Used to treat rheumatoid arthritis, the four drugs leave patients vulnerable to fungal infectionsWASHINGTON (AP) -- The Food and Drug Administration ordered stronger warnings Thursday on four medications widely used to treat rheumatoid arthritis and other serious illnesses, saying they can raise the risk of possibly fatal fungal infections.

The drugs -- Enbrel, Remicade, Humira and Cimzia -- work by suppressing the immune system to keep it from attacking the body. For patients with rheumatoid arthritis, the treatment provides relief from swollen and painful joints, but it's "a double-edged sword," said the FDA's Dr. Jeffrey Siegel. That's because the drugs also lower the body's defenses to various kinds of infections.

Siegel, who heads the office that oversees arthritis drugs, said the FDA became concerned after discovering information that doctors appeared to be overlooking a particular kind of fungal infection called histoplasmosis. Of 240 cases of the infection reported to the FDA, a total of 45 patients died -- about 20 percent.

The infection, which mimics the flu, is prevalent in much of the middle part of the country. It can have particularly grave consequences if it isn't caught early and spreads beyond the respiratory system to other organs of the body.

Siegel said the investigation began with a single case of a woman taking one of the drugs who died of histoplasmosis. Delving into the case, doctors at the FDA found that the woman had been sick with the fungal infection for a long time. "This case led us to be concerned that there may be other situations in which physicians may not recognize histoplasmosis," said Siegel.

FDA officials searched the agency's database and found the 240 cases of patients taking the medications who had also developed the fungal infection. Of those, at least 21 appeared to involve a late diagnosis. And 12 of these patients -- more than half -- ultimately died.

Siegel said the FDA's order Thursday means that the risk of histoplasmosis will be flagged in a "black box," the strongest warning information in a drug's prescribing literature. The four medications already have black box warnings about the risk of infections, but the language varies from drug to drug.

Patients will be alerted to call their doctors if they develop persistent fever, cough, shortness of breath or fatigue, which can be signs of the fungal infection.

And the FDA is also urging doctors to consider aggressive use of antifungal drugs in patients who develop such symptoms, even if the infection has not been confirmed by a laboratory test. Siegel said such a decision should not be taken lightly, since antifungal drugs can also have dangerous side effects. Doctors should also consider stopping treatment with the immune-suppressing drugs, he said.

The four drugs belong to a class known as TNF-alpha blockers, and are also used to treat Crohn's disease, juvenile arthritis, certain types of psoriasis, and other conditions. Three of the drugs, Enbrel, Humira and Remicade, are considered blockbusters, with sales of over $1 billion annually for each. Cimzia is newer and less widely used. All are delivered by injection.Copyright 2008 The Associated Press. All rights reserved.This material may not be published, broadcast, rewritten, or redistributed.

posted on: September 03, 2008 | about stocks: IAT / ITYC / KBE / KRE / RKH    

The Current Population Survey (CPS) is a monthly survey of households conducted by the Bureau of Census for the Bureau of Labor Statistics. It provides a comprehensive body of data on the: labor force, employment, unemployment and persons not in the labor force.

CPS News Releases

Government IT
By Roy Mark
2008-08-06

The Secret Service claims AdSurfDaily is a massive Internet-based wire fraud scheme. The alleged scam entices investors by promising huge returns if they invest and enroll in a paid autosurf program. Bloggers rally and rip into the government action.

The online pitch goes something like this: Invest in our paid autosurf program and earn a 125-150 percent return for every dollar invested. All the investor has to do is surf a few Web sites each day. At least that's what Thomas A. Bowdoin and his AdSurfDaily.com site claims.

Sound too good to be true? That's exactly what the U.S. Secret Service thinks, and on Aug. 1 the agency seized approximately $53 million in funds and two homes as part of an investigation into what federal authorities claim is a "massive Internet-based wire fraud scheme."

According to a complaint filed in the U.S. District Court for the District of Columbia, the scheme involves ASD (AdSurfDaily.com) generating advertising revenue by automatically rotating advertised Web sites into its investors' Internet browsers.

Since ASD creates no significant new wealth by selling advertising to purchasers outside of its investor-members, authorities claim ASD is a classic Ponzi scheme, using money from new investors to pay off earlier investors before the whole thing collapses.

Federal prosecutors and the Secret Service raided ASD's Quincy, Fla., headquarters Aug. 1, seizing the $53 million. In court documents filed Aug. 4, the Secret Service claims that the money and Bowdoin's homes in Quincy and Myrtle Beach, S.C., are forfeitable to the United States government.

Neither Bowdoin nor anyone else connected to ASD has been criminally charged in the investigation, although the seizure of Bowdoin's funds makes it difficult for ASD to do business for the time being.

The court complaint says ASD masked its Ponzi scheme ambitions by calling its investors "advertisers," their investments "ad purchases" and the ASD payments to investors "rebates." However, according to the complaint, ASD did not operate as a seller of advertising services and there was no legitimate product being sold to support the profits ASD promised to pay its investors for relinquishing their funds. 

While the Secret Service was mum on the investigation, bloggers were not.

"I truly believe Andy set this company up to be legal. He is a proven ethical businessman," wrote Ginger from Tennessee on Tallahassee's WCTV Web site. Quincy is located just outside Tallahassee, and the station covered the raids on Bowdoin's home and office.

Another post to the site claimed, "Just because the feds take civil action against someone does not mean the allegations are true, and this is one … such case. This company had only the best intentions, shared the wealth with all involved, and were working with their legal team to ensure government compliance on all laws."

But the Internet & Affiliate Marketing News blog carried this post: "First of all, they are a classic Ponzi scheme because money is being paid out from new members investing to the old members who already earned their credits and are ready to cash out. This scam is growing fast and there are more and more people cashing out, so they need more new members to cover all the payouts."

Government IT
By Roy Mark
2008-09-03

Once touted the as centerpiece of the National Counterterrorism Center's efforts to upgrade the government's terrorist watch list, Railhead program floundering after contractor turf battles over using an Oracle relational database or an Extensible Markup Language model. House Science and Technology Committee's Investigations and Oversight Subcommittee also faults program management and oversight by National Counterterrorism Center officials. Rep. Brad Miller calls Railhead on the brink of collapse after a $500 million investment of taxpayer dollars.

The U.S. House of Representatives is investigating what it calls the technical failure and mismanagement of one of the government's top counterterrorism programs. Dubbed "Railhead," the program was intended to upgrade the U.S. terrorist watch list and improve the integration of U.S. terrorist intelligence from the nation's 16 separate intelligence agencies.

Located at the NCTC (National Counterterrorism Center) in Northern Virginia, the Railhead program was the highly touted centerpiece of the NCTC's counterterrorism programs. The House Science and Technology Committee's Investigations and Oversight Subcommittee, though, claims the program is on the "brink of collapse" after an estimated $500 million in taxpayer funding.

According to the investigative panel, the majority of more than 800 private contractors from dozens of companies working on Railhead have been laid off and NCTC officials have "drastically curtailed" the program.

"The program not only can't connect the dots, it can't find the dots," Subcommittee Chairman Brad Miller, D-N.C., said Aug. 21. "This is a critical national security program that has been plagued by technical design and development errors, basic management blunders and poor government oversight."

The original plan for Railhead called for it to update and enhance the NCTC's terrorist intelligence database called TIDE (Terrorist Identities Datamart Environment) that provides the backbone of the FBI's consolidated terrorist watch list. Originally designed by Lockheed Martin in the aftermath of the 9-11 terrorist attacks, TIDE is built in Oracle as a relational database.

"This original database, however, suffers from basic design, management and maintenance inefficiencies and problems," states a Subcommittee memo on the Railhead program. "For instance, only about 60 percent of the data, including names and addresses, mentioned in CIA cables provided to NCTC are actually extracted from these messages and placed in the TIDE database."

As private contractors and government employees modified the program, TIDE was further hamstrung by dozens of tables or categories for identical fields of information that significantly limits search functions. In addition, TIDE uses SQL, which the Subcommittee calls a "cumbersome computer code," to query the tables, rows and columns of the database.

"Without a detailed index of the data stored in each table in TIDE, the SQL search engine is blindfolded, unable to locate or identify undocumented data," the memo states. Although the original Railhead design team suggested building a new database in Oracle, Railhead government program managers decided to move forward with the XML model.

A June program "gap analysis" by SRI International found serious shortcomings in the Railhead program.

"The ability to search e-mail and discussion threads, and the ability to search for images and attachments will be absent," the report states. "Advanced search capabilities such as selecting a timeframe for FININTEL [Finished Intelligence] searches and allowing Boolean keyword searches of results will be absent."

The report concluded, "Without these major functions, the system will not fulfill its information sharing mission for the counterterrorism community."

Miller said even if the program is abandoned, he wants an investigation into what happened with Railhead.

"The problems on the Railhead program appear to be depressingly similar to programs on other major IT initiatives which have resulted in schedule delays, increased financial costs and ultimately failure on some projects," Miller wrote to Edward Maquire, Inspector General of the Office of the Director of National Intelligence, on Aug. 21. "Turf battles among contractors, particularly between the design and development team, have hampered the sharing of critical technical data that has impaired the success of the Railhead program."