Big Troubles at Johnson & Johnson.

Dozens of studies sponsored by Johnson & Johnson that might have
warned doctors away were never published

From The New York Times, 6/10/05:
http://www.nytimes.com/2005/06/10/business/10drug.html?ex=1276056000&en=fdd014d6d1938784&ei=5090&partner=rssuserland&emc=rss

Lucrative Drug, Danger Signals and the F.D.A.

By GARDINER HARRIS and ERIC KOLI

Dozens had died and more than 100 patients had suffered serious heart
problems by March 1998 after taking Propulsid, a popular medicine for
heartburn.

Infants, given the drug to treat acid reflux, seemed particularly at
risk.

Federal officials told Propulsid's manufacturer, Johnson & Johnson,
that the drug might have to be banned for children, or even withdrawn
altogether.

Instead, the government and the company negotiated new warnings for
the drug's label - though not nearly as tough as regulators had
wanted.

Propulsid had a good year anyway.

Sales continued to surpass $1 billion.

Johnson & Johnson continued to underwrite efforts that promoted
Propulsid's use in children.

A survey that year found that about 20 percent of babies in neonatal
intensive care units were being given the drug.

Two years later, as reports of heart injuries and deaths mounted,
Johnson & Johnson continued defending the safety of Propulsid, but
then pulled it from the market before a government hearing threatened
to draw attention to the drug's long, largely hidden, record of
trouble.

That record, pieced together from newly obtained corporate and
government documents, provides an in-depth view of a pharmaceutical
company trying to save a lucrative drug in the face of growing
evidence of harmful side effects.

It is a story that has particular resonance now, as troubled arthritis
painkillers - Vioxx, Celebrex and Bextra - have again focused
attention on what critics say is the federal Food and Drug
Administration's inability to monitor and regulate pharmaceuticals
effectively once they are on the market.

Documents from lawsuits against Johnson & Johnson show that the
company did not conduct safety studies urged by federal regulators and
their own consultants that could have revealed Propulsid's danger
early on.

The F.D.A., moreover, did not disclose company research that cast
doubt on Propulsid's effectiveness against digestive disorders it was
being used to treat, since the studies are considered trade secrets.

Propulsid's history has striking parallels with the painkillers now at
the center of controversy.

Dozens of studies sponsored by Johnson & Johnson that might have
warned doctors away were never published, just as the pharmaceutical
manufacturer Pfizer failed to publish an early study of Celebrex that
indicated a heart risk.

And Johnson & Johnson was able to delay and soften some proposed label
changes, just as Merck later did with Vioxx.

An F.D.A. advisory panel concluded in February that the three
painkillers increased the risk of heart attacks and strokes.

In April, Pfizer, under pressure from the F.D.A., withdrew Bextra and
placed severe warnings about heart risks on the label for Celebrex, a
sister pill.

That followed a decision in September by Merck to withdraw Vioxx after
years of insisting that it was safe.

Members of a federal advisory committee on those painkillers cited
Propulsid as an example of how even the strongest warnings - known as
black box warnings - do not stop physicians from prescribing a drug
inappropriately.

Dr. Alastair Wood, the chairman of the panel, said in an interview
that label warnings of a drug's potentially lethal effects do not
protect all patients.

Eventually, Johnson & Johnson made five significant changes to
Propulsid's warning label and sent five letters to doctors across the
country.

But Dr. Wood, an associate dean at Vanderbilt University Medical
Center, said, "The case of Propulsid proves this: When people are
falling off a cliff, you don't put up more signs; you put up a fence."

Despite these public warnings about Propulsid, much of the
conversation between the company and regulators remained private as
the drug thrived.

With evidence mounting that Propulsid could interfere with the heart's
electrical system, government regulators became increasingly
confrontational with Johnson & Johnson executives.

But physicians were never made aware of the full depth of the agency's
concerns.

And even though Propulsid was never proved effective in children, the
company helped finance programs that encouraged the drug's pediatric
use, according to internal company documents.

Johnson & Johnson agreed last year to pay up to $90 million to settle
lawsuits that eventually involved claims that 300 people died and as
many as 16,000 were injured from taking Propulsid.

Many of the documents relating to Propulsid obtained by The New York
Times were filed under seal in the lawsuits.

The company declined repeated requests to make executives available to
be interviewed for this article.

In written responses, Johnson & Johnson defended the safety of
Propulsid and said that the marketing of the pill was appropriate.

The company said it removed the drug from the market because
physicians continued to prescribe it inappropriately despite repeated
attempts by the company to warn them against that.

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Harry