It 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withdrawn from the market altogether, the government and the company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
| 