(Reuters) ? Bristol-Myers Squibb Co said on Thursday its liver cancer drug brivanib failed to meet the primary endpoint in a late-stage clinical trial.
Brivanib failed to meet the main goal of improving overall survival versus placebo in liver cancer patients who failed or are intolerant to sorafenib. Sorafenib is used to treat advanced primary liver cancer.
Bristol-Myers said three other trials, to evaluate brivanib in different liver cancer patient groups, will continue as planned.
"We remain committed to the development of brivanib as a potential treatment option for patients with liver cancer, and the ongoing study investigating brivanib 'first-line' is expected to complete in 2012," senior vice president Brian Daniels said in a statement.
Shares of the company closed at $35.09 on Thursday on the New York Stock Exchange.
(Reporting by Soham Chatterjee in Bangalore; Editing by Bob Burgdorfer)
WASHINGTON ? Careening toward a politically toxic tax hike, President Barack Obama implored House Speaker John Boehner on Wednesday to get behind a two-month stopgap until a longer deal could be struck early next year, calling it the only real way out of a mess that is threatening the paychecks of 160 million workers and isolating House Republicans.
In a weary Washington, the outreach accomplished little. All sides seemed to end the day where they began, with heavy political and economic consequences at stake.
Boehner remained insistent on a full-year extension of the existing payroll tax cut before Jan. 1, urging Obama to haul Senate Democrats back to town to talk to his chosen negotiators. "Let's get this done today," Boehner told Obama, according to a speaker's aide, who required anonymity to characterize a private conversation.
But the Capitol was emptying out fast, and the Senate showed no inclination to return, having already passed a bipartisan two-month tax cut it thought had settled the matter.
For taxpayers, and for an economy starting to show some life again, the standoff was all holiday gloom.
Barring any action by Congress, Social Security payroll taxes will go up almost $20 a week for a worker making a $50,000 salary ? that's $40 less for a typical paycheck or $1,000 over the whole year. Almost 2 million people would lose unemployment benefits as well.
The political risks seemed only to deepen, too, particularly for House Republicans. They appeared poised to take the biggest blame for a tax increase even while pushing for a deeper one.
The reliably conservative editorial page of The Wall Street Journal blasted both Boehner and Sen. Mitch McConnell, the GOP leader, for how they handled the matter. "The GOP leaders have somehow managed the remarkable feat of being blamed for opposing a one-year extension of a tax holiday that they are surely going to pass," the paper's editorial said.
In a year of legislative brinksmanship remarkable even by Washington standards, the latest fight spilled into the lap of Republican candidates running for president.
Former House Speaker Newt Gingrich chastised Congress, particularly the Senate, for failing to extend the 2 percentage point tax cut for a full year.
"They can't figure out how to pass a one-year extension, so the Senate leaves town?" Gingrich remarked while campaigning in Iowa. "It's an absurd dereliction of duty."
Rival Mitt Romney refused to take a position, again steering clear of Washington's hot policy debate.
"I'm not going to get into the back-and-forth on the congressional sausage-making process," the former Massachusetts governor told reporters after events in New Hampshire. "I hope they're able to sit down and work out a solution that works for the American people."
But the White House made clear the time for talks were over for this year.
"The negotiating has happened already," presidential spokesman Jay Carney said, referring to the Senate bill the White House insists was sealed with Boehner's blessing.
Boehner disputes that he ever gave a nod of support to the two-month tax cut that many in his caucus oppose.
He and other House members call it a poor and unworkable tax policy.
Obama also called the Senate's Democratic leader, Harry Reid, and praised him for the bipartisan tax-cut bill with McConnell that passed the Senate.
Obama did most of the talking in his 10-minute call to Boehner.
The president made clear to Boehner that this was essentially his last legislative chance: There was no other option under consideration except the two-month tax bill, no surprise last-minute deal, and no real chance that Reid was calling the Senate back, according an administration official who spoke anonymously to describe the private phone call.
From Boehner's perspective, the only real progress was that Obama had shown engagement with the speaker that he had not in weeks, according to an aide who also spoke anonymously to describe internal thinking.
Obama for months has called for a year-long extension of the tax cut; he would prefer that it be deepened, too, although that idea never went anywhere in Congress. Obama reiterated to Boehner that he wants to work out a full-year deal with Congress but there is no time for that to be done right now.
Overall, the stalemate has centered on how to pay for another year's tax cut without adding to the deficit. That is the debate ahead ? if the two-month deal gets done first.
Boehner's reaction gave no hints of a breakthrough, even though House Republicans appear increasingly isolated. They're not getting support from Senate Republicans and are battling against a president whose approval numbers, while not impressive, are better than theirs.
Obama was to have left Washington by now for a Christmas vacation in Hawaii, where his wife and two daughters have been since the weekend.
Instead, after speaking to Boehner and Reid, he found a different escape from the White House.
He took his dog, Bo, and went holiday shopping.
___
Associated Press writers David Espo and Andrew Taylor in Washington, Thomas Beaumont in Des Moines, Iowa, and Kasie Hunt in Keene, N.H., contributed to this story.
The vulnerability, described in a tweet by webdevil, was confirmed by Secunia, which it categorized as a ?highly critical? flaw providing remote system access to an attacker.
?A vulnerability has been discovered in Microsoft Windows, which can be exploited by malicious people to potentially compromise a user's system?, Secunia said.
?The vulnerability is caused due to an error in win32k.sys and can be exploited to corrupt memory via, e.g., a specially crafted web page containing an IFRAME with an overly large 'height' attribute viewed using the Apple Safari browser. Successful exploitation may allow execution of arbitrary code with kernel-mode privileges. The vulnerability is confirmed on a fully patched Windows 7 Professional 64-bit. Other versions may also be affected?, it warned. Secunia stressed that ?no effective solution is currently available.?
Microsoft told Kaspersky Lab that they are looking into the reported vulnerability. "We are currently examining the issue and will take appropriate action to help ensure the customers are protected", said Jerry Bryant, group manager of response communications in Microsoft's Trustworthy Computing Group.
"There is no economy in the world.. that will be immune to the crisis we see not only unfolding, but escalating," Christine Lagarde, the head of the International Monetary Fund (IMF) said on Thursday, warning that the eurozone's crisis threatens not only the developed world, but the entire global economy.
Nothing short of a miracle will stop the eurozone from falling back into a recession, but how deep and how long that recession is depends on how quickly the politics can be fixed and money can be found to reassure not just investors, but corporate financiers and ground-level enterprises that the single currency can be saved and growth restarted.
As economists at Bank of America Merrill Lynch wrote in their global economic outlook, released on Friday morning, "We're all Europeans now."
"While US events have had a strong 'CNN effect' on global markets, European news has rarely been as powerful. For example, the US payroll report is much more impactful than the German IFO index and the Fed usually overshadows the ECB," The outlook said.
"Apparently, when the US sneezes the world catches a cold, but when Asia or Europe sneezes the world offers a handkerchief. Unfortunately, the current strain of euro-flu is more contagious. Europe matters a lot more today due to capital market linkages."
This is a universal across the bank research outlooks being released in the run up to Christmas. Deutsche Bank's macro strategy report warned that nearly anything could happen, but that the risks were all to the downside.
Expectations that rich emerging markets - or the US - might come to the rescue by increasing their commitments to the IMF or directly to the EU's bailout mechanisms have, so far, been met with insistences that Europe must solve Europe's problems.
European markets opened slightly up and had fallen flat after a couple of hours trading. Many investors have probably priced in the longer term macro risks now, and are waiting for someone - possibly the ECB - to deliver a Christmas miracle. Follow our liveblog below to keep up-to-date with the action.
Despite its dramatic 'no' to treaty change in the December 9 eurozone meeting, the UK is to return to the table for technical discussions surrounding the fiscal integration deal.
The move - agreed on Thursday night in a telephone call between Mr Cameron and the President of the European Council, Herman von Rompuy - is likely to be seen as an olive branch both to the other EU countries and his Liberal Democrat coalition partners.
"The Prime Minister reiterated that he wants the new fiscal agreement to succeed, and to find the right way forward that ensures the EU institutions fulfil their role as guardian of the EU treaty on issues such as the single market," a No 10 spokesman said.
After the crisis deal was agreed last week, there was immediate criticism of Cameron's stance, which many said would not protect the City of London from regulation from Brussels.
There are a few reasons why there never is a contagion of higher borrowing costs for other U.S. states when one state runs into budget difficulties, The Wall Street Journal's David Wessel wrote on Thursday.
A new working paper by the International Monetary Fund found that a rise in borrowing costs in one state resulted in lower borrowing costs in other states: the opposite of the contagion effect of higher borrowing costs in countries across Europe, Wessel noted.
Wessel wrote that there are a few possible reasons why: the markets trust that the federal government (unlike Germany) would bail out a state if necessary, the markets are not concerned that the dollar-union could split apart, and the markets still view the creditworthiness of different states as essentially different. Thus, a fiscal union in Europe both could help and not be enough to prevent higher borrowing costs for struggling countries.
Read the whole story on The Wall Street Journal's website.
--Bonnie Kavoussi
The European Central Bank said in a report on Thursday that Europe needs to adhere to stricter budgetary rules than agreed to at the Brussels summit last week.
The ECB particularly faulted the "discretion" that the European Commission and European Council will have in enforcing budgetary discipline, complaining that the European Union would take relevant factors into account and that the punishment of countries that spend more than allowed would not be automatic.
-- Bonnie Kavoussi
Mario Draghi, president of the European Central Bank, said in a speech on Thursday that there is "no external savior" for the eurozone and that struggling countries should supposedly save themselves by cutting spending and agreeing to more control of their budgets by the European Union, according to the Associated Press.
"There is no external savior for a country that doesn't want to save itself," Draghi said in Berlin.
Draghi claimed that countries could restore "financial markets' confidence" on their own by committing to restrained budgets over the long term.
Nobel Prize-winning Princeton economist Paul Krugman has dismissed attempts to restore business confidence by slashing government spending as an irrational belief in "the confidence fairy" which never arrives.
Draghi said in response to a question after the speech that he is skeptical about the potential economic impact of buying large amounts of securities, which in this case many observers would want to be European government bonds, according to The Wall Street Journal.
"I don't think quantitative easing leads to stellar economic performance. I see no evidence that quantitative easing greatly boosts the U.K. and U.S. economies," Draghi said.
--Bonnie Kavoussi
European stock markets clawed back some of the losses made over the last two days as US jobs data gave them slight hopes that the world's largest economy might pull itself out of its slump.
In Germany, the DAX gave back some of its early gains but closed up 0.98%, while the French CAC-40 ended the day up 0.76%. The FTSE-100 was up 0.63%. The euro came off its 11-month lows, but only just.
The day's main highlights:
The Anglo-French rift on Europe is widening, as both the president and the central bank governor make digs.
ECB chief Mario Draghi said very little in a speech, but indicated that there will be no infinite bond buying.
Technocratic Italian PM Mario Monti got a taste of the fractious politics that finished off his predecessor, and will face a vote of confidence.
Both the Markit Purchasing Managers Index and Ernst & Young forecast a eurozone recession early next year.
Investors, as they have since the EU summit last Friday, been trading into an information vacuum, with little, apart from speculation over the tangled legalities of the summit document.
European Central Bank (ECB) president Mario Draghi gave little away in a speech in Berlin, and the release of the monthly bulletin was equally unenlightening.
There were more weak projections of the eurozone's economic growth, which hit at its debt reduction strategies, but they failed to scare markets any more than they already are. Likewise, the fact that Mario Monti's government will have to face a confidence vote on austerity measures passed without real alarm.
It is possible the market was oversold on Tuesday and Wednesday, but with the way the politics has proceeded to date, it is unlikely that many investors will want to take long positions into the weekend.
This morning's robust rally on the stock markets has come off the boil a bit - the DAX is still on to gain 1.06% but the CAC-40 is now up 0.81% on the day, and the FTSE-100 up 0.77%.
The euro is off the floor - yesterday it hit 11-month lows - but is still below $1.30.
European Central Bank (ECB) head Mario Draghi said today that the need to recapitalise struggling banks needed to be balanced by the need to free up credit into the real economy.
He said:
Banks in the euro area have recently come under pressure both as regards their capital bases and their funding conditions.
The plan to strengthen their capital bases is an attempt to reinforce their standing in financial markets, but this is not an easy process. There are essentially three options for banks to pursue to raise their capital ratios as demanded by the European Banking Authority: they can raise their capital levels, sell assets or reduce their provision of credit to the real economy.
The first option is much better than the second, and the second option is much better than the third.
Speaking at the Ludwig Erhard Foundation's annual lecture - named after the economist who helped to shape Germany's postwar recovery - Draghi also made what could be a pointed remark about the pressure on the bank itself, saying:
Ludwig Erhard also helped to enshrine the principle of central bank independence. When in the early 1950s the independence of the German central bank system was not yet settled, he as minister of the economy argued that the government should not issue instructions to the central bank. You all know that the statutes of the ECB inherited this important principle and that central bank independence and the credible pursuit of price stability go hand in hand.
Here's the speech in full.
The morning's rally has held firm into the afternoon, as European stock markets keep the faith ahead of the US open. Solid job data from the US added to the positive sentiment. As of 2pm GMT, the German DAX had gained more than 1.85% and the French CAC-40 was up nearly 1.25%, reversing some of the big losses made over the previous two days. In London, the FTSE stayed strong over 1%.
This comes despite Mario Draghi, the president of the European Central Bank (ECB) reiterating that he does not see any extension of the bank's bond buying programme, and continuing worries about Italy.
Many investors expect the ECB to relax its stance and print money.
There is a very brief story on the Reuters wire that quotes a Russian aide to Vladimir Putin saying that the country could put $10bn into the IMF to help the EU.
Jose Manuel Barroso and Herman Van Rompuy are meeting with Russian President Dmitri Medvedev today to discuss possible contributions.
In the scheme of things, $10bn (?7.7bn) is not a great deal, when the EU is seeking hundreds of billions of euros.
In the face of renewed pressure over the strict austerity measures that Italy is going to have to undergo if it is to climb out of its debt hole, the technocratic government is to hold a vote of confidence. The move was announced after the session in the lower house had to be suspended this morning, AP reports.
Votes of confidence are relatively commonplace in Italy - Silvio Berlusconi survived more than 50 - and the move is a calculated gamble to reduce the dissent that saw lawmakers from the Northern League protesting in parliament.
From AP:
The vote of confidence was announced in the lower house, where the speaker earlier suspended the session and ejected two lawmakers from the unruly right-wing Northern League who held up banners against the resurrection of a tax on primary residences. The Northern League caucus, the only party not to support Monti's government in a vote of confidence confirming the new Cabinet last month, also whistled in protest of the measures before the chamber.
"Shepherds whistle, not lawmakers," a clearly agitated Gianfranco Fini told deputies as he sought to bring order.
Yet more bad news out of Italy, via the Financial Times.
The FT reports that the main lobby of Italian employers, Confindustria, is forecasting a contraction of 1.6% in the country's gross domestic product (GDP) in 2012. The group actually predicted a slight rise in its last release, in September, so the number seems indicative of a real worsening of sentiment amongst domestic employers.
Guy Dinmore writes:
?We are in recession,? Corrado Passera, minister for development, told a Confindustria conference in Rome. ?but this is not our fault,? he said, blaming the crisis on Europe?s ?inadequate management of the Greek crisis?.
Mr Passera warned that without economic growth the government?s programme would be ?unsustainable?, with its emphasis on social equity at risk.
The eurozone looks likely to fall into recession next year, according to a major business survey - the Markit Eurozone Composite Purchasing Managers Index (PMI).
A score of over 50 on the PMI is indicative of positive economic growth, while a score below that means recession. The survey compiles the investment activity of companies across the single currency area.
Better-than-expected results in Germany and France cause the index to beat expectations of a decline, as the PMI rose from 47.0 to 47.9, but it remains firmly in negative territory.
Ernst & Young also released their eurozone forecast this morning, and said that the economy in the region is likely to contract in the first quarter of 2012.
Spain has sold ?2.5bn of five-year bonds with a yield of just over 4% - considerably less than the 6% that investors demanded of Italy for debt with the same maturity earlier this week. The auction was covered twice over, showing that markets are still clinging onto confidence in Spain, if not in Italy.
The scale of Italy's debt problems, relative to the amount of money available in European and IMF coffers to backstop it, are coming to the fore, as Italy's politics shows signs of the kind of polarity and tension that characterised the Berlusconi government.
The European Financial Stability Facility (EFSF), the bail out fund, has ?275bn left, after committing to support Greece, Ireland and Portugal. The IMF has, possibly, ?100bn ready to deploy this year. Add to this the ?150-200bn (dependent on who agrees to pay) from the December 9 summit, and the total is between ?495-545bn that is deployable in the short term.
By the summer, Italy's debt was more than ?1.8tr. Italy and Spain between them are going to need to find nearly ?600bn next year, as existing stocks of debt mature. Their costs of borrowing are well above sustainable levels - Italy paid euro era record highs on its five-year debt auction earlier this week.
It is a concern echoed by John Paulson, the hedge fund manager, in an op-ed in the Financial Times this morning. Saying that the amount of money available was inadequate, he called on policymakers to learn from the US experience:
"Drawing on our experience restructuring companies along with lessons learned in the US following the bankruptcy of Lehman Brothers, we suggest the ECB consider a sovereign debt guarantee programme as a solution to the European sovereign debt crisis."
When the opportunity to review the high-tech Home Chef Apron by iRepel came around, I volunteered immediately. Before I was foolish enough to go to law school and join the computer/online industry, I worked as a chef for a few restaurants. This meant I spent a great deal of time turning kitchen whites and my [...]
IOM report recommends stringent limits on use of chimpanzees in biomedical and behavioral research Public release date: 15-Dec-2011 [ | E-mail | Share ]
Contact: Christine Stencel news@nas.edu 202-334-2138 National Academy of Sciences
WASHINGTON -- Given that chimpanzees are so closely related to humans and share similar behavioral traits, the National Institutes of Health should allow their use as subjects in biomedical research only under stringent conditions, including the absence of any other suitable model and inability to ethically perform the research on people, says a new report from the Institute of Medicine. In addition, use of these animals should be permissible only if forgoing their use will prevent or significantly hinder advances necessary to prevent or treat life-threatening or debilitating conditions, said the committee that wrote the report. Based on these criteria, chimpanzees are not necessary for most biomedical research.
NIH also should limit the use of chimpanzees in behavioral research to studies that provide otherwise unattainable insights into normal and abnormal behavior, mental health, emotion, or cognition, the report says. NIH should require these studies to be performed only on acquiescent animals using techniques that are minimally invasive and are applied in a manner that minimizes pain and distress. Animals used in either biomedical or behavioral studies must be maintained in appropriate physical and social environments or in natural habitats, the report adds.
"The report's recommendations answer the need for a uniform set of criteria for assessing the scientific necessity of chimpanzees in biomedical, comparative genomics, and behavioral research," said committee chair Jeffrey Kahn, senior faculty member, Johns Hopkins Berman Institute of Bioethics, Baltimore. "The committee concluded that research use of animals that are so closely related to humans should not proceed unless it offers insights not possible with other animal models and unless it is of sufficient scientific or health value to offset the moral costs. We found very few cases that satisfy these criteria."
Advances in the development of other research tools and methods, including cell-based tests and other animal models, have rendered chimpanzees largely nonessential as research subjects, the committee noted. It acknowledged two possible ongoing uses: the development of a limited number of monoclonal antibody therapies already in the pipeline, and development of a vaccine that would prevent infection by hepatitis C virus (HCV).
New methods such as recombinant technologies can replace the chimpanzee in efforts to develop monoclonal antibodies. While industry and academic laboratories are in the process of adopting these alternate approaches, there may be a few therapies in development that require continued use of chimpanzees to keep progress from stalling and slowing patients' access to needed new treatments. These cases should be assessed to ensure that they meet the criteria outlined in this report, and NIH should continue to support the development of and access to alternatives to make future use of chimpanzees unnecessary.
The committee did not reach a consensus decision on whether chimpanzees are essential to the development of a prophylactic HCV vaccine and if or how much the use of chimpanzees would accelerate or improve this work. Roughly 3.2 million Americans are chronically infected with HCV, and about 17,000 new infections occur each year in the United States alone. Persistent infection can lead to liver disease and cancer; it is the most common cause of liver failure and transplantation in the United States.
Chimpanzees and humans are the only two species that are susceptible to HCV infection, and no other suitable animal models currently exist to test a prophylactic vaccine. However, chimpanzees' immune systems clear HCV from their bodies more effectively, and they are less likely to develop liver damage. The committee members agreed that it would be possible and ethical to test a prophylactic vaccine candidate in humans without prior testing in chimpanzees, provided that it was first shown to be safe and to stimulate an immune response in other animals. However, the committee was evenly split on the necessity of testing various HCV vaccine candidates in chimpanzees before proceeding to human trials.
Research to develop a therapeutic HCV vaccine one that would be given to people already infected with HCV to boost their immune systems' ability to clear the virus and antiviral drugs for patients with chronic HCV infection can be performed without use of chimpanzees, the committee agreed. These products can be more readily and rapidly tested in people, and new drugs and therapeutic vaccine candidates are moving forward without the use of chimpanzees.
The committee would not close the door on the possibility that chimpanzees may be needed in future research to develop treatments or preventive tools against as yet unknown diseases or disorders. It is impossible to say in advance whether other animal models or research tools will always serve effectively and quickly enough in the face of a novel health threat.
The report's recommendations focus on the scientific necessity of the chimpanzee as a research subject, but also take ethical issues into account. Chimpanzees' genetic closeness to humans and their similar biological and behavioral characteristics not only make chimpanzees a uniquely valuable species for certain types of research but also demand greater justification for conducting research with them, the committee said.
###
The study was mandated by Congress and sponsored by the National Institutes of Health. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The Institute of Medicine, National Academy of Sciences, National Academy of Engineering, and National Research Council together make up the independent, nonprofit National Academies. For more information, visit http://national-academies.org or http://iom.edu. A committee roster follows.
Contacts:
Christine Stencel, Senior Media Relations Officer
Luwam Yeibio, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail news@nas.edu
Copies of Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Additional information is available at http://iom.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).
INSTITUTE OF MEDICINE
Board on Health Sciences Policy
Committee on the Use of Chimpanzees in Biomedical and Behavioral Research
Jeffrey P. Kahn, M.P.H., Ph.D. (chair)
Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy
Berman Institute of Bioethics
Johns Hopkins University
Baltimore
John G. Bartlett, M.D.
Professor of Medicine
School of Medicine
Johns Hopkins University
Baltimore
H. Russell Bernard, Ph.D.
Professor Emeritus
Department of Anthropology
University of Florida
Gainesville
Floyd E. Bloom, M.D.
Professor Emeritus
Molecular and Integrative Neuroscience Department
The Scripps Research Institute
La Jolla, Calif.
Warner C. Greene, M.D., Ph.D.
Director and Senior Investigator
Gladstone Institute of Virology and Immunology;
Nick and Sue Hellmann Distinguished Professor of Translational Medicine; and
Professor of Medicine, Microbiology, and Immunology
University of California
San Francisco
Diane E. Griffin, M.D., Ph.D.
Distinguished University Service Professor, and
Alfred and Jill Sommer Chair
W. Harry Feinstone Department of Molecular Microbiology and Immunology
Johns Hopkins Bloomberg School of Public Health
Baltimore
Edward E. Harlow Jr., Ph.D.
Professor
Harvard Medical School
Cambridge, MA
Jay R. Kaplan, Ph.D.
Professor of Pathology and Anthropology
Department of Comparative Medicine
Wake Forest School of Medicine
Winston-Salem, N.C.
Margaret S. Landi, D.V.M.
Vice President of Global Laboratory Animal Sciences, and
Chief of Animal Welfare
GlaxoSmithKline
King of Prussia, Pa.
Frederick A. Murphy, D.V.M., Ph.D.
Professor
Department of Pathology
University of Texas Medical Branch
Galveston
Robert Sapolsky, Ph.D.
John A. and Cynthia Fry Gunn Professor of Biological Sciences, Neurology and Neurological Sciences
Stanford University
Stanford, Calif.
Sharon Terry, M.A.
President and CEO
Genetic Alliance
Washington, D.C.
STAFF Bruce M. Altevogt, Ph.D.
Study Director
[ | E-mail | Share ]
?
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IOM report recommends stringent limits on use of chimpanzees in biomedical and behavioral research Public release date: 15-Dec-2011 [ | E-mail | Share ]
Contact: Christine Stencel news@nas.edu 202-334-2138 National Academy of Sciences
WASHINGTON -- Given that chimpanzees are so closely related to humans and share similar behavioral traits, the National Institutes of Health should allow their use as subjects in biomedical research only under stringent conditions, including the absence of any other suitable model and inability to ethically perform the research on people, says a new report from the Institute of Medicine. In addition, use of these animals should be permissible only if forgoing their use will prevent or significantly hinder advances necessary to prevent or treat life-threatening or debilitating conditions, said the committee that wrote the report. Based on these criteria, chimpanzees are not necessary for most biomedical research.
NIH also should limit the use of chimpanzees in behavioral research to studies that provide otherwise unattainable insights into normal and abnormal behavior, mental health, emotion, or cognition, the report says. NIH should require these studies to be performed only on acquiescent animals using techniques that are minimally invasive and are applied in a manner that minimizes pain and distress. Animals used in either biomedical or behavioral studies must be maintained in appropriate physical and social environments or in natural habitats, the report adds.
"The report's recommendations answer the need for a uniform set of criteria for assessing the scientific necessity of chimpanzees in biomedical, comparative genomics, and behavioral research," said committee chair Jeffrey Kahn, senior faculty member, Johns Hopkins Berman Institute of Bioethics, Baltimore. "The committee concluded that research use of animals that are so closely related to humans should not proceed unless it offers insights not possible with other animal models and unless it is of sufficient scientific or health value to offset the moral costs. We found very few cases that satisfy these criteria."
Advances in the development of other research tools and methods, including cell-based tests and other animal models, have rendered chimpanzees largely nonessential as research subjects, the committee noted. It acknowledged two possible ongoing uses: the development of a limited number of monoclonal antibody therapies already in the pipeline, and development of a vaccine that would prevent infection by hepatitis C virus (HCV).
New methods such as recombinant technologies can replace the chimpanzee in efforts to develop monoclonal antibodies. While industry and academic laboratories are in the process of adopting these alternate approaches, there may be a few therapies in development that require continued use of chimpanzees to keep progress from stalling and slowing patients' access to needed new treatments. These cases should be assessed to ensure that they meet the criteria outlined in this report, and NIH should continue to support the development of and access to alternatives to make future use of chimpanzees unnecessary.
The committee did not reach a consensus decision on whether chimpanzees are essential to the development of a prophylactic HCV vaccine and if or how much the use of chimpanzees would accelerate or improve this work. Roughly 3.2 million Americans are chronically infected with HCV, and about 17,000 new infections occur each year in the United States alone. Persistent infection can lead to liver disease and cancer; it is the most common cause of liver failure and transplantation in the United States.
Chimpanzees and humans are the only two species that are susceptible to HCV infection, and no other suitable animal models currently exist to test a prophylactic vaccine. However, chimpanzees' immune systems clear HCV from their bodies more effectively, and they are less likely to develop liver damage. The committee members agreed that it would be possible and ethical to test a prophylactic vaccine candidate in humans without prior testing in chimpanzees, provided that it was first shown to be safe and to stimulate an immune response in other animals. However, the committee was evenly split on the necessity of testing various HCV vaccine candidates in chimpanzees before proceeding to human trials.
Research to develop a therapeutic HCV vaccine one that would be given to people already infected with HCV to boost their immune systems' ability to clear the virus and antiviral drugs for patients with chronic HCV infection can be performed without use of chimpanzees, the committee agreed. These products can be more readily and rapidly tested in people, and new drugs and therapeutic vaccine candidates are moving forward without the use of chimpanzees.
The committee would not close the door on the possibility that chimpanzees may be needed in future research to develop treatments or preventive tools against as yet unknown diseases or disorders. It is impossible to say in advance whether other animal models or research tools will always serve effectively and quickly enough in the face of a novel health threat.
The report's recommendations focus on the scientific necessity of the chimpanzee as a research subject, but also take ethical issues into account. Chimpanzees' genetic closeness to humans and their similar biological and behavioral characteristics not only make chimpanzees a uniquely valuable species for certain types of research but also demand greater justification for conducting research with them, the committee said.
###
The study was mandated by Congress and sponsored by the National Institutes of Health. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The Institute of Medicine, National Academy of Sciences, National Academy of Engineering, and National Research Council together make up the independent, nonprofit National Academies. For more information, visit http://national-academies.org or http://iom.edu. A committee roster follows.
Contacts:
Christine Stencel, Senior Media Relations Officer
Luwam Yeibio, Media Relations Assistant
Office of News and Public Information
202-334-2138; e-mail news@nas.edu
Copies of Chimpanzees in Biomedical and Behavioral Research: Assessing the Necessity are available from the National Academies Press; tel. 202-334-3313 or 1-800-624-6242 or on the Internet at http://www.nap.edu. Additional information is available at http://iom.edu. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).
INSTITUTE OF MEDICINE
Board on Health Sciences Policy
Committee on the Use of Chimpanzees in Biomedical and Behavioral Research
Jeffrey P. Kahn, M.P.H., Ph.D. (chair)
Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy
Berman Institute of Bioethics
Johns Hopkins University
Baltimore
John G. Bartlett, M.D.
Professor of Medicine
School of Medicine
Johns Hopkins University
Baltimore
H. Russell Bernard, Ph.D.
Professor Emeritus
Department of Anthropology
University of Florida
Gainesville
Floyd E. Bloom, M.D.
Professor Emeritus
Molecular and Integrative Neuroscience Department
The Scripps Research Institute
La Jolla, Calif.
Warner C. Greene, M.D., Ph.D.
Director and Senior Investigator
Gladstone Institute of Virology and Immunology;
Nick and Sue Hellmann Distinguished Professor of Translational Medicine; and
Professor of Medicine, Microbiology, and Immunology
University of California
San Francisco
Diane E. Griffin, M.D., Ph.D.
Distinguished University Service Professor, and
Alfred and Jill Sommer Chair
W. Harry Feinstone Department of Molecular Microbiology and Immunology
Johns Hopkins Bloomberg School of Public Health
Baltimore
Edward E. Harlow Jr., Ph.D.
Professor
Harvard Medical School
Cambridge, MA
Jay R. Kaplan, Ph.D.
Professor of Pathology and Anthropology
Department of Comparative Medicine
Wake Forest School of Medicine
Winston-Salem, N.C.
Margaret S. Landi, D.V.M.
Vice President of Global Laboratory Animal Sciences, and
Chief of Animal Welfare
GlaxoSmithKline
King of Prussia, Pa.
Frederick A. Murphy, D.V.M., Ph.D.
Professor
Department of Pathology
University of Texas Medical Branch
Galveston
Robert Sapolsky, Ph.D.
John A. and Cynthia Fry Gunn Professor of Biological Sciences, Neurology and Neurological Sciences
Stanford University
Stanford, Calif.
Sharon Terry, M.A.
President and CEO
Genetic Alliance
Washington, D.C.
STAFF Bruce M. Altevogt, Ph.D.
Study Director
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MAKHACHKALA, Russia (Reuters) ? The founder of a newspaper that investigated government corruption was shot dead in Russia's North Caucasus region, in what an international watchdog called "a lethal blow to press freedom."
A gunman shot Gadzhimurat Kamalov as he was leaving the offices of the newspaper Chernovik in the capital of Dagestan province shortly before midnight on Thursday, the regional Interior Ministry said.
Police said Kamalov was shot eight times and was pronounced dead on the way to hospital.
The New York-based Committee to Protect Journalists (CPJ) said journalists at Chernovik, known for reporting on corruption in the provincial administration, had been "routinely persecuted for their work".
"The assassination of Gadzhimurat Kamalov is a massive loss for independent journalism in the North Caucasus, Russia's most dangerous place for reporters," the advocacy group's regional coordinator Nina Ognianova said in a statement.
Russian journalists who investigate corruption face serious risks, particularly in the provinces, where authorities are less likely to face scrutiny over attacks on journalists.
Predominantly Muslim Dagestan is plagued by violence stemming from an Islamist insurgency rooted in the 1990s separatist wars in neighboring Chechnya as well as conflicts over business and political power.
There have been 19 unsolved murders of journalists in Russia since 2000, including the 2006 killing of Kremlin critic Anna Politkovskaya, according to the CPJ.
It lists Russia as eighth on its "Impunity Index", a list of states where journalists are killed regularly and governments fail to solve the crimes.
(Writing by Steve Gutterman; Editing by Tim Pearce)
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Public release date: 15-Dec-2011
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