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Click here for the U.S. Food and Drug Administration's free, December 2004 video, online training seminar on "The FDA Process for Approving Generic Drugs," from the Center for Drug Evaluation and Research. The seminar provides viewers with an overview of the Food and Drug Administration's role in the generic process, including various aspects of the Abbreviated New Drug Application (ANDA) process, the "Orange Book," and the complexities of the patent certification process and its impact on the approval of generic drug products. The estimated completion time for this video is 60 minutes.

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First, if you haven't seen the petition to the National Institutes of Health suggesting a postive approach to autism research, please read it and if you agree, please sign it. Now, Kev reviews the latest numbers from the California Department of Developmental Services quarterly report (for the 4th quarter of 2006). Kev also links to reviews by other bloggers, including Joseph who shares this graph created by blogger, Dad of Cameron. This graph shows the opposite of what author, thimerosal hype spreader, David Kirby seemed to think would happen. Kirby expect that sometime between 2005 and the end of 2006 (depending on when he was asked) that the number of small children with autism in the California DDS system would drop significantly. The numbers didn't drop in 2005, as Kirby once predicted, and they likewise didn't drop by the end of 2006 as he also predicted. The other thing the graph fails to show is what inspired these dire pronouncements of calamity from Rick Rollens and others. Dr. David Amaral in May 2003: "These numbers are frightening," [...] "This is something that is devastating to families and devastating to children who have a lifelong disability. But it will be devastating to the state of California, too. If you think about it, there are now 20,000 kids in the system, and each of them will eventually get $2 million worth of services. Just do the math. Right. The "doing the math" part means that if someone could pay Amaral right then to find the cause of the devastation, he could save people money in the long run. Rick Rollens, April of 2004 The social and fiscal disaster that is the autism epidemic is upon us. God help us. Rollens again, January of 2005: According to the recently released report by the California Department of Developmental Services (DDS), California's 36-year old developmental services system has just experienced the largest number of new intakes of children with professionally diagnosed full syndrome autism during a Fourth Quarter reporting period in it's history. During the Fourth Quarter of 2004 (October - December), California's developmental services system added a record 807 new children with full syndrome autism, not including any children with any other autism spectrum disorder such as PDD, NOS, Asperger's, etc. The 807 new intakes represents a record number of new cases for a Fourth Quarter reporting period in the system's 36 year history. [...] The 807 new cases of full syndrome autism reported during the Fourth Quarter of 2004 accounted for 52% of all the new intakes for all the eligible disabilities for that reporting period. [...] The magnitude of this ongoing tragic epidemic is truly mind boggling . Ten years ago in January 1995, DDS reported that during the Fourth Quarter of 1994 the system added 142 new cases of full syndrome autism. Today, ten years later in January 2005, DDS reports that during the Fourth Quarter of 2004 there were 807 new cases added to the system. Ten years ago California 's developmental services system had a total of 5,775 cases of full syndrome autism in it's entire system. Ten years later in January 2005, there are now 26,578 cases of full syndrome autism in the system. In California 's developmental services system, 8 out of 10 persons with full syndrome autism are between the ages of 3 and 17 years old....7 out of 10 under the age of 14. The tsunami has arrived. (bold emphasis added) This tsunami press release was written within days of the real tsunami that hit South Asia at the end of 2004. Rick Rollens April of 2005: CA Reports: Autism Cases Decline 2005 From California autism advocate Rick Rollens. According to information released today by the California Department of Developmental Services (syndrome autism of any 1st quarter reporting period since year 2001. 736 new cases were DDS) www.dds.ca.gov/autism , the First Quarter of 2005 (1/4/05 to 4/4/05) produced the smallest number of new cases of professionally diagnosed DSM IV full added. Syndrome; Mental Retardation, Cerebral Palsy, and Epilepsy. [...] [...] At the beginning of 1988, some 17 short years ago, there were 2,778 cases of autism in California's developmental services system. Today there are 27,312 Today there are 27,312. Today, California is adding on average eight new children a day, seven days a week, with professionally diagnosed DSM IV full syndrome autism to it's system. 80%, or 8 out of 10, of all persons with autism in California's system are between the ages of 3 and 17 years old. The staggering tidal wave of young children is unique to the autism. Nice use of scare tactics there, too, which he uses even though he thinks there was a significant drop in the intake of autistic clients. Discussion around that press release showed that some interpreted this drop as proof that thimerosal had been the cause of the autism epidemic. Lyn Redwood was quoted around that time as saying that the numbers in California were coming down. While others from 2002 onward were mostly seeing scary increases in the autism case load the Geiers saw a significant drop, which they trumpeted as caused by the removal of thimerosal from vaccines starting around 1999. The red line was added by Autism Diva. The black lines show how they decided that the "new intakes" of autistics into the system started to decline with January of 2002. Two Sacramento area mercury dads who showed up at Fombonne's presentation at the MIND Institute in December of 2005, insisted (during the question period after Fombonne spoke) that the California DDS numbers were dropping since the removal of thimerosal. The above is Dad of Cameron's graph with some key points in time marked with red arrows and labels by Autism Diva. The Rollens quotes for the most part weren't referring to the increase in just 3-5 year olds in the DDS, but to increases in all ages, but we know that the DDS was adding clients all along who were over 10 years old, sometimes they were adding adults, which was confusing the issue of an "autism epdiemic" that was supposed to have started in 1990 or so and create kids who were un-missable, unmistakably autistic at age 2. This graph doesn't track a particular cohort of kids. The kids who were 3 at the point this graph starts would now be 7 1/2 now. This is a better graph for checking the effect of the removal of thimerosal. By now number of autistic children in the 3-5 age bracket in the DDS ought to be back where it was before 1990 and even lower than that, if autism was caused in a dosage dependent way by thimerosal, as Kirby's book proposed and the mercury hysterics believed starting around the middle of 2000. Maybe they'd all been infected by all the end-of-the-millenium Y2K talk we heard in 1999 and they needed some place to put their stockpiled hysteria and conspiratorial thinking in 2000. On the related topic of the MMR hysteria that started in the U.K. with Wakefield and a solicitor named Barr, read Michael Fitzpatrick's overview of Wakefield's doings and how they were uncovered by Brian Deer. Also, video of a discussion of autism and thimerosal between David Kirby and Arthur Allen on a San Diego television news (Fox 6) program is online. Try this link. Autism Diva so inclined

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Some general links for those who are interested Intro... Ed Grenda's intro to rapid prototyping Bowyer and the printing printers MiT's Centre of bits and atoms (home of Fab Labs) Fabbing at Home (they do chocolate too!) Commercial reports .. (i.e. cost money) Commercial Info on Printed Electronics Wohler provides a good overview of the industry LFF & the Solid FreeForm Fabrication symposium - a treasure trove Companies ...(there are lots, I'll pick three) Printing plastic chips Inkjet printing displays Online fabbing direct to you Hairy Scary ... but cool. Endy and the biological BioBrick builders at Open Wet Ware

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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?

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