Lead-Removal Therapy Doesn’t Appear to Aid Brain Development

Chelation therapy to remove lead from the bodies of young children apparently does nothing to improve development of their brains, federal researchers say.

Exposure to lead, such as in old paint or in dust contaminated by gasoline additives, is known to reduce IQ and otherwise impair brain development. Although lead exposures have declined, about 1% of children still have unusually high levels of the element in their blood. It had been hoped that use of the chelating agent succimer, which is known to remove lead from the body, might improve development in children who had suffered only minimal exposure. Succimer binds to lead and is then excreted from the body.

Dr. Walter Rogan of the National Institute of Environmental Health Sciences and his colleagues studied about 780 2-year-olds with above-normal blood lead levels. Half were given succimer and half a placebo. They were given a variety of tests measuring neural development before drug therapy began and at the age of 5. Rogan’s team reported in the May 10 New England Journal of Medicine (https://www.nejm.com) that it observed no improvements in IQ or other measures of development in the children given succimer and no differences between the two groups.

Chelation therapy is an effective way to remove heavy metals from the body. Some alternative medicine specialists have suggested that it also is a treatment for a variety of diseases, but there is no evidence to suggest this is true.

Contraceptive Patch Is Called as Effective as Pill

A contraceptive patch now being reviewed by the Food and Drug Administration is as effective as birth control pills at preventing pregnancy but is more likely to be used regularly, according to a new study.

The patch, about the size of a matchbook, releases small amounts of estrogen and progestin through the skin. It can be worn on the abdomen or buttocks. It is worn for three weeks of every month. The woman’s period then comes during the fourth week, when no patch is worn.

A team headed by Dr. George W. Creasy of the R.W. Johnson Pharmaceutical Research Institute studied 1,417 women at 45 clinics in the United States and Canada. Of those, 812 women received the patch and 605 received conventional oral contraceptives for either six or 13 menstrual cycles. The team reported in the May 10 Journal of the American Medical Assn. that there were five pregnancies among the women wearing the patch, compared with seven among women on the pill. The difference was not considered statistically significant, however. Compliance was nearly 90% among women using the patch, nearly 80% among those using the pill.

The study was sponsored by Ortho-McNeill Pharmaceuticals, which developed the patch. The company hopes for FDA approval within a year.

Anti-Fungal Drug Linked to Heart Failure

The anti-fungal drug Sporanox should not be taken by people with congestive heart failure because it can bring on symptoms of the disorder, the drug’s manufacturer said last week.

The drug is commonly used for fungal nail infections, but post-approval surveillance indicated it could be a problem for people with heart failure. The drug’s warning label will be changed to reflect that, said a spokesman for Janssen Pharmaceutical Products. Sporanox had global sales of $640 million in 2000, according to Janssen.

The U.S. Food and Drug Administration issued a statement Wednesday in which it estimated that Sporanox contributed to or caused 58 reported cases of congestive heart failure. Thirteen of the patients died, but the agency said “confounding factors” made any link between Sporanox and the deaths “very unclear.”

Transplant Trial Holds Promise for Parkinson’s

A preliminary trial of a new form of cell transplants for Parkinson’s disease victims has shown a 30% to 35% improvement in symptoms such as tremors in six patients after four to 12 months.

The safety study, conducted by Dr. Ray L. Watts of Emory University in Atlanta, used retinal epithelial cells, a form of eye cell that secretes dopamine--which is deficient in Parkinson’s victims.

The retinal cells can be obtained from cadavers and grown in culture, so only a small source is required. Using technology developed by Titan Pharmaceuticals Inc. of South San Francisco, the cells are encapsulated in a porous membrane that lets nutrients in and dopamine out, but that prevents attack by the recipient’s immune system. The transplants thus require no immune-suppressing drugs.

Watts reported last week at a Philadelphia meeting of the American Academy of Neurology that all patients improved and that no significant adverse effects were observed. Now that the safety studies are over, the team will perform larger studies of the cells’ efficacy.

Surgery for Heartburn No Better Than Drugs

Surgery to treat a severe form of heartburn called GERD is no more effective than medical treatment with anti-acid drugs, according to a new study.

GERD, or gastroesophageal reflux disease, occurs when stomach acid backs up into the esophagus, a phenomenon called reflux. Affecting about one in every five Americans, it causes heartburn, irritates the voice and can produce chronic coughing. Damage to the esophagus by the acid is a primary cause of esophageal cancer. Surgical treatment involves repair of the valve between the esophagus and the stomach; medical treatment involves the use of drugs to reduce secretion of acid by the stomach.

A team headed by Dr. Stuart J. Spechler of the Dallas VA Medical Center and the University of Texas Southwestern Medical Center studied 247 patients who had received surgical or medical treatment for GERD 10 years earlier. Eight could not be found, and 79 had died. Among the survivors, however, the team was surprised to find that most who had undergone surgery were still taking drugs to control GERD. There was no significant difference between the groups in the incidence of esophageal cancer, the team reported in the May 9 Journal of the American Medical Assn. For reasons that are not clear, those who underwent surgery were nearly 60% more likely to have died of heart disease, they said.

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Medical writer Thomas H. Maugh II can be reached at thomas.maugh@latimes.com.