Smells During Sleep May Shape Dreams

Title: Smells During Sleep May Shape Dreams
Category: Health News
Created: 9/22/2008
Last Editorial Review: 9/22/2008

Yes, according to the study recently reported on by lead researcher Dr. Ian G. Williamson, MD, from the University of Southampton, England. Dr Williamson's study reported the rather startling result that patients with sinus infections who were treated with a course of amoxicillin, the most commonly prescribed antibiotic for treating sinus infections, were no more likely to be cured than those who took nothing at all. In fact, some of the patients in the test took not only a course of antibiotics, but also a nasal steroid spray as well. Dr. Williamson said: "Overall we think antibiotics have a pretty small effect, if there is one there at all".

I should note that since I discovered pulsating nasal irrigation by reading the book by the famous ENT, Dr. Murray Grossan, I have not been sick very much. According to Dr. Grossan the machine he invented, called the Hydro Pulse, sends jets or pulses of a saline solution into the nose at a certain frequency. This frequency is close to that which the cilia oscillate in a healthy human being. So the idea is to both clean out the bacteria, pollen, viruses, dust, or whatever has been inhaled into the nose while breathing, and also to get the cilia moving properly. I used to get colds and sinus infections at regular intervals, but since then I am almost never sick. I have come to believe that even people who do not have recurrent sinusitis would benefit from this daily regimen. There's no doubt the procedure would prevent millions of people coming down with colds each year, for example.

Hopefully Dr. Williamson's study will bring this issue to the forefront of public discussion even more strongly than it has been considered in the past. In general it is becoming obvious that people should use antibiotics sparingly, both as medications and in everyday household products. Certainly for severe cases of sinusitis antibiotics will continue to play a significant role, but in many cases, it appears they are not needed and don't do much if any good.

Can 90% of American Doctors Be Wrong? Antibiotics and Sinus Infections

It is also clear that antibiotics in general have been largely abused. There are horror stories about antibiotic resistant bacteria which have developed because of the overuse of these drugs. In particular, many believe that the plethora of household cleaning products containing agents that kill bacteria which are on the market also contribute to the problem, rather than helping to solve it. The basic theory is that if some amount of bacteria survive the onslaught of antibiotics or antibiotic-enhanced cleaning agents, those bacteria will multiply and produce more bacteria which will also be capable of withstanding the effects of those antibiotics. And so on and so on. Once again, one reads reports these days of strains of bacteria that can withstand even the most enhanced antibiotics, some which were considered to be effective last resorts in years past.

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Drug Combo Fights Recurrent Ovarian Cancer Cell Growth

Title: Drug Combo Fights Recurrent Ovarian Cancer Cell Growth
Category: Health News
Created: 9/19/2008 2:00:00 AM
Last Editorial Review: 9/19/2008

It Remains Illegal to Promote Off-Label Use

Any author's financial interest in the product or manufacturer.

Limiting What Companies Can Distribute

The whole idea is that while the FDA recognizes that off-label use is common, and indeed quite legal, drug companies need strict guidance on what they disseminate regarding those uses. Contrary to what some of those news reports suggest, the FDA is not opening the door for drug companies to promote off-label uses of drugs. Instead, it puts very precise rules and standards in place for what the companies can use as supporting evidence, such as peer-reviewed publications.

Any significant risks or safety concerns the manufacturer knows about concerning the unapproved use that are not discussed in the journal article or reference text.

The funding source for the study, and

Given that healthcare professionals can legally prescribe drugs for off-label use, the FDA guidelines represent a significant advance in this whole area. I find it puzzling to read comments in the press and in online blogs about how this is going to open up the area of unapproved, off-label use and thereby put the public's safety as risk because the FDA is now going to completely endorse publications promoting such use. If anything, this proposal sets very strict and sensible boundaries for promoting off-label use. As Randall Lutter, an FDA deputy commissioner, said in a news release referring to the publications for off-label use, they "can contribute to the practice of medicine and may even constitute a medically recognized standard of care."

It was interesting to read recent media reports in such prominent outlets as Bloomberg.com and the Wall Street Journal about the FDA's plans to set guidelines for the kinds of literature drug makers can use to support the off-label use of FDA-approved drugs. Originally, the FDA stipulated that drug manufacturers could disseminate information on unapproved, off-label uses of FDA-approved products, under Section 401 of the Food and Drug Administration Modernization Act that expired on Sept. 30, 2006. It took a while but on Feb. 15, 2008, the agency announced new guidelines under the title "Good Reprint Practices."

The manufacturer's interest in the drug or medical device that is the subject of the journal reprint or reference text.

In the end, it is the doctors and healthcare practitioners who must decide on how to use a drug for a given condition. If an FDA-approved anti-epileptic drug has been shown to significantly improve a bipolar disorder in independent and peer-reviewed studies, then doctors and healthcare practitioners are the ones who are going to be in the best, and only, position to determine how best to treat the patient, on a case-by-case basis. With these guidelines in place, the promotion or advocacy of off-label use by drug-or medical device-companies is likely to be severely restricted.

Finally, it should be recognized that it is illegal for a drug company to promote off-label use for a drug or device, that constitutes a "new use" for that drug or device. If such promotion is carried out, then the FDA retains legal authority to decide upon the condition of unapproved "new use" and whether the distribution of an article or publication constitutes promotion of a new use. In some cases these decisions can result in a product being deemed misbranded or adulterated under the federal Food, Drug and Cosmetic Act.

In general, the FDA approves drugs only for certain indications, and this information is contained in the FDA label for the product. However, there is nothing illegal about healthcare professionals prescribing FDA-approved drugs for non-indicated uses, such as administering an anti-epileptic drug to treat bipolar disorder, for instance. Indeed, it is estimated that around 20 percent of all drugs are prescribed for off-label uses, particularly in the psychiatric arena. However, it is illegal for manufacturers to actively promote drugs for non-indicated uses.

Media Fuss Side Effect

Lastly, the FDA recommends that a journal reprint or copy also should carry a prominently displayed statement disclosing the following:

The new guidance recommends that individuals (such as drug company representatives) who disseminate literature in support of off-label use, use only letters to the editor, publication abstracts, and reports of Phase 1 trials in healthy subjects from peer-reviewed journals with recognized editorial boards. It also allows for reference publications that contain little or no substantive discussion of the relevant investigation or data. The publications should be generally available in bookstores or other independent distribution channels where medical textbooks are sold, according to the guidelines.

The guidelines also suggest that the articles should not be edited, abridged, marked, or highlighted in any way, and that reprints or copies should be accompanied by the FDA-approved labeling and an extensive and comprehensive bibliography. The articles should not be physically attached to any promotional material by sales representatives, nor should they constitute a subject of discussion during sales presentations. Similarly, sales representatives should not distribute these reprints at conferences.

Off The Label - Contrary To Reports, FDA Guidelines For Off-Label Promotion Tighten Loopholes

The uses described in the information have not been approved or cleared by FDA, as applicable to the described drug or medical device,

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