Hello David >Keith, > >Keith Addison wrote: >>> For example, only the makers of FDA approved drugs can use the >>>word cure... [and] the FDA only approves drugs that go through >>>its specific approval process --- one that costs hundreds of >>>billions of dollars. >>> >> > > Could that be right? It really costs hundreds of billions of >dollars to get a drug approved? Does it cost even hundreds of >millions? > > > >As someone who once ran a medical device company, and spent many a long >hour dealing with FDA, I can affirm that the FDA is like the IRS, except >they have no mercy,
The IRS has mercy? If so it seems to get left out in the telling, the way Americans tend to tell it. >and the audits go on for years unending. It does not >cost hundreds of billions, however. Such price tags are reserved for the >morass of war. And handouts for Wall Street. >Not even the conquest of AIDS in Africa would be that >expensive. > >That said, drug approval is often more expensive than device approval. >Devices can often be approved after fairly small trials consisting of >100-200 people. When trying to gain approval for a drug, by contrast >(after demonstrating sufficient safety in smaller trials), sometimes one >must try to tease out fairly subtle health improvements or rare >complications, and either requires many, many warm bodies. For example, >NSAIDs, drugs that help prevent heart problems, NSAIDs stands for Non-Steroidal Anti-Inflammatory Drugs. I'm aware that, as well as for the anti-inflammatory effect, they're used to lower fever and for pain relief, but (apart from aspirin) this is the first time I see them described as drugs that help prevent heart problems. A quick check finds that wikipedia says just the opposite: "A recent meta-analysis of all trials comparing NSAIDs found an 80% increase in the risk of myocardial infarction with both newer COX-2 antagonists and high dose traditional anti-inflammatories compared with placebo. (Kearney et al., BMJ 2006;332:1302-1308) "NSAIDs aside from (low-dose) aspirin are associated with a doubled risk of symptomatic heart failure in patients without a history of cardiac disease. In patients with such a history, however, use of NSAIDs (aside from low-dose aspirin) was associated with more than 10-fold increase in heart failure.[8] If this link is found to be causal, NSAIDs are estimated to be responsible for up to 20 percent of hospital admissions for congestive heart failure.[8]" This is the footnote reference: <http://archinte.ama-assn.org/cgi/content/full/160/6/777> Consumption of NSAIDs and the Development of Congestive Heart Failure in Elderly Patients An Underrecognized Public Health Problem John Page, MBBS(Hons); David Henry, MBChB Arch Intern Med. 2000;160:777-784. That's what I'd thought. (No I don't trust or rely on Wikipedia, though it's improving, but this checks out.) >must be given to enough >people over a long enough time to demonstrate that there is sufficient >positive reason to use them and a lack of a negative reason to avoid >them. A 25% improvement in a problem or reduction in a complication that >may afflict only a few tenths or hundredths of a percent of a certain >population may require thousands of participants in a long-term drug >trial before statistical certitude is sufficient. > >As implied, I often found dealing with the FDA to be like living in one >of the circles of hell. In spite of all of it, however, I think the >system is basically sound and that the ideas underlying it are >reasonable. Of course we need to test drugs. Of course we need to have >solid evidence of safety and efficacy. Science actually works. Science does, yes, within its limitations, when it's allowed to. Too often it depends who's paying the piper. Equating science with the FDA is stretching it more than a little, as the colloidal silver article states truly enough, despite small confusions over costs, and there's certainly a great deal of unshakeable substantiation for that view, much of it in the list archives. This for instance, have a read (the whole series is in the archives): How a New Policy Led to Seven Deadly Drugs Los Angeles Times By DAVID WILLMAN, Times Staff Writer Wednesday, December 20, 2000 Medicine: Once a wary watchdog, the Food and Drug Administration set out to become a "partner" of the pharmaceutical industry. Today, the public has more remedies, but some are proving lethal. <http://www.mail-archive.com/biofuel@sustainablelists.org/msg54672.html> It seems to be more the rule than the exception. On the other hand, it's a little hard these days to find solid evidence that the FDA is more a part of the solution than part of the problem. It's just another piper to be paid for. I don't understand how you can state that the system is basically sound, it's obvious that it's not sound. Not any part of it is sound (and not just in the US, though especially there). The real question is whether or not it's beyond repair. To go back to the question: > > Could that be right? It really costs hundreds of billions of >dollars to get a drug approved? Does it cost even hundreds of >millions? Or is it just millions? Or does the price necessarily include the usual Wall Street campaign contributions and the revolving door and so on? Best Keith >d. >-- >David William House Previous: >Not bad coverage. Pity about the Godwin's Law infringements with >"storm troopers" etc, it only weakens the force of the argument. > >Re this: > >>For example, only the makers of FDA approved drugs can use the word >>cure, or even imply any health benefits without the FDA considering >>the product a drug. The catch is that in order to be FDA approved, >>no matter how many PubMed cited studies or other studies have been >>performed, and no matter how much of a history of hundreds or >>thousands of years and users, the FDA only approves drugs that go >>through its specific approval process --- one that costs hundreds >>of billions of dollars. > >Could that be right? It really costs hundreds of billions of dollars >to get a drug approved? Does it cost even hundreds of millions? > >Best > >Keith > > >>Colloidal Silver Has Mainstream Medicine Singing the Blues >>Tuesday, February 26, 2008 >>by: Tony Isaacs, citizen journalist >>_http://www.naturalnews.com/022728.html_ >>(http://www.naturalnews.com/022728.html) >> >> >>(NaturalNews) The recent widespread mainstream media coverage of the >>**blue man** Paul Karason and his rare skin condition known as >>Argyria is the >>latest in a series of largely misleading and sensationalized scare stories >>about the dangers of colloidal silver turning a person`s skin blue. >> >>Although this latest story did not appear to originate from mainstream >>medicine or the FDA, there is little doubt that they have welcomed it with >>open arms and have been quick to trot out **medical experts** and past FDA >>warnings to help **sing the blues** about colloidal silver. The truth is that >>mainstream medicine has a very good reason to cry long and loud about >>colloidal silver, because it does represent a very real danger - a >>danger to the >>huge profits of the pharmaceutical industry*s patented antibiotics. >> >>The truth is that silver has been used effectively by mankind to fight >>germs and ailments for thousands of years, and the instances of >>modern use of >>colloidal silver turning people*s skin blue are so rare as to be almost >>non-existent - and unlike thousands of prescribed and approved >>over-the-counter >> mainstream medications including the common aspirin, silver has never >>killed anyone. As a matter of fact, almost all of the relative handful of >>reported instances have involved one or more of the following: older silver >>products that contained as much as 10% or more silver (compared to >>mere parts >>per million in modern colloidal silver), silver nitrate, home made colloidal >>silver that was contaminated with salt, and silver that has been consumed >>continuously in very large quantities over a very long period of time. >> >>In the case of Karason, he made his own ionic silver at home for almost >>two decades and for many years consumed a quart or more per day. I daresay >>that any prescribed or over-the-counter medication whose recommended dosage > >was a couple of teaspoons a day would do far worse than turn a person blue >>if they drank a quart or more of it a year! For the sake of comparison, >>drinking a quart or more per day of colloidal silver would be like a person >>taking several bottles of aspirin a day, a practice that would be lethal in > >short order. Karason actually appears to enjoy his notoriety as >the Papa Smurf >> blue man, and even though he sings the praises of how colloidal silver >>saved his life and the many ailments he believes it cured, the focus of >>attention is on his blue skin - a condition that is actually reversible with >>proper diet and herbal cleanses despite mainstream claims to the contrary. >> >>What is also true about colloidal silver is that it is far safer, more >>effective and less expensive than the marginally effective and side effect >>laden mainstream antibiotics - and has mainstream and university studies >>proving it dating back to the early 1900*s. The best and strongest of the FDA >>approved antibiotics are effective for a handful of bacteria at best, whereas >>colloidal silver is supremely effective against just about every kind of >>single celled pathogen, including bacteria, fungal growths and >>viruses (which >> antibiotics are often wrongly prescribed for, despite the fact that >>antibiotics have no effect on viruses). >> >>If the public were told the truth, a rarity when it comes to mainstream >>drugs versus natural competition, colloidal silver would represent a huge >>threat to literally billions of dollars of profits and so it is no >>wonder that >>mainstream medicine and their allies in the mainstream media are once again >> loudly singing the blues - just as they have repeatedly done in the past >>with misleading stories and studies about a great many popular natural >>plants, supplements, vitamins and minerals that represent threats >>to mainstream >>drug profits because they are safer, more effective and less expensive >>alternatives to the unnatural, side effect laden, hugely expensive and >>marginally effective synthetics created in the labs of the powerful world >>pharmaceutical empire. >> >>While there are a great many natural threats to mainstream profits, whose >>use and track records of safety and effectiveness date back hundreds and >>even thousands of years, perhaps no natural alternative to mainstream drugs >>represents as big of a threat to industry profits as colloidal silver, and >>it is no coincidence that colloidal silver has been placed at the very top >>of the FDA/mainstream medicine hit list. >> >>However, when it comes to warning and scaring people away from silver, >>both the mainstream medical industry and the FDA have serious credibility >>problems. First of all, silver has a history of safe and effective >>use dating >>back thousands of years. In addition, it continues to be widely used today, >>including being used by NASA, the US military and Potters for Peace for >>water purification, being used as a germicidal agent by hospitals and medical >>suppliers and was recently incorporated into a new line of hospital pajamas >>to prevent the spread of infection, to name just a few of its present day >>uses. >> >>The biggest credibility problem of all for mainstream medicine and the FDA >>regarding silver is likely how they both approved and embraced silver for >>medicinal use at one time - yet now would have us believe that silver is >>both ineffective and dangerous. At one time silver products were very much in >>favor with both mainstream medicine and the FDA. No fewer than 34 different >> prescribed over-the-counter medications containing silver were not only >>widely sold by industry, they were also approved by the very same FDA which >>now seeks to warn us of its dangers and have us believe it is ineffective. >> >>What changed their minds? Perhaps the obvious answer can be found in the >>fact that silver fell out of favor at the very same time that patented sulfa >>drugs and patented antibiotics created in drug company labs came on the >>market. Once that happened, the non-patentable silver was no longer a tool > >for healing, but a threat to profits. >> >>Zealous protection of mainstream approved drugs and suppression of natural >>competition is nothing new -look at the estimated 100,000 or more deaths >>caused by Vioxx before the FDA finally removed it from the market. Look at >>the ridiculous actions of the FDA when it threatened Washington cherry > >growers for telling the truth about the health benefits of eating >>cherries, or >>at the storm trooper actions against the makers of Charantia (bitter melon) >>tea in Florida who dared put references to some of the 650 plus PubMed >>studies and citations about bitter melon on their website. >> >>The FDA persecutions and prosecutions of cherry farmers, bitter melon, and >>a long line of other natural alternatives points out just how extreme the >>protection of the big drug companies` products and profits really is. >>Consider this: other than issues of national security, only in >>natural health is >>it a crime to tell the truth due to the way the FDA has construed their >>rules and definitions to protect industry. For example, if a company were to >>advertise that vitamin C was a cure for scurvy, as everyone knows is true, >>that company could be prosecuted for selling unapproved drugs. The same >>would be true if a company printed a testimonial from someone who reported >>health benefits due to vitamin C, or any other vitamin, mineral, >>supplement or >>non FDA approved drug. >> >>For example, only the makers of FDA approved drugs can use the word cure, >>or even imply any health benefits without the FDA considering the product a >>drug. The catch is that in order to be FDA approved, no matter how many >>PubMed cited studies or other studies have been performed, and no matter how >>much of a history of hundreds or thousands of years and users, the FDA only >>approves drugs that go through its specific approval process --- one that >>costs hundreds of billions of dollars. >> >>When it comes to natural alternatives, spending such money on a natural >>product is prohibitive, since it could not be patented and could be freely >>and cheaply sold by any number of competitors and it would be virtually >>impossible to ever recover all the costs of getting the natural product >>approved. Though the process is purported to be one which protects >>the public from >>unsafe medicines (and we see how well that worked for the hall of shame >>list of drugs like Vioxx, Avandia, etc.), the net effect of the FDA*s drug >>definitions and approval process is to exclude natural competition and insure >>that only the patentable and profitable synthetics created in drug company >>labs can be approved and marketed as having health benefits. >> >>The most recent example of such one-sided treatment favoring industry came >>in the following news story earlier this past week about a lawsuit filed >>against the FDA by Public Citizen after the FDA ignored years of complaints >>about the dangers of ruptured tendons caused by one of the drug industry*s >>most powerful and profitable antibiotics: >> >>WASHINGTON, D.C. **Despite long-standing evidence that fluoroquinolone >>antibiotics can cause tendon ruptures, the Food and Drug >>Administration (FDA) >>has failed to increase its warnings to patients and physicians about the >>dangers of the medicines, Public Citizen told a federal court Thursday. >> >>Public Citizen sued in the U.S. District Court for the District of >>Columbia, asking the court to force the FDA to act upon a petition >>the consumer >>group filed with the agency 16 months ago. The FDA has failed to respond to >>the petition, which asked the agency to put a **black box** warning on >>fluoroquinolone antibiotics (such as Cipro, Levaquin and others) to >>make doctors >>and patients more aware of the risk of serious tendon injury before >>tendons actually rupture. >> >>The petition also urged the FDA to send a warning letter to physicians, as >>well as require an FDA-approved medication guide to be dispensed when >>prescriptions are filled. Public Citizen contends that the FDA is >>violating the >>Administrative Procedure Act by not acting upon the petition. > > >>Stronger warnings could lead to earlier intervention and prevent needless >>injuries by allowing doctors to switch patients to other antibiotics, said >>Dr. Sidney Wolfe, director of Public Citizen*s Health Research Group. >> >>**While the FDA sits idly by and ignores the problem, more people will >>suffer serious tendon ruptures that could have been prevented,** Wolfe said. > >**The current warning is buried in a long list of possible adverse >reactions >>and is far too easy to miss.** >> >>>From November 1997 through December 2005, the FDA received 262 reports of >>tendon ruptures, mainly of the Achilles tendon, 258 cases of tendinitis and >>274 cases of other tendon disorders in patients using fluoroquinolone >>antibiotics. An additional 74 tendon ruptures have subsequently >>been reported >>to the FDA for a total of 336. Because only a small fraction of cases are >>typically reported to the FDA, the actual number of ruptures and >>other tendon >>injuries attributable to the antibiotic is much higher. >> >>Source: Healthy News >> >>One can only imagine the FDA*s reaction if 336 tendon ruptures had been >>reported for those who take the best antibiotic and pathogen >>destroyer on the >>planet - colloidal silver. No doubt, they would have raided the >>manufacturer with storm troopers and shut it down years ago, just as >>they have done >>many times with the manufacturers and sellers of other natural competitors >>to drug company products. >> >> >>In conclusion, as far as I can tell, not one single instance of Argyria >>has been attributed to properly made colloidal that was not consumed in >>amounts that were up to hundreds of times the recommended dosage, >>that has not >>stopped the FDA from continuing to **sing the blues** about silver or from >>going after those who make and sell colloidal silver products, not because >>silver represents a whit of threat to human health but rather because it >>represents a threat to the inflated bottom line profits of the >>mainstream drug >>manufacturers. >> >>Finding out who the FDA really serves is a simple task - all you have to >>do is follow the money. But don`t simply take my word, let a noted past FDA >>commissioner tell you very clearly what the FDA is really about: >> >>**The FDA *protects* the big drug companies and are subsequently rewarded, >>and using the government*s police powers they attack those who threaten >>the big drug companies. People think that the FDA is protecting them. >> >>It isn*t. >> >>What the FDA is doing and what the public thinks it is doing are as >>different as night and day.** >> >>Dr. Herbert Ley Former U.S. FDA Commissioner >> >>About the author >> >>Tony Isaacs, is a natural health advocate and researcher and the author of >>books and articles about natural health including "_Cancer's Natural >>Enemy_ (http://tbyil.com/rose-laurel.htm) " and "_Collected Remedies_ >>(http://www.tbyil.com/RLBooks.htm) "as well as song lyrics and >>humorous anecdotal >>stories. Mr. Isaacs also has _The Best Years in Life_ >>(http://www.tbyil.com/) >>website for baby boomers and others wishing to avoid prescription drugs >>and mainstream managed illness and live longer, healthier and happier lives >>naturally. He is currently residing in the scenic Texas hill country near >>Utopia, Texas where he serves as a consultant to the _Utopia Silver_ >>(http://www.utopiasilver.com/affiliates/jrox.php?id=18_1_bid_3) >>colloidal silver and >> supplement company and where he is working on a major book project due for >> publication later this year. Mr. Isaacs also hosts the CureZone "_Ask Tony >>Isaacs_ (http://curezone.com/forums/f.asp?f=861&p=14) " forum as well as >>the Yahoo Health Group "_Oleander Soup_ > >(http://health.groups.yahoo.com/group/oleandersoup/) " _______________________________________________ Biofuel mailing list Biofuel@sustainablelists.org http://sustainablelists.org/mailman/listinfo/sustainablelorgbiofuel Biofuel at Journey to Forever: http://journeytoforever.org/biofuel.html Search the combined Biofuel and Biofuels-biz list archives (70,000 messages): http://www.mail-archive.com/biofuel@sustainablelists.org/
