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Good Science

February 2017


February 24, 2017   animal testing

 

How do we know if we’re succeeding? It’s a question we are always trying to answer. If we want to improve research and testing by reducing animal experiments, we need to know how many animals are used in laboratories. But we don’t.

Rough estimates of how many animals are used in United States laboratories are as high as 100 million annually, but we have little idea whether that number is accurate. More importantly, we have no idea whether that number is going up or down. This lack of clarity can largely be blamed on a problem unique among industrialized nations – namely, our only federal law designed to regulate the use of animals in labs excludes from the definition of “animal” more than 90 percent of animals used in labs. Most rats and mice and all birds and cold-blooded vertebrates are not covered by the Animal Welfare Act.

For the small percentage of animals covered by the Animal Welfare Act, each research facility must send the U.S. Department of Agriculture (USDA) an annual report listing the number of animals used, categorized by species. Unfortunately, the use of these reports as a monitoring system hit a major snag earlier this month, when the USDA abruptly shut down its animal welfare database.

While the online database was very useful, even when research facilities’ annual reports were available, it’s not clear how much the numbers could be trusted. Under the Animal Welfare Act, every U.S. research facility must have an Institutional Animal Care and Use Committee, which is in charge of evaluating proposed requests for animal use and ensuring legal standards of animal care and husbandry. These committees are the primary entity in charge of compliance with federal law, but according to a USDA audit,over a three-year period ending in 2011, almost half of all them were found to be in violation of the law. One of the primary reasons for the committees’ 1,379 Animal Welfare Act violations over that time was that the groups “did not recognize the importance of submitting an accurate annual report.”

Compare the U.S. system to that of the European Union, where all vertebrates (including rats, mice, birds, and fish) and even octopuses and squid are covered by the region’s law on animal use for scientific purposes. That law also results in the collection of information on not only how many animals and what species are used in experimentation each year but also where the animals originate and for what purpose they are used (broadly speaking). This information, which has been published every three years by the EU in a public report, shows that between 2008 and 2011 the number of animals decreased by more than a half-million. Under a new law, the next report, including even more detail, will be published in 2019. If we had similar information in the U.S., we could know if efforts to reduce animal experimentation are succeeding or failing and which efforts are most successful.

On this side of the Atlantic, how do we get closer to a more transparent system? The best step might be to reverse the 2002 congressional action that changed the Animal Welfare Act’s definition of “animal” to exclude the species mentioned above. That’s unlikely given the current divisiveness on Capitol Hill. However, Republican Rep. Ken Calvert of California and others are trying at least to require that more information about the federal government’s use of animals in testing be made available to the public.

In addition, three scientists at Hannover Medical School in Germany think they might have one answer to this problem of transparency—registries of animal studies, which could include details of each experiment and animal numbers. As the journal Science reports, these registries would address the problem that half of all animal experiments are never published in scientific journals. In contrast to the dearth of publicly available numbers on animal studies, the U.S. Food and Drug Administration already mandates that researchers preregister human clinical trials online.

Ultimately, whatever the system of transparency, it’s clear more is needed. Unless the shutdown of USDA’s animal welfare database is either reversed by the agency or overturned by a court, organizations like ours will be forced to wait months or years to receive records via federal Freedom of Information Act requests, and  may have to bring separate lawsuits against the USDA to obtain the information. Meanwhile, numbers for most animals used in U.S. laboratories aren’t available from any central repository. The federal National Institutes of Health funds approximately $13 billion worth of animal experiments each year. The public deserves to know how that money is spent, and whether we are moving in the right direction—away from animal research.

 

February 17, 2017   Alzheimer's disease

 

A Need to Change Clinical Research Approaches in Studying Alzheimer's Disease

Alzheimer’s disease is the most common form of dementia, affecting more than 5 million Americans. This number is expected to triple in prevalence by 2050, which is estimated to quadruple health care costs to $1 trillion.

To prevent this oncoming public health crisis, in 2011 Congress passed the National Alzheimer’s Project Act (NAPA) to create a national strategic plan coordinating the federal government’s efforts to treat and prevent dementia. An Advisory Council on Alzheimer’s Research, Care, and Services, consisting of members from relevant federal agencies and nongovernmental organizations, meets quarterly to evaluate progress, update the strategic plan, and make recommendations to Congress.

At the Council’s Feb. 3 meeting, Physicians Committee scientist Feng-Yen Li, Ph.D., delivered a public commentary to outline impediments to progress to find an effective intervention to treat or prevent Alzheimer’s disease. For example:

  • Drug candidates are initially tested in animal models that do not recapitulate the human disease, unlike human-based models, which are derived from patients or patient data.
  • Patients with chronic health conditions (e.g., diabetes, cardiovascular disease) that often occur alongside the most common form of Alzheimer’s disease are often excluded from participating in clinical trials, which means important underlying factors may be overlooked and the drugs may fail to work in these patients.
  • Drug targets for clinical trials are often based on genetic defects or pathways characterized in the rare inherited form of Alzheimer’s but are tested in patients with the common form of Alzheimer's who may or may not have genetic risk factors.
  • Alzheimer's drug development is often focused on reducing the signs of pathology such as brain plaques. However, these may just be a consequence rather than a cause of the disease. Little focus is on the underlying lifestyle risk factors of the disease.

Dr. Li strongly recommended the Council direct future funding and research efforts in Alzheimer’s disease to clinical trials based on data derived from humans or human-based models and focused on modifying lifestyle risk factors such as diet. A copy of the full commentary is available here.

To further promote these concepts, the Physicians Committee’s Ann Lam, Ph.D., has organized a discussion panel on Shifting Perspectives on Dementia, Science, and Health Policy at the 2017 American Association for the Advancement of Science meeting, featuring three experts in Alzheimer’s prevention research: Drs. Rhonda Au, a professor at Boston University; Jessica Langbaum, an associate professor at the Banner Research Institute; and Neal Barnard, president of the Physicians Committee.

 

UPDATE – March 7: USDA has begun to release small amounts of information previously removed from its website. However, the online database remains down, and the vast amount of previously searchable information is still accessible to the public only through time-consuming FOIA requests. The Physicians Committee continues to pursue its lawsuit and work with allies in Congress to restore the database.

On Feb. 3, 2017, without warning, the U.S. Department of Agriculture (USDA) shut down its publicly available animal welfare database, known as the Animal Care Information System. This will make it harder to find out how animals are used in laboratories and whether those facilities are complying with federal law. Without this information, it will be dramatically more expensive and time-consuming to track whether researchers are moving away from animal experiments and toward human-relevant studies.

The database included inspection reports of research facilities, testing laboratories, and other institutions regulated under the federal Animal Welfare Act and Horse Protection Act. The database also included research and testing facilities’ annual reports, which allowed the public to see how many Animal Welfare Act-covered animals were used, organized by species.

We have filed a federal lawsuit in an effort to restore the database. You can also help by contacting your members of Congress.

In recent years, the Physicians Committee has used records from the USDA database to close a notorious primate research center, to end a university’s use of cats in a potentially painful medical training exercise, to support the eventual end of chimpanzee experimentation in the United States, and achieve many other advancements in medical research and training. Here are just a few key examples:

Harvard University’s New England Primate Research Center Closes

A 2011 Physicians Committee report detailed how a primate (later revealed to be a highly endangered cotton-top tamarin) was found dead in a cage at the Harvard facility after going through a machine that uses near-boiling water and caustic chemicals to wash cages. Later, we helped reveal other accounts of animal deaths and mistreatment, including a monkey dying after receiving an overdose of anesthetics and a cotton-top tamarin dying of dehydration because staff failed to place a water bottle in his cage. Records from these incidents provided grounds for a federal Endangered Species Act complaint because Harvard was negligently harming and killing cotton-top tamarins, a critically endangered species. In May 2015, Harvard closed the New England Primate Research Center for good.

University of Virginia Ends Use of Cats for Pediatrics Training

In 2010, the Physicians Committee launched a national campaign to end the use of live cats in the teaching of pediatrics residents at the University of Virginia (UVA). Physicians-in-training at UVA would repeatedly force breathing tubes down the throats of cats, a procedure that can cause tracheal bleeding, scarring, and severe pain. This was being done despite the widespread availability of human-relevant training methods modeled on human anatomy. Records obtained via the USDA database showed that the supplier of cats to UVA—Liberty Research in Waverly, N.Y.—habitually provided kittens with half as much space as required by the Animal Welfare Act during shipping to facilities like UVA. The company was cited 11 times in just an eight-month period for violating this section of the law. Sending these records to reporters helped generate media coverage and drive people to an online petition that gathered more than 185,000 signatures urging UVA to modernize its medical training. In 2013, UVA made the decision to end animal use and adopt the remaining cats to homes.

Chimpanzee Experiments End in the United States

In 2010, we discovered that the National Institutes of Health (NIH) was planning to transfer 186 chimpanzees from semi-retirement to a research facility in San Antonio, Tex. However, the USDA database revealed that the facility—the Southwest National Primate Research Center—had violated the Animal Welfare Act more than 30 times in five years. Using this information, we filed numerous federal petitions and brought the information to the attention of media outlets and members of Congress. That exposure was an important part of a broad campaign by the Physicians Committee and other organizations, which ultimately halted the chimpanzees’ transfer. It also served as the beginning of the end of chimpanzee experimentation in the United States. In 2015, after years of work, NIH announced that the last chimpanzees kept in reserve would be retired to sanctuary, along with the hundreds previously retired from experimentation by the agency. Had the database not been available, we would have been forced to file Freedom of Information Act requests that would taken months—possibly even years—to fulfill.

NASA Cancels Plans to Irradiate Monkeys

In November 2010, the National Aeronautics and Space Administration (NASA) announced plans to irradiate squirrel monkeys in a misguided attempt to learn the effects of deep-space radiation. Due to the basic anatomical and physiological differences between humans and squirrel monkeys (who weigh less than 2.5 pounds), these experiments were destined to fail. The Physicians Committee used records from the USDA database to reveal repeated violations of the Animal Welfare Act at the two laboratories where the experiments were to be conducted. These violations included multiple failures to ensure that procedures were in place to limit discomfort and pain in animals—a basic rule of the law. Using these documents and working with members of Congress, former researchers, and even a former NASA engineer who resigned her post in protest, we were able to halt the experiments before they began in little more than a year. The effort sent a strong message to NASA that it must more carefully consider the lack of scientific evidence for using animals in experiments.

These examples are just the tip of the iceberg. The Animal Care Information System is vital to understanding whether facilities regulated under the Animal Welfare Act are in compliance with the law and whether the USDA is carrying out its obligations under that same law.

We are working hard to restore the database. You can help by contacting your members of Congress.