emailpat
- 27 Oct 2004 23:29
Interesting small news stories that don't make the headlines from around the world.
We might get some perspective on genuine news stories as opposed to the rubbish that sells papers.
emailpat
- 27 Oct 2004 23:30
- 2 of 4
Gene geniuses hold promise for third world
THE science of genomics, which deals with genes,
holds out major promises for the developing world,
according to a major new report.
Novel technologies for diagnosis, and more effective
vaccines, are among the medical tools expected to be
available cheaply in developing countries within a
decade, according to the report launched in Montreal.
It sounds like wishful thinking, but the promises are
made by hard-headed scientists. Called Genomics and
Global Health, the report was produced for the
Genomics Working Group of the Science, Technology
and Innovation Task Force of the United Nations
Millennium Project.
In setting investment priorities, the authors consulted 28
eminent scientists in both developing and industrialised
countries to produce a Top Ten of New Technologies.
A doctor in the poorest country will be able to instantly
diagnose TB, malaria and other diseases, prescribe
microbiocides to protect women from HIV, and produce
clean water, said Peter Singer, Professor of Medicine
and director of the University of Toronto Joint Centre for
Bioethics, one of the authors of the report. Professor
Singer was speaking at the Fourth World Conference of
Science Journalists in Montreal.
The report says that the ten most promising cutting-
edge technologies for health in developing countries
are easy-to-use molecular diagnostic tests; genetically-
engineered vaccines; improved drug and vaccine
delivery methods; the exploitation of micro-organisms
to improve drinking water; working out the genetic code
of disease-causing organisms; producing
microbiocides for female-controlled protection against
HIV and other illnesses; using computer tools to identify
drug targets; nutrition-enriched crops; cheaper,
biotechnologically-produced insulin and interferons;
and advanced chemistry techniques to discover new
drugs.
The report calls for the creation of a Global Genomics
Initiative for the good of people worldwide. It would
need investment from governments and biotechnology
companies, large and small.
Whiskered Robot
A robot with real mouse whiskers - now theres a
thought. In a joint Japanese-Swiss project, a be-bristled
robot called AMouse (Artificial Mouse) has been built
by scientists from the University of Tokyo and the
University of Zurich.
It uses real mouse whiskers because simulations have
shown these to be perfect size and shape for
navigation. The electronic process imitates the way a
real mouse uses its whiskers to sense, by means of the
nerves in its nose.
Each AMouse whisker is plugged directly into a special
microphone at the front of the robot. This microphone
can detect vibrations with great precision.
AMouse is programmed to keep moving until it senses
an obstacle. Then it alters direction until it finds its way
around it. Artificial whiskers are to be developed later
on.
Read the signs
A new electronic drivers assistance system (DAS)
developed in Australia is able to detect road signs and
warn drivers not to ignore them. DAS was devised at
the National Information and Communications
Technology Australia laboratories in Canberra.
The system uses three cameras. One of them is
mounted on the rear view mirror and scans the road
ahead.
The other two, set on the instrument dashboard,
monitor where the driver is looking. The cars
speedometer is also connected to the system.
Images from the cameras are fed into a computer
system. Software detects road signs by recognising
their symmetrical shapes and images, and works out
where the driver is looking.
If the driver seems not to have been looking at a sign,
and the car does not slow down, an alert is issued.
Improved DVDs
In the future, DVDs could hold 100 times more
information than current discs. Researchers at Imperial
College London, together with colleagues in Greece
and Switzerland, are developing a new way of storing
data in four layers that could lead to discs capable of
holding 118 hours of video.
emailpat
- 29 Oct 2004 01:44
- 3 of 4
Antidepressants to bear suicide warning
WASHINGTON -- The Food and Drug Administration on Friday ordered that all antidepressants carry "black box" warnings that they "increase the risk of suicidal thinking and behavior" in children who take them.
Patients and their parents will be given medication guides that include the warning with each new prescription or refill.
Dr. Lester Crawford, acting FDA commissioner, said the agency based its decision on the "latest and best science."
"We continue to believe, however, that these drugs provide significant benefits for pediatric patients when used appropriately," he told reporters.
"Antidepressants increase the risk of suicidal thinking and behavior ... in children and adolescents with major depressive disorder and other psychiatric disorders," the warning begins. Those risks must be balanced against clinical need, the label indicates in a warning surrounded by a black box, hence the "black box" designation.
The information guide for patients and their parents echoes those warnings.
The FDA's action, which follows to the letter a recommendation of its advisers, was driven by data that showed that on average, 2 percent to 3 percent of children taking antidepressants have increased suicidal thoughts. Independent experts, working with Columbia University, based the finding on a review of data from 24 trials that involved more than 4,400 patients taking antidepressants. They found a greater risk during the first few months of treatment.
Crawford said suicides among juveniles decreased by 25 percent in the past decade, as antidepressant prescriptions to children soared. Children ages 1 to 17 now account for 7 percent of all antidepressant prescriptions.
The American Psychiatric Association expressed concern that the agency's actions could lead to fewer antidepressant prescriptions for patients most in need. "This would put seriously ill patients at grave risk," the association said in a statement.
Eli Lilly and Co., which manufactures Prozac, the only antidepressant found to be safe and effective for children, echoed the APA's concerns. In a statement, the company noted that depression affects 3 percent to 5 percent of all juveniles.
"Lilly supports the recent FDA efforts," the company said. However, a "black box warning on antidepressants may have a dangerous effect on appropriate prescribing for patients who urgently need proven treatment options."
Other drug manufacturers endorsed the FDA's action.
"We agree with the FDA that providing additional information to everyone -- from health care professionals to parents and patients -- is one of the most positive steps that can be taken to advance the diagnoses and treatment of adolescents with depression," said Mary Anne Rhyne, a GlaxoSmithKline spokeswoman.
Glaxo, the maker of Paxil, settled a lawsuit filed by New York's attorney general by releasing summaries of all its clinical trials. The lawsuit accused the company of not disclosing fully negative information about Paxil's safety record.
The FDA said parents and physicians will be advised to look for warning signs in children that include worsening depression, agitation, irritability and unusual changes in behavior. Those worrisome signs could come within the first months of starting an antidepressant or if the drug's dosage is changed, higher or lower.
Doctors and families are asked to have at least weekly, face-to-face contact with a child taking an antidepressant during the first four weeks of treatment. Biweekly visits would occur for eight more weeks and, as needed, after week 12.
The warning notice says caregivers and physicians should be equally as vigilant with adults who take antidepressants.
Kathleen Bodnar, a grieving mother, expressed the fear that the warning information will go to people receiving the drug but not necessarily to families or others who might best monitor behavior.
"If my daughter were living with me, I could be watching her every single day and notice the difference," said Bodnar, whose 21-year-old daughter, Liz Torlakson, killed herself two days after restarting an antidepressant that had been stopped because she had the flu. "If the doctor waits, even once a week, it's not going to be often enough."
Because the FDA chose its most strident alert, the warning must be included in advertising. That means a trend that startled federal advisers -- free samples of antidepressants given to treat other medical conditions -- also must carry warnings.
"These medications were being used outside their indications by physicians who sometimes distributed samples to the families," said Dr. Laurence Greenhill, a pediatric psychiatrist in New York. "In this case, advertising sampling always will have the black box warning on it."
The new warnings will be carried by all antidepressants, including Anafranil, Aventyl, Celexa, Cymbalta, Desyrel, Effexor, Elavil, Lexapro, Ludiomil, Luvox, Marplan, Nardil, Norpramin, Pamelor, Parnate, Paxil, Pexeva, Prozac, Remeron, Sarafem, Serzone, Sinequan, Surmontil, Symbyax, Tofranil, Tofranil-PM, Triavil, Vivactil, Wellbutrin, Zoloft and Zyban.
emailpat
- 30 Oct 2004 17:39
- 4 of 4
Anti-terror antidote?
SAN DIEGO -- When President George W. Bush signed Project BioShield into law in July, he said he was immediately making $5.6 billion available to counter such anticipated threats as smallpox genetically engineered to render current vaccines useless.
But the expected flood of contracts never materialized.
Project BioShield was supposed to jump-start a national security renaissance in the biotechnology and pharmaceutical industries by guaranteeing contracts to make drugs for combating potential bioweapons.
But all the law has done so far is to generate indifference or frustration among biodefense contractors, industry executives and experts say. Most are snubbing the program because of liability and intellectual property issues and confusion over what the government wants.
The corporate response to BioShield is summed up in a new study, by the Center for Biosecurity at the University of Pittsburgh, that criticizes the government's fuzzy mandate and concludes that the nation remains highly vulnerable to a biological attack.
Vaccine-making in general is a risky, low-margin business, as evidenced by Chiron Corp.'s spectacular failure this flu season. Making vaccines to combat potential bioweapons such as anthrax and smallpox is even riskier -- with little natural profit incentive.
So far, no money from BioShield has been allocated, though a contract for more than $800 million to make a genetically engineered anthrax vaccine could be awarded within days to one of the two biotechnology companies competing for it.
Companies complain that there's no guarantee the government won't claim ownership of drugs made with federal support. Nor does the law provide liability protection against consumer lawsuits, which is important since many of the drugs will be tested only on animals infected with nasty diseases such as ebola and smallpox. It's impossible to conduct similar studies in people, so the legislation allows for regulatory approval without the usual human experiments.
What's more, some scientists argue that creating vaccine stockpiles as envisioned by BioShield isn't the nimble solution needed to combat threats posed by diseases genetically engineered to defeat conventional treatments.
Dr. William Raub of the Department of Health and Human Services, which oversees Project BioShield with the Homeland Security Department, says he's optimistic the problems can be overcome to benefit national security.
"It fills a critical need," Raub said. "I can't imagine that we would be on the path to a new anthrax vaccine if it weren't for BioShield money."
According to the new study, based on interviews with 30 biodefense experts, most companies are wary about becoming research partners with the U.S. government -- however great the need for countermeasures.
"A group of leaders from government, academia and the private sector believe that there is a strong threat of a large-scale bioterrorist attack," the report concludes. "They generally think that the current U.S. biodefense countermeasure development strategy and process are not sufficient to meet the challenges posed by these threats."
Meanwhile, money-losing companies that supported BioShield's passage are growing impatient.
"Someone has dropped the ball," complained Richard Hollis, chief executive of Hollis-Eden Pharmaceuticals.
The tiny San Diego firm is developing an anti-radiation drug that has showed promise in monkeys. Hollis spent the better part of last year lobbying in Washington, D.C. His company's executives contributed a combined $18,000 to Bush and other key lawmakers and spent an additional $250,000 on lobbyists.
The behind-the-scenes politicking appeared to pay off for the company when Bush signed the measure into law and guaranteed that the U.S. government would buy drugs to fight radiation poisoning, anthrax, smallpox and other potential terrorists threats that have no natural markets.
Landing a federal contract for millions of doses of its radiation drug would make a company that has lost more than $118 million since its inception in 1997 instantly profitable.
But Hollis-Eden hasn't received a dime from Project BioShield and still isn't sure when -- or if -- it will ever see any benefit, since Homeland Security and Health and Human Services haven't made clear what they want beyond protection from anthrax and smallpox.
Other biotechnology companies have similar stories, prompting the recent introduction of legislation dubbed BioShield II to address some of those concerns.
"Since BioShield has passed we still have a very anemic response within the research communities and within the production communities to producing these types of vaccines and antitoxins, which would protect us in the case of an attack," Sen. Judd Gregg, R-N.H., said at a BioShield hearing last week.
The new legislation seeks to woo companies with tax incentives and some liability protections. It also offers to extend patent protection a few years in some cases and makes limited exemptions from antitrust laws.
But wrangling over how to fix BioShield appears to be bogging down this second round of legislation, and any resolution may come too late for struggling companies that have retooled themselves as biodefense contractors.
"This industry is very fragile and instead of growing it's getting worse and worse every day," said Michael Greenberger, director of the University of Maryland Center for Heath and Homeland Security. "When all is said and done, this industry is heading toward death."