The "bully tactics" and "intimidation" of drug industry operatives could cause "thousands of additional cancer deaths," cries an angry doctor in a May 29 oped in the Wall Street Journal.
But Mark O. Thornton, MD, MPH, PhD, is not talking about the lobbyists and reps embedded in doctors' and lawmakers' offices even as patients and constituents wait for access.
He's talking about Sen. Charles Grassley (R., Iowa), ranking member of the Senate Finance Committee.
You see, even though "Mr. Grassley did some good after the Vioxx episode, by focusing on the woeful manner in which postmarketing drug safety is managed and regulated by the FDA," writes Thornton, who the Journal identifies as a former medical officer in the Office of Oncology Products at the FDA who "volunteers as president of the Sarcoma Foundation of America," the Senator "and his staff should have kept their eyes on the ball."
Instead, Grassley wants the Government Accountability Office to investigate why the cancer drug Avastin was approved for use in metastatic breast cancer two months after the FDA's Oncologic Drugs Advisory Committee (ODAC) rejected approval--and on the basis of data that showed improvement in PFS--progression free survival, the period of time a patient doesn't get worse--but no improvement in overall survival.
Even drug reps were surprised it was approved.
"Not going to happen on basis of data presented to date," posted an anonymous salesman on industry chatroom cafepharma when approval rumors first surfaced. "Think about it. What is the label going to say? Improvement in PFS but not sure of clinical relevance of this. No improvement in overall survival. FDA is not going to do it."
Just because Vioxx caused 27,000 cardiac deaths, Avandia was found to increase cardiovascular death risk by 64 percent and Vytorin proved worthless in improving cardiovascular health all after approval, "The senator is demanding a full-scale review of each and every product ever approved," whines Thornton, "to ensure that drugs approved on surrogate endpoints are both safe and effective."
Imagine that.
Of course surrogate endpoints--short-term criteria a clinical study is judged on in lieu of mortality or survival data--vaulted to national fame when Merck and Schering-Plough sought to alter theirs in the suppressed ENHANCE study to keep Vytorin from looking like a national con job.
Surrogate endpoints spell Ka-Ching to the drug industry because it can start blitzing a drug while safety data is still out and Wall Street is sitting up and listening.
And if the drug turns South as it's used by the first patients/guinea pigs, it's cheaper to ask for forgiveness than permission; Merck, after all still made money on Vioxx despite its $4.85 billion settlement with tens of thousands of plaintiffs.
But the problem with surrogate endpoints is: your actual mileage may vary.
Vytorin reduced LDL but didn't clear arteries.
Avandia lowered blood sugar but raised not lowered heart attack risk.
New osteoporosis drugs stop bone turnover but cause instead of prevent fractures. Oops.
Your points are well-taken, with one exception. Crestor (rosuvastatin) has been shown to reduce cardiovascular morbidity and mortality as compared to placebo. See this press release:
I appreciate and respect your point of view raised in your piece. Indeed in my advocacy pieces, I do not mention the various companies I have worked for, since to do so would presuppose that they share my personal views. While fair to them, I fully understand how easy it is to believe that evil motives are at work in such a position.
It is unfortunate that we live in a time of such deep mistrust of motives of individuals. I consider my advocacy on behalf of cancer patients to be bipartisan and centrist, and engage often with advocactes on both ends of the political spectrum.
At any rate, I hope that through all the easy shots you took at all the fish in my barrel, one could appreciate that my views are not totally corrupted, and to perhaps consider the peril we may very well be in in being able to get new therapies out there for cancer patients.
Regarding profits in this industry, any bipartisan measures that you feel would help curb the profiteering going on in the industry when new cancer therapies get approved, I would surely support and mention to my fellow cancer advocates.
My best to you,
Mark Thornton
by
Mark Thornton (0 articles, 0 quicklinks, 0 diaries, 1 comments)
on Monday, June 9, 2008 at 7:34:19 AM
If you indeed are not corrupt as you say, then you will have no problem sharing the Truth to the American people the value of cannabis as medicine. Please do not insult me with propagated lies and doctored results paid for by the FDA, the oil, coal, timber, cotton, or chemical industries that state otherwise.
In 2000 Dr. Manuel Guzman of Complutense University in Madrid Spain rediscovered that THC, the active ingredient in cannabis destroyed tumors with no side effects whatsoever!!! Call him! I beg you, call him! These findings have since been confirmed by many other reputable Doctors and institutions as well. Why don't we hear about it sir? Answer the question please! Why don't we hear about it? The really sad thing is that our Government knew this in 1974. It was discovered at the Medical College of Virginia. Call them!!! Thats right sir, your Government knew we had a cure for cancer in 1974 and instead of rejoicing they hid the Truth from the people. Think about what I'm saying. How many people have suffered because of these lies and censorship? What does that say about our FDA sir. Answer the question!
In 2005 at the University of Saskatchewan Dr. Xia Zhang discovered that THC actually makes your brain grow, thats right unlike most drugs THC encourages the development of brain tissue. The Scripps Institute in 2006 writes that THC is a superior inhibitor of amyloid plaque aggregation that causes Alzheimers. This too has also been confirmed many more times. Why aren't we being told? Is Alzheimers a problem today? This should be screamed from every roof! This could be a miracle for stroke patients and those with nerve damage as well. Who are you working for?
Cannabis is also found to totally deter epilepsy, it's true. There is a new drug called Sativex, an under the tongue spray approved in Canada for MS that we hear nothing about. Why sir do we hear nothing? Cannabis is also being touted as the most effective treatment for autism currently available, and with immediate results. Mothers don't have to worry about the dosage either, it can't hurt you. Are amphetamines and other stimulants we are handing out for this disease safer for our kids? I thought these were the terrible drugs cannabis led them to? Which is it?
You are aware that all mammals, birds, fish, and reptiles have cannabinoid receptors throughout their body that work independent of those that govern the heart and breathing which is why cannabis CANNOT kill you aren't you? The Truth is that cannabis is the safest medicine on Earth and can also help with chronic pain, migraine, arthritis, diabetes, depression, asthma, emphysema, nausea, glaucoma, herpes, skin and eating disorders, ALS, ADHD, OCD, alcoholism, lupus, cystic fibrosis, Parkinsons, Huntingtons, Tourettes, Crohns disease, and more, but for some odd reason were just now looking. Why is this? Why are we just now looking? And why do we have to fight you to do so? Are you not interested in the health and welfare of the people? Are you for the people or have you been bought? Pretty obvious isn't it sir!
Why doesn't our FDA tell us that the cannabis hemp seed is the single most nutritious thing you can eat, and reintroduced in our diets could alleviate many of the conditions mentioned above. Why? They should know, it's their job isn't it? If you are really interested in the health and welfare of the people why do you continue to play these games of ignorance with them? Answer the question.
For now I'll give you the benefit of the doubt sir and pretent that you did not know these facts. But now that you do, you will have no excuse to continue with the lie. You also need to know that cannabis hemp is the only source of biomass on the planet capable of fixing our current ecological mess and that anything made from oil, coal, timber, or cotton can be made ecologically friendly with hemp. All paper, plastics, packaging, fuel, lubricants, textiles, paints, insulations, varnishes, plywood, structural components, many cosmetics, health foods, and medicines, over 25,000 known products can be made with it. It's true! Canvas is Dutch for cannabis. Henry Ford built and fueled a car primarily with hemp. For thousands of years all ships sails and clothing were of hemp fiber, which is the longest and strongest in nature. Why were we not taught this? The early Pioneers wagons were covered with hemp. The original draft of the Constitution is on hemp paper. The War of 1812 was fought over hemp. It was as important to them as oil is to us today. Why are we not taught about this? One acre of cannabis hemp equals four of timber for pulp and you harvest it every year, tree's take a lifetime. Do the math on that please. Are we having problems with deforestation? Cannabis is also far superior to corn, kenaf, or sugar cane for ethanol production and grows without most fertilizers, herbicides, or pesticides to foul the soil and water. I think thats a big deal, don't you? clean water? Farming just six to eight percent of our land in hemp can replace our current need for oil and coal. Why don't we ever hear about this sir? Do we need fuel, clean fuel? Are you aware that this nation is the only major nation that does not grow industrial hemp, to the Canadians delight, their growing it. China now grows 40% of the worlds crop and they are developing new technology for plastics, textiles, foods, fuel, and more that will ensure the people of the United States are not only at an economic but strategic deficit. Do you see what you are doing to this nation with your lie? Is it worth it?
If you knew, and now you do know the damage that the prohibition, censorship, and ignorance of the most useful plant on the planet, the Tree of Life has caused to this world and our FDA's part in it, you would hopefully stop the madness NOW. STOP IT!!! You and those misleading this nation are responsible for the biggest, most destructive curse ever placed on mankind. You have demonized the Tree of Life, Kaneh bosm, cannabis, hemp!!!!! You have demonized a harmless plant for the profit of a very few. You have killed children. But it had to happen, the Book say's so, we had to get here.
Christ is Anointed with a Holy oil as described in the original Hebrew text of the Old Testament, Exodus 30:23, that contains 250 shekels of an herb called "kaneh bosm," mistranslated as calamus in the Bible. Kaneh is also listed as an incense tree in Song of Songs 4:14 and again in Isaiah 43:24, Jeremiah 6:20, and Ezekiel 27:19. There are 141 references to anointing and 145 for burning incense in the standard Bible. A Polish Anthropologist named Sula Benet discovered the error in 1936, it was only verified by the Hebrew Institute of Jerusalem in 1980. For some reason we don't hear about this either. The Greeks mistranslated the Word "kaneh bosm" as calamus when they first rendered the Books in the 3rd century B.C., and it was then propagated as such from the Greek in all future translations because Hebrew ceased to be a spoken language and was not again revived until the late 1800's. Calamus was used then as well as today as an aphrodisiac and stimulant, it's active chemical asarone is a precursor for the psychedlic MDMA, ecstasy. I've used MDMA, it was an honest mistake! Plants were not illegal then. The Truth is that all Christians are to be Anointed with this oil and made Priests before God. Thats why Jesus came and why he's got to come back, the Truth got watered down along the way. The word antichrist means literally "opposed to or against anointed." They won the battle but not for much longer. The Word is out. The Gnostic Gospels discovered in 1945 at Nag Hammadi Egypt reveal the Mystical Chrism to those that know the Truth of the ingredients. John baptized with water but Jesus baptized with fire and the Holy Spirit. There is water in water, there is fire in Chrism!!!
1 Samuel 16:13, 1 John 2:18-29, Psalm 133
The Word of God is the new Law!
by
Garry (0 articles, 0 quicklinks, 0 diaries, 25 comments)
on Monday, June 9, 2008 at 1:15:29 PM
3 comments
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