[NVIC] Grassley Staffer Investigating Pharma Mugged

[Guest guest]

E-NEWS FROM THE NATIONAL VACCINE INFORMATION CENTER

Vienna, Virginia http://www.nvic.org

* * * * * * * * * * * * * * * * * * * * * * *

UNITED WAY/COMBINED FEDERAL CAMPAIGN

#8122

* * * * * * * * * * * * * * * * * * * * * * *

" Protecting the health and informed consent rights of children since 1982. "

============================================================================

==============

BL Fisher Note:

A staff member of Sen. Grassley, who has been investigating the

pharmaceutical industry and the regulation of Pharma by federal health

agencies, was mugged last week in front of her home. The FBI is

investigating. Learn about Grassley's investigation and the assault below.

http://quote.bloomberg.com/apps/news?pid=10000103 & sid=aa2RNxq6faeA & refer=new

s_index

Bloomberg

Grassley Demands Answers on Safety of U.S. Experimental Drugs

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 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 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 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 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 , 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 &

.

To contact the reporters on this story:

Hallam in Washington khallam@...

http://www.thehill.com/thehill/export/TheHill/News/Frontpage/110805/news1.ht

ml

THE HILL

November 9, 2005

FBI called in on Hill

By Bob Cusack and Jackie Kucinich

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.

=============================================

News@... is a free service of the National Vaccine Information

Center and is supported through membership donations. Learn more about

vaccines, diseases and how to protect your informed consent rights

http://www.nvic.org

Become a member and support NVIC's work

https://www.nvic.org/making%20cash%20donations.htm

To sign up for a free e-mail subscription http://www.nvic.org/emaillist.htm