Question:
- Hide quoted text — Show quoted text -Rob Duncan wrote: > "Michael" <muirh…@haidagwaii.net> wrote in message > news:MLednSgOyNrUONTfRVn-og@qcislands.net… >> Cowboy wrote: >>> The solution should be non-controversial. We’re not talking about >>> potential Vioxxes that will be widely used by generally healthy >>> people. We’re talking about treatments for dying patients. So let’s >>> have legislation mandating that the FDA grant access to these drugs >>> as soon as they show anti-cancer activity. >> Ah, but that *is* controversial. >> Cannabis has shown good anti-brain-cancer activity… but that’s a >> medical benefit, which is something the US government has decreed >> cannabis does not have – in much the same way as (and using the same >> reasoning with which) the Church of Rome declared that the earth did >> not orbit the sun. Way better to leave sick people to die in agony >> despite the >> possibility of effective treatment than for government to admit that >> it’s been completely full of shit for nearly 70 years. > Where is the US governments decree that Cannabis doesnt have any > medical benefit? They clearly wanted to make it legal for Marinol to > be sold,
That isn’t the case, nor was it necessary to legalize anything to do with the plant, because marinol is a fully lab-synthesized chemical, not a plant extract. > not to mention the most effective emergancy brain damage > medication in the world, used for traumatic brain injurty, is made of > marijauna and is in EVERY emergancy room in the entire nation. So, > Im unsure of your point. Our government clearly wanted those > marijauna medications made available. Not to mention the millions who > are on it whos States allow it. > Where is this decree? Just curious.
Do you mean where besides in US federal law and the Act of Congress that put it there? On Monday, May 14, 2003, the United States Supreme Court dealt a blow to organizations that grow or distribute medical marijuana to sick people, holding that such organizations may not raise a medical-necessity defense to charges of violating the federal prohibition on marijuana. According to the Court, by placing marijuana in Schedule I of the Controlled Substances Act–the schedule that is the most restrictive possible–Congress determined that marijuana has "no currently accepted medical use." The only exception to the strict prohibition on growing or distributing marijuana, said the court, is for government-approved research projects. Writing for the majority, Justice Clarence Thomas stated that by expressly determining that marijuana has no accepted medical use, Congress foreclosed a medical-necessity defense by an organization that grows or distributes marijuana to sick people: "It is clear from the text of the [Controlled Substances] Act that Congress has made a determination that marijuana has no medical benefits worthy of an exception. The statute expressly contemplates that many drugs ‘have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people,’ but it includes no exception at all for any medical use of marijuana. Unwilling to view this omission as an accident, and unable in any event to override a legislative determination manifest in a statute, we reject the [Oakland Cannabis Buyers'] Cooperative [medical-necessity] argument." (Opinion, p. 9.) Also… The Institute of Medicine of the National Academy of Sciences was commissioned by Barry McCaffrey, former Director of the Office of National Drug Control Policy, to study this issue. Their 267 page report concluded in 1999 that there are a variety of medical benefits from marijuana and its compounds. They noted the problems with smoking marijuana and the problems of using a crude plant as the source for the medicines. They also noted that marijuana use, per se, is NOT a gateway to other illegal drug use. They recommended more research, but concluded that persons with life threatening illnesses who did not respond to conventional medications be permitted to smoke marijuana. Disregarding the report it commissioned, the US Federal government continues to insist that marijuana has no medical value. The Federal government has resisted legal petitions to reschedule marijuana to permit its use in medicine, and repeated its arguments in numerous court cases. It opposes the use of marijuana in medicine on its websites, in case you’ve never seen those. http://www.usdoj.gov/dea/ongoing/marinol.html http://www.nida.nih.gov/MarijBroch/Marijteenstxt.html#Medicine
Response:
Cowboy wrote: > The solution should be non-controversial. We’re not talking about > potential Vioxxes that will be widely used by generally healthy > people. We’re talking about treatments for dying patients. So let’s > have legislation mandating that the FDA grant access to these drugs > as soon as they show anti-cancer activity.
Ah, but that *is* controversial. Cannabis has shown good anti-brain-cancer activity… but that’s a medical benefit, which is something the US government has decreed cannabis does not have – in much the same way as (and using the same reasoning with which) the Church of Rome declared that the earth did not orbit the sun. Way better to leave sick people to die in agony despite the possibility of effective treatment than for government to admit that it’s been completely full of shit for nearly 70 years.
Response:
"Michael" <muirh…@haidagwaii.net> wrote in message
news:MLednSgOyNrUONTfRVn-og@qcislands.net… – Hide quoted text — Show quoted text -> Cowboy wrote: >> The solution should be non-controversial. We’re not talking about >> potential Vioxxes that will be widely used by generally healthy >> people. We’re talking about treatments for dying patients. So let’s >> have legislation mandating that the FDA grant access to these drugs >> as soon as they show anti-cancer activity. > Ah, but that *is* controversial. > Cannabis has shown good anti-brain-cancer activity… but that’s a medical > benefit, which is something the US government has decreed cannabis does > not have – in much the same way as (and using the same reasoning with > which) the Church of Rome declared that the earth did not orbit the sun. > Way better to leave sick people to die in agony despite the possibility of > effective treatment than for government to admit that it’s been completely > full of shit for nearly 70 years.
Where is the US governments decree that Cannabis doesnt have any medical benefit? They clearly wanted to make it legal for Marinol to be sold, not to mention the most effective emergancy brain damage medication in the world, used for traumatic brain injurty, is made of marijauna and is in EVERY emergancy room in the entire nation. So, Im unsure of your point. Our government clearly wanted those marijauna medications made available. Not to mention the millions who are on it whos States allow it. Where is this decree? Just curious. Rob
Response:
How About a ‘Kianna’s Law’? March 24, 2005; Page A14 Of all the opinions being expressed about the Terri Schiavo case, the hardest to understand is cynicism about the politics of Congressional intervention. Only phony "federalists" question Washington’s competence on matters of fundamental rights. And whether you side with Mrs. Schiavo’s parents or husband, it is hard not to be impressed by the spectacle of the nation’s highest legislative body convening over the fate of a single person. No, if our solons have exposed themselves to criticism by taking up the Schiavo case, it should be focused not on their motives but on their inconsistency and lack of proportion. To wit: If Terri Schiavo deserves emergency federal intervention to save her life, people like Kianna Karnes deserve it even more. [Kianna Karnes] The 44-year-old Mrs. Karnes — mother of four and grandmother of one — is not brain-damaged. And the possibility (albeit remote, at this point) exists that she could return to a fully normal life. But she will almost certainly die in the near future as long as the federal government continues to deny her treatment for the kidney cancer that has by now spread throughout her body. What makes Mrs. Karnes’s predicament so depressing is that two different developmental drugs have shown great promise for several years now against this once near-untreatable disease. But not only has the Food and Drug Administration not moved with dispatch to approve the drugs, it has begun imposing new testing requirements that make it all but impossible for their developers — Bayer and Pfizer — to provide them to terminal patients on a "compassionate use" basis. The problem here is the FDA’s unethical — and let us stress, unscientific — insistence on gathering information about drugs by way of "blinded" placebo-controlled trials, in which a subset of study patients are knowingly denied the new treatment and in some cases denied access to any active treatment at all. This may be moral with an antihistamine; it’s certainly not with treatments for a terminal disease. What’s more, it’s entirely unnecessary. We already know what happens to most cancer patients who don’t get treated. They die. We generally know, on average, how long that will take. So placebo groups are entirely unnecessary to prove significant anti-cancer activity, as the yet-unnamed Bayer (BAY 43-9006) and Pfizer (SU 11248) compounds have already done. Yet the FDA is mandating an unethical placebo trial for the Bayer drug. (The Pfizer drug is at least being tested against another form of care, albeit one that’s already all but certain not to work as well.) A deadly follow-on effect of the placebo fetish is that it gives companies a disincentive to run compassionate use programs for unapproved drugs. That’s because companies won’t be able to satisfy FDA demands to enroll patients in placebo trials if patients know they can get the drug for sure (instead of running the risk of getting a sugar pill) through compassionate use. Hence Mrs. Karnes’s deadly predicament. "If the only alternative is death, then for God’s sake let ‘em have the drug," says Mrs. Karnes’s father, John Rowe, who himself survived leukemia only by getting himself into a clinical trial where he could get another investigational therapy (Gleevec, since approved). Who could disagree? Well, a few bureaucratic MDs at the FDA do. More specifically, one Richard Pazdur. He is the current head of cancer drugs evaluation at the FDA, and is unfortunately a leading candidate for a new position that would give him the power to thwart the would-be revolution in biotech cancer treatments as well. Late last year we reported how Dr. Pazdur had undermined — in fact, totally reversed — the meaning of guidelines issued by former Commissioner Mark McClellan intended to speed up drug reviews. His latest attack on the concept of accelerated approval has him demanding that companies enroll patients in placebo-controlled "Phase 3" trials before submitting applications for very promising drugs that should be eligible based on smaller "Phase 2" studies. A few years back, Dr. Pazdur was the agency’s public face in explaining the rejection of Erbitux. That drug has since been approved and become a clinical hit. So has Eloxatin, which the FDA held up for years even after it was approved in Europe but has since become standard care for colon cancer here too. In almost all recent cases of FDA dawdling, the drugs are proving to be far more beneficial in practice than even the supposed "gold-standard" of placebo trials would have ever suggested. So could someone explain, again, what the benefit is of doing such trials? We’re not suggesting Dr. Pazdur is some kind of ogre. But he seems to be more worried about letting drug companies get away with a so-called "race to the bottom" on trial design than he is with getting good drugs to patients. And it’s obvious that he can’t (or won’t) be educated in modern scientific and statistical methods that would allow drugs to be released sooner. We’ve never understood why the Republican majority in Washington hasn’t been more active on drug-approvals over the past four years. What better way to demonstrate compassionate conservatism and commitment to a "culture of life"? Or to unite the free-market wing of the GOP with the social conservative one? Finally, what better riposte to the left’s equation of support for embryonic stem cell research with support for medical progress? The solution should be non-controversial. We’re not talking about potential Vioxxes that will be widely used by generally healthy people. We’re talking about treatments for dying patients. So let’s have legislation mandating that the FDA grant access to these drugs as soon as they show anti-cancer activity. Instead of restricted-access placebo trials, drug researchers could be using large, open access trials in which everyone who wants the new drug can get it. They could then take advantage of advanced statistical methods to figure out whether the drug is working. Wall Street traders use these kinds of math tools all the time, and so do economists. So-called Bayesian statistics are already used in medical device regulation, where even the FDA recognizes that randomizing people into sham surgeries is simply beyond the pale. Well, what about cancer and other terminal patients? They are now dying needlessly in placebo-controlled trials. And would-be patients like Kianna Karnes are dying outside of them because they make "compassionate use" all but impossible. Won’t Congress do something? URL for this article: http://online.wsj.com/article/0,,SB111163190273988429,00.html Kianna’s Legacy March 29, 2005; Page A14 We regret to report that Kianna Karnes, featured in last Thursday’s editorial on the Food and Drug Administration’s fetish for the placebo-controlled testing of cancer drugs — "How About a ‘Kianna’s Law’1?" — died Friday night of complications from kidney cancer. She was 44. While it came too late to save Mrs. Karnes, our reporting of her plight certainly generated a lot of attention. Bayer and Pfizer — developers of two investigational drugs showing much promise for this particularly deadly cancer — both contacted her doctor almost immediately to discuss the appropriateness of providing the compounds. Mrs. Karnes’s family was also contacted by the FDA and told that the agency stood ready to approve such treatment on an emergency basis. All encouraging steps. But isn’t it a national scandal that cancer sufferers should have to be written about in The Wall Street Journal to be offered legal access to emerging therapies once they’ve run out of other options? The FDA’s oncology division has proven to be essentially incorrigible on this point in recent years, so it’s time for Congressional action mandating that the agency use 21st-century science and statistical methods to get these therapies to patients sooner. More specifically, drug approvals could be based on large trials open to all comers and analyzed with so-called Bayesian statistics, as already happens in the FDA’s medical device division. (Yes, the agency at least recognizes that studies involving, say, "placebo" defibrillators would be beyond the pale.) Mrs. Karnes’s father John Rowe — himself a leukemia survivor — plans intense Congressional lobbying in the coming weeks, and he’s had some interest from Congressman Dan Burton’s (R., Indiana) office in the possibility of sponsoring a "Kianna’s Law." No doubt there will be others willing to sign on. We’ll keep you posted. Meanwhile, we’d suggest that cancer patients looking for a constructive way to make their voices heard — and those looking to educate themselves on the issue — contact the Abigail Alliance for Better Access to Developmental Drugs at www.abigail-alliance.org2. URL for this article: http://online.wsj.com/article/0,,SB111205740262191466,00.html
Response:
Posted in Kidney Cancer | 
No Comments » |
) — People have written mournfully about the futility of our pitiful existence, knowing that our civilization will inexorably die when our world ends 
MUHAHAHAHA — Claudia Engel (no emails please) Rule #1: Don’t piss off the borderline when she’s forgot her meds again… 
Btw, I disagree with you (The friction begins when we try to communicate between sexes.) Perhaps it’s true in your case… However, it’s certainly is not in mine. For someone who edits scientific paper you tend to be prone to generalization a lot! I don’t blame you … you’re simply like most people, i.e. incapable of seeing beyond those generalizations — People have written mournfully about the futility of our pitiful existence, knowing that our civilization will inexorably die when our world ends 