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I recently attended the 2017 National Animal Interest Alliance (NAIA) Conference, titled “Animal Nation.”  There, I heard the remarkable, heart-wrenching but uplifting story about the life of Joshua Frase and the challenges he overcame with the support from his family who never gave up in their relentless search to find a cure for Myotubular Myopathy (MTM), a genetic disorder affecting skeletal muscle that Joshua was born with.

As described on the foundation’s website, children born with MTM “will often experience skeletal problems, gait problems, respiratory and feeding challenges, and fatigability along with poor muscle development . . . Statistically, 50% of these children do not live past their 2nd birthday.”

Joshua’s mom, Alison Rockett Frase shared her story at the NAIA conference:

On February 2, 1995, Alison gave birth to her son, Joshua—a baby so weak, he could only move his right hand.  The doctors said that he wouldn’t survive the day and, in a moment that defined the rest of her life, Alison said, “Let’s give him a chance.”  From that moment on, Alison became Joshua’s advocate. Before his first birthday, Alison determined that she would use her husband’s platform in the NFL to start a foundation that would one day find a cure or treatment for her son’s condition. I n 1996, together with her husband, she created the Joshua Frase Foundation.  Since that time, Alison has helped raise over $6 million to fund medical research, search for a cure and raise awareness of neuromuscular-related disorders.

During her search for a cure for this rare disease and to save her son and others similarly challenged, Alison, with scientists and researchers started unraveling the clues to a treatment and perhaps a cure.

After studying the use of gene therapy to restore normal function in mice with the same disorder, the search was on to find a larger animal model before the treatment could begin in humans.

Alison described that search:

This may be the last chance to save my son Joshua. His health has declined dramatically and I am sensing impending danger. It is a miracle that Joshua is now 14, given the odds he would never celebrate his first birthday. It has been a tough and critical year physically for Joshua. We knew the gene replacement therapy success we were showing in the mouse model had to translate to a larger animal before we could even consider getting the FDA’s attention for human trials.

Miraculously, Alison found that animal model in a Labrador Retriever living in Canada named Nibs, who carried the genes for MTM.  Nibs’ puppies born with MTM have been successfully treated.  Nibs, who had been given to Alison to help find a cure for Joshua, was returned to her owner to live out the rest of her life back on the farm in Canada, running with horses.

On September 21, 2017, “Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases . . . announced it has commenced dosing of patients in ASPIRO, a Phase 1 / 2 clinical trial of AT132 for the treatment of X-Linked Myotubular Myopathy (XLMTM).”

Alison is hopeful that this treatment will save the lives of those afflicted with this devastating disorder.  Sadly, Joshua passed away in 2010.

If you are interested in learning more about Joshua, the Foundation, and this remarkable research that will help save lives of children and puppies, please visit the website to learn more.

On September 22, 2017, the New Jersey Association for Biomedical Research (NJABR) offered its 24th Annual IACUC Conference,  – “the region’s premier training conference for Institutional Animal Care and Use Committee members, lab animal veterinarians, animal welfare compliance specialists and lab animal research team members.”

As described, the conference focused “focus on opportunities to improve laboratory animal welfare, while reducing regulatory burdens, cutting red tape and creating efficiencies within institutions.”  Toward that end, presenters from NIH and USDA (Patricia Brown, VMD, MS, Director, NIH, OLAW and William S. Stokes, ACLAM, DACAW, BCES, FATS, Assistant Director, Animal Welfare Operations, USDA, APHIS, respectively) requested recommendations from the attendees to reduce unnecessary or redundant regulatory burdens to researchers.

Following morning presentations, discussed further below, the conference included the following workshop selections that attendees could attend:

AAALAC Perspectives on Occupational Health & Safety Programs

Presenter: Richard B. Huneke, DVM, Council Member Emeritus

Animal Care & Use Committee Scenarios: You Make the Call

Presenter: Pam Straeter, RLATG, Asst. Director, Research Integrity and Assurance, Princeton University

Legal Update: USDA, Animals and the Law                               

Presenter: Nancy Halpern, DVM, Esq., Attorney, Fox Rothschild

New IACUC Member – Double Session   

Presenter: Amy Salem, PhD, Associate Director of Operations and Training for Animal Welfare, Merck

Ask the Regulators                                                                    

Presenters:

Patricia Brown, VMD, MS, Director, Office of Laboratory Animal Welfare

Tonya Hadjis, DVM, Supervisory Animal Care Specialist, Northeast Area, USDA, APHIS, Animal Care

John F. Lopinto, DVM, Veterinary Medical Officer, USDA, APHIS, Animal Care

Ashley C. McIntosh, DVM, Veterinary Medical Officer, USDA, APHIS

Animal Reproducibility & Relatability of Animal Research to Human Research

Panelists:

Damir Hamamdzic, DVM, PhD, Research and Regulatory Affairs, Post-Approval Monitoring Compliance Administrator, Rutgers University

Sarah E. Robertson, PhD, Director, Sponsored Projects and Research, University of the Sciences

Laszlo Szabo, Esq., Director, Research and Regulatory Affairs, Rutgers University

Andrew Gow, Ph.D., Professor and IACUC Chair, Rutgers University

Elizabeth Dodemaide, BVSc, MA, MANZCVS, Director Comparative Medicine Resources, Rutgers University

Gregory Reinhard, DVM, Director, Animal Welfare, University of Pennsylvania

Strategies to Enhance Animal Welfare Compliance Monitoring

Presenters:

Pharmaceutical: Lisa Stanislawczyk, Bristol-Myers Squibb, CRO: Mary Ann Jacobs, Envigo

Academic: Greg Reinhard, MBA, DVM, University of Pennsylvania, The Role of the Statistician in Study Design, IACUC Protocol Preparation Data Analysis

Presenter: Alfred Barron, Associate Director, Nonclinical Statistics/TMEDS, Janssen Research & Development

The keynote speaker, Jim Welch, Executive Director of the Elizabeth R. Griffin Research Foundation, presented a phenomenal motivational talk about “the importance of safe work practices, biosecurity, and collaboration among organizations and institutions seeking to advance scientific discovery.”  It does not sound like a topic that would lend itself to a motivational talk, anyone looking for a keynote should consider Jim.

Overall, it was another great conference.

 

Reports from two animal-related trade organizations provide insight into the current status and goals of animal rights organizations intent on eliminating the use of animals by humans, without regard to how humanely those animals are treated.

Based on these revealing comments from activists it remains vitally important that the public is exposed to the differences between animal rights activists and animal-related industries whose goals are to ensure that animals under the care of humans are treated humanely.

Members of the National Association for Biomedical Research and the Animal Agricultural Alliance attended the 2017 Animal Rights National Conference held on August 3-6 in Alexandria Virginia.

As advertised on the website

The Animal Rights National Conferences have been organized since 1981 by Farm Animal Rights Movement (FARM) with some breaks between 1987 and 2000, then every year since 2000. They are typically co-sponsored by more than a dozen national organizations.

Farm Animal Rights Movement (FARM) is a national non-profit organization working to end the use of animals for food through public education and grassroots activism. We believe in the inherent self-worth of animals, as well as environmental protection and enhanced public health.

Speakers at the conference talked about the “Power of confrontation in advancing animal rights,” and alleged abuses of animals used for all human purposes including: animals in Entertainment (circuses, rodeos, zoos, aquariums), animals in science (education, product testing, drug research),animals in Fashion, Companion animals, food Animals, and animals in the wild.

Kay Johnson Smith, Animal Agriculture Alliance president and CEO described this year’s conference:

The speakers at this year’s Animal Rights National Conference made their goals clear – ending all forms of animal agriculture, regardless of how well animals are cared for . . . Their persistent focus on pressure campaigns targeting restaurant, retail and foodservice brands is of great concern to the Alliance and our members. We encourage anyone with a vested interest in producing, processing or selling meat, poultry, eggs and dairy, to read this year’s report and hear how determined these groups are to eliminate food choices and make our society vegan.

The alliance reported that speaker encouraged attendees to protest and conduct rescues from farms without permission, and that “[b]reaking the law can often be a good thing to do.”

The Alliance also reported that one speaker, David Coman-Hidy with the Humane League encouraged attendees to damage the reputation of food companies.

Consistent with previous years, another key message from conference speakers was for attendees to focus efforts on eliminating farms of all types and sizes, not only the large-scale, modern operations (declared to be “factory farms”) that have historically been targeted.

National Association for Biomedical Research reported about the following speakers and their comments at the conference, intent on eliminating the use of animals in research:

  • Justin Goodman, lobbyist for the White Coat Waste project (WCW), an animal rights group that promotes itself as a fiscally conservative consumer watchdog group, spoke about WCW’s “defund” campaign to “take money away so [research institutions] can’t buy the animals to do the testing.” He continued to focus on making sure universities and other institutions that conduct animal research “don’t get their money.” 

  • Michael Budkie explained [Stop Animal Exploitation Now] SAEN seeks to end animal research by “hanging them with their own paperwork.” We understand this to mean the group attacks the reputations of research institutions and individual scientists by deliberately misusing or mischaracterizing written statements provided by the institutions to government agencies like the NIH and the USDA.

  • Speaking again on behalf of SAEN, Michael Budkie explained his approach to stopping animal research by targeting researchers: “We like to paint them as idiots. They are criminals. SAEN’s job is to let people know animal research is meritless. We will ruin their reputation and credibility. We are coming after them…It becomes news and we’re changing public opinion of what labs do.”

  • A celebrated figure in the animal rights world, Richard Couto conducts undercover investigations of factory farms and food enterprises that use animals. He gains access by working as an employee while filming and documenting abuse for later use in criminal prosecutions of his erstwhile employers. Joined by other so-called “undercover investigators,” they encouraged attendees to join their ranks by stating, “anybody in this room has what it takes to be an undercover investigator.”

Clearly, the goals of animal rights organizations, on display at this conference, should concern those who are involved in animal-related industries where animals are owned and cared for by humans.

Like many other animal-related businesses universities, researchers, pharmaceutical companies, their suppliers, associated businesses and non-profit trade associations, are facing increasing scrutiny by the public who seemingly object to the use of animals in research, even though research benefits animals as well as humans.

To address these issues and concerns head on, the New Jersey Association of Biomedical Research recently hosted one of the most significant efforts to promote biomedical research advocacy, the “Biomedical Research Summit,” presented by Bristol-Myers Squibb, also sponsored by Covance, Charles River Laboratories, s-tune software, Inc., Marshall BioResources, and Allentown, Inc. 

Representatives from interested state and national advocacy and professional organizations who are involved in the lab animal research community, as well as representatives from research institutions, including pharmaceuticals, academia and CRSOs, to find common ground and come together on key issues.

Vice-Chair of the NJABR Board of Directors, Laura Conour, DVM, DACLAM facilitated the discussions during the two-day event, encouraging participants to

find ways to enhance the public’s understanding of the critical work undertaken by the biomedical research community and to provide a strong support network for all members in our community, regardless of geography.

The Summit was a huge success, bringing together not only the biomedical research community but also other animal-related sectors under similar attack by animal rights activists.

The following needs and gaps identified include:

  1. A centralized approach for advocacy of biomedical research;
  2. A compelling, consistent, proactive national communication plan;
  3. A comprehensive and effective education effort to address society’s negative perception and lack of understanding about animal research;
  4. There is a lack of an organized and cohesive advocacy effort;
  5. There is a lack of a constituency (a group that support or offers authority and representation) interconnecting with all stakeholders to create a larger network of interests to build and establish effective education efforts; and
  6. Resources are needed to effectuate these goals.

The future of biomedical research advocacy requires a coalescence of all those involved with the humane use of animals for human and animal benefits to educate the public about, not only the necessity of animal use, but also that the animals are treated humanely, and with the understanding that as science advances, the treatment of animals is always evolving to ensure that animals are treated humanely.

Others in the global biomedical research community have launched campaigns in the U.S. and overseas to increase transparency and public education about the special care animals receive in research as well as the incredible importance of their contribution to animal and human health.  For example, as previously discussed, Americans for Medical Progress launched a virtual website “Come See Our World,” where visitors learn about the important role animals play in medical progress.  

Also, the non-profit “Understanding Animal Research” launched a new online tool that allows anyone interested to visit four research facilities in the U.K., through digital video tours.  Participating facilities include the MRC Harwell Institute, The Pirbright Institute, the University of Bristol, and the University of Oxford. 

Understanding Animal Research explains:

why animals are used in medical and scientific research. We aim to achieve a broad understanding of the humane use of animals in medical, veterinary, scientific and environmental research in the UK. We are funded by our members who include universities, professional societies, industry and charities.

 In addition to the virtual lab tours, Understanding Animal Research hosts another website “Concordat on Openness on Animal Research” for “Universities, charities, commercial companies, research councils, umbrella bodies and learned societies [that] have all committed to help the public understand more about animal research.”

Stay tuned for more information about these important developments.

American for Medical Progress (AMP),[1] “a nonprofit organization dedicated to protecting society’s investment in biomedical research,” just launched an important new educational tool for the public to see and understand the truth behind modern animal research.  “Come See Our World”  is a digital invitation into the world of “essential animal research,” that provides all those interested and concerned a behind-the-scenes glimpse into world of animal research, with a front seat to view the care that research animals receive.  Without this important research, medical advances in human and animal health would not be possible.

AMP invites you to “[j]oin us for a journey into our world of medical progress and discover the animals that help save lives,” including the following examples:

Mice have long been a model for human disease. Zebrafish provide insights into embryological development as well as human disease.  Dogs and Pigs were integral in the development of insulin treatments for diabetics.  Sheep have provided life-saving advancements for those with cardiovascular disease.  People with diseases like cancer and AIDS now have hope because of research with nonhuman primates. Our pets live long healthy lives thanks to vaccinations and many of the same treatments developed for humans.

From rodents, to primates, dogs and cats, farm animals, aquatic and other animals, this website provides more than pictures of well-cared for animals, it also educates the reader about what each animal contributes to the health of others-humans and animals alike.

I encourage you to visit the website and recognize the heroes these animals have been and continue to be.

[1] The author serves on the Board of Directors of AMP.

Japanese macaques, along with 11 other primate species were first listed as threatened on October 19, 1976 by FWS.[1]  However, by special rule, 50 C.F.R. §17.40(c)(2) captive members of these species were exempted from protections under the Endangered Species Act by FWS.  Now, People for the Ethical Treatment of Animals (PETA) has petitioned FWS to correct what they describe as the unlawful deprivation of protection under the ESA.  See Petition to Include the Captive Members of the Species of Primates Enumerated in 50 C.F.R. §17.40(c) as Protected Members of their Respective Species Under the Endangered Species Act.

PETA based its petition, at least in part, on FWS’s relisting captive chimpanzees as endangered species, along with their previously listed wild counterparts.  Endangered and Threatened Wildlife and Plants; Listing All Chimpanzees as Endangered Species, 80 Fed. Reg. 34500 (June 16, 2015).  .  In 2015 The U.S. Fish and Wildlife Service announced a final rule to classify all chimpanzees, both wild and captive, as endangered under the Endangered Species Act (ESA). Until this change, only wild chimpanzees were listed as endangered while captive chimpanzees were listed as threatened.

“We are listing all chimpanzees, whether in the wild or in captivity, as endangered under the Endangered Species Act of 1973, as amended (Act). We have determined that the Act does not allow for captive chimpanzees to be assigned separate legal status from their wild counterparts on the basis of their captive state, including through designation as a separate distinct population segment (DPS). It is also not possible to separate out captive chimpanzees for different legal status under the Act by other approaches. Therefore, we are eliminating the separate classification of chimpanzees held in captivity and listing the entire species, wherever found, as an endangered species under the Act.”

FWS will only issue permits for studies of chimpanzees “only for scientific purposes to benefit wild chimpanzees or to enhance the propagation or survival of chimpanzees, including habitat restoration and research on chimpanzees in the wild that contributes to improved management and recovery.”

If FWS adopts this position for the species currently listed as threatened, more than 316 Japanese macaques involved in research at various biomedical research facilities would be subject to the same fate as many chimpanzees, who unfortunately died when moved to “sanctuaries” since they were not permitted to remain under the care of knowledgeable and trained experts at research facilities.  See Dr. Collins please save our chimps, by Cindy Buckmaster.

Regardless of the outcome of this petition, these animals should remain in facilities where they can be properly cared for, and, if at all possible, the research they have been involved with should be completed so that it is not a loss.

[1] One of the original 12 primates was relisted as endangered in 1990.

I had the opportunity to present an “Animal Law Update” on October 21, 2016 at the New Jersey Association for Biomedical Research’s 23rd Annual IACUC Conference – the region’s premier training conference for professionals in laboratory animal research field.  Among this year’s 110 participants were key institution decision makers, Animal Care and Use Committee members, lab animal veterinarians, animal welfare compliance specialists and other lab animal research team members from the pharmaceutical industry, contract research organizations, academic research institutions, and government officials from USDA and NIH.

 

During my presentation I discussed the legal issues affecting animal-related industries, including the biomedical research community and analyzed activist activities that can help the research community predict, prepare for, and defend against such challenges.   I was also re-elected to the Board of Directors of the New Jersey Association for Biomedical Research during the annual meeting, held at the beginning of this conference.

 

Dr. William Stokes, Assistant Director, Animal Welfare Operations, USDA, APHIS, Animal Care provided an informative USDA Regulatory Update and Insights.  Dr. Stokes shared USDA Animal Care’s “5-year Strategic Plan” including the mission and vision of the agency, also available on its website:

New to the agency is the introduction of the term “critical noncompliant items” (“NCI’s) which includes all “direct noncompliant items” and certain “indirect noncompliant items.”  Dr. Stokes explained that this term was not really new, and had been used in practical effect, by the agency for a long time.

Dr. Stokes also provided important data from USDA’s inspections authorized by the Animal Welfare Act including:

  • There were over 10,000 unannounced inspections in FY16 of research facilities, breeders, dealers, exhibitors, transporters and intermediate handlers;
  • There were about 1350 inspections of the 1050 registered research facilities;
  • 76% of these inspections had no NCI’s;
  • Of the 561 NCI’s in research facilities, 38% of those were related to activities and conduct of Institutional Animal Care and Use Committees, and specifically related to the semi-annual reports that are required by the AWA.

Dr. Stokes  informed the attendees about the updated public search engine that serves as the database for USDA licensees and related inspection reports, known as the Animal Care Information System (ACIS3).  USDA  sent a bulletin on  09/22/2016 to stakeholders titled “New Terms Will Appear on USDA Inspection Reports.” As Dr. Stokes explained, there are two new terms that will appear on reports and in search results:

  • Focused inspections
  • Critical noncompliant items.

Dr. Stokes ended his presentation reminding all attendees that the goal of USDA and its licensees is to “optimize welfare.”

 

 

This is the time of year that nonprofit organizations hope for contributions from those who have the means and interest to support these organizations.

This year, I encourage you to consider supporting curiousSCIENCEwriters.

curiousSCIENCEwriters (cSw) is an innovative, independent steAm initiative that trains creative high school communicators to bring complex science to the general public through the power of story. Science and technology are advancing exponentially, yet fewer than 7% of American adults are scientifically literate. With growing medical, environmental and social issues facing us all, it is essential that the next generation of communicators be prepared to help people make sense of emerging science that affects their personal health and well-being, as well that of the world around them. Whether scientists, journalists or citizen scientists, they will require critical thinking and technical skills to fight science illiteracy that has reached historic levels.

How does it work?

“Each year, curiousSCIENCEwriters selects a group of high school students through a highly competitive application process to participate in an intensive extracurricular training program. A key element includes mentoring by scientists and science communications professionals through remote and onsite sessions. This collaborative process, which involves teams of student writers, editors, and graphic designers, results in credible, engaging science stories that the student staffers help disseminate through a variety of traditional and trending media outlets.”

Jayne Mackta, a colleague, supporter and friend, is the founder and creative director of curiousSCIENCEwriters.

Jayne has devoted her adult life to advocating for families affected by genetic disorders and promoting public understanding of biomedical research. Since her first job out of college with the Encyclopedia Americana where she reduced lengthy articles to single paragraphs, she has searched for the secret of saying more in fewer words. A fierce enemy of jargon, Jayne delights in coaching young editors in the art of deleting words that obscure meaning.

cSw, a program of States United for Biomedical Research (SUBR), relies exclusively on tax-deductible donations from citizens like you, concerned about the toll science illiteracy is taking on the health and welfare of our world.

Click here to read some of the fascinating stories written by cSw student staffers.

Consider this innovative and important program if you are donating this year. You can donate online by clicking here.

 

FDA issued a draft revised guidance for industry, “General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals” in July 2016 that “described the type of information that the Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM) recommends sponsors provide [the agency] to address the human food safety of new animal drugs used in food-producing animals.”

In addition to proving that drugs are safe and efficacious in the targeted livestock species, drug companies (sponsors) face increasing hurdles to prove that “food derived from treated animals is safe for human consumption.”

FDA has already begun implementing other changes to “the way medically important antibiotics have been used in animal agriculture for decades.” See FDA’s Guidance #213.

As reported on its website, FDA explains:

“[o]nce the changes are fully implemented, it will be illegal to use these medically important antibiotics for production purposes, and animal producers will need to obtain authorization from a licensed veterinarian to use them for prevention, control or treatment of a specifically identified disease.”

Food animal veterinarians and livestock farmers are concerned about their ability to treat animals with antibiotics appropriately when needed. In response,

“[t]he FDA acknowledges the important role medically important antimicrobials play in treating, controlling, and preventing disease in food-producing animals. However, the agency has been actively engaging veterinary organizations, animal producer organizations and other stakeholders to express our position that medically important antibiotics labeled for continuous or undefined durations of use is not consistent with judicious use principles, as outlined in previously-released guidance documents.”

In “General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals” FDA “provides, in one document, an overview of the overall process for the human food safety evaluation of new animal drugs used in food-producing animals, including:

  • Determining an acceptable daily intake (ADI);
  • Calculating safe concentrations;
  • Assignment of a tolerance;
  • Calculation of a withdrawal period and a milk discard time; and
  • Evaluation of carcinogenic compounds.”

In addition to analyzing the appropriate withdrawal times for meat, milk, and eggs, the agency evaluates the proposed drugs for their potential to create additional pressures on antibiotic resistance in humans.

However, FDA has identified drugs that may not have to undergo this analysis if it (and its metabolites and excipients) are not:

  • “regularly considered to have properties that would exert pressure towards the emergence or selection of bacteria of public health concern;
  • used to treat zoonotic gastroenteritis or other bacterial diseases in humans;
  • under development to treat bacterial diseases in humans; or
  • indicated for a bacterial disease in food-producing animals (i.e., indication is instead antifungal, antiprotozoal, anthelminthic, etc.).”

With the emergence of new methods of disease treatment and  prevention (using, for example, genetically immune livestock) hopefully veterinarians and farmers will not have to rely on antibiotics to treat animals and keep them healthy, since it will be increasingly difficult to obtain and retain the ability to use these drugs in livestock.

The intentional misrepresentation of facts is one of the most disturbing (if not illegal) tactics that animal rights organizations use to convince the public that individuals and businesses involved with the breeding, raising, and care of animals for companionship, biomedical research, conservation research, sports, entertainment, and food and fiber, is inhumane.

We have previously described the intentional misrepresentation that pet stores sell puppy mill puppies based on the false statement that all commercial breeders are puppy mills. Puppy mills are substandard, unlicensed large scale facilities where dogs are improperly cared for.  Pet stores buy from licensed USDA facilities, or small breeders who exceed the humane standards of care required by law, not from substandard breeding facilities.

Similar misrepresentations of facts are pervasive from animal rights organizations opposed to the use of animals in biomedical research, even when that research benefits animals.

The following purported quote from FDA is repeated by groups like PETA and the Beagle Freedom Fund to “prove” that research in animals does not provide valid scientific results that can lead to successful drug approvals for human use:

The Food and Drug Administration has confirmed that 92 percent of drugs that test safe and effective in animals are failing in Phase I clinical trials.

The biomedical research community has attempted to explain why this statement is misleading by reviewing the original statement made by FDA.

For example, as posted on July 25, 2008 on Speaking of Research :

The statistic is from the FDA (Food and Drug Administration), used to illustrate inefficiencies in drug development. However the actual statistic is much broader, it should be:

92% of drugs fail during human trials

The original quote was:

A new medicinal compound entering Phase 1 testing, often representing the culmination of upwards of a decade of preclinical screening and evaluation, is estimated to have only an 8 percent chance of reaching the market.

In another post on Speaking of Research on January 23, 2013, guest author Professor Robin Lovell-Badge further explained:

Those opposed to animal research often point out that most drugs that pass the legally required toxicology tests in animals go on to fail in human clinical trials. They then go on to suggest that this shows that animal research does not work, or that it is proof that animals are not accurate models for humans.

However, this is misleading without an understanding of the relevant context and the reasons for the animal safety tests.

Dr. Lovell-Badge goes onto explain that preclinical testing includes both animal testing an non-animal testing, all performed to prevent harm to humans during Phase 1 clinical trials in humans which has proven to protect humans from drugs found to be unsafe.

This topic is also the subject of a report published in Regulatory Toxicology and Pharmacology, “Use of animals for toxicology testing is necessary to ensure patient safety in pharmaceutical development,” by Raja Mangipudy, John Burkhardt and Vivek J. Kadambi. See Regul Toxicol Pharmacol. 2014 Nov;70(2):439-41. doi: 10.1016/j.yrtph.2014.07.014. Epub 2014 Jul 21.

I agree with the authors’ conclusion:

[W]e believe that for the foreseeable future, drug development will continue to depend upon nonclinical experimentation in animal models to provide data in hazard identification and characterization for healthy volunteers and patients. While offering great promise, alternative in vitro systems that can entirely recapitulate the complexity of higher organisms have yet to be designed. Development of engineered 3-dimensional organ systems will create new opportunities to conduct hypothesis-driven research into specific organ system toxicities or provide models for screening compound libraries for toxicity during the lead optimization process. As for all surrogate systems, they will evolve over time as the science improves, but will still falsely predict negatives for unique toxicities that result from complexities not replicated within the in vitro test system. Translation of our complex human biology into safe and effective treatments will continue to require the use of humane animal testing (Nature Medicine Editorial, 2013).