Presented
By Terence H. Young on
behalf of the Family of Vanessa C. Young - born April 8, 1984 ...
died March 19, 2000 after taking the prescription drug Propulsid.
On March 19, 2000 my fifteen-year-old
daughter Vanessa died suddenly after taking as directed a widely prescribed
Johnson and Johnson drug- Propulsid. We had absolutely no warning that
Propulsid held any danger.
We thought of it as a sort
of super Rolaids. Yet Propulsid at that time was associated with 80 deaths
and hundreds of injuries, including many children. No one saw fit to tell
us. Propulsid was ordered off the market in the U.S. just three days later.
Vanessa's story illustrates
so well what is wrong with the drug safety in Canada, and what needs to
be done to improve it.
The number of deaths linked
to Propulsid has now grown to 302 and I believe is actually far, far higher.
It has also been ordered off the market in Canada, the EEC, Bangladesh
and elsewhere.
Vanessa's
Death Is Outrage.
Propulsid isn't a drug for
cancer, or any other fatal disease. It's a drug for heartburn or bloating.
There was never any justification to give this potentially life-threatening
drug to treat non-life threatening symptoms. It was not even approved
for children.
With Propulsid the body count
began in the early nineties and continued to rise for ten years. Instead
of taking Propulsid off the market, or at least issuing clear patient
warnings, its manufacturer, Johnson and Johnson changed the fine print
on the label five times.
By 1998, Johnson and Johnson,
the people who make our baby powder, was still selling a billion dollars
worth of Propulsid a year in North America alone, for children, seniors,
and incredibly, hundreds of infants.
More
Than 100,000 People Die Every Year Due To Prescription Drugs In North
America.
We are here today to speak
for Vanessa and the thousands of innocent drug victims now gone who cannot
speak for themselves ... those who were robbed of their lives and those
who suffered permanent damage due to what amounts to a conspiracy of silence.
We are also here to caution you and others that think it couldn't happen
in their family. The truth is, it could. Anyone who takes prescription
drugs is at risk.
No one ever died from not taking
Propulsid. Proof this position is lame excuse is with recent warnings
in the media regarding PPF and Ephedrine on the same day. There was certainly
no panic, and no one died. No drug company has ever been sued for providing
a proper safety warning.
But perhaps this explains something
else. In November, 1998 it was discovered that President Clinton was taking
Propulsid with a contraindicated drug- omeprazole. He could have died.
In fact President Bush, his predecessor passed out at state function in
Japan due to an adverse reaction to another drug. Clinton's administration
was about to order Johnson and Johnson for the first time in history to
put a boxed warning right on the bottle of pills the patients gets in
hand and a package insert which states the warning up front in plain language.
Because most of the regulatory
authorities in most other countries are under funded, they normally copy
FDA orders. To avoid having to place a real warning on the bottle of pills
in all other 118 countries they sold Propulsid, and so damage sales world
wide for one of their most profitable drugs, Johnson and Johnson "voluntarily"
offered to do so as a "pilot project". This was no more a voluntary
pilot project than a roadside drunk driver walking the line to avoid arrest,
but was nevertheless a major event in drug safety.
In 1998, Propulsid thanks to
the FDA, was only sold in the U.S, with a proper warning written up-front
in plain language which said "May be fatal ... ' in the first paragraph
in bold print.
What did Johnson and Johnson
do in Canada? Nothing. What did Health Canada do?
Nothing. What warning did Canadian
patients receive? Nothing.
Vanessa and others may be alive
if they either had the decency or responsibility to provide Canadians
the same warnings they did Americans.
Most drug company senior executives
and all sales staff from top to bottom are paid based on how many pills
the company sells. At the Inquest into Vanessa's death none of four doctors
testified ever receiving a safety warning about Propulsid from company
sales reps. And no one is paid or recognized for providing or issuing
excellent safety warnings. I would question how long a sales representative
would last on the job who did so.
Johnson
and Johnson is still selling Propulsid in numerous countries; in some,
directly off the shelf for one reason - they haven't been ordered not
to.
Abstracted
from Red
Flags Weekly May 31, 2002
| 