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FDA Approves Gleevec to Treat Leukemia

 

FDA Approves Gleevec to Treat Leukemia

Chronic myelogenous leukemia (CML), one of four main types of leukemia, strikes about 5,000 people every year. On average, patients live 3-4 years after receiving a diagnosis of CML. Last week, the FDA approved Gleevec (imatinib mesylate, also known as STI 571) as an oral treatment for CML.

Gleevec has been shown to substantially reduce the level of cancerous cells in the bone marrow and blood of treated patients. In clinical trials, 90 percent of patients in the first phase of CML went into remission within the first six months of taking Gleevec. Of patients in the second phase of CML, 63 percent went into remission with Gleevec. The drug produced few side effects.

Additional studies need to be done to determine how long the effects of this drug last, whether patients become resistant to the drug, and, most importantly, whether Gleevec can actually extend a patient's life.

Still, the results are promising. Currently, the only cure for CML is a bone marrow transplant. Even if a patient is lucky enough to find a marrow donor match, the procedure is successful less than 2/3 of the time. Interferon, a widely used treatment for CML, can extend a patient's life for up to two years, but it has several serious side effects and does not cure the disease. Gleevec may be used in patients in the early stage of CML who do not respond to interferon therapy, and in patients in the later stages of CML.

Most people with CML have a chromosomal abnormality, known as the Philadelphia chromosome, in which portions of two different chromosomes are switched. The result is the creation of an abnormal protein that allows the uncontrolled production of white blood cells, which can interfere with the function of other organs in the body. Gleevec blocks a signal sent out by the abnormal protein, thus blocking the rapid growth of white blood cells.

The FDA's approval of the drug came after a surprisingly short 2½ months. Most drugs that, like Gleevec, are granted a priority review, take six months to approve. The approval was based on three separate studies that involved about 1,000 patients with CML. The drug has generated enthusiasm in the medical community because it targets a specific, cancer-causing protein, without damaging other cells.

Scientists at an American Society of Clinical Oncology meeting announced earlier this month that Gleevec had also produced remission in 180 patients with advanced cases of an intestinal cancer known as gastrointestinal stromal tumor (GIST). Until now, GIST cancers have been incurable; GIST patients normally die within one year of receiving their diagnosis.
May 2001 Update

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Good News for Breast-Fed Babies

Breast-feeding has been linked to many advantages, including fewer earaches, colds, and asthma attacks. Now, a large trial involving almost 16,500 mother-infant pairs has shown even more benefits of breast-feeding. The study demonstrated that long-term, exclusive breast-feeding significantly decreases the risk of gastrointestinal tract infections and atopic eczema during a child’s first year of life.

Published in the Journal of the American Medical Association, the study involved mothers from the former Soviet republic of Belarus. To avoid a conflict of interest, given the advantages of breast-feeding that are already established, the program studied mothers who breast fed for a long time compared to mothers who breast fed for a short time then switched to bottle feeding. Some hospitals were randomly chosen to promote breast- feeding, through programs involving counseling from doctors and midwives; other hospitals, which served as a control group, provided the usual obstetric care. After 12 months, nearly 20% of the infants who were part of the breast-feeding program were still nursing, compared to 11.4% of the control group.

In the first year, only 9% of the infants in the breast-feeding program had one or more gastrointestinal infection compared to about 13% of the control group. In addition, 3% of the breast-fed infants developed atopic eczema (a scaly, allergy-associated skin irritation), compared with 6% of the other babies.

The World Health Organization recommends only breast milk for the first four to six months, and recommends that breast-feeding (in combination with formula) continue until 2 years of age. The American Academy of Pediatrics recommends breast milk alone until 6 months, and breast-feeding plus formula until 12 months old. This study suggests that breast-feeding exclusively for the first year could provide greater health benefits to the child.
February 2001 Update

Constipation: A connection to heart disease?

To be on the safe side, take steps to avoid straining.


Avoid constipation and treat it with a healthy diet, good exercise habits —and laxatives, if needed.
Image: ChamilleWhite/Thinkstock

Nearly everyone has "occasional irregularity," as the laxative commercials say. But about one in five adults copes with a more chronic form of constipation, which is commonly defined as hard, dry, and small bowel movements that are painful or difficult to pass, and often occur less than three times a week. Now, new research hints of a possible link be-tween constipation and cardiovascular disease.

Coming to terms with constipation

There are several remedies for this common symptom, which is rarely a sign of serious illness.


 Image: Bigstock

Constipation affects women more than men and is more likely to occur at certain times, including pregnancy and in the days preceding menstruation, and becomes increasingly common after menopause. While constipation can cause discomfort and anxiety, it is usually not a symptom of a serious condition. However, it can often be difficult to determine just why someone is constipated.

Constipation isn't a simple problem. It is characterized by fewer than three bowel movements a week, hard dry stools, straining to move one's bowels, and a sense of an incomplete evacuation. "It also has many causes," says Dr. Kyle Staller, a gastroenterologist at Harvard-affiliated Massachusetts General Hospital. He notes the factors that cause symptoms can vary, depending on whether the condition is sporadic (occurring occasionally) or chronic (persisting for months or years).

Psyllium fiber: Regularity and healthier lipid levels?

Research we're watching

Psyllium, which comes from the seeds of the herb Plantago ovata, is a popular fiber supplement used to treat constipation (Metamucil is one familiar brand, but many similar products are available). Psyllium husk also helps lower LDL cholesterol levels as well as two other lipid markers for heart disease, according to a study in the Sept. 15, 2018, American Journal of Clinical Nutrition.

The study pooled findings from 28 trials in people with normal and high cholesterol levels. It found that a daily dose of about 10 grams of psyllium husk lowered harmful LDL cholesterol 13 mg/dL when taken for at least three weeks. It also led to a similar drop in non-HDL cholesterol (a number that includes LDL and other harmful lipoprotein particles) and ApoB (a substance found in many lipid particles, considered by some experts to be an even better predictor of heart disease than LDL or non-HDL).

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