fda

[Guest guest]

Subj: [HEALTHE] Criticism of the FDA's drug approval process

Date: 4/4/99 1:08:06 AM Central Daylight Time

From: UncleWolf@... ( Gach)

Sender: HEALTHE@... (Health and Environment Resource Center)

Reply-to: HEALTHE@...HEALTHE@...

(Health and Environment Resource Center)

To: HEALTHE@...

British Medical Journal, 1999;318:944 ( 3 April )

Letters

FDA approves drugs even when experts on its advisory panels raise safety

questions

EDITOR

After reading the editorial questioning whether the Food and Drug

Administration is approving drugs too fast I was perplexed by the

conclusion " probably not. " 1 Apparently the authors failed to read the

transcript of the meeting of the administration's advisory committee for

mibefradil (NDA 20-689), which is one of three drugs recently recalled

by the administration because of deaths and serious morbidity.

If they had read this transcript they would have been overwhelmed by the

number of disturbing signals from committee members throughout the

document (page numbers refer to the Acrobat version): " I'm afraid that

we are rushing into this " (p 199); " I think it's concerning that the

mortality data look the way they do right now " (p 202); " given the fact

that there are a lot of other effective therapies out there, why not be

safe with the public? " (p 205); " I think it's premature [to approve the

product] (p 209); " aren't we obligated to provide some

assurance that the ECG (electrocardiographic) changes we've seen here

today are not ultimately lethal? " (p 127); " I sure don't feel good about

what I've seen " [referring to electrocardiographic changes] (p 126);

" you have 8 deaths in the patients treated with mibefradil and 1 death

in the placebo or control populations " (p 135); " are you really

comfortable, with so little mortality data, ... that it's safe? " (p

138), etc.

To conclude, as the editorial does, that serious adverse events are

inevitable and " one more bittersweet fact of medical progress " is too

facile. A more plausible explanation recognises that, for some time,

formidable forces -both political and economic - have insisted that new

drugs and devices be approved more quickly than ever before by the

administration. This interpretation agrees with the view held by many

healthcare policy academics, patient advocate organisations, and

consumer watchdog groups. They argue that in the past few years the Food

and Drug Administration's role has changed. Rather than regulating the

drug industry to protect the health of consumers of prescription drugs,

the administration has become the industry's partner, rapidly approving

drugs for marketing even when medical

experts on its own advisory panels raise serious safety questions.

Although one may not entirely agree with this outlook, it does provide

an explanation for much of the evidence that Kleinke and Gottlieb seem

to have overlooked.

ce Landow, Instructor in anesthesia, Harvard Medical School.

Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA

elmrfudd@...

From 1996 to 1998 Dr Landow was a medical officer and acting team leader

in the Anesthetic and Critical Care Drugs Section of the Center for Drug

Evaluation and Research at the Food and Drug Administration.

1.Kleinke JD, Gottlieb S. Is the FDA approving drugs too fast? BMJ

1998; 317:899[Full Text]. (3 October.)

*Peace and Light*

The Health and Environment Round-Table

Educate the general public about potential environmental threats to

physical, emotional, and psychological health and well-being. Develop

management strategies to reduce risks and stay healthy in an increasingly

toxic world. A round-table forum for the public, medical, scientific,

and legal communities, industry and media to reach out and work together

toward making our world safer.

Bring your questions, opinions, concerns, information, articles, and

skepticism to the HealthE Round-Table. Please send personal mail

privately. SNIP! Limit excessive requoting of posts, do not quote this

banner.

Courtesy, tolerance, and respect at all times.

Commands in the BODY of email to: listserv@... as

follows:

Want DIGEST version of list? Send: set HealthE digest

Read ARCHIVES not email? Send: set HealthE nomail

Keyword searchable archives at:

http://206.241.12.9/archives/healthe.html

Automated list assistance send HELP in the body of email to:

HealthE-request@...

----------------------- Headers --------------------------------

Return-Path: owner-healthe@...>

Received: from rly-yb04.mx.aol.com (rly-yb04.mail.aol.com [172.18.146.4]) by

air-yb04.mail.aol.com (v59.4) with SMTP; Sun, 04 Apr 1999 01:08:06 -0500

Received: from LIME.EASE.LSOFT.COM (lime.ease.lsoft.com [209.119.1.41])

by rly-yb04.mx.aol.com (8.8.8/8.8.5/AOL-4.0.0)

with ESMTP id BAA15903;

Sun, 4 Apr 1999 01:16:59 -0500 (EST)

Received: from PEAR.EASE.LSOFT.COM (209.119.0.19) by LIME.EASE.LSOFT.COM

(LSMTP for Digital Unix v1.1b) with SMTP id 0.0019E91E@...>;

4 Apr 1999 1:06:36 -0500

Received: from HOME.EASE.LSOFT.COM by HOME.EASE.LSOFT.COM (LISTSERV-TCP/IP

release 1.8d) with spool id 24527783 for

HEALTHE@...;

Sun, 4 Apr 1999 01:11:16 -0500

Received: from mtiwmhc07.worldnet.att.net by home.ease.lsoft.com (LSMTP for

Windows NT v1.1b) with SMTP id 5.FFD943E1@...>; 4

Apr 1999 1:11:14 -0500

Received: from ATT ([12.72.102.55]) by mtiwmhc07.worldnet.att.net (InterMail

v03.02.07 118 124) with SMTP id <19990404060759.PUF21195@ATT> for

healthe@...>; Sun, 4 Apr 1999 06:07:59 +0000

X-Mailer: Mozilla 3.0 (Win95; U)

MIME-Version: 1.0

Content-Type: text/plain; charset=us-ascii

Content-Transfer-Encoding: 7bit

Message-ID: 370657F6.184B@...>

Date: Sat, 3 Apr 1999 10:03:34 -0800

Reply-To: Health and Environment Resource Center

HEALTHE@...>

Sender: Health and Environment Resource Center

HEALTHE@...>

Subject: [HEALTHE] Criticism of the FDA's drug approval process

To: HEALTHE@...