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

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[sSRI-Research] Bloomberg - Grassley Demands Answers on

Safety of U.S. Experimental Drugs

 

 

 

Three years ago, Dr. Arif Kahn published a metastudy that rocked the

psychiatric profession but didn't rate any space in the popular media

world. It showed that suicides in drug trials were fifty times the

rate in the general population. [--

http://www.ahrp.org/infomail/0902/06.php]

 

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

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

dex#

 

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

 

Last Updated: November 9, 2005 00:03 EST