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E-mails show he was worried about lost sales, disregarded salmonella tests

WASHINGTON – The owner of a peanut company urged his workers to ship tainted products after receiving test results identifying salmonella, according to internal company e-mails disclosed Wednesday by a House committee.

The company e-mails obtained by the House panel showed that Peanut Corp. of America owner Stewart Parnell ordered the shipments tainted with the bacteria because he was worried about lost sales.

Parnell was ordered by subpoena to appear before Congress on Wednesday to discuss the outbreak that has led to 600 illnesses, eight deaths and one of the largest recalls in history, more than 1,800 products pulled. His Georgia plant is blamed for the outbreak.  Rep. Greg Walden, R-Ore., revealed the internal correspondence from the company during a House Energy and Commerce hearing.

In prepared testimony, a laboratory owner told the House panel that the peanut company’s disregard for tests identifying salmonella in its product is “virtually unheard of” in the nation’s food industry and should prompt efforts to increase federal oversight of product safety.

Charles Deibel, president of Deibel Laboratories Inc., said his company was among those that tested Peanut Corp. of America’s products and notified the Georgia plant that salmonella was found in some of its peanut stock. Peanut Corp. sold the products anyway, according to a Food and Drug Administration inspection report.

“It is not unusual for Deibel Labs or other food testing laboratories to find that samples clients submit do test positive for salmonella and other pathogens, nor is it unusual that clients request that samples be retested,” Deibel said in prepared testimony to a House subcommittee. “What is virtually unheard of is for an entity to disregard those results and place potentially contaminated products into the stream of commerce.”

Deibel said he hopes the crisis leads to a greater role for FDA in overseeing food safety and providing more guidance to food makers.  Lawmakers want to hear from Parnell, who was ordered by subpoena to appear Wednesday before the House Energy and Commerce’s oversight subcommittee.

The investigation is starting to zero in on the question of who was responsible.

“Hopefully, people are going to be held accountable,” said Rep. Bart Stupak, D-Mich., chairman of the committee’s investigations panel.  Stupak says he wants know how Peanut Corp. managed to sell allegedly tainted goods month after month without triggering action by state and federal health authorities.

The company, now under FBI investigation, makes only about 1 percent of U.S. peanut products. But its ingredients are used by dozens of other food companies.

Federal law forbids producing or shipping foods under conditions that could harm consumers’ health.

Peanut Corp.’s troubles mounted this week as the FBI raided corporate headquarters in Lynchburg, Va., as well as the Georgia plant. On Monday night, the company closed a second facility, in Plainview, Texas, after test results earlier in the day indicated salmonella was present in samples taken at the Texas plant. None of the products had been distributed to consumers, but the finding raised the prospect of a broader recall.

Further testing is needed to confirm the results, said Doug McBride, spokesman for the Texas Department of State Health Services.  After the results came back Monday, the FDA sent inspectors back to the Texas plant to check more thoroughly for signs of problems similar to those found at the Georgia plant, which has been identified as the source of the salmonella outbreak.

The company has said it is still investigating what happened and has expressed regret and concern for people who became ill. It is not clear whether Parnell will testify Wednesday or assert his constitutional right to not answer questions that may incriminate him.

LOS ANGELES – The fertility doctor who helped a California woman have 14 children, including octuplets born last month, is now facing a state investigation on top of harsh criticism from medical ethicists.

The Medical Board of California did not identify the doctor who helped Nadya Suleman, 33, of Whittier, become pregnant with the six boys and two girls born on Jan. 26. Suleman has six other children.  “We’re looking into the matter to see if we can substantiate if there was a violation of the standard of care,” board spokeswoman Candis Cohen said Friday. She did not elaborate.

Suleman, a divorced single mother, told NBC’s “Today” show that the same fertility specialist provided in vitro fertilization for all 14 children using sperm donated by a friend.

In the interview broadcast Friday, Suleman also said six embryos were implanted for each of her pregnancies. In her latest, two of Suleman’s embryos split, resulting in two sets of twins among the octuplets.

When asked why so many embryos were implanted, Suleman said: “Those are my children, and that’s what was available and I used them. So, I took a risk. It’s a gamble. It always is.”

In the United States, there is no law dictating the number of embryos that can be placed in a mother’s womb. Doctors say the norm is to implant two or three embryos, at most, in women Suleman’s age.

“The revelation about one center treating her makes the treatment even harder to understand,” said Arthur Caplan, bioethics chairman at the University of Pennsylvania. “They went ahead when she had six kids, knowing that she was a single mom … and put embryos into her anyway.”

Suleman’s infants were born prematurely and are expected to remain in the hospital for several more weeks. Her six other children are between ages 2 and 7.

Suleman said she had never been on welfare and would find a way to get by with the help of family, friends and her church. She said she planned to return to school in the fall.

The births have raised questions about how the woman will be able to care for all of her children. Los Angeles County child welfare spokesman Stu Riskin said the agency doesn’t respond unless there has been a complaint, and such complaints are confidential.

“All I wanted was children. I wanted to be a mom. That’s all I ever wanted in my life,” Suleman said in the portion of the interview that aired Friday. “I love my children.”

She said she struggled for seven years before finally giving birth to her first child.

According to state documents, Suleman told a doctor she had three miscarriages. Another doctor disputed that number, saying she had two ectopic pregnancies, a dangerous condition in which a fertilized egg implants somewhere other than in the uterus.

The state documents describe Suleman becoming pregnant with her first child after a 1999 injury during a riot at a state mental hospital where she worked. Suleman feared she would lose the child and sunk into an intense depression, according to a psychological evaluation in her workers’ compensation case.

“When you have a history of miscarriages, you think it will take a miracle,” she told Dr. Dennis Nehamen. “I just wanted to die. I suspected I was pregnant but I thought, ‘That’s ridiculous.’”

But the 2001 birth of the baby “helped my spirits,” Suleman said.

More than 300 pages of documents were disclosed to The Associated Press following a public records request to the state Division of Workers’ Compensation. Among other things, they reveal that Suleman collected more than $165,000 in disability payments between 2002 and 2008 for the work injury, which she said left her in near-constant pain and helped end her marriage.

Consumers asked to return items for full refund; no illnesses reported

NEW YORK – Sears Holdings Corp. said Friday its Kmart stores were voluntarily recalling some Super Kmart bakery goods due to the risk of salmonella.

Sears said it learned some granulated peanut products supplied by Hickory Harvey Foods to Super Kmarts may have been made at a plant possibly contaminated by salmonella.

Kmart is not aware of any reports of illness linked to these products. The baked goods should not be eaten and can be returned for a full refund.

They include a single layer peanut butter cake, a single layer caramel apple cake, individual filled and variety doughnuts, individual regular doughnuts and “Mix or Match” 12-count doughnuts.

A salmonella outbreak blamed on the Peanut Corp. of America has sickened at least 575 people in 43 states. At least eight have died. More than 1,300 foods that used ingredients from the company’s processing plant in Blakely, Georgia, have been recalled. While the outbreak appears to be slowing down, new illnesses are still being reported.

Salmonella is the nation’s leading cause of food poisoning; common symptoms include diarrhea, fever and abdominal cramps.

First medication of its kind cleared to treat rare protein disorder

WASHINGTON – The Food and Drug Administration made history Friday as it approved the first drug made with materials from genetically engineered animals, clearing the way for a new class of medical therapies.

GTC Biotherapeutics said regulators cleared its drug ATryn, which is manufactured using milk from goats that have been scientifically altered to produce extra antithrombin, a protein that acts as a natural blood thinner.  The drug’s approval may be the first step toward new kinds of medications made not from chemicals, but from living organisms altered by scientists. Similar drugs could be available in the next few years for a range of human ailments, including hemophilia.

The FDA cleared the drug to treat patients with a rare hereditary disorder that causes a deficiency of the protein, putting them at higher risk of deadly blood clots. The injectable treatment will be marketed in the U.S. by Deerfield, Ill.-based Ovation Pharmaceuticals

About 1 in 5,000 people don’t produce enough antithrombin protein, according to Framingham, Mass.-based based GTC. As a result, their blood is more likely to stick together, occasionally causing clots that can travel to the lungs or brain, causing death. Pregnant women with the disorder are at higher risk of miscarriage or stillbirth, because of blood clots in the placenta.

Patients with hereditary anithrombin deficiency are currently prescribed conventional blood thinners, like Plavix from Bristol-Myers Squibb and Sanofi-Aventis. That will not change with the new approval. ATryn is only approved for use when patients are undergoing surgery or having a baby, times when the risk of dangerous clots is particularly high. Those patients would receive the drug by intravenous infusion for a limited time before and after their procedures.

Not clones

To make the drug, scientists at GTC put DNA for the human antithrombin protein into single cell embryos of goats. Goat embryos with the gene were then inserted into the wombs of surrogate mothers who gave birth to baby goats that produce the protein-charged milk.

Genetically engineered animals are not clones but rather animals that have had their DNA changed to produce a desirable characteristic. Amid growing questions about the technology, the FDA last month issued guidelines for how it will regulate products made from genetically altered animals.

FDA said it will not allow any such products to be sold without first submitting them to scrutiny by independent advisers at a public meeting. The agency’s panel of blood product experts recently concluded ATryn was safe and effective.

But consumer groups said the FDA’s long-awaited policy will not require all genetically engineered foods to be labeled as such. And they said the government has not done enough to examine the potential impact of genetically engineered animals on the environment, particularly if some escape and begin to mate with animals in nature.

The drug received European approval in 2006.