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