The Great Cholesterol Con - Vioxx

Vioxx, the arthritis drug, was estimated to have been linked to more

than 100,000 deaths in the USA in two years. And no one noticed! The

fatal effects of Vioxx were only picked up coincidentally as part of a

major trial to see if this drug could protect against bowel cancer.

Side effects of drugs might not be picked up in a V-Bi trial because they
are chaotic and hidden.  

The

impact on mortality was noted, and highlighted, by a rather heroic

employee of the Food and Drugs Administration (FDA), Dr David

Graham. For his efforts in. protecting the safety of the public he was

smeared in the press and ruthlessly attacked. Luckily, a certain Senator

Charles Grassley got involved in the case. He wrote a letter to Lester

Crawford, the acting commissioner at the FDA at the time. I reprint

some sections of it here, because it is an absolute cracker. A symphony

in restrained rage:

As Chairman of the Committee on Finance, I have made it clear

to you that I expect that Dr David Graham's right as a federal

employee will be fully respected by the Food and Drug

Administration. Last Wednesday, November 24, 2004, I

requested that the Office of Inspector General (DIG),

Department of Health and Human Services conduct a complete

and thorough investigation into the facts, events, persons,

policies, regulations and laws relating to allegations that a

number of management level employees at the FDA may have

acted 'to discredit an outspoken agency safety office who was

challenging the FDA's drug safety policies.' I referred to the

attached article from the Washington Post entitled, 'Attempt to

Discredit Whistle-Blower Alleged.'...

Often V companies use Iv agents to sell drugs that may have hidden
side effects, this is like door to door salesmen who might know their
product is not good but deceive B customers to get commissions. Some
of these Iv can become whistleblowers, they become then a path for I-O
regulators to get to the Y-V companies just like oy thieves might turn on the
Y mafia. So if the I-O police become Iv-Oy biased then they help 
whistle blowers much less causing them to not expose Y-V, then this chaos
can grow to a much larger problem before being exposed.   

I'd like to reiterate what I have repeatedly stated in writing and

have verbally communicated to your agency, namely that this

Committee takes its responsibility to protect witnesses and

particularly government witnesses very seriously, and that holds

particularly true for Dr Graham.'...

I understand that retaliatory action against dissident employees

can come under many guises. Therefore, I also request that you

address allegations that administrative action may be taken

against Dr Graham, including that he may be terminated or

transferred against his wishes to a job other than conducting

scientific research. Please advise me whether there is any truth to

these allegations and, if so, explain what actions are being taken to

transfer Dr Graham from his present position and duties at FDA ...

On at least 6 separate occasions - 3 by letter and 3 in meetings

with FDA staff - I have requested that FDA employees be advised

that they may come to Congress and speak freely without fear of

reprisal. Do you believe that FDA employees are free to speak to

members ofCongress without advising FDA's Office of Legislation?

If so, when are you going to act on this request?

Ouch!

This sorry saga highlights that fact that a drug could potentially kill

hundreds of thousands of people without anyone actually noticing.

You may think that this must be impossible. There have to be agencies

out there monitoring this sort of thing on a day-to-day basis, combing

through the statistics with a fine-tooth comb? Not so - and anyway,

how could they?

Usually I-O depends on whistlblowers so if they are not protected and
given commissions in effect comparable to what Y-V give them then these
things are not exposed. Often trials can also be biased to Iv-Oy which 
hides chaotic side effects. 

Drug safety is supposed to be fully established in the

clinical trial process. Once a drug is out there in the community it could

wipe out thousands, unnoticed - witness Vioxx.