CIRCARE: Citizens for Responsible Care & Research
A Human Rights Organization
veracare@...

FYI

CBS Healthwatch focusing on disturbing findings about research abuse,
correctly noting: "the current atmosphere of little white lies and
questionable financial arrangements points to a deepening crisis."
(this is a separate report sfrom the one to be aired by 60 Minutes on
Sunday)

"Documents from the National Institutes of Health show that informed-consent
problems accounted for 34% of government crackdowns on clinical trials over
the past 10 years, making this the second leading reason why researchers
were cited for violations." A new report in the Lancet found that " 22% of
mothers did not fully realize the discomfort their infant might go through
in a study."

"Patients are being encouraged to enter clinical trials with false promises
of access to 'cutting edge, free treatment,'" claims Vera Sharav of Citizens
for Responsible Care & Research. "Physicians are earning more money
recruiting their patients for clinical trials than treating them with proven
treatments."

The human cost is beginning to be recognized. How many lives are being
sacrificed? Noreen Townsend, whose daughter suffered from pulmonary
hypertension died, allegedly because of an NIH-sponsored prostacyclin
experiment. She is suing the University of Colorado and several other
doctors.

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http://healthwatch.medscape.com/medscape/p/G_Library/article.asp?RecID=23663
5&ContentType=Library&DietImg=1


"I Was in a Scientific Study? No One Told Me"

Eric Sabo, Medical Writer
Mar.2001

Administrators for the University of Missouri-Columbia admit they have a
delicate task on their hands. Several years after the fact, they must track
down patients who were involved in an experiment that compared a traditional
heart bypass surgery to a new one. The news is fine--both procedures worked
out well--but the federal Office for Human Research Protections is making
the university tell patients something that lead investigator Dr. Jack
Curtis neglected to: that they were involved in a study in the first place.

"We are trying to be appropriate and considerate to the patients on what
took place," says university spokesperson Mary Jo Banken. "The most
important thing to convey is that at no time did they not receive the best
medical care."

Experts say that few researchers are probably brazen enough to keep subjects
completely in the dark. But don't expect all fast-talking scientists to be
completely upfront about their intentions, either.

Patient advocates warn that a highly competitive drug development business
often provides sick and frail subjects with only part of the story.


Although safeguards exist, patient advocates warn that a highly competitive
drug development business often provides sick and frail subjects with only
part of the story.

"Patients are being encouraged to enter clinical trials with false promises
of access to 'cutting edge, free treatment,'" claims Vera Sharav of Citizens
for Responsible Care & Research. "Physicians are earning more money
recruiting their patients for clinical trials than treating them with proven
treatments."

Informed consent remains the Miranda rule for those entering a clinical
trial: Researchers must explain the reasonable benefits and risks that
subjects can expect from participating. But how good is this information,
and do patients really understand what they're getting into?

Based on a review of several research reports, court documents, and
government records brought to light by groups critical of the current
protections for human subjects--as well as interviews with nearly two dozen
experts familiar with these issues--CBS HealthWatch has turned up many
instances where the dangers of a study were far more serious than subjects
realized and far more serious than they had been told.


Bad Docs
In fact, withholding relevant information from study volunteers is a major
source of trouble. Documents from the National Institutes of Health show
that informed-consent problems accounted for 34% of government crackdowns on
clinical trials over the past 10 years, making this the second leading
reason why researchers were cited for violations. A similar pattern of bad
advice is also alleged in several recent lawsuits.
"Patients think they're talking to a doctor, but they're really talking to
an entrepreneur," says Alan Milstein, an attorney who represented Jesse
Gelsinger's family and is now suing the University of Oklahoma for
misleading subjects on the true nature of a cancer vaccine trial. "What we
find in these cases is that even though the risks may be in the consent
form, the doctor will say, 'Don't worry about it. This is just something our
lawyers make us put in.'"

Such serious breeches of trust, many experts contend, are far more the
exception than the rule. But some worry that these high-profile abuses may
scare off patients and undermine legitimate efforts to find new treatments.
US research has emerged from the Cold War days of secretly feeding
radioactive oatmeal to a group of mentally handicapped children--one of
several horror stories that came out of a 1995 investigation by the
Department of Energy. Still, the current atmosphere of little white lies and
questionable financial arrangements points to a deepening crisis.

Some worry that these high-profile abuses may scare off patients and
undermine legitimate efforts to find new treatments.


Some key concerns:

Drug companies are demanding faster recruitment, larger trials, and more and
more subjects with very specific types of problems. Out of all the research
protections in place, informed consent may take the biggest hit from these
pressures, concludes a recent US inspector general's report.

Clinical trials are rapidly shifting from public medical centers to private
research facilities, where there are no legal requirements that determine
what patients should be told about a study. Nearly half of all research is
done in private settings, up from 20% just 5 years ago.

Doctors have increasingly lucrative deals to recruit subjects and conduct
studies. Yet a recent survey of review boards that oversee this research
found that only 25% looked at whether these dealings might pose a conflict
of interest.

A record number of children are entering clinical trials, and parents may
not understand all the complicated problems that may be involved in
volunteering their kids for research. A new report in the Lancet, for
instance, found that 22% of mothers did not fully realize the discomfort
their infant might go through in a study.

Good Reasons To Join
There are of course many good reasons to join a trial. Along with free
treatment, patients often receive better care in a research setting than
most can expect to get otherwise.
Studies do pose certain risks, however, and that can be touchy to explain.
Patients need to know the possible dangers. But at the same time, too much
information can be just as confusing, experts say. Now there is a new twist.

The number of drugs in preclinical testing had jumped from 2,585 in 1995 to
3,278 by 1998, and the costs and number of subjects enrolled in each study
have skyrocketed. To help recoup their investments more quickly, companies
will sometimes pay researchers for each patient they sign up. If an
investigator gets a bonus for recruiting 30 subjects and has only 29, one
researcher explained to government investigators: "You could bet the site
would get the 30th subject...but I wouldn't guarantee what you'd find."

The secretive nature of these arrangements leaves patients to fend
themselves.

"A patient may think that doctor has their best interest at heart when they
recommend a study, but how do they know that they're not just doing it for
the money?" asks Abbey Meyers, president of the National Organization for
Rare Disorders. "It's a terrible problem."


Not Knowing
Noreen Townsend can only guess what doctors where thinking when they
enrolled her 40-year-old daughter, Julia Caren, in a trial. Caren suffered
pulmonary hypertension in addition to being deaf. After visiting a hospital
near her home in Mesquite, Texas, she was told she would have to go the
University of Colorado to get special medication for her heart. The drug
failed to work, and she died waiting for a heart and lung transplant.

It was only later that her family learned that another hospital closer to
home could have looked after Caren just fine. The University of Colorado,
however, was conducting a NIH-sponsored study on prostacyclin, a treatment
that Townsend blames for her daughter's death.

"We did not know it was a study," she says. "My daughter was deaf and she
was tricked into being a human research guinea pig."

Townsend is suing the University of Colorado and several other doctors
because of what happened to her daughter. Researchers forwarded a request
for comment to University spokesperson Sarah Ellis, who says they did
nothing wrong. "We believe the suit is without merit," she says.

Caren was clearly sick and it's hard to say one way or the other whether the
treatment was responsible for her death. But when Townsend contacted one of
the investigators, Dr. Norbert Voelkel, to see about an independent autopsy,
she was met with a long pause on the phone.

"'I would recommend that you not do that,'" she recalls Voelkel finally
said. "We told him that we had to know why she died. Dr. Voelkel then told
us that, 'Well, we still have her heart and lungs here.'" This was not what
the family said they agreed to.

"They took the organs they wanted for their research projects after we told
them 'no,'" Townsend says.

How To Protect Yourself
Patient advocates recommend that you keep these issues in mind before you
join a clinical trial:

Take time to consider whether the study is right for you. Talk to other
doctors, family members, or friends to see if they think the study is worth
joining. In other words, don't just sign on the dotted line when a doctor
hands you a consent form.

Be wary if researchers offer you a substantial amount money. Many clinical
trials will reimburse you for travel and other small expenses, but it's not
uncommon nowadays to hear about patients making thousands of dollars for
participation in a study. Experts worry that such lucrative incentives may
cloud people's judgement. Think of the long-term health consequences before
you consider making a fast buck.

Researchers should answer any questions you may have about the study. You
may want to ask if the experiment will be painful or uncomfortable. Or who's
responsible for your care if you get hurt? Who is sponsoring the study, and
for what purpose? How many other people have taken this drug? What happened
to them? You can request the answers in writing.



Mar.2001
© 2001 by Medscape, Inc. All rights reserved.

Eric Sabo is a staff writer for CBSHealthWatch. His work has appeared in
Johns Hopkins Health After 50, Newsday, and Men's Health.


Reviewed for medical accuracy by physicians at Beth Israel Deaconess Medical
Center (BIDMC), Harvard Medical School. BIDMC does not endorse any products
or services advertised on this Web site.
© 2001 Medscape, Inc. | URL