New therapies, advancements rely on dog research

Recently, Secretary of Veterans Affairs Robert Wilkie did something rarely seen in Washington, D.C., these days. He told the truth despite pressure from special interest groups to do otherwise. Mr. Wilkie explained that, like many other Americans, he is a dog lover. However, he also supports health studies in a limited number of canines to develop new therapies aimed at helping American veterans injured on the battlefield.

Animal research has improved the health of humans and animals alike through the development of countless medications and therapies. And while most research occurs in rodents, an incredibly small percentage of these breakthroughs require dogs. While speaking at the National Press Club, Mr. Wilkie highlighted past major advancements involving canines, including the heart pacemaker and a treatment for cardiac arrhythmias. Nowadays, dogs are helping us battle various forms of cancer. In addition, new therapies developed in dogs with a form of muscular dystrophy are now being tested in human patients.

Activists have been misleading Americans about animal studies for decades, falsely claiming they are no longer necessary. However, in many cases, there are simply no alternatives. You can’t model complex biological systems if you do not fully understand them.

It may be easy for some — including the PG editorial board — to accept animal rights fiction as fact (Nov. 17 editorial, “Put Him on a Leash: Dog Testing by Government is Wrong”). Thankfully, Mr. Wilkie did not make this mistake. He stood up for good, ethical science that benefits both veterans and animals. For that, he should be applauded, not criticized.

Paula Clifford
Washington, D.C.

The writer is the executive director of Americans for Medical Progress.

Clinical trials are commonly used during the development of drugs studied for approval by FDA for the use in animals.  Similar use in veterinary medicine has been increasing, but there are a number of interesting issues not considered in human clinical trials, where the individual involved in such trials is able to provide consent for inclusion in the trial.  Clearly, the animals that may be subject to such studies, cannot provide specific consent—their owner would have to do so on their behalf.  Those advocating for a change in status of animals as “property” to “persons” would be expected to object to such clinical trials, even if they benefit animals and people and help save their lives.

This issue was critically analyzed by veterinarians analyzing whether clinical veterinary studies must be reviewed by institutional animal care and use committees pursuant the Animal Welfare Act; the Office of Laboratory Animal Welfare for those studies funded by NIH; and/or reviewed and approved by a Veterinary Clinical Studies Committee established by a research entity, in a JAVMA published study, “Institutional animal care and use committee review of clinical studies.”

The study found

Determining whether activities conducted under the auspices of a clinical study are regulated by the USDA or OLAW, and thus require IACUC oversight, is not always a clear and simple issue. Institutions should develop their own guidance on how the IACUC oversees-or does not oversee-clinical trials.

Whether and to the extent certain clinical trials required review and approval by the IACUC pursuant to the Animal Welfare Act and/or OLAW requirements was dependent on whether the studying entities purchased the animals involved in the clinical trial and whether the proposed procedures would be required for the animal’s care, or were additional procedures only required for the purposes of the clinical trial.

The article presents 6 examples to help determine when USDA or OLAW oversight would be required.

Clearly, clinical trials, as utilized in human medicine, provide critical data related to the final approval of drugs and medical devices that will help prevent, diagnose and/or treat animals affected with life-altering diseases and conditions.

Typically, animal diseases have a seasonal presence.  For example, avian influenza, like other influenza viruses prefer cold damp conditions.  On the other hand, viruses transmitted by mosquitoes (arboviruses), including Equine Encephalitis virus and West Nile virus , are diagnosed when the mosquito population has peaked, often in in mid-late summer and early fall.

In addition to the seasonal prevalence of arboviruses in the United States, USDA APHIS has been tracking and reporting on an outbreak of Virulent Newcastle Disease (vND) in California, first identified in May 18, 2018.

USDA has confirmed 156 cases of vND in California, 102 in San Bernardino County, 22 in Riverside County, 31 in Los Angeles County and 1 in Ventura County.

To date the virus has been confirmed predominately in backyard exhibition chickens.  Backyard mixed species birds, backyard hobby turkeys and one live bird market have also been infected.  Virus has not been identified in commercial flocks to date, and state and federal animal health officials are emphasizing the importance of implementing enhances biosecurity practices to prevent additional transmission to other premises.  The last confirmed case was reported on October 4, 2018.

Across the globe, African Swine Fever, a highly contagious hemorrhagic disease of wild and domestic suids, has been spreading in Asia and across Europe.

As reported by USDA, China first reported the outbreak on August 3, 2018, “on a domestic swine farm in Shenyang, Liaoning Province with an onset date of August 1.”  This disease, like other highly pathogenic diseases of livestock and poultry are reportable to the World Animal Health Organization (“OIE”).

In addition to China, since the beginning of 2018, ASF has been reported in the following countries: Hungary, Romania, Moldova, Poland, Czech Repulic, Belgium, Russia, Latvia, Poland, Ukraine and Chad, as reported by OIE.

USDA reported that it met with the swine industry on September 5, 2018 “to discuss protections USDA has in place to prevent the introduction of African Swine Fever (ASF) to the United States as well as activities to enhance those protections.”

USDA provided a summary of recommended enhancement activities-“USDA industry prevention points.

To prevent the introduction of this virus to the United States, USDA has: scheduled biweekly calls for updates and discussion; will review state authorized waste feeding of swine to determine whether inspection of licensed facilities should be enhanced; reviewed the importation of potentially infected meat, casing, and feed; asked Custom and Border Protection to “target its inspections of passengers and cargo coming from ASF positive regions.”

According to a report by Rabobank, African Swine Fever Shifts Global Protein Picture,

These disruptions could open export opportunities for U.S., Canadian and Brazilian pork producers, including initial panic buying. However, Rabobank explained, the potential spread of the disease throughout Asia and/or Europe also poses a great risk to North American and South American producers.

The Division of Animal Health has proposed amendments to the regulation governing laboratory services provided by the State Animal Health Diagnostic Laboratory, available on its website as published in the New Jersey Register on September 4, 2018 (50 N.J.R. 1919).

The amendments would increase fees charged for animal disease diagnostic and testing services offered in the state of the art laboratory which replaced the long outdated facility previously located on the second floor in downtown Trenton.  The prior location made it impossible to perform certain diagnostic testing, such as necropsies on large animals.

The regulation would add 30 new tests and provide for molecular testing and referring services to other laboratories when required.  Some of the new tests pertain to bacterial isolation and identification and animals that are not domestic livestock.

Others would “facilitate the most economic and accurate diagnosis of clinical conditions by grouping tests. If done individually, the total cost to perform these tests would be more. Amendments are proposed in equine neurologic tests due to changes in the disease (West Nile, which is now endemic), increased knowledge of epidemiology (Western equine encephalitis), and unavailability of certain reagents for HI and IgG tests.”

The Division has proposed amendments to N.J.A.C. 2:10-2 to codify “the longstanding policy of not returning animal remains of any kinds due to the risks of disease transmission to the general community.”  New section 2:10-2.2 “would allow for submitters or animal owners to direct remains be disposed of to a licensed crematorium upon written request prior to the start of a necropsy.”

One of the most important amendments involves the protection of test results and related information (e.g., animal owner, animal identification, animal location) which reasonably protects the privacy of animal owners.  This longstanding policy should be codified.  The Division has identified a number of reasons to support this amendment, including: (1) laboratory reports are generally applicable only to the submitter; (2) reports include details of a private nature; (3) laboratory services are provided to livestock and other animal owners, veterinarians, and other submitters who pay for those services, which should remain private: (4) veterinary clients expect their information to remain private; (5) veterinarians are required to maintain the confidentiality of veterinary records  with few exceptions; (6) animal owners and veterinarians could circumvent disclosure of private information by using private or out of state laboratories which would decrease the State’s ability to identify and control disease; and (7) if tests are performed in other laboratories, interstate or international animal movement restrictions could be imposed without review by State animal health officials that might not be necessary or reasonable.

Comments to the proposed amendments are accepted until November 3, 2018.

Fees collected by the Division are not swept into the State coffers, but are instead “held separate and apart from all other funds of the State in a non-lapsing fund for annual appropriation to assure the provision of continuous support for the needed laboratory services.”

The New Jersey Department of Agriculture (NJDA), through its Division of Animal Health (DAH), operates the New Jersey Animal Health Diagnostic Laboratory (AHDL).

The AHDL provides diagnostic testing services to support disease control programs, health management, and productivity of livestock, equine, poultry, fish, and wildlife. The AHDL serves New Jersey’s companion animal owners by providing fast, accurate, convenient, and cost effective services to diagnose diseases in dogs, cats, exotics, and other pets. The AHDL serves as an expert veterinary diagnostic resource to state agencies, federal agencies, veterinarians, clinics, animal organizations, and universities.

Dr. Amar Patil, DVM, MS, PhD, DACVM is the Laboratory Director and the Assistant Director Division of Animal Health.

Dr. Manoel Tamassia, DVM, MS, PhD Dipl. Is the current Division Director and State Veterinarian, a position I previously held for nearly a decade.

The New Jersey Senate Environment and Energy Committee unanimously voted to release the Homes for Animal Heroes Act (S2826) from committee.  The bill would requires institutions of higher education to offer cats and dogs for adoption when they are no longer needed for education, research or other scientific purposes.  During the hearing on September 13, 2018 the following nonprofit associations or individuals submitted slips or testified:

Best Friends Animal Society; Merck; Tom Leach and Cindy Buckmaster, Ph.D., and Karen Froberg, VMD from the New Jersey Association for Biomedical Research; and the National Animal Interest Alliance.

Homes for Animal Heroes, created by Cindy Buckmaster, Ph.D., and an initiative of National Animal Interest Alliance (NAIA),

is a product of the research community’s desire to find loving homes for their animals, as well as the need to educate the public on the real facts about our animal heroes, how they are cared for, and how they improve human and animal lives.

As stated on its website 

Homes for Animal Heroes (HAH) is a national program dedicated to rehoming retired research animals, mainly dogs, and sharing the facts about the critical role animals in research play in curing disease. HAH is building a network of dog experts that can effectively work with research institutions to rehome retired research dogs in every state across the country, one location at a time. Our goal is to permanently rehome these animal heroes into loving homes through a comprehensive foster-based program.

The program builds in successful outcomes by temporarily housing dogs with caregivers, trained “to acclimate former study” dogs to a home environment.  Potential adopters are also screened and interviewed for lifelong compatibility.

The program and the bill, do not require research facilities to place dogs with animal rescue organizations, many of which have not been trained to handle these animals, and most are nearly entirely unregulated.  Instead, the institutions and the staff who have worked closely with these dogs and cats, are able to place them in homes where they will have the best chance of remaining for the rest of their lives.

A virulent form of Newcastle disease (vND), “a contagious and fatal viral disease affecting the respiratory, nervous and digestive systems of birds and poultry,” as described on USDA’s Virulent Newcastle Disease webpage has been confirmed in 93 cases in backyard exhibition chickens and turkeys by USDA since May 18, 2018.

The last outbreak of vND started in 2002 infecting 22 commercial premises and hundreds of backyard flocks, at a cost of over $180 million dollars to eradicate the outbreak, officially ending on March 26, 2003.  That outbreak, which started in California spread to four other states, but the majority of affected premises were in California.

Since May of this year, USDA has been regularly updating its stakeholders with information about the current outbreak, which to date, has not infected commercial poultry premises.

USDA reports that vND (previously called Exotic Newcastle Disease or END) “is one of the most infectious diseases of poultry in the world and is so deadly that many birds die without showing any signs of disease. A death rate of almost 100 percent can occur in unvaccinated poultry flocks. It can infect and cause death even in vaccinated birds.”

There are “three simple steps” USDA describes to prevent the disease from spreading to other flocks including:

Washing hands and scrubbing boots before and after entering an area with birds;

Cleaning and disinfecting tires and equipment before moving them off the property; and

Isolating any birds returning from shows for 30 days before placing them with the rest of the flock.

Bird owners are directed to contact state and federal animal health officials if their birds exhibit the following clinical signs:

Sudden death and increased death loss in flock

Sneezing, gasping for air, nasal discharge, coughing

Greenish, watery diarrhea

Decreased activity, tremors, drooping wings, twisting of head and neck, circling, complete stiffness

Swelling around the eyes and neck.

USDA also amended Veterinary Services Memorandum No. 800103 “Reissuance of Product Licenses for Autogenous Products and Guidance Concerning Restriction on the Production and Use of Veterinary Biologics,” seemingly related to concerns about the use of some virulent viruses in autogenous vaccines.

VS Memorandum 800.103 was signed on July 18, 2018, and cancels VS Memorandum 800.103 dated May 28, 2002. This memorandum provides guidance to licensees, permittees, and applicants concerning Animal and Plant Health Inspection Service’s restrictions on the production, importation, distribution, and use of autogenous biologics. This memorandum is effective immediately.

As described in Memorandum 800.103:  

APHIS restricts the importation and distribution of veterinary biologics from countries known to have exotic diseases, including, but not limited to, foot-and-mouth disease, rinderpest, highly pathogenic avian influenza, swine vesicular disease, Newcastle disease, African swine fever, and bovine spongiform encephalopathy if, in the opinion of APHIS, such products may endanger domestic animals, livestock, or poultry.

In addition, APHIS restricts the production and distribution of veterinary biologics, including, but not limited to, Brucella Abortus Vaccine, Vesicular Stomatitis Vaccine, and certain diagnostic products used in cooperative State/Federal/industry animal disease control and eradication programs, if it determines such products may interfere with disease surveillance and/or control and eradication efforts.

The instant amendments appear to be an attempt to prevent potentially virulent virus from inclusion in autogenous vaccines (a reasonable limitation).  Therefore, field isolates intended for inclusion in such products must be tested at an APHIS-approved laboratory before such use.

Hopefully, this outbreak will be resolved soon and without infecting more backyard or commercial-raised birds.

Originally posted on July 9, 2018 at NAIA Official Blog, reposted with permission.

More troubling news from the wild world of rescue import has been picked up by the Worms & Germs blog : a rescue dog with a known history of chronic health issues is imported into a private U.S. shelter from Thailand and tests positive for Melioidosis, a nasty zoonotic bacterial disease. This discovery leads to several potentially exposed people receiving blood tests (one showed signs of exposure, but none got sick), and ultimately the euthanasia of the dog.

Melioidosis is bad news

 

The plea for common sense from Worms & Germs author, Scott Weese (Ontario Veterinary College – University of Guelph), could have been written by us:

 

Logical importation practices are needed. How much time and expense went into shipping a paralysed dog transcontinentally from one shelter to another, when it was ultimately euthanized in the end anyway? I realize everything is done with good intentions, but thank about what could have been done for local homeless animals with the time, effort and expenses that were incurred here.

 

Dr. Weese generously labels the shelters and importers as well intentioned. But honestly, there must be a point where, when operations are carried out with such casual disregard for the health of shipped and local dogs (and adopters), where intentions can not be labeled as “good” — or at the end result is so damaging as to make intentions irrelevant.

 

Rescue importation, fueled by a lack of adoptable local dogs in many parts of the U.S. and the power of social media, has grown by leaps and bounds over the last two decades while U.S. dog import laws have not been updated since 1956. As a result, we are seeing dogs arrive here with everything from canine brucellosis, rabies, and the canine flu, to parasites and other vector-borne diseases. These are very serious issues, which is why NAIA has been working to modernize dog import laws for the last several years.

For more information, contact Patti Strand, NAIA President, at naia@naiaonline.org.

 

 

Equine herpes virus-1, a sometimes deadly virus that can cause myeloencephalopathy in some infected horses (Equine Herpesvirus Myeloencephalopathy or EHM), has surfaced at one horse farm in Union County, NJ, as reported by the New Jersey Department of Agriculture on March 20, 2018 and in theHORSE on March 21, 2018.

The second horse had an elevated temperature and was showing respiratory signs, but no neurological signs were noted by the attending veterinarian.

The first horse was moved into the isolation barn on the property last week and the property was placed under quarantine. The finding of another positive horse has reset the quarantine clock and will delay the release date another three days. These are the first reported EHV-1 cases in New Jersey in 2018.

As reported by the UK Gluck Equine Research Center, designated as a World Reference Center for EHV-1 and EHV-4:

Over the past decade there has been an unexpected increase in equine herpesvirus neurologic disease (equine herpesvirus myeloencephalopathy [EHM]) incidence. Previous research by other scientists suggests a significant percentage of EHM or paralytic herpes outbreaks are caused by a mutant strain. A single mutation has been identified in the gene encoding of the viral replication enzyme, which seems to confer the power of enhanced pathogenicity (a pathogen’s ability to cause disease in an organism) or neurovirulence to such strains.

New Jersey is not a novice in managing EHM outbreaks.  As previously described, New Jersey Department of Agriculture in partnership with the New Jersey Racing Commission, private practitioners, horse trainers, and with assistance from USDA, issued and supervised a quarantine of horses boarding at Monmouth Race Track in October 2006 which lasted two months. See, Equine Herpes Virus Myeloencephalopathy-A Guide to Effective Response; and Infectious Diseases In Animals And Humans – What Is Your Legal Risk?

USDA publishes “A Guide to Understanding the Neurologic Form of EHV Infection” equine_herpesvirus_brochure_2009,  and explains  that “Equine Herpes Virus (EHV-1) infection in horses can cause respiratory disease, abortion in mares, neonatal foal death, and/or neurologic disease. The neurologic form of EHV-1 is called Equine Herpes Virus Myeloencephalopathy (EHM). The virus can spread through the air, contaminated equipment, clothing and hands.”

In USDA’s Equine Herpesvirus Myeloencephalopathy: Mitigation Experiences, Lessons Learned, and Future Needs, in which responders to the Monmouth Race Park quarantine were interviewed (including me):

Dr. Peter Timoney, Professor, University of Kentucky, Gluck Equine Research Center and Chair of the Infectious Diseases of Horses Committee of the United States Animal Health Association (USAHA), pointed out that ‘. . . within the past few years, a mutant of the wild-type of EHV-1 has been identified which evidence would indicate is very frequently associated with outbreaks of EHM. Also, this mutant has been identified among isolates of EHV-1 made prior to 2000. As the distribution of this virus mutant becomes more widespread in the equine population, the frequency and severity of outbreaks of EHM is likely to increase further unless measures to control its spread and occurrence of the disease can be developed.’

In addition to animal health issues, EHM outbreaks can result in lawsuits, as evidenced by the New Jersey Thoroughbred Horsemen’s Ass’n v. Alpen House U.L.C., 942 F.Supp.2d 497 (D.N.J. 2013), in which

Racehorse owners and association to which they belonged brought action for strict liability and negligence against owner of training facility that allegedly was source of outbreak of Equine Herpes Virus—Type 1 (EHV–1) that caused racehorses to be quarantined, which prevented them from racing.

Id.  After Alpen House lost its motion for summary judgment, the parties likely settled, but this has not been confirmed.

Research is still underway to develop a vaccine that will protect horses against the neurological form of EHV, and until completed, more outbreaks should be expected.

An interesting study about ordinances governing backyard poultry ownership in Colorado was recently published, titled “A Method for Guarding Animal Welfare and Public Health: Tracking the Rise of Backyard Poultry Ordinances” (the “Report”).

The Report “tracks the development of municipal ordinances, with attention to provisions for animal health and welfare and significant concerns for public health.”

Public and animal health officials, as well as large commercial poultry operations, have been concerned about the spread of infectious, contagious diseases, such as avian influenza virus from small backyard flocks where owners are unaware of and not familiar with the typical biosecurity measures that are generally recommended in animal agriculture.

USDA has published a number of guidance documents for people interested in raising poultry for their personal consumption of eggs.

In “Biosecurity for Birds,” USDA explains:

Raising backyard poultry is a growing trend across the United States. It is very important for all backyard poultry owners to know the signs of two deadly poultry diseases, as well as the basic ‘biosecurity’ steps you can take to protect your birds. APHIS runs the Biosecurity for Birds campaign to help raise awareness among backyard, hobby and pet bird owners.

On the other hand, animal rights activists often blame commercial agriculture for the spread of avian influenza.  See, e.g., An HSUS Report: Human Health Implications of Intensive Poultry Production and Avian Influenza, and Avian Influenza Just One Marker of Sickness in Industrial Agriculture .

The fact is that avian influenza is most often spread from wildlife to privately owned domestic flocks, regardless of the size of the flock.  Therefore, for animal and public health concerns, statutes and regulations̶̶-federal, state, or local-should provide for the health and welfare of laying hens as well as ensuring quality standards for eggs.

Federal and state laws govern standards of egg quality relating to the prevention of contamination with Salmonella.  As the Report discusses:

The federal regulations include requirements related to egg handling and storage prior to point of purchase by consumers, as well as testing for Salmonella on farms that have more than 3000 hens and implementation of biosecurity programs on those farms to control egg safety risks. For poultry meat safety, USDA inspects live birds and carcasses at federally inspected slaughter plants (i.e., plants that process meat for export or interstate commerce) to ensure that they are free of disease, and also evaluates conditions at those plants to ensure that they are sanitary and following ‘good commercial practices.’

However, as the Report states, local ordinances that permit ownership of backyard poultry usually do not include provisions related to either the health or safety of the hens.

[B]ackyard birds may pose significant risks to the general public. The outbreak of highly pathogenic avian influenza (HPAI, H5N1) in Egypt offers a shocking example. The majority (107/112) of Egypt’s clinically confirmed HPAI cases of human infection from 2006 to 2009 are linked to close contact with diseased backyard birds resulting in 36 deaths and human-to-human spread. In addition, the 2002 California outbreak of Exotic Newcastle Disease (END) originated in backyard flocks. The outbreak spread into commercial operations and resulted in depopulation of over 3 million birds, costing taxpayers $161 million. (citations omitted).

The Report, analyzing backyard poultry ordinances in Colorado, found, in part:

  1. The most common guidelines for poultry ordinances pertain to housing design and placement, the sex of birds, and total number of birds allowed, including specific space requirements for birds, in come cases.
  2. Ordinances commonly required housing to be predator resistant, easily cleaned, and maintained regularly to prevent the development of pests, rodents, or odors that would cause nuisances.
  3. In urban locations, the number of birds permitted was often limited to between 4 and 6 birds per lot.
  4. Ventilation requirements were often not included in ordinances.
  5. Roosters were commonly prohibited.

Notably, the Report stated that “[r]egulations pertaining directly to animal health and welfare were rare.”

The Report concluded that ordinances should include these provisions.

[O]ur study indicates that there are fewer guidelines for the health and welfare of backyard poultry than their commercial counterparts. Regulation is important in disease prevention. Fragmented oversight of animal welfare and health creates policy blind spots critical to shared human and animal health.

I concur.

A set of bills introduced in the New Jersey legislature would dilute funds from the decades-long spay neuter program overseen by the Department of Health, to the detriment of pets and their owners.

New Jersey bill S883 and sister bill A 2197 would authorize the New Jersey Motor Vehicle Commission “to issue special Humane State license plates . . . [and] [a]fter the deduction of the cost of designing, producing, issuing, renewing, and publicizing the plates and of any computer programming changes that are necessary to implement the license plate program, in an amount not to exceed $150,000, the additional fees will be deposited into a special non-lapsing fund known as the ‘Humane State License Plate Fund”’ that will be appropriately annually to the Animal Welfare Federation of New Jersey (AWFNJ).  http://www.njleg.state.nj.us/2018/Bills/S1000/883_S2.HTM

The funds are mandated “to be used to provide grants to county societies for the prevention of cruelty to animals for the shelter and care of animals.”

While the bill was reported from the Senate Budget and Appropriations Committee, Senator Sarlo, Chair of that committee voted no, saying that he is opposed to this bill, like all others establishing a special license plate, because they all cost the taxpayers money.

Here, there is additional concern because New Jersey has a pre-existing special license described above, established during the Florio administration.  I remember attending the bill signing at Drumthwacket, the official residence of the governor of the State of New Jersey.  The “Animal Friendly” license plate, which debuted in 1994, helps fund “the animal population control program. . . [which] provides low cost spaying and neutering for thousands of pets and encourages the adoption of thousands more each year in New Jersey.”

If enacted into law, this new special plate will dilute the existing animal population program, which had, as of 2012, aided in the spaying and neutering of more than 192,000 cats and dogs, according to then Commissioner of Health, Mary E. O’Dowd.

The funds raised through the [program] support[s] the spay or neutering of dogs and cats adopted from New Jersey shelters, pounds and rescue groups, as well as those owned by persons on public assistance programs.

This fund has been historically popular but runs out of money quickly-many needy families are unable to benefit from the program.

An added benefit of the spay-neuter program, is that it introduces new pet owners to their local veterinarian (who performs the surgery at a greatly reduced fee) and establishes a veterinarian-client-patient relationship that serves as a basis for lifelong veterinary care.

If the State is interested in providing additional funding for animal welfare concerns, this pre-existing program could benefit from additional funds, or perhaps be expanded to assist pet owners without sufficient means provide veterinary care to their pets throughout their lives.