Written by a medical doctor in reply to someone from theStreet.com
that doesn't know what he's talking about:
I would like to post this content from the hotest NNTP in the land
(pre-approved by the author). Thank you much.. Authored by:
abducens2006 (MD)
I wanted to write a detailed explanation of why I felt Feuerstein is
wrong yet again earlier today, but I didn’t have time. Unlike
Feuerstein, I actually take care of patients with cancer, and I wanted
to take the time to review CTIC’s poster carefully before commenting
further on it. So, here is goes….
Feuerstein is up in arms over the cardiotoxicity data presented on
CTIC’s poster. First, Feuerstein criticizes CTIC for not reporting the
MUGA scan results for 36 patients on the pixantrone arm of the study.
Did he bother to read that >70% of patients had an IPI>2, and >70% had
stage III or IV disease? An IPI score of at least 2 correponds to
intermediate or high grade disease. Patients with stage III or higher
represent a population of patients with advanced disease. Did he
bother to read that these patients were on at least their third or, in
some cases, fourth chemotherapy regimen? In other words, these
patients had advanced disease, and were in a salvage setting. So,
unfortunately for these patients, they are more likely to fail
treatment and experience side effects. So, it is not surprising that
70% discontinued pixantrone (vs 75% for the comparator group), and
ultimately 58% died before the study concluded. I would like
Feuerstein to explain how a physician can ask that 36% of patients who
are probably going on hospice to have a MUGA scan before they die.
That’s ridiculous. I’m frankly amazed that they were able to get MUGA
scans on 40% of pixantrone patients all the way through, given the 70%
discontinuation rate and 58% death rate. Were there any deaths
attributed to pixantrone? Not based on these data. No grade 5 events
were noted. So, Feuerstein’s ridiculous statement about the 36%
unreported MUGA scans just shows he has no clue how to interpret data
properly, and worse yet, he has no concept of what a patient/family go
through who have cancer.
Next, he makes a big deal about 5% decline in LVEF, like pixantrone is
some horrible drug. Newsflash, Adam, 5% LVEF reduction does NOT
correlate with clinical significance. I guarantee you, if a patient
with an LVEF of 55% drops to 50%, the patient will not be symptomatic.
Plus, many times MUGA scans or echocardiograms may have subjective
interpretation, and the 5% may not be accurate anyway. To me,
Feuerstein obsessing over this 5% reduction in LVEF is just silly, and
shows he has no experience in clinically managing patients with
cancer. To add insult to injury, he makes some snide comment about the
comparator arm getting a 1% gain in LVEF. So, Adam, does that mean we
should give chemotherapies on the comparator arm as a treatment for
CHF? Of course not. Could it be that 1% is subjective, and not worth
obsessing over?
Furthermore, he makes note of CTIC’s serious cardiac disorder of 8.8%,
but refuses to acknowledge that rate is much lower than historically
treated patients with anthracyclines, right there for him to see on
the poster. Plus, the comparator arm had a serious cardiac disorder
rate of 4.5%, so does that mean all chemotherapies are banned for
usage in these patients as well? Of course not. I’ve got news for
Feuerstein, chemotherapy is TOXIC, and therefore is associated with
side effects. That is inevitable. If Feuerstein ever knew a patient
that had cancer, or he himself ever got cancer, he would understand
that. For oncologists, we understand that certain chemotherapies are
going to have serious toxicities. The payoff depends on benefit. For
example, did Feuerstein criticize avastin for Genentech with its 12%
risk of stroke/pulmonary embolism/DVT as reported by Duke in
glioblastoma patients? Or the 3% risk of intracranial hemorrhage?
Guess what? Avastin was FDA approved recently for recurrent
glioblastoma, knowing full well these risks are reported in clinical
trials. In other words, just because a drug has a low risk of a
serious adverse event does NOT disqualify the drug from FDA approval.
Avastin very clearly shows this, and I would love to see Feuerstein
try to worm his way out of that one.
In addition, he took shots at CTIC for the lack of statistically
significant data on overall survival. Someone please remind the
resident biotech guru at thestreet.com that 55 people are still alive,
and you can’t calculate overall survival reliably until enough time
has passed. Furthermore, did Feuerstein even bother to read the chart
for time to progression, which clearly shows a subgroup of patients
out as long as 25 months? CTIC cannot comment on overall survival with
any degree of accuracy until these patients who are still alive are
followed out until their death. That sounds morbid, but it’s true. So,
for him to rip CTIC for this one is just wrong.
Did he notice progression free survival was improved on the pixantrone
arm, and it was statistically significant? Know why? The response
rates were clearly far superior on the pixantrone arm.
Lastly, did Feuerstein even bother to note that 15% of the patients on
the pixantrone arm previously had stem cell transplants? That means
they received super high doses of chemotherapy that ablated their bone
marrow, and received a transplant to regrow their bone marrow. So,
again, we’re talking about a patient population that is at greater
risk of toxicity. I’m frankly amazed the toxicity in this trial was
not worse.
I hope investors take some time and due their DD, rather than listen
to an unqualified political science major masquerade as a biotech
consultant.
I personally think the response data are very encouraging. I think the
data on cardiotoxicity, while not perfect, are acceptable, and show a
reduction in historically evident cardiotoxicity in patients treated
with anthracyclines. I believe all toxicities are manageable, and I
would not hesitate to offer pixantrone to a patient based on these
results. I think the demographics are well-matched, and the trial was
conducted in a randomized, controlled fashion, and that is quite good.
I believe pixantrone will achieve FDA approval, and I can’t wait to
hear Feuerstein’s temper tantrum. Is he going to blame Renaissance
Technologies for sabotaging his agenda against CTIC?
I think Adam Feuerstein is not qualified to comment on biotech stocks.
I think CTIC should file a lawsuit against him for slander, because
his accusations are childish, immature, incorrect and based on
malicious intent. I think thestreet.com should fire Feuerstein and
consider hiring a physician who has experience in clinical trials to
write these articles. Feuerstein is not qualified to comment on
clinical trials, and should not be allowed to report on anything
related to medicine.
There, now I’m done.
Almost: Yes, there is enough data to conclude pixantrone is
acceptable, in terms of risk, to use on lymphoma patients with
advanced disease with few options to help them. I am confident this
data will be enough to get FDA approval. Once again, avastin has 12%
risk of stroke, pulmonary embolism and blood clots based on data from
Duke, and yet it was approved BY THE FDA for glioblastoma patients. I
mean, geez, if your logic made sense, avastin wouldn’t be used across
the world for patients with high grade brain tumors. Do you get that?
-Abducens
