Thursday, February 19, 2009

Wisconsin finds treatment for deadly medicine induced PML

PML is a deadly disease of the brain that was unknown before the advent of new autoimmune medications that help autoimmune disease but cripple the patient's immune system in some way. PML is an occult brain virus that many of us carry in our bodies. It is harmless to us unless our bodies loose the ability to fight it. Several really good autoimmune meds can trigger it in carriers. At first it was nearly 100% fatal and the VERY few survivors were left with mental deficits. Patients taking Tysabri, Rituxan and now Raptiva have come down with the disease.

Now good news, a Wisconsin hospital has found a way to eliminate the medicine that cripples the patient's immune system allowing PML to develop. The pull the blood serum (yellow fluid red blood cells float in) and replace it with donated serum. This procedure helps in two ways. One it reduces greatly the amount of medicine causing the problem. Two it introduces serum from healthy donors whose serum may have PML fighting antibodies in it as well as autoimmune fighting antibodies. IVIG--intravenous immunoglobin (serum) is one treatment for autoimmune disease.

Good news patients with PML now have a real chance to survive. Bad news is they can no longer take the medicine that was helping their autoimmune disease or any other med associated with allowing PML to break out as they will continue to carry the virus.

We need permanent cures for autoimmune disease. We need stem cells cures used in ALL patients now. Prochymal by Osiris is the fist of these. All patients especially those surviving PML should have ACCESS NOW! Prochymal is made of precursor immune cells. They live inside recipients body and make the regulatory cells and cytokines we need to get healthy again and stay healthy for years if not for life.

First article below is about Wisconsin breakthrough in PML treatment. (BROWN)

Second article is about Raptiva causing PML. (BLUE)
Source: Aurora St. Luke's Medical Center
Wednesday, February 18, 2009

Researchers at Aurora St. Luke's Medical Center have developed a technique that counteracts an unusual, but serious, side effect from natalizumab (Tysabri®), a drug that fights multiple sclerosis (MS).

The side effect is a brain virus called progressive multifocal leukoencephalopathy (PML).
"This virus looks like a multiple sclerosis relapse," Dr. Bhupendra Khatri says. "It rapidly destroys the white matter of the brain. Now we know exactly how to respond if this virus emerges."

The response is a series of plasma exchanges that filter the drug out of the blood stream, allowing the immune system to recover and fight the virus.

Multiple sclerosis is a disease where the body's immune system attacks the protective sheath surrounding the nerves. Natalizumab suppresses the immune system to slow or halt the progression of the disease. However, if the patient contracts PML, the immune system is not strong enough to combat the infection, so the drug needs to be removed from the body quickly.

Dr. Khatri, medical director of Aurora's Regional MS Center is lead author of the study published in the Feb. 3 issue of Neurology, the official publication of the American Academy of Neurology.

In the study 12 multiple sclerosis patients on natalizumab underwent three plasma exchange sessions over a five-day or an eight-day period. By replacing the drug-infused plasma with clean fluid, Dr. Khatri and his team were able to get 92 percent of the drug out of patients' bodies over a span of eight days instead of the 12 weeks it would take with no treatment.

Debra Goodwin, a clinical research nurse who worked on the study and a multiple sclerosis patient herself, says the discovery gives new hope to those with the disease who take natalizumab.

"If something were to go wrong, now there is a demonstrated method to remove the drug from the body and help the patient fight PML," Goodwin says.
The National Multiple Sclerosis Society estimates 400,000 people in the United States have MS. There is no cure for multiple sclerosis though there are several drugs that can slow or stop its progress. Symptoms can include blurred vision, loss of coordination and short-term or long-term memory loss.

Aurora Health Care is a not-for-profit health care provider and a national leader in efforts to improve the quality of health care. Aurora offers care at sites in more than 90 communities throughout eastern Wisconsin.
Aurora's online newsroom:
The Regional MS Center:
CONTACT: Myrle Croasdale, +1-414-649-3917, or pager, +1-414-222-4332,, for Aurora St. Luke's Medical Center
Web site:


FDA Advises Public of Serious Adverse Event with Psoriasis Drug Raptiva

The U.S. Food and Drug Administration today issued a public health advisory concerning three confirmed, and one possible report of progressive multifocal leukoencephalopathy (PML), a rare brain infection, in patients using the psoriasis drug Raptiva (efalizumab). Three of those patients have died. All four patients were treated with the drug for more than three years. None of the patients were receiving other treatments that suppress the immune system.

The FDA is reviewing this latest information. The agency will take appropriate steps to:
• ensure that the risks of Raptiva do not outweigh its benefits;
• that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML; and
• that health care professionals carefully monitor patients for the possible development of PML.

PML is caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened. It leads to an irreversible decline in neurologic function and death. Symptoms may include unusual weakness, loss of coordination, changes in vision, difficulty speaking and personality changes. There is no known effective prevention or treatment.

Psoriasis is a chronic disease, for which a number of effective therapeutic options are available, including four other approved biologic agents, ultraviolent light therapy, and the drugs cyclosporine, acitretin, and methotrexate. Generally, treatment for psoriasis patients involves a rotation of therapies.

In October 2008, the product labeling for Raptiva was revised to highlight in a boxed warning the risks of life-threatening infections, including PML. At that time, the FDA directed Genentech, the manufacturer, to develop a risk evaluation and mitigation strategy (REMS) to include a medication guide to educate patients about the drug’s risks.

The FDA strongly recommends that health care professionals carefully monitor patients on Raptiva, as well as those who have discontinued the drug, for any signs or symptoms of neurologic disease, and that they periodically reassess the benefits of continued treatment. Patients should be aware of the symptoms of PML and contact their health care professionals immediately if they experience any such symptoms.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy. The drug works by suppressing T-cells (blood cells that help fight infection) in the immune system. These cells, when activated, migrate to the skin and cause inflammation which results in the red, inflamed and scaly patches of skin, which is associated with psoriasis. By suppressing T-cells, Raptiva decreases the function of the immune system which increases a patient’s susceptibility to infections.

Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, fax or phone.

--Regular Mail: use postage-paid FDA form 3500 available at: and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088

Read the FDA’s 2009 Public Health Advisory

1 comment:

Ajlouny said...

I will say its curious that the EMEA immediately jumped on removing the drug from the market, while the FDA still needs to continue to look at this issue. There are other treatments on the market for psoriasis, so the delay by the FDA raises the issue again of the tail wagging the dog i.e. is Big Pharma again calling the shots.