Will Children Replace Chimpanzees in Gov’t Research?

"Use of Chimpanzees in NIH-Supported Research," a report issued by the National Institutes of Health recommends permanently retiring all 451 chimpanzees owned or supported by the NIH from further research.  The chimps are to be moved to retirement sanctuaries.   

Contrast the government’s humane consideration for chimpanzees with an unconscionable disregard for children’s human rights!kathleen_sebelius.jpg

children_at_risk.jpgA morally  indefensible  proposal by Kathleen Sibelius, the Secretary of the Department of Health and Human Services–to Test the SAFETY and EFFICACY of the ANTHRAX VACCINE IN CHILDREN exposing them to unnecessary risks of harm, pain and suffering!!

In 2000, The WASHINGTON POST reported about previously unreported evidence from military trials testing the anthrax vaccine’s efficacy in monkeys:

"The controversial anthrax vaccine that the Pentagon is trying to inject into 2.4 million troops does not provide complete immunity to an anthrax attack, according to an outside expert who has examined Defense Department records of laboratory tests.  Soldiers who are exposed to anthrax may become quite sick and be incapacitated for up to two weeks, even if they have received the full set of six inoculations, said George A. Robertson, a molecular biologist specializing in pharmaceuticals. "

"After being fully vaccinated, the monkeys were exposed to a highly lethal dose of aerosol spray of anthrax on June 13, 1991. "Although all vaccinated monkeys survived, they appeared to be sick over the course of two weeks," the lab report states.

"Robertson noted that the monkeys sickened even though they had been given significantly larger doses of vaccine than humans receive, relative to their weight."

Col. Arthur Friedlander, a senior scientist at the institute, rejected Robertson’s interpretation of the data. 
"It would be a misstatement to take away from the lab notebook that immunized animals when challenged with anthrax are uniformly incapacitated," Friedlander said. "That is a gross overstatement."

He and other officials at the institute said they don’t know for sure whether every animal in the 1991 test fell ill and don’t think any were sick for two full weeks. In another test last year, they said, 18 of 20 immunized monkeys survived exposure, and none were sickened."      http://www.thepowerhour.com/news/anthrax_challenged.htm

Twelve years later, the controversies about the existing anthrax vaccine’s safety and efficacy remain unresolved.

The 2012 FDA-approved label states:"Vaccination with BioThrax may not protect all individuals." And,
“The safety and efficacy of BioThrax in a post-exposure setting have not been established.” 
http://www.biothrax.com/prescribinginformation_biothrax_us.pdf

 The ANTHRAX VACCINE is not safe: 

The 2002 FDA label states:  "Approximately 6% of the reported events were listed as serious. Serious adverse events include those that result in death, hospitalization, permanent disability or are life-threatening."

FDA’s 2005 review of the Vaccine Adverse Event Reports found that 9.5% of the reports were designated by the FDA as serious.

The stated rationale for the proposed unconcionable experiment is TO GAIN DATA prior to–an admittedly unlikely, but conceivable–threat of an anthrax attack. .  amy_gutmann.jpg
presidential_seal.jpgThe Commission is chaired by Dr. Amy Gutmann, President of the University of Pennsylvania.

The Commission did not invite any independent anthrax vaccine experts, nor were they briefed about the safety / efficacy facts.Most of the invited presentations were by biodefense stakeholders in government and academia who sought to twist and redefine federal statutory prohibitions against exposing children to experiments involving greater than minimal risks when there is no potential benefit for the children involved.

Such an experiment is a throwback to long list of US government-sponsored non-therapeutic medical experiments that have brought shame to our nation.

The Commission’s decision will draw a moral line in the sand–that could be used to justify a government decree that circumvents regulatory safeguards for children that have been established during the past 35 years.
 

Vera Sharav

 

THE NEW YORK TIMES  chimps_blankets.jpg
January 22, 2013
Agency Moves to Retire Most Research Chimps By JAMES GORMAN

Almost all of the 451 chimpanzees owned or supported by the National Institutes of Health that are now at research facilities should be permanently retired from research and moved to sanctuaries, with planning for the move to start immediately, a report from an N.I.H. council unanimously recommended Tuesday.

The report, approved by the N.I.H. Council of Councils, is the latest step in a process that began more than two years ago when the agency began to review its use of chimpanzees in research. Its recommendations will be open to public comment for 60 days, and in late March, Dr. Francis S. Collins, the N.I.H. director, will decide whether to put them into effect.

He already accepted guidelines for reducing the use of chimpanzees that formed the basis of the current recommendations.

Kathleen Conlee, vice president for animal research of the Humane Society of the United States, said: “We are very pleased with these recommendations. Importantly, they did not recommend future breeding.”

The report says that for the future, only a small colony of about 50 chimps should be kept for the possibility of new research, which would have to be approved by an independent committee, including representation from the public.

Of the 451 N.I.H. chimps, 282 are available for research and 169 are considered inactive but are not permanently retired. An additional 219 chimpanzees owned or supported by the agency are already retired and are either at a sanctuary or headed for one. About 350 more chimps at research laboratories are owned by universities or private companies, according to the Humane Society.

The report also proposes standards for the social and physical welfare of N.I.H. chimps, including requirements that they live in groups of at least seven, have a minimum of 1,000 square feet per chimp, room to climb, access to the outdoors in all weather and opportunities to forage for food. “Not a single laboratory in the United States meets these recommendations,” Ms. Conlee said.

Within five years, at the latest, any N.I.H. chimpanzees that are approved for use in research will need to have housing that meets the new criteria.

Justin Goodman, the laboratory investigations department director of People for the Ethical Treatment of Animals, issued a statement supporting the recommendations, saying, in part, “At last, our federal government understands: a chimpanzee should no more live in a laboratory than a human should live in a phone booth.”

Dr. K. C. Kent Lloyd of the University of California, Davis, a co-chairman of the working group that prepared the report, said in a hearing Tuesday that was streamed online that his group made field trips to seven chimpanzee facilities, including laboratories and sanctuaries.

He said the group was asked to consider what living conditions were appropriate for chimpanzees, the species closest to humans and highly intelligent and social. Even if experiments are approved in the future as being necessary for human health and undoable in any other way than using chimps, he said the animals must have “environments that not only allow but promote the full range of natural chimp behavior.”

That means room for social groups, and, Dr. Lloyd added, “No chimp should live alone for an extended period of time.”

The report recommends canceling six of nine current biomedical research projects that involve immunology and infectious agents. The report does not specify the nature of the research, but one of the few areas where some scientists consider chimp use important is in work on hepatitis C because no other animals provide a useful model for research, which involves infecting the chimps with the virus.

In less invasive research on behavior and genetics, 15 projects were approved or conditionally approved to continue and six projects ended.

The report also offers a plan for the independent committee to evaluate future research proposals, based on the guidelines proposed in December 2011 by the Institute of Medicine, which emphasized that human health must be at issue and that there must be no other way to do the research.

Tuesday’s recommendations come in the midst of efforts on several fronts to end experiments on chimpanzees, including a bill to stop experimentation on all great apes, which did not pass in the last Congress, but which proponents hope to reintroduce, and a pending decision by the Fish and Wildlife Service on whether captive chimps should be considered endangered, as wild chimps are.

The process that led to the recommendations began in December 2010, when the N.I.H. decided to rethink its use of chimps in medical experiments and asked for a report from the Institute of Medicine. That group concluded that most current research on chimpanzees was not necessary and that chimps should be used only when public health is on the line, no other animals are appropriate and ethical experiments on humans are not possible.

Dr. Collins suspended new grants for medical research on chimpanzees and sought further guidance on how to implement the recommendations. For that he turned to the N.I.H. Council of Councils, which set up the working group, which delivered its report on Tuesday.

 

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Anthrax Shots’ Effect Challenged

Army Disputes Expert Who Reviewed Vaccine Tests

By Thomas E. Ricks

  Tuesday, July 18, 2000; Page A21

The controversial anthrax vaccine that the Pentagon is trying to inject into 2.4 million troops does not provide complete immunity to an anthrax attack, according to an outside expert who has examined Defense Department records of laboratory tests.

Soldiers who are exposed to anthrax may become quite sick and be incapacitated for up to two weeks, even if they have received the full set of six inoculations, said George A. Robertson, a molecular biologist specializing in pharmaceuticals.

But officials at the Army’s Medical Research Institute of Infectious Diseases at Fort Detrick, near Frederick, disagreed with Robertson’s interpretation of the data. They said he was exaggerating the extent of illness in monkeys that were vaccinated and then exposed to anthrax under laboratory conditions.

The dispute over the degree of immunity conferred by the anthrax vaccine is just the latest in a heap of problems encountered by the 2 1/2-year-old inoculation program.

Last week, the Pentagon announced that a looming shortage of the vaccine will force the military to cut the number of doses it administers from 75,000 to 14,000 a month. Blaming production problems at the sole maker of the vaccine, Bioport Corp. of Lansing, Mich., the Defense Department said that for the remainder of the year it will give up trying to vaccinate all troops and focus on those serving in Korea and the Persian Gulf, where the military sees the highest risk of germ warfare.

The Pentagon has expended millions of dollars and a huge amount of energy on the mass inoculations, which defense officials portray as an unfortunate but necessary response to a rising threat. The program was spurred by U.N. weapons inspectors’ discovery in the mid-1990s that Iraq had tried to develop germ weapons and had stockpiled 8,000 liters of anthrax spores before the 1991 Gulf War.

So far, 450,000 members of the U.S. military have received a total of about 1.8 million anthrax vaccinations. But the program has provoked controversy within the armed forces, with about 350 service members refusing to take the vaccine out of concern about its possible side effects. Several dozen have been court-martialed, and others have been allowed to leave the military.

Robertson, an expert in biological warfare, has been analyzing Defense Department test records obtained by Mark Zaid, executive director of the James Madison Project, which seeks to reduce government secrecy. Zaid is also an attorney representing several service members who are resisting the anthrax vaccinations.

Zaid and Robertson conceded that being ill for as long as two weeks is better than dying, the likely fate of those who aren’t inoculated or treated quickly with antibiotics after exposure to anthrax. But they said the Pentagon has failed to disclose publicly that the vaccine doesn’t confer full immunity to the disease.

"The Defense Department is telling people that anthrax vaccination will protect them 99 percent," said Robertson, a retired Army Reserve colonel who formerly worked at the Army’s Infectious Diseases Institute and is now an executive at BioReliance Corp. in Rockville. "It doesn’t tell them they will be incapacitated for two weeks."

Anthrax is an acute infectious disease carried by spore-forming bacteria. It usually occurs in farm animals but can be contracted by humans through tainted meat or, more rarely, inhalation of the spores. When inhaled, it first causes cold-like symptoms and is almost always fatal within a week unless treated immediately by antibiotics.

The Pentagon’s main Web site on anthrax (www.anthrax.osd.mil) seeks to reassure service members about the safety of the vaccinations but does not provide many details about the vaccine’s effectiveness.

Tests on monkeys "lead us to expect that anthrax vaccine would be quite effective in preventing inhaled anthrax," it says. What it doesn’t say is that some of the monkeys became very ill.

Zaid and Robertson analyzed the laboratory notebooks from one of the tests conducted on 10 immunized rhesus monkeys and a control group of five animals at the Army’s infectious diseases institute. After being fully vaccinated, the monkeys were exposed to a highly lethal dose of aerosol spray of anthrax on June 13, 1991.

"Although all vaccinated monkeys survived, they appeared to be sick over the course of two weeks," the lab report states.

Robertson noted that the monkeys sickened even though they had been given significantly larger doses of vaccine than humans receive, relative to their weight.

Col. Arthur Friedlander, a senior scientist at the institute, rejected Robertson’s interpretation of the data.

"It would be a misstatement to take away from the lab notebook that immunized animals when challenged with anthrax are uniformly incapacitated," Friedlander said. "That is a gross overstatement."

He and other officials at the institute said they don’t know for sure whether every animal in the 1991 test fell ill and don’t think any were sick for two full weeks. In another test last year, they said, 18 of 20 immunized monkeys survived exposure, and none were sickened.

"We don’t think that incapacitation of large numbers of troops would occur," said Col. Edward Eitzen, the institute’s commander.

But if it turns out that even fully inoculated soldiers would be unable to fight after exposure to anthrax, the implications for U.S. military operations are enormous, said Chris Seiple, a former Marine officer who serves on a panel studying chemical and biological warfare issues at the Center for Strategic and International Studies.

In addition to the military issues of how to protect troops and respond to such an attack, Seiple said he worries about the effect on public opinion. "People have been led to believe that you can be hit with this stuff and still be mission-ready," he said. "If you had a bunch of people taken prisoner because they were sick, you’d have a loss of public confidence."

© 2000 The Washington Post Company
 

Review:

The monkeys were vaccinated, were given time to develop immunity, then were exposed to anthrax in an efficacy trial.

With normal vaccines, you then have enough immunity that you do not get sick at all.

However, these monkeys got the disease, got sick (meaning the vaccine was NOT highly effective) and furthermore, they got anthrax by inhalation. What do we know about anthrax by inhalation? Of the seven people who survived it in 2001, only one has ever been able to go back to work. So if humans act like monkeys, then the vaccine might save us from death after an anthrax exposure but turn us into physical wrecks, forever.

That is very important. Because right now the millitary says that unvaccinated, sick soldiers would put their buddies at risk to get them evacuated, etc.

DOD knows the vaccine will not work like vaccines should (no illnesses at all) after an exposure–that is why DOD policy requires that vaccinated soldiers be given antibiotics immediately following exposure.

By the way, Friedlander is the person who conducted the 1991 experiment.

Meryl Nass, MD