(This runs with two sidebars: Connections between drug makers and educators abound and For vets association, transparency is an internal matter ID: For more Reuters Special Reports, double-click on )
By Duff Wilson and Mimi Dwyer
NEW YORK, Dec 23 (Reuters) - In 2016, a new U.S. Food and Drug Administration policy will give veterinarians a key role in combating a surge in antibiotic-resistant “superbugs” that infect humans. For the first time, the agency will require veterinarians, not farmers, to decide whenever antibiotics used by people are given to animals.
Medical doctors issue antibiotics by prescription only. Yet farmers and food companies have been able to buy the same or similar drugs over the counter to add to feed and water. The drugs not only help prevent disease but enable livestock to grow faster on less feed.
The new directive is meant to guard against the overuse of the drugs in American meat production. But by enlisting the help of veterinarians, a Reuters examination found, the FDA will be empowering a profession that not only has allegiances to animals, farmers and public health, but also has pervasive and undisclosed financial ties to the makers of the drugs.
The relationships between medical doctors and the pharmaceutical industry are subject to strict rules that require the public disclosure of payments for meals, trips, consulting, speaking and research.
No laws or regulations - including the new FDA directives - require veterinarians to reveal financial connections to drug companies. That means veterinarians can be wined and dined and given scholarships, awards, stipends, gifts and trips by pharmaceutical benefactors without the knowledge of the FDA or the public.
Of the 90,000 veterinarians who practice in the United States, about 11,000 - or one of every eight - work in food animal production, according to a 2013 workforce study. Livestock and poultry specialists advise growers on health issues from insemination to birth to weaning to fattening to euthanasia. They also treat a variety of illnesses and injuries. Many train farmhands how to spot disease and administer drugs.
In some ways, the role of the veterinarian is more complicated than that of the medical doctor. For a veterinarian, the patient is the animal but the client is the owner. In the case of food production, those clients are seeking to maximize profit, and part of the veterinarian’s job is to help them do so.
Veterinary medicine is a little-regulated corner of the medical profession, more dependent on industry funding than its human counterparts, and Reuters found that drug companies support veterinarians at every stage of their careers. Sometimes the payments are small - $10 for a meal or $250 for an hour’s talk. But larger funding arrangements - $100,000 for research, for example - are not uncommon.
Of the 22 veterinarians who advised the FDA in recent years on how to use antibiotics on farms, 11 received money from pharmaceutical companies. Many of these details weren’t disclosed by the FDA, which wasn’t required until 2007 to post on its website “the type, nature and magnitude of the financial interests” of its advisers. Reuters identified payments to FDA advisory group members by reviewing veterinary journals, industry publications, meeting transcripts, conference programs and resumes, among other sources.
The influence of drug companies also extends to the training that current and future veterinarians receive. For example, pharmaceutical companies routinely suggest topics and speakers for the continuing education events that veterinarians must attend to keep their licenses. Such involvement is forbidden in human medicine, according to the Accreditation Council for Continuing Medical Education.
The world’s largest animal-drug company, Zoetis, has also extended its reach into high schools: In 2011, the company gave $50,000 to help fund a weeklong Purdue University veterinary camp for 10th, 11th and 12th graders.
The American Veterinary Medical Association, the non-profit organization that represents the nation’s veterinarians, also benefits from contributions from the pharmaceutical industry. The association’s ethics code calls on veterinarians to divulge all potential conflicts of interests. But only after Reuters asked did the group disclose that it has accepted $3.3 million from drug companies over the past four years. It declined to say which pharmaceutical companies contributed to the group.
“I‘m very concerned that the profession is poised to lose public trust,” said Michael Blackwell, a former deputy director of the FDA’s Center for Veterinary Medicine. “I don’t think we can gain public trust if the perception exists of a conflict of interest.”
Told of the Reuters findings, U.S. Rep. Louise Slaughter, D-N.Y., said she will introduce legislation to require public disclosure of drug company payments to veterinarians. Billions of dollars in payments to doctors have been disclosed under the Physician Payments Sunshine Act of 2010, but that law does not apply to veterinarians.
“That’s a terrible omission,” said Slaughter, a microbiologist who has led congressional efforts to reduce antibiotics in livestock. She said transparency is essential as veterinarians prepare to take an important new role for public health.
WHAT‘S AT STAKE
Today, about 80 percent of all antibiotics used in the United States go to food animals, mostly as part of the feed or water given to whole herds and flocks. Some of the antibiotics serve a dual purpose: They help control and prevent outbreaks of disease, and they affect microorganisms in the digestive system in ways that help animals gain weight more effectively with less feed.
Earlier this year, Reuters reported that some of America’s largest poultry firms were giving antibiotics to their flocks far more often than regulators knew. In most cases, the drugs were being administered at the low levels that are especially conducive to the growth of superbugs.
Scientists with the U.S. Centers for Disease Control and Prevention said antibiotic use contributes to resistance by killing weaker bacteria and enabling the strongest to survive and multiply. Each year, about 2 million people are sickened in the United States with infections resistant to antibiotics, the CDC estimates. At least 23,000 people die.
Yet even as health professionals have issued warnings, antibiotics use on U.S. farms increased by 16 percent from 2009 to 2012, the FDA reported in October.
That’s one of the reasons the FDA has turned to veterinarians. The plan is to have vets supervise the use of antibiotics that are important to fighting human illnesses, and to create a paper trail of when and where those drugs are used. Currently the government keeps only overall sales data on antibiotic use in animals.
“We want to bring that professional supervision into the process,” said Michael Taylor, FDA deputy commissioner for foods and veterinary medicine.
As veterinarians are asked to safeguard public health, the financial conflicts they face deserve greater scrutiny, said Daniel Carlat, who directed a project for the nonprofit Pew Charitable Trust that examined medical conflicts of interest.
“It hasn’t come up because people have not been as concerned about the health and welfare of animals as they have humans,” said Carlat, an associate clinical professor of psychiatry at Tufts Medical School.
“I think the issue is much more germane to the health of humans now, because we’re talking about antibiotic use in animals that we’re eating and that could potentially affect the effectiveness of antibiotics that we use for our own health,” Carlat said. “Suddenly, conflicts of interest in veterinary medicine have become quite relevant for humans We need to know more.”
The typical starting income of a food-animal veterinarian is about $71,000 a year and grows to about $103,000, surveys show. Some treat dogs and cats, too. Many also sell medications in addition to services - a potential conflict that has been restricted in Denmark.
American veterinarians say that because there are no pharmacies that dispense animal drugs, their dual role as healers and distributors is a convenience, and what’s more, their drug profit margins are usually small. Drug companies also sell directly to the biggest livestock producers, and their direct-to-farmer advertising bypasses veterinarians entirely.
The best-paid veterinarians aren’t the ones treating animals. Rather, they work for drug companies. Veterinarians in pharmaceuticals, biotechnology, research and agrochemicals made on average $167,000 a year in 2009, a salary survey shows. Zoetis, the leading animal drug maker, has 825 veterinary technical advisors and sales people in the United States. The company had about $1.3 billion in antibiotic drug sales in 2013 - 26 percent of its total revenue.
In addition to the vets that Zoetis employs directly, the company also has financial relationships with veterinarians across the nation. That includes providing scholarships and loan assistance for veterinary students, awards for faculty, sponsorship of continuing education sessions, funding for veterinary associations, and payments for veterinarians to speak, consult and research.
Zoetis won’t say which veterinarians it helps, or how many. Spokeswoman Elinore White said the company monitors its payments to veterinarians “to ensure that our educational and promotional efforts do not inappropriately reward prescribing or dispensing behavior.” She declined to discuss how the tracking system works or whether the company has identified any problematic overprescribing.
The upcoming FDA directive means that “now there will be a gatekeeper” between drug companies and food producers, said Steven Henry, a Kansas veterinarian advising farmers who raise 2 million pigs a year.
Henry and others predict that the new rules will do little to stanch the flow of antibiotics to farmers because drug companies need to maintain volumes and profits. “These impediments are going to restrict sales - until they figure out a way not to restrict sales,” Henry said of drug companies.
Colorado cattle rancher Mike Callicrate said he expects veterinarians to follow the wishes of the ranchers who employ them. “These guys are going to fight to the death to keep their antibiotics,” Callicrate said of ranchers who operate the largest farms. What veterinarians end up prescribing, he said, “depends on who they’re getting paid by.”
Fred Gingrich, a veterinarian in Ashland, Ohio, and the incoming president of the American Association of Bovine Practitioners, said that was a cynical view of the ethics of veterinarians and growers. “I‘m proud of what we do,” he said. “We welcome the responsibility and the discussion.”
In its guidance to veterinarians and the industry, the FDA is emphasizing the term “judicious use.” Medications should be used judiciously to prevent and treat specific diseases, not for promoting growth or feed efficiency, the agency says.
Craig Rowles, a veterinarian in Carroll, Iowa, and an owner of Elite Pork Partnership, said he has stopped using antibiotics to promote growth. Each year, Rowles sells 150,000 hogs to Tyson Foods. He said he still puts doses of tetracycline in the animal feed for two weeks shortly after weaning. That’s when the pigs are most vulnerable, he said, and the antibiotics help stave off infections. Rowles considers such doses a judicious use even if the pigs aren’t sick. “That’s fairly routine for us,” he said.
Two new voluntary rules, effective in December 2016 and supported by drug makers, prohibit using antibiotics to promote fattening animals for food, and require prescriptions for all antibiotics used in both animal and human medicine. But the new guidelines still permit antibiotics to be used for disease prevention, a provision that some health advocates say will enable veterinarians to rationalize almost any prescription.
The FDA’s handling of the antibiotics issue itself illustrates the conflicts facing the industry and the government.
The agency’s Veterinary Medicine Advisory Committee, for example, discussed the use of antibiotics four times between 1999 and 2006. Among the 22 veterinarians who participated in those discussions, half had some sort of financial tie with one or more of the companies that sold antibiotics. In the two most recent meetings, an even higher percentage, seven of 10, had financial ties to drug makers.
Last year, the FDA dissolved the group, deeming the veterinary committee “no longer necessary because of other opportunities for input.” Among those other opportunities is a task force formed by veterinary colleges. The members include Willie Reed, the dean at Purdue University’s veterinary school.
Purdue pays Reed $276,000 a year. In March, Zoetis named him to its board of directors. That position pays Reed $240,000 annually in cash and stock and requires directors to act in the fiduciary interest of the company. The task force announcement last month didn’t mention Reed’s tie to Zoetis.
Reed’s dual role creates “an ethical smog” because the veterinary school and dean could be perceived as too close to the interests of a single drug company, said Thomas Donaldson, professor of business ethics at the Wharton School of the University of Pennsylvania. The connection to Zoetis, he said, should have been disclosed prominently when the colleges set up the antibiotics task force. “That’s a no brainer,” Donaldson said. “You’ve got a tiger by the tail there.”
Reed declined to talk to Reuters directly, but issued a statement - through Zoetis.
“I have taken an oath as a veterinarian and make recommendations regarding animal health issues based on my scientific knowledge, experience and skills in order to protect human and animal health,” he said. “The role I play as a member of the Zoetis board is consistent with this oath.'” (Reporting By Duff Wilson and Mimi Dwyer. Editing by Blake Morrison and Michael Williams)