PM360 February 2010

Hot Topics / Healthcare Highlights

SITTING DUCKS
YOU MAY WANT TO STAND BEFORE READING THIS. ARE YOU STANDING?
Good, because sitting can kill you. A recent study revealed that people who sit for the majority of their day have higher mortality rates, even if they are physically active for part of the day. The study tracked a representative sample of 17,000 Canadian adults who participated in a 1981 national Fitness Survey. The results, published recently in Medicine & Science in Sports & Exercise, showed that after 12 years, 20% of people who said they sat “almost all the time” and 12% of those who sat “almost half the time” had died compared to just 6% of those who sat “almost none of the time.” These results
were true for all participants including smokers, nonsmokers, thin, and obese.

You may wonder what exactly makes the simple act of sitting so deadly, and the simple answer is inactivity. “Muscles seem to be extremely inactive while sitting, and this may change the way they metabolize compounds and affect the regulation of insulin and glucose,” Peter Katzmarzyk, one of the study’s authors and an epidemiologist at the Pennington Biomedical Research Center in Baton Rouge, LA, told Nutrition Action Healthletter. “Just getting people to stand up changes the physiology in their limbs.” People need to get up more often, according to Katzmarzyk, because 30 minutes of physical activity a day is not enough to wipe out hours of sitting. He recommends standing, walking around, or doing anything to increase blood flow and muscle activity. He even suggests getting a treadmill desk, so you can work, walk, and maybe even add a few years to your life at the same time.
—Andrew Matthius

PIPELINE PROJECTIONS
Many drug developers are improving R&D efficiency, but in 2010 their continued success will depend more on their ability to work well with others. According to the Tufts Center for the Study of Drug
Development’s Outlook 2010, the key to future success is the ability to collaborate with other drug companies and partner with outside service providers. "Developers have made important progress in reducing R&D times, but because only 3 in 10 new drugs, on average, generate sufficient revenue to sustain R&D, pharmaceutical and biotech firms are under great and growing pressure to generate revenue to bring more products to market," said Tufts CSDD Director Kenneth Kaitin. The problem is more patents are expiring than products are launching. Between 2009 and 2012 the worldwide sales for all drugs coming off patent will exceed $88 billion, and it currently costs more than $1 billion and takes more than seven years to get a drug from clinical trials to prescription ready, according to Tufts CSDD. Here are some of the other near-term trends reported:

• More firms will prioritize improving clinical protocol design to reduce costs and speed development.
• Following healthcare reform, a more activist FDA will focus on a regulatory pathway for follow-on biologics approvals, over-the-counter product and drug safety, foreign facility inspections, preventable deaths from chronic diseases, and vaccine manufacturing capacity.
• Clinical development time for novel protein products is unlikely to decrease.
• Off-label prescribing of biopharmaceuticals in the U.S. will be subject to increased economic scrutiny.
• Higher-performing research investigators will become available due to a tougher global operating environment forcing marginal research sites to exit clinical development.

—A.M.

TO THE O.R., STAT!
Companies are now developing miniature robots, mere millimeters in size, that can enter bodies through small incisions or through the eyes, ears, or lungs to deliver drugs, take samples, or assist with surgeries. Four mini-medibots are currently in development, according to New Scientist.

HeartLander A 20mm device with footpads that allow it to inch across the heart like a caterpillar. During heart surgeries, either the heart must be stopped or the left lung is deflated and several incisions made to reach a beating heart. This device requires only a single keyhole incision to reach a beating heart without deflating a lung. Possible applications include taking tissue samples, injecting stem cells or gene therapies, or delivering pacemaker electrodes.

ViRob (shown) The 5mm-long, 1mm-diameter, 16-legged device is powered by a nearby electromagnet that moves the legs whenever its field fluctuates. Possible applications include taking tissues samples, delivering cancer drugs, getting cameras to hard-to-reach areas, developing a self-cleaning shunt for people born with fluid in the brain, and aiding with the insertion of cochlear implants.

SwiMicRob This 10mm-long, 3mm-diameter device can swim thanks to two twirling tails powered by an onboard motor. It may eventually be used in fluid-filled spaces such as those within the spine.

Ophthalmic robot Only 0.9mm by 0.3mm, this device shaped like a metal finned-football with a spike on its end is pulled around within the eye by outside electromagnets. Possible uses include measuring oxygen levels at the surface of the retina or treating retinal vein occlusion, a major cause of blindness.—A.M.

FDA UPDATE
The FDA has approved the first generic version of Aricept (donepezil hydrochloride) orally disintegrating tablets for the treatment of dementia related to Alzheimer’s disease. Aricept was co-promoted by Pfizer and Eisai in the U.S., Japan, and key European markets. The generic version is manufactured by Mutual Pharmaceutical of Philadelphia in 5 milligram and 10 milligram strengths.

Genentech’s Actemra (tocilizumab) has been approved to treat adults with moderate to severe rheumatoid arthritis. Its recommended use is limited to patients who have not adequately responded to or cannot take other approved drugs because of serious safety concerns. The FDA is also requiring a post-marketing clinical trial to evaluate the drug’s long-term safety. Actemra’s side effects include upper respiratory tract infections, headache, inflammation of the nose or nasal passage, high blood pressure, and increased liver enzymes.

The Celsius RMT ThermoCool catheter, developed by Stereotaxis and Biosense Webster, has been approved by the FDA for the treatment of Type 1 atrial flutter. The magnetic catheter works with Stereotaxis’s Niobe Magnetic Navigation System to destroy unhealthy tissue and return the heart to its normal rhythm. The device was approved for distribution in the European Union in October 2009. —A.M.