November 9, 2005

FBI Investigating Attack on Senate Staffer

This week Emilia DiSanto, top staffer for Senator Chuck Grassley (R-Iowa), was attacked in front of her home by a large, masked man wielding a baseball bat. The police are investigating it as an attempted murder. The FBI is looking into the possibility that the attack was work related and perpetrated by someone who did not like the Senator's "aggressive oversight of the public and private sector". The FDA and Big Pharma are among those in Grassley's cross hairs for not being vigilant enough with product safety.

I hate to think things have actually gotten that ugly, but thought it was something to keep an eye on.

Thanks to researcher Teresa Binstock putting these articles together.

FBI called in on Hill
By Bob Cusack and Jackie Kucinich
November 8, 2005

The FBI and Capitol Police are investigating the vicious attack of a top Senate staffer at her home last week amid concerns that the assault might be related to her work on the Finance Committee.

Emilia DiSanto, chief investigator for committee Chairman Chuck Grassley (R-Iowa), arrived at her suburban Virginia home after work Wednesday about 6:30 p.m. As she was unloading belongings from her car, a 6-foot-1-inch white man dressed in black struck her repeatedly with an unidentified object believed to be a baseball bat.

After she screamed to her family inside the house, the assailant fled. DiSanto was transported to Inova Fair Oaks Hospital, where she was treated for significant upper-body injuries. Nine staples were needed to close her head wound.

DiSanto, who declined to comment, has reported back to work.

The attack and the possibility that it was motivated by congressional business have made some people anxious on Capitol Hill.

"This is of obvious concern to anyone working here," a Senate staffer said. "It’s very disconcerting when you worry about someone resorting to violence. This could be intimidation, and you wonder whether it’s safe to do your job."

The attack on DiSanto came two days before a bomb threat caused alarm at an Iowa veterans home where Grassley was scheduled to appear.

According to the Iowa Times Republican, an anonymous caller told a switchboard operator Friday that a bomb would detonate in the center’s cemetery shortly before 1 p.m. The threat was not in the area where Grassley was scheduled to appear and later was deemed a false alarm. Grassley made the visit to the center as planned.

No evidence has surfaced that definitively points to DiSanto’s work on the Finance Committee as the trigger for the attack, but sources say there are a number of clues that suggest it could be.

The assailant was trying to hide his identity, wearing a hood and black gloves. He also did not make any demands before attacking the 49-year-old staffer. A working assumption among investigators is that he was waiting for her to arrive home.

Sources say acts of violence in DiSanto’s neighborhood are rare.

Grassley is known for his aggressive oversight of the public and private sector. Over the past year, he has scrutinized healthcare fraud, organ-donation procedures used by hospitals, drug-safety matters and the use of nonprofit groups related to former lobbyist Jack Abramoff.

In her line of work, DiSanto "doesn’t make a lot of friends," an aide said.

Grassley spokeswoman Jill Kozeny said federal and local law-enforcement officials have not ruled out the possibility that the attack was work-related. She said Grassley and DiSanto have discussed the incident.

The only reason why the FBI is involved is because the assault may have been work-related.

There is no indication that the bomb threat and the DiSanto event are related.

Fairfax County police are treating the attack as an attempted homicide.

Some Senate staffers said Capitol Police did not initially treat the attack as work-related late last week.

"We don’t do law enforcement, but that one was a really hard one to swallow," a Senate aide said.

Capitol Police said they were deferring to Fairfax County police, who are taking the lead on the probe.

In response to the attack, Ken Cunningham, Grassley’s chief of staff, sent an e-mail to Grassley employees urging them to report any suspicious activity or incidents to the Senate sergeant at arms. Cunningham noted in the e-mail that Grassley had asked the FBI to investigate.

Grassley is one of Capitol Hill’s most vocal critics of the FBI.

Capitol Police Chief Terrence Gainer said the unit is looking at the possible relationship between the attack on DiSanto and her position at the Capitol.

"I think all the agents involved are looking into the motive," he added.

Gainer said three agencies conferred Friday and yesterday to discuss the ongoing investigation.

An FBI spokeswoman confirmed the agency is looking into the attack.

Senate aides say they have been rattled by the incident, and some have taken extra precautions after hearing of it.

DiSanto has worked on the Hill for more than a decade. In July 2000, she was identified by Fortune magazine as one of the "Power 30" in Washington as the staff director for then-Senate Small Business Committee Chairman Kit Bond (R-Mo.). She also worked for the House Committee on Economic and Educational Opportunities in the mid 1990s.

Grassley Demands Answers on Safety of U.S. Experimental Drugs
by Kristen Hallam

Nov. 9 (Bloomberg) -- The head of the U.S. Senate committee that oversees the Medicare and Medicaid health insurance programs is demanding to know whether the government is doing enough to ensure safety during clinical trials of experimental drugs.

Citing what he called an "alarming" report by Bloomberg News, Senate Finance Committee Chairman Charles Grassley said federal agencies responsible for the drug trials owe the American people a better accounting of how the testing is conducted.

A report in the December issue of Bloomberg Markets magazine found conflicts of interest and lax oversight in the drug-testing industry. Over the past 14 years, the article said, private companies have largely taken over the job of conducting studies on experimental treatments, supplanting universities. Scores of people have died or been injured, the article said.

"Not only is this treatment of participating patients and their families alarming, but it also undermines the credibility of the pharmaceutical research and development process and places the value of new pharmaceutical products in question," Grassley, an Iowa Republican, wrote in a letter to the Health and Human Services Department's inspector general.

Grassley said Inspector General Daniel Levinson should quickly compile a list of recommendations his office has made since 1995 and determine whether the appropriate agencies are heeding them. The agencies include HHS, the Food and Drug Administration and the National Institutes of Health.

"We must take every possible step to ensure that our clinical trial system is in fact the 'gold standard' that we expect it to be," Grassley said. He asked for a briefing by Levinson's staff "at the earliest opportunity."

Tightening the Rules

Grassley said Levinson's office should examine the role of so-called institutional review boards that oversee the tests, with an eye toward adopting tougher oversight. The largest, Western Institutional Review Board of Olympia, Washington, is a for-profit company that oversees 17,000 trials.

Don White, a spokesman for Levinson, declined to say whether his boss has received the letter. "We are aware of Chairman Grassley's great interest in this area," White said. "We've obviously done work on this before and already have work plans for the future."

While Grassley's committee doesn't have direct jurisdiction over the FDA, he said its oversight of Medicare and Medicaid makes him responsible for ensuring medicines are safe. Grassley last year began an investigation of the FDA's handling of drug- safety issues after the withdrawal of Merck & Co.'s Vioxx painkiller.

Industry-Sponsored Tests

University medical faculties conducted 80 percent of industry-sponsored drug tests in 1991, according to the New England Journal of Medicine. Today, more than 75 percent of trials are done in doctors' offices or private test centers such as those run by SFBC International Inc., according to CenterWatch, a Boston-based compiler of clinical trial data.

In many cases, the people who volunteer for the drug trials are no longer protected by review boards at universities and now must rely on for-profit review boards. Drugmakers pay for both the private testers and the boards monitoring the trials, raising a potential conflict of interest, Grassley said.

Citing the Bloomberg article, Grassley wrote that test participants aren't always adequately warned of the risks.

"Some are dying as a result of the trials," Grassley said.

In Houston, the Fabre Research Clinic has been reviewed by an oversight company set up by Louis Fabre, the owner of the clinic. In Miami, SFBC International, which runs the largest private testing center in North America, has used a review company owned by the wife of an SFBC executive.

Shares of Miami-based SFBC dropped 26 percent after the Bloomberg report was published Nov. 2.

'Distortion of Our Work'

SFBC Chairman Lisa Krinsky said last week the report was a ``severe distortion of our work.'' She said the company complies with all regulatory standards and never has been issued a warning letter by the FDA.

A day after the Bloomberg report was published, Grassley said the FDA must do more to oversee clinical trials. In response to his comments, the FDA said last week in a statement that the agency ``is evolving our approach to clinical trial oversight. The protection of patients' rights is a fundamental focus.''

FDA spokeswoman Julie Zawisza yesterday declined to comment on Grassley's letter, saying she hasn't seen it.

"We do take very seriously our responsibility to protect people involved in clinical trials," she said.

The FDA also said it is examining its reporting rules and the other issues raised by the article.

Laboratory Rats

Because experiments on laboratory rats can't reliably predict how a chemical will affect people, human testing of new drugs is vital. Helped by extensive clinical trials, drugmakers have developed antibiotics capable of curing life-threatening infections and come up with revolutionary treatments for diseases like cancer and AIDS over the years.

"The vast majority of clinical trials conducted in the United States meet high ethical standards," the Pharmaceutical Research and Manufacturers of America, a Washington-based trade group, said last week in a written response to questions. "The U.S. regulatory system is the world's gold standard, and the Food and Drug Administration has the best product-safety record."

Ken Johnson, senior vice president for the trade group, said it would be inappropriate to provide detailed comments until the group reviews the practices in question.

"That review is now under way,'' he said. ``We are confident that our member companies are committed to conducting all clinical trials to the highest ethical standards."

The organization's members include Pfizer Inc., Merck & Co. and Johnson &

To contact the reporters on this story: Kristen Hallam in Washington

Philadelphia Inquirer Examines Grassley Investigations of FDA, Pharmaceutical Industry
July 6, 2005

The Philadelphia Inquirer on Sunday examined how Senate Finance Committee Chair Chuck Grassley (R-Iowa) "has increasingly turned his spotlight on [FDA] and the global pharmaceutical industry."

According to the Inquirer, Grassley has said that pharmaceutical companies and FDA moved too slowly to address safety problems of some drugs, including COX-2 inhibitors and antidepressants, in order to protect senior officials at the agency and possibly industry profits. His "investigators have swarmed over the FDA," and the finance committee "has become a favorite stop for agency whistleblowers," the Inquirer reports.

Grassley said, "If it looks like I am going after the pharmaceutical industry, it is probably because the FDA is not doing its job of faithfully executing the laws and carrying out their function of making sure that drugs are safe and effective." He added, "I guess it all comes down to making sure that Medicaid and Medicare dollars are spent on safe drugs."

Grassley ranks 30th in Congress in receiving campaign contributions from the pharmaceutical and biotechnology industries. He said those contributions are made to support his positions on low taxes and pro-business policy (Mondics, Philadelphia Inquirer, 7/3).

Sen. Grassley Calls for Investigation Into Reports That Drug Researchers Sold Early Drug Data to Wall Street Firms, USA
August 10, 2005

Senate Finance Committee Chair Chuck Grassley (R-Iowa) on Monday sent a letter to US Attorney General Alberto Gonzales urging the Department of Justice to investigate whether doctors participating in clinical trials are selling confidential information to stock analysts and investors, the New York Times reports.

Grassley also sent the letter to Securities and Exchange Commission Chair Christopher Cox, whose agency already is examining possible insider trading involving the approval of prescription drugs...

Update: Apparently Liberty Post thinks that the oil companies are behind the hit, while Kos believes that this is the Republican party eating itself.

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