Health care: September 2010 Archives

  • Eggs.jpgIn an opening statement, Rep. Michael Burgess (R-TX), a physician, reveals that the FDA took pictures of the concerning conditions at Wright County Egg. Inexplicably FDA Commissioner Margaret Hamburg and no USDA representatives will be testifying before today's Subcommittee hearing.
  • Rep. Henry Waxman (D-CA)whose bald head is the shape of a perfect eggcites stonewalling of a new food-safety bill by Senator Tom Coburn (R-OK), another physician turned Congressman.
  • Rep. Bruce Braley (D-IA), with a farming background, expresses shock and disgust at the FDA-reported conditions at Wright County Egg and promotes the new food-safety bill. Despite a large, historical consumption of eggs by his family and fellow Iowans, he denies throwing eggs at Halloween, when questioned by another Subcommittee member.
  • Rep. Diana DeGette (D-CO) highlights advantages of the pending food-safety bill, which she says would facilitate the FDA's investigation of food contamination.
  • Rep. Donna Christensen (D-Virgin Islands) also touts the advantages of the pending food-safety bill.
  • Rep. Edward Markey (D-MA) rhymes "eggs over easy" with "should not make you queasy" and likens the reported conditions at Wright County Egg with those described in Sinclair Lewis's The Jungle. He then chastises Senate Republicans, and specifically Coburn, for stalling the pending food-safety bill. Generally he incorporates way too many groan-inducing egg-related phrases (eg, "egg shells," "hard boiled") into his scolding opening statement.
  • Burgess objects to defend Senator Coburn and identifies Senator Harry Reid (D-NV) as blocking the food-safety bill, although the objection is not entered into the record, under the direction of Subcommittee Chairman Rep. Bart Stupak (D-MI).

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The first testifying panel is sworn in and seated.

  • 30-year-old Californian Sarah Lewis describes her experience of being infected recently with Salmonella enteritidis, which necessitated 2 hospitalizations and resulted in a Clostridium difficile infection (due to antibiotic treatment). She presumably acquired S. enteritidis, as did her sister, by eating a dessert custard at a graduation banquet in May. The custard was made with unpasteurized eggs. She reports that her family owns a retail butcher shop and later describes how the butcher shop is regulated by state and county authorities (although the meat in the shop is USDA inspected). This aspect of her history is used by the Subcommittee to highlight her familiarity with the food business, the importance of food-industry standards, and the benefits of food regulations.
  • 77-year-old Coloradan Carol Lobato describes her "septic shock" after eating at an upscale game restaurant in June (later revealed to be The Fort in Morrison, CO). Treated for rheumatoid arthritis, Lobato developed salmonella septicemia. The FDA identified the eggs in the "rattlesnake cake" [!] appetizer that she and others ate at the restaurant as the source of her illness. The DNA fingerprint of bacteria isolated from Lobato matched that of S. enteritidis cultured from Wright County Egg. Lobato reveals that she grew up on an Iowa farm, an experience that included the raising of "free range" chickens. She urges the Congressional panel to pass food-safety legislation that rewards companies for doing "the right thing" and punishes those that don't.
  • Stupak asks the salmonella victims to review the photos of conditions at Wright County Egg, which are included in a binder in front of them. Lobato calls the photos "deplorable." Lewis calls the photos "appalling."
  • After gently questioning the victims, Burgess attempts to enter a statement defending Senator Coburn, which results in a contentious exchange between Burgess and Stupak.
  • While Braley questions the victims, background squabbling (presumably between Burgess and Stupak) is heard. Braley later cites a salmonella outbreak associated with duck eggs in the 1920s and 30s, which prompted (he claims) Americans to switch to the consumption of chicken eggs.
  • Rep. Bob Latta (R-OH) asks Lobato to explain rattlesnake cake (sort of like a crab cake, it turns out). The contaminated raw egg that Lobato ate was likely contained in the sauce or "relish" that was served with the cake.
  • When questioning the salmonella victims, DeGette implies that current, pending "bipartison" legislation would facilitate the tracing of the origin of food-borne illnesses and necessary recalls.

The panel is dismissed. 

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  • Burgess asks Stupak for 30 seconds of time (presumably to read his defense of Senator Coburn), and Stupak denies Burgess the time. Burgess complains that Stupak silenced his mike and calls this act "censorship." Stupak chides Burgess for trying to "backdoor" his defense of Coburn. Stupak ultimately calls the next panel of witnessess, including the DeCosters.

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  • Three of the 4 panel members, including Austin "Jack" DeCoster, owner of Wright County Egg, name their counsel.
  • Jack DeCoster reads his opening statement. The beginning of his statement is interrupted by 2 banner-waving protestors, who chant on their escorted way out of the hearing room, "All eggs kill." Jack's statement does not appear to stray appreciably from his written testimony submitted to the Subcommittee.
  • Peter DeCoster, son of Jack, defends the managment and oversight of Wright County Egg, particularly as it relates to the control of "SE." He implicates meat and bone meal as the source of S. enteritidis in his eggs.
  • Orland Bethel, president of Hillandale Farms of Iowa, does not have an opening statement.
  • In his opening statement, Duane Mangskau, production representative of Hillandale Farms, expresses "shock" at the FDA allegation that 7 people acquired salmonella from their eggs after eating at a Mexican restaurant.
  • Stupak asks Bethel about an August 21st e-mail from Mangskau. Bethel takes the Fifth. Stupak then questions Jack DeCoster about why this outbreak occurred, if he cleaned up his operations as stated. DeCoster senior appears slightly stunned or confused when attempting to explain a photo of dead chickens in his laying facility. Peter interrupts in an attempt to answer this and other questions directed to his father. Peter claims that piled-up manure at Wright County Egg, which is shown in a photograph pushing out a large access door, was cleaned up the day that the photo was taken.
  • Burgess questions Bethel about an e-mail in which Bethel allegedly expressed a desire to dissociate from the DeCosters' operations. Bethel "respectively" declines to answer the question. Burgess then asks Peter DeCoster when and why he started testing for S. enteritidis, although it is not required by law. Burgess also asks DeCoster junior to explain what he did to address the positive S. enteritidis results. Peter cites vaccinations and methods to control molting.
  • Stupak dismisses Bethel from the panel.
  • Waxman asks DeCoster senior about his 30-year problem with S. enteritidis-infected eggs, including in Maine and Maryland. Waxman asks DeCoster to reconcile his claim of cleaning up his operations with the recent FDA-inspection report. "Does this sound like a clean facility to you?" Waxman asks. Again Peter attempts to intercept the question, but to no avail. DeCoster senior cites hiring some kind of fly and/or rodent expert more than 1 year ago. Waxman suggests that the DeCosters may want to fire this so-called expert. Peter DeCoster attempts to explain "excaped" chickens at his facilties. Waxman attempts to redirect DeCoster to explain how they've cleaned up their facilities. Peter objects that he's not being given enough time to respond to Waxman's questions. Waxman then asks Jack to respond, who begins to explain (in rambling fashion) what some company supervisor does to inspect and clean the hen houses each day. Waxman interrupts (because his time is nearly up) and expresses outrage that the DeCosters are attempting to implicate the bone-meal feed as the source of the S. enteritidis, given the FDA-documented conditions of their facilities.
  • Latta asks Peter DeCoster about his manure-management plan and any inspections conducted by the state's Department of Natural Resources (DNR). Peter explains a manure-removal procedure of every other year ("we was going with," he explains) to every year.
  • Braley asks the panel to respond to how this egg recall has adversely affected the industry and the livelihood of egg producers. They all respond that they feel bad. Iowan Braley also wants to know from Jack why the DeCoster name is appearing again in another recall of S. enteritidis-infected eggs. Jack rambles on about what he remembers from a Maryland-based egg recall years ago and chews up Bailey's time.
  • Rep. John Dingell (D-MI), who's 7 years older than Jack DeCoster and appears 7 times as sharp, grills Peter on the FDA-reported conditions at the DeCoster facilities. Dingell also asks Peter to describe the steps that are being taken to improve conditions at his egg farms. In his responses, Peter divulges that the family also leases hog facilities.
  • DeGette makes the point that DeCosters' facilities and the Peanut Corp. of America, both of which have been implicated in recent salmonella outbreaks, were inspected by a third-party auditor, AIB, and received "superior" ratings right before the outbreaks. Peter informs DeGette that AIB's inspection was of DeCosters' processing facilities, not their hen houses.
  • Rep. Mike Doyle (D-PA) asks Mangskau to clarify the relationship between Hillendale and Wright County and to explain what Hillendale is doing to ensure the safety of its eggs. Mangskau explains that Hillendale will no longer take chickens from Wright County and reiterates that Hillendale has severed its marketing relationship with Wright County.

The panel is dismissed.

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  • The third panel consists solely of Joshua Sharfstein, Principal Deputy Commissioner of the FDA. Sharfstein explains the FDA's recommendations for reducing the risk of egg-borne salmonella outbreaks and events of its most recent trace-back investigation, which led to Wright County and Hillendale. Sharfstein cites "significant" problems with pest control, manure management, and cross contamination at the DeCosters' facilities. He also implicates multiple probable sources of S. enteritidis contamination at Wright County Egg. He promotes new food-safety legislation, which would "strengthen" FDA's enforcement and recall capacities.
  • Stupak explains the "Final Rule" of the Egg Safety Action Plan, implemented in July 2009, that applies to egg farms with more than 3000 hens. Sharfstein explains that the Egg Safety Action Plan should improve the safety of eggs.
  • Burgess, through his questioning of Sharfstein, clarifies that the FDA wasn't prohibited from inspecting egg facilities, but that the new rule now provides standards by which the FDA can inspect egg facilities. Burgess also asks why communication between the USDA (which was grading DeCosters' eggs) and the FDA was apparently lacking. Burgess tries to identify what's new in the pending bill, other than the ability to mandate recalls. Burgess also stresses the fact that the bill won't necessarily improve communication between the 2 government agencies. Sharfstein says that there will be "enhanced" criminal penalties under the new bill. Sharfstein looks confused when Burgess asks about the difference between external and internal S. enteritidis contamination of eggs.
  • Waxman asks Sharstein to explain how the "Egg Rule" will improve the safety of eggs. Sharfstein explains that the Egg Rule provides certain standards or benchmarks for FDA inspections. Also new legislation will aid the FDA in its food inspections, Sharfstein argues, and provide the agency with mandatory-recall powers and stronger "teeth" with respect to civil and criminal penalities. Sharfstein concludes, "We need this bill," to prevent another salmonella outbreak.
  • Under questioning from DeGette, Sharfstein stresses that the FDA "does not agree with this conclusion" that the source of S. enteritidis at Wright County Egg is the chicken feed, as maintained by the DeCosters. DeGette also helps Sharfstein promote the "trace-back" provisions of the new bill.
  • Braley maintains that the cost of the new food-safety bill, which he implies would reduce hospitalizations and fatalities, would be borne by food manufacturers.
  • Under questioning from Markey, Sharfstein says that FDA will use information from OSHA and the USDA to prioritize inspections of the highest-risk facilities. Sharfstein clarifies that new legislation will give the FDA of new "tools" to fortify its inspections.

The Subcommittee meeting is adjourned by Stupak.

Vaccine.jpg
Another study showing that thimerosalthe ethylmercury-containing vaccine preservativedoes not increase the risk of autism hardly seems necessary. For the rational majority, who are inclined to believe the results of credibly authored reports, there are at least 5 studies that fail to show a link between pre- or postnatal exposure to thimerosal and poor neuropsychologic outcomes or autism. (Moreover autism rates continue to rise despite the removal of thimerosal from childhood vaccines in 1999.) For the small group of irrational and very vocal citizens who maintain a causal connection between thimerosal and autism, no amount of negative data appears sufficient.

Nevertheless the results of a new case-control study, published in Pediatrics, are now available. And not only do they deny an increased risk of autism with thimerosal exposure (either in utero or later); they actually indicate that postnatal exposure to thimerosal significantly reduces the risk of autismby about 40%. The authors (perhaps wisely) avoided speculating as to the reason for the reduced risk, however.

The case-control data were collected from children* enrolled continuously in 3 managed care organizations that participate in the CDC's Vaccine Safety Datalink. The study methods are distinctive in that the authors, in addition to mining electronic databases and medical charts, validated autism diagnoses in person and conducted parent interviews.

* 256 with autism spectrum disorder and 752 controls matched for birth year, sex, and MCO.