Monday, August 04, 2008

Biogen and Elan stand firm behind Tysabri despite PML cases - Clinics make a mint on fake HIV treatment

Seattle Genetics Initiates SGN-70 Phase I Clinical Trial - Investigational Therapy For Autoimmune Diseases

Seattle Genetics, Inc. (Nasdaq:SGEN) announced that it has initiated a phase I clinical trial of SGN-70, a humanized monoclonal antibody targeting CD70 that is being developed as an investigational therapy for autoimmune diseases.


Biogen and Elan stand firm behind Tysabri despite PML cases
Biogen Idec and Irish partner Elan Corp have said that they have no intention of suspending sales of Tysabri despite being linked to two new cases of progressive multifocal leukoencephalopathy in patients with multiple sclerosis

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Copaxone competitor again linked to illnesses
Globes - Rishon Le-Zion,Israel
Copaxone competitor for treating multiple sclerosis Tysabri may again be taken off the shelves, after it was linked to new cases of progressive
multifocal ...
See all stories on this topic

Out of the shadows
Irish Independent - Dublin,Ireland
About this time, Marie began to hear about a drug called Tysabri, which might reduce the number of relapses she was having. Tysabri is not suitable for all ...
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Lightning strikes third time at Elan
Irish Independent - Dublin,Ireland
Potentially far more serious was Friday's announcement that long-standing problems with Tysabri, its much touted Multiple Sclerosis drug, had recurred. ...
See all stories on this topic


Two fresh cases of brain infection linked to Biogen/Elan's Tysabri
Biogen Idec and Elan Corp have suffered a stock slide in after-hours trading after the firms revealed two new cases of progressive multifocal leukoencephalopathy, in MS patients being treated with Tysabri, the brain infection that led to the drug being withdrawn in 2005

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Makers of MS Drug Confirm Two Cases of Life-Threatening Brain Infection
CAMBRIDGE, Mass. -- Two multiple sclerosis patients -- both in Europe -- have developed progressive multifocal leukoencephalopathy (PML) as a result of treatment with natalizumab (Tysabri), according to the makers of the drug.  full story

MRI in Differential Diagnosis of MS

In this case-based CME/CE newsletter, Dr. Tracy DeAngelis seeks an accurate diagnosis for a patient whose MRI suggests chronic demyelinating disease by applying updated McDonald Criteria and performing additional workups to rule out other potential causes of the MRI abnormalities.
Source: Projects In Knowledge


The Advanced Certificate Program:

Multiple Sclerosis Management

As required by the ACCME, all participants must read the information below before proceeding to this activity.
After doing so, please click the Launch Activity button at the bottom of this page.

Tx Reporter Newsletter

Case Study: MRI in Differential Diagnosis of MS

In this case-based Tx Reporter, Tracy M. DeAngelis, MD, navigates the complicated task of achieving an accurate diagnosis for a 31-year-old woman who presents with migraines and whose MRI suggests chronic demyelinating disease. Dr. DeAngelis illustrates the step-by-step process implemented to obtain a diagnosis, including the updated McDonald Criteria, the consideration of multiple conditions that could account for the MRI abnormalities, and the additional workup needed to rule out these conditions. This course is part of The Advanced Certificate Program: Multiple Sclerosis Management.



Aaron E. Miller, MD 

Professor of Neurology and
  Medical Director
The Corinne Goldsmith
  Center for Multiple Sclerosis
Mount Sinai School of Medicine
New York, NY

Tracy M. DeAngelis, MD 

Assistant Professor of
The Corinne Goldsmith
  Center for Multiple Sclerosis
Mount Sinai School of Medicine
New York, NY Dear Colleague:

Magnetic resonance imaging (MRI) has emerged as an invaluable noninvasive tool in the early diagnosis of multiple sclerosis (MS). While diagnostic criteria incorporating MRI findings are highly sensitive and “dissemination in time and space” remains a standard for MS, it is important to recognize that MRI findings alone are not diagnostic. Careful consideration must be taken of the patient’s history, clinical symptomatology, and laboratory studies such as cerebrospinal fluid analysis. Numerous other conditions can produce MRI findings similar to those of MS, and should be considered in the appropriate clinical setting before a definitive diagnosis is made.

In this Tx Reporter, MRI in Differential Diagnosis of MS, Dr. DeAngelis describes the complicated diagnosis of a patient whose MRI suggests demyelinating disease after she presented for migraine. Through this case, Dr. DeAngelis illustrates how to apply updated McDonald criteria to diagnose MS, other conditions to consider in the differential diagnosis, and the steps necessary to exclude alternative possible etiologies for MRI mimickers of MS before arriving at a definitive diagnosis. Although the benefits of early treatment of MS have been at the forefront of recent research, this case underscores the importance of conducting a thorough diagnostic evaluation of atypical clinical presentations prior to initiating therapy for MS.

This newsletter represents course 4 in The Advanced Certificate Program: Multiple Sclerosis Management. I hope you find this newsletter and the other CME activities in this curriculum both enlightening and helpful to your practice.


Aaron E. Miller, MD

Target Audience

This series of activities is designed for neurologists and other clinicians who specialize in and care for patients with multiple sclerosis.
Activity Goal
The goal of these CME/CE activitities is to examine current and emerging strategies for treating and managing patients with multiple sclerosis.
Learning Objectives
•      Interpret MRI findings along with clinical signs and symptoms and results of other testing to make an accurate diagnosis of MS based on updated McDonald criteria.
•      Recognize conditions that present with MRI findings similar in appearance to MS that must be considered in the differential diagnosis, according to recent reviews of this issue.
CME Information: Physicians
Statement of Accreditation
Projects In Knowledge® is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Credit Designation
Projects In Knowledge designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

CE Information: Pharmacists

Projects In Knowledge® is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.
This program has been planned and implemented in accordance with the ACPE Criteria for Quality and Interpretive Guidelines. This Tx Reporter Newsletter is worth up to 1.50 contact hours (0.15 CEUs). The ACPE Universal Program Number assigned to this activity is 052-000-08-037-H01-P.


Disclosure Information
The Disclosure Policy of Projects In Knowledge requires that presenters comply with the Standards for Commercial Support. All faculty are required to disclose any personal interest or relationship they or their spouse/partner have with the supporters of this activity or any commercial interest that is discussed in their presentation. Any discussions of unlabeled/unapproved uses of drugs or devices will also be disclosed in the course materials. For complete prescribing information on the products discussed during this CME activity, please see your current Physicians' Desk Reference (PDR).

Aaron E. Miller, MD, has received grant/research support from Acorda Therapeutics, Biogen Idec, Genzyme, Novartis, and Teva Neuroscience; is a consultant for Acorda Therapeutics, Bayer, Biogen Idec, EMD Serono, Genentech, Inc, GlaxoSmithKline, Sanofi-Aventis, and Teva Neuroscience; and is on the speakers bureau for Bayer, Biogen Idec, EMD Serono, Pfizer Inc, and Teva Neuroscience.
Tracy M. DeAngelis, MD, is a consultant for Bayer and Teva Neuroscience.
Peer Reviewer has disclosed no significant relationships.
Projects In Knowledge’s staff members have no significant relationships to disclose.

Conflicts of interest are thoroughly vetted by the Executive Committee of Projects In Knowledge. All conflicts are resolved prior to the beginning of the activity by the Trust In Knowledge peer review process.
The opinions expressed in this activity are those of the faculty and do not necessarily reflect those of Projects In Knowledge.
This CME activity is provided by Projects In Knowledge solely as an educational service. Specific patient care decisions are the responsibility of the clinician caring for the patient.

Contract for Mutual Responsibility in CME

Projects In Knowledge has developed the contract to demonstrate our commitment to providing the highest quality professional education to clinicians, and to help clinicians set educational goals to challenge and enhance their learning experience.
For more information on the contract,
click here

Projects In Knowledge is a registered trademark of Projects In Knowledge, Inc.


Available for CME:

Physicians / Pharmacists
  Release Date: July 25, 2008.
  Termination Date: July 25, 2009.

Estimated time for completion of this activity:

 1.5 hours

 1.5 hours

CME Instructions:
To obtain CME credit for this activity:

  1. Read the Tx Reporter Newsletter carefully.
  2. Achieve a passing score on the posttest.
  3. Complete/submit the posttest and evaluation.
  4. Instantly access and print out your certificate.

There is no fee for this activity.

Multiple Sclerosis News powered by
MedPage Today

MS Treatment

Ms. Walker

Hospital Pharmacist
View BIO

Q :
A friend of mine recently moved to Canada from England and has been taking Avonex for the past 8 years. She told me yesterday that she has never kept her medication refrigerated as I was instructed to do by the MS Clinic here in B.C. Who is right and who is wrong?
A :
Interferon beta-1a is also known as Avonex. Storage instructions from country to country can be confusing as sometimes the drug is manufactured/made and stored slightly differently from one country to another. While I'm unsure about the product from England, the following information applies to the storage of the Canadian product.
Avonex vials must be stored in the refrigerator at 2-8C. Should refrigeration be unavailable, it may be stored at up to 25C for up to 30 days. After 30 days, if the drug has been stored at room temperature, discard the vial(s) even if the product expiry date is shorter since the drug as it may not work as well.

Avonex PS (prefilled syringes) must be stored in a refrigerator at 2-8C. Once removed from the refrigerator, the prefilled syringe should be allowed to warm to room temperature (approx 30 min) and used within 12 hours. After 12 hours at room temperature, discard the syringe as it may not work as well. Do not use external heat sources (hot water etc) to warm the prefilled syringe.
Information as per Biogen Idec CPS 2007

Sometimes it is less painful to inject a drug a room temperature than from the refrigerator. With either product, it is reasonable to allow it to warm to room temperature before injecting.
8/4/2008 7:31:55 AM
More answers from Ms. Kelly Walker
More answers in the category: Treatment


DISCLAIMER: Please be aware that this information does not necessarily represent the opinion of the MS Society of Canada, and is not intended as medical advice. For specific advice and opinion, always consult a physician.
© 2008 Multiple Sclerosis Society of Canada

Vitamin D

Losing sleep over FDA's quinine ban
Seattle Times - United States
Q: I want to warn others about taking too much calcium and vitamin D. Apparently, I took more than my limit and ended up with soft tissue calcifications. ...
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Sodium raises gastric cancer risk, vitamin E reduces it
Food Consumer - Lisle,IL,USA
By David Liu, Ph.D. SATURDAY August 2, 2008 ( -- Published in Annals of oncology 2008 Jul 31, a study suggests that high intake of vitamin ...
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Trial Into The Link Between Prenatal Vitamin D Levels And ...
Medical News Today (press release) - UK
"Undeniably, low maternal vitamin D affects the way the brain develops," Dr Eyles said. "Over the past four years we've been able to show that low vitamin D ...
See all stories on this topic

AGAINST THE LAW?   The Fatal Flaw of  Calif. SB 1565

July 31, 2008  

When a submarine goes under, it groans. The ocean squeezes in with a pressure of tons, and the sub's metal walls grind and strain-- and the life of every sailor aboard is at risk.

What if a submarine was built with a structural weakness? Cruising across the surface, the vessel makes a great appearance. Nothing seems wrong. But there is a design flaw, a faulty joining of the metal plates, and when the submarine dives to its working depth, 200 feet down, the cumulative pressure of tons of sea will burst through the walls.

Senate Bill 1565 (Kuehl, Runner) has a fatal flaw, and to let it go forward would be as wrong as sending sailors out in a sub with a hole in it.

SB 1565 would make fundamental changes in the California stem cell program, over-riding the wishes of the voters.

This is only one legal reason way this can be done: to further the purpose of the program. If it does not, and is accordingly illegal, SB 1565 can and should be challenged in court.

Here is the relevant language.

"Sec. 8. Amendments.

"The statutory provisions of this measure…may be amended to enhance the ability of the institute to further the purposes of…the measure…"

Does Senate Bill 1565 "further the purposes" of the California stem cell program?

The purpose of Prop 71 is crystal clear: to fund pluripotent and progenitor stem cell research unlikely to be funded by the Bush Administration.

To accomplish this, Prop 71 established a priority and a prohibition: the priority in favor of pluripotent stem cell research, and a prohibition against spending California's limited funds on other forms of stem cell research already eligible for federal funding.

Article XXXV of the California Constitution: Section 5, Chapter 3. California Stem Cell Research and Cures Bond Act, Article 1. 125290.60

"(C) In order to ensure that institute funding does not duplicate or supplant existing funding, a high priority shall be placed on funding pluripotent stem cell and progenitor cell research that cannot, or is unlikely to, receive timely or sufficient federal funding, unencumbered by limitations that would impede the research. In this regard, other research categories funded by the National Institutes of Health shall not be funded by the institute."

Notice two points:

1. a priority: preference for research "unlikely to be funded" by the Federal government:

2. a prohibition: "other research categories… shall not be funded by the institute."

SB 1565 would overturn the prohibition, and throw out the priority.

Such enormous changes do not "further the purposes" of the program.

But don't take my word for it.

Here is the actual changed paragraph in SB 1565:

"(D) "Notwithstanding paragraph (C), any other scientific and medical research and technologies and/or any stem cell research proposal not actually funded by the institute under subparagraph (C) may be funded by the institute if at least a simple majority of a quorum of the members of the Scientific and Medical Research Funding Working Group recommend to the ICOC that the research proposal is a vital research opportunity."

Word changes matter. Buried in that legalese is an enormous change: important to stem cell research as the small print on a real estate contract is important to the buyer. The original language of "Shall not be funded" has become "may be funded".

Imagine the Biblical Commandment: "Thou shalt not kill." What if "shalt not" had been changed to "may"?

Granted, almost every law requires an exception—the soldier in war must sometimes kill.

The writers of Prop 71 left room for an exception. Anticipating there might be advances that would not be embryonic, they required a 2/3 majority support of the Scientific working group to recommend non-embryonic stem cell research (heavily favored by the Bush Administration). This exception has worked quite well: and has allowed the funding of non-embryonic stem cell research work by CIRM-funded scientists. But the new language removes the 2/3 requirement, and replaces it with a bare majority.

Such changes plainly do not "further the purpose" of Prop 71.

How could the California Senate vote to approve such a bill? They didn't. The Senate has not yet been told about this change in SB 1565. It was added by Senator George Runner after the bill left the Senate. Senator George Runner, of course, is the man called "the virulently anti-embryonic stem cell Republican George Runner"—he opposes embryonic stem cell research in general and Proposition 71 in particular-- this is his amendment, and it was added after the bill left the Senate.

The Senate Concurrence Committee will meet to consider these changes.

It is to be hoped they will take notice of this bill's fatal flaw, and vote NO! on SB 1565.

Please send letters to opposing SB 1565 to Senator Tom Torlakson, Senate Concurrence Committee, Capitol Office, Room 5050, Sacramento, CA 95814

Or Email (less effective, but definitely worth doing) to:

Don C. Reed
Sponsor, Roman Reed Spinal Cord Injury Research Act
co-chair, Californians for Cures
Vice President, Public Policy, Americans for Cures

A daily dose of garlic can help lower your BP

August 3rd, 2008 - 6:29 pm ICT by ANI

London, Aug 1 (ANI): A daily dose of garlic can help in lowering blood pressure, says a new research

What’’s more, the magical plant can also be as effective as drugs, the study says.

The discovery means that readily available over-the-counter supplements could be used to help save lives.
Figures show that high blood pressure - also called hypertension - is responsible for up to 40 per cent of the 150,000 strokes every year and tens of thousands of heart attacks.

But, in the latest research, patients suffering from the condition who took garlic supplements every day for up to five months saw their blood pressure levels drop significantly.

In some cases, the drop was as much as that seen in patients taking drugs such as beta-blockers and ACE inhibitors. However, researchers have yet to establish whether garlic supplements are as effective as prescribed medicines when used for many years.

“I think this is interesting research as it shows a reasonably consistent effect. The reduction in blood pressure is not trivial, it is the same as gained from taking pills,” The Daily Express quoted Dr Tim Chico, a cardiologist and academic from the Centre for Developmental and Biomedical Genetics at Sheffield University, as saying.

“What we do not know is if garlic works as well as pills over the long term or if it would reduce the risk of heart attack or stroke. But I was surprised at the extent of blood pressure reduction seen with garlic.

“There is no harm in taking garlic along with other lifestyle factors such as eating less red meat, less salt, less alcohol and taking more exercise and also continuing to take blood pressure medication,” Chico added.

People can reduce blood pressure by cutting their intake of salt, losing weight and getting fit.

But many still need to be placed on medication to reduce their blood pressure readings to the safe level of 140/90.
Dr Karin Ried, of the University of Adelaide, examined 11 studies in which patients were randomly assigned to garlic or a placebo.

The higher a person’’s blood pressure was at the beginning of the study, the more it was reduced by taking garlic.

Dr Rosemary Leonard, the Daily Express doctor, said: “Anyone could benefit from regular doses of garlic, but it is important not to assume that taking supplements is all you need to treat high blood pressure.

“If you have high blood pressure and are overweight, then it is important to take regular exercise and eat a healthy diet.” (ANI)

Air Pollution And Blood Pressure
NewsRadio 610 WTVN - Columbus,OH,USA
... hypertensive as we call it," Rajagopalan said. "They had very high blood pressure compared to the controlled population that were exposed to clean air."
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US Congress slams FDA for off-label promotion control failures

The US Food and Drug Administration has been rapped by Congressional watchdog the Government Accountability Office (GAO) for failing to track the promotional materials which it is responsible for reviewing to ensure that they do not promote off-label uses of prescription medicines.
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ICAD: Pondering Over Woes in Middle Age May Save the Brain in Later Life CME
CHICAGO -- Men who spend their 40s and 50s focusing on the difficulties of daily life may be rewarded with a dementia-free old age, researchers reported here. full story
ICAD: Pondering Over Woes in Middle Age May Save the Brain in Later Life CME

Phase II results stir excitement over TauRx Alzheimer’s therapy

Phase II results stir excitement over TauRx Alzheimer’s therapy
30 July 2008

Hopes that an alternative to the prevailing beta-amyloid theory of Alzheimer’s could spawn a genuinely disease-modifying therapy have been raised by the results of a Phase II trial with TauRx Therapeutics’ rember, a novel form of methylthioninium chloride (MTC) that targets the neurofibrillary tau tangles in the brain first discovered by Alois Alzheimer in 1907.

In the trial with 321 Alzheimer’s patients reported by scientists from TauRx Therapeutics and the UK’s University of Aberdeen at the Alzheimer’s Association International Conference on Alzheimer’s Disease (ICAD 2008) in Chicago, a 60mg dose of rember was shown to reduce the rate of cognitive decline by 81% over a 50-week period.

A final, 84-week analysis confirmed the long-term effect of the 60mg dose in those Alzheimer’s patients who remained on treatment, with “apparent decline still not significantly different from baseline at the final assessment, whereas there was significant decline at other doses”, the researchers noted, adding: “In essence, TAI [tau aggregation inhibitor] therapy appears to stabilise patients who remain on treatment for at least 19 months”.

The TauRx-Aberdeen University team plans to start a Phase III trial with rember sometime next year. If this confirms the Phase II findings, a new treatment for Alzheimer’s could be on the market by 2012, the researchers believe. At the same time, TauRx continues to work on refining rember, suggesting that restoration of cognitive function may be possible at least during the earlier stages of the disease with improved versions of the drug.

The lesions or tangles – toxic aggregates of abnormal tau protein fibres that form inside nerve cells in the brain – associated with dementia “are already destroying nerve cells in parts of the brain critical for memory in people in their fifties and upwards”, the researchers commented. “The ultimate goal is to develop a product that is convenient for patients that could be widely used at the very earliest stages of the disease, long before patients experience the first symptoms of Alzheimer’s.”

“Unprecedented result”

The demonstrated effects of rember on disease progression were hailed by Professor Claude Wischik, chairman of TauRx Therapeutics and Professor of Psychiatric Geratology and Old Age Psychiatry at the University of Aberdeen’s Institute of Medical Sciences, as “an unprecedented result in the treatment of Alzheimer’s disease”.

The primary objective of the Phase II study reported in Chicago was actually to investigate the effects of oral MTC versus placebo at doses of 30mg, 60mg and 100mg over 24 weeks on cognitive function in patients with mild or moderate Alzheimer’s, as measured by ADAS-cog (Alzheimer’s Disease Assessment Scale cognitive subscale).

The trial conducted at 16 centres in the UK and one in Singapore (where TauRx Therapeutics, a spin-off from Aberdeen University, has its headquarters), involved a 24-week, double-blind, randomised, placebo-controlled phase followed by a 60-week blinded active-treatment extension, in which the control arm received a minimal efficacy dose. In parallel, molecular brain scans (SPECT and PET) were taken from 100 of the mild Alzheimer’s disease (AD) patients after 18 and 24 weeks of treatment.

On the primary outcome measure, the researchers said, treatment with 60mg rember produced clinically relevant, significant benefit compared with the control group at 24 weeks in moderate AD patients (effect size: -5.5 ADAS-cog units; p = 0.0208) and at 50 weeks in both mild and moderate patients (effect size: -6.8 ADAS-cog units; p = < 0.0001). Initial efficacy analysis in mild AD patients over 24 weeks was confounded by the absence of any placebo decline in the control group during this period.

SPECT scan

In the SPECT brain scan, which measures neuronal function indirectly by assessing regional cerebral blood flow (rCBF), 60mg rember was found to alter the trajectory of rCBF decline over six months in mild Alzheimer’s. The efficacy of rember was most pronounced in those regions of the brain characterised by the most severe tau aggregation, namely the hippocampus and the entorhinal cortex.

This finding “raises the possibility that treatment targeting the tau aggregation cascade that underlies Alzheimer’s tangle may be an important component of the long-term management and prevention of Alzheimer’s disease”, the researchers stated.

The UK-based Alzheimer’s Society sounded a note of caution. While this “first modestly sized trial in humans is potentially exciting” and suggests that rember “could be over twice as effective as any treatment that is currently available”, larger-scale trials are needed to confirm the drug’s safety and “establish how far it could benefit the thousands of people living with this devastating disease”, commented director of research Professor Clive Ballard.

The active substance in rember, MTC, has a long history of clinical use in urinary tract infection and methaemoglobinaemia, a condition in which excessive haemoglobin in the blood is converted to methaemoglobin and can no longer deliver oxygen to body tissues.
By Peter Mansell

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Medicare patient Alexander McCray is seen leaving a clinic that is accused of filing false claims for HIV-infusion treatments to the government health insurance program. McCray visited the clinic, located off Southwest Eighth Street, on June 18.


Clinics make a mint on fake HIV treatment

The men show up on foot, on bicycles, by van or car. Before entering the sky-blue door at the rear of the vast office plaza, they carefully look around to make sure no one is watching them go in.


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