Hello Ted,

I have been involved in medicines control for about 10 years now, and
can give you the South African position. It is likely to hold for many
other agencies, as the principles applied in most countries that are
serious about regulating medicines is very much the same.

The decisions are made on "evidence". Rarely decisions are based on
recommendations of "expert" groups (e.g. the recommendation for the use
of antiretroviral therapy in occupational exposure where the database is
as yet small.)

The evidence is usually clinical trials, and these are usually
eventually published and are then publically acessble. The regulatory
authority has the option to ask for the data in a format not
neccessarily published- e.g. stratified by age, or even the raw data.
The FDA is the only authority that routinely does its own analysis of
the raw data. So, the authority often receives the data before
publishing has been completed, and may so make decisions at variance
with the authors of the publication. It also happens that some studies
put to the authority do not get published - this is especially likely to
happen with "negative" results - but there may be pertinent information,
such as side effects, that are nevertheless incorporated in the
decision. Of course, the company also submits information to the
authority about the manaufacturing process etc. These data are trade
secrets and will not get to the public domain. For this reason, most
countries have legislation that protects the company's confidential
information. (In South Africa, jail of 2 years may be imposed on any
person divulging such information) The reason for this is clear - if a
company could not depend on confidentiality, they would be less than
forthcoming in divulging potentially problematic areas in the
manufacture of their product. 
For this reason most authorities appear very reluctant to divulge the
"evidence" for their registration decisions.
But, before you start feeling that the user (prescriber) is kept in the
dark by this process, every country has a document that summarizes the
product characteristics. You may rest assured that in most of the first
league players every claim in this document has been carefully vetted
against the evidence. In many countries this information appears in the
package insert (PI). In the FDA PI you will often find an "executive
summary" of the major clinical trials on which the claims are based,
allowing the prescriber to weigh the evidence for him/herself.
Many of the larger pharmaceutical companies prepare a product book(let)
containing all recognized claims that contains all the references. 
The FDA freedom of information act DOES allow access to at least some of
the data, but it is likely that they will have some mechanism to ensure
confidentiality.

>From the above, you may conclude that the registering agency, such as
the MCA is not likely to be a satisfactory source, perhaps asking the
company for the references (or their product characteristic summary) and
then careful comaprison with a professional package insert (I would
suggest the FDA) may go a long way to achieving your purpose

Sincerely,

-- 
********************************
Prof A.L. van Gelder FRCP
Head, Dept of Internal Medicine
University of Pretoria and
Pretoria Academic Hospital
Tel 012 3542287, Fax 012 3291327
********************************

"(Ted Harding)" wrote:
> 
> Hi Folks,
> 
> This is a bit of a catch-all question and I'm not sure how best
> to put it. Anyway:
> 
> There are various bodies in the UK whose function is to pronounce
> on the efficacy and/or safety of medical treatements and/or
> other substances etc which people might be exposed to.
> 
> For instance, the Medicines Control Agency and Committee for Safety of
> Medicines for medical drugs and treatments.
> There is also NICE for questions of cost-effectiveness etc.
> 
> There are other bodies who deal with products such as agricultural
> pesticides or insecticides or growth-promoters etc.; and I presume
> that at least in certain cases there are bodies who deal with
> the safety of domestic products (again pesticides and the like;
> also cleaning agents, air fresheners, ... with potentially noxious
> effects; etc.).
> 
> Now (as best I can) my question: Assuming one of these bodies
> has approved the product in question, they have presumably done
> so on the basis of some evidence specific to the product.
> 
> So: can an interested party learn what the evidence was?
> 
> That is the question.
> 
> It is my impression that, pretty well across the board, the evidence
> is not avaiable and the "user" has to trust the approving agency
> (and assume that they are not motivated by a political agenda,
> as has been suggested for NICE for instance; nor by improper
> commercial pressure as had been suggested in the case of GM foods,
> etc.)
> 
> (There is the occasional exception -- for instance the WWW-accessible
> report http://www.open.gov.uk/mca/mmr1.htm about the MMR vaccine
> question).
> 
> So if anyone has informative comment I'd be interested to learn of it.
> 
> Is the situation different, for instance, in the US ("Freedom of
> Information Act" and all that)?
> 
> No doubt in the case of some agencies their _guidelines_, at least,
> are available for inspection; but this does not solve the question
> where specific products are concerned.
> 
> With thanks,
> Ted.
> 
> --------------------------------------------------------------------
> E-Mail: (Ted Harding) <[log in to unmask]>
> Date: 06-Dec-99                                       Time: 12:23:40
>                                                 2201780 seconds left
> ------------------------------ XFMail ------------------------------


%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%%