Oh, To Be a Koala: Battling Fat & Diets

This week has seen a lot of fat-loss-related news. Now I used to be infatuated with biology in high school and if I weren't going to school for finance, I would've happily done pre-med. So let me share a secret with you that I learned from my favorite teacher Mr. Fenoli. First day of class he hammered in something he hoped would save us girls (he wasn't sexist...it was an all-girls school) a lot of time with: to lose weight, burn more calories than you eat.

I've always wondered about fad diets. The above mantra is so simple and common sense, so what's wrong here? Funny how one of the things that saved us from death in our caveman days is now the sixth leading cause of death according to the Center for Disease Control's latest data (2006). But I guess people know smoking kills/causes sallow skin and acne/reduces sperm count and they do it anyway.

So this new cookie diet is one fad that's as ridiculous as the others and another testament to our national eating disorder (but it's not all our fault-our political leaders started a cheap food farm policy in the 70s and it worked too well: US farmers now can produce 500 more calories per person per day and logically a lot of that went into our guts). To follow this new diet, simply eat six cookies and one meal totaling 1,000 calories every day. How this is better or healthier than just counting calories but eating balanced meals (that's plural) is beyond me.

This week was also when we found a new weight-loss drug, liraglutide, to be more effective than the one we had- orlistat of Alli and Xenical. There's no mention of orlistat's pleasant side effects of leaking oils and suffering from stool incontinence. Rather, with this new wonder drug you might be more likely to vomit. And we all know that's a pretty effective weight loss method itself.

So liraglutide's already been approved in Europe and is being sold as Victoza by Denmark-based big pharma company Novo Nordisk. They seem to be doing pretty well since the drug was approved this April.


While there's no information on how many people used orlistat when they didn't need to (weren't obese nor were diabetes patients), I would guess there were a lot of people using it as a shortcut to get fit for summer. I doubt liraglutide will be any different.

Also consider that it seems plain vanilla diet supplements are not enough when we can get prescription drugs. We still like our diet replacement meals though, according to Euromonitor International. And Americans really like spending money to replace old fashioned self-control.

Why is it this hard? If you want the full answer, read Michael Pollan's The Omnivore's Dilemma. To illustrate the "dilemma" Pollan references a thirty-year-old paper written by UPenn researcher Paul Rozin titled "The Selection of Foods by Rats, Humans, and Other Animals," contrasting the koala's choiceless, thought-free approach to what's for dinner (nothing but eucalyptus leaves) with an omnivore's, where possibilities are endless and for which we need large brains to ponder about.

Because we aren't koalas, however, we'll always be tempted with that hot dog, that cheesecake, that steakburger. But because we are also gifted with modern technology that is the iPhone calorie-counting app, please don't turn yourself into a malnourished cookie monster. Just move more than you eat. And another tip: As Pollan puts it in the opening of his second book, In Defense of Food -

Eat Food. Not too much. Mostly plants.

Lashes to Maybe Literally Die For

This spring I visited Taiwan to see about resuscitating my Chinese by applying to Normal University's summer program (although I got in, I stayed in NYC for some entrepreneurship experience instead). This was about at least the tenth time I came, my parents hailing from Taiwan and taking me on trips to Asia EVERY year since I was three...no hyperbole here.

Two things struck me as most different from my previous trip last summer. The first was how much traffic increased (no doubt a sign of economic recovery after China somewhat unfroze relations by, for example, allowing direct flights between the two just last year in June of 2008-great help when there's such heavy trade on the line). The deterioration then was so apparent I thought there was some China-esque anti-pollution government mandate in effect when for an entire string of weekdays major roads were void of traffic even during rush hours.

But, and here comes the blog-related stuff, the second most visible change was how many girls were wearing eyelash extensions.

Now Asian obsession with longer eyelashes has been around for a long time, with Asians having characteristically (and being one myself, let me say frustratingly) short, straight and sparse fringes. I've even emailed Jared Diamond, the author of my favorite book Guns, Germs and Steel, on this subject about the origins of human societies. I'll let you know if he responds. Maybe Asia just wasn't as dusty back then so we didn't need as many eyelashes. Then again there is no race gene so it might be anyone's guess.

So from this we see that several innovations to enhance eyelashes have stemmed from Asia from the famously infallible $19 Shu Uemura eyelash curler and their insane false eyelashes (loved by the likes of Jennifer Lopez who had custom-designed fox or mink ones to wear to the Academy Awards in 2001 with a "Tokyo Lash Bar" that's been making waves in the industry) to Imju's Fiberwig, the first mascara that uses fibers and a formula to form individual tubes around each lash. I also saw heated eyelash curlers in the aisles of Watson's (aka Rite Aid of Asia) and had been bringing them back for friends a decade before beauty retailer Sephora had them here.

So plain mascara isn't good enough anymore, as about half of Taiwanese girls I saw there had obviously glued on a pair of fakes-a big change when I only noticed them on Sogo and Xin Guang San Yue department store salesgirls last year. When I asked a girl about her false set, she just said everyone else had them and saw it as no big deal.

(But they are if you consider these things are a couple bucks (to $20) a set, you've got to take the time and effort every morning to glue the lashes on and risk tearing out a few real ones, and they're as reuseable as fake nails.)

While I couldn't find specific numbers to find out exactly how much sales in these things have risen, there's a lot of news on this new focus on eyelashes not just in Taiwan but in the US.

In fact, there's been talk about a "mascara indicator" to replace the "lipstick indicator," which Estee Lauder Chairman Leonard Lauder coined when right after 9/11 deflated the economy he noticed lipstick sales were stronger than usual. But the indicator was debunked this year when it seemed lipstick was actually not impervious to the economy, tanking six percent earlier this spring. On the other hand, according to WWD, mascara sales jumped 6.68 percent which made some hail mascara as the new indicator (with a methodology about indicators which I have major beef against, but that's a whole other story). This mascara trend was noted as early as last October by the WSJ. Although no specific mascara data is available (NYU doesn't have access to NPD group unfortunately), Euromonitor International shows (big surprise) the US leads the pack with Japan in second when it comes to spending on lip and eye make-up products.

But now, it looks like the West is leading the craze for lusher lashes with our own way - tools and harmless inky black stuff, a method used for centuries, is no longer good enough. We need prescription drugs!

So in the last year, we've been seeing a lot of new lash-growers on the market.

Latisse was the first-a prescription drug for nothing but longer lashes brought to you by Allergan, the people that gave us Botox. Latisse is made from a prostaglandin (in this case, Bimatoprost), a chain of fats that's used to treat glaucoma. Actually, it was glaucoma patients who discovered this eyelash side effect in their battle against blindness. So now we've got perfectly healthy people like Latisse spokesperson Brooke Shields using drugs that glaucoma patients have no choice but to use.

Allergan's Latisse actually came out this year (and was slapped by the FDA for downplaying risks on its website last month) but it wasn't the first to discover prostaglandins' effect on lashes. Jan Marini Skin Research came out with their first lash booster back around 2005 but then the FDA had US marshalls seize $2 million worth of the stuff in 2007 when it turned out JMSR never applied for FDA approval (some say Allergan tipped them off) for including in the casual product a drug that could cause eye inflammation and BLINDNESS from nerve damage.


Of course JMSR had their own version of events saying they had discontinued sales in 2006, and then introduced a new version last year that now just vaguely lists among ingredients "proprietary peptides" and "other essential factors." Other similar products touting the same effect are Revitalash, Peter Thomas Roth's Lashes To Die For, Lilash (all of which use prostaglandins) and Talika's Lipocils (which has all natural ingredients and being a previous user, I can't say whether it works).

But here's the bad. Peter Thomas Roth warns its unsafe to use the product if you're pregnant or under 18. Latisse's possible side effects are darkened eyes (as in pupil color), itchy, dry or red eyes, red eyelids, darkened skin where the solution is applied. Allergan also cautions that contact lens wearers should remove their lens and wear them 15 minutes after application, and also for users to discontinue use if "visual acuity" is compromised (ie you turn blind).

I was turned off by the products when I read the "don't use if pregnant or under 18" warning. And anything that might compromise your eyesight is probably not the best-it might be depressing if you use what glaucoma patients use and turn into an eye-problem patient yourself. Until we see what happens after long term use (for me, that's around 50 years, at which time I probably won't care so much about the length of my lases), I think I'll stick with plain old mascara.

Speaking of NyQuil: Supplements and Multivitams

This NyQuil case was a good step toward closer scrutiny of supplements, and thinking about it again, there's another misconception I'd love to address:

Not all supplements are created equal.

Those cheap, one-tablet-a-day multivitamins? You might just consider them garbage when you're talking about whether you're even absorbing any of it, whether the manufacturer is lying about how much is in them, or worse if they contain poison.

While numbers are hard to come by when you're trying to figure out how much a human body is absorbing (called "bioavailability") from a specific source and the FDA says repeatedly that it's not their responsibility to regulate, you can be sure it's a business that needs regulating, especially when it's a $22.75 billion business from last year alone (Americans spent $7.54 billion) according to Euromonitor International.

ConsumerLabs actually found that taking whatever cheap multivitamin out there can be useless or dangerous: 52 percent of the multivitamins it examined were contaminated with lead, didn't disintegrate properly, or had more or less of certain ingredients than indicated on the label.

Such is the seriousness of this matter that there is a nonprofit organization called U.S. Pharmacopeia (USP) devoted to testing multivitamins and certifying ones that are safe and worth taking (this certification is displayed on the packaging).

Then, if you're thinking about taking multis even if they don't prevent the common cold because they might prevent long-term, more serious illnesses, it's no good there either. In 2006 scientists in the State of the Science Conference at the National Institutes of Health found after extensive trials that the "evidence is insufficient to prove the presence or absence of benefits from use of multivitamin or mineral supplements to prevent cancer and chronic disease."Obviously this wasn't such resounding news as year-on-year growth of multivitamin sales was higher from 2006-2007 than the year prior according to Euromonitor International. Or we didn't get the memo until the next year, which had a lower rate of YOY growth.


But if you're really bent on getting your vitamins and can't go the fruit and veggie route, get the USP certified stuff and stop drowning yourself in OJ once you're sick (not that oranges are even in the top five most Vitamin C-packed raw fruit list - Barbados cherries are first, then guavas, currants, kiwis, and longans, then lemons according to nutritiondata.com). Or more effectively, just invest in some all-natural hand-sanitizer. I would consider it more effective and safe than cultivating expensive pee and lead pills.

NyQuil, Vitamin C and Multivitamins

I can't talk enough about viral sicknesses after being completely enraptured by the infectious but unliving genetic structures in high school after reading stuff like The Great Influenza by John Barry and The Hot Zone by Richard Preston. That was the only type of terror I could happily handle, being so traumatized by movies like The Ring that I used to lie in bed in the middle of the night debating whether or not to get up and pee.

So here's a third post on the subject of fighting viruses in about a month...because it is very important:

You MUST know that gorging on massive quantities of Vitamin C when you're sick will not doing anything except maybe give you the runs. Vitamin C does not cure the flu.

This myth about Vitamin C curing common sicknesses is something I vehemently would love to eradicate with pleasure, so much that I used to troll Yahoo! Answers for the opportunity to warn people about this.

Well, we are one step closer to greater enlightenment, when today the FDA told Vicks to stop putting Vitamin C in NyQuil, since leads people to believe the FDA has evaluated the vitamin's efficacy when in fact (and big surprise) the agency's experts have found that Vitamin C does not cure the common cold. That this is clearly stated in the third line of the NYT article is even better.

I became aware of this pervasive misconception when in high school I read a small blurb on the subject in Newsweek's Periscope section (which ceased to exist this year), debunking both Vitamin C as well as Echinacea, saying that Zinc, instead, has been shown to slow growth of rhinoviruses (common cause of the cold) in recent studies at Wesleyan and as early as 1974. And then while Zinc hasn't exactly been completely debunked with several conflicting studies, there have been health concerns about taking too much of it, leading to the recall of Zicam earlier this year.

This is on top of last year's lawsuit in March against Airborne, which settled, paying $23.25 million to compensate for marketing itself as a cure of the common cold.


So where did the myth come from? Linus Pauling, a Nobel Prize-winning chemist (1901-1994) who wrote a book in 1970 exalting the benefits of Vitamin C without any scientific evidence. Even Pauling's biographer, Thomas Hager, said to Newsweek here that "he seemed to be prescribing a major change in dietary habits without much evidence."

I told my dad about this but old habits die hard with a fervent believer, so whenever he tells me to knock back a couple Airborne tablets when I'm feeling sick I just let him go on. After all, the placebo effect is undeniable, especially with major scientific proof to actually see it in action...so just forget about all this if you can't stand to see the light and you'd rather stay in Plato's cave.

Plastic Surgery Beauty Pageant

Plastic surgery is becoming as common as any other beauty routine, and it is far from a exclusively American trend, as I found out after a business school-sponsored trip to South Korea junior year. One of the first things they told us at orientation in Korea was 1. the country's lack of garbage cans despite the litter-free streets (clean and less wasteful culture?) and 2. EVERYONE's had plastic surgery done, with fourteen-year-olds getting their eyelids done. Well, everyone being 30 percent of all women. Which is as common as braces in the States.



So even though plastic surgery has been down in these economic times with surgeries in the states having fallen 15 percent from 2007 to 2008 (the same thing is happening in S. Korea too) while we Americans are still spending a ton on it (like $10 billion. See below), I guess with the ubiquitous nature of the trend it would be inevitable that one day we would have surgically-enhanced beauty pageants. Which is what happened Friday in Budapest, Hungary.

In the world's first plastic surgery beauty contest called Miss Plastic Hungary (winner Réka Urbán at left, who's a hostess and had only her breasts done just this year, won a new apartment...her surgeon won a prize also), the only requirements were to be female, at least 18 and to have undergone at least one cosmetic surgery. And organizer István Venyige asked that the surgeries not be too "extreme."

Of course the judging might not have been too level since contestants weren't grouped by what they had enhanced, but it's the world's first pageant of its kind so there's room for improvement. Or Venyige (not much information available on him unfortunately. I'd be very curious to know what his stake is in the biz) just wanted the publicity and didn't care.

But officially, why the pageant? Venyige says on his website that cosmetic surgeries in Hungary are not widely accepted. While there's not much reliable information on surgeries broken down by country, a Medical Treatment Abroad Survey said Hungary, along with India and Turkey, were the most popular cosmetic surgery destinations for UK patients.

But Venyige could also be comparing Hungary to the US, where we make everyone else look like puritans. According to the British Association of Aesthetic Plastic Surgeons (BAAPS), in 2006 there were 5,655 or 50 percent more breast augmentations (most popular in Europe and the States) compared to the prior year. Britons also apparently spent almost $1 billion (£497) total on surgeries in 2006.

Now compare that to the US, where in the same period we spent an estimated $10 billion on surgeries! But that's pretty easy to believe when as early as in 1997 we had 101,178 breast augmentations and last year we were up to 355,671. It might just be like the alarm clock thing where Americans are a lot more open to (sometimes shameless) self-improvement.

Anyway angry protesters aside, this is a small but interesting development toward acceptance that we have come a mind-blowingly far way from our caveman times. It sounds like science fiction when we're creating smarter, more (artificially) beautiful versions of ourselves. What about IQ tests on Adderall? Art contests on LSD?

Drug competitions might sound dangerous but it's comparable to plastic surgery. We're not just altering our minds but also bodies. And people seem to forget that plastic surgery is, well, surgery. The American Society of Plastic Surgeons (ASPS) say the plastic surgery fatality rate is 0.25%, comparable to the overall surgery fatality rate, and this is from the pro-plastic surgery folk. Then the FDA says that liposuction deaths could be higher than deaths from car crashes.

Whatever the rate I'm sure we can all agree it is a pretty unfortunate way to die when some out have no choice but to undergo surgery. So I hope people remember that before they opt for it that plastic's a pretty terrible way to die.

Allergan's Free-Speech Suit Against FDA

For the first time a drug maker, Allergan (NYSE:AGN), filed suit Thursday against the FDA and US government for violating the First Amendment of the right to free speech.

Currently, drug companies are prohibited from communicating anything related to uses of a drug that is unapproved by the FDA. But once a drug is approved, doctors can prescribe the drugs for uses other than what the drug was approved for. In this way the Botox-manufacturer wants to legally share with doctors what it calls "truthful and relevant" information concerning off-label uses of Botox such as dosing, patient selection criteria, and injection technique.

Allergan contends that 1 out of 5 drugs in the US are prescribed for off-label uses, and although the company won't disclose what that statistic is for Botox, it does say that half of Botox prescriptions are for medical, rather than cosmetic, reasons.

Regulatory authorities have approved botox not just for wrinkles but for 21 indications in 80 countries, including eyelid spasms, excessive sweating, crossed eyes and neck contortions. But doctors still prescribe Botox for unapproved uses such as facial spasms and headaches.

Whatever the ruling will be (NYT cites analysts who believe Allergan won't really pursue the lawsuit and is just using it as leverage for wiggle-room in providing off-label information), there's no doubt other drug companies are watching closely. But I doubt Allergan can win this one. After all, if drug companies are able to share such information with doctors, the FDA will have to investigate whether that information is true, so what's the point? The FDA might as well just approve it for that use anyway. Or will it be that the FDA-approved uses are more thoroughly approved than the non-approved uses because approving everything will take too long? Or if companies are just allowed to say whatever they say is "truthful" who will have the time to monitor those claims? It just doesn't seem viable either way.

And Allergan's investors seem to know it too. The company's shares fell 1.77 percent when the market closed Friday at $54.96.

Cephalon's Smart-Pill Sale Tactic

Biopharmaceutical company Cephalon (NASDAQ:CEPH) announced last week that the FDA will review its sleep disorder drug, Nuvigil, for treatment of jet lag. If it is approved (the decision is expected by December 29 this year), Nuvigil will be the only FDA-approved treatment for jet lag. However, Nuvigil is just a improved version of Cephalon's flagship alertness drug, Provigil (in the same "brain pill" class as Ritalin and Adderall), which was introduced in 1998. There are actually no head-to-head clinical efficacy trials comparing the two drugs, but Cephalon claims Nuvigil lasts longer in a 24-hour period.

Launched in the US markets in just June this year, Nuvigil is really Cephalon's answer to Provigil's potential generic drug competitors. And Provigil is worth protecting for the company, accounting for 54.9 percent of Cephalon's revenues in the US and 48.9 percent internationally in the first half of 2009. This is a 16 percent increase from the same period last year. However the increase was more due to a 10 percent price hike, offset by a 3 percent decline in prescription growth.

And let's look at this price hike, because you can be sure the company's focused on squeezing as much money out of this as quickly possible. But the tactic Cephalon has been using to protect sales quite clever...although described as shameful by some.

The company increased the price of Provigil by 28 percent last year in March according to WSJ, a 74 percent total increase from four years before that (this year, Provigil's about 10 bucks a pill), and has been offering Nuvigil at a 11 percent discount. And it's been working: in July Nuvigil had around 6,000 prescriptions a week, in a 50-50 split between new users and Provigil-to-Nuvigil users. 40 percent of new prescriptions were also supported largely by coupons, as CFO Kevin Buchi said in the 2Q earnings call in August.

Cephalon has also had run-ins with the Federal Trade Commission on antitrust and misleading marketing issues. In a case that is yet to be settled, the FTC alleges that the company broke antitrust laws by paying generic drug manufacturers $200 million not to flood the market with generics before 2011 or 2012. Then last year, Cephalon plead guilty to a criminal misdemeanor, paying at least $440 million for promoting three of its drugs, including Provigil for uses other than its FDA-approved treatment of sleep disorders.

This also comes at a time when, according to The Christian Science Monitor this May, 10 percent of American college students use prescription mind-enhancement drugs as study aids. The British science journal Nature also ran a survey in April 2008 of 1,400 people in 60 countries, finding that 20 percent had used such drugs for nonmedical reasons (only half had prescriptions for the drugs they were using), and even though half reported unpleasant side effects, 4 out of 5 "thought that healthy adults should be able to take the drugs if they want to." This view is shared by the editor of Nature as well.

The only largely publicized danger so far that the drugs may be habit-forming. Cephalon doesn't deny it, pointing out that Provigil has disclaimers warning exactly this. But this "danger" isn't saying much considering how everyone knows cigarettes are addictive but smokers love their cancer sticks regardless. Now imagine cigarettes that give you the effect of coffee on steroids. I doubt there will be much resistance to that, even if they are addictive. But given our inability to see long-term consequences, I wouldn't be surprised if we find 50 years from now that those who do use such drugs are more likely to suffer from brain disorders. After all, these users are trying fix what ain't broke.

Andrew von Eschenbach

Thinking again about this ReGen matter, I realized I didn't pay much attention to where focus should be due. And it seems there is some dirt to be re-exposed here.

So we turn to former FDA Commissioner Andrew von Eschenbach. Described by some as a "silver-haired, lasso-tongued" Bush family friend, von Eschenbach actually has a history of conflicts of interest and political dealings, two of which I think are pretty severe:

1. Providing a false written testimony on events concerning approval of the antibiotic Ketek, which has been linked to 18 deaths and at least 134 cases of liver damage. In 2007 the FDA finally revised their review, adding a black box warning to the drug, the strongest form of warning.

2. The anti-diabetic drug Avandia scandal: von Eschenbach stunningly stripped power from FDA safety supervisor Rosemary Johann-Liang after she approved a black box warning of the risk for congestive heart failure. Eight years later the FDA issued an alert about a 43 percent increased risk for heart attacks and increased risk of death.

Questions were also raised about a triple conflict of interest by simultaneously being part of the FDA, National Cancer Instutitute as well as C-Change, a forum for cancer organizations that von Eschenbach founded. And he was even accused of "complete and utter disrespect for congressional authority and hence the law" by Sen. Charles Grassley (R-IA).

So I find the focus on the four Congressmen a bit surprising. Who thinks the FDA is completely unbiased from political pressure? And who doesn't believe companies use lobbying to their benefit? It seems the Congressmen weren't defiling the virgin as much as they were paying the prostitute. And where the Chinese executed their FDA director Zheng Xiaoyu for bribes (okay, he did take more than $832,000 and did approve fake drugs), von Eschenbach got off comparatively easier when Ketek and Avandia killed people too. Plus when even the ReGen story broke out, not much attention was paid to von Eschenbach. I just hope Obama's pick, Margaret Hamburg (appointed this May) will be a step in the right direction.

ReGen's Menaflex and the FDA

For the first time the Food and Drug Administration on Thursday has publicly admitted a process of approval might have been unduly influenced by politics. The FDA accused four New Jersey congressmen and a former FDA of questionable conduct in the approval of Menaflex, a knee device manufactured by Hackensack, N.J.-based ReGen Biologics (OTC:RGBO).

In the preliminary report, the FDA acknowledges that although it is not unusual for members of Congress to inquire about a constituent's application, it describes the involvement of four New Jersey democrats — Reps. Frank Pallone and Steve Rothman and Sens. Robert Menendez and Frank Lautenberg — in the ReGen matter as "highly unusual" in persistence and interest.

The Director of FDA's Office of Legislation called the pressure as "the most extreme he had seen" and acquiescence to this pressure as "unprecedented in his experience" while the Assistant Commissioner for Accountability and Integrity described daily interactions with the Company's political consultant as "increasingly tense."

Furthermore, the FDA points the finger at the FDA Commissioner, Andrew von Eschenbach, M.D., who was pushed to intervene by the Congressmen and therefore took charge of matters usually under the control of the Review Division or Center Director. Von Eschenbach even agreed to a 90-minute meeting with ReGen executives, who appeared to want von Eschenbach to review Menaflex himself.

Anyway, of course on Friday ReGen gave its own press release making clear that the quality of its device was not the primary topic under question, as opposed to the FDA approval process which was the source of controversy. CEO Gerald E. Bisbee, Jr. calls the scientific evidence for the device "solid" and reminds us that 3,000 in Europe and the U.S. have had successful Menaflex surgery.

What ReGen conveniently does not mention though, is that the FDA reports although ReGen had repeatedly complained of "unfair treatment" when Menaflex did not receive the positive reviews from various groups of scientists reviewing the device, there was absolutely no finding of "unfair treatment" and the proceedings "did not substantially prejudice ReGen in any event."

Then, the report continues, instead of ReGen appealing the unsupportive reviews according to standard appeal procedure, the Office of Legislature simply began receiving phone calls from the Congressmen complaining about the "unfair" reviews.

I guess that might work when according to lobbying watchdog website opensecrets.org three ReGen exectuvies had given $26,000 to the four Congressmen in political contributions (in fact, ReGen became the third largest donor for Rep. Steve Rothman, picture at left, in 2008. ReGen wasn't even the top 100 top donor list for Rothman in 2006).

The FDA is now revisiting the approval of the device. But with efficient market theory beautifully at work here, the company's stock price has responded accordingly, crashing from $2.00 earlier this month to a low of $1.01 on Friday, closing at $1.25. Down because of the news, and still down because of shareholders' realization that the company might use lobbying rather than a device's benefits to speak for approval. ReGen has been posting losses since at least 2005, but a revisition of approval might be good for potential troubles it may save.

OncoMethylome blood screening

Liege, Belgium-based molecular diagnostics firm OncoMethylome Sciences (EBR:ONCOB) announced today it has developed blood tests that can screen for colorectal cancer (CRC) with 90% accuracy. The blood test screens for genetic markers of the disease (SYNE1 and FOXE1, if you must know) and is extremely inexpensive-as little as $10 per test.

Compare that to the only options today: complex procedures and/or unpleasant examinations (colonoscopy, fecal analysis) which can only be performed by experienced practitioners with expensive equipment. Therefore potential patients are often discouraged from undergoing examinations; according to cancer.org, only 40% of CRCs are detected at an early stage since at this stage CRC usually does not even have symptoms. After CRC has spread regionally, only 68% of patients are expected to survive past 5 years. So such a blood test is great news, especially when CRC is the third-most common cancer in the U.S. (accounting for 9% of all cancer deaths).OncoMethylome also said it is currently in talks with large companies concerning licensing rights. With such a breakthrough, the firm should be able to ink a profitable deal, and OncoMethylome needs it.

Just end of last month when the Euronext Brussels-listed company reported its half-year 2009 financial results, it disclosed that revenues in the first six month of 2009 fell 17 percent to €1.3 million from €1.5 million in the first half of 2008. It was then that CFO Philip Devine said that same day in an interview with Reuters that OncoMethylome was inking deals with other companies for its blood-screening cancer test and that contracts "are not signed but ready to be signed."

CleanWell

One more weapon can be added to the inner-germophobe's arsenal, and we are one step closer to controlling organisms and viruses that have plagued us since the beginning.

The first ecofriendly, all-natural hand sanitizer brand CleanWell is launching a Foaming Desktop Hand Sanitizer sometime this month, Marketing Director Holly Bornstein said last week in an interview with CleanWell partner Honest Foods. Currently all CleanWell products are in spray-form only, and with a new product for those who prefer foam sanitizers, CleanWell's popularity should receive a substantial boost.
Not that it needs it, though: introduced just in February 2008 by a San Francisco start-up, CleanWell has been wildly popular, being offered in fine retailers from Target to Wholefoods and used by chemical-wary moms to green types to President Obama himself (who became a fan on the campaign trail). CleanWell was also a finalist in the 2008 International Design Excellence Awards. I myself just discovered CleanWell while waiting to check out at Whole Foods (1 oz. selling for $2.49).

This is well-timed given the rising concerns about alcohol and chemical-based santizers, from dry skin to alcohol-poisoning (several sanitizers are frangranced for child-appeal, but dangerously so) to environmental damage (released last month, a report on the toxic, hormone-disrupting sanitizing agent Triclosan found in 76% of all liquid soaps to be one of the most frequently detected chemicals in US streams according to the US Geological Survey).

To get down to it, what makes CleanWell different from the recent plethora of alcohol-free sanitizers assaulting the market (Viraban, SafeHands, Soapopular, Pro-Tex and Hands2Go which all use benzalkonium chloride) is it's active ingredient: Thyme oil. Thus CleanWell is void of ingestion risk and the "Poison Control Center" label, being 100% natural and biodegradable. However it is just as effective, killing 99.99% of germs including E. coli, Salmonella, Staph and MRSA bacteria as well as flu viruses. Even better, its patented formula of plant oils is derived from rapidly renewable natural resources and sustainably grown without pesticides or fertilizer.

So remarkable was the product that with the support of the global design consultancy Ideo, CleanWell went from concept to design within two years.

What started the idea was when the founder, Sam DeAth (last name not published on CleanWell website for obvious reasons), discovered his son Conor had Severe Immune Deficiency (a.k.a. "Bubble-Boy Syndrom") and almost all of their household products contained toxins that were just another tax on Conor's already struggling immune system. Thus working with his mother Joy, an aromacologist, and scientists at a environmental micriobiology laboratory, Mr. DeAth spearheaded the project to develop the formula. Then with the help of Dr. Larry Weiss (now Chief Technology Officer) and Ideo, CleanWell came into the market.

And with good timing, too. According to data company ACNielsen in a USAToday article last year, "through late 2006, sales in supermarkets and drugstores alone were up 14.4% from 2005 to $70 million, with Purell the market leader at $36.6 million. That growth built on a huge 53.5% rise in 2005." Then with swine flu on the news this year, demand for sanitizers skyrocketed: from April to August Americans spent 54% more on sanitizers in stores than in 2008.

Outbreaks Near Me

In a new turn of technology fighting the spread of viruses (which have plagued organisms as long as living cells have existed), the free online information system HealthMap has introduced an also no-fee interactive iPhone app which collaborates with iPhone's GPS service to give you real-time outbreak information or alerts in your area as well as the ability to send in tips on outbreaks.


What's unique about this system is that it mines the internet and media to track diseases, taking into account official and unofficial sources. With the iPhone app, individuals worldwide can participate in disease surveillance.

The system covers data on over a hundred of the most common infectious diseases in 137 countries. Reuters estimated earlier this month that HealthMap's website averages 10,000 users a day but rose to 150,000 when the H1N1 swine flu epidemic broke out this spring.

HealthMap is directly funded by google.org and was created in 2006 by by John Brownstein, assistant professor at the Children's Hospital Informatics Program (CHIP), and Clark Freifeld, software developer at CHIP. The two first conceived of the idea of HealthMap after noticing that the earliest reports of the severe acute respiratory syndrome (SARS) outbreak came not from official laboratory or health reports, ministries and records but from local news media and similar unofficial reports.

To most, this might seem common sense. Yet our existing infectious disease surveillance networks largely rely on data gathered from official sources and agencies and therefore often suffer from surprisingly incomplete coverage and data flow (and this would explain why local reporters knew about SARS in the province of GuangDong, where it started, before officials did). HealthMap thus attempts to bridge this gap. According to their overview published in the Public Library of Science (PLoS) journal, HealthMap aggregates and filters through reports from 20,000 websites, averaging 300 reports a day with 85.1% of these sources being news media sources. The system then uses algorithms to determine the relevance and accuracy of reports.

Then in 2008, HealthMap received $3 million in funding from google.org to improve and expand HealthMap's coverage by intensifying collaborations with the Program of Monitoring Emerging Diseases (ProMED), a network of the International Society for Infectious Diseases (ISID). At the time of the gift, Google.org had granted over $23 million in funding as part of its "Prepare & Prevent" initiative.

What's unique about their new app though, is that it's completely ad-free and so isn't making any money from this when it seems they could be making a lot (although they do make it very clear on their website and the app about their Google support). I really scoured for information on a breakdown of how they are using this grant, but aside from vague focus points, there is really nothing on whether they intend to keep this nonprofit afloat on pure donations or simply Google.

I have no idea why they wouldn't go the ad way but maybe it's to save screen space so you can be fully alert to the newly-infected swine flu cases exploding viruses just a couple blocks next to you, who knows. In any case, HealthMap is proven to be widely used so getting users isn't an issue (which I think is really the major obstacle for any business), especially in this environment of hand-sanitizer-loving paranoia, so I would be very interested in seeing how this model plays out.

Zeo Sleep Coach

Earlier this week I read about an alarm clock I am very keen to try. This new gadget, called Zeo, came out July 6 this year and consists of a patented, wireless sensor attached to an elastic headband, and its bedside display clock. This sensor monitors your brain waves to wake you up at the optimal phase of your sleep.

Touted as a personal sleep coach, Zeo also offers sleep analysis to improve your snoozing habits. Its memory card can hold thousands of nights of sleep and you can upload the data to Zeo's website to see how long it takes for you to fall asleep, your patterns of of light, deep and REM sleep, and how often you woke up during the night, perceived or unperceived. Zeo then gives you a "ZQ" score to summarize the quality and quantity of your sleep. With the $399 price tag, Zeo also comes with a 6 month service of an actual online sleeping coach who will help you analyze your data and advise on ways to improve your ZQ.

The idea of a machine waking you up at a certain phase of sleep is certainly not a very new one, as research on REM began as early as 1953 and by 1968 two sleep researchers, Allan Rechtschaffen and Anthony Kales, developed an "R&K sleep scoring manual" based on the various sleep cycles.

However it was only in this decade that actual consumer products came into fruition. Zeo in particular is the creation of three young Brown graduates, Jason Donahue, Ben Rubin and Eric Shashoua. Based in Newton, MA, Zeo succeeded following five years and $14 million of research and development after its 2005 prototype, SleepSmart, proved to be too clunky to appeal to investors. The three had actually incorporated Axon Labs (now named Zeo, Inc.) in 2003 to create SleepSmart, financing the project themselves with help from several informal investors as well as two grants: $12,500 cash from the Brown Entrepreneurship Program (out of 18 participants) and an $1,800 grant from Brown's National Collegiate Inventors and Innovators Alliance (twice yearly out of 300 applicants). Today, newly-named Zeo Inc.'s current major investors include Trident Capital ($1.6 billion under management) and iD Ventures ($340 million under management).

For now, Zeo is the first of its kind of brainwave-smart alarm clocks and is only sold on its website, www.myzeo.com. Shashoua also told Fortune last month in August that they plan to expand to Australia, where he says sleep deprivation is almost as much of a problem as it is in the States.

I find this a bit odd, as according to this year's OECD Social Indicators report, the United States is the second-most rested country (averaging 518 minutes of sleep per day) after France (530 minutes). Australia is in fifth place. Perhaps it just seems Americans are more likely to shell out for self-improvement than Koreans, Japanese and Norwegians are, which I can believe.

Coincidentally, one of the few (distant) competitors on the market, aXbo, is actually from Australia and created by a German designer. However, I restate "distant" since aXbo, like another competitor, SleepTracker, is a wristband that monitors only your sleep movements, has only one night of memory space so you must upload your data nightly, and you must also estimate and tell it when you are asleep. aXbo has a display clock whereas SleepTracker is indistinguishable from a chunky digital watch.

aXbo currently sells for $349 and SleepTracker for $102. So really I don't know why anyone would go for aXbo if it's as expensive as Zeo but does what SleepTracker does. But until there's more user feedback on these products, we won't know for sure. There is a lot of curiosity out there though, so I am guessing it won't be too long until we find out.