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BioWorld Bytes: Cranky commentary by Cynthia Robbins-Roth

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Cranky commentary by Cynthia Robbins-Roth

Editor's note: BioWorld Today columnist Cynthia Robbins-Roth is a founding partner of BioVenture Consultants, founded BioPeople magazine, is a former editor of BioWorld Today, and authored two books on the biotech industry. Her monthly column, "BioWorld Bytes," is exclusive to BioWorld Perspectives.

Spring is sprung, and biotech continues to be a tiny boat tossed on the seas of international uproar on many fronts.

A Patriotic Niche Market
For all those companies going for the orphan strategy, there's an experiment happening in the Rocky Mountains this summer you might want to check out.

Benjamin Levine, director of the Dallas, Texas-based Institute for Exercise & Environmental Medicine, and Robert Roach, director of the Altitude Research Center in Aurora, Colo., are recruiting 140 Texas college students – who are living pretty-darned-close-to-sea-level – to the 9,600 foot elevation of Breckenridge, Colo. The students will be screened for six genes that appear to contribute to one's susceptibility to altitude sickness. Once in Colorado, they will be put through an intense workout, including a 12-mile hike to 12,000 feet.

While this sounds a bit like what goes on at high-end spas, the purpose is to see if a genetic test can predict who will develop altitude sickness – headaches, nausea, dizziness, fatigue, and sometimes life-threatening lung effects.

As the U.S. military stays entrenched in high-altitude warfare in Afganistan, Pakistan and Iraq, altitude sickness has rendered soldiers unable to fight, and sometimes puts their lives in danger.

According to The Wall Street Journal, the military estimates that at least 25 percent of unacclimatized troops dropped at 10,000 feet are affected along with 80 percent 90 percent of troops at 13,200 feet. One study showed that 14 percent of troops evacuated for medical treatment had no combat injuries- they had altitude sickness. Other soldiers get left at base camps to recover, which can take three days.

The drugs to counter altitude sickness have nasty side effects, so the military would love to have a way to identify in advance those who will need pretreatment.

The military is funding this summer study, based on an earlier study by Roach with 28 subjects that showed the six genes predicted with 96 percent accuracy who would fall ill.

In classic entrepreneur style, Roach is contemplating the use of a predictive altitude sickness test for tourists planning ski trips in the high peaks of the Rockies and other tall mountains. The WSJ cites a study estimating a $288 million hit to ski resorts from altitude sickness slowing the spending of tourists.

Marketing mavens can argue about whether tourists would actually pay for a pre-trip genetic test. Maybe the resorts could shoulder the cost as part of their package. Something for you niche players to contemplate.

Taking the Rare Disease Model TOO Far
StemCells Inc. recently announced that it is halting its clinical development of a stem cell treatment for neuronal ceroid lipofuscinosis (Batten disease) because it couldn't find the six patients needed to complete a Phase Ib study.

To be fair, the company is developing human neural stem cells as a platform to treat other, less rare (though still qualifying as rare) diseases.

Our Winner for This Month's 'Shocking!' Prize
An astute reader forwarded the news that Johnson & Johnson admitted to bribing doctors in Greece, Poland and Romania and paying kickbacks in Iraq under the infamous UN "oil for food" program. The Securities and Exchange Commission detailed the used of slush funds, sham contracts and off-shore companies on the Isle of Man (UK) to pull off the slimy deals.

In a great quote surely headed for the upcoming film, SEC Enforcement Director Robert Khuzami (played by Russell Crowe?) said, "Any competitive advantage gained through corruption is a mirage."

The article in Bloomberg noted that J&J earned profits of more than $24 million by bribing Greek doctors to buy its surgical implantable artificial joints. Makes you wonder how so many Greeks are needing knee and hip replacement. . . . The head of the DePuy Orthapedics subsidiary resigned in February.

J&J will pay $48.6 million in "disgorgement and interest" (sounds disgusting) to settle the SEC claims, and $21.4 million to settle criminal charges with the Justice Department. Another $7.9 million will be paid by J&J's DePuy subsidiary for the Greek bribes, according to the UK Serious Fraud Office. (Monty Python fans will note that there is no corresponding Silly Fraud Office, though there certainly should be.)

Before you decide that J&J is the bad apple, the Hals Report writes:

in the last 2 years alone, the U.S. government has fined six of America's top ten pharmaceutical companies for fraud. Ongoing investigations continue against three of the four remaining companies. During this specific period in time the industry has paid out over five billion dollars in fines.

Sort of puts a damper on the biopharma industry's attempts to define itself as "the good guys" saving mankind from disease.

Seasonal Science
Another astute reader forwarded the definitive website – www.peepresearch.org – examining the science of marshmallow Peeps, the wildly popular Easter candy.

The scientists involved explore key aspects of Peeps physiology and well-being, concluding that: "Thus we arrive at our paradigm-shattering conclusion that billions of Peep spores were scattered throughout the galaxy millions of years ago, landing on all planets throughout our solar system and beyond. While these courageous pioneers of Peepdom fared the ammonia atmosphere of Venus without any ill effects, the temperature must have proved to much for even the heartiest marshmallow chicks."

Biopharma folks will be happy to hear that "Before any testing begins, all peep subjects are thoroughly examined and sign a disclosure form explaining the potential risks of their volunteer service."

Sing Your Hypertension Away
In yet another devastating blow to the conventional biopharma industry, the April issue of Arthritis Care & Research reports that singing reduced pre-operative hypertension in a drug-resistant patient.

A team at Harvard Medical School was treating a 76-year-old woman with hypertension who was admitted for knee replacement surgery. Her blood pressure, normally kept in check with medication, skyrocketed to 240/120 mg Hg prior to surgery. The team delayed surgery but could not reduce her blood pressure.

The woman noted that she often sings to calm herself, and the team encouraged her to give it a try. With 20 minutes of singing, her blood pressure dropped to 180/90 mm Hg and stayed there for several hours. She was instructed to sing periodically until surgery the next morning, when she was cleared for surgery.

Noted Nina Niu, part of the Harvard team, "Singing is simple, safe, and free." And pretty hard to patent.

Whining Online
Check out http://letter2read.blogspot.com/, a site dedicated to whining at Ian Read, Pfizer Inc.'s CEO, about his decision to close the Sandwich R&D site. States the blog writer and Pfizer principal scientist Jimmy McWhinger, "It's down to your bad management, not our uselessness at all. It's you who should be fired, not us. So I'm going to whine at you in this blog until you change your mind. You have been warned."

Well alright then. Just so we're clear.