NEWARK, N.J. – State regulators on Friday temporarily suspended the medical license of a doctor who health officials suspect is linked to a hepatitis B outbreak.
Nearly 3,000 of Dr. Parvez Dara's patients have been warned to get tested after five cancer patients tested positive for the disease, which is transmitted through exposure to infected blood and can cause serious liver damage.
On Friday, the state presented evidence about the conditions at the oncologist's Toms River office. Investigators said they found blood on the floor of a room where chemotherapy was administered, blood in a bin where blood vials were stored, open medication vials and unsterile saline and gauze.
Inspectors also cited problems with cross-contamination of pens, refrigerators and countertops; use of contaminated gloves; and misuse of antiseptics, among other health code violations.
"This was not a one-time episode," Deputy Attorney General Siobhen Krier told regulators. "This is a case of egregious, bad medical judgment displayed over a long period of time."
A special committee of the state Board of Medical Examiners issued the suspension, effective immediately, on an emergency basis. The full board will consider whether to continue the suspension on Wednesday.
During the hearing Friday, Krier said Dara had a history of health code violations dating to 2002 and posed "a clear and imminent danger to the public."
Since 2002, Dara has paid nearly $56,000 in fines for infection control health code violations, court records show.
Dara said he only used sterile supplies and equipment and took steps correct the violations. He questioned whether the patients may have contracted the disease some other way, such as from a hospital or from surgery, and suggested some may have been latent carriers — meaning they had the virus but it was dormant — until they began receiving chemotherapy, which can suppress the body's immune system.
"It's not that rare," Dara said.
In making its decision, the committee said Dara showed "a significant and gross deficiency in judgment" and that that could not be remedied by changing office practices.
"Dr. Dara's own testimony has not persuaded the committee that he has an appreciation for the gravity of multiple breaches of basic infection control practices," the committee said in its order to suspend Dara's license.
Dara did express sympathy for his patients: "This is hurting them so much more than it's hurting me."
A March 28 letter was sent to his patients warning them of the risk and suggesting they be tested for the liver diseases hepatitis B and hepatitis C and for HIV, the virus that causes AIDS.
Dara, originally from Pakistan, has been practicing at his Toms River office for 23 years. He estimated that he sees between 45 and 60 patients a day, with about a dozen receiving chemotherapy each day.
His attorney, Robert Conroy, argued to the board that there was no direct evidence the hepatitis cases were linked to Dara's office. He characterized the state's investigation as sloppy and said the fact that the outbreak investigation is ongoing should have precluded regulators from drawing any conclusions.
Conroy said Dara plans to immediately appeal the decision.
Minggu, 05 April 2009
Doctor in hepatitis B case has license suspended
Kraft Foods offers salmonella timeline
FRESNO, Calif. – Kraft Foods Inc., the company whose testing led to the nationwide pistachio recall, said Friday it first heard there was salmonella in its trail mix in late 2007, but could not trace the possible source to tainted nuts from California until two weeks ago.
Workers at one of Kraft's manufacturers in Illinois turned up a contaminated batch of fruits and nuts in December 2007. Then, in September of last year, another positive sample appeared.
Only after thousands of tests could the company pinpoint the source for the second positive test as California-based Setton Pistachio of Terra Bella, Inc., said Kraft spokeswoman Susan Davison.
Last week, the food products giant recalled or destroyed all suspect foods, and notified its suppliers and the Food and Drug Administration, which on Monday issued a sweeping national warning against eating the nuts.
"If we did detect salmonella, of course we would never ship our products," Davison said. "We conducted extensive testing of all our food, and we were just unable to zero in until March that pistachios were the root cause."
On Friday, Lee Cohen, a production manager for Setton's sister company in New York, said Kraft did not tell Setton until recently that they had detected salmonella-tainted pistachios last year. The company later retracted his statement without explanation.
Setton, the second-largest pistachio processor in the nation, sells its nuts to Kraft and 35 other wholesalers across the country, which use them in everything from ice cream to cake mixes. As FDA officials scour its records and swab its factory, the plant has temporarily shut down after recalling more than 2 million pounds of nuts.
No pistachio-related illnesses have been reported.
Also Friday, the FDA sent out a letter to the pistachio industry reminding nut processors to follow good manufacturing practices to protect consumers, something food safety experts called welcome guidance.
Dr. David Acheson, FDA's assistant commissioner for food safety, said Kraft first told the administration about the problems last week.
Neither federal nor state laws require food manufacturers to test the safety of their products or to report any findings of contamination, though many do if they plan to recall a product, Acheson said.
"If they find problems in a product prior to shipment, they'll pull it back and destroy it," Acheson said. "I wouldn't call that a good manufacturing practice, but that is clearly a good public health practice."
Kraft finally determined pistachios caused last year's problem in March, when their manufacturer in Illinois detected salmonella for the third time — this time in the nuts, the only common ingredient between the second and third batch of trail mix, Davison said. Kraft has not traced the source for the first positive salmonella test in 2007.
Salmonella, the most common cause of food-borne illness, causes diarrhea, fever and cramps. Most people recover, but the infection can be life-threatening for children, the elderly and people with weakened immune systems.
Roasting is supposed to kill the bacteria in nuts, but problems can occur if the roasting is not done correctly or if roasted nuts are re-contaminated. That can happen if mice, rats or birds get into the facility.
Setton Pistachio officials suspect the roasted pistachios sold to Kraft Foods may have become mixed at the plant with raw nuts that could have contained traces of the bacteria.
Cohen, the production official at Setton International Foods Inc. in Commack, N.Y., said Friday that Setton Pistacio's internal tests had detected salmonella on some of its raw pistachios in the past, but said all tainted pistachios were later roasted. He did not specify when those tests were performed.
"We have found salmonella on raw pistachios, but that doesn't mean anything because those nuts are coming straight from the orchards where you could have had a very small localized contamination from birds," Cohen said. "Those nuts never hit the marketplace."
More than a dozen other companies that got their nuts from the California plant have recalled their pistachio products this week for fear of possible contamination. On Friday, Setton International announced it was also voluntarily recalling about 118,000 pounds of pistachio products.
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CDC: Rocket fuel chemical found in baby formula
ATLANTA – Traces of a chemical used in rocket fuel were found in samples of powdered baby formula, and could exceed what's considered a safe dose for adults if mixed with water also contaminated with the ingredient, a government study has found.
The study by scientists at the U.S. Centers for Disease Control and Prevention looked for the chemical, perchlorate, in different brands of powdered baby formula. It was published last month, but the Environmental Working Group — a Washington, D.C.-based advocacy organization — issued a press release Thursday drawing attention to it.
The chemical has turned up in several cities' drinking water supplies. It can occur naturally, but most perchlorate contamination has been tied to defense and aerospace sites.
No tests have ever shown the chemical caused health problems, but scientists have said significant amounts of perchlorate can affect thyroid function. The thyroid helps set the body's metabolism. Thyroid problems can impact fetal and infant brain development.
However, the extent of the risk is hard to assess. The government requires that formula contain iodine, which counteracts perchlorate's effects. The size of the infant and how much formula they consume are other factors that can influence risk.
The U.S. Food and Drug Administration, aware of the debate over perchlorate in food and water, has not recommended that people alter their diet or eating habits because of the chemical.
The study itself sheds little light on how dangerous the perchlorate in baby formula is. "This wasn't a study of health effects," said Dr. Joshua Schier, one of the authors.
The largest amounts of the chemical were in formulas derived from cow's milk, the study said.
The researchers would not disclose the brands of formula they studied. Only a few samples were studied, so it's hard to know if the perchlorate levels would be found in all containers of those brands, a CDC spokesman said.
"This study provides no data on potential health effects of perchlorate. Health authorities continue to emphasize that infant formula is safe," said Haley Curtis Stevens of the International Formula Council, which represent formula manufacturers.
Earlier this year, the U.S. Environmental Protection Agency said it was considering setting new limits on the amount of perchlorate that would be acceptable in drinking water. A few states have already set their own limits.
The agency issued a statement Friday saying perchlorate exposure is a serious issue and "a top priority" for EPA Administrator Lisa Jackson. EPA officials expect to announce a decision soon about future steps in dealing with the chemical.
The EPA has checked nearly 4,000 public water supplies serving 10,000 people or more. About 160 of the water systems had detectable levels of perchlorate, and 31 had levels high enough to exceed a new safety level the EPA is considering.
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CDC: http://www.cdc.gov/
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