Monday, November 2, 2009 Monday, October 12, 2009
Jaw bone created from stem cells (via BBC News)

Scientists have created part of the jaw joint in the lab using human adult stem cells. They say it is the first time a complex, anatomically-sized bone has been accurately created in this way. It is hoped the technique could be used not only to treat disorders of the specific joint, but more widely to correct problems with other bones too.

Jaw bone created from stem cells (via BBC News)

Scientists have created part of the jaw joint in the lab using human adult stem cells. They say it is the first time a complex, anatomically-sized bone has been accurately created in this way. It is hoped the technique could be used not only to treat disorders of the specific joint, but more widely to correct problems with other bones too.

New Strategy For Mending Broken Hearts? (via ScienceDaily)

By mimicking the way embryonic stem cells develop into heart muscle in a lab, Duke University bioengineers believe they have taken an important first step toward growing a living “heart patch” to repair heart tissue damaged by disease.
In a series of experiments using mouse embryonic stem cells, the bioengineers used a novel mold of their own design to fashion a three-dimensional “patch” made up of heart muscle cells, known as cardiomyocytes. The new tissue exhibited the two most important attributes of heart muscle cells -– the ability to contract and to conduct electrical impulses. The mold looks much like a piece of Chex cereal in which researchers varied the shape and length of the pores to control the direction and orientation of the growing cells.
The researchers grew the cells in an environment much like that found in natural tissues. They encapsulated the cells within a gel composed of the blood-clotting protein fibrin, which provided mechanical support to the cells, allowing them to form a three-dimensional structure. They also found that the cardiomyocytes flourished only in the presence of a class of “helper” cells known as cardiac fibroblasts, which comprise as much as 60 percent of all cells present in a human heart.

New Strategy For Mending Broken Hearts? (via ScienceDaily)

By mimicking the way embryonic stem cells develop into heart muscle in a lab, Duke University bioengineers believe they have taken an important first step toward growing a living “heart patch” to repair heart tissue damaged by disease.

In a series of experiments using mouse embryonic stem cells, the bioengineers used a novel mold of their own design to fashion a three-dimensional “patch” made up of heart muscle cells, known as cardiomyocytes. The new tissue exhibited the two most important attributes of heart muscle cells -– the ability to contract and to conduct electrical impulses. The mold looks much like a piece of Chex cereal in which researchers varied the shape and length of the pores to control the direction and orientation of the growing cells.

The researchers grew the cells in an environment much like that found in natural tissues. They encapsulated the cells within a gel composed of the blood-clotting protein fibrin, which provided mechanical support to the cells, allowing them to form a three-dimensional structure. They also found that the cardiomyocytes flourished only in the presence of a class of “helper” cells known as cardiac fibroblasts, which comprise as much as 60 percent of all cells present in a human heart.

Thursday, September 24, 2009
HIV Vaccine Reduces Infection (via BBC News)

An experimental HIV vaccine has for the first time cut the risk of infection, researchers say.
The vaccine - a combination of two earlier experimental vaccines - was given to 16,000 people in Thailand, in the largest ever such vaccine trial. Researchers found that it reduced by nearly a third the risk of contracting HIV, the virus that leads to Aids. It has been hailed as a significant, scientific breakthrough, but a global vaccine is still some way off….

HIV Vaccine Reduces Infection (via BBC News)

An experimental HIV vaccine has for the first time cut the risk of infection, researchers say.

The vaccine - a combination of two earlier experimental vaccines - was given to 16,000 people in Thailand, in the largest ever such vaccine trial. Researchers found that it reduced by nearly a third the risk of contracting HIV, the virus that leads to Aids. It has been hailed as a significant, scientific breakthrough, but a global vaccine is still some way off….

Thursday, September 10, 2009
Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why. (via WIRED)

From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebo. Despite historic levels of industry investment in R&D, the US Food and Drug Administration approved only 19 first-of-their-kind remedies in 2007—the fewest since 1983—and just 24 in 2008. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills.
The upshot is fewer new medicines available to ailing patients and more financial woes for the beleaguered pharmaceutical industry. Last November, a new type of gene therapy for Parkinson’s disease, championed by the Michael J. Fox Foundation, was abruptly withdrawn from Phase II trials after unexpectedly tanking against placebo. A stem-cell startup called Osiris Therapeutics got a drubbing on Wall Street in March, when it suspended trials of its pill for Crohn’s disease, an intestinal ailment, citing an “unusually high” response to placebo. Two days later, Eli Lilly broke off testing of a much-touted new drug for schizophrenia when volunteers showed double the expected level of placebo response.
It’s not only trials of new drugs that are crossing the futility boundary. Some products that have been on the market for decades, like Prozac, are faltering in more recent follow-up tests. In many cases, these are the compounds that, in the late ’90s, made Big Pharma more profitable than Big Oil. But if these same drugs were vetted now, the FDA might not approve some of them. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time.
It’s not that the old meds are getting weaker, drug developers say. It’s as if the placebo effect is somehow getting stronger.
The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis. The stakes could hardly be higher. In today’s economy, the fate of a long-established company can hang on the outcome of a handful of tests.
Why are inert pills suddenly overwhelming promising new drugs and established medicines alike? The reasons are only just beginning to be understood. A network of independent researchers is doggedly uncovering the inner workings—and potential therapeutic applications—of the placebo effect. At the same time, drugmakers are realizing they need to fully understand the mechanisms behind it so they can design trials that differentiate more clearly between the beneficial effects of their products and the body’s innate ability to heal itself. A special task force of the Foundation for the National Institutes of Health is seeking to stem the crisis by quietly undertaking one of the most ambitious data-sharing efforts in the history of the drug industry. After decades in the jungles of fringe science, the placebo effect has become the elephant in the boardroom…..

Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why. (via WIRED)

From 2001 to 2006, the percentage of new products cut from development after Phase II clinical trials, when drugs are first tested against placebo, rose by 20 percent. The failure rate in more extensive Phase III trials increased by 11 percent, mainly due to surprisingly poor showings against placebo. Despite historic levels of industry investment in R&D, the US Food and Drug Administration approved only 19 first-of-their-kind remedies in 2007—the fewest since 1983—and just 24 in 2008. Half of all drugs that fail in late-stage trials drop out of the pipeline due to their inability to beat sugar pills.

The upshot is fewer new medicines available to ailing patients and more financial woes for the beleaguered pharmaceutical industry. Last November, a new type of gene therapy for Parkinson’s disease, championed by the Michael J. Fox Foundation, was abruptly withdrawn from Phase II trials after unexpectedly tanking against placebo. A stem-cell startup called Osiris Therapeutics got a drubbing on Wall Street in March, when it suspended trials of its pill for Crohn’s disease, an intestinal ailment, citing an “unusually high” response to placebo. Two days later, Eli Lilly broke off testing of a much-touted new drug for schizophrenia when volunteers showed double the expected level of placebo response.

It’s not only trials of new drugs that are crossing the futility boundary. Some products that have been on the market for decades, like Prozac, are faltering in more recent follow-up tests. In many cases, these are the compounds that, in the late ’90s, made Big Pharma more profitable than Big Oil. But if these same drugs were vetted now, the FDA might not approve some of them. Two comprehensive analyses of antidepressant trials have uncovered a dramatic increase in placebo response since the 1980s. One estimated that the so-called effect size (a measure of statistical significance) in placebo groups had nearly doubled over that time.

It’s not that the old meds are getting weaker, drug developers say. It’s as if the placebo effect is somehow getting stronger.

The fact that an increasing number of medications are unable to beat sugar pills has thrown the industry into crisis. The stakes could hardly be higher. In today’s economy, the fate of a long-established company can hang on the outcome of a handful of tests.

Why are inert pills suddenly overwhelming promising new drugs and established medicines alike? The reasons are only just beginning to be understood. A network of independent researchers is doggedly uncovering the inner workings—and potential therapeutic applications—of the placebo effect. At the same time, drugmakers are realizing they need to fully understand the mechanisms behind it so they can design trials that differentiate more clearly between the beneficial effects of their products and the body’s innate ability to heal itself. A special task force of the Foundation for the National Institutes of Health is seeking to stem the crisis by quietly undertaking one of the most ambitious data-sharing efforts in the history of the drug industry. After decades in the jungles of fringe science, the placebo effect has become the elephant in the boardroom…..

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