The FDA approved Vioxx for use in children a month before it was withdrawn.

[Guest guest]

SSRI-Research@

Sun, 17 Oct 2004 22:34:51 -0400

Subject:[sSRI-Research] The FDA approved Vioxx for use in children a

month before it was withdrawn.

 

Merck under spotlight for 'deal' with US drug regulators

 

By Christopher Bowe in New York

Published: October 16 2004 03:00 | Last updated: October 16 2004 03:00

http://news.ft.com/cms/s/7984664c-1f0f-11d9-9015-00000e2511c8.html

 

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children a month before it was withdrawn.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.

 

Find this article at:

http://news.ft.com/cms/s/7984664c-1f0f-11d9-9015-00000e2511c8,ft_acl=,s01=1.html