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The most important safeguard in protecting the rights of participants in clinical trials is the informed consent process. All participants in clinical trials in the United States (and in most areas of the world) are required to sign an informed consent document. In the event that the participant is not competent to sign, this responsibility is assigned to the spouse, parent, an adult child, or a brother or sister (in that order). The informed consent document must also be signed by a witness and by the investigator.      Information in the consent form usually includes the following:     Purpose of the trial. The informed consent document must include an explanation of the scientific question the trial is to answer. It must also include an explanation of why the participant qualifies for the trial.     Procedures. Informed consent must include an explanation of the trial’s design, that is, exactly how the trial will proceed. The explanation will include: the nature of the treatment arms; the method by which participants are assigned to a specific arm; the requirements for participation, including the number of clinic visits or the duration of hospitalization; the frequency and types of tests that will be done; the amount of blood that will be required; the duration of the trial; and the end point of the trial.     Risks. Informed consent must include an explanation of the drug’s side effects, including their anticipated frequency and severity. It is unrealistic to list every possible side effect, or even all of the side effects that have occurred in previous trials. But certainly the most severe and the most frequent side effects should be noted.     Benefits. Informed consent must include a statement of whether the participant has any realistic likelihood of benefiting from participation. Expenses for the drugs or for monitoring, and any payment to the participant, should also be explained.     Alternatives to participation. Informed consent must include the various options people have if they choose not to participate. This generally includes the statement that a decision not to participate will not affect your care. In other words, no one at the center offering the trial will bear a grudge if you choose not to participate.     Confidentiality of records. People with HIV infection are often concerned about the confidentiality of their trial records. Some trials are done without identifiers, that is without the names, addresses, hospital numbers, or social security numbers that would connect the data to a specific person. Trials done without identifiers essentially guarantee anonymity for the participant.     Unfortunately, it is often impractical and undesirable for clinical trials that collect clinically useful data over a prolonged period to be done without identifiers. The next best option to guarantee confidentiality is to keep the records in a locked file with limited access. The FDA and the drug company that sponsors the trial can require access to these locked files, but we are not aware that this access has ever resulted in a participant’s name being revealed to inappropriate persons.     In many instances, data obtained in the trial are also recorded in the participant’s medical record: such data can be relevant to medical treatment. Occasionally, participants object to what they view as an unnecessary dispersal of sensitive information. The best advice is to read the consent form carefully for an explanation of how data from the trial are handled and who has access to the record. If such an explanation is not included in the consent form, ask for further information.     Further information. No consent form can provide all the information desired by all the participants. And consent forms often include technical information and medical terms that may be difficult to understand. It is expected that most participants will need to discuss any questions not answered or points not clarified with a member of the investigating team. If, either before or after signing the consent form, you have questions about toxicity, alternatives to drugs, possible participation in other studies, or compensation for injury as a result of participation, you should be answered to your satisfaction. You should not sign the consent form until you are satisfied and have no further questions. One option is to take the consent form home and list the questions you have after you have reviewed the form and discussed it with others. In addition, most consent forms include the name and phone number of an appropriate person to contact if the participant has any further questions after participation begins.     Withdrawal of consent. Informed consent continues throughout the course of the trial, but withdrawal of consent at any time is the participant’s right. Withdrawal must not have any repercussions for the participant. Withdrawal may not interfere with the availability of care.     Participation. To find the nearest clinical trial, call the hotline at the National Institute of Allergy and Infectious Diseases: 1-800-TRIALS-A.*189\191\2*

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The second major medication for preserving and increasing bone density is calcitonin (brand name Miacalcin). Calcitonin is a natural hormone made by the thyroid gland that limits the release of calcium from bones into the blood. Levels in the body generally decrease with age, and estrogen stimulates the secretion of it; menopause, with markedly decreased levels of estrogen, causes even lower levels. Low bodily calcitonin does not indicate low bone density, but prescription calcitonin can help protect bones. What you get in a prescription, though, is actually from salmon because it is fifty to a hundred times stronger than human calcitonin. Like estrogen and bisphosphonates, calcitonin acts to slow bone breakdown.Over three-quarters of the patients who use calcitonin will see increases in their bone density. Studies show gains of over 3 percent a year in bone density after two years of taking calcitonin, in most—but not all—patients, and a 40 percent reduction in risk of fractures in the spine. So my patient was ahead of the curve—a plug for adopting a healthy lifestyle to maximize the results of drug treatment. Even if there is no gain but there is also no loss, calcitonin is beneficial. It works best in men, and women more than five years after menopause and hence no longer in the accelerated phase of bone loss, and it may be more effective in the spine than other parts of the skeleton. (Although I’m convinced we’ll eventually find out that it is equally effective all over the body, and I use it as if it is.) Calcitonin is not yet proven to decrease the rate of fractures.Calcitonin is the best choice for those who do not take estrogen and who cannot tolerate alendronate. Calcitonin, unlike other treatment options, can help control bone pain, although we don’t know why. So it may also be the best choice for those in pain from vertebral fractures. More studies have been done on alendronate than on calcitonin, so it is most doctors’ first recommendation. But given the safety record of and lack of side effects associated with calcitonin, I usually recommend starting with that. I’m betting that as more studies are completed, calcitonin will be shown to equal or even surpass alendronate in overall effectiveness, especially in women not taking HRT. My stance Is slightly against the current, but I’m a believer in giving calcitonin a chance to work as long as there is time to play with, because it is the safest and most physiologically natural choice when a prescription is required.For years, the only way to get calcitonin was by injection several times a week, but now a nasal spray makes using it much simpler (not to mention more appealing). The usual dose is 200IU, sprayed in alternating nostrils daily. About 10 percent of patients experience nasal dryness and irritation. Calcitonin must be kept refrigerated. You should take supplements of calcium and vitamin D to maximize the effectiveness. Calcitonin is considered very safe, since it has been used (in the injectable form) for over twenty years to treat bone disease without any significant problems.*156\228\2*

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Dairy products do not have to be a significant source of fat in your diet. To get an idea of the differences among dairy products, consider that 8 ounces of whole milk contain about as much fat as 8 ounces of skim milk plus 2 teaspoons of butter or margarine. Skim milk has an added advantage—the calcium content is higher than that of whole milk. For women who especially need adequate calcium to help prevent osteoporotic dairy products are a main source of calcium. You can get the benefits without the fat by focusing on low-fat or no-fat varieties.For example, instead of eating a slice of regular American cheese, you can cut the calories in half and reduce the fat by three-fourths by choosing reduced-fat American cheese.Although switching to milk with less fat is a good way to reduce calories and fat in the diet for most adults, infants and children younger than age 2 may need the extra calories and fat in whole milk.*294\252\8*

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