Vast F.D.A. Effort Tracked E-Mails of Its Scientists

Eric Lichtblau and Scott Shane, The New York Times, July 14, 2012

WASHINGTON — A wide-ranging surveillance operation by the Food and Drug Administration against a group of its own scientists used an enemies list of sorts as it secretly captured thousands of e-mails that the disgruntled scientists sent privately to members of Congress, lawyers, labor officials, journalists and even President Obama, previously undisclosed records show.

What began as a narrow investigation into the possible leaking of confidential agency information by five scientists quickly grew in mid-2010 into a much broader campaign to counter outside critics of the agency’s medical review process, according to the cache of more than 80,000 pages of computer documents generated by the surveillance effort. 

Moving to quell what one memorandum called the “collaboration” of the F.D.A.’s opponents, the surveillance operation identified 21 agency employees, Congressional officials, outside medical researchers and journalists thought to be working together to put out negative and “defamatory” information about the agency. 

F.D.A. officials defended the surveillance operation, saying that the computer monitoring was limited to the five scientists suspected of leaking confidential information about the safety and design of medical devices. 

While they acknowledged that the surveillance tracked the communications that the scientists had with Congressional officials, journalists and others, they said it was never intended to impede those communications, but only to determine whether information was being improperly shared.

The agency, using so-called spy software designed to help employers monitor workers, captured screen images from the government laptops of the five scientists as they were being used at work or at home. The software tracked their keystrokes, intercepted their personal e-mails, copied the documents on their personal thumb drives and even followed their messages line by line as they were being drafted, the documents show.

The extraordinary surveillance effort grew out of a bitter dispute lasting years between the scientists and their bosses at the F.D.A. over the scientists’ claims that faulty review procedures at the agency had led to the approval of medical imaging devices for mammograms and colonoscopies that exposed patients to dangerous levels of radiation.

A confidential government review in May by the Office of Special Counsel, which deals with the grievances of government workers, found that the scientists’ medical claims were valid enough to warrant a full investigation into what it termed “a substantial and specific danger to public safety.”

The documents captured in the surveillance effort — including confidential letters to at least a half-dozen Congressional offices and oversight committees, drafts of legal filings and grievances, and personal e-mails — were posted on a public Web site, apparently by mistake, by a private document-handling contractor that works for the F.D.A. The New York Times reviewed the records and their day-by-day, sometimes hour-by-hour accounting of the scientists’ communications.

With the documents from the surveillance cataloged in 66 huge directories, many Congressional staff members regarded as sympathetic to the scientists each got their own files containing all their e-mails to or from the whistle-blowers. Drafts and final copies of letters the scientists sent to Mr. Obama about their safety concerns were also included.

Last year, the scientists found that a few dozen of their e-mails had been intercepted by the agency. They filed a lawsuit over the issue in September, after four of the scientists had been let go, and The Washington Post first disclosed the monitoring in January. But the wide scope of the F.D.A. surveillance operation, its broad range of targets across Washington, and the huge volume of computer information that it generated were not previously known, even to some of the targets.

F.D.A. officials said that in monitoring the communication of the five scientists, their e-mails “were collected without regard to the identity of the individuals with whom the user may have been corresponding.” While the F.D.A. memo described the Congressional officials and other “actors” as collaborating in the scientists’ effort to attract negative publicity, the F.D.A. said that those outside the agency were never targets of the surveillance operation, but were suspected of receiving confidential information.

While federal agencies have broad discretion to monitor their employees’ computer use, the F.D.A. program may have crossed legal lines by grabbing and analyzing confidential information that is specifically protected under the law, including attorney-client communications, whistle-blower complaints to Congress and workplace grievances filed with the government.

Other administration officials were so concerned to learn of the F.D.A. operation that the White House Office of Management and Budget sent a governmentwide memo last month emphasizing that while the internal monitoring of employee communications was allowed, it could not be used under the law to intimidate whistle-blowers. Any monitoring must be done in ways that “do not interfere with or chill employees’ use of appropriate channels to disclose wrongdoing,” the memo said.

Although some senior F.D.A. officials appear to have been made aware of aspects of the surveillance, which went on for months, the documents do not make clear who at the agency authorized the program or whether it is still in operation.

But Stephen Kohn, a lawyer who represents six scientists who are suing the agency, said he planned to go to federal court this month seeking an injunction to stop any surveillance that may be continuing against the two medical researchers among the group who are still employed there.

The scientists who have been let go say in a lawsuit that their treatment was retaliation for reporting their claims of mismanagement and safety abuses in the F.D.A.’s medical reviews.

Members of Congress from both parties were irate to learn that correspondence between the scientists and their own staff had been gathered and analyzed.

Representative Chris Van Hollen, a Maryland Democrat who has examined the agency’s medical review procedures, was listed as No. 14 on the surveillance operation’s list of targets — an “ancillary actor” in the efforts to put out negative information on the agency. (An aide to Mr. Van Hollen was No. 13.)

Mr. Van Hollen said on Friday after learning of his status on the list that “it is absolutely unacceptable for the F.D.A. to be spying on employees who reach out to members of Congress to expose abuses or wrongdoing in government agencies.”

Senator Charles E. Grassley, an Iowa Republican whose former staff member’s e-mails were cataloged in the surveillance database, said that “the F.D.A. is discouraging whistle-blowers.” He added that agency officials “have absolutely no business reading the private e-mails of their employees. They think they can be the Gestapo and do anything they want.”

While national security agencies have become more aggressive in monitoring employee communications, such tactics are unusual at domestic agencies that do not handle classified information.

Much of the material the F.D.A. was eager to protect centered on trade secrets submitted by drug and medical device manufacturers seeking approval for products. Particular issues were raised by a March 2010 article in The New York Times that examined the safety concerns about imaging devices and quoted two agency scientists who would come under surveillance, Dr. Robert C. Smith and Dr. Julian Nicholas.

Agency officials saw Dr. Smith as the ringleader, or “point man” as one memo from the agency put it, for the complaining scientists, and the surveillance documents included hundreds of e-mails that he wrote on ways to make their concerns heard. (Dr. Smith and the other scientists would not comment for this article because of their pending litigation.)

Lawyers for GE Healthcare charged that the 2010 article in The Times — written by Gardiner Harris, who would be placed first on the surveillance program’s list of “media outlet actors” — included proprietary information about their imaging devices that may have been improperly leaked by F.D.A. employees.

F.D.A. officials went to the inspector general at the Department of Health and Human Services to seek a criminal investigation into the possible leak, but they were turned down. The inspector general found that there was no evidence of a crime, noting that “matters of public safety” can legally be released to the news media.

Undeterred, agency officials began the electronic monitoring operation on their own.

The software used to track the F.D.A. scientists, sold by SpectorSoft of Vero Beach, Fla., costs as little as $99.95 for individual use, or $2,875 to place the program on 25 computers. It is marketed mainly to employers to monitor their workers and to parents to keep tabs on their children’s computer activities.

“Monitor everything they do,” says SpectorSoft’s Web site. “Catch them red-handed by receiving instant alerts when keywords or phrases are typed or are contained in an e-mail, chat, instant message or Web site.”

The F.D.A. program did all of that and more, as its operators analyzed the results from their early e-mail interceptions and used them to search for new “actors,” develop new keywords to search and map out future areas of concern.

The intercepted e-mails revealed, for instance, that a few of the scientists under surveillance were drafting a complaint in 2010 that they planned to take to the Office of Special Counsel. A short time later, before the complaint was filed, Dr. Smith and another complaining scientist were let go and a third was suspended.

In another case, the intercepted e-mails indicated that Paul T. Hardy, another of the dissident employees, had reapplied for an F.D.A. job “and is being considered for a position.” (He did not get it.)

F.D.A. officials were eager to track future media stories too. When they learned from Mr. Hardy’s e-mails that he was considering talking to PBS’s “Frontline” for a documentary, they ordered a search for anything else on the same topic.

While the surveillance was intended to protect trade secrets for companies like G.E., it may have done just the opposite. The data posted publicly by the F.D.A. contractor — and taken down late Friday after inquiries by The Times — includes hundreds of confidential documents on the design of imaging devices and other detailed, proprietary information.

The posting of the documents was discovered inadvertently by one of the researchers whose e-mails were monitored. The researcher did Google searches for scientists involved in the case to check for negative publicity that might hinder chances of finding work. Within a few minutes, the researcher stumbled upon the database.

“I couldn’t believe what I was seeing,” said the researcher, who did not want to be identified because of pending job applications. “I thought: ‘Oh my God, everything is out there. It’s all about us.’ It was just outrageous.”

Progress Is Our Most Important Product

Mark Bittman,  The New York Times, June 19, 2012

Certainly there is plenty wrong with our food “system,” and it’s easy to point that out week after week. Every day there’s more bad news, and when credible people say that 900 million Indians are hungry — really hungry, not “dying” for a Snickers — the tendency is to get so depressed that one overlooks progress. (Perhaps, too, New Yorkers are born to kvetch.)

But here in the United States at least, every week there’s evidence that the pendulum is swinging. One could allow pessimism to reign, but it’s my sworn duty to occasionally point out some of The Good Stuff. And there’s been plenty the last few weeks. (All tempered, of course, but we’ll try to tame the inner curmudgeon here.)

To wit:
The Walt Disney Co. announced a curb on junk food marketing aimed at kids, to be implemented by 2015. At that point, all products advertised on any of Disney’s media outlets must meet certain nutrition guidelines. Kudos to Disney for taking the lead on this issue, and though we’d like to see others follow suit, this should not be a voluntary system based on the good will of individual companies: we need real standards to which all advertisers and marketers must adhere. Attempts to curb junk food marketing through voluntary guidelines have been nearly useless, and junk food is now advertised on school buses and in schools. It’s unlikely Disney is setting a real trend; it’s just showing what needs to be the norm.
McDonald’s is also helping to set new norms, by establishing a 10-year timeline to phase out pork gestation crates from its U.S. supply chain. And other companies have set earlier deadlines. Even though one wishes that McDonald’s would get a move on, this is big. Kroger, the nation’s largest grocery chain, has urged its suppliers to speed up the elimination of gestation crates, and a New Jersey Senate committee has approved a proposed law that would ban them.

Write this down: gestation crates will be gone within a generation.

Perhaps equally significant, Subway has announced not one, not two, but three new vegan sandwiches, on what appears to be a trial run. It will be interesting to see how they do, and how the company promotes them because Subway talks a lot about their “healthier” fast food, but promotes the BMT, steak-and-cheese and other high-fat sandwiches like mad.

Speaking of Subway, in 2011 the chain said it cut salt by 15 percent across the board. This might be good news, but only if you believe that salt is harmful. The real good news is in this Gary Taubes piece which essentially maintains that everything you thought you knew about salt was wrong. Pass the shaker.

A court ruled that the Food and Drug Administration must reconsider two petitions urging the agency to restrict the subtherapeutic use of antibiotics on livestock. This decision follows a March order that the F.D.A. begin withdrawing the use of two major classes of antibiotics from livestock production if they cannot be proved to be safe. The most recent ruling could be read as a scolding: “For over thirty years, the Agency has been confronted with evidence of the human health risks associated with the widespread subtherapeutic use of antibiotics in food-producing animals, and, despite a statutory mandate to ensure the safety of animal drugs, the Agency has done shockingly little to address these risks.” (Why is curbing antibiotic use so critical? Read Maryn McKenna.)

We need the F.D.A., and we need it to do its job well. It’s good that it’s also considering placing a ban on BPA in infant formula containers (although one could easily say “just do it”), and that it denied the Corn Refiners Association’s petition to change the name of high-fructose corn syrup to “corn sugar.” (Although, come on. What difference would it make? You could call it Gold Spun From Straw for all it matters. It’s still not food.)

The Farm Bill is a mess, and no one understands it (which is why it’s so susceptible to lobbyists), but at least this time some people are paying attention. First there was the laudable Local Farms, Food, and Jobs Act from Representative Chellie Pingree, Democrat of Maine. Then Senator Frank Lautenberg, Democrat of New Jersey, introduced an amendment mandating that the government study the link between sugary beverages and obesity. Bernie Sanders, Independent of Vermont, suggests that an amendment be added allowing states to require GMO labeling. And the Senate at large voted to reject the Tea-Party-led effort to cut nutrition assistance nearly in half.

It’s a bit of a mess. Hundreds of amendments to the farm bill have been introduced, and my guess is that ultimately we’ll be saying what we said five years ago — “Wait ‘til next time!” — but there are signs that more members of Congress are at least trying to do the right thing.

It’s our job to get more of those types elected come November. (To make that easier, there will soon be a scorecard of how your elected representatives are acting, Farm-Bill-wise.)
Finally, and this is a good omen, an Ohio judge has ruled that a state law limiting the ability of local governments to regulate restaurants in order to improve public health is not constitutional. To disambiguate this, as Wikipedia would say, it’s O.K. in Ohio, according to this judge, anyway, for municipalities to boss restaurants around, health-wise.)
And why not?

Antibiotics Off the Farm - NYTimes.com

The New York Times, April 15, 2012

Two important events in recent weeks — a regulatory guideline and a federal court decision — have raised hopes that progress can be made in curbing the widespread use of antibiotics to spur growth in cattle, chickens, pigs and other food animals.

The decades-long practice of feeding small doses of antibiotics continuously to entire herds or flocks has a high cost for human health. It has fostered the emergence of germs that are resistant to veterinary drugs and to the very similar drugs used to treat humans.

Last Wednesday, the Food and Drug Administration issued new regulatory guidelines, as part of an effort to get drug companies, animal producers and veterinarians to rein in indiscriminate use of antibiotics that are important for treating humans. There is a lot of reining in to do — about 80 percent of all antibiotics sold in the United States are used in animals, the vast majority to promote rapid weight gain, not to treat sick animals.

Under the F.D.A.’s approach, the drug makers would voluntarily change their labels on medically important drugs to eliminate growth promotion as an approved use in animals — a step that would make it illegal for animal producers to use the drugs for that purpose. The labels would also require that veterinarians supervise use of the drugs to treat or prevent disease. That would end the current unrestricted over-the-counter sales. Some advocacy groups wanted the F.D.A. to work for outright bans on use of medically important drugs to promote growth. But the Pew Campaign on Human Health and Industrial Farming endorsed what it said was a “sweeping” approach to the problem. Federal officials argue it will work because, they say, drug manufacturers have largely bought into the idea.

It will be critically important for the F.D.A. to monitor whether drug companies change their labels and whether use of the drugs on farms declines over the next few years. If those things don’t happen, the agency will need to take stronger action.

Meanwhile, a Federal District Court judge in New York issued an order last month requiring the F.D.A. to ban low-dose use of penicillin and two forms of tetracycline by animal producers to promote growth unless manufacturers can prove in hearings that such usage is safe for humans and is not promoting drug-resistant microbes.

That is the kind of case-by-case approach the agency was hoping to avoid with its new voluntary guidelines. Even so, it would be useful to proceed down both tracks at once to see which is most effective. Unless producers change their practices, more and more drugs won’t be able to protect humans against resistant germs.

Maryland set to become first state to ban arsenic in chicken feed

Darryl Fears,  The Washington Post, April 9, 2012

Maryland is about to become the first state to ban the use of additives containing arsenic in chicken feed, a practice already prohibited by Canada and the European Union.

The state’s House of Delegates and Senate approved the legislation last week and placed it before Gov. Martin O’Malley on Monday. The governor could sign it soon, said Del. Tom Hucker (D-Montgomery), who sponsored the House legislation.

“He congratulated me. He likes the bill. And he’s communicated with his staff about the bill,” Hucker said.

Arsenic occurs naturally in the environment but can also be a toxic carcinogen that contributes to diabetes and heart disease. Last year, the Food and Drug Administration tested 100 chickens by giving them feed that contained the additive roxarsone, an arsenic-based drug used to fight parasites in animals. Half the chickens later showed trace amounts of inorganic arsenic, a known carcinogen, in their livers.

The finding prompted Pfizer to suspend sales of roxarsone, which also makes the meat appear pinker and more plump by promoting growth in chickens’ blood vessels. Perdue Farms stopped using the additive years ago, and McDonald’s does not allow its suppliers to use it.

The United States produced 8.5 billion broiler chickens in 2009, according to the Agriculture Department. Georgia was the nation’s largest producer of broilers, turning out 1.3 billion. Maryland was 10th, with nearly 300 million that year, or about 1.4 billion pounds, generating 40 percent of the state’s farm revenue, according to the DelMarva Poultry Industry trade group.

Growers in Maryland, particularly on the Eastern Shore, continued to use stockpiles of the feed after Pfizer suspended it, feeding about 3 million chickens per year, according to Hucker and one of the bill’s supporters, Food & Water Watch. 

The chickens produced about a billion pounds of waste, often spread as fertilizer. Hucker said unknown levels of arsenic have seeped into the state’s soil since the product was first used in 1946 or have washed into waters that run into the Chesapeake Bay.

“We know arsenic causes cancer, heart disease and diabetes,” Hucker said. “We’ll never know how much is caused by arsenic in chicken, but we do know it’s highly avoidable.” 

“I would think it’s a huge marketing opportunity for Maryland chicken growers to let consumers know only Maryland chickens are guaranteed to be free of arsenic,” said Hucker, who is in discussions with lawmakers in other states who want to pass similar legislation. 

Saying Maryland poultry is arsenic-free “doesn’t amount to a hill of beans,” said Del. Charles J. Otto (R-Somerset), who opposed the legislation. “You don’t know where your chicken comes from.”

Otto argued that arsenic occurs naturally and shows up in extremely low amounts in chickens.

“It’s not an environmental threat or human health threat,” he said. Tying it to disease “is a scare tactic,” Otto said.

But scientists have seen growing evidence that organic arsenic can become toxic. In the FDA test, roxarsone widely used by farmers was fed to the chickens. 

“So we think the danger to public health and the environment was such that Maryland needed to take a major first step in eliminating this poison from our chicken,” said Jorge Aguilar, southern region director for Food & Water Watch.

The Myth of Sustainable Meat

James E. McWilliams, The New York Times, April 12, 2012

THE industrial production of animal products is nasty business. From mad cow, E. coli and salmonella to soil erosion, manure runoff and pink slime, factory farming is the epitome of a broken food system. 

There have been various responses to these horrors, including some recent attempts to improve the industrial system, like the announcement this week that farmers will have to seek prescriptions for sick animals instead of regularly feeding antibiotics to all stock. My personal reaction has been to avoid animal products completely. But most people upset by factory farming have turned instead to meat, dairy and eggs from nonindustrial sources. 

Indeed, the last decade has seen an exciting surge in grass-fed, free-range, cage-free and pastured options. These alternatives typically come from small organic farms, which practice more humane methods of production. They appeal to consumers not only because they reject the industrial model, but because they appear to be more in tune with natural processes. 

For all the strengths of these alternatives, however, they’re ultimately a poor substitute for industrial production. Although these smaller systems appear to be environmentally sustainable, considerable evidence suggests otherwise. 

Grass-grazing cows emit considerably more methane than grain-fed cows. Pastured organic chickens have a 20 percent greater impact on global warming. It requires 2 to 20 acres to raise a cow on grass. If we raised all the cows in the United States on grass (all 100 million of them), cattle would require (using the figure of 10 acres per cow) almost half the country’s land (and this figure excludes space needed for pastured chicken and pigs). A tract of land just larger than France has been carved out of the Brazilian rain forest and turned over to grazing cattle. Nothing about this is sustainable. 

Advocates of small-scale, nonindustrial alternatives say their choice is at least more natural. Again, this is a dubious claim. Many farmers who raise chickens on pasture use industrial breeds that have been bred to do one thing well: fatten quickly in confinement. As a result, they can suffer painful leg injuries after several weeks of living a “natural” life pecking around a large pasture. Free-range pigs are routinely affixed with nose rings to prevent them from rooting, which is one of their most basic instincts. In essence, what we see as natural doesn’t necessarily conform to what is natural from the animals’ perspectives. 

The economics of alternative animal systems are similarly problematic. Subsidies notwithstanding, the unfortunate reality of commodifying animals is that confinement pays. If the production of meat and dairy was somehow decentralized into small free-range operations, common economic sense suggests that it wouldn’t last. These businesses — no matter how virtuous in intention — would gradually seek a larger market share, cutting corners, increasing stocking density and aiming to fatten animals faster than competitors could. Barring the strictest regulations, it wouldn’t take long for production systems to scale back up to where they started. 

All this said, committed advocates of alternative systems make one undeniably important point about the practice called “rotational grazing” or “holistic farming”: the soil absorbs the nutrients from the animals’ manure, allowing grass and other crops to grow without the addition of synthetic fertilizer. As Michael Pollan writes, “It is doubtful you can build a genuinely sustainable agriculture without animals to cycle nutrients.” In other words, raising animals is not only sustainable, but required. 

But rotational grazing works better in theory than in practice. Consider Joel Salatin, the guru of nutrient cycling, who employs chickens to enrich his cows’ grazing lands with nutrients. His plan appears to be impressively eco-correct, until we learn that he feeds his chickens with tens of thousands of pounds a year of imported corn and soy feed. This common practice is an economic necessity. Still, if a farmer isn’t growing his own feed, the nutrients going into the soil have been purloined from another, most likely industrial, farm, thereby undermining the benefits of nutrient cycling. 

Finally, there is no avoiding the fact that the nutrient cycle is interrupted every time a farmer steps in and slaughters a perfectly healthy manure-generating animal, something that is done before animals live a quarter of their natural lives. When consumers break the nutrient cycle to eat animals, nutrients leave the system of rotationally grazed plots of land (though of course this happens with plant-based systems as well). They land in sewer systems and septic tanks (in the form of human waste) and in landfills and rendering plants (in the form of animal carcasses). 

Farmers could avoid this waste by exploiting animals only for their manure, allowing them to live out the entirety of their lives on the farm, all the while doing their own breeding and growing of feed. But they’d better have a trust fund. 

Opponents of industrialized agriculture have been declaring for over a decade that how humans produce animal products is one of the most important environmental questions we face. We need a bolder declaration. After all, it’s not how we produce animal products that ultimately matters. It’s whether we produce them at all. 

James E. McWilliams is the author of “Just Food: Where Locavores Get It Wrong and How We Can Truly Eat Responsibly.”

Arsenic in Our Chicken? - NYTimes.com

Nicholas D. Kristof, The New York Times, April 4, 2012

Let’s hope you’re not reading this column while munching on a chicken sandwich.

That’s because my topic today is a pair of new scientific studies suggesting that poultry on factory farms are routinely fed caffeine, active ingredients of Tylenol and Benadryl, banned antibiotics and even arsenic.

“We were kind of floored,” said Keeve E. Nachman, a co-author of both studies and a scientist at the Johns Hopkins University Center for a Livable Future.  “It’s unbelievable what we found.”

He said that the researchers had intended to test only for antibiotics. But assays for other chemicals and pharmaceuticals didn’t cost extra, so researchers asked for those results as well.

“We haven’t found anything that is an immediate health concern,” Nachman added. “But it makes me question how comfortable we are feeding a number of these things to animals that we’re eating. It bewilders me.”

Likewise, I grew up on a farm, and thought I knew what to expect in my food. But Benadryl? Arsenic? These studies don’t mean that you should dump the contents of your refrigerator, but they do raise serious questions about the food we eat and how we should shop.

It turns out that arsenic has routinely been fed to poultry (and sometimes hogs) because it reduces infections and makes flesh an appetizing shade of pink. There’s no evidence that such low levels of arsenic harm either chickens or the people eating them, but still...

Big Ag doesn’t advertise the chemicals it stuffs into animals, so the scientists conducting these studies figured out a clever way to detect them. Bird feathers, like human fingernails, accumulate chemicals and drugs that an animal is exposed to. So scientists from Johns Hopkins University and Arizona State University examined feather meal — a poultry byproduct made of feathers.

One study, just published in a peer-reviewed scientific journal, Environmental Science & Technology, found that feather meal routinely contained a banned class of antibiotics called fluoroquinolones. These antibiotics (such as Cipro), are illegal in poultry production because they can breed antibiotic-resistant “superbugs” that harm humans. Already, antibiotic-resistant infections kill more Americans annually than AIDS, according to the Infectious Diseases Society of America.

The same study also found that one-third of feather-meal samples contained an antihistamine that is the active ingredient of Benadryl. The great majority of feather meal contained acetaminophen, the active ingredient in Tylenol. And feather-meal samples from China contained an antidepressant that is the active ingredient in Prozac.

Poultry-growing literature has recommended Benadryl to reduce anxiety among chickens, apparently because stressed chickens have tougher meat and grow more slowly. Tylenol and Prozac presumably serve the same purpose.

Researchers found that most feather-meal samples contained caffeine. It turns out that chickens are sometimes fed coffee pulp and green tea powder to keep them awake so that they can spend more time eating. (Is that why they need the Benadryl, to calm them down?)

The other peer-reviewed study, reported in a journal called Science of the Total Environment, found arsenic in every sample of feather meal tested. Almost 9 in 10 broiler chickens in the United States had been fed arsenic, according to a 2011 industry estimate.

These findings will surprise some poultry farmers because even they often don’t know what chemicals they feed their birds. Huge food companies require farmers to use a proprietary food mix, and the farmer typically doesn’t know exactly what is in it. I asked the United States Poultry and Egg Association for comment, but it said that it had not seen the studies and had nothing more to say.

What does all this mean for consumers? The study looked only at feathers, not meat, so we don’t know exactly what chemicals reach the plate, or at what levels. The uncertainties are enormous, but I asked Nachman about the food he buys for his own family. “I’ve been studying food-animal production for some time, and the more I study, the more I’m drawn to organic,” he said. “We buy organic.”

I’m the same. I used to be skeptical of organic, but the more reporting I do on our food supply, the more I want my own family eating organic — just to be safe.

To me, this underscores the pitfalls of industrial farming. When I was growing up on our hopelessly inefficient family farm, we didn’t routinely drug animals. If our chickens grew anxious, the reason was perhaps a fox — and we never tried to resolve the problem with Benadryl.

My take is that the business model of industrial agriculture has some stunning accomplishments, such as producing cheap food that saves us money at the grocery store. But we all may pay more in medical costs because of antibiotic-resistant infections.

Frankly, after reading these studies, I’m so depressed about what has happened to farming that I wonder: Could a Prozac-laced chicken nugget help?

I invite you to visit my blog, On the Ground. Please also join me on Facebook and Google+, watch my YouTube videos and follow me on Twitter.

White House and the F.D.A. Often at Odds

Gardiner Harris, The New York Times. April 3, 2012





Nancy-Ann DeParle, the whip-smart and sometimes caustic White House deputy chief of staff, picked up The Wall Street Journal one summer day in 2010 and got an unwelcome shock. The Food and Drug Administration was proposing as part of the new health care law to require that movie theaters post calorie counts for popcorn — and this was the first she had heard of it. 

In the F.D.A.’s view, the law called for moviegoers to know that many a buttery bucket of popcorn had more calories than two Big Macs, but Ms. DeParle, President Obama’s chief health adviser, thought the requirement was unnecessary and would probably be lampooned on Fox News as an especially silly example of the government intrusions that conservatives often mocked as the nanny state. 

Dr. Margaret A. Hamburg, the F.D.A. commissioner appointed by Mr. Obama, soon heard about the White House’s displeasure and called Ms. DeParle at home one evening, people with knowledge of the call confirmed. The women had a decidedly chilly conversation. Within days, the F.D.A., an agency charged with protecting public health, backed down and dropped the notion of calorie counts for foods served in movie theaters and on airplanes.

Similar tussles have erupted between top administration officials and the F.D.A. over issues from the regulation of sunscreens and asthma inhalers to the enforcement of an agency decision on a drug to prevent premature births. 

Should makers of lotions that do not prevent skin cancer be prohibited from calling them sunscreens, as the F.D.A. advocated, or should the lotions just be labeled ineffective, as the White House insisted? Should regulators weigh the cost of a drug or only the drug’s efficacy and safety? 

The internal clashes over F.D.A. policy played out against a broader backdrop of regulatory politics. Republicans have made the charge that Mr. Obama is an overzealous and job-killing regulator — a central element of their case against his re-election. And on issues from clean air to investor protections, the White House has been carefully calibrating its election season positions. 

In December, Kathleen Sebelius, the secretary of health and human services, drew criticism that she had put politics ahead of science when she overruled an agency decision that would have allowed over-the-counter sales of a contraceptive that helps prevent pregnancy after sexual intercourse, including to girls under age 17. 

Scientists advising the F.D.A. had concluded the drug was safe and effective, but Ms. Sebelius, the reserved, no-nonsense former governor of Kansas, expressed concern that 11-year old girls might use it improperly. 

It was the first time a cabinet member had ever publicly countermanded a determination by the F.D.A., the agency charged with ensuring the safety of foods and medicines. And it displayed the administration’s awareness that the politics of regulation do not always mesh with ideological or scientific judgments. An examination of these tensions shows how the Obama administration has often been more cautious on regulatory issues than the F.D.A. Its top officials — many of whom have been at the agency for decades — contend that their decisions should be divorced from politics and based solely on assessments of the science. 

Three powerful women — Ms. DeParle, Ms. Sebelius and Dr. Hamburg — have been the main players in this struggle. As leading defenders of the health reform law, Ms. Sebelius and Ms. DeParle, deeply loyal to the president, have been in the political trenches. Dr. Hamburg, the polished, cerebral former head of New York City’s health department and a well-known public health advocate, has sought to balance representing the administration and the F.D.A.

Dr. Hamburg declined to respond to specific questions for this article and provided a brief written statement which stressed that the F.D.A. “will continue to work with our colleagues at the White House and across government to protect and promote the health of all Americans.” Ms. DeParle declined to comment for this article. 

White House officials describe their disagreements with the F.D.A. as part of the normal, constructive give-and-take over policy that has never undermined the agency’s mission.

“Under President Obama’s leadership, the Food and Drug Administration has new authority and resources to help stop kids from smoking, protect our food supply and approve more affordable prescription drugs,” said the White House press secretary, Jay Carney. 

The administration also views the agency’s hostility to its oversight as hopelessly naïve, given a 24-hour news cycle and a ferocious political environment that punishes any misstep.

“They want a world that doesn’t exist anymore,” an administration official said. 

Consumer advocates credit the Obama administration with bolstering the F.D.A.’s budget and championing landmark legislation that strengthened the agency’s authority to regulate food and tobacco. But they also express concerns that the administration has been overly cautious, sitting on important regulatory policies regarding foods and medical devices to avoid giving Republicans fodder for attacks. 

And some analysts worry that the administration’s increased engagement could erode the F.D.A.’s reputation for regulatory thoroughness and integrity. 

“In a globalizing world, where trust is a huge part of what American manufacturers have to sell, the politicization of the F.D.A. could hurt not only consumer protection but industry profits as well,” said Daniel Carpenter, an F.D.A. historian at Harvard University. “If this trend continues, one could easily see major government purchasing programs in Europe, India, China and elsewhere saying, ‘We’re not going to follow F.D.A. recommendations anymore.’ ” 

The tensions between the White House and the F.D.A. are also a window on Mr. Obama’s governing style. The White House is concerned about managing its message, and news reports or announcements — even mundane ones — that catch advisers unaware lead to sharp rebukes, according to health officials across the government. 

“The White House wants to know everything, but telling everything takes a huge amount of work,” a health official at the Centers for Disease Control and Prevention said. “And in the end, it can’t really be done.” 

Agency Independence

When the F.D.A. was considering in 1999 whether to approve the hugely controversial abortion drug RU-486, Dr. Jane E. Henney, the agency’s commissioner at the time, went to a routine meeting with her boss, Donna E. Shalala, the Clinton administration’s health secretary. Dr. Henney advised Ms. Shalala that the F.D.A. would use its usual product approval process regarding RU-486, which would mean that neither Ms. Shalala nor any other administrative official outside the agency would have access to information about its review and decision or any say in the matter. 

“I get it,” Ms. Shalala said, according to accounts from her and Dr. Henney in recent interviews. “We need to keep the White House and everyone else away from you, and you have my absolute assurance that will happen.” 

Congress gave the power to regulate food, drugs and other health products to the nation’s health secretary, but that authority was for decades delegated almost wholly to the F.D.A., which jealously guarded its independence. 

The George W. Bush White House began more closely supervising the F.D.A. Republicans were critical of government regulations, and no agency issued more rules with greater influence over daily life than the F.D.A., which oversees foods, drugs, tobacco, cosmetics and other products that account for 25 cents of every dollar consumers spend. 

The Bush administration repeatedly stopped the agency from issuing rules to prevent contamination of eggs, produce and other foods, though both industry and consumer groups agreed they were needed as the death toll rose from such incidents. Mr. Bush’s health department also demanded that it approve all agency press releases. 

Much of the agency’s staff assumed that the Obama administration would restore the agency’s independence. 

A Turning Point

A decision that had nothing to do with the F.D.A. proved the turning point in the agency’s relationship with the White House. In the midst of the bitter 2009 battle to pass a law to provide health care to tens of millions of uninsured Americans, the United States Preventive Services Task Force announced in November that most women should not get routine mammograms until age 50 because the risks of the X-ray screens and surgical biopsies that often follow outweighed the benefits in younger women. 

Although the task force did not consider cost in its analysis, Republicans charged that its recommendation was the start of health care rationing, an accusation given prominent play on Fox News. 

“That scared the bejesus out of everybody,” a top F.D.A. official said.

The Obama administration became extremely risk averse, fearing further controversies might jeopardize the passage of health care reform, agency and administration officials said. It refused many interview requests for agency officials and scientists until the health law passed. 

“To the career people, that was disappointing,” a top F.D.A. official said. “Employees here waited eight long years for deliverance that didn’t come.” 

A provision of the new law required chain restaurants and “similar retail food establishments” to post calorie counts on menus, a provision championed by consumer advocates and the restaurant industry, which favored standardized rules over a hodgepodge of state and local ones. 

The F.D.A.’s first draft of the guidelines — approved by the Department of Health and Human Services and the White House — stated that movie theaters, lunch wagons, trains and airlines would be included. A report about the proposal in The Wall Street Journal on Aug. 31, 2010, nevertheless caught the White House by surprise. 

“This was the era of Glenn Beck, and the White House was terrified that Beck would get up and say this is all part of the nanny state,” a senior F.D.A. official said. 

Beth Martino, the F.D.A.’s chief spokeswoman, was instructed to write a blog post reversing the agency’s draft guidance even before the comment period closed and did so on Sept. 8.

Consumer advocates were outraged. 

“Movie theater popcorn is such a nutritional disaster that people deserve to know what they’re getting,” said Margo Wootan, director of nutrition policy at the Center for Science in the Public Interest. 

An administration official denied that the White House had worried about Mr. Beck and defended the decision. “When was the last time you went to a movie theater and you said, ‘Man, I’m so excited to eat here?’ ” the official asked. But the official also noted that the administration has not made a final decision about what food establishments will be covered. 

The Price Factor

Then in February 2011, the F.D.A. approved an application from KV Pharmaceutical to sell 17P, a decades-old drug used to prevent premature births. Since KV’s version, called Makena, was the only one officially approved, the F.D.A. would normally have banned the sale of cheaper unapproved ones. To the agency, the only issue was that KV’s drug offered guaranteed safety while those made by pharmacists were riskier. 

For years, pharmacists had been making unapproved versions of this injectable form of progesterone for $200 to $400 for a 20-week course. Though F.D.A. officials were then not aware of any safety complaints about the pharmacy-made 17P, they worried about repeated instances over the years when other pharmacy-made drugs had been found to lack potency or be contaminated with deadly bacteria. 

Once it had won F.D.A. approval, KV announced its price — $30,000 for a 20-week treatment, a hundredfold increase. 

Administration officials then stepped in to halt any effort to ban pharmacy-made versions, citing the need to check an exorbitant price increase from a drug company that suddenly found itself with a monopoly, an increase that could burden women who needed the drug. The administration instructed the F.D.A. to issue a press release stating that, “at this time and under this unique situation, F.D.A. does not intend to take enforcement action against pharmacies” that make unapproved versions of 17P. Cindy Mann, the Medicaid director at the Centers for Medicare and Medicaid Services, sent a memorandum to state Medicaid programs that they were free to continue buying the cheaper versions. 

An administration official said that the health department and the F.D.A. worked together on the 17P issue and that the White House was not involved. 

“The notion that the statement or the action was somehow forced down F.D.A.’s throat isn’t accurate,” the administration official said. 

F.D.A. officials said they had often been wrongly accused of considering price in drug approval deliberations and had always been able to reply that price was never a factor. “We can’t say that anymore,” a top F.D.A. official said unhappily. 

Four months later, the White House approved a requirement that sunscreens protect equally against two kinds of the sun’s radiation, UVB and UVA, to earn the coveted designation of offering “broad spectrum” protection. 

Top F.D.A. officials wanted to prohibit lotions with sun protection factors, or SPFs, of less than 15 from being called sunscreens because they do not protect against cancer or skin aging, while the administration insisted they could still be called sunscreens as long as they carried a label that said such lotions were ineffective. The F.D.A. replied that people often fail to read labels and warnings. 

“It was all a personal reaction on their part,” a top F.D.A. official involved in the discussions said of White House officials. “They made it clear they used these products and they thought they were fine.” 

An administration official said that as long as consumers are properly informed about the risks, they should generally be allowed to make such choices. Cass R. Sunstein, director of the White House’s Office of Information and Regulatory Affairs, advocates what he calls “libertarian paternalism,” a regulatory philosophy that encourages rather than mandates changes that improve or save lives. In a compromise Mr. Sunstein supported, the F.D.A. decided products with SPFs of 14 or lower could be called sunscreens but must carry warnings. 

Some months later, the F.D.A. and the White House disagreed over whether to remove from the market the asthma medicine Primatene Mist because it contained chlorofluorocarbons or CFCs, banned by international treaty because they have been found to deplete the earth’s ozone layer. The F.D.A. had for years warned Primatene’s maker of the impending ban, but the company had not followed other inhaler makers and created a product that did not use CFCs even after an additional year’s reprieve. 

Amphastar, Primatene’s maker, underwrote an expensive lobbying campaign to stop the F.D.A.’s planned ban. 

More than a dozen members of the House signed a letter to the Obama administration asking for an extension of the deadline. Senators Pat Roberts of Kansas and Jim DeMint of South Carolina, both Republicans, introduced legislation that would have barred the F.D.A. from removing Primatene from the market because they said the ban was a burdensome regulation. 

Such lobbying is not unusual for the F.D.A. What was unusual, several top agency officials said, was the effort by Mr. Sunstein to persuade the agency to give Primatene a reprieve. “Usually, we can ignore all the lobbying stuff. We get it all the time,” a top F.D.A. official said. 

“But when we get pressure from inside the administration, that’s when it gets really tough.”

Mr. Sunstein must approve new government rules. But in the case of Primatene, the law and rules were already in effect. The F.D.A. did not need his agreement and resisted his entreaties, officials said. 

Mr. Sunstein would not comment for this article. An administration official said Mr. Sunstein’s brief use of Primatene many years ago had played no role in his views. Mr. Sunstein was simply asking for more information about the product’s market removal and was worried about the removal’s effects on the poor and the uninsured, the official said. 

Disquiet among senior F.D.A. officials culminated in December when Ms. Sebelius overruled the agency’s decision to allow over-the-counter access to an emergency contraceptive called Plan B One-Step, a decision many public health experts saw as a politically motivated effort to avoid riling religious groups and others opposed to making birth control available to girls. 

The emergency contraceptive gradually loses effectiveness the longer women wait before taking it after unprotected sex, so the case for easier access is compelling, the F.D.A. had concluded. The current requirement that those 16 and younger need a prescription means pharmacies cannot place the pills on public shelves, making access more difficult for all. 

Susan Wood, a former head of the office of women’s health at the F.D.A., had resigned in 2005 to protest the Bush administration’s repeated refusal to make emergency contraceptives available without a prescription. In 2009, the White House invited Dr. Wood to attend a ceremony during which Mr. Obama signed a presidential memorandum pledging to restore scientific integrity to government decision-making and to listen to scientists “even when it’s inconvenient — especially when it’s inconvenient.” 

Dr. Wood said that she feels Mr. Obama broke that promise and fears future administrations will overrule the F.D.A. in other such controversial areas. 

“But I’m an optimist,” she added, “and hope that the president will find a way to stand by his promise.”

Food Politics » The Lancet on nudging and nagging vs. environmental change

Marion Nestle, Food Politics, March 9, 2012

I’m getting caught up on my journal reading and just ran across an editorial from The Lancet, January 21.  It takes on the UK government’s “personal responsibility” approach to health promotion based on the idea that

gently ‘nudging’ people to change their unhealthy behaviours was the key to public health.

Even the UK government has to admit that the nudge approach isn’t working.  Now it is telling physicians in the National Health Service (NHS) to nag:

use every contact with patients and the public to help them maintain and improve their physical and mental health and wellbeing.

The Lancet asks:

Is this a realistic, sensible, and effective recommendation? We would say not.

Effective, evidenced-based public health measures do not include nudging people into healthy behaviours or getting NHS staff to lecture patients on healthy lifestyles.

They include measures such as raising taxes on cigarettes, alcohol, fatty foods, and sugary drinks, reducing junk food and drink advertising to children, and restricting hours on sale of alcoholic drinks….Focusing on other approaches is foolish.

The nudge and nag approaches need one thing: the firm elbow.

I do enjoy reading The Lancet.  Its editors are so clear about the need for environmental changes to make it easier for people eat better diets and be more active.