Thursday, March 10, 2011

Health : Health Buzz: FDA OKs First Lupus Drug in 50 Years

Health : Health Buzz: FDA OKs First Lupus Drug in 50 Years


Health Buzz: FDA OKs First Lupus Drug in 50 Years

Posted: 10 Mar 2011 09:00 AM PST

Government Approves New Lupus Drug

For the first time in half a century, the U.S. Food and Drug Administration has approved a new drug to treat lupus, a chronic, incurable disease in which the body attacks its own healthy cells and tissues. The injectable drug, called Benlysta, is designed to treat flare-ups and pain in patients with systemic lupus erythematosus (SLE), the most common form. Besides painkillers, lupus sufferers currently have limited treatment options, including steroids and antimalarial drugs, which often cause severe side effects. Though the new drug isn't risk-free, it's expected to be more tolerable. Benlysta, developed by Human Genome Sciences and GlaxoSmithKline, works by blocking a protein that fuels lupus. About 1.5 million Americans have the disease—mostly women—and complications include arthritis, chest pain, skin rashes, severe fatigue, and fatal organ damage. Clinical trial results, however, suggest the drug is no panacea: It's less effective in African Americans—those most commonly affected— its benefits may weaken over time, and it may not work against the deadliest forms of the disease, federal officials warned Wednesday. Still, "It's a historic day. It really does open a door," Sandra Raymond, president of the Lupus Foundation of America, told The Baltimore Sun. The drug is expected to be available in about two weeks.

Overmedication: Are Americans Taking Too Many Drugs?

Socrates once declared that medicine "acts as both remedy and poison" and that "this charm, this spellbinding virtue, this power of fascination, can be­—alternately or simultaneously—beneficent or maleficent." Modern America clearly appreciates the benefits. Today, a full 61 percent of adults use at least one drug to treat a chronic health problem, a nearly 15 percent rise since 2001, U.S. News reported in October. More than 1 in 4 seniors gulp down at least five medications daily. The trend has multiple causes: a spike in diabetes, heart disease, and arthritis related to obesity; revised medical guidelines that treat high blood sugar, hypertension, and high cholesterol sooner; and a multibillion-dollar push by pharmaceutical companies to speak directly to consumers about the payoff in trusting our hearts to Lipitor, say, or taking Boniva to help stop bone loss.

Therapeutic advances have, no question, proved lifesaving for many. Heart disease deaths have dropped steadily over the past 15 years, for example, thanks in large part to cholesterol-lowering statins and clot-busting drugs administered during heart attacks and strokes. But a growing chorus of experts worries that one unintended effect of all the pharmacological success is that many people may be blithely taking drugs they don't need, potentially setting themselves up for severe consequences. Clinical trials that prove a medicine safe and effective may demonstrate nothing about long-term risks or whether it benefits elderly folks or people with multiple health issues; usually new drugs are tested for just three or so years in a few thousand middle-age adults with a single particular problem. Given that a drug's serious side effects might show up only after months or years on the market, someone whose dangerous heart disease can't be controlled by existing meds has a much clearer incentive to try a new drug than people with a mild condition. [Read more: Overmedication: Are Americans Taking Too Many Drugs?]

Your Doctor's Role in Helping You Change Your Health Habits

In an issue of the Annals of Internal Medicine last year, researchers at Kaiser Permanente's Center for Health Research in Portland, Oregon reviewed the latest scientific evidence on how effective medical counseling really is in terms of getting patients to improve their eating and exercise behaviors. Their analysis, which included data from 73 studies, found that counseling does, in fact, help patients make changes that lead to modest improvements in their health. They were able to lose excess weight, increase their activity, and improve their blood pressure and cholesterol levels. While few studies followed patients for more than a year, one long-term study indicated that those with mildly elevated blood pressure who were extensively counseled on switching to a low-sodium diet had a reduced risk of heart attacks and heart failure 10 to 15 years later.

But there's a catch, family physician Kenny Lin writes for U.S. News. The researchers found that in order to achieve these changes, patients needed far more counseling time than doctors or nurses can offer in our current healthcare system. "Low-intensity" counseling—a total of 30 minutes or less which is typical for most patients—appeared in the study to have no beneficial effect. Only "medium" (totaling up to six hours) and "high" intensity (more than six hours) counseling made a significant difference, and these sessions were typically led by specially trained health educators rather than the patients' own physicians who may not be as well trained in dispensing specialized nutrition or fitness advice. While study participants got these services for free, those patients in the real world often find that their health insurance will only pay for counseling if they have diabetes or heart disease. [Read more: Your Doctor's Role in Helping You Change Your Health Habits.]

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