Commentary on So-Called 'Biological'
Vera Hassner Sharav President of CIRCARE: Citizens for Responsible Care &
Research, writes:Informed consent is not trivial–every human being has the
inalienable legal right NOT to be subjected to medical experiments without
his/her voluntary, informed consent.
The FDA’s failure to enforce federal requirements of informed consent
has resulted in the unethical exploitation of individual patients,
some of whom were put in harm’s way. Furthermore, the Commissioner’s
failure to use the agency’s authority to improve compliance, puts
industry interests above patients interests, and by extension the
Aug 3, 2000, Page 18A
Rethink method of protecting patients
As a medical officer at the Food and Drug Administration, I was
delighted to read Commissioner Jane E. Henney’s Opposing View
editorial about the safeguards that exist within the FDA to protect
participants in drug trials and the rules that require ”fully
informed written consent.” Unfortunately, she did not articulate how
these rules should be enforced (”Better surveillance planned,”
Finding cancer cures debate, July 13).
As recently as May 1999, the FDA ignored a finding that written
informed consent had not been properly obtained from approximately 300
patients who participated in trials of the new diabetes drug Avandia.
Because more than 4,000 patients had been studied, exclusion of
results from these 300 patients would not have delayed approval of
this new medication.
The FDA could have sent a message to the pharmaceutical industry that
it took informed consent seriously. Missing this opportunity was not
simply an oversight.
To the contrary, I was advised not to bring up the informed-consent
problem at a public meeting of the FDA advisory committee where the
Avandia application was being discussed.
Although Henney states that her obligation to protect patients’ rights
is “deeply felt,” her method of implementing that obligation seems
designed to be ineffective.
Why did she write to USA TODAY, but not to her own staff?
Robert I. Misbin, M.D.
Here we have a federal employee, a medical officer at the Food and
Drug Administration advised/warned not to speak of informed consent
violations pertaining to Avandia, a new diabetes drug before the FDA for
approval. We, as a people, have a serious civil rights problem when
agencies of our own federal government allow violations of our informed
consent rights, in medical research, and orchestrate to cover it up.
Nor is this primarily a medical problem--it is a civil rights problem.
Nor is the situation, regarding informed consent, any better when you
are sick and seek care as an actual patient in our flawed, failing,
fee-for-service (fee-for-what?) health care system.
Researchers from the University of Washington found that physicians
dont sufficiently discuss treatment or tests with patients so as to
allow for informed consent. This research "tells us that the practice
of informed decision-making (fb-informed consent) is far below the
ideal" said Dr. Clarence Braddock UW assistant professor [Seattle Times,
San Diego Union-Tribune 12/ 23 /99, JAMA of the same week]. In 1057
doctor-patient encounters analyzed, only 9 percent of decisions
regarding care were fully informed. Visit were to 59 general internists
and general practitioners and general and orthopedic surgeons in Oregon
and Colorado and analyzed 3,552 clinical decisions (all of which should
have been made with informed consent. “Basic” decisions, like having a
blood test or physical therapy were completely informed only 17% of the
time. None (zero) of the “intermediate” decisions, such as whether to
take a new medication was fully informed. And only 0.5 % (1/2 of 1 %)
of “complex” decisions, such as surgery were adequately informed. 71%
(seventy-one) fully described the nature of treatment, such as the
purpose of medication. However, they were worst at determining whether
or not patients understood the treatment, or therapy. Physicians
assured that they did in only 1.5% of physician-patient encounters.
The only possible conclusion is that today, in the U.S., both in
practice settings and in federally-sponsored, federally-protected
research, the right of informed consent is almost always violated. It
is especially shocking to think that true informed consent almost never
attends surgical operations. We must ask why. We must ask whether this
is more often the case in fee-for-service care than in HMOs, and whether
more in some HMOs than others. Is there an incentive to limit care in
some HMOs and, if so, does this factor in an of itself beget misleading
disclosure and abridging the informed consent right? We know there is
an incentive to maximize, even inflate both diagnosis and treatment more
in some sectors of fee-for-service care than othersto what extent does
this lead to misrepresentation of the facts and to violation of informed
To what extent does biological psychiatry, that claiming to treat
illusory, never-validated diseases, violate informed consent. How could
it be other than universally the case, given there representation of
mental illnesses, symptoms and behaviors as diseases, when none of them
The burning question now is: What is the rate of valid informed consent
in medical research generally? In surgical research? In research in so
called “biological” psychiatry and psychopharmacology? I have seen
National Institute of Health/National Institute of Mental Health
informed consent documents regarding ADHD research and all of them
suggested that ADHD was biological, a disease, without directly saying
so. Such wording violates informed consent. My suspicion is that most
biological psychiatry research imparts by way of disclosure for informed
consent purposes, that the psychiatric disorders are “diseases”,
violating informed consent, skewing results in favor of the ‘biological’
These study results indicated something terribly amiss with US
healthcare generally. They also suggest a frightening level of
cavalier, ongoing violations of a fundamental civil, human rightthat of