On Fri, 2005-04-29 at 10:46 +0100, Tim Bedding wrote: > Bill > > > Check out their processes and requirements. It'll be all the > > list you need. > > I do not understand this. Just because the FDA has complicated > processes does not imply that they are excessive.
We weren't talking about excess, we were/are discussing efficiency. In most systems any increase in complexity is in decrease in efficiency. This is a hard lesson to learn in the field, one I've had to learn myself as a system analyst/engineer. The most obvious inefficiency is directly proportional to the amount if time needed to comprehend the complexity of the system. Economically this is a barrier of entry. Given that the barriers (the complexity) is artificial (i.e. government mandated) this is an automatic increase in inefficiency. The blanket mandating of tests is an inefficiency. I can speak to this in the hardware testing field with personal professional knowledge. Not all tests are required for each and every item/drug. Again, remember that such things as reusable cloth feminine pads are under the purview of the FDA. Implements and devices used, even when they are NOT used in connection with a patient likewise fall under the FDA as opposed to a private certification organization. This, too, by it's very nature is an inefficiency. Perhaps it is wise to explain exactly what is meant by efficiency in this field. Efficiency as I, and most of us, use it is getting effective medications into the hands of the people who need them in a timely and cost effective manner. This means not keeping a medication off the market for 3-9 years over minutia, politics, and expense. This means not making it such that companies are effectively prohibited from making drugs that are not "high dollar" value drugs. This aspect can not be stressed enough. It costs millions of dollars in FDA approval/testing alone. Not considering development costs, the costs to bring a product to market can be enough to flat out prevent a company from bringing the medicine to market. There is zero efficiency in these cases. Consider propanolol. This medicine was sold in Europe yet the FDA drug it's feet on it for three years. A conservative estimate the lives this cost numbers northward of 30,000. That is efficient only if the goal was lost lives. Though I'd argue it an inefficient manner of doing that, too. Consider the "Sensor Pad". This tool, a simple 7 dollar device, makes the detection of breast cancer lumps earlier easier. It is a simple device consisting of two thin sheets of plastic with silicone lubricant between them. It operates by reducing the friction of manual lump detection. By all means go read the details of this near-typical example of FDA gross inefficiency: http://www.fdareview.org/devices.shtml What makes it atypical is that the inventor ignored the FDA and sold the device w/o approval. In the process he saved the lives of many, many women. Most just roll over. In the end we Americans can use this simple, no risk device. But only UNDER PRESCRIPTION, and after millions of dollars in legal costs. As you'll also not on that page, the FDA is now considering SOFTWARE under their purview. Another aspect of efficiency is that the more disparate things you try to do, the less efficient you become. Most people know this by the phrase "Jack of all trades, master of none". Tongue depressor: Device required to undergo FDA approval testing. http://www.fdareview.org/incentives.shtml is a start for you. Examine the table of errors carefully. (Fig. 3) What you will see is a gross inefficiency. There are two types of errors: self-correcting and all others. The FDA as a matter of process, scope, and bloat routinely makes errors that are not self-correcting. This is a quality of gross inefficiency. "more than one hundred studies and inquiries have documented the negative impacts of the existing system." -- (last link) Pay particular attention to the last two paragraphs of this link: http://www.fdareview.org/devices.shtml This site does an excellent job. Given the desire to conduct and look at the research you will find that the delays in only a handful of cases have far superseded the lives "saved" by the FDA. Since the reported goal is to save lives, a process that results in a greater loss of lives is one that is not only inefficient but horribly broken. If the FDA was a private organization and operated the way it does now, it'd have been put under a long time ago for the increased loss of life and suffering. One of the institutional preventions is the immunity of the FDA officials from errors. It's essentially like the tenure system. Much of the research that needs done would never result in a drug or medical treatment. The FDA, for example, went after makers of oat cereal for the claim that it can help lower your cholesterol. That it does appears to not be the issue. That they didn't get FDA approval for oat cereal as a treatment for high cholesterol was apparently the issue. Much of the research we need, or that was done in the past, is in the agricultural field. Prior to 1962, the FDA *ONLY* concerned itself with "safety" not efficacy. A return to this would be an improvement as well. The "IP" laws, as I mentioned, "enhance" this bad situation. Any treatment that is not patentable can not be capitalized on after going through the FDA process. The one semi-decent thing that I see come out of the delay is that a given patent has less time in effect due to the years the patent holder spends in the FDA approval process. But even though I am against such patents, I still see this as an inefficiency because it destroys profitability and/or raises costs to compensate. Indeed, medical experience is more and more going outside the bounds of the federally mandated FDA process. It is known as "off label use". A modern and, dare I say it outstanding, example is Viagra. Contrary to popular belief, Pfizer did not set out to create a drug to handle impotence. This was a side-effect. Viagra was initially developed for cardio problems. Some side effect reporting in journals led some doctors to try it out for ED. This led to clinical trails and years later, FDA approval. Yet the story does not end there. It is being prescribed to infants. Why? It is being found effective in fighting infant pulmonary hypertension. After some clinical trials Pfizer will likely go back through the entire FDA process again. Why? Well each new use it is classified as a "New Drug". So all those tests get conducted *AGAIN*. If that isn't inefficient, not much is. Forcing a drug maker to go back through the entire process as if it had never done it merely because a new use is found is a gross inefficiency. Nearly all chemotherapy is off-label. These reactions (off-label uses) are due to the onerous FDA approval process. The FDA and it's proponents are seeking to ban this too. Other modern nations have better "FDA" systems in place as well as "reciprocity". Reciprocity is the act/policy of taking foreign certifications or approvals into account. Many countries have a one-way process of his with the US. They accept US approvals but the FDA refuses to consider other countries' certs and approvals. All this and we haven't even touched the problems of the FDA forcing products off the market WITHOUT solid scientific evidence of a problem. Yes, it happens. More than forcing bad products off the market. -- Bill Anderson <[EMAIL PROTECTED]> _______________________________________________ Libnw mailing list Libnw@immosys.com List info and subscriber options: http://immosys.com/mailman/listinfo/libnw Archives: http://immosys.com/mailman//pipermail/libnw
