Just a Bump in the Beltway

FDA Rules Override Warnings About Drug
Cattle Antibiotic Moves Forward Despite Fears of Human Risk

By Rick Weiss
Washington Post Staff Writer
Sunday, March 4, 2007; A01

The government is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency's own expert advisers that the decision will be dangerous for people.

The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among medicine's last defenses against several serious human infections. No drug from that class has been approved in the United States for use in animals.

The American Medical Association and about a dozen other health groups warned the Food and Drug Administration that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotics, as has happened with other drugs. Those super-microbes could then spread to people.

Echoing those concerns, the FDA's advisory board last fall voted to reject the request by InterVet Inc. of Millsboro, Del., to market the drug for cattle.

Yet by all indications, the FDA will approve cefquinome this spring. That outcome is all but required, officials said, by a recently implemented "guidance document" that codifies how to weigh the threats to human health posed by proposed new animal drugs.

Rolling Back the Regs

A series of executive orders, the most recent being number 12866, have allowed the White House to review regulations before they are published in the Federal Register. The new order gives the OMB the expanded power to review “guidance documents” published by federal agencies.

Guidance documents are statements that explain how an existing regulation will be interpreted, implemented and enforced. In a worst-case scenario, the OMB review of guidance documents could take the nuts and bolts of interpretation and enforcement out of the hands of agency experts and turn it over to White House appointees with political agendas.

During a Feb. 13 House Science and Technology Committee hearing, Rep. Brad Miller (D-N.C.) said, “It is not good government when agency action is based on economic or political back room deals rather than environmental or public health consequences.”
....
Watchdog groups Public Citizen and OMB Watch are particularly disturbed because these processes will likely be overseen by Susan Dudley, a hard-line anti-regulation ideologue. During her tenure at the industry-funded Mercatus Center at George Mason University, Dudley opposed safeguards against arsenic in drinking water and smog.

“I read this as an invitation for Dudley to go on the attack, handing her an axe to chop Congress off at the knees,” says Shull.

Critics fear the extra studies and proof required by the order could delay critical environmental, health and safety regulations from taking effect for years. Shull notes that guidance documents largely govern the implementation of the Superfund environmental clean-up program. The new regulations could cause massive delays in the already severely underfunded and bureaucratically mired program.

The OMB bulletin describes the executive order, which was published in the Jan. 23 Federal Register and takes effect 180 days later, as a way to increase government agencies’ transparency and accountability. It mandates that electronic versions of guidance documents be available to the public, and that agencies accept public comment on significant guidance documents. These are arguably positive developments, but it does not obligate them to take action based on public comments.

Far from increasing public participation in policy, critics say the executive order does just the opposite. “This,” says Learner, “is inside baseball in the extreme.”

In other words, fuck your health. W has friends in the cattle bidness and their interest trumps you, the FDA and science. You'd think Rick Weiss could provide a little context here.

Update: Public health agency linked to chemical industry
The work of a federal risk-assessment center is guided by a company with manufacturing ties. Some scientists see bias.
By Marla Cone, Times Staff Writer
March 4, 2007

For nearly a decade, a federal agency has been responsible for assessing the dangers that chemicals pose to reproductive health. But much of the agency's work has been conducted by a private consulting company that has close ties to the chemical industry, including manufacturers of a compound in plastics that has been linked to reproductive damage.

In 1998, the Center for the Evaluation of Risks to Human Reproduction was established within the National Institutes of Health to assess the dangers of chemicals and help determine which ones should be regulated. Sciences International, an Alexandria, Va., consulting firm that has been funded by more than 50 industrial companies, has played a key role in the center's activities, reviewing the risks of chemicals, preparing reports, and helping select members of its scientific review panel and setting their agendas, according to government and company documents.

The company produces the first draft of the center's reports on the risks of chemicals, including a new one on bisphenol A, a widely used compound in polycarbonate plastic food containers, including baby bottles, as well as lining for food cans.

The center's work is considered important to public health because people are exposed to hundreds of chemicals that have been shown to skew the reproductive systems of newborn lab animals and could be causing similar damage in humans. Chemical companies and industry groups have staunchly opposed regulation of the compounds and have developed their own research to dispute studies by government and university scientists.

The bisphenol A report, which some scientists say has a pro-industry bias, is a public document scheduled for review by the center's scientific panel on Monday. Employees of Sciences International involved in writing it will preside over the meeting.

May we repeat our earlier understanding? Your health doesn't matter as long as industry is getting their share. They can kill you in the long term as long as they are getting the Q4 number they need.