Jim
I think a case can be made for a distinction between individuals and
organizations, particularly for regulators.
Regulators are regularly "captured" by those they are supposed to
regulate. This is a general problem, and not limited to health or to
the USA. Perhaps the most glaring evidence comes from the financial
crisis that started in 2007: banking and financial services regulators
around the world have been captured by banks and the financial
services industry.
Quis custodiet ipsos custodes?
It is heroic individuals like Frances Kelsey, not organisations, who
overcome institutional opposition to shine the light on the evidence
that regulatory procedures need to be thief- (not fool-) proof.
Michael
On 1/4/12, Ash Paul <[log in to unmask]> wrote:
> Point taken Jim, Frances Kelsey must have certainly had supporters within
> the FDA, but I had read in a few years ago that the pharma company and her
> detractors inside and outside the FDA made life so difficult for her that
> anybody else would have given up in disgust and thrown in the towel a long
> time back.
> The full story of Frances Kelsey and Thalidomide makes for an
> astonishing/fascinating read of her resilience and determination:
> http://biotech.matcmadison.edu/resources/methods/quality/documents/220_16_KelseyCaseStudy.pdf
> Regards,
> Ash
>
>
>
>
>>________________________________
>>From: Jim Walker <[log in to unmask]>
>>To: [log in to unmask]
>>Sent: Wednesday, 4 January 2012, 13:55
>>Subject: Re: Annals of Medicine on EBM and HPV vaccine policy (similarities
>> to Pirfenidone)
>>
>>Hi Ash.
>>Interesting binary distinction between an organization and the individuals
>> who comprise it.
>>I take it that Kelsey had no supporters (active or passive) within FDA?
>>
>>Jim
>>
>>James M. Walker, MD, FACP
>>Chief Health Information Officer
>>Geisinger Health System
>>
>>
>>>>> Ash Paul <[log in to unmask]> 1/4/2012 3:03 AM >>>
>>Dear Jacob,
>>The fact that the FDA refused to license Thalidomide in the USA, was not a
>> testimonial to the organisation in general but to one individual in
>> particular viz Frances Oldham Kelsey
>>Ref:
>>The Public's Quiet Saviour from Harmful Medicines
>>http://www.nytimes.com/2010/09/14/health/14kelsey.html
>>Regards,
>>Ash
>>
>>
>>>________________________________
>>>From: Puliyel <[log in to unmask]>
>>>To: [log in to unmask]
>>>Sent: Tuesday, 3 January 2012, 17:18
>>>Subject: Re: Annals of Medicine on EBM and HPV vaccine policy
>>> (similarities to Pirfenidone)
>>>
>>>
>>>Dear Ash
>>>You ask
>>>Why are you venting your ire and frustration solely at the FDA?
>>>
>>>The Annals Med article says
>>>The world looks to the FDA as a leader in medicine and science.
>>>
>>>Perhaps because of the fact that FDA refused to license thalidomide for
>>> general use in the USA, it has something of a cult status. It is sad that
>>> the present administration is willing to sell itself for mess of pottage.
>>>
>>>Jacob
>>>
>>>
>>>
>>>
>>>On 03-Jan-2012, at 8:32 PM, Ash Paul <[log in to unmask]> wrote:
>>>
>>>
>>>Regards,
>>>
>>>
>>
>>
>>
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