Why We Missed the Warning Signs of an Unreliable Drug System

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http://www.mercola.com/2005/jun/30/drug_system.htm

 

Why We Missed the Warning Signs of an Unreliable Drug System

 

t has long been suspected that mega-drug makers were negotiating

behind-the-scene deals to keep their potentially toxic drugs on the

market. According to corporate and government documents, the Food and

Drug Administration (FDA) may have an inadvertent hand in facilitating

that behavior.

 

Case in point: The fatal side effects evoked by Johnson & Johnson's

popular heartburn medicine Propulsid and the desire to make a profit

at the expense of the public's health. For example, when federal

officials informed Johnson & Johnson that Propulsid might be withdrawn

from the market altogether, the government and the company negotiated

new warnings for the drug's label rather than looking out for the

public's best interest and immediately removing the drug from the market.

 

And it wasn't until two years later with mounting reports of heart

injuries and deaths that Johnson & Johnson finally pulled the drug

from the market. At that time, a government hearing threatened to

highlight the drug's long and concealed record of trouble. It's that

hidden record in conjunction with newly obtained corporate and

government documents that allowed the public to see:

 

*

 

A pharmaceutical company focused on saving a profitable drug

despite growing evidence of harmful effects.

*

 

A drug agency with an inability to monitor and regulate

pharmaceuticals effectively once they hit the market.

 

Though Johnson & Johnson eventually made five significant changes to

Propulsid's warning label and sent five letters to doctors across the

country, for many innocent patients it was simply too late.

 

Propulsid's Horrific History

 

The history behind Propulsid has many eerie similarities with some of

the painkillers currently at the heart of controversy. For example,

just as Pfizer failed to publish an early study of Celebrex that

indicated a heart risk, dozens of studies on Propulsid sponsored by

Johnson & Johnson that might have warned doctors away were also never

published. Moreover, Johnson & Johnson was able to delay and soften

some proposed label changes, just as Merck later did with Vioxx.

 

But let's start at the beginning ...

 

The first signs of trouble regarding Propulsid emerged soon after the

drug was approved in 1993 for the treatment of nighttime heartburn in

adults. Then, in January 1995, the FDA received reports of 18 patients

using Propulsid who developed serious heart arrhythmias; one infant

died. Johnson & Johnson executives claimed such side effects occurred

only in patients who took Propulsid with other drugs or who had heart

problems.

 

By July 1996, regulators received reports of 57 Propulsid patients

(including seven children) who had developed serious arrhythmias or

other heart problems. In August 1997, a top FDA official wrote to

Johnson & Johnson stating that Propulsid's increasing number of

cardiac problems among infants and children suggested that younger

patients may be at a greater risk. Regardless, by 1998, doctors were

writing more than half a million prescriptions a year for children and

infants.

 

Finally, in May 1998, the FDA proposed major changes to Propulsid's

label. Yet throughout the negotiations and label changes, the company

kept up its support of physician and patient groups that were

promoting the drug as safe for use in children.

 

The company and the government negotiated for five years before

Propulsid was finally pulled from the market. But clearly that wasn't

soon enough; by January 2000, the FDA had reports of 80 heart-related

deaths and 341 injuries among patients taking the drug. And just last

year Johnson & Johnson agreed to pay some $90 million to settle

lawsuits that eventually involved claims that 300 people died and as

many as 16,000 were injured from taking Propulsid.

 

New York Times June 10, 2005

 

Dr. Mercola's Comment:

 

The above article provides strong evidence that the debacle involving

COX-2 inhibiting drugs like Vioxx, Celebrex and Bextra had important

historical precedents. Unfortunately, the evidence appears very strong

that this is typical behavior for many drug companies.

 

Perhaps you may not be surprised to learn that those who are paid to

protect your health frequently cooperate, and some might say conspire,

with the very companies they are mandated to monitor. When the fox

starts protecting the henhouse, you can bet that your long-term

interests are not at the forefront of the fox's intentions.

 

When will our country begin to fully appreciate that the drug

companies and the FDA are typically forced to action after large

numbers of people pay the price for corporate greed with their lives?

 

Related Articles:

 

How Could Drug Companies be so Evil?

 

Can You Trust the FDA?

 

More Evil Behavior from Merck