Archive for January 22nd, 2009

FDA Eyes DTC

January 22nd, 2009 | No Comments | Source: MedPageToday

The FDA has announced plans to study whether TV ads for prescription drugs display side-effect information in a fair and balanced manner.

The plan is to concoct a series of sham TV advertisements for a fictitious blood pressure drug and play them for 2,000 adults. The ads will differ in the images displayed during the time the announcer recites side-effect information.

ibelievewhatisee 300x199 FDA Eyes DTCThe ads will display scenes ranging from highly consistent with the information being presented to highly inconsistent—maybe something like a buff couple relaxing in bathtubs positioned for sunset-watching on a beach.

After being shown the sham ads, study participants will be quizzed about what was said regarding the risks and benefits of the drug.

The FDA requires that DTC ads strike a “fair balance” in presenting risks and benefits and worries that visual images can distract viewers to a point where they’re unable to retain information about risk.

“Do images of people frolicking on a beach counteract the risk information being presented?” Allan Coukell, policy director at the Prescription Project asked MedPageToday.

cialis FDA Eyes DTCRhetorically, we can only assume.

“The concern is that every ad ends with the litany of risks–you sort of discount it,” Coukell continued.

The FDA study also plans to assess whether the addition of text describing the risks, in addition to the announcer’s scripted remarks, might impact recall.

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Silver Bullet for Solar Power

January 22nd, 2009 | No Comments | Source: Economist

The key component of solar panels is silicon, but the stuff is expensive so producers are always tempted to utilize less of it.

capturingsolarenergy 300x198 Silver Bullet for Solar PowerIn fact the latest generation of panels features silicon layers no more than 2 microns thick. Earlier generations were 100 times thicker.

The problem is that thinner cells are less efficient, and these new ones produce 20% less electricity per unit area than the older ones.

But Kylie Catchpole, from Canberra’s Australian National University and Albert Polman, from the Institute for Atomic and Molecular Physics in Amsterdam might have solved the problem.

All they did was add a few silver atoms to those thin silicon panels.

When sunlight strikes the silver atoms, it excites their electrons. A moment later, they fall back to an unexcited state and release light of their own.

If the silver atoms are arrayed correctly along the silicon layers of a solar panel, that light runs along the surface of the layer rather than penetrating through it.

This has the effect of maximizing the photoelectric effects of whatever small amounts of silicon may be present in the cell.

The scientists write in Optics Express that their silver bullet increases the efficiency of the thin silicon cells to a point where they produce approximately as much electricity as the more expensive, earlier generation panels.

And yes silver is itself expensive, but the new technique uses so little of it, it adds only a few pennies to the price.

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Economy Driving People to Participate

January 22nd, 2009 | No Comments | Source: Boston Globe

Omaha resident Pam Ford has participated in several clinical trials in the last 2 years. She likes participating in efforts to get low cost generic drugs on the market and doesn’t mind the free health care she gets along the way.

But these aren’t her primary motivations. “It’s absolutely to make extra money,” she told the Boston Globe, and if that’s the case, she’s not alone.

The US economy shed 2.5 million jobs last year, the most since 1945. No region or sector was spared and the unemployment rate stands at 7.2%.

doesnotdotricks 300x199 Economy Driving People to ParticipateMeanwhile Ford has pocketed $10,000 for her efforts, a nice supplement to what she makes from her cleaning business.

During the Great Economic Crisis of ’08-’09, record numbers of people are applying for positions in clinical research trials that pay participants up to several thousand dollars in return for a commitment of between a few and several weekends to various clinical protocols.

At Omaha-based Qualia Clinical Services for example, the participant database has risen from 9,000 to 16,000 in the last year. Qualia handles Phase 1 testing of generic drugs on healthy volunteers.

And the pool has grown more diverse than the usual college crowd, according to Steve Peck, director of operations. The trend is large enough to possibly convince some clinical research organizations to cease outsourcing early phase trials to developing nations like India.

The weakening economy has probably also helped increase plasma donation rates by 50% in the last 2 years, according to Josh Penrod, VP of the Plasma Protein Therapeutics Association.

Penrod added that payment is essential to assuring an adequate supply of blood products. Plasma collection centers develop their own payment rules, although overall compensation and time commitment remains a small fraction of that associated with clinical trials.

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