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Drug test finding no surprise to local doctor

November 25, 2008|By ANDREW SCHOTZ

HAGERSTOWN -- A Hagerstown doctor said a report released Monday, linking a diabetes drug to a higher rate of congestive heart failure, validates concerns she and a colleague raised about nine years ago.

Dr. Mary Money, an internist, said she and Dr. Stephen Lippman, starting in 1999, found a similar connection among 33 local patients taking the drug Avandia, a drug used to control blood-sugar levels.

But when Money contacted the drug's manufacturer, their findings were downplayed and the company later told her not to spread the hypothesis to other doctors, she said.

Jeffrey McLaughlin, a spokesman for the company, now known as GlaxoSmithKline, said Monday that the drug had a warning about congestive heart failure from the time it hit the market in 1999, before Money spoke up.

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The company objected to Money implying a causal relationship that hadn't been established and that conflicted with available data, McLaughlin said.

Money said the new report, published in the Archives of Internal Medicine, backs up her and Lippman's previous observations.

The new study, based on nearly 29,000 people, found that more elderly patients who used Avandia died or had congestive heart failure than those who used another particular diabetes drug.

There was no difference, though, in the rate of heart attack or stroke between the two groups, the study found.

The tussle between GlaxoSmithKline and Money is part of a simmering question about Avandia's health risks and whether the manufacturer tried to downplay them.

The Wall Street Journal reported Wednesday that Sen. Chuck Grassley of Iowa, the top Republican on the U.S. Senate Finance Committee, has been investigating the matter and is expected to release a report soon.

The investigation is looking at allegations that a University of North Carolina researcher who raised similar concerns about a connection between heart problems and Avandia was pressured not to say more, according to The Wall Street Journal.

Messages left Monday for Finance Committee press contacts, seeking information about the investigation and report, were not returned.

The North Carolina researcher, Dr. John Buse, was quoted in a New York Times story about Monday's report saying other studies also have suggested an association between Avandia and heart problems, but there's no proof yet.

Lippman - who moved to Sacramento, Calif., last year after 14 years working at Washington County Hospital - said in a phone interview Monday that even if the link isn't certain yet, the information he and Money compiled was enough to suggest a correlation.

Money told the FDA and other area doctors what she had seen.

In a letter to Washington County Hospital's chief of staff at the time, SmithKline Beecham, as the drug company was known then, asked for an immediate stop to "the dissemination of this unsubstantiated information ...."

In May 2007, the FDA issued a new safety alert about Avandia. The alert says controlled clinical tests have shown "a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia."

However, Avandia's long-term clinical trials show "contradictory evidence about the risks ...," the alert says.

In November 2007, the FDA announced that GlaxoSmithKline would upgrade its warning about Avandia again to include information about the potential increased risk for heart attacks.

The FDA says there was no proof the risk was greater for Avandia than for other diabetes treatments and asked GlaxoSmithKline to do another long-term study.

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