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Drug, Food Risks Stay Secret as Inquiries to U.S. FDA Pile Up


Drug, Food Risks Stay Secret as Inquiries to U.S. FDA Pile Up
By Justin Blum

June 19 (Bloomberg) -- Claudia Krcmarik can't get documents about her father-in-law's death during a medical study. Meryl Nass keeps asking for records she thinks will show an anthrax vaccine is dangerous. The American Bakers Association's request for a paper on the safety of imported honey has languished.

All filed public information requests with the U.S. Food and Drug Administration at least four years ago and have yet to receive what they asked for -- even though American law says agencies must release records ``promptly.''

The FDA's 20,365 unfilled requests for information exceed the totals for the departments of Defense and Justice. One company, FOI Services Inc., accounts for 44 percent of the backlog, according to the agency. Researchers, consumer groups and individuals say the delays limit their ability to alert the public to food and drug dangers and to hold the FDA accountable.

``It is important information that we need to tell this story,'' said Krcmarik, of Ann Arbor, Michigan, who wants to know how her father-in-law was given an overdose in an FDA- regulated clinical trial before he died in 2002. ``That information should be available, and it should be timely. What we wanted to avoid is this happening to anyone else.''

The FDA's oversight of food and drug safety has come under criticism by advocacy groups and lawmakers. They say the agency failed to act effectively before Vioxx, a Merck & Co. painkiller, was withdrawn in 2004 because of a link to heart attacks and strokes and didn't alert the public more recently to heart risks associated with GlaxoSmithKline Plc's diabetes drug Avandia. They also fault the FDA for failing to prevent contamination of peanut butter, spinach and pet food.

Freedom of Information Act

U.S. agencies are required to provide access to documents under the Freedom of Information Act, a law passed in 1966 to increase accountability. When President Lyndon B. Johnson signed the measure, he said in a statement: ``A democracy works best when the people have all the information that the security of the Nation permits.''

Requests to the FDA, which regulates food, drugs and medical devices, can involve life-and-death matters, including reports of deadly effects from medications and studies used to justify the safety or effectiveness of products cleared for sale.

Backlogs of requests at U.S. agencies have grown in recent years, and lawmakers have criticized the government for failing to provide documents promptly. The number of requests at the FDA exceeds the backlog of 18,216 at the Defense Department and 8,004 at the Justice Department at the end of fiscal 2006, the most recent data available.

Backlog Increases

The FDA's total of 20,365 on a day last month when the agency provided data was up from 19,948 at the end of the 2006 fiscal year and 13,626 at the end of fiscal 2000, according to the FDA's Web site. The most recent figure included 1,924 that are more than three years old.

To determine the effect of the FDA's backlog, Bloomberg News filed a Freedom of Information Act request with the agency last November for copies of the longest-pending inquiries. The FDA responded in April.

The requests for documents came from drugmakers, such as Pfizer Inc. and Merck & Co., consumer advocacy groups, individuals and, most of all, from FOI Services.

The closely held company built a business out of obtaining agency documents and reselling them. In the process, it ``inundates the agency with workload,'' said Fred Sadler, head of the FDA office that handles the public inquiries.

FOI Services, of Gaithersburg, Maryland, says on its Web site that it has collected more than 150,000 FDA documents, amassing what it bills as the ``World's Largest Private Library of FDA-Related Documents & Reports.''

`Aggregating Requests'

The company seeks material for customers, mostly drug and medical-device companies that don't want their identities revealed because they may be seeking information about a competitor's product, said Marlene Bobka, vice president of FOI.

FOI Services, founded by lawyers whose clients sought information from the FDA, also requests documents to post on its Web site on speculation that the information will attract buyers.

``What we're doing really is aggregating requests from industry,'' Bobka said. Without her company, the FDA ``would still get these requests. They would just come from different firms,'' she said.

It's impossible to assess independently whether FOI Services has made the FDA's backlog worse than it would be otherwise, and Sadler said he isn't sure.

$50.95 for a $5.40 Document

The company won't reveal its profit on documents. A two- page report on an FDA inspection from 2002 sells for $50.95 on the FOI Services Web site. The FDA billed the company $5.40 to process and provide the document, according to Sadler.

As the FDA's backlog has increased, the agency has cut back the number of workers handling requests. The equivalent of 88 full-time staffers worked on filings last year, down from 123 in fiscal year 1995, according to Sadler. During that time, the number of new requests has decreased as the FDA has posted more free information on its Web site.
The backlog ``suggests that maybe we need to put some more resources into'' handling the requests for documents, Sadler said in an interview. An FDA spokeswoman, Julie Zawisza, said in an e-mail that the agency has limited money and must ``divvy it out as conscientiously as we can.''

Pfizer, Merck, Public Citizen

Among requests that FDA records showed as pending for more than four years, New York-based Pfizer sought all inspection reports for a plant in Puerto Rico. Merck, of Whitehouse Station, New Jersey, requested documents on thimerosal, a preservative containing mercury that is used in vaccines.

Public Citizen, a Washington-based public-interest organization, sought information on the dangers of various drugs.

The Freedom of Information Act generally requires federal agencies to determine within 20 days whether to provide requested information or to decline on the basis of exceptions such as national security or to avoid revealing trade secrets. No deadline is set for producing documents, although the law says agencies must make the records ``promptly available.''

The FDA's backlog includes requests that were filed as long ago as 2000. The agency says it generally processes requests in the order received. Some divisions in the agency have bigger backlogs than others, resulting in longer waits. Some cases also take longer because they're more complicated and may require extensive searching and removal of confidential information, Sadler said.

The average number of unfulfilled requests has increased across 26 federal agencies tracked by the Coalition of Journalists for Open Government, a group in Arlington, Virginia, that advocates access to government records. Reporters from news organizations, including Bloomberg News, are among those whose requests the FDA hasn't fulfilled.

Year-End Backlog

The coalition compared the year-end backlog of requests with the number processed during the year. For fiscal 2005, the most recent data available, the backlog at 26 agencies equaled 31 percent of the requests. Applying the same calculation to the FDA, which wasn't included in the tally, the ratio was 94 percent, according to data on the FDA's Web site.
Krcmarik, the Michigan woman seeking information on her father-in-law's death, has been waiting since February 2003 for documents. Cyril Krcmarik, the father-in-law, died in 2002 at a veterans hospital in Detroit while being treated for prostate cancer as part of a research study. Over less than a month, he was given a nine-month supply of a steroid for side effects of chemotherapy.

Family Lawsuit

Claudia Krcmarik, who works for a drugmaker, sought the documents from the FDA for a lawsuit against the U.S. Veterans Affairs Department that the family later settled. She still wants the paperwork made public.

``If there's any information that could help other people know as consumers what they're getting into, then that information should be available,'' she said.

Nass, a doctor in Bar Harbor, Maine, said she has treated patients who suffered harmful side effects from the anthrax vaccine. She requested documents from the FDA that she said will show the product's dangers and that the agency never should have cleared it for use.
She first asked for records in 2001 and sent a follow-up request in 2003. Most of the documents she needs haven't been turned over, Nass said.

`Protecting the Agency'

``Clearly, protecting the agency and previous agency decisions is much more important to the FDA than providing the public information that would allow it to make an independent decision about the safety and efficacy of licensed drugs,'' said Nass, who served as a consultant on litigation brought by members of the military against the Defense Department for requiring anthrax vaccinations.

The FDA doesn't withhold information to protect its decisions from criticism, agency spokeswoman Zawisza said.

The maker of the vaccine, Emergent BioSolutions Inc. of Rockville, Maryland, stands by the product's safety. ``Not a single death has been documented to have resulted from receipt of anthrax vaccine,'' company spokesman Robert Burrows wrote in an e-mail.

Lee Sanders, a senior vice president with the American Bakers Association, requested FDA documents on imported honey in 2002. The Washington-based association wanted to know about a pesticide in honey imported from China, she said in an interview.

``You would hope that those types of requests would be handled in a more expeditious way,'' she said.

To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net .