More on MRSA on Farms and in Farm Workers, and the Arguments for and Against

In my last post I promised to catch up on some of the other research that has been published on the flow of MRSA (and other resistant organisms) between farm animals and farm workers as a result of farm antibiotic use.

Before I do that, though, I want to nod toward two other great pieces published on this. First, Mark Bittman examined this issue closely at the New York Times. And Clare Leschin-Hoar also covered the new research at Take Part. (Bonus: Don’t miss her dissection of the news that a National Geographic photographer was arrested in Kansas after taking pictures of a feedlot — from the air.)

Next, I promised I’d revisit the paper by Tara Smith and group on antibiotic-resistant bacteria on farms and in farm personnel. This research was published in May, but it has been a long time coming. Now that it is out, it is an important addition to the still-sparse literature on livestock MRSA and the influence of farm antibiotic use on antibiotic resistance. (If that idea is new to you, start here.)

As a reminder, Smith and her colleagues were the first to identify livestock MRSA, or MRSA ST398 for short, in pigs and pig-farm workers in the United States, after it had already been identified broadly in the European Union and also in Canada. That first study in 2009 was small and they wanted to do a larger one. Here from their abstract is what they looked for and found:

We collected nasal swabs from pigs and farm workers at 45 swine herds (21 antibiotic-free herds; 24 conventional herds) in Illinois, Iowa, Minnesota, North Carolina and Ohio. MRSA was isolated from 50 of 1085 pigs (4.6%) and 31 of 148 (20.9%) of farm workers. MRSA-positive pigs and people were clustered in four conventional swine farms in Iowa and Illinois. Based on genotyping, spa type t034, a common livestock associated variant, was predominant among both human and swine isolates. These results confirm the presence of LA-MRSA in pigs and swine farm workers in the USA, but the prevalence found is relatively low compared with European studies.

As I mentioned in my last post, that staph or MRSA would be found in farm workers is not unusual: roughly one-third of the population carries staph in their nostrils at any time, without experiencing an infection, and about 4 percent of the population carries MRSA, drug-resistant staph. The question has been, how common is MRSA ST398, a strain of drug-resistant staph that can be linked back to farm drug use by its specific resistance signature? The answer is important, not just because it reveals a specific potential human health risk, but also because it helps to fill in the still-disputed question of how much farm-drug use contributes to the increase in antibiotic resistance overall. The table to the right, from Smith’s paper, answers the question for the group of farm workers they took samples from: Out of 31 people in the group who carried some strain of MRSA, 21 were carrying the livestock strain.

Those workers were in Iowa and Illinois, and one was in Ohio; and the previous work Smith and colleagues did found livestock MRSA in Iowa as well. That makes North Carolina, discussed in my last post, the fourth state in which livestock MRSA has been found in farm workers. Livestock MRSA has now been found in pigs in those states, and Minnesota, South Dakota and Connecticut.

As I mentioned, livestock MRSA has a specific genetic signature — resistance to tetracycline — that has been interpreted to be the result of tetracycline use in swine-raising. (Tetracycline resistance is unusual in human MRSA because tetracycline isn’t commonly prescribed for the infection. When it appears, it may be because the gene for tetracycline resistance has traveled into the bacterium as part of a set of genes conferring resistance to several antibiotics at once.) There is an interesting discussion in Smith’s paper of whether on-farm antibiotic use is in fact responsible, or whether other factors are influencing the staph strains; but it is complex enough to leave for another post.

Meanwhile: that antibiotic use on farms causes the emergence of antibiotic resistance is supposed to be settled science at this point. On the basis of that assumption, governments in Europe have banned the use of certain drug types and formulas in farming, and for decades, researchers in the US have been pressing this government to do the same. (Unsuccessfully, so far — which is why Rep. Louise Slaughter of New York keeps introducing PAMTA, the Preservation of Antibiotics for Medical Treatment Act.)

But a piece in the new BMJ captures that for many people, notably in agriculture and veterinary pharma, the question isn’t settled at all. The colloquy between physician David Wallinga and veterinarian David G.S. Burch, titled “Does adding routine antibiotics to animal feed pose a serious risk to human health?” does a great job of capturing how far apart the two sides remain. The colloquy is open access and I urge you to read it. Quick excerpts that capture the two authors’ points of view:

Wallinga: “Routine antibiotics are not necessary for animal health. Pasture based production was the norm before antibiotics. Industrial style meat production, in which animals are confined in close quarters and fattened on soy and maize based feeds, also is possible without routine antibiotics… Almost every European and North American public health authority agrees: routine antibiotic use in animal food production likely worsens the epidemic of resistance.”
Burch: “Given that the critical antimicrobials in human medicine are not used in animal feed, that regulatory authorities conduct thorough assessments of the risk of resistance from use of antimicrobial substances, and that the environmental effect and the effects of residues in edible tissues are also assessed, it is highly unlikely that adding antibiotics to feed poses a serious risk to humans, especially compared with the extensive use of antibiotics directly in humans.”

After closing arguments, Apple's fate in e-book antitrust case goes to judge

“Word games,” an “overreaching narrative” and a “case of inferences” were a few choice phrases used by attorney Orin Snyder Thursday in closing arguments for Apple in the U.S. Department of Justice’s antitrust, ebooks price fixing case against the tech giant.

 

The DOJ brought the case against Apple and five of the largest book publishers in the U.S. for allegedly conspiring to limit price competition and raise prices in the ebook market in 2010 in an effort to stop Amazon from pricing their best-selling electronic books at $9.99 each.

 

Both the DOJ and Apple are making their closing arguments Thursday before Judge Denise Cote, who will decide the outcome of the antitrust suit. The five large publishers also named in the DOJ suit have already settled for a cumulative $164 million, leaving Apple to defend its practices in court. Cote presided over the three-week, non-jury trial in the U.S. Southern District Court of New York in Manhattan.

 

For Apple’s summation, Snyder characterized the interactions that Apple had with the five publishers as typical conversations and negotiations that accompany any business agreement. At no point did Apple try to coordinate the activities of the publishers in an attempt to fix the prices of electronic books for the market. “The evidence does not show this,” Snyder told the court, arguing that the DOJ made this case solely on “overreaching” interpretation of electronic documents.

 

Snyder focused on the timeline between December 2009 and January 2010 to rebut the DOJ’s assertions over what took place between Apple and the publishers. He noted that at the time there was “turmoil” in the ebook market and that Apple executives, who had no prior knowledge of this market, were speaking with publishing heads just to hear their concerns. He also offered multiple examples of disagreement between Apple and the publishers over the proposed contracts, this contention serving as proof that the parties were not acting in unison to fix retail prices.

 

The case stems from contracts that Apple made with the publishers in 2010, just before the company launched its iPad mobile computing device. In January of that year, each publisher—HarperCollins, Penguin, Hachette, MacMillan, and Simon & Schuster—agreed to let Apple sell their electronic books in a relatively novel business model, one in which Apple would sell their books at the prices the publishers had set, and reap 30 percent of the retail price.

 

This approach, called the agency model, differed from the standard decades-old wholesale model of book selling, in which the retailer, not the publisher, set the book prices. With the new agency approach, retailers “lost their ability to compete on price, including their ability to sell the most popular ebooks for $9.99 or for other low prices,” charged the DOJ in its complaint.

 

According to the testimony of Apple Senior Vice President Eddy Cue, publishers immediately expressed a desire to move electronic book sales to the agency model when he initially approached them in December 2009 to secure electronic book rights for the iPad.

 

The publishers saw the agency model as the solution to the issue of Amazon pricing the electronic versions of best selling books for $9.99, less than what the online retailer paid for these titles in many cases. The publishers worried that Amazon, which enjoyed a 90 percent share of the electronic book market in 2009, was lowering the perceived price point of books in consumers’ eyes, as well as laying plans to cut publishers out of Amazon’s book sales altogether and to deal with authors directly. The publishers had met throughout 2009 to discuss the issue, according to Apple.

 

Cue proposed the agency model to then Apple CEO Steve Jobs, who liked the idea, given that Apple was already using the agency model for its iTunes media store and the company’s App store. So, in early January, Apple proposed an agency model agreement with all the publishers, in which Apple would in effect get a fixed 30 percent commission for each sale.

 

Apple also added a number of additional provisions to the contract. It established a tier of price points for books. Best sellers, for instance, could be priced at $12.99 and $14.99 and, later at the publishers’ insistence, $16.99 and $19.99. Apple mandated caps, or limits to how much publishers could charge for electronic books. It prohibited publishers from both withholding best-selling titles from electronic release, and delaying the release of some titles in electronic form, a practice known as windowing.

 

Finally, Apple added what it called a “most favored nation” (MFN) clause. The MFN stipulated that the publishers must offer their electronic books to Apple at 70 percent of the lowest price offered on the retail market elsewhere. In this way Apple could match the lowest price of ebooks elsewhere and still make its 30 percent cut.

 

The DOJ had argued that MFN was proof that Apple was trying to set the prices for ebooks not just for itself, but for the entire industry. Snyder argued Apple was only looking out for its own best interest. Apple did not care what prices the publishers would charge, as long as Apple got its 30 percent cut. “If books were sold at $1.99, we’d make a ton of money,” he said.

 

Snyder also pointed out that after Apple settled on the idea of including an MFN in its contract, it had no preferences as to whether the book publishers signed other retailers such as Amazon to an agency model. He showed a number of different pieces of correspondence that Cue and Jobs had had with publishers to back this point.

 

Five of the six largest book publishers all signed Apple agency contracts within a few days of one another in January (the sixth and largest publisher, Random House, abstained). Over the next few months, the publishers had set up other agency agreements with other retailers as well, such as Amazon.

 

Immediately after the contracts took effect in April 2010, and publishers moved all their retailers to the agency model, and prices of electronic books offered by both Amazon and Barnes & Noble increased by almost 20 percent, the DOJ calculated.

 

In his summation, Snyder made the case that the publishers, and even other retailers such as Barnes & Noble and Google, were already considering the use of the agency model before meeting with Cue. He noted for instance that Barnes & Noble had also approached the publishers in January 2010 with an agency model to sell ebooks for its Nook reader. This was proof, he asserted, that the whole industry was about to undergo a transformation in how electronic books were sold to retailers.

 

While the DOJ had highlighted the many talks Cue had with publishing executives as evidence that they were coordinating activities, Snyder asserted that these meetings were simply introductory meetings and, later, individual contract negotiations. Snyder cast doubt on the idea of a price fixing conspiracy given that the publishers had already been in talks for more than a year about dealing with Amazon. “How can Apple be a ringmaster before the iBookstore was even a twinkle in Apple’s eyes,” he rhetorically asked, referring how up until late December 2009, Jobs wasn’t even interested in entering the electronic book market.

 

At one point, Cote asked Snyder if Apple was aware that the publishers may have been colluding among themselves. “We don’t have an opinion on that. It’s not our burden” to disprove that type of assertion in court, he responded. He also pointed out that the contract negotiations between Apple and the publishers were far too contentious to be considered collusion. As of mid-January Apple didn’t have any agreements with the publishers and each publisher had taken issue with different parts of the proposed agreement, such as the MFN clause, or the price caps. If there was a secret agreement already in place, the negotiations would have gone far more smoothly, he asserted.

 

When making its case, the DOJ had to prove anticompetitive behavior in a number of ways. It had to show that the publishers had conferred with one another in order to set up a new cross-publishing company pricing model that would limit retailer price control, and that Apple helped exchange information among the publishers. It also had to show that the publishers had attempted to conceal their communications. In addition, it had to show that consumers were harmed by this collusion.

 

Whether the DOJ has made its case sufficiently to Cote remains to be seen. Early reports indicated that she believed that the government had a strong case. Thus far, the DOJ has compiled a copious amount of email and other electronic documentation that it feels points to how the different parties worked with one another.

 

Legal observers, however, have doubted that the DOJ documentation is sufficient, and that its case relies too heavily on inference.

 

For the government's summation, DOJ director of litigation Mark Ryan challenged Snyder's idea that difficult negotiations between Apple and the publishers constituted proof there was no conspiracy.

 

"Sure, there was some dispute ... about what the price should be," he said. "But disagreement among a cartel doesn't mean there isn't a cartel." He urged the court to look beyond the discussion of the agency model, MFN and other details, and to focus on how book prices immediately changed after the agency agreements went into play.

 

Ryan described the events of early 2010 as "the publishers acting as a group, and Apple bringing that group along." There was a "fairly brazen price-fixing element to this," he said.

 

He discounted the fact that Apple was a new entrant -- and not yet a powerhouse -- in the e-book market, asserting that the Sherman Antitrust Act, the law on which the suit is based, made no distinctions for new entrants. "There is no court decision saying that because you are new you can organize the suppliers of the market. This is not a defense," Ryan said.

 

Ryan also noted that Apple, in its talks with book publishers, stressed how moving to the agency model would solve "the industry's" problems with Amazon. Less often did Cue and Jobs talk about how it would help an individual publisher.

 

Cote asked if Apple, in talking about the Amazon issue, wasn't just making a sales pitch. Perhaps Apple recognized the difficulties publishers were having and proposed a solution like any new business might, she posited. Ryan countered that part of Apple's pitch was to help all the publishers confront Amazon in unison, which was an antitrust violation.

 

Apple put the MFN in place with one goal in mind, Ryan argued: to get Amazon to move to the agency model. Without Amazon doing so, Apple could not compete on price. But it was essential for the major book suppliers to act in unison to get Amazon to agree to an agency model, or so the publishers thought at the time. In a free market, Ryan said, each publisher would work out their issues with Amazon independently.

 

It was the "collective force" of the publishers that prompted Amazon to adopt the agency model and stop offering $9.99 best sellers, Ryan said.

 

"Apple was simply indifferent to customers paying higher prices," Ryan said.

 

Cote is expected to reach her decision within a few weeks.