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Statins could reduce heart attack rates by one-third
Dr. Venkat Appaji | Wednesday, July 31, 2002, 08:00 Hrs  [IST]

Imagine a simple pill saving hundreds of thousands of people from heart attack and stroke across the globe. That''s what a major new study says would happen if cholesterol-lowering statin drugs were prescribed to the millions of at-risk individuals who could benefit from them. Researchers say prescribing statins to a wider range of people could reduce heart attack and stroke rates by at least a third.

Until now, statins have been primarily used to treat people who have high cholesterol levels. But the results of the British Heart Protection Study (HPS) show statins also reduce risks for people with diabetes, narrowing of the arteries (the major cause of heart disease), and a history of stroke Researchers say guidelines should be changed so that a statin is considered for use in anyone at increased risk for heart attack or stroke regardless of cholesterol level.

The study examined the effects of statin use in more than 20,000 men and women between the ages of 40 to 80 with various risk factors for heart disease. After five years, the risk of heart-related deaths was reduced by 18% among those who received statins. People who took statins were also 25% less likely to suffer a nonfatal heart attack or stroke or require heart bypass surgery "Previously there has been concern that statins have been used too much; after the results of HPS have been published there should be concern that they may not be used enough in the future," says Horton. The study also looked at the effect of using antioxidant supplements, such as vitamins E and C and beta-carotene, in people at risk for heart disease. But researchers found taking these supplements did not provide any significant reduction in risk for heart attack, stroke, cancer, or other major events.

Stem cells linked to life expectancy

The length of our lives may be determined by the toughness of our stem cells. A team at the University of Kentucky has found that the mouse strains that live the longest have stem cells in their bone marrow that are particularly good at repairing DNA. The stem cells found in bone marrow and elsewhere are the source of new cells for many tissues in the body, from the liver to the immune system. The finding supports the theory that we age because our stem cells essentially run out of juice and can no longer cope with the degree of cell turnover needed to keep our organs young. If so, it might be possible to extend life by altering or replacing our stem cells to make them better at withstanding DNA damage, an idea a growing number of researchers are looking at.

The researchers tested bone marrow stem cells from various mice strains to see how good they were at resisting DNA damage. By breeding the mice, they were able to home in on the regions in the mouse genome associated with this trait. In what they refer to as a "striking overlap", it turned out that several of those regions had previously been linked to longevity. Now the researchers think they have found a gene in one of those regions, located in chromosome 11, that could explain the overlap.

Johnson & Johnson''s US mfrg facilities under inquiry

The US government is conducting a criminal investigation into a Johnson & Johnson factory that makes an anemia drug that has been linked to a spate of serious illnesses in Europe and Canada The factory, in Puerto Rico, manufactures Eprex, a drug that is used to increase the levels of red blood cells in people who are undergoing kidney dialysis or suffering from anemia caused by chemotherapy. Health authorities in Europe and North America have become increasingly concerned over the last few months about a mysterious rise in the number of Eprex users who have developed pure red cell aplasia, a condition in which the body can lose its ability to produce red blood cells, leaving the patient dependent on blood transfusions to survive.

The investigation, by the Food and Drug Administration and the Justice Department, is tied to a whistle-blower lawsuit filed against Johnson & Johnson by Hector Arce, a former employee at the factory. Mr. Arce, who was fired in March 1999, contends he was pressed to falsify data to cover up manufacturing lapses and then was suspended a few days before an expected interview with F.D.A. inspectors. Johnson & Johnson denies the accusations.

It said Mr. Arce was a boiler operator not directly involved in the manufacture of Eprex and that he was fired for numerous violations of company procedures and for dishonesty. "We investigated the allegations, and we found no support for them," said Carol Goodrich, a spokeswoman for Johnson & Johnson. "Even if they were true, they would not have affected the product integrity." But Ms. Goodrich said the company was "aware of an investigation by the F.D.A. presumably related to the lawsuit."

She said the company did not know the precise nature of the investigation but intended to cooperate. The F.D.A. did not comment. Johnson & Johnson said it did not know what is causing the aplasia. But the company and health authorities have speculated it might have to do with manufacturing. Even slight changes in manufacturing conditions can affect products like Eprex, which are made in living cells, scientists say.

Eprex is a brand name for erythropoietin or EPO, a human protein that stimulates the production of red blood cells. The drug, developed by Amgen and licensed to Johnson & Johnson, is produced by splicing the human EPO gene into animal cells. More than three million people worldwide have used EPO; combined sales for Johnson & Johnson and Amgen exceed $5 billion, making it the best-selling product produced by genetic engineering and one of the biggest-selling drugs in the world.

FDA Panel Backs Bristol-Myers'' Pravachol/Aspirin Combo

In its second attempt, Bristol Myers-Squibb convinced a US federal advisory panel to endorse the company''s proposed combination pack of aspirin plus its cholesterol-lowering drug Pravachol as a way to cut down on heart attacks, stroke and deaths from heart disease.The Food and Drug Administration will likely follow its panel''s advice and approve the combination pack, although the agency isn''t bound by the group''s vote. Bristol-Myers wants to first sell the two pills in a joint package and later market one pill that combines the two products. The company says this proposed move would cut down on missed doses, a problem with some patients who take multiple medicines.

Hormone May Spur Dramatic Weight Loss

The only known adults in the world who possess a rare genetic mutation that prevents their bodies from producing leptin may open the door to a new way of fighting fat. After injections with leptin -- a human hormone linked to appetite control -- the adults'' dramatic weight loss suggests that leptin offers significant promise for treating obesity. "We hypothesized that leptin deficiency may lead to obesity and, in some cases, delay sexual and psychological maturity," explained Licinio, a professor of psychiatry and biobehavioral sciences at the UCLA Neuropsychiatric Institute.

After receiving leptin injections, the prepubescent adult began experiencing a wide range of physiological changes associated with adolescence and rapidly reached sexual maturity. "At the end of the study, we measured the subjects'' brains with MRI and discovered that the organs had expanded a small but significant amount," Licinio said. "While the relevance of this outcome is currently unclear, it poses the first known instance of brain growth in adults."

Earlier research conducted on laboratory animals born without the ability to make leptin showed that they possessed brains 30 percent smaller than their normal counterparts. Until now, however, scientists had never studied the effect of leptin deficiency and replacement in humans. Manufactured in the fat cells, leptin plays three important roles in the human body. First, the hormone signals fullness, controls the appetite and tells the brain to stop eating. Second, it is triggered by puberty and regulates sexual development. And third, it helps the immune system fight off diseases -- a critical weapon in staving off childhood diseases. The only side effect of the leptin replacement therapy was a minor rash at the injection site that lasted briefly in one patient.

FDA Approves Controversial Bowel Drug

Women who suffer constipation-causing irritable bowel syndrome won their first government-approved treatment .Zelnorm''s approval comes just weeks after the Food and Drug Administration let another controversial bowel drug, Lotronex, back on the market, two years after serious side effects halted its sales.

The two drugs are for different types of irritable bowel syndrome, a mysterious disorder that gives millions of Americans, mostly women, abdominal pain and either severe diarrhea or constipation or both. Lotronex is for the diarrhea type, while Zelnorm became the only FDA-approved therapy for women with constipation-predominant IBS. Until now, these women could try laxatives, but they did not relieve the cause of IBS. Zelnorm appears to go a step further, acting on nerve cells to speed the colon''s movement of stools. It is far from a cure. In studies, patients fared only a little better - 5 percent to 11 percent better - when taking Zelnorm than when taking dummy pills. It has not been studied in men, and seems to work best the first month before its effects wane after three months of treatment, the FDA concluded. To be sure, the FDA ordered Zelnorm maker Novartis to study how patients fare as sales begin, and pledged to closely monitor any reports of side effects.

Compiled from WWW by Dr. Venkat Appaji Padmanabhuni

e-mail : appajipv@hotmail.com

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