Senator Grasslety Turns Up the Heat on the FDA!

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SSRI-Research@

Tue, 02 Aug 2005 05:01:44 -0000

[sSRI-Research] [drugawareness] Senator Grasslety Turns Up

the Heat on the FDA!

 

 

Senator Grassley of Iowa, chairman of the Senate Finance Committee,

has continued to keep the pressure on the FDA - pressure which it so

rightly deserves. We applaud his tireless efforts to force the FDA to

disclose critical safety information to the public on all products.

 

Of course we are extremely grateful for his push for disclosure on

antidepressants. But with serotonergic antidepressants and

antipsychotics causing so many heart problems and irregular

heartbeats we need to be just as grateful that he is working to

discover more about these heart defibrillators and pacemakers.

 

And because these drugs also produce so many arthritic pains we need

to be just as grateful for the information on Vioxx and other pain

killers like Bextra, Celebrex, etc.

 

Thank you Senator Grassley and whatever you do, don't back down on

this for a second because all of us at the International Coalition

for Drug Awareness are all behind you one hundred percent!!!!!!

 

Dr. Tracy

______________________

 

Dr. Ann Blake Tracy, Executive Director,

International Coalition For Drug Awareness

www.drugawareness.org

Author of the " Bible on Antidepressants, " Prozac:

Panacea or Pandora? - Our Serotonin Nightmare

& audio " Help! I Can't Get Off My Antidepressant! "

(Order: 800-280-0730)

_________________________

 

 

The Iowa Republican began conducting oversight of the embattled

regulatory agency after concerns surfaced about how it handled the

suicide risks of teenagers using antidepressants and the

cardiovascular risks associated with the painkiller Vioxx.

 

Now Grassley has requested copies of annual post-approval reports for

the models of defibrillators and pacemakers that were the subject of

Guidant safety alerts in recent weeks. These reports, he said, are

not available to the public, even though they might contain important

performance data about the devices.

 

He asked Crawford to explain why these reports are not posted on the

FDA's website, and whether the agency is reconsidering procedures for

surveillance of devices once they're approved and widely available to

the public.

 

In that vein, Grassley and Sen. Christopher Dodd, D-Conn., have

introduced legislation creating a publicly accessible national data

bank of clinical trial information. In addition, the two have

introduced a measure to establish an independent office for drug

safety within the FDA that would regulate drugs once they're on the

market. Both bills are pending.

 

Grassley's efforts have gained support from several consumer groups

including Ralph Nader's Public Citizen, which has battled the FDA for

decades.

 

" The FDA is getting direct cash, over $200 million a year, from

industries [it regulates] and it has a very detrimental effect of the

ability of the FDA to protect the public, " said Dr. Sidney Wolfe,

director of Public Citizen's Health Research Group.

 

 

http://www.startribune.com/stories/535/5533694.html

Guidant may face Senate scrutiny

 

Janet Moore, Star Tribune

July 31, 2005

 

At first blush, it might seem a bit unusual that the chairman of the

Senate Finance Committee has taken a sudden interest in a series of

heart device recalls by Guidant Corp.

 

Though a big-money business, defibrillators and pacemakers hardly

seem the purview of one of Congress' most powerful bodies.

 

But no one in the medical technology industry was terribly surprised

this month when Sen. Charles Grassley asked the Food and Drug

Administration (FDA) for documents relating to the recent recall of

some 150,000 heart defibrillators and pacemakers.

 

As Grassley pointed out in two recent letters to FDA Commissioner

Lester Crawford, his committee has jurisdiction over Medicare and

Medicaid programs, which provides health insurance for more than 80

million Americans and often pays for the sophisticated devices.

 

In the past year, Grassley, 72 and a farmer by trade, has emerged an

ardent critic of the FDA, which regulates the drugs and devices

approved for use in the United States.

 

The Iowa Republican began conducting oversight of the embattled

regulatory agency after concerns surfaced about how it handled the

suicide risks of teenagers using antidepressants and the

cardiovascular risks associated with the painkiller Vioxx.

 

Now Grassley has requested copies of annual post-approval reports for

the models of defibrillators and pacemakers that were the subject of

Guidant safety alerts in recent weeks. These reports, he said, are

not available to the public, even though they might contain important

performance data about the devices.

 

He asked Crawford to explain why these reports are not posted on the

FDA's website, and whether the agency is reconsidering procedures for

surveillance of devices once they're approved and widely available to

the public.

 

Indianapolis-based Guidant, which makes its heart devices in Arden

Hills, came under fire after the death in March of a 21-year-old

Grand Rapids college student, Joshua Oukrop, whose heart condition

was treated in 2001 with one of the company's defibrillators. It was

subsequently revealed that his model of defibrillator had an

electrical flaw that was remedied in 2002 -- action that was

reported to the FDA.

 

However, neither Oukrop nor his doctors were told that he was

implanted with a potentially faulty device until it was too late.

Other physicians and patients were not notified until May of this

year when his doctors went public with their concerns about the

device.

 

The controversy raises questions about when doctors should be told

about device malfunctions, and to what extent. Fred McCoy, president

of Guidant's cardiac rhythm management business, said this week that

it's clear doctors want more information and that the company is more

than willing to provide it.

 

Asked specifically about Grassley's questions for the FDA, McCoy said

in an interview that " Guidant is an open book. We'll follow that

process wherever it leads, it's certainly not something we're

concerned about. "

 

Grassley also asked Crawford to describe the agency's disclosure

policy regarding post-approval documents for devices not only for

defibrillators and pacemakers, but for all devices.

 

The dissemination of post-approval information about drugs and

possible harmful side effects has long concerned the senator. He

declined, through a spokeswoman, to be interviewed.

 

" The job for Congress, the FDA and consumer advocates is to get to

the bottom of drug safety procedures and figure out, once and for

all, what it'll take to make sure Americans can trust what's in our

medicine cabinets, " Grassley said in a speech to the Consumer

Federation of America last March.

 

" Better-informed patients and doctors can make informed decisions

about whether a drug is right for them, " he said.

 

Grassley has also questioned whether the FDA is too cozy with the

pharmaceutical industry, and has called for changes that he says

would bring greater responsiveness and transparency to the agency.

 

In that vein, Grassley and Sen. Christopher Dodd, D-Conn., have

introduced legislation creating a publicly accessible national data

bank of clinical trial information. In addition, the two have

introduced a measure to establish an independent office for drug

safety within the FDA that would regulate drugs once they're on the

market. Both bills are pending.

 

Grassley's efforts have gained support from several consumer groups

including Ralph Nader's Public Citizen, which has battled the FDA for

decades.

 

" The FDA is getting direct cash, over $200 million a year, from

industries [it regulates] and it has a very detrimental effect of the

ability of the FDA to protect the public, " said Dr. Sidney Wolfe,

director of Public Citizen's Health Research Group.

 

Whether Grassley's recent request for device-related documents will

result in committee hearings or legislation is unclear at this point.

His spokeswoman said a decision about whether hearings will be

held " will be made as the process unfolds. "

 

Wolfe supports the idea of a public forum to discuss these

issues. " I'm sure there are a lot more things that the FDA knows or

that the company knows about the Guidant or many of these other

disasters that would only come out if there's a public hearing where

pointed questions were asked and the people answering them fearing

perjury if they lied or gave incomplete answers, " he said.

 

An FDA spokeswoman said Friday that the agency would " carefully

consider " Grassley's request.

 

 

Janet Moore is at

 

jmmoore.

 

 

 

 

 

 

 

 

 

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