Multiple Sclerosis Treatment
Replacing the blood plasma in multiple sclerosis patients
suffering from acute attacks of the mysterious disease helped about 40 percent of them improve, a study released yesterday said.
The Mayo Clinic study found eight of 19 patients who underwent blood plasma replacement, which is sometimes used to fight other illnesses, showed "moderate to marked improvement in their neurologic condition."
Participants in the study had been suffering disabling attacks from the disease, in which the body attacks its own central nervous system, causing symptoms such as paralysis and speech loss that standard anti-inflammatory steroid treatment had been ineffective against.
In plasma exchange treatment, the patient's blood is removed and the blood cells separated from the fluid plasma. The blood cells are then combined with new plasma and the mixture returned to the patient. Patients in the study underwent seven treatments over 14 days.
Though the reason for the treatment's effectiveness was not understood, Weinshenker speculated that replacing patients' plasma blunted the attack on the nervous system by antibodies contained in the original plasma.
However, four of the eight patients who responded well to the treatment experienced recurrent attacks over six months of follow-up.
New Use for Taxol Urged
A Food and Drug Administration panel unanimously recommended yesterday that the approved uses for Taxol, the leading cancer drug, should be expanded to patients with early-stage breast cancer.
Taxol, which is sold by Bristol-Myers Squibb Co. and is the world's most widely used cancer drug, already has the government's approval as a treatment for metastatic breast cancer and some lung cancers. It also is the leading drug for ovarian cancer and had 1998 sales of $1.2 billion.
The panel voted 8 to 0 to recommend that the FDA approve Taxol as part of a treatment regimen for patients with "node-positive" breast cancer that had spread to the lymph nodes but no further.
The FDA usually follows its panels' advice.
Panel members debated whether Taxol was beneficial to all node-positive patients or just those with "receptor-negative" tumors that are faster growing and harder to treat.
The committee urged the FDA to inform doctors in the drug's packaging that data was not clear on whether the benefits for receptor-positive tumors outweighed the drug's risks. Receptor-positive tumors can be treated with another drug, tamoxifen.
Side effects for Taxol included neutropenia, a potentially dangerous drop in some white blood cells. At least two deaths in the company's study of 3,000 patients were linked to Taxol, said FDA reviewer James O'Leary.
Study subjects had surgery to remove their tumors followed by four courses of chemotherapy with standard drugs doxorubicin and cyclophosphamide.
A randomly selected group later received Taxol and were compared to a group that had no Taxol treatment. The study showed Taxol reduced the risk of cancer recurrence by 22 percent and reduced the risk of death by 26 percent, said Craig Henderson of the University of California at San Francisco, who presented the company's data.