Senator Grasslety Turns Up the Heat on the FDA!

[Guest guest]

atracyphd2

Mon, 1 Aug 2005 06:16:59 EDT

[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.