My Tysabri Diary...

Happy New Year everyone! Before I tell you how my new year began this morning (below), I'd like to answer a question raised recently in an anonymous comment on my Blog regarding Anita Smith from the Tysabri combo Trials (Sentinel) with Avonex that developed PML and died, as she did not have MS, nor did the Crohns patient that developed PML and subsequently died. In other words, no patient with a confirmed dx of MS that received Tysabri as a monotherapy (approx. 3,000 trial and 5,000 general population) from 11/04 through 2/28/05 (that's 8,000 patients) none developed PML and died...again ZERO, or a risk factor of 0:8000.

Pasted below are pertinent portions of the testimony provided to the FDA Advisory Committee in March '06 from her neuroradiologist, Gregory Shoukimas, MD, who testified that “Her autopsy report was published in the New England Journal of Medicine in 2005, and the results of that autopsy report indicate that she did not have any histopathological evidence of MS.” I have also pasted below the pertintent portions of testimony from Mark Godec, MD, who reviewed Anita Smith’s medical records at the request of her family. Anyone can research the FDA website for the full testimony transcripts.

Here are the pertinent portions of testimony indicated above:

9 DR. SHOUKIMAS: Good afternoon. My name
10 is Dr. Gregory Shoukimas. I am a neuroradiologist
11 and have been practicing for 20 years, and I am
12 here at the request of the Smith family. I am not
13 sponsored by Biogen, and I am not sponsored by any
14 competitors.
15 I am here to address primarily the issue
16 of the raw data, that is, the individual data that
17 a patient presents with and was enrolled in the
18 study, the Tysabri study. That is, how did Anita
19 Smith present clinically, what was her
20 symptomatology, what was her physical examination,
21 and what tests aided in making the diagnosis of
22 multiple sclerosis.
(225 of 356) [3/17/2006 10:41:27 AM]
1 In the talks that you have heard this
2 morning, it is assumed that Anita Smith had
3 remitting-relapsing multiple sclerosis, and that
4 has been called into question. I have no time to
5 go into the details of her physical examination,
6 but suffice as to say that her clinical
7 symptomatology was benign, relatively benign, was
8 not disabling, and certainly did not contribute to
9 her disability scores.
10 Her physical examinations for the most
11 part were normal. She showed very minimal signs of
12 decreased leg strength, spasticity, and slight
13 hyperreflexia.
14 In December of 2001, her physical
15 examination was entirely normal. She had reported
16 to her neurologist she was doing well, and she had
17 normal muscle strength in all major muscle groups,
18 but despite all this clinical information that was
19 available, she was being considered by her
20 neurologist for the Antegren or Tysabri study,
21 which she was told would be starting shortly, that
22 is, within three or four months.
(226 of 356) [3/17/2006 10:41:27 AM]
1 I had the fortune of talking with the
2 Smith family for about an hour, and it was related
3 to me by Mr. Smith and his daughter, Beth, that
4 from the time of her visit to enrollment in the
5 study, that is, the time of her first visit to the
6 neurologist to enroll in the study, she thought of
7 her problem as an annoyance.
8 She worked, carried the laundry up and
9 down stairs, clearly not indicative of a disabled
10 patient. She didn't get worse, and she didn't get
11 better. There was some indication that she had
12 visual problems, but this was never tested formally
13 with electrophysiology tests to confirm that she
14 had optic neuritis.
15 Her magnetic resonance imaging study in
16 1999, which I have reviewed, showed some
17 nonspecific white matter changes, and, in fact,
18 given her previous history of migraine, may have
19 reflected previous migraine. The changes were
20 nonspecific, and while demyelination was considered
21 criteria for this, for the diagnosis of MS was not
22 fulfilled.
(227 of 356) [3/17/2006 10:41:27 AM]
1 She had a cerebrospinal fluid analysis,
2 which was normal, including IgG assessment,
3 oligoclonal bands were nonexistent, and had one
4 lymphocyte, which is nonspecific.
5 Electrophysiology studies were not
6 performed especially visual, evoked potentials,
7 which would have been helpful in making the
8 diagnosis of optic neuritis.
9 Her clinical examination, as briefly, very
10 briefly detailed, but more fully talked about by
11 Dr. Godec later today, showed that she did not
12 really have two clinically symptomatic attacks and
13 that her objective lesions were not clearly
14 defined.
15 So, the question really is did Anita Smith
16 have multiple sclerosis. The talks again have
17 assumed that she had relapsing-remitting disease,
18 but, in fact, this was not ever clearly
19 established. If, in fact, it was present at all,
20 it was mild and stable with minimal neurological
21 manifestations, and any objective tests that might
22 have been helpful were ignored.
(228 of 356) [3/17/2006 10:41:27 AM]
1 These are the MRI scans, which were not
2 available when the New England Journal of Medicine
3 published its clinical pathological study detailing
4 the effects of MS on Mrs. Smith, and the Tysabri
5 results and the progressive multifocal
6 leukoencephalopathy which ensued.
7 These were the lesions that were described
8 as 9 lesions. These are two illustrative MRs.
9 There is a lesion back here. These are not very
10 typical of MS. They are nonspecific findings.
11 These are two patients that have MS,
12 similar in presentation, a little bit more severe,
13 more objectively defined disease, but these MR
14 scans are clearly contributory. There are some
15 lesions in the periventricular white matter, close
16 to the cephalo-junction region. In the Annals of
17 Neurology 2001, the McDonald criteria were
18 published, and clearly defined how MRs should be
19 interpreted with respect to MS. The MR scan that
20 Mrs. Smith underwent did not meet that criteria.
21 After her enrollment with two potent
22 immunosuppressant and modified immunomodified
(229 of 356) [3/17/2006 10:41:27 AM]
1 drugs, she was a minimally symptomatic patient
2 whose diagnosis was questionable, and yet she was
3 given the drugs, and progressive multifocal
4 leukoencephalopathy ensued, causing her demise....
(230 of 356) [3/17/2006 10:41:27 AM]
1 examination in the literature. Her autopsy report
2 was published in the New England Journal of
3 Medicine in 2005, and the results of that autopsy
4 report indicate that she did not have any
5 histopathological evidence of MS. In fact, the
6 report showed widely disseminated PML and evidence
7 of possible vasculitis.
8 The enrollment MRI I obtained on court
9 order was not available to the New England Journal
10 of Medicine at the time that the report was made
11 regarding her clinical history and ultimate demise.
12 The British Medical Journal and Lancet
13 have recently published articles also questioning
14 whether or not, in fact, Anita Smith had MS, and...
(231 of 356) [3/17/2006 10:41:27 AM]
1 other patients were enrolled as well, especially
2 since new clinical trials by Biogen Idec are
3 anticipated and possible approval of Tysabri for
4 clinical use is anticipated.
5 Thank you.
# # # # # # # # # # # # # # # # # # #

5 DR. GODEC: I am Dr. Mark Godec, a
6 physician in private practice in the Washington,
7 D.C. area. I have no financial interest in Biogen
8 and Elan, and I have not received financial support
9 from any competing companies.
10 I would like to thank the committee for
11 the opportunity to speak today.
12 Anita Smith was a healthy, active woman
13 until her final months and untimely death from PML...
(317 of 356) [3/17/2006 10:41:27 AM]
1 However, the medical evaluation that led
2 to the diagnosis of MS was incomplete and produced
3 results that were not diagnostic of MS. At most,
4 only her presenting episode provided objective
5 clinical evidence of a CNS lesion that might be due
6 to MS.
7 An MRI of her brain revealed only a small
8 number of nonspecific lesions that did not enhance
9 with gadolinium. Her CSF never showed oligoclonal
10 bands that are characteristic of MS.
11 EP studies were not performed and she was
12 not evaluated by a neuro-ophthalmologist...
(318 of 356) [3/17/2006 10:41:27 AM]
5 enrollment MRI actually shows only four or five
6 nonspecific lesions per Dr. Greg Shoukimas, who you
7 heard earlier today.
8 In November 2004, Ms. Smith developed much
9 more serious neurological signs and symptoms.
10 Tysabri was eventually discontinued, but her
11 condition continued to deteriorate.
12 Anita Smith tragically died on February
13 24th, 2005, from PML at the age of 46.
14 Neuropathological examination of her brain and
15 spinal cord revealed only PML lesions, and no MS
16 plaques, verifying that she did not have MS....
(319 of 356) [3/17/2006 10:41:27 AM]
14 Thank you very much.
*******

Now, on to happier news....My new year started today, when this morning, I was able to take one step again (not very graceful and kind of shakey) while holding onto my caregiver... BUT wooooooohooooooo!

Also see the following email that I received yesterday from another RemedyFind viewer...DOUBLE WOOHOO! Tysabri equals Hope!

Subj: Happy New Year
Date: 1/1/07 7:32:39 PM Pacific Standard Time
From: xxx
To: lglbgl2003@aol.com
Sent from the Internet (Details)

Thank you for the info you have posted on this site about Tysabri. I was a little scared to try it, but reading things like what you had written pushed me in that direction. I had my 1st infusion in Dec. and go again on Jan. 18th. The circulation has come back in my right foot and leg for the 1st time in about 2 years. That foot has remained freezing cold until about 10 days after my infusion when my whole leg got pins and needles and the warmth returned that same night. UNBELIEVABLE !!! I'm hoping that my foot drop and limp will begin to improve also. Thank you again for your encouraging words and I wish you the best of health for the New Year. xxx -------------------------------------------------------------------------------------------------------------
(This email was sent to you from another RemedyFind member. They have not seen your email address, as the email was sent through the RemedyFind web site. If you reply to this email however, then they will be able to see your email address.)
***

2007 is looking good! Woooooooohooooooo and Yeeeeeeehaaaaaaaaaw!

(((hugs)))
Love, Lauren
A very proud member of www.MSpatientsforchoice.org