Vlad, this from electronic WSJ yesterday.
The Wall Street Journal Interactive Edition -- June 10, 1998
Recall of Roche's Posicor Raises
Questions About Approval Process
By ROBERT LANGRETH
Staff Reporter of THE WALL STREET JOURNAL
The abrupt withdrawal this week of Posicor, Roche Holding AG's popular
hypertension drug introduced 10 months ago but since found to have potentially adverse interactions with two dozen other medications, raises questions about the testing and approval process that let it get on the market.
Deaths of Men Taking Viagra Point to Limits of Drug Testing
The drug was approved in June 1997 following studies on 3,400 patients,
the newest arrival in a large class of drugs known as calcium-channel
blockers. But it was withdrawn by the Swiss drug company on Monday after
a new study showed it could cause dangerous interactions with some 25 other
widely used medications, including Viagra and several leading
cholesterol-lowering medications.
How could Roche and government regulators miss so many harmful interactions?
Roche scientists said they did test for drug interactions with several
common medicines and found a few problems. But only after Posicor went
on the market and was taken by 400,000 people world-wide did they spot
the more alarming interactions that led to the recall this week.
The company contends that it is simply impossible to test for everything
before a drug is approved.
But other scientists and health advocates disagree. "There's a stampede
for efficiency in getting drugs approved, and it may be getting in the
way of safety," said biostatistician Lemuel Moye of the University of
Texas Health Science Center in Houston. He was one of three dissenting
members of an advisory panel to the U.S. Food and Drug Administration
that voted to recommend approval of Posicor last winter. Drug companies
"need to conduct much longer-term clinical trials before a drug is approved,
" he contended.
Sidney Wolfe of Public Citizen, an advocacy group, added:
"This drug should never have been on the market" without additional
studies. "There were a lot of safety problems, and there was no evidence
it was better than other drugs for high blood pressure."
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