Healthy Skepticism Library item: 17366

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Publication type: news

Bowe C
Merck under spotlight for 'deal' with US drug regulators
The Finanical Times 2004 Oct 16

Full text:

Senator Charles Grassley, chairman of the powerful Senate finance committee,
has asked Merck for information on an alleged secret deal with US regulators
that would have made the US drugmaker privy to government studies on its
drugs.

Mr Grassley’s request expands his existing investigation into whether the
Food and Drug Administration is too cosy with drugmakers, and is lenient
over safety concerns. The Iowa Republican has repeatedly blasted the FDA
over concerns that it has willingly suppressed negative findings about drug
dangers, including paediatric antidepressants.

His interest in the FDA’s relationship with Merck follows the company’s
surprise announcement two weeks ago to withdraw Vioxx, its $2.5bn-a-year
controversial pain drug. A study showed Vioxx doubled the risk of heart
attacks and strokes after 18 months’ use. The FDA approved Vioxx for use in
children a month before it was withdrawn.

An FDA e-mail, released by Mr Grassley, suggested that regulators in May
discussed a notification agreement with Merck, particularly related to
Vioxx.

In a May 14 2002 e-mail, Ann Trontell, FDA deputy drug safety director,
warned colleagues that a Merck official had reminded her that “there had
been an agreement that Merck would be informed prior to any FDA publication
about one of their drug products”.

The Grassley investigation is reviewing studies and data that dogged Vioxx
since its release in 1999, raising questions about heart risks.

Mr Grassley has also interviewed David Graham, an FDA researcher. An August
study that he conducted concluded that Vioxx had heart attack risks. The
full report has yet to be released.

Another e-mail from Dr Trontell dated August 12 2004 said that Merck needed
to be informed about the Graham study.

“The issue for doctors and their patients is, did the government agency
that’s supposed to regulate pharmaceuticals have an inappropriate agreement
with Merck?” Mr Grassley said yesterday. “And did a cosy relationship
between the FDA and a pharmaceutical company allow a drug with known safety
risks to stay on the market longer than it should have?

Merck said yesterday that it would co-operate with the Grassley
investigation. “The company is confident in how we have conducted research
on Vioxx safety and in how we have communicated with the FDA about Vioxx,”
Merck said in a statement.