From: "Steve Harris" <sbharris@ix.netcom.com>
Newsgroups: sci.med
Subject: Re: 60 Minutes
Date: Tue, 17 Dec 2002 15:44:36 -0800
Message-ID: <atocu2$re1$1@slb9.atl.mindspring.net>

KyroDoc wrote in message <20021217122038.19671.00000059@mb-bd.aol.com>...
>60 MINUTES: DRUG RESEARCH ABUSE
>
>(CBS) Patients taking experimental drugs in clinical trials often don't
>know the doctors administering them are usually paid by drug companies -
>and that the drugs can sometimes worsen their health, Steve Kroft
>reports.


No, sorry-- the word "often" is dead wrong in this context. All these
studies require patients to sign an experimental consent form, which
includes all the stuff about experimentalism, and possible side effects. In
fact, usually patients are PAID to participate in these trials, and usually
paid in actual cash. If not, they are paid in free treatment and free
drugs-- NEVER ever does a patient have pay for an experimental drug in a
phase II or III trial. Only a socialist would fail to notice that the doctor
was handing out some pills without charging for them. That in itself should
be clue, even for a moron. What, do all these patients think that Santa
Claus came to them early this year?

The signed patient study disclosure forms remain on file. If the FDA audits
your study and you don't have them, you're up the creek. So is a drug
company which applies for drug approval without them.



>Tom Parham was one of those patients. His family doctor, who was one of
>Fiddes' partners, told him there may be some problems with his prostate,
>and suggested he go see Dr. Fiddes to enroll in a study on an
>experimental prostate medicine.


Well, then he knew it was experimental, didn't he?  And what did he (the
patient) get for being in the study?



>
>The doctor neglected to tell Parham that his history of heart problems
>put him at great risk if he took this medication.


But no doubt it was on the form the patient signed but didn't read. Because
the patient had a real incentive to be in this study, also. Nobody really
wants to talk about that.


>Dr. Fiddes got even more creative. When he couldn't find patients with
>ear infections for an antibiotic study, he just ordered up bacteria from
>an outside lab and faked the specimens.


Okay, here we have a completely dishonest researcher, and a thief. So this
one guy is the reason for 60 Minutes using the word "often"?

>Dr. Greg Koski, who runs the government's Office of Human Research
>Protection, says it's unfortunate but the system depends on
>whistleblowers. Koski's agency was upgraded recently and he now reports
>directly to the Secretary of Health and Human Services. The change was
>made last year, he said, to make sure that cases like the one involving
>Dr. Fiddes don't happen again. But his office has only 30 employees to
>watch the entire industry.
>
>That industry involves about a million human research subjects. But
>several recent government studies have found that not all these so-called
>"volunteers" know what they're volunteering for, or even that they're
>volunteering.



One would like to read these studies. Where are they published, please?



>
>The need for human study subjects has gotten so great that the
>pharmaceutical industry has resisted virtually any regulation that would
>make their job more difficult. Even major universities, which are
>supposed to oversee their own research studies, often have a financial
>stake in the drug being tested and stand to make millions in royalties if
>that drug is approved.
>
>According to Dr. Koski, this creates a situation in which a university
>stands to make millions of dollars on a drug that it partly owns. This
>same university appoints a review board to evaluate it.
>
>That, says Dr. Koski, "is exactly why they're not the ones who should be
>engaging in the research.




Why no.  Obviously the people doing the research should have financial stake
in it. Hmmm. Which would mean they'd have to be donating their time to a
private pharmaceutical company.  Perhaps they could send postcards around to
MDs and statisticians in the Christmas season, sort of like Toys for Tots?

Obviously this is a big problem. It's not like other government agencies,
where (let me see) the Highway Patrolman doesn't get fired if he writes no
traffic tickets, and the district attorney doesn't get fired if he gets no
convictions, and so on. And the police department has the same budget if it
confiscates 10 million in "drug money," vs. none.

And let us take a look at Dr. Koski, who is being interviewed. Now there's
an example of a fine public servant who has no stake whatever financially in
what he's saying: "Dr. Greg Koski, who runs the government's Office of Human
Research Protection, says it's unfortunate but the system depends on
whistleblowers. Koski's agency was upgraded recently and he now reports
directly to the Secretary of Health and Human Services. The change was made
last year, he said, to make sure that cases like the one involving Dr.
Fiddes don't happen again. But his office has only 30 employees to watch the
entire industry."

Which translated means that he wants more employees and more money, just
like every other government agency. And he certainly isn't going to get
these by singing songs about how everything is hunky dory in the regulatory
process, is he?

Well?  Is he?

SBH