Thursday, August 05, 2004

SKIP THE STENT! BOSTON (CBS.MW) -- Boston Scientific said Thursday it is recalling 3,000 more stents due to a design defect that could damage coronary arteries. It's the third recall since July 2 for the company's Taxus stents; more than 96,000 such systems already have been recalled for the defect. Stents are metal devices used to prop open clogged arteries in patients suffering from coronary artery disease; they are inserted using angioplasty balloons. The design defect driving the recalls can result in the angioplasty balloon's failure to deflate, causing serious damage toaffected artery. Boston Scientific has emphasized that patients who already have had Taxus stents successfully inserted are not at risk, as the problem lies with the delivery system apparatus, rather than with the stents themselves. Most of the stents recalled Thursday were sold in the United States. 3:28:23 PM    comment [] WHY MOST DRUGS ARE LITTLE MORE THAN COSTLY (OFTEN DANGEROUS) BAND-AID Do Potentially Dangerous Medications Get Past the FDA? Of course.  Due to the structure of the FDA labeling guidelines, when the FDA denies approval for the use of a new drug, that drug company doesn't have to disclose any negative testing findings on the label. There's a far too cozy relationship between the FDA and major drug companies which has put your health and that of the American public in grave danger. The pharmaceutical industry has dishonorable motives--usually greed--and that forms the basis of the current establishment's methods.  More than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial relationships with the pharmaceutical companies that will be helped or hurt by their decisions, a USA TODAY study found. These experts are hired to advise the Food and Drug Administration on which medicines should be approved for sale, what the warning labels should say and how studies of drugs should be designed. The experts are supposed to be independent, but USA TODAY found that 54% of the time, they have a direct financial interest in the drug or topic they are asked to evaluate. These conflicts include helping a pharmaceutical company develop a medicine, then serving on an FDA advisory committee that judges the drug. The conflicts typically include stock ownership, consulting fees or research grants. Federal law generally prohibits the FDA from using experts with financial conflicts of interest, but the FDA has waived the restriction more than 800 times since 1998. These pharmaceutical experts, about 300 on 18 advisory committees, make decisions that affect the health of millions of Americans and billions of dollars in drugs sales. With few exceptions, the FDA follows the committees' advice. The FDA reveals when financial conflicts exist, but it has kept details secret since 1992, so it is not possible to determine the amount of money or the drug company involved. A USA TODAY analysis of financial conflicts at 159 FDA advisory committee meetings from Jan. 1, 1998, through last June 30 found: At 92% of the meetings, at least one member had a financial conflict of interest. At 55% of meetings, half or more of the FDA advisers had conflicts of interest. Conflicts were most frequent at the 57 meetings when broader issues were discussed: 92% of members had conflicts. At the 102 meetings dealing with the fate of a specific drug, 33% of the experts had a financial conflict. "The best experts for the FDA are often the best experts to consult with industry," says FDA senior associate commissioner Linda Suydam, who is in charge of waiving conflict-of-interest restrictions. But Larry Sasich of Public Citizen , an advocacy group, says, "The industry has more influence on the process than people realize." 2:52:07 PM    comment [] ARE OVER-THE-COUNTER MEDICATIONS SAFE???? NO-O-O-O, NOT ALWAYS... Acetaminophen overdose causes more than 450 deaths due to acute liver failure each year in the United States and this number appears to be on the rise. In 2001, the U.S. Acute Liver Failure (ALF) Study found acetaminophen responsible for 39 percent of cases. In 2003, the number had risen to 49 percent. William M. Lee, M.D., of the University of Texas Southwestern Medical Center in Dallas, Texas and a principal investigator of the NIH-funded U.S. Acute Liver Failure Group, suggests that the FDA should consider a more aggressive and broader approach toward regulating the pain reliever to lessen the incidence of such poisonings. http://www.scienceblog.com/community/modules.php?name=News&;file=article&sid=3339 2:48:23 PM    comment [] THE TRUTH ABOUT CRESTOR: IS CRESTOR DANGEROUS AND, IF SO, WHY? The Intensive Marketing of This New, Super-Strong, Cholesterol-Lowering Statin Drug Raises Questions and Concerns. Are Crestor Users in Jeopardy? Is Crestor Especially Dangerous for Asians? Who Should Take Crestor and When? A Lower, Safer Approach That Most Doctors and Patients Don't Know About. What is Crestor and What Is the Problem? Crestor is the newest statin and the strongest statin yet. Statins are the highly touted drugs for reducing cholesterol. Studies clearly show that statins improve cholesterol numbers (by lowering LDL and raising HDL) and may reduce C-reactive protein. Statins impede atherosclerosis, reduce heart attacks and strokes, and cardiac death. Thus, the statins Lipitor and Zocor are not only the #1 and #2 top-selling drugs in America, but also household names. FOR THE WHOLE TRUTH, READ WHAT DR. JAY COEHN,MD HAS TO SAY: http://www.medicationsense.com/articles/july_sept_04/crestor_truth.html   2:39:48 PM    comment []

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