JAMA: Postmarketing surveillance must change

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outrider - 21 Nov 2004 22:17 GMT

JAMA Editors Call for Major Restructuring of Postmarketing Surveillance
System

CHICAGO - In an editorial in the December 1 issue, JAMA
Editor-in-Chief, Catherine D. DeAngelis, M.D., M.P.H., Executive Deputy
Editor, Phil B. Fontanarosa, M.D., and Deputy Editor Drummond Rennie,
M.D., write:

"Physicians and patients expect that when medications are prescribed
correctly for labeled indications and are used as directed, these
medications generally will have beneficial effects and will not cause
significant harm. This confidence in pharmaceutical products reflects
trust in the effectiveness and integrity of the drug approval and
monitoring process. However, the current approval process for drugs
and biological agents in the United States has come under intense
scrutiny, most notably because of concerns about influence from
industry."

"To improve the necessary measures to monitor the safety of marketed
drugs, the drug approval process must be decoupled from the
postmarketing safety and surveillance system. It is unreasonable to
expect that the same agency that was responsible for approval of drug
licensing and labeling would also be committed to actively seek
evidence to prove itself wrong (i.e., that the decision to approve the
product was subsequently shown to be incorrect.) One option worth
strong consideration, as others have suggested, is to establish an
independent drug safety board or independent agency for drug safety,
specifically to oversee postmarketing surveillance for drugs and
devices." ... "Above all, the agency must be completely independent
of influence from the pharmaceutical industry, biotechnology firms, and
medical device manufacturers."

"The postmarketing surveillance system requires a long overdue major
restructuring. Until that occurs - as indicated by the articles in
this issue of JAMA, as epitomized by recent evidence of serious harms
from widely used and heavily promoted medications, as demonstrated by
the influence of industry over postmarketing data, and as illustrated
by the lengths to which some manufacturers will go to protect their
interests - the United States will still be far short of having an
effective, vigilant, and trustworthy system of postmarketing
surveillance to protect the public."

(JAMA. 2004;292: 2647 - 2650)

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Steve Marcus - 22 Nov 2004 10:06 GMT

> JAMA Editors Call for Major Restructuring of Postmarketing Surveillance
> System
[quoted text clipped - 8 lines]
> medications generally will have beneficial effects and will not cause
> significant harm.

*Generally* will have? *Significant* harm? Can this mean that physicians
and patients do not expect 100% effectiveness 100% of the time and do not
expect drugs to be 100% safe 100% of the time? Who would have thought it?

> This confidence in pharmaceutical products reflects
> trust in the effectiveness and integrity of the drug approval and
[quoted text clipped - 10 lines]
> evidence to prove itself wrong (i.e., that the decision to approve the
> product was subsequently shown to be incorrect.)

Hmmm.... If a decision is made based upon evidence sets A, B, and C, and
subsequent to the decision, evidence set D becomes available, was the person
or organization incorrect in making the decision, or was the person or
organization making the decision wrong? Seems to me that the *decision*
turns out to be wrong, but the person or organization who made the decision
was not incorrect when the decision was made and the decision, when made,
wasn't wrong.

A fine point to be sure, and it may well be that in the realm of
pharmaceuticals, there should be separate organizations charged with drug
approval and subsequent surveillance of the drug to insure safety. But the
implication that this would necessarily improve product safety is not
logical. Some drugs genuinely believed to be safe based upon honest
evaluation of statistically significant evidence adduced prior to approval
and evaluaged during the approval process will continue to be approved for
dissemination, and will continue to turn out to be dangerous after the
product is marketed and is used (and misused/abused while required patient
monitoring is neglected). Increasing the sample size guarantees this.

> One option worth
> strong consideration, as others have suggested, is to establish an
[quoted text clipped - 3 lines]
> of influence from the pharmaceutical industry, biotechnology firms, and
> medical device manufacturers."

Probably an improvement. Not necessarily a complete cure for the problem.

> "The postmarketing surveillance system requires a long overdue major
> restructuring. Until that occurs - as indicated by the articles in
[quoted text clipped - 7 lines]
>
> (JAMA. 2004;292: 2647 - 2650)

Steve

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outrider - 23 Nov 2004 00:37 GMT

evaluaged

Couldn't agree more. Mint?

Zee

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