Health Supreme by Sepp Hasslberger

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April 30, 2005

Bayer Lobbies For Animal Antibiotic - Disregards Human Health Concerns

An article in the Washington Post brings to light pharmaceutical lobby excesses as Bayer fights the FDA's decision to limit antibiotic use in farm animals disregarding the increase in prevalence of antibiotic resistant germs that has been found in recent times.

Although bacteria found in chicken sold in stores are showing increased levels of drug resistance, chemical giant Bayer was not content with the FDA's decision to withdraw Baytril, a new generation antibiotic used for companion animals and in factory chicken farms. When FDA's the decision was already taken, Bayer went to Congress and, together with chicken farmers, got Rep Charles W. Pickering's help to produce a letter intended to put pressure in the FDA's administrative judge reviewing the case.

The FDA said Members of Congress could not interfere in a judicial review proceeding in that manner, but then "forgot" to make the letter part of the public record until four months later.

The investigation opens an interesting window on the realities of pharmaceutical lobby methods - and shows how financial interests think nothing of overriding common sense and concern for people's health.

Kudos to Dan Morgan and Marc Kaufman of the Washington Post for bringing a bit of transparency into these murky dealings. Here's the dirty details...

- - -

Lawmakers' Help for Drug Firm Tests Limits

FDA Calls Efforts For Bayer Illegal

By Dan Morgan and Marc Kaufman
Washington Post Staff Writers
Saturday, April 30, 2005; Page A01

(go to original here)

The German pharmaceutical giant Bayer suffered a serious setback last year when a federal administrative law judge backed a proposed ban on a drug used to fight poultry infections at factory farms. The judge cited growing scientific evidence suggesting that the practice was reducing the effectiveness of antibiotics vital to human health.

Facing defeat in a three-year legal battle, Bayer sought help in a new arena -- Congress. In a letter written in the office of Rep. Charles W. "Chip" Pickering Jr. (R-Miss.), and with the assistance of a Bayer lobbyist who was a longtime Pickering friend, 26 House members argued that the poultry medicine was "absolutely necessary to protecting the health of birds." It called on Lester M. Crawford, acting commissioner of the Food and Drug Administration, to set aside the judge's decision regarding the class of drugs. The Bayer product is known as Baytril.

The Baytril case provides an unusual look at an attempt by lawmakers to influence the executive branch's handling of an important public health issue involving parochial economic interests and complex science. In stepping in, the congressmen entered a murky area and overstepped legal limits on their involvement, FDA officials said. While members of Congress frequently write to agencies as part of regular oversight, they are not supposed to intervene in formal, trial-type proceedings.

Less than a month after the July 22, 2004, letter, the FDA informed the legislators in writing that their attempt to sway Crawford violated federal rules intended to shield him and other decision makers in similar quasi-judicial proceedings from outside pressure. They admonished the lawmakers that they were "not allowed" to communicate with Crawford because the lengthy public record of testimony and documentary evidence was closed.

Pickering, who is vice chairman of the House Energy and Commerce Committee, which has jurisdiction over the FDA, strongly defends the letter. A statement from his office said he "acted under legislative branch rules, representing his constituents and defending their interests." The congressman, it added, "believes the medicine discussed in the letter is vital to maintaining the jobs and businesses in Mississippi based on poultry, and he stands by the content of the letter."

Crawford, now awaiting confirmation as FDA commissioner, is still considering Bayer's formal appeal of the judge's decision upholding the proposed ban. The FDA has declined to say whether he saw the congressmen's letter. Baytril is still being used in the poultry business.

Federal rules require communications from outside channels, such as the lawmakers' letter, to be made part of the public record of the case so that all sides are aware of them. But in this case the letter was not placed in the public docket until December, more than four months after it was sent, because of what the FDA said was an "inadvertent oversight."

"They are weighing in on the side of parochial economic interests against the public health, and that's disappointing," said Margaret Mellon, director of food and environment programs at the Union of Concerned Scientists.

Antibiotic Resistance

The October 2000 decision by the FDA's Center for Veterinary Medicine to withdraw approval for Baytril was a milestone in the agency's attempts to protect human health. It was the FDA's first formal withdrawal notice for an animal drug based on concerns that it could make human drugs less effective. The decision set the stage for current regulatory steps that could lead to bans on other animal drugs, such as penicillin and tetracycline.

Baytril is a fluoroquinolone antibiotic, among the strongest class available to treat humans suffering from food poisoning and a broad range of bacterial infections, including anthrax. When the FDA's veterinary division approved Baytril in 1996, public health advocates warned that it could lead to an increase in bacteria impervious to Cipro, Bayer's highly successful fluoroquinolone for humans.

In withdrawing approval, the CVM cited a study that found rising levels of fluoroquinolone-resistant bacteria in supermarket chicken and in people who prepared and ate chicken. Cipro-resistant bacteria, all but unknown in the 1990s, soared to 13 percent of the bacteria sampled in 1997. Follow-ups showed resistance rising to 20 percent in 2002 before dropping slightly in 2003.

The FDA's findings and proposed action were supported by the Centers for Disease Control and Prevention, the American Medical Association, the Union of Concerned Scientists, and two agencies at the Department of Agriculture.

None of the research pointed to Baytril as the sole culprit. Public health officials had long recognized that the overprescribing of antibiotics increased resistance to the drugs in humans. But the data persuaded the FDA's veterinary regulators to propose banning Baytril and SaraFlox, a similar product from Abbott Laboratories. Abbott agreed to withdraw its product.

But Bayer contended the FDA data were so flawed that there would be repercussions for the entire animal-drug industry if they went unchallenged. Forty to 70 percent of U.S. antibiotics are used in agriculture.

Robert Walker, spokesman for Bayer's Animal Health Division in Shawnee Mission, Kan., denies that Baytril is a significant contributor to the spread of resistant bacteria, saying there are "a lot of other factors at play." He added: "We don't feel there's anything from a scientific standpoint that supports taking it off the market."

Bayer has argued that although only 2 percent of chickens were treated with Baytril, the industry would lose millions of dollars a year if it were removed as an option. The company noted that the incidence of human infections resistant to Cipro-type medicines has declined sharply. The congressmen's letter said cases in which Cipro did not work dropped from 3.28 per 100,000 in 1997 to 2.62 per 100,000 in 2001.

Bayer's appeal triggered a review that over the next 38 months produced thousands of pages of documents and days of testimony before FDA Administrative Law Judge Daniel J. Davidson. To wage the legal battle, Bayer HealthCare, the subsidiary that oversees animal drug production, hired McDermott, Will and Emery of Chicago, the world's 14th-largest law firm.

The Animal Health Institute (AHI), the main trade group of animal-drug makers, quickly joined Bayer in contesting the ruling.

Bayer and AHI got little public help from the huge, vertically integrated retail chicken producers that are the main users of Baytril. While the broiler industry, as it is known, views Baytril as "a valuable medication that ought to be available," said Richard Lobb, spokesman for the National Chicken Council, many big companies that sell chicken under their own labels to customers in supermarkets were unwilling to publicly embrace the use of antibiotics.

"It's not something we're up there banging away on" in Congress, Lobb said.

Bayer and AHI pursued other avenues. AHI filed petitions with the FDA and the CDC under a new business-friendly law, the Data Quality Act, seeking a "correction" of the information the agencies were putting out about Baytril. And in 2002, AHI hired former senator Robert W. Kasten Jr. (R-Wis.), paying him $75,000 a year to facilitate contacts with top officials at the Department of Health and Human Services on the Baytril matter. The department was the FDA's parent and was then led by former governor Tommy G. Thompson, a longtime Kasten political ally.

AHI was "writing letters and not getting answers back," Kasten said. He said he arranged meetings with "legal people around the secretary" and may have mentioned the matter to Thompson. He also recalled at least one meeting with Crawford, then number two at the FDA.

Separately, Bayer HealthCare hired lobbyist Wayne Valis to work with administration officials on the validity of the government data on fluoroquinolones. Valis recalled setting up one or more meetings with officials at the White House office that oversees regulatory issues, as well as with officials from the FDA and several other agencies.

Bayer was unsuccessful in getting the corrections it sought from the FDA or the CDC, however, and in March 2004, Davidson strongly backed the veterinary division's proposed ban in a 68-page decision. He said the evidence "does not establish that the social and economic benefits [of this class of antibiotics] outweigh the risks to public health."

Davidson cited recent studies of bacteria in chicken showing increased levels of drug resistance. A 1999-2000 sampling of retail meat in the Washington area also mentioned in his ruling found that 35 percent of the suspect bacteria was resistant to Cipro-type drugs.

Cash and Catfish

By then, Bayer had already begun looking for help in Congress.

Christopher Myrick, a lobbyist hired by Bayer in early 2004, had a long-standing connection to Pickering. They both grew up in Jones County, Miss., and their families knew each other well, attending church and school together, according to the congressman's office. When Pickering -- whose father was a federal judge and former state GOP chairman -- decided to run for a House seat in 1995, Myrick was one of his first contributors.

Myrick, a former Senate staff member, has been counsel to pharmaceutical giant Wyeth/American Home Products Corp., and has held leadership posts on trade associations, including AHI, according to his résumé.

In March 2004, he attended a small Pickering fundraiser for drug company representatives at the 116 Club, a Capitol Hill favorite of southern lawmakers that serves home-style catfish on request, along with chicken, dumplings and crab.

The event raised $11,000, Pickering spokesman Brian Perry said. Lobbyists for Merck, Pfizer, Abbott Laboratories and Hoffmann-LaRoche chipped in, campaign finance records show. Myrick contributed $1,000, and two partners in his lobbying firm, Larson, Dodd, Stewart & Myrick, donated to Pickering then or later in the year.

Myrick did not return a phone call seeking comment.

Bayer representatives met with Pickering's congressional staff on June 17 and 23, according to his office. Perry identified the participants as Myrick and Julie Spagnoli, Bayer HealthCare's new chief Washington representative. Bayer, he said, "produced verbiage" for the letter and "brought in a lot of the material."

"We put together a kit to educate members of the media on the issue. It's most likely that is what she [Spagnoli] shared with them," said Walker, the spokesman for Bayer's Animal Health Division. "But I must stress generation of the letter was not due to Bayer writing it."

Pickering's office said a senior House Democrat, Rep. Bobby R. Etheridge (N.C.), and members of the House Agriculture Committee were given a chance to make changes. In all, 18 Republicans and eight Democrats signed. Among them were the House's third-ranking Republican, Whip Roy D. Blunt (Mo.); John A. Boehner (Ohio), second-ranking Republican on the Agriculture Committee; and Nathan Deal (R-Ga.), who recently became chairman of the Energy and Commerce Committee's health panel.

Blunt's office explained his stance by saying, "The poultry industry is a $1.77 billion industry in Missouri's 7th District, creating nearly 16,000 jobs for Congressman Blunt's constituents."

Ten of the 26 signers, including Pickering, Etheridge and Blunt, received campaign contributions from Bayer's political fund in 2003 and 2004.

Rep. Sherrod Brown (Ohio), ranking Democrat on the Energy and Commerce Committee health panel, said he learned of it only when told about it in March.

The lawmakers, who did not mention either Bayer or Baytril by name, urged Crawford to "go the extra mile" to ensure FDA action on fluoroquinolones was based on valid science. But last Aug. 17, the FDA responded that the Code of Federal Regulations prohibited such contacts at that stage. The code, however, specifies no criminal penalties.

In defending the decision to send the letter while Crawford was reviewing the case, Pickering's office cited a 1970 advisory opinion of the House ethics committee saying a member may contact a federal agency to "call for reconsideration of an administrative response which he believes is not supported by established law, federal regulation or legislative intent."

Lawyers specializing in ethics issues say Congress's oversight duties give members considerable leeway to contact officials, but there are limits during formal proceedings such as those the FDA is conducting. The House Ethics Manual states, "Since 1976, the Government in the Sunshine Act has prohibited anyone from making an ex parte communication to an administrative agency decision-maker concerning the merits of an issue that is subject to formal agency proceedings."

Such an intrusion amounts to "unfair and undue congressional interference in a judicial proceeding," said Stanley Brand, a former chief counsel of the House.

Donald Kennedy, a former FDA commissioner, said: "I never received any letters like that when I was in the position of making a quasi-judicial decision, and should not have. It is clearly improper."

See also:

Keep Antibiotics Working Praises FDA`s First Ever Ban of Agricultural Drug Due to Antibiotic-Resistance Effects in Humans - Ban on Cipro-like Drugs in Poultry Initiated During Clinton Administration.
The Keep Antibiotics Working (KAW) coalition commended newly confirmed U.S. Food and Drug Administration (FDA) Commissioner Lester Crawford for today issuing a precedent-setting, final decision to withdraw approval for use of Cipro-like antibiotics in poultry.
This action is the first time that FDA has ever withdrawn an agricultural antibiotic from the market because of concerns about antibiotic resistance affecting human health. The ban was proposed in October 2000, but took nearly five years to finalize because of numerous procedural delays created by Bayer Corp., the only manufacturer of the drug, whose trade name is Baytril. Both Baytril and Cipro are members of the fluoroquinolone class of antibiotics.
In April, KAW members Environmental Defense, Food Animals Concerns Trust, and the Union of Concerned Scientists, along with the American Academy of Pediatrics and the American Public Health Association, petitioned FDA to ban the use of medically important antibiotics as feed additives for chickens, hogs, and beef cattle. The petition is based on a detailed analysis showing that such use violates the specific safety criteria in FDA's official Guidance on agricultural antibiotics (see FDA guidance). The American Medical Association and nearly 300 other groups have joined in supporting the bipartisan "Preservation of Antibiotics for Medical Treatment Act," legislation that would end the use of medically important antibiotics as feed additives unless FDA finds that they are safe.

Keep Antibiotics Working
The Campaign to end antibiotic overuse

How pigs could be launchpad for bird flu pandemic

Chinese misuse ruins drug against avian flu

FDA bans antibiotic use for poultry
The U.S. Food and Drug Administration (FDA) has banned the use of a poultry antibiotic made by Bayer. The action, which is unprecedented, is aimed at preventing the rise of drug-resistant germs that infect people. The FDA first proposed the ban five years ago, saying the use of the drug, Baytril, in chickens had made it difficult for doctors to treat human patients with food poisoning. Farmers would sometimes use the drug to treat entire poultry flocks when only a few birds showed signs of respiratory disease.

- Tim O'Shea
It was great while it lasted: the age of antibiotics. Sure came and went in a hurry, though, didn't it? Left me with a few questions...

Indonesian researcher finds herbal formula to curb bird flu

Ending Battle With FDA, Bayer Withdraws Poultry Antibiotic
For the first time, the Food and Drug Administration has succeeded in forcing off the market an antibiotic used to treat animals because of concerns that it will make similar antibiotics less effective in treating people. After a five-year battle, Bayer Corp. said yesterday that it would immediately stop selling its poultry antibiotic, Baytril, a close relative to its widely used human antibiotic, Cipro. The company could have appealed the FDA ban on the drug to a federal court but instead decided to comply.

"We disagree with the FDA's conclusion about our drug," said Bayer spokesman Robert Walker. "But we understand they made a scientific decision, and courts tend to defer back to the agency. . . . It seemed like the chances that we would be successful in court were small."

Limits on antibiotics go back to Congress
A years-long battle to end the widespread practice of adding antibiotics to animal feed is headed back to Congress. Prominent doctor groups are backing bills, one of which was introduced Monday, that they say are necessary to keep antibiotics working effectively for humans. The American Medical Association, the American Academy of Pediatrics and others point to a body of research indicating that overuse of antibiotics in animal feed has led to the development of hard-to-kill germs. The result, they contend, is that doctors are running out of treatment options.

70 Percent of All Antibiotics Given to Healthy Livestock
Every year in the United States 25 million pounds of valuable antibiotics -- roughly 70 percent of total US antibiotic production -- are fed to chickens, pigs, and cows for nontherapeutic purposes like growth promotion, according to a new report from the Union of Concerned Scientists. This finding -- 40 percent greater than the estimate of the livestock industry for all animal uses -- is the first transparent estimate of the quantities of antibiotics used in meat production.

"The excessive use of antibiotics by the livestock industry is sobering," said Dr. Charles Benbrook, an independent economist and co-author of the report. "Feeding antibiotics to animals from birth to slaughter may modestly improve meat industry profits, but it puts everyone's health at risk. It is time to rethink how pigs, cattle and poultry are raised in the United States."

April 2007: Sex disease turns into a 'superbug'
HEALTH officials in the US have recommended nationwide use of a new drug to treat gonorrhoea because the sexually transmitted disease, now considered a superbug, is steadily becoming resistant to the long-time standard antibiotic. The disease has grown increasingly resistant to fluoroquinolones, the most common treatment for the bacterial disease since the early 1990s. The US federal Centres for Disease Control and Prevention recommended yesterday that a different class of antibiotics, cephalosporins, be used instead. "Gonorrhoea has now joined the list of superbugs for which treatment options have become dangerously few," Infectious Disease Society of America president Henry Masur said.

Bacteria in Pork Showing Resistance to Antibiotics
Scientists are beginning to detect antibiotic-resistant bacteria in pork, pigs and some veterinarians, raising the issue of whether these so-called superbugs might find a new route to infect farmworkers or even people who eat pork.

FDA Reverses Its Order on Antibiotics in Animals
This past summer the FDA instituted an order banning the off-label use of drugs in food-producing animals, while noting that the same family of drugs was important to treat disease in humans. This fall, the FDA echoed again the same sentiment, taking note of the increasing evidence of antibiotic-resistant bacteria in cattle. But the FDA's action met with harsh industry criticism.

On November 25 the FDA revoked their earlier order, to the profound dismay of the Keep Antibiotics Working coalition and researchers like Dr. Stuart Levy at Tufts University, who leads the Alliance for the Prudent Use of Antibiotics.


posted by Sepp Hasslberger on Saturday April 30 2005
updated on Friday December 10 2010

URL of this article:


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