Re: FDA Again!

[Guest guest]

In a message dated 5/30/99 9:04:59 AM Eastern Daylight Time,

hickorywind_98@... writes:

<<

If I wanted to put more time into this, I could say a

whole lot more and maybe I will if we go on and on,

but right now I am pressed for time (do I hear a

collective sigh of relief?) so again I'm outta here!

>>

Any time you feel like saying more, I feel like reading it. This is

absolutely invaluable! Thank you so much, Jane, for taking the time and

trouble to give us this information. I can't tell you how much I appreciate

it.

You certainly deserve a rest now. Have a wonderful weekend!

Connie

[Guest guest]

Hello to Everyone,

I had decided that I would not post any more messages

re this particular issue as I am now incredibly tired

of it.

The FDA has different offices which perform different

functions. One office (usually the office of

compliance or surveillance - depends upon the area,

i.e., drugs, biologics, etc.) is involved with

inspections of manufacturers to see if they are

keeping proper records (specification standards for

raw goods or chemicals, sterility, patient and

physician complaints and it goes on and on) and

complying with good manufacturing practices (outlined

in the Code of Federal Regulations).

Another office (for example, the office that monitors

the clinical trials, the actual accrual and content of

the clinical data - is almost totally populated by

physicians and scientists, engineers, statisticians,

most with advanced degrees) reviews and analyses the

clinical data on the safety and effectiveness of a

drug or biologic, whatever is being tested. This

review process does not begin with the conclusion of

the clinical studies and submission of the marketing

application. It begins before the studies are started

and continues throughout the studies.

Sometimes clinical investigators are paid by the drug

company, sometimes the medical center may be given a

grant and sometimes there is no money involved at all.

Clinical investigators are required by law to report

all of this information regarding monetary

arrangements to FDA. Potential conflict of interest

is considered and evaluated by FDA. Not only the

clinical investigators, but the members of the expert

advisory panels (panels of independent physicians and

scientists who review the same data as FDA) are

required to provide detailed information to the agency

regarding ALL of their financial interests, their

spouse's financial interests, etc. and here we are

talking about some of the most highly regarded

physicians in the U.S.A.-

The evaluative office of the agency compares the

results from investigators who have a monetary

interest, whether it be a grant to their institution

or an actual financial interest in the company, to

results obtained by investigators who do not have any

financial connection. The data are exhaustively

examined, compared - the FDA looks for anything that

could suggest bias on the part of the investigators.

Bias is looked for from other perspectives also - not

just on the basis of who got what and who got nothing

in terms of $$$.

In addition, medical centers are audited - that is FDA

goes to the doctor's offices (not all of them - not

enough resources - usually the ones with the most

patients or perhaps one where there is $$$ involved) -

these audits go on for weeks and the reports filed are

voluminous. As you can imagine, physicians involved

in these studies are overjoyed to see FDA people on

their doorsteps.

This process is not perfect, but I believe it to be

the most thorough of its kind on this planet. Do some

drugs get approved that we later find out have side

effects that did not emerge in the clinical studies -

yes. Why? One reason is that in a clinical study a

relatively small (compared to the population as a

whole who will use the drug) group of patients is

studied. These patients are carefully screened so

they meet very strict selection criteria. Once the

drug gets approved, this often is not the case.

Another reason is time - you cannnot expect a clinical

study to continue for 20 years - especially if the

drug is showing benefit and minimal side effects in

the study. There are people who can be helped and

quite frankly - who knows how long is long enough - 3

years, 5 years, 7 years??????? Finally there is an

issue of insurance coverage (for drugs, medical

devices like heart valves, etc.) - usually it is

difficult for patients to get reimbursed by their

insurance carriers for drugs, devices, etc. that are

not approved by FDA.

If I wanted to put more time into this, I could say a

whole lot more and maybe I will if we go on and on,

but right now I am pressed for time (do I hear a

collective sigh of relief?) so again I'm outta here!

Jane

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