Vioxx: In short, no-one noticed 27,000 Vioxx related deaths.

[Guest guest]

SSRI-Research@

Fri, 12 Nov 2004 07:57:33 -0500

[sSRI-Research] Vioxx: In short, no-one noticed 27,000 Vioxx

related deaths.

 

 

 

Breaking Biology News

 

Vioxx Pulled From Shelve--Is Celebrex Next?

 

By Red Flags Columnist, Dr. Malcolm Kendrick

Nov 11, 2004, 12:44

 

http://www.earthchangestv.com/secure/2004/printer_5026.php

 

 

" Pfizer defended the safety of Celebrex Thursday after the

publication of a report in Canada's National Post newspaper suggested

the COX-2 drug was linked to at least 14 deaths, as well as heart and

brain side effects, CNN Money and other news sources report. The

newspaper cited adverse-events documents on Celebrex from the Canadian

health department.

 

Nonetheless, while the documents allegedly show over 100

adverse-reaction reports on Celebrex over the past five years, which

include 19 cases of heart attack, cardiac arrest or heart failure plus

five strokes, a spokeswoman for Canada's health department said that a

" causal link " has not been established between the COX-2 inhibitor and

the adverse events, as reported in Morningstar and TheStreet.

 

Pfizer issued a statement on the article saying, " The news

report, based on voluntary spontaneous event reporting to Canadian

health authorities, is misleading. The story is not supported by any

clinical or epidemiological studies and has the potential to cause

undue confusion among patients and physicians, " as reported in

Finance. "

 

--pharmaceutical industry journal FirstWord.

 

Of course what is not mentioned, but is most interesting,

about reported deaths and adverse reports, is that no-one reports an

adverse drug event unless they thought it was the drug that caused the

death.

 

Most people who die are, by their nature, pretty unwell.

They are also, usually, on a whole whack of different drugs. Did the

drugs kills them? Did a specific drug kill them? How could you

possibly know?

 

Many people on Cox II drugs, Vioxx, Celebrex etc. are

elderly. Many of them will have varying degrees of heart disease. If

they die of a heart attack, who is going to point the finger at

Celebrex and write an adverse event report? Not I. Especially not I,

if this adverse event is not even listed as a known effect of the drug.

 

A review of Vioxx, in an internal Merck memo suggested

that Vioxx may have caused 27,000 deaths. (From FirstWord again)

 

The FDA published details of a memo by Dr. David J. Graham

that suggested Merck's Vioxx (rofecoxib) might have contributed to

over 27,000 heart attacks and deaths, based on data from 1999 through

2003, reports the Financial Times and other news sources. The memo was

dated September 30, the same day Merck announced it was withdrawing

the drug.

 

In short, no-one noticed 27,000 Vioxx related deaths. The

adverse event reporting system reported precisely nothing. How many

deaths, one wonders, does a drug have to cause before the alarm bells

ring. Fifty thousand, a million, a Google?

 

So, just because there have been only fourteen deaths

associated with Celebrex in Canada - as recorded by a system very

similar to the one that miserably failed to notice 27,000 deaths in

the USA - does not actually mean anything at all. Watch this space -

my bet is that Celebrex will be gone before the end of the year. You

read it here first.