HEART FAILURE DRUG IS A FAILURE - FOR THE FDA

  Nesitiride was a new drug rapidly approved by the FDA in 2001 for acute heart failure based on studies showing that it reduced pressure in the lungs and reduced symptoms after a few hours of treatment. However, after several more studies were conducted, higher risks were noted. In a study published in the NEJM in July, 2011, nesitiride was no better than placebo and had a much greater risk of hypotension (low blood pressure).

COMMENT: On the surface, this study proved that this drug was ineffective, as well as leading to excess risk. The major point, however, is that the drug was not thoroughly tested on patient outcomes before being approved by the FDA. As I discuss in Chapter 6 of my BOOM or BUST book, there is a huge push by pharmaceutical companies to get quicker approval for drugs from the FDA. As I also discuss, the majority of drugs that have had rapid approval have been taken off the market, have proven not as effective and/or have caused side effects that were not substantially identified before approval. Although patients suffering from various diseases would like to benefit from new drugs, it is not wise to rush approval until the benefits and side effects are well established.

1 comment (Add your own)

1. Julio wrote:
Best of luck in keeping the weghit off that's the hard part. Keep in mind the following when dieting:Every year Americans invest billions of dollars in weghit loss diets and gimmicks, many of which yield few results. However, the lure of quick, easy weghit loss is hard to resist. Despite ineffective tools, most hopeful consumers are willing to give the next weghit loss fad a chance. If you're planning to start a new diet, it is important to remember the following information.Food-specific diets: Have you ever tried the cabbage diet or the fruit-only diet? These are just a couple of examples of diets that promote one specific food that causes weghit loss. No matter how much you think you'll enjoy ice cream at every meal, inevitably you will get bored with eating the same food repeatedly. As a result, you'll eat less food than needed to maintain your weghit. This type of diet will not teach you healthier eating habits or provide a balance of nutrients, and consequently is not effective for long-term weghit loss.High-protein, low-carbohydrate diets: One of the most recent trends in dieting, these diets are based on the concept that carbohydrates are bad and that everyone has some degree of insulin resistance, resulting in poor carbohydrate metabolism. Many proponents of these diets suggest that including carbohydrates in your diet will cause weghit gain. The reality, though, is that eating more calories (whether as carbohydrate, fats, or protein) than you burn will cause weghit gain.High-fiber, low-calorie diets: Fiber-rich foods play an important role in a healthy diet. They are a helpful ingredient of weghit loss efforts because they provide bulk to the diet, which helps you feel fuller sooner. Be careful, though: if you plan to increase the fiber in your diet, be sure to increase your fluid intake at the same time or you may experience cramping, bloating, and constipation. High-fiber diets will help with weghit loss only if you restrict calories in conjunction with addition of extra grains, fruits and vegetables.Liquid diets: Consumers face a couple of different liquid diet options. Your local grocery store and pharmacy sell over-the-counter liquid meal replacements, which can be expensive and frequently add extra calories to daily consumption if not managed carefully. On the other hand are liquid diets that require medical supervision. These diets are usually very low in calories and may result in metabolic abnormalities if dieters are not carefully monitored. Neither type of liquid diet should be used for long-term weghit loss unless monitored by a health care professional. Radically changing your caloric intake in this way will not result in long-term behavior modification and healthy eating patterns.Fasting: As a way to cleanse the body or jump-start a weghit-loss program, fasting has been recommended for years. However, all that fasting really does is deprive your body of nutrients and decrease your energy, leaving you feeling weak and lightheaded. If the right nutrients are not available for your cells to use as energy, your liver will convert fat stores to ketones for use as energy (ketosis). Long-term ketosis can be harmful to your health.No fad diet or gimmick will work magic for safe and effective weghit loss. The following are some suggestions for ensuring a long-term healthy eating plan and getting your weghit loss efforts off to an encouraging start:Eat a variety of foods. Remember, a balanced diet will ensure that you get all necessary nutrients. Get some physical activity every day. Calories in must be less than calories out to ensure successful weghit loss. To keep calories out at a healthful level, make you get at least 30 minutes of physical activity every day.Include sources of fiber in your diet. They will add bulk and give you a feeling of fullness.Choose a diet low in fats, saturated fats, and cholesterol. You do need to consume some fat for good health. Aim for no more than 30 percent of your total calories as fat calories, of which no more than 10 percent should be saturated fat calories.Choose foods moderate in sugars. Foods that are high in simple sugars usually offer little nutritional value and will add unwanted calories.Choose foods moderate in salt and sodium. Remember that salt has been added to many foods during preparation or processing, so it's not necessary to add extra salt at the table.

Mon, May 21, 2012 @ 2:59 PM

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