“Knowledge is the antidote to fear.”

Ralph Waldo Emerson

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Target Health has developed Internet-based software tools which will give competitive advantages to CROs as well as Pharmaceutical and Device companies. Through Target e*CRF®, we work collaboratively with many CROs. The following are our software tools:

  • Target Document® can revolutionize clinical trial document management in a cost effective way and includes a communication tool
  • Target e*CRF® Version 1 can be provided as a service to CROs and comes with Project Management and a communication tool
  • Target e*CRF® Version 3.1 (available April 2007) can be brought in-house and is very cost effective
  • Target Encoder™ for MedDRA and WHODRUG
  • Target Newsletter™ for communications to clinical sites
  • Target Patient Profiler™ to evaluate individual patients in a graphic mode

For more information, please contact Dr. Jules T. Mitchel.

Think of how this latest report warns us of future health problems, like the spread of malaria.

New climate report: More bad news

By SETH BORENSTEIN, AP Science Writer

The harmful effects of global warming on daily life are already showing up, and within a couple of decades hundreds of millions of people won’t have enough water, top scientists will say next month at a meeting in Belgium.

At the same time, tens of millions of others will be flooded out of their homes each year as the Earth reels from rising temperatures and sea levels, according to portions of a draft of an international scientific report obtained by The Associated Press.

Tropical diseases like malaria will spread. By 2050, polar bears will mostly be found in zoos, their habitats gone. Pests like fire ants will thrive.

For a time, food will be plentiful because of the longer growing season in northern regions. But by 2080, hundreds of millions of people could face starvation, according to the report, which is still being revised.

The draft document by the authoritative Intergovernmental Panel on Climate Change focuses on global warming’s effects and is the second in a series of four being issued this year. Written and reviewed by more than 1,000 scientists from dozens of countries, it still must be edited by government officials.

But some scientists said the overall message is not likely to change when it’s issued in early April in Brussels, the same city where European Union leaders agreed this past week to drastically cut greenhouse gas emissions by 2020. Their plan will be presented to President Bush and other world leaders at a summit in June.

The report offers some hope if nations slow and then reduce their greenhouse gas emissions, but it notes that what’s happening now isn’t encouraging.

“Changes in climate are now affecting physical and biological systems on every continent,” the report says, in marked contrast to a 2001 report by the same international group that said the effects of global warming were coming. But that report only mentioned scattered regional effects.

“Things are happening and happening faster than we expected,” said Patricia Romero Lankao of the National Center for Atmospheric Research in Boulder, Colo., one of the many co-authors of the new report.

The draft document says scientists are highly confident that many current problems — change in species’ habits and habitats, more acidified oceans, loss of wetlands, bleaching of coral reefs, and increases in allergy-inducing pollen — can be blamed on global warming.

For example, the report says North America “has already experienced substantial ecosystem, social and cultural disruption from recent climate extremes,” such as hurricanes and wildfires.

But the present is nothing compared to the future.

Global warming soon will “affect everyone’s life … it’s the poor sectors that will be most affected,” Romero Lankao said.

And co-author Terry Root of Stanford University said: “We truly are standing at the edge of mass extinction” of species.

The report included these likely results of global warming:

_Hundreds of millions of Africans and tens of millions of Latin Americans who now have water will be short of it in less than 20 years. By 2050, more than 1 billion people in Asia could face water shortages. By 2080, water shortages could threaten 1.1 billion to 3.2 billion people, depending on the level of greenhouse gases that cars and industry spew into the air.

_Death rates for the world’s poor from global warming-related illnesses, such as malnutrition and diarrhea, will rise by 2030. Malaria and dengue fever, as well as illnesses from eating contaminated shellfish, are likely to grow.

_Europe’s small glaciers will disappear with many of the continent’s large glaciers shrinking dramatically by 2050. And half of Europe’s plant species could be vulnerable, endangered or extinct by 2100.

_By 2080, between 200 million and 600 million people could be hungry because of global warming’s effects.

_About 100 million people each year could be flooded by 2080 by rising seas.

_Smog in U.S. cities will worsen and “ozone-related deaths from climate (will) increase by approximately 4.5 percent for the mid-2050s, compared with 1990s levels,” turning a small health risk into a substantial one.

_Polar bears in the wild and other animals will be pushed to extinction.

_At first, more food will be grown. For example, soybean and rice yields in Latin America will increase starting in a couple of years. Areas outside the tropics, especially the northern latitudes, will see longer growing seasons and healthier forests.

Looking at different impacts on ecosystems, industry and regions, the report sees the most positive benefits in forestry and some improved agriculture and transportation in polar regions. The biggest damage is likely to come in ocean and coastal ecosystems, water resources and coastal settlements.

The hardest-hit continents are likely to be Africa and Asia, with major harm also coming to small islands and some aspects of ecosystems near the poles. North America, Europe and Australia are predicted to suffer the fewest of the harmful effects.

“In most parts of the world and most segments of populations, lifestyles are likely to change as a result of climate change,” the draft report said. “Net valuations of benefits vs. costs will vary, but they are more likely to be negative if climate change is substantial and rapid, rather than if it is moderate and gradual.”

This report — considered by some scientists the “emotional heart” of climate change research — focuses on how global warming alters the planet and life here, as opposed to the more science-focused report by the same group last month.

“This is the story. This is the whole play. This is how it’s going to affect people. The science is one thing. This is how it affects me, you and the person next door,” said University of Victoria climate scientist Andrew Weaver.

Many — not all — of those effects can be prevented, the report says, if within a generation the world slows down its emissions of carbon dioxide and if the level of greenhouse gases sticking around in the atmosphere stabilizes. If that’s the case, the report says “most major impacts on human welfare would be avoided; but some major impacts on ecosystems are likely to occur.”

___

On the Net:

Intergovernmental Panel on Climate Change: http://www.ipcc-wg2.org/

Transgenic Pigs and Brain Power

Pigs can be 1) ___ to produce large quantities of omega-3 fatty acids, found at high concentrations in foods such as flax seeds and certain fish. Transgenic pork containing omega-3s would avoid the potential problem of 2) ___ found in some fish, and also circumvent fears about over-fishing. Omega-3s are still thought to 3) ___ brain power. A team at Harvard Medical School in Boston used 4) techniques to produce piglets carrying a version of a gene from a nematode 5) ___ that converts unhealthy omega-6 fatty acids into omega-3s. 6) ___ made up an average of 8% of the total fat in muscles of the six transgenic pigs, compared with 1 to 2 per cent in normal pigs.

Target Document® is a secure, USER FRIENDLY, web-based document distribution and management system which enables users, depending on their roles and responsibilities to post, share, electronically sign, search, and archive any electronic document, all within a web browser and without installing any software. Access to documents can also be timed to be viewed and/or expired, and there is a communication tool which allows for discussions about specific documents.

Target Document® reduces the need to distribute documents via email and is ideal for companies wanting their own system to communicate with vendors, CROs, study sites, CRAs, etc. It is also ideal for CROs needing to deal with many sponsors.

Target Document® can also be used in any industry and is multi-functional.

Click here to download the brochure

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As part of the corporate global community, Target Health is a member of the Nippon Club here in New York City. The Nippon Club, an organization dedicated to promoting Japan’s culture and international networking, held a spectacular exhibit and reception, last night featuring Sake Vessels.

This exhibition included over 50 Sake Vessels (pottery or glass) by outstanding artists from around the world, such as Mr. Tatsuzo Shimaoka, a national asset in Japan and Mr. Jukan Chin, visiting Professor from Myongii University, Korea. The exhibition’s theme is creating “a place in which people gather” of transcending cultural borders and are shared universally around the world by Sake and Sake Vessels.

Memories Are Made of This

The function of an 1) ___ in the brain, strongly linked to a number of major brain diseases such as Alzheimer’s, schizophrenia and bi-polar disorder, has been identified for the first time. These findings, published in the March edition of the journal Neuron, should help in the understanding of how 2) ___ are laid down and what goes wrong in these disorders. The research shows how controlling the activity of glycogen synthase kinase-3 (GSK3) might prevent a memory being 3) ___ by improving the strength of connections between neurons in the brain, thus allowing better consolidation of new information. While GSK3 has previously been implicated in major 4) ___ disorders, until now its role in normal neuronal function has been largely unknown. This new understanding will help 5) ___ companies develop drugs to inhibit it when things go wrong. The activity of GSK3 facilitates a form of ‘cross-talk’ between the two major forms of synaptic plasticity in the 6) ___. Synaptic plasticity is the strength of a connection between neurons and forms the basis of 7) ___ and memory.

We’re still thinking about what to give away. If you have any suggestions, please send your emails to joycehays at targethealth.com.

Science Daily — Sweat may be another way to pass on hepatitis B infection during contact sports, suggests research published ahead of print in the British Journal of Sports Medicine.

Hepatitis B virus attacks the liver and can cause lifelong infection, cirrhosis (scarring) of the liver, liver cancer, liver failure, and death.

The research team analysed blood and sweat samples from 70 male Olympic wrestlers for evidence of hepatitis B infection (HBV).

The wrestlers, who were all aged between 18 and 30, were all asked about injuries, as blood-borne infection is a common route of transmission.

Over a third said they had had bleeding or weeping wounds during training and competition. And almost half said that they had had an episode of bleeding during other activities.

None of the wrestlers had active HBV infection, as evidenced by a lack of antibodies to the virus.

Nevertheless, the virus itself was found in the blood of nine (13%), suggesting that they had hidden or occult infection, says the author. This is perfectly plausible, given that intense training temporarily suppresses a normal immune response, she says.

Eight (11%) also had particles of the virus present in their sweat, and levels of the virus found in the blood closely matched those found in the sweat.

The findings prompt the author to suggest that sweat, like open wounds and mucous membranes, could be another way of transmitting the infection.

Some sporting bodies have ruled that HIV testing should be mandatory for all contact sport competitors, but no such recommendations have been made for HBV, says the author.
Yet HBV is far more transmissible, because much higher levels of the virus are found in the blood and it is not as fragile as HIV, she says, calling for HBV testing and vaccination for all wrestlers at the start of their career.

News From FDA Website

FDA Publishes Guidance on Communication of Drug Safety Information

The U.S. Food and Drug Administration (FDA) today issued final guidance that describes FDA’s current approach to communicating drug safety information, including emerging safety information, to the public. The guidance also includes the factors that influence when such information is communicated. Important drug safety information has the potential to alter the benefit/risk analysis for a drug in a way that can affect decisions about prescribing or taking the drug. The guidance affirms the agency’s commitment to communicate important drug safety information in a timely manner, including in some situations when the agency is still evaluating whether to take any regulatory action.

The information in the guidance, “Drug Safety Information-FDA’s Communication to the Public,” is intended to make emerging information on important drug safety issues available to the public and will facilitate patient and healthcare provider access to the most current information concerning the potential risks and benefits of a marketed drug.

“The guidance provides for timely communication of drug safety information, which has been, and continues to be, an extremely high priority for FDA,” said Steven Galson MD, Director of FDA’s Center for Drug Evaluation and Research (CDER). “Our goal is to make emerging drug safety information available in a balanced, impartial manner so that health care professionals and patients can consider the information when making decisions about medical treatments despite uncertainties in the data.”

The guidance describes the various methods FDA currently uses to communicate established and emerging drug safety information to the public. FDA’s drug safety communications are available through the FDA Web site. In addition to drug product labeling, FDA’s methods of communicating important drug safety information includes:

* Public Health Advisories – provide information and advice regarding an emerging drug safety issue or other important public health information to the public, including patients and health care professionals.
* Patient Information Sheets – provide concise summaries in plain language, with the most important information about a particular drug.
* Health care Professional Sheets – provide a summary of important and often emerging drug safety issues, with information about the detection of the issue, and points to consider for clinical decision-making.
* Alerts on Patient Information and Health Professional Sheets – provide a summary of important, and often emerging, drug safety issues. Alerts may be placed on public health advisories, or patient and health care professional sheets. These may include:

  • newly observed serious adverse events that may be associated with a drug;
  • information about how such serious adverse events might be prevented by appropriate patient selection, monitoring of patients, or use or avoidance of the therapy; and
  • information regarding a serious adverse event that FDA believes may be associated with use of a drug in populations in whom the drug was not previously studied.

The guidance describes the role of the Drug Safety Oversight Board and its staff in advising the Director of the Center for Drug Evaluation and Research on the management of and communication about emerging drug safety issues.

This guidance also achieves FDA’s goal of issuing, in the first quarter of 2007, final guidance on communicating important drug safety information, including emerging drug safety information, as described in FDA’s Response to the Institute of Medicine’s (IOM) 2006 Report on the Future of Drug Safety.

FDA’s risk communication efforts are part of a larger drug safety initiative that began in November 2004. In connection with FDA’s drug safety initiative, FDA published a draft guidance in May 2005 that described a proposal to establish a new communication channel called the “Drug Watch” Web page to provide information to the public on emerging drug safety issues. FDA received and evaluated 30 comments from the public on this draft guidance and also has considered comments received in connection with a public hearing held in December 2005 regarding risk communication tools employed by FDA.

This final guidance (which supersedes the draft guidance on “FDA’s ‘Drug Watch’ for Emerging Drug Safety Information”) reflects FDA’s consideration of these comments, as well as FDA’s experience with posting emerging drug safety information. The guidance also describes the factors that influence when such information is communicated.

Due to potential confusion between the proposed “Drug Watch” and FDA’s long-standing “MedWatch” program for alerting providers and the public to new information about medical products, FDA no longer plans to use the name “Drug Watch” to describe the Web page that contains links to drug safety information. The agency will continue to evaluate its communication efforts, and will modify them as appropriate to enhance their accessibility and effectiveness.

The public can access FDA’s safety postings about specific drugs at http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm. The Index to the Drug-Specific Information Web page contains information about drugs that are the subject of a Public Health Advisory and/or an Alert regarding an important, and often emerging, drug safety issue, as well as established drug safety information. Drugs that have an active FDA safety alert are identified by an asterisk.

The guidance on “Drug Safety Information-FDA’s Communication to the Public” is available at http://www.fda.gov/cder/guidance/index.htm .

For more information, visit: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01551.html

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