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.