TIME TO REPLACE, NOT REFORM FDA

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http://www.newswithviews.com/Emord/jonathan142.htm

TIME TO REPLACE, NOT REFORM FDA

By Attorney

Emord

Author of "The Rise of Tyranny"

July 12, 2010

NewsWithViews.com

In my book The Rise of Tyranny, I reveal many

instances in which drug industry executives have been complicit with

FDA political appointees in causing unsafe drugs to enter the market

over the objections of FDA medical reviewers. The political angst now

expressed over just one of the drugs I wrote about, GlaxoKline’s

Avandia, is dreadfully late—coming a decade after FDA Medical Reviewer

I. Misbin first sounded the alarm within FDA on the link between

that Type 2 diabetes drug and heart problems. Had Misbin been credited

instead of discredited by FDA management, the drug never would have

entered the market or, if it did, it would have been accompanied by

extreme warnings.

The

story

of FDA’s approval of Avandia over the objection of agency medical

reviewers (and FDA defense of the drug for over a decade) reveal

precisely why FDA cannot be counted upon to protect the American

public. In an April 2, 1999 internal memo Misbin explained to his

superiors his concerns “about deleterious long term effects on the

heart” from the drug. His criticisms were rejected. On May 25, 1999,

FDA approved the drug for marketing without referencing the heart

risks. Dr. Misbin later stated that “[o]ne of [his] superiors said

something to [him] that [he] never [forgot], that we have to maintain

good relations with the drug companies because they are our customers.”

In February 2006, another FDA Medical reviewer, Dr. Rosemary

Johann-Liang, strenuously urged that FDA require GlaxoKline to put

a black box warning on the drug, alerting people to its effect of

increasing the risk of heart attack. Dr. Johann-Liang’s supervisor told

her that FDA management was “upset with [her] recommendation” and

“decided to act like [her] review never happened.”

California

Congresswoman

Diane E. used the drug for her diabetes. She

developed a heart murmur which she attributed to Avandia in a

congressional hearing. On the advice of her physician, she stopped

taking the drug. Seven years after the drug entered the market, caving

to pressure brought on in no small measure by the efforts of FDA Office

of Drug Safety Associate Director Graham, FDA ordered a black box

warning in Avandia labeling, but kept the drug on the market. In July

of 2007, an FDA advisory panel voted 20-3 that Avandia increases

cardiac ischemic risk in type 2 diabetics but voted in favor of keeping

the drug on the market despite the extraordinary risk. In short, the

economic interests of the drug industry won out over sound medical

judgment.

There

are

many treatments for Type 2 diabetes that do not entail a 43%

increased risk of heart attack (New England Journal of Medicine, May

2007, Meta-Analysis by Drs. Nissen and Kathy Wolski), yet FDA

has until recently been a dogged defender of this drug seemingly

unaffected by severe medical, scientific, political, and public

criticism. If there was any doubt that the drug industry exercises

undue influence over FDA, the case of Avandia (and over a dozen unsafe

drugs now on the market) should have eliminated that doubt.

The

solution

to this problem lies not in “reforming” FDA. FDA is inherently

corrupt. The solution lies in replacing FDA review altogether. In The

Rise of Tyranny I offer an alternative. The approach I advocate

involves creation of a new statute that would vest authority for drug

reviews outside government, in independent University testing centers.

Each center would have to qualify by establishing that the academics

who would man it are free of any present or past association with drug

companies. New drug applications would be filed with the Department of

Justice. DOJ would remove all identifying information from the

applications so that the drug company sponsor would not be visible to

the university reviewers.

The

DOJ

would then randomly (and in secret) assign each new drug

application to a university testing site for evaluation. Actual

clinical testing to determine safety and efficacy would occur in secret

with the identities of the reviewers known only to DOJ and with severe

penalties for disclosures either from the drug industry or from the

reviewers. The university would then publicly issue an evaluation. The

evaluation would determine whether the drug was safe and efficacious

under a system that would focus on a comparative assessment of risks

and benefits, focusing primarily on whether the drug agent would

eliminate disease symptoms or cure disease without placing patients in

mortal peril.

The

final

evaluation, together with the University’s recommended physician

and patient labeling, would then be published in the Federal Register

and adopted automatically as the position of the United States. The

drug company, if displeased with the result, could then challenge it in

federal court to determine whether the testing was inadequate in some

particular; in which case a court could order a new blinded evaluation.

In this way, FDA,

a captive of the drug industry, would be removed from the equation and

science would reign over politics once and for all. Under the present

system, FDA political managers know that if they play their cards right

(and approve drug applications even in the face of serious safety

questions), they may enjoy lucrative post-government employment. Were

it not for comparable corruption in Congress, the system could be

replaced now. Sadly, until we vote all of the rascals out, we are

likely to see the business of industry protection continue at FDA at

the expense of human life.

© 2010 W. Emord - All

Rights Reserved

W.

Emord is an attorney who practices constitutional and administrative

law before the federal courts and agencies. Congressman Ron calls

“a hero of the health freedom revolution” and says “all

freedom-loving Americans are in [his] debt . . . for his courtroom

[victories] on behalf of health freedom.” He has defeated the FDA in

federal court a remarkable seven times, six on First Amendment grounds,

and is the author of Amazon bestsellers The Rise of Tyranny, and Global Censorship of Health Information. For more info visit Emord.com.

Website: Emord.com

E-Mail: jwemord@...