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Science and Medicine: Antibiotics

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Rick Weiss
Washington Post Staff Writer
Monday, March 5, 2007; 12:00 PM

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.

Read the Story: FDA Rules Override Warnings About Drug ( Post, March 4)

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. Read the rest of the article here.

Washington Post staff writer Rick Weiss was online Monday, March 5 at Noon ET to discuss this story.

A transcript follows.

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Rick Weiss: Hello readers and viewers. I see we already have a long queue of questions and comments lined up. People seem to care a lot about animals, medicines, and human health, all of which come together in this tale. So here we go ...

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Washington, D.C.: As a former food and drug industry attorney, I am appalled but not at all surprised by these developments. How likely do you think it is that Congress will step in and intervene before the FDA is able to take this action?

Rick Weiss: I don't know what Congress may do with regard to this particular drug or approval, but I do know that Sen. Ted Kennedy and others are pushing once again (for something like the fifth year in row) to get legislation passed that would phase out the now widespread use of antibiotics in HEALTHY farm animals -- a common and controversial use today, for growth enhancement. His bill would also beef up (no pun intended) the reporting requirements for companies, so epidemiologists would know how much of these drugs are being used and where and how. That can help track any untoward effects on public health.

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Oklahoma City, Okla: Since Cefquinome is cephalosporin, will people who are allergic to cephalosporin antibiotics have any adverse reactions if they eat the meat of cows given the drug?

Rick Weiss: No, and in fact cephalosporins (older ones) are already being used in animals. The drugs break down in the animals, and even more so during cooking, so I know of no risk of allergic reactions in consumers.

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NYC, N.Y.: It appears that every time the FDA has approved a drug that is used for humans for use in the animal industry, microbes resistant to the drug in humans appear at some later point in time. Is this commonsense idea simply not part of the risk analysis at FDA, or is it more subtle?

Rick Weiss: Well, it's not that simple. Yes, resistance is virtually certain to arise at some point from use of these drugs in animals. But let's remember that these medicines have their benefits too. Animals do get sick -- and not only because of intensive farming practices. It is good to be able to treat them, both for humane reasons and for economic reasons. The question is how to balance the animal care concerns with the human public health concern

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Gaithersburg, Md.: Why doesn't the FDA consider common-sense steps that could be taken to improve the way animals raised for food are housed and transported to reduce illness and injury, thus the need for antibiotics? Wouldn't that be a logical first step in slowing the development of antibiotic resistance?

Rick Weiss: It seems like a loogical integration on its face: To blend "best practices" with the regulation of veterinary drugs atc. But in fact, that is not how the government is organized. The FDA is not authorized to tell farmers how to raise their animals (the USDA has some authority there, but that is limited too, unless you want to earn the increasingly coveted "organic" label. There are probably some good reasons for FDA to focus on the difficult and complicated work of judging safety and efficacy of drugs and related matters. But it does mean we end up with a fragmented oversight system -- and one that defers in large part to market forces, for better and worse.

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Cheverly, Md.: What's really going on. A few months back it was cloned animals were safe; now we want to make a sick cow safe versus the potential effects on humans. Is this the tail wagging the dog as the industry runs the FDA now or what? Can pressure on Congress reverse this decision? I have been needing a reason to go vegan, and this may force the change.

Rick Weiss: It's never as simple as "money running the show," but there are longstanding concerns in some corners about the possibly topheavy influence of drug companies on how the FDA works, especially in the past decade or so when FDA became monetarily dependent on "user fees" paid by the drug companies. The same is true in the veterinary drug division at FDA. It has helped speed things up, but does raise issues of independence for such an important regulatory agency. Of course, the money is playing out on both sides. Opponents of the way things are going today are in some cases funded by organic food interests, which can only benefit from grorwing public distaste for conventional, commercial meat. Welcome you to my country!

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Washington, D.C.: How likely is it that the drug will pass to humans through cow's milk?

Rick Weiss: There are rules in place with regard to how long a cow must be off antibiotics before its milk is allowed to be included in the food stream again. I don't know the details, and have not looked at the science to see if those rules are widely appreciated as adequate, but if they are followed by farmers I suspect there is a reasonable safey margin there.

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Falls Church, Va.: What options remain for citizens wishing to stop this from being approved? Is there an open public comment period? Thanks.

Rick Weiss: The FDA already heard public comments last fall. It is now in period of internal deliberation. Late yesterday it sent out a rather angry response to my story, emphasizing that they have not yet made up their mind (I didn't say they had -- just that all signs are pointing in the direction of approval). So perhaps the end result will still be something you are pleased with.

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Washington, D.C.: Just a comment. I read this article with disgust. The FDA has not been in the corner of the everyday person for a long time; but in the pocket of the big corporations who pay them. We are already suffering the effects of antibiotics and hormones in the food supply; the evidence is in the hormonal health problems of women in particular; we are already seeing incidences of resistant strains (i.e., necrotizing fascitis(sp?), etc.) in hospitals and in people who contract these illnesses. I don't know what can be done, other than patronizing and buying meat/dairy from farmers who do not use these damaging medicines, which not everyone has a choice to do because of the cost. When are we going to wake up and smell the coffee!?

washingtonpost.com: FDA Rules Override Warnings About Drug ( Post, March 4)

Rick Weiss: I have seen a few surveys in the past 6 months or so that indicate FDA has fallen considerably from its old levels of public trust, which used to be among the highest in the federal government. This is important because trust is what keeps the economic and social mandala turning in this country. Our food can be the safest in the world (it probably is) but if people don't trust the FDA -- which regulates something like 25 percent of the GDP in this country -- then everything becomes precarious.

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Washington, D.C.:"But it does mean we end up with a fragmented oversight system -- and one that defers in large part to market forces, for better and worse."

By market forces, I presume you mean drug companies. How do we get better oversight -- and oversight that doesn't rubber-stamp anything drug companies want?

Rick Weiss: Well, I don't mean only "the drug companies" when I say "market forces." You and I are market forces too. We like meat, many of us. We like inexpensive meat. There are some data from Europe -- touted by the drug industry and unchecked by me at this point -- that in places where routine antibiotic use has been banned (as in some parts of Europe)the animals get sick more often, adding to costs (and to animal suffering). All this is part of the market equation. As for better oversight, I have to say from my interviews with people within FDA and other agences, I mostly get the impression that these agencies are almost entirely staffed with dedicated scientists and others who really care. It is a complicated, inefficient system. There certainly are political and economic forces at work, but there is a dedicated work force of people trying to keep this process scientific. It is these people who probably need to be further empowered. they know better than the politicians, the lobbyists and -- yes -- better than most of us.

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Lorton, Va.: Doctors are now being told to not prescibe antibiotics for mild childhood ear infections and other things that should clear up on their own. Is this related at all to the use of antibiotics in meats? It seem, on the surface, a dumb question, but yet both uses contribute to resistant strains. Would we be able to use antibiotics more on ourselves if they weren't in our meats?

Rick Weiss: The overuse of antibiotics by people is a big problem, as is overuse of them in farm animals. Both contribute to resistance. I'm not sure how to rank the problems. Some stats suggest that the majority of antibiotics in this country go to animals, not people -- many of them to healthy animals, as I alluded to earlier. Then again, there are more farm animals in this country than there are people. But if antibiotics cut just one day off the course of an avergae ear infection (I think that is the latest finding) then we all have to ask ourselves: Is it worth it? Is it worth the expense, and is it worth the extra contribution to resistance. It strikes me as a global warming kind of issue: Can we each drive a little less? Sometimes that day of no ear pain will be important and worth it (flying to Calif. at the end of the week? It's worth it!) Sometimes not.

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Washington, D.C. : FDA and USDA have had funding cuts over the years that have caused serious damage their abilities to perform their duties.

Veterinarians are key players in both branches -- large animal vets inspect meat, and they also are responsible for making certain drugs do not cross into the human food supply. We use FARAD (Food animal residue avoidance databank Food Animal Residue Avoidance Databank that helps us to know when it is safe to take milk, meat, etc.

I am a vet, and my opinion is that antibiotics are, as they have always been, a double-edged sword. They can cure, but misused, they can do real harm.

Rick Weiss: Thanks for that.

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Washington, D.C.: What are the chances that if the FDA approves this, that farmers -- who have more common sense than bureaucrats -- will choose not to use it?

Rick Weiss: That's an interesting question. Farmers often say they are the country's first environmentalists. Maybe they will decide to become public health advocates too, though they have other, more pressing concerns. They will have a lot to balance. As a new drug, I suspect cefquinome will be a little expensive. And I don't believe there has been any head-to-head comparison of effectiveness between cefquinome and older, still useful drugs (FDA does not require that -- you only have to show it's better than nothing). But if the pattern holds, the drug's maker will pitch it as the newest and "best." And ironic as it may seem, it's not unusual for drug companies to emphasize their new drugs by making the point that bacteria are becoming resistant to the older drugs.... never mind why.

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Rockville, Md.: Dear Mr. Weiss,

Thank you for this important piece. It might be useful to ask ourselves why we (or our government) often choose to err on the side of serious risk to human health rather than to err on the side of caution in cases such as this. One side of the debate on these cattle drugs includes medical doctors and consumer advocates, while the other side includes groups representing the drug company (or companies) involved in veterinary medicine. Clearly, the latter is driven by the profit motive. Does anyone else beside the pharma company benefit from introducing these important (to human health!) antibiotics into the cattle population? Is anyone else better off for this potentially dangerous choice? We should be clear on these answers before we proceed with down this road: it may not be possible to put Humpty Dumpty back together again.

Rick Weiss: Again, as I mentioned above, we live in a society and an economy that says, If you make a new medicine, and it works, and is safe, then you can sell it. If people buy it, you're in business. Arguably, that process wiuld be wiser and more holisitic if the definition of "safe" were to include a broader array of issues than the short-term toxicity that is generally considered. And in fact, that is exactly what Guidance for Industry #152 was created to accomplish. Part of the problem is that the science of drug resistance is more complicated and less mature than the science of standard toxicity, so scientists and regulators are still feeling their way through it. FDA's veterinary chief Sundlof has said that the Guidnace is a work in progress, so perhaps what you are seeking in your question will gradually come to pass.

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Lexington, Ky.: I agree with you that the FDA is by and large made up of talented and dedicated scientists with the interests of the general public in mind. In this case, it looks like drug companies are putting pressure on the politicians to whom they've contributed heavily, who are in turn putting pressure on the politically-appointed FDA administration to do something that is NOT in the public interest.

I'm not in any way suggesting that it would be a good idea to let animals suffer. But when there are other medications that are effective against the diseases they want to treat with this class of antibiotic, I think it borders on criminal to approve this for use in animals knowing that other antibiotics that have been used prophylactically in animals end up less useful to both animals and people because they encourage drug-resistant bacteria.

Rick Weiss: I'll just post this as a comment.

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Alexandria, Va.: Why would treat products, and the companies that sell them, like individuals and assume they are innocent until proven guilty? There is ample reason to conclude that this new antibiotic will lead the evolution of resistant strains of bacteria, some of which will find their way into humans. Evolutionary theory and plenty of examples tell us this is a stupid thing to do. But, wait! Let's just take the recommendation from those who sell the antibiotic. They'll take care of us because human well being is their overriding concern ... NOT!

Rick Weiss: I knew a reporter at the New York Times who had a bunch of post cards printed up to deal with the many opinions and commentaries he received -- like yours -- that he (and I) just cannot speak to, in the interest of maintaining some objective neutrality as we pursue our stories. His post cards said simply (and I say to you):

Dear Sir/Madam.

You may be right.

Sincerely,

etc

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San Antonio, Tex.: If Sen. Ted Kennedy and a like-minded group of senators have been pushing for these changes (as outlined in your first response this noon) in reporting and regulations for five years running, then why has no legislation been passed? Until recently, a Republican-controlled Congress? Powerful drug lobby? Lack of interest by federal agencies involved? Why?

Rick Weiss: I can't tell you why the bills failed to get sufficient traction in years past. I was not covering the issue then. I plan to pay attention this term and will tell you all what I learn, as completely and fairly as I can, as the story unfolds on Capitol Hill.

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Washington, D.C.: Thank you for a great article; I only wish it was not so depressing. The scientific link between the non-clinical use use of antibiotics in cattle, poultry and pigs and the spread of microbial resistance in humans is well-established. Our food supply has become a major, if not the major source of resistant micro-organisms. Why can't the FDA and USDA work together to establish rules that will protect the public health?

Rick Weiss: Again, you may be right, but the Animal Health Institute, which represents veterinary drug makers, points to science that it says shows that routine use of low-dose antibiotics as growth promoters does not increase the rate or risk of drug resistance in humans. I have not investigated this evidence (it was not the topic of Sunday's story) but it seems worth looking into.

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Re FDA money and politics: Through the course of this administration's efforts, hard science has taken a back seat to political expedience and ideology. Has this been the case in this effort? Has the FDA leadership been changed in such a way that the FDA has lost credibility in the scientfic community?

Rick Weiss: One part of the letter that I mentioned in my story, which was sent from Rep. Louise Slaughter (Congress's only microbiologist!) to FDA commissioner von Eschenbach, made the assertion that FDA is increasingly being seen as a politicized agency. As I mentioned before, such an impression, whether true or not, is potentially very damaging. These things are hard to measure (the actual amount of politicization; the impression is easy to measure, and is clearly increasing. Short of catching a political appointee actually intervening in crucial decisions (as happened at NASA last year, when that politically appointed aide was caught making changes in documents about global warming and the Big Bang)it can be pretty hard to prove.

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Upper Marlboro, Md.: Isn't the FDA worried that this approval will antagonize foreign customers? The foreign customers already worry about Mad Cow and nvCJD. Why make it worse?

Rick Weiss: Actually, Europe is already using fourth generation cephalosporins in their cattle. It's a decision they made before the World Health organization came out with its recommendations, which, by ranking risks differently than the FDA does, would make it difficult for such an approval to go throough. The good news is that this means we have an experiment going on. Europe has been using these drugs in animals and we -- so far -- have not. Scientists are comparing patterns of resistance in these two regions and hopefully this will gradually tell us a lot about how the dynamics of drug resistance work.

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Rochester, N.Y.: I wrote to my congressional delegation after reading your story yesterday. Is there anything that Congress can do, or is FDA approval entirely up to the executive branch?

Rick Weiss: Congress could give the FDA the authority to demand certain kinds of data from drug companies, which could vastly help the FDA and the CDC understand better how resistance emerges and then impose limits, where apropriate, to minimize that problem. Right now, for example, companies have to tell FDA how much of a drug they sold. But not how much of it was sold domestically vs internationally; not how much went into which different animals and in what proportions,or what the dosing was -- all of which would help a lot as CDC people watch for emerging patterns of drug resistance in poeple and try to figure out any possible links to the drugs' use in animals.

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Washington, D.C.: My early training in microbiology makes me very sensitive to these important questions. But relative to a previous comment, experts widely agree that the overwhelming percentage (estimated at 95 percent or so) of infections that are resistant to antibiotics are the result of human overuse and misuse of these medicines. The comment that most are due to agricultural use of antibiotics simple is not accurate. That doesn't mean we shouldn't do everything we can to be sure antibiotics are used appropriately across the board (and in some cases NOT approved at all), but we should do our best to base these decisions on the best science that's available.

Rick Weiss: That does not surprise me, since the meat we eat is mostly cooked, which alone does a lot to kill the resistant bacteria we might otherwise get colonized by.

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Rick Weiss: That was a quick hour. Obviously an infectious topic.

Thanks for the feedback and interesting questions.

Now I need to get back to work!

Rick

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