FRIDAY, MAY 28, 2010
KLMNO
POLITICS THE NATION
&
DIGEST
Drugmaker accused of hiding recall
Maker of children’s medicine tried to buy back defective Motrin
by Lyndsey Layton
NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION VIAGETTY IMAGES
A satellite image shows Hurricane Katrina in the Gulf of Mexico in August 2005, a year that brought a record 28 named Atlantic storms.
Video on the forecast is at
washingtonpost.com/nation.
ATLANTIC COAST
23 named storms in hurricane forecast
Federal weather experts pre-
dicted Thursday a busy hurricane season this year, with the possibil- ity of as many as 23 named storms, 14 hurricanes and seven major hurricanes (storms with winds of 111 mph or higher). Last year saw only three hurri- canes. The 2005 season was the busiest on record, with 28 named storms, including Hurricane Ka- trina, which wrecked New Or- leans. The season starts Tuesday and ends Nov. 30. “We’re facing a season that
could rank among the more active on record,” said National Oceanic and Atmospheric Administration Administrator Jane Lubchenco, The National Hurricane Center will begin issuing warnings and watches for tropical storms and hurricanes hours earlier than in prior years, Lubchenco said at the National Press Club. Lubchenco and Federal Emer-
gency Management Agency Ad- ministrator Craig Fugate suggest- ed that summer storms could help disperse the oil slicks in the Gulf of Mexico. “The high winds and seas will mix and weather the oil, which can help accelerate the natural biodegradtion process,” she said.
—Michael E. Ruane
Army changes enlistment pro-
cedure: The Army will no longer simply accept discharge papers as proof of prior military service, a spokesman said Thursday. Now recruiters must also seek to verify the documents. The change comes after a reservist apparently faked a background as a Marine
and received the rank of sergeant.
Conn. smoker wins $8 million
award: A Connecticut woman who developed larynx cancer af- ter smoking Salem cigarettes for more than 25 years has won $8 million in a lawsuit against a to- bacco company, the first such jury verdict in New England, her attor- ney said Thursday. David Golub, attorney for Barbara Izzarelli of Norwich, said that a judge will de- cide additional punitive damages next month, which could bring the award to $24 million. A spokesman for R.J. Reynolds said the company was disappointed and plans to appeal.
Kansas doctor admits knowing
patients overdosed: A Kansas doctor accused of illegally pre- scribing drugs linked to 68 deaths testified Thursday that he knew that some patients had died from overdoses, but he said his clinic changed its practices to prevent them. Stephen Schneider and his wife, Linda, are charged in a 34- count indictment with illegally prescribing drugs and commit- ting health-care fraud and money laundering.
Somali diplomat concerned about Tex. terror alert: A Somali
diplomat said Thursday he is con- cerned that a member of a terror- ist group from his country may be trying to get to Texas through Mexico, but he urged American authorities “to be careful who is bad and good in this new alarm.” The Department of Homeland Se- curity has asked law enforcement in Houston to be on the lookout for a suspected member of the al- Shabaab group, an al-Qaeda ally based in Somalia.
—From News Services
The company at the center of a massive recall of children’s Tyle- nol and other popular over-the- counter products tried to per- form a “phantom recall” of defec- tive Motrin by sending contrac- tors around the country to buy up the medicine from stores without alerting regulators or the public, according to the chairman of a Congressional committee investigating the
“It is a moral outrage for a company specifically marketing its products for children to allow a culture of neglect and irrespon- sibility to taint the medicines that parents and physicians trust to help children get well,” said Rep. Darrell Issa (Calif.), the committee’s ranking Republican, who displayed a bottle of Chil- dren’s Tylenol at his seat. The FDA, which is investigat-
ing McNeil’s three production fa- cilities in the United States and is considering criminal prosecu- tions, found multiple violations of good manufacturing practices atMcNeil’s largest facility in Fort Washington, Pa., according to FDA officials. The company
for any child in the U.S. was re- mote,” said Sharfstein, a father of young children who said he had several of the affected medicines at home. “From what we know, we don’t have evidence of chil- dren who had serious problems because of quality problems.” Colleen Goggins, a senior exec-
utive at Johnson and Johnson, told the committee that as a re- sult of the problems, six senior executives were removed from their jobs, a consultant is helping redesign McNeil’s manufactur- ing processes, and production at the Fort Washington plant will not restart until the company and the FDA are certain that im- provements have been made.
at an “extraordinary” meeting between FDA officials and senior executives at Johnson and John- son, Sharfstein said. “We went over the heads at McNeil to talk to the corporate parent,” he said. Rep. Edolphus Towns (D-N.Y.), chairman of the committee, fo- cused on what he called the “phantom recall” in which McNeil’s contractors tried to qui- etly remove defective Motrin from stores in 2009. “I find this very disturbing,” he said. Goggins said the company had no intention of hiding a defective product. She said it hired a con- tractor to take a statistical sam- ple of the amount of the affected Motrin IB in stores, so the com-
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McNeil Consumer Healthcare’s plan was discovered after a contractor sent to buy up the bad Motrin dropped an instruction sheet in a store.
company.
When faced last year with Mo-
trin IB caplets that were not dis- solving properly, McNeil Con- sumer Healthcare, a division of Johnson and Johnson, hired con- tractors to buy the products un- der orders not to mention the term “recall,” according to docu- ments released by the House Committee on Oversight and Government Reform. After the Food and Drug Ad-
ministration discovered the ef- fort — because one of the con- tractors accidentally dropped an instruction sheet on the floor of a store — McNeil announced a re- call of roughly 88,000 packages of the product. It became the first of four re- calls of McNeil products in the past year, including the April 30 recall of 136 million bottles of in- fant and children’s Tylenol, Mo- trin, Benadryl and Zyrtec, which have shaken consumers’ confi- dence and threaten to stain Johnson and Johnson’s brand name.
stopped production at that facil- ity in April just days before FDA officials conducted a two-week inspection that resulted in the re- call of more than 40 varieties of the medicines for infants and children. It remains closed. The recalled medicine may contain extra dosages of active ingredients and tiny particles that the FDA has identified as in- cluding nickel, chromium and cellulose. Some of the medicines also contained an ingredient that came from a master lot that was contaminated with a bacterium known as B. cepacia, according to the FDA. The FDA has collected 775 re-
ports of children and infants who experienced an adverse reaction after taking one of the recalled medicines, including 37 deaths. But Joshua M. Sharfstein, a pe-
diatrician and deputy FDA com- missioner, said the illnesses and deaths appear to be side effects of the medicine and not related to its quality. “Our experts believe the risk
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“I apologize to mothers, fa- thers and caregivers for the con- cern and inconvenience caused by the recall,” Goggins said. “We will work hard to earn back your confidence.” Sharfstein described how reg-
ulators grew increasingly con- cerned over the past year about McNeil’s multiple recalls, its fail- ure to adhere to its own quality standards, and its tardiness in fixing problems, responding to complaints and notifying federal regulators as required. “As man- ufacturing problems go, there were serious problems,” he said. It came to a head in February
pany could decide whether to conduct a recall. But she could not answer further questions. “I can’t tell you right now what they were instructed to do or not, sir,” Goggins said. Allan Coukell, a pharmacist and director of the Pew Prescrip- tion Project, which is aimed at improving drug safety, said after the hearing that he’d never heard of a “phantom recall.” “It’s fairly shocking — the idea
that if there was a quality prob- lem, they’d try to bring the prod- uct back instead of being trans- parent,” he said.
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