X Prize Foundation has established similarly sized prizes for groups that achieve specified cost and speed targets in the area of gene sequencing, and a $30 million prize for the first private group that lands and operates a rover on the moon.

And as Eric Hintz points out, America Competes is not the first example of government-sponsored innovation challenges. In 1714, Hintz writes, the British Parliament offered prizes to those who would develop a means to calculate longitude at sea. It took awhile, but eventually John Harrison won nearly £14,315 for his marine chronometer. And in 1800, the French government created a Food Preservation Prize as a means to help supply food to Napoleon’s army. A decade later, Nicolas Appert won 12,000 francs for a vacuum-packing process, that is used for canned foods to this very day.

Until now however, the federal government had not implemented a prize-oriented open innovation strategy

But, as summarized in a post by Tom Kalil and Robynn Sturm on the Open Government Initiative blog, President Obama triggered momentum to change that when he floated the idea as part of his 2009 proposal titled, Strategy for American Innovation. Then, 6 months after a March, 2010 memo from the Office of Management and Budget confirmed the Administration’s commitment to the new approach, the White House and the General Services Administration “launched Challenge.gov, a one-stop shop where entrepreneurs, innovators, and citizen solvers can compete for prestige and prizes by providing novel solutions to tough national problems, large and small.”

In just 3 months since the launch, Challenge.gov helped 27 federal agencies release 57 challenges on topics ranging from childhood obesity and Type 1 Diabetes to advanced vehicle technologies and financing for small businesses.

Comment
Frankly, I can’t remember a more creative, dynamic initiative coming out of Washington. Innovation is in this country’s DNA. It has helped make our country great. In today’s increasingly competitive global economy, we need it more than ever. Moreover, prize competitions, whether sponsored by governments or other entities, do work. They allow sponsors to exponentially increase the number and diversity of people that are focused on the toughest of challenges.

And as Hintz said, the sponsor pays only for positive results. Nice work, fellas!

Maybe it’s time to bring Junior in for a heart check-up.

Heart attacks are vanishingly rare in kids and adolescents, but a growing body of literature suggests that the seeds of heart problems later in life are sewn in this age group. Two studies published recently in Circulation lend further credence to this idea.

In the first of these, Markus Juonala and colleagues at Finland’s Turku University Hospital followed a cohort of 4,380 people from a very young age through their 40s, and found that high systolic blood pressure, high cholesterol levels and a high body mass index in—get this—kids as young as age 9 are strong predictors of arterial wall thickening more than 3 decades later. This thickening is good non-invasive evidence of arteriosclerosis, the proximate cause of heart attacks and strokes.

Interestingly, Juonala’s group found that the presence of these risk factors at either age 3 or age 6 did not have a similar predictive value for problems later in life.

The second study, by Mika Kähönen and colleagues of Tampere University Hospital (also in Finland) used a similar longitudinal design. This group essentially proved that what your mother has been telling you all these years is correct: kids who ate fruits and vegetables at least once per day turned out to have healthier arteries when they became young adults than those who consumed these heart healthy foods twice a month or less.

Both studies relied on an arterial pulse wave velocity test to assess arterial wall thickening.

The results of these studies support many earlier ones which have indicated that all those well-established cardiac risk factors start kicking-in between the ages of 8 and 10. And yes, they do suggest it might not be a bad idea to get Junior checked for cardiac risk factors about the time he enters 4th grade.

The visit might include a blood pressure check, a cholesterol test, an assessment of the body mass index and a careful history covering exercise, diet and exposure to second-hand cigarette smoke. That said, it’s essential to seek guidance on the meaning of this visit from your doctor, since norms for these tests and historical factors aren’t as well established for kids as they are for adults.

Studies about the health effects of alcohol always make headlines.

And it’s remarkable how complicated those health effects have turned out to be. In a 2-week period last September for example, the press covered 2 negative studies and 1 positive study about the health impact of alcohol: on down side were studies showing that consuming one lousy alcoholic beverage per day increased the risk of cancer in women, and that that people who consumed 2 or more alcoholic drinks per day had a 22% higher risk of pancreatic cancer. On the up side was a study showing that moderate drinking was associated with a reduced the risk of dementia.

Well guess what, Edith? Scientists have presented, and the press has duly covered, 2 more studies on the health effects of alcohol. And both of them were positive!

Edith? Edith? Are you listening?

In the first, Qi Sun of Brigham and Women’s Hospital looked at 14,000 women from the Nurse’s Health Study, 1,440 of which had survived to age 70 without cardiac disease or cancer, and without memory problems or physical impairments. He compared alcohol consumption during midlife in this healthy cohort with that in women who had one or more chronic diseases, or mental or physical limitations. He found that the women who downed one or two drinks on most days of the week were 28% more likely to be members of the healthy cohort than women who drank no alcohol at all.

The second study focused on the risk of stroke. It also relied on data from the Nurse’s Health Study. In this instance, scientists looked at 73,000 women with no history of heart disease or cancer at the time they enrolled in the study. Going forward from their enrollment date, women who consumed an alcoholic beverage per day had a 20% lower risk of stroke than their tea-totaling counterparts. Alcohol intake higher than one drink per cay conferred no additional benefits. Interestingly, women who took hormone-replacement therapy and who consumed at least 2 drinks per day had a slightly increased risk of stroke.

The Nurses’ Health Study has enrolled over 200,000 women since its inception 35 years ago. It provides a good data set for studies like this because staff personnel obtain detailed histories about alcohol intake at regular intervals. This reduces errors caused by faulty memory.

Both the above studies were presented at the annual meetings of the American Heart Association last month. The AHA and other groups recommend that women should consume no more than one drink per day (for men, it’s two), and that no one should start drinking alcohol in order to gain these health benefits, since by all accounts they are small.