Thursday, February 26, 2009

FDA Ignored Debris in Syringes

FDA ignored debris in syringes

Complaints of filth came in 2005; plant's microbiologist was a teenage dropout

Sarah Avery and Sabine Vollme

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Months before an Angier company shipped deadly bacteria-tainted drugs, the federal Food and Drug Administration received numerous complaints about sediment and debris in the medicine.

The FDA received reports about AM2PAT as early as 2005, but not until December 2007 did the agency issue recall notices to pull the drugs off the market.

AM2PAT, which is now the subject of a criminal investigation, sold tainted syringes of heparin and saline that have been linked to five deaths. At least 100 more people were sickened, often after receiving the medicines during chemotherapy, kidney dialysis and other intravenous procedures.

Two men pleaded guilty in U.S. District Court this week for their roles in the scheme, which involved falsifying documents to make it appear that proper sterility tests had been conducted. The company’s president, Dushyant Patel, faces 10 charges, but he has not been arrested. Authorities believe he fled to his native India.

Conditions at the plant, detailed in court documents and photographs, depict a facility in flagrant violation of proper manufacturing processes. Prosecutor Jason Cowley said the company’s “chief microbiologist” was a teenager who dropped out of high school. A key piece of laboratory equipment designed to catch evidence of contamination was broken, and another gauge was out of commission for a year. The so-called clean room, where air is carefully controlled to reduce the spread of germs, was ventilated with an ordinary room fan.

The U.S. Food and Drug Administration — charged with overseeing more than 10,000 drug-device makers in addition to thousands more pharmaceutical manufacturers, food processing companies and animal-feed plants — received complaints about the company’s saline products the summer before the bacterial infections erupted in December 2007 and January 2008.

Starting in June 2007, doctors and clinics began reporting to the FDA orange specks floating in the syringes. Other complaints noted "wispy debris" or "yellow-orange sediment" that caused the normally clear product to be tan, orange, "muddy" and "dingy brown" in color.

A complaint in 2005 noted food particles inside a heparin syringe.

An FDA spokeswoman. Siobhan DeLancey, said a "non-exhaustive" search of inspection reports indicates the Angier plant was visited six times by FDA inspectors, including May 1999, February 2000, March 2004, June 2005, January 2006 and December 2007. But the company wasn't licensed to do business in North Caroline until 2001, and it's original home was in Raleigh. It didn't get FDA approval to load syringes with heparin until 2003.

Patient advocates said the issues that criminal prosecutors detailed in court documents about the plant were red flags that would have prompted an investigator to shut down the plant.

"If they had done inspections, those people would be alive," said Dr. Ned Feder, a former scientist with the National Institutes of Health who now researches FDA issues at the advocacy group Project On Government Oversight. The plant operators, he said, "were counting on the fact that they were unlikely to be inspected. They were counting on it."

Federal law does not require the FDA to inspect a device plant such as AM2PAT before production starts, said Jeffrey Gibbs, an FDA expert with the Washington law firm of Hyman, Phelps & McNamara, who advises health-care companies.

Although they are supposed to be inspected every two years, plants such as AM2PAT have instead gotten site visits about once every five years, according to a report from the Government Accountability Office. Between 2002 and 2007, FDA inspectors visited only about one-quarter of the 5,616 registered plants per year, the GAO report states.

"The system depends on companies complying with the law," Gibbs said. "If they don’t comply, the FDA is not there double-checking all the time. They can’t. They don’t have the resources."

Patient advocates said the regulatory agency is woefully underfunded and overburdened. Recent scandals involving medicines that cause heart attacks, imported toys full of lead, and contaminated peanut butter have caused a string of embarrassments for the federal agency.

"The FDA is clearly asleep at the switch," said Forest Horne, a medical malpractice lawyer with Martin & Jones in Raleigh.

A few years ago, Horne sued a manufacturer that shipped steroid-filled syringes contaminated with a fungus. Horne’s client died in 2002 after she received an injection from one of the tainted syringes and developed meningitis.

Lacking the funds to prevent harm, the FDA often doesn’t step in until patients start to get sick or doctors complain, Horne said.

In the AM2PAT case, the agency issued recall notices of the heparin and saline in December 2007. Both drugs are used to flush intravenous lines, and people who used the tainted syringes became immediately and dangerously sick. At least five deaths are associated with the drugs, while others suffered irreparable brain damage. Most incurred massive hospital bills.

Many survivors and their families have sued the company, but their prospects for recovering damages may be dim. The company’s insurance carrier has filed court papers indicating it covered liability of only $2 million, and wants AM2PAT to be excluded from paying damages above that amount.

A criminal case was launched last spring after the falsified reports were discovered. The plant manager, Aniruddha Patel, and the quality control director, Ravindra Sharma, were sentenced to 4.5 years in federal prison Monday for their participation. The Indian men, in the United States legally with work visas, said they feared they would lose their jobs and their U.S. residencies if they didn’t go along with Dushyant Patel’s scheme.

The company sold $6.9 million worth of heparin and saline syringes in 2006-07 that did not undergo proper sterility testing.

"This strikes at the fear everyone has when it comes to the medical supplies or medicine," said George Holding, U.S. attorney for the Eastern District of North Carolina, whose office prosecuted the case. "We’re talking about things you need to have confidence in. This raises serious alarms."

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