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 &
Johnson.
To contact the reporters on this story: Kristen Hallam in Washington khallam@bloomberg.net
Philadelphia Inquirer Examines Grassley Investigations of FDA, Pharmaceutical Industry
http://www.medicalnewstoday.com
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
http://www.medicalnewstoday.com
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...
When my Dear Daughter's supervisor showed me this letter from one of her other clients, I immediately wanted to share it with all of you. I was amazed at how articulate this boy is and his depth of thought on the topic.
He is 9 years old, nonverbal, and diagnosed with severe autism. He just began using a Facilitated Communication device recently. The question my dd's supervisor posed was "What does autism mean to you." Here is his reply. I have typed his words verbatim. I have not altered his sentence structure or thoughts at all.
"What do I think autism means. To me it means not to be able to fully connect with myself. I can not control some of the things I say or do. I feel at times out of control. Other times I feel scared of what others may think. I have all my life had to prove to people that I am really intelligent and kind. Huge amount of people have finally believed in me. The toughest part of being autistic is the silly thoughts that go through your head. People don't understand what I am thinking of. It's frustrating. Autism is not easy to define to somebody who isn't but, the easiest way to put it into words would be probably disconnection from yourself and others. People are now understanding that it more prevalent. There needs to be more research on infants while in the tummy. I know there is some clues there. As to why there is autism. I'm just happy to be alive and healthy. I'm just lucky to have my family and friends. Having them helps me cope with life. I'm very lucky."
When my daughter's supervisor asked him if she could share this letter with others so that they could understand what it's like to have autism, he typed the following response:
"Yes. Yes please. I want others to know. I think it's important for people to know. I'm really proud of my paper. I worked really hard on it. Thank you."
I was blown away by the complexity of mind that this boy displayed. I taught typical 9-10 year olds in 4th grade for 5 years and this level of thought is rare indeed.
I hope you enjoyed it as much as I did.
Shelly and Natalie (3 and we have high hopes!)
Vaccine Additive Linked to Autism
By Douglas Fischer, STAFF WRITER
A mercury-laced preservative once widely added to pediatric vaccines exposes infants' brains to twice the neurotoxin previously suspected, offering evidence that health guidelines may underestimate the risk newborns face, researchers say in a report being published today.
The additive, thimerosal, has been used in vaccines since the 1930s and is almost 50 percent mercury by weight. Since 2001, manufacturers have gradually phased it out of almost all domestic pediatric vaccines, though it remains in use overseas in cheaper "multidose" vaccines.
The study, being published today in Environmental Health Perspectives, a peer-reviewed publication of the National Institutes of Health, also chides health officials for abandoning an earlier recommendation that the preservative be completely phased out and further studies conducted.
And it fuels the debate over the federal government's aggressive vaccination plan that subjects infants to a battery of shots some of which contain aluminum and other potentially harmful compounds in their first weeks of life.
"We're talking about a low-level delivery of a toxin given to a baby on the first day of its life," said mercury expert Boyd Haley, chairman of the chemistry department at the University of Kentucky, who was not involved in the study.
"What's needed is a total study of the sensibility of the vaccine program. Why would you want to vaccinate a baby on the first day of its life?"
The report is one of the first to look beyond mercury blood levels resulting from vaccines. Instead it examines both the amount and type of mercury reaching the brain. It suggests health officials examined the wrong compound and failed to look far enough when assessing the danger of mercury in thimerosal.
This is largely a past concern for the United States, given the predominance today of thimerosal-free vaccines. Both the study's lead author and the Centers for Disease Control and Prevention on Wednesday urged parents to have their children vaccinated.
"That's the first message," said Thomas Burbacher, lead author and associate professor in the Department of Environmental and Occupational Health Sciences at the University of Washington's School of Public Health.
"The bottom line is that trying to assess the effects of acompound with very little or no data is not a good thing to do. ... Unfortunately, we started doing studies on this compound way too late. Basic information like this should've been available decades ago."
The problem is very much alive for developing nations, however, where the additive is common. The World Health Organization has expressed interest in Burbacher's research.
The problem, Burbacher said, is that regulators trying to assess thimerosal's harm used as a benchmark methylmercury, a widely studied compound, rather than the little-known compound called ethylmercury in thimerosal. Both compounds cross the blood- brain barrier. But methylmercury breaks down slowly, whereas ethylmercury dissipates fairly rapidly, suggesting to regulators that a standard based on methylmercury would adequately protect infants.
Burbacher and colleagues found ethylmercury's fast breakdown leaves higher levels of so-called "inorganic" mercury in the brain. Inorganic mercury lingers in the brain for a year or more, potentially altering certain cells. A previous study has shown such damaged cells are also found in children with autism. Using monkeys, Burbacher found the brains of thimerosal-exposed infants had twice as much inorganic mercury as methylmercury- exposed infants.
The Food and Drug Administration has never required testing of thimerosal's safety or of its safe exposure levels for newborns and children. Although high mercury levels particularly as a result of vaccinations have long been suspected as a leading cause of skyrocketing autism levels, the CDC and Burbacher cautioned Wednesday against drawing any conclusion linking the two.
"To date, the vast majority of the science doesn't support an association between thimerosal and incidences of autism," said CDC spokesman Glen Nowak. But "at the end of the day, we still don't know what causes autism." Others, however, expect such links to become apparent as thimerosal fades from use in the United States. Already, noted Haley, California's autism rates have decreased three of the past four quarters a first. "There's something in the vaccines doing it. That something is thimerosal."
The FDA's Web site on thimerosal and vaccinations, including a chart showing common pediatric vaccines and the date thimerosal was eliminated, can be found at http:// www.fda.gov/cber/vaccine/thimerosal.htm. Contact Douglas Fischer at dfischer@angnewspapers.com.
Burr's bill would make vaccines risky
In response to
"Burr steps into the spotlight" (Oct. 22):
Every parent should be concerned by Sen. Richard Burr's fast-tracked drug development bill.
If the vaccine industry is accountable to absolutely no one, how can we ensure that
profit won't stand in the way of safety?
We cannot allow the pharmaceutical industry's fear tactics to steal a basic right of our children: the right to go to court after being harmed.
Burr's bill is a slap in the face to families who believe their autistic children were damaged by thimerosal in vaccines.
The threat to children from vaccines produced without accountability far exceeds the threat from bioterrorism. If our government won't protect them, who will?
Kelly and Matt Langston
Autism survivors speak in L.B.
By Kevin Butler, Staff writer
LONG BEACH — Hundreds of people attending an autism conference on Friday heard from parents who say that various treatments greatly reduced, or eliminated, their autistic children's symptoms.
The three-day "Defeat Autism Now!" conference, organized by a San Diego think tank, The Autism Research Institute, featured parents saying their autistic children dramatically improved, thanks to dietary regimens, behavioral therapy and various medications.
Not all researchers believe that all the touted remedies have been scientifically demonstrated.
About 10 children whose parents say have recovered from the condition were interviewed on-stage in front of a large audience at The Westin Long Beach.
Stan Kurtz said he and his wife were devastated when they learned their young son Ethan had autism.
"It's life-changing," he said. "You lose your child. Â… and you have to rebuild. You have to see what's really going on."
Ethan, now 4 years old, didn't speak and often just stared out the window, Kurtz said.
Now his son's symptoms have largely gone away, thanks to a combination of drugs and dietary changes, said Kurtz, a Tarzana resident.
Kurtz on Friday asked his son to describe his favorite book, "Charlotte's Web."
Speaking of the main character, a
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pig called Wilbur, Ethan Kurtz smiled and said, "He was a baby, and then he grew up."
Cindy Goldenberg said until her son started a drug treatment when he was 3 years old, he wouldn't speak, make eye contact or play appropriately.
At around age 3, her son Garrett now 16 years old started receiving infusions of a protein used to treat immune deficiencies, she said. She said his symptoms were gone by the time he was 5 years old.
"I feel like I not only got a miracle, but I got a second chance," said Goldenberg, a Laguna Niguel resident.
Goldenberg, like some other parents at the conference, subscribes to the controversial theory that her child's condition was linked to a vaccine used to ward off measles, mumps and rubella.
The U.S. Centers for Disease Control and Prevention, however, has stated that "the weight of the evidence indicates that vaccines are not associated with autism."
