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Medical Forum / General / General / September 2005the constant gardener: what the movie missed
'The Constant Gardener': What the Movie Missed "...drug companies {to} shift the burden of experimentation away from Western consumers and onto the world's poor--with all the moral quandaries, ethical lapses and egregious violations that inevitably follow." "...90 percent of the global medical research budget takes aim at illnesses that cause just 10 percent of the world's disease burden. by SONIA SHAH A lush, atmospheric drama, The Constant Gardener brings unprecedented exposure to crucial issues facing the Western pharmaceutical industry and all those who partake of it. Set mostly in a sun-dappled Kenya and based on a John le Carré thriller, the film is a fierce but flawed indictment of Big Pharma's complicity in African illness and poverty. The film revolves around the transformation of mild-mannered career diplomat Justin Quayle, played by Ralph Fiennes. Quayle's wife, Tessa, played by Rachel Weisz, has exposed a botched experimental trial conducted by a Western drug company upon unsuspecting African villagers. After she is found mysteriously murdered, Justin is infected with his firebrand wife's righteous indignation. The plot couldn't be more timely. According to a May 16 report in USA Today, giant drug outfits are outsourcing increasing numbers of drug trials outside the United States and Europe. Merck is now conducting 50 percent of its trials outside the United States. By 2006, 70 percent of Wyeth Pharmaceuticals trials are expected to occur offshore. Across Latin America, Eastern Europe, Asia and Africa, the sick are abundant, desperate and doc-trusting, and so recruitment into clinical trials is rapid. As one executive from an outfit specializing in running drug trials in Asia put it, patients in developing countries are "more willing to be guinea pigs." As the film makes all too clear, Big Pharma's new experimental bodies in the developing world only rarely enjoy the benefits of the research they participate in. Sometimes the new drugs are unlicensed in their countries or priced out of reach, but more often the drugs are irrelevant to the medical needs of their communities. After all, 90 percent of the global medical research budget takes aim at illnesses that cause just 10 percent of the world's disease burden. And so, while 500 million cases of malaria rage across the developing world, the working poor of India, South Africa and elsewhere, desperate for the kind of high-tech care available to them almost solely through clinical research, line up for experimental doses of the latest arthritis, heart disease and obesity drugs. Not surprisingly, ethical lapses are strikingly common. In one inquiry, out of thirty-three subjects enrolled in an experiment trial in Thailand, all of whom had signed forms stating their informed consent, thirty were found to be dangerously misinformed. The experimental HIV vaccine they were about to receive had no known protective value, but, according to the subjects, it would, in fact, protect them from the deadly virus. "Informed consent is a joke," said one industry researcher in an anonymous survey sponsored by the National Bioethics Advisory Commission. But challenging these practices is not nearly as black-and-white as this film would have it. Tessa Quayle, the martyred activist, stands up to yell "bullshit" at public lectures, shaking her lovely dark mane while she's at it. At cocktail parties, she loudly embarrasses the health minister, who marches off in a huff. Good stuff, but the reality is that uncompromising activists--even if they look like Rachel Weisz--rarely enjoy this kind of privileged access to power so effortlessly. Tessa has it too good and too bad, too. She ends up paying with her life for her exposure of the botched trial; in real life, bad drugs and unethical research practices often continue unhindered despite mountains of data and reports detailing their defects. As I found while researching a book on the topic, experimental protocols that would be condemned as unethical in the West--including placebo trials among ailing AIDS patients--are frequently described in the medical press; when the subjects are poor Africans or Asians, nary an eye is batted. (Recall that papers describing this country's most egregious scientific study, the Tuskegee Syphilis Study, in which government doctors denied treatment to black syphilitics, regularly appeared in the medical press from the 1930s onward. That study wasn't terminated until 1972.) In the film, the trial's results are so dangerous that they must be suppressed by an international conspiracy of corporate execs and state authorities. If only. The trouble is that most of the time new drugs aren't uniformly deadly, rendering unequivocal data showcasing their killer properties. Rather, new drugs do work, just not very well, or not for everyone, or not without side effects or, most frequently, not any better than older, safer drugs. What that means is that challenging unethical trials requires more than wrenching a few critical reports from official dustbins. Most disappointing, perhaps, is that the film tells us precious little about the explosive trial at its center, despite the fact that the entire plot hinges on its wickedness. Some of the African subjects died in the trial, the film tells us, but little else is revealed. There's a reason for this strange omission. Most Western audiences will easily jump to the conclusion that any experiment that rendered any deaths is irredeemable, no matter the condition of the patients, the purpose of the trial or the rates of deaths from traditional therapies or no therapy. And yet the business of testing experimental drugs in humans is a risky one, no matter what the condition or drug. Humane research practices may minimize the risks, which must be balanced against potential benefits, but the risks remain, regardless. As one HIV researcher put it, "I mean, sh.t, we learn by climbing over the bodies of humans." That the film makes no allowance for this reality is more than a problem of accuracy. Our reluctance to acknowledge the risks of drug development is the single biggest reason why drug companies have fled the empty test clinics of the United States and Western Europe to set up shop in Africa, Asia, Eastern Europe and Latin America in the first place. On average, every American buys more than ten prescription drugs every year, and yet most are loath to participate in the clinical trials that make new drugs possible. Less than one in twenty Americans take part in experimental trials, with half the American public maligning test subjects as "guinea pigs," according to a June 2004 Harris poll. The logical outcome of this "all gain, no pain" attitude toward modern drugs is for drug companies to shift the burden of experimentation away from Western consumers and onto the world's poor--with all the moral quandaries, ethical lapses and egregious violations that inevitably follow. To paraphrase the rousing finale of The Constant Gardener, we enjoy the benefits of civilization so affordably because their lives are bought so cheaply. To end the cycle, we must own up to the risks of developing new drugs, and decide together how much we are willing to take on and who shall pay the price. http://www.thenation.com/doc/20050912/shah http://www.thenation.com/docprint.mhtml?i=20050912&s=shah fairuse I'm not sure that would work well. Many of the diseases in the Western world are caused by lifestyle - e.g. obesity. So, for example, a statin trial might detect side effects but could not tell how well it works. Also genetic differences might be an issue. Bill 'The Constant Gardener': What the Movie Missed "...drug companies {to} shift the burden of experimentation away from Western consumers and onto the world's poor--with all the moral quandaries, ethical lapses and egregious violations that inevitably follow." "...90 percent of the global medical research budget takes aim at illnesses that cause just 10 percent of the world's disease burden. by SONIA SHAH A lush, atmospheric drama, The Constant Gardener brings unprecedented exposure to crucial issues facing the Western pharmaceutical industry and all those who partake of it. Set mostly in a sun-dappled Kenya and based on a John le Carré thriller, the film is a fierce but flawed indictment of Big Pharma's complicity in African illness and poverty. The film revolves around the transformation of mild-mannered career diplomat Justin Quayle, played by Ralph Fiennes. Quayle's wife, Tessa, played by Rachel Weisz, has exposed a botched experimental trial conducted by a Western drug company upon unsuspecting African villagers. After she is found mysteriously murdered, Justin is infected with his firebrand wife's righteous indignation. The plot couldn't be more timely. According to a May 16 report in USA Today, giant drug outfits are outsourcing increasing numbers of drug trials outside the United States and Europe. Merck is now conducting 50 percent of its trials outside the United States. By 2006, 70 percent of Wyeth Pharmaceuticals trials are expected to occur offshore. Across Latin America, Eastern Europe, Asia and Africa, the sick are abundant, desperate and doc-trusting, and so recruitment into clinical trials is rapid. As one executive from an outfit specializing in running drug trials in Asia put it, patients in developing countries are "more willing to be guinea pigs." As the film makes all too clear, Big Pharma's new experimental bodies in the developing world only rarely enjoy the benefits of the research they participate in. Sometimes the new drugs are unlicensed in their countries or priced out of reach, but more often the drugs are irrelevant to the medical needs of their communities. After all, 90 percent of the global medical research budget takes aim at illnesses that cause just 10 percent of the world's disease burden. And so, while 500 million cases of malaria rage across the developing world, the working poor of India, South Africa and elsewhere, desperate for the kind of high-tech care available to them almost solely through clinical research, line up for experimental doses of the latest arthritis, heart disease and obesity drugs. Not surprisingly, ethical lapses are strikingly common. In one inquiry, out of thirty-three subjects enrolled in an experiment trial in Thailand, all of whom had signed forms stating their informed consent, thirty were found to be dangerously misinformed. The experimental HIV vaccine they were about to receive had no known protective value, but, according to the subjects, it would, in fact, protect them from the deadly virus. "Informed consent is a joke," said one industry researcher in an anonymous survey sponsored by the National Bioethics Advisory Commission. But challenging these practices is not nearly as black-and-white as this film would have it. Tessa Quayle, the martyred activist, stands up to yell "bullshit" at public lectures, shaking her lovely dark mane while she's at it. At cocktail parties, she loudly embarrasses the health minister, who marches off in a huff. Good stuff, but the reality is that uncompromising activists--even if they look like Rachel Weisz--rarely enjoy this kind of privileged access to power so effortlessly. Tessa has it too good and too bad, too. She ends up paying with her life for her exposure of the botched trial; in real life, bad drugs and unethical research practices often continue unhindered despite mountains of data and reports detailing their defects. As I found while researching a book on the topic, experimental protocols that would be condemned as unethical in the West--including placebo trials among ailing AIDS patients--are frequently described in the medical press; when the subjects are poor Africans or Asians, nary an eye is batted. (Recall that papers describing this country's most egregious scientific study, the Tuskegee Syphilis Study, in which government doctors denied treatment to black syphilitics, regularly appeared in the medical press from the 1930s onward. That study wasn't terminated until 1972.) In the film, the trial's results are so dangerous that they must be suppressed by an international conspiracy of corporate execs and state authorities. If only. The trouble is that most of the time new drugs aren't uniformly deadly, rendering unequivocal data showcasing their killer properties. Rather, new drugs do work, just not very well, or not for everyone, or not without side effects or, most frequently, not any better than older, safer drugs. What that means is that challenging unethical trials requires more than wrenching a few critical reports from official dustbins. Most disappointing, perhaps, is that the film tells us precious little about the explosive trial at its center, despite the fact that the entire plot hinges on its wickedness. Some of the African subjects died in the trial, the film tells us, but little else is revealed. There's a reason for this strange omission. Most Western audiences will easily jump to the conclusion that any experiment that rendered any deaths is irredeemable, no matter the condition of the patients, the purpose of the trial or the rates of deaths from traditional therapies or no therapy. And yet the business of testing experimental drugs in humans is a risky one, no matter what the condition or drug. Humane research practices may minimize the risks, which must be balanced against potential benefits, but the risks remain, regardless. As one HIV researcher put it, "I mean, sh.t, we learn by climbing over the bodies of humans." That the film makes no allowance for this reality is more than a problem of accuracy. Our reluctance to acknowledge the risks of drug development is the single biggest reason why drug companies have fled the empty test clinics of the United States and Western Europe to set up shop in Africa, Asia, Eastern Europe and Latin America in the first place. On average, every American buys more than ten prescription drugs every year, and yet most are loath to participate in the clinical trials that make new drugs possible. Less than one in twenty Americans take part in experimental trials, with half the American public maligning test subjects as "guinea pigs," according to a June 2004 Harris poll. The logical outcome of this "all gain, no pain" attitude toward modern drugs is for drug companies to shift the burden of experimentation away from Western consumers and onto the world's poor--with all the moral quandaries, ethical lapses and egregious violations that inevitably follow. To paraphrase the rousing finale of The Constant Gardener, we enjoy the benefits of civilization so affordably because their lives are bought so cheaply. To end the cycle, we must own up to the risks of developing new drugs, and decide together how much we are willing to take on and who shall pay the price. http://www.thenation.com/doc/20050912/shah http://www.thenation.com/docprint.mhtml?i=20050912&s=shah fairuse > I'm not sure that would work well. Many of the diseases in the Western world > are caused by lifestyle - e.g. obesity. So, for example, a statin trial might > detect side effects but could not tell how well it works. Also genetic > differences might be an issue. > > Bill Well whether it would work very well or not is now beside the point, because this is being done. So that means some not very good science is going on. Eh? Among other "egregious violations." Zee > 'The Constant Gardener': What the Movie Missed > [quoted text clipped - 129 lines] > > fairuse > > I'm not sure that would work well. Many of the diseases in the Western world > > are caused by lifestyle - e.g. obesity. So, for example, a statin trial might [quoted text clipped - 6 lines] > because this is being done. So that means some not very good science is > going on. Eh? COMMENT: Non. What's the point of testing a drug if you can't show an effect on the disease it's supposed to treat, because the disease wasn't present? What's the drug company going to do with THAT data? Again, one must distinguish small pilot trials looking for toxic effects and at kinetics, from the larger trials where the drugs really are being used against a disease, and will generally be compared against the best existing standard treatment. The first kind of trial, for not-very-toxic drugs, was in the past often done in healthy people, who were paid, or who volunteered. Or got some benefit half-way in between, like days-off-with pay from work. Example: You don't want to do your first small trials of an antidepressant in people who are actually depressed! Depressed people have more of every kind of complaint, they don't take their pills, they don't show up for check visits, they overdose, they're generally very difficult. If you really want to know the actual side effects caused by the anti-depressant pill itself, not the disease it's used to treat, you give it to some perfectly happy people (along with placebo) and see what happens to THEM. But those people could be in the US or Africa--- from the ethical view it makes no difference. Those healthy happy people don't get any benefit, unless it's serice to mankind, or your money. Would you deny them either? SBH SBH As Le Caree's book, the movie and the reviewer point out, third-world people are being used to test lifestyle drugs for the west. Essential drugs: http://www.essentialdrugs.org/index.php Rational use of essential medicines: http://www.haiweb.org/01_about_a.htm Your scenario ain't what's goin' down. There's a real life story that Le Carre's used as jumping off point for his book. Ever heard of Nancy Olivieri? Zee > As Le Caree's book, the movie and the reviewer point out, third-world > people are being used to test lifestyle drugs for the west. The fact that they all say that in promoting their book and movie, means nothing. I've heard the same about the DaVinci Code. This is called media hype. Say, do you read anything into the fact that the Harrison Ford remake of the old Fugitive series featured the new fact that the one-armed man actually turned out to work for the pharm companies? Consider it. Might be true. Had to have a jumping off point, there, too. And a train. What's a "lifestyle drug?" Are these modern Mengeles torturing Tanzanians with poisonous baldness and acne cures? What? I need examples. You know, I once heard Viagra mentioned as a "lifestyle drug." But since you yourself did a certain amount of complaining about misogynistic male doctors being inappropriately unconcerned about the thought of women possibly losing their sexual function, I'm sure I won't hear any of THAT coming from you, when it comes to same happenning to the opposite sex. We'd have to send you to mandatory gender-issues sensitivity training. > Essential drugs: > http://www.essentialdrugs.org/index.php > > Rational use of essential medicines: > http://www.haiweb.org/01_about_a.htm Terrible lack of information. The point? > Your scenario ain't what's goin' down. > There's a real life story that Le Carre's used as jumping off point for > his book. Ever heard of Nancy Olivieri? No. Had to Google her: http://www.caut.ca/en/issues/academicfreedom/Olivieri_CPSO.pdf Nothing to do with Africa or lifestyle drugs, that's for sure. The stuff with liver biopsies and nasty drug companies did remind me of the Fugitive Movie, though. Though no murders or one-armed men. I think the drug itself, Ferriprox, might fly. God knows we need a good oral iron chelator. http://www.news.utoronto.ca/bin3/020910f.asp The stories involved highlight the difficulties and politics of medical research, where two alternative treatments are being compared, in the treatment of an otherwise fatal problem when not treated (transfuion iron overload in thal major). You brought up the cse. Would you like to make your point, here? Cause after going through all this, it wasn't obvious. SBH > > As Le Care's book, the movie and the reviewer point out, third-world > > people are being used to test lifestyle drugs for the west. > > The fact that they all say that in promoting their book and movie, > means nothing. I've heard the same about the DaVinci Code. This is > called media hype. I have no idea who Da Vinci is. Did I read his book? You don't mean THE Da Vinci I think. The Constant Gardener is based on fact. I know the fact it's based on. > Say, do you read anything into the fact that the Harrison Ford remake > of the old Fugitive series featured the new fact that the one-armed man > actually turned out to work for the pharm companies? Consider it. > Might be true. Had to have a jumping off point, there, too. And a > train. Having a night in with the dogs are we? > What's a "lifestyle drug?" Are these modern Mengeles torturing > Tanzanians with poisonous baldness and acne cures? What? I need > examples. They're the ones you're horking. > You know, I once heard Viagra mentioned as a "lifestyle drug." But > since you yourself did a certain amount of complaining about > misogynistic male doctors being inappropriately unconcerned about the > thought of women possibly losing their sexual function, I'm sure I > won't hear any of THAT coming from you, when it comes to same > happenning to the opposite sex. I wouldn't use such drugs. They're not safe; carcinogenic. There are other ways and means. Beginning with not removing healthy organs. Far different to do sparring surgeries where possible (and there are some just not usually used for post-menopausal women--yet) than to eviscerate and then think a lifestyle drug will fill in. Viagra is a lifestyle drug. Tell me Steve which came first; the Statin or the Viagra? We'd have to send you to mandatory > gender-issues sensitivity training. Ahhh. Baby got a boo boo? > > Essential drugs: > > http://www.essentialdrugs.org/index.php [quoted text clipped - 30 lines] > > SBH > > > As Le Care's book, the movie and the reviewer point out, third-world > > > people are being used to test lifestyle drugs for the west. [quoted text clipped - 5 lines] > I have no idea who Da Vinci is. Did I read his book? You don't mean THE > Da Vinci I think. I do. You don't get out much, do you? http://www.danbrown.com/novels/davinci_code/reviews.html > The Constant Gardener is based on fact. I know the fact it's based on. And what would those be? This Dr. Olivieri wasn't murdered. She wasn't testing drugs on Africans, but Americans with a fatal disease. I'm not even sure her concerns will turn out to be justified. She seems to have acted with integrity. But she also may have been wrong. The people who went after her seem to have been doing the drug company's dirty work, but they were using leftist arguments (lack of informed consent, experimental procedures not in patient's interests, administration of drugs even after safety concerns were raised, yada.) So again, what is your point? If Ferriprox turns out to be new Canadian drug, then woo hoo for you-all. If it turns out to cause liver fibrosis then Health Canada's gunna be embarrassed. But time will tell. Sometimes there are no good or bad guys in these tales. You try something new; it works or it doesn't. > > Say, do you read anything into the fact that the Harrison Ford remake > > of the old Fugitive series featured the new fact that the one-armed man [quoted text clipped - 3 lines] > > Having a night in with the dogs are we? Looks like it. :))) Say woof. > > What's a "lifestyle drug?" Are these modern Mengeles torturing > > Tanzanians with poisonous baldness and acne cures? What? I need > > examples. > > They're the ones you're horking. Is that the best you can do? > > You know, I once heard Viagra mentioned as a "lifestyle drug." But > > since you yourself did a certain amount of complaining about [quoted text clipped - 5 lines] > I wouldn't use such drugs. They're not safe; carcinogenic. There are > other ways and means. Beginning with not removing healthy organs. Sometimes you need to, for maximum safety. It's a lifestyle choice, I suppose. Do you want your future style to include "life"? As in breathing? > Far different to do sparring surgeries where possible (and there are > some just not usually used for post-menopausal women--yet) than to > eviscerate and then think a lifestyle drug will fill in. > > Viagra is a lifestyle drug. None of these surgeries are perfect. And if I said the same about urinary incontience drugs (used mainly by women) I think you'd get the point. Lifestyle drugs they are. You can wear a diaper. > Tell me Steve which came first; the Statin or the Viagra? Gunna suggest statins are lifestyle drugs? 30% stroke reduction? I guess the wheelchair is a lifestyle too. > > > Your scenario ain't what's goin' down. > > > There's a real life story that Le Carre's used as jumping off point for [quoted text clipped - 22 lines] > > > > SBH > > > > As Le Care's book, the movie and the reviewer point out, third-world > > > > people are being used to test lifestyle drugs for the west. > > I have no idea who Da Vinci is. Did I read his book? You don't mean THE > > Da Vinci I think. > > I do. You don't get out much, do you? > http://www.danbrown.com/novels/davinci_code/reviews.html Oh. I don't know it. I'm reading the Selected Poetry and Prose of Byron; The Change by Germaine Greer, and The Greatest Experiment Ever Performed on Women, by Barbara Seaman. > > The Constant Gardener is based on fact. I know the fact it's based on. > > And what would those be? This Dr. Olivieri wasn't murdered. Well pharma took *shots* at her alright. Just not from a gun. She wasn't > testing drugs on Africans, but Americans with a fatal disease. I'm not > even sure her concerns will turn out to be justified. She seems to have > acted with integrity. She did. And you would have too I think in the circumstances. I hope so. But she also may have been wrong. The people who > went after her seem to have been doing the drug company's dirty work, > but they were using leftist arguments (lack of informed consent, [quoted text clipped - 7 lines] > or bad guys in these tales. You try something new; it works or it > doesn't. > > Having a night in with the dogs are we? > > Looks like it. :))) Say woof. I'm flattered. Dogs are some of the nicest people I know. > > > You know, I once heard Viagra mentioned as a "lifestyle drug." But > > > since you yourself did a certain amount of complaining about [quoted text clipped - 9 lines] > suppose. Do you want your future style to include "life"? As in > breathing? If people need a drug; fine. Most of the lifestyle drugs aren't need. Particularly Viagra and it's class. Of course there are exceptions, and some may have real medical need; but I wouldn't want any man I was with to use them just because he wasn't 25 anymore. I wouldn't be with that kind of man. Lots of women think the same. We don't want people to be hurt anymore, but drugs they don't need. > > Far different to do sparring surgeries where possible (and there are > > some just not usually used for post-menopausal women--yet) than to [quoted text clipped - 5 lines] > urinary incontience drugs (used mainly by women) I think you'd get the > point. Lifestyle drugs they are. You can wear a diaper. Women can refuse episiotomies, delivering on their backs, the use of forceps; sedation during delivery that isn't necessary. The only adult I know who does use a diaper is a male doctor. Uses them so he can work 18 hour shifts. > > Tell me Steve which came first; the Statin or the Viagra? Gunna suggest statins are lifestyle drugs? 30% stroke reduction? I > guess the wheelchair is a lifestyle too. Statins do affect hormones, and libido, and can cause ED. Viagra I hear, came along just about in time. > > > No. Had to Google her: > > > > > > http://www.caut.ca/en/issues/academicfreedom/Olivieri_CPSO.pdf > > > > > > Nothing to do with Africa or lifestyle drugs, that's for sure. To do with a drug that affects a certain disadvantaged population, a researcher who put loyalty to her patients first. > > > The stories involved highlight the difficulties and politics of medical > > > research, where two alternative treatments are being compared, in the [quoted text clipped - 5 lines] > > > > > > SBH > > > > http://www.caut.ca/en/issues/academicfreedom/Olivieri_CPSO.pdf > > > > > > > > Nothing to do with Africa or lifestyle drugs, that's for sure. > > To do with a drug that affects a certain disadvantaged population, a > researcher who put loyalty to her patients first. COMMENT: They're not all disadvantaged. Beta-thal major (the big one with the transfusion iron overload) affects Africans, Mediterranians, and South East Asians. It's one of these genes selected for by malarial areas, you know, like sickle. As for Olivieri putting loyalty to patients first, did she do them any good thereby? She's probabaly single handedly responsible for keeping deferiprone off the market in Canada and the US. Okay. But most of the people who need it are in Europe and Africa. Where it has been approved, and is in use. The "disadvantaged" in Canada can't have it. Riddle me that, Batman. Where are the bad-guys in this tale? The Dark Side were we seeking. Clearly find it, we did not. Y. > > > > > http://www.caut.ca/en/issues/academicfreedom/Olivieri_CPSO.pdf > > > > > [quoted text clipped - 9 lines] > East Asians. It's one of these genes selected for by malarial areas, > you know, like sickle. Yes. Malarial areas; like parts of Africa. > As for Olivieri putting loyalty to patients first, did she do them any > good thereby? She's probabaly single handedly responsible for keeping > deferiprone off the market in Canada and the US. Okay. But most of the > people who need it are in Europe and Africa. Where it has been > approved, and is in use. The "disadvantaged" in Canada can't have it. This is my opinion: The drug is harmful. Like statins. Like Vioxx. And pharma has found ways and means to slip through. It's wrong. They've gone where poverty and hunber move people to do things that may hurt them. No doubt some similar drug is needed. Some "better" similar drug. Olivieri can't stop them from what they've done now, although I think she tried. Legally ongoing. Speak further I cannot. I'm trying now to download her newspaper review of the movie. I'll post it soon's I do. But it's not the version I've got. Too bad I can't trust you or you'd have it too. Zee > Riddle me that, Batman. Where are the bad-guys in this tale? The Dark > Side were we seeking. Clearly find it, we did not. > > Y. >> COMMENT: >> [quoted text clipped - 4 lines] > >Yes. Malarial areas; like parts of Africa. Cripes. Thalassemia research and treatment are important in Toronto because Toronto (and Ontario) has a large population of Italian, Greek and Portuguese origin. At one point there were more people living in Toronto who were born in Italy than there were in Milan. These people came to Canada after WWII and mostly worked in the construction trades. Their children and grandchildren are far from disadvantaged -- they are ordinary middle class and professional people, like Dr. Olivieri. I live in a working class area and many of my neighbours are retired construction workers whose children come in from the suburbs to visit on weekends. I could tell you some hilarious stories about my Italian neighbour who made his living pouring concrete for 50 years, and his son and son-in-law, stockbrokers, who keep trying to get him to live a higher class lifestyle instead of continuing to grow vegetables in his backyard and make his own wine. People are getting state-of-the-art medical treatment for thalassemia at places like the Hospital for Sick Children, where Olivieri works, a major teaching and research hospital of the University of Toronto, with a world-wide reputation. So how many different ways can you have it? It's bad to research drugs on poor people in Africa. It's bad to research drugs on well-to-do people in Canada. It's bad to research "lifestyle drugs": they should be developing drugs that help people in poor countries. So here's a drug that can help people in Africa, Canada and Europe, and it's bad to research it, too? So who do you test drugs on? Zee doesn't think drugs are tested enough, especially enough on women, but she also thinks that testing drugs is exploitive, especially of women. So if testing is bad, and using without testing is bad, what's good? The only conclusion is that only harmless drugs should be tested and used, and let's ignore that not much is both harmless and effective and the only way to determine how harmless something is is by testing it. Many people have no concept of risk vs benefit, although it affects every aspect of life, medical or otherwise. Everything has risks. Risks and benefits are not easy to quantify, never completely known, but you have to keep on going, making the best decisions you can with the limited information available. What's more, even with good data, a one in a million risk is not zero risk. You might be that one in a million. That's reality. >> As for Olivieri putting loyalty to patients first, did she do them any >> good thereby? She's probabaly single handedly responsible for keeping [quoted text clipped - 8 lines] >Olivieri can't stop them from what they've done now, although I think >she tried. Well, is this drug better or worse than other treatments? Is it better than doing nothing? How would you find out? How would you find out if a "better similar drug" is better or worse, if it's not ethical to test it? It isn't ethical to enroll people in drug trials because the drugs might harm them. It isn't ethical to put them in the placebo group, because the drugs might benefit them. Is it ethical to tell people they'll just have to suffer and die because it isn't ethical to research and test new treatments? And sorry, poverty and hunger aren't driving Canadians to take their children to the Hospital for Sick Children to get the best care they can find for beta thalassemia. It's a disease. It causes harm. The current treatments aren't ideal. New treatments may be better. You don't want new treatments to be tested, on poor people or non-poor people. You don't want them to be used without testing. So how do you propose we determine whether the new treatment is better than the current ones? Is it better to just stick to current treatments, which also cause harm? Or not treat at all, and let all the harm be natural? Statins have been tested, and as Steve says, they can cut stroke risk by 30% for some people at risk. If I had a high risk of stroke, a 30% lowered risk would sound good to me, and I'd try them to see if i could tolerate the side effects. If the side effects were hard to bear, I'd have to weigh that against the benefit, the reduced stroke risk. I'd have to do that in absence of perfect knowledge, because nobody has done a double-blind controlled study on 100,000 clones of me. Even that wouldn't give me perfect knowledge, because I'd have no way of determining which clones I'd most resemble in response to the drug. I'm in my mid-fifties, and I know I'm not as sharp mentally as I was in my prime. I can't sustain intense intellectual effort for hour after hour as I could thirty years ago. I get tired. I get absent minded, and I miss or forget details, especially when there are a lot of details to keep in mind. I have to count on experience and intuition developed from experience because I can no longer count on flashes of brilliance. Why do you think people in technical professions go into management when they get older? They can't keep up with those hotshot kids on the front line any more. Now, if I were taking statins, I'd be delighted to blame my cognitive deficits on drug damage. However, I lucked out in the genetic lottery and have great blood lipid levels, so I have to admit that people at 55 are not as sharp as they were at 25. I wonder how many people are blaming the cognitive effects of aging on statin use? It would be a lot more comforting to feel like a victim of Evil Venal Pharma or the Arrogant Greedy Misogynistic Medical Establishment than of the natural process of deterioration with age. Righteous anger is a very enjoyable emotion, you know, much more pleasurable than resignation. <bae@cs.toronto.no-uce.edu> wrote in message > Many people have no concept of risk vs benefit, although it affects every > aspect of life, medical or otherwise. Everything has risks. Risks and [quoted text clipped - 4 lines] > That's > reality. Not for wards of the state and professional whiners like Zee. As long as there is someone with power (government) or money (big business) to support and accept blame, there is no need for addressing risk vs. reward. Life is a continuum of peace disturbed only by the witch burning and necessary visible whining necessary to maintain the correct flow of public resources. Hypocrisy is a side effect that's easily ignored. moo Well written and I agree totally with all of that. I think other people really haven't thought out completely how they think things should be. There would be no progress for fear of hurting anyone. > >> COMMENT: > >> [quoted text clipped - 13 lines] > trades. Their children and grandchildren are far from disadvantaged -- > they are ordinary middle class and professional people, like Dr. Olivieri. COMMENT: Exactly so. Duh. Dr. Olivieri is an Italian-Canadian working on a common disease of Italian-Canadians. It's middle-class Italians who need iron overload treatment, because poor Africans who have beta-thal-major don't get enough transfusions to worry about the problem in the first place. Instead, they simply die. Those that do get a few transfusions, get HIV with them, so they don't have to worry much about long term effects like iron, either. > >> As for Olivieri putting loyalty to patients first, did she do them any > >> good thereby? She's probabaly single handedly responsible for keeping [quoted text clipped - 8 lines] > >Olivieri can't stop them from what they've done now, although I think > >she tried. COMMENT: Ah, the martyrdom of the lady doctor, risking her career at the university (yeah right-- like they're going to fire a female physician professor), for the sake of the disadvantaged of the world! Such opera! And I see Zee has graced us with her medical opinion on this issue of liver problems, which divides the European drug safety reviewers from the reviewers in North America. She should write them a letter, like she proposed I do: "(signed) Zee, from Usenet..." Alas, as for "poverty and hunger" Zee talks about, I think you and I have both touched on that, albeit not in a way that has penetrated Zee's noggin. If you're getting regular transfusions for your thal-major so that you need an iron chelator, you're not IN the "poverty-and-hunger" class! So QED that's simply NOT the people the (almost)martyred Dr. Olivieri was developing deferiprone FOR. Okay? Oh, how shabby our fairytales look, when exposed to the light of reality. I also see Zee has erased most of her messages in this thread, probably out of embarrassment. And rightly so. I'd be embarrassed to have writen them, too. For the reasons that you amply set out below, and which are worth everybody reading one more time. > Well, is this drug better or worse than other treatments? Is it better > than doing nothing? How would you find out? How would you find out if [quoted text clipped - 45 lines] > process of deterioration with age. Righteous anger is a very enjoyable > emotion, you know, much more pleasurable than resignation. COMMENT: You know, as an aside, I don't have those "out of the box" flashes as often anymore, either. I, too, could blame them on statins (which I have taken off and on, having borderline high lipids but no other risk factors besides gender). However, I'm a geriatrician, and a realist about brain-aging. As we age, we trade creativity for wisdom, at best. The best teams are composed of young turks who don't know enough to know what's supposedly not possible, and the old farts who know too much (but can still spot the difference between a maybe-idea and forget-it idea). SBH > > >> COMMENT: > > >> [quoted text clipped - 123 lines] > > SBH "...forget-it ideal." But you missed it here boyo. I took my posts out because I'm ashamed alright; ashamed for having spent any time talking to you. B's snore was well-written? <<LOL>> <fresh~horses@despammed.com> wrote in message news: >> You know, as an aside, I don't have those "out of the box" flashes as >> often anymore, either. I, too, could blame them on statins (which I [quoted text clipped - 5 lines] >> much (but can still spot the difference between a maybe-idea and >> forget-it idea). < Snip, oh, nothing. There was no response> > "...forget-it ideal." > > But you missed it here boyo. I took my posts out because I'm ashamed > alright; ashamed for having spent any time talking to you. Excessively careful for an anonymous twat. If you directed some shame at your reliance on the tax dollars squandered in your favour, that would be something. The OP is unknowingly spared by virtue that you have no buddies in any branch of the US Government that regulates any of his concerns. The job you do of misdirecting resources is impressive. But your narcissistic pride is misplaced. Nobody, save those feeding at the same trough, gives sh.t one about you. You might be able to get a real job if you had to. But you don't. moo ><fresh~horses@despammed.com> wrote in message news: >>> much (but can still spot the difference between a maybe-idea and [quoted text clipped - 3 lines] > >> "...forget-it ideal." What ideal? He said idea. I realize that Zee the Journalist refuses to learn the difference between obviate and vitiate, even after they are pointed out to her, but idea and ideal are short words. >> But you missed it here boyo. I took my posts out because I'm ashamed >> alright; ashamed for having spent any time talking to you. > >Excessively careful for an anonymous twat. What gets me is that she can insult Steve in very childish and content-free ways like this, and like implying that his opinions are of no value because of his sex, race and physical appearance, then turn around a few hours later and tell him she respects him and his opinions and knowledge when she wants some medical information about her own health. Then a few hours later, she'll insult him again for helping her out, if she doesn't like what she reads, or thinks she reads. She does this to other knowledgable posters in this group, including the other medical doctors who generally don't have a political axe to grind like Steve does. I find this rather bizarre. Btw, moo, do you think she's really Canadian? I mean, Canadians are noted for their civility, y'know. Maybe she's part of a giant CIA plot to convince Americans that we are scum, so it's okay to invade us and steal all our petroleum? >><fresh~horses@despammed.com> wrote in message news: >>>> much (but can still spot the difference between a maybe-idea and [quoted text clipped - 29 lines] >plot to convince Americans that we are scum, so it's okay to invade >us and steal all our petroleum? You mean it's not? Hmm. I must have misunderstood all these new political ideas. I thought anything the US wanted to do was OK. How disillusioning. -- David Wright :: alphabeta at prodigy.net These are my opinions only, but they're almost always correct. "If you can't say something nice, then sit next to me." -- Alice Roosevelt Longworth > ><fresh~horses@despammed.com> wrote in message news: > >>> much (but can still spot the difference between a maybe-idea and [quoted text clipped - 29 lines] > plot to convince Americans that we are scum, so it's okay to invade > us and steal all our petroleum? I must admit, and take blame in falling victim for some of what she says and the way she portrays Canadians. I agree that there is a mental component to her personality that others have mentioned like the narcissistic aspects of only talking to "scientists and doctors" who relay their concerns to her. She also threatened me by stating she would contact my professional organization and exposing where I work if I did not shut-up. One sick puppy and now she's deleting her posts. "Robert" <Robertitsme@hotmail.com> > She also threatened me by stating she would contact my professional > organization and exposing where I work if I did not shut-up. Did she do that here or via email? I suspect that she did a similar thing to me. Can't prove it since she's anonymous. And, even then it would be hard. But I could make the situation uncomfortable for somebody if I knew their name. When losing an argument badly, as she does so often with zeal, she claimed her trump card was access to inside information not legally available to the public that proved her idiotic point. Then she posted information about me that I suspect she illegally obtained from a government source to verify her superior knowledge. I don't believe she was threatening me. Just being an a.shole. > One sick puppy and now she's deleting her posts. Narcissism is incurable. She's a menace. I don't know why the MDs here take the risk of talking to her. moo <bae@cs.toronto.no-uce.edu> wrote in message >>> But you missed it here boyo. I took my posts out because I'm ashamed >>> alright; ashamed for having spent any time talking to you. [quoted text clipped - 12 lines] > the other medical doctors who generally don't have a political axe to > grind like Steve does. I find this rather bizarre. That and, has the gift of shamelessly asking for help from them directly. That ability is common among those who think that their oppression grants them the right to use others, especially ones they deem to be unfairly in possession of anything they want, as they see fit. > Btw, moo, do you think she's really Canadian? I mean, Canadians are > noted for their civility, y'know. Maybe she's part of a giant CIA > plot to convince Americans that we are scum, so it's okay to invade > us and steal all our petroleum? She is an Officially Certified whiner first and a Canadian second. What's yours should be hers, via your government. moo For anyone out there how do you take posts out? I have laid a few eggs in my time. "Robert" <Robertitsme@hotmail.com> wrote in message > For anyone out there how do you take posts out? I have laid a few eggs in > my > time. Accept responsibility. Move on. Of all the things you might wish to be able to edit, Usenet musings are among the most benign. moo > > > > > http://www.caut.ca/en/issues/academicfreedom/Olivieri_CPSO.pdf > > > > > [quoted text clipped - 20 lines] > > Y. Did you read this on the liver biopsies in the CAUT PDF? The liver biopsy smear was obviously an attempt to discredit her. Liver Biopsies (page 18) The panel felt that the concern that Dr. Olivieri failed to meet a reasonable standard of practice in ordering liver -biopsies was also not supported, for the following reasons: · frequent liver biopsies were consistent with Dr. Olivieri's practice and are becoming more the standard ofcare; · if she had-not performed the biopsies, the parents would have questioned why she had not done so, du-e- to her established practice and the concerns ofhepatic toxicity/lack ofefficacy that had been raised regarding Li; · if disease progression was noted, additional therapyin the form ofmore aggressive forms of deferoxamine was available; and · the risks associated with liver biopsies were very low. Once again, the Committee concurs with the conclusion of the panel in this regard. The Committee notes specifically that frequent biopsies are the standard in monitoring patients suffering from conditions such as Thalassemia. And, as also pointed out by the panel, the current risks associated with biopsies ofthis sort are relatively low. The Committee is of the opinion that Dr. Olivieri's judgment in advising patients to undergo biopsies was not only reasonable, but commendable in the circumstances." More on the Olivieri ethics case here, and its connection to globalization: http://www.healthcoalition.ca/nancy.html > > As Le Caree's book, the movie and the reviewer point out, third-world > > people are being used to test lifestyle drugs for the west. [quoted text clipped - 55 lines] > > SBH I have a different take. The stories involved highlight the difficulties and politics of medical research... . Yes. So far so good....but there we part company. In the Olivieri case, as I understand it, she found the medication was dangerous, moved to protect her patients, was told to shut-up, refused, her employers the university and university medical school turned their backs on her and co-operated with pharma, but not openly, and she and her associates were hounded, sued, and harrassed by the pharma. It's ongoing. The book and the movie are based on Olivieri. Zee > I have a different take. The stories involved highlight the > difficulties and politics of medical research... . Yes. [quoted text clipped - 12 lines] > > Zee As I pointed out, the irony is the arguments used against Olivieri by The Big Establishment are all the same ones you're using against African drug research. (I guess Leftist rhetoric is all that CAN be used in academic fights). She was in the drug company's pocket. She did keep using the drug after beginning to suspect it had dangers (but not using it had dangers too, since the disease itself had dangers). She did subject her patients to biospies (not a zero risk thing) to look for these drug dangers, even while continuing the drug. (First, do no harm? Did any patient fully understand what was happenning? Maybe, maybe not). Eventually she stopped giving the drug. I didn't see anything dreadfully wrong with anything she did, but then I'm pro-research. Most of what she did was looking for truth. She got hounded. She kept her job. In academia, that's a yawner. Meanwhile, the drug's been through a couple of other studies and looks good. It's not exactly Thalidomide. As I said, time will tell. Liver fibrosis is caused by iron overload, too, and that's what the drug is given for. Perhaps some patients get fibrosis from it, and some never do, as with alcohol. The world is complex. Drugs are neither wholely good nor bad either, just like people. My (admittedly quick) reading of the whole thing didn't really turn up anything that smacked of gross incompetence by *anybody.* No patients were killed. Nobody died. Nobody even got fired. Mainly, the biggest mistake was a problem of people shooting off their mouths to the press before all the thinking had been done. Witchhunting vs. Science with Olivieri as this month's witch. If you have a more cogent analysis, feel free. Again, the relevence of all this to testing lifestyle drugs in Africa is just not there for me. I don't care how La Carrie got started. SBH > 'The Constant Gardener': What the Movie Missed > [quoted text clipped - 7 lines] > > by SONIA SHAH > As I found while researching a book on the topic, experimental > protocols that would be condemned as unethical in the West--including > placebo trials among ailing AIDS patients--are frequently described in > the medical press; when the subjects are poor Africans or Asians, nary > an eye is batted. COMMENT: There is some debate about whether or not placebo controlled trials are ethical in places were, without the trial, ALL of the patients would get no treatment (instead of just half of them). In Africa, the politically correct way to put it is that the placebo group are given a sugar pill and returned to the usual standard of medical are for their culture. Including all those "traditional medicines and remedies" and healing ceremonies which we're all supposed to be so respectful of. Except when it suits us to be polemical about them. And they DON'T get the dangerous drug that we're all so concerned about here. But they do get paid for being in the trial. So where now, the ethics? There is also a difference in expectation for placebo between small (phase I and II) trials in which the drug is being tested for side effects (and sometimes initial effect), and the larger phase III trials in which it is almost always compared with the best standard medical treatment, if an active one exists. If phase III trials are being done in Africa without providing the best standard treatment as alternative, the drug companies are being stupid, because they'll need to do this eventually. Are they being accused of frank stupidity, here? > As the film makes all too clear, Big Pharma's new experimental bodies > in the developing world only rarely enjoy the benefits of the research [quoted text clipped - 8 lines] > research, line up for experimental doses of the latest arthritis, heart > disease and obesity drugs. COMMENT: Perhaps in small phase I trials (looking for tox and side effects, and doing pharmakinetics). But that's the same anywhere-- they often aren't expected to be of use to the population trying them (especially if it's a drug of low toxicity being tested). That's where the money come in, and Africans can use it more than anyone. Nobody in their right mind would do a major phase III trial of obestity drugs in a population without obesity, or a heart disease drug in a population without much heart disease. Again, the drug companies aren't that dumb. So this reporter needs to differentiate types of trials. Again, for the small lead-in phase I trials, often nobody is expected to benefit anyway, and that's why they're often paid (both in the US and Africa). In the larger trials, done on diseased patients, you have to have patients with the proper disease, so by definition what the author is talking about cannot happen. > That the film makes no allowance for this reality is more than a > problem of accuracy. Our reluctance to acknowledge the risks of drug [quoted text clipped - 7 lines] > maligning test subjects as "guinea pigs," according to a June 2004 > Harris poll. COMMENT: The fact that fewer than 1 in 20 has done it, does NOT mean "most are loathe" to do it. That's nonsense. The reason is nobody ever asked them to. The reason more clinical studies of drugs aren't done in the US has nothing to do with risk to the patient, and everything to do with risk to the company in our local legal climate. > The logical outcome of this "all gain, no pain" attitude toward modern > drugs is for drug companies to shift the burden of experimentation away [quoted text clipped - 5 lines] > developing new drugs, and decide together how much we are willing to > take on and who shall pay the price. COMMENT: We know who will pay the economic price--- and it's not Africa. As for risks, that's not the issue. In the US, the most litigious country on the planet, where you can be found liable civilly for 400 million dollars if one of your study subjects drops dead of a heart attack the jury thinks he shouldn't have had, nobody is going to do clinical medical research any more. Nobody can AFFORD it. Human research is outsourced because of legal costs and regulatory burden, not for lack of people with courage to take risks. It wasn't always this way. The first dose of the first anit-HIV drug AZT ever to be taken by a human being, was taken by a perfectly healthy Burroughs Wellcome senior executive, in 1985. In North Carolina. That was phase I. It took 16 months to get that drug from that moment, to market. But it's all gone down-hill from there. SBH Per zwalanga@yahoo.com: > the Tuskegee Syphilis Study, in which >government doctors denied treatment to black syphilitics, regularly >appeared in the medical press from the 1930s onward. That study wasn't >terminated until 1972.) Shortly after I joined the USAF early in 1963, one of the med techs that was processing us at Lackland AFB in Texas shot me with one of those trans-dermal injectors saying that ".... this is some kind of test and you're gonna be really sick for awhile...". Sure enough, I was really, *really*, REALLY sick for about two weeks. No idea what it was - but in more cynical moments, it occurs to me maybe they experiment on GI's before wasting the money on animals...  SignaturePeteCresswell |
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