"There's now enough data to support consideration of access under an emergency use authorization by FDA." "The data from NIAID [National Institute of Allergy and Infectious Diseases] study should push this firmly over the line." Scott Gottlieb, former commissioner, U.S.Food and Drug Administration
"The
study demonstrates the potential for some patients to be treated with a
five-day regimen, which could significantly expand the number of
patients who could be treated." Chief Medical Officer Merdad Parsey, Gilead Sciences Inc.
"As part of the FDA's commitment to expediting the development and
availability of potential COVID-19 treatments, the agency has been
engaged in ... discussions with Gilead Sciences regarding making
remdesivir available to patients as quickly as possible, as
appropriate." Michael Felberbaum, spokesman, U.S. Food and Drug Administration
"The data shows that remdesivir has a clear-cut, significant, positive
effect in diminishing the time to recovery." "Although a 31% improvement doesn't seem like a knockout 100%, it is
very important proof of concept." "What it has
proven is that a drug can block this virus." "[But] whenever you have clear-cut evidence that a drug works, you have an
ethical obligation to immediately let the people in the placebo group
know so that they can have access." Dr. Anthony Fauci, immunologist, director, National Institute of Allergy and Infectious Diseases
"[The drug is] not the end of the story [when it comes to treatments for Covid-19]."
"We have work to do. We are looking for other therapies. This trial is going to continue."
"Four
days [fewer] in a hospital is, for me as a clinician -- as a clinical
practitioner -- it is not only significant but very meaningful. [This would matter] to all my patients and even to myself,
if I would be in the same situation."
Dr.Andre Kalil, principal investigator behind the clinical trial
The experimental
antiviral drug remdesivir, according to results out of Gilead Sciences'
Inc.Bottles of remdesivir in a hospital for Covid-19 patients in Wuhan,
China.
FeatureChina via AP
The experimental antiviral drug remdesivir, according to conclusions
reached through a clinical trial launched by Gilead Sciences Inc.,
helped to improve outcomes for patients diagnosed with COVID-19, the
data indicating that the drug worked more efficiently when used earlier
in the course of the illness that has caused a global pandemic,
infecting over a million people world-wide and leading to countless
deaths.
Several studies had previously been released whose outcomes presented a
contradictory picture of the drug's effectiveness. There were two
clinical trials linked to Gilead; a study conducted by the NIAID met its
major goal helping patients suffering a severity range of symptoms from
the disease caused by the novel coronavirus. That trial compared how
patients receiving remdesivir fared in comparison to others given a
placebo, expected to definitively demonstrate any benefits provided by
the drug.
Gilead announced that 62 percent of patients given early treatment with
remdesivir were able to be discharged early from hospital, as opposed to
40 percent of patients who were given the drug treatment later in the
course of the infection. The trial, with 397 patients taking part,
evaluated safety and efficacy related to the five-day regimen. Still,
there have been doubts expressed that it may not present a significant
benefit.
The Lancet
medical journal published results of a trial conducted in China which
reached the conclusion that remdesivir had failed to improve the
condition of patients. Gilead expressed its opinion that the Chinese
trial was inconclusive merely as a result of the study being terminated
too early. The result of the Chinese trial had been inadvertently
released by the WHO's emergencies program. Dr.Mike Ryan who heads the
WHO program declined comment.
"I just want to do what's best for Max. And sometimes that's tough love." "I
have no animosity toward Sarah on this issue. I think we both believe
we are doing the right thing. And I believe we both have Max's best
interest in mind." "I thought it was a long process and nothing drastic was going to really happen, at least without consent." "You don't just jump them into things they can't change back. When she's 18 and she does it, I'll support her 100 percent." "What if?" Clark, father of daughter/son (identities withheld) "I have a male brain that doesn't match up with the body I'm in. It's like being trapped in a cage." "It just kind of clicked right away [after watching YouTube video "Boy" while in Grade 7]." "Even if I'm open with who I am, I'm still insecure." Max, 14, Grade 9, Surrey, British Columbia
"I
didn't quite understand transgenderism myself, didn't know if I fully
believed in it. But having gone through the experience, I've gone
through with my son I fully believe that yes, it is very possible that
transgenderism does exist and there are people wandering around feeling
excruciatingly uncomfortable in their own skin." "If
this [testosterone injections] is what alleviates my child experiencing
this dysphoria, I'd rather move forward. ... If it happens to have side
effects down the road, we're OK to handle that -- at least our child
would still be alive." "I
don't want it on my conscience knowing that if this is all it took to
alleviate that dysphoria from my child then why didn't we follow through
with it? Sarah, Max's mother
"Max's
health care team has concluded that he possesses sufficient maturity
and intelligence to be capable of consenting to his own medical care,
notwithstanding the fact that he is only 14 years old. Furthermore, the
team agrees that the proposed course of treatment is in his best
interests." "Under
these circumstances we are of the view that it is ultimately up to Max
to give or withhold consent to is own medical care; neither you nor his
mother can make this decision for him." Letter to Clark, Max's father, from B.C. Children's Hospital
"I
have seen in some circumstances ,,, where young people have had health
care delayed and denied because everybody wasn't on board. One parent
is supportive, and one is not, and nothing happens. That can be a
problem. If the clinicians, the psychologists, the endocrinologists, the
family doctor, if all of them have done the assessment and have
determined that this is medically necessary, then it's important to
actually pay attention to the expertise." Elizabeth Aaewye, professor, UBC school of nursing
Some enterprising researcher who may have doubts about the new open and
accepting attitude of medical professionals toward accepting a child's
confident assertion that they are not in fact, a girl despite having
been born female, or a boy, identified as such at birth -- but in
reality a member of the opposite sex yearning to be recognized as such
and anxious to be given medical treatment to make the physical
transformation to match their psychological belief -- should begin
interviewing women of all ages to ask whether such gender-identification
confusion ever resonated with them.
It would, without doubt, be recognized that a good proportion of girls
in their early years fantasized being a boy, imagining how much freedom
it would confer upon them to do things that boys do so effortlessly and
so physically well coordinated, in rebellion against the cultural
confines they struggle against as girls. The same would be true for many
boys who resent the expectation that they will do
manly things and behave in a manner that fails to suit their
personalities, imagining that pressure would be relieved if they were
girls instead.
Children are suggestible, hugely so, and their imaginations can run
rampant into fanciful territory. We are a species never quite satisfied
with who and what we are, seeking to portray ourselves differently to
reflect what we would prefer, and at the same time we are
attention-seekers, wanting to stand out in the crowd, generally to be
admired, even if it takes a leap at non-conformity in rebellion to do
so; we see ourselves as individualists so often, entitled to insist on
having things our way. Who is it that can claim with complete confidence
that children are not in fact gender-confused psychologically and
briefly as part of maturation?
The general scientific, medical consensus seems now to have succumbed to
the confidence in belief of a biological mismatch between
ego/personality and birth presentation in gender. This is not now seen
as a type of brief psychosis, but rather a biological error in need of
intervention by medical science to remediate an error that nature
produced. And if this doesn't represent a confusion of medical arrogance
and layman effort to salve an emotional conundrum afflicting a steadily
increasing group of people for whom transgenderism has become an escape
from their reality in life, what else is it?
Max, all of 14, born a girl, feels she is a boy and insists she must
live out her life as a male. Her/his mind is settled on self as male and
all that is now wanting is to convince her father just as he was
successful in convincing his mother, and undergoing treatment to
transform his voice, his physique and confer upon him the male
characteristics that she so fervently wishes to acquire. All the medical
personnel consulted agree with that candidacy, as does mother Sarah,
but father Clark is the holdout. The parents are separated, with joint
custody and a provision in the custody agreement that both must agree on
any issues of substance.
Clark and Sarah must jointly exercise "all parental responsibilities" inclusive of "giving, refusing or withdrawing consent to medical, dental and other health-related treatments for the child",
reads their legal document. Despite which the B.C. Children's Hospital
invokes the B.C. Infants Act to insist that as long as a health care
provider is satisfied a child understands the nature, consequences,
benefits and risks of the proposed treatment and concludes that the
treatment is in the child's best interests the right to consent "belongs to the child alone".
Max was assessed a half dozen times over a period of several months
starting in Grade 8, by a clinical psychologist. When those sessions
ended, the psychologist considered Max a good candidate for testosterone
therapy, for Max demonstrated to the psychologist a "long-lasting and intense pattern of gender non-conformity or gender dysphoria"
among other issues related to the matter at hand. Sarah and Max went to
the B.C. Children's Hospital's gender clinic, reputed to be one of the
busiest in North America.
They met with a medical team that included a paediatric endocrinologist,
a social worker and a nurse. All described the treatment that Max would
undergo. On a three-page "informal consent form", the risks of testosterone therapy were laid out. The "treatment in young adolescents is a newer development, the long-term effects of which are not fully known".
Testosterone use would lead to permanent changes; a lower-pitched
voice, facial hair and thicker hair on arms, legs and torso, that would
prevail even should treatment be stopped.
Testosterone treatment could lead as well to an elevated risk of heart disease, stroke and diabetes. "It is not known", according to the consent form, what the effects of testosterone are on fertility. "You may or may not be able to get pregnant in the future". Max, said his mother, was definitely not undergoing some "phase".
Staff at the hospital were prepared to initiate injections that very
day, but Sarah felt it incumbent upon her to advise Max's father who was
shocked at the swiftness of the conclusion.
He refused his assent on the basis of the information on the form. A
court hearing has ensued. Clark's lawyer speaking for his client advised
they take the position that Max not be rushed into treatment, that no
injections should commence until such time as both parents agree to
consent, or Max turns 18, or the court orders treatment to proceed. The
judge, in hearing the details felt he had never encountered a case quite
like this before in his career.
He was not aware whether provincial law recognizing Max's rights to give
informed consent trumps family law and the parents' joint
responsibilities in care of their child as per their separation
agreement.
This represents a general opinion site for its author. It also offers a space for the author to record her experiences and perceptions,both personal and public. This is rendered obvious by the content contained in the blog, but the space is here inviting me to write. And so I do.
