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Morton Mintz: Out of Oversight, Out of Mind

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atracyphd2

Mon, 2 May 2005 03:47:43 EDT

[drugawareness] Morton Mintz: Out of Oversight, Out of Mind

 

 

 

 

 

The following is an article by Morton Mintz, the author of the absolutely

fantastic book, " A Theraputic Nightmare " (with a later name change to " By

Prescription Only)! For those of you who have read my book or

researched our website

closely you know how much I honor and revere Morton Mintz and his

work. Our

website www.drugawareness.org is dedicated to him.

 

The following is a quote from our site in honor of Morton Mintz:

 

" Morton Mintz, a former Washington Post reporter, and a Nieman Fellow

who won

the Raymond Clapper award for reporting the thalidomide tragedy

published a

book in 1965 entitled, THE THERAPEUTIC NIGHTMARE. His warnings heeded

then, and

the warnings coming from many other men of great integrity since then,

could

have spared us the agony we have experienced from the drug tragedies since

that time and those we are engulfed in today.

 

" He begins with, " Here we shall see that there have been instances

when our

excessive trust in certain Corporate Consciences has been rewarded with

inadequately and even fraudulently tested drugs, with useless drugs

and inferior

versions of good drugs, with protraction of illness, and with waste of

our money.

In order that sales may begin and continue, regardless of whether we are

healed and spared pain, evidence of serious and even lethal effects

has been

withheld from the responsible government agency and concealed from the

medical

profession and the public. " (p.xiv)

 

" We wish to honor him here (and those who have followed in his

footsteps) in

their unending efforts to warn us of these serious problems associated

with

the drugs we have come to learn to blindly trust. This site is to

assist us in

making sure that trust is no longer a " blind " trust. We must take the

responsibility to educate ourselves about what we are putting into our

bodies and

brains. "

 

Obviously had the world listened to Morton Mintz when his book came out in

the mid 60's thousands upon thousands of lives would have been saved

from then

to the present.

 

In 1994 when Morton told me it would do no good to finish writing my book

" Prozac: Panacea or Pandora? " or publish it, due to the fact that no

one would

read it since " no one really wants to be informed about this issue, "

luckily I

did not listen. Obviously I finished the book and published it and

would hope

that in some way my work has now helped us reach the point of giving

Morton

Mintz a stronger voice once again - a voice the world desperately

needs to hear!

And this time we had better listen and listen very closely.

 

Although his entire article is absolutely incredible, I particularly

enjoyed

his comments about the press, who I hold criminally responsible for

the deaths

of thousands, due to their lack of coverage of this issue.

 

 

" It's all very well to criticize the FDA and the likes of Gingrich,

Tauzin,

Barton and Greenwood. But does the press deserve a pass? No way. For a

full

decade, it has failed to inform the public of the prolonged, corrupt

pre-Grassley

abdication of congressional oversight of the agency responsible for the

safety of their medicines and of its causes, consequences and

implications. Failed,

that is, to connect the dots. "

 

Dr. Tracy

________________________

 

Dr. Ann Blake Tracy, Executive Director,

International Coalition For Drug Awareness

www.drugawareness.orgÂ

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)

_________________________

 

 

http://niemanwatchdog.org/index.cfm?fuseaction=Showcase.view & showcaseid=0013

 

 

Morton Mintz on out of oversight, out of mind

 

SHOWCASE | May 02, 2005

 

A personal account by the longtime investigative reporter and adviser

to this

Web site on his experience with Congressional oversight, how it should

work,

and how Congress, with some recent exceptions, and the press are falling

terribly short. (The remarks were prepared by Mintz for a recent

gathering of

Washington area Nieman fellows.)

 

By Morton MintzÂ

 

mintzm

 

Â

The thalidomide story changed my life--changed it profoundly. It's the

primary reason why I received a Nieman Fellowship. It's why I became a

first-time

author with a blurb from John Kenneth Galbraith on the dust jacket of

the book I

wrote while at Harvard. It's why I won my first journalism prizes.

It's why I

came to devote much of the last 40+ years to reporting on corporate

crime and

grave misconduct, particularly in the drug, tobacco, and automobile

industries.Â

 

The effects on me were the least of it. For example, the story dealt a

lasting blow to a notion, widely if foolishly held, that science and

technology

always or nearly always produce benign results.

 

The lead, from the Washington Post of Sunday, July 15, 1962, sums it

up: Â

 

This is the story of how the skepticism and stubbornness of a government

physician prevented what could have been an appalling American

tragedy, the birth

of hundreds or indeed thousands of armless and legless children.

 

 The story of Dr. Frances Oldham Kelsey, a Food and Drug Administration

medical officer, is not one of inspired prophesies nor of dramatic

research

breakthroughs.

 

She saw her duty in sternly simple terms, and she carried it out,

living the

while with insinuations that she was a bureaucratic nitpicker,

unreasonable †"

even, she said, stupid…Â

 

What she did was refuse to be hurried into approving an application for

marketing a new drug. Â

 

In September 1960, the U.S. licensee of the German investor and

manufacturer

of thalidomide†" a sedative or tranquilizer, depending on

dosage†" applied for

FDA approval to sell it in the United States. Not until April 1962 did

it become

widely known that in numerous other countries, the mothers of several

thousand thalidomide children had taken the drug during the first

trimester of

pregnancy. I interviewed Dr. Kelsey three months later.Â

 

I finished the story†" 2400 words†" at around 2 A.M. on Saturday, July

14th.

Several hours later, my wife, Anita, and I and our three children left

by car for

Cape Cod. My spies told me afterward that the Managing Editor thought the

piece was too long, but the News Editor had said, " I can get it in. "

He did.

 

Seventeen days later, a Senate subcommittee led by Hubert Humphrey held an

FDA oversight hearing at which it came out that in a promotional

stunt, the

licensee, the William S. Merrell Co., had contrived to give away 2.5

million

so-called " experimental " thalidomide pills to physicians, causing 10

American

infants to be born with seal-like flippers rather than arms and legs.

 

Sy Fishbein, an assistant city editor, had assigned me to interview Dr.

Kelsey after a colleague, the late Bernard Nossiter, passed on a tip

that she had

kept thalidomide off the market. I learned subsequently that Sy picked me

because he wanted an interviewer with a capacity for outrage; I had

that, famously

or infamously, along with zero expertise about the FDA or medicines.

 

The tip came from an aide to Estes Kefauver, who had been fighting a long,

losing battle to drastically strengthen the Food, Drug, and Cosmetic

Act of

1938. Building on findings in investigative hearings by his Senate

Antitrust

Subcommittee, he proposed amendments to require a manufacturer to

provide the FDA

with substantial scientific evidence †" well-controlled clinical

studies †"

showing that a medicine was not only safe, but also effective in its

intended use.

The amendments also proposed mechanisms to prevent the price-gouging

that was

rampant even then.

 

Only a few weeks before my story ran, his Senate foes, mostly Republican

friends of the pharmaceutical industry, gutted the amendments. They

did this in a

secret meeting he'd known nothing about.

 

The story transformed Capitol Hill. Suddenly, Congress became a tiger,

rushing to toughen the drug law by passing what came to be called the

Kefauver-Harris Amendments of 1962. It refused only to enact the

proposals for competitive

pricing, these being far more repugnant to the industry than efforts

to assure

safety and efficacy.

 

The legislation then went to the White House. President Kennedy did not

invite Kefauver to the signing ceremony. He did invite Senate Minority

Leader

Everett Dirksen, who had led opposition to all of Kefauver's reforms.

 

But the system worked then, and for a long time thereafter.Â

 

" From the mid-1960s through much of the 1980s " †" I’m quoting a 2002

article in

The American Prospect†" “Congress played an integral role in drug

safety.

Lawmakers " †" principally the late Reps. L.H. Fountain and Ted Weiss,

but also

including Gaylord Nelson and Ted Kennedy in the

Senate†" “meticulously probed the

regulatory histories of dubious drugs, uncovered FDA weaknesses and

ordered

corrections.â€

The writer was Daniel Sigelman, who, as an investigator for Weiss,

found that

Eli Lilly, in the case of the anti-arthritis drug Oraflex, and Hoechst

AG, in

the case of the antidepressant Merital, had known of but failed to report

many deaths of patients on these drugs. Thanks to the Weiss subcommittee's

digging, Lilly and Hoechst were criminally prosecuted. I was

privileged to cover all

or nearly all of those oversight hearings even if at the Fountain and

Weiss

hearings I was alone at the press table much of the time. Â

 

Decline of oversight began in the late ‘80s

 

Congressional oversight of the FDA and the drug industry began to

decline in

the late 1980s, while the Democrats still controlled the House. It

spiraled

sharply downward in 1992†" still on the Democrats' watch†" with

passage of a highly

dubious law allowing the industry to pay so-called user fees as a way to

speed FDA approval of new drugs. Oversight collapsed utterly in

January 1995,

when the Republicans took control of the House and drug and tobacco

industry

campaign contributions took control of them. Speaker Newt Gingrich

called the FDA

the " leading job killer in America. " He denounced its

then-Commissioner, David

Kessler, who wanted to regulate tobacco, as " a thug " and " a bully. "

 

The collapse of oversight had appalling consequences.

 

In the decade ending in the Fall of 2002, 13 dangerous drugs were

withdrawn

from the market after causing many hundreds of deaths and many

thousands of

injuries. Consider the diet pills Pondimin and Redux. Taken in

combination, they

reliably caused heart-valve damage and sometimes a lung disorder

that's fatal

more than half the time. The resulting wrongful-conduct litigation was the

largest ever against a pharmaceutical manufacturer. It was expected to

cost what

was then Wyeth-Ayerst Laboratories an astounding $13.2 billion, Sigelman

wrote.

 

Just seven of the unsafe drugs caused more than one thousand deaths.

How and

why had FDA hurried them to the market? Why had withdrawals been slow?

David

Willman of the L.A. Times investigated. He found that the FDA had become a

partner rather than a watchdog of the pharmaceutical industry. But

unlike David,

who in 2002 won a Pulitzer for a terrific series, House leaders had no

interest

in investigating the FDA's role in approving even one of the drugs that

caused needless deaths and injuries or in determining what led up to

$13 billion in

legal claims and costs. Least of all did they want to investigate why

and how

the FDA had become a partner of an industry that has more lobbyists than

Congress has members, that was filling the campaign coffers of

friendly lawmakers

to overflowing, and that held out the prospect of high-paying jobs for

overseers who wouldn't oversee.

 

As chairman of the House Energy and Commerce Committee, Billy Tauzin

had FDA

oversight jurisdiction but didn't exercise it. Over the course of 15

years, he

took $218,000 from the drug industry. In January 2005, the Louisiana

Republican became president of the Pharmaceutical Research and

Manufacturers of

America. His annual pay package is reportedly worth at least $2 million.

 

All of you know about Vioxx, which caused an estimated 88,000 to 139,000

heart attacks and strokes. But it and related painkillers such as

Bextra and

Celebrex were not a problem for Tauzin. Nor for his successor, Joe

Barton. The FDA,

Barton has declared, should make no more rulings on the effectiveness of

drugs; rather, it should confine itself to measuring whether they are

" safe, pure,

and packaged safely. "

 

James C. Greenwood of Pennsylvania served under Tauzin as chairman of the

Subcommittee on Oversight and Investigation. Thus he too had

jurisdiction over

FDA. Of his 2003-04 donors, the Washington Post reported, 10Â identified

themselves as drug company presidents; six are vice presidents, and

another six are

executives. " In July, he left the Hill to become President of the

Biotechnology Industry organization.

 

Grassley to the rescue, but where is the press?

 

Early last year in the Senate, in startling contrast, Charles Grassley

broke

from the Republican pack. The chairman of the Finance Committee undertook

tough oversight of the FDA, notably including its handling of childhood

antidepressants and Vioxx and related painkillers. Moreover, Grassley

served notice that

he'd protect the FDA's internal whistleblowers, such as medical

officer David

Graham, who had called Vioxx a " profound regulatory failure " by an agency

" incapable of protecting America against another Vioxx. "

 

It's all very well to criticize the FDA and the likes of Gingrich, Tauzin,

Barton and Greenwood. But does the press deserve a pass? No way. For a

full

decade, it has failed to inform the public of the prolonged, corrupt

pre-Grassley

abdication of congressional oversight of the agency responsible for

the safety

of their medicines and of its causes, consequences and implications.

Failed,

that is, to connect the dots.

 

Maybe I've missed something, but I have yet to see a story in which Billy

Tauzin, or Joe Barton, or House Speakers, or House and Senate majority

leaders,

were asked why, say, there'd not been an oversight investigation of

the seven

drugs that caused the deaths of a thousand Americans. Or a story on

why these

deaths seemed to matter not at all to them while the death of Terry

Schiavo

became their be-all and end-all. Or a story in which Mike Enzi was

asked why his

Senate Health committee hasn't done the FDA oversight that is being

done by

Charles Grassley's Finance Committee.Â

 

Let me end with a few questions:

 

If over the past dozen years Capitol Hill had properly overseen the

FDA, and

if the press had seriously and consistently reported on this nonfeasance,

would the agency have rushed as it did to release, and not rushed to

pull back,

the 13 killer drugs, Vioxx, and the rest? Could there be a reasonable

doubt that

many thousands of Americans would not have been gravely or fatally harmed?

 

Even more importantly, were the lapses I've described symptomatic of a

collapse of congressional oversight†" and of press oversight of that

oversight†" in a

host of other areas that bear heavily on national security and our lives,

safety, health and pocketbooks?

 

I'm talking about everything from drug prices to military spending and

National Missile Defense, from global warming to protections against

another Al

Qaeda attack, from the buildup to the invasion of Iraq to the

treatment of

prisoners and detainees.Â

 

We've got a problem.

 

 

 

 

 

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