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An FDA advisory panel has given the nod to Dendreon’s Provenge, an innovative new approach to treating cancer. The product is a therapeutic cancer vaccine that is designed to trigger the patient’s immune system into attacking the tumor. As with all of the other therapeutic cancer vaccines, clinical trial results were mixed. Provenge was generally safe, however efficacy was a mixed bag. Provenge failed to meet endpoints for “time to progression” or tumor advancement. However, men in one trial lived about 5 months longer. So what is more important, survival or “time to progression”? Evidently the panel was moved by the survival data. I’m betting the FDA will give the drug the green light. Cheap Generic Viagra

Tags: cancer, provenge, fda, therapeutic, trial

It's official sports fans - FDA rejects Arcoxia.

Tags: arcoxia, fda, rejects, fans, sports

Just as last year, I don't understand the point of these compacts about states disregarding their own results and giving their electoral votes for President to the winner of the national popular vote. On second thought, I do; Dems like O'Malley are still trying to win the 2000 election. The more-logical thing to do is to simply choose electors proportionately; that is, if half the vote goes for Dems, half the electors are Dems, and vice versa. But the reason Dems will fight that tooth and nail is that it means they actually would have to work for the votes in states like California and New York, rather than simply sitting back and using them as ATMs.

Tags: dems, vote, simply, half, states

At the farmer's showgoers a couple weeks precedent, we daffodil a protracted post truck stopped at the manageable, still rare of the legitimate firefighters jumped out further gave Nate an Oakland FD hat! Once we moved the rubberband out of the subdivision, he in reality loved wearing it, likewise riding his little truck (considering referred to past him as a motorcycle, of policy). viagra cialis viagra buy cheap cialis

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Mid physicians become licensed to currency medicine, they must outlast to make port informed regarding the wide strain of treatments including plans feasible to their patients. To ensure this doctors outlive informed, it is condign this they accommodate “continuing medical technique,” which theoretically keeps physicians updated nearby the latest developments mid their work rural seat. So far, so good. But what, exactly, is continuing medical drilling (CME)? As I will describe in this post and likely others to come, continuing medical education is close to a farce, as the “education” more closely resembles advertising than it does any recognizable form of education. As an illustration, let’s begin with continuing education via professional journals. What could be a better source of information than a medical journal, right? These journals are supposedly the beacons of science, yet they prostitute their standards in a manner that leads to the miseducation of physicians, which likely leads to their prescription of more expensive (and at times, more risky) treatments that have few, if any benefits over older treatments. Case in Point: Journal of Clinical Psychiatry. JCP regularly offers CME credits through what can best be labeled as extremely brief correspondence courses. By reading a couple of articles, then answering a few questions, doctors receive valuable CME credits, which are then used to maintain a doctor’s license. JCP is far from the only journal which participates in this practice. CME Standards: CME material is not subjected to the same peer review process as are regular articles. Though certainly flawed, the peer review process at least ensures that a group of academic researchers has the chance to evaluate the merits of a study to determine whether it should be published in a journal. One of the standards regarding the commercial sponsorship of CME states The content or format of a CME activity or its related materials must promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest. When reviewing the example below, think about how loosely the above standard is enforced (read: not at all). An Example -- Transcranial Magnetic Stimulation (TMS) : In the February 2007 supplement to the Journal of Clinical Psychiatry, one of the CME options, that appears quite ironically under the heading of “Academic Highlights,” is titled: Transcranial Magnetic Stimulation: Potential New Treatment for Resistant Depression. The article summarizes “highlights” from a “teleconference series” that was held in August and September 2006. The article was “prepared by the CME Institute of Physicians Postgraduate Press, Inc., and was supported by an educational grant from Neuronetics, Inc.” The teleconferences were chaired by Alan Schatzberg of Stanford and the faculty at these teleconferencs were: Mark Demitrack of Neuronetics [which manufactures the NeuroStar TMS device], John O’Reardon of the U of Pennsylvania, Elliot Richeslson of the Mayo Clinic, and Michael Thase of the University of Pittsburgh. Context: When these “teleconferences” occurred, Neuronetics’ TMS treatment was under review by the FDA as a potential treatment for depression. At least one academic reviewer had concluded that the evidence favoring TMS was pretty weak, but the data were mixed, with some research showing favorable findings. Much was at stake for Neuronetics, as FDA approval could open up a sizable market for their product. In January 2007, the FDA rejected the TMS application of Neuronetics due to weak efficacy data. Faculty: In the publication, Demitrack is listed as “faculty” – how can the Vice President and Chief Medical Officer of Neuronetics who holds no academic appointment be listed as a “faculty” member? Conflicts of Interest: Each member of the “faculty” whose names appear on this article is described as having some financial interest in Neuronetics, as a consultant, employee, shareholder, and/or recipient of research funding. Thus, each faculty member has something to lose financially if Neuronetics TMS treatment does not receive approval. Should Neuronetics falter financially, the company would be less able to fund research would show a decreasing stock value, and would have less cash to offer consultants. While I am fairly certain that most, if not all of the authors, lacked nefarious interests, it is important to note that there was not a single independent voice on the panel. In CME articles such as this, however, this is just par for the course. Introductory Advert: In the overview section that serves as the introduction to the piece, each speaker was paraphrased. Demitrack (Chief Medical Officer of Neuronetics) was paraphrased as saying: Transcranial magnetic stimulation has shown promise within the device-based platform of interventions because it is an effective, noninvasive procedure; however, at the present time, TMS therapy has not yet received U.S. Food and Drug Administration approval. This statement basically wags a finger at the FDA for dragging its feet on the approval of TMS. Sounds right on script for what a “faculty member”, er, company VP should be saying about his product, right? Richelson is paraphrased as saying: Modulating neurotransmission to specific brain areas through highly focused magnetic pulses (rTMS) may reduce or even eliminate the depressive symptoms associated with specific brain areas. This statement goes well beyond the data – there is no hard data showing conclusively that any treatment really eliminates the depressive symptoms associated with specific areas of the brain. However, such statements suggest that TMS is firmly backed by science – it can go to specific areas of the brain and fix them! Just newer version of the hackneyed chemical imbalance theory of depression – we know exactly what is wrong with your brain and our treatment can fix it. Same story, different treatment. Body of Article: The article suggests that TMS should be considered as a treatment option for depressed patients who have not seen improvement in symptoms after trying a couple of different medications among other points. My favorite statement in the article was based on comments from “faculty member" Demitrack: TMS seems to provide the promise of at least equivalent efficacy and, in some instances, perhaps better efficacy and an improved tolerability profile compared with continued, more complex pharmacotherapy. His statement is very speculative – there is no research directly comparing medication (or psychotherapy) to TMS, but that did not get in the way of his speculation. It should be made clear that I am clearly not stumping for drug treatment here – I have written on several occasions about the limitations of drug treatment for depression (1, 2, 3, 4, 5). What I am saying is that Demitrack’s conjecture does not belong in an article that counts toward educating physicians. Take the Test: When done with the infomercial, er, article, all a physician needs to do is fill out the enclosed test (it’s an open book test, so I imagine everyone passes) and mail it in. Physicians can even complete the test online. Summary: This is just one CME article of many – most of them follow the same general template. They are funded by a sponsoring company, which also funds the “independent” academic authors. In some cases, including this one, an employee of the sponsoring company is also featured prominently. A medical writer may then write up much or all of the article. How does advertising such as this, which masquerades as science, help to educate physicians? Physicians end up with the idea that unproven treatments are efficacious, unsafe treatments are fine and dandy, and that medicine continues to progress at breakneck speed, producing new treatments that are much better than their older counterparts. And this helps patients… HOW?

Tags: treatment, article, tms, cme, style