Regulators

FDA's Pazdur in the middle of intense debate

Tue, 18 Mar 2008 07:59:59 -0400

The argument over the FDA's role in regulating cancer therapies often comes down to one man: Dr. Richard Pazdur, a veteran oncologist and chief of the agency's oncology office. Patient groups and developers complain that Pazdur's demanding style has raised the bar too high for many cancer drugs, leaving desperate, dying patients without drugs that could make a significant difference in their battle against the disease. Others, though, say the FDA should employ even tougher standards in order to protect people from harsh therapies that offer little or no hope of fighting cancer.

The Wall Street Journal reports that Pazdur has effectively reached out to one of the most important patient advocacy groups. And he's quick to pick up a dinner tab, anxious to avoid the appearance of a conflict with anyone who may be involved in a cancer program that could wind up under his review. Only a relatively small percentage of new cancer drugs make it all the way through to a positive opinion at the FDA, but regulators under Pazdur have demonstrated a willingness to weigh benefits--even disregarding its panel votes when the agency feels that patients should have access to a therapy.

- read the profile in the Wall Street Journal

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Nanotech advocates seek new federal research funds

Tue, 04 Mar 2008 06:59:59 -0500

Leaders in the nanotech field have been beating a path to Congress, asking lawmakers to significantly boost federal support of research into molecular-level advances. Currently, taxpayers fund about $1.5 billion in annual grants to the field. And one lawmaker, Rep. Kirsten Gillibrand, is suggesting a low-interest loan program to add to the research money.

While the science of the very small has played a big role in tech research and product development, nanotechnology has also been playing a growing role in biomedical research. A wide array of programs have been looking at new ways to resize doses of medication as well as polymers and thin-films that can play a role delivering a new generation of therapeutics.

The advocates journeying to Washington D.C. may find it tough going in gaining more research money. After several years in the late '90s and the early part of this decade in which lawmakers passed ever larger NIH budgets, the Bush administration has kept a lid on new research spending. Researchers have been harshly critical about the gradual erosion of support.

- read the report in the San Francisco Chronicle

ALSO: Scientists at Edinburgh University announced progress with bacteria-produced nanomagnets that can be used to fight cancer. Adding cobalt made the nanomagnets much stronger, increasing the chances of their effectiveness. Report

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Debate over ESC support centers on distant objectives

Tue, 12 Feb 2008 06:59:59 -0500

The Boston Globe uses California's experience with its stem cell program as a cautionary tale as lawmakers debate a proposed bill that would provide a billion dollars to support the life sciences field. Even advocates of the legislation, notes the Globe, acknowledge that "it could take years, if not decades, for the grants to pay off." Research for new therapies takes time, of course, and is generally tracked in decades.

You could also argue that providing funds for new research has a more immediate impact. And an important one at that. The purpose of the California stem cell institute is to encourage research, bring in top scientists, dedicate new labs and provide the financial freedom for them to make significant progress. In the research field, heading in the right direction can be a major advance.

- read the article in The Boston Globe

ALSO: California's stem cell institute has received 50 applications for its New Cell Lines Award. Report

PLUS: California has been touting the creation of thousands of new jobs in the biomedical field. Report

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U.S. pipeline bone dry for new antibiotics

Tue, 29 Jan 2008 06:59:59 -0500

Even as the demand for new antibiotics grows, new research programs to advance fresh therapies have been drying up fast. While existing antibiotics steadily weaken against the onslaught of some scary strains of bacteria, developers have been turning away from the field, says a new report on the San Francisco Chronicle. Back in the '80s, 16 antibiotics were approved over a 5-year stretch. But in the last five years, only five have been approved by the FDA.

The Chronicle concludes that it's basically the result of economics. Developers are drawn more to chronic diseases that offer huge, ongoing returns rather than the occasional user who needs antibiotics for a week or two. At the same time, lawmakers took out a fresh set of incentives in the FDA reauthorization bill last fall that would have made it easier for antibiotic developers to extend legal safeguards against generic competition. To sum up: Don't look for this trend to change anytime soon.

- see the report
- read the article for more

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Singapore researchers support human/animal chimeras

Tue, 15 Jan 2008 06:59:59 -0500

Scientists in Singapore are advocating new rules that would permit researchers to splice human DNA into animals to further stem cell research. The development of human/animal chimeras would allow research projects that would, for example, splice human cells into the brains of mice in order to test a new generation of therapies for Parkinson's and Alzheimer's.

The notion of chimeras has raised protests around the world. In the UK, lawmakers are considering a similar approach. But Singapore's Professor Lim Pin, chairman of the Bioethics Advisory Committee, notes that there would be strict limits on the animal combinations. "Even if possible, it would be ethically unacceptable for scientists to create subhuman creatures with potentially human consciousness," Lim said.

- read the report from Monsters and Critics

ALSO: Singapore plans to intensify it's focus on immunology research. Report

Related Articles:
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UK stops some animal testing

Tue, 15 Jan 2008 06:59:59 -0500

A combo act featuring a slate of top European companies and clinical research organizations are bringing a close to an 80-year era of animal tests for acute toxicity. Since 1927 drug researchers have cut short the lives of countless rats and mice to determine a drug's toxicity. But new methods that don't depend on rodents are better and a lot less time consuming. That's a victory--the first big one--for the UK's National Centre for the Replacement, Refinement and Reduction of Animals in Research. Regulators around the world say they have no objection to removing this step in drug development, paving the way to a wider rollout of the new approach. Researchers say this first step is likely to save the lives of some 15,000 rodents.

- check out the report from the Financial Times
- read the report from the Wall Street Journal

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ALSO NOTED: Three-parent embryos?; Ultraviolet light advances cancer therapy; Is most medical research a waste of money?;

Tue, 20 Nov 2007 06:59:58 -0500

More Research

Lawmakers in the UK are scheduled to debate a controversial new law that would allow couples to create embryos derived from three parents. The procedure would require the nucleus of one woman's egg and the mitochondria from another woman that spurs cell growth. If approved, couples would have an option for avoiding the threat of mitochondrial disease like epilepsy and diabetes. A wide array of opponents is prepared to wage a battle against the approach. Report

An expert in biostatistics--and a new member of the Royal Society of Canada--says that with two million research articles being published each year, only about one percent of it is either scientifically valid or clinically useful. Report

A new "lung-on-a-chip" developed at the University of Michigan mimics the fluid mechanics of the real thing on a plastic wafer just bigger than a quarter. It allows researchers to grow lung airway cells that act more like they're in a human body instead of a Petri dish. Release

MIT researchers have identified enzymes that play a key role in promoting the brainpower of Alzheimer's patients, adding that the enzymes appear to be good targets for new therapies. Release

The protein cystatin C appears to inhibit the development of amyloid beta plaques involved in Alzheimer's, opening up a new target for drug developers able to mimic that activity. Report

Researchers have found how the cowpox virus can essentially hide itself from the body's immune system, offering a new approach to vaccine development. Release

Bioengineers led by Luke Lee at the University of California, Berkeley, have discovered a technique that for the first time enables the detection of biomolecules' dynamic reactions in a single living cell. Release

Researchers at Yale School of Medicine report that a biomarker, the protein YKL-40, can be used to identify the most aggressive form of asthma and help lead the way to new therapies for the disease. "This may allow us to identify a subpopulation of patients with severe asthma and give us insights into the biologic processes that make the disease so severe in these individuals," says Jack Elias, MD. "Our studies also have demonstrated that eliminating YKL-40 decreases specific types of tissue inflammation--which could be of particular benefit to asthmatic patients with an elevated level of this protein." Release

The $63 million Queensland Brain Institute has opened, beginning work on dementia, stroke, depression and more. Release

Stem Cell Research

A scientist who has worked closely with Alan Trounson--the new chief of California's $3 billion stem cell program--has been cited for "research misconduct" in a program funded by the Australian government. Trounson was not a subject of the investigation. Report

Using embryonic stem cells, scientists at Hebrew University in Jerusalem were able to determine an important mechanism in fragile X syndrome, a common cause of inherited mental retardation in boys. Their insights point to new therapies to prevent the condition from occurring. Release

Menstrual blood contains adult stem cells that can be coaxed to develop into nine different types of cells, including heart, lung and nerve cells. Report

A database that includes the molecular profiles of the major components of the blood system--including the stem cells and the cells differentiated from them--enabled researchers at Baylor College of Medicine (BCM) in Houston to identify at least two genes involved in the differentiation process for two different kinds of blood cells. Release

Cancer Research

Scientists are testing a new technique that relies on ultraviolet light to trigger a personalized vaccine targeting cancer tumors. By applying photodynamic therapy at the exact site needed, the therapy can avoid the kind of toxic overloads that afflict many cancer patients today. Article

Researchers in Australia have proved in a study that the immune system can stop cancer from advancing, offering a new approach to treating the disease as a chronic condition. Report

Researchers at the University of Southern California have identified how genes are "silenced" in cancer cells through changes in the density of nucleosomes within the cells. The findings of the study are published in forthcoming issue of the journal Cancer Cell. According to lead author Peter A Jones, the study shows "for the first time exactly how genes get shut down in cancer cells... It identifies what the target looks like so that new therapies can be designed to turn them back on." Release

The BBC is reporting that much of the money being spent on cancer research in the UK is being wasted. Article

Genetics

New research indicates that variants of the HLA-DQB1 and HLA-DRB1 genes raise the risk of juvenile diabetes. Report

U.K. approves 'cybrids' for stem cell research

Tue, 11 Sep 2007 06:59:59 -0400

In the interest of making more and better human stem cells for research, U.K. regulators have approved the creation of short-lived human/animal hybrid embryos. Only tiny fragments of animal DNA will be used, they say, and no freaks of nature will be unleashed. These will be the first human/animal embryos allowed for research. The first cytoplasmic hybrid embryos--dubbed cybrids--should be created by the end of the year. There's still a chance that opponents could block the move in court.

Several research teams have been seeking permission to create cybrids for work on Alzheimer's and Parkinson's. Another team focused on motor neuron disease is also expected to file for approval as well.

- read the statement on the decision
- see the Times report

Related Article:
Human/animal chimeras get a reprieve in the U.K. Report

ALSO NOTED: ACT develops ESC lines without harming embryos; New treatment for colon cancer; TB research helps ID drug targets;

Mon, 25 Jun 2007 20:01:38 -0400

Stem Cell Research

Researchers at Advanced Cell Technology has developed three new stem cell lines by taking an individual cell from an embryo and then froze the embryo with no harm done to it. ACT had generated a wave of criticism for its earlier announcement on the process. That work involved destroying the embryo to prove the theory that you could develop stem cell lines by withdrawing cells from an embryo. This new work saves the embryo to prove that the theory works in practice. Report

Scientists in Australia have created embryonic stem cells from monkey embryos, moving ever closer to the goal of human therapeutic cloning. Report

Lawmakers in New Jersey have been advancing legislation to ask citizens for their approval to issue $450 million to back new stem cell research. Report

Scientists have sped the repair of inner ear damage by injecting bone marrow stem cells to the injury site. Release

In the first trial of its kind in the world, 60 patients who have recently suffered a major heart attack will be injected with selected stem cells from their own bone marrow during routine coronary bypass surgery. Report

Cancer Research

Leire García Navarro, a researcher at the School of Pharmacy of the University of Navarra, has developed a new treatment which slows the growth of colon and liver cancers. In order to carry out the study, this scientist of the Department of Pharmacy and Pharmaceutical Technology used genetic therapy with non-viral vectors for transferring genetic material to the cancerous cells. Release

The sea-squirt derived drug trabectedin (ecteinascidinin-743) shows anti-tumour activity in more than half of patients with a specific type of cancer, conclude authors of a recent article. Release

A group of researchers at the University of Michigan Nanotechnology Institute for Medicine and Biological Sciences have devised a multifunctional nanoparticle platform comprising nanoparticles synthesized within dendrimers equipped with targeting molecules and dyes. These dendrimer nanoparticle systems are able to seek out and specifically bind to cancer cells. Report

Research led by scientists at Weill Cornell Medical College has uncovered two new potential points of vulnerability on a key cancer-promoting protein, called XIAP. Drugs that target either of these activities could help push cancer cells back into a more regular programmed cell death and thereby reduce or eliminate tumors. Release

Levels of a small non-coding RNA molecule called let-7 appear to define different stages of cancer better than some of the "classical" markers for tumor progression. Report

More Research

A team of researchers from the University of Surrey has completed the first genome-scale model of the microbe that causes tuberculosis. The model may be a highly useful tool to identify new drug targets and design new vaccines. Release

Researchers at the University of California, San Diego (UCSD) Skaggs School of Pharmacy and Pharmaceutical Sciences have patented a strategy for developing a human vaccine to prevent against Human Cytomegalovirus (hCMV) infection and disease. Report

Australian researchers say that cholesterol drugs could prevent nerve damage spurred by diabetes. Report

Scientists at the University of California, San Diego have determined a key mechanism by which the body regulates iron metabolism, a discovery that may provide new approaches for the treatment of anemia. Release

The University of Nottingham has been advancing studies into finding alternatives to using animals in drug research. Report

Eight common gene variations have been linked to a susceptibility to fever following a smallpox vaccination. Report

Investigators at St. Jude Children's Research Hospital have discovered how a single molecular "on switch" triggers gene activity that might cause effects ranging from learning and memory capabilities to glucose production in the liver. Release

Two proteins that are implicated in autism have been found to control the strength and balance of nerve-cell connections, according to researchers at UT Southwestern Medical Center. Release

And Finally… An Amazon tribe say they were lied to and exploited by researchers who gathered blood samples in exchange for medicine that never arrived. Now the samples are being sold online and the tribe wants compensation. Article

NIH chief breaks with Bush on stem cell research

Mon, 19 Mar 2007 20:01:39 -0400

The head of the National Institutes of Health has called on the White House to reverse its position limiting federal funding of embryonic stem cell research, calling it a shortsighted approach that has sidelined the NIH in an important field. Up until Elias Zerhouni's (photo) testimony to a Senate committee yesterday, he had been careful not to repudiate President Bush's decision to limit federal funding to a group of stem cell lines that already existed when Bush announced his policy in 2001. For the first few years, Zerhouni told lawmakers, the federal policy was harmless and allowed NIH to create an infrastructure for studies. But since 2004, he said, the U.S. has been falling behind other countries that are now taking the lead in the field.

"It's very clear these cell lines will not be sufficient to do all the research we need to do," Zerhouni told lawmakers. "It is clear today that American science will be better served and the nation will be better served if we let our scientists have access to more cell lines."

- read the UPI report on Zerhouni's testimony

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